10-Q
1
form10-q.htm
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
[X]
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2021
OR
[ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from __________ to __________
Commission
File No. 001-38148
CO-DIAGNOSTICS,
INC.
(Exact
Name of Registrant as Specified in Its Charter)
Utah
3841
46-2609396
(State
or other jurisdiction of
incorporation or organization)
(Primary
Standard Industrial
Classification Code Number)
(I.R.S.
Employer
Identification Number)
2401
S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address
of principal executive offices and zip code)
(801)
438-1036
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class
Trading Symbol(s)
Name
of each exchange on which registered
Common
Stock
CODX
NASDAQ-CM
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes [ ] No [X]
Indicate
by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Act. Yes [ ] No [X]
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act
of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and
(2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ]
Indicate
by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this chapter) during the
preceding 12 months (or such shorter period that the registrant was required to submit and post such files). Yes [X] No [ ]
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405 of this chapter) is not
contained herein, and will not be contained, to the best of registrant’s knowledge, in definitive proxy or information statements
incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. [ ]
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller
reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
[ ]
Accelerated
filer
[ ]
Non-accelerated
filer
[ ]
Smaller
reporting company
[X]
Emerging
growth company
[X]
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. [ ]
Indicate
by check mark whether the registrant has filed a report on and attestation to its management’s assessment of the effectiveness
of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered
public accounting firm that prepared or issued its audit report. [ ]
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Act). Yes [ ] No [X]
The
aggregate market value of the voting and non-voting common equity held by non-affiliates computed by reference to the price at
which the common stock was last sold as of the last business day of the registrant’s most recently completed second fiscal
quarter was approximately $485,000,000.
As
of May 11, 2021, there were 28,666,972 shares of common stock, par value $0.001 per share, outstanding.
CO-DIAGNOSTICS,
INC .
FORM
10-Q
PART I FINANCIAL INFORMATION:
Item
1.
Financial Statements
3
Condensed Consolidated Balance Sheets as of March 31, 2021 and December 31, 2020 (unaudited)
3
Condensed Consolidated Statements of Operations for the Three Months Ended March 31, 2021 and 2020 (unaudited)
4
Condensed Consolidated Statements of Cash Flows for the Three Months Ended March 31, 2021 and 2020 (unaudited)
5
Condensed Consolidated Statements of Stockholders’ Equity for the three months ended March 31, 2021 and 2020 (unaudited)
6
Notes to Condensed Consolidated Financial Statements (unaudited)
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
15
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
19
Item
4.
Controls and Procedures
19
PART II OTHER INFORMATION:
Item
1.
Legal Proceedings
20
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
20
Item
3.
Defaults Upon Senior Securities
21
Item
4.
Mine Safety Disclosures
21
Item
5.
Other Information
21
Item
6.
Exhibits
21
Signatures
22
2
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
CO
– DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED BALANCE SHEETS
(Unaudited)
March 31, 2021
December 31, 2020
Assets
Current assets
Cash and cash equivalents
$ 57,788,893
$ 42,976,713
Marketable investment securities
2,302,644
4,335,446
Accounts receivable, net
12,117,127
12,136,833
Inventory
6,197,608
7,995,189
Prepaid expenses
483,501
369,028
Deferred tax asset
244,824
547,224
Total current assets
79,134,597
68,360,433
Property and equipment, net
1,022,192
949,639
Investment in joint venture
962,182
1,927,125
Total assets
$ 81,118,971
$ 71,237,197
Liabilities and stockholders’ equity
Current liabilities
Accounts payable
$ 667,592
$ 598,318
Accrued expenses, current
1,594,312
2,849,503
Accrued expenses (related party), current
120,000
120,000
Income taxes payable
1,765,998
637,560
Deferred revenue
158,791
305,307
Total current liabilities
4,306,693
4,510,688
Long-term liabilities
Accrued expenses, noncurrent
554,802
-
Accrued expenses (related party), noncurrent
-
30,000
Total long-term liabilities
554,802
30,000
Total liabilities
4,861,495
4,540,688
Commitments and contingencies (Note 9)
Stockholders’ equity
Convertible preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued
and outstanding as of March 31, 2021 and December 31, 2020
-
-
Common stock, $0.001 par value; 100,000,000 shares authorized; 28,665,714 and 28,558,033
shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively
28,666
28,558
Additional paid-in capital
50,819,120
49,157,236
Accumulated earnings
25,409,690
17,510,715
Total stockholders’ equity
76,257,476
66,696,509
Total liabilities and stockholders’ equity
$ 81,118,971
$ 71,237,197
See
accompanying notes to unaudited condensed consolidated financial statements
3
CO
– DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended March 31,
2021
2020
Revenue
$ 20,024,769
$ 1,548,528
Cost of revenue
3,272,565
481,740
Gross profit
16,752,204
1,066,788
Operating expenses
Sales and marketing
1,197,546
268,483
General and administrative
2,935,689
1,459,484
Research and development
2,217,063
400,022
Depreciation and amortization
67,005
20,748
Total operating expenses
6,417,303
2,148,737
Income (loss) from operations
10,334,901
(1,081,949 )
Other income (expense)
Interest income
14,657
7,575
Gain (loss) on equity method investment in joint venture
(464,943 )
9,181
Total other income (expense)
(450,286 )
16,756
Income (loss) before income taxes
9,884,615
(1,065,193 )
Income tax provision
1,985,640
-
Net income (loss)
$ 7,898,975
$ (1,065,193 )
Earnings (loss) per common share:
Basic
$ 0.28
$ (0.05 )
Diluted
$ 0.26
$ (0.05 )
Weighted average shares outstanding:
Basic
28,662,885
22,820,450
Diluted
30,002,729
22,820,450
See
accompanying notes to unaudited condensed consolidated financial statements
4
CO
– DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three Months Ended March 31,
2021
2020
Cash flows from operating activities
Net income (loss)
$ 7,898,975
$ (1,065,193 )
Adjustments to reconcile net income (loss) to cash used in operating activities:
Depreciation and amortization
67,005
20,748
Stock-based compensation expense
1,513,012
432,823
Loss (gain) from equity method investment
464,943
(9,181 )
Deferred income taxes
302,399
-
Bad debt expense
79,700
31,000
Changes in assets and liabilities:
Accounts receivable
(59,994 )
(924,356 )
Prepaid and other assets
(114,473 )
(167,761 )
Inventory
1,797,581
(488,910 )
Deferred revenue
(146,516 )
443,009
Income taxes payable
1,128,438
-
Accounts payable and accrued expenses
(661,115 )
392,293
Net cash provided by (used in) operating activities
12,269,955
(1,335,528 )
Cash flows from investing activities
Purchases of property and equipment
(139,558 )
(100,370 )
Proceeds from maturities of marketable investment securities
2,032,802
-
Investment in joint venture
500,000
(150,000 )
Net cash provided by (used in) investing activities
2,393,244
(250,370 )
Cash flows from financing activities
Proceeds from sale of common stock
-
19,470,005
Proceeds from exercise of options and warrants
148,981
50,000
Payment of offering costs
-
(1,457,922 )
Net cash provided by financing activities
148,981
18,062,083
Net increase in cash and cash equivalents
14,812,180
16,476,185
Cash and cash equivalents at beginning of period
42,976,713
893,138
Cash and cash equivalents at end of period
$ 57,788,893
$ 17,369,323
Supplemental disclosure of cash flow information
Interest paid
$ -
$ -
Income taxes paid
$ -
$ -
See
accompanying notes to unaudited condensed consolidated financial statements
5
CO
– DIAGNOSTICS, INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
For
the Three Months ending March 31, 2021 and 2020
(Unaudited)
Convertible Preferred Stock
Common Stock
Additional Paid-in
Accumulated Earnings
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
(Deficit)
Equity
Balance as of December 31, 2020
-
$ -
28,558,033
$ 28,558
$ 49,157,236
$ 17,510,715
$ 66,696,509
Common stock issued for option exercises
-
-
65,891
66
148,914
-
148,980
Stock-based compensation
-
-
41,790
42
1,512,970
-
1,513,012
Net income
-
-
-
-
-
7,898,975
7,898,975
Balance as of March 31, 2021
-
$ -
28,665,714
$ 28,666
$ 50,819,120
$ 24,409,690
$ 76,257,476
Balance as of December 31, 2019
25,600
$ 26
17,342,922
$ 17,343
$ 26,687,701
$ (24,967,814 )
$ 1,737,256
Public offering, net of offering costs of $1,457,922
-
-
7,242,954
7,243
18,004,840
-
18,012,083
Common stock issued for warrant exercises
-
-
719,492
720
49,280
-
50,000
Stock-based compensation expense
-
-
12,363
12
432,811
-
432,823
Conversion of preferred stock to common
(25,600 )
(26 )
2,133,333
2,133
(2,107 )
-
-
Net loss
-
-
-
-
-
(1,065,193 )
(1,065,193 )
Balance as of March 31, 2020
-
$ -
27,451,064
$ 27,451
$ 45,172,525
$ (26,033,007 )
$ 19,166,969
See
accompanying notes to unaudited condensed consolidated financial statements
6
CO
– DIAGNOSTICS, INC.
NOTES
TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
March
31, 2021
(Unaudited)
Note
1 – Overview and Basis of Presentation
Description
of Business
Co-Diagnostics,
Inc., a Utah corporation (the “Company” or “CDI”), is developing robust and innovative molecular tools
for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications. The Company develops,
manufactures and sells reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules
(DNA or RNA). In connection with the sale of these tests, the Company may sell diagnostic equipment and supplies from other manufacturers.
Unaudited
Condensed Consolidated Financial Statements
The
accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with accounting
principles generally accepted in the United States of America for interim financial information and with the instructions to Form
10-Q as they are prescribed for smaller reporting companies. Accordingly, they do not include all the information and footnotes
required by accounting principles generally accepted in the United States of America for complete financial statements. In the
opinion of management, all adjustments (consisting of normal recurring accruals) considered necessary to make the financial statements
not misleading have been included. Operating results for the three months ended March 31, 2021 are not necessarily indicative
of the results that may be expected for the year ending December 31, 2021. These statements should be read in conjunction with
the Company’s audited financial statements and related notes for the year ended December 31, 2020, included in the Company’s
Annual Report on Form 10-K filed on March 25, 2021.
Certain
2020 financial statement amounts have been reclassified to conform to 2021 presentations.
Use
of Estimates
The
preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates
and assumptions that affect the amounts reported in the financial statements and the accompanying notes. Such estimates include
receivables and other long-lived assets, legal and regulatory contingencies, income taxes, share based arrangements, and others.
These estimates and assumptions are based on management’s best estimates and judgments. Actual amounts and results could
differ from those estimates.
Note
2 – Summary of Significant Accounting Policies
Cash
and Cash Equivalents
Cash
and cash equivalents consist of cash on hand, money market funds and highly liquid investments with an original maturity date
of 90 days or less from the date of purchase. The fair value of cash equivalents approximated their carrying value as of March
31, 2021 and December 31, 2020. The Company has its cash and cash equivalents with a large creditworthy financial institution
and the balance exceeded federally insured limits. The Company has not experienced any losses in such accounts, and management
believes the Company is not exposed to any significant credit risk on cash and cash equivalents.
Marketable
Investment Securities
The
Company’s marketable investment securities are comprised of investments in certificates of deposit. The Company determines the
appropriate classification of its marketable investment securities at the time of purchase and re-evaluates such designation at
each balance sheet date. The Company has classified and accounted for its marketable investment securities as available-for-sale securities
as the Company may sell these securities at any time for use in its current operations or for other purposes, even prior to maturity.
As a result, the Company classifies its marketable investment securities, including securities with stated maturities beyond twelve months,
within current assets in the condensed consolidated balance sheets. Any unrealized gains or losses are immaterial.
7
Accounts
Receivable
Trade
accounts receivable are recorded at the invoiced amount (net of allowance) and do not bear interest. The Company maintains an
allowance for doubtful accounts for amounts the Company does not expect to collect. In establishing the required allowance, management
considers historical losses, current market condition, customers’ financial condition, the age of receivables, and current
payment patterns. Account balances are written off against the allowance once the receivable is deemed uncollectible. Recoveries
of trade receivables previously written off are recorded when collected. At March 31, 2021, total accounts receivable was $12,988,627
with an allowance for uncollectable accounts of $871,500 resulting in a net amount of $12,117,127. At December 31, 2020 total
accounts receivable was $12,928,633 with an allowance for uncollectable accounts of $791,800 resulting in a net amount of $12,136,833.
Equity-Method
Investments
Our
equity method investments are initially recorded at cost and are included in other long-term assets in the accompanying condensed
consolidated balance sheet. We adjust the carrying value of our investment based on our share of the earnings or losses in the
periods which they are reported by the investee until the carrying amount is zero. The earnings or losses are included in other
income (expense) in the accompanying condensed consolidated statements of operations.
Inventory
Inventory
is stated at the lower of cost or net-realizable value. Inventory cost is determined on a first-in first-out basis that approximates
average cost in accordance with ASC 330-10-30-12. At March 31, 2021, the Company had $6,197,608 in inventory, of which $925,560
was finished goods and $5,272,048 was raw materials. At December 31, 2020, the Company had $7,995,189 in inventory, of which $598,881
was finished goods and $7,396,308 was raw materials. The Company establishes reserves to reduce slow-moving, obsolete, or unusable
inventories to their estimated useful or scrap values.
Property
and Equipment
Property
and equipment are stated at cost less accumulated depreciation and amortization. Depreciation is provided using the straight-line
method over the estimated useful lives of the property, generally from three to five years. Repairs and maintenance costs are
expensed as incurred except when such repairs significantly add to the useful life or productive capacity of the asset, in which
case the repairs are capitalized.
The
Company reviews its long-lived assets, including property and equipment, for impairment whenever an event or change in facts and
circumstances indicates that their carrying amounts may not be recoverable. Recoverability of these assets is measured by comparing
the carrying amount to the estimated undiscounted future cash flows expected to be generated. If the carrying amount exceeds the
undiscounted cash flows, the assets are determined to be impaired and an impairment charge is recognized as the amount by which
the carrying amount exceeds fair value.
Revenue
Recognition
The
Company generates revenue from product sales and license sales. The Company recognizes revenue when all of the following criteria
are satisfied: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised
goods or services are performance obligations, including whether they are distinct in the context of the contract; (iii) measurement
of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the
performance obligations; and (v) recognition of revenue when, or as the Company satisfies each performance obligation.
8
The
Company constrains revenue by giving consideration to factors that could otherwise lead to a probable reversal of revenue. The
Company records any payments received from customers prior to the Company fulfilling its performance obligation(s) as deferred
revenue.
Deferred
Revenue
Deferred
revenue primarily consists of payments received from customers prior to the Company fulfilling its performance obligation of providing
the product. When this occurs, the Company records a contract liability as deferred revenue. Deferred revenue is recognized as
revenue as the related performance obligations are satisfied.
Research
and Development
Research
and development costs are expensed when incurred. The Company expensed $2,217,063 and $400,022 of research and development costs
for the three months ended March 31, 2021 and 2020, respectively.
Stock-based
Compensation
The
Company has granted stock-based awards, including restricted stock, stock options, stock warrants and restricted stock units (“RSUs”),
to its employees, certain consultants and members of its board of directors. The Company records stock-based compensation based
on the grant date fair value of the awards and recognizes the fair value of those awards as expense using the straight-line method
over the requisite service period of the award. The Company estimates the grant date fair value of stock options using the Black-Scholes
option-pricing model. When an award is forfeited prior to the vesting date, the Company recognizes an adjustment for the previously
recognized expense in the period of the forfeiture.
Income
Taxes
The
Company accounts for income taxes in accordance with the liability method of accounting for income taxes. Under this method, deferred
income tax assets and deferred income tax liabilities represent the tax effect of temporary differences between financial reporting
and tax reporting measured at enacted tax rates in effect for the year in which the differences are expected to reverse. The Company
recognizes only the impact of tax positions that, based on their technical merits, are more likely than not to be sustained upon
an audit by the taxing authority.
Valuation
allowances are provided when it is more-likely-than-not that some or all of the deferred income tax assets may not be realized.
In assessing the need for a valuation allowance, the Company has considered its historical levels of income, expectations of future
taxable income and ongoing tax planning strategies.
Developing
the provision for income taxes, including the effective tax rate and analysis of potential tax exposure items, if any, requires
significant judgment and expertise in federal and state income tax laws, regulations and strategies, including the determination
of deferred income tax assets and liabilities and any estimated valuation allowances deemed necessary to value deferred income
tax assets. Judgments and tax strategies are subject to audit by various taxing authorities. While the Company believes it has
no significant uncertain income tax positions in the consolidated financial statements, adverse determinations by these taxing
authorities could have a material adverse effect on the consolidated financial positions, result of operations, or cash flows.
Concentrations
Risk and Significant Customers
The
Company had certain customers which are each responsible for generating 10% or more of the total revenue for the three months
ended March 31, 2021. Three customers together accounted for approximately 57% of total revenue for the three months ended March
31, 2021.
Two
customers each accounted for more than 10% of accounts receivable at March 31, 2021. These two customers together accounted for
approximately 61% of accounts receivable at March 31, 2021.
9
Net
Income (Loss) per Share
Basic
net income or loss per common share is computed by dividing net income or loss applicable to common shareholders by the weighted
average number of shares outstanding during each period.
Diluted
net income or loss per share is computed by dividing net income or loss attributable to common stockholders by the weighted-average
number of shares of common stock outstanding during the period increased by common shares that could be issued upon conversion
or exercise of other outstanding securities to the extent those additional common shares would be dilutive. The dilutive effect
of potentially dilutive securities is reflected in diluted net income or loss per share by application of the treasury stock method.
During periods when the Company is in a net loss position, basic net loss per share is the same as diluted net loss per share
as the effects of potentially dilutive securities are anti-dilutive.
Recent
Accounting Pronouncements
From
time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board (“FASB”) that are
adopted by the Company as of the specified effective date. If not discussed, management believes that the impact of recently issued
standards, which are not yet effective, will not have a material impact on the Company’s financial statements upon adoption.
As
an emerging growth company (“EGC”), the Company has elected to take advantage of the benefits of the extended transition
period provided for in Section 7(a)(2)(B) of the Securities Act of 1933, as amended, for complying with new or revised accounting
standards which allows the Company to defer adoption of certain accounting standards until those standards would otherwise apply
to private companies.
In
February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), which requires recognition of leased assets and liabilities
on the balance sheet and disclosing key information about leasing arrangements. This update is effective for annual periods and
interim periods with those periods beginning after December 15, 2021, for public EGC companies like us. The Company expects to
use the modified retrospective transition method with the option to recognize a cumulative-effect adjustment at the date of adoption.
The Company expects its balance sheet will be impacted as it records right-of-use assets and lease liabilities on its consolidated
balance sheet but does not expect the adoption of this standard will have a material impact on its consolidated statements of
operations and cash flows.
In
June 2016, the FASB issued ASU No. 2016-13, Financial Instruments-Credit Losses (Topic 326) (“ASU 2016-13”), which
requires the measurement and recognition of expected credit losses for certain financial instruments, which includes the Company’s
accounts receivable. ASU 2016-13 replaces the existing incurred loss impairment model with an expected loss methodology, which
will result in more timely recognition of credit losses. The update is effective for annual periods and interim periods with those
periods beginning after December 15, 2021, for public EGC companies like us. The standard requires a cumulative effect adjustment
to the balance sheet as of the beginning of the first early reporting period in which the guidance is effective. The Company is
evaluating the impact of the adoption of ASU 2016-13 on its consolidated financial statements.
In
December 2019, the FASB issued ASU 2019-12, Income Taxes (Topic 740) (“ASU 2019-12”), which removes certain exceptions
for investments, intra-period allocations and interim calculations and adds guidance to reduce complexity in accounting for income
taxes. The Company adopted this standard on January 1, 2021 and it did not have a material impact on its consolidated financial
statements and related disclosures.
Note
3 – Fair Value Measurements
The
Company measures and records certain financial assets at fair value on a recurring basis. Fair value is based on the price that
would be received from selling an asset or paid to transfer a liability in an orderly transaction between market participants
at the measurement date.
The
Company’s financial instruments that are measured at fair value on a recurring basis consist of money market funds. The
following three levels of inputs are used to measure the fair value of financial instruments:
Level
1: Quoted market prices in active markets for identical assets or liabilities.
10
Level
2: Observable market-based inputs or unobservable inputs that are corroborated by market data.
Level
3: Unobservable inputs that are not corroborated by market data.
The
Company’s financial instruments that are measured at fair value on a recurring basis consist of certificates of deposit.
The following table summarizes the assets measured at fair value on a recurring basis as of March 31, 2021 and December 31, 2020,
by level within the fair value hierarchy:
March 31, 2021
(Level 1)
(Level 2)
(Level 3)
Total
Marketable investment securities:
Certificates of deposit
$ -
$ 2,302,644
$ -
$ 2,302,644
December 31, 2020
(Level 1)
(Level 2)
(Level 3)
Total
Marketable investment securities:
Certificates of deposit
$ -
$ 4,335,446
$ -
$ 4,335,446
Note
4 – Revenue
The
following table sets forth revenue by geographic area:
Three Months Ended March 31,
2021
2020
United States
$ 12,493,950
$ 614,025
Rest of World
7,530,819
934,503
Total
$ 20,024,769
$ 1,548,528
Percentage of revenue by area:
United States
62 %
40 %
Rest of World
38 %
60 %
Deferred
Revenue
Changes
in the Company’s deferred revenue balance for the three months ended March 31, 2021 were as follows:
Balance as of December 31, 2020
$ 305,307
Revenue recognized included in deferred revenue balance at the beginning of the period
(200,071 )
Increase due to prepayments from customers
53,555
Balance as of March 31, 2021
$ 158,791
The
Company expects to perform its performance obligation and recognize the deferred revenue as revenue during the year ended December
31, 2021.
11
Note
5 – Earnings Per Share
The
following table reconciles the numerator and the denominator used to calculate basic and diluted earnings per share for three
months ended March 31, 2021 and 2020:
Three Months Ended March 31,
2021
2020
Numerator
Net income (loss), as reported
$ 7,898,975
$ (1,065,193 )
Denominator
Weighted average shares, basic
28,662,885
22,820,450
Dilutive effect of stock options, warrants and RSUs
1,339,844
-
Shares used to compute diluted earnings per share
30,002,729
22,820,450
Basic earnings per share
$ 0.28
$ (0.05 )
Diluted earnings per share
$ 0.26
$ (0.05 )
As
a result of incurring a net loss for the three months ended March 31, 2020, no potentially dilutive securities are included in
the calculation of diluted earnings per share because such effect would be anti-dilutive. The Company had potentially dilutive
securities as of March 31, 2020, consisting of: (i) 2,121,817 options and (ii) 199,090 warrants.
Note
6 – Stock-Based Compensation
Stock
Incentive Plans
The
Co-Diagnostics, Inc. 2015 Long Term Incentive Plan (the “Incentive Plan”) reserves an aggregate of 6,000,000 shares
of common stock issuable upon the grant of awards under the Incentive Plan. The number of awards available for issuance under
the Incentive Plan was 2,798,683 at March 31, 2021.
Stock
Options
The
following table summarizes option activity during the three months ended March 31, 2021:
Number of Options
Weighted Average Exercise Price
Weighted Average Fair Value
Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2020
1,300,588
$ 2.44
$ 1.24
Granted
-
-
-
Expired
-
-
-
Forfeited/Cancelled
-
-
-
Exercised
(65,891 )
2.26
1.07
Outstanding at March 31, 2021
1,234,697
$ 2.15
$ 1.25
7.68
Exercisable at March 31, 2021
938,030
$ 2.20
$ 1.19
7.42
The
total intrinsic value of options exercised during the three months ended March 31, 2021 was approximately $574,000. The aggregate
intrinsic value of outstanding options at March 31, 2021 was $6,889,338.
Stock-based
compensation cost is measured at the grant date based on the fair value of the award granted and recognized as expense over the
vesting period using the straight-line method. The Company uses the Black-Scholes model to value options granted.
In
January 2021, the Company modified the exercise price of 100,000 of the options from $16.49 to $9.30. Due to the modification,
the Company will recognize incremental stock-based compensation cost of $65,000, Of this amount, the Company recognized approximately
$21,800 during the three months ended March 31, 2021.
12
As
of March 31, 2021, there were 296,667 of unvested options and $258,885 of unrecognized stock-based compensation expense. The unrecognized
stock-based compensation expense is expected to be recognized over 1.2 years.
Restricted
Stock Units
The
grant date fair value of RSUs granted is determined using the closing market price of the Company’s common stock on the
grant date with the associated compensation expense amortized over the vesting period of the awards. The following table sets
forth the outstanding RSUs and related activity for the three months ended March 31, 2021:
Number of RSUs
Weighted Average Grant Date Fair Value
Outstanding at December 31, 2020
522,500
$ 10.49
Granted
480,000
10.40
Vested
(68,750 )
10.62
Forfeited/Cancelled
-
-
Outstanding at March 31, 2021
933,750
$ 10.43
As
of March 31, 2021, there was approximately $8,900,000 of unrecognized stock-based compensation expense related to outstanding
RSUs which is expected to be recognized over a weighted-average period of 2.9 years.
Warrants
The
Company has issued warrants related to past financings and as compensation to third parties for services provided. The Company
estimates the fair value of issued warrants on the date of issuance as determined using a Black-Scholes pricing model. The Company
amortizes the fair value of issued warrants using a vesting schedule based on the terms and conditions of each warrant if granted
for services.
The
following table summarizes warrant activity during the three months ended March 31, 2021:
Number of Warrants
Weighted Average Exercise Price
Weighted Average Fair Value
Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2020
70,000
$ 1.83
$ 5.21
Granted
-
-
-
Forfeited/Cancelled
-
-
-
Exercised
-
-
-
Outstanding at March 31, 2021
70,000
$ 1.83
$ 5.21
3.0
The
aggregate intrinsic value of outstanding warrants at March 31, 2021 was approximately $540,000. All outstanding warrants are exercisable
at March 31, 2021 and there was no unrecognized stock-based compensation expense related to warrants.
Stock
Issued for Services
The
Company has issued restricted stock to third parties for services provided. The grant date fair value of the restricted stock
granted is determined using the closing market price of the Company’s common stock on the grant date with the associated
compensation expense amortized over the vesting period of the stock awards. The Company has issued 4,290 shares of restricted
stock for services during the three months ended March 31, 2021 and there was no unrecognized stock-based compensation expense
related to restricted stock issued.
13
Stock-Based
Compensation Expense
The
Company recognized stock-based compensation expense related to the types of awards discussed above as follows:
Three Months Ended March 31,
2021
2020
Options
$ 76,672
$ 401,630
Restricted stock units
1,396,440
-
Warrants
-
-
Stock
39,900
31,193
Total stock-based compensation expense
$ 1,513,012
$ 432,823
Note
7 – Income Taxes
For
the three months ended March 31, 2021, the Company recognized an expense from income taxes of $1,985,640, representing
an effective tax rate of 20.1%. The Company’s effective tax rate will generally differ from the U.S. Federal statutory
rate of 21.0% due to state taxes, permanent items, and discrete items. For the three months ended March 31, 2020, no benefit from
income taxes was recorded due to the Company being in a full valuation allowance position, resulting in an effective tax rate
of 0.0%.
Note
8 – Related Party Transactions
The
Company acquired the exclusive rights to the CoPrimer technology pursuant to an exclusive license agreement, dated April 2014
(the “Exclusive License Agreement”), between the Company and DNA Logix, Inc., which was assigned to Dr. Brent Satterfield,
a former executive officer, prior to the Company’s acquisition of DNA Logix, Inc. On March 1, 2017, the Company entered
into an amendment to its Exclusive License Agreement for its Cooperative Primers (“License”) technology with Dr. Satterfield.
The amendment provides in part that all accrued royalties under the License cease as of January 1, 2017, and the Company began
in January 2017 to pay to Dr. Satterfield $700,000 of accrued royalties at the rate of $10,000 per month. At March 31, 2021, the
aggregate balance of this related party liability was $120,000.
Note
9 – Commitments and Contingencies
Lease
Obligations
The
Company’s offices are located at 2401 S. Foothill Dr., Suite D, Salt Lake City, Utah 84109-1479. In February 2020, the Company
entered into a 4-year lease agreement for its office space and in March 2020, the Company entered into an addendum with our landlord
for additional space. The new aggregate space consists of approximately 13,687 square feet at a monthly rate of $28,825 and expires
in February 2024. For the three months ended March 31, 2021 the Company expensed $86,588 for rent. For the three months ended
March 31, 2020, the Company expensed $51,818 for rent. The Company’s future minimum lease payments were as follows as of
March 31, 2021:
Year Ending March 31,
2021 (remainder)
$ 214,425
2022
293,595
2023
303,059
2024
50,774
2025
-
Total lease payments
$ 861,853
Litigation
Liabilities
for loss contingencies arising from claims, assessments, litigation, fines, and penalties and other sources are recorded when
it is probable that a liability has been incurred and the amount can be reasonably estimated. Legal costs incurred in connection
with loss contingencies are expensed as incurred.
In
July and September 2020, securities class action complaints were filed by certain stockholders of the Company against the Company
claiming that the Company promulgated false and misleading press releases to increase the price of our stock to improperly benefit
the officers and directors of the Company. The plaintiffs demand compensatory damages sustained as a result of the Company’s
alleged wrongdoing in an amount to be proven at trial. The Company believes these lawsuits are without merit and intends to defend
the cases vigorously. The Company is unable to estimate a range of loss, if any, that could result were there to be an adverse
final decision in these cases. As of the date of this report, the Company does not believe it is probable that these cases will
result in an unfavorable outcome; however, if an unfavorable outcome were to occur in these cases, it is possible that the impact
could be material to the Company’s results of operations in the period(s) in which any such outcome becomes probable and
estimable.
Note
10 – Subsequent Events
The
Company evaluated subsequent events pursuant to ASC Topic 855 and has determined that there are no events that need to be reported.
14
Item
2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
Cautionary
Note Regarding Forward-Looking Statements
This
Quarterly Report on Form 10-Q contains “forward-looking statements” that involve risks and uncertainties. All statements
other than statements of historical fact contained in this Quarterly Report and the documents incorporated by reference herein,
including statements regarding future events, our future financial performance, business strategy, and plans and objectives of
management for future operations, are forward-looking statements. We have attempted to identify forward-looking statements by
terminology including “anticipates,” “believes,” “can,” “continue,” “could,”
“estimates,” “expects,” “intends,” “may,” “plans,” “potential,”
“predicts,” “should,” or “will” or the negative of these terms or other comparable terminology.
Although we do not make forward looking statements unless we believe we have a reasonable basis for doing so, we cannot guarantee
their accuracy. These statements are only predictions and involve known and unknown risks, uncertainties and other factors and
the documents incorporated by reference herein, which may affect our or our industry’s actual results, levels of activity,
performance or achievements expressed or implied by these forward-looking statements. Moreover, we operate in a highly regulated,
very competitive, and rapidly changing environment. New risks emerge from time to time and it is not possible for us to predict
all risk factors, nor can we address the impact of all factors on our business or the extent to which any factor, or combination
of factors, may cause our actual results to differ materially from those contained in any forward-looking statements.
We
have based these forward-looking statements largely on our current expectations and projections about future events and financial
trends that we believe may affect our financial condition, results of operations, business strategy, short term and long-term
business operations, and financial needs. These forward-looking statements are subject to certain risks and uncertainties that
could cause our actual results to differ materially from those reflected in the forward-looking statements. Factors that could
cause or contribute to such differences include, but are not limited to, those discussed in this Quarterly Report, and in particular,
the risks discussed below and under the heading “Risk Factors” in other documents we file with the SEC. The following
discussion should be read in conjunction with the Annual Report on Form 10-K for the fiscal year ended December 31, 2020 filed
with the SEC on March 25, 2021 and the audited financial statements and notes included therein.
You
should not place undue reliance on any forward-looking statement, each of which applies only as of the date of this Quarterly
Report. Except as required by law, we undertake no obligation to update or revise publicly any of the forward-looking statements
after the date of this Quarterly Report to conform our statements to actual results or changed expectations.
You
are advised, however, to consult any further disclosures we make on related subjects in our periodic and current reports filed
with the SEC. You should understand that it is not possible to predict or identify all risk factors. Consequently, you should
not consider this list to be a complete set of all potential risks or uncertainties.
Important
factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation:
●
the
results of clinical trials and the regulatory approval process;
●
market
acceptance of any products that may be approved for commercialization;
●
our
ability to protect our intellectual property rights;
●
the
impact of any infringement actions or other litigation brought against us;
●
competition
from other providers and products;
●
our
ability to develop and commercialize new and improved products and services;
●
changes
in government regulation; and
●
and
other factors (including the risks contained in the section entitled “Risk Factors” in other documents we file
with the SEC) relating to our industry, our operations and results of operations.
15
Should
one or more of these risks or uncertainties materialize, or should the underlying assumptions prove incorrect, actual results
may differ significantly from those anticipated, believed, estimated, expected, intended or planned.
Factors
or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict
all of them. We cannot guarantee future results, levels of activity, performance or achievements. Except as required by applicable
law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform
these statements to actual results.
As
used in this Quarterly Report, the terms “we”, “us”, “our”, and “Co-Diagnostics”
means Co-Diagnostics, Inc., a Utah corporation and its consolidated subsidiaries (the “Company”), unless otherwise
indicated.
Executive
Overview
The
following management’s discussion and analysis of financial condition and results of operations describes the principal
factors affecting the results of our operations, financial condition, and changes in financial condition. This discussion should
be read in conjunction with the accompanying unaudited financial statements and notes thereto included elsewhere in this report.
The information contained in this discussion is subject to a number of risks and uncertainties. We urge you to review carefully
the section of this report entitled “Cautionary Note Regarding Forward-Looking Statements” for a summary of the risks
and uncertainties associated with an investment in our securities.
Business
Overview
Co-Diagnostics,
Inc., a Utah corporation (the “Company” or “CDI”), is developing robust and innovative molecular tools
for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications. We develop, manufacture
and sell reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or
RNA). In connection with the sale of our tests we may sell diagnostic equipment from other manufacturers as self-contained lab
systems (which we refer to as the “MDx Device”).
Our
diagnostics systems enable very rapid, low-cost, molecular testing for organisms and genetic diseases by automating historically
complex procedures in both the development and administration of tests. CDI’s technical advance involves a novel approach
to Polymerase Chain Reaction (“PCR”) test design of primer and probe structure (“CoPrimers”) that eliminates
one of the key vexing issues of PCR amplification, the exponential growth of primer-dimer pairs (false positives and false negatives)
which adversely interferes with identification of the target DNA/RNA.
We
believe our proprietary molecular diagnostics technology is paving the way for innovation in disease detection and life sciences
research through our enhanced detection of genetic material. Because we own our platform, we believe we will be able to accomplish
this faster and more economically, allowing for significant margins while still positioning the Company to be a low-cost provider
of molecular diagnostics and screening services.
In
addition, continued development has demonstrated the unique properties of our CoPrimer technology that make it ideally suited
for a variety of applications where specificity is key to optimal results, including multiplexing several targets, enhanced Single
Nucleotide Polymorphism (“SNP”) detection and enrichment for next gen sequencing.
Our
scientists use the complex mathematics of DNA/RNA test design, to engineer and optimize a DNA/RNA test and to automate algorithms
that rapidly screen millions of possible options to pinpoint the optimum design. Dr. Satterfield, our founder, developed the Company’s
intellectual property consisting of the predictive mathematical algorithms and proprietary reagents used in the testing process,
which together represent a major advance in PCR testing systems. CDI technologies are now protected by eight granted or pending
US and foreign patents, as well as certain trade secrets and copyrights. Ownership of our proprietary platform permits us the
advantage of avoiding payment of patent royalties required by other PCR test systems, which enables the sale of diagnostic tests
at a lower price than competitors, while enabling us to maintain profit margins.
16
We
design our tests by identifying the optimal locations on the target gene for amplification and pair the location with the optimized
primer and probe structure to achieve outputs that meet the design input requirements identified from market research. This is
done by following planned and documented processes, procedures and validation protocols. In other words, the data resulting from
our tests verify that we succeeded in designing what we intended at the outset. Verification is a series of testing that concludes
that the product is ready to proceed to validation in an evaluation either in our lab or in an independent laboratory setting
using initial production tests to confirm that the product as designed meets the user needs.
In
addition to testing for infectious disease, the technology lends itself to identifying any section of a DNA or RNA strand that
describe any type of genetic trait, which creates a number of significant applications. We, in conjunction with our customers,
are active in designing and licensing tests that identify genetic traits in plant and animal genomes. We also have three multiplexed
tests developed to test mosquitos for the identification of diseases carried by the mosquitos to enable municipalities to concentrate
their efforts in spraying mosquito populations on the specific areas known to be breeding the mosquitos that carry deadly viruses.
Recent
Developments
Because
we believe that testing for the COVID-19 virus is going to be a consideration for public health worldwide even after the current
pandemic has subsided, we have initiated a project to facilitate frequent testing in schools, businesses, the hospitality industry,
and at home. We believe this may be accomplished through the development of a low cost, easy to use by non-professionals, testing
device that can provide PCR quality test results in less than an hour. This project is possible due to the facts that in 2020
we were able to successfully lyophilize our Logix Smart COVID-19 test reagents and additionally developed a saliva-based collection
system that does not require the RNA/DNA extraction. While the final result is the same as if done through a lab-based IVD process,
it has the advantages of increased speed and ease of handling thanks to lyophilization. We have engaged the services of a group
of professionals who have the expertise and track record to develop the hardware for such a device using our CoPrimers as the
reagent chemistry. The device will be available to homes, offices, event facilities, and the travel industry at a cost that will
allow screening frequently to prevent spread of the COVID-19 virus and its variants in the future. The device would also be available
to test for other pathogens detectable through saliva samples as we develop those tests and offer them to the marketplace.
RESULTS
OF OPERATIONS
The
Three Months Ended March 31, 2021 Compared to the Three Months ended March 31, 2020
Revenues
For
the three months ended March 31, 2021, we generated revenues of $20,024,769 compared to revenues of $1,548,528 for the three months
ended March 31, 2020. The increase in revenue of $18,476,241 was primarily due to sales of our LogixSmart COVID-19 test developed
in response to the current COVID-19 pandemic. Of the total revenue in the three months ended March 31, 2021, $266,515 related
to the sale of third party manufactured equipment and consumables, which we sourced and sold to customers to facilitate the sales
of our COVID-19 test compared to $105,492 of revenue from the sales of such equipment for the three months ended March 31, 2020.
Cost
of Revenues
We
recorded cost of revenues of $3,272,565 for the three months ended March 31, 2021, compared to $481,740 for the three months ended
March 31, 2020. This increase is due to the increase in revenue in 2021 due to the sale of our LogixSmart COVID-19 test. Of the
total cost of sales during the three months ended March 31, 2021, $202,636 was from equipment sold to our customers compared to
$70,427 for equipment sold to customers for the three months ended March 31, 2020.
17
Expenses
We
incurred total operating expenses of $6,417,303 for the three months ended March 31, 2021, compared to total operating expenses
of $2,148,737 for the three months ended March 31, 2020. The increase in operating expenses was primarily due to the increase
in business activities experienced as a result of our increase in revenue and increased investment in research and development.
General
and administrative expenses increased $1,476,205, from $1,459,484 for the three months ended March 31, 2020 to $2,935,689 for
the three months ended March 31, 2021. The increase in general and administrative expenses was primarily due to increased activity
to support the growth of our business. The primary drivers of the increased expenses related to increases in compensation including
stock-based compensation, insurance expense, contributions to retirement plans and increased expenses for professional services.
Our
sales and marketing expenses for the three months ended March 31, 2021 were $1,197,546, compared to $268,483 for the three months
ended March 31, 2020. The increase of $929,063 was primarily a result of increased personnel related expenses, including commissions
paid to our sales team, and increased stock-based compensation due to the growth in revenue.
Our
research and development expenses increased by $1,817,041, from $400,022 for the three months ended March 31, 2020 to $2,217,063
for the three months ended March 31, 2021. The primary increase in expenses was research expenditures of greater than one million
dollars for our point-of-care device in addition to increases in salaries and related benefits, including stock-based compensation,
as we have added additional employees to our research and development team to increase our product development activities. Additionally,
there has been an increase in professional and lab services utilized to further help us in our research and product development
activities.
Other
Income (Expense)
For
the three months ended March 31, 2021 we had total other expense of $450,286, compared to total other income of $16,756 for the
three months ended March 31, 2020. The decrease was due primarily due to recording a loss of $464,943 from our India joint venture
compared to income of $9,181 from our joint venture in the same period in 2020.
Net
Income
We
realized net income for the three months ended March 31, 2021 of $7,898,975, compared with a net loss for the three months
ended March 31, 2020 of $1,065,193. The increase in net income of $8,964,168 was primarily the result of sales of our LogixSmart
COVID-19 test and resulting margins from those sales offset by increased operating expenses as discussed above. Additionally,
we recorded income tax expense of $1,985,640 for the three months ended March 31, 2021.
Liquidity
and Capital Resources
At
March 31, 2021, we had cash and cash equivalents of $57,788,893 and marketable investment securities of $2,302,644 that could
readily be converted into cash if needed. Additionally, our total current assets of March 31, 2021, were $79,436,997 compared
to total current liabilities of $5,748,255.
Net
cash provided by operating activities during the three months ended March 31, 2021 was $12,269,955, compared to cash used
in operating activities of $1,335,528 for the three months ended March 31, 2020. The increase in cash from operating activities
was primarily due to our increased revenue.
We
received $2,393,244 of cash from investing activities during the three months ended March 31, 2021 from maturity of marketable
investments and repayment of advances from our India joint venture as compared uses of cash of $250,370 during the three months
ended March 31, 2020.
Net
cash provided by financing activities was $148,981 for the three months ended March 31, 2021 realized from the exercise
of options, compared to $18,062,083 for the same period in the prior year. The decrease is primarily due to net proceeds of $18,012,083
received from a series of three registered direct offerings in January and February 2020 pursuant to our shelf registration in
addition to receiving $50,000 from the exercise of warrants and options for the three months ended March 31, 2020.
18
Since
commencing sales of our Logix Smart COVID-19 test in March 2020, we have used our cash generated from those sales to fund the
increase in our inventories and receivables and pay our operating expenses. We have increased our work force primarily in the
area of research and development to complete development of additional tests to enable us to use our distributor network to sell
other products throughout the world and remain profitable in the future.
We
believe that our existing capital resources and the cash generated from future sales will be sufficient to meet our projected
operating requirements for the next 12 months. However, our available capital resources may be consumed more rapidly than currently
expected and we may need or want to raise additional financing for strategic opportunities.
If
needed, we expect additional investment capital to come from (i) additional issuances of our common stock with existing and new
investors or (ii) the private placement of other securities with investors similar to those that have provided funding in the
past. We may not be able to secure such financing in a timely manner or on favorable terms, if at all.
On
October 30, 2020, we filed a Registration Statement on Form S-3 (File No: 333-249651) with the Securities and Exchange Commission
(the “SEC”). The SEC declared the Form S-3 effective on November 5, 2020. Pursuant to a prospectus supplement to the
Form S-3, we may offer and sell up to $100 million of the following securities separately or together, in one or more series or
classes and in amounts, at prices and on terms described in one or more offerings: common stock; preferred stock; warrants to
purchase our securities, each of which may be convertible into equity securities; or units comprised of, or other combinations
of, the foregoing securities through underwriting syndicates managed or co-managed by one or more underwriters or dealers, through
agents or directly to purchasers. Each time our securities are offered, we will provide a prospectus supplement to the Form S-3
containing more specific information about the particular offering. We did not sell any securities pursuant to the Form S-3.
The
foregoing estimates, expectations and forward-looking statements are subject to change as we make strategic operating decisions
from time to time and as our revenue and expenses fluctuate from period to period.
Off-Balance
Sheet Arrangements
We
have no off-balance sheet arrangements.
Item
3. Quantitative and Qualitative Disclosures about Market Risk
Not
required under Regulation S-K for “smaller reporting companies.”
Item
4. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act
that are designed to ensure that information required to be disclosed by a company in the reports that it files or submits under
the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and
forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information
required to be disclosed by a company in the reports that it files or submits under the Exchange Act is accumulated and communicated
to the company’s management, including its principal executive and principal financial officers, as appropriate to allow
timely decisions regarding required disclosure. Our management, with the participation of our Chief Executive Officer and our
Chief Financial Officer, evaluated the effectiveness of our disclosure controls and procedures as of March 31, 2021. Based on
the evaluation of our disclosure controls and procedures as of March 31, 2021, our Chief Executive Officer and Chief Financial
Officer concluded that, as of such date, our disclosure controls were effective.
Changes
in Internal Control over Financial Reporting
As
we previously reported on a Form 8-K, on February 22, 2021, our Board of Directors appointed Brian L. Brown, CPA as the Company’s
Chief Financial Officer. Other than the appointment of Mr. Brown as the Company’s Chief Financial Officer, there
have been no changes in our internal control over financial reporting during the three months ended March 31, 2021, that has materially
affected or, are reasonably likely to materially affect, our internal control over financial reporting.
19
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
There have been no material developments
to the legal proceedings previously disclosed under Item 3 of our Annual Report on Form 10-K for the fiscal year ended December
31, 2020.
From
time to time, we may become involved in litigation relating to claims arising out of our operations in the normal course of business.
Although we have received inquiries from FINRA, NASDAQ and the SEC, to which we have responded, to the best of our knowledge,
no governmental authority is contemplating any proceeding to which we are a party or to which any of our properties or businesses
are subject, which would reasonably be likely to have a material adverse effect on the Company.
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
We
issued the unregistered securities below. For the issuances of unregistered securities, we relied on the exemption from registration
requirements of the Securities Act of 1933, as amended, available under Section 4(a)(2) promulgated thereunder due to the fact
that such issuances did not involve a public offering of securities.
●
On
April 6, 2021, we issued an aggregate of 1,258 shares of our common stock for services rendered pursuant to a consulting agreement.
20
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
Item
6. Exhibits
Exhibit
Index
(a)
Exhibits
Exhibit
Number
Description
31.1*
Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
31.2*
Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
32.1*
Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
32.2*
Certification of 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 Extension Definition Linkbase Document
101.LAB
XBRL
Taxonomy Extension Label Linkbase Document
101.PRE
XBRL
Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File
*
Filed herewith.
21
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
CO-DIAGNOSTICS, INC.
Date: May 13, 2021
By:
/s/ Dwight H. Egan
Name:
Dwight H. Egan
Title:
Chief Executive Officer, President and Principal Executive Officer
Date: May 13, 2021
By:
/s/ Brian Brown
Name:
Brian Brown
Title:
Chief Financial Officer and Principal Financial and Accounting Officer
22
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.