- Meeting date aligns with prior guidance - - FDA to review AEON’s analytical development plan and initial data - IRVINE, Calif., Oct. 01, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) as a BOTOX® (onabotulinumtoxinA) biosimilar, today announced that the U.S. Food and Drug Administration (FDA) has scheduled a Biosimilar Biological Product Development (BPD) Type 2a meeting for ABP-450 on November 19, 2 ...

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]

Core Points - AEON Biopharma has appointed Rob Bancroft as President and CEO, effective April 29, 2025, with Bancroft also joining the Board of Directors [1][2] - Bancroft has over 25 years of experience in the life sciences industry, including leadership roles at Revance Therapeutics and Allergan, where he was involved in the commercialization of BOTOX [2][3] - The company is focused on advancing its ABP-450 program along the 351(k) biosimilar regulatory pathway, aiming to bring ABP-450 to the U.S. market for all current and future BOTOX indications under a single FDA approval [2][3] Company Overview - AEON Biopharma is a clinical-stage biopharmaceutical company developing ABP-450 (prabotulinumtoxinA) for various therapeutic indications, initially targeting the neurosciences market [3] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic use as Jeuveau by Evolus and is manufactured in compliance with cGMP [3] - The product has been approved as a biosimilar in Mexico and India, with AEON holding exclusive rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [3]

Leadership Transition - Marc Forth is stepping down as President and CEO of AEON Biopharma, effective April 4, 2025, to pursue another opportunity, but will remain on the Board of Directors [1] - Jost Fischer, the current Chairman of the Board, will serve as Interim CEO while the Board searches for a permanent replacement [1][2] Company Progress and Strategy - AEON is making progress along a 351(k) biosimilar regulatory pathway to potentially bring ABP-450 to the U.S. market for all of BOTOX's approved and future therapeutic indications under a single FDA approval [2] - The company anticipates a Biosimilar BPD Type 2a meeting with the FDA in the second half of 2025, with current cash balance expected to support this process [2] Product Development - AEON is focused on developing its proprietary botulinum toxin complex, ABP-450, for debilitating medical conditions, initially targeting the neurosciences market [3] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use as Jeuveau by Evolus and is approved as a biosimilar in Mexico and India [3]

Core Insights - AEON Biopharma, Inc. is advancing its biosimilar development program for ABP-450, utilizing BOTOX as the reference product under the 351(k) regulatory pathway [2][3] - The company initiated primary analytical studies in Q4 2024 to support its regulatory efforts and plans to hold a BPD Type 2a meeting with the FDA in the second half of 2025 [6][7] - AEON closed a public offering in January 2025, raising gross proceeds of $20 million, which will fund its operational plans through 2025 [7] Financial Performance - As of December 31, 2024, AEON reported total current assets of $1.59 million, a decrease from $6.22 million in 2023 [13] - Total liabilities amounted to $31.71 million, down from $159.89 million in the previous year, indicating a significant reduction in financial obligations [14] - The company reported a net income of $2.08 million for Q4 2024, a recovery from a net loss of $26.24 million in Q4 2023 [16] Business Development - AEON is focused on developing its proprietary botulinum toxin complex, ABP-450, for various therapeutic indications, with an initial emphasis on the neurosciences market [5] - The product is already approved as a biosimilar in Mexico and India, and AEON holds exclusive rights for therapeutic indications in the U.S., Canada, and the EU [5][8] - The management team has extensive experience in biopharmaceutical and botulinum toxin development, positioning the company for future growth [8]

Group 1: Med Spa Industry Overview - The med spa industry has experienced significant growth, expanding sixfold from 2010 to 2023, with over 10,000 locations in the U.S. and average annual revenue per spa nearing $1.5 million [33] - In 2023, the med spa market was valued at $15 billion, with projections indicating a 15% annual growth rate moving forward [34] - The industry is characterized by a mix of medical and spa services, requiring medical professionals for certain procedures, but with relatively low barriers to entry [32] Group 2: Investment Opportunities - Limited direct investment opportunities exist in the med spa business, as many are privately held, but there are opportunities in the products sold, particularly dermal fillers and neurotoxins [34][35] - AbbVie, the owner of Botox, and Evolus, which specializes in aesthetic products like Jeuveau, are key players in this market, with Evolus expected to expand its product line to include fillers [35][37] - Evolus' unique cash pay business model allows for greater flexibility in pricing and marketing compared to competitors, potentially leading to higher profitability for injectors [36] Group 3: Competitive Landscape - Botox remains the market leader with a market share in the mid-60s, but faces increasing competition from Evolus and other neurotoxins, which have been gaining market share [39] - Evolus has reported a 30% year-over-year sales growth for Jeuveau, indicating strong demand and market penetration [39] - The overall market for neurotoxins and fillers is expected to grow at high single-digit to low double-digit rates, driven by increasing consumer demand [39]