AEON Biopharma(US:AEON)2024-08-12 20:05Financial Performance - AEON Biopharma has an accumulated deficit of $427.5 million as of June 30, 2024, and has never generated revenue from ABP-450[159]. - Losses from operations for the three months ended June 30, 2024, were $7.8 million, compared to $18.1 million for the same period in 2023[159]. - Consolidated net income for the three months ended June 30, 2024, was $164.1 million, while the loss for the same period in 2023 was $15.4 million[159]. - The company reported a net income of $164.1 million for the three months ended June 30, 2024, compared to a net loss of $(15.4) million for the same period in 2023[188]. - Basic and diluted net income per share for the three months ended June 30, 2024, was $4.22, compared to a loss of $(0.11) per share for the same period in 2023[188]. - Other income was $10.6 million for the three months ended June 30, 2024, compared to a loss of $1.4 million for the same period in 2023[194]. - A loss of $33.2 million was recorded for other income (loss), net for the six months ended June 30, 2024, compared to a loss of $6.0 million for the same period in 2023[195]. - The net cash used in operating activities for the six months ended June 30, 2024, was $16.7 million, with a net income of $46.1 million and non-cash charges totaling $60.8 million[213]. - Net cash used in operating activities for the six months ended June 30, 2023, was $21.1 million, primarily due to a net loss of $33.0 million and non-cash items of $8.7 million[214]. - Net cash provided by financing activities for the six months ended June 30, 2024, and June 30, 2023, were $15.0 million and $14.0 million, respectively, mainly related to the issuance of convertible notes[216]. Research and Development - A Phase 2 study of ABP-450 for cervical dystonia met all primary endpoints, supporting further development[158]. - The company has completed enrollment for a Phase 2 study of ABP-450 for chronic and episodic migraine, but these trials did not meet their primary endpoints[153]. - The company expects R&D expenses to continue to increase as it develops and initiates a Phase 3 study of ABP-450 in cervical dystonia and a Phase 2 study for gastroparesis[178]. - R&D expenses for the three months ended June 30, 2024, were $4.4 million, a decrease of $4.6 million, or 51%, compared to $9.0 million for the same period in 2023[192]. - R&D expenses decreased by $8.1 million, or 44%, to $10.2 million for the six months ended June 30, 2024, compared to $18.2 million for the same period in 2023[193]. Cash Position and Financing - AEON Biopharma has $3.4 million in cash and cash equivalents as of June 30, 2024, and substantial doubt exists about its ability to continue as a going concern without additional financing[159]. - The company expects to have sufficient cash to fund operations into the fourth quarter of 2024 but is actively seeking additional capital[205]. - AEON Biopharma entered into a Subscription Agreement for Convertible Notes totaling up to $15.0 million to support late-stage clinical development of ABP-450[168]. Market and Regulatory Pathway - The global therapeutic botulinum toxin market is estimated at $3.0 billion and projected to grow to $4.4 billion by 2027[152]. - AEON Biopharma plans to pursue a 351(k) biosimilar regulatory pathway for ABP-450, using AbbVie Inc.'s Botox as a reference product[153]. - The company has entered into a License Agreement Amendment with Daewoong, which includes a Termination Purchase Right for $1.00 if certain conditions are met[171]. Operating Expenses - SG&A expenses for the three months ended June 30, 2024, were $3.3 million, a decrease of $1.6 million, or 33%, compared to $4.9 million for the same period in 2023[189]. - The company anticipates increased SG&A expenses in the future to support ongoing R&D activities and compliance with public company requirements[177]. - The company expects to incur significant expenses related to building its commercialization infrastructure for ABP-450[160]. - The company expects to incur additional annual expenses related to being a public company, including liability insurance and compliance costs[174]. Company Status and Reporting - The company remains an emerging growth company and intends to rely on certain exemptions from public company reporting requirements until at least December 31, 2026, or until specific revenue or market value thresholds are met[218]. - The company qualifies as a smaller reporting company, with the market value of its common stock held by non-affiliates being less than $700 million and annual revenue below $100 million[220]. - The company has reduced disclosure obligations regarding executive compensation due to its status as an emerging growth company and smaller reporting company[220]. - The company may continue to rely on exemptions from certain disclosure requirements if it remains a smaller reporting company after ceasing to be an emerging growth company[220]. - The company has not included all executive compensation-related information that would be required if it were not an emerging growth company[218]. - There have been no changes to the company's critical accounting policies as of June 30, 2024, compared to those reported in the Annual Report Form 10-K[217]. - Actual results may differ materially from estimates and assumptions made in the financial statements, which could be material to the financial position and results of operations[217].