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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): August 10, 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
August 10, 2023, Co-Diagnostics, Inc. (the “Company”) issued a press release announcing financial results for its quarter
ended June 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:
August 10, 2023 |
By: |
/s/
Brian Brown |
|
Name: |
Brian
Brown |
|
Title: |
Chief
Financial Officer
(Principal
Financial and Accounting Officer) |
Exhibit
99.1
Co-Diagnostics,
Inc. Reports Second Quarter 2023 Financial Results
Co-Dx
receives grant awards from the Bill
& Melinda Gates Foundation; NIH RADx® Tech to develop tests on our new Co-Dx PCR Home™ platform
SALT
LAKE CITY, August 10, 2023— Co-Diagnostics, Inc. (NASDAQ: CODX), a molecular diagnostics company with a unique, patented platform
for the development of molecular diagnostic tests, announced today financial results for the quarter ended June 30, 2023.
Second
Quarter 2023 Financial Results:
|
● |
Revenue
of $0.2 million, down from $5.0 million during the prior year primarily due to the anticipated decline in global demand for the Logix
Smart® COVID-19 tests |
|
● |
Operating
expenses of $11.7 million increased by 42.1% from the prior year same period due to our pre-commercialization investments in our
Co-Dx PCR Home platform* |
|
● |
Operating
loss of $12.0 million compared to operating loss of $4.1 million a year ago |
|
● |
Net
loss of $8.9 million, compared to net loss of $2.7 million in the prior year second quarter, representing EPS loss of $0.31
per fully diluted share, compared to EPS loss of $0.08 in the prior year period |
|
● |
Adjusted
EBITDA loss of $9.6 million |
|
● |
Repurchased
0.4 million shares of common stock at an average price of $1.51 per share for an aggregate purchase price of approximately $0.6 million |
|
● |
Cash,
cash equivalents, and marketable securities of $69.1 million as of June 30, 2023 |
2023
Recent Business Highlights: |
|
|
|
|
● |
NIH
awarded the Company $1.2 million as part of the Rapid Acceleration of Diagnostics
(RADx®) Tech program for completion of its upcoming upper respiratory panel on the
Company’s Co-Dx PCR Home testing platform
|
|
● |
The
company was awarded two grants by the Bill & Melinda Gates Foundation in the amounts of $1.33 million and $987K, to support the development of TB and
HPV tests, respectively
|
|
● |
Signed
lease and began build-out of
new manufacturing facility with capacity for up to 12 lines
of production; first lines expected to be operational by end of 2023 |
|
● |
Received
results from a recent usability and analytical study
conducted by PATH, which investigated the limit-of-detection and ease-of-use of the Company’s Co-Dx PCR Home platform, running the platform’s COVID-19 assay |
Dwight
Egan, Co-Diagnostics’ Chief Executive Officer, said, “While sales of our COVID diagnostic kits declined as
expected, we continue to strengthen our position as we seek to expand our advanced PCR technology reach beyond the four walls of the
lab to the places of greatest unmet need. We remain on track for FDA submission of our new Co-Dx PCR Home platform and
initial testing product by the end of this year.”
“We
remain steadfast in our strategy and continue to progress toward our mission of making affordable, high-quality real-time PCR diagnostics
available to all,” said Brian Brown, Co-Diagnostics’ Chief Financial Officer. “We are making notable progress toward
our goals and move into the second half of this year with strong momentum.”
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 Home platform is subject to FDA review and is not currently 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 Home™ 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 (i) completion of development and FDA submission for approval of the Co-Dx PCR Home platform by end of this year
and (ii) 12 lines of production with first lines expected to be operational by end of 2023. 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)
| |
June
30, 2023 | | |
December
31, 2022 | |
Assets | |
| | |
| |
Current assets | |
| | | |
| | |
Cash
and cash equivalents | |
$ | 13,830,846 | | |
$ | 22,973,803 | |
Marketable investment securities | |
| 55,307,146 | | |
| 58,289,066 | |
Accounts receivable, net | |
| 1,097,393 | | |
| 3,453,723 | |
Inventory, net | |
| 4,691,068 | | |
| 5,310,473 | |
Income taxes receivable | |
| 1,439,451 | | |
| 1,870,419 | |
Prepaid expenses and other
current assets | |
| 981,996 | | |
| 761,187 | |
Note
receivable | |
| 37,500 | | |
| 75,000 | |
Total current assets | |
| 77,385,400 | | |
| 92,733,671 | |
Property and equipment,
net | |
| 2,795,023 | | |
| 2,539,483 | |
Deferred tax asset | |
| 2,012,181 | | |
| - | |
Operating lease right-of-use
asset | |
| 3,228,774 | | |
| 372,115 | |
Intangible assets, net | |
| 26,555,000 | | |
| 26,768,333 | |
Investment
in joint venture | |
| 824,808 | | |
| 672,679 | |
Total
assets | |
$ | 112,801,186 | | |
$ | 123,086,281 | |
Liabilities and stockholders’ equity | |
| | | |
| | |
Current liabilities | |
| | | |
| | |
Accounts payable | |
$ | 1,712,204 | | |
$ | 952,296 | |
Accrued expenses, current | |
| 1,628,765 | | |
| 934,447 | |
Operating lease liability,
current | |
| 772,515 | | |
| 297,209 | |
Contingent consideration
liabilities, current | |
| 744,172 | | |
| 1,689,471 | |
Deferred
revenue | |
| 257,999 | | |
| - | |
Total current liabilities | |
| 5,115,655 | | |
| 3,873,423 | |
Long-term liabilities | |
| | | |
| | |
Income taxes payable | |
| 1,203,975 | | |
| 1,181,284 | |
Deferred tax liability | |
| - | | |
| 2,417,987 | |
Operating lease liability | |
| 2,458,072 | | |
| 50,708 | |
Contingent
consideration liabilities | |
| 591,107 | | |
| 1,042,885 | |
Total
long-term liabilities | |
| 4,253,154 | | |
| 4,692,864 | |
Total
liabilities | |
| 9,368,810 | | |
| 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 June 30, 2023 and December 31, 2022, respectively | |
| - | | |
| - | |
Common stock, $0.001 par value; 100,000,000
shares authorized; 35,348,350 shares issued and 30,788,871 shares outstanding as of June 30, 2023 and 34,754,265 shares issued and 30,872,607
shares outstanding as of December 31, 2022 | |
| 35,348 | | |
| 34,754 | |
Treasury stock, at cost;
4,559,479 and 3,881,658 shares held as of June 30, 2023 and December 31, 2022, respectively | |
| (15,249,796 | ) | |
| (14,211,866 | ) |
Additional paid-in capital | |
| 92,810,883 | | |
| 88,472,935 | |
Accumulated other comprehensive
income | |
| 579,127 | | |
| 293,140 | |
Accumulated
earnings | |
| 25,256,815 | | |
| 39,931,031 | |
Total
stockholders’ equity | |
| 103,432,377 | | |
| 114,519,994 | |
Total
liabilities and stockholders’ equity | |
$ | 112,801,186 | | |
$ | 123,086,281 | |
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME (LOSS)
(Unaudited)
|
|
Three
Months Ended June 30, |
|
Six
Months Ended June 30, |
|
|
2023 |
|
|
2022 |
|
|
2023 |
|
|
2022 |
|
Revenue |
|
$ |
197,806 |
|
|
$ |
5,023,226 |
|
|
$ |
799,763 |
|
|
$ |
27,722,270 |
|
Cost of revenue |
|
|
459,095 |
|
|
|
915,432 |
|
|
|
961,336 |
|
|
|
4,197,383 |
|
Gross
profit |
|
|
(261,289 |
) |
|
|
4,107,794 |
|
|
|
(161,573) |
|
|
|
23,524,887 |
|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and marketing |
|
|
1,732,966 |
|
|
|
1,472,225 |
|
|
|
3,439,297 |
|
|
|
4,124,373 |
|
General and administrative |
|
|
3,713,895 |
|
|
|
2,468,421 |
|
|
|
6,727,860 |
|
|
|
5,390,616 |
|
Research and development |
|
|
5,981,043 |
|
|
|
3,889,844 |
|
|
|
10,995,103 |
|
|
|
7,661,171 |
|
Depreciation
and amortization |
|
|
305,246 |
|
|
|
424,342 |
|
|
|
621,256 |
|
|
|
671,606 |
|
Total
operating expenses |
|
|
11,733,150 |
|
|
|
8,254,832 |
|
|
|
21,783,516 |
|
|
|
17,847,766 |
|
Income
(loss) from operations |
|
|
(11,994,439 |
) |
|
|
(4,147,038 |
) |
|
|
(21,945,089 |
) |
|
|
5,677,121 |
|
Other income |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest income |
|
|
191,892 |
|
|
|
61,671 |
|
|
|
394,264 |
|
|
|
73,064 |
|
Realized gain on investments |
|
|
411,190 |
|
|
|
- |
|
|
|
829,272 |
|
|
|
- |
|
(Loss) on disposition of
assets |
|
|
- |
|
|
|
(48,740 |
) |
|
|
- |
|
|
|
(142,161 |
) |
Gain on remeasurement of
acquisition contingencies |
|
|
359,405 |
|
|
|
812,822 |
|
|
|
1,397,077 |
|
|
|
4,192,712 |
|
Gain
(loss) on equity method investment in joint venture |
|
|
(125,193 |
) |
|
|
(106,525 |
) |
|
|
152,129 |
|
|
|
(127,864 |
) |
Total
other income |
|
|
837,294 |
|
|
|
719,228 |
|
|
|
2,772,742 |
|
|
|
3,995,751 |
|
Income (loss) before income taxes |
|
|
(11,157,145 |
) |
|
|
(3,427,810 |
) |
|
|
(19,172,347 |
) |
|
|
9,672,872 |
|
Income tax provision
(benefit) |
|
|
(2,238,320 |
) |
|
|
(741,507 |
) |
|
|
(4,498,131 |
) |
|
|
644,580 |
|
Net income (loss) |
|
$ |
(8,918,825 |
) |
|
$ |
(2,686,303 |
) |
|
$ |
(14,674,216 |
) |
|
$ |
9,028,292 |
|
Other
comprehensive income (loss) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Change
in net unrealized gains on marketable securities, net of tax |
|
$ |
107,366 |
|
|
$ |
- |
|
|
$ |
285,987 |
|
|
$ |
- |
|
Total other comprehensive
income |
|
$ |
107,366 |
|
|
$ |
- |
|
|
$ |
285,987 |
|
|
$ |
- |
|
Comprehensive income
(loss) |
|
$ |
(8,811,459 |
) |
|
$ |
(2,686,303 |
) |
|
$ |
(14,388,229 |
) |
|
$ |
9,028,292 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings per common share: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
$ |
(0.31 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.50 |
) |
|
$ |
0.28 |
|
Diluted |
|
$ |
(0.31 |
) |
|
$ |
(0.08 |
) |
|
$ |
(0.50 |
) |
|
$ |
0.27 |
|
Weighted average shares outstanding: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
29,088,159 |
|
|
|
32,472,251 |
|
|
|
29,284,175 |
|
|
|
32,509,664 |
|
Diluted |
|
|
29,088,159 |
|
|
|
32,472,251 |
|
|
|
29,284,175 |
|
|
|
33,253,612 |
|
CO-DIAGNOSTICS,
INC. AND SUBSIDIARIES
GAAP
AND NON-GAAP MEASURES
(Unaudited)
Reconciliation of net income to adjusted EBITDA: | |
| | |
| | |
| | |
| |
| |
Three
Months Ended June 30, | |
Six
Months Ended June 30, | |
| |
2023 | |
2022 | | |
2023 | | |
2022 | |
Net income (loss) | |
$ | (8,918,825 | ) | |
$ | (2,686,303 | ) | |
$ | (14,674,216 | ) | |
$ | 9,028,292 | |
Interest income | |
| (191,892 | ) | |
| (61,671 | ) | |
| (394,264 | ) | |
| (73,064 | ) |
Realized gain on investments | |
| (411,190 | ) | |
| - | | |
| (829,272 | ) | |
| - | |
Depreciation and amortization | |
| 305,246 | | |
| 424,342 | | |
| 621,256 | | |
| 671,606 | |
Transaction costs | |
| 310 | | |
| 47,943 | | |
| 310 | | |
| 126,171 | |
Change in fair value of contingent consideration | |
| (359,405 | ) | |
| (812,822 | ) | |
| (1,397,077 | ) | |
| (4,192,712 | ) |
Stock-based compensation expense | |
| 2,169,800 | | |
| 1,533,286 | | |
| 4,338,542 | | |
| 2,908,381 | |
Income tax provision | |
| (2,238,320 | ) | |
| (741,507 | ) | |
| (4,498,131 | ) | |
| 644,580 | |
Adjusted
EBITDA | |
$ | (9,644,276 | ) | |
$ | (2,296,732 | ) | |
$ | (16,832,852 | ) | |
$ | 9,113,254 | |
v3.23.2
Cover
|
Aug. 10, 2023 |
Cover [Abstract] |
|
Document Type |
8-K
|
Amendment Flag |
false
|
Document Period End Date |
Aug. 10, 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 |
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