UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Commission file number 001-40700 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ____________ to ____________ ABVC BioPharma, Inc. (Exact name of Registrant as specified in its charter) Nevada 26-0014658 State or jurisdi ...

Financial Results - ABVC BioPharma, Inc. announced its financial results for the fiscal year ended December 31, 2024, in a press release issued on April 15, 2025[4]. Financial Misstatements - The company identified material misstatements in its financial statements for the fiscal year ended December 31, 2023, due to errors in accounting guidance and recognition of expenses[7]. - The misstatements affected key financial metrics including construction in progress, carrying value of convertible notes payable, and stock-based compensation[8]. - The company plans to file an amendment to its Annual Report on Form 10-K to address the identified errors and their impacts[9]. Internal Controls - ABVC BioPharma's Audit Committee has acknowledged a material weakness in its internal controls over financial reporting[10].

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].

Company Overview - ABVC BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on innovative treatments in ophthalmology, CNS, and oncology/hematology [1] - The company has an active pipeline of six drugs and one medical device under development, utilizing inlicensed technology from renowned research institutions [5] Product Development - ABVC's ABV-1504, containing the active pharmaceutical ingredient Radix Polygala (PDC-1421), aims to address the gap left by the discontinuation of Prozac, particularly in treating Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD) [1][3] - PDC-1421 has completed Phase II clinical trials and is progressing towards Phase III trials globally, with patents approved in the USA and other countries valid until 2041 [1] Market Opportunity - The global MDD market is projected to grow from $11.51 billion in 2022 to $14.96 billion by 2032, with a CAGR of 2.8% [4] - The global ADHD treatment market is expected to increase from $15.23 billion in 2022 at a CAGR of 7.3% through 2032 [4] - The global botanical drug market, valued at $163 million in 2021, is forecasted to grow at a CAGR of 39% through 2030, reaching $3.2 billion [4] Competitive Advantage - ABV-1504 is positioned as a safer and more effective alternative to traditional antidepressants like Prozac, with a favorable safety profile and fewer side effects [3] - Internal studies indicate that PDC-1421 achieved a MADRS score reduction of -13.21 from baseline over 6 weeks, with a placebo-subtracted difference of -4.1, demonstrating significant efficacy in treating MDD [3]

Company Overview - ABVC BioPharma, Inc. is a clinical-stage biopharmaceutical company focused on developing therapeutic solutions in ophthalmology, central nervous system (CNS), and oncology/hematology [1] - The company has an active pipeline consisting of six drugs and one medical device (ABV-1701/Vitargus®) under development [2] - ABVC utilizes in-licensed technology from prestigious research institutions, including Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center, to conduct proof-of-concept trials through Phase II of clinical development [2] Recent Developments - ABVC announced a $200,000 cash payment from OncoX BioPharma Inc. as part of a strategic licensing agreement for oncology-related products, marking the first installment of a potential $5 million in licensing fees [1] - The total cash payments received by ABVC from its three strategic partners for licensing various products now amount to $546,000 [1] - ABVC and its subsidiaries are eligible to receive up to 10 million OncoX shares, an additional $5 million cash payment, and royalties up to $50 million after product launches [1] Market Position - The global cancer therapeutics market is projected to reach $393.61 billion by 2032, growing at a compound annual growth rate (CAGR) of 9.20% [1] - ABVC is strategically positioned to capitalize on this rapidly expanding market, reinforcing its competitive position within the oncology landscape [1]

Financial Performance - ABVC BioPharma achieved its first operational profit in Q3 2024, with a 102% improvement over the same quarter last year[1] - Revenue for Q3 2024 reached $389,276, a significant increase from $15,884 in Q3 2023, reflecting strong demand for CNS and oncology R&D services[2] - The net loss for Q3 2024 decreased to $134,272 from $3.37 million in Q3 2023, indicating effective financial management[3] - Earnings per share (EPS) improved to $(0.02) in Q3 2024, a notable advancement from $(0.82) per share in Q3 2023[4] - Cash and cash equivalents increased to $137,344 as of September 30, 2024, up from $60,155 at the end of 2023[5] Strategic Partnerships and Licensing - ABVC secured long-term licensing agreements that could generate up to $292 million in income, including $187 million from ForSeeCon Eye Corporation for Vitargus[9] Clinical Development and Regulatory Progress - The company completed Phase II trials for ABV-1504 in Major Depressive Disorder and is preparing for an FDA End-of-Phase 2 meeting[7] - ABVC's first-in-class vitreous substitute, Vitargus, is advancing through regulatory stages with approvals for further trials in Australia[8] Intellectual Property and Future Growth - The company has been granted multiple patents in the U.S., Taiwan, and Australia, enhancing its intellectual property portfolio[10] - ABVC anticipates further revenue growth through strategic collaborations and ongoing clinical developments in CNS, oncology, and ophthalmology programs[12]

Financial Performance - Total revenues for the three months ended September 30, 2024, were $389,276, a significant increase from $15,884 in the same period of 2023[11] - The gross profit for the nine months ended September 30, 2024, was $506,860, compared to a loss of $12,566 in the same period of 2023[11] - The net loss attributable to ABVC and subsidiaries for the three months ended September 30, 2024, was $186,561, compared to a loss of $3,317,516 in the same period of 2023[11] - Net loss for the nine months ended September 30, 2024, was $5,387,980, an improvement from a net loss of $7,580,535 for the same period in 2023, representing a 29% reduction[13] - The net loss attributable to common stockholders for the three months ended September 30, 2024, was $186,561, compared to a loss of $3,317,516 for the same period in 2023[168] - The net loss attributable to common stockholders for the nine months ended September 30, 2024, was $5,132,182, compared to $7,404,722 for the same period in 2023[169] Assets and Liabilities - Total current assets increased to $2,148,327 as of September 30, 2024, compared to $1,656,709 as of December 31, 2023, representing a growth of approximately 29.6%[9] - Cash and cash equivalents increased to $137,344 as of September 30, 2024, from $60,155 as of December 31, 2023, reflecting a growth of approximately 128.5%[9] - Total liabilities decreased to $6,483,523 as of September 30, 2024, from $6,361,627 as of December 31, 2023, showing a slight increase of 1.9%[9] - The accumulated deficit increased to $(70,552,277) as of September 30, 2024, from $(65,420,095) as of December 31, 2023[9] - The company had net cash outflows of $1,315,534 from operating activities for the nine months ended September 30, 2024[25] Cash Flow and Financing Activities - Cash used in operating activities decreased to $1,315,534 for the nine months ended September 30, 2024, compared to $3,756,385 for the same period in 2023, indicating a 65% improvement[13] - The company reported a net cash provided by financing activities of $1,399,313 for the nine months ended September 30, 2024, down from $3,831,540 in the same period of 2023, a decrease of 64%[13] - The issuance of common stock for cash amounted to $1,050,000 during the nine months ended September 30, 2023[16] - The Company issued 300,000 shares of common stock at a price of $3.50 per share, resulting in gross proceeds of $1,750,000 from a registered direct offering[145] Stock-Based Compensation - Stock-based compensation increased significantly to $2,957,736 for the nine months ended September 30, 2024, compared to $1,409,969 for the same period in 2023, marking a 109% increase[13] - Total employee stock-based compensation expenses for the nine months ended September 30, 2024, were $1,935,756, compared to $0 for the same period in 2023[64] - Total non-employee stock-based compensation expenses for the nine months ended September 30, 2024, were $1,021,980, down from $1,409,969 for the same period in 2023[65] Revenue Recognition - The Company recognizes revenue from collaborative agreements upon satisfaction of performance obligations, with no royalty revenues received to date[48] - The Company evaluates milestone payments under collaborative agreements, recognizing revenue when the underlying triggering event occurs[53] - The Company recognizes revenues related to research and development services when the related activities are performed[59] - The Company applies ASC 606 for revenue recognition, ensuring that revenue is recognized when performance obligations are satisfied[46] Licensing Agreements and Collaborations - The company entered into a multi-year, global licensing agreement for CNS drugs with AiBtl, receiving 23 million shares of AIBL stock[24] - BioLite Taiwan has a milestone payment agreement with BHK totaling $10 million, with specific payments tied to clinical trial phases and regulatory submissions[71] - The Company entered into a definitive agreement with OncoX BioPharma, Inc. for exclusive rights to develop and commercialize a botanical drug extract for Non-Small Cell Lung Cancer, with expected payments totaling $6,250,000 and 5% royalties on net sales[101] - The Company has entered into multiple licensing agreements with OncoX for various botanical drug extracts, each with a total payment of $6,250,000 and additional milestone payments of $625,000[101] Debt and Interest Expenses - The principal amount of the secured convertible note issued to Lind Global Fund II, LP is $3,704,167, convertible at an initial price of $10.5 per share[110] - The total interest expenses related to convertible notes were $209,022 for the three months ended September 30, 2024, compared to $1,198,290 for the same period in 2023[119] - The effective interest rate for the Cathay United Bank loan was 3.01% as of September 30, 2024, compared to 2.87% at the end of 2023[123] Operational Developments - The Company plans to initiate Phase I/II clinical studies for drug ABV-1601 in cancer patients in Q4 2024, indicating ongoing investment in drug development[198] - The Construction-in-progress is expected to be completed before the end of 2024[105] Corporate Structure and Ownership - BioLite was incorporated in Nevada with 500,000,000 shares authorized, par value $0.0001[205] - BioLite Taiwan, a key subsidiary, has been developing new drugs for over ten years[205] - BioLite and BioLite BVI are holding companies and have not conducted substantive business operations of their own[206]

Core Insights - ABVC BioPharma, Inc. has received an additional $50,000 in licensing fees from AiBtl BioPharma, bringing the total to $346,000, which supports the confidence in ABVC's mission [1][2] - The payment is linked to ABVC's psychiatric disorder pipeline, which includes treatments for Major Depressive Disorder (MDD) and Attention Deficit Hyperactivity Disorder (ADHD), valued at $667 million [2] - ABVC is strategically positioned in growing markets, with the global MDD market projected to grow from $11.51 billion in 2022 to $14.96 billion by 2032, and the ADHD treatment market expected to increase from $15.23 billion in 2022 at a CAGR of 7.3% [3] Company Overview - ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development [3] - The company utilizes in-licensed technology from renowned research institutions, including Stanford University and Cedars-Sinai Medical Center, to conduct proof-of-concept trials through Phase II of clinical development [3]

Core Insights - ABVC BioPharma, Inc. has executed significant global licensing agreements that could yield up to $292 million in income, enhancing its financial position and operational capabilities [1][2][3] Group 1: Licensing Agreements - The company secured a licensing agreement for Vitargus® with ForSeeCon Eye Corporation, potentially generating up to $187 million, including $60 million in upfront payments and $120 million in royalties post-launch [1] - ABVC entered into eight licensing agreements with OncoX BioPharma, Inc. for oncology products, which could provide up to $105 million, including $55 million in upfront payments and $50 million in royalties [2] Group 2: Financial Performance - Earnings Per Share (EPS) improved by approximately 86.8%, reaching -$0.09 in Q2 2024 from -$0.68 in Q2 2023, reflecting effective management of operational expenses [3] - Revenue surged to $117,142 in Q2 2024, a significant increase from $6,109 in Q2 2023, driven by the successful execution of licensing agreements [3] - Shareholders' equity as of June 30, 2024, was reported at $7.8 million, indicating a solid financial foundation [3] Group 3: Strategic Partnerships and Market Positioning - ABVC has formed strategic partnerships that are expected to enhance the value of its equity holdings and drive shareholder value [3] - The company is positioned for significant market capitalization growth by leveraging its pipeline accomplishments and international partnerships [4] Group 4: Operational and Regulatory Milestones - ABVC received multiple patents and FDA approvals for treatments targeting major depressive disorder, ADHD, and ophthalmology, expanding its intellectual property portfolio [4][9] - The company completed Phase II trials for major depressive disorder and initiated Phase IIb trials for ADHD, with FDA approvals for multiple IND applications [5][10] Group 5: Future Outlook - ABVC BioPharma is on a promising trajectory focused on sustainable growth, innovation, and value creation through strategic partnerships, preparing for future success [8]

Financial Performance - The company reported a significant year-over-year improvement in earnings per share (EPS), rising approximately 86.8% to -$0.09 in Q2 2024 from -$0.68 in Q2 2023[3]. - Revenue increased to $117,142 in Q2 2024, a substantial rise from $6,109 in Q2 2023, driven by strategic licensing agreements[3]. - Shareholders' equity as of June 30, 2024, stood at $7.8 million, indicating a solid financial foundation[3]. Licensing Agreements - ABVC BioPharma executed global licensing agreements that could provide up to $292 million in income, including $187 million from Vitargus® and $105 million from oncology products[1][2]. - A legally binding term sheet was signed with Xinnovation Therapeutics for exclusive licensing of ABV-1504 and ABV-1505 in mainland China, with a potential aggregate income of $20 million[10]. Intellectual Property and Regulatory Approvals - ABVC received multiple patents and FDA approvals for treatments targeting major depressive disorder, ADHD, and ophthalmology, enhancing its intellectual property portfolio[4]. - ABVC is advancing the development of Vitargus, a biodegradable hydrogel for retinal detachment surgery, with regulatory approval to initiate the next trial phase in Australia[12][13]. Clinical Development - The company completed Phase II trials for major depressive disorder (MDD) and initiated Phase IIb trials for ADHD, positioning itself for continued growth[4][9]. Strategic Focus - The company is focused on expanding its partnerships and driving sustainable growth through strategic licensing agreements and innovative therapies[6][5]. - ABVC's operational achievements and strategic partnerships are expected to enhance shareholder value and market positioning[4][6].