Onabotulinumtoxin A

– Continue to conduct analytical studies to prepare for a potential Biosimilar Biological Product Development (“BPD”) Type 2a meeting with the FDA in the second half of 2025 – – Pursuing a 351(k) regulatory pathway for ABP-450, which offers potential access to the U.S. market under a single approval for all of BOTOX’s currently approved and future therapeutic indications – – Appointed Rob Bancroft as the Company’s President and Chief Executive Officer; Mr. Bancroft also joined AEON’s Board of Directors – IRVINE, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- AEON Biopharma, Inc. (“AEON” or the “Company”) (NYSE: AEON), a clinical-stage biopharmaceutical company focused on developing a botulinum toxin complex for the treatment of multiple therapeutic indications, announced its financial results for the first quarter ended March 31, 2025, and provided a business update. “I am excited to report that our team is quickly advancing the biosimilar development program for ABP-450 under the 351(k) regulatory pathway utilizing BOTOX as the reference product. By utilizing this pathway, we plan to bring ABP-450 to the U.S. market under a single FDA approval that could cover all of BOTOX’s currently approved and future therapeutic indications,” commented Rob Bancroft, AEON’s President and Chief Executive Officer. “We are making progress in conducting the primary analytical studies. Once the initial analytical studies are completed, we will be able to conduct the primary comparative analytical assessment, which the FDA will evaluate at our Biosimilar BPD Type 2a meeting and determine the next steps for the program.” “Once we successfully complete the FDA's rigorous approval process for ABP-450 as a biosimilar to Botox, we believe our therapeutic neurotoxin has the potential to offer a more economically viable solution that would enhance patient access and optimize cost-efficiency for payers and healthcare providers. These changes would likely be widely welcomed by these stakeholders, given the current dynamics of the therapeutic toxin market, which is estimated to be at least $3.3 billion worldwide and predominantly controlled by a single toxin,” concluded Mr. Bancroft. Recent Clinical and Corporate Highlights Advancing its development plan for ABP-450 utilizing 351(k) regulatory pathway for biosimilars – The Company is pursuing a 351(k) biosimilar regulatory pathway for ABP-450 (prabotulinumtoxinA) injection, using BOTOX® (onabotulinumtoxinA) as a proposed reference product for all of the therapeutic indications for which BOTOX is approved. The Company believes it is aligned with the FDA on the initial key requirements to proceed with the 351(k) regulatory pathway. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Management Changes – The Company appointed Rob Bancroft as President and Chief Executive Officer, effective April 29, 2025. He was also appointed to the Company’s Board of Directors. Mr. Bancroft has over 25 years of leadership experience in the life sciences industry, spanning biopharmaceuticals, medical devices, and healthcare technology. Prior to joining AEON, he served as General Manager of the Therapeutics business at Revance Therapeutics, where he led the launch of Daxxify® in cervical dystonia with a novel strategy that prioritized expert endorsement, payer coverage, and reimbursement infrastructure ahead of broader investment - driving strong early adoption and differentiated positioning in the $3.3 billion botulinum toxin therapeutics market. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. Liquidity and Capital Resources – The Company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to be sufficient to fund the Company’s operating plan through the fourth quarter of 2025 and its planned BPD Type 2a meeting with the FDA targeted in the second half of 2025. NYSE American Listing – AEON recently announced the NYSE American LLC (“NYSE American”) accepted the Company's previously submitted plan to regain compliance with continued listing standards relating to minimum market capitalization and stockholders' equity. The NYSE American granted the Company until August 3, 2026 to regain compliance with the continued listing standards, subject to the Company’s continued monitoring by NYSE American in the interim. The Company continues to conduct the primary analytical studies to fulfill the standard regulatory requirements for a comparative analytical assessment (CAA). Extensive preclinical toxicology and other data have been previously generated by the Company’s licensing partner. The Company plans to hold a Biosimilar Biological Product Development (BPD) Type 2a meeting with FDA in the second half of 2025 to discuss the outcome from these studies and determine the next steps in development. Former CEO, Marc Forth, to remain as a member of the Company’s Board of Directors, through which he will continue to advise the Company’s management team and provide strategic guidance. About AEON Biopharma AEON is a clinical stage biopharmaceutical company focused on developing its proprietary botulinum toxin complex, ABP-450 (prabotulinumtoxinA) injection, or ABP-450, for debilitating medical conditions. ABP-450 is the same botulinum toxin complex that is currently approved and marketed for cosmetic indications by Evolus under the name Jeuveau. ABP-450 is manufactured by Daewoong in compliance with current Good Manufacturing Practice, or cGMP, in a facility that has been approved by the U.S. Food and Drug Administration, Health Canada and European Medicines Agency. The product is approved as a biosimilar in Mexico and India. AEON has exclusive development and distribution rights for therapeutic indications of ABP-450 in the United States, Canada, the European Union, the United Kingdom, and certain other international territories. The Company has built a highly experienced management team with specific experience in biopharmaceutical and botulinum toxin development and commercialization. To learn more about AEON, visit www.aeonbiopharma.com. Forward-Looking Statements Certain statements in this press release may be considered forward-looking statements. Forward-looking statements generally relate to future events or AEON’s future financial or operating performance. For example, statements regarding meetings with the FDA, the timing of primary comparative analytical studies, and potential determination that ABP-450 is highly similar to the reference product for currently approved and future therapeutic indications are forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as "plan", "possible", "forecast", "expect", "intend", "will", "estimate", "anticipate", "believe", "predict", "potential" or "continue", or the negatives of these terms or variations of them or similar terminology. Such forward-looking statements are subject to risks, uncertainties, and other factors which could cause actual results to differ materially from those expressed or implied by such forward-looking statements. These forward-looking statements are based upon estimates and assumptions that, while considered reasonable by AEON and its management, are inherently uncertain. Factors that may cause actual results to differ materially from current expectations include, but are not limited to: (i) the outcome of any legal proceedings that may be instituted against AEON or others; (ii) AEON’s future capital requirements; (iii) AEON’s ability to raise financing in the future; (iv) AEON’s ability to continue to meet continued stock exchange listing standards; (v) the possibility that AEON may be adversely affected by other economic, business, regulatory, and/or competitive factors; (vi) the outcomes from any meetings or discussions with regulatory authorities; and (vii) other risks and uncertainties set forth in the section entitled “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements” in the Company’s filings with the Securities and Exchange Commission (the "SEC"), which are available on the SEC’s website at www.sec.gov. Nothing in this press release should be regarded as a representation by any person that the forward-looking statements set forth herein will be achieved or that any of the contemplated results of such forward-looking statements will be achieved. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. AEON does not undertake any duty to update these forward-looking statements. Contacts Investor Contact: Corey Davis, Ph.D. LifeSci Advisors +1 212 915 2577 cdavis@lifesciadvisors.com Source: AEON Biopharma The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America (“U.S. GAAP”) and include the accounts of the Company and its controlled subsidiaries.

Should pharmaceutical-specific tariffs come down, AbbVie expects the impact on its operations to be “in line with our peers,” the company's CEO said Friday. With the potential for pharmaceutical import tariffs spurring a rush of life sciences investments in the U.S., AbbVie is joining the trend with plans to spend billions in the country over the next decade.AbbVie aims to invest $10 billion in the U.S. through 2035 to support its current growth plans and expand into new areas like obesity, the Chicago drugmaker’s CEO, Rob Michael, said on a call with analysts Friday.AbbVie’s executives did not go into the fine details of the domestic investment plan on the call, though the company’s CFO Scott Reents noted that a portion of the sum will be earmarked to build four new U.S. production facilities devoted to active pharmaceutical ingredients (API), drug product, peptides and devices.The company, like many of its pharma peers, is bracing for potential sector-specific tariffs on pharmaceuticals under the Trump administration, which has made import duties a cornerstone of its trade policy.Pharmaceuticals were exempt from an initial round of reciprocal tariffs President Donald Trump unveiled in early April, though comments from the administration and an ongoing probe into drug imports suggest the biopharma industry will soon face levies of its own. Should those pharmaceutical-specific tariffs come down, AbbVie expects the impact on its operations to be “in line with our peers,” Michael said on the call.He credited that expected resilience to AbbVie’s already-strong manufacturing presence in the U.S., which boasts a workforce of 6,000 employees across 11 sites producing API, small molecules, biologics and toxins. Plus, AbbVie’s top-selling drug, Skyrizi, is made in the U.S., the CEO added.Nevertheless, AbbVie is bracing for potential near-term headwinds if pharmaceutical tariffs touch down, said CFO Reents.“We are actively preparing for a number of potential scenarios and would expect to put into place mitigation strategies as we have more information relevant to these dynamics,” he explained.While the manufacturing expansion constitutes AbbVie’s long-term strategy, the company could explore alternative API sources or implement “productivity initiatives” to weather any trade turbulence in the near term, Michael said.“I think what’s more challenging is trying to pass the tariff impacts to our customers, especially with penalties in the government channel and with existing contracts in the commercial setting,” the CEO said. “So, I don’t see that as a viable source for mitigation.”During the call, the executives also reflected on AbbVie’s policy preference in light of expected tariffs.“As we continue to invest and grow our U.S. operational footprint, we believe a more competitive tax policy, building on what was accomplished through 2017 tax reform, will encourage a sustainable shift towards U.S. manufacturing over the long term,” Reents explained.The executives made their remarks as AbbVie reported $13.34 billion in first-quarter revenues for 2025, good for an 8.4% increase year over year. The company’s first-quarter earnings haul beat Wall Street estimates of $12.9 billion, according to a note from analysts at William Blair.Immunology sales continued to lead the charge, with the company’s bell cow Skyrizi trumping up roughly $3.43 billion for the period. Rinvoq also performed well, growing sales 57% to $1.7 billion.Meanwhile, Humira—which is now facing biosimilar erosion on all fronts—experienced a sales drop of 50% to $1.12 billion in the quarter.Humira now comprises just 8% of AbbVie’s total revenue, down 3% quarter over quarter, analysts at Citi wrote in a Friday note to clients. The continued downturn of the former megablockbuster reflects its “diminishing importance on topline growth,” the team said.Looking ahead, AbbVie is boosting its guidance for the year and now expects to bring home full-year sales of $59.7 billion, up $700 million from the company’s previous forecast, Reents said on the call.The CFO attributed that adjustment to updated predictions for a number of AbbVie’s key drugs, including Skyrizi in psoriasis and IBD, Rinvoq across all its indications, and lower Humira sales, he explained. The company also expects sales of Botox, Imbruvica, Venclexta and its oral CGRPs to come in modestly above its previous predictions for the full year, Reents said. AbbVie is just the latest major drugmaker to beef up its U.S. investment as the threat of pharmaceutical tariffs loom.This week alone, Thermo Fisher, Regeneron and Roche revealed major outlays in the States.Prior to that, Novartis, Eli Lilly and Johnson & Johnson have made major pledges to increase their U.S. footprints, unveiling investments ranging from $23 billion to $55 billion.