Financial Performance - Net income for 2024 was $42,005,000, compared to a net loss of $323,954,000 in 2023, representing a turnaround of approximately $365,959,000[578]. - Basic net income per share improved from a loss of $627.33 in 2023 to a profit of $77.74 in 2024[578]. - The company reported a segment net income of $42,005 thousand for the year ended December 31, 2024, compared to a net loss of $323,954 thousand for the year ended December 31, 2023[601]. - The company experienced recurring losses from operations, raising substantial doubt about its ability to continue as a going concern[569]. - The company has substantial doubt about its ability to continue as a going concern due to recurring losses and negative cash flows from operations[592]. - The company reported an accumulated deficit of $431.6 million as of December 31, 2024[588]. - The total stockholders' deficit improved from $(153,044,000) in 2023 to $(28,569,000) in 2024, a positive change of approximately 81.3%[575]. - Total operating costs and expenses for the year ended December 31, 2024, were $72,985 thousand, significantly lower than $318,442 thousand for the previous year[601]. - The company incurred professional and legal fees of $6,233 thousand in 2024, up from $5,499 thousand in 2023, indicating a rise of about 13%[601]. - The company experienced a net cash used in operating activities of $20,292, an improvement from $26,080 in the previous year[582]. Clinical Development - The Phase 2 clinical study of ABP-450 for cervical dystonia enrolled 59 patients across approximately 20 sites in the U.S., with a treatment cycle consisting of one treatment cycle tailored to individual patient needs[57]. - ABP-450 met the primary endpoint of safety and tolerability, with zero discontinuations due to treatment-emergent adverse events (TEAEs) and a low rate of treatment-related TEAEs[59]. - TWSTRS scores improved by 14.01 points in the 150 unit arm, 11.28 points in the 250 unit arm, and 9.92 points in the 350 unit arm, compared to a 3.57 point improvement in the placebo group, indicating statistically significant changes[60]. - The median duration of treatment effect for all three treatment arms was at least 20 weeks[61]. - The company acknowledges the need for additional funding to continue the development of ABP-450 for cervical dystonia, including Phase 3 clinical trials[61]. - AEON Biopharma announced the discontinuation of its Phase 2 clinical trials for episodic and chronic migraine in May 2024 due to not meeting primary or secondary endpoints[589]. Market and Competitive Landscape - The global therapeutic botulinum toxin market is projected to grow, with the current market leader holding approximately 95% market share in the US therapeutic market as of 2019[79]. - The estimated market for episodic migraine treatments is $18.5 billion, with ABP-450 aiming to enhance safety and tolerability for patients[82]. - The pharmaceutical industry is highly competitive, with many competitors having greater resources for R&D, marketing, and promotion[99]. - ABP-450 will compete directly with other injectable botulinum toxins, including Botox, Dysport, Xeomin, Myobloc, and Daxxify, which are already approved for various therapeutic uses[102]. - The company faces competition from CGRP agonists for the preventative treatment of chronic migraine, including Aimovig, Ajovy, and Emgality, which are self-administered[106]. Regulatory and Compliance - The FDA requires a comprehensive process for marketing approval of biological products, including nonclinical tests, clinical studies, and submission of a Biologics License Application (BLA)[109]. - The company plans to submit an original Biologics License Application (BLA) for its product candidate ABP-450 after developing necessary safety and efficacy data[119]. - The FDA's goal is to review standard BLA applications within ten months and priority review applications within six months after acceptance for filing[124]. - The FDA may require substantial post-approval testing and surveillance to monitor the product's safety and efficacy, which could affect market potential[130]. - The company must comply with ongoing FDA regulations, including record-keeping and reporting of adverse experiences, after product approval[139]. - The FDA may condition approval of a BLA on the requirement for post-marketing studies to further assess safety and effectiveness[130]. - The BPCIA allows for a biosimilar application to be submitted only four years after the reference product's first licensure, with a twelve-year exclusivity period for the reference product[146]. - In the EEA, new products receive eight years of data exclusivity and an additional two years of market exclusivity upon marketing authorization[152]. - The market exclusivity period in the EEA prevents generic or biosimilar applicants from commercializing their products for ten years from the initial authorization of the reference product[154]. - The approval process for products varies significantly across countries, impacting the timeline for clinical studies and marketing[160]. Financial Position and Funding - The company expects to have sufficient cash to fund its operating plan into Q4 2025, including $18.3 million in net proceeds from a public offering in January 2025[53]. - The company raised $197 million for investment in AEON since 2019, including $20 million in gross proceeds from a public offering in January 2025[82]. - The company is preparing for a potential Biosimilar Biological Product Development Type 2a meeting with the FDA in the second half of 2025[75]. - The company entered into an at-the-market sales agreement with Leerink Partners, allowing for gross proceeds of up to $50 million, with $49.8 million remaining available as of December 31, 2024[591]. - The company relies exclusively on Daewoong Pharmaceutical Co., Ltd. for the manufacturing of its source material, which poses a risk if the agreement is terminated[604]. Intellectual Property - A patent for a treatment paradigm involving fewer injections for migraine was issued in November 2023, enhancing the company's intellectual property portfolio[94]. - The company currently owns one issued patent and has six pending Patent Cooperation Treaty international patent applications related to ABP-450, which could expire in 2040 if issued[95]. - The company relies on trade secrets, know-how, and confidentiality agreements to protect proprietary information, although these may be breached[98]. Operational Challenges - The company is subject to significant federal, state, and local regulations, which govern various aspects of product development and marketing[108]. - Non-compliance with healthcare regulations can lead to severe penalties, including exclusion from federal healthcare programs[162]. - Coverage and reimbursement for products in the U.S. depend on third-party payors, which may challenge pricing and medical necessity[163]. - Third-party payors may require additional studies to demonstrate cost-effectiveness, increasing the financial burden on the company[164]. - The cost of preparing and submitting a BLA is substantial, and the submission is subject to a significant application fee and annual program fees[123].

Financial Performance - AEON Biopharma reported a net income of $2.083 million for Q4 2024, compared to a net loss of $26.241 million in Q4 2023[17]. - Research and development expenses for the year 2024 were $14.181 million, compared to $13.243 million in 2023, reflecting an increase of about 7.1%[17]. - The company’s accumulated deficit improved from $(473.602) million in 2023 to $(431.597) million in 2024, a reduction of approximately 8.9%[15]. Capital and Funding - The company closed a public offering on January 7, 2025, raising gross proceeds of $20.0 million, which will fund operations through 2025[5][6]. - Approximately 89% of the Series B warrants from the public offering have been exercised as of March 21, 2025[6]. Assets and Liabilities - Total current assets decreased from $6.222 million in 2023 to $1.590 million in 2024, a decline of approximately 74.5%[15]. - Current liabilities increased from $13.049 million in 2023 to $14.149 million in 2024, an increase of about 8.4%[15]. - The total liabilities decreased significantly from $159.889 million in 2023 to $31.711 million in 2024, a reduction of approximately 80.2%[15]. Regulatory and Development Activities - AEON is pursuing a 351(k) regulatory pathway for ABP-450, with primary analytical studies initiated in Q4 2024[4][2]. - The company plans to hold a Biosimilar Biological Product Development Type 2a meeting with the FDA in the second half of 2025[4]. Corporate Changes - The merger resulted in the historical financial statements of AEON Biopharma Sub, Inc. becoming the historical financial statements of the combined Company[19]. - The financial statements reflect the Successor periods for the three months ended December 31, 2024, and December 31, 2023, as well as the year ended December 31, 2024[21]. - A reverse stock split at a ratio of 1-for-72 was effectuated on February 24, 2025, combining 72 pre-split shares into one new share of Common Stock[22].

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]

Company Overview - AEON Biopharma, Inc. is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway [1][3] - The company is developing its proprietary product, ABP-450 (prabotulinumtoxinA) injection, targeting debilitating medical conditions, with an initial focus on the neurosciences market [3] - ABP-450 is the same botulinum toxin complex currently marketed for cosmetic use by Evolus under the name Jeuveau [3] - The product is manufactured by Daewoong in compliance with current Good Manufacturing Practice (cGMP) and has been 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, and AEON holds exclusive development and distribution rights for therapeutic indications in the U.S., Canada, EU, UK, and other territories [3] Upcoming Events - Marc Forth, AEON's President and CEO, will present a corporate overview at the Leerink Global Healthcare Conference from March 10 to 12, 2025, in Miami, FL [1] - The corporate presentation is scheduled for March 10 at 1:00-1:30 PM ET [2]

Core Points - AEON Biopharma, Inc. announced a 1-for-72 reverse stock split to comply with NYSE American requirements [1][2] - The reverse stock split will take effect on February 26, 2025, with trading resuming under the existing ticker symbol "AEON" [2] - The ownership percentage of each stockholder will remain unchanged, except for fractional shares, which will be rounded up [3] Company Overview - AEON is a clinical-stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450, for medical conditions, particularly in the neurosciences market [5] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use by Evolus under the name Jeuveau and is approved as a biosimilar in Mexico and India [5] - The company has exclusive rights for therapeutic indications of ABP-450 in the U.S., Canada, EU, UK, and other territories, and has a management team experienced in biopharmaceutical development [5]

Core Viewpoint - AEON Biopharma, Inc. is facing non-compliance with NYSE American listing standards due to a stockholders' deficit of $32.1 million and reported losses in two of the last three fiscal years [1][2] Group 1: Compliance and Regulatory Actions - AEON must submit a plan to regain compliance by March 5, 2025, with a deadline to meet listing standards by August 3, 2026 [2] - If the plan is accepted, AEON will undergo periodic reviews; failure to comply may lead to delisting proceedings [2] - The notice does not immediately affect the trading status of AEON's common stock, which will continue to trade under the symbol "AEON" with a ".BC" designation indicating non-compliance [3] Group 2: Company Overview - AEON is a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex, ABP-450, for medical conditions, particularly in the neurosciences market [5] - ABP-450 is the same product marketed for cosmetic use as Jeuveau and is approved as a biosimilar in Mexico and India [5] - The company has exclusive rights for therapeutic indications of ABP-450 in several regions, including the U.S., Canada, and the EU [5]

Core Points - AEON Biopharma, Inc. has successfully closed a public offering, raising approximately $20.0 million in gross proceeds [1][4] - The offering included 40,000,000 Common Units, each comprising one share of Common Stock and two types of warrants (Series A and Series B) with an exercise price of $0.625 [2][3] - Aegis Capital Corp. acted as the sole book-running manager for the offering and has a 45-day option to purchase additional shares and warrants to cover over-allotments [3][5] Financial Details - The public offering price per Common Unit was set at $0.50, and the total gross proceeds were approximately $20.0 million before expenses [1][4] - The Series A and Series B Warrants are exercisable following stockholder approval and have different expiration periods of 60 months and 30 months, respectively [2][3] Company Overview - AEON Biopharma is focused on developing a proprietary botulinum toxin complex, ABP-450, for medical conditions, with an initial emphasis on the neurosciences market [7][8] - ABP-450 is the same botulinum toxin complex marketed for cosmetic use under the name Jeuveau and is approved as a biosimilar in Mexico and India [8] - The company holds exclusive development and distribution rights for therapeutic indications of ABP-450 in several regions, including the U.S., Canada, and the EU [8]

IRVINE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (NYSE:AEON) (the "Company"), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced the pricing of a firm commitment underwritten public offering with gross proceeds to the Company expected to be approximately $20.0 million, before deducting underwriting fees and other estimated offering expenses payable by the Company. The offering consists of 40,000, ...

IRVINE, Calif., Jan. 03, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. ("AEON" or the "Company") (NYSE:AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex under a 351(k) biosimilar pathway, today announced that it has commenced a public offering (the "Offering") to offer and sell units, consisting of (i) shares of Common Stock (or pre-funded warrants in lieu thereof) and (ii) warrants to purchase shares of Common Stock. In addition, the Company expects to grant ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 2024 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-40021 AEON Biopharma, Inc. (Exact name of registrant as specified in its charter) Delaware 85-3940478 (St ...