UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
DC 20549
FORM
10-Q
☒
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended March 31, 2022
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
46-2609396
(State
or other jurisdiction of
incorporation or organization)
(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
The
Nasdaq Capital Market
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 ☒ No ☐
Indicate
by check mark whether the registrant has submitted electronically 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 ☒ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller
reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer
☐
Accelerated
filer
☐
Non-accelerated
filer
☐
Smaller
reporting company
☒
Emerging
growth company
☒
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 is a shell company (as defined in Rule 12b-2 of the Act). Yes ☐ No ☒
As
of May 12, 2022, there were 33,987,736 shares of common stock, par value $0.001 per share, outstanding.
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
TABLE
OF CONTENTS
PART I FINANCIAL INFORMATION:
Item
1.
Financial Statements (unaudited):
3
Consolidated Balance Sheets
3
Consolidated Statements of Operations
4
Consolidated Statements of Cash Flows
5
Consolidated Statements of Stockholders’ Equity
6
Notes to Consolidated Financial Statements
7
Item
2.
Management’s Discussion and Analysis of Financial Condition and Results of Operations
16
Item
3.
Quantitative and Qualitative Disclosures About Market Risk
20
Item
4.
Controls and Procedures
20
PART II OTHER INFORMATION:
Item
1.
Legal Proceedings
21
Item
1A.
Risk Factors
21
Item
2.
Unregistered Sales of Equity Securities and Use of Proceeds
21
Item
3.
Defaults Upon Senior Securities
21
Item
4.
Mine Safety Disclosures
21
Item
5.
Other Information
21
Item
6.
Exhibits
22
Signatures
23
2
PART
I. FINANCIAL INFORMATION
Item
1. Financial Statements
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
March 31, 2022
December 31, 2021
Assets
Current assets
Cash and cash equivalents
$ 97,421,739
$ 88,607,234
Marketable investment securities
-
1,255,266
Accounts receivable, net
21,662,403
20,839,182
Inventory
4,901,057
2,004,169
Prepaid expenses and other current assets
1,278,598
2,338,444
Note receivable
75,000
75,000
Total current assets
125,338,797
115,119,295
Property and equipment, net
2,252,853
1,933,216
Operating lease right-of-use asset
604,837
-
Goodwill
14,808,411
14,706,818
Intangible assets, net
27,088,333
27,195,000
Investment in joint venture
983,614
1,004,953
Note receivable
75,000
75,000
Total assets
$ 171,151,845
$ 160,034,282
Liabilities and stockholders’ equity
Current liabilities
Accounts payable
$ 1,215,049
$ 607,506
Accrued expenses, current
2,613,218
3,859,652
Operating lease liability, current
283,299
-
Contingent consideration liabilities, current
4,065,537
5,767,304
Income taxes payable
4,843,592
2,213,088
Deferred revenue
-
150,000
Total current liabilities
13,020,695
12,597,550
Long-term liabilities
Income taxes payable
1,284,745
1,067,853
Deferred tax liability
5,868,728
7,228,444
Operating lease liability
275,672
-
Contingent consideration liabilities
2,987,214
4,665,337
Total long-term liabilities
10,416,359
12,961,634
Total liabilities
23,437,054
25,559,184
Commitments and contingencies (Note 12)
-
-
Stockholders’ equity
Convertible preferred stock, $ 0.001
par value; 5,000,000
shares authorized; 0
shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively
-
-
Common stock, $ 0.001 par value; 100,000,000 shares authorized; 33,984,068 and 33,819,862 shares issued and outstanding as of March 31, 2022 and December 31, 2021, respectively
33,984
33,820
Additional paid-in capital
81,796,933
80,271,999
Accumulated earnings
65,883,874
54,169,279
Total stockholders’ equity
147,714,791
134,475,098
Total liabilities and stockholders’ equity
$ 171,151,845
$ 160,034,282
See
accompanying notes to unaudited consolidated financial statements
3
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS
(Unaudited)
2022
2021
Three Months Ended March 31,
2022
2021
Revenue
$ 22,699,044
$ 20,024,769
Cost of revenue
3,281,951
3,272,565
Gross profit
19,417,093
16,752,204
Operating expenses
Sales and marketing
2,652,148
1,197,546
General and administrative
2,922,195
2,935,689
Research and development
3,771,327
2,217,063
Depreciation and amortization
247,264
67,005
Total operating expenses
9,592,934
6,417,303
Income from operations
9,824,159
10,334,901
Other income (expense)
Interest income
11,393
14,657
Loss on disposition of assets
( 93,421 )
-
Gain on remeasurement of acquisition contingencies
3,379,890
-
(Loss) on equity method investment in joint venture
( 21,339 )
( 464,943 )
Total other income (expense)
3,276,523
( 450,286 )
Income before income taxes
13,100,682
9,884,615
Income tax provision
1,386,087
1,985,640
Net income
$ 11,714,595
$ 7,898,975
Earnings per common share:
Basic
$ 0.35
$ 0.28
Diluted
$ 0.34
$ 0.26
Weighted average shares outstanding:
Basic
33,935,570
28,662,885
Diluted
34,711,476
30,002,729
See
accompanying notes to unaudited consolidated financial statements
4
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(Unaudited)
2022
2021
Three Months Ended March 31,
2022
2021
Cash flows from operating activities
Net income
$ 11,714,595
$ 7,898,975
Adjustments to reconcile net income to cash used in operating activities:
Depreciation and amortization
247,264
67,005
Stock-based compensation expense
1,375,097
1,513,012
Change in fair value of acquisition contingencies
( 3,379,890 )
-
Non-cash lease expense
8,762
-
Loss from equity method investment
21,339
464,943
Loss on disposition of assets
93,421
-
Deferred income taxes
( 1,359,716 )
302,399
Bad debt expense
47,862
79,700
Changes in assets and liabilities:
Accounts receivable
( 871,083 )
( 59,994 )
Prepaid expenses
1,042,932
( 114,473 )
Inventory
( 3,088,944 )
1,797,581
Deferred revenue
( 150,000 )
( 146,516 )
Income taxes payable
2,745,803
1,128,438
Accounts payable, accrued expenses and other liabilities
( 641,604 )
( 661,115 )
Net cash provided by operating activities
7,805,838
12,269,955
Cash flows from investing activities
Purchases of property and equipment
( 396,600 )
( 139,558 )
Proceeds from maturities of marketable investment securities
1,255,266
2,032,802
Investment in joint venture
-
500,000
Net cash provided by investing activities
858,666
2,393,244
Cash flows from financing activities
Proceeds from exercise of options and warrants
150,001
148,981
Net cash provided by financing activities
150,001
148,981
Net increase in cash and cash equivalents
8,814,505
14,812,180
Cash and cash equivalents at beginning of period
88,607,234
42,976,713
Cash and cash equivalents at end of period
$ 97,421,739
$ 57,788,893
Supplemental disclosure of cash flow information
Interest paid
$ -
$ -
Income taxes paid
$ -
$ -
Supplemental disclosure of non-cash investing and financing transactions
Inventory moved to property, plant and equipment
$ 192,056
$ -
Right-of-use assets obtained in exchange for new operating lease liabilities
$ 681,327
$ -
See
accompanying notes to unaudited consolidated financial statements
5
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(Unaudited)
Shares
Amount
Shares
Amount
Capital
(Deficit)
Equity
Convertible Preferred Stock
Common Stock
Additional Paid-in
Accumulated Earnings
Total Stockholders’
Shares
Amount
Shares
Amount
Capital
(Deficit)
Equity
Balance as of December 31, 2021
-
$ -
33,819,862
$ 33,820
$ 80,271,999
$ 54,169,279
$ 134,475,098
Common stock issued for option exercises
-
-
45,456
45
49,956
-
50,001
Common stock issued for warrant exercises
-
-
50,000
50
99,950
100,000
Stock-based compensation
-
-
68,750
69
1,375,028
-
1,375,097
Net income
-
-
-
-
-
11,714,595
11,714,595
Balance as of March 31, 2022
-
$ -
33,984,068
$ 33,984
$ 81,796,933
$ 65,883,874
$ 147,714,791
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
-
-
73,040
42
1,512,970
-
1,513,012
Net income
-
-
-
-
-
7,898,975
7,898,975
Balance as of March 31, 2021
-
$ -
28,696,964
$ 28,666
$ 50,819,120
$ 25,409,690
$ 76,257,476
See
accompanying notes to unaudited consolidated financial statements
6
CO
– DIAGNOSTICS, INC. AND SUBSIDIARIES
NOTES
TO UNAUDITED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)
Note
1 – Overview and Basis of Presentation
Description
of Business
Co-Diagnostics,
Inc., a Utah corporation (the “Company”, “Co-Dx” or “CODX”), develops, manufactures and sells
reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including
robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications.
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”). We are also developing a unique, groundbreaking portable PCR testing platform (the “Co-Dx
PCR home testing platform”) designed to bring affordable, reliable gold-standard polymerase chain reaction (“PCR”)
to patients in point-of-care and even at-home settings.
Unaudited
Consolidated Financial Statements
The
accompanying unaudited 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 and emerging growth 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, 2022 are not necessarily indicative of the results that may be expected
for the year ending December 31, 2022. These statements should be read in conjunction with the Company’s audited financial statements
and related notes for the year ended December 31, 2021, included in the Company’s Annual Report on Form 10-K filed on March 24,
2022.
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, 2022 and December
31, 2021. 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 reevaluates 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 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, 2022, total accounts receivable was $ 22,379,861 with an allowance for uncollectable
accounts of $ 717,458 resulting in a net amount of $ 21,662,403 . At December 31, 2021, total accounts receivable was $ 21,508,779 with an
allowance for uncollectable accounts of $ 669,597 resulting in a net amount of $ 20,839,182 .
Equity-Method
Investments
Our
equity method investments are initially recorded at cost and are included in other long-term assets in the accompanying 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 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, 2022, the Company had $ 4,901,057 in inventory, of which $ 4,119,549 was
finished goods and $ 781,508 was raw materials. At December 31, 2021, the Company had $ 2,004,169 in inventory, of which $ 983,088 was finished
goods and $ 1,021,081 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.
Business
Combinations
We
estimate the fair value of assets acquired and liabilities assumed in a business combination. Goodwill as of the acquisition date is
measured as the excess of consideration transferred over the net of the acquisition date fair values of the assets acquired and the liabilities
assumed. Such valuations require management to make significant estimates and assumptions, especially with respect to intangible assets.
Management’s estimates of fair value are based upon assumptions believed to be reasonable, but which are inherently uncertain and
unpredictable, and as a result, actual results may differ from estimates.
Leases
As
described in “Recently Adopted Accounting Standards” below, the Company adopted ASC 842, Leases (“ASC 842”) effective
January 1, 2022. Under ASC 842, the Company determines if an arrangement is or contains a lease at inception by assessing whether the
arrangement contains an identified asset and whether it has the right to control the identified asset. Right-of-use (ROU) assets represent
the Company’s right to use an underlying asset for the lease term and lease liabilities represent the Company’s obligation
to make lease payments arising from the lease. Lease liabilities are recognized at the lease commencement date based on the present value
of future lease payments over the lease term. ROU assets are based on the measurement of the lease liability and also include any lease
payments made prior to or on lease commencement and exclude lease incentives and initial direct costs incurred, as applicable.
As
the implicit rate in the Company’s leases is generally unknown, the Company uses its incremental borrowing rate based on the information
available at the lease commencement date in determining the present value of future lease payments. The Company considers its credit
risk, term of the lease, total lease payments and adjusts for the impacts of collateral, as necessary, when calculating its incremental
borrowing rates. The Company evaluates renewal options at lease inception and on an ongoing basis and includes renewal options that it
is reasonably certain to exercise in its expected lease terms when classifying leases and measuring lease liabilities. Lease costs for
the Company’s operating leases are recognized on a straight-line basis within operating expenses and cost of revenue over the reasonably
assured lease term.
The
Company has elected to not separate lease and non-lease components for leases of office space and, as a result, accounts for any lease
and non-lease components for office space as a single lease component, to the extent they are fixed. Non-lease components that are not
fixed are expensed as incurred as variable lease payments. The Company’s office leases typically include non-lease components such
as common-area maintenance costs. The Company has also elected to not apply the recognition requirement to any leases within its existing
classes of assets with a term of 12 months or less.
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. For the three months ended March 31, 2022, the Company expensed $ 3,771,327 of research
and development costs, respectively. For the three months ended March 31, 2021, the Company expensed $ 2,217,063 .
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.
Net
Income 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.
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, 2022. Three customers together accounted for approximately 54 % and 57 % of total revenue for the three months ended March 31, 2022
and March 31, 2021, respectively.
Two
customers each accounted for more than 10% of accounts receivable at March 31, 2022 and December 31, 2021. These two customers together
accounted for approximately 62 % and 66 % of accounts receivable at March 31, 2022 and December 31, 2021, respectively.
9
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.
Recently
Adopted Accounting Standards
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 Company adopted ASU 2016-13 on January 1, 2022. The adoption did not have an impact on
the Company’s financial statements.
In
February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842) (“ASU 2016-02”), which requires a lessee to recognize
most leases on the balance sheet as lease liabilities with corresponding right-of-use assets. The objective of ASU 2016-02 is to increase
transparency and comparability among organizations by recognizing lease assets and lease liabilities on the balance sheet and disclosing
key information about leasing arrangements. The recognized lease liabilities and lease assets represent the obligation to make payments
and the right to use or control the use of a specified asset for the lease term, respectively.
On
January 1, 2022, the Company adopted Topic 842 using the modified retrospective approach with the effective date as the date of initial
application. Consequently, results for the three months ended March 31, 2022 are presented under Topic 842. No prior period amounts were
adjusted and continue to be reported in accordance with previous lease guidance, ASC Topic 840, Leases. The Company elected the practical
expedients available under the provisions of the new standard, including not reassessing whether expired or existing contracts are or
contain leases; not reassessing the classification of expired or existing leases; and not reassessing the initial direct cost for any
existing leases. Upon adoption, the Company recognized an operating lease liability of $ 626,699 and a corresponding operating right-of-use
asset of $ 681,327 .
Note
3 – Business Combinations
On
December 31, 2021, the Company completed its acquisition of Advanced Conceptions, Inc. (“ACI”) and Idaho Molecular Inc. (“IdMo”),
which were related entities developing, with the Company, an at-home/point-of-care medical diagnostic device. Upon the completion of
the acquisition, all outstanding ACI and Idaho Molecular common stock was exchanged for approximately 3.2 million shares of the Company’s
common stock and contingent consideration that includes up to approximately 1.4 million shares and approximately 456,000 warrants to
purchase shares of the Company’s common stock. The contingent consideration is based on the achievement of certain milestones,
which include regulatory approval for identified products, as well as production and net revenue targets. Upon the completion of the
acquisition, both ACI and IdMo became 100 % wholly-owned subsidiaries of the Company.
Note
4 – Goodwill and Intangible Assets
Goodwill
Goodwill
represents the excess of purchase price and related costs over the value assigned to net tangible and identifiable intangible assets
acquired in business combinations. The following table presents the changes in the carrying amount of goodwill for the three months ended
March 31, 2022:
Schedule
of Goodwill
Balance as of December 31, 2021
$ 14,706,818
Measurement period adjustments
101,593
Balance as of March 31, 2022
$ 14,808,411
Intangible
Assets, Net
The
following table presents details of the Company’s intangible assets, excluding goodwill:
Schedule
of Intangible Assets, Net
Weighted-Average
Gross
Net
Useful Life (1)
Carrying
Accumulated
Carrying
(in Years)
Amount
Amortization
Amount
In-process research and development
Indefinite
$ 26,101,000
$ -
$ 26,101,000
Non-competition agreements
2.7
1,094,000
( 106,667 )
987,333
Total intangible assets
$ 27,195,000
$ ( 106,667 )
$ 27,088,333
Weighted-Average
Gross
Net
Useful Life (1)
Carrying
Accumulated
Carrying
(in Years)
Amount
Amortization
Amount
In-process research and development
Indefinite
$ 26,101,000
$ -
$ 26,101,000
Non-competition agreements
2.7
1,094,000
-
1,094,000
Total intangible assets
$ 27,195,000
$ -
$ 27,195,000
(1) Based on weighted-average useful life established as of the acquisition date.
Note
5 – 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.
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.
10
The
following table summarizes the assets measured at fair value on a recurring basis as of March 31, 2022, and December 31, 2021, by level
within the fair value hierarchy:
Schedule of Fair Value Assets and Liabilities
(Level 1)
(Level 2)
(Level 3)
Total
March 31, 2022
(Level 1)
(Level 2)
(Level 3)
Total
Liabilities:
Contingent consideration - common stock
$ -
$ -
$ 6,013,939
$ 6,013,939
Contingent consideration - warrants
-
-
1,038,812
1,038,812
Total liabilities measured at fair value
$ -
$ -
$ 7,052,751
$ 7,052,751
(Level 1)
(Level 2)
(Level 3)
Total
December 31, 2021
(Level 1)
(Level 2)
(Level 3)
Total
Assets:
Marketable securities (certificates of deposit)
$ -
$ 1,255,266
$ -
$ 1,255,266
Total assets measured at fair value
$ -
$ 1,255,266
$ -
$ 1,255,266
Liabilities:
Contingent consideration - common stock
$ -
$ -
$ 8,684,669
$ 8,684,669
Contingent consideration - warrants
-
-
1,747,972
1,747,972
Total liabilities measured at fair value
$ -
$ -
$ 10,432,641
$ 10,432,641
The
Company’s financial instruments that are measured at fair value on a recurring basis consist of certificates of deposit.
The
changes for Level 3 items measured at fair value on a recurring basis are as follows:
Schedule of Changes in Fair Value Measurement
Fair value as of December 31, 2021
$ 10,432,641
Change in fair value of contingent consideration issued for business acquisitions
( 3,379,890 )
Fair value as of March 31, 2022
$ 7,052,751
The
fair value of the contingent consideration is based on the fair value of the contingent consideration-common stock and contingent consideration-warrants.
The fair value of the contingent consideration-common stock is equal to the probability-adjusted value of the Company’s common
stock as of March 31, 2022. The fair value of the contingent consideration-warrants is equal to the probability adjusted value of a call
option with terms consistent with the terms of the warrants as of March 31, 2022. Prior to the probability adjustments, the warrants
were valued based on the following inputs:
Schedule of Contingent Consideration Common Stock and Warrants
March
31, 2022
December 31, 2021
Stock price
$ 6.18
$ 8.93
Strike price
$ 9.13
$ 9.13
Volatility
77.50 %
80.00 %
Risk-free rate
2.40 %
1.30 %
Expected term
4.8
5.0
Note
6 – Revenue
The
following table sets forth revenue by geographic area:
Summary of Revenue by Geographic Area
Three Months Ended March 31,
2022
2021
United States
$ 14,218,398
$ 12,493,950
Rest of World
8,480,646
7,530,819
Total
$ 22,699,044
$ 20,024,769
Percentage of revenue by area:
United States
63 %
62 %
Rest of World
37 %
38 %
Deferred
Revenue
Changes
in the Company’s deferred revenue balance for the three months ended March 31, 2022 were as follows:
Schedule of Deferred Revenue
Balance as of December 31, 2021
$ 150,000
Revenue recognized included in deferred revenue balance at the beginning of the period
( 150,000 )
Balance as of March 31, 2022
$ -
11
Note
7 – 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, 2022:
Schedule of Basic and Diluted Earnings Per Share
2022
2021
Three Months Ended March 31,
2022
2021
Numerator
Net income, as reported
$ 11,714,595
$ 7,898,975
Denominator
Weighted average shares, basic
33,935,570
28,662,885
Dilutive effect of stock options, warrants and RSUs
775,906
1,339,844
Shares used to compute diluted earnings per share
34,711,476
30,002,729
Basic earnings per share
$ 0.35
$ 0.28
Diluted earnings per share
$ 0.34
$ 0.26
For
the three months ended March 31, 2022, potentially dilutive securities of 1,271,304 were excluded from the calculation because their
effect would have been anti-dilutive. For the three months ended March 31, 2021, potentially dilutive securities of 2,320,907 were excluded
from the calculation because their effect would have been anti-dilutive. The computation of diluted earnings per share for the three
months ended March 31, 2022 also excludes the approximately 1.4 million shares of common stock and approximately 456,000 warrants to
purchase shares of common stock that are contingent upon the achievement of certain milestones.
Note
8 – Stock-Based Compensation
Stock
Incentive Plans
The
Co-Diagnostics, Inc. Amended and Restated 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 2,095,266 at March 31, 2022.
Stock
Options
The
following table summarizes option activity during the three months ended March 31, 2022:
Schedule of Option Activity
Number of Options
Weighted Average Exercise Price
Weighted Average Fair Value
Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2021
1,111,363
$ 2.12
$ 1.31
6.62
Granted
-
-
-
Expired
-
-
-
Forfeited/Cancelled
-
-
-
Exercised
( 45,456 )
1.10
0.51
Outstanding at March 31, 2022
1,065,907
$ 2.17
$ 1.35
6.65
Exercisable at March 31, 2022
1,049,241
$ 2.05
$ 1.21
6.63
The
total intrinsic value of options exercised during the three months ended March 31, 2022 was approximately $ 0.3 million. The aggregate
intrinsic value of outstanding options at March 31, 2022 was approximately $ 4.5 million.
12
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.
As
of March 31, 2022, there were 16,666 of unvested options and $ 37,241 of unrecognized stock-based compensation expense. The unrecognized
stock-based compensation expense is expected to be recognized over 0.2 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, 2022:
Schedule of Outstanding Restricted Stock Units and Related Activity
Number of RSUs
Weighted Average Grant Date Fair Value
Unvested at December 31, 2021
1,267,415
$ 9.94
Granted
-
-
Vested
( 68,750 )
10.23
Forfeited/Cancelled
-
-
Unvested at March 31, 2022
1,198,665
$ 9.92
As
of March 31, 2022, there was approximately $ 10.3 million of unrecognized stock-based compensation expense related to outstanding RSUs
which is expected to be recognized over a weighted-average period of 2.1 years.
Warrants
The
Company has issued warrants related to financings, acquisitions 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, 2022:
Schedule of Warrant Activity
Number of Warrants
Weighted Average Exercise Price
Weighted Average Fair Value
Weighted Average Remaining Contractual Life (Years)
Outstanding at December 31, 2021
526,281
$ 8.15
$ 4.01
4.7
Granted
-
-
-
Expired
-
-
-
Forfeited/Cancelled
-
-
-
Exercised
( 50,000 )
2.00
1.22
Outstanding at March 31, 2022
476,281
$ 8.80
$ 2.82
4.8
13
The
intrinsic value of warrants exercised during the three months ended March 31, 2022 and 2021 was approximately $ 0.3 million and $ 0 , respectively.
The aggregate intrinsic value of outstanding warrants at March 31, 2022 was approximately $ 0.1 million.
The
total number of warrants exercisable at March 31, 2022 are 20,000 . The ability to exercise the approximately 456,000 warrants issued
in connection with acquisitions in the prior year is contingent upon the achievement of certain development and revenue milestones on
or before January 1, 2027. 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 issued 0 and 4,290 shares of restricted stock for services during
the three months ended March 31, 2022 and 2021, respectively. There was no unrecognized stock-based compensation expense related to restricted
stock issued.
Stock-Based
Compensation Expense
The
Company recognized stock-based compensation expense related to the types of awards discussed above as follows:
Schedule of Recognized Stock-based Compensation Expense
2022
2021
Three Months Ended March 31,
2022
2021
Options
$ 40,874
$ 76,672
Restricted stock units
1,334,223
1,396,440
Stock
-
39,900
Total stock-based compensation expense
$ 1,375,097
$ 1,513,012
Note
9 – Income Taxes
For
the three months ended March 31, 2022, the Company recognized expense from income taxes of $ 1,386,087 , representing an effective tax
rate of 10.6 %. 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, 2021, the Company recognized expense from income taxes
of $ 1,985,640 .
Note
10 – 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, 2022 and 2021, the aggregate balance of this related party
liability was $ 0 and $ 120,000 , respectively.
14
Note
11 – Leases
The
Company leases office space under a non-cancelable operating lease and leases cancellable with one month notice. The Company expenses
the cancellable leases in the period incurred in accordance with the practical expedient elected. As such, one lease makes up the entirety
of the right-of-use asset and lease liability disclosed.
For
the three months ended March 31, 2022, components of lease expense are summarized as follows:
Schedule
of Lease Expense
Three Months Ended March 31, 2022
Operating lease costs
$ 86,588
Short-term lease costs
76,080
Total lease costs
$ 162,668
Short-term
lease costs under month-to-month lease agreements are paid to related parties.
As
of March 31, 2022, the maturities of the Company’s lease liabilities are as follows:
Schedule
of Maturities on Company Lease Liabilities
Year Ending
December 31,
2022 (remainder)
$ 221,350
2023
303,059
2024
50,774
2025
-
2026
-
Thereafter
-
Total lease payments
575,183
Less: imputed interest
16,212
Present value of operating lease liabilities
558,971
Less: current portion
283,299
Long-term portion
$ 275,672
Other
information related to operating leases was as follows:
Schedule
of Other Information Related to Operating Lease
Three Months Ended March 31, 2022
Cash paid for operating leases included in operating cash flows
$ 154,882
Remaining lease term of operating leases
2
years
Discount rate of operating leases
3.1 %
As
previously disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021, future lease payments under ASC 840 for
operating leases were as follows:
Schedule of Future Minimum Lease Payments
Year Ending December 31,
2022
$ 293,595
2023
303,059
2024
50,774
Total lease payments
$ 647,428
Note
12 – Commitments and Contingencies
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.
The
Company is currently a defendant in five different securities class action complaints that were filed by certain stockholders of 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
13 – Share Repurchase Program
In
March 2022, the Company’s Board of Directors authorized a share repurchase program that would allow the Company to repurchase up
to $ 30.0 million of CODX common stock. The repurchase program does not obligate the Company to acquire any particular amount of common
shares, and the repurchase program may be suspended or discontinued at any time at the Company’s discretion. The timing and amount
of any share repurchases under the share repurchase program will be determined by Co-Diagnostics’ management at its discretion
based on ongoing assessments of the capital needs of the business, the market price of the Company’s common stock, corporate and
regulatory requirements, and general market conditions.
The
Company has not made any repurchases under the share purchase program since its implementation.
Note
14 – 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.
15
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, 2021, filed with the SEC on March 24, 2022, 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
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.
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.
16
Business
Overview
Co-Diagnostics,
Inc., a Utah corporation (the “Company”, “Co-Dx” or “CODX”), develops, manufactures and sells
reagents used for diagnostic tests that function via the detection and/or analysis of nucleic acid molecules (DNA or RNA), including
robust and innovative molecular tools for detection of infectious diseases, liquid biopsy for cancer screening, and agricultural applications.
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”). We are also developing a unique, groundbreaking portable PCR testing platform (the
“Co-Dx PCR home testing platform”) designed to bring affordable, reliable gold-standard polymerase chain reaction (“PCR”)
to patients in point-of-care and even at-home settings.
Our
diagnostics systems enable dependable, low-cost, molecular testing for organisms and genetic diseases by automating historically complex
procedures in both the development and administration of tests. CODX’s technical advance involves a novel, patented approach to
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. For various reasons, including owning our own 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 CoPrimers™ technology that we believe makes 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 generation sequencing.
Our
scientists use the complex mathematics of DNA/RNA test design to engineer and optimize DNA/RNA tests and to automate algorithms that
rapidly screen millions of possible options to pinpoint the optimum design. Dr. Brent Satterfield, our founder, developed the Company’s
intellectual property consisting of the predictive mathematical algorithms and patented molecular structure used in the testing process,
which together represent a major advance in PCR testing systems. CODX technologies are now protected by more than 20 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 may allow the sale of diagnostic PCR tests at a lower
price than competitors, while enabling us to maintain profit margins.
We
may either sell or lease the MDx Device to labs and diagnostic centers, through sale or lease agreements, and sell the reagents that
comprise our proprietary tests to those laboratories and testing facilities.
Our
proprietary test design process involves identifying the optimal locations on the target genes for amplification and pair the locations
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 testing. In other words, we use the data resulting from our
tests to verify whether 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 laboratory or in an independent laboratory setting
using initial production tests to confirm that the product as designed meets the user needs.
Using
our proprietary test design system and proprietary reagents, we have designed and obtained regulatory approval in the European Community
and in India to sell PCR diagnostic tests for the detection of COVID-19, influenza, tuberculosis, hepatitis B and C, human papillomavirus,
malaria, chikungunya, dengue, and the zika virus. In the United States, CODX has obtained Emergency Use Authorization (“EUA”)
for its Logix Smart™ COVID-19 detection test from the Food and Drug Administration, or FDA, and sells that test to qualified labs.
In addition, our COVID-19 detection test and certain of our other suite of COVID-19 products have been approved for sale in countries
such as the United Kingdom, Australia and Mexico by the regulatory bodies in those countries and have been registered for sale in many
more countries.
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 managing
mosquito populations on the specific areas known to be breeding the mosquitos that carry deadly viruses.
Because
we believe that testing for COVID-19 is going to be a consideration for public health worldwide even after the current pandemic has subsided,
we have initiated the Co-Dx PCR home testing platform to facilitate frequent testing in homes, schools, businesses, and
the hospitality industry. We believe this may be accomplished through the development of a low-cost testing device, easy to use by non-professionals,
that can provide PCR test results in around 30 minutes. The initial project built on this platform, an at-home and point-of-care COVID-19
PCR test, was ultimately facilitated by our development of a saliva or nasal swab-based PCR test that does not require the RNA/DNA extraction.
While the final result is believed to be approximately equivalent to those processed by a high-complexity clinical laboratory, it has
the advantages of increased speed and ease of handling thanks to lyophilization (or freeze-drying) of our testing reagents to allow for
stability at room temperatures.
On
February 15, 2021, we engaged the services of a group of professionals at Idaho Molecular, Inc. (IdMo) and Advanced Conceptions, Inc
(ACI) with the expertise to develop the hardware for such a device using our CoPrimers™ as the reagent chemistry. On December 22,
2021, we announced that we would be acquiring IdMo and ACI, and on December 31, 2021, we completed the acquisitions, along with all existing
and future assets and intellectual property related to the platform and device. It is expected that the device and test will be available
to homes, schools, offices, and the travel industry among other locations at a cost that will allow screening frequently to prevent spread
of the COVID-19 virus in the future. The device would also be available to test for other pathogens detectable through saliva or other
samples as we develop those tests and offer them to the marketplace. All such tests will be subject to regulatory approval.
17
RESULTS
OF OPERATIONS
The
Three Months Ended March 31, 2022 Compared to the Three Months ended March 31, 2021
Revenues
For
the three months ended March 31, 2022, we generated revenues of $22,699,044, compared to revenues of $20,024,769 for the three months
ended March 31, 2021. The increase in revenue of $2,674,275 was primarily due to sales of our Logix Smart™ COVID-19 test developed
in response to the current COVID-19 pandemic. Of the total revenue in the three months ended March 31, 2022, $364,950 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 $266,515 of revenue from the sales of such equipment for the three months ended March 31, 2021.
Cost
of Revenues
We
recorded cost of revenues of $3,281,951 for the three months ended March 31, 2022, compared to $3,272,565 for the three months ended
March 31, 2021. The increase in revenues combined with a reduction of product production costs resulted in improved gross margin. Of
the total cost of sales during the three months ended March 31, 2022, $374,683 was from equipment sold to our customers compared to $202,636
for equipment sold to customers for the three months ended March 31, 2021.
Expenses
We
incurred total operating expenses of $9,592,934 for the three months ended March 31, 2022, compared to total operating expenses of $6,417,303
for the three months ended March 31, 2021. The increase in operating expenses was due to the increase in business activities experienced
as a result of our increase in revenue, increased third party sales commissions reflected in sales and marketing, and increased investment
in research and development.
Our
sales and marketing expenses for the three months ended March 31, 2022 were $2,652,148, compared to $1,197,546 for the three months ended
March 31, 2021. The increase was primarily a result of increased third-party sales commissions, advertising and promotional expenses,
including tradeshows and related travel, and increased stock-based compensation due to the growth in revenue.
General
and administrative expenses decreased from $2,935,689 for the three months ended March 31, 2021 to $2,922,195 for the three months ended
March 31, 2022. The slight decrease in general and administrative expenses was primarily due to decreased stock-based compensation expense,
partially offset by increased activity to support the growth of our business, including increased insurance expense and professional
and advisory fees related to our recent acquisitions.
Our
research and development expenses increased from $2,217,063 for the three months ended March 31, 2021 to $3,771,327 for the three months
ended March 31, 2022. The primary increase in expenses was a result of increases in personnel expenses related to our acquisitions of
IdMo and ACI on December 31, 2021.
18
Other
Income (Expense)
For
the three months ended March 31, 2022 we had total other income of $3,276,523, compared to total other expense of $450,286 for the three
months ended March 31, 2021. The increase was due primarily to a change in the fair value of contingent consideration liabilities recorded
in conjunction with the acquisitions of IdMo and ACI.
Net
Income
We
realized net income for the three months ended March 31, 2022 of $11,714,595, compared with net income for the three months ended March
31, 2021 of $7,898,975. The increase in net income was primarily the result of an increase in operating expenses, offset by an increase
of product revenues and resulting margins from those sales, as well as changes in the fair value of acquisition contingencies. Additionally,
we recorded income tax expense of $1,386,087 for the three months ended March 31, 2022, compared to $1,985,640 for the three months ended
March 31, 2021.
Liquidity
and Capital Resources
At
March 31, 2022, we had cash and cash equivalents of $97,421,739 that could readily be converted into cash if needed. Additionally, our
total current assets of March 31, 2022, were $125,338,797 compared to total current liabilities of $13,020,695.
Net
cash provided by operating activities during the three months ended March 31, 2022 was $7,805,838, compared to $12,269,955 for the three
months ended March 31, 2021. The decrease in cash from operating activities was primarily due to increased operating expenses, increases
in inventory, and the effects of non-cash items.
We
received $858,666 of cash from investing activities during the three months ended March 31, 2022, primarily from maturities of marketable
investments offset by purchases of property and equipment, compared to cash from investing activities of $2,393,244 during the three
months ended March 31, 2021.
Net
cash provided by financing activities was $150,001 for the three months ended March 31, 2022 realized from the exercise of options and
warrants, compared to $148,981 for the same period in the prior year.
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. In March 2022 our board of directors authorized repurchasing up to $30.0 million
of the company’s outstanding common stock. We have no obligation to repurchase any shares under the repurchase program and may
suspend or discontinue it at any time without prior notice. We have not repurchased any of our outstanding common shares under the repurchase
program.
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.
19
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, 2022. Based on the evaluation of our disclosure controls and procedures as of
March 31, 2022, 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
There
have been no changes in our internal control over financial reporting 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.
20
PART
II – OTHER INFORMATION
Item
1. Legal Proceedings
There
have been no material developments to the legal proceedings previously disclosed under Part I. Item 3 of our Annual Report on Form 10-K
for the fiscal year ended December 31, 2021.
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
1A. Risk Factors.
Not
required under Regulation S-K for “smaller reporting companies.”
Item
2. Unregistered Sales of Equity Securities and Use of Proceeds
None.
Dividends
We
have never declared or paid any cash dividends on our capital stock. The payment of dividends on our common stock in the future will
depend on our earnings, capital requirements, operating and financial condition and such other factors as our Board of Directors may
consider appropriate. We currently expect to use all available funds to finance the future development and expansion of our business
and do not anticipate paying dividends on our common stock in the foreseeable future.
Pursuant
to Section 16-10a-640 of the Utah Revised Business Corporation Act, no distribution may be made
if, after giving it effect:
(a)
the
corporation would not be able to pay its debts as they become due in the usual course of business; or
(b)
the
corporation’s total assets would be less than the sum of its total liabilities plus, unless the articles of incorporation permit
otherwise, the amount that would be needed, if the corporation were to be dissolved at the time of the distribution, to satisfy the
preferential rights upon dissolution of shareholders whose preferential rights are superior to those receiving the distribution.
Share
Repurchase Program
In
March 2022 our board of directors authorized repurchasing up to $30.0 million of the company’s outstanding common stock. We did
not repurchase any of our outstanding common shares under the repurchase program during the first quarter ending March 31, 2022.
Item
3. Defaults Upon Senior Securities
None.
Item
4. Mine Safety Disclosures
Not
applicable.
Item
5. Other Information
None.
21
Item
6. Exhibits
Exhibit
Index
(a)
Exhibits
Exhibit
Number
Description
3.1
Amended and Restated Bylaws of Co-Diagnostics, Inc. (Incorporated by reference herein from Form 8-K (Exhibit 3.1), filed 04/01/22, SEC File No. 001-38148.
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
Inline
XBRL Instance Document
101.SCH
Inline
XBRL Taxonomy Extension Schema Document
101.CAL
Inline
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
Inline
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
Inline
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
Inline
XBRL Taxonomy Extension Presentation Linkbase Document
104
Cover
Page Interactive Data File
*
Filed herewith.
22
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 12, 2022
By:
/s/
Dwight H. Egan
Name:
Dwight
H. Egan
Title:
Chief
Executive Officer, President and Principal Executive Officer
Date:
May 12, 2022
By:
/s/
Brian Brown
Name:
Brian
Brown
Title:
Chief
Financial Officer and Principal Financial and Accounting Officer
23
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.