QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934.
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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(State or other jurisdiction of incorporation)
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(IRS Employer Identification Number)
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Large accelerated filer ☐
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Non-accelerated filer ☐
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Smaller reporting company
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Emerging growth company
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Title of each class
|
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Trading Symbol
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Name of each exchange on which registered
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Page
|
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Part I. FINANCIAL INFORMATION:
|
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Item 1. Financial Statements:
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4
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5
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6 |
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7 |
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9 |
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10 |
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27 | ||
36
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Part II. OTHER INFORMATION:
|
||
36 | ||
36 | ||
43 | ||
44 |
Item 1.
|
FINANCIAL STATEMENTS
|
(Unaudited)
March 31,
2022 |
December 31,
2021
|
|||||||
- ASSETS -
|
||||||||
CURRENT ASSETS:
|
||||||||
Cash and cash equivalents
|
$
|
|
$
|
|
||||
Accounts receivable, net of allowance for doubtful accounts of $
|
|
|
||||||
Inventories, net
|
|
|
||||||
Prepaid expenses and other current assets
|
|
|
||||||
TOTAL CURRENT ASSETS
|
|
|
||||||
FIXED ASSETS:
|
||||||||
Property, plant and equipment, net
|
|
|
||||||
Finance lease right-of-use asset, net
|
|
|
||||||
OTHER ASSETS:
|
||||||||
Operating lease right-of-use assets, net
|
|
|
||||||
Goodwill
|
|
|
||||||
Deposits and other assets
|
|
|
||||||
TOTAL ASSETS
|
$
|
|
$
|
|
||||
- LIABILITIES AND STOCKHOLDERS’ EQUITY -
|
||||||||
CURRENT LIABILITIES:
|
||||||||
Accounts payable and accrued liabilities
|
$
|
|
$
|
|
||||
Current portion of long-term debt
|
|
|
||||||
Operating lease liabilities
|
|
|
||||||
Finance lease liabilities
|
|
|
||||||
TOTAL CURRENT LIABILITIES
|
|
|
||||||
OTHER LIABILITIES:
|
||||||||
Long-term operating lease liabilities
|
|
|
||||||
Long-term finance lease liabilities
|
|
|
||||||
Long-term debt, net
|
|
|
||||||
TOTAL LIABILITIES
|
|
|
||||||
COMMITMENTS AND CONTINGENCIES
|
||||||||
STOCKHOLDERS’ EQUITY:
|
||||||||
Preferred stock -
|
|
|
||||||
Common stock - $
|
|
|
||||||
Additional paid-in capital
|
|
|
||||||
Accumulated deficit
|
(
|
)
|
(
|
)
|
||||
Treasury Stock,
|
(
|
)
|
(
|
)
|
||||
Accumulated other comprehensive (loss)
|
(
|
)
|
(
|
)
|
||||
TOTAL STOCKHOLDERS’ EQUITY
|
|
|
||||||
TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY
|
$
|
|
$
|
|
For the three months
ended March 31, |
||||||||
2022
|
2021
|
|||||||
REVENUES:
|
||||||||
Product revenue
|
$
|
|
$
|
|
||||
R&D revenue
|
|
|
||||||
Government grant income
|
|
|
||||||
License and royalty revenue
|
|
|
||||||
TOTAL REVENUES
|
|
|
||||||
COSTS AND EXPENSES:
|
||||||||
Cost of product revenue
|
|
|
||||||
Research and development expenses
|
|
|
||||||
Selling, general and administrative expenses
|
|
|
||||||
Impairment, restructuring, severance and related costs
|
|
|
||||||
TOTAL COSTS AND EXPENSES
|
|
|
||||||
LOSS FROM OPERATIONS
|
(
|
)
|
(
|
)
|
||||
OTHER EXPENSE:
|
||||||||
Interest expense, net
|
(
|
)
|
(
|
)
|
||||
LOSS BEFORE INCOME TAXES
|
(
|
)
|
(
|
)
|
||||
Income tax (expense)/benefit
|
(
|
)
|
|
|||||
NET LOSS
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Basic and diluted loss per share
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Weighted average number of shares outstanding, basic and diluted
|
|
|
|
For the three months
ended March 31,
|
|||||||
|
2022
|
2021
|
||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Other comprehensive income (loss):
|
||||||||
Foreign currency translation adjustments, net of tax
|
|
(
|
)
|
|||||
Comprehensive loss
|
$
|
(
|
)
|
$
|
(
|
)
|
For the three months ended
March 31, 2022
|
||||||||||||||||||||||||||||||||
Common Stock
|
Additional
Paid-in-
Capital
|
Treasury
Stock
|
Accumulated
Deficit
|
AOCI
|
Total
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
Balance at December 31, 2021
|
|
$
|
|
$
|
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||
Common Stock:
|
||||||||||||||||||||||||||||||||
Restricted stock issued
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Restricted stock compensation, net
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Shares tendered for withholding taxes
|
|
|
(
|
)
|
|
|
|
|
(
|
)
|
||||||||||||||||||||||
Options:
|
||||||||||||||||||||||||||||||||
Stock option compensation
|
-
|
|
|
-
|
|
|
|
|
||||||||||||||||||||||||
Comprehensive income
|
-
|
|
|
-
|
|
|
|
|
||||||||||||||||||||||||
Net loss
|
-
|
|
|
-
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||||||||
Balance at March 31, 2022
|
|
$
|
|
$
|
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
For the three months ended March 31, 2021
|
||||||||||||||||||||||||||||||||
Common Stock
|
Additional
Paid-in-Capital
|
Treasury
Stock
|
Accumulated
Deficit
|
AOCI
|
Total
|
|||||||||||||||||||||||||||
Shares
|
Amount
|
Shares
|
Amount
|
|||||||||||||||||||||||||||||
Balance at December 31, 2020
|
|
$
|
|
$
|
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
||||||||||||||
Common Stock:
|
||||||||||||||||||||||||||||||||
Restricted stock issued
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Restricted stock compensation, net
|
|
|
|
|
|
|
|
|
||||||||||||||||||||||||
Shares tendered for withholding taxes
|
|
|
(
|
)
|
|
|
|
|
(
|
)
|
||||||||||||||||||||||
Options:
|
||||||||||||||||||||||||||||||||
Stock option compensation
|
-
|
|
|
-
|
|
|
|
|
||||||||||||||||||||||||
Comprehensive loss
|
-
|
|
|
-
|
|
|
(
|
)
|
(
|
)
|
||||||||||||||||||||||
Net loss
|
-
|
|
|
-
|
|
(
|
)
|
|
(
|
)
|
||||||||||||||||||||||
Balance at March 31, 2021
|
|
$
|
|
$
|
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
(
|
)
|
$
|
|
March 31,
2022
|
March 31,
2021
|
|||||||
CASH FLOWS FROM OPERATING ACTIVITIES:
|
||||||||
Cash received from customers and grants
|
$
|
|
$
|
|
||||
Cash paid to suppliers and employees
|
(
|
)
|
(
|
)
|
||||
Cash paid for operating leases
|
(
|
)
|
(
|
)
|
||||
Cash paid for finance leases
|
(
|
)
|
(
|
)
|
||||
Interest and taxes, net
|
(
|
)
|
(
|
)
|
||||
Net cash used in operating activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS FROM INVESTING ACTIVITIES:
|
||||||||
Patent application costs
|
|
(
|
)
|
|||||
Acquisition of and deposits on fixed assets
|
(
|
)
|
(
|
)
|
||||
Net cash used in investing activities
|
(
|
)
|
(
|
)
|
||||
CASH FLOWS FROM FINANCING ACTIVITIES:
|
||||||||
Payments of tax withholding on stock award
|
(
|
)
|
(
|
)
|
||||
Payments on finance lease
|
(
|
)
|
(
|
)
|
||||
Net cash used in financing activities
|
(
|
)
|
(
|
)
|
||||
Effect of exchange rate changes on cash
|
|
(
|
)
|
|||||
DECREASE IN CASH AND CASH EQUIVALENTS
|
(
|
)
|
(
|
)
|
||||
Cash and cash equivalents - beginning of the period
|
|
|
||||||
Cash and cash equivalents - end of the period
|
$
|
|
$
|
|
||||
RECONCILIATION OF NET LOSS TO NET CASH USED IN OPERATING ACTIVITIES:
|
||||||||
Net loss
|
$
|
(
|
)
|
$
|
(
|
)
|
||
Adjustments:
|
||||||||
Depreciation and amortization
|
|
|
||||||
Share based compensation
|
|
|
||||||
Benefit from deferred tax liability
|
|
(
|
)
|
|||||
Provision of (recovery of) doubtful accounts
|
(
|
)
|
|
|||||
Impairment
|
|
|
||||||
Changes in assets and liabilities:
|
||||||||
Accounts receivable
|
|
|
||||||
Inventories
|
|
(
|
)
|
|||||
Prepaid expenses and other current assets
|
(
|
)
|
(
|
)
|
||||
Deposits and other assets
|
|
|
||||||
Accounts payable and accrued liabilities
|
(
|
)
|
(
|
)
|
||||
Deferred revenue
|
|
(
|
)
|
|||||
Net cash used in operating activities
|
$
|
(
|
)
|
$
|
(
|
)
|
•
|
Enhanced sensitivity and specificity: This is achieved via the Company’s proprietary approach to separating the sample path from the
buffer path, together with patent and other proprietary strategies, which differ significantly from traditional lateral flow test.
|
•
|
Advanced multiplexing capabilities: Through advanced multiplexing, the DPP platform can detect and differentiate up to eight distinct
test results from a single patient sample, which can deliver greater clinical value than other rapid tests currently on the market.
|
•
|
Objective results: For some diagnostic applications, the Company’s easy-to-use, highly portable, battery-operated DPP Micro Reader
optical analyzers can report accurate results in approximately 15 seconds, making it well-suited for decentralized testing where real-time results enable patients to be clinically assessed while they are still onsite. Objective results
produced by the DPP Micro Reader can reduce the possibility of the types of human error that can be experienced in the visual interpretations required by many rapid tests.
|
•
|
an emergency use authorization (“EUA”), from the U.S.
Food and Drug Administration (the “FDA”), as well as 510(k) clearance from the FDA, for the DPP SARS-CoV-2 Antigen test system;
|
•
|
an EUA from the FDA for the DPP Respiratory Antigen
Panel; and
|
•
|
a Clinical Laboratory Improvement Amendment (“CLIA”),
waiver from the FDA for the DPP HIV-Syphilis test system.
|
(a) |
Basis of presentation:
|
•
|
Focus on higher margin business in growth markets
|
•
|
Lower manufacturing costs
|
•
|
Reduce infrastructure costs
|
•
|
Strategic review of non-core businesses and assets:
|
•
|
The ongoing healthcare and economic impacts of COVID-19 on the global customer base for the Company’s non‑COVID-19 products continue to negatively affect the timing and rate of recovery of the Company’s revenues from those products by,
for example, decreasing the allocation of funding for HIV testing, thereby continuing to adversely affect the Company’s liquidity.
|
•
|
Although the Company has entered into agreements to distribute third-party COVID-19 products in the United States, its ability to sell those products could be
constrained because of staffing and supply chain limitations affecting the suppliers of those products.
|
(b) |
Significant Accounting Policies:
|
(c) |
Fair Value of Financial Instruments:
|
Level 1: |
Unadjusted quoted prices in active markets that are accessible at the measurement date for
identical, unrestricted assets or liabilities;
|
Level 2: |
Quoted prices in markets that are not active, or inputs which are observable, either directly or
indirectly, for substantially the full term of the asset or liability; and,
|
Level 3: |
Prices or valuation techniques that require inputs that are both significant to the fair value
measurement and unobservable (i.e., supported by little or no market activity).
|
(d) |
Cash and Cash Equivalents:
|
(e) |
Loss Per Share:
|
(f) |
Income Taxes:
|
(g) |
Recently Issued
Accounting Standards Affecting the Company:
|
March 31, 2022
|
March 31, 2021
|
|||||||||||||||||||||||
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
Exchange
Transactions
|
Non-Exchange
Transactions
|
Total
|
|||||||||||||||||||
Net product revenue
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||||||
R&D Revenue
|
|
|
|
|
|
|
||||||||||||||||||
Government grant revenue
|
|
|
|
|
|
|
||||||||||||||||||
License and royalty revenue
|
|
|
|
|
|
|
||||||||||||||||||
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
$
|
|
For the three months ended
|
||||||||
March 31, 2022
|
March 31, 2021
|
|||||||
Africa
|
$
|
|
$
|
|
||||
Asia
|
|
|
||||||
Europe & Middle East
|
|
|
||||||
Latin America
|
|
|
||||||
United States
|
|
|
||||||
$
|
|
$
|
|
March 31,
2022 |
December 31,
2021
|
|||||||
Raw materials
|
$
|
|
$
|
|
||||
Work in process
|
|
|
||||||
Finished goods
|
|
|
||||||
$
|
|
$
|
|
(a) |
Common Stock
|
(b) |
Preferred Stock
|
(c) |
Treasury Stock
|
(d) |
Options, Restricted Stock, and Restricted Stock Units
|
a) |
Concentrations:
|
For the three months ended
|
Accounts Receivable as of
|
|||||||||||||||||||||||
March 31, 2022
|
March 31, 2021
|
March 31,
2022
|
December
31, 2021
|
|||||||||||||||||||||
Product
Sales
|
% of
Product
Sales
|
Product
Sales
|
% of
Product
Sales
|
|||||||||||||||||||||
Customer 1
|
$ | % |
$
|
|
$ |
$
|
|
For the three months ended
|
Accounts Payable as of
|
|||||||||||||||||||||||
March 31, 2022
|
March 31, 2021
|
March 31,
2022
|
December
31, 2021
|
|||||||||||||||||||||
Purchases
|
% of
Purchases
|
Purchases
|
% of
Purchases
|
|||||||||||||||||||||
Vendor 1
|
$
|
|
|
%
|
$
|
|
|
$
|
|
$ | ||||||||||||||
Vendor 2
|
|
|
%
|
|
|
%
|
|
|
b) |
Employment Contracts:
|
2022
|
$
|
|
||
2023
|
|
|||
2024
|
c) |
Benefit Plan:
|
d) |
Leases:
|
Three Months Ended
March 31
|
||||||||
2022
|
2021
|
|||||||
Operating lease expense
|
$
|
|
$
|
|
||||
Finance lease cost
|
||||||||
Amortization of right-of-use assets
|
$
|
|
$
|
|
||||
Interest on lease liabilities
|
|
|
||||||
Total finance lease expense
|
$
|
|
$
|
|
|
Three Months Ended
March 31
|
|||||||
|
2022
|
2021
|
||||||
Cash paid for amounts included in the measurement of lease liabilities:
|
||||||||
Operating cash flows for operating leases
|
$
|
|
$
|
|
||||
Operating cash flows for finance leases
|
|
|
||||||
Financing cash flows for finance leases
|
|
|
||||||
Right-of-use assets obtained in exchange for lease obligations:
|
||||||||
Finance leases
|
|
|
|
March 31, 2022
|
March 31, 2021
|
||||||
Finance Leases
|
||||||||
Finance lease right of use asset
|
$
|
|
$
|
|
||||
Accumulated depreciation
|
(
|
)
|
(
|
)
|
||||
Finance lease right of use asset, net
|
$
|
|
$
|
|
||||
|
||||||||
Weighted Average Remaining Lease Term
|
||||||||
Operating leases
|
|
|
||||||
Finance leases
|
|
|
||||||
|
||||||||
Weighted Average Discount Rate
|
||||||||
Operating leases
|
|
%
|
|
%
|
||||
Finance leases
|
|
%
|
|
%
|
|
March 31, 2022
|
March 31, 2021
|
||||||||||||||
|
Operating
Leases
|
Finance
Leases
|
Operating
Leases
|
Finance
Leases
|
||||||||||||
2022
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
2023
|
|
|
|
|
||||||||||||
2024
|
|
|
|
|
||||||||||||
2025
|
|
|
|
|
||||||||||||
2026
|
|
|
|
|
||||||||||||
Thereafter
|
|
|
|
|
||||||||||||
Total lease payments
|
$
|
|
$
|
|
$
|
|
$
|
|
||||||||
Less: imputed interest
|
|
|
|
|
||||||||||||
Total
|
$
|
|
$
|
|
$
|
|
$
|
|
e) |
Litigation:
|
•
|
Sergey Chernysh v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 18, 2020;
|
•
|
James Gowen v. Chembio Diagnostics, Inc., Richard L. Eberly, and Gail S. Page, filed on June 22, 2020;
|
•
|
Anthony Bailey v. Chembio Diagnostics, Inc. Richard J. Eberly, Gail S. Page, and Neil A. Goldman, filed on July 3, 2020; and;
|
•
|
Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P., and Special Situations Private Equity Fund, L.P. v. Chembio Diagnostics, Inc.,
Richard Eberly, Gail S. Page, Robert W. Baird & Co. Inc. and Dougherty & Company LLC, filed August 17, 2020.
|
(a) |
Equity Plans:
|
(b) |
Stock Compensation Expense:
|
|
For the three months
ended March 31
|
|||||||
|
2022
|
2021
|
||||||
Cost of product sales
|
$
|
|
$
|
|
||||
Research and development expenses
|
|
|
||||||
Selling, general and administrative expenses
|
|
|
||||||
|
$
|
|
$
|
|
For the three
months ended
March 31,
2021
|
||||
Expected term (in years)
|
|
|||
Expected volatility
|
|
%
|
||
Expected dividend yield
|
|
|||
Risk-free interest rate
|
|
%
|
Stock Options
|
Number
of Shares
|
Weighted
Average
Exercise Price
per Share
|
Weighted
Average
Remaining
Contract Term
|
Aggregate
Intrinsic
Value
|
||||||
Outstanding at December 31, 2021
|
|
$
|
|
|
$
|
|
||||
Granted
|
|
|
|
|||||||
Exercised
|
|
|
|
|||||||
Forfeited
|
|
|
|
|||||||
Expired
|
|
|
||||||||
Outstanding at March 31, 2022
|
|
$
|
|
|
$
|
|
||||
Exercisable at March 31, 2022
|
|
$
|
|
|
$
|
|
Stock Options Outstanding
|
Stock Options Exercisable
|
|||||||||||||||||||||||||||
Range of
Exercise Prices
|
Number
of Shares
|
Average
Remaining
Contract Term
(Year)
|
Weighted
Average
Exercise
Price
|
Aggregate
Intrinsic
Value
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
Aggregate
Intrinsic
Value
|
|||||||||||||||||||||
_
|
|
|
$
|
|
$
|
|
|
$
|
|
$
|
|
|||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||
|
|
|
|
|
|
|
|
|||||||||||||||||||||
Total
|
|
|
$
|
|
$
|
|
|
$
|
|
$
|
|
|
Number of
Shares & Units
|
Weighted
Average
Grant Date
Fair Value
|
||||||
Outstanding at December 31, 2021
|
|
$
|
|
|||||
Granted
|
|
|
||||||
Vested
|
|
|
||||||
Forfeited
|
|
|
||||||
Outstanding at March 31, 2022
|
|
$
|
|
For the three months ended
March 31
|
||||||||
2022
|
2021
|
|||||||
Africa
|
$
|
|
$
|
|
||||
Asia
|
|
|
||||||
Europe & Middle East
|
|
|
||||||
Latin America
|
|
|
||||||
United States
|
|
|
||||||
$
|
|
$
|
|
March 31, 2022
|
December 31, 2021
|
|||||||
Asia
|
$
|
|
$
|
|
||||
Europe & Middle East
|
|
|
||||||
Latin America
|
|
|
||||||
United States
|
|
|
||||||
$
|
|
$
|
|
March 31, 2022
|
December 31, 2021
|
|||||||
Accounts payable – suppliers
|
$
|
|
$
|
|
||||
Accrued commissions and royalties
|
|
|
||||||
Accrued payroll
|
|
|
||||||
Accrued vacation
|
|
|
||||||
Accrued bonuses
|
|
|
||||||
Accrued professional fees
|
|
|
||||||
Accrued expenses – other
|
|
|
||||||
TOTAL
|
$
|
|
$
|
|
Beginning balance at December 31, 2021
|
$
|
|
||
Impairment |
( |
) | ||
Change in foreign currency exchange rate
|
|
|||
Balance at March 31,
2022
|
$
|
|
ITEM 2. |
MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
|
•
|
an emergency use authorization, or EUA, from the U.S. Food and Drug Administration, or FDA, as well as 510(k) clearance from the FDA, for the DPP SARS-CoV-2 Antigen test
system;
|
•
|
an EUA from the FDA for the DPP Respiratory Panel; and
|
•
|
a Clinical Laboratory Improvement Amendment, or CLIA, waiver from the FDA for the DPP HIV-Syphilis test system.
|
•
|
Focus on higher margin business in growth markets
|
•
|
Lower manufacturing costs
|
•
|
Reduce infrastructure costs
|
•
|
Strategic review of non-core businesses and assets:
|
•
|
The ongoing healthcare and economic impacts of COVID-19 on the global customer base for our non‑COVID-19 products continue to negatively affect the timing and rate of recovery of our revenues from those products by, for example,
decreasing the allocation of funding for HIV testing, thereby continuing to adversely affect our liquidity.
|
•
|
Although we entered into agreements to distribute third-party COVID-19 products in the United States, our ability to sell those products could be constrained because of
staffing and supply chain limitations affecting the suppliers of those products
|
March 31, 2022
|
March 31, 2021
|
|||||||||||||||
TOTAL REVENUES
|
$
|
18,817
|
100
|
%
|
$
|
8,724
|
100
|
%
|
||||||||
OPERATING COSTS AND EXPENSES:
|
||||||||||||||||
Cost of product sales
|
15,224
|
81
|
%
|
3,548
|
41
|
%
|
||||||||||
Research and development expenses
|
1,654
|
9
|
%
|
2,863
|
33
|
%
|
||||||||||
Selling, general and administrative expenses
|
6,946
|
37
|
%
|
6,086
|
70
|
%
|
||||||||||
Severance and other related costs
|
3,043
|
16
|
%
|
83
|
1
|
%
|
||||||||||
TOTAL OPERATING COSTS AND EXPENSES
|
26,867
|
12,580
|
||||||||||||||
LOSS FROM OPERATIONS
|
(8,050
|
)
|
(3,856
|
)
|
||||||||||||
OTHER (EXPENSE) INCOME, NET
|
(734
|
)
|
(712
|
)
|
||||||||||||
LOSS BEFORE INCOME TAXES
|
(8,784
|
)
|
(47
|
)%
|
(4,568
|
)
|
(52
|
)%
|
||||||||
Income tax (expense) benefit
|
(6
|
)
|
68
|
|||||||||||||
NET LOSS
|
$
|
(8,790
|
)
|
$
|
(4,500
|
)
|
For the three months
ended March 31
|
Favorable/(unfavorable)
|
|||||||||||||||
2022
|
2021
|
$ Change
|
% Change
|
|||||||||||||
Net product sales
|
$
|
18,527
|
$
|
4,025
|
$
|
14,502
|
360
|
%
|
||||||||
Less: Cost of product sales
|
(15,224
|
)
|
(3,548
|
)
|
(11,676
|
)
|
329
|
%
|
||||||||
Gross product margin
|
$
|
3,303
|
$
|
477
|
$
|
2,826
|
592
|
%
|
||||||||
Gross product margin percentage
|
18
|
%
|
12
|
%
|
For the three months
ended March 31
|
Favorable/(unfavorable)
|
|||||||||||||||
2022
|
2021
|
$ Change
|
% Change
|
|||||||||||||
Clinical and regulatory affairs
|
$
|
295
|
$
|
765
|
$
|
(470
|
)
|
$
|
(61
|
)%
|
||||||
Other research and development
|
1,359
|
2,098
|
(739
|
)
|
(35
|
)%
|
||||||||||
Total research and development
|
$
|
1,654
|
$
|
2,863
|
$
|
(1,209
|
)
|
(42
|
)%
|
•
|
Principal Amount. The Credit Agreement provides for a $20,000,000 senior secured term loan credit facility, which was drawn in full on September 4, 2019. Under the terms of
the Credit Agreement, we may use the proceeds (i) for general working capital purposes and other permitted corporate purposes, (ii) to refinance certain of our existing indebtedness and (iii) to pay fees, costs and expenses incurred in
connection with the Credit Agreement, including the Lender’s closing cost amount of $550,000, which was netted from the proceeds, and a financing fee of $600,000 (3.0% of gross proceeds) payable to Craig-Hallum Capital Group LLC, our
financial advisor for the financing.
|
•
|
Interest Rate. Principal outstanding under the Credit Agreement bears interest at a rate per annum equal to the sum of (a) the greater of the one-month London Interbank
Offered Rate and 2.5% plus (b) 8.75%. At any time at which an event of default (as described under “—Default Provisions” below) has occurred and is continuing, the interest rate will increase by 4.0%. Accrued interest is payable on a
monthly basis. On March 31, 2022, the interest rate was 11.25%.
|
•
|
Scheduled Repayment. No principal repayments are due prior to September 30, 2022, unless we elect to prepay principal as described under “—Optional Prepayment” below or
principal is accelerated pursuant to an event of default as described under “—Default Provisions” below. Principal installments in the amount of $300,000 are payable on the last day of each of the eleven months from September 2022
through July 2023, and all remaining principal is payable at maturity on September 3, 2023.
|
•
|
Optional Prepayment. We may prepay outstanding principal from time to time, subject to payment of a premium on the prepaid
principal amount equal to 10% through September 3, 2020, 8% from September 4, 2020 through September 3, 2021, and 4% from September 4, 2021 through September 3, 2022. No premium will be due with respect to any prepayment made on or
after September 4, 2022.
|
•
|
Guarantees. Our subsidiaries Chembio Diagnostic Systems Inc. and Chembio Diagnostics Malaysia Sdn Bhd. have guaranteed, and the Lender from time to time may require our
other subsidiaries to guarantee, our obligations under the Credit Agreement.
|
•
|
Security. Our obligations under the Credit Agreement are secured by a first priority, perfected lien on substantially all of our property and assets, including our equity
interests in our subsidiaries. Our subsidiary Chembio Diagnostic Systems Inc. has secured its guarantee of our Credit Agreement obligations with a lien on substantially all of its assets, and the Lender from time to time may require
Chembio Diagnostics Malaysia Sdn Bhd. and any of our other subsidiaries that has guaranteed our Credit Agreement obligations to do the same.
|
•
|
Representations and Warranties; Financial and Other Covenants. In the Credit Agreement we made customary representations and
warranties as well as customary affirmative and negative covenants, including covenants limiting additional indebtedness, liens, guarantees, mergers and acquisitions, substantial asset sales, investments and loans, sale and leasebacks,
transactions with affiliates, and fundamental changes. The Credit Agreement also contains financial covenants requiring that (i) we maintain aggregate unrestricted cash of not less than $3,000,000 at all times and (ii) we achieve
specified minimum rolling four-quarter (“last twelve month”) total revenue amounts as of September 30, 2019 and the last day of each calendar quarter thereafter. For the next year, the minimum total revenue requirements range from $43.8
million for the twelve months ending June 30, 2022, and $ 48.8 million for the twelve months ending March 31, 2023. The minimum total revenue amounts were developed for purposes of the Credit Agreement and do not reflect the internal
estimates and plans used by our management and board of directors to understand and evaluate our operating performance, to establish budgets, and to establish operational goals for managing our business. We therefore do not believe that
the covenant requirements provide useful information to investors or others in enhancing an understanding of our future prospects.
|
•
|
Default Provisions. The Credit Agreement provides for customary events of default, including events of default based on non-payment of amounts due under the Credit
Agreement, defaults on other debt, misrepresentations, covenant breaches, changes of control, insolvency, bankruptcy and the occurrence of a material adverse effect on our company. Upon an event of default resulting from a
voluntary or involuntary proceeding for bankruptcy, insolvency or receivership, the amounts outstanding under the Credit Agreement will become immediately due and payable and the Lender’s commitments will be automatically
terminated. Upon the occurrence and continuation of any other event of default, the Lender may accelerate payment of all obligations and terminate its commitments under the Credit Agreement.
|
March 31,
2022
|
||||
(in thousands)
|
||||
Cash and cash equivalents
|
$
|
24,399
|
||
Accounts receivable, net of allowance for doubtful amounts
|
9,880
|
|||
Inventories, net
|
11,844
|
|||
Prepaid expenses and other current assets
|
2,097
|
|||
Total current assets
|
48,220
|
|||
Less: Total current liabilities
|
(13,632
|
)
|
||
Working capital
|
$
|
34,588
|
ITEM 3. |
CONTROLS AND PROCEDURES
|
(a)
|
Disclosure Controls and Procedures. Under the supervision and with the participation of our senior management, consisting of our principal
executive officer and our principal financial officer, we conducted an evaluation of the effectiveness of the design and operation of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) under the
Securities Exchange Act of 1934, as amended, or the Exchange Act, as of the end of the period covered by this report. Based on this evaluation, our management, including our principal executive officer and principal financial officer,
concluded that as of March 31, 2022 our disclosure controls and procedures were effective to ensure that information required to be disclosed by us in the reports that we file under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified in SEC rules and forms. Our disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by us in
our Exchange Act reports is accumulated and communicated to our management, including our principal executive officer and principal financial officer, as appropriate to allow timely decisions regarding required disclosure. Management
recognizes that any controls and procedures, no matter how well designed and operated, can provide only reasonable assurance of achieving their objectives, and management necessarily applies its judgment in evaluating the cost-benefit
relationship of possible controls and procedures.
|
(b)
|
Changes in Internal Control over Financial Reporting. There were no changes in our internal control over financial reporting identified in
connection with the evaluation required by paragraph (d) of Rule 13a-15 or Rule 15d-15 under the Exchange Act that occurred during the three months ended March 31, 2022, that have materially affected, or are reasonably likely to
materially affect, our internal control over financial reporting.
|
PART II. |
OTHER INFORMATION
|
ITEM 1. |
LEGAL PROCEEDINGS
|
ITEM 1A. |
RISK FACTORS
|
•
|
perceptions by members of the health care community, including physicians, about the safety and effectiveness of our products;
|
•
|
limitation on use or warnings required by the FDA or other global regulators in our product labeling;
|
•
|
the cost of our products relative to competing products;
|
•
|
convenience and ease of administration;
|
•
|
potential advantages of alternative diagnostic and treatment methods;
|
•
|
availability of reimbursement for our products from government or other healthcare payers;
|
•
|
effectiveness of marketing and distribution efforts by us and our licensees and distributors, if any; and
|
•
|
the ability of our diagnostic solutions to address different variants.
|
• |
third parties lose confidence in our ability to continue to operate in the ordinary course, which could impact our ability to execute on our business strategy;
|
• |
it may become more difficult for us to attract, retain or replace employees;
|
• |
employees could be distracted from performance of their duties;
|
• |
we could lose some or a significant portion of our liquidity, either due to stricter credit terms from vendors, or, in the event we undertake a Chapter 11 proceeding and conclude that we need to procure debtor-in-possession
financing, an inability to obtain any needed debtor-in-possession financing or to provide adequate protection to certain secured lenders to permit us to access some or all of our cash; and
|
• |
our vendors and service providers could seek to renegotiate the terms of our arrangements, terminate their relationships with us or require financial assurances from us.
|
Number
|
Description
|
|
Employment Agreement, dated as of December 30, 2021 and effective as of January 5, 2022, between Chembio Diagnostics, Inc. and Lawrence J. Steenvoorden
(incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on January 6, 2022)
|
||
Amendment No. 1 dated February 9, 2022 between Chembio Diagnostics, Inc. and Richard L. Eberly, amending the Employment Agreement dated March 4, 2020
(incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed on February 14, 2022)
|
||
Certification of the Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||
Certification of the Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
||
Certification of Chief Executive Officer and Chief Financial Officer pursuant to 18 U.S.C. Section 1350 as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002
|
||
101.INS
|
XBRL Instance Document
|
|
101.SCH
|
XBRL Taxonomy Extension Schema Document
|
|
101.CAL
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
101.DEF
|
XBRL Taxonomy Definition Linkbase Document
|
|
101.LAB
|
XBRL Taxonomy Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Presentation Linkbase Document
|
†
|
Indicates management contract or compensatory plan or arrangement.
|
*
|
Certain sensitive personally identifiable information in this exhibit was omitted by means of redacting a portion of the text and replacing it with [***]. ç The
certifications attached as Exhibit 32.1 accompany the Quarterly Report on Form 10-Q pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed “filed” by the
registrant for purposes of Section 18 of the Securities Exchange Act of 1934, as amended.
|
Chembio Diagnostics, Inc.
|
|
Date: May 5, 2022
|
By: /s/ Richard Eberly
|
Richard Eberly
|
|
Chief Executive Officer and President
|
|
Date: May 5, 2022
|
By: /s / Lawrence J. Steenvoorden
|
Lawrence J. Steenvoorden
|
|
Chief Financial Officer and Executive Vice President
|
1. |
I have reviewed this Quarterly Report on Form 10-Q of Chembio Diagnostics, Inc.
|
2. |
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of
the circumstances under which such statements were made, not misleading with respect to the period covered by this report.
|
3. |
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition,
results of operations and cash flows of the registrant as of, and for, the periods presented in this report.
|
4. |
The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)
and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
(a) |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d) |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
5. |
The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors
and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
(a) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the registrant’s ability to record, process, summarize and report financial information; and
|
(b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls.
|
Date: May 5, 2022
|
/s/ Richard L. Eberly
|
|
Richard L. Eberly
|
|
Chief Executive Officer and President
|
(a) |
designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information
relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
(b) |
designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable
assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
(c) |
evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure
controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
(d) |
disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the
registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting.
|
(a) |
all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect
the registrant’s ability to record, process, summarize and report financial information; and
|
(b) |
any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal controls.
|
Date: May 5, 2022
|
/s/ Lawrence J. Steenvoorden
|
|
Lawrence J. Steenvoorden
|
|
Chief Financial Officer and Executive Vice President
|
1. |
the Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
2. |
the information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of Chembio Diagnostics, Inc. for the
period presented therein.
|
Date: May 5, 2022
|
/s/ Richard L. Eberly
|
|
Richard L. Eberly
|
|
Chief Executive Officer and President
|
Date: May 5, 2022
|
/s/ Lawrence J. Steenvoorden
|
|
Lawrence J. Steenvoorden
|
|
Chief Financial Officer and Executive Vice President
|
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CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - USD ($) |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
CURRENT ASSETS: | ||
Accounts receivable, allowance for doubtful accounts | $ 242,981 | $ 243,042 |
STOCKHOLDERS' EQUITY: | ||
Preferred stock, shares authorized (in shares) | 10,000,000 | 10,000,000 |
Preferred stock, shares outstanding (in shares) | 0 | 0 |
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, shares authorized (in shares) | 100,000,000 | 100,000,000 |
Common stock, shares issued (in shares) | 30,269,916 | 30,104,986 |
Treasury stock, shares (in shares) | 48,057 | 48,057 |
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS - USD ($) |
3 Months Ended | |
---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS [Abstract] | ||
Net loss | $ (8,790,294) | $ (4,500,163) |
Other comprehensive income (loss): | ||
Foreign currency translation adjustments, net of tax | 348,151 | (455,722) |
COMPREHENSIVE LOSS | $ (8,442,143) | $ (4,955,885) |
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) |
Common Stock [Member] |
Additional Paid-in-Capital [Member] |
Treasury Stock [Member] |
Accumulated Deficit [Member] |
AOCL [Member] |
Total |
---|---|---|---|---|---|---|
Balance at Dec. 31, 2020 | $ 202,235 | $ 124,961,514 | $ (190,093) | $ (97,106,331) | $ (90,916) | $ 27,776,409 |
Balance (in shares) at Dec. 31, 2020 | 20,223,498 | (41,141) | ||||
Common Stock: | ||||||
Restricted stock issued | $ 622 | 58,909 | $ 0 | 0 | 0 | 59,531 |
Restricted stock issued (in shares) | 62,197 | 0 | ||||
Restricted stock compensation, net | $ 0 | 309,010 | $ 0 | 0 | 0 | 309,010 |
Restricted stock compensation, net (in shares) | 0 | 0 | ||||
Shares tendered for withholding taxes | $ 0 | (115,059) | $ 0 | 0 | 0 | (115,059) |
Shares tendered for withholding taxes (in shares) | 0 | 0 | ||||
Options: | ||||||
Stock option compensation | $ 0 | 211,140 | $ 0 | 0 | 0 | 211,140 |
Comprehensive income (loss) | 0 | 0 | 0 | 0 | (455,722) | (455,722) |
Net loss | 0 | 0 | 0 | (4,500,163) | 0 | (4,500,163) |
Balance at Mar. 31, 2021 | $ 202,857 | 125,425,514 | $ (190,093) | (101,606,494) | (546,638) | 23,285,146 |
Balance (in shares) at Mar. 31, 2021 | 20,285,695 | (41,141) | ||||
Balance at Dec. 31, 2021 | $ 301,050 | 165,772,636 | $ (206,554) | (131,009,860) | (592,372) | 34,264,900 |
Balance (in shares) at Dec. 31, 2021 | 30,104,986 | (48,057) | ||||
Common Stock: | ||||||
Restricted stock issued | $ 1,649 | 264,437 | $ 0 | 0 | 0 | 266,086 |
Restricted stock issued (in shares) | 164,930 | 0 | ||||
Restricted stock compensation, net | $ 0 | 229,563 | $ 0 | 0 | 0 | 229,563 |
Restricted stock compensation, net (in shares) | 0 | 0 | ||||
Shares tendered for withholding taxes | $ 0 | (38,514) | $ 0 | 0 | 0 | (38,514) |
Shares tendered for withholding taxes (in shares) | 0 | 0 | ||||
Options: | ||||||
Stock option compensation | $ 0 | 255,254 | $ 0 | 0 | 0 | 255,254 |
Comprehensive income (loss) | 0 | 0 | 0 | 0 | 348,151 | 348,151 |
Net loss | 0 | 0 | 0 | (8,790,294) | 0 | (8,790,294) |
Balance at Mar. 31, 2022 | $ 302,699 | $ 166,483,376 | $ (206,554) | $ (139,800,154) | $ (244,221) | $ 26,535,146 |
Balance (in shares) at Mar. 31, 2022 | 30,269,916 | (48,057) |
DESCRIPTION OF BUSINESS |
3 Months Ended | ||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||
DESCRIPTION OF BUSINESS [Abstract] | |||||||||||||||||||
DESCRIPTION OF BUSINESS |
NOTE 1 — DESCRIPTION OF BUSINESS:
Chembio Diagnostics, Inc. (“Chembio”) and its subsidiaries (collectively with Chembio, the “Company”) develop and commercialize point-of-care diagnostic tests used for
the rapid detection and diagnosis of infectious diseases, including sexually transmitted disease, insect vector and tropical disease, COVID-19 and other viral and bacterial infections, enabling expedited treatment.
The Company’s product portfolio is based upon our proprietary DPP technology, a diagnostic platform that provides high-quality, cost-effective results in 15
to 20 minutes using fingertip blood, nasal swabs and other sample types. The DPP technology platform addresses the rapid diagnostic test market, which includes infectious diseases such as STIs and HIV, Gastroenterology and Women’s Health.
Compared with traditional lateral flow technology, the DPP technology platform can provide:
The Company targets the market for rapid diagnostic test solutions for infectious diseases, which is driven by the high prevalence of infectious diseases globally, an
increase in the geriatric population, growing demand for rapid test results, and advancements in multiplexing. The Company has a broad portfolio of infectious disease products, which prior to 2020 were focused principally on sexually transmitted
disease and fever and tropical disease. In February 2020 the Company began the process of shifting substantially all of its resources to seek to leverage the DPP technology platform to address the acute and escalating need for diagnostic testing
for COVID-19. The Company is continuing to pursue:
|
SIGNIFICANT ACCOUNTING POLICIES |
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | |||||||||||||||||||||||||||||||||||||||||||
SIGNIFICANT ACCOUNTING POLICIES |
NOTE
2 — SIGNIFICANT ACCOUNTING POLICIES:
The accompanying unaudited condensed consolidated financial statements include the
accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S.
generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the Securities and Exchange Commission (the “SEC”). Certain
information and footnote disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Certain reclassifications have been made to the
unaudited condensed consolidated balance sheet of the prior year to conform to the current year presentation. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto contained in Chembio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC.
Going Concern Considerations
The Company continued to experience market, clinical trial and regulatory complications in seeking to develop and commercialize a portfolio of COVID-19 test
systems during the continuing, but evolving, uncertainty resulting from COVID‑19. For the three months ended March 31, 2022, the Company continued to incur significant
expenses in connection with pending legal matters (see Note 6 – Commitments, Contingencies, and Concentrations: Litigation).
The Company performed an assessment to determine whether there were conditions or events that, considered in the aggregate, raised substantial doubt about the
Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are being issued. Initially, this assessment did not consider the potential mitigating effect of
management’s plans that had not been fully implemented. Because, as described below, substantial doubt was determined to exist as the result of this initial assessment, management then assessed the mitigating effect of its plans to determine if it
is probable that the plans (1) would be effectively implemented within one year after the date the accompanying unaudited condensed consolidated financial statements are issued and (2) when implemented, would mitigate the relevant conditions or
events that raise substantial doubt about the Company’s ability to continue as a going concern.
The Company achieved significant revenue growth in recent years while profitability has not been at levels as expected. It has taken steps including investments in
automation to mitigate headwinds such as labor availability, volatile capacity planning and implementation of operational efficiency targets to proactively monitor production with the overarching goal for profitable growth. During the three months
ended March 31, 2022, the Company undertook measures to increase its total revenues and improve its liquidity position by implementing the Global Competitiveness Program. The main pillars of the Global Competitiveness Program include the following:
In addition, the Company will continue to focus on regulatory approvals for its DPP SARS-CoV-2 Antigen test system, DPP Respiratory Antigen Panel, and DPP HIV-Syphilis
test system. These measures and other plans and initiatives have been designed to provide the Company with adequate liquidity to meet its obligations for at least the twelve-month period following the date the accompanying unaudited condensed
consolidated financial statements are being issued. The Company’s execution of those measures and its other plans and initiative continue to depend, however, on factors and uncertainties that are beyond the Company’s control, or that may not be
addressable on terms acceptable to the Company or at all. The Company considered in particular how:
The Company further considered how these factors and uncertainties could impact its ability over the next year to meet the obligations specified in the Credit Agreement
with the Lender (both as defined in Note 7 – Long-Term Debt). Those obligations include covenants requiring: i) minimum cash balance of $3.0 million and ii) minimum total revenue amounts for the twelve months preceding each quarter end. For the next
year, the minimum total revenue requirements range from $43.8 million for the twelve months ending June 30, 2022 to $48.8 million for the twelve months ending March 31, 2023. Upon an event of default under the Credit Agreement, the Lender could elect to declare all
amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such an event, there can be no assurance that the Company would have sufficient liquidity to fund payment of the amounts that would be due under the
Credit Agreement or that, if such liquidity were not available, the Company would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a
going concern. The Company’s inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for its operations, could
have a material adverse effect on its business, prospects, results of operations, liquidity and financial condition.
Accordingly, management determined the Company could not be certain that the Company’s plans and initiatives would be effectively implemented within one year after the
date on which the accompanying unaudited condensed consolidated financial statements are being issued. Without giving effect to the prospect of raising additional capital pursuant to the Company’s At the Market Offering Agreement dated July 19, 2021
with Chembio Diagnostics, Inc. and Craig-Hallum Capital Group LLC, increasing product revenue in the near future or executing other mitigating plans, many of which are beyond the Company’s control, it is unlikely that the Company will be able to
generate sufficient cash flows to meet its required financial obligations, including its debt service and other obligations due to third parties. The existence of these conditions raises substantial doubt about the Company’s ability to continue as a
going concern for the twelve-month period following the date on which the accompanying unaudited condensed consolidated financial statements are being issued.
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates
continuity of operations, realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are issued. As
such, the accompanying unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amount and classification of liabilities that
may result should the Company be unable to continue as a going concern.
During the three months ended March 31, 2022, there has been no significant changes
to the Company’s summary of significant accounting policies contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2021, as filed with the SEC.
The carrying values
for cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other current liabilities approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash
equivalents were $ 17.1 million and $25.0
million as of March 31, 2022 and December 31, 2021, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company’s total debt of $20.0 million (carrying value of $18.9 million) and $20.0 million (carrying value of $18.8
million) as of March 31, 2022 and December 31, 2021 respectively, is a Level 2 fair value measurement under the hierarchy and the Company’s debt face value approximates the recorded value, as the rate is based upon the current rates available to
the Company for similar financial instruments.
Fair value measurements of all financial assets and liabilities that are measured
and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:
Cash and cash
equivalents are defined as short-term, highly liquid investments, such as money market funds, with original maturities of three months or less at date of purchase.
Basic loss per share is computed by dividing net loss attributable to common
stockholders by the weighted-average number of common shares outstanding for the period excluding unvested restricted stock. Diluted loss per share for the three months ended March 31, 2022 and 2021 reflects the potential dilution from the exercise
or conversion of other securities into common stock, if dilutive.
There were 3,760,787 and 1,848,286 options outstanding as of March 31, 2022
and 2021, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.
There were 1,739,944 and 847,795 shares of restricted stock outstanding as of
March 31, 2022 and 2020, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.
At the end of each interim reporting period, the Company estimates its effective tax
rate expected to be applied for the full year. This estimate is used to determine the income tax provision or benefit on a year-to-date basis, and may change in subsequent interim periods. Accordingly, the Company’s effective tax rate for the three
months ended March 31, 2022 was (0.1)%, compared to the effective tax rate of 1.6% for the three months ended March 31, 2021. The Company’s effective tax rates for both periods were affected primarily by a full valuation allowance on domestic net deferred
tax assets.
Recently Adopted
ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities
about Government Assistance
In November 2021, the Financial Accounting Standards Board (“FASB”) issued
Accounting Standards Update (“ASU”) 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which creates Accounting Standards Codification (“ASC”) 832 and aims to provide increased transparency by
requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements. The disclosure requirements in ASC 832 only apply to transactions with a government that are
accounted for by analogizing to either a grant model (for example, in International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance), or a contribution model (for example, in ASC 958-605,
Not-for-Profit Entities – Revenue Recognition). The FASB broadly defined “government assistance” in ASC 832 to ensure that assistance received from most types of governmental entities or other related organizations would be disclosed. Entities are
required to provide the new disclosures prospectively for all transactions with a government entity that are accounted for under either a grant or a contribution accounting model and are reflected in the financial statements at the date of initially
applying the new amendments, and to new transactions entered into after that date. Retrospective application of the guidance is permitted. The Company adopted the standard effective January 1, 2022 and has determined that the adoption did not have a
material impact on the Company’s consolidated financial statements.
Not Yet Adopted
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
On August 5, 2020, the FASB issued ASU 2020-06, which simplifies the accounting for
certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary
complexity in GAAP. ASU 2020-06 simplifies the guidance in GAAP on the issuer’s accounting for convertible debt instruments, requires entities to provide expanded disclosures about “the terms and features of convertible instruments” and how the
instruments have been reported in the entity’s financial statements. It also removes from ASC 815-40-25-10 certain conditions for equity classification and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and
contracts on an entity’s own equity. An entity can use either a full or modified retrospective approach to adopt the ASU’s guidance. The ASU’s amendments are effective for smaller public business entities fiscal years beginning after December 15,
2023. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.
ASU 2021-08—Business Combinations (Topic 805): Accounting for Contract Assets
and Contract Liabilities from Contracts with Customers
On October 28, 2021, the FASB issued ASU 2021-08,1 which amends ASC 805 to
“require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination.” Under current GAAP, an acquirer generally recognizes such items at fair value on the acquisition date. ASU
2021-08 amends ASC 805 to add contract assets and contract liabilities to the list of exceptions to the recognition and measurement principles that apply to business combinations and to “require that an entity (acquirer) recognize and measure
contract assets and contract liabilities acquired in a business combination in accordance with Topic 606.” While primarily related to contract assets and contract liabilities that were accounted for by the acquiree in accordance with ASC 606, “the
amendments also apply to contract assets and contract liabilities from other contracts to which the provisions of Topic 606 apply, such as contract liabilities from the sale of nonfinancial assets within the scope of Subtopic 610-20.” The ASU’s
amendments are effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The amendments should be applied prospectively to business combinations occurring on
or after the effective date of the amendments. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.
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REVENUE |
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REVENUE [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
REVENUE |
NOTE 3 — REVENUE:
Disaggregation of Revenue
The following table disaggregates Total Revenues by revenue type:
Exchange transactions are recognized in accordance with ASC 606, while non-exchange transactions are recognized in accordance with ASU No. 2018-08.
The following table disaggregates Total Revenues by geographic location:
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INVENTORY |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
INVENTORY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
INVENTORY |
NOTE 4 — INVENTORY:
Inventories are presented net of reserves and consist of the following at:
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STOCKHOLDERS' EQUITY |
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Mar. 31, 2022 | |||||||||||||
STOCKHOLDERS' EQUITY [Abstract] | |||||||||||||
STOCKHOLDERS' EQUITY |
NOTE 5 — STOCKHOLDERS’ EQUITY:
During the first three months of 2022 and 2021, there were no options
exercised.
Chembio has 10,000,000 shares of preferred stock authorized and none outstanding. These shares can become issuable upon an approved resolution by the board of directors
of Chembio (the “Board”) and the filing of a Certificate of Designation with the state of Nevada.
Chembio has 48,057 shares of treasury stock acquired
upon the vesting of restricted stock awards related to the tax withholding requirements paid on behalf of the employees.
The Board or its Compensation Committee may issue options, restricted stock, and restricted
stock units pursuant to equity incentive plans that have been approved by Chembio’s stockholders.
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COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS |
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COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS |
NOTE 6 — COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS:
The following table discloses product sales the Company had to each customer that purchased in excess of 10% of the Company’s net product sales for the periods
indicated:
Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.
The following table discloses purchases the Company had to each vendor that purchased in excess of 10% of the Company’s net purchases for the periods indicated:
In the tables above, an asterisk (*)
indicates that indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.
The Company purchases materials pursuant to intellectual property rights agreements that are important components in its products. Management believes that other
suppliers could provide similar materials on comparable terms. A change in suppliers, however, could cause a delay in manufacturing and a possible loss of sales, which could adversely affect operating results.
The Company has multi-year contracts with three key
employees. The contracts call for salaries presently aggregating $1,178,000 per year. The contracts expire in The
following table is a schedule of future minimum salary commitments:
and December 31, 2024.
Chembio has a 401(k) plan established for the Company’s employees whereby it matches 40% of the first 5% of salary (or up to 2% of salary) that an employee contributes to the plan. Matching contribution expenses totaled approximately $67,135 and $35,456 for the three months ended March 31, 2022 and
2021, respectively.
The Company leases facilities in New York, Germany, Malaysia, and Brazil, and certain equipment.
The Company’s facility leases generally include optional renewal periods. Upon entering into a new facility lease, the Company evaluates the leasehold improvements and
regulatory requirements related to its operations in that location. To the extent that the initial lease term of the related facility lease is less than the useful life of the leasehold improvements and potential regulatory costs associated with
moving the facility, the Company concludes that it is reasonably certain that a renewal option will be exercised, and thus that renewal period is included in the lease term and the related payments are reflected in the right-of-use asset and lease
liability.
The Company’s leases generally include fixed rental payments with defined annual increases. While certain of the Company’s leases are gross leases, the majority of the
Company’s leases are net leases in which the Company makes separate payments to the lessor based on the lessor’s property and casualty insurance costs, the property taxes assessed on the property, and a portion of the common area maintenance where
applicable. The Company has elected the practical expedient not to separate lease and non-lease components for all of the Company’s facility leases.
The components of lease expense were as follows:
Supplemental cash flow information related to leases was as follows.
Supplemental balance sheet information related to leases was as follows:
Maturities of lease liabilities were as follows.
SEC Investigation
The SEC is conducting a non-public, fact-finding investigation relating to the public offering of common stock that Chembio completed in May 2020 (the “May 2020
Offering”) and to the FDA’s revocation in June 2020 of an emergency use authorization for the DPP COVID-19 IgM/IgG system that was issued by the FDA in April 2020. Chembio received subpoenas from the SEC in July 2020 and April 2021 seeking the
production of documents in connection with this investigation. In addition, the SEC delivered subpoenas in April 2021 to five of Chembio’s employees (including its three executive officers, who consist of its Chief Executive Officer and President,
its former Executive Vice President and Chief Financial Officer, and its Executive Vice President and Chief Scientific and Technology Officer). An additional subpoena was issued in June 2021 to Chembio’s former Interim Chief Executive Officer and
Executive Chair. Each subpoena requested the production of documents relating to the same matters as are the subject of the subpoenas Chembio received. Chembio and the six individuals are cooperating fully in the SEC’s investigation and expect to
continue to do so.
The SEC’s letters transmitting the subpoenas expressly provide that the inquiry does not mean that the SEC or its staff have concluded that anyone has violated the
federal securities laws or have a negative opinion of any person, entity or security. The Company cannot predict the scope, duration or outcome of the investigation or the impact, if any, of the investigation on its results of operations.
Legal Proceedings
Stockholder Litigation
Putative Stockholder Securities Class-Action Litigation
In 2020 four purported securities class-action lawsuits
were filed in the United States District Court for the Eastern District of New York by alleged stockholders of Chembio:
The plaintiffs in each of the above cases alleged claims under Section 10(b) of the Securities Exchange Act of 1934 (the “Exchange Act”), Rule 10b-5 thereunder and
Section 20(a) of the Exchange Act. Special Situations Fund III QP, L.P., Special Situations Cayman Fund, L.P. and Special Situations Private Equity Fund, L.P. (collectively, the “Special Situations Funds”) also asserted claims under Sections 11,
12(a)(2) and 15 of the Securities Act of 1933 (the “Securities Act”) relating to the May 2020 Offering.
Chembio and the plaintiffs entered into Court-approved stipulations relieving Chembio and the other defendants of the obligation to respond to the complaints in these
cases pending the designation of a lead plaintiff pursuant to the Private Securities Litigation Reform Act of 1995. Eight motions for
appointment as lead plaintiff were filed by various prospective lead plaintiffs. However, all but two of these motions were withdrawn or
otherwise abandoned, leaving before the Court two motions for appointment as lead plaintiff - one filed by the Special Situations Funds and one by Municipal
Employees’ Retirement System of Michigan. By order entered December 29, 2020, Magistrate Judge Lindsay consolidated the cases and appointed the Special Situations Funds and Municipal Employees’ Retirement System of Michigan (together, the “Lead
Plaintiffs”), as co-lead plaintiffs and their respective counsel as co-lead counsel. The consolidated cases are now pending under the caption “In re Chembio Diagnostics, Inc. Securities Litigation.”
The Lead Plaintiffs filed their Consolidated Amended Complaint (the “CAC”) on February 12, 2021. In summary, the CAC purported to allege claims based on assertedly false
and misleading statements and omissions concerning the performance of the DPP COVID-19 IgM/IgG System, as well as an asserted failure to timely disclose that the emergency use authorization that had been granted by the FDA with respect to the DPP
COVID-19 IgM/IgG System “was - or was at an increased risk of - being revoked.” The CAC named as defendants Chembio, Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan, John Potthoff (together, the
“Chembio Defendants”) and the underwriters for the May 2020 Offering, Robert W. Baird & Co., Inc. and Dougherty & Company LLC (the “Underwriter Defendants”).
The CAC purported to assert five counts under the Securities Act and the Exchange Act. Counts I through III were brought under the Securities Act, allegedly on behalf of
a purported class consisting of all persons who purchased Chembio common stock directly in or traceable to the May 2020 Offering pursuant to Chembio’s shelf registration statement on Form S 3 (File No. 333-227398) and the related prospectus, as
supplemented by a prospectus supplement dated May 7, 2020 (the “Securities Act Class”). Count I purported to allege a claim for violation of Section 11 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count II
purported to allege a claim for violation of Section 12 of the Securities Act against all defendants other than Messrs. Eberly and Esfandiari. Count III purported to allege a claim under Section 15 of the Securities Act against Ms. Davis, Dr. Polan,
Dr. Potthoff, Ms. Page and Mr. Goldman.
Counts IV and V alleged claims under the Exchange Act on behalf of a purported class consisting of all persons who purchased Chembio common stock on the open market from
March 12, 2020 through June 16, 2020 (the “Exchange Act Class”). Count IV purported to allege a claim for violation of Section 10(b) of the Exchange Act and Rule 10b-5 thereunder against Chembio, Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari.
Count V purported to allege a claim under Section 20(a) of the Exchange Act against Mr. Eberly, Ms. Page, Mr. Goldman and Mr. Esfandiari.
In their CAC, the Lead Plaintiffs sought, on behalf of the Securities Act Class and the Exchange Act Class, among other things, an award of damages in an amount to be
proven at trial, as well as an award of reasonable costs, including attorneys’ fees and expenses, expert fees, pre-judgment and post-judgment interest, and such other relief as the Court deems just and proper. The Lead Plaintiffs also sought
rescission “or a rescissory measure of damages” on behalf of the Securities Act Class as to Count II.
Pursuant to an order entered by the Court on January 29, 2021, any defendant wishing to move against the amended complaint was required to file, by February 18, 2021, a
letter requesting a pre-motion conference. On that date, the defendants submitted letters to the Court requesting a pre-motion conference regarding anticipated motions to dismiss the CAC, and the Lead Plaintiffs responded on February 24, 2021. In its
January 29, 2021 order, the Court indicated that it would consider a briefing schedule on motions to dismiss after it had received and reviewed the parties’ correspondence.
On March 5, 2021, the Court entered an order in which it advised the parties that it had determined a pre motion conference was not necessary and established a briefing
schedule on the defendants’ anticipated motions to dismiss. However, the defendants subsequently agreed with the Lead Plaintiffs’ counsel to a modification of the schedule, which was then approved by the Court. Pursuant to that schedule, defendants’
motions and supporting papers were filed on March 26, 2021, the Lead Plaintiffs’ opposition papers were filed on April 16, 2021, and the defendants’ reply papers were filed on April 30, 2021.
The Court issued its Opinion and Order (the “Order”) on the defendants’ motions to dismiss on February 23, 2022. In its Order, the Court: (i) dismissed Counts I and II
without prejudice as to all defendants named in those Counts except the Underwriter Defendants as to which Counts I and II were not dismissed; (ii) dismissed Count III without prejudice as to all defendants named in that Count; and (iii) dismissed
Counts IV and V with prejudice as to all defendants named in those Counts. The Court gave Lead Plaintiffs fourteen days within which to
attempt to replead their claims under the Securities Act against Chembio, Ms. Page, Mr. Goldman, Ms. Davis, Ms. Polan and Mr. Potthoff.
On March 4, 2022, Lead Plaintiffs filed a letter motion in which they advised the Court that they intended to file an amended complaint, but that they wished to first
seek reconsideration of the Court’s February 23 order. They accordingly requested, and the Court granted, an adjournment of the deadline for filing an amended complaint until three business days after the Court’s ruling on Lead Plaintiffs’
anticipated motion for reconsideration. The Court also granted a request by the Underwriter Defendants to extend the time for them to file their answer to the CAC, and set May 2, 2022 as the date for the filing of that answer.
On March 7, 2022, Magistrate Judge John Wicks entered an order requiring that the parties meet and confer regarding the scheduling of discovery in the case,
requiring that the parties submit a Proposed Scheduling Order by March 23, and setting a hearing (via zoom) on March 30. The Chembio Defendants filed a letter motion requesting that the Court adjourn the initial conference and suspend the other
requirements in the March 7, 2022 order. Magistrate Judge Wicks granted the letter motion on March 14, and further ordered that the initial conference would be rescheduled “following the resolution of all preliminary dispositive issues.”
On March 9, 2022, Lead Plaintiffs filed a motion for partial reconsideration of the Court’s February 23 Order. In their motion, Lead Plaintiffs requested that the
Court reconsider and reverse its dismissal of Counts IV and V with prejudice, and its dismissal of Counts I, II and III without prejudice. The Chembio Defendants filed their memorandum in opposition to this motion on March 23, 2022; Lead
Plaintiffs filed their reply memorandum in support of the motion on March 30, 2022. The Court has not yet ruled upon the motion for partial reconsideration.
On April 26, 2022, the Court entered an order canceling the previously-set May 2 date by which the Underwriter Defendants were required to file their answer to the
CAC, and providing that the Underwriter Defendants’ answer to an amended complaint shall be due within three weeks after such amended complaint has been served.
Putative Stockholder Derivative Litigation
On September 11, 2020,
a putative stockholder derivative action captioned Karen Wong, derivatively on behalf of Chembio Diagnostics, Inc., Plaintiff v. Richard L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan and John G.
Potthoff, Defendants, and Chembio Diagnostics, Inc., Nominal Defendant (the “Wong complaint”) was filed purportedly on Chembio’s behalf in the United States District Court for the Eastern District of New York. The Wong complaint purports to assert
a claim for violation of Section 14(a) of the Exchange Act and Rule 14a-9 thereunder based on ostensibly false and misleading statements and omissions concerning the Company’s rapid COVID-19 antibody test in the proxy statement disseminated in
advance of Chembio’s Annual Meeting of Stockholders held on July 28, 2020. The Wong complaint also asserts claims against the individual defendants for purported breaches of fiduciary duties owed to Chembio, as well as unjust enrichment.
The Wong complaint requests a declaration that the individual defendants have breached or aided and abetted the breach of their fiduciary duties to Chembio, an award of
damages to us, restitution, and an award of the plaintiff’s costs and disbursements in the action, including reasonable attorneys’ and experts’ fees, costs and expenses, and improvements to Chembio’s corporate governance and internal procedures
regarding compliance with laws. Pursuant to a stipulation by which the individual defendants named in the Wong complaint agreed to waive service of process, the Court ordered that the time for defendants to answer or otherwise respond to the
complaint be extended to November 19, 2020. The parties subsequently entered into a stipulation for a stay of proceedings in the action relating to the Wong complaint pending final disposition of motions to dismiss the pending putative class-action
litigation, subject to certain conditions. The Court entered an order granting the requested stay on November 3, 2020. At this stage of the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.
On March 31, 2022, a second putative stockholder derivative action captioned Michelle Chen, derivatively on behalf of Chembio Diagnostics, Inc., Plaintiff v. Richard
L. Eberly, Gail S. Page, Neil A. Goldman, Javan Esfandiari, Katherine L. Davis, Mary Lake Polan and John G. Potthoff, Defendants, and Chembio Diagnostics, Inc., Nominal Defendant (the “Chen complaint”) was filed purportedly on behalf of Chembio in
the Supreme Court for the State of New York, County of Suffolk. The Chen complaint purports to assert a claim for breach of fiduciary duty against the defendants based on ostensibly false and misleading statements and omissions concerning the
Company’s rapid COVID-19 antibody test. The Chen complaint goes on to allege that the misconduct asserted in the complaint gave rise to the filing of the consolidated securities litigation described above.
Counsel for the defendants in the Chen action are engaged in discussions with counsel for Chen concerning a possible stay of the Chen action.
Employee Litigation
On March 19, 2021, John J. Sperzel III, Chembio’s former chief executive officer, filed a fifteen-count complaint in the United States District Court for the Eastern District of New York. The complaint was filed following the dismissal of an action previously filed by Mr. Sperzel in the United States
District Court in Maine, which was dismissed for lack of personal jurisdiction over Chembio. In summary, the complaint filed in the Eastern District of New York alleges that Chembio wrongfully refused to allow Mr. Sperzel to exercise certain options
to purchase, for an aggregate exercise price of $943,126, a total of 266,666 shares of common stock that were allegedly vested as of the date of his separation from Chembio, on January 3, 2020. The complaint alleges that under the terms of the
applicable stock incentive plans, Mr. Sperzel had thirty days after the date on which he ceased to qualify as an “Eligible Person” under
the plans within which to exercise the options, and asserts that by reason of his alleged continued service to us, he remained an “Eligible Person” and ostensibly retained the right to exercise the options. The Compensation Committee of the Board
determined that the options expired on February 3, 2020, thirty days after Mr. Sperzel’s separation from Chembio, and that a purported attempt by Mr. Sperzel to exercise the options after that date was not valid.
Count I of the complaint purports to allege that Chembio breached Mr. Sperzel’s separation agreement by refusing to allow him to exercise the stock options. Counts II
through XI of the complaint purport to allege claims for breach of each of ten separate stock option agreements, collectively asserting
damages of “at least” $3,190,198. Count XII of the complaint alleges a breach of Mr. Sperzel’s separation agreement based on Chembio’s
purported failure to pay Mr. Sperzel consulting fees to which he claims to be entitled for consulting services allegedly performed following his separation. Count XIII of the complaint alleges a claim for breach of an implied covenant of good faith
and fair dealing under Nevada common law based on the allegation that Chembio prevented Mr. Sperzel from obtaining the benefits of the stock option agreements and separation agreement. Mr. Sperzel alleges that he suffered damages in excess of $3 million as a result of the purported breach of the covenant of good faith and fair dealing. Count XIV of the complaint purports to assert a claim for
quantum meruit, alleging that “it is reasonable for Sperzel to expect payment in exchange for ... services” he allegedly provided to us and, based on allegations that upon his separation Mr. Sperzel was not informed as to the pending expiration of
the stock options he later sought to exercise, that Chembio has been unjustly enriched. Finally, Count XV of the complaint seeks a declaratory judgment that Mr. Sperzel is relieved from performance under his separation agreement due to asserted
material breaches of the agreement based on the allegations summarized above. The complaint seeks compensatory damages in an unspecified amount, a declaration, as described above, and an award of Mr. Sperzel’s costs and expenses in the litigation,
including reasonable attorneys’ fees, expert costs and disbursements. The complaint requests a trial by jury. In his initial disclosures served in discovery, Mr. Sperzel claims entitlement to recover damages in a total amount not less than $10 million, together with prejudgment interest at the rate of 9% per annum.
On May 20, 2021, Chembio filed its answer and affirmative defenses denying the material allegations of Mr. Sperzel’s complaint. Chembio and Mr. Sperzel are presently
engaged in discovery. Under the present case schedule, all fact discovery was completed on April 28, 2022, and the parties are currently in the midst of an additional period of expert witness discovery, concluding on June 28, 2022. At this stage of
the litigation, the Company is not able to predict the probability of a favorable or unfavorable outcome.
Other
From time to time the Company may become involved in legal proceedings or may be subject to claims arising in the ordinary course of its business. Although the results
of litigation and claims cannot be predicted with certainty, the Company currently believes that the final outcome of these ordinary course matters will not have a material adverse effect on its business, operating results, financial condition or
cash flows. Regardless of the outcome, litigation can have an adverse impact on the Company because of defense and settlement costs, diversion of management resources, and other factors.
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LONG-TERM DEBT |
3 Months Ended |
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Mar. 31, 2022 | |
LONG-TERM DEBT [Abstract] | |
LONG-TERM DEBT |
NOTE 7 — LONG-TERM DEBT:
On September 3, 2019, Chembio entered into a Credit Agreement and Guaranty (the “Credit Agreement”) with Perceptive Credit Holdings II, LP (the “Lender”). The Credit Agreement provides for a $20,000,000 senior secured term loan credit facility, which was drawn in full on September 4, 2019. Under the terms of the Credit Agreement, Chembio may
use the proceeds (i) for general working capital purposes and other permitted corporate purposes, (ii) to refinance certain of Chembio’s existing indebtedness and (iii) to pay fees, costs and expenses incurred in connection with the Credit
Agreement, including the Lender’s closing cost amount of $550,000, which was netted from the proceeds, and a financing fee of $600,000 (3.0% of gross proceeds) payable
to Craig-Hallum Capital Group LLC, Chembio’s financial
advisor for the financing.
Principal outstanding under the Credit Agreement bears interest at a rate per annum equal to the sum of (a) the greater of the one-month London Interbank Offered Rate and 2.5%
plus (b) 8.75%. At any time at which an event of default has occurred and is continuing, the interest rate will increase by 4.0%. Accrued interest is payable on a monthly basis. On March 31, 2022 the interest rate was 11.25%.
No principal repayments are due under the Credit Agreement prior to September 30, 2022, unless Chembio elects to prepay principal or principal is accelerated pursuant
to an event of default identified in the Credit Agreement. Principal installments in the amount of $300,000 are payable on the last day
of each of the eleven months from September 2022 through July 2023, and all remaining principal is payable at maturity on September 3, 2023.
The Company may prepay outstanding principal from time to time, subject to payment of a premium on the prepaid principal amount equal to 10%
through September 3, 2020, 8% from September 4, 2020 through September 3, 2021, and 4% from September 4, 2021 through September 3, 2022. No premium will be due with respect to any prepayment made on or after September 4, 2022.
Chembio’s obligations under the Credit Agreement are secured by a first priority, perfected lien on substantially all of its property and assets, including its
equity interests in subsidiaries.
As of March 31, 2022, the loan balance, net of unamortized discounts and debt issuance costs, was $18.9 million, and Chembio was in compliance with its loan covenants.
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EQUITY INCENTIVE PLAN |
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EQUITY INCENTIVE PLAN [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
EQUITY INCENTIVE PLAN |
NOTE 8 — EQUITY INCENTIVE PLAN:
Effective June 19, 2014, Chembio’s stockholders voted to approve the 2014 Stock Incentive Plan (the “2014 Plan”), with 800,000 shares of common stock available to be issued. Under the terms of the 2014 Plan, the Board or its Compensation Committee has the discretion to select the persons to whom
awards are to be granted. Awards can be in the form of Equity Award Units. The awards vest at such times and under such conditions as determined by the Board or its Compensation Committee. Cumulatively through March 31, 2022, there were 732,064 Equity Award Units expired, forfeited or exercised. At March 31, 2022, 46,875 Equity Award Units were outstanding and 21,061
shares were not issued. All shares that expired, forfeited or were not issued rolled over into the 2019 Plan. No Equity Award Units remain available to be issued under the 2014 Plan.
Effective June 18, 2019, Chembio’s stockholders voted to approve the 2019 Omnibus Incentive Plan
(the “2019 Plan”), with 2,400,000 shares of common stock available to be issued. At the Annual Stockholder Meeting on June 25, 2021, Chembio’s stockholders voted to approve an increase to the shares of common stock issuable under the SIP by
2,400,000 to 4,800,000. In
addition, shares of common stock underlying any outstanding award granted under the 2019 Plan that, following the effective date of the 2019 Plan, expire, or are terminated, surrendered or forfeited for any reason without issuance of such shares,
shall be available for the grant of new awards under the 2019 Plan. Under the terms of the 2019 Plan, the Board or its Compensation Committee has the discretion to select the persons to whom awards are to be granted. Awards can be in the form of
options, stock appreciation rights, restricted stock, restricted stock units, performance stock units or other stock-based awards under the 2019 Plan (collectively, “2019 Equity Units”). The 2019 Equity Units become vested at such times and under
such conditions as determined by the Board or its Compensation Committee. Cumulatively through March 31, 2022, 866,709 2019 Equity Units have been cancelled or forfeited. At March 31, 2022, 4,915,279 2019 Equity
Units were outstanding, and 83,234 2019 Equity Units were available to be awarded.
Stock-based compensation expense (net of recovery) recognized in the condensed consolidated statements of operations was classified as follows:
The weighted-average assumptions made in calculating the fair values of options are as follows:
The following table provides stock option activity for the three months ended March 31, 2022:
The following table summarizes information about stock options outstanding at March 31, 2022:
As of March 31, 2022, there was $3,073,502 of net
unrecognized compensation cost related to stock options that had not vested, which is expected to be recognized over a weighted-average period of approximately 3.32 years. The total fair value of shares vested during the three months ended March 31, 2022 and 2021 was $693,290
and $188,179, respectively.
The following table summarizes information about restricted stock, restricted stock units and
performance stock units outstanding as of March 31, 2022:
As of March 31, 2022, there was $2,120,646 of net
unrecognized compensation cost related to restricted stock and restricted stock units that had not vested, which is expected to be recognized over a weighted average period of approximately 2.50 years.
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GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY |
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GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY |
NOTE 9 — GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY:
The Company produces only one group of similar products known collectively as “rapid medical tests”, and it operates in a operating segment. Net product revenue by geographic area were as follows:
Property, plant and equipment by geographic area were as follows at:
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ACCOUNTS PAYABLE AND ACCRUED LIABILITIES |
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ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES |
NOTE 10 — ACCOUNTS PAYABLE AND ACCRUED LIABILITIES:
Accounts payable and accrued liabilities consisted of:
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GOODWILL AND INTANGIBLE ASSETS |
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Mar. 31, 2022 | |||||||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS [Abstract] | |||||||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS |
NOTE 11 — GOODWILL AND INTANGIBLE ASSETS:
The following table reflects changes in goodwill:
Goodwill represents the excess of the purchase price the Company paid over the fair value of the net tangible and identifiable intangible assets acquired in the
Company’s acquisition. Goodwill is not amortized but rather is tested annually as of the first day of the fiscal fourth quarter, or sooner if the Company believes that indicators of impairment exist. The Company makes a qualitative evaluation about
the likelihood of goodwill impairment, which is based on a number of applicable factors. If the Company concludes that it is more likely than not that the carrying value of the applicable reporting unit is greater than its fair value, then it would
recognize an impairment charge for the amount by which the carrying value exceeds the reporting unit’s fair value, provided the impairment charge does not exceed the total amount of goodwill allocated to the reporting unit.
The quantitative goodwill impairment test is performed using a one-step process. The process is to compare the fair value of a reporting unit with its carrying amount.
If the fair value of a reporting unit exceeds its carrying amount, goodwill of the reporting unit is not impaired. If the carrying amount of a reporting unit exceeds its fair value, goodwill of the reporting unit is impaired, and an impairment loss
is recognized in an amount equal to that excess.
The Company operates as a
operating segment and
has one reporting unit. As of March 31, 2022, the Company determined indicators of impairment existed. As a result, the Company recognized
an impairment loss of its goodwill totaling $3.0 million. |
OTHER MATTERS |
3 Months Ended |
---|---|
Mar. 31, 2022 | |
OTHER MATTERS [Abstract] | |
OTHER MATTERS |
NOTE 12 — OTHER MATTERS:
On March 28, 2022, Chembio Diagnostics GmbH, Chembio’s German subsidiary formed under the laws of the Federal Republic of Germany, successfully withdrew its petition
for insolvency filed in February 2022 in the Charlottenburg District Court (“Amtsgericht Charlottenburg“) in Berlin, Germany. The subsidiary has taken various measures to improve profitability, including a viable business plan, and the Company has
provided liquidity and other support to continue the operations.
|
SIGNIFICANT ACCOUNTING POLICIES (Policies) |
3 Months Ended | |||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Mar. 31, 2022 | ||||||||||||||||
SIGNIFICANT ACCOUNTING POLICIES [Abstract] | ||||||||||||||||
Basis of Presentation |
The accompanying unaudited condensed consolidated financial statements include the
accounts of Chembio and its subsidiaries. All significant intercompany accounts and transactions have been eliminated in consolidation. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S.
generally accepted accounting principles (“GAAP”) for interim financial information and in accordance with the instructions to Form 10-Q and Article 10 of Regulation S-X issued by the Securities and Exchange Commission (the “SEC”). Certain
information and footnote disclosures normally included in consolidated financial statements prepared in accordance with GAAP have been condensed or omitted pursuant to such rules and regulations. Certain reclassifications have been made to the
unaudited condensed consolidated balance sheet of the prior year to conform to the current year presentation. The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial
statements and notes thereto contained in Chembio’s Annual Report on Form 10-K for the fiscal year ended December 31, 2021, as filed with the SEC.
Going Concern Considerations
The Company continued to experience market, clinical trial and regulatory complications in seeking to develop and commercialize a portfolio of COVID-19 test
systems during the continuing, but evolving, uncertainty resulting from COVID‑19. For the three months ended March 31, 2022, the Company continued to incur significant
expenses in connection with pending legal matters (see Note 6 – Commitments, Contingencies, and Concentrations: Litigation).
The Company performed an assessment to determine whether there were conditions or events that, considered in the aggregate, raised substantial doubt about the
Company’s ability to continue as a going concern within one year after the date the accompanying unaudited condensed consolidated financial statements are being issued. Initially, this assessment did not consider the potential mitigating effect of
management’s plans that had not been fully implemented. Because, as described below, substantial doubt was determined to exist as the result of this initial assessment, management then assessed the mitigating effect of its plans to determine if it
is probable that the plans (1) would be effectively implemented within one year after the date the accompanying unaudited condensed consolidated financial statements are issued and (2) when implemented, would mitigate the relevant conditions or
events that raise substantial doubt about the Company’s ability to continue as a going concern.
The Company achieved significant revenue growth in recent years while profitability has not been at levels as expected. It has taken steps including investments in
automation to mitigate headwinds such as labor availability, volatile capacity planning and implementation of operational efficiency targets to proactively monitor production with the overarching goal for profitable growth. During the three months
ended March 31, 2022, the Company undertook measures to increase its total revenues and improve its liquidity position by implementing the Global Competitiveness Program. The main pillars of the Global Competitiveness Program include the following:
In addition, the Company will continue to focus on regulatory approvals for its DPP SARS-CoV-2 Antigen test system, DPP Respiratory Antigen Panel, and DPP HIV-Syphilis
test system. These measures and other plans and initiatives have been designed to provide the Company with adequate liquidity to meet its obligations for at least the twelve-month period following the date the accompanying unaudited condensed
consolidated financial statements are being issued. The Company’s execution of those measures and its other plans and initiative continue to depend, however, on factors and uncertainties that are beyond the Company’s control, or that may not be
addressable on terms acceptable to the Company or at all. The Company considered in particular how:
The Company further considered how these factors and uncertainties could impact its ability over the next year to meet the obligations specified in the Credit Agreement
with the Lender (both as defined in Note 7 – Long-Term Debt). Those obligations include covenants requiring: i) minimum cash balance of $3.0 million and ii) minimum total revenue amounts for the twelve months preceding each quarter end. For the next
year, the minimum total revenue requirements range from $43.8 million for the twelve months ending June 30, 2022 to $48.8 million for the twelve months ending March 31, 2023. Upon an event of default under the Credit Agreement, the Lender could elect to declare all
amounts outstanding thereunder, together with accrued interest, to be immediately due and payable. In such an event, there can be no assurance that the Company would have sufficient liquidity to fund payment of the amounts that would be due under the
Credit Agreement or that, if such liquidity were not available, the Company would be successful in raising additional capital on acceptable terms, or at all, or in completing any other endeavor to continue to be financially viable and continue as a
going concern. The Company’s inability to raise additional capital on acceptable terms in the near future, whether for purposes of funding payments required under the Credit Agreement or providing additional liquidity needed for its operations, could
have a material adverse effect on its business, prospects, results of operations, liquidity and financial condition.
Accordingly, management determined the Company could not be certain that the Company’s plans and initiatives would be effectively implemented within one year after the
date on which the accompanying unaudited condensed consolidated financial statements are being issued. Without giving effect to the prospect of raising additional capital pursuant to the Company’s At the Market Offering Agreement dated July 19, 2021
with Chembio Diagnostics, Inc. and Craig-Hallum Capital Group LLC, increasing product revenue in the near future or executing other mitigating plans, many of which are beyond the Company’s control, it is unlikely that the Company will be able to
generate sufficient cash flows to meet its required financial obligations, including its debt service and other obligations due to third parties. The existence of these conditions raises substantial doubt about the Company’s ability to continue as a
going concern for the twelve-month period following the date on which the accompanying unaudited condensed consolidated financial statements are being issued.
The accompanying unaudited condensed consolidated financial statements have been prepared assuming the Company will continue as a going concern, which contemplates
continuity of operations, realization of assets and the satisfaction of liabilities in the normal course of business for the twelve-month period following the date the accompanying unaudited condensed consolidated financial statements are issued. As
such, the accompanying unaudited condensed consolidated financial statements do not include any adjustments relating to the recoverability and classification of assets and their carrying amounts, or the amount and classification of liabilities that
may result should the Company be unable to continue as a going concern.
|
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Fair Value of Financial Instruments |
The carrying values
for cash and cash equivalents, accounts receivable, accounts payable and accrued expenses and other current liabilities approximate fair value due to the immediate or short-term maturity of these financial instruments. Included in cash and cash
equivalents were $ 17.1 million and $25.0
million as of March 31, 2022 and December 31, 2021, respectively, of money market funds that are Level 1 fair value measurements under the hierarchy. The fair value of the Company’s total debt of $20.0 million (carrying value of $18.9 million) and $20.0 million (carrying value of $18.8
million) as of March 31, 2022 and December 31, 2021 respectively, is a Level 2 fair value measurement under the hierarchy and the Company’s debt face value approximates the recorded value, as the rate is based upon the current rates available to
the Company for similar financial instruments.
Fair value measurements of all financial assets and liabilities that are measured
and reported on a fair value basis are required to be classified and disclosed in one of the following three categories:
|
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Cash and Cash Equivalents |
Cash and cash
equivalents are defined as short-term, highly liquid investments, such as money market funds, with original maturities of three months or less at date of purchase.
|
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Loss Per Share |
Basic loss per share is computed by dividing net loss attributable to common
stockholders by the weighted-average number of common shares outstanding for the period excluding unvested restricted stock. Diluted loss per share for the three months ended March 31, 2022 and 2021 reflects the potential dilution from the exercise
or conversion of other securities into common stock, if dilutive.
There were 3,760,787 and 1,848,286 options outstanding as of March 31, 2022
and 2021, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.
There were 1,739,944 and 847,795 shares of restricted stock outstanding as of
March 31, 2022 and 2020, respectively, that were not included in the calculation of diluted per common share equivalents for the three months ended March 31, 2022 and 2021, respectively, because the effect would have been anti-dilutive.
|
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Income Taxes |
At the end of each interim reporting period, the Company estimates its effective tax
rate expected to be applied for the full year. This estimate is used to determine the income tax provision or benefit on a year-to-date basis, and may change in subsequent interim periods. Accordingly, the Company’s effective tax rate for the three
months ended March 31, 2022 was (0.1)%, compared to the effective tax rate of 1.6% for the three months ended March 31, 2021. The Company’s effective tax rates for both periods were affected primarily by a full valuation allowance on domestic net deferred
tax assets.
|
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Recently Issued Accounting Standards Affecting the Company |
Recently Adopted
ASU 2021-10 - Government Assistance (Topic 832): Disclosures by Business Entities
about Government Assistance
In November 2021, the Financial Accounting Standards Board (“FASB”) issued
Accounting Standards Update (“ASU”) 2021-10, Government Assistance (Topic 832): Disclosures by Business Entities about Government Assistance, which creates Accounting Standards Codification (“ASC”) 832 and aims to provide increased transparency by
requiring business entities to disclose information about certain types of government assistance they receive in the notes to the financial statements. The disclosure requirements in ASC 832 only apply to transactions with a government that are
accounted for by analogizing to either a grant model (for example, in International Accounting Standard 20, Accounting for Government Grants and Disclosure of Government Assistance), or a contribution model (for example, in ASC 958-605,
Not-for-Profit Entities – Revenue Recognition). The FASB broadly defined “government assistance” in ASC 832 to ensure that assistance received from most types of governmental entities or other related organizations would be disclosed. Entities are
required to provide the new disclosures prospectively for all transactions with a government entity that are accounted for under either a grant or a contribution accounting model and are reflected in the financial statements at the date of initially
applying the new amendments, and to new transactions entered into after that date. Retrospective application of the guidance is permitted. The Company adopted the standard effective January 1, 2022 and has determined that the adoption did not have a
material impact on the Company’s consolidated financial statements.
Not Yet Adopted
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
On August 5, 2020, the FASB issued ASU 2020-06, which simplifies the accounting for
certain financial instruments with characteristics of liabilities and equity, including convertible instruments and contracts on an entity’s own equity. The ASU is part of the FASB’s simplification initiative, which aims to reduce unnecessary
complexity in GAAP. ASU 2020-06 simplifies the guidance in GAAP on the issuer’s accounting for convertible debt instruments, requires entities to provide expanded disclosures about “the terms and features of convertible instruments” and how the
instruments have been reported in the entity’s financial statements. It also removes from ASC 815-40-25-10 certain conditions for equity classification and amends certain guidance in ASC 260 on the computation of EPS for convertible instruments and
contracts on an entity’s own equity. An entity can use either a full or modified retrospective approach to adopt the ASU’s guidance. The ASU’s amendments are effective for smaller public business entities fiscal years beginning after December 15,
2023. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.
ASU 2021-08—Business Combinations (Topic 805): Accounting for Contract Assets
and Contract Liabilities from Contracts with Customers
On October 28, 2021, the FASB issued ASU 2021-08,1 which amends ASC 805 to
“require acquiring entities to apply Topic 606 to recognize and measure contract assets and contract liabilities in a business combination.” Under current GAAP, an acquirer generally recognizes such items at fair value on the acquisition date. ASU
2021-08 amends ASC 805 to add contract assets and contract liabilities to the list of exceptions to the recognition and measurement principles that apply to business combinations and to “require that an entity (acquirer) recognize and measure
contract assets and contract liabilities acquired in a business combination in accordance with Topic 606.” While primarily related to contract assets and contract liabilities that were accounted for by the acquiree in accordance with ASC 606, “the
amendments also apply to contract assets and contract liabilities from other contracts to which the provisions of Topic 606 apply, such as contract liabilities from the sale of nonfinancial assets within the scope of Subtopic 610-20.” The ASU’s
amendments are effective for public business entities for the fiscal years beginning after December 15, 2022, including interim periods within those fiscal years. The amendments should be applied prospectively to business combinations occurring on
or after the effective date of the amendments. The Company continues to assess the potential impact of the standard and will disclose the nature and reason for any elections that the Company makes.
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REVENUE (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
REVENUE [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Disaggregation of Revenue |
The following table disaggregates Total Revenues by revenue type:
The following table disaggregates Total Revenues by geographic location:
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INVENTORY (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||
INVENTORY [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||
Inventories |
Inventories are presented net of reserves and consist of the following at:
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COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
COMMITMENTS, CONTINGENCIES, AND CONCENTRATIONS [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Customer and Purchase Concentration Risks |
The following table discloses product sales the Company had to each customer that purchased in excess of 10% of the Company’s net product sales for the periods
indicated:
Revenue includes product sales only, while accounts receivable reflects the total due from the customer, including freight.
The following table discloses purchases the Company had to each vendor that purchased in excess of 10% of the Company’s net purchases for the periods indicated:
In the tables above, an asterisk (*)
indicates that indicates that sales, accounts receivable, purchases or accounts payable, as applicable to the tabular column, did not exceed 10% for the period indicated.
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Future Minimum Salary Commitment | The
following table is a schedule of future minimum salary commitments:
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Components of Lease Expense |
The components of lease expense were as follows:
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Supplemental Cash Flow Information Related to Leases |
Supplemental cash flow information related to leases was as follows.
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Supplemental Balance Sheet Information Related to Leases |
Supplemental balance sheet information related to leases was as follows:
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Maturities of Lease Liabilities |
Maturities of lease liabilities were as follows.
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EQUITY INCENTIVE PLAN (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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EQUITY INCENTIVE PLAN [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Stock-Based Compensation Expense (Net of Recovery) Recognized |
Stock-based compensation expense (net of recovery) recognized in the condensed consolidated statements of operations was classified as follows:
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Assumptions Made in Calculating Fair Values of Options |
The weighted-average assumptions made in calculating the fair values of options are as follows:
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Stock Option Activity |
The following table provides stock option activity for the three months ended March 31, 2022:
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Stock Options Outstanding |
The following table summarizes information about stock options outstanding at March 31, 2022:
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Summary of Restricted Stock and Restricted Stock Units Outstanding |
The following table summarizes information about restricted stock, restricted stock units and
performance stock units outstanding as of March 31, 2022:
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GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Tables) |
3 Months Ended | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract] | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Product Revenue by Geographic Area |
The Company produces only one group of similar products known collectively as “rapid medical tests”, and it operates in a operating segment. Net product revenue by geographic area were as follows:
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Long-lived Assets by Geographic Area |
Property, plant and equipment by geographic area were as follows at:
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ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Tables) |
3 Months Ended | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Mar. 31, 2022 | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Accounts Payable and Accrued Liabilities |
Accounts payable and accrued liabilities consisted of:
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GOODWILL AND INTANGIBLE ASSETS (Tables) |
3 Months Ended | ||||||||||||||||||||
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Mar. 31, 2022 | |||||||||||||||||||||
GOODWILL AND INTANGIBLE ASSETS [Abstract] | |||||||||||||||||||||
Changes in Goodwill |
The following table reflects changes in goodwill:
|
SIGNIFICANT ACCOUNTING POLICIES, Going Concern Considerations (Details) - USD ($) $ in Millions |
12 Months Ended | |
---|---|---|
Mar. 31, 2023 |
Jun. 30, 2022 |
|
Forecast [Member] | ||
Credit Agreement [Abstract] | ||
Covenant amount, revenue | $ 48.8 | $ 43.8 |
SIGNIFICANT ACCOUNTING POLICIES, Fair Value of Financial Instruments (Details) - USD ($) |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 24,399,388 | $ 28,772,892 |
Level 2 [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Fair value of total debt | 20,000,000.0 | 20,000,000.0 |
Carrying value | 18,900,000 | 18,800,000 |
Money Market Funds [Member] | Level 1 [Member] | ||
Fair Value of Financial Instruments [Abstract] | ||
Cash and cash equivalents | $ 17,100,000 | $ 25,000,000.0 |
SIGNIFICANT ACCOUNTING POLICIES, Loss Per Share (Details) - shares |
3 Months Ended | |
---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
Options [Member] | ||
Loss Per Share [Abstract] | ||
Antidilutive securities excluded from calculation of diluted earnings per share (in shares) | 3,760,787 | 1,848,286 |
Restricted Stock [Member] | ||
Loss Per Share [Abstract] | ||
Antidilutive securities excluded from calculation of diluted earnings per share (in shares) | 1,739,944 | 847,795 |
SIGNIFICANT ACCOUNTING POLICIES, Income Taxes (Details) |
3 Months Ended | |
---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
|
Income Taxes [Abstract] | ||
Effective tax rate | 0.10% | 1.60% |
INVENTORY (Details) - USD ($) |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
INVENTORY [Abstract] | ||
Raw materials | $ 7,197,257 | $ 7,306,095 |
Work in process | 1,932,069 | 3,556,878 |
Finished goods | 2,714,795 | 2,057,478 |
Inventories | $ 11,844,121 | $ 12,920,451 |
STOCKHOLDERS' EQUITY (Details) - shares |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2022 |
Mar. 31, 2021 |
Dec. 31, 2021 |
|
Common Stock [Abstract] | |||
Number of stock options exercised under the plan (in shares) | 0 | 0 | |
Preferred Stock [Abstract] | |||
Preferred stock - shares authorized (in shares) | 10,000,000 | 10,000,000 | |
Preferred stock - shares outstanding (in shares) | 0 | 0 | |
Treasury Stock [Abstract] | |||
Treasury stock, shares (in shares) | 48,057 | 48,057 |
LONG-TERM DEBT (Details) - Senior Secured Term Loan Credit Facility [Member] - USD ($) |
3 Months Ended | |
---|---|---|
Sep. 03, 2019 |
Mar. 31, 2022 |
|
Credit Agreement [Abstract] | ||
Debt instrument, face amount | $ 20,000,000 | |
Lender's closing cost | 550,000 | |
Financing fee | $ 600,000 | |
Percentage of gross proceeds considered as financing fee | 3.00% | |
Interest rate | 8.75% | 11.25% |
Increase in interest rate in event of default | 4.00% | |
Principal installment payable | $ 300,000 | |
Debt instrument maturity date | Sep. 03, 2023 | |
Outstanding loan balance, net | $ 18,900,000 | |
September 4, 2019 to September 3, 2020 [Member] | ||
Credit Agreement [Abstract] | ||
Percentage of prepaid principal as premium | 10.00% | |
September 4, 2020 to September 3, 2021 [Member] | ||
Credit Agreement [Abstract] | ||
Percentage of prepaid principal as premium | 8.00% | |
September 4, 2021 to September 3, 2022 [Member] | ||
Credit Agreement [Abstract] | ||
Percentage of prepaid principal as premium | 4.00% | |
LIBOR [Member] | ||
Credit Agreement [Abstract] | ||
Term of variable rate | 1 month | |
Basis spread on variable rate | 2.50% |
EQUITY INCENTIVE PLAN, Summary (Details) - USD ($) |
3 Months Ended | 12 Months Ended | ||||
---|---|---|---|---|---|---|
Jun. 25, 2021 |
Mar. 31, 2022 |
Mar. 31, 2021 |
Dec. 31, 2021 |
Jun. 18, 2019 |
Jun. 19, 2014 |
|
Stock Compensation Expense [Abstract] | ||||||
Allocated share-based compensation expense | $ 750,903 | $ 579,789 | ||||
Stock Options, Additional Disclosure [Abstract] | ||||||
Outstanding, aggregate intrinsic value, end of period | 0 | |||||
Exercisable, aggregate intrinsic value, end of period | 0 | |||||
Cost of Product Sales [Member] | ||||||
Stock Compensation Expense [Abstract] | ||||||
Allocated share-based compensation expense | 54,250 | 28,768 | ||||
Research and Development Expenses [Member] | ||||||
Stock Compensation Expense [Abstract] | ||||||
Allocated share-based compensation expense | 91,189 | 90,920 | ||||
Selling, General and Administrative Expenses [Member] | ||||||
Stock Compensation Expense [Abstract] | ||||||
Allocated share-based compensation expense | $ 605,464 | $ 460,101 | ||||
Stock Options [Member] | ||||||
Assumptions Made in Calculating Fair Values of Options [Abstract] | ||||||
Expected term | 6 years | |||||
Expected volatility | 91.40% | |||||
Expected dividend yield | ||||||
Risk-free interest rate | 1.91% | |||||
Stock Options, Number of Shares [Roll forward] | ||||||
Outstanding, beginning of period (in shares) | 1,600,372 | |||||
Granted (in shares) | 2,358,539 | |||||
Exercised (in shares) | 0 | |||||
Forfeited (in shares) | 14,883 | |||||
Expired (in shares) | 183,241 | |||||
Outstanding, end of period (in shares) | 3,760,787 | 1,600,372 | ||||
Exercisable, end of period (in shares) | 565,215 | |||||
Stock Options, Weighted Average Exercise Price per Share [Roll Forward] | ||||||
Outstanding, beginning of period (in dollars per share) | $ 4.18 | |||||
Granted (in dollars per share) | 1.23 | |||||
Exercised (in dollars per share) | 0 | |||||
Forfeited (in dollars per share) | 2.42 | |||||
Expired (in dollars per share) | 5.63 | |||||
Outstanding, end of period (in dollars per share) | 2.27 | $ 4.18 | ||||
Exercisable, end of period (in dollars per share) | $ 3.68 | |||||
Stock Options, Additional Disclosure [Abstract] | ||||||
Outstanding, weighted average remaining contract term | 8 years 7 months 24 days | 6 years 7 months 2 days | ||||
Exercisable, weighted average remaining contract term | 5 years 10 months 20 days | |||||
Outstanding, aggregate intrinsic value, beginning of period | $ 0 | |||||
Granted, aggregate intrinsic value | 0 | |||||
Exercised, aggregate intrinsic value | 0 | |||||
Forfeited, aggregate intrinsic value | 0 | |||||
Outstanding, aggregate intrinsic value, end of period | 0 | $ 0 | ||||
Exercisable, aggregate intrinsic value, end of period | $ 0 | |||||
2014 Stock Incentive Plan [Member] | Stock Options [Member] | ||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | ||||||
Number of shares authorized under the plan (in shares) | 800,000 | |||||
Number of stock options expired, forfeited or exercised under the plan (in shares) | 732,064 | |||||
Options still available to be issued (in shares) | 0 | |||||
Stock Options, Number of Shares [Roll forward] | ||||||
Outstanding, end of period (in shares) | 46,875 | |||||
2019 Omnibus Incentive Plan [Member] | Stock Options [Member] | ||||||
Share-based Arrangements with Employees and Nonemployees [Abstract] | ||||||
Number of shares authorized under the plan (in shares) | 4,800,000 | 2,400,000 | ||||
Increase in number of shares authorized (in shares) | 2,400,000 | |||||
Number of stock options expired, forfeited or exercised under the plan (in shares) | 866,709 | |||||
Options still available to be issued (in shares) | 83,234 | |||||
Stock Options, Number of Shares [Roll forward] | ||||||
Outstanding, end of period (in shares) | 4,915,279 | |||||
2014 & 2019 Stock Incentive Plan [Member] | Stock Options [Member] | ||||||
Stock Options, Number of Shares [Roll forward] | ||||||
Outstanding, end of period (in shares) | 21,061 |
EQUITY INCENTIVE PLAN, Stock Options (Details) - USD ($) |
3 Months Ended | |||
---|---|---|---|---|
Jan. 03, 2020 |
Mar. 31, 2022 |
Mar. 31, 2021 |
Dec. 31, 2021 |
|
Stock Options Outstanding [Abstract] | ||||
Shares outstanding (in shares) | 3,760,787 | |||
Average remaining contract term | 8 years 7 months 24 days | |||
Weighted average exercise price (in dollars per share) | $ 2.27 | |||
Aggregate intrinsic value | $ 0 | |||
Stock Options Exercisable [Abstract] | ||||
Shares exercisable (in shares) | 565,215 | |||
Weighted average exercise price (in dollars per share) | $ 3.69 | |||
Aggregate intrinsic value | $ 0 | |||
Total fair value of stock options vested during period | $ 943,126 | |||
Stock Options [Member] | ||||
Stock Options Outstanding [Abstract] | ||||
Aggregate intrinsic value | 0 | $ 0 | ||
Stock Options Exercisable [Abstract] | ||||
Aggregate intrinsic value | 0 | |||
Net unrecognized compensation cost | $ 3,073,502 | |||
Weighted average period for recognition of net unrecognized compensation cost | 3 years 3 months 25 days | |||
Total fair value of stock options vested during period | $ 693,290 | $ 188,179 | ||
1 to 2.79999 [Member] | ||||
Range of Exercise Prices [Abstract] | ||||
Range of exercise prices, minimum (in dollars per share) | $ 1 | |||
Range of exercise prices, maximum (in dollars per share) | $ 2.79999 | |||
Stock Options Outstanding [Abstract] | ||||
Shares outstanding (in shares) | 2,863,910 | |||
Average remaining contract term | 8 years 9 months 29 days | |||
Weighted average exercise price (in dollars per share) | $ 1.44 | |||
Aggregate intrinsic value | $ 0 | |||
Stock Options Exercisable [Abstract] | ||||
Shares exercisable (in shares) | 317,758 | |||
Weighted average exercise price (in dollars per share) | $ 2.36 | |||
Aggregate intrinsic value | $ 0 | |||
2.8 to 4.59999 [Member] | ||||
Range of Exercise Prices [Abstract] | ||||
Range of exercise prices, minimum (in dollars per share) | $ 2.8 | |||
Range of exercise prices, maximum (in dollars per share) | $ 4.59999 | |||
Stock Options Outstanding [Abstract] | ||||
Shares outstanding (in shares) | 30,795 | |||
Average remaining contract term | 9 years 2 months 8 days | |||
Weighted average exercise price (in dollars per share) | $ 3.05 | |||
Aggregate intrinsic value | $ 0 | |||
Stock Options Exercisable [Abstract] | ||||
Shares exercisable (in shares) | 0 | |||
Weighted average exercise price (in dollars per share) | $ 0 | |||
Aggregate intrinsic value | $ 0 | |||
4.6 to 6.39999 [Member] | ||||
Range of Exercise Prices [Abstract] | ||||
Range of exercise prices, minimum (in dollars per share) | $ 4.6 | |||
Range of exercise prices, maximum (in dollars per share) | $ 6.39999 | |||
Stock Options Outstanding [Abstract] | ||||
Shares outstanding (in shares) | 819,207 | |||
Average remaining contract term | 8 years 5 months 4 days | |||
Weighted average exercise price (in dollars per share) | $ 4.81 | |||
Aggregate intrinsic value | $ 0 | |||
Stock Options Exercisable [Abstract] | ||||
Shares exercisable (in shares) | 209,957 | |||
Weighted average exercise price (in dollars per share) | $ 4.88 | |||
Aggregate intrinsic value | $ 0 | |||
6.4 to 8.19999 [Member] | ||||
Range of Exercise Prices [Abstract] | ||||
Range of exercise prices, minimum (in dollars per share) | $ 6.4 | |||
Range of exercise prices, maximum (in dollars per share) | $ 8.19999 | |||
Stock Options Outstanding [Abstract] | ||||
Shares outstanding (in shares) | 46,875 | |||
Average remaining contract term | 1 year 1 month 9 days | |||
Weighted average exercise price (in dollars per share) | $ 8.15 | |||
Aggregate intrinsic value | $ 0 | |||
Stock Options Exercisable [Abstract] | ||||
Shares exercisable (in shares) | 37,500 | |||
Weighted average exercise price (in dollars per share) | $ 8.15 | |||
Aggregate intrinsic value | $ 0 |
EQUITY INCENTIVE PLAN, Restricted Stock and Restricted Stock Units (Details) - Restricted Stock, Restricted Stock Units, and Performance Stock Units [Member] |
3 Months Ended |
---|---|
Mar. 31, 2022
USD ($)
$ / shares
shares
| |
Number of Shares & Units [Abstract] | |
Outstanding, beginning of period (in shares) | shares | 705,325 |
Granted (in shares) | shares | 1,210,448 |
Vested (in shares) | shares | 167,782 |
Forfeited (in shares) | shares | 8,047 |
Outstanding, end of period (in shares) | shares | 1,739,944 |
Weighted Average Grant Date Fair Value [Abstract] | |
Outstanding, beginning of period (in dollars per share) | $ / shares | $ 3.34 |
Granted (in dollars per share) | $ / shares | 0.76 |
Vested (in dollars per share) | $ / shares | 3.60 |
Forfeited (in dollars per share) | $ / shares | 2.31 |
Outstanding, end of period (in dollars per share) | $ / shares | $ 1.52 |
Net unrecognized compensation cost | $ | $ 2,120,646 |
Weighted average period for recognition of net unrecognized compensation cost | 2 years 6 months |
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY (Details) |
3 Months Ended | ||
---|---|---|---|
Mar. 31, 2022
USD ($)
Segment
Group
|
Mar. 31, 2021
USD ($)
|
Dec. 31, 2021
USD ($)
|
|
GEOGRAPHIC INFORMATION AND ECONOMIC DEPENDENCY [Abstract] | |||
Number of groups of similar products | Group | 1 | ||
Number of operating segments | Segment | 1 | ||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | $ 18,816,611 | $ 8,724,359 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Property, plant and equipment, net | 8,414,313 | $ 8,556,773 | |
Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 18,527,456 | 4,024,662 | |
Africa [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 767,352 | 1,344,858 | |
Africa [Member] | Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 767,352 | 1,344,858 | |
Asia [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 15,558 | 216,954 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Property, plant and equipment, net | 85,351 | 86,041 | |
Asia [Member] | Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 15,558 | 216,954 | |
Europe & Middle East [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 723,745 | 2,600,274 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Property, plant and equipment, net | 101,231 | 113,883 | |
Europe & Middle East [Member] | Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 717,908 | 1,493,734 | |
Latin America [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 12,557,390 | 258,019 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Property, plant and equipment, net | 58,685 | 36,224 | |
Latin America [Member] | Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 12,545,054 | 258,019 | |
United States [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | 4,752,566 | 4,304,254 | |
Geographic Areas, Long-Lived Assets [Abstract] | |||
Property, plant and equipment, net | 8,169,046 | $ 8,320,625 | |
United States [Member] | Net Product Revenue [Member] | |||
Geographic Areas, Revenues from External Customers [Abstract] | |||
Net product revenue | $ 4,481,584 | $ 711,097 |
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES (Details) - USD ($) |
Mar. 31, 2022 |
Dec. 31, 2021 |
---|---|---|
ACCOUNTS PAYABLE AND ACCRUED LIABILITIES [Abstract] | ||
Accounts payable - suppliers | $ 5,622,558 | $ 7,745,592 |
Accrued commissions and royalties | 1,510,865 | 1,359,691 |
Accrued payroll | 494,653 | 494,258 |
Accrued vacation | 657,008 | 421,416 |
Accrued bonuses | 544,567 | 1,378,706 |
Accrued professional fees | 893,745 | 522,935 |
Accrued expenses - other | 819,455 | 1,205,395 |
TOTAL | $ 10,542,851 | $ 13,127,993 |
GOODWILL AND INTANGIBLE ASSETS (Details) |
3 Months Ended |
---|---|
Mar. 31, 2022
USD ($)
Segment
Unit
| |
Goodwill [Roll Forward] | |
Goodwill, Beginning balance | $ 3,022,787 |
Impairment | (3,033,565) |
Changes in foreign currency exchange rate | 10,778 |
Goodwill, Ending balance | $ 0 |
Number of operating segment | Segment | 1 |
Number of reporting unit | Unit | 1 |
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