Q2 2024 Evolus Inc Earnings Call
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Operator: Good afternoon, everyone, and thank you for standing by. Welcome to Evolus, 2nd quarter of 2024 earnings conference call. As a reminder, today's conference is being recorded and webcast live.
Speaker Change: Good afternoon, everyone, and thank you for standing by. Welcome to Evolus' second quarter 2024 earnings conference call. As a reminder, today's conference is being recorded and webcast live.
Operator: All participants are on a listen-only mode. After the speakers are marked, there will be a question and answer session.
Speaker Change: All participants are on a listen-only mode. After the speaker's remarks, there will be a question and answer session. I would now like to turn the conference over to your host, Nareg Sagherian, Vice President and Head of Global Investor Relations and Corporate Communications. Please go ahead.
Nareg Sagherian: I would now like to start on the conference over to your host, Nareg Sagherian, Vice President, Head of Global Industrial Relations and Corporate Communications. Please go ahead. Thank you, operator, and welcome to everyone joining us on today's call to review Evolus's 2nd quarter 2024 financial results. Our 2nd quarter 2024 press release is now on our website and Evolus.com. With me today are David Moatazedi, President and Chief Executive Officer, and Sandra Beaver, Chief Financial Officer. Rui Avelar, Chief Medical Officer and Head of R&D, is also with us for the Q&A portion of the call.
Nareg Sagherian: I would now like to turn the conference over to your host, Nareg Sagherian, Vice President and Head of Global Investor Relations and Corporate Communications. Please go ahead.
Unknown Executive: Thank you, Operator, and welcome to everyone joining us on today's call to review Evolus's second quarter 2024 financial results. Before we begin our discussion, I'd like to note that during our call, our prepared remarks 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.
Nareg Sagherian: Thank you, Operator, and welcome to everyone joining us on today's call to review Evolus's second quarter 2024 financial results.
Nareg Sagherian: Our second quarter 2024 press release is now on our website at evolus.com.
Speaker Change: With me today are David Moatazedi, President and Chief Executive Officer, and Sandra Beaver, Chief Financial Officer.
Speaker Change: Rui Avelar, Chief Medical Officer and Head of R&D is also with us for the Q&A portion of the call.
Nareg Sagherian: Before we begin our discussion, I'd like to note that during our call, our prepared remarks 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. Listeners are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this call, and the company undertakes no obligation to update or review any estimate, projections, or forward-looking statements, except as required by laws.
Speaker Change: Before we begin our discussion, I'd like to note that during our call, our prepared remarks 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.
Speaker Change: 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.
Speaker Change: Listeners are cautioned not to place undue reliance on these forward-looking statements which speak only as of the date of this call, and the company undertakes no obligation to update or review any estimate, projections, or forward-looking statements except as required by law.
Nareg Sagherian: These forward-looking statements are based on estimates and assumptions that all will be to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties. 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.
Unknown Executive: These forward-looking statements are based on estimates and assumptions that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
Speaker Change: These forward-looking statements are based on estimates and assumptions that, although believed to be reasonable, are inherently uncertain and subject to a number of risks and uncertainties.
Speaker Change: 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.
Nareg Sagherian: 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 8-K filed today with the SEC and on our investor relations website at evelis.com.
Speaker Change: 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.
Speaker Change: 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 evolus.com.
Nareg Sagherian: Following the conclusion of today's call, a replay will be available on our website at Evelis.com.
Speaker Change: Following the conclusion of today's call, a replay will be available on our website at evolus.com.
David Moatazedi: With that, I'll turn the call over to our CEO, David Modizetti. Thank you, Nuregg. Good afternoon, everyone. Thank you for joining us on our second quarter 2024 earnings conference call. This is a very exciting time for Evelis as we've now completed the first half of 2024, and it's demonstrated continued market share gains with Jevo. This year's focus on our flagship product will be prepared to expand our portfolio. We are incredibly pleased with the continued momentum in our business, which is clearly reflected in our second quarter results announced earlier today. In the second quarter, we achieved an important milestone: profitability, and Jervos's market share increased to 13%.
David Moatazedi: and Javeau's market share increased to 13%. Importantly, this is a brand that continues to grow at over 30% in its fifth year on the market. We have a unique position as the only dedicated cash-pay aesthetic toxin company and a differentiated approach to building a performance beauty brand, which is approaching 50% penetration of the market. Our Evolus Consumer Loyalty Program is also thriving and on track to surpass 1 million consumers in the program by year-end.
David Moatazedi: With that, I'll turn the call over to our CEO , David Moatazedi. Thank you, Nareg. Good afternoon, everyone. Thank you for joining us on our second quarter 2024 earnings conference call.
David Moatazedi: This is a very exciting time for Evolus, as we've now completed the first half of 2024 and have demonstrated continued market share gains with Jivo.
David Moatazedi: This year is focused on our flagship product while we prepare to expand our portfolio.
Speaker Change: We are incredibly pleased with the continued momentum in our business, which is clearly reflected in our second quarter results announced earlier today.
Speaker Change: In the second quarter, we achieved an important milestone, profitability.
David Moatazedi: We accomplished this with a single product while investing in the launch of our fellow line. Our focus is delivering exceptional results, and our unique structure and value proposition are operating at a high level. Our reported revenue, a 66.9 million in the second quarter, represents 36% growth over the prior year. The combination of the continued strength of our execution and the momentum we have built during the first half of the year, give us the confidence to raise our full year 2024 net revenue guidance to between 260 million and 270 million. This updated guidance equates to 34% growth at the top end and is several degrees of magnitude above the estimated growth rate for our category.
Speaker Change: And Gervaud's market share increased to 13%.
Speaker Change: We accomplished this with a single product while investing in the launch of our Feller line.
Speaker Change: Our focus is delivering exceptional results, and our unique structure and value proposition are operating at a high level.
Speaker Change: Our reported revenue of $66.9 million in the second quarter represents 36% growth over the prior year.
Speaker Change: The combination of the continued strength of our execution and the momentum we have built during the first half of the year give us the confidence to raise our full year 2024 net revenue guidance to between $260 million and $270 million.
Speaker Change: This updated guidance equates to 34% growth at the top end and is several degrees of magnitude above the estimated growth rate for our category.
David Moatazedi: Importantly, this is a brand that continues to grow at over 30% in its 50th year on the market, signaling the quality of the Jervos brand and the strength of our unique business model. We continue to build loyalty and trust with our customers. We have a unique position as the only dedicated cash pay aesthetic toxic company and a differentiated approach to building a performance beauty brand. We remain focused on the younger generations and helping practices grow. Our differentiation is evident in the continued growth in new purchasing accounts, increasing by 770 in the quarter. This brings our total number of customers purchasing since launch, to approximately 14,000, which is approaching 50% penetration of the market.
Speaker Change: Importantly, this is a brand that continues to grow at over 30% in its fifth year on the market, signaling the quality of the Givaud brand and the strength of our unique business model.
Speaker Change: We continue to build loyalty and trust with our customers.
Speaker Change: We have a unique position as the only dedicated cash pay aesthetic toxin company and a differentiated approach to building a performance beauty brand.
Speaker Change: We remain focused on the younger generation and helping practices grow. Our differentiation is evident in the continued growth in new purchasing accounts, increasing by 770 in the quarter.
Speaker Change: This brings our total number of customers purchasing since launch to approximately 14,000.
David Moatazedi: Our Eveless Consumer Loyalty Program is also thriving and on track to surpass 1 million consumers in the program by year end. The underlying strength of our business and our strategic focus are just part of the story.
Speaker Change: which is approaching 50% penetration of the market.
Speaker Change: Our Evolus Consumer Loyalty Program is also thriving and on track to surpass 1 million consumers in the program by year-end.
Speaker Change: The underlying strength of our business and our strategic focus are just part of the story. Internally, we are preparing for a transformative year in 2025.
David Moatazedi: Internally, we are preparing for a transformative year in 2025. This preparation starts with the commercialization of our novel dermal filler line. In June, we submitted our pre-market approval application to the FDA for Eveless Lifts and Eveless Smooth. In Europe, regulatory approvals for the esteemed dermal filler products are anticipated later this year, and we remain on track for US and international launch in 2025.
Unknown Executive: This preparation starts with the commercialization of our novel dermal filler line. In June, we submitted our pre-market approval application to the FDA for Evalise Lift and Evalise Smooth. In Europe, regulatory approvals for the esteemed dermal filler products are anticipated later this year, and we remain on track for US and international launch in 2025. Javeau's brand recognition, clinical performance, and high satisfaction profile are well positioned for new consumers entering the category. This positioning will allow us to continue capturing demand while we actively prepare to integrate our novel dermal filler line, Evolese. Thank you, David.
Speaker Change: This preparation starts with the commercialization of our novel dermal filler line.
Speaker Change: In June , we submitted our pre-market approval application to the FDA for Evalise Lift and Evalise Smooth.
Speaker Change: In Europe , regulatory approvals for the esteemed dermal filler products are anticipated later this year, and we remain on track for U.S. and international launch in 2025.
David Moatazedi: Our commercialization plans are well underway, and we will share more details at our investor day in September. Internationally, we continue to make significant progress with New Siva. We continue to expand our international business with a focus on deeper penetration in the UK, Germany, and Italy, while broadening our global footprint by commercially launching in Spain and Australia. With these recent launches, we are now operating in all the major markets needed to deliver our 2028 guidance. The toxin market remains strong and we are well-sufficient to benefit from the growing shifts toward Eveless and the Javogran. Jervos, brand recognition, clinical performance, and high satisfaction profile are well-positioned for new consumers entering the category.
Speaker Change: Our commercialization plans are well underway and we will share more details at our Investor Day in September .
Speaker Change: Internationally, we continue to make significant progress with Nuceva.
Speaker Change: We continue to expand our international business with a focus on deeper penetration in the UK, Germany, and Italy while broadening our global footprint by commercially launching in Spain and Australia.
Speaker Change: With these recent launches, we are now operating in all the major markets needed to deliver our 2028 guidance.
Speaker Change: The toxin market remains strong and we are well positioned to benefit from the growing shift towards Evolus and the Givaud brand.
Speaker Change: Jiveau's brand recognition, clinical performance, and high satisfaction profile are well-positioned for new consumers entering the category.
David Moatazedi: This positioning will allow us to continue capturing demand while we actively prepare to integrate our novel thermal filler line, Evelese. These efforts collectively keep us on pace to our long-term revenue target of at least 700 million by 2028.
Speaker Change: This positioning will allow us to continue capturing demand while we actively prepare to integrate our novel dermal filler line, Evolis.
Speaker Change: These efforts collectively keep us on pace to our long-term revenue target of at least $700 million by 2028.
David Moatazedi: Our differentiated go-to-market strategy continues to set us apart, and I look forward to sharing more updates as we progress.
Speaker Change: Our differentiated go-to-market strategy continues to set us apart, and I look forward to sharing more updates as we progress. Now I'll turn it over to Sandra, who will cover the financials.
Sandra Beaver: Now I'll turn it over to Sandra, who will cover the financials. Thank you, David. I would like to congratulate the Evelese team on another quarter of above-market sales growth and prudent management of our operating expenses that enabled us to achieve profitability two quarters earlier than anticipated. These above-market Q2 results represent a meaningful step towards achieving our guidance in 2024, delivering full-year profitability for 2025, and positive tax generation. Turning to the results. Global net revenues to the second quarter were 66.9 million, plus 36 percent compared to net revenue in the second quarter of 2023. Sales in the US comprise more than 95 percent of revenues this quarter.
David Moatazedi: I would like to congratulate the Evolus team on another quarter of above-market sales growth and prudent management of our operating expenses that enabled us to achieve profitability two quarters earlier than anticipated. Turning to the results.
Sandra Beaver: Thank you, David.
Sandra Beaver: I would like to congratulate the Evolus team on another quarter of above-market sales growth and prudent management of our operating expenses that enabled us to achieve profitability two quarters earlier than anticipated.
Sandra Beaver: These above-market Q2 results represent a meaningful step towards achieving our guidance in 2024, delivering full-year profitability for 2025, and positive cash generation.
Unknown Executive: Global net revenues for the second quarter were $66.9 million, up 36% compared to net revenue in the second quarter of 2023. In the US, where our price remained strong, our customer reorder rate was approximately 70%, and our sales were driven primarily by higher volume. Our GAAP operating expenses for the second quarter were $74.6 million, compared to $68.3 million in the first quarter. For the first time and two quarters ahead of our expectations, we achieved profitability in the second quarter.
Sandra Beaver: Turning to the results.
Sandra Beaver: Global net revenues for the second quarter were $66.9 million, up 36% compared to net revenue in the second quarter of 2023.
Sandra Beaver: Sales in the U.S. comprise more than 95% of revenues this quarter.
Sandra Beaver: International revenue contribution will continue to increase as international toxic growth will outpace the US. In the US, where our price remains strong, our customer reorder rate was approximately 70 percent, and our sales were driven primarily by higher volumes. Our reported growth margin for the second quarter was 70.3 percent, and our adjusted growth margin, which excludes the amortization of intangible, was 71.5 percent and above the top end of our full-year guidance. Our gap operating expenses for the second quarter were 74.6 million compared to 68.3 million in the first quarter. Now on GAP operating expenses for the second quarter were 46.7 million compared to 42.1 million in the prior quarter.
Sandra Beaver: International revenue contribution will continue to increase as international toxin growth will outpace the U.S.
Sandra Beaver: In the U.S., where our price remained strong, our customer reorder rate was approximately 70% and our sales were driven primarily by higher volumes.
Sandra Beaver: Our reported growth margin for the second quarter was 70.3%, and our adjusted growth margin, which excludes the amortization of intangibles, was 71.5%, and above the top end of our full year guidance.
Sandra Beaver: Our GAAP operating expenses for the second quarter were $74.6 million, compared to $68.3 million in the first quarter.
Sandra Beaver: non-GAAP operating expenses for the second quarter were $46.7 million compared to $42.1 million in the prior quarter.
Sandra Beaver: Reported selling, general and administrative expenses for the second quarter were 50.2 million, compared to 45.1 million recorded in the first quarter. This quarter, SGDA expenses included by 28 million of non-cash stock-based compensation compared to 5.1 million in the first quarter. Operating expenses saw a modest increase this quarter, but trends we expect to continue as we prepare for the 2025 bill or launch. For the first time and two quarters ahead of our expectations, we achieved profitability in the second quarter. Our non-gas income from operations in the second quarter was 1.1 million. This represents a 2 million sequential improvement in non-gas income from operations as compared to our Q1 non-gas operating loss of 0.9 million and represents meaningful continued progress on our passwords profitability for the full-year 2025 and positive. As a reminder, due to three is seasonally lower revenue as compared to Q2.
Sandra Beaver: Reported selling general and administrative expenses for the second quarter were $50.2 million compared to $45.1 million recorded in the first quarter.
Sandra Beaver: This quarter, SGA expenses included $5.8 million of non-cash stock-based compensation compared to $5.1 million in the first quarter.
Sandra Beaver: Operating expenses saw a modest increase this quarter, a trend we expect to continue as we prepare for the 2025 filler launch.
Sandra Beaver: For the first time, and two quarters ahead of our expectations, we achieved profitability in the second quarter.
Sandra Beaver: Our non-GAAP income from operations in the second quarter was $1.1 million.
Sandra Beaver: This represents a $2 million sequential improvement in non-GAAP income from operations, as compared to our Q1 non-GAAP operating loss of $0.9 million.
Sandra Beaver: and represents meaningful continued progress on our path towards profitability for the full year 2025 and positive cash generation.
Unknown Executive: As a reminder, Q3 is seasonally lower revenue as compared to Q2. Considering this expected seasonal revenue decrease, it is likely we will not be profitable in the third quarter. Both non-GAAP operating expenses and non-GAAP operating income exclude stock-based compensation expense.
Sandra Beaver: As a reminder, Q3 is seasonally lower revenue as compared to Q2. Considering this expected seasonal revenue decrease, it is likely we will not be profitable in the third quarter.
Sandra Beaver: Considering this expected seasonal revenue decrease, it is likely we will not be profitable in the third quarter. Both non-doubt operating expenses and non-doubt operating income exclude stock-based compensation expense, re-evaluation of the contingent royalty obligation, and depreciation and amortization.
Sandra Beaver: Both non-GAAP operating expenses and non-GAAP operating income exclude stock-based compensation expense.
Unknown Executive: Re-evaluation of the contingent royalty obligation and depreciation and amortization. We had a low single-digit cash burn with our second quarter cash use of $3.3 million. We ended the second quarter with $93.7 million in cash, compared to $97 million at March 31, 2024. Net cash used for operating activities was $6.5 million, which improved $6.8 million as compared to Q2 2023. This equates to a compounded annual growth rate of 28% since 2023 on a total addressable market of approximately $6 billion today, growing to approximately $10 billion by 2028.
Sandra Beaver: Re-evaluation of the contingent royalty obligation and depreciation and amortization.
Sandra Beaver: Turning to the balance sheet, with our consistent operating performance, we continue to be efficient with our use of cash. We have a low single-digit cash firm with our second quarter cash use of 3.3 million. We ended the second quarter with 93.7 million in cash compared to 97 million at March 31, 2024. The cash balance includes 4.2 million of remaining net proceeds from the 50 million underwritten offering of common stock in March 2024. Net cash use for operating activities was 6.5 million, which improved 6.8 million as compared to Q2 2023. We expect that our existing liquidity will fully fund us to positive cash generation and the repayment of our 125 million debt facility in 2026 and 2027.
Sandra Beaver: Turning to the balance sheet.
Sandra Beaver: With our consistent operating performance, we continue to be efficient with our use of cash. We had a low single-digit cash burn with our second quarter cash use of $3.3 million.
Sandra Beaver: We ended the second quarter with $93.7 million in cash compared to $97 million at March 31, 2024.
Sandra Beaver: The cash balance includes $4.2 million of remaining net proceeds from the $50 million underwritten offering of common stock in March 2024.
Sandra Beaver: Net cash used for operating activities was $6.5 million, which improved $6.8 million as compared to Q2 2023.
Sandra Beaver: We expect that our existing liquidity will fully fund us to positive cash generation and the repayment of our $125 million debt facility in 2026 and 2027.
Sandra Beaver: We continue to target total net revenues of at least 700 million by 2028, driven by continued growth and share gains in our neurotoxin business in the U.S. and international markets, along with the growing contribution from our novel line of fillers that begin in 2025. This equates to a compounded annual growth rate of 28% since 2023, on a total addressable market of approximately 6 billion today, growing to approximately 10 billion by 2028.
Sandra Beaver: We continue to target total net revenues of at least $700 million by 2028, driven by continued growth and share gains in our neurotoxin business in the U.S. and international markets, along with a growing contribution from our novel line of fillers that begins in 2025.
Sandra Beaver: This equates to a compounded annual growth rate of 28% since 2023, on a total addressable market of approximately $6 billion today, growing to approximately $10 billion by 2028.
Sandra Beaver: With that context in mind, I'd like to summarize our guidance. Based on our strong year-to-date performance, we have raised our total net revenues to between 260 million and 270 million. Over 95% of which will come from the sales in the U.S. and the balance from international markets. Our quarterly revenue assumes typical industry seasonality. In addition, it is worth noting that we expect first half growth rates to exceed second half growth rates, primarily driven by the 2023 compare period. And adjusted growth profit margin in the range of 68% to 71%. Non-GAAP operating expense guidance is between 185 million and 190 million.
Sandra Beaver: With that context in mind, I'd like to summarize our guidance.
Sandra Beaver: Based on our strong year-to-date performance, we have raised our total net revenues to between $260 million and $270 million, over 95% of which will come from the sales in the U.S. and the balance from international markets.
Sandra Beaver: Our quarterly revenue assumes typical industry seasonality. In addition, it is worth noting that we expect first half growth rates to exceed second half growth rates, primarily driven by the 2023 compare period.
Sandra Beaver: An adjusted growth profit margin in the range of 68% to 71%.
Unknown Executive: Non-GAAP operating expense guidance is between $185 million and $190 million. Driven by the increase in our revenue guidance range, we expect to be at the top end of our operating expense guidance range. It is worth noting that within the year 2025, profitability may not be sustained every quarter due to the filler launch. Finally, the company projects its total net revenue could reach at least $700 million by 2028. Now, let me turn the call back to the operator to begin the Q&A. Thank you.
Sandra Beaver: non-GAAP operating expense guidance is between $185 million and $190 million. Driven by the increase in our revenue guidance range, we expect to be at the top end of our operating expense guidance range.
Sandra Beaver: Driven by the increase in our revenue guidance range, we expect to be at the top end of our operating expense guidance range. We expect to achieve positive non-GAAP operating income on a consolidated basis for the fourth quarter of 2024 and the full year 2025. It is worth noting that, within the year 2025, profitability may not be sustained every quarter due to the filler launch. Finally, the company projects its total net revenue can reach at least 700 million by 2028.
Sandra Beaver: We expect to achieve positive non-GAAP operating income on a consolidated basis for the fourth quarter of 2024 and the full year 2025.
Sandra Beaver: It is worth noting that within the year 2025, profitability may not be sustained every quarter due to the filler launch.
Sandra Beaver: Finally, the company projects its total net revenue can reach at least $700 million by 2028.
Operator: Now, let me turn the call back to the operator to begin Q&A. Thank you.
Speaker Change: Now let me turn the call back to the operator to begin Q&A.
Operator: We will now be conducting a question in the answer session. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation: don't indicate that your question is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. One moment, please. Please, while we pull for questions.
Speaker Change: Thank you. We will now be conducting a question and answer session. If you'd like to ask a question, please press star one on your telephone keypad.
Speaker Change: A confirmation tone will indicate that your question is in the question queue. You may press star 2 if you'd like to remove your question from the queue.
Speaker Change: For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start keys. One moment please while we poll for questions.
Operator: One moment, please, while we poll for questions.
Jack Padovano: Our first question comes from Jack Padovano with Steve. Please proceed with your question. Hi, this is Jack On for Annabelle. Thanks for taking our questions. So how are you seeing the state of play in the filler fields? Because I know that this has been a little thorn in the side for aesthetics companies recently. Have you specifically did see some recovery there, but it wasn't quite as much as anticipated. So do you have a pulse on that market yet? And what state of affairs will you be seeing as you approach launch?
Speaker Change: Our first question comes from Jack Padovano with Stiefel. Please proceed with your question.
Jack: Hi, this is Jack on behalf of Annabel. Thanks for taking our questions.
Speaker Change: Hi, this is Jack on for Annabel. Thanks for taking our questions.
Annabel: So how are you seeing the state of play in the filler field? Because I know that this has been a little thorn in the side for aesthetics companies recently.
Speaker Change: AbbVie specifically did see some recovery there, but it wasn't quite as much as anticipated. So do you have a pulse on that market yet? And what state of affairs will you be seeing as you approach launch?
David Moatazedi: Great, thanks for the question. What we're seeing, as you know, it's always hard to parse out procedural growth. As you look at different companies reporting, you have companies that are newer into their launch and companies that are more mature. Overall, we're seeing a filler market on the full year that is growing. Clearly, there's some shareships happening within the category, but also a market that is going at a lower rate relative to the historical trends that we've seen. So we do see sort of a load amid single-digit growth rate on the filler market in the US this year.
David Moatazedi: Um, how are you seeing the state of play in the filler field? Because I know that this has been a little thorn in the side for aesthetics companies recently. Abby specifically did see some recovery there, but it wasn't quite as much as anticipated. So do you have a pulse on that market yet? And what state of affairs will you be seeing as you approach launch?
Speaker Change: Great, thanks for the question.
Speaker Change: What we're seeing, as you know, it's always hard to parse out procedural growth as you look at different companies reporting.
Speaker Change: Companies that are newer into their launch and companies that are more mature Overall, we're seeing a filler market on the full year that is growing
David Moatazedi: Great, thanks for the question. What we're seeing, as you know, it's always hard to parse out procedural growth as you look at different companies reporting. You have companies that are newer to their launch and companies that are more mature. Overall, we're seeing a filler market for the full year that is growing. Clearly, there are some share shifts happening within the categories, but also a market that is growing at a lower rate relative to the historical trend that we've seen.
Speaker Change: Clearly there's some share shifts happening within the category, but also a market that is going at a lower rate relative to the historical trend that we've seen. So we do see sort of a
David Moatazedi: So we do see sort of a low to mid-single-digit growth rate in the filler market in the U.S. this year, and we do anticipate that filler market wrapping around on this depressed growth rate and benefiting from the boon of patients coming in for GLCs, achieving their optimal weight, and looking at fillers. We have multiple data points that confirm that the market should benefit from the GLC trends, and we should start to see that in the coming quarter.
Speaker Change: Low to mid-single-digit growth rate on the filler market in the U.S. this year.
David Moatazedi: And we do anticipate that filler market wrapping around on this depressed growth rate and benefiting from the boon of the patients coming in for GLCs, achieving their optimal weight and looking at on a filler. We have multiple data points that can confirm that. The market should benefit from the GLC trends, and we should start to see that in the coming quarter. So we feel very good about the market we're entering. Keep in mind, the filler market is a 1.8 billion dollar category. We expect it'll grow in this mid to high single digits over the five year horizon through 2028, where we've given our guidance outlook, and it's a favorable market in the sense that there's really three families of fillers that command roughly 80 to 90% of the US market.
Speaker Change: And we do anticipate that filler market wrapping around on this depressed growth rate and benefiting
Speaker Change: from the boon of the patients coming in for GLPs.
Speaker Change: [inaudible]
David Moatazedi: So we feel very good about the market we're entering. Keep in mind, the filler market is a $1.8 billion category. We expect it will grow at this mid-to-high single-digit rate over the five-year horizon through 2028, where we've given our guidance outlook. And it's a favorable market in the sense that there are really three families of fillers that command roughly 80% to 90% of the U.S. market. And the Evalise line is clearly differentiated in the way that it's manufactured and in the clinical data that we've shared relative to one of the market-leading fillers.
Speaker Change: The filler market is a $1.8 billion category. We expect it will grow in this mid-to-high single digit.
Speaker Change: Over the five-year horizon through 2028 where we've given our guidance outlook, and it's a favorable market in the sense that there's
Speaker Change: Really, three families of fillers that command roughly 80 to 90 percent of the U.S. market. And the Evolus line is clearly differentiated in the way that it's manufactured, in the clinical data that we've shared relative to one of the market-leading fillers. And of course, putting it into our cash-paid platform, we think there'll be a tremendous amount of value. We shared it with our advisors in a number of advisory board meetings and in research. We're very excited to see a product come in with the profile of the product Evolus that we're going to be bringing. So we'll look forward to sharing more color on that at our upcoming investor day.
David Moatazedi: And the Evalese line is clearly differentiated in the way that it's manufactured in the clinical data that we shared relative to one of the market leading fillers. And of course, putting it into our cash tape platform. We think there'll be a tremendous amount of value. We shared it with our advisors, and the number of advisory board meaning and in research, they're very excited to see a product come in with the profile of the product. Evalese that we're going to be bringing.
David Moatazedi: And, of course, putting it into our cash pay platform, we think there will be a tremendous amount of value. We shared it with our advisors at a number of advisory board meetings and in research, and they're very excited to see a product come in with the profile of the Evalise product that we're going to be bringing. So we'll look forward to sharing more color on that at our upcoming investor day.
David Moatazedi: So we'll look forward to sharing more color on that at our upcoming events today. Great. And then just one more if I may. I'm the toxin side. Are there any additional competitor programs that you're seeing out there, whether it be loyalty programs or promotional programs, that you expect to have to adapt to, or in other words, do you sense the need for any shift in your marketing strategies as the field starts to get a little bit more crap. Yeah, we continue to maintain our marketing strategy, which is really a strategic level. It's our cash pay advantage that's enabled us to create a different experience for these practices.
David Moatazedi: Great. And then just one more question, if I may, on the toxin side, are there any additional competitor programs that you're seeing out there, whether it be loyalty programs or promotional programs that you expect to have to adapt to? Or in other words, do you sense the need for any shift in your marketing strategies as the field starts to get a little bit more crowded?
Speaker Change: Great, and then just one more if I may, on the toxin side, are there any additional competitor programs that you're seeing out there, whether it be loyalty programs or promotional programs?
Speaker Change: that you expect to have to adapt to.
Speaker Change: Or, in other words, do you sense the need for any shift in your marketing strategies as the field starts to get a little bit more crowded?
David Moatazedi: Yeah, we've continued to maintain our marketing strategy, which is really at a strategic level. It's our cash pay advantage that's enabled us to create a different experience for these practices.
Speaker Change: Yeah, we've continued to maintain our marketing strategy, which is really at a strategic level. It's our cash pay advantage that's enabled us to create a different experience for these practices.
Jack: And we've leaned more heavily into that, whether you think about our consumer loyalty program or the way we engage with practices and co-branded media, in the sense that both of them, the co-branded media and the rewards, are growing at a very healthy clip, and they remain our areas of focus. We've stayed really disciplined, and a lot of credit to the team for continuing to build our scale and presence in the market.
David Moatazedi: And we've leaned more heavily into that, whether using about our consumer loyalty program or the way we engage with practices in co-brand media in the sense that both of them, the co-brand media and the rewards, are growing in a very healthy clip. And they remain our areas of focus. We stay really disciplined, and a lot of credit for the team for continuing to build our scale and presence in the market. I do believe that's why you're continuing to see a business down in fifth year growing at 36%, which is effectively the growth rate we had on the full year last year.
Speaker Change: And we've leaned more heavily into that, whether you think about our consumer loyalty program, or the way we engage with practices in co-branded media, in the sense that both of them, the co-branded media and the rewards, are growing at a very healthy clip, and they remain our areas of focus. We've stayed really disciplined, and a lot of credit to the team for continuing to build our scale and presence in the market. I do believe that's why you're continuing to see a business down its fifth year growing at 36%, which is effectively the growth rate we had on the full year last year. It's because of that continued operating discipline that we've had as a company. As it relates to promotions in the market, look...
Jack: I do believe that's why you're continuing to see a business now in its fifth year growing at 36%, which is effectively the growth rate we had for the full year last year. It's because of that continued operating discipline that we have as a company. As it relates to promotions in the market, these markets, there are a lot of promotions each quarter. Every manufacturer has their own set that they introduce into the category. But, as you point out, nothing that changes the way that we've approached the JVO and how we bring it to the market.
David Moatazedi: It's because of that continued operating discipline that we've had as a company. As it relates to promotions in the market, look, these markets, there's a lot of promotions. Each order, every manufacturer has their own set that they introduce into the category. But, as you point out, nothing that changes the way that we've approached Jibbo and how we bring it to the market.
Speaker Change: These markets, there's a lot of promotions each quarter. Every manufacturer has their own set that they introduce into the category. But as you point out, nothing that changes the way that we've approached Giveau and how we bring it to the market.
Jack Padovano: Great, thanks so much, and congrats on the quarter. Thank you.
Unknown Executive: Great, thanks so much, and congrats on the quarter. Thank you.
Speaker Change: Great, thanks so much and congrats on the quarter.
Speaker Change: Thank you.
Mark Goodman: Our next question comes from Mark Goodman with the Ranked Partners. Please proceed with your question. Hi, this is Mubu on the line from Mark. Just piggybacking off of that.
Speaker Change: Our next question comes from Marc Goodman with LARINC Partners. Please proceed with your question.
Madhu: Hi, this is Madhu on the line for Marc.
Madhu: Hi, this is Madhu on the line for Mark. Just piggybacking off of that, could you talk a little bit more about your fillers and the differentiation from other products on the market and sort of how you're thinking about talking about those filler lines once they're launching and comparing them to what's already out there?
Mark Goodman: Could you talk a little bit more about your fillers and the differentiation from other products on the market and sort of how you're thinking about talking about those filler lines once they're launching and comparing them to what's already out there. Thanks. So, hi, Mubu. I'll briefly touch on it. I think there's a section in our investor deck that highlights the scientific differentiation, and you can expect a lot more color from Rui at our upcoming investor day. But clearly, this product is the first one manufactured under freezing cold temperatures. Every other hyaluronic acid is heated in the manufacturing process, and that preserves the natural HH brand, and clearly the word natural is a significant term in the world of aesthetics. The manufacturers of this technology have developed one of the leading hyaluronic acids currently available on the market.
David Moatazedi: Hi Madhu, I'll briefly touch on it. I think there's a section in our investor deck that highlights the scientific differentiation, and you can expect a lot more color from Rui at our upcoming investor day. But clearly, this product is the first one manufactured under freezing cold temperatures. Every other hyaluronic acid is heated in the manufacturing process, and that preserves the natural HA strands.
Speaker Change: Thanks.
Speaker Change: Hi Madhu. I'll briefly touch on it. I think there's a section in our investor deck that highlights the scientific differentiation and you can expect a lot more color from Rui at our upcoming investor day. But clearly this product is the first one manufactured under freezing cold temperatures. Every other hyaluronic acid is heated in the manufacturing process and that preserves the natural HA strands. Clearly the word natural is a significant term in the world of aesthetics.
David Moatazedi: Clearly, the word natural is a significant term in the world of aesthetics, and the manufacturers of this technology have developed one of the leading hyaluronic acids currently available on the market. So there's a lot of credibility in the technology and the science behind it. And then, of course, the clinical data that we've shared from our trials now supports the science that we saw in the data. So I think we have a clear story in terms of the product and the data.
Speaker Change: And the manufacturers of this technology have developed one of the leading hyaluronic acids currently available on the market, so there's a lot of credibility in the technology and the science behind it, and then, of course, the clinical data that we've shared from our trials now supports.
David Moatazedi: So, there's a lot of credibility in the technology and the science behind it, and then of course the clinical data that we've shared from our trials now supports the science that we saw in the data. So, I think we have a clear story in terms of the product and the data. It's still the early endings what you're seeing. This, you know, multiple products under clinical development in different areas of the phase where this line was designed specifically for each area, and we'll be sharing more clinical data as we get closer to the commercialization. Thank you.
David Moatazedi: It's still in the early innings what you're seeing. There are, as you know, multiple products under clinical development in different areas of the face where this line was designed specifically for each area. And we'll be sharing more clinical data as we get closer to commercialization.
Speaker Change: The science that we saw in the data, so I think we have a clear story in terms of the product and and the data. It's still the early innings. What you're seeing there's, as you know, multiple products under clinical development in different areas of the face where this line was designed specifically for each area. And we'll be sharing more clinical data as we get closer to commercialization.
Speaker Change: Thank you.
Von Tai: Our next question comes from Von Tai with BNP. Please thank for taking my questions.
Navanti: Our next question comes from Navanti with BNP. Please proceed with your question.
Speaker Change: Our next question comes from Navanti with BNP. Please proceed with your question.
Von Tai: First, can you discuss the appointment of Cooper Currency or to the board and what it will bring to Evolution?
Nivantai: Hi, thanks for taking my questions. First, can you discuss the appointment of Cooper, current CEO , to the board and what it will bring to Evolus?
David Moatazedi: And also if you have any timing updates on Bujel's Letibu and Geldera QM-Tribu-14. Please, thank you. Great, thanks very much for this question.
Nivantai: and also if you have any timing updates on Pugel's, Le Thiebaud's and Galderma QM 1114.
David Moatazedi: Great. Thanks, Ramon, for the question. I'll start with the addition of Al White. We did a search, and we were very selective about who we brought onto the board. And I tell you, Al White clearly stood out for a number of reasons.
Speaker Change: Thank you.
David Moatazedi: I'll start with the edition of All White. We did a search, and we were very selective about who we brought on to the board, and I tell you, All White clearly stood out for a number of reasons. One is obviously background with a tremendous track record of success, having moved, built the Cooper company, which now of course cover a number of therapeutic areas and he moved his way into the CEO role which he's been in for about as long as I have now, but he's played a significant role in building that company and that was important to us as we look at geographic expansion, profitability, building out our portfolio, a lot of the same elements that Alice faced as Cooper has grown, and so having his experience around the table is invaluable for us as a company entering this next stage of our growth and so I've really enjoyed the time I've spent with Al.
Speaker Change: Great. Thanks, Namann, for the question. I'll start with the addition of Al White. We did a search and we were very selective about who we brought onto the board.
David Moatazedi: One is, obviously, his background with a tremendous track record of success, having moved and built the Cooper Company, which now, of course, covers a number of therapeutic areas, and he moved his way into the CEO role, which he's been in for about as long as I have now, but he's played a significant role in building that company. And that was important to us as we look at geographic expansion, profitability, building out our portfolio, a lot of the same elements that Al has faced as Cooper has grown.
Speaker Change: And I tell you, Al White clearly stood out for a number of reasons. One is, obviously, his background with a tremendous track record of success.
Speaker Change: Having moved, built the Cooper Company, which now, of course, covers a number of therapeutic areas, and he moved his way into the CEO role, which he's been in for about as long as I have now, but he's played a significant role in building that company, and that was important to us.
Speaker Change: As we look at geographic expansion, profitability, building out our portfolio, a lot of the same elements that Al has faced as Cooper has grown. And so having his experience around the table is invaluable for us as a company entering this next stage.
David Moatazedi: And so having his experience around the table is invaluable for us as a company entering this next stage of our growth. And so I've really enjoyed the time I've spent with Al. I know he's very excited about the story. He knows the aesthetic market well, and he's also excited to see what we've been able to do and help contribute to our future growth story. And then we actually had him on a board call earlier this week for the first time, so it's been great to have Al.
Speaker Change: of our growth. And so I've really enjoyed the time I've spent with Al. I know he's very excited about the story. He knows the aesthetic market well.
David Moatazedi: I know he's very excited about the story. He knows the aesthetic market well, and he's also excited to see what we've been able to do and help contribute to our future growth story. Then we actually had him on a board call earlier this week for the first time, so it's been great to have Al. On the recently announced a partner in the US and they planned to commercialize sometime here in the back half of the year. At this point, as you know, we're competing with Latino in Europe, and we're aware of the product and the dimensions of that brand as it enters the market. We will be prepared as well when they enter the US, and I'll just remind you that as we've had an entrance that have entered since we launched, the market continues to grow at a very healthy clip.
Al White: And he's also excited to see what we've been able to do and help contribute to our future growth story. And then we actually had him on a board call earlier this week for the first time, so it's been great to have Al. On the competitive front, as you saw, Lativo received approval earlier this year. They most recently announced a partner in the U.S.
David Moatazedi: On the competitive front, as you saw, Lativo received approval earlier this year. They most recently announced a partner in the U.S., and they plan to commercialize sometime here in the back half of the year. At this point, as you know, we're competing with Lativo in Europe, and we're aware of the product and the dimensions of that brand as it enters the market. We'll be prepared.
Al White: and they plan to commercialize sometime here in the back half of the year. At this point, as you know, we're competing with Lativo in Europe and we're aware of the product and the dimensions of that brand as it enters the market. We'll be prepared.
David Moatazedi: I'll just remind you that we've had entrants that have entered since we launched, and the market continues to grow at a very healthy clip. Our growth wasn't impacted by the latest entrant. In fact, we accelerated a bit. I think the focus on toxins only increases with new entrants. Our value proposition is clearly defined in this space. The entrants, whether that's Lecebo or Galderma, which I believe did receive a CRL for the liquid, but they do plan to refile sometime next year, which could put them on the market towards the end of next year or the following. It's not clear.
Al White: as well when they enter the U.S. And I'll just remind you that we've had entrants that have entered since we launched. The market continues to grow at a very healthy clip.
David Moatazedi: Our growth was an impact by the latest entrance; if anything, we accelerated a bit. I think the focus on toxins only increases with new entrance, and our value proposition is clearly defined in the space. And so the entrance, whether that the SIBO or Galderma, which I believe they did receive the CRL for the liquid, but they do plan to refile sometime next year, which could put them on the market towards the end of next year, the following dot clear. I think it ultimately leads to continue focus on this category and growth, which is significant. In the end, it was nice to see this quarter.
Al White: Our growth wasn't impacted by the latest entrant. If anything...
Al White: We accelerated a bit. I think the focus on toxins only increases with new entrants.
Al White: And our value proposition is clearly defined in this space. And so the entrance, whether that's...
Al White: Lefebo or Galderma which I believe they did receive a CRL for the liquid but they do plan to refile.
Al White: sometime next year, which could put them on the market towards the end of the next year or the following.
David Moatazedi: I think it ultimately leads to continued focus on this category and growth, which is significant. In the end, it was nice to see this quarter that all the significant players in the space reported positive growth despite an increasing competitive environment. I think that just speaks to the backdrop that we have very low consumer penetration in this market and there's a lot of growth ahead of us. As a new player comes in, they can carve out an opportunity for themselves just as we've done successfully with this younger generation of consumers.
Al White: leads to continued focus on this category.
Al White: and growth, which is significant. In the end, it was nice to see this quarter, all the significant players in the space reported positive growth despite an increasing competitive environment. And I think that just speaks to the backdrop that we have very low consumer penetration in this market. And there's a lot of growth ahead of us. And as a new player comes in, they can carve out an opportunity for themselves just as we've done successfully in this younger generation of consumers.
David Moatazedi: All the significant players in the space reported positive growth, despite an increasing competitive environment. I think that just speaks to the backdrop that we have very low consumer penetration in this market, and there's a lot of growth ahead of us. As a new player comes in, they can carve out an opportunity for themselves, just as we've done successfully, and it's a younger generation of consumers.
David Moatazedi: Thank you, that's very helpful, and can I add one? Do you have a recent breakdown of facial injectables used by age range? Is the share of millennials and Gen Z users increasing? Yeah, so the question is around millennials and the younger, and what percentage of our patient base that represents? I can't answer for the category at this time, but in terms of when we look at our consumer loyalty program, and it's a sizable base, as you know, approaching 1 million consumers. We have over 50% or the majority our millennial patients are younger, so we're really pleased with that younger demographic. It's been our focus and it's work. We do believe we over index relative to the overall market, and it continues to be the growth driver for this space. That this younger generation is more likely to get treated; they view this product as a beauty treatment, and we think we're incredibly well positioned to capitalize on that shift towards the younger movement.
Unknown Executive: Thank you, that's very helpful. And can I add one? Do you have a recent breakdown of facial injectables used by age range? Is the share of millennials and Gen Z users increasing? Thank you.
Speaker Change: Thank you, that's very helpful. And can I add one? Do you have a recent breakdown of facial injectables used by age range? Is the share of millennials and Gen Z users is it increasing? Thank you.
David Moatazedi: Yeah, so the question is around Millennials and younger and what percentage of our patient-based death represents. I can't answer that for the category at this time, but in terms of when we look at our Consumer Loyalty Program, and it's a sizable base, as you know, approaching one million consumers, we have over 50%, or the majority are Millennial patients or younger. So we're really pleased with that younger demographic. It's been our focus, and it's We do believe we over-indexed relative to the overall market, and it continues to be the growth driver for this space, because this younger generation is more likely to get treated. They view this product as a beauty treatment, and we think we're incredibly well-positioned to capitalize on that shift towards the younger movement.
Speaker Change: Yeah, so the question is around Millennials and Younger and what percentage of our patient-based debt represents. I can't answer it for the category at this time, but in terms of when we look at our consumer loyalty program.
Speaker Change: And it's a sizable base, as you know, approaching one million consumers.
Speaker Change: We have over 50%, or the majority,
Speaker Change: With that younger demographic, it's been our focus and it's worked. We do believe we over-indexed relative to the overall market.
Speaker Change: and it continues to be the growth driver for this space. That this younger generation is more likely to get treated. They view this product as a beauty treatment and we think we're incredibly well positioned to capitalize on that shift towards the younger movement.
Operator: Thank you.
Speaker Change: Thank you.
Operator: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for questions.
Operator: As a reminder, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for questions. Our next question comes from Uy Ear with Missouho Securities. Please proceed with your question.
Speaker Change: As a remind, if you'd like to ask a question, please press star one on your telephone keypad. One moment, please, while we poll for questions.
Charles: Our next question comes from Uy Ear, with Mizuho Securities. Please proceed with your question. Hi, this is Charles on for Uy. I just had one question about kind of the fillers. So in the US, I believe you said that the lift filler would be kind of the workhorse, and I guess I was just kind of curious how XUS those fillers would be like would they lift the were also be the workhorse or would the lips filler kind of take over XUS. So just trying to get a better sense of those dynamics. Yeah, thank you.
Speaker Change: Our next question comes from Uy Ear with Mizuho Securities. Please proceed with your question.
Speaker Change: Hi, this is Charles on for Uy.
Charles: I just had one question about kind of the fillers.
Speaker Change: So in the U.S., I believe you said that the lift filler would be kind of the workhorse.
Speaker Change: And I guess I was just kind of curious how XUS, those fillers, would be, like would the lip filler also be the workhorse or would the lips filler kind of take over XUS? So just trying to get a better sense of those dynamics.
David Moatazedi: That's a great question, Charles. The dynamics with filler use in the US and abroad are actually quite similar. There's obviously more choices in Europe than there are here in the US, but in the end, we do believe that the lift products that we'll introduce here in the United States will be the workhorse in the line, regardless of which market you're in. But clearly areas like the cheeks are an area of high use, as are the lips. But keep in mind when you're going into areas like the lips, the volumes are lower than they are when they're treating areas like the nasolabial folds and highest in areas like the cheeks, even though maybe the percentage of patients getting it in the cheeks is lower.
Speaker Change: Yeah, thank you.
Charles: That's a great question Charles. The dynamics with filler use in the U.S. and abroad are actually quite similar. There's obviously more choices in Europe than there are here in the U.S.
Speaker Change: But in the end, we do believe that the list products that we'll introduce here in the United States will be the workforce in the line, regardless of which market you're in. But clearly, areas like the cheeks...
Speaker Change: are an area of high use, as are the lips. But keep in mind, when you're going into areas like the lips, the volumes are lower than they are when they're treating areas like the nasolabial folds.
Speaker Change: In areas like the cheeks, even though maybe the percentage of patients getting it in the cheeks are the lowest. So, I think we'll give you a lot more color around the market during our Investor Day. We've received a lot of questions around...
David Moatazedi: So I think we'll give you a lot more color around the market during our Investor Day. We received a lot of questions around the growth of the category going forward. The impact of GLCs as well. The utility of the different products and what we've learned from them in the real world, you can expect to get a lot more color around that in September. Great.
Speaker Change: The growth of the category going forward, the impact of GLPs as well as the utility of the different products and what we've learned from them in the real world, you can expect to get a lot more color around that in September .
Uy Sieng Ear: Great, thank you, and congrats on the quarter.
Charles: Thank you and congrats on the quarter.
Speaker Change: Great, thank you and congrats on the quarter.
Serge Belanger: Our next question comes from Serge Belinger with Need Him and Company. Please proceed with your question. I Good afternoon. Thanks for taking my questions. I guess the first one for David. Both of the large aesthetic Belweathers reported last week, and both kind of reported some softness in the US market across both fillers and toxins, especially in terms of procedure volumes. Just curious if you've, you know, what you have noticed over the second quarter regarding the growth of those volumes. And then secondly, can you just remind us of the PMA process for the fillers? So both of them have now been filed.
Speaker Change: Our next question comes from Serge Belanger with Needham & Company. Please proceed with your question.
Serge D. Belanger: Hi, good afternoon. Thanks for taking my questions.
Serge D. Belanger: I guess the first one for David, both of the large aesthetic bellwethers reported last week.
Serge D. Belanger: and both kind of reported.
Speaker Change: Some softness in the U.S. market across both fillers and toxins, especially in terms of procedure volumes.
Speaker Change: I'm just curious if you've you know what you have noticed over the second quarter regarding the growth of those volumes and then secondly can you just remind us of the PMA process for the fillers so
David Moatazedi: Is this a 12-month process, and should we expect radios silent until approval, or will there be some updates along the way before the second half of 2025 when you expect approval much? All right.
Speaker Change: Both of them have now been filed. Is this a 12-month process, and should we expect radio silent until approval here, or there'll be some updates along the way before the second half of 2025 when you expect approval and launch? Thanks.
David Moatazedi: I'll agree to take the second question in just a moment, and I'll take your first one. What's interesting is the messaging across the board on toxins is that it's a very resilient category. We're seeing healthy growth. I think you heard that from all the bigger players in the space, and we've seen the same thing. And even though we continue to hear this sort of this backdrop of is there softness in the market that continues to persist, which we've heard it now for almost two years, the reality of it is having spent a lot of time in markets.
Speaker Change: I'll ask Rui to take the second question in just a moment, and I'll take your first one. What's interesting is...
Speaker Change: The messaging across the board on toxins is that it's a very resilient category. We're seeing healthy growth.
Speaker Change: I think you heard that from all the bigger players in the space, and we've seen the same thing.
Speaker Change: Even though we continue to hear there's sort of this backdrop of is there softness in the market that continues to persist, we've heard it now for almost two years. The reality of it is, having spent a lot of time in the market,
David Moatazedi: These practices are growing. The groups that have multiple facilities that we're planning to expand are continuing with their expansion plan. And we're seeing healthy growth all around as far as toxins are very affordable, to three to $500 procedures. And this movement with this younger generation is clearly a meaningful catalyst for this market. I think pillars have not had as much as the same level of consistency as toxins. We're hearing that fairly consistently, but it continues to remain a healthy business. It is growing. We believe in terms of procedural volume here today. And we expect the market to wrap around on what happened, depressed growth rates throughout the historical and potentially start to benefit from them from the GLP use as we turn the corner into next year.
Speaker Change: These practices are growing. The groups that have multiple facilities that we're planning to expand are continuing with their expansion plan and we're seeing healthy growth all around.
Speaker Change: As far as toxins, they're very affordable, they're $300 to $500 procedures, and this movement with this younger generation is clearly a meaningful catalyst.
Speaker Change: for this market. I think spillers have not had as much as the same level of consistency as toxins and we're hearing that fairly consistency but it continues to remain.
Speaker Change: Healthy Business. It is growing, we believe, in terms of procedural volume year-to-date.
Speaker Change: And we expect the market to wrap around on what have been depressed growth rates throughout the historical.
Speaker Change: and potentially start to benefit from them.
David Moatazedi: So our timing for the launch we're excited about. We think we'll be launching into a healthy market environment and when that's going to continue to benefit from a backdrop of more consumers going into weight loss treatment. And when they achieve that optimal weight that opens the door for the filler.
Speaker Change: from the GLP use as we turn the corner into next year. So our timing for the launch.
Speaker Change: We're excited about. We think we'll be launching into a healthy market environment and one that's going to continue to benefit
Rui: from a backdrop of more consumers going in for weight loss treatment, and when they achieve that optimal weight, that opens the door for the filler. I'll turn it over to Rui to talk a little bit about the FDA and the timeline.
Rui Avelar: I'll turn it over to Ruiz to talk a little bit about the FDA in the timeline. Sure, thank you. You're a question about Padufa and the devices versus drugs. This is a great one. When you're dealing with a drug, you know, we all hear about that PDUFA timeline, and what happens is industry pays a user fee, and then the FDA gets back to you and they give you a specific PDUFA date, and, you know, you hear about a year timeline. PMA is different. There is no Padufa date that's giving, and they basically follow what's called the Madhufa, and that's the Medical Device User Fee Modernization Act.
Unknown Executive: Sure. Thank you.
Unknown Executive: Sure, thank you.
Unknown Executive: Your question about PDUFA and devices versus drugs is a great one. When you're dealing with a drug, you know, we all hear about that PDUFA timeline, and what happens is the industry pays a user fee, and then the FDA gets back to you, and they give you a specific PDUFA date. And you hear about a year timeline. PMA is different.
Rui: Sure, thank you.
Rui: Your question about PDUFA and devices versus drugs is a great one.
Rui: When you're dealing with a drug, you know, we all hear about that PDUFA timeline, and what happens is industry pays a user fee, and then the FDA gets back to you, and they give you a specific PDUFA date, and, you know, you hear about a year timeline.
Unknown Executive: There is no PDUFA date that's given, and they basically follow what's called the MDUFA, and that's the Medical Device User Fee Modernization Act. And the way that works is they have a, quote-unquote, 180-day clock, and what happens during that process is they work, then they stop the clock, ask you questions, and you respond, and it's a back-and-forth process, very different So, as such, you know, it can take a while for it to get done.
Rui: PMA is different. There is no PDUFA date that's given and they basically follow what's called the MDUFA and that's Medical Device User Fee Modernization Act.
Rui Avelar: And the way that works is they have a quote-unquote 180-day clock, and what happens during that process is they work, then they stop the clock, ask you questions, and you respond, and it's a back-and-forth process. Very different from the drug, so as such, you know, it can take a while for it to get done. It's not uncommon for it to be a year or longer, and that's why we've conservatively said that in the back half of 2025, we'd expect approval because we take into consideration that this is a new technology. These are new facilities and usually their audits and visits.
Rui: and the way that works is they have a quote-unquote 180-day clock.
Rui: And what happens during that process is...
Rui: They work, then they stop the clock, ask you questions, and you respond, and it's a back and forth process, very different from the drug. So as such, you know, it can take a while for it to get done. It's not uncommon for it to be a year or longer. And that's why we've conservatively said that in the back half of 2025, we'd expect approval, because we take into consideration that this is a new technology. These are new facilities, and usually there are audits and visits.
Unknown Executive: It's not uncommon for it to be a year or longer, and that's why we've conservatively said that in the back half of 2025, we'd expect approval, because we take into consideration that this is a new technology, these are new facilities, and usually there are audits and visits. And then the other part of your question is, you're absolutely right. We, you know, as a rule of thumb, we will announce when we've filed, and then we will announce when we get the approval.
Serge Belanger: And then your other part of your questions, you're absolutely right. We, you know, as a rule of thumb, we will announce when we filed and then we will announce when we get the approval. Thank you. Thank you for all your questions.
Rui: And then your other part of your questions, you're absolutely right, we, you know, as a rule of thumb, we will announce when we've filed and then we will announce when we get the approval.
Speaker Change: Thank you.
Operator: Thank you for all your questions. At this time, I'd like to turn the call back over to David Moatazedi, President and Chief Executive Officer, for closing comments.
David Moatazedi: At this time, I'd like to turn the call back over to David Modizetti, President and Chief Executive Officer, for closing comments. Thank you. It's an incredibly exciting time at Abilist, and I want to take a moment to acknowledge the exceptional execution by our team this quarter. Their dedication and the hard work have been instrumental in achieving these milestones. Abilist has continued above-market performance in the second quarter, marked by record revenue and achieving profitability ahead of expectations, showcasing the unique difference we bring to the market as an innovator in the industry. Our flagship products of O continue to drive strong demand, and our strategic initiatives have successfully expanded our customer base.
Speaker Change: Thank you for all your questions. At this time, I'd like to turn the call back over to David Moatazedi, President and Chief Executive Officer, for closing comments.
David Moatazedi: It's an incredibly exciting time at Evolus, and I want to take a moment to acknowledge the exceptional execution by our team this quarter. Their dedication and hard work have been instrumental in achieving these milestones. Avelus has continued above-market performance in the second quarter, marked by record revenue and achieving profitability ahead of expectations, showcasing the unique difference we bring to the market as an innovator in the industry. Our flagship product, Jiveau, continues to drive strong demand, and our strategic initiatives have successfully expanded our customer base.
David Moatazedi: Thank you.
David Moatazedi: It's an incredibly exciting time at Evolus and I want to take a moment to acknowledge the exceptional execution by our team this quarter. Their dedication and hard work has been instrumental in achieving these milestones.
Speaker Change: Evolus has continued above-market performance in the second quarter, marked by record revenue and achieving profitability ahead of expectations, showcase the unique difference we bring to the market as an innovator in the industry.
David Moatazedi: Our flagship product, Jiveau, continues to drive strong demand, and our strategic initiatives have successfully expanded our customer base.
David Moatazedi: The results from this quarter show our abilities consistently build and maintain momentum. As we evolve from a single product to a multi-product company, we expect to expand our leadership position in this category. With the US and EU filings well into the approval process, we're actively preparing for the 2025 launch of the new bill of product. These near term milestones will enable Abilist to continue to outpace the market. Looking ahead, we remain on track to achieve profitability in the fourth quarter of 2024 and are confident in our strategy to continue to gain market share. Our commitment to financial performance, operating expense discipline, and capital efficient investments will drive us to sustained profitability while achieving our long-term goal of at least 700 million in revenue by 2028.
David Moatazedi: The results from this quarter show our ability to consistently build and maintain momentum. As we evolve from a single product to a multi-product company, we expect to expand our leadership position in this category. With the U.S. and EU filings well into the approval process, we are actively preparing for a 2025 launch of the new filler product. These near-term milestones will enable Avelus to continue to outpace the market. Looking ahead, we remain on track to achieve profitability in the fourth quarter of 2024 and are confident in our strategy to continue to gain market share.
David Moatazedi: The results from this quarter show our ability to consistently build and maintain momentum.
David Moatazedi: As we evolve from a single product to a multi-product company, we expect to expand our leadership position in this category.
David Moatazedi: With the U.S. and EU filings well into the approval process, we are actively preparing for a 2025 launch of the new filler product. These near-term milestones will enable Avelis to continue to outpace the market.
David Moatazedi: Looking ahead, we remain on track to achieve profitability in the fourth quarter of 2024 and are confident in our strategy to continue to gain market share.
David Moatazedi: Our commitment to financial performance, operating expense discipline, and capital-efficient investments will drive us to sustained profitability while achieving our long-term goal of at least $700 million in revenue by 2028. We are dedicated to building a sustainable, leading performance beauty company and are grateful for the continued support and confidence of our customers and shareholders. Thank you for joining us today and for your ongoing commitment to Evolus. We're looking forward to seeing you on September 12th at our Investor Day in New York City.
David Moatazedi: Our commitment to financial performance, operating expense discipline, and capital efficient investments will drive us to sustain profitability while achieving our long-term goal of at least $700 million in revenue by 2028.
David Moatazedi: We are dedicated to building a sustainable leading performance speedy company and are grateful for the continued support and confidence of our customers and shareholders. Thank you for joining us today and for your ongoing commitment to Abilist.
David Moatazedi: We are dedicated to building a sustainable, leading performance beauty company and are grateful for the continued support and confidence of our customers and shareholders.
David Moatazedi: We're looking forward to seeing you on September 12th in our Investor Day in New York City. Thank you.
Speaker Change: Thank you for joining us today and for your ongoing commitment to Evolus. We're looking forward to seeing you on September 12th at our Investor Day in New York City.
Operator: Thank you. This concludes today's call. You may now disconnect your lines.
Operator: This concludes today's call. You may now disconnect your...
Speaker Change: Thank you. This concludes today's call. You may now disconnect your lines.
Speaker Change: www.thevenusproject.com www.thevenusproject.com
Speaker Change: www.globalonenessproject.org www.globalonenessproject.org