ABVC BioPharma Reports Annual 2023 Financials and Provides Fiscal Year 2024 First Quarter Business Update
- ABVC BioPharma, Inc. disclosed its 2023 financial and operational outcomes, showcasing a year-over-year comparison.
- The Company entered into a licensing agreement with AiBtl BioPharma Inc., receiving 23 million shares of AIBL stock each.
- ABVC regained Nasdaq compliance, met strategic investments with Zhong Hui Lian He Ji Tuan, Ltd., and acquired real estate assets.
- The Company executed a definitive agreement with Senior Paradise, Inc. to lease real estate properties for plant factory development.
- ABVC issued convertible notes to Lind Global Fund II, LP and engaged in securities purchase agreements for common stock offerings.
- Financially, ABVC's revenues decreased by approximately 84%, while operating expenses, other income (expense), and net loss showed significant changes.
- The Company obtained patents and FDA approvals for various treatments, signaling progress in its R&D operations.
- ABVC's recent R&D highlights cover advancements in neurology, ophthalmology, oncology/hematology, and CDMO services.
- BioKey, ABVC's subsidiary, continues to produce dietary supplements and secure distribution agreements in the global market.
- ABVC's revenues experienced a significant decline of approximately 84% in 2023 compared to the previous year.
- The decrease in net loss by 31% was attributed to reduced expenses and discontinuation of certain consulting services.
- The Company's operating expenses, other income (expense), and cash equivalents also exhibited fluctuations, impacting its financial performance.
Insights
An examination of ABVC BioPharma's 2023 annual financial results reveals several strategic maneuvers that could influence the company's financial health and investor sentiment. The licensing deal with AIBL, involving CNS drugs for MDD and ADHD, has provided ABVC with a significant equity stake in AIBL. This deal, which includes milestone payments and royalties, has the potential to bolster ABVC's revenue stream, contingent upon the successful commercialization of the licensed products. Such partnerships can often lead to increased investor confidence if the market perceives the licensed products as having a high potential for market success.
ABVC's compliance with Nasdaq Marketplace Rules is a critical factor in maintaining its listing and facilitating investor trust. The regained compliance indicates improved financial stability and governance, which are positive signals for current and potential investors.
The company's diversification into real estate, with the acquisition of property rights and subsequent licensing of healthcare-related expertise, represents an unconventional revenue stream for a biotech firm. While this could provide financial cushioning, it also introduces a different risk profile associated with real estate development and management, which investors need to consider alongside the core biopharma business.
ABVC BioPharma's strategic investments in real estate and its foray into healthcare infrastructure development are particularly noteworthy. The joint development of a healthcare center with Zhonghui and the lease agreement with Senior Paradise, Inc. for a plant factory suggest a pivot towards integrating healthcare services with their biopharmaceutical expertise. This could potentially open up new market segments and provide a competitive edge. However, the success of such ventures depends on execution and market demand for such integrated services.
The company's patent acquisitions and FDA approvals reflect a robust R&D pipeline, which is crucial for long-term growth in the biopharmaceutical industry. Patents provide a competitive moat and FDA approvals are critical milestones that can significantly impact a company's market valuation and future revenue prospects.
From a medical research perspective, the progress in ABVC's R&D operations, particularly the successful completion of the MDD Phase II trials and the initiation of ADHD Phase IIb trials, is encouraging. The readiness for Phase III trials for MDD treatment and the IND approval for advanced non-small cell lung cancer therapy could be pivotal in ABVC's transition from a developmental to a commercial-stage company. These developments are likely to be closely monitored by stakeholders for their potential to transform the company's revenue profile in the coming years.
The licensing agreements for MDD and ADHD treatments in China and the global licensing agreement with AIBL are strategic moves that could significantly expand ABVC's market reach and hasten the commercialization process. The financial implications of these agreements, including upfront payments, milestone payments and royalties, could be substantial and are critical factors for investors to monitor.
FREMONT, CA, March 14, 2024 (GLOBE NEWSWIRE) -- via NewMediaWire -- ABVC BioPharma, Inc. (NASDAQ: ABVC) (“Company”), a biotechnology company specializing in botanically based solutions that deliver high efficacy and low toxicity to improve health outcomes, announced its 2023 annual financial and operating results. These results, including the financial statements included herein, can be found in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 13, 2024.
2023 Annual Financial Results
All comparisons are made on a year-over-year basis.
Licensing Deal:
On November 12, 2023, the Company and one of its subsidiaries, BioLite, Inc. (“BioLite”), each entered into a multi-year, global licensing agreement (the “AIBL Agreement”) with AiBtl BioPharma Inc. (“AIBL”) for the Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit Hyperactivity Disorder) (collectively, the “Licensed Products”). As per the respective agreements, each of ABVC and BioLite received 23 million shares of AIBL stock (with an expected value of
The Company is hopeful that those licensing incomes will enable it to start becoming profitable in the near future.
Nasdaq Compliance
The Company has regained compliance with Nasdaq Marketplace Rules relating to maintaining a minimum
Strategic Investments
The Company entered a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan, Ltd. (“Zhonghui”). The Company acquired
On February 06, 2024, ABVC acquired an additional real estate asset via an equity transfer of 703,495 shares at
To that end, on February 16, 2024, the Company executed a definitive agreement to license its healthcare-related expertise (“Know-How”) to Senior Paradise, Inc. (“SPI”), which will also lease certain of the Company’s real estate properties. Under the lease, SPI may build a plant factory based on good agricultural practices (GAP) for ABVC’s botanical drug products and dietary supplements. This deal marks the Company’s first step towards generating revenue through its real estate acquisitions. Under the agreement, SPI shall pay ABVC
Stockholders’ Equity
On February 23, 2023, the Company entered into a securities purchase agreement with Lind Global Fund II, LP (“Lind”), according to which the Company issued Lind a secured, convertible note in the principal amount of
On July 27, 2023, the Company entered into a certain securities purchase agreement relating to the offer and sale of 300,000 shares of common stock, par value
On August 14, 2023, the Company entered a cooperation agreement with Zhonghui. The Company acquired
On November 17, 2023, the Company entered into a securities purchase agreement (the “2nd Lind Securities Purchase Agreement”) with Lind, under which the Company issued Lind a secured, convertible note in the principal amount of
On January 17, 2024, the Company entered into a third securities purchase agreement with Lind, under which the Company issued Lind another secured, convertible note in the principal amount of
The Company and Lind later agreed to a floor price of
As of December 31, 2023, the Company achieved a total of stockholders’ equity of
| ● | Revenues. We generated |
| ● | Operating Expenses. Our operating expenses were |
| ● | Other Income (expense). The other expense was |
| ● | Net Loss. The net loss was |
| ● | Cash and Cash Equivalents. The Company considers highly liquid investments with three months or less maturities as cash equivalents when purchased. As of December 31, 2023, and 2022, the Company’s cash and cash equivalents amounted to |
Recent R&D Operational Highlights
Patents and FDA Approvals
The Company received a US patent (US 16/936,032), valid until September 04, 2040, a Taiwanese (TW I821593) Patent, valid until July 22, 2040, and an Australian (AU2021314052B2) Patent, valid until April 09, 2041, for Polygala extract for the treatment of major depressive disorder. The Company received a US (US17/120,965), valid until December 20, 2040, and Taiwanese (TW 110106546), valid until February 24, 2041, Patent for Polygala Extract for treating Attention Deficit Hyperactive Disorder. A Taiwanese Patent (TW I792427) for Storage Media for the Preservation of Corneal Tissue was obtained on February 11, 2023, and is valid till July 19, 2041. As we work towards expanding our patent map into global coverage, we eagerly await the results of patent applications in the European Union, China, Japan, and others.
On December 30, 2022, the Company received US FDA approval for the IND ABV-1519 to proceed with the Combination therapy for treating Advanced Inoperable or Metastatic EGFR Wild-type Non-Small Cell Lung Cancer was approved and the study can proceed. The IND was then submitted to the Taiwan FDA, and the approval was received on January 04, 2024. The United States Food & Drug Administration (US FDA) has approved four INDs, ABV-1501 for Triple Negative Breast Cancer (TNBC), ABV-1519 for Non-Small Cell Lung Cancer (NSCLC), ABV-1702 for Myelodysplastic Syndrome (MDS), and ABV-1703 for Pancreatic Cancer Therapy.
Neurology
The MDD Phase II trials for ABV-1504 were completed successfully with good tolerance to the drug, and no serious adverse effects were reported. The product is ready for an End-of-Phase 2 meeting with the FDA to finalize the protocol for Phase III trials. At the same time, we commenced the ADHD Phase IIb trials at the University of California, San Francisco (UCSF) and five other sites in Taiwan. The trials are heading for the interim report, which we expect to complete by early Q2 2024. ABV-1601 for MDD in cancer patients has completed Phase I study preparation, including the Site Initiation Visit (SIV). The study is set to initiate in Q2 2024.
On July 31, 2023, ABVC signed a legally binding term sheet with a Chinese pharmaceutical company, Xinnovation Therapeutics Co., Ltd, for the exclusive licensing of ABV-1504 for Major Depressive Disorder (MDD) and ABV-1505 for Attention-Deficit Hyperactivity Disorder in mainland China. Under this agreement, Xinnovation will hold exclusive rights to develop, manufacture, market, and distribute our innovative drugs for MDD and ADHD in the Chinese market and shall bear the costs for clinical trials and product registration in China. We are negotiating definitive agreements with Xinnovation and are excited that the licensing deal carries a possible aggregate income of
In November 2023, each of ABVC and one of its subsidiaries, BioLite, Inc. (“BioLite”), 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 license covers the Licensed Products’ clinical trial, registration, manufacturing, supply, and distribution rights. The Licensed Products for MDD and ADHD, owned by ABVC and BioLite, were valued at
Ophthalmology
Vitargus®, a vitreous substitute, is a groundbreaking, advanced-staged R&D product that we believe will be the first biodegradable hydrogel used in retinal detachment surgery. Vitargus® has completed the feasibility study in Australia and was approved by the Australian Therapeutic Goods Administration (TGA) to initiate the next trial phase in two participating sites. This is vital to obtaining final regulatory approval for Vitargus® in Australia.
The Science Park Administration in Taiwan approved ABVC’s plan to set up a pilot Good Manufacturing Practice (GMP) facility to produce Vitargus® and to pursue the process development work for manufacturing optimization. We are undertaking this project, proposed by ABVC’s Taiwan affiliate and co-development partner, BioFirst Corporation, to upgrade the Vitargus® manufacturing processes with the expectation that it can ultimately handle the global market supply. ABVC and BioFirst Corporation expect to complete the facility’s construction in Hsinchu Biomedical Science Park, Taiwan, in 2025.
Oncology/Hematology
The United States Food & Drug Administration (US FDA) approved the Investigational New Drug (IND) application for the proposed clinical investigation of BLEX 404, the primary active ingredient in ABV-1519, for advanced inoperable or metastatic EGFR wild-type non-small cell lung cancer. This treatment is being co-developed by BioKey, Inc. (“BioKey”) and by the Rgene Corporation, Taiwan. The study received approval from the Taiwan FDA. This is the fourth IND approved by the US FDA for BLEX 404. The previous three INDs are for the combination therapies of triple-negative breast cancer, myelodysplastic syndromes (MDS), and pancreatic cancer.
CDMO
BioKey, a wholly-owned subsidiary of the Company based in Fremont, California, produces dietary supplements derived from the maitake mushroom in tablet and liquid forms. BioKey has entered the second year of the distribution agreement with Define Biotech Co. Ltd. BioKey is currently set to produce an additional
On the regulatory services front for our clients, we received two ANDA approvals from the US FDA. We have a three-year contract, worth up to
About ABVC BioPharma
ABVC BioPharma is a clinical-stage biopharmaceutical company with an active pipeline of six drugs and one medical device (ABV-1701/Vitargus®) under development. For its drug products, the Company utilizes in-licensed technology from its network of world-renowned research institutions to conduct proof-of-concept trials through Phase II of clinical development. The Company’s network of research institutions includes Stanford University, University of California at San Francisco, and Cedars-Sinai Medical Center. For Vitargus®, the Company intends to conduct global clinical trials through Phase III.
Forward-Looking Statements
Clinical trials are in early stages, and there is no guarantee that any specific outcome will be achieved. This press release contains “forward-looking statements.” Such statements may be preceded by the words “intends,” “may,” “will,” “plans,” “expects,” “anticipates,” “projects,” “predicts,” “estimates,” “aims,” “believes,” “hopes,” “potential,” or similar words. Forward-looking statements are not guarantees of future performance, are based on certain assumptions, and are subject to various known and unknown risks and uncertainties, many of which are beyond the Company’s control, and cannot be predicted or quantified, and, consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. None of the outcomes expressed herein are guaranteed. Such risks and uncertainties include, without limitation, risks and uncertainties associated with (i) our inability to manufacture our product candidates on a commercial scale on our own, or in collaboration with third parties; (ii) difficulties in obtaining financing on commercially reasonable terms; (iii) changes in the size and nature of our competition; (iv) loss of one or more key executives or scientists; and (v) difficulties in securing regulatory approval to proceed to the next level of the clinical trials or to market our product candidates. More detailed information about the Company and the risk factors that may affect the realization of forward-looking statements is set forth in the Company’s filings with the Securities and Exchange Commission (SEC), including the Company’s Annual Report on Form 10-K and its Quarterly Reports on Form 10-Q. Investors are urged to read these documents free of charge on the SEC’s website at http://www.sec.gov. The Company assumes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.
This press release does not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of that state or jurisdiction.
Contact:
Leeds Chow
Email: leedschow@ambrivis.com
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
| December 31, 2023 | December 31, 2022 | |||||||
| ASSETS | ||||||||
| Current Assets | ||||||||
| Cash and cash equivalents | $ | 60,155 | $ | 85,265 | ||||
| Restricted cash | 656,625 | 1,306,463 | ||||||
| Accounts receivable, net | 1,530 | 98,325 | ||||||
| Accounts receivable – related parties, net | 10,463 | 757,343 | ||||||
| Due from related parties – current | 747,573 | 513,819 | ||||||
| Short-term investments | 79,312 | 75,797 | ||||||
| Prepaid expense and other current assets | 101,051 | 150,235 | ||||||
| Total Current Assets | 1,656,709 | 2,987,247 | ||||||
| Property and equipment, net | 7,969,278 | 573,978 | ||||||
| Operating lease right-of-use assets | 809,283 | 1,161,141 | ||||||
| Long-term investments | 2,527,740 | 842,070 | ||||||
| Deferred tax assets, net | - | 117,110 | ||||||
| Prepaid expenses – non-current | 78,789 | 135,135 | ||||||
| Security deposits | 62,442 | 58,838 | ||||||
| Prepayment for long-term investments | 1,274,842 | 2,838,578 | ||||||
| Due from related parties – non-current, net | 113,516 | 865,477 | ||||||
| Total Assets | $ | 14,492,599 | $ | 9,579,574 | ||||
| LIABILITIES AND EQUITY | ||||||||
| Current Liabilities | ||||||||
| Short-term bank loans | $ | 899,250 | $ | 1,893,750 | ||||
| Accrued expenses and other current liabilities | 3,696,380 | 2,909,587 | ||||||
| Contract liabilities | 79,500 | 10,985 | ||||||
| Taxes payables | 112,946 | - | ||||||
| Operating lease liabilities – current portion | 401,826 | 369,314 | ||||||
| Due to related parties | 173,132 | 359,992 | ||||||
| Convertible notes payable – third parties, net | 569,456 | - | ||||||
| Total Current Liabilities | 5,932,490 | 5,543,628 | ||||||
| Tenant security deposit | 21,680 | 7,980 | ||||||
| Operating lease liability – non-current portion | 407,457 | 791,827 | ||||||
| Total Liabilities | 6,361,627 | 6,343,435 | ||||||
| COMMITMENTS AND CONTINGENCIES | ||||||||
| Equity | ||||||||
| Preferred stock, | - | - | ||||||
| Common stock, | 7,940 | 3,286 | ||||||
| Additional paid-in capital | 82,636,966 | 67,937,050 | ||||||
| Stock subscription receivable | (451,480 | ) | (1,354,440 | ) | ||||
| Accumulated deficit | (65,420,095 | ) | (54,904,439 | ) | ||||
| Accumulated other comprehensive income | 516,387 | 517,128 | ||||||
| Treasury stock | (8,901,668 | ) | (9,100,000 | ) | ||||
| Total Stockholders’ equity | 8,388,050 | 3,098,585 | ||||||
| Noncontrolling interest | (257,078 | ) | 137,554 | |||||
| Total Equity | 8,130,972 | 3,236,139 | ||||||
| Total Liabilities and Equity | $ | 14,492,599 | $ | 9,579,574 | ||||
| (1 | ) | Prior period results have been adjusted to reflect the 1-for-10 reverse stock split effected on July 25, 2023. |
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
| Year Ended December 31, | ||||||||
| 2023 | 2022 | |||||||
| Revenues | $ | 152,430 | $ | 969,783 | ||||
| Cost of revenues | 302,037 | 286,415 | ||||||
| Gross (loss) profit | (149,607 | ) | 683,368 | |||||
| Operating expenses | ||||||||
| Selling, general and administrative expenses | 5,368,278 | 6,067,545 | ||||||
| Research and development expenses | 1,062,916 | 2,693,457 | ||||||
| Stock-based compensation | 1,635,708 | 7,036,778 | ||||||
| Total operating expenses | 8,066,902 | 15,797,780 | ||||||
| Loss from operations | (8,216,509 | ) | (15,114,412 | ) | ||||
| Other income (expense) | ||||||||
| Interest income | 185,481 | 187,817 | ||||||
| Interest expense | (2,493,340 | ) | (293,968 | ) | ||||
| Operating sublease income | 65,900 | 107,150 | ||||||
| Impairment loss | - | (110,125 | ) | |||||
| Investment loss | - | (7,446 | ) | |||||
| Gain (loss) on foreign exchange changes | 22,690 | (259,463 | ) | |||||
| Loss on investment in equity securities | (221,888 | ) | - | |||||
| Other income (expenses) | 3,384 | (24,149 | ) | |||||
| Total other income (expenses) | (2,437,773 | ) | (400,184 | ) | ||||
| Loss before provision income tax | (10,654,282 | ) | (15,514,596 | ) | ||||
| Provision for income tax expense | 256,006 | 797,778 | ||||||
| Net loss | (10,910,288 | ) | (16,312,374 | ) | ||||
| Net loss attributable to noncontrolling interests | (394,632 | ) | 110,865 | |||||
| Net loss attributed to ABVC and subsidiaries | (10,515,656 | ) | (16,423,239 | ) | ||||
| Foreign currency translation adjustment | (741 | ) | (22,532 | ) | ||||
| Comprehensive loss | $ | (10,516,397 | ) | $ | (16,445,771 | ) | ||
| Net loss per share: | ||||||||
| Basic and diluted | $ | (2.43 | ) | $ | (5.19 | ) | ||
| Weighted average number of common shares outstanding(1): | ||||||||
| Basic and diluted | 4,335,650 | 3,166,460 | ||||||
| (1 | ) | Prior period results have been adjusted to reflect the 1-for-10 reverse stock split effected on July 25, 2023. |
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEAR ENDED DECEMBER 31, 2023 AND 2022
| 2023 | 2022 | |||||||
| Cash flows from operating activities | ||||||||
| Net loss | $ | (10,910,288 | ) | $ | (16,312,374 | ) | ||
| Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
| Depreciation | 28,531 | 23,799 | ||||||
| Stock-based compensation | 1,635,708 | 7,036,778 | ||||||
| Inventory allowance for valuation losses | - | 25,975 | ||||||
| Provision for doubtful accounts | 1,455,101 | 184,589 | ||||||
| Other non-cash expenses | 2,413,746 | 32,350 | ||||||
| Impairment of prepaid expenses | - | 110,125 | ||||||
| Loss on investment in equity securities | 221,888 | - | ||||||
| Deferred tax expense | 115,668 | 864,802 | ||||||
| Changes in operating assets and liabilities: | ||||||||
| Decrease (increase) in accounts receivable | 228,557 | (614,166 | ) | |||||
| Decrease (increase) in prepaid expenses and other current assets | 101,926 | 238,092 | ||||||
| Decrease (increase) in due from related parties | (321,776 | ) | (837,014 | ) | ||||
| Increase (decrease) in accrued expenses and other current liabilities | 786,793 | 1,608,784 | ||||||
| Increase (decrease) in contract liabilities | 68,515 | - | ||||||
| Increase (decrease) in tenant security deposit | 13,700 | (2,600 | ) | |||||
| Increase (decrease) in Taxes payables | 112,946 | - | ||||||
| Increase (decrease) in due to related parties | (186,860 | ) | 242,469 | |||||
| Net cash used in operating activities | (4,235,845 | ) | (7,398,391 | ) | ||||
| Cash flows from investing activities | ||||||||
| Purchase of equipment | (21,201 | ) | (119,692 | ) | ||||
| Prepayment for equity investment | (338,985 | ) | (1,601,992 | ) | ||||
| Net cash used in investing activities | (360,186 | ) | (1,721,684 | ) | ||||
| Cash flows from financing activities | ||||||||
| Issuance of common stock | 1,050,000 | 3,663,925 | ||||||
| Repayment of short-term bank loans | (1,000,000 | ) | - | |||||
| Proceeds from issuance of warrants | 2,406,338 | - | ||||||
| Proceeds from short-term bank loans | - | 350,000 | ||||||
| Proceeds from convertible notes payable | 1,462,622 | - | ||||||
| Net cash provided by financing activities | 3,918,960 | 4,013,925 | ||||||
| Effect of exchange rate changes on cash and cash equivalents and restricted cash | 2,123 | (67,337 | ) | |||||
| Net increase (decrease) in cash and cash equivalents and restricted cash | (674,948 | ) | (5,173,487 | ) | ||||
| Cash and cash equivalents and restricted cash | ||||||||
| Beginning | 1,391,728 | 6,565,215 | ||||||
| Ending | $ | 716,780 | $ | 1,391,728 | ||||
| Supplemental disclosure of cash flows | ||||||||
| Cash paid during the year for: | ||||||||
| Interest expense paid | $ | 33,180 | $ | 285,465 | ||||
| Income taxes paid | $ | 27,392 | $ | 1,600 | ||||
| Non-cash financing and investing activities | ||||||||
| Purchase of Property and equipment by issuing common stock to a third party | $ | 7,400,000 | $ | - | ||||
| Issuance of common stock for conversion of debt | $ | 3,306,112 | $ | - | ||||
FAQ
What were ABVC's revenues for the years ended December 31, 2023, and 2022?
What were the operating expenses for ABVC in the year ended December 31, 2023?
What licensing agreement did ABVC enter into in November 2023?
What strategic investments did ABVC make in 2023?
What FDA approvals did ABVC receive for its treatments?
