Revenue and Financial Performance - For the year ended December 31, 2024, the Company generated $509,589 in revenue, primarily from outlicensing intellectual property and providing CDMO services [250]. - Revenue for the year ended December 31, 2024, was $509,589, a 234% increase from $152,430 in 2023, primarily due to outlicensing of intellectual properties [443]. - Gross profit for 2024 was $508,826, compared to a gross loss of $149,607 in 2023, reflecting a change of $658,433 [443]. - Operating expenses decreased to $5,214,068 in 2024 from $6,617,127 in 2023, a reduction of approximately 21% [444]. - Loss from operations improved to $(4,705,242) in 2024, a decrease of $2,061,492 or 30% from $(6,766,734) in 2023 [443]. - Net loss for 2024 was $5,259,037, down $3,021,807 or 36% from $8,280,844 in 2023, attributed to more cost-efficient funding and discontinuation of certain consulting services [447]. - Other expense decreased to $664,334 in 2024 from $1,258,104 in 2023, primarily due to reduced interest expenses [445]. - Interest expense for 2024 was $(738,541), a decrease of $389,649 or approximately 35% from $(1,128,190) in 2023 [446]. - Stock-based compensation expenses for employees totaled $1,995,049 in 2024, compared to $0 in 2023 [429]. - Total employee benefits expenses were $11,642 in 2024, up from $10,314 in 2023, reflecting the mandated contribution of 6% of employees' salaries [428]. Clinical Trials and Product Development - The Company is currently conducting Phase II clinical trials for ABV-1701 (medical device) and ABV-1505 (ADHD drug) in collaboration with various institutions in Australia and the United States [254]. - The Company plans to seek a partner for Phase III studies and NDA submission upon successful completion of Phase II trials [255]. - The Company initiated a Phase II study for Vitargus® in Australia and Thailand, with the study starting in Q2 2023 [278]. - ABV-2002, a solution for storing donor corneas, is being developed to maintain corneal transparency and prevent swelling, with early tests indicating it may be more effective than current storage media [279][280]. - The Company is advancing to the pivotal trial phase of ABV-1701 Vitargus® for the treatment of retinal detachment or vitreous hemorrhage, which is expected to generate future revenues [324]. - The Company has completed Phase II, Part 2 clinical trial for ABV-1505 for the treatment of attention deficit hyperactivity disorder (ADHD) [324]. - The Company plans to conduct Phase I and II clinical trials for investigational new drugs and medical devices in CNS, Hematology/Oncology, and Ophthalmology [320]. - The Company expects to build a substantial portfolio of Oncology/Hematology, CNS, and Ophthalmology products through an assertive product development approach [321]. Collaborations and Agreements - The Company entered into a cooperation agreement with Zhonghui United Technology, acquiring a 20% ownership of certain property for 370,000 shares at $1.87 per share [258]. - The Company and Zhonghui plan to develop a healthcare center focusing on ophthalmology, oncology, and central nervous systems, targeting the China market [259]. - A multi-year global licensing agreement was signed with AiBtl for CNS drugs, valued at $667 million, with potential royalties of 5% on net sales [262]. - The Company has entered into multiple agreements with OncoX BioPharma for the development of botanical drug extracts, with upfront payments of $6,250,000 and royalties of 5% on net sales [265][266][267]. - The Company has a co-development agreement with Rgene Corporation, which includes a payment of $3 million for past research efforts and a 50% share of future net licensing income [335]. - The Company has a collaborative agreement with BioFirst Corporation, granting global licensing rights to medical use of ABV-1701 Vitreous Substitute for Vitrectomy [346]. - The Company will pay BioFirst a total of $3,000,000 for past research efforts, with future net licensing revenue shared equally [347]. - The Company entered into a Joint Venture Agreement with BioLite Japan K.K. to co-develop drugs and medical devices, with the Company owning 49% of Biolite JP [356]. Stock and Compliance - A 1-for-10 reverse stock split was authorized to reduce the number of outstanding shares and potentially increase the trading value [270]. - The company regained compliance with Nasdaq Listing Rule 5550(a)(2) after the closing bid price of its common stock was at least $1.00 for 10 consecutive business days from July 25, 2023, to August 7, 2023 [274]. - As of March 31, 2023, the company's stockholders' equity was $1,734,507, below the required minimum of $2,500,000, prompting a deficiency letter from Nasdaq [275]. - The company increased its stockholders' equity by approximately $10.65 million through various transactions, including issuing 300,000 shares and entering a cooperation agreement with Zhonghui United Technology [275]. - The company has been actively monitoring its stock price to avoid delisting and has until January 6, 2025, to regain compliance with Nasdaq's minimum bid price requirement [276][277]. Financial Restatements and Adjustments - The Company restated its financial statements for the year ended December 31, 2023, to correct misstatements related to share-based payments and convertible debts [372]. - The company overstated interest expenses by $1,179,667 for the year ended December 31, 2023, due to misapplication of accounting standards [375]. - Stock-based compensation expenses were reversed by $902,960 for the year ended December 31, 2023, impacting the accumulated deficit [378]. - The total assets were restated from $14,492,599 to $7,784,499 as of December 31, 2023, reflecting significant adjustments [380]. - The net loss attributable to the company was adjusted from $(10,910,288) to $(8,280,844) for the year ended December 31, 2023 [380]. Asset Management and Investments - The Company acquired land to support its product pipeline and reduce costs, ensuring quality control for botanical drug raw materials [269]. - The fair value of the acquired real estate assets is estimated at $7,400,000, with adjustments leading to a reduction of $6,708,100 in recognized assets for 2023 [374]. - The allowance for expected credit losses was $616,505 as of December 31, 2023 [399]. - Non-marketable equity investments are assessed for impairment based on qualitative and quantitative factors, impacting their valuation [421]. - Convertible notes payable are evaluated for embedded conversion features, with proceeds allocated between debt and equity components [422]. - Marketable equity investments are measured at fair value, with unrealized gains and losses recognized in net income [423].
ABVC BioPharma(ABVC) - 2024 Q4 - Annual Report