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2023-11-09
2023-11-09
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xbrli:shares
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
Date
of report (Date of earliest event reported): November 9, 2023
CO-DIAGNOSTICS,
INC.
(Exact
name of small business issuer as specified in its charter)
Utah |
|
1-38148 |
|
46-2609363 |
(State
or other jurisdiction of |
|
(Commission |
|
(IRS
Employer |
incorporation
or organization) |
|
File
Number) |
|
Identification
Number) |
2401
S. Foothill Drive, Suite D, Salt Lake City, Utah 84109
(Address
of principal executive offices)
(801)
438-1036
(Issuer’s
telephone number)
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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, par value $0.001 per share |
|
CODX |
|
The
Nasdaq Capital Market |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
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. ☐
Item
2.02. Results of Operations and Financial Condition.
On
November 9, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter
ended September 30, 2023. The full text of the press release, which includes information regarding the Company’s use of a non-GAAP
financial measure, is furnished as Exhibit 99.1 to this Form 8-K.
The
information contained in this Item 2.02, including Exhibit 99.1 attached hereto, is being furnished and shall not be deemed to be “filed”
for the purposes of Section 18 of the Securities Exchange Act of 1934, or otherwise subject to the liabilities of that section. Furthermore,
the information contained in this Item 2.02 or Exhibit 99.1 shall not be deemed to be incorporated by reference into any registration
statement or other document filed pursuant to the Securities Act of 1933, except as shall be expressly set forth by specific reference
in such filing.
Item
7.01. Regulation FD. Disclosure.
The
information set forth under Item 2.02 is incorporated by reference as if fully set forth herein.
Item
9.01 Financial Statements and Exhibits.
(d)
Exhibits
SIGNATURE
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, hereunto duly authorized.
|
CO-DIAGNOSTICS,
INC. |
|
|
|
Date:
November 9, 2023 |
By: |
/s/
Brian Brown |
|
Name: |
Brian
Brown |
|
Title: |
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
99.1
Co-Diagnostics,
Inc. Reports Third Quarter 2023 Financial Results
Receives
grant award from the Bill & Melinda Gates Foundation in the amount of $9.0M for the development of tuberculosis test on Co-Dx™
PCR platform.
SALT
LAKE CITY, November 9, 2023— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform
for the development of molecular diagnostic tests, today announced financial results for the quarter ended September 30, 2023.
Third
Quarter 2023 Financial Results:
|
● |
Revenue
of $2.5 million, down from $5.1 million during the prior year primarily due to the anticipated decline in global demand for COVID-19
tests. Grant revenue totaled $2.3 million while product revenue totaled $0.1 million |
|
● |
Operating
expenses of $11.1 million increased by 2.5% from the prior year same period due to investments in our Co-Dx™ PCR platform* |
|
● |
Operating
loss of $8.9 million compared to operating loss of $6.5 million a year ago |
|
● |
Net
loss of $6.0 million, compared to net loss of $1.4 million in the prior year second quarter, representing a loss of $0.20 per fully
diluted share, compared to a loss of $0.04 per fully diluted share in the prior year period |
|
● |
Adjusted
EBITDA loss of $6.5 million |
|
● |
Repurchased
149,041 shares of common stock at an average price of $1.12 per share for an aggregate purchase price of approximately $0.2 million
|
|
● |
Cash,
cash equivalents, and marketable securities of $63.4 million as of September 30, 2023 |
2023
Recent Business Highlights:
|
|
● |
Continue
to expect EUA submission to the FDA for our Co-Dx PCR Pro™ platform and COVID-19 assay before the end of 2023 |
|
● |
Received
additional grant funding from the Bill & Melinda Gates Foundation in the amount of $9.0M, to be applied towards regulatory and
clinical validation activities for our tuberculosis test and additional manufacturing and platform development |
|
● |
Appointed
Ivory Chang as Chief Regulatory Affairs Officer, who previously worked at multiple large, renowned diagnostic companies, and brings
many years of experience in in-vitro diagnostic product and point-of-care regulatory submissions to Co-Diagnostics |
|
● |
Participated
in several investor conferences, trade shows, and industry events to share Co-Diagnostics’ vision for increasing accessibility
of PCR diagnostics worldwide, the Company’s unique value proposition, and updates on its new platform |
Dwight
Egan, Co-Diagnostics’ Chief Executive Officer, said, “We are pleased to report $2.3 million in grant revenue, bringing our
total revenue to approximately $2.5 million in the third quarter of 2023. We remain excited for the future of Co-Diagnostics and believe
that the additional grant funding we recently received further validates the disruptive nature of our platform. The Company expects to
finalize an EUA submission to the FDA for the COVID-19 test on our Co-Dx PCR platform by year-end. We anticipate our new platform will
serve as the foundation for Co-Diagnostics’ future development initiatives and believe that our patented Co-Primers™ technology
allows for reliable, affordable high-quality test results and look forward to delivering our unique platform to the market.”
“We
remain committed on our strategy and mission and continue to progress in the development of other test indications beyond Covid-19 for
the new platform: TB, multiplex respiratory, and HPV,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer. “We
are pleased with our progress this year and believe in the potential for the new platform to have a transformative effect on diagnostics
worldwide.”
Conference
Call and Webcast
Co-Diagnostics
will host a conference call and webcast at 4:30 p.m. EDT today to discuss its financial results with analysts and institutional investors.
The conference call and webcast will be available via:
Webcast:
ir.codiagnostics.com on the Events & Webcasts page
Conference
Call: 844-481-2661 (domestic) or 412-317-0652 (international)
The
call will be recorded and later made available on the Company’s website: https://codiagnostics.com.
*The
Co-Dx PCR at-home and point-of-care platform (including the PCR Home™, PCR Pro™, mobile app, and all associated tests) is
subject to review by the FDA and/or other regulatory bodies and is not currently available for sale.
About
Co-Diagnostics, Inc.:
Co-Diagnostics,
Inc., a Utah corporation, is a molecular diagnostics company that develops, manufactures and markets state-of-the-art diagnostics technologies.
The Company’s technologies are utilized for tests that are designed using the detection and/or analysis of nucleic acid molecules
(DNA or RNA). The Company also uses its proprietary technology to design specific tests for its Co-Dx PCR at-home and point-of-care platform
and to locate genetic markers for use in applications other than infectious disease.
Non-GAAP
Financial Measures:
This
press release contains adjusted EBITDA, which is a non-GAAP measure defined as net income excluding depreciation, amortization, income
tax (benefit) expense, net interest (income) expense, stock-based compensation, and one-time transaction related costs. The Company believes
that adjusted EBITDA provides useful information to management and investors relating to its results of operations. The Company’s
management uses this non-GAAP measure to compare the Company’s performance to that of prior periods for trend analyses, and for
budgeting and planning purposes. The Company believes that the use of adjusted EBITDA provides an additional tool for investors to use
in evaluating ongoing operating results and trends and in comparing the Company’s financial measures with other companies, many
of which present similar non-GAAP financial measures to investors, and that it allows for greater transparency with respect to key metrics
used by management in its financial and operational decision-making.
Management
does not consider the non-GAAP measure in isolation or as an alternative to financial measures determined in accordance with GAAP. The
principal limitation of the non-GAAP financial measure is that it excludes significant expenses that are required by GAAP to be recorded
in the Company’s financial statements. In order to compensate for these limitations, management presents the non-GAAP financial
measure together with GAAP results. Non-GAAP measures should be considered in addition to results prepared in accordance with GAAP, but
should not be considered a substitute for, or superior to, GAAP results. A reconciliation table of the net income, the most comparable
GAAP financial measure to adjusted EBITDA, is included at the end of this release. The Company urges investors to review the reconciliation
and not to rely on any single financial measure to evaluate the company’s business.
Forward-Looking
Statements:
This
press release contains forward-looking statements. Forward-looking statements can be identified by words such as “believes,”
“expects,” “estimates,” “intends,” “may,” “plans,” “will” and
similar expressions, or the negative of these words. Such forward-looking statements are based on facts and conditions as they exist
at the time such statements are made and predictions as to future facts and conditions. Forward-looking statements in this release include
statements regarding completion of development and FDA submission for approval of the Co-Dx PCR platform by end of this year. Forward-looking
statements are subject to inherent uncertainties, risks and changes in circumstances. Actual results may differ materially from those
contemplated or anticipated by such forward-looking statements. Readers of this press release are cautioned not to place undue reliance
on any forward-looking statements. There can be no assurance that any of the anticipated results will occur on a timely basis or at all
due to certain risks and uncertainties, a discussion of which can be found in our Risk Factors disclosure in our Annual Report on Form
10-K, filed with the Securities and Exchange Commission (SEC) on March 16, 2023, and in our other filings with the SEC. The Company does
not undertake any obligation to update any forward-looking statement relating to matters discussed in this press release, except as may
be required by applicable securities laws.
Investor
Relations Contact:
Andrew
Benson
Head
of Investor Relations
+1
801-438-1036
investors@codiagnostics.com
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
BALANCE SHEETS
(Unaudited)
|
|
September
30, 2023 |
|
|
December
31, 2022 |
|
Assets |
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
|
Cash
and cash equivalents |
|
$ |
10,239,898 |
|
|
$ |
22,973,803 |
|
Marketable
investment securities |
|
|
53,188,999 |
|
|
|
58,289,066 |
|
Accounts
receivable, net |
|
|
806,704 |
|
|
|
3,453,723 |
|
Inventory,
net |
|
|
4,520,430 |
|
|
|
5,310,473 |
|
Income
taxes receivable |
|
|
1,245,854 |
|
|
|
1,870,419 |
|
Prepaid
expenses and other current assets |
|
|
1,290,146 |
|
|
|
761,187 |
|
Note
receivable |
|
|
18,750 |
|
|
|
75,000 |
|
Total
current assets |
|
|
71,310,781 |
|
|
|
92,733,671 |
|
Property
and equipment, net |
|
|
2,808,339 |
|
|
|
2,539,483 |
|
Deferred
tax asset |
|
|
4,272,002 |
|
|
|
- |
|
Operating
lease right-of-use asset |
|
|
3,032,337 |
|
|
|
372,115 |
|
Intangible
assets, net |
|
|
26,479,333 |
|
|
|
26,768,333 |
|
Investment
in joint venture |
|
|
778,943 |
|
|
|
672,679 |
|
Total
assets |
|
$ |
108,681,735 |
|
|
$ |
123,086,281 |
|
Liabilities
and stockholders’ equity |
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
|
Accounts
payable |
|
$ |
1,416,435 |
|
|
$ |
952,296 |
|
Accrued
expenses, current |
|
|
1,826,639 |
|
|
|
934,447 |
|
Operating
lease liability, current |
|
|
794,516 |
|
|
|
297,209 |
|
Contingent
consideration liabilities, current |
|
|
710,651 |
|
|
|
1,689,471 |
|
Deferred
revenue |
|
|
349,499 |
|
|
|
- |
|
Total
current liabilities |
|
|
5,097,740 |
|
|
|
3,873,423 |
|
Long-term
liabilities |
|
|
|
|
|
|
|
|
Income
taxes payable |
|
|
1,359,725 |
|
|
|
1,181,284 |
|
Deferred
tax liability |
|
|
- |
|
|
|
2,417,987 |
|
Operating
lease liability |
|
|
2,250,393 |
|
|
|
50,708 |
|
Contingent
consideration liabilities |
|
|
484,332 |
|
|
|
1,042,885 |
|
Total
long-term liabilities |
|
|
4,094,450 |
|
|
|
4,692,864 |
|
Total
liabilities |
|
|
9,192,190 |
|
|
|
8,566,287 |
|
Commitments
and contingencies (Note 10) |
|
|
|
|
|
|
|
|
Stockholders’
equity |
|
|
|
|
|
|
|
|
Convertible
preferred stock, $0.001 par value; 5,000,000 shares authorized; 0 shares issued and outstanding as of September 30, 2023 and December
31, 2022, respectively |
|
|
- |
|
|
|
- |
|
Common
stock, $0.001 par value; 100,000,000 shares authorized; 35,367,100 shares issued and 30,658,580 shares outstanding as of September
30, 2023 and 34,754,265 shares issued and 30,872,607 shares outstanding as of December 31, 2022 |
|
|
35,367 |
|
|
|
34,754 |
|
Treasury
stock, at cost; 4,708,520 and 3,881,658 shares held as of September 30, 2023 and December 31, 2022, respectively |
|
|
(15,416,122 |
) |
|
|
(14,211,866 |
) |
Additional
paid-in capital |
|
|
94,983,030 |
|
|
|
88,472,935 |
|
Accumulated
other comprehensive income |
|
|
612,649 |
|
|
|
293,140 |
|
Accumulated
earnings |
|
|
19,274,621 |
|
|
|
39,931,031 |
|
Total
stockholders’ equity |
|
|
99,489,545 |
|
|
|
114,519,994 |
|
Total
liabilities and stockholders’ equity |
|
$ |
108,681,735 |
|
|
$ |
123,086,281 |
|
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
|
|
Three
Months Ended September 30, |
|
|
Nine
Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Product
revenue |
|
$ |
136,533 |
|
|
$ |
5,094,456 |
|
|
$ |
936,296 |
|
|
$ |
32,816,726 |
|
Grant
revenue |
|
|
2,320,565 |
|
|
|
- |
|
|
|
2,320,565 |
|
|
|
- |
|
Total
revenue |
|
|
2,457,098 |
|
|
|
5,094,456 |
|
|
|
3,256,861 |
|
|
|
32,816,726 |
|
Cost
of revenue |
|
|
255,772 |
|
|
|
767,936 |
|
|
|
1,217,108 |
|
|
|
4,965,319 |
|
Gross
profit |
|
|
2,201,326 |
|
|
|
4,326,520 |
|
|
|
2,039,753 |
|
|
|
27,851,407 |
|
Operating
expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales
and marketing |
|
|
1,904,395 |
|
|
|
1,889,907 |
|
|
|
5,343,692 |
|
|
|
6,014,280 |
|
General
and administrative |
|
|
3,147,753 |
|
|
|
3,622,273 |
|
|
|
9,875,613 |
|
|
|
9,012,888 |
|
Research
and development |
|
|
5,788,789 |
|
|
|
5,037,461 |
|
|
|
16,783,892 |
|
|
|
12,698,632 |
|
Depreciation
and amortization |
|
|
296,340 |
|
|
|
312,494 |
|
|
|
917,596 |
|
|
|
984,100 |
|
Total
operating expenses |
|
|
11,137,277 |
|
|
|
10,862,135 |
|
|
|
32,920,793 |
|
|
|
28,709,900 |
|
(Loss)
from operations |
|
|
(8,935,951 |
) |
|
|
(6,535,615 |
) |
|
|
(30,881,040 |
) |
|
|
(858,493 |
) |
Other
income, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income |
|
|
322,877 |
|
|
|
298,184 |
|
|
|
717,141 |
|
|
|
371,248 |
|
Realized
gain on investments |
|
|
425,446 |
|
|
|
- |
|
|
|
1,254,718 |
|
|
|
- |
|
Gain
(loss) on disposition of assets |
|
|
(2,578 |
) |
|
|
4,044 |
|
|
|
(2,578 |
) |
|
|
(138,117 |
) |
Gain
on remeasurement of acquisition contingencies |
|
|
140,296 |
|
|
|
2,886,734 |
|
|
|
1,537,373 |
|
|
|
7,079,446 |
|
Gain
(loss) on equity method investment in joint venture |
|
|
(45,865 |
) |
|
|
(129,047 |
) |
|
|
106,264 |
|
|
|
(256,911 |
) |
Total
other income, net |
|
|
840,176 |
|
|
|
3,059,915 |
|
|
|
3,612,918 |
|
|
|
7,055,666 |
|
Income
(loss) before income taxes |
|
|
(8,095,775 |
) |
|
|
(3,475,700 |
) |
|
|
(27,268,122 |
) |
|
|
6,197,173 |
|
Income
tax (benefit) |
|
|
(2,113,581 |
) |
|
|
(2,114,638 |
) |
|
|
(6,611,712 |
) |
|
|
(1,470,058 |
) |
Net
income (loss) |
|
$ |
(5,982,194 |
) |
|
$ |
(1,361,062 |
) |
|
$ |
(20,656,410 |
) |
|
$ |
7,667,231 |
|
Other
comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in net unrealized gains on marketable securities, net of tax |
|
$ |
33,522 |
|
|
$ |
- |
|
|
$ |
319,509 |
|
|
$ |
- |
|
Total
other comprehensive income |
|
$ |
33,522 |
|
|
$ |
- |
|
|
$ |
319,509 |
|
|
$ |
- |
|
Comprehensive
income (loss) |
|
$ |
(5,948,672 |
) |
|
$ |
(1,361,062 |
) |
|
$ |
(20,336,901 |
) |
|
$ |
7,667,231 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings
(loss) per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.20 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.70 |
) |
|
$ |
0.24 |
|
Diluted |
|
$ |
(0.20 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.70 |
) |
|
$ |
0.23 |
|
Weighted
average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
29,361,300 |
|
|
|
31,321,368 |
|
|
|
29,306,572 |
|
|
|
32,109,213 |
|
Diluted |
|
|
29,361,300 |
|
|
|
31,321,368 |
|
|
|
29,306,572 |
|
|
|
33,002,539 |
|
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
GAAP
AND NON-GAAP MEASURES
(Unaudited)
Reconciliation
of net income to adjusted EBITDA: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Three
Months Ended September 30, |
|
|
Nine
Months Ended September 30, |
|
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Net
income (loss) |
|
$ |
(5,982,194 |
) |
|
$ |
(1,361,062 |
) |
|
$ |
(20,656,410 |
) |
|
$ |
7,667,231 |
|
Interest
income |
|
|
(322,877 |
) |
|
|
(298,184 |
) |
|
|
(717,141 |
) |
|
|
(371,248 |
) |
Realized
gain on investments |
|
|
(425,446 |
) |
|
|
- |
|
|
|
(1,254,718 |
) |
|
|
- |
|
Depreciation
and amortization |
|
|
296,340 |
|
|
|
312,494 |
|
|
|
917,596 |
|
|
|
984,100 |
|
Transaction
costs |
|
|
- |
|
|
|
13,038 |
|
|
|
310 |
|
|
|
139,209 |
|
Change
in fair value of contingent consideration |
|
|
(140,296 |
) |
|
|
(2,886,734 |
) |
|
|
(1,537,373 |
) |
|
|
(7,079,446 |
) |
Stock-based
compensation expense |
|
|
2,172,165 |
|
|
|
2,230,434 |
|
|
|
6,510,708 |
|
|
|
5,138,815 |
|
Income
tax provision |
|
|
(2,113,581 |
) |
|
|
(2,114,638 |
) |
|
|
(6,611,712 |
) |
|
|
(1,470,058 |
) |
Adjusted
EBITDA |
|
$ |
(6,515,889 |
) |
|
$ |
(4,104,652 |
) |
|
$ |
(23,348,740 |
) |
|
$ |
5,008,603 |
|
v3.23.3
Cover
|
Nov. 09, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Nov. 09, 2023
|
Entity File Number |
1-38148
|
Entity Registrant Name |
CO-DIAGNOSTICS,
INC
|
Entity Central Index Key |
0001692415
|
Entity Tax Identification Number |
46-2609363
|
Entity Incorporation, State or Country Code |
UT
|
Entity Address, Address Line One |
2401
S. Foothill Drive
|
Entity Address, Address Line Two |
Suite D
|
Entity Address, City or Town |
Salt Lake City
|
Entity Address, State or Province |
UT
|
Entity Address, Postal Zip Code |
84109
|
City Area Code |
(801)
|
Local Phone Number |
438-1036
|
Written Communications |
false
|
Soliciting Material |
false
|
Pre-commencement Tender Offer |
false
|
Pre-commencement Issuer Tender Offer |
false
|
Title of 12(b) Security |
Common
Stock, par value $0.001 per share
|
Trading Symbol |
CODX
|
Security Exchange Name |
NASDAQ
|
Entity Emerging Growth Company |
false
|
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