ABVC BioPharma(ABVC) - 2023 Q3 - Quarterly Report

PART I - FINANCIAL INFORMATION Item 1. Financial Statements (Unaudited) This section presents ABVC BioPharma's unaudited consolidated financial statements, including Balance Sheets, Statements of Operations, Cash Flows, and Stockholders' Equity, along with detailed explanatory notes Unaudited Consolidated Balance Sheets Total assets and equity significantly increased, driven by property, equipment, and long-term investments, while current assets decreased and liabilities rose due to convertible notes | Metric (USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:---------------------------|:-------------------------|:-------------------| | Total Current Assets | $2,493,534 | $2,987,247 | | Property and equipment, net| $7,953,936 | $573,978 | | Long-term investments | $2,677,395 | $842,070 | | Total Assets | $16,591,507 | $9,579,574 | | Total Current Liabilities | $5,363,076 | $5,543,628 | | Convertible notes payable | $1,654,004 | $- | | Total Liabilities | $7,529,911 | $6,343,435 | | Total Stockholders' Equity | $9,099,855 | $3,098,585 | Unaudited Consolidated Statements of Operations and Comprehensive Loss Net loss decreased by 11% to $3.37 million for the three months and 36% to $7.58 million for the nine months, driven by reduced operating expenses despite higher interest costs | Metric (3 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:------------------------------------|:-----------------|:-----------------| | Revenues | $15,884 | $42,269 | | Gross (loss) profit | $(13,730) | $31,528 | | Total operating expenses | $2,141,143 | $3,747,369 | | Loss from operations | $(2,154,873) | $(3,715,841) | | Interest expense | $(1,218,624) | $(126,536) | | Net loss | $(3,368,080) | $(3,776,524) | | Basic and diluted EPS | $(0.82) | $(1.14) | | Metric (9 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:------------------------------------|:-----------------|:-----------------| | Revenues | $150,265 | $380,789 | | Gross (loss) profit | $(12,566) | $359,785 | | Total operating expenses | $6,242,333 | $12,341,207 | | Loss from operations | $(6,254,899) | $(11,981,422) | | Interest expense | $(1,390,039) | $(159,507) | | Net loss | $(7,580,535) | $(11,811,472) | | Basic and diluted EPS | $(2.08) | $(3.71) | Unaudited Consolidated Statements of Cash Flows Net cash used in operating and investing activities decreased, while financing cash flow also declined due to convertible notes and warrant proceeds offset by loan repayments | Cash Flow Activity (9 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:------------------------------------------------|:-----------------|:-----------------| | Net cash used in operating activities | $(3,756,385) | $(6,937,322) | | Net cash used in investing activities | $(514,359) | $(1,638,396) | | Net cash provided by financing activities | $3,831,540 | $4,267,425 | | Net decrease in cash and restricted cash | $(270,791) | $(4,595,068) | | Ending cash and restricted cash | $1,120,937 | $1,970,147 | Unaudited Consolidated Statements of Stockholders' Equity (Deficit) Total equity significantly increased to $9.06 million, primarily from additional paid-in capital due to stock issuances for services, warrants, property, and convertible note exercises | Equity Component (as of Sep 30, 2023, USD) | Amount | |:-------------------------------------------|:-------------| | Common Stock | $4,823 | | Additional Paid-in Capital | $80,662,290 | | Stock Subscription Receivable | $(677,220) | | Accumulated Deficit | $(62,309,161)| | Accumulated Other Comprehensive Income | $519,123 | | Treasury Stock | $(9,100,000) | | Total Stockholders' Equity | $9,099,855 | | Noncontrolling interest | $(38,259) | | Total Equity | $9,061,596 | - Total Equity increased from $3,236,139 as of December 31, 2022, to $9,061,596 as of September 30, 2023[18] Notes to Unaudited Consolidated Financial Statements Detailed notes explain the company's business, accounting policies, significant transactions, financial instruments, going concern, revenue recognition, related parties, and financing activities 1. Organization and Description of Business ABVC BioPharma, a clinical-stage biopharmaceutical company, develops plant-derived drugs and medical devices but faces going concern doubts due to recurring losses and a working capital deficit - ABVC BioPharma, Inc. (formerly American BriVision (Holding) Corporation) is a Nevada corporation engaged in biotechnology, focusing on plant-derived new drugs and medical devices[22] - The company licenses drugs/medical devices from original researchers and conducts Phase II clinical trials in the United States, Australia, and Taiwan, including at institutions like Memorial Sloan Kettering Cancer Center and MD Anderson Cancer Center[22] - The company reported net losses of $3,368,080 and $7,580,535 for the three and nine months ended September 30, 2023, respectively, and had a working capital deficit of $2,869,542 as of September 30, 2023, raising substantial doubt about its ability to continue as a going concern[23] - Management plans to improve operations to generate positive cash flows and raise additional capital through private or public offerings to address going concern issues[24] 2. Summary of Significant Accounting Policies This section details key accounting policies, including basis of presentation, estimates, stock splits, fair value, revenue recognition, asset accounting, convertible notes, R&D, stock-based compensation, and income taxes - The unaudited interim consolidated financial statements are prepared in conformity with U.S. GAAP, with certain information condensed or omitted consistent with Regulation S-X[25] - On July 25, 2023, the Company effected a 1-for-10 reverse stock split to reduce outstanding shares and increase per-share trading value, aiming to restore NASDAQ Capital Market listing compliance[31] - Revenue is recognized when customers obtain control of promised goods or services, following a five-step model, including identifying performance obligations, determining transaction price, and allocating it[46] - Goodwill was determined to be impaired as of September 30, 2023, due to the company's current financial condition and inability to generate future operating income without substantial sales volume increases[74] - Non-employee stock-based compensation expenses were $817,740 for the three months ended September 30, 2023, and $1,409,969 for the nine months ended September 30, 2023[80] 3. Collaborative Agreements The company maintains collaborative agreements with related parties like BHK, Rgene, and BioFirst for co-development, involving milestone payments, royalties, and shared costs, sometimes settled in cash or equity - The company has co-development agreements with BHK for BLI-1401-2 (TNBC), BLI-1005 (MDD), and BLI-1006 (IBD) in Asia, with development costs shared 50/50 and potential royalties of 12% on net sales[93][96][97][99] - An agreement with Rgene Corporation for ABV-1507, ABV-1511, and ABV-1527 (later amended to ABV-1519 and ABV-1526) involved a $3 million payment for past research, received in cash and Rgene stock, which was fully written off due to impairment[100][101][103] - A Clinical Development Service Agreement with Rgene (a related party where the Company owns 31.62%) provides BioKey up to $3.0 million over 3 years for guiding RGC-1501, RGC-1502, and RGC-1503 through Phase II clinical studies[104][105] - The company loaned $1.0 million to Rgene via a 5% working capital convertible loan, which if fully converted, would increase ABVC's ownership in Rgene by an additional 6.4%[106] - A collaborative agreement with BioFirst Corporation for BFC-1401 Vitreous Substitute (later ABV-1701, ABV-2001, ABV-2002) involved a $3 million payment for past research, fully expensed as R&D, and the company issued shares to BioFirst for this payment and a loan[108][110][111][112][114] 4. Property and Equipment Net property and equipment significantly increased to $7.95 million, primarily due to a $7.4 million construction-in-progress asset for a healthcare center in Chengdu, China | Asset Category (USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:---------------------------|:-------------------------|:-------------------| | Land | $344,522 | $361,193 | | Construction-in-Progress | $7,400,000 | $- | | Buildings and improvements | $2,221,105 | $2,226,687 | | Machinery and equipment | $1,132,876 | $1,116,789 | | Office equipment | $166,027 | $173,766 | | Total (Gross) | $11,264,530 | $3,878,435 | | Less: Acc. Depreciation | $(3,310,594) | $(3,304,457) | | Property and equipment, net| $7,953,936 | $573,978 | - Construction-in-progress of $7.4 million relates to a 20% ownership acquisition in a property in Chengdu, China, for a healthcare center, in exchange for 370,000 shares of common stock[117][118] - Depreciation expenses were $7,459 and $20,949 for the three and nine months ended September 30, 2023, respectively[119] 5. Long-Term Investments Long-term investments significantly increased to $2.68 million, driven by higher equity method investments, especially in BioFirst Corporation, through increased ownership and loan conversion | Investee Name | Ownership Sep 30, 2023 (%) | Ownership Dec 31, 2022 (%) | Accounting Treatment | |:-----------------------------------|:---------------------------|:---------------------------|:---------------------| | Braingenesis Biotechnology Co., Ltd.| 0.22% | 0.22% | Cost Method | | Genepharm Biotech Corporation | 0.92% | 0.92% | Cost Method | | BioHopeKing Corporation | 8.03% | 8.03% | Cost Method | | BioFirst Corporation | 23.53% | 21.77% | Equity Method | | Rgene Corporation | 28.85% | 28.85% | Equity Method | | Long-term Investment Category (USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:------------------------------------|:-------------------------|:-------------------| | Non-marketable Cost Method | $803,205 | $842,070 | | Equity Method Investments | $1,874,190 | $- | | Total | $2,677,395 | $842,070 | - The company increased its equity interest in BioFirst Corporation to 23.53% by purchasing additional shares and converting a $1,284,570 loan into 677,450 shares[126] - The company accounts for its 28.85% equity investment in Rgene Corporation using the equity method, with Dr. Tsung-Shann Jiang (CEO and Chairman of BioLite Inc.) also serving as Chairman of Rgene[131] 6. Convertible Notes Payable A $3.7 million secured convertible note was issued to Lind Global Fund II, LP, convertible at $1.05 per share, incurring $1.32 million in interest expense for the nine months - On February 23, 2023, the Company issued a secured, convertible note to Lind Global Fund II, LP with a principal of $3,704,167 for a purchase price of $3,175,000, convertible at $1.05 per share[137] - Monthly payments of $308,650.58 can be made in cash (with a 5% premium) or common stock, with the number of shares determined by 90% of the average of the 5 lowest daily VWAPs during the 20 trading days prior to payment[138] - Total interest expenses from this convertible note were $1,323,032 for the nine months ended September 30, 2023[140] - The aggregate carrying value of convertible debentures was $1,654,004 as of September 30, 2023[140] 7. Bank Loans Short-term bank loans decreased to $0.85 million due to a $1 million Cathay Bank repayment, with existing loans from Cathay United and CTBC renewed at 2.85% and 2.5% interest | Bank Name (USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:-------------------|:-------------------------|:-------------------| | Cathay United Bank | $232,500 | $243,750 | | CTBC Bank | $620,000 | $650,000 | | Cathay Bank | $- | $1,000,000 | | Total | $852,500 | $1,893,750 | - The Cathay Bank loan of $1,000,000 was fully repaid on February 23, 2023[149] - Cathay United Bank loan of $232,500 was extended to September 6, 2024, with an effective interest rate of 2.85% per annum as of September 30, 2023[142] - CTBC Bank loans totaling $620,000 bear a fixed interest rate of 2.5% per annum, secured by a savings account and personal guarantees[144] 8. Related Parties Transactions The company conducts various transactions with related parties, including BioFirst, Rgene, BioHopeKing, and the Jiangs, involving receivables, revenue, and loans, with significant current and non-current balances | Related Party (Current Due From, USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:--------------------------------------|:-------------------------|:-------------------| | Rgene | $535,046 | $513,819 | | Total | $535,046 | $513,819 | | Related Party (Non-Current Due From, USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:------------------------------------------|:-------------------------|:-------------------| | BioFirst (Australia) | $822,781 | $752,655 | | BioHopeKing Corporation | $107,615 | $112,822 | | Total | $930,396 | $865,477 | | Related Party (Due To, USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:----------------------------|:-------------------------|:-------------------| | BioFirst Corporation | $315,947 | $188,753 | | The Jiangs | $19,789 | $19,789 | | Due to shareholders | $144,460 | $151,450 | | Total | $480,196 | $359,992 | - Revenue from related parties for the nine months ended September 30, 2023, was $1,900, significantly down from $307,788 in the prior year, with Rgene being the sole contributor[154] 9. Income Taxes A $80,696 income tax provision was reported for the nine months, contrasting with a prior-year benefit, mainly due to deferred foreign income tax and valuation allowances on deferred tax assets | Income Tax Component (9 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:--------------------------------------------------|:-----------------|:-----------------| | Total Current | $- | $1,600 | | Total Deferred | $80,696 | $(166,696) | | Total provision for (benefit from) income tax | $80,696 | $(165,096) | - A valuation allowance is recorded against deferred tax assets if their realization is not more likely than not, considering future taxable income projections and tax planning strategies[86] 10. Equity 2023 equity activities included common stock issuances for consulting, warrants, and property acquisition, with significant shares issued to Zhonghui for a China property and to Lind upon convertible note conversion - In January 2023, 223,411 common shares were issued to a consultant for NASDAQ listing services[169] - In February 2023, the company issued a secured, convertible note and a common stock purchase warrant to Lind Global Fund II, LP[169] - During the period ended September 30, 2023, the company repaid Lind with securities for 614,912 shares, totaling $1,814,800[169] - In July 2023, the company sold 300,000 common shares and 200,000 pre-funded warrants at $3.50 per share/warrant, generating $1,750,000 gross proceeds[169] - In August 2023, 370,000 common shares were issued to Zhonghui for a 20% ownership in a property in Chengdu, China, valued at $20.0 per share[169] 11. Stock Options No unvested stock options existed as of September 30, 2023, with no employee stock-based compensation, but non-employee compensation totaled $817,740 and $1,409,969 for the three and nine months, respectively | Stock Option Metric (Dec 31, 2022) | Number of Shares | Weighted-Average Exercise Price (USD) | |:-----------------------------------|:-----------------|:--------------------------------------| | Outstanding | 2,587,104 | $2.79 | | Exercisable | 2,587,104 | $2.79 | | Vested and expected to vest | 2,587,104 | $2.79 | - No employee stock-based compensation expenses were recognized for the three and nine months ended September 30, 2023 and 2022[79][173] - Non-employee stock-based compensation expenses were $817,740 and $1,409,969 for the three and nine months ended September 30, 2023, respectively[80] 12. Loss Per Share Basic and diluted loss per share improved to $(0.82) for three months and $(2.08) for nine months, reflecting a decrease in net loss compared to prior year periods | Loss Per Share (3 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:--------------------------------------------|:-----------------|:-----------------| | Net loss attributable to common stockholders| $(3,317,516) | $(3,704,864) | | Weighted-average shares outstanding (Shares)| 4,055,345 | 3,257,912 | | Basic and diluted loss per share | $(0.82) | $(1.14) | | Loss Per Share (9 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:--------------------------------------------|:-----------------|:-----------------| | Net loss attributable to common stockholders| $(7,404,722) | $(11,559,301) | | Weighted-average shares outstanding (Shares)| 3,555,474 | 3,119,795 | | Basic and diluted loss per share | $(2.08) | $(3.71) | 13. Lease The company adopted ASC 842, recognizing $899,817 in operating lease ROU assets and liabilities, with lease expenses totaling $288,751 for the nine months - The company adopted FASB ASC Topic 842, Leases, using the modified retrospective approach, effective January 1, 2019[178] | Lease Metric (USD) | Sep 30, 2023 (Unaudited) | Dec 31, 2022 (USD) | |:--------------------------------------|:-------------------------|:-------------------| | Operating lease ROU assets | $899,817 | $1,161,141 | | Operating lease liabilities (current) | $392,666 | $369,314 | | Operating lease liabilities (non-current) | $507,151 | $791,827 | | Lease Expense (9 months ended Sep 30, USD) | 2023 (Unaudited) | 2022 (Unaudited) | |:-------------------------------------------|:-----------------|:-----------------| | Operating lease expenses | $288,751 | $261,494 | - The weighted average remaining lease term is 2.04 years, and the weighted average discount rate is 1.53% as of September 30, 2023[186] 14. Subsequent Events Post-September 30, 2023, the company repaid Lind with $1.57 million in securities and entered a $667 million global licensing agreement with AIBL for CNS drugs, including potential shares and milestones - From October 1, 2023, to November 15, 2023, the Company repaid Lind Global Fund II, LP with 2,329,495 shares, totaling $1,572,600[187] - In November 2023, the Company and BioLite, Inc. entered into a multi-year, global licensing agreement with AIBL for CNS drugs (MDD and ADHD), valued at $667 million[188] - Under the AIBL agreement, ABVC and BioLite are each to receive 23 million shares of AIBL stock at $10 per share, and if certain milestones are met, $3,500,000 and royalties equaling 5% of net sales, up to $100 million[188] Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations Management discusses financial condition, operations, business developments, strategic objectives, and performance for the three and nine months, including critical accounting policies, liquidity, and capital resources Caution Regarding Forward-Looking Information This section cautions that forward-looking statements are subject to risks and uncertainties, advising against undue reliance and disclaiming any obligation to update them - Forward-looking statements are subject to risks and uncertainties, including economic conditions, ability to manage growth, acquisitions, raw material costs, regulatory compliance, competition, and financing[191] - Investors should not place undue reliance on forward-looking statements, and the company disclaims any obligation to update them publicly[192] Overview ABVC BioPharma, a clinical-stage biopharmaceutical company, focuses on plant-derived drugs and medical devices, with BioKey providing CDMO services, and recent events include a reverse stock split, new CEO, and China healthcare center agreement - ABVC BioPharma Inc. is a clinical-stage biopharmaceutical company developing new drugs and medical devices derived from plants[193] - Current clinical trials include ABV-1701 (Vitargus for vitrectomy surgery, Phase II), ABV-1505 (Adult ADHD, Phase II Part II), ABV-1601 (Major Depression in Cancer Patients, Phase I/II), ABV-1703 (Advanced Pancreatic Cancer, Phase II), and ABV-1519 (EGFR Positive NSCLC, Phase I/II)[197] - BioKey, a wholly-owned subsidiary, provides Contract Development & Manufacturing Organization (CDMO) services, including API characterization, formulation development, and regulatory submissions[198] - The Vitargus Phase II study was put on hold due to Serious Adverse Events (SAEs) observed in Thailand sites, with investigations ongoing to develop a safe in-situ procedure[203] - Dr. Howard Doong resigned as CEO and was replaced by Dr. Uttam Patil as of June 21, 2023[205] - The company acquired 20% ownership of a property in Leshan, Sichuan, China, for $7.4 million (in exchange for 370,000 common shares) to jointly develop a healthcare center for senior living, long-term care, and medical care[206] - In November 2023, the company and BioLite, Inc. entered into a global licensing agreement with AIBL for CNS drugs (MDD and ADHD), valued at $667 million, with potential for 46 million AIBL shares and up to $3.5 million in milestones plus royalties[207] Common Stock Reverse Split A 1-for-10 reverse stock split was completed on July 25, 2023, to reduce outstanding shares, increase per-share value, and regain NASDAQ listing compliance - A 1-for-10 reverse stock split was authorized on July 25, 2023, and became effective on the same date[208] - The reverse stock split was intended to reduce the number of issued and outstanding shares and increase the per share trading value to restore compliance with NASDAQ Capital Market listing standards[208] Series A Convertible Preferred Stock The company designated 3.5 million shares as Series A Convertible Preferred Stock, senior to common stock, convertible into one common share, with no shares issued as of December 31, 2022 - The company designated 3,500,000 shares of preferred stock as Series A Convertible Preferred Stock, with a par value of $0.001 per share[209] - Series A Stock ranks senior to common stock for dividend and liquidation rights, has the same voting rights as common stock, and is convertible into one common share, automatically converting after four years[209] - No Series A Convertible Preferred Stock had been issued as of December 31, 2022[211] NASDAQ Listing The company's NASDAQ listing faced deficiency for bid price and stockholders' equity, but it believes compliance was regained for equity by September 30, 2023, with equity reaching $7.55 million - Common Stock commenced trading on The Nasdaq Capital Market under 'ABVC' on August 3, 2021[212] - Received a deficiency letter in August 2022 for failing to meet the minimum $1.00 bid price requirement (Rule 5550(a)(2)), with an extended compliance deadline of August 14, 2023[214][215] - Received a deficiency letter in May 2023 for failing to meet the minimum $2,500,000 stockholders' equity requirement (Rule 5550(b)(1))[216] - The company believes it regained compliance with the stockholders' equity requirement as of August 31, 2023, with stockholders' equity reaching $7,548,308 by September 30, 2023[216] Joint Venture Agreement A joint venture with Lucidaim Co., Ltd. established BioLite Japan K.K. for R&D in Japan, with the company holding 49% ownership and potential bank facility guarantee liability - On October 6, 2021, the company and Lucidaim Co., Ltd. entered into a Joint Venture Agreement to operate BioLite Japan K.K., focusing on R&D of drugs, medical devices, and digital media in Japan[217] - The company owns 49% of BioLite JP, while Lucidaim owns 51%[219] - The company may be liable for up to JPY 14,925,400 (approximately USD134,000) as a guarantee for BioLite JP's JPY 30,460,000 bank facility[222] - The joint venture is expected to enhance the company's ability to provide therapeutic solutions and access early-stage product candidates in CNS and oncology/hematology[226] Recent Research Results ABV-1504 received a patent extension, Vitargus Phase II was halted due to SAEs, and ABV-1505 Phase II Part I showed efficacy with Part II enrollment ongoing - Received a Notice of Allowance for ABV-1504 (Polygala Extract for MDD) from the US Patent and Trademark Office, extending its patent life to 2041[228] - Vitargus (BFC-1401/ABV-1701) Phase I clinical trial showed it was well-tolerated and safe as a vitreous substitute[229] - The Vitargus Phase II study in Thailand was put on hold due to Serious Adverse Events (SAEs) observed in patients, with investigations ongoing to develop a safe in-situ procedure[231] - ABV-1505 Phase II Part I clinical trial for adult ADHD found PDC-1421 Capsule to be safe, well-tolerated, and efficacious, meeting primary endpoints[233] - Enrollment for ABV-1505 Phase II Part II clinical study for ADHD is ongoing, with 69 subjects enrolled across Taiwan and UCSF[236] - Cedars-Sinai Medical Center approved participation in the Phase I study of ABV-1601 for treating depression in cancer patients, with the main objective to evaluate PDC-1421's safety[237] Public Offering & Financings The company secured 2023 financing through a $3.7 million convertible note from Lind and a $1.75 million registered direct offering of common stock and pre-funded warrants Financing in 2023 2023 financing included a $3.7 million secured convertible note from Lind, with a market capitalization default waiver, and a $1.75 million registered direct offering of common shares and pre-funded warrants - On February 23, 2023, the Company issued a secured, convertible note with a principal of $3,704,167 to Lind Global Fund II, LP for a purchase price of $3,175,000[238] - The Lind Note is convertible into common stock at an initial conversion price of $1.05 per share, and monthly payments of $308,650.58 can be made in cash or shares[238][239] - A letter agreement on September 12, 2023, waived a default condition related to the company's market capitalization being below $12.5 million until February 23, 2024[240][247] - On July 27, 2023, the Company completed a registered direct offering of 300,000 common shares and 200,000 pre-funded warrants at $3.50 per share/warrant, raising $1,750,000 gross proceeds[248] Financing in May 2022 In May 2022, the company completed a registered direct offering of 2 million common shares and issued 5-year warrants to purchase 2 million common shares at $2.45 per share - On May 11, 2022, the Company completed a registered direct offering of 2,000,000 common shares and issued 5-year warrants to purchase 2,000,000 common shares at an exercise price of $2.45 per share[251] Strategy The company's strategy focuses on advancing Vitargus to pivotal trials, licensing ABV-1504, completing ABV-1505 Phase II Part 2, and out-licensing post-Phase II candidates to build a portfolio in CNS, Hematology/Oncology, and Ophthalmology - Key strategic elements include advancing ABV-1701 (Vitargus) to pivotal trials, licensing ABV-1504 (MDD), and completing Phase II Part 2 for ABV-1505 (ADHD)[252] - The company plans to out-license post-Phase II drug and medical device candidates to major pharmaceutical companies for Phase III and commercialization[252][253] - The company aims to build a substantial portfolio of Oncology/Hematology, CNS, and Ophthalmology products, focusing on Phase I and II research[253] Business Objectives Core business objectives involve generating revenue from collaborative agreements through upfront fees, milestones, R&D reimbursements, and royalties, with revenue recognition adhering to ASC 606 - Business objectives include generating current and future revenues through collaborative research, development, and/or commercialization joint venture agreements[254] - Revenue streams include nonrefundable upfront license fees, development and commercial milestones, partial/complete reimbursement of R&D costs, and royalties on net sales (none received to date)[254][255] - Revenue is recognized upon satisfaction of a performance obligation by transferring control of a good or service to the collaboration partner, following ASC 606[255][328] - Milestone payments are recognized as revenue when the underlying triggering event occurs, provided they are substantive and relate solely to past performance[259][335] Collaborative agreements with BHK, a related party Three joint venture agreements with BioHopeKing (BHK) for co-development of ABV-1501, ABV-1504, and ABV-1505 in Asia include $10 million in milestone payments, with $2 million received, and a 12% royalty entitlement - Three joint venture agreements with BioHopeKing (BHK) for co-development of ABV-1501 (TNBC), ABV-1504 (MDD), and ABV-1505 (ADHD) in certain Asian countries[270] | Milestone | Payment (USD) | |:----------------------------------------|:--------------| | Execution of BHK Co-Development Agreement | $1,000,000 | | Investigational New Drug (IND) Submission | $1,000,000 |\ | Phase II Clinical Trial Complete | $1,000,000 | | Initiation of Phase III Clinical Trial | $3,000,000 | | New Drug Application (NDA) Submission | $4,000,000 | | Total | $10,000,000 | - The company received initial cash payments of $1 million upon agreement execution (2015) and a second $1 million milestone payment (2016)[271][272] - BioLite Inc. is entitled to a 12% royalty on BHK's net sales related to the co-developed products, but no royalties have been earned as of September 30, 2023[272] Collaborative agreement with BioLite, Inc., a related party The company acquired sole licensing rights to six compounds from BioLite, Inc., including up to $100 million in milestones and 5% royalty on ABV-1501, with a $5 million milestone settled by debt cancellation - The company acquired sole licensing rights to develop and commercialize six compounds from BioLite, Inc. for therapeutic purposes[275] - The agreement includes milestone payments up to $100 million and a 5% royalty on net sales of ABV-1501[275] - A $5,000,000 milestone payment due December 31, 2021, was paid by canceling BioLite's outstanding debt to the company[276] - BioLite received a new patent granted notice for PDC-1421 from the Intellectual Property Office of Taiwan on September 13, 2023[276] Co-Development agreement with Rgene Corporation, a related party A co-development agreement with Rgene Corporation for ABV-1507, ABV-1511, and ABV-1527 involved a $3 million payment for past research, fully written off, with the company entitled to 50% of future net licensing income - Co-development agreement with Rgene Corporation for ABV-1507, ABV-1511, and ABV-1527 (later amended to ABV-1519 and ABV-1526)[277][279] - Rgene was required to pay $3,000,000 for past research efforts, received in cash and 1,530,000 shares of Rgene's common stock[277][278] - The investment in Rgene was fully written off as of December 31, 2018, due to impairment assessment[278] - The company is entitled to 50% of future net licensing income or net sales profit earned by Rgene[277] Clinical Development Service Agreement with Rgene Corporation, a related party BioKey's Clinical Development Service Agreement with Rgene for Phase II studies could yield up to $3.0 million, complemented by a $1.0 million convertible loan from the company to Rgene - BioKey entered a Clinical Development Service Agreement with Rgene to guide RGC-1501, RGC-1502, and RGC-1503 through Phase II clinical studies[281] - BioKey is eligible to receive up to $3.0 million over a 3-year period, with payments tied to regulatory milestones[281] - The company loaned $1.0 million to Rgene via a 5% working capital convertible loan, which if fully converted, would increase ABVC's ownership in Rgene by an additional 6.4%[283] - The company holds 31.62% ownership of Rgene through a series of transactions[282] Collaborative agreement with BioFirst Corporation, a related party A collaborative agreement with BioFirst Corporation grants global licensing rights for BFC-1401 and other ocular solutions, involving a $3 million R&D expense, common stock issuance, and BioFirst's GMP factory construction - Collaborative agreement with BioFirst Corporation for global licensing rights to BFC-1401 Vitreous Substitute, later expanded to include ABV-2001 Intraocular Irrigation Solution and ABV-2002 Corneal Storage Solution[285][290] - A $3,000,000 payment for BioFirst's past research efforts was fully expensed as research and development expense in 2017[288] - The company issued 428,571 shares of common stock to BioFirst for the $3,000,000 owed under the collaborative agreement and 414,702 shares for a $2,902,911 loan[289][290] - BioFirst is constructing a GMP factory in Taiwan, targeting completion in 2024, to produce Vitargus for the global market[293] Co-Development agreement with BioLite Japan K.K. A joint venture with Lucidaim Co., Ltd. established BioLite Japan K.K. for R&D in Japan, with the company holding 49% ownership, contributing $150,000, and potentially guaranteeing a $134,000 bank facility - Joint Venture Agreement with Lucidaim Co., Ltd. to operate BioLite Japan K.K., with the company owning 49% of BioLite JP[295][296] - The joint venture's business includes R&D of drugs, medical devices, and digital media, investment, fund running, consulting, and marketing of supplements in Japan[295] - The company paid $150,000 towards the setup of the joint venture[302] - The company may be liable for up to JPY 14,925,400 (approximately USD134,000) as a guarantee for BioLite JP's bank facility[299] BioKey Revenues BioKey, a wholly-owned subsidiary, generates revenue through comprehensive CDMO services, including API characterization, formulation, analytical studies, regulatory submissions, and manufacturing, while also supporting ABVC's drug development - BioKey provides a wide range of CDMO services, including API characterization, pre-formulation studies, formulation development, analytical method development, stability studies, IND/NDA/ANDA/510K submissions, and manufacturing clinical trial materials and commercial products[304] - BioKey also offers regulatory services, including proofreading and review of submission documents for various product types, and supports ABVC's new drug development[305] Impact of COVID-19 Outbreak COVID-19 adversely impacted the CDMO business due to restricted lab access and reduced demand, which has not fully recovered, with potential material adverse impacts on financial estimates - The COVID-19 pandemic has adversely affected the company's CDMO business sector due to constrained researcher access to labs globally, limiting scientific discovery capacity and reducing demand[308] - While lab operations are increasing with lifted social distancing and vaccination programs, underlying demand has not yet returned to pre-COVID-19 levels[308] - The company cannot reasonably estimate the full magnitude of the impact on its consolidated results of operations and acknowledges potential material adverse impacts on financial estimates in the near term[306][309] Summary of Critical Accounting Policies This section reiterates significant accounting policies from Note 2, covering basis of presentation, estimates, stock splits, fair value, revenue recognition, asset accounting, convertible notes, R&D, stock-based compensation, and income taxes - This section largely reiterates the significant accounting policies detailed in Note 2 to the unaudited consolidated financial statements, covering areas such as basis of presentation, use of estimates, stock reverse split, fair value measurements, cash and restricted cash, credit risk, revenue recognition, property and equipment, long-term investments, goodwill, convertible notes, R&D expenses, post-retirement benefits, stock-based compensation, income taxes, and recent accounting pronouncements[310][311][312][314][315][317][318][320][321][322][323][324][325][326][328][329][330][331][332][334][335][336][337][338][340][341][342][343][344][345][347][349][350][351][352][353][355][356][357][358][359][360][362][363][364][365][366][367][369][370][371][372][374][375][376][377] Results of Operations — Three Months Ended September 30, 2023 Compared to Three Months Ended September 30, 2022 Revenues decreased by 62.5% to $15,884, operating expenses fell by 43% to $2.14 million, and net loss improved by 11% to $3.37 million, despite higher interest expense | Metric (3 months ended Sep 30) | 2023 (Unaudited, USD) | 2022 (Unaudited, USD) | Change (USD) | Change (%) | |:-------------------------------|:----------------------|:----------------------|:-------------|:-----------| | Revenues | $15,884 | $42,269 | $(26,385) | -62.4% | | Operating Expenses | $2,141,143 | $3,747,369 | $(1,606,226) | -42.9% | | Other (expense) income | $(1,214,206) | $(56,461) | $(1,157,745) | 2050.6% | | Net Loss | $(3,368,080) | $(3,776,524) | $408,444 | -10.8% | - The decrease in revenues was due to the completion of ongoing projects and awaiting new approvals[381] - The increase in other expense was principally caused by a significant increase in interest expense due to the recognition of interest expense for converted notes[382][383] Results of Operations — Nine Months Ended September 30, 2023 Compared to Nine Months Ended September 30, 2022 Revenues decreased by 60.5% to $150,265, operating expenses fell by 49% to $6.24 million, and net loss improved by 36% to $7.58 million, despite higher interest expense | Metric (9 months ended Sep 30) | 2023 (Unaudited, USD) | 2022 (Unaudited, USD) | Change (USD) | Change (%) | |:-------------------------------|:----------------------|:----------------------|:-------------|:-----------| | Revenues | $150,265 | $380,789 | $(230,524) | -60.5% | | Operating Expenses | $6,242,333 | $12,341,207 | $(6,098,874) | -49.4% | | Other (expense) income | $(1,244,940) | $4,854 | $(1,249,794) | -25748.7% | | Net Loss | $(7,580,535) | $(11,811,472) | $4,230,937 | -35.8% | - The decrease in revenues was mainly due to the completion of ongoing projects and waiting for new approval[385] - The decrease in operating expenses was mainly attributable to decreases in selling, general and administrative expenses, research and development expenses, and stock-based compensation expenses[385] - The significant change in other income (expense) was primarily due to a substantial increase in interest expense from converted notes[386] Liquidity and Capital Resources Working capital deficit increased to $2.87 million, net cash used in operations decreased to $3.76 million, and financing cash flow decreased to $3.83 million, driven by convertible notes and loan repayments | Metric (as of) | Sep 30, 2023 (Unaudited, USD) | Dec 31, 2022 (USD) | |:----------------------|:------------------------------|:-------------------| | Current Assets | $2,493,534 | $2,987,247 | | Current Liabilities | $5,363,076 | $5,543,628 | | Working Capital (Deficit) | $(2,869,542) | $(2,556,381) | - Net cash used in operating activities decreased to $3,756,385 for the nine months ended September 30, 2023, from $6,937,322 in the prior year[390] - Net cash provided by financing activities decreased to $3,831,540 for the nine months ended September 30, 2023, from $4,267,425 in the prior year, primarily due to proceeds from convertible notes and warrant issuance, offset by repayment of short-term loans[392] Item 3. Quantitative and Qualitative Disclosures About Market Risk As a smaller reporting company, ABVC BioPharma, Inc. is exempt from providing quantitative and qualitative disclosures about market risk - As a smaller reporting company, the company is not required to provide quantitative and qualitative disclosures about market risk[393] Item 4. Controls and Procedures Disclosure controls and procedures were ineffective as of September 30, 2023, due to a material weakness, with no changes in internal control over financial reporting during the nine months - Disclosure controls and procedures were not effective as of September 30, 2023, due to a material weakness described in the Annual Report on Form 10-K for the year ended December 31, 2022[394] - There has been no change in internal control over financial reporting during the nine months ended September 30, 2023[395] PART II - OTHER INFORMATION Item 1. Legal Proceedings The company is not currently involved in any legal proceedings that would materially adversely affect its business, financial condition, or results of operations - The company is not currently a party to any legal proceedings that would have a material adverse effect on its business, financial condition, or results of operations[397] Item 1A. Risk Factors As a smaller reporting company, ABVC BioPharma, Inc. is exempt from providing specific risk factor disclosures in this report - As a smaller reporting company, the company is not required to provide risk factor information[398] Item 2. Unregistered Sales of Equity Securities and Use of Proceeds The company issued unregistered securities, including 142,857 common shares from a $500,000 convertible note conversion and 370,000 common shares to Zhonghui per a Cooperation Agreement - On August 1, 2023, a $500,000 convertible note was converted into 142,857 shares of common stock at $3.50 per share[400] - On August 28, 2023, 370,000 shares of common stock were issued to Zhonghui United Technology (Chengdu) Group Co., Ltd. pursuant to a Cooperation Agreement[400] Item 3. Defaults Upon Senior Securities No defaults upon senior securities were reported during the period - No defaults upon senior securities were reported[400] Item 4. Mine Safety Disclosures This item is not applicable to the company - This item is not applicable[400] Item 5. Other Information No other information is reported under this item - No other information is reported under this item[400] Item 6. Exhibits This section lists all exhibits filed with the Form 10-Q, including agreements, corporate documents, and certifications, with references to prior filings or current submission - The exhibits include Share Exchange Agreement, Articles of Incorporation, Bylaws, Certificates of Amendment, Forms of Warrant, Collaboration Agreements, Employment Agreements, Loan Agreements, Securities Purchase Agreements, Joint Venture Agreement, and various Security Agreements[402][405][406][407][409][410] - Recent exhibits include the Cooperation Agreement with Zhong Hui Lian He Ji Tuan, Ltd. (August 14, 2023), Amendment to the Cooperation Agreement (September 6, 2023), Letter Agreement (September 13, 2023), and License Agreements with AiBtl BioPharma, Inc. (filed herewith)[403]