Good day, ladies and gentlemen. Welcome to the Evolus conference call. At this time, all participants are in a listen-only mode. Later, we will conduct a question -and -answer session. Instructions will be given at that time. If anyone should require operator assistance, please press star and then zero on your touch-tone telephone. As a reminder, today's conference call is being recorded. I would now like to introduce your host for today's conference, Mr. Ashwin Agarwal, Vice President of Finance, Investor Relations, and Treasury. Sir, please go ahead.
Thank you, operator. Welcome everyone participating in today's call. This call is being broadcast live over the internet at www.evolus.com. The webcast and the company slides can be accessed from the Events and Presentations page in the Investors section of 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 Avellar, MD, Chief Medical Officer and Head of R&D, Michael Jafar, Chief Marketing Officer, and Lauren Silvernail, Chief Financial Officer and EVP Corporate Development. During today's call, management will include statements that are considered forward-looking statements within the meaning of U.S. securities laws. 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 the periodic reports we file with the SEC. 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 made today. Let me hand the call over to David Moatazedi.
Good morning. Thank you all for joining us. For those of you viewing our slide deck, I will begin on slide four. Let me start by saying that we are all joined, Evolus, to arrive at this moment in time. The FDA approval of Jeuveau marks the inflection point in our transition to a commercial-stage company. With the approval, we will be the first company with the neurotoxin to enter the U.S. market in nearly a decade. We will leverage our strategic advantage of being the first ever aesthetic-only neurotoxin, free from reimbursement constraints. To do so, we will remain deliberate and calculated in every measure we take in executing an aggressive corporate strategy. Our clear path forward has been forged by and will be grounded in the quality of our extensive clinical work.
Over the past year, we have assembled what I believe to be the highest quality and most experienced management team in the aesthetic industry. Together, we spent the back half of 2018 further building an exceptional team of experts to prepare for commercialization of Jeuveau. Today, you will hear for the first time from our Chief Marketing Officer, Mike Jafar, who will preview our brand. Rui Avellar will review our TRANSPARENCY Global Clinical Program, which we unveiled alongside our FDA approval on Friday. The name TRANSPARENCY was chosen because we believe physicians value data transparency, and we are committed to sharing our entire data set of greater than 2,100 patients over the course of the coming months. What makes the TRANSPARENCY program uniquely compelling is that Jeuveau will be the first neurotoxin to enter the U.S. market with the largest head-to-head phase III aesthetic trial ever conducted versus Botox.
We believe this data set will provide the utmost level of confidence to physicians as they consider recommending Jeuveau to their patients. Beginning immediately, we are extending offers to sales reps, and we plan to have our entire sales force hired and trained prior to our spring launch. In a few moments, Mike will provide a curtain raise on how we are branding the company and Jeuveau. Mike has extensive experience building brands in aesthetics, and he will preview how Evolus and Jeuveau will stand out from the existing companies and products in this space. As we look toward our spring launch, you can expect to learn more about our commercialization efforts. We have an internal project with the code name FUSE, designed with the goal of catapulting Jeuveau to be number two in the U.S. market within 24 months of launch.
These activities will all be supported by our frictionless, entirely new digital platform, which will power the company. We look forward to providing a full picture of all commercial activities at our investor day prior to spring launch. Moving to slide five. We're excited to share with you today our label for Jeuveau and a preview of the TRANSPARENCY program, both of which Rui will review. It's important to give credit to Rui and the entire R&D team. From the outset, we designed our clinical trials recognizing the challenges other competitors have faced against Botox. Instead of measuring duration, we focused on the measurement of responder rates. We believe this ultimately will be one of the key deciding factors for the success of Jeuveau. We have an experienced management team that recognized the traps for the unwary and knew the challenges faced by other competitors who fell into those traps.
What ultimately matters at launch is how we can promote to both providers and consumers. To providers, we'll be able to promote Jeuveau using the largest phase III head-to-head aesthetic study versus Botox. We've received tremendous response from the physician community as we've shared this data in advisory board meetings. To consumers, we plan to market Jeuveau based on the language in our label, which states that in our open label repeat dose safety study, patients received three treatments on average in one year. We believe physicians will value this promotional effort as it aligns with their consumer messaging. Let me turn the call over to Rui Avellar. Rui will discuss our TRANSPARENCY global clinical data set and our FDA-approved label for Jeuveau. Rui?
Great. Thank you, David. Yes, we are excited. We did receive the Jeuveau indication, which is for appearance of moderate to severe glabellar lines associated with corrugator and procerus muscle activity in adult patients.
I'd like to provide a quick overview of the clinical program that was used to gain approval. It consisted of two identical phase III studies in the U.S., which were the primary studies, supported by a phase III head-to-head Canadian, European-based study. The application was also supported by two phase II long-term repeat treatment studies, EV-004 and EV-006. You'll also note that the formulation varied between studies. This is on slide seven. The initial prabotulinum formulation was freeze-dried. This process is known to denature proteins. In the EV-004 study, the initial study, it used a freeze-dried formulation. From there, we moved into our commercial formulation, which is vacuum-dried. Vacuum drying has the benefit of causing very little to no protein denaturing.
This represents our final commercial formulation. You'll notice it was used in all our phase III studies and in the EV-006 repeat treatment open label one-year study. On slide eight, our proprietary Jeuveau formulation is manufactured in a brand-new state-of-the-art facility using a Hi-Pure technology. The facility began manufacturing Jeuveau last year in anticipation of the approval and the launch. You may recall in May of last year, we received from the FDA an Establishment Inspection Report. This, of course, was a very important milestone for the company. Slide 10. The primary endpoint of both U.S. pivotal trials were composed of two-point composite improvements measured at day 30. This measurement represents a high statistical bar. Clinically, it's less meaningful. From a statistical standpoint, it's considered a rigorous hurdle.
By definition, to be a responder, both the investigator and the subject must simultaneously agree that a two-point improvement at maximum frown using the Glabellar Line Scale had occurred. The responder rates were 67.5% and 70.4% in EV-001 and EV-002 trials, respectively. Clearly superior to placebo. On the right-hand side of the slide, you can see the individual components of the composite score, specifically the investigator and the subject responders broken out individually for both trials. Slide 11. Given the two-point composite responder definition is considered a rigorous statistical test, we ask the question if at four months and five months, the treatment arm was still statistically superior to placebo. You can see here that in both phase III studies, Jeuveau remained statistically superior to placebo, both at four months and at five months. Again, a two-point composite is considered a statistically rigorous test.
However, it does not give a clinician a sense of how the drug performs clinically over time. On slide 12, we have a one-point improvement on the Glabellar Line Scale. A one-point improvement on this scale, by definition, is considered to be clinically significant improvement. In these graphs, you can see both the investigator and the subject assessment. The small bars are in the placebo arms, and the taller bars are the treatment arms. You can see the response over time from the beginning of the trial out to the end of the study at day 150. Slide 13. We have the Global Aesthetic Improvement Scale. It's a balanced scale looking at aesthetic outcomes. Patients can either be much improved, no change, worse, or much worse. Here you can see the responders defined as improved or much improved.
Once again, the assessments are from both the investigator and the subjects and go until the end of the study at 150 days. Slide 14 shows the subject satisfaction scale. Once again, a balanced scale where subjects can be very satisfied, no change, unsatisfied, or very unsatisfied. A responder was defined as a subject who was satisfied or very satisfied. Again, you can see the results right out to 150 days. Slide 16. We have the responder rates for the head-to-head Canadian-European phase III study. A responder was defined as a zero, no wrinkle, or a one, mild wrinkles, at maximum frown using the GLS at day 30 as assessed by the investigator. 87.2% of Jeuveau subjects were responders, compared to 82.8% of Botox subjects. On slide 17, you can see the result of the primary endpoint non-inferiority analysis.
The difference between the two treatments was in favor of Jeuveau at 4.4%. You can see the lower limit of the two-sided confidence interval was well above the non-inferiority. Clearly, the study met the primary endpoint of non-inferiority. Slide 18. 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 is statistically superior to placebo as measured by a one-point improvement on the GLS scale by investigator assessment. We also looked at subject satisfaction on day 30. Again, you can see that Jeuveau is superior to placebo, 91% versus 6% in the placebo arm. On slide 19, we get a sense of how Jeuveau performs over time. Looking at a one-point GLS improvement or more, as assessed by both investigator and subjects, out to 150 days.
Once again, the small bars are the placebo arms. The large bars are the treatment arms. Slide 20 gives you the Global Aesthetic Improvement Scale perspective. You can see the assessment from the beginning to the end of the study. On slide 21, you can see the subjects' assessment of subject satisfaction over the course of the entire study. Slide 22 has a summary of the adverse events for all phase III studies. The top line represents all adverse events, which includes both drug-related and unrelated. The bottom line has drug-related adverse event rates for comparison. On slide 23, in our label, you'll see all adverse events with a rate of greater than 1% where the Jeuveau group was higher than placebo. Again, this is all adverse events, which includes both Jeuveau-related and unrelated events.
As the label provides limited information, in the second table below in the slide, we have provided additional information for you, and you can see the adverse events related to Jeuveau where the overall rates was greater than 1%. Also, as you all know, in our label, we have a black box warning, and this is standard for this class of drugs in this indication. On slide 24, our open-label repeat treatment studies also gave us some additional insights. With retreatment, we did not see worsening of adverse events. In fact, you can see what happens with adverse events after retreatment. A common question that we're getting is, what's the duration claim in our label?
As I'm sure you know, the way duration is calculated in the various labels is different from sponsor to sponsor, and therefore, duration claims cannot really be compared from product to product, unless there's actually a head-to-head study where the same calculations apply. When clinician asks to compare duration, what they're really asking is, how does your product compare to another product? This is why we did a head-to-head and look forward to publishing the entire results. Given this compelling data, we did not need to study durations. One way to look at overall clinical performance of the product is how often patients get retreated. When we look at our open-label repeat treatment safety studies, which include 922 subjects, the average number of treatments was three over the course of one year. On slide 25, we outline our immunogenicity results.
As I previously mentioned, the EV-004 formulation was freeze-dried and represented a transitional formulation and will not be commercialized. In this study, there were two seroconversions and no cases of neutralizing antibodies. Our commercial formulation is vacuum-dried. We chose this because unlike freeze-drying, with vacuum-drying, there's little to no protein denaturing. You can see that in our phase III U.S. studies and in the EV-006 one-year repeat treatment study, there are over 2,200 treatments, and there are zero cases of seroconversion and zero cases of neutralizing antibodies. Slide 25. As you know, labels have very limited information, and fortunately, the rules have changed. Promotional material is no longer restricted to the information in the FDA-approved label. It can also now include published data from well-controlled and statistically sound studies.
As such, we have submitted our three phase III studies for publication, both our placebo-controlled U.S. studies and our phase III Canadian European study, where you'll be able to see head-to-head results any way you like, by glabellar line scale, by Global Aesthetic Scale, or subject satisfaction. These publications will complement our label, provide clinically relevant information, and give physicians a transparent look into our data. Now, with that, let me turn it over to Mike Jafar to discuss what it takes to build a brand.
Thanks, Rui. It's a pleasure and honor to be with you today. I'm excited to be here at an opportune time in our space. The excitement is palpable, our walls are filled with energy, and customers are actively calling to engage with us. It's a great time to be at Evolus and in the most exciting market in healthcare. The medical aesthetics business is one of the fastest-growing segments, and within this market, neurotoxins represent the most frequently administered procedure. I'll start on slide 28 by saying our purpose is to make the beauty experience delightful and achievable. Our unique position and singular beauty lens are the reasons why we can deliver on that promise. It's important to note we are a beauty company by design, not by default. If I could draw your attention on slide 29, I'll begin by defining the name Evolus.
A name derived from the phrase "evolve with us," representing a market longing for a company to evolve with it. Slide 30 captures what it means to have a design orientation. Our design-driven strategy is central to every decision we make. Over the past several months, the design team at Evolus has developed the following. Our company branding, introducing a new and memorable marker representing movement, evolution, and beauty. We applied a custom font and brought color to the name Jeuveau, which stems from the word nouveau, meaning modern and up-to-date. Our FDA-approved packaging gives us one of the most aesthetically pleasing products in this category, and with a specific mention that it's designed by Evolus. Based on tremendous customer feedback, we credentialed our science under the trademark Hi-Pure.
The 2,100-patient dataset has been branded TRANSPARENCY, a platform upon which we can disseminate the data physicians are asking for. Lastly, technology is often used to enhance the overall experience, and we have designed a platform to limit friction within the market. This is a highly differentiated company with a premium brand consumers will want to experience and ask for by name. Shifting your attention to slide 31. While I won't go into too much detail, I'll say that our proprietary platform was designed and guided by some of the smartest individuals outside of the aesthetic industry. We recruited a team out of the tech industry from companies like Facebook, Tesla, and Microsoft. Their work has been guided and validated by an all-female digital advisory board chaired by Jessica Fetter, former Bayer Chief Digital Officer, and several key executives from companies such as GE and Google.
As we near our spring launch, you will hear more about the platform and more from these individuals. As represented on slide 32, we know that it's never been easier to start a brand, especially in the beauty category. The catch is it's never been more difficult to stand apart. We know exactly how to charter our path, and our success will be driven off of our singular focus. On slide 33, that focus is on the user, not the buyer. A really important distinction. Our aesthetic focus may be underappreciated today but will be our key differentiator tomorrow. On slide 34, you can see where our focus lies. It is against one gender, the female, who represents over 90% of this market. Demographically speaking, she's in her 30s with an average household income of $40,000-$50,000.
She's part of the fastest-growing generation with a very different approach to beauty. She grew up in the social and selfie movement. She's more open to treatments and starting to use aesthetics products at a younger age. More importantly, she's part of the first generation to influence up to Gen X and boomers. Approximately 1.7 million females between the ages of 30 and 39 are considering a neurotoxin treatment in the next 12 months. While she doesn't like to be called millennial, it's the millennial mindset that we are focusing on. On slide 35, that mindset will be reflected in our communication style, model selection, and emotion. Based on what you see on slide 36, we consider ourselves a premium challenger brand. We will deliver an experience that's unrivaled, build awareness in both traditional and non-traditional forums, and establish a new voice in a market long seeking one.
I encourage you all to visit our site and follow our social handles to feel the Evolus experience. I'll close by saying our purpose is to make the beauty experience delightful and achievable. Let me turn the call back over to David.
Thanks, Mike. We have accomplished a tremendous amount over the past year and have an exciting launch around the corner. In the immediate term, we have several catalysts, beginning with the highly anticipated U.S. launch of Jeuveau in spring, the anticipated publications of our phase III trial data, and our EU and Canada head-to-head data versus Botox. We expect European approval mid-year and plan to launch with our partner in Canada in the first half of this year. We are committed to establishing Evolus as a performance beauty company with a customer-centric approach focused on delivering breakthrough products. I would like to thank all the Evolus employees, clinical investigators, patients, and our partner, Daewoong, for their diligent efforts in bringing Jeuveau to the market. With that, I'll turn the call over for questions. Operator?
Thank you. Ladies and gentlemen on the phone lines, if you'd like to ask a question at this time, please press star and then the number one key on your touch-tone telephone. If your question has been answered or you wish to remove yourself from the queue, please press the pound key. Our first question comes from Louise Chen of Cantor Fitzgerald. Your line is now open.
Hi. Thanks for taking my questions, and congratulations on the approval. I had a few questions for you here. First question I had was at the AAD, the upcoming meeting, what data will you present on Jeuveau? Is there anything new? Will you have any more details on your 150-day head-to-head study? The other question I had was if you could provide more color on the denial of the recent CP by Medytox, the recent denial of the CP by Medytox. Is there any read-through from that to the other claims that they're asserting against you? I have a few other additional questions, but I just wanted to start there. Thanks.
Great. Well, good morning, and thanks for the questions, Louise. I'll take them individually here, starting with your question around medical meetings. As you know, the front half of the year has a number of significant meetings, including the American Academy of Dermatology, which is coming up in the near term, as well as the American Society for Aesthetic Plastic Surgery in the month of May. We will have a presence at both meetings, and we will continue to reinforce the value proposition of Evolus. As far as data releases, at this time, the publications are the next two sets of data, and that's where you can expect as they become available to the broader market, we will make you aware of those.
They will not be centered around the medical meetings but rather around the publication dates, which we anticipate will take place prior to the launch in the spring. As it relates to the citizen petition, we were pleased to see that the FDA declined the citizen petition with the approval of Jeuveau on Friday. As you may know, Louise, the claims behind the citizen petition are similar to the ones that are present in the court case between Daewoong and Medytox and also present in the ITC case that was recently brought forward. We were pleased to see that the FDA declined that.
Okay, just two other quick questions here. Where are you with your plans to expand to additional aesthetic offerings? Another question we've been getting a lot is, where is your current cash balance, and where does that take you out until? Thank you.
Sure. I'll start by taking the question around the portfolio and then turn it over to Lauren. As mentioned before, one of our priorities is to build out a quality portfolio of aesthetic products. That's something from the very beginning, the board has been encouraging us to actively look for high-quality assets. You may know that our head of R&D, Rui Avellar here, has extensive experience developing products, not just neurotoxins, but facial fillers as well as other devices in this space. We are actively searching for different assets, and as we learn more and we're in a position to share that, we certainly will. I'll turn it over to Lauren.
Good morning, Louise. Our cash at the end of the year was at $93 million. Well funds us for the launch in an excellent position. We're quite dilution sensitive going forward. Thanks for the question.
All right. Thank you, and congratulations again.
Thank you. Our next question comes from Annabel Samimy of Stifel. Your line is now open.
Hi, all. Thanks for taking my questions, and congratulations also. Just want to ask a couple questions. The first, you mentioned that you hadn't had any duration data in your label. I just want to make sure I understand the reason being is because you have the head-to-head data, for that reason, you don't feel like there's any need to have that duration data in the label. That's the first question. The second question, you're focusing on the user. I just want to understand a little bit how you are focusing on the actual purchaser of the toxin, which is a physician. Maybe you can talk to us about how you focus on the physician, at what point you focus on the user, and maybe how you roll that out. Thanks.
Great. Thanks, Annabel, for the questions. I'll start with the first question around duration in the label and then turn it over to Mike to talk about the consumer. As you mentioned, we did not measure duration. We did measure responder rates. There are several reasons for this. The first is the definition of duration has evolved over time with the FDA. We did not want a comparison of apples to oranges as a result of that shifting of the definition. We believe that the doctor will make the decision to bring Jeuveau into their practice based on the comprehensive TRANSPARENCY data.
As you know, that includes the U.S. phase III data that Rui walked you through, which follows patients out to five months with responder rates at each time point, as well as the European and Canadian phase III head-to-head data compared to Botox, which also follow patients out to five months. We feel the combination of that data is adequate to assess the clinical profile of our product.
Yeah. I think you summarized it well. Every clinician wants to talk about duration in a different way. This way you can pick whatever way you like. With the data coming out from the head-to-head, you can look at whatever day, be it 120, be it 150, whatever you want, you can make whatever comparison you like. Again, it's important, a head-to-head study.
Great. Thanks, Mike.
Sure.
Great question. The biggest difference between a user and a buyer really sits in the experience. When you focus on the buyer, you're mainly focused on the bottom line. When you focus on the user, you enhance both the top and bottom line. That obsession of the experience stems to both customers and consumers. As it pertains to customers purchasing our products, our user-centric focus here is to enhance that entire operation and the experience in which accounts are created and transacted with. As it pertains to the consumer, we aim to make her life easier and delight that experience in and outside the office.
Sorry, just to clarify, are you rolling it out strictly as a user experience, or are you working with the physicians who have, I guess, become fatigued with some of the ways that manufacturers have been interacting with them?
Annabel, these are all great questions. As we get closer to commercialization, Mike will provide more color around how we plan to execute the details of our plan. At this point, I think Mike did a great job of outlining how design has impacted our strategy and how we're thinking about the consumer in that mindset. The details around how we'll deploy that will come out in the spring launch.
Okay, great. Thank you.
Thank you. Our next question comes from Ashwani Verma of SunTrust. Your line is now open.
Hi, everyone. Congratulations for the approval. I have two questions really. The first one is, one of the pushback that we've been getting from investors is around the assumption that Evolus is aiming to capture number two position by volume by the end of 24 months. If you can just instill some confidence there why the other prior, Dysport and Xeomin, were not able to do that, and how Evolus would be able to achieve that position in the market. That's the first question. Second question is just around EU partnership. As you head into the CHMP opinion or EU approval, if you can give any update on where the EU partnership discussions are, that would be really great. Thanks a lot.
Great. Thanks for the questions, Ashwani. First off, I would say that we're very confident in our entry in the market and the rapid uptake that we've observed with other products in the space. This category, generally, doctors will assess a product, trial the product and then determine how much of a market share they'll ascribe to it. If you use other launch products as an analog, generally the first 12-18 months is where they achieve the majority of their market share. We believe the combination of our TRANSPARENCY data, our focus around branding and messaging, and building this in the aesthetic markets with our commercial experience will lead to a very rapid uptake and adoption of our product.
That is a significant distinction from other toxins that have entered that did not have head-to-head data when they entered or a focus on building a brand and a company with a differentiated aesthetic-only platform. As it relates to the EU partnership, that is something that we are continuing to explore our options, and we are expecting an approval closer to the middle of this year, and you can anticipate we'll be able to provide more color around that timeline.
Great. Thanks a lot.
Thank you. Once again, ladies and gentlemen, if you would like to ask a question at this time, please press star and then the number one key on your touch-tone telephone. Our next question comes from Irina Koffler of Mizuho. Your line is now open.
Hi. Thanks for taking the questions and congrats from me as well. Can you just update us on the pricing strategy of this product? Also, what type of competitive response do you expect from smaller players like Galderma and Merz? Thank you.
Great. On the pricing, Irina, we are sticking with the messaging that we had provided prior. We're not providing an update. As you know, we've communicated historically that we anticipate pricing at a 20%-25% discount relative to the market leader. As we get closer to launch, I can assure you we'll provide a more detailed view on how we think about pricing. We've done extensive work to understand how competitive pricing models have been developed, as well as how we could maximize the value of Jeuveau in this marketplace today. Clearly, profitability of this procedure has been under pressure for some time, and given this is the number one procedure in medical aesthetics, there's a high degree of attention around Jeuveau's entry as well as the pricing dynamics.
We're going to be very thoughtful about how we navigate through that, and of course, we'll provide more detail in due time. The second part of the question-
Was about competitive response
was related to the competitive set. Look, I think for all three competitors, as we would expect that all three competitors will be actively prepared and will develop their respective plans in order to limit the share potential loss that comes from the entry of Jeuveau. In the end, we believe this market has a very low penetration of consumers, less than 10% of consumers in the office. You saw Mike's focus on that millennial mindset. It's not just the younger demographic, but it's how they influence even above. That focus, we believe, in the end, will continue to fuel the growth of this category.
In the end, of course, there's going to be some share loss attributed from the relative competitive set, but longer term, this market is all about growth, and we want to establish Evolus and Jeuveau as a company dedicated to the aesthetic space with a plan to help build this category for the long term.
Just one follow-up. In the label, it says that there's three treatments on average over the course of one year. Can you frame that for us? How does that compare relative to brands like Botox and Dysport? Is that generally in line, or is it slightly better?
The way I'd answer it is first, if you were to speak with a group of doctors in the space, what they would tell you is they're consistently reinforcing to patients that they should come in at a frequency of every four months, which works out to three times per year. Having that safety data in our label, where patients came back three times over the course of one year, further reinforces what's occurring already in the marketplace. We believe that messaging getting out to the consumer is meaningful, both to the doctor who's already reinforcing that, but also supported in the label of our product. As it relates to how a doctor might assess our product relative to the competitive set, that's why the head-to-head data was designed.
It was designed to show exactly how Jeuveau compares directly against the market leader, Botox Cosmetic. That was captured at every time point over the course of five months. We look forward to sharing with the market the publication that has the responder rates at each time point.
Okay, great. Thank you so much.
Thank you. Our next question comes from Donald Ellis of JMP Securities. Your line is now open.
Thank you. Good morning. Also want to congratulate you on the approval. I've got a couple questions, one is going back to this duration claim that Rui was referencing back on slide 12, I guess, where you're showing 42%-43%, one-point response at five months. All the other three toxins have duration claims in their label. Are you saying that you're not going to have a duration claim in the label, or that you believe the FDA has moved the goalposts on what they require for a duration claim? In other words, Kaplan-Meier analysis, a zero to one and a two-point improvement, the primary endpoint. Which one is it? Has the FDA moved the goalposts on duration, or are you going to have a duration claim in like the other three?
Our opening position, just like David explained why we're not having a duration claim in our label, to your point, that's exactly right. If you look at the way duration is calculated for the various competitors, it has consistently changed. Botox was the first one in approved in 2002. They had one metric. Dysport came in, they had a different metric, Xeomin came in and had a different metric. As tempting as it is to try and compare a duration claim in a label, it's actually misleading because the calculation behind it, as you mentioned, Don, Kaplan-Meier based, has changed because the responder definition has changed. David made I think really explained it really well in terms of what people really want to understand is how do I compare it to another product?
One way to compare it is to look at the responder rates at any time interval you choose, using whatever metric you choose. We, with the publication of the head-to-head study, people can pull it out, and they can actually look at the different time intervals and then take whatever metric they want, and they can compare it, say, at four months, five months, whatever you want. We've changed the way that we've approached it. Then retreatment, if we're trying to get a sense of retreatment, how often that takes place. Again, David outlined it very nicely. In our open label safety study, you can see that the average patient over the course of the year came in three times.
Okay, great. Thank you. My second question is regarding the discount. Have you talked to physicians and been able to determine roughly what percent of those physicians will pass on all or part of that discount to the patient?
Yeah. What we've found in our research, and it's consistent with what we see with other products that are at a discount, is that roughly half of the market will take any discount provided to them, and they will absorb that, meaning that that discount will improve the profitability of the procedure for the doctor. The other half will do a range of passing along some portion of it back to the consumer. That seems to be the consistent theme with products in this category, not unique to toxins, but fillers and other brands in this space. We don't think that it will be any different with Jeuveau. Thanks for the question, Don.
Great. Thank you.
Thank you. Our next question comes from Umer Raffat of Evercore ISI. Your line is now open.
Hi. Thanks so much for taking my questions. Congrats on the approval. David, Ashwin, maybe a quick one for both of you. Can you remind us what the economics are for an average injector out there using a Botox versus, let's say, one of the Dysport or Xeomins versus what it will be for your product?
Hi, Umer. Thanks for the question. I think, first off, I'd try to frame it as the following, which is, as you know, there are three competitors in the marketplace, and so the economics could vary greatly, not just by product, but by customer type. As we start to talk about averages, those don't pertain to the doctor on an individual level. What we do know is that when you look at neurotoxin profitability over time, it has declined. As an example, Botox in 2002, the price per unit was $4 and has increased to $6.12 in 2018. That's based on their list price. The patient price per unit during that same window of time has increased by roughly 10%.
When you juxtapose the 53% increase in price per unit against a 10% increase per price, as you can imagine, what you've seen is a profit margin degradation over time. That is what you continue to hear in research from doctors, is that the profitability of the procedure has declined. Of course, that number could vary depending on the market or the customer volume, but the trend is consistent across the country.
Thank you very much.
Thank you. That concludes our question and answer session for today. I'd like to turn the conference back over to David Moatazedi for closing remarks.
Great. Thank you all for taking the time to join the line. We are looking forward to the spring launch of Jeuveau and our upcoming investor date prior to that launch, and we'll update you on that date once we have it confirmed. Thank you.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program, and you may all disconnect. Everyone have a great day.