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, Aug. 10, 2023 /PRNewswire/ --
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.
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
|
|
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SOURCE Co-Diagnostics