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spk01: Greetings. Welcome to Evalyst's first quarter 2023 earnings call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the conference over to David Erickson, Vice President of Investor Relations. Thank you. You may begin.
spk08: Thank you, Operator, and welcome to everyone joining us on today's call. With me today are David Modizetti, President and Chief Executive Officer, Rui Avalar, Chief Medical Officer and Head of R&D, and Sandra Beaver, Chief Financial Officer. Our prepared remarks today will include forward-looking statements within the meaning of United States securities laws, and 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 review any estimate, projection, or forward-looking statement. Additionally, today's discussion will include non-GAAP financial measures, which should be considered in addition to and not as a substitute for or in isolation from our GAAP results. A reconciliation of GAAP to non-GAAP results may be found in our earnings release, which was furnished with our Form 8K filed today with the SEC, and on our investor relations website at evelis.com. On the homepage of our investor relations website, we have added a slide deck pertaining to today's dermal filler announcement. These slides are intended as a supplement to our remarks, and you do not need them for this call. Lastly, following the conclusion of today's call, a replay will be available on our website at evelis.com. And with that, I'll turn the call over to David. Thank you, David.
spk07: Along with strong first quarter financial results, We are excited to announce we have taken a strategic step in achieving our goal of transforming Evelis into a multi-product aesthetics company. As you read in the press release issued today, Evelis has signed an exclusive long-term agreement with Cimetate for a first-generation coal technology hyaluronic acid line of fillers in the United States. After a thorough assessment of the global filler landscape, we identified an exceptional partner with a comprehensive and differentiated line of fillers in late-stage development. Simitase, which is the same firm that developed the latest generation of Restylane fillers for Galderma, has a long history of success in medical aesthetics. Our announcement today is the beginning of a strategic and long-term partnership. Our deep experience in the clinical development and commercialization of market-leading fillers, together with Cimetase's rich history in R&D excellence, makes for a powerful combination to bring this first-generation technology to market. This highly competitive filler line, which we have branded Evelisse, is in the late stages of development and is expected to launch in the first half of 2025. For background, injectable neurotoxins and dermal fillers are the top two aesthetic procedures and represent nearly half the value of the current $9 billion US aesthetic market. Dermal fillers represent a $1.6 billion market today and are projected to nearly double in size to $3 billion by 2028. From a consumer standpoint, toxins and fillers are synergistic, with fillers being the most common add-on procedure by toxin patients. From a competitive standpoint, today's thermal filler market comprises a handful of players with approximately 80% share held by the top two brands, Juvederm and Restylane. In a few moments, Rui will share the unique attributes of the products that we are bringing to market and why these attributes will empower us to compete effectively and capture meaningful share in the large and fast growing dermal filler market. Looking ahead to commercialization, we have the existing infrastructure to power the launch of Evelisse. Our cash pay focused platform was designed for scale and the launch of Evelisse will benefit from our four key pillars. First, our tenured sales force, which has propelled Jabot to a double-digit chair position in the past two years. Second, a fast-growing consumer loyalty program, which has quickly reached a half million members and is on pace to exceed one million prior to the launch. Third, a proprietary and cost-efficient digital infrastructure that enables a frictionless customer experience, And lastly, due to our cash pay focus, a co-branded media program that drives faster practice growth and supports building the brand. From a financial standpoint, this long-term partnership is highly capital efficient and margin accretive at scale. Sandra will provide additional financial color during her prepared remarks, but here are the key elements. Avalos will pay Cimites 16.2 million euros in total milestones over five years. This includes an upfront cash payment of €4.1 million with a balance based on annual milestone payments, gated by product approval requirements beginning in 2025. We will also pay a mid-single-digit royalty to Cimetase, We will draw down the $50 million available from our credit facility, which we have set aside for corporate development, and this $50 million is expected to continue to fund the company to profitability, including milestone payments and development and launch costs associated with this transaction. The combination of a highly competitive filler line with a capital-efficient deal structure makes this a unique opportunity to create a lasting filler franchise that has the potential to add tremendous value to Evalus and our shareholders. Together with GEVO, the total addressable market for our combined product portfolio expands by 70%. This gives us the confidence to increase our 2028 total net revenue target by $200 million to $700 million, which is a compound annual growth rate of nearly 30%. Now I'll turn it over to Rui to provide more product information. Thank you, David.
spk09: As background, hyaluronic acid, or HA, is the main component in our extracellular matrix, and the most popular soft tissue fillers today are made from HA. When injected, HA takes up space in the soft tissue, which in turn reduces the appearance of lines and wrinkles. They can also be used to add volume in areas of the face where volume is being lost because of aging. These products are widely used in aesthetics, and generally administered by the same providers who inject neurotoxins. Cimetase is a private company headquartered in France with more than 25 years of global leadership in R&D and manufacturing of aesthetics and medical biomaterials. As previously mentioned, we're the developers of the Restylane lines for Galderma known as OBT technology outside the US and Expression technology in the US. Our new Evelisse line of fillers was developed by the same renowned scientists, but with a brand new process that solves one of the manufacturing issues that leads to impurities and the breakdown of the natural HA structure. Typically during manufacturing, the HA strands are cross-linked with BDDE in order to create a desired rheological profile, such as hardness and elastic properties, and also to increase the duration of the gel. This crosslinking reaction is commonly done with heat to facilitate the crosslinking. However, this hot environment also causes the naturally long and complex structures to fragment and generally low molecular weight and generate low molecular weight HA. Not only does this fragmentation take away from the natural dynamic properties of the HHL, but these fragments are also known to be pro-inflammatory and can lead to adverse events. Cimetase has developed a novel manufacturing process that helps preserve the natural structure of the HA. One of the key puzzles they solved was how to do the cross-linking reaction in a cold environment, avoiding the fragmentation caused by heat. This cold technology not only preserves more of the natural structure of HA, it means that less cross-linking with BDD is required to obtain the same gel dynamics. Our Evelisse product line has five distinct fillers that will cover a broad spectrum of filler indications, including mid-face volume restoration, nasolabial folds, lip volume and contouring, and an eye product to address the hollows under the eye that can lead to dark circles. Each of these five fillers are in late stage development. The first two, Smooth and Lift, are expected to receive FDA clearance in 2025 and will address nasolabial folds. The Sculpt product will address midface volume loss and should be approved in 2026. The Lip and Eye products are expected to follow in 2027. which provides for a metered cadence of product launches over three consecutive years. The development costs associated with the first three fillers have been funded by CIMITES, and EBLIS will support the activities to obtain these approvals. The eye and lip product registration process will be led by EBLIS, and the expenses for obtaining these approvals will be shared by both EBLIS and CIMITES. This partner with Cimetase, a company with a heritage in HA innovation, has provided us with a very competitive and full portfolio of HA fillers and we look forward to bringing this new cool technology to the US market. With that, I'll hand it back to you David.
spk07: Thanks Rui. We're fortunate to have Rui and his R&D team who collectively have an extensive history of bringing dermal fillers to market globally including leading numerous Juvener products to approval. As you can tell, we're very excited about Evelisse and the potential to offer this first-generation cold technology with unique attributes that can compete effectively against the market-leading fillers. As we continue to add customers in Gros Givaud's market position, it will provide an even larger base from which to launch Evelisse. Our strong digital capabilities, including the Evelisse Rewards Loyalty Program and our co-branded media, offer a platform on which we can build another durable brand. Together, Givaud and Evelisse will form the backbone of what can be an even broader portfolio of leading aesthetic products. Now I'll shift gears and talk about our continued strong execution in the quarter before turning it over to Sandra, who will cover the financials and transaction terms. Following a record 2022, we are off to a strong start in 2023 and are very pleased with our first quarter performance. Strong sales growth reflected continued market share gains, which keeps us on track to achieve total net revenue of $180 to $190 million for the year. In addition, we continue to manage operating expenses. Overall, we're off to a good start in 2023, and we expect another year of strong growth. Now I'll get into some of the details. As reported, quarterly revenue grew 23% year-over-year, a rate well above the growth rate reported by the industry leader, and a clear indication that JaVo continued to gain market share. Our key metrics continue to reflect strong momentum and validate the resilience of our unique business strategy. During the first quarter, we added more than 600 new accounts, bringing our total customer count to more than 10,000. While this growth is impressive, I'll remind you that we have just now penetrated one-third of potential U.S. customers, and our customer reorder rates remain very healthy, tracking above 70%. In the quarter, we added more than 60,000 new members to our Eveless Rewards Consumer Loyalty Program, bringing our total user base to 570,000. Total redemptions for the quarter hit an all-time high as existing users continue to return for repeat treatments of Juveau, demonstrating sustained brand loyalty. Looking at the health of the U.S. toxin market overall, we continue to be encouraged by the strong demand for neurotoxins, which is driving continued growth and adoption. Shifting attitudes about health and beauty, broader acceptance of aesthetics, and growing consumer purchasing power are continuing to fuel this market, particularly among the younger demographic who prioritize personal beauty treatments over other discretionary purchases. As a reminder, our 2023 revenue goal is driven by a combination of continued account expansion and deepening our relationships with both recently added and established customers. The attributes of Jouveau and the unique brand we have built provide a compelling reason for new accounts to trial Jouveau. Then as customers gain confidence, they increase their purchase quantities and unlock greater practice building benefits through our Avalux program, such as our co-branded marketing or CBM. CBM, which is a program unique to Avalos and only possible because of our cash pay focus, offers a range of advertising options from digital promotion to billboards to streaming TV. Our CBM program continues to be a key driver of customer loyalty. Our internal metrics show that accounts that take advantage of Avalos CBM benefits and participate in our consumer loyalty program grow two to three times faster than those that do not. Now turning to our international business. We are continuing to gain traction with Nuceva in Great Britain and in Germany and Austria where we just initiated our launch. We are pleased with our first few quarters into the launch in Europe, and we plan to continue broadening our European presence this year as part of a phased expansion into this $500 million market. Looking forward, our investment into international geographies positions Avalos to become a global market leader in this space. Beyond Europe, we recently received regulatory clearance in Australia for Nusivo, where we are planning for product launch. Australia is one of the largest market opportunities for aesthetic neurotoxins outside the U.S., and our expansion there, combined with continued growth in Europe and Canada, is expected to ultimately comprise 15% to 20% of our total toxin revenue in 2028. Finally, I'm pleased to inform you that we will complete our Phase II extra strength study later this month. Presentation of the full data set is planned for early November at the American Society for Dermalogic Surgery Conference in Chicago. Since the presentation of the interim data in January, we have received interest from customers about combining the unique precision profile and natural-looking results of GIVO with the option of a longer-duration formulation. We are in the process of collecting input from key opinion leaders and groups of injectors to help us determine the best strategy for maximizing the value of this important data. And with that, Sandra, over to you.
spk05: Thank you, David. I would like to echo David's earlier comments and congratulate the Evelis team for another quarter of strong sales growth, operating expense management, and overall performance. I would also like to echo my enthusiasm over the filler partnership with Cimetase we have announced. This represents a material benefit to our financial forecast across the top line, growth margin, and operating income margin, and a meaningful step in transforming Evalyst into a multi-product aesthetic company. Turning to the results. Global net revenues for the first quarter were $41.7 million, up 23% compared to net revenue in the first quarter of 2022. Sales in the U.S. comprised more than 90% of revenues this quarter, as sales in international markets continue to build. In the U.S., where the pricing environment remains strong overall, our sales were driven primarily by higher volumes and a modestly higher average selling price. Our reported gross margin for the first quarter was 69.1%, and our adjusted gross margin, which excludes the amortization of intangibles, was 70.9%, and in line with our guidance. Our GAAP operating expenses for the first quarter were $53.8 million compared to $54.3 million in the fourth quarter. Non-GAAP operating expenses for the first quarter were $35.5 million compared to $35.7 million in the prior quarter. As a reminder, non-GAAP operating expenses excludes product cost of sale. Reported selling general and administrative expenses for the first quarter were $37.4 million and slightly higher than the $36.7 million recorded in the fourth quarter. This quarter, SG&A expenses included $3.2 million of non-cash stock-based compensation compared to $2.3 million in the fourth quarter. Our non-GAAP loss from operations in the first quarter was $5.9 million compared to $5.4 million reported in the fourth quarter. Both non-GAAP operating expenses and non-GAAP loss from operations exclude stock-based compensation expense, revaluation of the contingent royalty obligation, and depreciation and amortization. Turning to the balance sheet, we ended the first quarter with $31.5 million in cash compared to $53.9 million at December 31, 2022. In the first quarter, net cash used for operating activities was $20.6 million, which included our final settlement payment of $5 million under the MediTalk settlement agreement. Net cash used in the first quarter of 2023 was lower than the first quarter of 2022, representing continued progress towards cash flow break-even. Managing our operating expenses and cash remain high priorities. We continue to have confidence in the performance of Givaud and DeSiva as evidenced by our strong first quarter results and are on track to deliver $180 to $190 million in revenue as we announced earlier this year. The filler agreement announced today is capital efficient, with Evelis being fully funded to profitability, utilizing the additional $50 million of Pharmacon debt, accretive to both gross margin and operating margins. while providing significant top-line growth without diluting shareholders. Turning to the details of the transaction, the agreement we have signed with Cimetase gives us the exclusive rights to the Evalis Dermal Filler line throughout the United States for all aesthetic and dermatologic uses. The contract covers a 15-year period with automatic five-year renewal. The total consideration of 16.2 million euros which is approximately $17.8 million based on current foreign exchange rates, includes an upfront cash payment of 4.1 million euros and 12.1 million euros in milestones payments, beginning with 1.6 million euros in 2025, 4.1 million euros in 2026, 3.2 million euros in 2027, and 3.2 million euros in 2028. Except for the upfront payment, All milestone payments are payable in June of each year and are anticipated to be capitalized. Evolis continues to be funded to profitability, utilizing the available $50 million second tranche of debt from Pharmacon. There is no dilution resulting from this agreement as no Evolis shares are being issued. In addition to the amounts already mentioned, Evolis will pay Cimetase, a mid-single-digit royalty on net sales that will start once the product is launched in 2025. Evelis has also agreed to meet certain minimum purchase targets each year for the duration of the agreement. In order to fund this transaction, we are drawing the $50 million in two parts, half now and the other half before it expires at the end of this year. We believe the structure of this transaction represents a very efficient use of our capital and ensures that we are fully funded to sustain profitability. Overall, this agreement shifts our profitability to 2025, and it has positive implications for both gross margin and operating income margin. There will be high utilization of our existing sales force, digital infrastructure, Avalos Rewards Program, and co-branded media offerings, along with a modest expansion of our sales force and medical affairs clinicians to support the filler launch. This will result in improved operating leverage. As David mentioned in his opening remarks, we are raising our projected 2028 total net revenue target to $700 million from $500 million. This equates to a compounded annual growth rate of 29% on a total addressable market that is 70% greater with the addition of the filler product line. This higher 2028 target assumes we launch two filler products in 2025, one in 2026, and two products in 2027. With that context in mind, I'd like to summarize our 2023 guidance. Total net revenues of between $180 and $190 million, over 90% of which will come from sales in the U.S. and the balance from international markets. Our quarterly revenue assumptions assume a return to an industry seasonal revenue pattern. An adjusted growth margin in the range of 68% to 71%. We are making a modest revision to our full year 2023 non-GAAP operating expense guidance, which is now between 153 and 158 million, and revised from 145 to 150 million. This difference is the investment associated with our filler launch, including the upfront cash payment of 4.1 million euros. This modest increase in non-GAAP operating expense guidance, as noted previously, will shift our profitability out of 2023, and with the additional $50 million tranche from Pharmacon, we remain fully funded to sustained profitability once it is reached in 2025. Back to you, David.
spk07: Thank you, Sandra. Today marks an exceptional milestone in the history of our company. As envisioned, Evelis is evolving from a single product line into a multi-product aesthetics company. The addition of the Evelisse thermal filler line expands our addressable market by 70% into the most relevant and complementary market adjacent to neurotoxins. We have the platform, the sales force, the loyalty program, the co-branded marketing, the financing, in fact, everything in place to seamlessly lever our capabilities and efficiently bring these products to market. Most importantly, the unique attributes of Evelisse position us to compete effectively and gain share in the large and growing dermal filler market. Today marks an inflection point in the growth trajectory of Evelisse. We are augmenting the strong underlying growth of our Chabot franchise, which by itself is expected to grow over 20% on a compound basis. Together, Chabot and Evalis will drive 29% compounded revenue growth over the next five years with expanded growth and operating margins at scale. Today is the first day of a new future for Evalis, for our employees, our customers, and their patients, and importantly, for our shareholders. We could not be more excited about what the future holds, and we look forward to sharing the journey with you. With that, we're ready to take questions.
spk01: Thank you. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. And for participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. Our first question is from Luis Chen with Cantor Fitzgerald. Please proceed.
spk03: Hi, this is Wayne Wu on Forduice. Congrats on the progress this quarter, and thanks for taking our questions. So the first thing I'd like to ask is on Avalos. Right now you have the exclusive U.S. distribution rights, and is it possible to expand it to international markets? And then the second question I have is on Javu. Besides the ones you have already received approval at FUS, which ones are you most excited about, and how do you size those opportunities? Thank you.
spk07: Great. Thank you for the questions, Wayne. I'll have Sandra comment on the our pathway forward internationally, but as you pointed out, today we announced the U.S. distribution rights. That was our focus from a corporate development standpoint. In the U.S., as you know, we've had success in building the Jevo franchise since launch, and we've built the infrastructure now that enables us to take that platform and add additional assets around it. So that has been our focus. I'll turn it over to Sandra to comment a bit on international, and then I'll turn it over to Rui to give his comments on the different filler products before I add a few.
spk05: Yeah, so I guess as it relates to Evelisse, as David mentioned, our focus was on the U.S. rice. It's by far sort of the largest market where we currently operate, so offers us the greatest incremental short-term opportunity with this new portfolio. We are, as far as Javeau goes, entering markets in Europe in a sort of rational way, so we're trying to ensure the highest degree of success in each market. As you know, we are already launched in Great Britain last year, we launched in Germany and Austria as well as this year, and we continue to work on our progress in terms of where we will launch throughout Europe with the rights that we have today, as well as Australia.
spk09: And just from my side, your question was where was it launched? Right now, all these products are in late stage development for the most part. And one of the products has just been launched in Europe in a limited fashion, the Lift product. But effectively, they're all brand new. And we're pretty excited about all of them, again, because of the full spectrum. We've got two different products that will go to the nasolabial folds that have those attributes appropriate for there. And then the Sculpt product is very interesting because we know that The midface volume is one of the bigger sectors when it comes to fillers, in particular on the A side. And then we have those other two products following on that are going to be much softer, like the lip product, which will give us both the contouring and the volume, and then the eye product, which there aren't very many out there right now approved with that indication.
spk07: Thanks, Rui. The one piece I underlined there in Rui's comments is that this is a broad portfolio that covers the large majority of needs in the facial filler market. And because it's differentiated with each of the different five products, it gives us some unique advantages that, of course, as we get closer to commercialization, will provide more color around that. And then lastly, on the international front, We do have plans to build out our portfolio internationally as well. As Sandra pointed out, we're in the early days of commercialization, so we'll continue to be thoughtful about what we do on the corporate development side. As you can sense, we have been very dilution sensitive in the deals that we've done, and I think in this case, we were able to structure a partnership with Cimetase where they saw the value of what we're building here in the U.S., and we designed a deal structure that allowed them to benefit from the long-term growth of value that we can create with the launch of their filler line.
spk03: Very helpful. Thank you so much.
spk08: Thank you, Wayne.
spk01: Our next question is from Annabelle Samimi with Stifo. Please proceed.
spk04: Hi, guys. Thanks for taking my question, and congratulations on an interesting deal and a good quarter. So I guess first with regard to the new product, so you outlined very clearly what the coal technology offers in terms of, I guess, the benefits in manufacturing and, I guess, some of the shortfalls of the other products. But in terms of feel or outcome for the patient? Is there any level of differentiation for the patient or from an injector experience? Maybe you can help us understand that a little bit because the filler space is obviously getting somewhat crowded. Just a little bit of help there. Thanks.
spk09: Thanks for the question, Annabelle. Right now, what we're seeing is what we were hoping obviously was when we decrease the fragmentation, that these gels will have properties that will be much more dynamic with the use of less BDDE. And, of course, with taking away that fragmentation element, potentially eliminating some of the adverse events that we see, and we've all heard of the late-onset and early-onset reactions that we've had, these products right now where we have some data is coming out of Europe. and small studies that are there. And when we look at it from an efficacy standpoint, from a patient satisfaction perspective, from an aesthetic improvement, we're getting very positive results there. And obviously the trials here in the United States are still in process, but in the very late stage. So it's a good question. We'll see. But right now the main reason that we're very excited about it is this cold technology. At the end of the day, safety is paramount, and we believe we've got a leg up on that.
spk04: Okay, and maybe I can follow up with Sandra. You noted the OPEX is going up this year as a result of this deal. So does that mean that you're going to be starting the – you're sharing in the LIP and I, I believe. So are you starting the R&D programs now, and is that the reason for the increase in the expenses, or is it something else?
spk05: So it's a couple of things. One is obviously the initial milestone payment, which we did mention, is the largest portion of that increase in the OpEx guidance. Yes, we are starting the registration process for the two additional indications this year as well, so that is also included in there, and some just modest other expenses that fall into OpEx associated with the deal.
spk04: Okay, got it. And then maybe, David, for you, I know you haven't reached final data with the extra strength trial yet, but obviously the interim data has been made public. You sort of touched on this earlier, but obviously I'm sure your loyal customers have taken notice, and how receptive are they to having that flexibility to offer long-term treatment? How should we think about adoption? Just based on their feedback, do you think it's the same now that there's some more noise about long duration toxins in the space. Are they getting more excited about it or is it still the same assumptions going forward? There's going to be one smaller segment of the market and the initial Juvo line is going to be the biggest bulk of it. Thanks.
spk07: Sure. Thanks for the question, Annabelle. So I think our view has been all along this is very interesting data to demonstrate the extra strength of Jebel last 26 weeks. We've seen a lot of interest from our customers in understanding the formulation of the product as well as the data. As you pointed out, we do not yet have a final data set, and it has not been published. So everything I'm sharing with you is anecdotal, but I can say that there's interest around it, but at the same time, the use of extra strength, it's early days, and changing habits in a market doesn't happen overnight. It's going to take time to better understand what the opportunity is there, and our views have not shifted. The large majority of views will continue to be the original strength. Our original research that we did last year helped us form that hypothesis, and in our conversations, with customers who are using the higher strength dose, it confirms the same as well. And so we continue to believe that the original strength will be the lion's share of the category going forward.
spk04: Okay, great. Thank you so much.
spk01: Our next question is from Mark Goodman with SVB Securities. Please proceed.
spk06: David, what's your sense of how the market grew in the first quarter? You know, given what Allergan reported for their Botox number, and how are you thinking about the full year growth of the category now, just, you know, given that we're already into May? Thank you.
spk07: Great. Thanks for the question, Mark. We're triangulating just as you are in terms of what the procedural growth is. We are seeing that the market is growing. We do believe in the first quarter we had modest growth, let's call it somewhere in the single-digit range, could be upper to mid-single digits. And we think this category continues to be resilient. As we speak with customers, what we hear back is toxins remain the gateway procedure in aesthetics, and that patients are continuing to come back with a high level of frequency. And then, of course, if you assume for a moment here that the market grew mid-single digits, We continue to gain on both growing within our existing customer base, where our share continues to expand, and we see a differentiation even within the segmentation of our customers that use our co-branded media. They grow faster than those that don't. And when you layer on Evelis Rewards, they grow even faster with Evelis Rewards and co-branded media than those that do not. So we feel very good about the underlying strength of our existing customer set. And then the overlay to our growth is, of course, the continued addition of new accounts. And we're pleased to get to 10,000. That's a meaningful scale to have in the United States market. It creates a great baseline for us as we think about down the road launching future products. But there's still so much opportunity for us to continue to go wider. I think you've now seen the consistency by which we're operating our business, that the market is fluctuates to some degree a few points here and there in market growth. The underlying strength of our business continues to be resilient through that, and I think it speaks to our cash-based strategy is working and will continue to gain that value as you see us achieve our guidance range for the year.
spk06: Are you still thinking the market growth for the full year is 5% to 10%? Is that how you're thinking about it?
spk07: Yeah, we had said high single, low double-digit growth rate. It's still early to call out the full year any differently than how we perceived it going into the year, but we remain very confident in the outlook we provided in our guidance.
spk01: Thanks.
spk07: Thanks, Mark.
spk01: Our next question is from Navantai with BNP Powerbus. Please proceed.
spk02: Hi. Congratulations on the solid quarter and the deal. This is Jason for Navant. So I have two questions. The first one is for Rui. It's on the extra strength study. So now with the control group data on hand, can you help us understand how does it compare with the DAXified data in terms of duration? And I will follow up with the second one. Thanks.
spk09: Sure. Thank you for the question. The first comment I'll make, of course, We should always be very, very conservative when we try to talk about how one study data set compares to another data set unless you actually did a head-to-head. I think that's important for us to all say that. In terms of the control, we saw control that behaved just like we saw in other studies. Control was just in line with what we expected. We saw a duration profile of 26 weeks. If we look at the published data from Daxify. If we look at a one-point improvement, they came in at 23 and a half weeks in one study, Belmont, and about 24 weeks in the Sakura studies. We came in, when we looked at one point, at 26 weeks, so fairly close. And when we looked at time for patients to return back to their baseline, we came in at about 26 weeks. One of the Sakura studies showed about 26 weeks and the other one showed just shy of 27 weeks. So I would say right now when we use 40 units of GVO Extra Strength, it looks fairly comparable to the DACSI 40 unit data with the data set that we have. And the last reminder, of course, is a couple of things. The patient demographics were quite different. Most of our patients were actually difficult patients. They were severe. DAX was a little different in baseline demographics. They were mostly moderate. And so that's one consideration taken in place.
spk02: Okay. Okay. Thank you so much. That's very helpful. And the second one is you just touched on the competitive advantage of Ebilis, which is the code technology. Can you give us more color on how do you plan to leverage this cold technology advantage to compete with RHA filler and potentially Juvederm?
spk09: Sure. So I'll start with, you know, that cold technology right now, top of mind for a clinician is, you know, how well the product works. But safety, of course, is paramount. And we know from the literature that these small fragments are a problem. They can be pro-inflammatory. And the FDA is very aware of this also. When you interact with the FDA, that's something that they want visibility in. So from that perspective, I think we have a very nice product. And then ultimately, from an efficacy standpoint, we'll be revealing the data. We've got controls in the studies. We're using the Restlin line out. So I think to be responsible, once the data comes out, it'll speak for itself.
spk01: Thank you. Our next question is from Douglas Dow with HC Wainwright. Please proceed.
spk10: Hi, can you hear me?
spk01: Yes.
spk10: Hi. David, congrats on the deal. I'm just curious, you know, obviously you're emphasizing the safety advantage. Are there anything about the Evelisse line from a filler stamp that, from a performance standpoint that sort of makes it particularly appropriate for your targeted customer set in terms of how it will be used?
spk07: That's a great question, Doug. You know, launching an entire new filler line requires the positioning work, the clinical data, and then the commercial strategy comes out of that. Clearly today we've only announced the product line, and Rui and I spend a significant amount of time assessing different dermal filler technologies around the globe. And I can tell you that firsthand, this is one of the most differentiated assets that's going to enter the market anytime in the near future. And that is hard to come across because hyaluronic acids are very safe and effective products. We're also very impressed by the amount of scrutiny that's been put into these studies, the scale of the studies, as well as what they're measuring. And, of course, we don't have that data to share with you today, but that will be data that will be forthcoming along with our commercial strategy. So there's a lot more to come. However, we do know that the number one product line that's added following a neurotoxin for these patients is facial fillers. So clearly there's a lot of synergy with the consumer base where they are willing to add on fillers, and they'll add on fillers in different areas of the face, which is why it's so important for us to enter the market with a broader, differentiated portfolio of facial fillers. And then beyond that, from a customer standpoint, we referenced in 10,000 customers today, the overlap is almost entirely one-to-one, meaning accounts that use neurotoxins are using facial fillers as well. So there's clearly a lot of synergy here by having the two sides. As far as the differentiation, both to the consumer and to the practitioner, that's going to be forthcoming. Of course, we wouldn't reveal that level of detail until we get closer to commercialization.
spk10: Okay. And then just as a follow-up, David, I'm just curious, how long were you engaged with Synthase in terms of getting this deal done and I'm curious, was it a competitive process? Thank you.
spk07: Yeah, that's a good question. Of course, that's confidential to imitate, so I can't get in the details.
spk10: You can ask. Well, so that's a table. But, of course, as you can imagine, we're the only –
spk07: a company with a neurotoxin in the U.S. that is not partnered with another filler. Cimetase has been in this aesthetic category for 25 years. It has extensive experience in R&D. And their head of R&D, this particular product line, is the next generation, the latest generation that they've designed. So they wanted to enter a partnership that was longer term. And you can see from the construct of the deal, the single-digit royalty structure, they wanted to benefit from the success. of this Abilese line over time, and that is why we were able to structure a deal that was constructive for both parties for the long term.
spk10: Great. Thank you.
spk01: Our next question is from Balaji Prasad with Barclays. Please proceed.
spk11: Good afternoon. This is for Balaji. Thanks for taking our questions, and congrats on the deal. So just a quick one on the dermal filler. As the code technology keeps the natural structure of the molecule, would you give us like a ballpark range of the safety differentiation versus the existing products that you expect to see in real world setting? Thank you.
spk09: Yeah, the question is, can we give you a safety? That's why we do the clinical studies. So I really can't, wouldn't be proper for me to speak about a safety definition. and how it compares to others without having the final data set from the studies. What I can share with you is what I shared earlier. We know in the literature that these pro-inflammatory low molecular weights can be problematic. The other thing I can share is with this new technology, there are other attributes I didn't get into. One of the really interesting things about the gel is We know that we all come at G prime, which is a hardness of a gel. But when you stress it thermally and then you retest it, a lot of the other fillers tend to lose a lot of those properties. And with this new technology, what we're seeing is it actually withstands that. And we believe that that will also have benefits as we go through our clinical trials and generate our final data set.
spk11: Got it. Very helpful. Thank you.
spk01: We have reached the end of our question and answer session. I would like to turn the conference back over to management for closing comments.
spk08: Okay. Thank you, operator. If you missed any portion of this call, a replay will be posted to our website later today. Thanks to everyone for joining us. We appreciate your interest in Evelis, and we'll be available if you have any additional questions.
spk01: Thank you. This will conclude today's conference. You may disconnect your lines at this time, and thank you for your participation.
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