Item 1. Financial Statements
Item
1. Financial Statements.
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
September 30,
2023
December 31,
2022
(Unaudited)
ASSETS
Current Assets
Cash and cash equivalents
$ 500,069
$ 85,265
Restricted cash
620,868
1,306,463
Accounts receivable, net
1,530
98,325
Accounts receivable – related parties, net
624,373
757,343
Due from related party – current
535,046
513,819
Short-term Investment
68,521
75,797
Prepaid expenses and other current assets
143,127
150,235
Total Current Assets
2,493,534
2,987,247
Property and equipment, net
7,953,936
573,978
Operating lease right-of-use assets
899,817
1,161,141
Long-term investments
2,677,395
842,070
Deferred tax assets
34,256
117,110
Prepaid expenses – non-current
128,898
135,135
Security deposits
44,259
58,838
Prepayment for long-term investments
1,429,016
2,838,578
Due from related parties – non-current
930,396
865,477
Total Assets
$ 16,591,507
$ 9,579,574
LIABILITIES AND EQUITY
Current Liabilities
Short-term bank loans
$ 852,500
$ 1,893,750
Accrued expenses and other current liabilities
3,558,213
2,909,587
Contract liabilities
79,501
10,985
Operating lease liabilities – current portion
392,666
369,314
Due to related parties
480,196
359,992
Total Current Liabilities
5,363,076
5,543,628
Tenant security deposit
5,680
7,980
Operating lease liability – non-current portion
507,151
791,827
Convertible notes payable – third parties
1,654,004
-
Total Liabilities
7,529,911
6,343,435
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, 10,000,000 authorized, 4,823,043 and 3,286,190 shares issued and outstanding as of September 30, 2023 and December 31, 2022, respectively (1)
4,823
3,286
Additional paid-in capital
80,662,290
67,937,050
Stock subscription receivable
( 677,220 )
( 1,354,440 )
Accumulated deficit
( 62,309,161 )
( 54,904,439 )
Accumulated other comprehensive income
519,123
517,128
Treasury stock
( 9,100,000 )
( 9,100,000 )
Total Stockholders’ Equity
9,099,855
3,098,585
Noncontrolling interest
( 38,259 )
137,554
Total Equity
9,061,596
3,236,139
Total Liabilities and Equity
$ 16,591,507
$ 9,579,574
(1) Prior period results have been adjusted to reflect the 1-for-10 reverse stock split effected on July 25, 2023.
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
1
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(UNAUDITED)
Three months Ended
September 30,
Nine months Ended
September 30,
2023
2022
2023
2022
Revenues
$ 15,884
$ 42,269
$ 150,265
$ 380,789
Cost of revenues
29,614
10,741
162,831
21,004
Gross (loss) profit
( 13,730 )
31,528
( 12,566 )
359,785
Operating expenses
Selling, general and administrative expenses
1,182,093
3,216,146
3,841,633
6,000,055
Research and development expenses
141,310
305,483
990,731
1,197,669
Stock-based compensation
817,740
225,740
1,409,969
5,143,483
Total operating expenses
2,141,143
3,747,369
6,242,333
12,341,207
Loss from operations
( 2,154,873 )
( 3,715,841 )
( 6,254,899 )
( 11,981,422 )
Other income (expense)
Interest income
40,246
48,164
147,998
127,354
Interest expense
( 1,218,624 )
( 126,536 )
( 1,390,039 )
( 159,507 )
Operating sublease income
( 3,000 )
21,597
53,900
78,523
Gain/Loss on foreign exchange changes
( 25,059 )
( 177 )
( 55,625 )
17,865
Other (expense) income
( 7,769 )
491
( 1,174 )
( 59,381 )
Total other (expense) income
( 1,214,206 )
( 56,461 )
( 1,244,940 )
4,854
Loss before income tax
( 3,369,079 )
( 3,772,302 )
( 7,499,839 )
( 11,976,568 )
Provision for (benefit from) income tax
( 999 )
4,222
80,696
( 165,096 )
Net loss
( 3,368,080 )
( 3,776,524 )
( 7,580,535 )
( 11,811,472 )
Net loss attributable to noncontrolling interests
( 50,564 )
( 71,660 )
( 175,813 )
( 252,171 )
Net loss attributed to ABVC and subsidiaries
( 3,317,516 )
( 3,704,864 )
( 7,404,722 )
( 11,559,301 )
Foreign currency translation adjustment
( 15,082 )
( 190,019 )
1,995
( 426,579 )
Comprehensive loss
$ ( 3,332,598 )
$ ( 3,894,883 )
$ ( 7,402,727 )
$ ( 11,985,880 )
Net loss per share:
Basic and diluted
$ ( 0.82 )
$ ( 1.14 )
$ ( 2.08 )
$ ( 3.71 )
Weighted average shares used in computing net loss per share of common stock (1) :
Basic and diluted
4,055,345
3,257,912
3,555,474
3,119,795
(1) Prior period results have been adjusted to reflect the 1-for-10 reverse stock split effected on July 25, 2023.
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
2
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(UNAUDITED)
Nine months Ended
September 30,
2023
2022
Cash flows from operating activities
Net loss
$ ( 7,580,535 )
$ ( 11,811,472 )
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation
20,949
17,364
Stock-based compensation for non-employees
1,409,969
5,143,483
Provision for doubtful accounts
38,500
521,955
Other non-cash expenses
1,422,362
30,564
Deferred tax expense
( 35,719 )
( 31,247 )
Changes in operating assets and liabilities:
Decrease (increase) in accounts receivable
191,265
( 31,909 )
Decrease (increase) in prepaid expenses and security deposits
27,924
243,065
Decrease (increase) in tenant security deposit
( 2,300 )
-
Decrease (increase) in due from related parties
189,755
( 983,707 )
Decrease in inventory
-
5,486
Increase (decrease) in accrued expenses and other current liabilities
648,626
( 99,306 )
Increase (decrease) in contract liabilities
68,516
-
Increase (decrease) in due to related parties
( 155,697 )
58,402
Net cash used in operating activities
( 3,756,385 )
( 6,937,322 )
Cash flows from investing activities
Purchase of equipment
( 21,201 )
( 119,603 )
Increase in prepayment for long-term investments
( 493,158 )
( 1,518,793 )
Net cash used in investing activities
( 514,359 )
( 1,638,396 )
Cash flows from financing activities
Issuance of common stock
1,050,000
3,917,425
Proceeds from issuance of warrant
2,429,028
-
Proceeds from convertible notes payable – third parties
1,352,512
-
Proceeds from short-term loan
-
350,000
Repayment of short-term bank loans
( 1,000,000 )
-
Net cash provided by financing activities
3,831,540
4,267,425
Effect of exchange rate changes on cash and cash equivalents and restricted cash
168,413
( 286,775 )
Net decrease in cash and cash equivalents and restricted cash
( 270,791 )
( 4,595,068 )
Cash and cash equivalents and restricted cash
Beginning
1,391,728
6,565,215
Ending
$ 1,120,937
$ 1,970,147
Supplemental disclosure of cash flows
Cash paid during the year for:
Interest expense paid
$ 27,525
$ 161,741
Income taxes paid
$ -
$ 1,600
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
3
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE NINE MONTHS ENDED SEPTEMBER 30, 2023 AND 2022
(UNAUDITED)
Common
Stock
Stock
Additional
Accumulated
Other
Treasury
Stock
Non
Total
Number of
shares (1)
Amounts (1)
Subscription
Receivable
Paid-in
Capital (1)
Accumulated
Deficit
Comprehensive
Income
Number of
Shares (1)
Amount
controlling
Interest
Equity
(Deficit)
Balance
at December 31, 2021
2,893,089
$
2,893
$
( 2,257,400
)
$
58,139,700
$
( 38,481,200
)
$
539,660
( 27,535
)
$
( 9,100,000
)
$
26,689
$
8,870,342
Issuance of common stock
for cash
200,000
200
4,466,125
4,466,325
Issuance
of common stock for consulting service
138,101
138
-
3,663,725
-
-
-
-
-
3,663,863
Stock-based
compensation
-
-
451,480
-
-
-
-
-
-
451,480
Net loss
for the period
-
-
-
-
( 7,854,437
)
-
-
-
( 180,511
)
( 8,034,948
)
Cumulative
transaction adjustments
-
-
-
-
-
( 236,560
)
-
-
-
( 236,560
)
Balance
at June 30, 2022
3,231,190
$
3,231
$
( 1,805,920
)
$
66,269,550
$
( 46,335,637
)
$
303,100
( 27,535
)
$
( 9,100,000
)
$
( 153,822
)
$
9,180,502
Issuance
of common stock for consulting service
32,500
33
-
253,467
-
-
-
-
-
253,500
Stock-based
compensation
-
-
225,740
-
-
-
-
-
-
225,740
Net loss
for the period
-
-
-
-
( 3,704,864
)
-
-
-
( 71,660
)
( 3,776,524
)
Cumulative
transaction adjustments
-
-
-
-
-
( 190,019
)
-
-
-
( 190,019
)
Balance
at September 30, 2022
3,263,690
$
3,264
$
( 1,580,180
)
$
66,523,017
$
( 50,040,501
)
$
113,081
( 27,535
)
$
( 9,100,000
)
$
( 225,482
)
$
5,693,199
Common
Stock
Stock
Additional
Accumulated
Other
Treasury
Stock
Non
Total
Number of
shares (1)
Amounts (1)
Subscription
Receivable
Paid-in
Capital (1)
Accumulated
Deficit
Comprehensive
Income
Number of
Shares (1)
Amount
controlling
Interest
Equity
(Deficit)
Balance
at December 31, 2022
3,286,190
$ 3,286
$ ( 1,354,440 )
$ 67,937,050
$ ( 54,904,439 )
$ 517,128
( 27,535 )
$ ( 9,100,000 )
$ 137,554
$ 3,236,139
Issuance
of common stock for consulting service
22,341
22
-
140,727
-
-
-
-
-
140,749
Issuance of warrant
-
-
-
1,729,028
-
-
-
-
-
1,729,028
Stock-based
compensation
-
-
451,480
-
-
-
-
-
-
451,480
Net
loss for the period
-
-
-
( 4,087,206 )
-
-
-
( 125,249 )
( 4,212,455 )
Cumulative
transaction adjustments
-
-
-
-
-
17,077
-
-
-
17,077
Balance
at June 30, 2023
3,308,531
$ 3,308
$ ( 902,960 )
$ 69,806,805
$ ( 58,991,645 )
$ 534,205
( 27,535 )
$ ( 9,100,000 )
$ 12,305
$ 1,362,018
Issuance
of common stock for cash
300,000
300
-
1,049,700
-
-
-
-
-
1,050,000
Issuance
of common stock for consulting service
29,600
30
-
591,970
-
-
-
-
-
592,000
Issuance
of common stock for acquiring of Property
370,000
370
-
7,399,630
-
-
-
-
-
7,400,000
Issuance
of common stock upon exercise of convertible notes
614,912
615
-
1,814,185
-
-
-
-
-
1,814,800
Issuance
of pre-funded warrant
-
-
-
700,000
-
-
-
-
-
700,000
Exercise
of pre-funded warrant
200,000
200
-
( 700,000 )
-
-
-
-
-
( 699,800 )
Stock-based
compensation
-
-
225,740
-
-
-
-
-
-
225,740
Net
loss for the period
-
-
-
( 3,317,516
)
-
-
-
( 50,564
)
( 3,368,080
)
Cumulative
transaction adjustments
-
-
-
-
-
( 15,082
)
-
-
-
( 15,082
)
Balance
at September 30, 2023
4,823,043
$ 4,823
$ ( 677,220 )
$ 80,662,290
$ ( 62,309,161
)
$ 519,123
( 27,535 )
$ ( 9,100,000 )
$ ( 38,259
)
$ 9,061,596
(1) Prior period results have been adjusted to reflect the 1-for-10 reverse stock split effected on July 25, 2023.
The
accompanying notes are an integral part of these unaudited consolidated financial statements.
4
ABVC
BIOPHARMA, INC. AND SUBSIDIARIES
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
(UNAUDITED)
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.
Going
Concern
The accompanying unaudited 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 unaudited 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 three and nine months ended September 30, 2023, the Company reported net loss of $ 3,368,080 and
$ 7,580,535 , respectively. As of September 30, 2023, the Company’s working capital deficit was $ 2,869,542 . In addition, the Company
had net cash outflows of $ 3,756,385 from operating activities for the nine months ended September 30, 2023. 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 of 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.
5
2.
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Basis
of Presentation
The
unaudited interim consolidated financial statements do not include all the information and footnotes required by the U.S. GAAP for complete
financial statements. Certain information and note disclosures normally included in the annual financial statements prepared in accordance
with the U.S. GAAP have been condensed or omitted consistent with Article 10 of Regulation S-X. In the opinion of the Company’s
management, the unaudited interim consolidated financial statements have been prepared on the same basis as the audited financial statements
and include all adjustments, in normal recurring nature, as necessary for the fair statement of the Company’s financial position
as of September 30, 2023, and results of operations and cash flows for the nine months ended September 30, 2023 and 2022. The unaudited
interim consolidated balance sheet as of December 31, 2022 has been derived from the audited financial statements at that date but does
not include all the information and footnotes required by the U.S. GAAP. Interim results of operations are not necessarily indicative
of the results expected for the full fiscal year or for any future period. These financial statements should be read in conjunction with
the audited consolidated financial statements as of and for the years ended December 31, 2022 and 2021, and related notes included in
the Company’s audited consolidated financial statements.
The
accompanying unaudited 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 unaudited financial statements are expressed in U.S. dollars.
Reclassifications
of Prior Year Presentation
Certain
prior year unaudited consolidated balance sheet and unaudited consolidated cash flow statement amounts have been reclassified for consistency
with the current year presentation. These reclassifications had no effect on the reported results of operations.
Use
of Estimates
The
preparation of financial statements in conformity with accounting principles generally accepted 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 unaudited consolidated financial statements and the amount of revenues and expenses during
the reporting periods. Actual results could differ materially from those results.
6
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.
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.
On
July 25, 2023, the Company filed a Certificate of Amendment to its Articles of Incorporation authorizing a 1-for-10 reverse stock split
of the issued and outstanding shares of its common stock. The Company’s stockholders previously approved the Reverse Stock Split
at the Company’s Special Shareholder Meeting held on July 7, 2023. The Reverse Stock Split was effected to reduce the number of
issued and outstanding shares and to increase the per share trading value of the Company’s common stock, although that outcome
is not guaranteed. In turn, the Company believes that the Reverse Stock Split will enable the Company to restore compliance with certain
continued listing standards of NASDAQ Capital Market. All shares and related financial information in this Form 10-Q reflect this 1-for-10
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, prepaid expenses and other current assets, accounts payable, accrued liabilities, convertible notes payable,
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.
7
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 September
30, 2023 and December 31, 2022, the Company’s cash and cash equivalents amounted $ 500,069 and $ 85,265 , respectively. Some of
the Company’s cash deposits are held in financial institutions located in Taiwan where there is currently regulation mandated on
obligatory insurance of bank accounts. The Company believes this financial institution is of high credit quality.
Restricted
Cash
Restricted cash primarily consist of certificate
of deposits as a collateral of short-term loan held in CTBC Bank. As of September 30, 2023 and December 31, 2022, the Company’s
restricted cash amounted $ 620,868 and $ 1,306,463 , 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.
The
Company performs 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. The Company determines 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 September 30, 2023, the most major client, who specializes in developing and commercializing dietary supplements and therapeutics
in the dietary supplement industry, accounted for 99.76 % of the Company’s total account receivables. As of December 31, 2022,
the most major client, who specializes in developing and commercializing dietary supplements and therapeutics in the dietary supplement
industry, accounted for 71.89 % of the Company’s total account receivable; the second major client, with its Chairman also having
a position as one of the Board of Directors of BioKey, accounted for 16.62 % of the Company’s total account receivable.
For
the nine months ended September 30, 2023, the most major client, manufacturing drugs, dietary supplements, and medical products,
accounted for 81.19 % of the Company’s total revenues. For the nine months ended September 30, 2022, one major client, who
is a Shareholder of the Company that works in development and commercialization of new drugs in Taiwan, accounted for 79.18 % of the Company’s
total revenues.
8
Accounts receivable and allowance for expected credit losses accounts
Accounts
receivable is recorded and carried at the original invoiced amount less an allowance for any potential uncollectible amounts.
The
Company make estimates of expected credit and collectability trends for the allowance for credit losses and allowance for unbilled receivables
based upon our assessment of various factors, including historical experience, the age of the accounts receivable balances, credit quality
of customers, current economic conditions reasonable and supportable forecasts of future economic conditions, and other factors that
may affect our ability to collect from customers. The provision is recorded against accounts receivable balances, with a corresponding
charge recorded in the consolidated statements of income. Actual amounts received may differ from management’s estimate of credit
worthiness and the economic environment. Delinquent account balances are written-off against the allowance for doubtful accounts after
management has determined that the likelihood of collection is not probable.
Allowance for expected credit losses accounts was
113,694 and 194,957 as of September 30, 2023 and December 31, 2022, respectively.
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.
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.
9
(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).
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.
10
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.
The
Company receives payments from its customers based on billing schedules established in each contract. Upfront payments and fees may be
recorded as contract liabilities 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.
11
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
Construction-in-Progress
The Company acquires constructions that constructs
certain of its fixed assets. All direct and indirect costs that are related to the construction of fixed assets and incurred before the
assets are ready for their intended use are capitalized as construction-in-progress. No depreciation is provided in respect of construction-in-progress.
Construction in progress is transferred to specific fixed asset items and depreciation of these assets commences when they are ready for
their intended use.
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.
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.
12
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 impairment of equity investments were $ 0 for the nine months ended September 30, 2023 and 2022, 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.
The
Company completed the required testing of goodwill for impairment as of September 30, 2023, 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.
Convertible
Notes
The
Company accounts for the convertible notes issued at a discount, by comparing the principal amount and book value, with the calculation
of discounted method. The Company assess the discount per month. The amortization period of the promissory note is 18 months.
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.
For
CDMO business unit, 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.
13
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 $ 2,566 and $ 3,302 for the
three months ended September 30, 2023 and 2022, respectively, and $ 7,825 and $ 9,948 for the nine months ended September 30, 2023 and
2022, 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 unaudited 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 $ 0 and $ 0 for the
three and nine months ended September 30, 2023 and 2022, 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 $ 817,740 and $ 225,740 for the three
months ended September 30, 2023 and 2022, respectively. Total non-employee stock-based compensation expenses were $ 1,409,969 and $ 5,143,483
for the nine months ended September 30, 2023 and 2022, respectively.
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 three and nine months ended September 30, 2023 and 2022. GAAP also provides guidance
on de-recognition, classification, interest and penalties, accounting in interim periods, disclosures and transition.
14
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.
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 stock 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 stock that would
have been outstanding if the potential common stock equivalents had been issued and if the additional common stock 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).
15
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 unaudited
consolidated financial statements.
3.
COLLABORATIVE AGREEMENTS
Collaborative
agreements with BHK, a related part y
(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.
16
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 September 30, 2023 and December 31, 2022, the Company has not earned the royalty under the BHK Co-Development Agreement.
(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 $1.64 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 $1.64 million, BioLite Taiwan is entitled to receive 50% of the future
net licensing income or net sales profit. As of September 30, 2023 and December 31, 2022, 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 8). 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 $1.64 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.
17
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.
On
June 10, 2022, the Company expanded its co-development partnership with Rgene. On that date, BioKey, ABVC has entered into a Clinical
Development Service Agreement with Rgene to guide three Rgene drug products, RGC-1501 for the treatment of Non-Small Cell Lung Cancer
(NSCLC), RGC-1502 for the treatment of pancreatic cancer and RGC 1503 for the treatment of colorectal cancer patients, through completion
of Phase II clinical studies under the U.S. FDA IND regulatory requirements. Under the terms of the new Services Agreement, BioKey is
eligible to receive payments totaling $ 3.0 million over a 3 -year period with each payment amount to be determined by certain regulatory
milestones obtained during the agreement period. The Service Agreement shall remain in effect until the expiration date of the last patent
and automatically renew for 5 more years unless terminated earlier by either party with six months written notice. Either party may terminate
the Service Agreement for cause by providing 30 days written notice.
Through a series of transactions over the past
5 years, the Company and Rgene have co-developed the three drug products covered by the Service Agreement, which has resulted in the
Company owning 31.62 % of Rgene.
As part of the Rgene Studies, the Company agreed to loan $ 1.0 million
to Rgene, for which Rgene has provided the Company with a 5 % working capital convertible loan (the “Note”). If the Note is
fully converted, the Company will own an additional 6.4 % of Rgene. The Company is expected to receive the outstanding loan from the related
party by the 2023 Q4, either by cash or conversion of shares 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 Note if not cured after 5 business days of written notice regarding the breach is provided. Upon an event of default, the outstanding
principal and any accrued and unpaid interest shall be immediately due and payable.
The Service Agreement shall remain in effect until the expiration date
of the last patent and automatically renew for 5 more years unless terminated earlier by either party with six months written notice.
Either party may terminate the Service Agreement for cause by providing 30 days written notice.
Rgene has further agreed, effective July 1, 2022, to provide the Company
with a seat on Rgene’s Board of Directors until the loan is repaid in full. The Company has nominated Dr. Jiang, its Chief Strategy
Officer and Director to occupy that seat; Dr. Jiang is also one of the Company’s largest shareholders, owning 12.8 % of the Company.
The Rgene Studies is a related party transaction.
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 8).
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 Corporation. 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 Corporation.
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.
18
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 clinical development was put on hold due to the lack
of funding.
In
addition, BioFirst was incorporated on November 7, 2006, focusing on the R&D, manufacturing, and sales of innovative patented pharmaceutical
products. The technology of BioFirst comes from the global exclusive licensing agreements BioFirst maintains with domestic R & D
institutions. Currently, BioFirst’s 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 centers in Taiwan. Completion
of this factory would allow ABVC to manufacture Vitargus with world-class technology in a GMP certified pharmaceutical factory. BioFirst
is targeting to complete the construction in 2024.
The
above-mentioned equity is before the reverse stock split in 2023.
4. PROPERTY
AND EQUIPMENT
Property
and equipment as of September 30, 2023 and December 31, 2022 are summarized as follows:
September
30,
2023
December 31,
2022
(Unaudited)
Land
$ 344,522
$ 361,193
Construction-in-Progress
7,400,000
-
Buildings and leasehold improvements
2,221,105
2,226,687
Machinery and equipment
1,132,876
1,116,789
Office equipment
166,027
173,766
11,264,530
3,878,435
Less: accumulated
depreciation
( 3,310,594 )
( 3,304,457 )
Property and equipment,
net
$ 7,953,936
$ 573,978
19
Construction-in-progress consists of the property
recently acquired in Chengdu, China. The Company entered into a cooperation agreement on August 14, 2023, with Zhong Hui Lian He Ji Tuan,
Ltd. (the “Zhonghui”). Pursuant thereto, the Company acquired 20 % of the ownership of certain property and a parcel of the
land, with a view to jointly develop the property into a healthcare center for senior living, long-term care, and medical care in the
areas of ABVC’s special interests, such as Ophthalmology, Oncology, and Central Nervous Systems. The plan is to establish a base
for the China market and global development of these interests.
The valuation of such property is US$ 37,000,000 ;
based on the Company’s 20 % ownership, the Company acquired the value of US$ 7,400,000 . In exchange, the Company issued to Zhonghui
an aggregate of 370,000 shares (the “Shares”) of common stock, at a per share price of $ 20.0 . The Shares are subject to a
lock-up period of one year following the closing date of the transaction. In addition, the parties agreed that, after one year following
the closing of the transaction, if the market value of the Shares or the value of the Property increases or decreases, the parties will
negotiate in good faith to make reasonable adjustments.
The asset ownership certification is in the application
process. However, the Company's ownership rights to the property and the associated land parcel, or a suitable replacement property, are
safeguarded under the terms of the cooperation agreement, which is legally binding and enforceable.
The Construction-in-progress is planned to finish
before the end of 2024.
Depreciation
expenses were $ 7,459 and $ 6,462 for three months ended September 30, 2023 and 2022, respectively.
Depreciation
expenses were $ 20,949 and $ 17,364 for nine months ended September 30, 2023 and 2022, respectively.
5. LONG-TERM
INVESTMENTS
(1) The ownership percentages of each investee are listed as follows:
Ownership
percentage
September 30,
December 31,
Accounting
Name
of related party
2023
2022
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
23.53 %
21.77 %
Equity Method
Rgene Corporation
28.85 %
28.85 %
Equity Method
20
(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 investee and provides research and development support service
Rgene Corporation
Collaborating with the Company to develop and commercialize drugs
(3) Long-term investment mainly consists of the following:
September
30,
2023
December 31,
2022
(Unaudited)
Non-marketable Cost Method Investments, net
Braingenesis Biotechnology Co.,
Ltd.
$
6,838
$
7,169
Genepharm Biotech Corporation
20,876
21,887
BioHopeKing Corporation
775,491
813,014
Sub total
803,205
842,070
Equity Method Investments, net
BioFirst Corporation
1,874,190
-
Rgene Corporation
-
-
Total
$
2,677,395
$
842,070
(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 September 30, 2023 and December 31, 2022, the Company owns 23.53 % and 21.77 % common stock shares of BioFirst, respectively.
The Company made a 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. On July 19, 2023, the Company
successfully completed the registration process for this Investment. The initial prepayment amounted to $ 589,620 , transferred into 317,000
shares. In addition, The Company also converted a loan of $ 1,284,570 into 677,450 shares of BioFirst.
Summarized
financial information for the Company’s equity method investee, BioFirst, is as follows:
Balance
Sheet s
September
30,
2023
December 31,
2022
(Unaudited)
Current Assets
$ 1,690,060
$ 1,543,152
Non-current Assets
651,221
739,472
Current Liabilities
2,236,708
2,663,051
Non-current Liabilities
366,634
103,447
Stockholders’ Equity (Deficit)
( 262,061 )
( 483,874 )
21
Statement
of Operations
Nine
months Ended
September 30,
2023
2022
(Unaudited)
Net sales
$
739
$
23,079
Gross profit
291
5,747
Net loss
( 986,181
)
( 993,643
)
Share of losses from investments accounted for using
the equity method
-
-
(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
account 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 September 30, 2023 and December 31, 2022, the Company owns 28.85 % and 28.85 % Common Stock shares of Rgene,
respectively. On March 31, 2023, Dr. Tsung-Shann Jiang has been elected to become the Chairman of Rgene.
Summarized
financial information for the Company’s equity method investee, Rgene, is as follows:
Balance
Sheets
September
30,
2023
December 31,
2022
(Unaudited)
Current Assets
$ 56,091
$ 68,302
Non-current Assets
239,594
303,893
Current Liabilities
2,407,204
2,478,868
Non-current Liabilities
1,465
2,441
Shareholders’ Deficit
( 2,112,984 )
( 2,109,114 )
Statement
of Operations
Nine
months Ended
September 30,
2023
2022
(Unaudited)
Net sales
$ -
$ -
Gross Profit
-
-
Net loss
( 231,445 )
( 450,995 )
Share of loss from investments accounted for
using the equity method
-
-
(4)
Disposition of long-term
investment
During
the nine months ended September 30, 2023 and 2022, there is no disposition of long-term investment.
22
(5)
Losses on Equity Investments
The
components of losses on equity investments for each period were as follows:
Nine months Ended
September 30,
2023
2022
(Unaudited)
Share of equity method investee
losses
$
-
$
-
6.
CONVERTIBLE NOTES PAYABLE
On
February 23, 2023, the Company entered into a securities purchase agreement (the “Lind Securities Purchase Agreement”) with
Lind Global Fund II, LP (“Lind”), pursuant to which the Company issued Lind a secured, convertible note in the principal
amount of $ 3,704,167 (the “Lind Offering”), for a purchase price of $ 3,175,000 (the “Lind Note”), that is convertible
into shares of the Company’s common stock at an initial conversion price of $ 1.05 per share, subject to adjustment (the “Note
Shares”). The Company also issued Lind a common stock purchase warrant (the “Lind 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 (each, a “Warrant
Share,” together with the Note, Note Shares and Warrants, the “Lind Securities”).
Beginning
with the date that is six months from the issuance date of the Lind Note and on each one (1) month anniversary thereafter, the Company
shall pay Lind an amount equal to $ 308,650.58 , until the outstanding principal amount of the Lind Note has been paid in full prior to
or on the Maturity Date or, if earlier, upon acceleration, conversion or redemption of the Lind Note in accordance with the terms thereof
(the “Monthly Payments”). At the Company’s discretion, the Monthly Payments shall be made in (i) cash, (ii) shares
of the Company’s common stock, or (iii) a combination of cash and Shares; if made in shares, the number of shares shall be determined
by dividing (x) the principal amount being paid in shares by (y) 90 % of the average of the 5 lowest daily VWAPs during the 20 trading
days prior to the applicable payment date. The Lind Notes sets forth certain conditions that must be satisfied before the Company may
make any Monthly Payments in shares of common stock. If the Company makes a Monthly Payment in cash, the Company must also pay Lind a
cash premium of 5 % of such Monthly Payment.
Upon
the occurrence of any Event of Default (as defined in the Lind Note), the Company must pay Lind an amount equal to 120 % of the then
outstanding principal amount of the Lind Note (the “Mandatory Default Amount”), in addition to any other remedies under the
Note or the other Transaction Documents. The Company and Lind entered into a letter agreement on September 12, 2023, pursuant to which
the Mandatory Default Amount was reduced to 115 % of the then outstanding principal amount of the Lind Note; pursuant to the letter agreement,
Lind also agreed to waive any default associated with the Company’s market capitalization being below $ 12.5 million for 10 consecutive
days through February 23, 2024, but retained its right to convert its Note. In addition, if the Company is unable to increase its market
capitalization and is unable to obtain a further waiver or amendment to the Lind Note, then the Company could experience an event of
default under the Lind Note, which could have a material adverse effect on the Company’s liquidity, financial condition, and results
of operations. The Company cannot make any assurances regarding the likelihood, certainty, or exact timing of the Company’s ability
to increase its market capitalization, as such metric is not within the immediate control of the Company and depends on a variety of
factors outside the Company’s control.
The
Lind Warrant may be exercised via cashless exercise.
During July 2023, the warrant exercise price was
reset to $ 3.5 in accordance to the issuance of common stock in relation to securities purchase agreement on July 2023.
As of September 30, 2023 and December 31, 2022,
the aggregate carrying values of the convertible debentures were $ 1,654,004 and $ 0 , respectively.
Total interest expenses in connection with the
above convertible note payable were $ 1,323,032 and $ 0 for the nine months ended September 30, 2023 and 2022, respectively.
23
7.
BANK LOANS
(1) Short-term bank loan consists of the following:
September
30,
December 31,
2023
2022
(Unaudited)
Cathay United Bank
$ 232,500
$ 243,750
CTBC Bank
620,000
650,000
Cathay Bank
-
1,000,000
Total
$ 852,500
$ 1,893,750
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 a credit limit amount of NT$ 7,500,000 , equivalent to $ 232,500 . 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. The Company renews the agreement with the bank every year. On September 6, 2022,
BioLite Taiwan extended the Cathay United Loan Agreement with the same principal amount of NT$ 7,500,000 , equivalent to $232,500
for one year, which is due on September 6, 2023. On September 6, 2023, BioLite Taiwan extended the Cathay United Loan Agreement
with the same principal amount of NT$ 7,500,000 , equivalent to $ 232,500 for one year, which is due on September 6, 2024. As of
September 30, 2023 and December 31, 2022, the effective interest rates per annum was 2.85 % and 2.67 %, respectively. The loan is
collateralized by the building and improvement of BioLite Taiwan, and is also personal guaranteed by the Company’s
chairman.
Interest
expenses were $ 1,742 and $ 1,604 for the three months ended September 30, 2023 and 2022, respectively.
Interest
expenses were $ 5,136 and $ 4,401 for the nine months ended September 30, 2023 and 2022, respectively.
CTBC Bank
On
June 12, 2017 and July 19, 2017, BioLite Taiwan and CTBC Bank entered into two short-term saving secured bank loan agreements (the “CTBC
Loan Agreements”) in a credit limit amount of NT$ 10,000,000 , equivalent to $ 310,000 , and NT$ 10,000,000 , equivalent to $ 310,000 ,
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 . The Company renews the agreement with the bank every year. The loan balances
bear interest at a fixed rate of 2.5 % 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, 2020, BioLite
Taiwan has opened a TCD account with CTBC bank to guarantee the loan going forward.
Interest
expenses were $ 3,752 and $ 3,289 for the three months ended September 30, 2023 and 2022, respectively.
Interest
expenses were $ 11,681 and $ 9,002 for the nine months ended September 30, 2023 and 2022, respectively.
24
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 June 30, 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 October 31, 2021,
the Company renewed the Loan Agreement with the principal amount of $ 650,000 for twelve months, which is due on October 30, 2022. 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. As of September 30, 2023 and December 31, 2022, the effective interest rates per annum was 0 % and
8 %, respectively and the outstanding loan balance were $ 0 and $ 1,000,000 .
Interest
expenses were $ 0 and $ 12,446 for the three months ended September 30, 2023 and 2022, respectively.
Interest
expenses were $ 10,209 and $ 28,109 for the nine months ended September 30, 2023 and 2022, respectively.
25
8.
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; the Chairman of Rgene is Mr. Tsung-Shann Jiang
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; the Chairman of 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:
September
30,
December 31,
2023
2022
(Unaudited)
GenePharm Inc.
$ -
$ 142,225
Rgene
624,373
615,118
Total
$ 624,373
$ 757,343
Revenue
- related parties
Revenue
due from related parties consisted of the following as of the periods indicated:
September
30,
September
30,
2023
2022
(Unaudited)
(Unaudited)
Rgene
$ 1,900
$ 307,788
Total
$ 1,900
$ 307,788
26
Due
from related parties
Amount
due from related parties consisted of the following as of the periods indicated:
Due
from related–party - Current
September 30,
December 31,
2023
2022
(Unaudited)
Rgene
$
535,046
$
513,819
Total
$
535,046
$
513,819
Due
from related parties – Non-Current
September 30,
December 31,
2023
2022
(Unaudited)
BioFirst (Australia)
$
822,781
$
752,655
BioHopeKing Corporation
107,615
112,822
Total
$
930,396
$
865,477
(1) On June 16, 2022, the Company entered into a one-year convertible loan 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 September 30, 2023 and December 31, 2022, the outstanding loan balance were both $ 500,000 ; and accrued interest was $ 32,518 as of September 30, 2023; while the accrued interest as of December 31, 2022 was $ 13,819 .
As
of September 30, 2023 and December 31, 2022, the Company has other receivables of $ 2,528 and $ 0 , respectively.
(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 July 27, 2021,
the Company repaid a loan 249,975 to BioFirst (Australia). 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. During the first quarter of 2023, the Company entered into several loan agreements
with BioFirst (Australia) for a total amount of $ 88,091 to increase the cost for upcoming projects. During the second quarter of 2023,
the Company entered into several loan agreements with BioFirst (Australia) for a total amount of $ 25,500 to increase the cost for upcoming
projects. All the loans period was twelve months with an interest rate of 6.5 % per annum. For accounting purpose, the due from and
due to related party balances was being net off. As of September 30, 2023 and December 31, 2022, the outstanding loan balance and allocated
research fee was $ 681,185 and $ 660,484 , respectively; and accrued interest was $ 141,596 and $ 92,171 , respectively. The Company is
expected to receive the outstanding amount in full by 2023 Q4.
(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 September 30, 2023 and December 31, 2022, due from BHK was $ 107,615 and $ 112,822 , respectively. The Company made an impairment to write off the amount due from BHK.
27
Due to
related parties
Amount
due to related parties consisted of the following as of the periods indicated:
September 30,
December 31,
2023
2022
(Unaudited)
BioFirst Corporation
$ 315,947
$ 188,753
The Jiangs
19,789
19,789
Due to shareholders
144,460
151,450
Total
$ 480,196
$ 359,992
(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 September 30, 2023 and December 31, 2022, the aggregate amount of outstanding balance and accrued interest is
$ 315,947 and $ 188,753 , respectively. Interest expenses in connection with these loans were$ 9,327 and $ 0 for the three months ended September
30, 2023 and 2022, respectively.
Interest
expenses in connection with these loans were $ 24,400 and $ 0 for the nine months ended September 30, 2023 and 2022, respectively.
(2) Since 2019, the Jiangs advanced funds to the Company for working capital purpose. As of September 30, 2023, and December 31, 2022, the outstanding balance due to the Jiangs amounted to $ 19,789 and $ 19,789 , respectively. These loans bear interest rate of 0 % to 1 % per month, and are due on demand.
Interest expenses in connection with these advanced funds were$ 499
and $ 0 for the nine months ended September 30, 2023 and 2022, respectively.
(3) Since 2018, the Company’s shareholders have advanced funds to the Company for working capital purpose. The advances bear interest rate of 12% per annum. As of September 30, 2023 and December 31, 2022, the outstanding principal and accrued interest was $ 144,460 and $ 151,450 , respectively. Interest expenses in connection with these loans were $ 5,015 and $ 5,208 for the three months ended September 30, 2023 and 2022, respectively. Interest expenses in connection with these loans were $ 15,082 and $ 15,922 for the nine months ended September 30, 2023 and 2022, respectively.
9. INCOME
TAXES
Income
tax expense for the nine-month period ended September 30, 2023 and 2022 consisted of the following:
Nine months Ended
September 30,
2023
2022
(Unaudited)
Current:
Federal
$ -
$ -
State
-
1,600
Foreign
-
-
Total Current
$ -
$ 1,600
Deferred:
Federal
$ -
$ -
State
-
-
Foreign
80,696
( 166,696 )
Total Deferred
$ 80,696
$ ( 166,696 )
Total provision for (benefit from) income taxes
$ 80,696
$ ( 165,096 )
Deferred
tax assets (liability) as of September 30, 2023 and December 31, 2022 consist approximately of:
September 30,
2023
December 31,
2022
(Unaudited)
Loss on impairment of Assets
679,428
709,961
Net operating loss carryforwards
5,713,161
5,866,623
Operating lease liabilities
213,482
213,482
Operating lease assets
( 213,482 )
( 213,482 )
Deferred tax assets, Gross
6,392,589
6,576,584
Valuation allowance
( 6,358,333 )
( 6,459,474 )
Deferred tax assets, net
$ 34,256
$ 117,110
28
10. EQUITY
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 stock, 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 stock 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 September 30, 2023, 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 stock to Euro-Asia Investment & Finance Corp
Ltd. and Thalia Media Ltd. for consulting and advisory services.
On
January 3, 2023, the Company issued 223,411 common stock to a consultant for providing consulting services on listing to NASDAQ
in 2021.
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. During the period ended September 30, 2023, the Company has been repaying Lind with securities for 614,912
shares, totaling $ 1,814,800 . During July 2023, the warrant exercise price was reset to $ 3.5 in accordance to the issuance of common
stock in relation to securities purchase agreement on July 2023. As of September 30, 2023, the warrant has not yet been exercised.
On July 27, 2023, the Company entered into that
certain securities purchase agreement. relating to the offer and sale of 300,000 shares of common stock, par value $ 0.001 per share and
200,000 pre-funded warrants, at an exercise price of $ 0.001 per share, in a registered direct offering. Pursuant to the Purchase Agreement,
the Company agreed to sell the Shares and/or Pre-funded Warrants at a per share purchase price of $ 3.50 , for gross proceeds of $ 1,750,000 ,
before deducting any estimated offering expenses. On August 1, 2023, the pre-funded warrants were exercised.
On August 14, 2023, the Company entered into a cooperation agreement
with Zhonghui. Pursuant thereto, the Company acquired 20 % of the ownership of a property and the parcel of the land owned by Zhonghui
in Leshan, Sichuan, China. During the third quarter of 2023, the Company issued to Zhonghui, an aggregate of 370,000 shares of the Company’s
common stock, at a per share price of $ 20 .
The
above-mentioned equity is before the reverse stock split in 2023.
11. 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 September 30, 2023, these stock options have not been granted.
Options
issued and outstanding as of December 31, 2022, and their activities during the year then ended are as follows:
Number
of
Underlying
Shares
Weighted-
Average
Exercise
Price
Per Share
Weighted-
Average
Contractual
Life
Remaining
in Years
Aggregate
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
$ -
29
The
fair value of stock options granted for the year ended December 31, 2022 was calculated using the Black-Scholes option-pricing model
applying the following assumptions:
Year ended
December 31,
2022
Risk free interest rate
2.79 %
Expected term (in years)
5.00
Dividend yield
0 %
Expected volatility
83.86 %
The
weighted average grant date fair value of options granted during the years ended December 31, 2022 was $ 2.79 . 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 $ 0 and $ 0 for the nine months ended September 30, 2023 and 2022, respectively. There were no options
exercised during the nine months ended September 30, 2023. As of September 30, 2023, there were no unvested options.
The
above-mentioned equity is before the reverse stock split in 2023.
12. LOSS
PER SHARE
Basic
loss per share is computed by dividing net loss by the weighted-average number of common stock outstanding during the year. Diluted loss
per share is computed by dividing net loss by the weighted-average number of common stock and dilutive potential common stock outstanding
during the three and nine months ended September 30, 2023 and 2022.
For the Three Months Ended
September 30,
2023
September 30,
2022
(Unaudited)
Numerator:
Net loss attributable to ABVC’s common stockholders
$ ( 3,317,516 )
$ ( 3,704,864 )
Denominator:
Weighted-average shares outstanding:
Weighted-average shares outstanding - Basic
4,055,345
3,257,912
Stock options
–
–
Weighted-average shares outstanding - Diluted
4,055,345
3,257,912
Loss per share
-Basic
$ ( 0.82 )
$ ( 1.14 )
-Diluted
$ ( 0.82 )
$ ( 1.14 )
For the Nine Months Ended
September 30,
2023
September 30,
2022
(Unaudited)
Numerator:
Net loss attributable to ABVC’s common stockholders
$ ( 7,404,722 )
$ ( 11,559,301 )
Denominator:
Weighted-average shares outstanding:
Weighted-average shares outstanding - Basic
3,555,474
3,119,795
Stock options
–
–
Weighted-average shares outstanding - Diluted
3,555,474
3,119,795
Loss per share
-Basic
$ ( 2.08 )
$ ( 3.71 )
-Diluted
$ ( 2.08 )
$ ( 3.71 )
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.
30
13.
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.
September
30,
2023
December 31,
2022
ASSETS
(Unaudited)
Operating lease right-of-use assets
$ 899,817
$ 1,161,141
LIABILITIES
Operating lease liabilities (current)
392,666
369,314
Operating lease liabilities (non-current)
507,151
791,827
Supplemental
Information
The
following provides details of the Company’s lease expenses:
Three Months Ended
September 30,
2023
2022
(Unaudited)
Operating lease expenses
$ 96,875
$ 87,367
Nine Months Ended
September 30,
2023
2022
(Unaudited)
Operating lease expenses
$ 288,751
$ 261,494
31
Other
information related to leases is presented below:
Nine
months Ended
September 30,
2023
2022
(Unaudited)
Cash paid for amounts included
in the measurement of operating lease liabilities
$ 288,751
$ 261,494
September
30,
2023
December 31,
2022
Weighted Average Remaining Lease Term:
Operating leases
2.04 years
2.48 years
Weighted Average Discount Rate:
Operating leases
1.53 %
1.49 %
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 (excluding nine months ended
September 30, 2023)
$ 96,585
2024
400,432
2025
350,693
2026
56,916
Thereafter
-
Total future minimum lease payments, undiscounted
904,626
Less: Imputed interest
( 4,809 )
Present value of future
minimum lease payments
$ 899,817
14.
SUBSEQUENT EVENTS
During the period from Oct 1, 2023 until the
date of this report, the Company has been repaying Lind, pursuant to the securities purchase agreement executed on February 23, 2023,
with securities for 2,329,495 shares, totaling an amount of $ 1,572,600 .
In November 2023, the Company and one of its
subsidiaries, BioLite, Inc. (“BioLite”) each entered into a multi-year, global licensing agreement with AIBL for the
Company and BioLite’s CNS drugs with the indications of MDD (Major Depressive Disorder) and ADHD (Attention Deficit
Hyperactivity Disorder) (the “Licensed Products”). The potential license will cover the Licensed Products’
clinical trial, registration, manufacturing, supply, and distribution rights. The Licensed Products for MDD and ADHD, owned by ABVC
and BioLite, were valued at $667M by a third-party evaluation. The parties are determined to collaborate on the global development
of the Licensed Products. The parties are also working to strengthen new drug development and business collaboration, including
technology, interoperability, and standards development. As per each of the respective agreements, each of ABVC and BioLite shall
receive 23 million shares of AIBL stock at $10 per share, and if certain milestones are met, $3,500,000 and royalties equaling 5% of
net sales, up to $100 million.
The Company has evaluated subsequent events and transactions
that occurred after September 30, 2023 up through the date the Company issued these unaudited consolidated financial statements on November
15, 2023. All subsequent events requiring recognition as of September 30, 2023 have been incorporated into these unaudited consolidated
financial statements and there are no other subsequent events that require disclosure in accordance with FASB ASC Topic 855, “Subsequent
Events.”
32
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.