What changed in ABVC BIOPHARMA, INC.'s 2024 10-K compared to 2023?

Across the narrative sections we track, ABVC BIOPHARMA, INC. (ABVC) added 267 paragraphs, removed 211, and edited 139 between the 2023 and 2024 10-K filings. The biggest movers are Item 7. Management's Discussion & Analysis (+181/−135), Item 1. Business (+42/−32), Item 5. Market for Registrant's Common Equity (+21/−13).

Did ABVC BIOPHARMA, INC. add new Risk Factors in the 2024 10-K?

Yes — Item 1A Risk Factors shows 16 new/edited paragraphs and 10 removed paragraphs versus the 2023 10-K.

What changed in ABVC BIOPHARMA, INC.'s MD&A (Item 7) in 2024?

Item 7 Management's Discussion & Analysis shows 181 new/edited paragraphs and 135 removed paragraphs year-over-year. Read the side-by-side diff to see exactly which revenue, margin, and outlook commentary was rewritten.

Did ABVC BIOPHARMA, INC.'s Legal Proceedings (Item 3) change in 2024?

Item 3 shows 2 added/edited paragraphs and 1 removed paragraphs — usually indicating new litigation disclosed or settled cases removed.

Where does this ABVC 10-K diff come from?

The source filings are ABVC BIOPHARMA, INC.'s official 2023 and 2024 Form 10-K annual reports from SEC EDGAR. 10q10k.net parses each filing, aligns paragraphs by section (Item 1, 1A, 1C, 2, 3, 7, 7A), and highlights every added, removed and edited sentence side-by-side.

ABVC BIOPHARMA, INC.ABVC決算レポート

Nasdaq · ヘルスケア · 医薬製剤

詳細分析

ABVC Biopharma Inc. is a clinical-stage biopharmaceutical enterprise focused on developing innovative therapies for unmet medical needs, with core areas including oncology, ophthalmology, and central nervous system disorders. It operates across North American and Asian markets, advancing multiple proprietary drug candidates through clinical development phases.

What changed in ABVC BIOPHARMA, INC.'s 10-K — 2023 vs 2024

Top changes in ABVC BIOPHARMA, INC.'s 2024 10-K

267 paragraphs added · 211 removed · 139 edited across 7 sections

Item 7. Management's Discussion & Analysis+181 / −135 · 82 edited
Item 1. Business+42 / −32 · 32 edited
Item 5. Market for Registrant's Common Equity+21 / −13 · 12 edited
Item 1A. Risk Factors+16 / −10 · 7 edited
Item 6. [Reserved]+1 / −16 · 1 edited

Item 1. Business

Business — how the company describes what it does

32 edited+10 added−0 removed178 unchanged

2023 filing

2024 filing

The subjects enrolled in the study has reached the number for interim analysis in 2023 December, and the interim analysis of the study is in progress. ● Drug: ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator: Scott Irwin, MD, Ph.D. – Cedars Sinai Medical Center (CSMC).

The subjects enrolled in the study has reached the number for interim analysis in December 2023, and the interim analysis of the study is in progress. ● Drug: ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator: Scott Irwin, MD, Ph.D. – Cedars Sinai Medical Center (CSMC).

NHRI 7 granted AU 2011/215775 B2 4/17/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Australia NHRI 8 granted KR 10-1428898 8/4/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Korea NHRI 9 granted CA 2786911 (C) 10/6/2015 2/10/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Canada NHRI 10 granted WO2011100469 A1 N/A (4) N/A (4) Cross-linked oxidized hyaluronic acid for use as a vitreous substitute PCT NHRI 11 granted EP 2534200 4/8/2015 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute European Union (Germany, United Kingdom, France, Switzerland, Spain, Italy) NHRI 12 granted 特許第 5885349號 2/9/2011 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Japan NHRI 13 granted ZL 201180005494.7 12/24/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute (3) China NHRI 14 granted HK1178188 3/6/2015 6/21/2030 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute (3) Hong Kong (5) NHRI 15 granted US 16/936,032 9/4/2020 9/4/2040 Polygala extract for the treatment of major depressive disorder US BioLite 16 granted TW I821593 11/1/2023 7/22/2040 Polygala extract for the treatment of major depressive disorder Taiwan BioLite 17 granted US17/120,965 12/20/2020 12/20/2040 Polygala Extract for the Treatment of Attention Deficit Hyperactive Disorder U.S.

NHRI 7 granted AU 2011/215775 B2 4/17/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Australia NHRI 8 granted KR 10-1428898 8/4/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Korea NHRI 9 granted CA 2786911 (C) 10/6/2015 2/10/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Canada NHRI 10 granted WO2011100469 A1 N/A (4) N/A (4) Cross-linked oxidized hyaluronic acid for use as a vitreous substitute PCT NHRI 11 granted EP 2534200 4/8/2015 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute European Union (Germany, United Kingdom, France, Switzerland, Spain, Italy) NHRI 12 granted 特許第 5885349號 (P5885349) 2/9/2011 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute Japan NHRI 13 granted ZL 201180005494.7 12/24/2014 2/9/2031 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute (3) China NHRI 14 granted HK1178188 3/6/2015 6/21/2030 Cross-linked oxidized hyaluronic acid for use as a vitreous substitute (3) Hong Kong (5) NHRI 15 granted US 16/936,032 9/4/2020 9/4/2040 Polygala extract for the treatment of major depressive disorder US BioLite 16 granted TW I821593 11/1/2023 7/22/2040 Polygala extract for the treatment of major depressive disorder Taiwan BioLite 17 granted US17/120,965 12/20/2020 12/20/2040 Polygala Extract for the Treatment of Attention Deficit Hyperactive Disorder U.S.

Name Change and Cusip Number The Company’s shareholders approved an amendment to the Company’s Articles of Incorporation to change the Company’s corporate name to “ABVC BioPharma, Inc.” and approved and adopted the Certificate of Amendment to affect same at the 2020 annual meeting of shareholders (the “ Annual Meeting ”).

The following trials are expected to begin in the third quarter of 2024: ● Drug: ABV-1519, Non-Small Cell Lung Cancer treatment, Phase I/II Study in Taiwan, Principal Investigator: Dr. Yung-Hung Luo, M.D., Taipei Veterans General Hospital (TVGH) ● Drug: ABV-1703, Advanced Inoperable or Metastatic Pancreatic Cancer, Phase II, Principal Investigator: Andrew E.

The following trials are expected to begin in the third quarter of 2025 ● Drug: ABV-1519, Non-Small Cell Lung Cancer treatment, Phase I/II Study in Taiwan, Principal Investigator: Dr. Yung-Hung Luo, M.D., Taipei Veterans General Hospital (TVGH) ● Drug: ABV-1703, Advanced Inoperable or Metastatic Pancreatic Cancer, Phase II, Principal Investigator: Andrew E.

Upon the issuance of the shares, AIBL became a subsidiary of ABVC. 13 The following chart illustrates the corporate structure of ABVC: Effective March 5, 2022, the Company’s Board for Directors approved amending the Company’s Bylaws to remove Section 2.8, which permitted cumulative voting for directors since cumulative voting is specifically prohibited by our Articles of Incorporation.

Upon the issuance of the shares, AiBtl became a subsidiary of ABVC. 13 The following chart illustrates the corporate structure of ABVC: Effective March 5, 2022, the Company’s Board for Directors approved amending the Company’s Bylaws to remove Section 2.8, which permitted cumulative voting for directors since cumulative voting is specifically prohibited by our Articles of Incorporation.

We must pay BioFirst $3,000,000 (the “Total Payment”) in cash or common stock of BriVision on or before September 30, 2018 in two installments. An upfront payment of $300,000, representing 10% of the Total Payment due under the Collaboration Agreement, was to be paid upon executing the BioFirst Agreement.

We must pay BioFirst $3.0 million (the “Total Payment”) in cash or common stock of BriVision on or before September 30, 2018 in two installments. An upfront payment of $300,000, representing 10% of the Total Payment due under the Collaboration Agreement, was to be paid upon executing the BioFirst Agreement.

If any such changes were to be imposed, they could adversely affect the operation of our business. Employees As of December 31, 2023, we, including the subsidiaries, have 19 employees, 16 of which are full-time, located in the U.S. and Taiwan. 18

If any such changes were to be imposed, they could adversely affect the operation of our business. Employees As of December 31, 2024, we, including the subsidiaries, have 19 employees, 16 of which are full-time, located in the U.S. and Taiwan. 18

As of the date of this report, we are engaging Cedars-Sinai Medical Center in the U.S. to conduct the Phase II clinical trial and plan to initiate the Phase II trial in 2024. We plan to submit ABV-1703’s Phase II clinical trial IND to the Taiwan FDA after we commence the clinical trials in the United States. 3.

As of the date of this report, we are engaging Cedars-Sinai Medical Center in the U.S. to conduct the Phase II clinical trial and plan to initiate the Phase II trial in 2025. We plan to submit ABV-1703’s Phase II clinical trial IND to the Taiwan FDA after we commence the clinical trials in the United States. 3.

As per each of the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock at $10 per share, and if certain milestones are met, each may receive $3,500,000 and royalties equaling 5% of net sales, up to $100 million.

As per each of the respective agreements, each of ABVC and BioLite received 23 million shares of AiBtl stock at $10 per share, and if certain milestones are met, each may receive $3,500,000 and royalties equaling 5% of net sales, up to $100 million.

Pursuant to the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as of September and together with the Monthly Shares, the Company repaid Lind a total of $1M by September 2023. As a result, the stockholders’ equity increased by an additional $1M.

Pursuant to the terms of the Lind Note, Lind increased the amount of the next monthly payment to one million dollars, such that as of September and together with the Monthly Shares, the Company repaid Lind a total of $1 million by September 2023. As a result, the stockholders’ equity increased by an additional $1 million.

The Company expects to begin Phase II clinical trials of ABV-1702 in the fourth quarter of 2024 and is actively looking for qualified principal investigators and an appropriate site for the study; therefore, the timing cannot be guaranteed. 8 2.

The Company expects to begin Phase II clinical trials of ABV-1702 in the fourth quarter of 2025 and is actively looking for qualified principal investigators and an appropriate site for the study; therefore, the timing cannot be guaranteed. 8 2.

Additionally, on August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu) Group Co., Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land owned by Zhonghui in exchange for an aggregate of 370,000 shares of Common Stock. Accordingly, stockholders’ equity increased by $7.4M.

The Common Stock was approved for listing on The Nasdaq Capital Market and commenced trading under the ticker symbol “ABVC” on August 3, 2021. 4 On August 19, 2022, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “ Staff ”) of the Nasdaq Stock Market LLC (“ Nasdaq ”) notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (“ Rule 5550(a)(2) ”).

The Common Stock was approved for listing on The Nasdaq Capital Market and commenced trading under the ticker symbol “ABVC” on August 3, 2021. 4 On August 19, 2022, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) of the Nasdaq Stock Market LLC (“Nasdaq”) notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (“Rule 5550(a)(2)”).

Since both Rgene and the Company are related parties and under common control by a controlling beneficiary shareholder of YuanGene Corporation and the Company, the Company has recorded the total amount of $3,000,000 in connection with the Co-Dev Agreement as additional paid-in capital during the year ended September 30, 2017.

Since both Rgene and the Company are related parties and under common control by a controlling beneficiary shareholder of YuanGene Corporation and the Company, the Company has recorded the total amount of $3.0 million in connection with the Co-Dev Agreement as additional paid-in capital during the year ended September 30, 2017.

In addition to the $3,000,000, the Company is entitled to receive 50% of the future net licensing income or net sales profit earned by Rgene, if any, and both BriVision and Rgene shall equally share any development costs. By June 1, 2017, the Company had delivered all research, technical, and development data to Rgene.

In addition to the $3.0 million, the Company is entitled to receive 50% of the future net licensing income or net sales profit earned by Rgene, if any, and both BriVision and Rgene shall equally share any development costs. By June 1, 2017, the Company had delivered all research, technical, and development data to Rgene.

Corporate History and Structure ABVC was incorporated under the laws of the State of Nevada on February 6, 2002 and has three wholly-owned Subsidiaries: BriVision, BioLite Holding, Inc. and BioKey, Inc. BriVision was incorporated in July 2015 in the State of Delaware and is in the business of developing pharmaceutical products in North America.

Corporate History and Structure ABVC was incorporated under the laws of the State of Nevada on February 6, 2002 and has four wholly-owned Subsidiaries: BriVision, BioLite Holding, Inc., BioKey Cayman, and BioKey, Inc. BriVision was incorporated in July 2015 in the State of Delaware and is in the business of developing pharmaceutical products in North America.

On June 30, 2019, the Company and BioFirst entered into a Stock Purchase Agreement (the “Purchase Agreement”), according to which the Company will issue 428,571 shares of the Company’s common stock to BioFirst in consideration for $3,000,000 owed by the Company to BioFirst in connection with the BioFirst Collaborative Agreement.

On June 30, 2019, the Company and BioFirst entered into a Stock Purchase Agreement (the “Purchase Agreement”), according to which the Company will issue 428,571 shares of the Company’s common stock to BioFirst in consideration for $3.0 million owed by the Company to BioFirst in connection with the BioFirst Collaborative Agreement.

Pursuant to this transaction, the stockholders’ equity was increased by $1.75M. On August 1, 2023, $500,000 of Notes were converted at $3.50 per share and the holder received 142,857 shares of Common Stock. As a result of this conversion, the stockholders’ equity was increased by $0.5M.

Pursuant to this transaction, the stockholders’ equity was increased by $1.75 million. On August 1, 2023, $500,000 of Notes were converted at $3.50 per share and the holder received 142,857 shares of Common Stock. As a result of this conversion, the stockholders’ equity was increased by $0.5 million.

As a result of the four transactions referenced above, the Company’ estimated that its stockholders’ equity would increase by approximately $10.65M.

As a result of the four transactions referenced above, the Company’ estimated that its stockholders’ equity would increase by approximately $10.65 million.

The Phase I clinical study will be initiated in the 1 st quarter of 2024. ● Medical Device: ABV-1701, Vitargus® in vitrectomy surgery, Phase II Study has been initiated in Australia and Thailand, Principal Investigator: Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand Sites and Professor/Dr. Matthew Simunovic, Sydney Eye Hospital; Dr.

The Phase I clinical study will be initiated around the end of 2025. ● Medical Device: ABV-1701, Vitargus® in vitrectomy surgery, Phase II Study has been initiated in Australia and Thailand, Principal Investigator: Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand Sites and Professor/Dr. Matthew Simunovic, Sydney Eye Hospital; Dr.

The agreement grants Define Biotech the exclusive right to distribute this new dietary supplement in China and Taiwan in exchange for the commitment to purchase $3.0 million of the new product over three years.

The mushrooms, supplied by Shogun Maitake Canada, Co. Ltd., are grown in a controlled temperature and humid environment free of pesticides and chemicals. Initially, sales of the new supplement in the US and Canada will be targeted to high-end grocery stores worldwide via online distribution.

In 2022, BioKey began manufacturing a dietary supplement based on the maitake mushroom. The mushrooms, supplied by Shogun Maitake Canada, Co. Ltd., are grown in a controlled temperature and humid environment free of pesticides and chemicals. Initially, sales of the new supplement in the US and Canada will be targeted to high-end grocery stores worldwide via online distribution.

As of the date of this report, Part I of Phase II clinical protocol, which is an open trial, has been approved by the Cedars-Sinai Medical Center IRB Committee. This study will be initiated in the 3 rd quarter of 2024. II. Oncology 1.

Business As of the date of this Report, the Company’s minimal revenue has come from selling CDMO services through BioKey. However, the Company focuses on developing a product pipeline by carefully tracking new medical discoveries or medical device technologies in research institutions in the Asia-Pacific region.

Business As of the date of this Report, the Company’s revenue has come from outlicensing our intellectual properties and providing CDMO services. The Company focuses on developing a product pipeline by carefully tracking new medical discoveries or medical device technologies in research institutions in the Asia-Pacific region.

The facility was remodeled in December 2008 and received its first drug manufacturing license in June 2009. ABVC’s current drug manufacturing license allows it to manufacture drug products under IND for human clinical trials until the expiration of the license on December 2, 2024. In 2022, BioKey began manufacturing a dietary supplement based on the maitake mushroom.

Beta-glucans in maitake mushrooms have been shown to reduce cholesterol, resulting in improved artery functionality and overall better cardiovascular health, lowering the risk of heart disease. Further, studies have shown that the beta-glucans in maitake mushrooms strengthen the immune system. In a trial of postmenopausal breast cancer patients, oral administration of a maitake extract was shown to have immunomodulatory effects.

The parties are also working to strengthen new drug development and business collaboration, including technology, interoperability, and standards development.

The parties are determined to collaborate on the global development of the Licensed Products. The parties are also working to strengthen new drug development and business collaboration, including technology, interoperability, and standards development.

Further, clinical trials have shown beta-glucans to lower blood glucose levels, helping to activate insulin receptors while reducing insulin resistance in diabetes management. BioKey has entered into a three-year distribution agreement with Define Biotech Co. Ltd. This Taiwan-based pharmaceutical marketing company focuses on selling drugs, dietary supplements, and medical products in the Asia-Pacific region.

BioKey has entered into a three-year distribution agreement with Define Biotech Co. Ltd. This Taiwan-based pharmaceutical marketing company focuses on selling drugs, dietary supplements, and medical products in the Asia-Pacific region.

In a trial of postmenopausal breast cancer patients, oral administration of a maitake extract was shown to have immunomodulatory effects. In a different Memorial Sloan Kettering Cancer Center trial, maitake extracts enhanced neutrophil and monocyte function in patients with myelodysplastic syndrome. It boosts the production of lymphokines (protein mediators) and interleukins (secreted proteins), improving immune response.

In a different Memorial Sloan Kettering Cancer Center trial, maitake extracts enhanced neutrophil and monocyte function in patients with myelodysplastic syndrome. It boosts the production of lymphokines (protein mediators) and interleukins (secreted proteins), improving immune response. Further, clinical trials have shown beta-glucans to lower blood glucose levels, helping to activate insulin receptors while reducing insulin resistance in diabetes management.

(“AIBL”) for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed Products”). The license covers the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights. The parties are determined to collaborate on the global development of the Licensed Products.

(“BioLite”) each entered into a multi-year, global licensing agreement with AiBtl BioPharma Inc. (“AiBtl”, or “AiBtl”) for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed Products”). The license covers the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights.

As a result, BioLite Holding owns via BioLite BVI approximately 73% of BioLite Taiwan. The other shareholders who did not enter this Share Purchase/ Exchange Agreement retain their equity ownership in BioLite Taiwan. Incorporated in California on November 20, 2000, BioKey has chosen to initially focus on developing generic drugs to ride the opportunity of the booming industry.

As a result, BioLite Holding owns via BioLite BVI approximately 73% of BioLite Taiwan. The other shareholders who did not enter this Share Purchase/ Exchange Agreement retain their equity ownership in BioLite Taiwan. Yunzhiyi, a Taiwan corporation, was incorporated in August 2024, with 90% owned by BioLite Taiwan and 10% owned by Shuling Jiang, one of the Company’s director.

Upon closing of the Mergers on February 8, 2019, BioLite and BioKey became two wholly-owned subsidiaries of ABVC. In November 2023, the Company and one of its subsidiaries, BioLite, Inc. (“BioLite”) each entered into a multi-year, global licensing agreement with AiBtl BioPharma Inc.

Upon closing of the Mergers on February 8, 2019, BioLite and BioKey became two wholly-owned subsidiaries of ABVC. BioKey Cayman was incorporated in Cayman Islands in July 2023, which is 100% owned by ABVC. This subsidiary has no activities since inception. In November 2023, the Company and one of its subsidiaries, BioLite, Inc.

Added

On July 10, 2024, the Company received a notification letter from the Staff notifying the Company that the minimum bid price per share for its common shares has been below $1.00 for a period of 30 consecutive business days and the Company therefore no longer meets the minimum bid price requirements set forth in Nasdaq Listing Rule 5550(a)(2).

Added

The notification received has no immediate effect on the listing of the Company’s common stock on Nasdaq. Under the Nasdaq Listing Rules, the Company has until January 6, 2025, to regain compliance.

Added

If at any time during such 180-day period the closing bid price of the Company’s common shares is at least $1 for a minimum of 10 consecutive business days, Nasdaq will provide the Company written confirmation of compliance.

Added

If the Company does not regain compliance during such 180-day period, the Company may be eligible for an additional 180 calendar days, provided that the Company meets the continued listing requirement for market value of publicly held shares and all other initial listing standards for Nasdaq except for Nasdaq Listing Rule 5550(a)(2), and provide a written notice of its intention to cure this deficiency during the second compliance period, by effecting a reverse stock split, if necessary.

Added

On January 9, 2025, the Company received a notification from Nasdaq granting the Company an additional 180 days, until July 7, 2025, to meet the minimum bid price requirement of $1.00 per share, as outlined in Nasdaq Listing Rule 5550(a)(2) (the “Rule”).

Added

To satisfy the Rule, the Company’s common stock must achieve a closing bid price of at least $1.00 for a minimum of ten consecutive trading days within this extension period; if successful, Nasdaq will confirm compliance with the Rule and close this matter.

Added

If compliance is not achieved by the new deadline, Nasdaq may initiate delisting procedures, which the Company would have the right to appeal.

Added

This entity is set up for holding the land in Taiwan that AiBtl is in the process of acquiring, which land will be used for developing health related business. As of the date hereof, the transfer of the land’s title is currently under government review, pending completion of the title transfer registration.

Added

Due to Taiwan’s legal restrictions prohibiting foreign entities from directly owning farmland, the parties agreed to structure the arrangement through nominee holdings. Incorporated in California on November 20, 2000, BioKey has chosen to initially focus on developing generic drugs to ride the opportunity of the booming industry.

Added

Effective March 14, 2024, the Company’s Board for Directors approved amending the Company’s Bylaws to amend Section 2.8 of the Company’s Bylaws to revise the number of shares needed to establish a quorum at shareholder meetings. The Amendment changes the quorum requirement from a majority to 33-1/3% of the votes entitled to be cast on a matter.

Item 1A. Risk Factors

Risk Factors — what could go wrong, per management

7 edited+9 added−3 removed284 unchanged

2023 filing

2024 filing

Our management has identified a material weakness in our internal control over financial reporting related to not having sufficient and skilled accounting personnel with appropriate level of technical accounting knowledge and experience in the application of accounting principles generally accepted in the United States commensurate with the Company’s financial reporting requirements and has concluded that, due to such material weakness, our disclosure controls and procedures were not effective as of December 31, 2023.

Sales to customers outside the United States accounted for 93% and 66% for the years ended December 31, 2023 and 2022, respectively. Our international sales and operations are subject to a wide range of risks, which may vary from country to country or region to region.

Sales to customers outside the United States accounted for 100% and 93% for the years ended December 31, 2024 and 2023, respectively. Our international sales and operations are subject to a wide range of risks, which may vary from country to country or region to region.

The regulations relating to penny stocks, coupled with the typically higher cost per trade to the investor of penny stocks due to factors such as broker commissions generally representing a higher percentage of the price of a penny stock than of a higher-priced stock, would further limit the ability of investors to trade in our common stock. 41 In the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital Market or another national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq Capital Market’s minimum bid price requirement, or prevent future non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.

In the event of a delisting, we anticipate that we would take actions to restore our compliance with the Nasdaq Capital Market or another national exchange’s listing requirements, but we can provide no assurance that any such action taken by us would allow our Common Stock to remain listed on the Nasdaq Capital Market, stabilize our market price, improve the liquidity of our common stock, prevent our common stock from dropping below the Nasdaq Capital Market’s minimum bid price requirement, or prevent future non-compliance with the Nasdaq Capital Market or another national exchange’s listing requirements.

If our common stock were delisted from the Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc.

If compliance is not achieved by the new deadline, Nasdaq may initiate delisting procedures, which the Company would have the right to appeal. 41 If our common stock were delisted from the Nasdaq, trading of our common stock would most likely take place on an over-the-counter market established for unlisted securities, such as the OTCQB or the Pink Market maintained by OTC Markets Group Inc.

If not remediated, or if we identify further material weaknesses in our internal controls, our failure to establish and maintain effective disclosure controls and procedures and internal control over financial reporting could result in material misstatements in our financial statements and a failure to meet our reporting and financial obligations, each of which could have a material adverse effect on our financial condition and the trading price of our common stock.

If not remediated, or if we identify additional material weaknesses, our failure to maintain effective internal controls could continue to adversely impact our ability to meet our reporting and financial obligations and could have a material adverse effect on our financial condition and the trading price of our common stock.

As of December 31, 2023, our outstanding current liabilities were approximately $5.6 million, which consisted primarily of short-term bank loans and accrued expenses.

As of December 31, 2024, our working capital is in deficit of $4.4 million, consisting of outstanding current liabilities were approximately $6.6 million, which consisted primarily of short-term bank loans and accrued expenses. 35 Failure to remediate a material weakness in internal accounting controls could result in material misstatements in our financial statements.

Failure to maintain the effectiveness of our disclosure controls and procedures may lead to restatement of our financial statements, harm our operating results, subject us to regulatory scrutiny and sanction, cause investors to lose confidence in our reported financial information and have a negative effect on the market prices for our Common Stock.

If we do not remediate the identified material weakness and continue to lack effective internal controls, we may be unable to prevent additional errors or misstatements in the future, which could harm our operating results, subject us to regulatory scrutiny or sanctions, cause investors to lose confidence in our reported financial information, and negatively impact the market price of our common stock.

Removed

On April 5 and 20, 2020, we entered into certain exchange agreements separately with certain U.S. and non-U.S. holders of certain convertible promissory notes in the aggregate amount of $1,446,780; pursuant to the exchange agreements, we issued to the Holders an aggregate of 795,735 shares of Common Stock and warrants to purchase 795,735 shares of Common Stock.

Added

Due to such material weakness, we were unable to maintain effective disclosure controls over financial reporting, which did result in material misstatements in our financial statements and led to a restatement.

Removed

On November 9, 2020, we entered into an exchange agreement with a certain non-U.S. holder of certain convertible promissory notes in the amount of $270,272; pursuant to the exchange agreements, we will issue to the holder an aggregate of 120,121 shares of Common Stock and warrants to purchase 120,121 shares of Common Stock.

Added

Failure to maintain the effectiveness of our disclosure controls and procedures has led to a misstatement in our financial statements and a restatement.

Removed

We also agreed to issue an aggregate of 545,182 options of common stock to some of our employees in lieu of their deferred salaries in an aggregate amount of $1,090,360. 35 Failure to remediate a material weakness in internal accounting controls could result in material misstatements in our financial statements.

Added

Item 2. Properties

Properties — owned and leased real estate

4 edited+0 added−0 removed2 unchanged

2023 filing

2024 filing

ITEM 2. PROPERTIES Our Subsidiary BioLite has its laboratories located in Hsinchu Biomedical Science Park, with an address of 20, Sec. 2, Shengyi Rd., 2nd Floor, Zhubei City, Hsinchu County 302, Taiwan (R.O.C.).

ITEM 2. PROPERTIES Our Subsidiary BioLite has its laboratories located in Hsinchu Biomedical Science Park, with an address of 2nd Floor, No. 20, Sec. 2, Shengyi Rd., Zhubei City, Hsinchu County 302, Taiwan (R.O.C.).

The leased space counts for approximately 1.9% of the total space of the building. On January 1, 2020, BioLite Taiwan extended the contract for another five years. The new expiration date is on December 31, 2024. The rent increases by a small percentage each year during the term of the lease agreement.

The leased space counts for approximately 1.9% of the total space of the building. On January 1, 2020 and January 1, 2024, BioLite Taiwan extended the contract for another five and five years respectively. The new expiration date is on December 31, 2029. The rent increases by a small percentage each year during the term of the lease agreement.

BioLite paid $50,572 and $60,104 in rental expense for the laboratory space for the years ended December 31, 2023 and 2022, respectively. Another subsidiary BioKey is headquartered in Fremont, California. BioKey’s office lease will end on February 28, 2026 and the office occupies approximately 28,186 square feet.

BioLite paid $48,406 and $50,572 in rental expense for the laboratory space for the years ended December 31, 2024 and 2023, respectively. Another subsidiary BioKey is headquartered in Fremont, California. BioKey’s office lease will end on February 28, 2026 and the office occupies approximately 28,186 square feet.

The total BioKey’s rental expenses were $353,466 and $328,051 for the years ended December 31, 2023 and 2022, respectively.

The total BioKey’s rental expenses were $421,894 and $353,466 for the years ended December 31, 2024 and 2023, respectively.

Item 3. Legal Proceedings

Legal Proceedings — active lawsuits and investigations

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ITEM 3. LEGAL PROCEEDINGS Unless disclosed otherwise, we are currently not a party to any material legal or administrative proceedings and are not aware of any pending legal or administrative proceedings against us. We may from time to time become a party to various legal or administrative proceedings arising in the ordinary course of our business.

Added

MINE SAFETY DISCLOSURES. Not applicable 43 PART II

Item 5. Market for Registrant's Common Equity

Market for Common Equity — stock, dividends, buybacks

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ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information . As of December 31, 2023, our common stock, par value $.001 per share (the “Common Stock”), is currently quoted on the Nasdaq Capital Markets under the symbol “ABVC”. Holders .

ITEM 5. MARKET FOR REGISTRANT’S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES Market Information . As of December 31, 2024, our common stock, par value $0.001 per share (the “Common Stock”), is currently quoted on the Nasdaq Capital Markets under the symbol “ABVC”. Holders .

On February 6, 2024, the Company entered into a definitive agreement with Shuling Jiang (“ Shuling ”), pursuant to which Shuling shall transfer the ownership of certain land she owns located at Taoyuan City, Taiwan (the “ Land ”) to the Company (the “ Agreement ”).

On February 6, 2024, the Company entered into a definitive agreement with Shuling Jiang ( “Shuling”), pursuant to which Shuling shall transfer the ownership of certain land she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).

On July 10, 2022, the Board approved the issuance of 75,000 shares of common stock to Barlew Holdings, LLC pursuant to the consulting agreement by and between Barlew Holdings, LLC and the Company dated July 1, 2022, and 250,000 shares of common stock to Inverlew Advisors, LLC, in accordance with the consulting agreement by and between Inverlew Advisors, LLC and the Company dated July 1, 2022.

On July 10, 2022, the Board approved the issuance of 7,500 shares of common stock to Barlew Holdings, LLC pursuant to the consulting agreement by and between Barlew Holdings, LLC and the Company dated July 1, 2022, and 25,000 shares of common stock to Inverlew Advisors, LLC, in accordance with the consulting agreement by and between Inverlew Advisors, LLC and the Company dated July 1, 2022.

In consideration for the Land, the Company issued Shuling (i) 703,495 restricted shares of the Company’s common stock (the “ Shares ”) at a price of $3.50 per share and (ii) five-year warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.00 per share. 44 ITEM 6. [Reserved]

In consideration for the Land, the Company issued Shuling (i) 703,495 restricted shares of t he Company’s common stock ( the “Shares”) at a price of $3.50 per share and (ii) five-year warrants to purchase up to 1,000,000 shares of the Company’s common stock, with an exercise price of $2.00 per share.

As of March 12, 2024, we had approximately 656 shareholders of record of our common stock. Dividends . Holders of our common stock are entitled to receive such dividends as may be declared by our board of directors.

As of April 11, 2025, we had approximately 656 shareholders of record of our common stock. Dividends . Holders of our common stock are entitled to receive such dividends as may be declared by our board of directors.

On December 1, 2022, the Company issued 125,000 and 100,000 common shares to Euro-Asia Investment & Finance Corp Ltd. and Thalia Media Ltd. for consulting and advisory services. On January 3, 2023, the Company issued 223,411 common shares to a consultant for providing consulting services on listing to NASDAQ in 2021.

On December 1, 2022, the Company issued 12,5000 and 10,000 common shares to Euro-Asia Investment & Finance Corp Ltd. and Thalia Media Ltd. for consulting and advisory services. On January 3, 2023, the Company issued 22,341 common shares to a consultant for providing consulting services on listing to NASDAQ in 2021.

In March 2022, the Company issued 242,247 warrants to a FINRA member firm. On May 11, 2022, the Company and certain investors entered into certain securities purchase agreement relating to the offer and sale of 2,000,000 shares of common stock, par value $0.001 per share in a registered direct offering.

On May 11, 2022, the Company and certain investors entered into certain securities purchase agreement relating to the offer and sale of 200,000 shares of common stock, par value $0.001 per share in a registered direct offering.

In March 2022, the Company issued 75,000 shares to BarLew Holdings, LLC, a consultant (“Barlew”). On January 1, 2022, the Company engaged Barlew for consulting and advisory services for six months, with a monthly payment of USD15,000, as well as additional compensation of 75,000 shares of restricted common stock.

On January 1, 2022, the Company engaged Barlew for consulting and advisory services for six months, with a monthly payment of USD15,000, as well as additional compensation of 7,500 shares of restricted common stock. In March 2022, the Company issued 24,225 warrants to a FINRA member firm.

Pursuant to the Purchase Agreement, the Company agreed to sell the Shares and/or Pre-funded Warrants at a per share purchase price of $3.50, for gross proceeds of $1,750,000, before deducting any estimated offering expenses. On August 1, 2023, the pre-funded warrants were exercised. The above-mentioned equity is before the reverse stock split in 2023.

Pursuant to the Purchase Agreement, the Company agreed to sell the Shares and/or Pre-funded Warrants at a per share purchase price of $3.50, for gross proceeds of $1,750,000, before deducting any estimated offering expenses. On August 1, 2023, the pre-funded warrants were exercised. 44 On August 14, 2023, the Company entered into a cooperation agreement with Zhonghui.

On January 27, 2024, the company granted 1,241,615 restricted shares to its employees and directors under the 2016 Equity Incentive Plan, with an issuance date of February 2, 2024. These shares are subject to a three-year restriction period.

The Company also issued 29,600 common stock to consultants for providing consulting services on the above transaction. On January 27, 2024, the company granted 1,302,726 restricted shares to its employees and directors under the 2016 Equity Incentive Plan, with an issuance date of February 2, 2024. These shares are subject to a three-year restriction period.

All recipients had adequate access, though their relationships with the Registrant, to information about the Registrant. In January 2022, the Company agreed to pay the deferred service fees related to the public offering closed on August 5, 2021 amounting to $4,296,763 by issuing 1,306,007 shares of unrestricted common shares, valued at $3.29 per share on the grant date.

In January 2022, the Company agreed to pay the deferred service fees related to the public offering closed on August 5, 2021 amounting to $4,296,763 by issuing 130,601 shares of unrestricted common shares, valued at $32.9 per share on the grant date. In March 2022, the Company issued 7,500 shares to BarLew Holdings, LLC, a consultant (“Barlew”).

On August 14, 2023, the Company entered into a cooperation agreement with Zhonghui. Pursuant thereto, the Company acquired 20% of the ownership of a property and the parcel of the land owned by Zhonghui in Leshan, Sichuan, China (collectively, the “Property”).

Pursuant thereto, the Company acquired 20% of the ownership of a property and the parcel of the land owned by Zhonghui in Leshan, Sichuan, China (collectively, the “Property”). During the third quarter of 2023, the Company issued to Zhonghui, an aggregate of 370,000 shares of the Company’s common stock, at a per share price of $1.87.

Removed

During the third quarter of 2023, the Company issued to Zhonghui, an aggregate of 370,000 shares of the Company’s common stock, at a per share price of $20. The Company also issued 29,600 common stock to consultants for providing consulting services on the above transaction.

Added

All recipients had adequate access, though their relationships with the Registrant, to information about the Registrant. All following number of shares are post-split.

Added

Under the Agreement, Shuling was to also transfer outstanding liability owed on the Land (approximately $500,000) to the Company.

Added

On May 16, 2024, the Company’s board of directors determined that it was in the best interest of the Company and its shareholders to terminate the Agreement and not proceed with the transfer of land ownership; the Company may reconsider the transaction at a later date. The shares were returned and the warrants were not issued.

Added

On May 24, 2024, the Company issued 200,000 shares of common stock to a consultant for providing business and funding opportunities. In June 2024, the Company entered into a stock purchase agreement with an investor, which the Company will issue 41,387 shares of common stock at $0.75 per share to the investor for cash.

Added

As of December 31, 2024, the proceeds were received. Due to certain stock transfer processes, one of the Company’s shareholders transferred such shares to the investor on behalf of the company in July 2024; the company plans to issue the same number of shares to the transferring shareholder soon.

Added

In July 2024, the Company entered into an agreement with its landlord in California, pursuant that the Company issued 169,992 shares of common stock for the rent payable through July 2024, in total of $127,494.

Added

The Company also issued 43,458 shares on August 14, 2024 for the August 2024 rent, and 46,072 shares were issued on September 3, 2024 for the September 2024 rent.

Added

Further, we issued 64,147 shares on October 29, 2024 for October rent, 45,293 shares on November 13, 2024 for November rent, and 30,422 shares on December 26, 2024 for half month of December rent. In 2025, we issued 28,135 shares, 22,031 shares, and 30,488 shares for each of the half month rent from January 2025 to March 2025, respectively.

Added

In December 2024, the Company issued 117,277 shares of its common stock to employees as compensation. In April 2025, the Company conducted a private offering of its common stock to several individual non-US investors, issuing an aggregate of 502,081 unregistered shares of common stock at $0.60 per share, raising a total of $301,250. 45 ITEM 6. [Reserved]

Item 6. [Reserved]

Selected Financial Data — reserved (removed by SEC in 2021)

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Item 6. [Reserved] 45 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 45 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 67 Item 8. Financial Statements and Supplementary Data F-1 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 68 Item 9A. Controls and Procedures 68 Item 9B.

Item 6. [Reserved] 46 Item 7. Management’s Discussion and Analysis of Financial Condition and Results of Operations 46 Item 7A. Quantitative and Qualitative Disclosures about Market Risk 71 Item 8. Financial Statements and Supplementary Data F-1 Item 9. Changes in and Disagreements with Accountants on Accounting and Financial Disclosure 72 Item 9A. Controls and Procedures 73 Item 9B.

Removed

Other Information 69 Item 9C. Disclosure Regarding Foreign Jurisdictions That Prevent Inspections 69 Part III Item 10. Directors, Executive Officers and Corporate Governance 70 Item 11. Executive Compensation 77 Item 12. Securities Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters 80 Item 13. Certain Relationships and Related Transactions, and Director Independence 81 Item 14.

Removed

Principal Accountant Fees and Services 83 Part IV Item 15. Exhibits, Financial Statement Schedules 84 Item 16.

Removed

Form 10-K Summary 87 Signatures 88 i CONVENTIONS Except where the context otherwise requires and for purposes of this annual report only: “APR” or “annual percentage rate” refers to the annual rate that is charged to borrowers, including a fixed interest rate and a transaction fee rate, expressed as a single percentage number that represents the actual yearly cost of borrowing over the life of a loan; “BioKey” means BioKey, Inc. refers to a California corporation and wholly-owned subsidiary of ABVC; “BioLite” means BioLite Holding, Inc. refers to a Nevada corporation and a wholly-owned subsidiary of ABVC; The “Board” or “Board of Directors” refers to the board of directors of the Company; “CDMO” refers to the Contract Development& Manufacturing Organization services BioKey provides, such as a API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials (phase I through phase III) and commercial manufacturing.

Removed

“China” and “P.R.C.” refer to the People’s Republic of China, including Hong Kong Special Administrative Region and the Macau Special Administrative Region, unless referencing specific laws and regulations adopted by the PRC and other legal or tax matters only applicable to mainland China, excluding Taiwan for purposes of this report; “Common Stock” is the Common Stock of ABVC Biopharma, Inc., par value US$0.001 per share; “Lind” refers to Lind Global Fund II, LP; “Merger Agreement” means the Agreement and Plan of Merger dated as of January 31, 2018, pursuant to which the Company, BioLite, BioKey, “BioLite Acquisition Corp.” a Nevada corporation, and BioKey Acquisition Corp.” a California corporation completed a business combination on February 8, 2019 where ABVC acquired BioLite and BioKey via the issuance of additional shares of Common Stock to the shareholders of BioLite and BioKey; “Series A Convertible Preferred Stock” is the Series A convertible preferred stock of ABVC Biopharma, Inc., par value US$0.001 per share; The terms “we,” “us,” “our,” “the Company,” “our Company” or “ABVC” refers to ABVC Biopharma, Inc., a Nevada corporation, and all of the Subsidiaries as defined herein unless the context specifies; “R.O.C.” or “Taiwan” refers to Taiwan, the Republic of China; “Subsidiary” or “Subsidiaries,” refer to American BriVision Corporation, sometimes referred to as “BriVision”, BioLite Holding, Inc. or BioLite and BioKey, Inc. or BioKey; All references to “NTD” and “New Taiwan Dollars” are to the legal currency of R.O.C.; and All references to “U.S. dollars”, “dollars”, and “$” are to the legal currency of the U.S.

Removed

This report specifies certain NTD amounts and in parenthesis the approximate U.S. dollar amounts at the exchange rate on the date of this report. The conversion rates regarding NTD and U.S. dollars are subject to change and, therefore, we can provide no assurance that U.S. dollar amounts specified in this report will not change.

Removed

For clarification, this report follows English naming convention of first name followed by last name, regardless of whether an individual’s name is Chinese or English. This report does not discuss any affiliates of the Company that are not controlled by the Company. ii PART I Except for statements of historical fact, the information presented herein constitutes forward-looking statements.

Removed

These forward-looking statements generally can be identified by phrases such as “anticipates,” “believes,” “estimates,” “expects,” “forecasts,” “foresees,” “intends,” “plans,” or other words of similar import. Similarly, statements herein that describe our business strategy, outlook, objectives, plans, intentions or goals also are forward-looking statements.

Removed

Such forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.

Removed

Such factors include, but are not limited to, our ability to: successfully commercialize our technology; generate revenues and achieve profitability in an intensely competitive industry; compete in products and prices with substantially larger and better capitalized competitors; secure, maintain and enforce a strong intellectual property portfolio; attract additional capital sufficient to finance our working capital requirements, as well as any investment of plant, property and equipment; develop a sales and marketing infrastructure; identify and maintain relationships with third party suppliers who can provide us a reliable source of raw materials; acquire, develop, or identify for our own use, a manufacturing capability; attract and retain talented individuals; continue operations during periods of uncertain general economic or market conditions, and; other events, factors and risks previously and from time to time disclosed in our filings with the Securities and Exchange Commission.

Removed

Although we believe the expectations reflected in our forward-looking statements are reasonable, we cannot guarantee future results, levels of activity, performance or achievements. Except as required by law, we do not undertake to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Removed

Summary of Risk Factors The following summarizes some, but not all, of the risks provided below. Please carefully consider all of the information discussed in Item 1A “Risk Factors” in this annual report for a more thorough description of these and other risks.

Removed

Risks Related to the Company’s Business ● Risks relating to unfavorable global economic conditions, including health and safety concerns on the business, financial condition, and results of operations. ● Risks relating to no history in obtaining regulatory approval for, or commercializing, any new drug candidate. ● Risks relating to dependence on successful development, acquisition or licensing of new drugs. ● Risks relating to side effects associated with current or future products that could impact growth. ● Risks relating to product liability claims and substantial liabilities ● Risks relating to conducting clinical trials at sites outside the United States. ● Risks relating to failure in demonstrating safety and efficacy of product candidates in clinical trials. ● Risks relating to failure to achieve market acceptance. ● Risks relating to failure to enter successful collaborations or establish and maintain additional strategic partnerships ● Risks relating to termination of license agreements. ● Risks relating to dependence on one supplier for API of certain drug candidates. ● Risks relating to claims relating to improper handling, storage or disposal of hazardous chemicals and biological materials. ● Risks relating to failure to maintain and monitor the sample of drug candidates. 1 Risks Related to Intellectual Property ● Risks relating to improper disclosure and misappropriation of confidential information or trade secrets ● Risks relating to protection of our IP or infringement of IP rights of other parties ● Risks relating to unable to protect and enforce our IP rights throughout the world.

Removed

Regulatory Risks Relating to Biopharmaceutical Business ● Risks relating to fail or delay to obtain regulatory approval ● Risks relating to competition from more established and well-resourced companies. Risks Relating to Doing Business Outside the United States ● Risks relating to international operations.

Removed

Risks Related to the Company’s Financial Condition ● Risks relating to our existing indebtedness. ● Risks relating to our disclosure controls and procedures and internal financial reporting controls. ● Risks relating to creation of new series of preferred stock. ● Risks relating to failure in safeguarding our computer network system.

Removed

Risks Related to the Company’s Common Stock ● Risks relating to volatility of share price. ● Risks relating to certain shareholders have substantial influence over our Company and their interests may not be aligned with the interests of our other shareholders ● Risks relating to future sales and issuances of our common stock or rights to purchase common stock 2

Item 7. Management's Discussion & Analysis

Management's Discussion & Analysis (MD&A) — revenue / margin commentary

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The parties later agreed to a floor price of $1.00 for the Variable Price and that the Company would compensate Lind in cash if the variable price was less than such floor price at the time of conversion.

The Securities Purchase Agreement also contains customary representation and warranties of the Company and the Investors, indemnification obligations of the Company, termination provisions, and other obligations and rights of the parties.

To determine the stand-alone selling price, the Company relies on assumptions which may include forecasted revenues, development timelines, reimbursement rates for R&D personnel costs, discount rates and probabilities of technical and regulatory success. The Company had multiple deliverables under the collaborative agreements, including deliverables relating to grants of technology licenses, regulatory and clinical development, and marketing activities.

Estimation of the performance periods of the Company’s deliverables requires the use of management’s judgment. Significant factors considered in management’s evaluation of the estimated performance periods include, but are not limited to, the Company’s experience in conducting clinical development, regulatory and manufacturing activities.

The Company reviews the estimated duration of its performance periods under its collaborative agreements on an annually basis, and makes any appropriate adjustments on a prospective basis. Future changes in estimates of the performance period under its collaborative agreements could impact the timing of future revenue recognition.

Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina, Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital. ● Drug: ABV-1505, Adult Attention-Deficit Hyperactivity Disorder (ADHD), Phase II, NCE drug Principal Investigators: Keith McBurnett, Ph.D. and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine ● Drug: ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator: Scott Irwin, MD, Ph.D. – Cedars Sinai Medical Center (CSMC) ● Drug: ABV-1519, A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR wild-type Non-Small Cell Lung Cancer Patients 45 Upon successful completion of the Phase II trial, the Company will seek a partner – a large pharmaceutical company – to complete a Phase III study, submit the New Drug Application (NDA), and commercialize the drug upon approval by the FDA and Taiwan FDAs.

Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina, Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital. ● Drug: ABV-1505, Adult Attention-Deficit Hyperactivity Disorder (ADHD), Phase II, NCE drug Principal Investigators: Keith McBurnett, Ph.D. and Linda Pfiffner, Ph.D., University of California San Francisco (UCSF), School of Medicine ● Drug: ABV-1601, Major Depression in Cancer Patients, Phase I/II, NCE drug Principal Investigator: Scott Irwin, MD, Ph.D. – Cedars Sinai Medical Center (CSMC) ● Drug: ABV-1519, A Phase I/II, Open Label Study to Evaluate the Safety and Efficacy of BLEX 404 Oral Liquid Combined with Pemetrexed + Carboplatin Therapy in Patients with Advanced Inoperable or Metastatic EGFR wild-type Non-Small Cell Lung Cancer Patients 46 Upon successful completion of the Phase II trial, the Company will seek a partner – a large pharmaceutical company – to complete a Phase III study, submit the New Drug Application (NDA), and commercialize the drug upon approval by the FDA and Taiwan FDAs.

ABV-2002 also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection. 47 Early testing by BioFirst indicates that ABV-2002 may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be manufactured at lower cost.

ABV-2002 also contains an abundant phenolic phytochemical found in plant cell walls that provides antioxidant antibacterial properties and neuroprotection. Early testing by BioFirst indicates that ABV-2002 may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be manufactured at lower cost.

Vitargus has started the construction of a GMP factory in Hsinchu Biomedical Science Park, Taiwan, with the aim at building a production base to supply the global market, and promote the construction of bio-degradable vitreous substitute manufacturing centers in Taiwan. Completion of this factory would allow ABVC to manufacture Vitargus with world-class technology in a GMP certified pharmaceutical factory.

BioFirst has started the construction of a GMP factory in Hsinchu Biomedical Science Park, Taiwan, with the aim at building a production base to supply the global market, and promote the construction of bio-degradable vitreous substitute manufacturing centers in Taiwan. Completion of this factory would allow ABVC to manufacture Vitargus with world-class technology in a GMP certified pharmaceutical factory.

Early testing by BioFirst indicates that ABV-2002 may be more effective for protecting the cornea and retina during long-term storage than other storage media available today and can be manufactured at lower cost. Further clinical development was put on hold due to the lack of funding.

Further clinical development task was put on hold due to the lack of funding. In addition, BioFirst was incorporated on November 7, 2006, focusing on the R&D, manufacturing, and sales of innovative patented pharmaceutical products. The technology of BioFirst comes from the global exclusive licensing agreements BioFirst maintains with domestic R & D institutions.

Further clinical development was put on hold due to the lack of funding. In addition, BioFirst was incorporated on November 7, 2006, focusing on the R&D, manufacturing, and sales of innovative patented pharmaceutical products. The technology of BioFirst comes from the global exclusive licensing agreements BioFirst maintains with domestic R & D institutions.

In such situations, the adjustment made to the deferred tax asset would have a favorable impact on its effective income tax rate and results in the period such determination was made. Loss Per Share of Common Stock The Company calculates net loss per share in accordance with ASC Topic 260, “Earnings per Share”.

The foregoing description of the Transaction Documents is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and incorporated herein by reference. 49 On February 23, 2023, the Company entered into a securities purchase agreement (the “Lind Securities Purchase Agreement”) with Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”), that is convertible into shares of the Company’s common stock at an initial conversion price of $1.05 per share, subject to adjustment (the “Note Shares”).

The foregoing description of the Transaction Documents is qualified by reference to the full text of the forms of the Transaction Documents, which are filed as Exhibits hereto and incorporated herein by reference. 52 On February 23, 2023, the Company entered into a securities purchase agreement (the “Lind Securities Purchase Agreement”) with Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible note in the principal amount of $3,704,167 (the “Lind Offering”), for a purchase price of $3,175,000 (the “Lind Note”), that is convertible into shares of the Company’s common stock at an initial conversion price of $1.05 per share, subject to adjustment (the “Note Shares”).

Stock-based Compensation The Company measures expense associated with all employee stock-based compensation awards using a fair value method and recognizes such expense in the consolidated financial statements on a straight-line basis over the requisite service period in accordance with FASB ASC Topic 718 “Compensation-Stock Compensation”.

Stock-based Compensation The Company measures expense associated with all employee stock-based compensation awards using a fair value method and recognizes such expense in the consolidated financial statements on a straight-line basis over the requisite service period in accordance with ASC Topic 718 “Compensation-Stock Compensation”.

In connection with the Offering, the Company and its subsidiaries: (i) Biokey, Inc., a California corporation (“BioKey”), (ii) Biolite Holding, Inc., a Nevada corporation (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite, and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection with the offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter defined). 48 The sale of the 3 rd Lind Note and the terms of the offering, including the Guaranty are set forth in the securities purchase agreement, the 3 rd Lind Note, the 3 rd Lind Warrant, the Second Amendment to Guaranty, the Second Amendment to Security Agreement, and the Second Amendment to Guarantor Security Agreement (collectively, the “Transaction Documents”).

In connection with the Offering, the Company and its subsidiaries: (i) Biokey, Inc., a California corporation (“BioKey”), (ii) Biolite Holding, Inc., a Nevada corporation (“BioLite”), (iii) Biolite BVI, Inc., a British Virgin Islands corporation (“BioLite BVI”) and (iv) American BriVision Corporation, a Delaware corporation (“American BriVision” and, collectively with the Company, BioKey, BioLite, and BioLite BVI, the “Guarantors”), jointly and severally guaranteed all of the obligations of the Company in connection with the offering (the “Guaranty”) with certain collateral, as set forth in the related Transaction Documents (as hereinafter defined). 51 The sale of the 3 rd Lind Note and the terms of the offering, including the Guaranty are set forth in the securities purchase agreement, the 3 rd Lind Note, the 3 rd Lind Warrant, the Second Amendment to Guaranty, the Second Amendment to Security Agreement, and the Second Amendment to Guarantor Security Agreement (collectively, the “Transaction Documents”).

By acquiring land, ABVC plans to grow its botanical drug raw materials under its control; doing this will help the Company maintain the quality of the product and lower the cost of raw materials, which in turn will lower the cost of the drug substance and the drug product when it’s botanical drugs become commercialized.

Actual results could differ materially from those results. Stock Reverse Split On July 25, 2023, the Company filed a Certificate of Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split of the issued and outstanding shares of its common stock.

Actual results could differ materially from those results. 61 Stock Reverse Split On July 25, 2023, the Company filed a Certificate of Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split of the issued and outstanding shares of its common stock.

Unless otherwise noted, all shares and related financial information in this Form 10-K reflect this 1-for-10 reverse stock split. 46 NASDAQ Listing In August 2022, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (“Rule 5550(a)(2)”).

Unless otherwise noted, all shares and related financial information in this Form 10-K reflect this 1-for-10 reverse stock split. 48 NASDAQ Listing In August 2022, we received a deficiency letter from the Nasdaq Listing Qualifications Department (the “Staff”) notifying us that, for the last 30 consecutive business days, the closing bid price for our common stock was below the minimum $1.00 per share required for continued listing on The Nasdaq Capital Market pursuant to Nasdaq Listing Rule 5550(a)(2) (“Rule 5550(a)(2)”).

Other provisions of the Rgene Agreement remain in full force and effect. Clinical Development Service Agreement with Rgene Corporation, a related party On June 10, 2022, the Company expanded its co-development partnership with Rgene.

Other provisions of the Rgene Agreement remain in full force and effect. 56 Clinical Development Service Agreement with Rgene Corporation, a related party On June 10, 2022, the Company expanded its co-development partnership with Rgene.

Public Offering & Financings 2024 Financings On January 17, 2024, the Company entered into a securities purchase agreement with Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible note in the principal amount of $1,000,000, for a purchase price of $833,333 (the “3 rd Lind Note”), that is convertible into shares of the Company’s common stock at a conversion price, which shall be the lesser of (i) $3.50 (the “Fixed Price”) and (ii) 90% of the average of the three lowest VWAPs (as defined in the 3 rd Lind Note) during the 20 trading days prior to conversion (“Variable Price”), subject to adjustment (the “Note Shares”).

On January 17, 2024, the Company entered into a securities purchase agreement with Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible note in the principal amount of $1,000,000, for a purchase price of $833,333 (the “3 rd Lind Note”), that is convertible into shares of the Company’s common stock at a conversion price, which shall be the lesser of (i) $3.50 (the “Fixed Price”) and (ii) 90% of the average of the three lowest VWAPs (as defined in the 3 rd Lind Note) during the 20 trading days prior to conversion (“Variable Price”), subject to adjustment (the “Note Shares”).

In addition to supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf in compliance with new electronic submission guidelines of the FDA. 56 Impact of COVID-19 Outbreak On January 30, 2020, the World Health Organization declared the coronavirus outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic.

In addition to supporting ABVC’s new drug development, BioKey submits INDs, NDAs, ANDAs, and DMFs to the FDA, on ABVC’s behalf in compliance with new electronic submission guidelines of the FDA. 59 Impact of COVID-19 Outbreak On January 30, 2020, the World Health Organization declared the coronavirus outbreak a “Public Health Emergency of International Concern” and on March 10, 2020, declared it to be a pandemic.

Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance method, as applicable, as of the period ending date. 60 At the inception of an arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone.

Revenue recognized is limited to the lesser of the cumulative amount of payments received or the cumulative amount of revenue earned, as determined using the straight-line method or proportional performance method, as applicable, as of the period ending date. 64 At the inception of an arrangement that includes milestone payments, the Company evaluates whether each milestone is substantive and at risk to both parties on the basis of the contingent nature of the milestone.

Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the collaboration partners. 59 As part of the accounting for these arrangements, the Company applies judgment to determine whether the performance obligations are distinct, and develop assumptions in determining the stand-alone selling price for each distinct performance obligation identified in the collaboration agreements.

Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the collaboration partners. 63 As part of the accounting for these arrangements, the Company applies judgment to determine whether the performance obligations are distinct, and develop assumptions in determining the stand-alone selling price for each distinct performance obligation identified in the collaboration agreements.

Penalties and interest incurred related to underpayment of income tax are classified as income tax expense in the year incurred. No significant penalty or interest relating to income taxes has been incurred for the years ended December 31, 2023 and 2022. GAAP also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures and transition.

Penalties and interest incurred related to underpayment of income tax are classified as income tax expense in the year incurred. No significant penalty or interest relating to income taxes has been incurred for the years ended December 31, 2024 and 2023. GAAP also provides guidance on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures and transition.

(“BioLite”) each entered into a multi-year, global licensing agreement with AIBL for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed Products”). The potential license will cover the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights.

(“BioLite”) each entered into a multi-year, global licensing agreement with AiBtl for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (the “Licensed Products”). The potential license will cover the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights.

As per each of the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock at $10 per share, and if certain milestones are met, each of ABVC and BioLite may receive $3,500,000 and royalties equaling 5% of net sales, up to $100 million. Upon the issuance of the shares, AIBL became a subsidiary of ABVC.

As per each of the respective agreements, each of ABVC and BioLite received 23 million shares of AiBtl stock at $10 per share, and if certain milestones are met, each of ABVC and BioLite may receive $3,500,000 and royalties equaling 5% of net sales, up to $100 million. Upon the issuance of the shares, AiBtl became a subsidiary of ABVC.

Our estimates are often based on complex judgments, probabilities and assumptions that we believe to be reasonable, but that are inherently uncertain and unpredictable. We are also subject to other risks and uncertainties that may cause actual results to differ from estimated amounts. Results of Operations — Year Ended December 31, 2023 Compared to Year Ended December 31, 2022. Revenues.

The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667M by a third-party evaluation. The parties are determined to collaborate on the global development of the Licensed Products. The parties are also working to strengthen new drug development and business collaboration, including technology, interoperability, and standards development.

The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at $667 million by a third-party evaluation. The parties are determined to collaborate on the global development of the Licensed Products. The parties are also working to strengthen new drug development and business collaboration, including technology, interoperability, and standards development.

On August 14, 20 23, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu) Group Co., Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land (collectively, the “Property”) owned by Zhonghui in exchange for an aggregate of 370,000 shares of Common Stock at $20 per share (the “Zhonghui Shares”).

On August 14, 2023, the Company entered into a cooperation agreement with Zhonghui United Technology (Chengdu) Group Co., Ltd., pursuant to which the Company acquired a 20% ownership of certain property and a parcel of the land (collectively, the “Property”) owned by Zhonghui in exchange for an aggregate of 370,000 shares of Common Stock at $1.87 per share (the “Zhonghui Shares”).

Diluted earnings per share excludes all dilutive potential shares if their effect is anti-dilutive. 64 Commitments and Contingencies The Company has adopted ASC Topic 450 “Contingencies” subtopic 20, in determining its accruals and disclosures with respect to loss contingencies.

Diluted earnings per share excludes all dilutive potential shares if their effect is anti-dilutive. 68 Commitments and Contingencies The Company has adopted ASC 450 “Contingencies” subtopic 20, in determining its accruals and disclosures with respect to loss contingencies.

The closing of the transaction is conditioned upon the approval and receipt of all necessary government approvals, which have been received.

Th e closing of the transaction is conditioned upon the approval and receipt of all necessary government approvals, which have been received.

On February 6, 2024, the Company entered into a definitive agreement with Shuling Jiang (“Shuling”), pursuant to which Shuling shall transfer the ownership of certain land she owns located at Taoyuan City, Taiwan (the “Land”) to the Company (the “Agreement”).

As of December 31, 2023 and 2022, the Company’s cash and cash equivalents amounted to $60,155 and $85,265, respectively. Some of the Company’s cash deposits are held in financial institutions located in Taiwan where there is currently regulation mandated on obligatory insurance of bank accounts. The Company believes this financial institution is of high credit quality.

As of December 31, 2024 and 2023, the Company’s cash and cash equivalents amounted to $248,382 and $60,155, respectively. Some of the Company’s cash deposits are held in financial institutions located in Taiwan where there is currently regulation mandated on obligatory insurance of bank accounts. The Company believes this financial institution is of high credit quality.

As a result of the four transactions referenced above, the Company’ estimated that its stockholders’ equity would increase by approximately $10.65M.

As a result of the four transactions referenced above, the Company’ estimated that its stockholders’ equity would increase by approximately $10.65 million.

The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $10,314 and $13,031 for the years ended December 31, 2023 and 2022, respectively. Other than the above, the Company does not provide any other post-retirement or post-employment benefits.

The Company has no legal obligation for the benefits beyond the contributions made. The total amounts for such employee benefits, which were expensed as incurred, were $11,642 and $10,314 for the years ended December 31, 2024 and 2023, respectively. Other than the above, the Company does not provide any other post-retirement or post-employment benefits.

Accordingly, stockholders’ equity increased by $7.4M. The Company and Zhonghui plan to jointly develop the Property into a healthcare center for senior living, long-term care, and medical care in the areas of ABVCs’ special interests, such as Ophthalmology, Oncology, and Central Nervous Systems. The plan is to establish a base for the China market and global development of these interests.

The Company and Zhonghui plan to jointly develop the Property into a healthcare center for senior living, long-term care, and medical care in the areas of ABVCs’ special interests, such as Ophthalmology, Oncology, and Central Nervous Systems. The plan is to establish a base for the China market and global development of these interests.

The Agreement further provides that the Company and Biolite shall assign the research collaboration and license agreement between them to Biolite or prepare the same (the “ License Agreement ”). The aforementioned transactions occurred on the Completion Date. 55 As per the Agreement, the Shareholders shall supervise and manage the business and operations of Biolite JP.

The Agreement further provides that the Company and Biolite shall assign the research collaboration and license agreement between them to Biolite or prepare the same (th e “License Agreement”). The aforementioned transactions occurred on the Completion Date. 58 As per the Agreement, the Shareholders shall supervise and manage the business and operations of Biolite JP.

On August 5, 2019, the Company entered into a second Stock Purchase Agreement with BioFirst whereby the Company issued 414,702 shares of the Company’s common stock to BioFirst as repayment in full for a loan in the amount of $2,902,911 provided to BriVision from BioFirst.

Pursuant to the Purchase Agreement, the Company issued 428,571 shares of the Company’s common stock to BioFirst as payment for $3,000,000 owed by the Company to BioFirst in connection with the BioFirst Agreement. 57 On August 5, 2019, the Company entered into a second Stock Purchase Agreement with BioFirst whereby the Company issued 414,702 shares of the Company’s common stock to BioFirst as repayment in full for a loan in the amount of $2,902,911 provided to BriVision from BioFirst.

Cash Flow from Investing Activities During the years ended December 31, 2023 and 2022, the net cash used in investing activities were $360,186 and $1,721,684, respectively.

Cash Flow from Investing Activities During the years ended December 31, 2024 and 2023, the net cash used in investing activities were $0 and $360,186, respectively.

The market approach includes the use of comparable financial metrics of private and public companies and recent financing rounds. The income approach includes the use of a discounted cash flow model, which requires significant estimates regarding the investees’ revenue, costs, and discount rates.

Quantitative assessments of the fair value of its investments are developed using the market and income approaches. The market approach includes the use of comparable financial metrics of private and public companies and recent financing rounds. The income approach includes the use of a discounted cash flow model, which requires significant estimates regarding the investees’ revenue, costs, and discount rates.

Total employee stock-based compensation expenses were $0 and $1,241,930 for the years ended December 31, 2023 and 2022, respectively.

Total employee stock-based compensation expenses were $1,995,049 and $0 for the years ended December 31, 2024 and 2023, respectively.

Biolite JP is a private limited company (a Japanese Kabushiki Kaisha ) incorporated on December 18, 2018 and at the date of the Agreement has 10,000 ordinary shares authorized, with 3,049 ordinary shares issued and outstanding (the “Ordinary Shares”). Immediately prior to the execution of the Agreement, Lucidaim owned 1,501 ordinary shares and the Company owned the 1,548 ordinary shares.

The Company’s assessment of these factors in determining whether an impairment exists could change in the future due to new developments or changes in applied assumptions. Other-Than-Temporary Impairment The Company’s long-term equity investments are subject to a periodic impairment review.

The Company’s assessment of these factors in determining whether an impairment exists could change in the future due to new developments or changes in applied assumptions.

The change was principally caused by the increase in interest expense, mainly from the convertible notes payable, while being offset by the increase in foreign exchange for the year ended December 31, 2023, loss on investment in equity securities and decrease in impairment loss and investment loss for the year ended December 31, 2023.

The change was principally caused by the decrease in interest expense, mainly from the convertible notes payable (pay off the 1 st Lind Note and monthly repayment of 2 nd Lind Note), while being offset by increase in loss on investment in equity securities for the year ended December 31, 2024.

Qualitative analysis of its investments involves understanding the financial performance and near-term prospects of the investee, changes in general market conditions in the investee’s industry or geographic area, and the management and governance structure of the investee. Quantitative assessments of the fair value of its investments are developed using the market and income approaches.

Its yearly analysis considers both qualitative and quantitative factors that may have a significant impact on the investee’s fair value. Qualitative analysis of its investments involves understanding the financial performance and near-term prospects of the investee, changes in general market conditions in the investee’s industry or geographic area, and the management and governance structure of the investee.

All shares and related financial information in this Form 10-K reflect this 1-for-10 reverse stock split. 57 Fair Value Measurements FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements.

Fair Value Measurements FASB ASC 820, “Fair Value Measurements” defines fair value for certain financial and nonfinancial assets and liabilities that are recorded at fair value, establishes a framework for measuring fair value and expands disclosures about fair value measurements.

In turn, the Company believes that the Reverse Stock Split will enable the Company to restore compliance with certain continued listing standards of NASDAQ Capital Market.

In turn, the Company believes that the Reverse Stock Split will enable the Company to restore compliance with certain continued listing standards of NASDAQ Capital Market. All shares and related financial information in this Form 10-K reflect this 1-for-10 reverse stock split.

As per FDA guidelines, the raw material of botanical drugs must be grown in a specific area under Good Agricultural Practices (GAP) or in an environmentally fully controlled plant factory to maintain quality.

Use of acquired land ABVC acquired the real estate described above for the long-term purpose of supporting its pipeline of products and reducing costs. As per FDA guidelines, the raw material of botanical drugs must be grown in a specific area under Good Agricultural Practices (GAP) or in an environmentally fully controlled plant factory to maintain quality.

Depreciation is calculated on the straight-line method, including property and equipment under capital leases, generally based on the following useful lives: Estimated Life in Years Buildings and leasehold improvements 5 ~ 50 Machinery and equipment 5 ~ 10 Office equipment 3 ~ 6 61 Construction-in-Progress The Company acquires constructions that constructs certain of its fixed assets.

Depreciation is calculated on the straight-line method, including property and equipment under capital leases, generally based on the following useful lives: Estimated Life in Years Buildings and leasehold improvements 5 ~ 50 Machinery and equipment 5 ~ 10 Office equipment 3 ~ 6 65 Impairment of Long-Lived Assets The Company has adopted ASC subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”).

Co-Development agreement with BioLite Japan K.K., a related party On October 6, 2021 (the “ Completion Date ”), the Company, Lucidaim Co., Ltd., a Japanese corporation (“ Lucidaim ,” together with the Company, the “ Shareholders ”), and BioLite Japan K.K., a Japanese corporation (“ Biolite JP” ) entered into a Joint Venture Agreement (the “ Agreement ”).

BioFirst is targeting to complete the construction in 2024. Co-Development agreement with BioLite Japan K.K., a related party On October 6, 2021 (the “Completion Date”), the Company, Lucidaim Co., Ltd., a Japanese corporation (“Lucidaim,” together with the Company, the “Shareholders”), and BioLite Japan K.K., a Japanese corporation (“Biolite JP”) entered into a Joint Venture Agreement (the “Agreement”).

Income Taxes The Company accounts for income taxes using the asset and liability approach which allows the recognition and measurement of deferred tax assets to be based upon the likelihood of realization of tax benefits in future years.

Total non-employee stock-based compensation expenses were $506,583 and $185,933 for the years ended December 31, 2024 and 2023, respectively. 67 Income Taxes The Company accounts for income taxes using the asset and liability approach which allows the recognition and measurement of deferred tax assets to be based upon the likelihood of realization of tax benefits in future years.

The Phase II study has started in the 2 nd quarter of 2023. The company is working on improvements to the Vitargus Product through the new batch of investigational product.

Matthew Simunovic, Sydney Eye Hospital; Dr. Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina of the two Australian sites. The Phase II study has started in the 2 nd quarter of 2023. The company is working on improvements to the Vitargus Product through the new batch of investigational product.

Concentration of Clients As of December 31, 2023, the most major client, specializes in developing and commercializing of dietary supplements and therapeutics in dietary supplement industry, accounted for 87.24% of the Company’s total account receivable.

As of December 31, 2023, the most major client, specializes in developing and commercializing of dietary supplements and therapeutics in dietary supplement industry, accounted for 87% of the Company’s total account receivable. For the year ended December 31, 2024, the out-licensing income from our two major licensees, accounts for 58% and 39% of the Company’s total revenues.

Immediately prior to the execution of the Agreement, Lucidaim owned 1,501 ordinary shares and the Company owned the 1,548 ordinary shares. The Shareholders entered into the joint venture to formally reduce to writing their desire to invest in and operate Biolite as a joint venture.

The Shareholders entered into the joint venture to formally reduce to writing their desire to invest in and operate Biolite as a joint venture.

The carrying value of the Company’s long-term bank loan approximates fair value because the interest rates approximate market rates that the Company could obtain for debt with similar terms and maturities. Concentration of Clients As of December 31, 2024, management estimated all accounts receivable balances are uncollectible and recognized $11,993 of credit loss.

For the year ended December 31, 2022, one major client, who is a Shareholder of the Company that works in development and commercialization of new drugs in Taiwan, accounted for 93.22% of the Company’s total revenues. Cash and Cash Equivalents The Company considers highly liquid investments with maturities of three months or less to be cash equivalents when purchased.

For the year ended December 31, 2023, the most major client, distributing nutritional supplement in Asia Pacific, accounted for 80% of the Company’s total revenues. Cash and Cash Equivalents The Company considers highly liquid investments with maturities of three months or less to be cash equivalents when purchased.

For further details about these difference payment arrangements, see “Summary of Critical Accounting Policies” below. 51 Examples of recent collaborative agreements the Company has entered into are as follows: Collaborative agreements with BHK, a related party (i) In February and December of 2015, BioLite, Inc. entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

Oncox may use its revenue to fund the licensing fees. 55 Collaborative agreements with BHK, a related party (i) In February and December of 2015, BioLite, Inc. entered into a total of three joint venture agreements with BioHopeKing to jointly develop ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1504 for MDD and ABV-1505 for ADHD.

For the year ended December 31, 2023, the Company generated $152,430 in revenue, mainly from the sale of Contract Development & Manufacturing Organization (“CDMO”) services.

For the year ended December 31, 2024, the Company generated $509,589 in revenue, mainly from the outlicensing our intellectual property and providing Contract Development & Manufacturing Organization (“CDMO”) services.

Interest income (expense), net, was $(2,307,859) for the year ended December 31, 2023, compared to $(106,151) for the year ended December 31, 2022. The increase of $(2,201,708), or approximately 2,074%, was primarily due to the increase in interest expense due to recognition of interest expense for the converted notes for proper accounting purpose. Net Loss.

Interest Income (Expense), Net , was $(738,541) for the year ended December 31, 2024, compared to $(1,128,190) for the year ended December 31, 2023. The decrease of $389,649 (or approximately 35%, was primarily due to the decrease in interest expense related to recognition of less interest expense for the converted notes for proper accounting purpose. Net Loss.

On November 4, 2020, the Company executed an amendment to the BioFirst Agreement with BioFirst to add ABV-2001 Intraocular Irrigation Solution and ABV-2002 Corneal Storage Solution to the agreement.

On November 4, 2020, the Company executed an amendment to the BioFirst Agreement with BioFirst to add ABV-2001 Intraocular Irrigation Solution and ABV-2002 Corneal Storage Solution to the agreement. ABV-2002 is utilized during a corneal transplant procedure to replace a damaged or diseased cornea while ABV-2001 has broader utilization during a variety of ocular procedures.

The decrease in the amount of $1,361,498 was primarily due to the decrease in prepayment for equity investment and purchase of equipment, while being offset by the increase in prepayment for long-term investments during the year ended December 31, 2023. 66 Cash Flow from Financing Activities During the years ended December 31, 2023 and 2022, the net cash provided by financing activities were $3,918,960 and $4,013,925, respectively.

The decrease in the amount of $360,186 was primarily due to the decrease in prepayment for equity investment and purchase of equipment, while being offset by the increase in prepayment for long-term investments during the year ended December 31, 2024.

Under the terms of the Service Agreement, BioKey is eligible to receive payments totaling up to $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained during the agreement period. 53 Through a series of transactions over the past 5 years, the Company and Rgene have co-developed the three drug products covered by the Service Agreement, which has resulted in the Company owning 31.62% of Rgene.

FDA IND regulatory requirements (the “Rgene Studies”). Under the terms of the Service Agreement, BioKey is eligible to receive payments totaling up to $3.0 million over a 3-year period with each payment amount to be determined by certain regulatory milestones obtained during the agreement period.

Significant judgment is required to identify whether an impairment exists in the valuation of the Company’s non-marketable equity investments, and therefore the Company considers this a critical accounting estimate. Its yearly analysis considers both qualitative and quantitative factors that may have a significant impact on the investee’s fair value.

The Company recognizes its proportionate share of the investee’s income or loss in gains (losses) on equity investments on a monthly basis. Significant judgment is required to identify whether an impairment exists in the valuation of the Company’s non-marketable equity investments, considering this a critical accounting estimate.

Recent Research Results Vitargus® Phase II Study has been initiated in Australia and Thailand, Principal Investigator: Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand sites and Professor/Dr. Matthew Simunovic, Sydney Eye Hospital; Dr. Elvis Ojaimi, East Melbourne Eye Group & East Melbourne Retina of the two Australian sites.

If compliance is not achieved by the new deadline, Nasdaq may initiate delisting procedures, which the Company would have the right to appeal. 49 Recent Research Results Vitargus® Phase II Study has been initiated in Australia and Thailand, Principal Investigator: Duangnate Rojanaporn, M.D., Ramathibodi Hospital; Thuss Sanguansak, M.D., Srinagarind Hospital of the two Thailand sites and Professor/Dr.

ABV-2002 is utilized during a corneal transplant procedure to replace a damaged or diseased cornea while ABV-2001 has broader utilization during a variety of ocular procedures. 54 Initially the Company will focus on ABV-2002, a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial keratoplasty (back layer cornea transplant).

Initially the Company will focus on ABV-2002, a solution utilized to store a donor cornea prior to either penetrating keratoplasty (full thickness cornea transplant) or endothelial keratoplasty (back layer cornea transplant). ABV-2002 is a solution comprised of a specific poly amino acid that protects ocular tissue from damage caused by external osmolarity exposure during pre-surgery storage.

The UCSF Medical Center Institutional Review Board has approved participation in the Part II study, and the site initiation visit was conducted in March 2023.

The UCSF Medical Center Institutional Review Board has approved participation in the Part II study, and the site initiation visit was conducted in March 2023. Public Offering & Financings 2025 Financings During the first quarter of 2025, the Company continued to strategically manage its outstanding convertible debt obligations with Lind Global Fund II, LP.

ABV-2002 is a solution comprised of a specific poly amino acid that protects ocular tissue from damage caused by external osmolarity exposure during pre-surgery storage. The specific polymer in ABV-2002 can adjust osmolarity to maintain a range of 330 to 390 mOsM thereby permitting hydration within the corneal stroma during the storage period.

The specific polymer in ABV-2002 can adjust osmolarity to maintain a range of 330 to 390 mOsM thereby permitting hydration within the corneal stroma during the storage period. Stromal hydration results in (a) maintaining acceptable corneal transparency and (b) prevents donor cornea swelling.

On June 30, 2019, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with BioFirst. Pursuant to the Purchase Agreement, the Company issued 428,571 shares of the Company’s common stock to BioFirst as payment for $3,000,000 owed by the Company to BioFirst in connection with the BioFirst Agreement.

On June 30, 2019, the Company entered into a Stock Purchase Agreement (the “Purchase Agreement”) with BioFirst.

Such decrease in operating expenses was mainly attributable to the decreased stock-based compensation and selling, general and administrative expenses, by $6,100,337, and decreasing research and development expenses of $1,630,541. Other Income (expense). The other expense was $2,437,773 in the year ending December 31, 2023, compared to other income of $400,184 on December 31, 2022.

Our operating expenses were $5,214,068 for the year ended December 31, 2024, compared to $6,617,127 for the year ended December 31, 2023. Such decrease in operating expenses was mainly attributable to the decreased in selling, general and administrative expenses, decreased in research and development expenses, but offset by increasing in stock-based compensation expenses.

The Company is currently evaluating the impact that the standard will have on its consolidated financial statements. 65 Estimates and Assumptions In preparing our consolidated financial statements, we use estimates and assumptions that affect the reported amounts and disclosures.

This ASU will likely result in the required additional disclosures being included in our consolidated financial statements once adopted. 69 Estimates and Assumptions In preparing our consolidated financial statements, we use estimates and assumptions that affect the reported amounts and disclosures.

Allowance for expected credit losses accounts was $616,505 and $194,957 as of December 31, 2023 and 2022, respectively.

Allowance for expected credit losses accounts was $616,414 and $616,505 as of December 31, 2024 and 2023, respectively. Revenue Recognition The Company recognizes revenue in accordance with ASC Topic 606 (ASC 606), Revenue from Contracts with Customers.

Furthermore, the Company anticipates future cash flows indicate that the recoverability of goodwill is not reasonably assured. Research and Development Expenses The Company accounts for the cost of using licensing rights in research and development cost according to ASC Topic 730-10-25-1.

Changes in the estimated fair value of the warrants are recognized as a non-cash gain or loss on the statements of operations. Research and Development Expenses The Company accounts for the cost of using licensing rights in research and development cost according to ASC Topic 730-10-25-1.

The Company accounts for non-marketable equity and other equity investments for which the Company does not have control over the investees as: ● Equity method investments when the Company has the ability to exercise significant influence, but not control, over the investee.

Fair value is determined based on quoted market prices or other observable inputs. ● Non-marketable equity investments: When the equity method does not apply, non-marketable equity investments are accounted for at cost, adjusted for observable price changes in orderly transactions for identical or similar investments and for impairments, if applicable. ● Equity method investments: Investments in which the Company has the ability to exercise significant influence, but not control, over the investee, are accounted for using the equity method.

We generated $152,430 and $969,783 in revenues for the years ended December 31, 2023 and 2022, respectively. The decrease of $817,353, or approximately 84%, was primarily caused by the completion of ongoing projects and waiting for new approval. Operating Expenses . Our operating expenses were $8,066,902 in the year ended December 31, 2023, compared to $15,797,780 in December 31, 2022.

We generated $509,589 and $152,430 in revenues for the years ended December 31, 2024 and 2023, respectively. The increase of $357,159, or approximately 234%, was primarily caused by outlicensing our intellectual properties completed in 2024, comparing to certain CDOM service provided in 2023. Operating Expenses .

The Company records other-than-temporary impairments on marketable equity securities and marketable equity method investments in gains (losses) on equity investments. ● Non-marketable equity investments based on the Company’s assessment of the severity and duration of the impairment, and qualitative and quantitative analysis of the operating performance of the investee; adverse changes in market conditions and the regulatory or economic environment; changes in operating structure or management of the investee; additional funding requirements; and the investee’s ability to remain in business.

Other-Than-Temporary Impairment The Company periodically reviews its non-marketable equity investments and equity method investments, with recognition in earnings when declines in value are considered other than temporary. the Company assesses the severity and duration of any impairment, along with qualitative and quantitative factors, such as the investee’s financial performance, adverse market or regulatory conditions, operational changes, or additional funding needs.

The intrinsic value of the beneficial conversion feature is recorded as a debt discount with a corresponding amount to additional paid in capital. The debt discount is amortized to interest expense over the life of the note using the effective interest method.

The debt component is carried at amortized cost, with any discount amortized to interest expense over the term of the note using the effective interest method. Upon conversion, the carrying amount of the debt is reclassified to equity, and no gain or loss is recognized.

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Other ABVC 10-K year-over-year comparisons

ABVC 10-K 2022 vs 2023