Item 8. Financial Statements and Supplementary Data
Item
8. Financial Statements and Supplementary Data
Our Consolidated Financial Statements and Notes
thereto and the report of WWC P.C. CPA, our independent registered public accounting firm, are set forth on pages F-1 through F-35 of
this Report.
PAGE
F-2
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM (PCAOB ID 1171)
PAGE
F-4
CONSOLIDATED BALANCE SHEETS AS OF DECEMBER 31, 2022 AND DECEMBER 31, 2021.
PAGE
F-5
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS FOR THE YEARS ENDED DECEMBER 31, 2022 AND DECEMBER 31, 2021.
PAGE
F-6
CONSOLIDATED STATEMENTS OF CASH FLOWS FOR THE YEARS ENDED DECEMBER 31, 2022 AND DECEMBER 31, 2021.
PAGES
F-7
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT) FOR THE YEARS ENDED DECEMBER 31, 2022 AND DECEMBER 31, 2021.
PAGES
F-8
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS.
F- 1
REPORT
OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
To: The Board of Directors and Stockholders of
ABVC BioPharma, Inc. and subsidiaries
Opinion on the Financial Statements
We have audited the accompanying consolidated
balance sheet of ABVC BioPharma, Inc. and subsidiaries (collectively the “Company”) as of December 31, 2022, and the related
consolidated statements of operation and comprehensive loss, cash flows, stockholders’ equity (deficit), and the related notes (collectively
referred to as the “financial statements”). In our opinion, the financial statements present fairly, in all material respects,
the financial position of the Company as of December 31, 2022, and the results of its operations and its cash flows for the year ended
December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.
Emphasis of Matter
The accompanying financial statements have been
prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company incurred
substantial losses during the year ended December 31, 2022. As of December 31, 2022, the Company had a working capital deficit and net
cash outflows from operating activities. Accordingly, as of December 31, 2022, these factors gave rise to substantial doubt that the Company
would continue as a going concern. Management closely monitors the Company’s financial position and has prepared a plan that is
found in Note 1 that addresses this substantial doubt. These financial statements do not include any adjustments that might result from
the outcome of this uncertainty.
Basis for Opinion
These financial statements are the responsibility
of our management. Our responsibility is to express an opinion on the financial statements based on our audit. We are a public accounting
firm registered with the Public Company Accounting Oversight Board (United States) (PCAOB) and are required to be independent with respect
to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange
Commission and the PCAOB.
We conducted our audits in accordance with the
standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial
statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged
to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding
of internal control over financial reporting, but not for the purpose of expressing an opinion on the effectiveness of our internal control
over financial reporting. Accordingly, we express no such opinion.
Our audits included performing procedures to assess
the risks of material misstatement of the financial statements, whether due to error or fraud, and performing procedures that respond
to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the financial statements.
Our audit also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating
the overall presentation of the financial statements. We believe that our audit provides a reasonable basis for our opinion.
Critical Audit Matters
The critical audit matters communicated below
are matters arising from the current period audit of the financial statements that were communicated or required to be communicated to
the audit committee and that: (1) relate to accounts or disclosures that are material to the financial statements and (2) involved our
especially challenging, subjective, or complex judgments. The communication of critical audit matters does not alter in any way our opinion
on the consolidated financial statements, taken as a whole, and we are not, by communicating the critical audit matters below, providing
separate opinions on the critical audit matters or on the accounts or disclosures to which they relate.
F- 2
Long-term investments
As described in Note 6 of the financial statements,
certain of the Company’s investments are entered into and governed by complex agreements. The terms and conditions of the agreement
will dictate the proper categorization and recognition of these investments in the Company’s financial statements. Accordingly,
we have identified long-term investments as a critical audit matter due to the complexity of such investment agreements. We believe management
assertions most affected by this critical audit matter are existence, rights, and valuation.
The primary audit procedures we performed in order
to address this critical audit matter were the following: (i) examine the investment agreements and other related documents, evaluate
the terms and conditions, (ii) gain and understanding of the structure set forth by the agreements by enquiring with management, (iii)
confirm with the investees their understanding of the terms and conditions of the agreements and compare their responses with the Company’s
books and records, (iv) test the reasonableness, completeness, mathematical accuracy and relevance of key underlying data used in the
valuation of the investments. The long-term investment and investment loss accounts are affected by this critical audit matter.
Stock-based compensation to third parties
As described in Note 14 of the financial statements,
the Company granted common stock to third parties as consideration to consultants for services rendered; these grants were recorded as
stock-based compensation expense in the Company’s results of operations. We identified the recognition of stock-based compensation
to non-employees as a critical audit matter due to the significant judgments and assumptions made by management to apply proper valuation
and allocation to such grants.
The primary procedures we performed in order to
address this critical audit matter were the following: (i) obtained and examined the board meeting minutes, board resolutions, and service
contracts, (ii) evaluated the reasonableness of the fair value of services received from the non-employees receiving the grants, either
measured at the fair value at the outset of the contract, or around the completion date of the service contract and compared those amounts
against the fair value of the grants based on the prevailing market value. Common stock, additional paid in capital and stock based compensation
are affected by this critical audit matter.
Stock-based compensation expense for employees
and insiders
As described in Note 15 of the financial statements,
the Company granted stock options to its directors and employees and estimated total stock compensation expense related to those issuances
in the amount of $1,241,930 for the year ended December 31, 2022. The stock compensation cost was valued at the grant date, and management
evaluated the fair value of these stock options at the grant date and recognized the expense in accordance to the time frame set forth
by the vesting schedule. We identified the stock-based compensation expense for related to the issuance of stock options to directors
and employees as a critical audit matter due to significant judgments and assumptions made by management in order to develop an appropriate
valuation for the compensation given out.
The primary procedures we performed in order to
address this critical audit matter were the following: (i) obtained all board meeting minutes and board resolutions, (ii) gained an understanding
and assessed the reasonableness of the stock option valuation model, (iii) vouched underlying source data and assessed the appropriateness
of the data entered into the valuation model, and (iv) re-performed the calculation to test the accuracy of the output. Additional paid
in capital and stock based compensation are affected by this critical audit matter.
WWC, P.C.
Certified Public Accountants
PCAOB ID No. 1171
We have served as the Company’s auditor since 2022.
San Mateo, California
March 31, 2023
F- 3
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
December 31,
2022
December 31,
2021
ASSETS
Current Assets
Cash and cash equivalents
$ 85,265
$ 5,828,548
Restricted cash and cash equivalents
1,306,463
736,667
Accounts receivable, net
98,325
280,692
Accounts receivable – related parties, net
757,343
145,399
Due from related parties
513,819
-
Inventories, net
-
25,975
Short-term investments
75,797
108,147
Prepaid expense and other current assets
150,235
528,354
Total Current Assets
2,987,247
7,653,782
Property and equipment, net
573,978
525,881
Operating lease right-of-use assets
1,161,141
1,471,899
Long-term investments
842,070
932,755
Deferred tax assets, net
117,110
981,912
Prepaid expenses – noncurrent
135,135
119,309
Security deposits
58,838
41,157
Prepayment for long-term investments
2,838,578
1,153,155
Due from related parties – noncurrent
1,141,378
818,183
Total Assets
$ 9,855,475
$ 13,698,033
LIABILITIES AND EQUITY
Current Liabilities
Short-term bank loans
$ 1,893,750
$ 1,640,000
Accrued expenses and other current liabilities
2,909,587
1,300,803
Advance from customers
10,985
10,985
Operating lease liabilities – current portion
369,314
347,100
Due to related parties
635,893
393,424
Total Current Liabilities
5,819,529
3,692,312
Tenant security deposit
7,980
10,580
Operating lease liability – noncurrent portion
791,827
1,124,799
Total Liabilities
6,619,336
4,827,691
COMMITMENTS AND CONTINGENCIES
Equity
Preferred stock, $ 0.001 par value, 20,000,000 authorized, nil shares issued and outstanding
-
-
Common stock, $ 0.001 par value, 100,000,000 authorized, 32,857,329 and 28,926,322 shares issued and outstanding as of December 31, 2022 and 2021, respectively
32,857
28,926
Additional paid-in capital
67,907,479
58,113,667
Stock subscription receivable
( 1,354,440 )
( 2,257,400 )
Accumulated deficit
( 54,904,439 )
( 38,481,200 )
Accumulated other comprehensive income
517,128
539,660
Treasury stock
( 9,100,000 )
( 9,100,000 )
Total Stockholders’ equity
3,098,585
8,843,653
Noncontrolling interest
137,554
26,689
Total Equity
3,236,139
8,870,342
Total Liabilities and Equity
$ 9,855,475
$ 13,698,033
The accompanying notes are an integral part
of these consolidated financial statements.
F- 4
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE
LOSS
Year Ended December 31,
2022
2021
Revenues
$ 969,783
$ 355,797
Cost of revenues
286,415
5,086
Gross profit
683,368
350,711
Operating expenses
Selling, general and administrative expenses
6,067,545
5,746,119
Research and development expenses
2,693,457
1,003,805
Stock based compensation
7,036,778
5,306,755
Total operating expenses
15,797,780
12,056,679
Loss from operations
( 15,114,412 )
( 11,705,968 )
Other income (expense)
Interest income
187,817
43,196
Interest expense
( 293,968 )
( 227,210 )
Operating sublease income
107,150
134,576
Operating sublease income – related parties
-
4,800
Impairment loss
( 110,125 )
-
Investment loss
( 7,446 )
-
Gain/Loss on foreign exchange changes
( 259,463 )
426,316
Gain/Loss on investment in equity securities
-
( 269,844 )
Other income
( 24,149 )
22,409
Government grant income
-
360,898
Total other income (expenses)
( 400,184 )
495,141
Loss before provision income tax
( 15,514,596 )
( 11,210,827 )
Provision for income tax expense
797,778
825,024
Net loss
( 16,312,374 )
( 12,035,851 )
Net loss attributable to noncontrolling interests
110,865
802,962
Net loss attributed to ABVC and subsidiaries
( 16,423,239 )
( 12,838,813 )
Foreign currency translation adjustment
( 22,532 )
( 25,200 )
Comprehensive loss
$ ( 16,445,771 )
$ ( 12,864,013 )
Net loss per share:
Basic and diluted
$ ( 0.52 )
$ ( 0.51 )
Weighted average number of common shares outstanding:
Basic and diluted
31,664,660
25,053,522
The accompanying notes are an integral part
of these consolidated financial statements.
F- 5
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR THE YEAR ENDED DECEMBER 31, 2022 AND 2021
2022
2021
Cash flows from operating activities
Net loss
$ ( 16,312,374 )
$ ( 12,035,851 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
23,799
11,993
Stock based compensation
7,036,778
5,306,755
Loss on investment in equity securities
-
269,844
Inventory allowance for valuation losses
25,975
-
Provision
for doubtful accounts, net of recovery
184,589
-
Government grant income
-
( 360,898 )
Other non-cash income and expenses
32,350
-
Impairment of prepaid expenses
110,125
-
Deferred tax
864,802
824,199
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable
( 614,166 )
( 120,980 )
Decrease (increase) in prepaid expenses and other current assets
238,092
( 357,276 )
Decrease (increase) in due from related parties
( 837,014 )
( 595,037 )
Decrease (increase) in inventories
-
( 25,830 )
Increase (decrease) in accounts payable
-
( 23,044 )
Increase (decrease) in accrued expenses and other current liabilities
1,608,784
( 173,151 )
Increase (decrease) in advanced from customers
-
( 1,085 )
Increase (decrease) in tenant security deposit received
( 2,600 )
-
Increase (decrease) in due to related parties
242,469
( 317,358 )
Net cash used in operating activities
( 7,398,391 )
( 7,597,719 )
Cash flows from investing activities
Purchase of investments
-
( 107,547 )
Purchase of equipment
( 119,692 )
( 17,503 )
Prepayment for equity investment
( 1,601,992 )
( 680,916 )
Net cash used in investing activities
( 1,721,684 )
( 805,966 )
Cash flows from financing activities
Issuance of common stock
3,663,925
11,119,452
Payment for offering costs
-
( 850,429 )
Repayment of convertible notes
-
( 306,836 )
Repayment of short-term loan
-
( 100,000 )
Repayment of notes payable
-
( 107,400 )
Proceeds from long-term loan
-
236,498
Proceeds from short term loan
350,000
-
Proceeds from short term borrowings from third parties
-
4,265
Net cash provided by financing activities
4,013,925
9,995,550
Effect of exchange rate changes on cash and cash equivalents and restricted cash
( 67,337 )
( 28,021 )
Net increase(decrease ) in cash and cash equivalents and restricted cash
( 5,173,487 )
1,563,844
Cash and cash equivalents and restricted cash
Beginning
6,565,215
5,001,371
Ending
$ 1,391,728
$ 6,565,215
Supplemental disclosure of cash flows
Cash paid during the year for:
Interest expense paid
$ 285,465
$ 333,873
Income taxes paid
$ 1,600
$ -
Non-cash financing and investing activities
Common shares issued for debt conversion
$ -
$ 2,693,548
The accompanying notes are an integral part
of these consolidated financial statements.
F- 6
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’
EQUITY (DEFICIT)
FOR THE YEAR ENDED DECEMBER 31, 2022 AND 2021
Common Stock
Stock
Additional
Accumulated
Other
Treasury Stock
Non
Stockholders’
Number of
shares
Amounts
Subscription
Receivable
Paid-in
Capital
Accumulated
Deficit
Comprehensive
Income
Number of
Shares
Amount
controlling
Interest
Total
Equity
Balance at December 31, 2020
24,420,526
$ 24,420
$ ( 3,160,360 )
$ 40,751,807
$ ( 25,642,387 )
$ 564,860
( 275,347 )
$ ( 9,100,000 )
$ ( 776,273 )
$ 2,662,067
Issuance of common shares for cash
3,027,750
3,028
-
10,265,995
-
-
-
-
-
10,269,023
Issuance of common shares for consulting service
366,934
367
-
1,728,223
-
-
-
-
-
1,728,590
Issuance of common shares for debt conversion
1,111,112
1,111
-
2,692,437
-
-
-
-
-
2,693,548
Stock based compensation for services
-
-
902,960
-
-
-
-
-
-
902,960
Stock based compensation for options granted
-
-
-
2,675,205
-
-
-
-
-
2,675,205
Net loss for the year
-
-
-
-
( 12,838,813 )
-
-
-
802,962
( 12,035,851 )
Cumulative transaction adjustments
-
-
-
-
-
( 25,200 )
-
-
-
( 25,200 )
Balance at December 31, 2021
28,926,322
$ 28,926
$ ( 2,257,400 )
$ 58,113,667
$ ( 38,481,200 )
$ 539,660
( 275,347 )
$ ( 9,100,000 )
$ 26,689
$ 8,870,342
Issuance of common shares for cash
2,000,000
2,000
-
3,661,925
-
-
-
-
-
3,663,925
Issuance of common shares for consulting service
1,931,007
1,931
-
4,889,957
-
-
-
-
-
4,891,888
Stock based compensation for services
-
-
902,960
-
-
-
-
-
-
902,960
Stock based compensation for options granted
-
-
-
1,241,930
-
-
-
-
-
1,241,930
Net loss for the year
-
-
-
-
( 16,423,239 )
-
-
-
110,865
( 16,312,374 )
Cumulative transaction adjustments
-
-
-
-
-
( 22,532 )
-
-
-
( 22,532 )
Balance at December 31, 2022
32,857,329
$ 32,857
$ ( 1,354,440 )
$ 67,907,479
$ ( 54,904,439 )
$ 517,128
( 275,347 )
$ ( 9,100,000 )
$ 137,554
$ 3,236,139
The accompanying notes are an integral part
of these consolidated financial statements.
F- 7
ABVC BIOPHARMA, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. ORGANIZATION AND DESCRIPTION OF BUSINESS
ABVC BioPharma, Inc. (the “Company”),
formerly known as American BriVision (Holding) Corporation, a Nevada corporation, through the Company’s operating entity, American
BriVision Corporation (“BriVision”), which was incorporated in July 2015 in the State of Delaware, engages in biotechnology
to fulfill unmet medical needs and focuses on the development of new drugs and medical devices derived from plants. BriVision develops
its pipeline by carefully tracking new medical discoveries or medical device technologies in research institutions in the Asia-Pacific
region. Pre-clinical, disease animal model and Phase I safety studies are examined closely by the Company to identify drugs that BriVision
believes demonstrate efficacy and safety. Once a drug appears to be a good candidate for development and ultimately commercialization,
BriVision licenses the drug or medical device from the original researchers and begins to introduce the drugs clinical plan to highly
respected principal investigators in the United States, Australia and Taiwan to conduct a Phase II clinical trial. At present, clinical
trials for the Company’s drugs and medical devices are being conducted at such world-famous institutions as Memorial Sloan Kettering
Cancer Center (“MSKCC”) and MD Anderson Cancer Center. BriVision had no predecessor operations prior to its formation on
July 21, 2015.
Name Change
The Company’s shareholders approved an
amendment to the Company’s Articles of Incorporation to change the Company’s corporate name from American BriVision (Holding)
Corporation 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 name change amendment to the Company’s Articles of Incorporation was filed
with Nevada’s Secretary of State and became effective on March 8, 2021 and FINRA processed our request to change our name on April
30, 2021, which became effective as of May 3, 2021.
The Company’s stock symbol remains ABVC.
Reverse Merger
On February 8, 2016, a Share Exchange Agreement
(the “Share Exchange Agreement”) was entered into by and among the Company, BriVision, and Euro-Asia Investment & Finance
Corp. Limited, a company incorporated under the laws of Hong Kong Special Administrative Region of the People’s Republic of China
(“Euro-Asia”), being the owners of record of 164,387,376 ( 52,336,000 pre-stock split) shares of Common Stock of the Company,
and the owners of record of all of the issued share capital of BriVision (the “BriVision Stock”).
Pursuant to the Share Exchange Agreement, upon
surrender by the BriVision Shareholders and the cancellation by BriVision of the certificates evidencing the BriVision Stock as registered
in the name of each BriVision Shareholder, and pursuant to the registration of the Company in the register of members maintained by BriVision
as the new holder of the BriVision Stock and the issuance of the certificates evidencing the aforementioned registration of the BriVision
Stock in the name of the Company, the Company issued 166,273,921 ( 52,936,583 pre-stock split) shares (the “Acquisition Stock”)
(subject to adjustment for fractionalized shares as set forth below) of the Company’s Common Stock to the BriVision Shareholders
(or their designees), and 163,159,952 ( 51,945,225 pre-stock split) shares of the Company’s Common Stock owned by Euro-Asia were
cancelled and retired to treasury. The Acquisition Stock collectively represented 79.70 % of the issued and outstanding Common Stock of
the Company immediately after the Closing, in exchange for the BriVision Stock, representing 100 % of the issued share capital of BriVision
in a reverse merger (the “Merger”).
Pursuant to the Merger, all of the issued and
outstanding common shares of BriVision were converted, at an exchange ratio of 0.2536-for-1, into an aggregate of 166,273,921 (52,936,583
pre-stock split) common shares of the Company and BriVision had become a wholly owned subsidiary of the Company. The holders of Company’s
Common Stock as of immediately prior to the Merger held an aggregate of 205,519,223 ( 65,431,144 pre-stock split) shares of Company’s
Common Stock. Because of the exchange of the BriVision Stock for the Acquisition Stock (the “Share Exchange”), BriVision
had become a wholly owned subsidiary (the “Subsidiary”) of the Company and there was a change of control of the Company following
the closing. There were no warrants, options or other equity instruments issued in connection with the share exchange agreement.
F- 8
Upon the consummation of the Share Exchange,
BriVision became a wholly owned subsidiary of the Company.
Following the Share Exchange, the Company has
abandoned prior business plan and is now pursuing BriVision’s historically proposed businesses, which focus on the development
of new drugs and innovative medical devices to fulfill unmet medical needs. The business model of the Company is to integrate research
achievements from world-famous institutions, conduct clinical trials of translational medicine for Proof of Concept (“POC”),
out-license to international pharmaceutical companies, and explore global markets.
Accounting Treatment of the Reverse Merger
For financial reporting purposes, the Share Exchange
represents a “reverse merger” rather than a business combination and BriVision is deemed the accounting acquirer
in the transaction. The Share Exchange is being accounted for as a reverse-merger and recapitalization. BriVision is the acquirer
for financial reporting purposes and the Company is the acquired company. Consequently, the assets and liabilities and the
operations reflected in the historical financial statements prior to the Share Exchange will be those of BriVision and recorded
at the historical cost basis of BriVision. In addition, the consolidated financial statements after completion of the Share Exchange
will include the assets and liabilities of the Company and BriVision, and the historical operations of BriVision and operations
of the Combined Company from the closing date of the Share Exchange.
Merger
On February 8, 2019, the Company, BioLite Holding,
Inc. (“BioLite”), BioKey, Inc. (“BioKey”), BioLite Acquisition Corp., a direct wholly-owned subsidiary of Parent
(“Merger Sub 1”), and BioKey Acquisition Corp., a direct wholly-owned subsidiary of Parent (“Merger Sub 2”) (collectively
referred to as the “Parties”) completed the business combination pursuant to the Agreement and Plan of Merger (the “Merger
Agreement”) dated as of January 31, 2018 where ABVC acquired BioLite and BioKey via issuing additional Common Stock of ABVC to
the shareholders of BioLite and BioKey.
Pursuant to the terms of the Merger Agreement,
BioLite and BioKey became two wholly-owned subsidiaries of the Company on February 8, 2019. ABVC issued an aggregate of 104,558,777 shares
(prior to the reverse stock split in 2019) to the shareholders of both BioLite and BioKey under a registration statement on Form S-4
(file number 333-226285), which became effective by operation of law on or about February 5, 2019.
BioLite Holding, Inc. (the “BioLite Holding”)
was incorporated under the laws of the State of Nevada on July 27, 2016. BioLite BVI, Inc. (the “BioLite BVI”), a wholly
owned subsidiary of BioLite Holding, was incorporated in the British Virgin Islands on September 13, 2016. BioLite Holding and BioLite
BVI are holding companies and have not carried out substantive business operations of their own.
BioLite, Inc., (the “BioLite Taiwan”)
was incorporated on February 13, 2006 under the laws of Taiwan. BioLite is in the business of developing and commercialization of new
botanical drugs with application in central nervous system, autoimmunity, inflammation, hematology, and oncology. In addition, BioLite
Taiwan distributes dietary supplements made from extracts of Chinese herbs and Maitake mushroom.
In January 2017, BioLite Holding, BioLite BVI,
BioLite Taiwan, and certain shareholders of BioLite Taiwan entered into a share purchase / exchange agreement (the “BioLite Share
Purchase / Exchange Agreement”). Pursuant to the BioLite Share Purchase / Exchange Agreement, the shareholder participants to the
BioLite Share Purchase / Exchange Agreement have sold their equity in BioLite Taiwan and were using the proceeds from such sales to purchase
shares of Common Stock of BioLite Holding at the same price per share, resulting in their owning the same number of shares of Common
Stock as they owned in the BioLite Taiwan. Upon closing of the Share Purchase/ Exchange Agreement in August 2017, BioLite Holding ultimately
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.
BioKey, Inc. was incorporated on August 9, 2000
in the State of California. BioKey provides a wide range of services, including, 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. It also licenses out its technologies and initiates joint research and development
processes with other biotechnology, pharmaceutical, and nutraceutical companies.
F- 9
Accounting Treatment of the Merger
The Company adopted ASC 805, “Business
Combination” to record the merger transactions of BioKey. Since the Company and BioLite Holding are the entities under Dr. Tsung-Shann
Jiang’s common control, the transaction is accounted for as a restructuring transaction. All the assets and liabilities of
BioLite Holding, BioLite BVI, and BioLite Taiwan were transferred to the Company at their respective carrying amounts on the closing
date of the Merger. The Company has recast prior period financial statements to reflect the conveyance of BioLite Holding’s common
shares as if the restructuring transaction had occurred as of the earliest date of the financial statements. All material intercompany
accounts, transactions, and profits have been eliminated in consolidation. The nature of and effects on earnings per share (EPS) of nonrecurring
intra-entity transactions involving long-term assets and liabilities is not required to be eliminated and EPS amounts have been recast
to include the earnings (or losses) of the transferred net assets.
Going Concern
The accompanying financial statements have been
prepared in conformity with U.S. GAAP which contemplates continuation of the Company on a going concern basis. The going concern basis
assumes that assets are realized, and liabilities are settled in the ordinary course of business at amounts disclosed in the financial
statements. The Company’s ability to continue as a going concern depends upon its ability to market and sell its products to generate
positive operating cash flows. For the year ended December 31, 2022, the Company reported net loss of $ 16,312,374 . As of December 31,
2022, the Company’s working capital deficit was $ 2,832,282 . In addition, the Company had net cash outflows of $ 7,398,391 from operating
activities for the year ended December 31, 2022. These conditions give rise to substantial doubt as to whether the Company will be able
to continue as a going concern.
Management’s plan is to continue improve
operations to generate positive cash flows and raise additional capital through private and public offerings. If the Company is not able
to generate positive operating cash flows, and raise additional capital, there is the risk that the Company may not be able to meet its
short-term obligations.
2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis of Presentation
The accompanying consolidated financial statements
have been prepared in accordance with the generally accepted accounting principles in the United States of America (the “U.S. GAAP”).
All significant intercompany transactions and account balances have been eliminated.
This basis of accounting involves the application
of accrual accounting and consequently, revenues and gains are recognized when earned, and expenses and losses are recognized when incurred.
The Company’s financial statements are expressed in U.S. dollars.
Fiscal Year
The Company changed its fiscal year from the period beginning on October
1st and ending on September 30th to the period beginning on January 1st and ending on December 31st, beginning January 1, 2018.
Use of Estimates
The preparation of financial statements in conformity
with generally accepted accounting principles in the United States of America requires management to make estimates and assumptions that
affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated
financial statements and the amount of revenues and expenses during the reporting periods. Actual results could differ materially from
those results.
Inventory
Inventory consists of raw materials, work-in-process,
finished goods, and merchandise. Inventories are stated at the lower of cost or market and valued on a moving weighted average cost basis.
Market is determined based on net realizable value. The Company periodically reviews the age and turnover of its inventory to determine
whether any inventory has become obsolete or has declined in value, and incurs a charge to operations for known and anticipated inventory
obsolescence.
Forward Stock Split
On March 21, 2016, the Board of Directors of
the Company approved an amendment to Articles of Incorporation to effect a forward split at a ratio of 1 to 3.141 and increase the number
of our authorized shares of Common Stock, par value $ 0.001 per share, to 360,000,000 , which was effective on April 8, 2016.
F- 10
Stock Reverse Split
On March 12, 2019, the Board of Directors of
the Company by unanimous written consent in lieu of a meeting approved to i) effect a stock reverse split at the ratio of 1-for-18 (the
“Reverse Split”) of both the authorized common stock of the Company (the “Common Stock”) and the issued and outstanding
Common Stock and ii) to amend the articles of incorporation of the Company to reflect the Reverse Split. The Board approved and authorized
the Reverse Split without obtaining approval of the Company’s shareholders pursuant to Section 78.207 of Nevada Revised Statutes.
On May 3, 2019, the Company filed a certificate of amendment to the Company’s articles of incorporation (the “Amendment”)
to effect the Reverse Split with the Secretary of State of Nevada. The Financial Industry Regulatory Authority (“FINRA”)
informed the Company that the Reverse Split was effective on May 8, 2019. All shares and related financial information in this Form 10-K
reflect this 1-for-18 reverse stock split.
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. It requires that an entity measure its financial instruments
to base fair value on exit price, maximize the use of observable units and minimize the use of unobservable inputs to determine the exit
price. It establishes a hierarchy which prioritizes the inputs to valuation techniques used to measure fair value. This hierarchy increases
the consistency and comparability of fair value measurements and related disclosures by maximizing the use of observable inputs and minimizing
the use of unobservable inputs by requiring that observable inputs be used when available. Observable inputs are inputs that reflect
the assumptions market participants would use in pricing the assets or liabilities based on market data obtained from sources independent
of the Company. Unobservable inputs are inputs that reflect the Company’s own assumptions about the assumptions market participants
would use in pricing the asset or liability developed based on the best information available in the circumstances. The hierarchy prioritizes
the inputs into three broad levels based on the reliability of the inputs as follows:
●
Level 1 - Inputs are quoted
prices in active markets for identical assets or liabilities that the Company has the ability to access at the measurement date.
Valuation of these instruments does not require a high degree of judgment as the valuations are based on quoted prices in active
markets that are readily and regularly available.
●
Level 2 - Inputs other
than quoted prices in active markets that are either directly or indirectly observable as of the measurement date, such as quoted
prices for similar assets or liabilities; quoted prices in markets that are not active; or other inputs that are observable or can
be corroborated by observable market data for substantially the full term of the assets or liabilities.
●
Level 3 - Valuations based
on inputs that are unobservable and not corroborated by market data. The fair value for such assets and liabilities is generally
determined using pricing models, discounted cash flow methodologies, or similar techniques that incorporate the assumptions a market
participant would use in pricing the asset or liability.
The carrying values of certain assets and liabilities
of the Company, such as cash and cash equivalents, restricted cash, accounts receivable, due from related parties, inventory, prepaid
expenses and other current assets, accounts payable, accrued liabilities, and due to related parties approximate fair value due to their
relatively short maturities. The carrying value of the Company’s short-term bank loan, convertible notes payable, and accrued interest
approximates their fair value as the terms of the borrowing are consistent with current market rates and the duration to maturity is
short. 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.
Cash and Cash Equivalents
The Company considers highly liquid investments with maturities of
three months or less, when purchased, to be cash equivalents. As of December 31, 2022 and 2021, the Company’s cash and cash equivalents
amounted $ 85,265 and $ 5,828,548 , 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.
F- 11
Restricted Cash Equivalents
Restricted cash equivalents primarily consist
of cash held in a reserve bank account in Taiwan. As of December 31, 2022 and 2021, the Company’s restricted cash equivalents amounted
$ 1,306,463 and $ 736,667 , respectively.
Concentration of Credit Risk
The Company’s financial instruments that
are exposed to concentrations of credit risk consist primarily of cash and cash equivalents. The Company places its cash and temporary
cash investments in high quality credit institutions, but these investments may be in excess of Taiwan Central Deposit Insurance Corporation
and the U.S. Federal Deposit Insurance Corporation’s insurance limits. The Company does not enter into financial instruments for
hedging, trading or speculative purposes.
We perform ongoing credit evaluation of our customers
and requires no collateral. An allowance for doubtful accounts is provided based on a review of the collectability of accounts receivable.
We determine the amount of allowance for doubtful accounts by examining its historical collection experience and current trends in the
credit quality of its customers as well as its internal credit policies. Actual credit losses may differ from our estimates.
Concentration
of clients
As of December
31, 2022, the most major clients, specializes in developing and commercializing of dietary supplements and therapeutics in dietary supplement
industry, accounted for 71.89 % of the Company’s total account receivable; the second major client with its Chairman being the Board
of Director of Biokey, accounted for 16.62 % of the Company’s total account receivable. As of December 31, 2021, the major clients
in biotechnology research accounted for 37.48 % of the Company’s total account receivable; the second major client accounted for
33.38 % if the Company’s total account receivable.
For the
year ended December 31, 2022, one major client, Rgene Corporation, a related party under common
control by controlling beneficiary shareholder of YuanGene Corporation and the Company, which works in development and commercialization
of new drugs in Taiwan, accounted for 93.22 % of the Company's total revenues. For the year ended December 31, 2021, one major client,
GLIA, LLC, accounted for 46.24 % of the Company’s total revenue.
Revenue Recognition
During the fiscal year 2018, the Company adopted
Accounting Standards Codification (“ASC”), Topic 606 (ASC 606), Revenue from Contracts with Customers, using the modified
retrospective method to all contracts that were not completed as of January 1, 2018, and applying the new revenue standard as an adjustment
to the opening balance of accumulated deficit at the beginning of 2018 for the cumulative effect. The results for the Company’s
reporting periods beginning on and after January 1, 2018 are presented under ASC 606, while prior period amounts are not adjusted and
continue to be reported under the accounting standards in effect for the prior period. Based on the Company’s review of existing
collaborative agreements as of January 1, 2018, the Company concluded that the adoption of the new guidance did not have a significant
change on the Company’s revenue during all periods presented.
Pursuant to ASC 606, the Company recognizes revenue
when its customer obtains control of promised goods or services, in an amount that reflects the consideration that the Company expects
to receive in exchange for those goods or services. To determine revenue recognition for arrangements that the Company determines is
within the scope of ASC 606, the Company performs the following five steps: (i) identify the contract(s) with a customer; (ii) identify
the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance
obligations in the contract; and (v) recognize revenue when (or as) the Company satisfies a performance obligation. The Company only
applies the five-step model to contracts when it is probable that the Company will collect the consideration the Company is entitled
to in exchange for the goods or services the Company transfers to the customers. At inception of the contract, once the contract is determined
to be within the scope of ASC 606, the Company assesses the goods or services promised within each contract, determines those that are
performance obligations, and assesses whether each promised good or service is distinct. The Company then recognizes as revenue the amount
of the transaction price that is allocated to the respective performance obligation when (or as) the performance obligation is satisfied.
The following are examples of when the Company
recognizes revenue based on the types of payments the Company receives.
Collaborative Revenues — The Company
recognizes collaborative revenues generated through collaborative research, development and/or commercialization agreements. The terms
of these agreements typically include payment to the Company related to one or more of the following: non-refundable upfront license
fees, development and commercial milestones, partial or complete reimbursement of research and development costs, and royalties on net
sales of licensed products. Each type of payments results in collaborative revenues except for revenues from royalties on net sales of
licensed products, which are classified as royalty revenues. To date, the Company has not received any royalty revenues. Revenue is recognized
upon satisfaction of a performance obligation by transferring control of a good or service to the collaboration partners.
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. 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.
F- 12
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.
(i) Non-refundable upfront payments
If a license to the Company’s intellectual
property is determined to be distinct from the other performance obligations identified in an arrangement, the Company recognizes revenue
from the related non-refundable upfront payments based on the relative standalone selling price prescribed to the license compared to
the total selling price of the arrangement. The revenue is recognized when the license is transferred to the collaboration partners and
the collaboration partners are able to use and benefit from the license. To date, the receipt of non-refundable upfront fees was solely
for the compensation of past research efforts and contributions made by the Company before the collaborative agreements entered into
and it does not relate to any future obligations and commitments made between the Company and the collaboration partners in the collaborative
agreements.
(ii) Milestone payments
The Company is eligible to receive milestone
payments under the collaborative agreement with collaboration partners based on achievement of specified development, regulatory and
commercial events. Management evaluated the nature of the events triggering these contingent payments, and concluded that these events
fall into two categories: (a) events which involve the performance of the Company’s obligations under the collaborative agreement
with collaboration partners, and (b) events which do not involve the performance of the Company’s obligations under the collaborative
agreement with collaboration partners.
The former category of milestone payments consists
of those triggered by development and regulatory activities in the territories specified in the collaborative agreements. Management
concluded that each of these payments constitute substantive milestone payments. This conclusion was based primarily on the facts that
(i) each triggering event represents a specific outcome that can be achieved only through successful performance by the Company of one
or more of its deliverables, (ii) achievement of each triggering event was subject to inherent risk and uncertainty and would result
in additional payments becoming due to the Company, (iii) each of the milestone payments is non-refundable, (iv) substantial effort is
required to complete each milestone, (v) the amount of each milestone payment is reasonable in relation to the value created in achieving
the milestone, (vi) a substantial amount of time is expected to pass between the upfront payment and the potential milestone payments,
and (vii) the milestone payments relate solely to past performance. Based on the foregoing, the Company recognizes any revenue from these
milestone payments in the period in which the underlying triggering event occurs.
(iii) Multiple Element Arrangements
The Company evaluates multiple element arrangements
to determine (1) the deliverables included in the arrangement and (2) whether the individual deliverables represent separate units of
accounting or whether they must be accounted for as a combined unit of accounting. This evaluation involves subjective determinations
and requires management to make judgments about the individual deliverables and whether such deliverables are separate from other aspects
of the contractual relationship. Deliverables are considered separate units of accounting provided that: (i) the delivered item(s) has
value to the customer on a standalone basis and (ii) if the arrangement includes a general right of return relative to the delivered
item(s), delivery or performance of the undelivered item(s) is considered probable and substantially within its control. In assessing
whether an item under a collaboration has standalone value, the Company considers factors such as the research, manufacturing, and commercialization
capabilities of the collaboration partner and the availability of the associated expertise in the general marketplace. The Company also
considers whether its collaboration partners can use the other deliverable(s) for their intended purpose without the receipt of the remaining
element(s), whether the value of the deliverable is dependent on the undelivered item(s), and whether there are other vendors that can
provide the undelivered element(s).
F- 13
The Company recognizes arrangement consideration
allocated to each unit of accounting when all of the revenue recognition criteria in ASC 606 are satisfied for that particular unit of
accounting. In the event that a deliverable does not represent a separate unit of accounting, the Company recognizes revenue from the
combined unit of accounting over the Company’s contractual or estimated performance period for the undelivered elements, which
is typically the term of the Company’s research and development obligations. If there is no discernible pattern of performance
or objectively measurable performance measures do not exist, then the Company recognizes revenue under the arrangement on a straight-line
basis over the period the Company is expected to complete its performance obligations. Conversely, if the pattern of performance in which
the service is provided to the customer can be determined and objectively measurable performance measures exist, then the Company recognizes
revenue under the arrangement using the proportional performance method. 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.
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. This evaluation includes an assessment of whether: (1) the consideration is commensurate with either the Company’s
performance to achieve the milestone or the enhancement of the value of the delivered item(s) as a result of a specific outcome resulting
from its performance to achieve the milestone, (2) the consideration relates solely to past performance and (3) the consideration is
reasonable relative to all of the deliverables and payment terms within the arrangement. The Company evaluates factors such as the scientific,
clinical, regulatory, commercial, and other risks that must be overcome to achieve the particular milestone and the level of effort and
investment required to achieve the particular milestone in making this assessment. There is considerable judgment involved in determining
whether a milestone satisfies all of the criteria required to conclude that a milestone is substantive. Milestones that are not considered
substantive are recognized as earned if there are no remaining performance obligations or over the remaining period of performance, assuming
all other revenue recognition criteria are met.
(iv) Royalties and Profit Sharing Payments
Under the collaborative agreement with the collaboration
partners, the Company is entitled to receive royalties on sales of products, which is at certain percentage of the net sales. The Company
recognizes revenue from these events based on the revenue recognition criteria set forth in ASC 606. Based on those criteria, the Company
considers these payments to be contingent revenues, and recognizes them as revenue in the period in which the applicable contingency
is resolved.
Revenues Derived from Research and Development
Activities Services — Revenues related to research and development and regulatory activities are recognized when the related services
or activities are performed, in accordance with the contract terms. The Company typically has only one performance obligation at the
inception of a contract, which is to perform research and development services. The Company may also provide its customers with an option
to request that the Company provides additional goods or services in the future, such as active pharmaceutical ingredient, API, or IND/NDA/ANDA/510K
submissions. The Company evaluates whether these options are material rights at the inception of the contract. If the Company determines
an option is a material right, the Company will consider the option a separate performance obligation.
If the Company is entitled to reimbursement from
its customers for specified research and development expenses, the Company accounts for the related services that it provides as separate
performance obligations if it determines that these services represent a material right. The Company also determines whether the reimbursement
of research and development expenses should be accounted for as revenues or an offset to research and development expenses in accordance
with provisions of gross or net revenue presentation. The Company recognizes the corresponding revenues or records the corresponding
offset to research and development expenses as it satisfies the related performance obligations.
The Company then determines the transaction price
by reviewing the amount of consideration the Company is eligible to earn under the contracts, including any variable consideration. Under
the outstanding contracts, consideration typically includes fixed consideration and variable consideration in the form of potential milestone
payments. At the start of an agreement, the Company’s transaction price usually consists of the payments made to or by the Company
based on the number of full-time equivalent researchers assigned to the project and the related research and development expenses incurred.
The Company does not typically include any payments that the Company may receive in the future in its initial transaction price because
the payments are not probable. The Company would reassess the total transaction price at each reporting period to determine if the Company
should include additional payments in the transaction price.
F- 14
The Company receives payments from its customers
based on billing schedules established in each contract. Upfront payments and fees may be recorded as advance from customers upon receipt
or when due, and may require deferral of revenue recognition to a future period until the Company performs its obligations under these
arrangements. Amounts are recorded as accounts receivable when the right of the Company to consideration is unconditional. The Company
does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period
between payment by the customers and the transfer of the promised goods or services to the customers will be one year or less.
Property and Equipment
Property and equipment is carried at cost net
of accumulated depreciation. Repairs and maintenance are expensed as incurred. Expenditures that improve the functionality of the related
asset or extend the useful life are capitalized. When property and equipment is retired or otherwise disposed of, the related gain or
loss is included in operating income. Leasehold improvements are depreciated on the straight-line method over the shorter of the remaining
lease term or estimated useful life of the asset. 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
Impairment of Long-Lived Assets
The Company has adopted Accounting Standards
Codification subtopic 360-10, Property, Plant and Equipment (“ASC 360-10”). ASC 360-10 requires that long-lived assets and
certain identifiable intangibles held and used by the Company be reviewed for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. The Company evaluates its long-lived assets for impairment annually
or more often if events and circumstances warrant. Events relating to recoverability may include significant unfavorable changes in business
conditions, recurring losses, or a forecasted inability to achieve break-even operating results over an extended period. Should impairment
in value be indicated, the carrying value of intangible assets will be adjusted, based on estimates of future discounted cash flows resulting
from the use and ultimate disposition of the asset. ASC 360-10 also requires assets to be disposed of be reported at the lower of the
carrying amount or the fair value less costs to sell.
Long-term Equity Investment
The Company acquires the equity investments to
promote business and strategic objectives. 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. Its proportionate share of
the income or loss is recognized monthly and is recorded in gains (losses) on equity investments.
●
Non-marketable cost method
investments when the equity method does not apply.
F- 15
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. 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. 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. 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. Impairments affect earnings as follows:
●
Marketable equity securities
include the consideration of general market conditions, the duration and extent to which the fair value is below cost, and our ability
and intent to hold the investment for a sufficient period of time to allow for recovery of value in the foreseeable future. The Company
also considers specific adverse conditions related to the financial health of, and the business outlook for, the investee, which
may include industry and sector performance, changes in technology, operational and financing cash flow factors, and changes in the
investee’s credit rating. 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. A series of operating losses of an investee or other factors may indicate that a decrease in value of the investment has occurred that is other than temporary and that shall be recognized even though the decrease in value is in excess of what would otherwise be recognized by application of the equity method. A loss in value of an investment that is other than a temporary decline shall be recognized. Evidence of a loss in value might include, but would not necessarily be limited to, absence of an ability to recover the carrying amount of the investment or inability of the investee to sustain an earnings capacity that would justify the carrying amount of the investment. The Company records other-than-temporary impairments for non-marketable cost method investments and equity method investments in gains (losses) on equity investments.
Other-than-temporary impairments of equity investments were $ 0 and
$ 0 for the year ended December 31, 2022 and 2021, respectively.
Goodwill
The Company evaluates goodwill for impairment
annually or more frequently when an event occurs or circumstances change that indicate the carrying value may not be recoverable. In
testing goodwill for impairment, the Company may elect to utilize a qualitative assessment to evaluate whether it is more likely than
not that the fair value of a reporting unit is less than its carrying amount. If the qualitative assessment indicates that goodwill impairment
is more likely than not, the Company performs a two-step impairment test. The Company tests goodwill for impairment under the two-step
impairment test by first comparing the book value of net assets to the fair value of the reporting units. If the fair value is determined
to be less than the book value or qualitative factors indicate that it is more likely than not that goodwill is impaired, a second step
is performed to compute the amount of impairment as the difference between the estimated fair value of goodwill and the carrying value.
The Company estimates the fair value of the reporting units using discounted cash flows. Forecasts of future cash flows are based on
our best estimate of future net sales and operating expenses, based primarily on expected category expansion, pricing, market segment
share, and general economic conditions.
F- 16
The Company completed the required testing of
goodwill for impairment as of December 31, 2022, and determined that goodwill was impaired because of the current financial condition
of the Company and the Company’s inability to generate future operating income without substantial sales volume increases, which
are highly uncertain. 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. This guidance provides that absent alternative future uses
the acquisition of product rights to be used in research and development activities must be charged to research and development expenses
when incurred.
The Company accounts
for R&D costs in accordance with Accounting Standards Codification (“ASC”) 730, Research and Development (“ASC
730”). Research and development expenses are charged to expense as incurred unless there is an alternative future use in other
research and development projects or otherwise. Research and development expenses are comprised of costs incurred in performing research
and development activities, including personnel-related costs, facilities-related overhead, and outside contracted services including
clinical trial costs, manufacturing and process development costs for both clinical and preclinical materials, research costs, and other
consulting services. Non-refundable advance payment for goods and services that will be used in future research and development activities
are expensed when the activity has been performed or when the goods have been received rather than when the payment is made. In instances
where the Company enters into agreements with third parties to provide research and development services, costs are expensed as services
are performed.
Post-retirement and post-employment benefits
The Company’s subsidiaries in Taiwan adopted
the government mandated defined contribution plan pursuant to the Labor Pension Act (the “Act”) in Taiwan. Such labor regulations
require that the rate of contribution made by an employer to the Labor Pension Fund per month shall not be less than 6 % of the worker’s
monthly salaries. Pursuant to the Act, the Company makes monthly contribution equal to 6 % of employees’ salaries to the employees’
pension fund. 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 $ 13,031 and $ 11,375 for the years ended December 31, 2022 and 2021, respectively.
Other than the above, the Company does not provide any other post-retirement or post-employment benefits.
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”.
Total employee stock-based compensation expenses were $ 1,241,930 and $ 2,675,205 for the years ended December 31, 2022 and 2021, respectively.
The Company accounted for stock-based compensation
to non-employees in accordance with FASB ASC Topic 718 “Compensation-Stock Compensation” and FASB ASC Topic 505-50 “Equity-Based
Payments to Non-Employees” which requires that the cost of services received from non-employees is measured at fair value at the
earlier of the performance commitment date or the date service is completed and recognized over the period the service is provided. Total
non-employee stock-based compensation expenses were $ 5,794,848 and $ 2,631,550 for the years ended December 31, 2022 and 2021, respectively.
F- 17
Beneficial Conversion Feature
From time to time, the Company may issue convertible
notes that may contain an imbedded beneficial conversion feature. A beneficial conversion feature exists on the date a convertible note
is issued when the fair value of the underlying common stock to which the note is convertible into is in excess of the remaining unallocated
proceeds of the note after first considering the allocation of a portion of the note proceeds to the fair value of the warrants, if related
warrants have been granted. 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.
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. Under the asset and liability approach, deferred taxes are provided for the net tax effects of temporary
differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts used for income tax
purposes. A valuation allowance is provided for deferred tax assets if it is more likely than not these items will expire before the
Company is able to realize their benefits, or future deductibility is uncertain.
Under ASC 740, a tax position is recognized as
a benefit only if it is “more likely than not” that the tax position would be sustained in a tax examination, with
a tax examination being presumed to occur. The evaluation of a tax position is a two-step process. The first step is to determine whether
it is more-likely-than-not that a tax position will be sustained upon examination, including the resolution of any related appeals or
litigations based on the technical merits of that position. The second step is to measure a tax position that meets the more-likely-than-not
threshold to determine the amount of benefits recognized in the financial statements. A tax position is measured at the largest amount
of benefit that is greater than 50 percent likely of being realized upon ultimate settlement. Tax positions that previously failed to
meet the more-likely-than-not recognition threshold should be recognized in the first subsequent period in which the threshold is met.
Previously recognized tax positions that no longer meet the more-likely-than-not criteria should be de-recognized in the first subsequent
financial reporting period in which the threshold is no longer satisfied. 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, 2022 and 2021. GAAP also provides guidance on de-recognition, classification, interest and penalties,
accounting in interim periods, disclosures and transition.
On December 22, 2017, the SEC issued Staff Accounting
Bulletin (“SAB 118”), which provides guidance on accounting for tax effects of the Tax Act. SAB 118 provides a measurement
period that should not extend beyond one year from the Tax Act enactment date for companies to complete the accounting under ASC 740.
In accordance with SAB 118, a company must reflect the income tax effects of those aspects of the Act for which the accounting under
ASC 740 is complete. To the extent that a company’s accounting for certain income tax effects of the Tax Act is incomplete but
it is able to determine a reasonable estimate, it must record a provisional estimate to be included in the financial statements. If a
company cannot determine a provisional estimate to be included in the financial statements, it should continue to apply ASC 740 on the
basis of the provision of the tax laws that were in effect immediately before the enactment of the Tax Act. While the Company is able
to make reasonable estimates of the impact of the reduction in corporate rate and the deemed repatriation transition tax, the final impact
of the Tax Act may differ from these estimates, due to, among other things, changes in our interpretations and assumptions, additional
guidance that may be issued by the I.R.S., and actions the Company may take. The Company is continuing to gather additional information
to determine the final impact.
Valuation of Deferred Tax Assets
A valuation allowance is recorded to reduce the
Company’s deferred tax assets to the amount that is more likely than not to be realized. In assessing the need for the valuation
allowance, management considers, among other things, projections of future taxable income and ongoing prudent and feasible tax planning
strategies. If the Company determines that sufficient negative evidence exists, then it will consider recording a valuation allowance
against a portion or all of the deferred tax assets in that jurisdiction. If, after recording a valuation allowance, the Company’s
projections of future taxable income and other positive evidence considered in evaluating the need for a valuation allowance prove, with
the benefit of hindsight, to be inaccurate, it could prove to be more difficult to support the realization of its deferred tax assets.
As a result, an additional valuation allowance could be required, which would have an adverse impact on its effective income tax rate
and results. Conversely, if, after recording a valuation allowance, the Company determines that sufficient positive evidence exists in
the jurisdiction in which the valuation allowance was recorded, it may reverse a portion or all of the valuation allowance in that jurisdiction.
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.
F- 18
Loss Per Share of Common Stock
The Company calculates net loss per share in
accordance with ASC Topic 260, “Earnings per Share”. Basic loss per share is computed by dividing the net loss by the weighted
average number of common shares outstanding during the period. Diluted loss per share is computed similar to basic loss per share except
that the denominator is increased to include the number of additional common shares that would have been outstanding if the potential
common stock equivalents had been issued and if the additional common shares were dilutive. Diluted earnings per share excludes all dilutive
potential shares if their effect is anti-dilutive.
Commitments and Contingencies
The Company has adopted ASC Topic 450 “Contingencies”
subtopic 20, in determining its accruals and disclosures with respect to loss contingencies. Accordingly, estimated losses from loss
contingencies are accrued by a charge to income when information available before financial statements are issued or are available to
be issued indicates that it is probable that an asset had been impaired or a liability had been incurred at the date of the financial
statements and the amount of the loss can be reasonably estimated. Legal expenses associated with the contingency are expensed as incurred.
If a loss contingency is not probable or reasonably estimable, disclosure of the loss contingency is made in the financial statements
when it is at least reasonably possible that a material loss could be incurred.
Foreign-currency Transactions
For the Company’s subsidiaries in Taiwan,
the foreign-currency transactions are recorded in New Taiwan dollars (“NTD”) at the rates of exchange in effect when the
transactions occur. Gains or losses resulting from the application of different foreign exchange rates when cash in foreign currency
is converted into New Taiwan dollars, or when foreign-currency receivables or payables are settled, are credited or charged to income
in the year of conversion or settlement. On the balance sheet dates, the balances of foreign-currency assets and liabilities are restated
at the prevailing exchange rates and the resulting differences are charged to current income except for those foreign currencies denominated
investments in shares of stock where such differences are accounted for as translation adjustments under the Statements of Stockholders’
Equity (Deficit).
Translation Adjustment
The accounts of the Company’s subsidiaries
in Taiwan were maintained, and their financial statements were expressed, in New Taiwan Dollar (“NT$”). Such financial statements
were translated into U.S. Dollars (“$” or “USD”) in accordance ASC 830, “Foreign Currency Matters”,
with the NT$ as the functional currency. According to the Statement, all assets and liabilities are translated at the current exchange
rate, stockholder’s deficit are translated at the historical rates and income statement items are translated at an average exchange
rate for the period. The resulting translation adjustments are reported under other comprehensive income (loss) as a component of stockholders’
equity (deficit).
Recent Accounting Pronouncements
In August 2020, the FASB issued ASU 2020-06,
Debt — Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own
Equity (Subtopic 815-40): Accounting for Convertible Instruments and Contracts in an Entity’s Own Equity (“ASU 2020-06”).
ASU 2020-06 simplifies the accounting for convertible debt by eliminating the beneficial conversion and cash conversion accounting models.
Upon adoption of ASU 2020-06, convertible debt, unless issued with a substantial premium or an embedded conversion feature that is not
clearly and closely related to the host contract, will no longer be allocated between debt and equity components. This modification will
reduce the issue discount and result in less non-cash interest expense in financial statements. ASU 2020-06 also updates the earnings
per share calculation and requires entities to assume share settlement when the convertible debt can be settled in cash or shares. For
contracts in an entity’s own equity, the type of contracts primarily affected by ASU 2020-06 are freestanding and embedded features
that are accounted for as derivatives under the current guidance due to a failure to meet the settlement assessment by removing the requirements
to (i) consider whether the contract would be settled in registered shares, (ii) consider whether collateral is required to be posted,
and (iii) assess shareholder rights. ASU 2020-06 is effective for fiscal years beginning after December 15, 2023. Early adoption is permitted,
but no earlier than fiscal years beginning after December 15, 2020, and only if adopted as of the beginning of such fiscal year. The
Company is currently evaluating the impact that the standard will have on its consolidated financial statements.
F- 19
In May 2021, the FASB issued ASU 2021-04, Earnings
Per Share (Topic 260), Debt — Modifications and Extinguishments (Subtopic 470-50), Compensation — Stock Compensation (Topic
718), and Derivatives and Hedging — Contracts in Entity’s Own Equity (Subtopic 815-40): Issuer’s Accounting for Certain
Modifications or Exchanges of Freestanding Equity-Classified Written Call Options (“ASU 2021-04”). ASU 2021-04 provides guidance
as to how an issuer should account for a modification of the terms or conditions or an exchange of a freestanding equity-classified written
call option (i.e., a warrant) that remains classified after modification or exchange as an exchange of the original instrument for a
new instrument. An issuer should measure the effect of a modification or exchange as the difference between the fair value of the modified
or exchanged warrant and the fair value of that warrant immediately before modification or exchange and then apply a recognition model
that comprises four categories of transactions and the corresponding accounting treatment for each category (equity issuance, debt origination,
debt modification, and modifications unrelated to equity issuance and debt origination or modification). ASU 2021-04 is effective for
all entities for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. An entity should
apply the guidance provided in ASU 2021-04 prospectively to modifications or exchanges occurring on or after the effective date. Early
adoption is permitted for all entities, including adoption in an interim period. If an entity elects to early adopt ASU 2021-04 in an
interim period, the guidance should be applied as of the beginning of the fiscal year that includes that interim period.
In March 2022, the FASB issued ASU 2022-02, Troubled
Debt Restructurings and Vintage Disclosures. This ASU eliminates the accounting guidance for troubled debt restructurings by creditors
that have adopted ASU 2016-13, Measurement of Credit Losses on Financial Instruments. This ASU also enhances the disclosure requirements
for certain loan refinancing and restructurings by creditors when a borrower is experiencing financial difficulty. In addition, the ASU
amends the guidance on vintage disclosures to require entities to disclose current period gross write-offs by year of origination for
financing receivables and net investments in leases within the scope of ASC 326-20. The ASU is effective for annual periods beginning
after December 15, 2022, including interim periods within those fiscal years. Adoption of the ASU would be applied prospectively. Early
adoption is also permitted, including adoption in an interim period.
The Company is currently evaluating the impact
that the standards mentioned above will have on its consolidated financial statements.
3. COLLABORATIVE AGREEMENTS
Collaborative agreements with BHK, a related
party
(i) On February 24, 2015, BioLite Taiwan and
BioHopeKing Corporation (the “BHK”) entered into a co-development agreement, (the “BHK Co-Development Agreement”),
pursuant to which it is collaborative with BHK to develop and commercialize BLI-1401-2 (Botanical Drug) Triple Negative Breast Cancer
(TNBC) Combination Therapy (BLI-1401-2 Products) in Asian countries excluding Japan for all related intellectual property rights, and
has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50 between BHK
and the Company. The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial sale of the
Product in in Asia excluding Japan.
On July 27, 2016, BioLite Taiwan and BHK agreed
to amend the payment terms of the milestone payment in an aggregate amount of $ 10 million based on the following schedule:
● Upon the signing of the BHK Co-Development Agreement: $1 million, or 10% of total payment
●
Upon the first Investigational
New Drug (IND) submission and BioLite Taiwan will deliver all data to BHK according to FDA Reviewing requirement: $1 million, or
10% of total payment
●
At the completion of first
phase II clinical trial: $1 million, or 10% of total payment
●
At the initiation of phase
III of clinical trial research: $3 million, or 30% of total payment
●
Upon the New Drug Application
(NDA) submission: $4 million, or 40% of total payment
In December 2015, BHK has paid a non-refundable
upfront cash payment of $ 1 million, or 10 % of $ 10,000,000 , upon the signing of BHK Co-Development Agreement. The Company concluded that
the deliverables are considered separate units of accounting as the delivered items have value to the customer on a standalone basis
and recognized this cash receipt as collaboration revenue when all research, technical, and development data was delivered to BHK in
2015. The receipt is for the compensation of past research efforts and contributions made by BioLite Taiwan before this collaborative
agreement was signed and it does not relate to any future commitments made by BioLite Taiwan and BHK in this collaborative agreement.
In August 2016, the Company has received the second milestone payment of NT$ 31,649,000 , approximately equivalent to $ 1 million, and recognized
collaboration revenue for the year ended December 31, 2016. As of the date of this report, the Company has not completed the first phase
II clinical trial.
In addition to the milestone payments, BioLite
Taiwan is entitled to receive royalty on 12 % of BHK’s net sales related to BLI-1401-2 Products. As of December 31, 2022 and December
31, 2021, the Company has not earned the royalty under the BHK Co-Development Agreement.
F- 20
(ii) On December 9, 2015, BioLite Taiwan entered
into another two collaborative agreements (the “BHK Collaborative Agreements”), pursuant to which it is collaborative with
BHK to co-develop and commercialize BLI-1005 for “Targeting Major Depressive Disorder” (BLI-1005 Products) and BLI-1006 for
“Targeting Inflammatory Bowel Disease” (BLI-1006 Products) in Asia excluding Japan for all related intellectual property
rights, and has developed it for medicinal use in collaboration with outside researchers. The development costs shall be shared 50/50
between BHK and the Company. The BHK Co-Development Agreement will remain in effect for fifteen years from the date of first commercial
sale of the Product in in Asia excluding Japan.
In 2015, the Company recognized the cash receipt
in a total of NT$50 million, approximately equivalent to $1.6 million, as collaboration revenue when all research, technical, and development
data was delivered to BHK. The Company concluded that the deliverables are considered separate units of accounting as the delivered items
have value to the customer on a standalone basis and recognized this payment as collaboration revenue when all research, technical, data
and development data was delivered to BHK. The cash receipt is for the compensation of past research efforts and contributions made by
BioLite Taiwan before this BHK Collaborative Agreements was signed and it does not relate to any future commitments made by BioLite Taiwan
and BHK in this BHK Collaborative Agreements.
In addition to the total of NT$50 million, approximately
equivalent to $1.60 million, BioLite Taiwan is entitled to receive 50% of the future net licensing income or net sales profit. As of
December 31, 2022 and 2021, the Company has not earned the royalty under the BHK Collaborative Agreements.
Co-Development agreement with Rgene Corporation,
a related party
On May 26, 2017, BriVision entered into a co-development
agreement (the “Co-Dev Agreement”) with Rgene Corporation (the “Rgene”), a related party under common control
by controlling beneficiary shareholder of YuanGene Corporation and the Company (See Note 12). Pursuant to Co-Dev Agreement, BriVision
and Rgene agreed to co-develop and commercialize ABV-1507 HER2/neu Positive Breast Cancer Combination Therapy, ABV-1511 Pancreatic Cancer
Combination Therapy and ABV-1527 Ovary Cancer Combination Therapy. Under the terms of the Co-Dev Agreement, Rgene is required to pay
the Company $ 3,000,000 in cash or stock of Rgene with equivalent value by August 15, 2017. The payment is for the compensation of BriVision’s
past research efforts and contributions made by BriVision before the Co-Dev Agreement was signed and it does not relate to any future
commitments made by BriVision and Rgene in this Co-Dev Agreement. In addition to $ 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 any development costs shall be equally shared by both
BriVision and Rgene.
On June 1, 2017, the Company has delivered all
research, technical, data and development data to Rgene. 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 full amount of $ 3,000,000
in connection with the Co-Dev Agreement as additional paid-in capital during the year ended December 31, 2017. During the year ended
December 31, 2017, the Company has received $ 450,000 in cash. On December 24, 2018, the Company received the remaining balance of $2,550,000
in the form of newly issued shares of Rgene’s Common Stock, at the price of NT$50 (approximately equivalent to $1.60 per share),
for an aggregate number of 1,530,000 shares, which accounted for equity method long-term investment as of December 31, 2018. During the
year ended December 31, 2018, the Company has recognized investment loss of $549. On December 31, 2018, the Company determined to fully
write off this investment 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 of Rgene, additional funding requirements, and Rgene’s ability to remain in business.
All projects that have been initiated will be managed and supported by the Company and Rgene.
The Company and Rgene signed an amendment to
the Co-Dev Agreement on November 10, 2020, pursuant to which both parties agreed to delete AB-1507 HER2/neu Positive Breast Cancer Combination
Therapy and AB 1527 Ovary Cancer Combination Therapy and add ABV-1519 EGFR Positive Non-Small Cell Lung Cancer Combination Therapy and
ABV-1526 Large Intestine / Colon / Rectal Cancer Combination Therapy to the products to be co-developed and commercialized. Other provisions
of the Co-Dev Agreement remain in full force and effect.
F- 21
Collaborative agreement with BioFirst Corporation,
a related party
On July 24, 2017, BriVision entered into a collaborative
agreement (the “BioFirst Collaborative Agreement”) with BioFirst Corporation (“BioFirst”), pursuant to which
BioFirst granted the Company the global licensing right for medical use of the product (the “Product”): BFC-1401 Vitreous
Substitute for Vitrectomy. BioFirst is a related party to the Company because a controlling beneficiary shareholder of YuanGene Corporation
and the Company is one of the directors and Common Stock shareholders of BioFirst (See Note 12).
Pursuant to the BioFirst Collaborative Agreement,
the Company will co-develop and commercialize the Product with BioFirst and pay BioFirst in a total amount of $ 3,000,000 in cash or stock
of the Company before September 30, 2018. The amount of $ 3,000,000 is in connection with the compensation for BioFirst’s past research
efforts and contributions made by BioFirst before the BioFirst Collaborative Agreement was signed and it does not relate to any future
commitments made by BioFirst and BriVision in this BioFirst Collaborative Agreement. In addition, the Company is entitled to receive
50 % of the future net licensing income or net sales profit, if any, and any development cost shall be equally shared by both BriVision
and BioFirst.
On September 25, 2017, BioFirst has delivered
all research, technical, data and development data to BriVision. The Company determined to fully expense the entire amount of $ 3,000,000
since currently the related licensing rights do not have alternative future uses. According to ASC 730-10-25-1, absent alternative future
uses the acquisition of product rights to be used in research and development activities must be charged to research and development
expenses immediately. Hence, the entire amount of $ 3,000,000 is fully expensed as research and development expense during the year ended
December 31, 2017.
On June 30, 2019, BriVision 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 in consideration for $ 3,000,000 owed by the Company to BioFirst (the “Total
Payment”) in connection with a certain collaborative agreement between the Company and BioFirst dated July 24, 2017 (the “Collaborative
Agreement”). Pursuant to the Collaborative Agreement, BioFirst granted the Company the global licensing right to co-develop BFC-1401
or ABV-1701 Vitreous Substitute for Vitrectomy for medical purposes in consideration for the Total Payment.
On August 5, 2019, BriVision entered into a second
Stock Purchase Agreement (“Purchase Agreement 2”) with BioFirst. Pursuant to Purchase Agreement 2, the Company issued 414,702
shares of the Company’s common stock to BioFirst in consideration for $ 2,902,911 owed by the Company to BioFirst in connection
with a loan provided to BriVision from BioFirst.
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.
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 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. 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. Further ABV-2002 product development was put on hold due 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 from domestic R & D institutions. Currently, the main research and development product is
the vitreous substitute (Vitargus®) Licensed by the National Health Research Institutes. Vitargus is the world’s first bio-degradable
vitreous substitute and offers a number of advantages over current vitreous substitutes by minimizing medical complications and reducing
the need for additional surgeries.
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 center in Taiwan, allowing ABVC to achieve the world-class technology of manufacturing Vitargus and
GMP certified pharmaceutical factory. BioFirst is targeting to complete the construction in 2024.
F- 22
4. INVENTORY
Inventory consists of the following:
December 31,
2022
December 31,
2021
Finished goods
$ -
$ 96,725
Work-in-process
-
-
Raw materials
-
84,620
Allowance for inventory valuation and obsolescence loss
-
( 155,370 )
Inventories, net
$ -
$ 25,975
For the year
ended December 31, 2022, the inventories were expensed as research and development expenses.
5. PROPERTY AND EQUIPMENT
Property and
equipment as of December 31, 2022 and 2021 are summarized as follows:
December 31,
2022
December 31,
2021
Land
$ 361,193
$ 400,091
Buildings and leasehold improvements
2,226,687
2,235,061
Machinery and equipment
1,116,789
1,013,376
Office equipment
173,766
191,824
3,878,435
3,840,352
Less: accumulated depreciation
( 3,304,457 )
( 3,314,471 )
Property and equipment, net
$ 573,978
$ 525,881
Depreciation expense were $ 23,799 and $ 11,993
for the years ended December 31, 2022 and 2021, respectively. As of December 31, 2022 and 2021, Land with book value amounted to approximately
$ 361,193 and $ 400,091 , respectively, were pledged for obtaining bank loan (see Notes 8 Bank loans).
6. LONG-TERM INVESTMENTS
(1)
The ownership percentages of each investee are listed
as follows:
Ownership percentage
December 31,
December 31,
Accounting
Name of related party
2022
2021
treatments
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
21.77 %
21.77 %
Equity Method
Rgene Corporation
28.85 %
28.85 %
Equity Method
(2)
The extent the investee relies on the company for its
business are summarized as follows:
Name
of related party
The
extent the investee relies on the Company for its business
Braingenesis Biotechnology Co., Ltd.
No specific business relationship
Genepharm Biotech Corporation
No specific business relationship
BioHopeKing Corporation
Collaborating with the Company to develop and commercialize drugs
BioFirst Corporation
Loaned from the investee and provides research and development support service
Rgene Corporation
Collaborating with the Company to develop and commercialize drugs
F- 23
(3)
Long-term investment mainly consists of the following:
December 31,
2022
December 31,
2021
Non-marketable Cost Method Investments, net
Braingenesis Biotechnology Co., Ltd.
$ 7,169
$ 7,941
Genepharm Biotech Corporation
21,887
24,244
BioHopeKing Corporation
813,014
900,570
Subtotal
842,070
932,755
Equity Method Investments, net
BioFirst Corporation
-
-
Rgene Corporation
-
-
Total
$ 842,070
$ 932,755
(a)
BioFirst Corporation (the “BioFirst”):
The Company holds an equity interest
in BioFirst Corporation, accounting for its equity interest using the equity method to accounts for its equity investment as prescribed
in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include the Company’s
proportionate share of investee’s income or loss and other adjustments required by the equity method. As of December 31, 2022 and
2021, the Company owns 21.77 % and 21.77 % common stock shares of BioFirst, respectively. During year ended December 31, 2021, the Company
made prepayment for equity investment in BioFirst to purchase additional 317,000 shares to be issued by BioFirst in the aggregate
amount of $ 618,150 , recorded as prepayment for long-term investments as of December 31, 2022. The amount due from BioFirst has been reclassified as prepayment for investment.
Summarized financial information for the Company’s
equity method investee, BioFirst, is as follows:
Balance Sheet
December 31,
2022
December 31,
2021
Current Assets
$ 1,543,151
$ 2,205,669
Noncurrent Assets
739,472
959,454
Current Liabilities
2,663,051
2,909,703
Noncurrent Liabilities
103,447
32,522
Stockholders’ Equity
483,874
222,898
Statement of operation
Year Ended
December 31,
2022
2021
Net sales
$ 30,162
$ 26,693
Gross profit
8,239
8,348
Net loss
( 1,274,539 )
( 2,276,892 )
Share of losses from investments accounted for using the equity method
-
( 269,844 )
F- 24
(b)
Rgene Corporation (the
“Rgene”)
Both Rgene and the Company are under
common control by Dr. Tsung-Shann Jiang, the CEO and chairman of the BioLite Inc. Since Dr. Tsung-Shann Jiang is able to exercise significant
influence, but not control, over the Rgene, the Company determined to use the equity method to accounts for its equity investment as
prescribed in ASC 323, Investments—Equity Method and Joint Ventures (“ASC 323”). Equity method adjustments include
the Company’s proportionate share of investee’s income or loss and other adjustments required by the equity method. As of
December 31, 2022 and 2021, the Company owns 28.85 % and 28.85 % common stock shares of Rgene, respectively.
Summarized financial information for the Company’s
equity method investee, Rgene, is as follows:
Balance Sheets
December 31,
2022
December 31,
2021
Current Assets
$ 68,302
$ 73,452
Noncurrent Assets
303,893
374,423
Current Liabilities
2,478,868
1,934,786
Noncurrent Liabilities
2,441
-
Shareholders’ Deficit
( 2,481,309 )
( 1,486,911 )
Statement of operations
Year Ended
December 31,
2022
2021
Net sales
$ -
$ -
Gross Profit
-
-
Net loss
( 1,550,123 )
( 576,514 )
Share of loss from investments accounted for using the equity method
-
-
(4)
Disposition of long-term
investment
During the years ended December 31,
2022 and 2021, there is no disposition of long-term investment.
(5)
Losses on Equity Investments
The components of losses on equity investments
for each period were as follows:
Year Ended
December 31,
2022
2021
Share of equity method investee losses
$ -
$ ( 269,844 )
F- 25
7. CONVERTIBLE NOTES PAYABLE
On October 23, 2020, the Company entered into
a Securities Purchase Agreement (the “October SPA”) with one accredited investor. Pursuant to the October SPA, the Company
sold and issued a convertible promissory note (the “October Note”) in the principal amount of $2,500,000 to the investor
and received the payment from such investor on October 30, 2020. The October Note was issued on October 23, 2020 and the maturity date
of the October Note is the twenty-four (24) month anniversary from the issuance date (the “Maturity Date”). Upon the Maturity
Date, the Company shall pay to the holder, in cash, an amount representing all outstanding principal amount and accrued and unpaid interest
under the October Note. The October Note bears an interest rate of ten percent (10%) per annum and may be convertible into shares of
the Company’s common stock at a fixed conversion price of $2.25 per share. The holder of the October Note may elect to convert
part or all of the outstanding balance of the October Note from the issuance date until the Maturity Date. The Company may prepay the
outstanding amount at any time, in whole or in part, without any penalty.
On May 17, 2021, the parties to the October SPA
signed Amendment No. 1 to Promissory Note (the “Amendment”). Pursuant to the Amendment, the Note shall also be automatically
converted into shares of the Company’s common stock immediately following the Company’s receipt of conditional approval to
list its common stock on the NASDAQ stock market, if and when the Company receives such approval, at a conversion price equal to $ 2.25
per share. On July 21, 2021, The Company converted all convertible promissory note amounted $ 2,500,000 into 1,111,112 shares of
the Company’s common stock and warrants.
As of December 31, 2022 and 2021, the aggregate
carrying values of the convertible debentures were both $ 0 ; and accrued convertible interest were both $ 0 .
Total interest expenses in connection with the
above convertible note payable were $ 208,657 and $ 193,548 for the years ended December 31, 2022 and 2021, respectively.
8. BANK LOANS
(1)
Short-term bank loan consists of the following:
December 31,
December 31,
2022
2021
Cathay United Bank
$ 243,750
$ 270,000
CTBC Bank
650,000
720,000
Cathay Bank
1,000,000
650,000
Total
$ 1,893,750
$ 1,640,000
Cathay United Bank
On June 28, 2016, BioLite Taiwan and Cathay United
Bank entered into a one-year bank loan agreement (the “Cathay United Loan Agreement”) in an amount of NT$ 7,500,000 , equivalent
to $ 243,750 . The term started June 28, 2016 with maturity date at June 28, 2017 . The loan balance bears interest at a floating rate of
prime rate plus 1.15 %. The prime rate is based on term deposit saving interest rate of Cathay United Bank. On September 6, 2017, BioLite
Taiwan extended the Cathay United Loan Agreement for one year , which was due on September 6, 2018, with the principal amount of NT$ 7,500,000 ,
equivalent to $ 243,750 . On October 1, 2018, BioLite Taiwan extended the Cathay United Loan Agreement with the same principal amount of
NT$ 7,500,000 , equivalent to $ 243,750 for one year , which was due on September 6, 2019. On September 6, 2019, BioLite Taiwan extended
the Cathay United Loan Agreement with the same principal amount of NT$ 7,500,000 , equivalent to $ 243,750 for one year , which is due on
September 6, 2020. On September 6, 2020, BioLite Taiwan extended the Cathay United Loan Agreement with the same principal amount of NT$ 7,500,000 ,
equivalent to $ 243,750 for one year , which is due on September 6, 2021. On September 6, 2021, BioLite Taiwan extended the Cathay United
Loan Agreement with the same principal amount of NT$ 7,500,000 , equivalent to $ 243,750 for one year , which is due on September 6, 2022.
On September 6, 2022, BioLite Taiwan extended the Cathay United Loan Agreement with the same principal amount of NT$ 7,500,000 , equivalent
to $ 243,750 for one year , and same interest rate, which is due on September 6, 2023. As of December 31, 2022 and December 31, 2021, the
effective interest rates per annum was 2.67 % and 2.10 %. The loan is collateralized by the Land of BioLite Taiwan, and is also personal
guaranteed by the Company’s chairman.
Interest expenses were $ 5,960 and $ 5,639 for the
years ended December 31, 2022 and 2021, respectively.
F- 26
CTBC Bank
On June 12, 2017 and July 19, 2017, BioLite Taiwan and CTBC Bank entered
into short-term saving secured bank loan agreements (the “CTBC Loan Agreements”) in an amount of NT$ 10,000,000 , equivalent
to $ 325,000 , and NT$ 10,000,000 , equivalent to $ 325,000 , respectively. Both two loans with the same maturity date at January 19, 2018 .
In February 2018, BioLite Taiwan combined two loans and extended the loan contract with CTBC for one year . On January 18, 2019, BioLite
Taiwan and CTBC Bank agreed to extend the loan with a new maturity date, which was July 18, 2019 . On July 18, 2019, BioLite Taiwan extended
the CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months, which is due on January
17, 2020. On January 19, 2020, BioLite Taiwan extended the CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 , equivalent
to $ 650,000 for six months, which is due on July 19, 2020. On July 17, 2020, BioLite Taiwan extended the CTBC Loan Agreement with the
same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months, which is due on January 15, 2021. On January 15, 2021,
BioLite Taiwan extended the CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months,
which is due on July 15, 2021. On July 15, 2021, BioLite Taiwan extended the CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 ,
equivalent to $ 650,000 for six months, which is due on January 14, 2022. The loan balances bear interest at a fixed rate of 1.68 % per
annum. The loan is secured by the money deposited in a savings account with the CTBC Bank. This loan was also personal guaranteed by the
Company’s chairman and BioFirst. During the year ended December 31, 2021, BioLite Taiwan has opened a TCD account with CTBC bank
to guarantee the loan going forward.
On July 14, 2022, BioLite Taiwan extended the CTBC Loan Agreement with
the same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months, which is due on January 14, 2023. The loan balance bear interest at a fixed rate of 2.00 % per annum.
On January 14, 2023, BioLite Taiwan extended
the CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months, which is due on July
14, 2023. The loan balance bear interest at a fixed rate of 2.50 % per annum.
Interest expenses were $ 12,220 and $ 12,029 for
the years ended December 31, 2022 and 2021, respectively.
Cathay Bank
On January 21, 2019, the Company received a loan
in the amount of $ 500,000 from Cathay Bank (the “Bank”) pursuant to a business loan agreement (the “Loan Agreement”)
entered by and between the Company and Bank on January 8, 2019 and a promissory note (the “Note”) executed by the Company
on the same day. The Loan Agreement provides for a revolving line of credit in the principal amount of $ 1,000,000 with a maturity date
(the “Maturity Date”) of January 1, 2020. The Note executed in connection with the Loan Agreement bears an interest rate
(the “Regular Interest Rate”) equal to the sum of one percent ( 1 %) and the prime rate as published in the Wall Street Journal
(the “Index”) and the accrued interest shall become payable each month from February 1, 2019. Pursuant to the Note, the Company
shall pay the entire outstanding principal plus accrued unpaid interest on the Maturity Date and may prepay portion or all of the Note
before the Maturity Date without penalty. If the Company defaults on the Note, the default interest rate shall become five percent ( 5 %)
plus the Regular Interest Rate.
In connection with the Note and Loan Agreement,
on January 8, 2019, each of Dr. Tsung Shann Jiang and Dr. George Lee, executed a commercial guaranty (the “Guaranty”) to
guaranty the loans for the Company pursuant to the Loan Agreement and Note, severally and individually, in the amount not exceeding $ 500,000
each until the entire Note plus interest are fully paid and satisfied. Dr. Tsung Shann Jiang is the Chairman and Chief Executive Officer
of BioLite Holding, Inc. and Dr. George Lee serves as the Chairman of the board of directors of BioKey. On December 29, 2020, the Company
entered into a new loan extension agreement and assignment of deposit account with the Bank, which allowed Dr. Tsung Shann Jiang and
Dr. George Lee to be removed as guarantees from the list of Guaranty.
In addition, on January 8, 2019, each of the
Company and BioKey, a wholly-owned subsidiary of the Company, signed a commercial security agreement (the “Security Agreement”)
to secure the loans under the Loan Agreement and the Note. Pursuant to the Security Agreements, each of the Company and BioKey (each,
a “Grantor”, and collectively, the “Grantors”) granted security interest in the collaterals as defined therein,
comprised of almost all of the assets of each Grantor, to secure such loans for the benefit of the Bank. On March 31, 2020, the Company
extended the Loan Agreement with the same term for seven months, which is due on October 31, 2020. On April 8, 2020 and October 3, 2020,
the Company repaid an aggregated principal amount of $ 350,000 . On December 3, 2020, The Company renewed the Loan Agreement with the principal
amount of $ 650,000 for ten months, which is due on October 31, 2021. On September 24, 2021, the Cathay Bank has increased the line of
credit to $ 1,000,000 from $ 650,000 . The Loan Agreement was further extended and due on December 31, 2022. The outstanding loan balance
was $ 1,000,000 as of December 31, 2022. On February 23, 2023, the bank loan from Cathay Bank was fully repaid.
Interest expenses were $ 46,957 and $ 18,143 for
the years ended December 31, 2022 and 2021, respectively.
F- 27
9. PAYCHECK PROTECTION PROGRAM LOAN PAYABLE
On April 14, 2020, the Company received a loan
in the amount of $ 124,400 under the Paycheck Protection Program (“PPP”) administered by the United States Small Business
Administration (the “SBA”) from East West Bank. According to the Coronavirus Aid, Relief, and Economic Security Act (the
“Cares Act”), PPP loan provides for forgiveness of up to the full principal amount and accrued interest if the funds are
used for payroll costs, interest on mortgages, rent, and utilities. However, at least 60 % of the forgiven amount must have been used
for payroll.
The loan was granted pursuant to a promissory
note dated April 14, 2020 issued by the Company, which matures on April 13, 2022 and bears interest at a rate of 1.00% per annum. The
Company will pay the principal in one payment of all outstanding principal plus all accrued unpaid interest on that date that is two
years after the date of the promissory note. In addition, the Company will pay regular monthly payments in an amount equal to one month’s
accrued interest commencing on the date that is seven months after the date of the promissory note, with all subsequent interest payments
to be due on the same day of each month after that. No collateral or personal guarantees are required.
On January 29, 2021, BioKey received a loan in
the amount of $ 132,331 under the Paycheck Protection Program administered by the United States Small Business Administration from East
West Bank. According to the Coronavirus Aid, Relief, and Economic Security Act, PPP loan provides for forgiveness of up to the full principal
amount and accrued interest if the funds are used for payroll costs, interest on mortgages, rent, and utilities. However, at least 60 %
of the forgiven amount must have been used for payroll. The loan was granted pursuant to a promissory note dated January 27, 2021 issued
by the Company, which matures on January 28, 2026 and bears interest at a rate of 1.00% per annum. The Company will pay the principal
in one payment of all outstanding principal plus all accrued unpaid interest on that date that is five years after the date of the promissory
note. No collateral or personal guarantees are required.
On February 7, 2021, the Company received a loan
in the amount of $ 104,167 under the Paycheck Protection Program administered by the United States Small Business Administration from
Cathay Bank. According to the Coronavirus Aid, Relief, and Economic Security Act, PPP loan provides for forgiveness of up to the full
principal amount and accrued interest if the funds are used for payroll costs, interest on mortgages, rent, and utilities. However, at
least 60 % of the forgiven amount must have been used for payroll. The loan was granted pursuant to a promissory note dated February 7,
2021 issued by the Company, which matures on February 6, 2026 and bears interest at a rate of 1.00 % per annum. The Company will pay the
principal in one payment of all outstanding principal plus all accrued unpaid interest on that date that is five years after the date
of the promissory note. No collateral or personal guarantees are required.
PPP loan Forgiveness
On February 27, 2021, the Company submitted all
required documents, such as application form and use of funds, to East West Bank for the application of forgiveness. The PPP loan
from East West Bank of $ 124,400 and $ 132,331 was forgiven by the SBA as a gesture of supporting the operation of the Company on March
15, 2021 and September 28, 2021, respectively.
On September 23, 2021, the Company submitted
the required documents, such as application form and use of funds, to Cathay Bank for the application of forgiveness. The PPP loan
from Cathay Bank of $ 104,167 was forgiven by the SBA as a gesture of supporting the operation of the Company on November 15, 2021.
As a result, the Company recorded the forgiveness
of the PPP loans as government grant income in the aggregate amount of $ 360,898 during the year ended December 31, 2021. As of December
31, 2022, there was no outstanding balance payable to the bank.
10. NOTES PAYABLE
In January, 2019, BioLite Taiwan entered an unsecured
loan agreement with one individual bearing interest at fixed rates at 12 % per annum of NT$ 3,000,000 , equivalent to $ 106,800 , for working
capital purpose. On September 11, 2021 the outstanding balance has been repaid in full. As of December 31, 2022 and 2021, the balance
due to this individual amounted to both $ 0 . Interest expense was $ 0 and $ 8,592 for the years ended December 31, 2022 and 2021, respectively.
11. SHORT-TERM LOAN
On February 18, 2020, the Company entered an
unsecured loan agreement with a third-party in the amount of $ 100,000 . This loan bears the interest rate of 1.5 % per annum and will be
matured on August 17, 2020. On August 18, 2020, the Company extended the contract for six months under the same term. On February 18,
2021, the Company extended the contract for six months under the same term. On August 26, 2021, the loan with interest totaling $ 102,272
has been repaid in full. Accrued interest expense were both $ 0 as of December 31, 2022 and 2021, respectively.
F- 28
12. RELATED PARTIES TRANSACTIONS
The related parties of the company with whom
transactions are reported in these financial statements are as follows:
Name
of entity or Individual
Relationship
with the Company and its subsidiaries
BioFirst Corporation (the
“BioFirst”)
Entity controlled by controlling beneficiary shareholder of YuanGene
BioFirst
(Australia) Pty Ltd. (the “BioFirst (Australia)”)
100% owned by BioFirst; Entity controlled by controlling beneficiary shareholder of YuanGene
Rgene Corporation (the
“Rgene”)
Shareholder of the Company; entity controlled by controlling beneficiary shareholder of YuanGene
YuanGene Corporation (the
“YuanGene”)
Controlling beneficiary shareholder of the Company
AsiaGene Corporation (the
“AsiaGene”)
Shareholder; entity controlled by controlling beneficiary shareholder of YuanGene
Eugene Jiang
Former President and Chairman
Keypoint Technology Ltd.
(the “Keypoint’)
The Chairman of Keypoint is Eugene Jiang’s mother.
Lion Arts Promotion Inc.
(the “Lion Arts”)
Shareholder of the Company
Yoshinobu Odaira (the “Odaira”)
Director of the Company
GenePharm Inc. (the “GenePharm”)
Dr. George Lee, Board Director of Biokey, is the Chairman of GenePharm.
Euro-Asia
Investment & Finance Corp Ltd. (the “Euro-Asia”)
Shareholder of the Company
LBG USA, Inc. (the “LBG
USA”)
100% owned by BioFirst; Entity controlled by controlling beneficiary shareholder of YuanGene
LionGene Corporation (the
“LionGene”)
Shareholder of the Company; Entity controlled by controlling beneficiary shareholder of YuanGene
Kimho Consultants Co.,
Ltd. (the “Kimho”)
Shareholder of the Company
The Jiangs
Mr. Tsung-Shann Jiang, the controlling beneficiary shareholder of the Company and Rgene, the Chairman and CEO of the BioLite Holding Inc. and BioLite Inc. and the President and a member of board of directors of BioFirst
Ms. Shu-Ling Jiang, Mr. Tsung-Shann Jiang’s wife, is the Chairman of Keypoint; and a member of board of directors of BioLite Inc.
Mr. Eugene Jiang is Mr. and Ms. Jiang’s son. Mr. Eugene Jiang is the chairman, and majority shareholder of the Company and a member of board of directors of BioLite Inc.
Mr. Chang-Jen Jiang is Mr. Tsung-Shann Jiang’s sibling and the director of the Company.
Ms. Mei-Ling Jiang is Ms. Shu-Ling Jiang’s sibling.
Amkey Ventures, LLC (“Amkey”)
An entity controlled by Dr. George Lee, who serves as one of the board directors of BioKey, Inc
BioLite Japan
Entity controlled by controlling beneficiary shareholder of ABVC
BioHopeKing Corporation
Entity controlled by controlling beneficiary shareholder of ABVC
ABVC BioPharma (HK), Limited
An entity 100% owned by Mr. Tsung-Shann Jiang
Accounts receivable - related parties
Accounts receivable due from related parties
consisted of the following as of the periods indicated:
December 31,
December 31,
2022
2021
GenePharm Inc.
$ 142,225
$ 142,225
Rgene
615,118
2,374
Amkey
-
800
Total
$ 757,343
$ 145,399
F- 29
Due from related parties
Amount due from related parties consisted of
the following as of the periods indicated:
Due from related party- Current
December 31,
December 31,
2022
2021
Rgene
$ 513,819
$ -
Total
$ 513,819
$ -
Due from related parties- Noncurrent
December 31,
December 31,
2022
2021
Rgene
$ -
$ 49,110
BioFirst (Australia)
1,028,556
491,816
BioHopeKing Corporation
112,822
124,972
LBG USA
-
675
BioLite Japan
-
150,000
Keypoint
-
1,610
Total
$ 1,141,378
$ 818,183
(1) As of December 31, 2021, due from Rgene amounted
to $ 49,110 . Under the terms of the loan agreement, the loan bears interest at 1 % per month (or equivalent to 12 % per annum) and the maturity
date was December 31, 2020. As of December 31, 2021, the outstanding loan balance was $ 33,520 ; and accrued interest was $ 13,701 , respectively.
On January 1, 2021, BioLite Taiwan entered into a consultant services agreement with Rgene, of which the amount due from Rgene was $ 1,889
for the year ended December 31, 2021.
On June 16, 2022, the Company entered into a one-year convertible loan
agreement with Rgene, with a principal amount of $1,000,000 to Rgene which bears interest at 5% per annum for the use of working capital
that, if fully converted, would result in ABVC owning an additional 6.4% of Rgene. The Company may convert the Note at any time into shares
of Rgene’s common stock at either (i) a fixed conversion price equal to $1.00 per share or (ii) 20% discount of the stock price
of the then most recent offering, whichever is lower; the conversion price is subject to adjustment as set forth in the Note. The Note
includes standard events of default, as well as a cross-default provision pursuant to which a breach of the Service Agreement will trigger
an event of default under the convertible note if not cured after 5 business days of written notice regarding the breach is provided.
As of December 31, 2022, the outstanding loan balance was $ 500,000 ; and accrued interest was $ 13,819 .
(2) On July 1, 2020, the Company entered into a loan agreement with BioFirst
(Australia) for $ 361,487 to properly record R&D cost and tax refund allocation based on co-development contract executed on July 24,
2017. The loan was originally set to be mature on September 30, 2021 with an interest rate of 6.5 % per annum, but on September 7, 2021,
the Company entered into a loan agreement with BioFirst (Australia) for $ 67,873 to meet its new project needs. On December
1, 2021, the Company entered into a loan agreement with BioFirst (Australia) for $ 250,000 to increase the cost for upcoming projects.
The loan will be matured on November 30, 2022 with an interest rate of 6.5 % per annum. In 2022, the Company entered into several
loan agreements with BioFirst (Australia) for a total amount of $507,000 to increase the cost for upcoming projects. All the loans period
was twelve months with an interest rate of 6.5 % per annum. As of December 31, 2022 and 2021, the aggregate amount of outstanding loan
and accrued interest was $ 1,028,556 and $ 491,816 , respectively.
F- 30
(3)
On February 24, 2015, BioLite Taiwan and BioHopeKing Corporation (the “BHK”) entered into a co-development agreement, (the “BHK Co-Development Agreement”, see Note 3). The development costs shall be shared 50/50 between BHK and the Company. Under the term of the agreement, BioLite issued relevant development cost to BHK. As of December 31, 2022 and 2021, due from BHK was $ 112,822 and $ 124,972 , respectively.
(4) On May 8, 2020, the Company and Lucidaim entered into a Letter of Intent
(LOI) in regard to a potential joint venture of BioLite Japan. Based on the LOI, each party will advance an aggregated amount of $ 150,000
to meet BioLite Japan’s working capital needs, which the Company advanced an amount of $ 150,000 and the advance bear 0 % interest
rate. As of December 31, 2022 and 2021, the outstanding advance balances was $ 0 and $ 150,000 , respectively. The outstanding balance was
reclassified as prepayment for long-term investments due to the debt-to-equity agreement with BioLite Japan, while format document is
pending to be executed.
Due to related parties
Amount due to related parties consisted of the
following as of the periods indicated:
December 31,
December 31,
2022
2021
BioFirst Corporation
$ 188,753
$ 40,878
BioFirst (Australia)
275,901
132,443
AsiaGene
-
24,017
YuanGene
-
9,205
The Jiangs
19,789
18,750
Due to shareholders
151,450
168,131
Total
$ 635,893
$ 393,424
(1) Since 2019, BioFirst has advanced funds to the Company for working capital purpose. The advances bear interest 1 % per month (or equivalent to 12 % per annum). As of December 31, 2022 and 2021, the aggregate amount of outstanding balance and accrued interest is $ 188,753 , a combination of $ 147,875 from loan, and $ 40,878 from expense-sharing, and $ 40,878 , respectively.
(2) As of December 31, 2022 and 2021, BioFirst (Australia) has advanced the Company an aggregate amount of $ 275,901 and $ 132,443 , respectively for new project purpose.
(3) Since 2019, the Jiangs advanced funds to the Company for working capital purpose. As of December 31, 2022 and 2021, the outstanding balance due to the Jiangs amounted to $ 19,789 and $ 18,750 , respectively. These loans bear interest rate of 0 % to 1 % per month, and are due on demand.
(4) Since 2018, the Company’s shareholders have advanced funds to the Company for working capital purpose. The advances bear interest rate from 12 % to 13.6224 % per annum. As of December 31, 2022 and 2021, the outstanding principal and accrued interest was $ 151,450 and $ 168,131 , respectively. Interest expenses in connection with these loans were $ 21,378 and $ 22,779 for the years ended December 31, 2022 and 2021, respectively.
F- 31
Revenue from related party
Year
Ended
December 31,
2022
2021
Rgene
$ 904,043
$ 2,373
Total
$ 904,043
$ 2,373
13. INCOME TAXES
Income tax expense for the years ended
December 31, 2022 and 2021 consisted of the following:
Year Ended
December 31,
2022
2021
Current:
Federal
$ -
$ -
State
2,400
800
Foreign
-
-
Total Current
$ 2,400
$ 800
Deferred:
Federal
$ -
$ -
State
-
-
Foreign
795,378
( 187,055 )
Total Deferred
$ 795,378
$ ( 187,055 )
Total provision for income taxes
$ 797,778
$ ( 186,255 )
Deferred tax assets (liability) as of December 31, 2022
and December 31, 2021 consist approximately of:
December 31,
December 31,
2022
2021
Loss on impairment of Assets
709,961
741,390
Net operating loss carryforwards
5,866,623
2,801,363
Tax credit of investment
-
698,187
Operating lease liabilities
213,482
-
Operating lease assets
( 213,482 )
-
Deferred tax assets, Gross
6,576,584
4,240,940
Valuation allowance
( 6,459,474 )
( 3,259,028 )
Deferred tax assets, net
117,110
981,912
14. EQUITY
On July 8, 2020, the Company entered an agreement
with View Trade Securities Inc. (“ViewTrade”) to engage ViewTrade as the placement agent and the Company’s advisor/consultant
with respect to its ongoing capital events. Pursuant to the agreement, the Company agreed to pay View Trade 60,000 restricted common
shares of the Company and 60,000 warrants to purchase common shares of the Company at an exercise price of $6 per share for a period
of 5 years with cashless exercise provision. As of December 31, 2020, the Company has issued 60,000 shares of common stock to ViewTrade
for the consulting fee with an estimated value of $ 135,000 . The warrants were never issued and the parties mutually agreed to terminate
the agreement on November 19, 2020.
Pursuant to the termination agreement, the Company
issued 50,000 shares of the Company’s common stock at a price of $ 5 per share as a termination fee on June 29, 2021, of which 6,000
shares were issued to WallachBeth Capital LLC (“WallachBeth”). In January 2021, WallachBeth entered into a consulting agreement
with the Company pursuant to which the Company engaged WallachBeth to conduct due diligence and research work with respect to the Company.
On June 29, 2021, WallachBeth was issued 6,000 shares of common stock as compensation for those services.
F- 32
In July 2021, 1,111,112 shares of the Company’s
common stock and warrants were issued pursuant to the conversion of convertible promissory note of $ 2,500,000 entered in October 2020
(see Note 7).
On August 5, 2021, the Company closed its public
offering (the “Public Offering”) of 1,100,000 units (the “Units”), with each Unit consisting of one share of
the Company’s common stock, one Series A warrant (the “Series A Warrants”) to purchase one share of common stock at
an exercise price equal to $6.30 per share, exercisable until the fifth anniversary of the issuance date, and one Series B warrant (the
“Series B Warrants,” and together with the Series A Warrants, the “Public Warrants”) to purchase one share of
common stock at an exercise price equal to $10.00 per share, exercisable until the fifth anniversary of the issuance date; the exercise
price of the Public Warrants are subject to certain adjustment and cashless exercise provisions as described therein. The Company completed
the Public Offering pursuant to its registration statement on Form S-1 (File No. 333-255112), originally filed with the Securities and
Exchange Commission (the “SEC”) on April 8, 2021 (as amended, the “Original Registration Statement”), that the
SEC declared effective on August 2, 2021 and the registration statement on Form S-1 (File No. 333-258404) that was filed and automatically
effective on August 4, 2021 (the “S-1MEF,” together with the Original Registration Statement, the “Registration Statement”).
The Units were priced at $6.25 per Unit, before underwriting discounts and offering expenses, resulting in gross proceeds of $6,875,000.
In August 2021, 2,354,145 shares of the Company’s common stock were issued for gross proceeds of $ 6,875,000 , before placement agent
fees and legal fees of $ 850,429 .
In November 2021, the Company received $ 4,244,452 in
gross proceeds from the exercise of warrants issued in the Company’s August 3, 2021, public offering of securities. Investors exercised
a total of 673,405 Series A warrants at a price of $ 6.30 per share and 200 Series B warrants at a price of $ 10 per
share. Pursuant to these exercises, the Company issued an aggregate of 673,605 shares of Common Stock.
In November 2021, the Company entered into consulting
agreements with service providers for consulting and advisory services, pursuant to which the Company agreed to pay the service fee amounted
$ 1,478,590 by issuing 316,934 shares of unrestricted common shares, valued at the closing price from $ 2.31 to $ 6.3 per share on the
grant date. These shares have been issued during the year ended December 31, 2021.
In January 2022, the Company agreed to pay the
deferred service fees related to Public Offering amounted $ 4,296,763 by issuing 1,306,007 shares of unrestricted common shares, valued
at $ 3.29 per share on the grant date. These shares have been issued in January 2022.
In March 2022, the Company issued 75,000 common
shares to BarLew Holdings, LLC for consulting and advisory services amounted to $ 169,500 , valued at $ 2.26 per share.
In May 2022, the Company and an institutional
investor entered into certain securities purchase agreement relating to the offer and sale of 2,000,000 shares of common stock at an offering
price of $ 2.11 per share in a registered direct offering. The shares of the Company’s common stock were issued for gross proceeds
of $ 4,220,000 , before placement agent fees and legal fees of $ 556,075 . Pursuant to the offering, the Company will also issue 5 -year warrants
to purchase 2,000,000 shares of common stock, exercisable at a price of $ 2.45 per share. As of December 31, 2022, these warrants have
been issued but not exercised.
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 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.
15. STOCK OPTIONS
On October 30, 2020, the Company issued an aggregate
of 545,182 shares of common stock in lieu of unpaid salaries of certain employees and unpaid consulting fees under the 2016 Equity Incentive
Plan, as amended, at a conversion price of $ 2 per share; the total amount of converted salaries and consulting fees was $ 1,090,361 . On
November 21, 2020, the Company entered into acknowledgement agreements and stock option purchase agreements with these
employees and consultant; pursuant to which the Company granted stock options to purchase 545,182 shares of the Company’s common
stock in lieu of common stock. The options were vested at the grant date and become exercisable for 10 years from the grant date.
On October 15, 2021, the Company entered into
stock option agreements with 11 directors and 3 employees, pursuant to which the Company granted options to purchase an aggregate of 1,280,002
shares of common stock under the 2016 Equity Incentive Plan, as amended, at an exercise price of $ 3 per share. The options were vested
at the grant date and become exercisable for 10 years from the grant date.
On April 16, 2022, the Company entered into stock option agreements
with 5 directors, pursuant to which the Company agreed to grant options to purchase an aggregate of 761,920 shares of common stock under
the 2016 Equity Incentive Plan, at an exercise price of $ 3 per share, exercisable for 10 years from the grant date. As of December 31,
2022, these stock options have not been granted.
F- 33
Options issued and outstanding as of December 31, 2022, and their activities
during the year then ended are as follows:
Weighted-
Weighted-
Average
Average
Contractual
Number of
Exercise
Life
Aggregate
Underlying
Shares
Price
Per Share
Remaining
in Years
Intrinsic
Value
Outstanding as of January 1, 2022
1,825,184
$ 2.70
Granted
761,920
3.00
Forfeited
-
-
Outstanding as of December 31, 2022
2,587,104
2.79
8.74
$ -
Exercisable as of December 31, 2022
2,587,104
2.79
8.74
$ -
Vested and expected to vest
2,587,104
$ 2.79
8.74
$ -
The fair value of stock options granted for the
years ended December 31, 2022 and 2021 was calculated using the Black-Scholes option-pricing model applying the following assumptions:
Year ended
December 31
2022
2021
Risk free interest rate
2.79 %
1.13 %
Expected term (in years)
5.00
5.00
Dividend yield
0 %
0 %
Expected volatility
83.86 %
108.51 %
The Company granted options to purchase 761,920 and 1,280,002 shares
of common stock to employees and certain consultants during the years ended December 31, 2022 and 2021, respectively. The
weighted average grant date fair value of options granted during the years ended December 31, 2022 and 2021 was $ 1.63 and
$ 2.09 , respectively. There are 3,860,211 options available for grant under the 2016 Equity Incentive Plan as of December 31, 2022.
Compensation costs associated with the Company’s stock options are recognized, based on the grant-date fair values of these options
over vesting period. Accordingly, the Company recognized stock-based compensation expense of $ 1,241,930 and $ 2,675,205 for the years
ended December 31, 2022 and 2021, respectively. As of December 31, 2022 and 2021, there were no unvested options. There were no options
exercised during the years ended December 31, 2022 and 2021.
16. LOSS PER SHARE
Basic loss per share is computed by dividing net
loss by the weighted-average number of common shares outstanding during the year. Diluted loss per share is computed by dividing net loss
by the weighted-average number of common shares and dilutive potential common shares outstanding during the years ended December 31, 2022
and 2021.
For the Year Ended
December 31,
2022
December 31,
2021
Numerator:
Net loss attributable to ABVC’s common stockholders
$ ( 16,423,239 )
$ ( 12,838,813 )
Denominator:
Weighted-average shares outstanding:
Weighted-average shares outstanding - Basic
31,664,600
25,053,522
Stock options
Weighted-average shares outstanding - Diluted
31,664,600
25,053,522
Loss per share
-Basic
$ ( 0.52 )
$ ( 0.51 )
-Diluted
$ ( 0.52 )
$ ( 0.51 )
F- 34
Diluted loss per share takes into account the
potential dilution that could occur if securities or other contracts to issue Common Stock were exercised and converted into Common Stock.
17. LEASE
The Company adopted FASB Accounting Standards
Codification, Topic 842, Leases (“ASC 842”) using the modified retrospective approach, electing the practical expedient that
allows the Company not to restate its comparative periods prior to the adoption of the standard on January 1, 2019.
The Company applied the following practical expedients in the transition
to the new standard and allowed under ASC 842:
●
Reassessment of expired
or existing contracts: The Company elected not to reassess, at the application date, whether any expired or existing contracts contained
leases, the lease classification for any expired or existing leases, and the accounting for initial direct costs for any existing
leases.
●
Use of hindsight: The Company
elected to use hindsight in determining the lease term (that is, when considering options to extend or terminate the lease and to
purchase the underlying asset) and in assessing impairment of right-to-use assets.
●
Reassessment of existing
or expired land easements: The Company elected not to evaluate existing or expired land easements that were not previously accounted
for as leases under ASC 840, as allowed under the transition practical expedient. Going forward, new or modified land easements will
be evaluated under ASU No. 2016-02.
●
Separation of lease and
non- lease components: Lease agreements that contain both lease and non-lease components are generally accounted for separately.
●
Short-term lease recognition
exemption: The Company also elected the short-term lease recognition exemption and will not recognize ROU assets or lease liabilities
for leases with a term less than 12 months.
The new leasing standard requires recognition
of leases on the consolidated balance sheets as right-of-use (“ROU”) assets and lease liabilities. ROU assets represent the
Company’s right to use underlying assets for the lease terms and lease liabilities represent the Company’s obligation to
make lease payments arising from the leases. Operating lease ROU assets and operating lease liabilities are recognized based on the present
value and future minimum lease payments over the lease term at commencement date. The Company’s future minimum based payments used
to determine the Company’s lease liabilities mainly include minimum based rent payments. As most of Company’s leases do not
provide an implicit rate, the Company uses its estimated incremental borrowing rate based on the information available at commencement
date in determining the present value of lease payments.
The Company recognized lease liabilities, with
corresponding ROU assets, based on the present value of unpaid lease payments for existing operating leases longer than twelve months.
The ROU assets were adjusted per ASC 842 transition guidance for existing lease-related balances of accrued and prepaid rent, unamortized
lease incentives provided by lessors, and restructuring liabilities. Operating lease cost is recognized as a single lease cost on a straight-line
basis over the lease term and is recorded in Selling, general and administrative expenses. Variable lease payments for common area maintenance,
property taxes and other operating expenses are recognized as expense in the period when the changes in facts and circumstances on which
the variable lease payments are based occur.
The Company has no finance leases. The Company’s
leases primarily include various office and laboratory spaces, copy machine, and vehicles under various operating lease arrangements.
The Company’s operating leases have remaining lease terms of up to approximately five years.
December 31,
2022
December 31,
2021
ASSETS
Operating lease right-of-use assets
$ 1,161,141
$ 1,471,899
LIABILITIES
Operating lease liabilities (current)
369,314
347,100
Operating lease liabilities (noncurrent)
791,827
1,124,799
F- 35
Supplemental Information
The following provides details of the Company’s
lease expenses:
Year Ended
December 31,
2022
2021
Operating lease expenses
$ 358,576
$ 335,208
Other information related to leases is presented
below:
Year Ended
December 31,
2022
2021
Cash paid for amounts included in the measurement of operating lease liabilities
$ 358,576
$ 335,208
December 31,
2022
December 31,
2021
Weighted Average Remaining Lease Term:
Operating leases
2.48 years
2.90 years
Weighted Average Discount Rate:
Operating leases
1.49 %
1.39 %
The minimum future annual payments under non-cancellable
leases during the next five years and thereafter, at rates now in force, are as follows:
Operating leases
2023
$ 374,478
2024
389,613
2025
348,837
2026
56,916
2027
-
Total future minimum lease payments, undiscounted
1,169,844
Less: Imputed interest
8,703
Present value of future minimum lease payments
$ 1,161,141
18. COMMITMENTS AND CONTINGENCIES
The Company is party to a lawsuit filed on October
12, 2022, by its former Chief Financial Officer, Chihliang An (“Plaintiff”), in the Superior Court of California In and For
the County of Alameda (Case No. 22cv019544) (the “Employment Action”), which seeks an award of monetary damages, including,
(1) unpaid wages; (2) Company common stock; (3) stock options; (4) penalties pursuant to Labor Code § 203; and any other and further
relief the Court deems necessary. Plaintiff’s Complaint alleges four (4) causes of action against the Company. The Complaint alleges
claims for (1) breach of written contract; (2) breach of oral contract; (3) failure to pay wages; and (4) failure to pay wages upon termination.
The Company filed its Answer to Plaintiff’s Complaint on December 5, 2022. The Company is currently participating in discovery.
However, the Company continues to believe that Plaintiff’s claims have no merit. As such, the Company will continue to vigorously
defend against Plaintiff’s claims in the Employment Action.
19. SUBSEQUENT EVENTS
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 January 14, 2023, BioLite Taiwan extended the
CTBC Loan Agreement with the same principal amount of NT$ 20,000,000 , equivalent to $ 650,000 for six months, which is due on July 14, 2023.
On February 23, 2023, 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 $ 3,704,167 , for a purchase price of $ 3,175,000 , 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 Company also issued Lind a common stock purchase
warrant to purchase up to 5,291,667 shares of the Company’s common stock at an initial exercise price of $ 1.05 per share, subject
to adjustment. Subsequently on February 23, 2023, the bank loan from Cathay Bank was fully repaid.
The Company has assessed all events from December
31, 2022, up through March 31, 2023, which is the date that these consolidated financial statements are available to be issued, Other
than the events disclosed above, no other subsequent events have occurred that would require recognition or disclosure in the Company's
consolidated financial statements.
F- 36
ITEM 9. CHANGES IN AND DISAGREEMENTS WITH
ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
Previous Independent Registered Public Accounting
Firm
On October 18, 2022, the Company’s Audit
Committee accepted and approved the resignation of the Company’s auditor, KCCW Accountancy Corp. (the “Former Auditor”)
as the Company’s independent registered public accounting firm.
The reports of the Former Auditor on the Company’s
consolidated financial statements as of and for the fiscal years ended December 31, 2021 and 2020 did not contain an adverse opinion
or a disclaimer of opinion, and were not qualified or modified as to uncertainty, audit scope or accounting principle.
During fiscal years ended December 31, 2021 and
2020, and the subsequent interim period through October 17, 2022, there were no disagreements as described under Item 304(a)(1)(iv) of
Regulation S-K with Former Auditor on any matter of accounting principles or practices, financial statement disclosure, or auditing scope
or procedure, which disagreements, if not resolved to Former Auditor’s satisfaction, would have caused Former Auditor to make reference
to the subject matter thereof in connection with its reports on the financial statements of the Company for such years. In addition,
during the fiscal years ended December 31, 2021 and 2020, and the subsequent interim period through October 17, 2022, there were no reportable
events as described under Item 304(a)(1)(v) of Regulation S-K.
New Independent Registered Public Accounting
Firm
Effective as of October 18, 2022, the Company
engaged WWC P.C. CPA (“WWC”) as its independent registered public accounting firm for the Company’s fiscal year ended
December 31, 2022. The decision to engage the New Auditor as the Company’s independent registered public accounting firm was approved
by the Audit Committee of the Board of Directors and the Board of Directors of the Company.
During the two fiscal years ended December 31,
2021 and the subsequent interim period through October 17, 2022, neither the Company nor anyone acting on its behalf has consulted with
WWC with respect to (i) the application of accounting principles to a specified transaction, either completed or proposed, or the type
of audit opinion that might be rendered on the Company’s financial statements, and neither a written report nor oral advice was
provided to us by WWC that was an important factor considered by us in reaching a decision as to any accounting, auditing or financial
reporting issue, or (ii) any other matter that was the subject of a disagreement as defined in Item 304(a)(1)(iv) of Regulation S-K and
the related instructions to Item 304 of Regulation S-K or a reportable event as described in Item 304(a)(1)(v) of Regulation S-K.