Core Insights - AEON Biopharma has successfully completed its BPD Type 2a meeting with the FDA, marking a significant procedural milestone in the development of its biosimilar product ABP-450, which aims to compete with BOTOX [1][2][6] - Shareholders have approved key transactions that will enhance the company's financial position, including PIPE financing and the exchange of convertible notes with Daewoong Pharmaceutical, which will simplify AEON's capital structure and reduce outstanding debt [1][6] Company Overview - AEON Biopharma is focused on gaining accelerated and full-label access to the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually, through the development of ABP-450 as a biosimilar to BOTOX [4] - ABP-450 is manufactured by Daewoong Pharmaceutical under cGMP standards and is already approved as a biosimilar in India, Mexico, and the Philippines, with exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [4] Regulatory Context - The FDA regulates biosimilars under the Public Health Service Act's 351(k) pathway, requiring developers to demonstrate that their product is highly similar to an approved reference biologic without clinically meaningful differences in safety, purity, or potency [3]

Core Insights - Evolus Inc. is projected to double in value by 2026 despite recent challenges in consumer sentiment and inflationary pressures affecting demand for elective aesthetic procedures [1] - Mizuho has lowered Evolus's price target to $19 from $20 while maintaining an Outperform rating, reflecting a cautious outlook on the company's product estimates [1][3] Financial Performance - In Q3 2025, Evolus reported global net revenue of $69 million, a 13% year-over-year increase, driven by strong demand for its neurotoxin Jeuveau, which generated $63.2 million [2] - The new Hyaluronic Acid filler, Evolysse, contributed $5.7 million in revenue during the same quarter [2] - For the full year 2025, Evolus revised its total net revenue outlook to between $295 million and $305 million [2] Market Position and Challenges - Evolus holds a 14% market share in the US aesthetic neurotoxin market, supported by a customer loyalty program that has grown to over 1.3 million members, a 34% increase year-over-year [3] - The company added approximately 500 new purchasing accounts in Q3, indicating expansion in its professional customer base [3] - The US aesthetic market is facing challenges, particularly in consumer spending, with the HA filler market experiencing a double-digit decline, complicating Evolysse's market entry [3]

Summary of Evolus Conference Call Company Overview - Evolus is currently in a significant growth phase, having launched its second product, Evolysse, alongside its flagship product Jeuveau, which has established a strong market presence in the U.S. and Europe [2][3][4] Key Points and Arguments Product Development and Market Position - Jeuveau has been recognized as the fastest-growing brand in the U.S. aesthetic market, capturing mid-teens market share, marking the first time a company has achieved double-digit market share since the entry of the first two players [2][4] - Evolysse is positioned as a differentiated product utilizing new technology (COLDEX) for hyaluronic acid (HA) production, with plans to introduce a sculpt product for the mid-face in the upcoming year [3][4][22] - The company has built a customer base of 17,000 clinics across the U.S., which presents significant growth opportunities as it enters the second phase of commercialization [3][4] Market Dynamics and Performance - Despite a challenging macroeconomic environment, Evolus has reported double-digit growth, with Jeuveau continuing to grow in the U.S. and strong international performance, particularly in the U.K. [4][5][48] - The aesthetic market, particularly for neuromodulators, has historically shown resilience during economic downturns, although current conditions are presenting unique challenges [6][7][8] - The company anticipates a rebound in the market, driven by pent-up consumer demand, as consumers are currently delaying treatments due to economic pressures [8][9] Competitive Landscape - The competitive landscape includes established players like AbbVie and Galderma, with Evolus focusing on differentiating its products through quality and innovative marketing strategies [6][7][9] - Evolus has successfully positioned Jeuveau against Botox through head-to-head clinical trials, demonstrating superior efficacy in multiple endpoints [12][13][14] Consumer Trends and Marketing Strategy - There is a growing consumer trend towards preventive aesthetic treatments, with younger demographics increasingly seeking these services [7][8] - Evolus has launched a campaign to rebrand HA fillers, moving away from the term "filler" to "injectable HA," which has resonated positively with consumers [29][30] - The company is leveraging its loyalty program to encourage repeat purchases and cross-selling between Jeuveau and Evolysse [19][22] Financial Outlook and Business Development - Evolus has access to $100 million in capital for business development, with a focus on achieving profitability by the fourth quarter of 2025 and for the full year of 2026 [41][42][48] - The company expects to see sequential improvement in performance as it wraps around a depressed market base, with a strong international growth trajectory anticipated [46][47][48] Future Product Pipeline - The introduction of the Skulpt product is expected in the second half of 2026, which will complement the existing HA product line and enhance the company's market position [46][47] - Evolus is exploring opportunities in biostimulators and other innovative products to expand its portfolio [43][44] Additional Important Insights - The company has successfully reduced expenses by $25 million, positioning itself for profitability amidst a declining market [48] - Evolus is focused on building partnerships with clinics, emphasizing the importance of training and support for product adoption [20][21][25] This summary encapsulates the key insights from the Evolus conference call, highlighting the company's strategic direction, market dynamics, and future growth potential.

Financial Data and Key Metrics Changes - Global net revenue for Q3 2025 was $69 million, representing a 13% increase compared to Q3 2024 [30] - Gross margin for Q3 was reported at 66.5%, with adjusted gross margin at 67.6% [31] - Non-GAAP operating loss for Q3 was $3.1 million, an improvement from a loss of $6.7 million in Q3 2024 [35] Business Line Data and Key Metrics Changes - Jeuveau revenue for Q3 was $63.2 million, while Evolisse contributed $5.7 million [31] - The Evolus consumer loyalty program grew to over 1.3 million members, a 34% increase year-on-year [7] - Evolisse's revenue increased sequentially to approximately $5 million after initial stocking [14] Market Data and Key Metrics Changes - The U.S. aesthetic market remains down in single digits, but Jeuveau outperformed the category with unit volume growth year-to-date [10][12] - The company strengthened its market share to 14% in the U.S. year-to-date [13] Company Strategy and Development Direction - Evolus aims to achieve profitability in 2025 and sustainable annual profitability starting in 2026 [11][37] - The company is focusing on expanding its portfolio and has introduced a bundled offering to drive market share gains [15][56] - Evolus is actively pursuing strategic business development opportunities to expand its pipeline [29] Management's Comments on Operating Environment and Future Outlook - Management noted early signs of stabilization in consumer demand for injectables, despite challenges in the aesthetic market [11] - The company remains confident in navigating potential tariff impacts and maintaining financial performance [18][32] Other Important Information - Evolus submitted a PMA to the U.S. FDA for Evolve's Sculpt, with potential approval anticipated in 2026 [17] - The company has taken proactive measures to mitigate potential tariff impacts on pharmaceuticals, including Jeuveau [18][32] Q&A Session Summary Question: Can you discuss the dynamics of Evolisse and the impact of market sentiment? - Management highlighted that initial training is crucial for product adoption, with significant inflection points observed after second training sessions [44][45] - The market is currently facing challenges, but Q4 is expected to be stronger due to accumulated experience and seasonal factors [48] Question: What are the usage trends between Evolisse Smooth and Form? - Both products are used for the nasolabial fold, but Smooth is preferred for a softer effect while Form provides more structure [57][62] Question: Can you elaborate on the sequential growth for Jeuveau in Q3? - The company maintained consistent promotional efforts and engaged consumers through loyalty programs, which contributed to the growth [66] Question: What is the split between U.S. and international sales for Jeuveau? - The company does not provide detailed segment reporting but noted growth in both U.S. and international markets [71][73] Question: What are the potential impacts of tariffs on the business? - Management is closely monitoring tariff developments and has taken steps to mitigate potential impacts, including pulling forward inventory purchases [103][104]

Core Insights - The FDA has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for AEON's ABP-450 on November 19, 2025, which aligns with prior guidance [1][4] - The meeting will focus on AEON's analytical development plan under the 351(k) biosimilar pathway, aiming to establish alignment with the FDA on the analytical framework [2][3] Company Overview - AEON Biopharma is developing ABP-450 as a biosimilar to BOTOX, targeting the U.S. therapeutic neurotoxin market, which exceeds $3.0 billion annually [5] - ABP-450 is manufactured by Daewoong Pharmaceutical and is already approved as a biosimilar in India, Mexico, and the Philippines [5] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, the EU, the UK, and other territories [5]

Financial Data and Key Metrics Changes - Global net revenue for Q2 2025 was $69.4 million, a 4% increase compared to 2024, driven by the successful launch of Evolisse and international revenue growth [28] - Reported gross margin for Q2 was 65.3%, with adjusted gross margin at 66.5%, impacted by a higher mix of international sales and introductory pricing for Evolisse [28][29] - GAAP operating expenses for Q2 were $55.5 million, down from $61.8 million in Q1, while non-GAAP operating expenses were $54 million compared to $52.9 million in Q1 [30][31] - Non-GAAP operating loss in Q2 was $7.9 million, compared to non-GAAP operating income of $1.1 million in 2024 [31] Business Line Data and Key Metrics Changes - Jeuveau experienced its first year-over-year decrease since launch, reflecting a decline in consumer sentiment and procedural volumes in the U.S. aesthetic toxin market [6][8] - Evolisse generated $9.7 million in revenue in its first quarter, marking the strongest first-quarter filler launch in over a decade [18] - The company maintained a 14% market share in the toxin market through the first half of the year, an increase from 13% in 2024 [15] Market Data and Key Metrics Changes - Procedural volumes in the U.S. toxin category have decreased over the past three consecutive quarters, with a notable impact on Jeuveau demand in Q2 [8][10] - Surveys indicated a potential rebound in patient volume in the second half of the year, with a majority of practices expecting growth of over 10% [9] Company Strategy and Development Direction - The company revised its 2025 revenue guidance to a range of $295 million to $305 million, reflecting 11% to 15% growth over 2024 [11][34] - Evolisse is expected to contribute 10% to 12% of total revenue for 2025, with a focus on maintaining long-term growth and profitability [20][34] - The company aims to achieve $700 million in revenue by 2028, with a non-GAAP operating income margin of 20% [33][34] Management's Comments on Operating Environment and Future Outlook - Management noted that the market environment has been challenging, with a significant slowdown in demand observed in the last two weeks of Q2 [6][10] - Despite the challenges, management expressed confidence in the company's ability to deliver sustainable growth, supported by strong early adoption of Evolisse and ongoing international expansion [21][90] Other Important Information - The company has implemented strategic reductions in operating expenses, resulting in over $25 million in annualized savings, while maintaining investment in customer-facing activities [13][34] - Evolus Rewards program saw record redemptions of over $224,000, with 65% coming from repeat patients, indicating strong brand loyalty [16] Q&A Session Summary Question: What dynamics are being seen regarding reduced demand? - Management indicated that procedural demand declined in the high single digits, with the slowdown not driven by competitive dynamics but rather overall market conditions [36][38] Question: What was the impact of inventory buying on recorded revenue? - Management suggested that the initial revenue from Evolisse included both stocking and pull-through elements, making it difficult to quantify precisely [40] Question: How do you explain the improvement seen in July? - Management noted a significant shift in business in July, correlating with internal and third-party research indicating a potential rebound [41] Question: What are the expectations for toxin demand trends? - Management highlighted that overall procedural volume did slow in the first half of the year, with some competitors experiencing significant declines [51] Question: What promotional activities are planned for Q4? - Management mentioned adjustments to promotional strategies to help practices with pull-through, including collaborations with beauty magazines [54] Question: What is driving the current consumer sentiment? - Management noted that consumers earning $150,000 or less are feeling the pinch from increased prices and tariffs, impacting their spending on aesthetic treatments [67] Question: How does the company plan to achieve its 2028 targets? - Management reiterated confidence in reaching the $700 million target, emphasizing that the revised guidance does not change the long-term outlook [87]

Core Insights - AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for various therapeutic indications [1][3] - The company will present a corporate overview at the Aegis Capital Corp. 2025 Virtual Conference on May 21, 2025 [1] Company Overview - AEON is developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, for debilitating medical conditions [3] - ABP-450 is the same botulinum toxin complex marketed for cosmetic uses under the name Jeuveau by Evolus [3] - The product is manufactured by Daewoong in compliance with current Good Manufacturing Practice (cGMP) and is approved by the U.S. FDA, Health Canada, and the European Medicines Agency [3] - ABP-450 is approved as a biosimilar in Mexico and India [3] - AEON holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other international territories [3] - The company has a highly experienced management team with expertise in biopharmaceutical and botulinum toxin development and commercialization [3]

Financial Data and Key Metrics Changes - Evolus reported global net revenue of $68.5 million for Q1 2025, representing a 15.5% increase compared to Q1 2024, supported by a strong commercial engine [6][15][12] - The company achieved a gross margin of 68.1% and an adjusted gross margin of 69.2% for the first quarter [18] - Non-GAAP operating loss for Q1 was $500,000, an improvement from a loss of $900,000 in Q1 2024, with expectations of achieving profitability in Q4 2025 [21][28] Business Line Data and Key Metrics Changes - Product revenue accounted for approximately 94% of total sales, with a customer reorder rate of about 70% [15] - The company added 675 new purchasing accounts, bringing the total to over 16,000, indicating strong market penetration [7] - The loyalty program saw over 220,000 redemptions, with 65% from existing consumers, highlighting high consumer satisfaction [8] Market Data and Key Metrics Changes - Evolus gained a 14% market share by the end of 2024, exceeding initial guidance, and continued to gain share in Q1 2025 [17] - International revenue contribution increased and is expected to outpace U.S. growth, validating the strong growth trajectory of the toxin business outside the U.S. [16] - The company reduced its toxin market growth expectation to low single digits for 2025, reflecting a more conservative outlook [6][17] Company Strategy and Development Direction - Evolus is transitioning into a multiproduct company with the launch of Evolisse, aiming to redefine the category and capture market share [8][11] - The company is focused on building long-term customer relationships and deepening its presence within existing accounts [11] - Evolus aims to achieve total net revenue of at least $700 million by 2028, with a compounded annual growth rate of 27% from 2024 [24][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate a challenging market environment while maintaining growth [14][12] - The early success of Evolisse is seen as a momentum builder, reinforcing growth across the portfolio [12] - Management reiterated full-year revenue guidance of $345 million to $355 million, projecting continued growth above 30% [27][28] Other Important Information - The company has taken proactive steps to strengthen its balance sheet through debt refinancing, reducing interest expenses and increasing cash generation [22][23] - Evolus is closely monitoring tariff impacts on its products, with limited exposure expected for 2025 [18][19] Q&A Session Summary Question: Market trends and demand changes - Management indicated that both macroeconomic factors and negative sentiment around the term "filler" are impacting demand, but they see an opportunity to revive the market segment [30][32] Question: Impact of AbbVie's loyalty program changes - Management acknowledged the impact of AbbVie's loyalty program changes on market dynamics but believes they continue to gain share despite this [44][46] Question: Confidence in 2025 revenue guidance - Management reiterated confidence in 2025 guidance due to accelerated share uptake despite slower market growth [54][56] Question: Early adopters of Evolisse - The initial adoption of Evolisse is primarily among existing customers, with high interest in trialing the product [65][66] Question: Seasonality and market softness - Management noted a consistent seasonal pattern but acknowledged slight slowing in new patient starts, impacting overall market dynamics [70][78]

Financial Data and Key Metrics Changes - Evolus reported global net revenue of $68.5 million for Q1 2025, representing a 15.5% increase compared to Q1 2024 [15][26] - The gross margin for Q1 was reported at 68.1%, with an adjusted gross margin of 69.2% [18] - Non-GAAP operating loss for Q1 was $500,000, an improvement from a loss of $900,000 in Q1 2024 [21] Business Line Data and Key Metrics Changes - Product revenue accounted for approximately 94% of total sales, with a customer reorder rate of about 70% [15][16] - The company added 675 new purchasing accounts, bringing the total to over 16,000 [7] - The repeat treatment rate for Jeuveau indicates strong consumer loyalty, with over 220,000 redemptions in the loyalty program, 65% from existing consumers [7] Market Data and Key Metrics Changes - Evolus gained a 14% market share by the end of 2024, which is 1% above the initial guidance for 2025 [17] - International revenue contribution is increasing and is expected to outpace U.S. growth [16] - The company has reduced its toxin market growth expectation to low single digits for 2025 [6][17] Company Strategy and Development Direction - Evolus is transitioning into a multiproduct company with the launch of Evolisse, aiming to redefine the market narrative around fillers [8][11] - The company is focused on building long-term customer relationships and deepening its presence within existing accounts [11] - Evolus is reaffirming its full-year revenue guidance of $345 million to $355 million, targeting over 30% growth for the sixth consecutive year [12][26] Management's Comments on Operating Environment and Future Outlook - Management noted a cautious market environment but expressed confidence in the company's ability to capture market share and drive growth [6][12] - The early success of Evolisse is seen as a momentum builder for the company, reinforcing growth across its product portfolio [12] - Management remains optimistic about achieving at least $700 million in net revenue by 2028, with a target of 20% non-GAAP operating income margin [26][83] Other Important Information - The company has taken proactive steps to strengthen its balance sheet through debt refinancing, reducing interest expenses and increasing cash generation [14][22] - The impact of tariffs on the injectable hyaluronic acid gel is estimated to be less than $2 million for 2025, and the company has incorporated this into its planning [18][19] Q&A Session Summary Question: Market trends and demand changes - Management indicated that both macroeconomic factors and negative sentiment around the term "filler" are impacting demand, but they see an opportunity to revive the market segment with their new product [30][32] Question: Impact of AbbVie's loyalty program changes - Management acknowledged the impact of AbbVie's loyalty program changes on market dynamics but emphasized that they continue to gain market share despite these challenges [42][45] Question: Confidence in 2025 revenue guidance - Management reiterated confidence in the 2025 revenue guidance due to accelerated share uptake and strong performance in a challenging market [49][51] Question: Early adopters of Evolisse - The early adopters of Evolisse include existing customers, with a high interest in trialing the product, indicating strong initial feedback [58][59] Question: Seasonal market trends - Management noted a consistent seasonal pattern in the market, with Q4 typically being the strongest quarter, and they expect a bounce back in Q2 [62][65] Question: Broader market softness - Management reported slight slowing in new patient starts but noted that existing patients continue to engage with the product [71][73]

Group 1 - AEON Biopharma has appointed Rob Bancroft as President and CEO, and the Compensation Committee has approved inducement awards for him [1] - Mr. Bancroft will receive a non-qualified stock option to purchase 59,034 shares of AEON Class A common stock and 177,103 restricted stock units (RSUs) under the 2025 Employment Inducement Incentive Award Plan [2][3] - The stock option and RSUs will vest over four years, with 25% vesting on each annual anniversary of the vesting commencement date [3] Group 2 - AEON Biopharma is focused on developing its proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, initially targeting the neurosciences market [4] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use by Evolus under the name Jeuveau and is manufactured in compliance with cGMP [4] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories [4]