Clinical trials for Co-Dx PCR Home™ platform
remain on track;
Solid cash position and grant funding support
long-term strategy
SALT
LAKE CITY, May 11, 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 March 31, 2023.
First Quarter 2023 Financial Results:
- Revenue of $0.6 million, down
from $22.7 million during the prior
year primarily due to lower global demand for the Logix Smart™
COVID-19 tests
- Gross profit of $0.1 million,
representing 16.6% of consolidated revenue
- Operating loss of $10.0 million
compared to operating income of $9.8
million a year ago, due to lower revenue and continued
investments into research and development for the Co-Dx PCR Home™
Platform
- Net loss of $5.8 million,
compared to net income of $11.7
million in the prior year, representing EPS loss of
$0.20 per fully diluted share,
compared to EPS of $0.34 in 2022
- Adjusted EBITDA loss of $7.2
million
- Repurchased 0.3 million shares of common stock at an average
price of $1.56 per share for an
aggregate purchase price of approximately $0.5 million
- Cash, cash equivalents, and marketable securities of
$75.3 million as of March 31, 2023
Dwight Egan, Co-Diagnostics'
Chief Executive Officer, said, "Our financial performance during
the quarter reflects the expected decline in COVID-related sales
year-over-year. However, we continue to advance our longer-term
strategy, most notably with progress in our clinical evaluations
for our Co-Dx PCR Home™ platform. We believe that the innovation of
this new platform has been validated after recently receiving
notification of various grant awards, which we expect will be the
subject of future press releases."
Mr. Egan continued, "Looking ahead, we remain focused in our
strategy and will continue to leverage our assets and impressive
team to deliver innovative and affordable diagnostic testing
solutions. To help guide and measure our progress through the
remainder of this year, we have established a set of goals we
anticipate achieving. We expect completion of clinical evaluations
for our Co-Dx PCR Home™ platform and submission to the FDA by the
end of this calendar year. We also anticipate clinical trials for
our ABC+RSV tests (both for clinical laboratories and on the new
platform) to commence during this upcoming flu season."
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,
(ii) completion of clinical evaluations for our Co-Dx PCR Home
platform, and (iii) clinical trials for our ABC+RSV tests to
commence during this upcoming flu season. 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)
|
|
|
|
March 31,
2023
|
|
|
December
31,
2022
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
6,359,380
|
|
|
$
|
22,973,803
|
|
Marketable investment
securities
|
|
|
68,920,535
|
|
|
|
58,289,066
|
|
Accounts receivable,
net
|
|
|
2,702,196
|
|
|
|
3,453,723
|
|
Inventory,
net
|
|
|
5,294,653
|
|
|
|
5,310,473
|
|
Income taxes
receivable
|
|
|
1,695,480
|
|
|
|
1,870,419
|
|
Prepaid expenses and
other current assets
|
|
|
913,175
|
|
|
|
761,187
|
|
Note
receivable
|
|
|
37,500
|
|
|
|
75,000
|
|
Total current
assets
|
|
|
85,922,919
|
|
|
|
92,733,671
|
|
Property and
equipment, net
|
|
|
2,510,083
|
|
|
|
2,539,483
|
|
Operating lease
right-of-use asset
|
|
|
952,176
|
|
|
|
372,115
|
|
Intangible assets,
net
|
|
|
26,661,667
|
|
|
|
26,768,333
|
|
Investment in joint
venture
|
|
|
950,001
|
|
|
|
672,679
|
|
Total
assets
|
|
$
|
116,996,846
|
|
|
$
|
123,086,281
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
829,819
|
|
|
$
|
952,296
|
|
Accrued expenses,
current
|
|
|
1,492,611
|
|
|
|
934,447
|
|
Operating lease
liability, current
|
|
|
277,290
|
|
|
|
297,209
|
|
Contingent
consideration liabilities, current
|
|
|
992,229
|
|
|
|
1,689,471
|
|
Deferred
revenue
|
|
|
18,120
|
|
|
|
-
|
|
Total current
liabilities
|
|
|
3,610,069
|
|
|
|
3,873,423
|
|
Long-term
liabilities
|
|
|
|
|
|
|
|
|
Income taxes
payable
|
|
|
1,193,080
|
|
|
|
1,181,284
|
|
Deferred tax
liability
|
|
|
203,335
|
|
|
|
2,417,987
|
|
Operating lease
liability
|
|
|
658,137
|
|
|
|
50,708
|
|
Contingent
consideration liabilities
|
|
|
702,455
|
|
|
|
1,042,885
|
|
Total long-term
liabilities
|
|
|
2,757,007
|
|
|
|
4,692,864
|
|
Total
liabilities
|
|
|
6,367,076
|
|
|
|
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 March 31,
2023 and December 31,
2022, respectively
|
|
|
-
|
|
|
|
-
|
|
Common stock, $0.001
par value; 100,000,000 shares
authorized; 34,823,015
shares issued and 30,632,345 shares
outstanding as of March
31, 2023 and 34,754,265 shares issued
and 30,872,607 shares
outstanding as of December 31, 2022
|
|
|
34,823
|
|
|
|
34,754
|
|
Treasury stock, at
cost; 4,190,670 and 3,881,658 shares held as
of March 31, 2023 and
December 31, 2022, respectively
|
|
|
(14,694,062)
|
|
|
|
(14,211,866)
|
|
Additional paid-in
capital
|
|
|
90,641,608
|
|
|
|
88,472,935
|
|
Accumulated other
comprehensive income
|
|
|
471,761
|
|
|
|
293,140
|
|
Accumulated
earnings
|
|
|
34,175,640
|
|
|
|
39,931,031
|
|
Total stockholders'
equity
|
|
|
110,629,770
|
|
|
|
114,519,994
|
|
Total liabilities and
stockholders' equity
|
|
$
|
116,996,846
|
|
|
$
|
123,086,281
|
|
|
See
accompanying notes to unaudited condensed consolidated financial
statements
|
CO-DIAGNOSTICS, INC.
AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS)
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Revenue
|
|
$
|
601,957
|
|
|
$
|
22,699,044
|
|
Cost of
revenue
|
|
|
502,241
|
|
|
|
3,281,951
|
|
Gross
profit
|
|
|
99,716
|
|
|
|
19,417,093
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
|
1,706,331
|
|
|
|
2,652,148
|
|
General and
administrative
|
|
|
3,013,965
|
|
|
|
2,922,195
|
|
Research and
development
|
|
|
5,014,060
|
|
|
|
3,771,327
|
|
Depreciation and
amortization
|
|
|
316,010
|
|
|
|
247,264
|
|
Total operating
expenses
|
|
|
10,050,366
|
|
|
|
9,592,934
|
|
Income (loss) from
operations
|
|
|
(9,950,650)
|
|
|
|
9,824,159
|
|
Other income
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
202,372
|
|
|
|
11,393
|
|
Realized gain on
investments
|
|
|
418,082
|
|
|
|
-
|
|
(Loss) on disposition
of assets
|
|
|
-
|
|
|
|
(93,421)
|
|
Gain on remeasurement
of acquisition contingencies
|
|
|
1,037,672
|
|
|
|
3,379,890
|
|
Gain (loss) on equity
method investment in joint venture
|
|
|
277,322
|
|
|
|
(21,339)
|
|
Total other
income
|
|
|
1,935,448
|
|
|
|
3,276,523
|
|
Income (loss) before
income taxes
|
|
|
(8,015,202)
|
|
|
|
13,100,682
|
|
Income tax provision
(benefit)
|
|
|
(2,259,811)
|
|
|
|
1,386,087
|
|
Net income
(loss)
|
|
$
|
(5,755,391)
|
|
|
$
|
11,714,595
|
|
Other comprehensive
income
|
|
|
|
|
|
|
|
|
Change in net
unrealized gains on marketable securities, net of tax
|
|
$
|
178,621
|
|
|
$
|
-
|
|
Total other
comprehensive income
|
|
$
|
178,621
|
|
|
$
|
-
|
|
Comprehensive income
(loss)
|
|
$
|
(5,576,770)
|
|
|
$
|
11,714,595
|
|
|
|
|
|
|
|
|
|
|
Earnings per common
share:
|
|
|
|
|
|
|
|
|
Basic
|
|
$
|
(0.20)
|
|
|
$
|
0.35
|
|
Diluted
|
|
$
|
(0.20)
|
|
|
$
|
0.34
|
|
Weighted average shares
outstanding:
|
|
|
|
|
|
|
|
|
Basic
|
|
|
29,483,540
|
|
|
|
33,935,570
|
|
Diluted
|
|
|
29,483,540
|
|
|
|
34,711,476
|
|
|
See accompanying
notes to unaudited condensed consolidated financial
statements
|
CO-DIAGNOSTICS, INC.
AND SUBSIDIARIES
GAAP AND NON-GAAP
MEASURES
(Unaudited)
|
|
Reconciliation of
net income to adjusted EBITDA:
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2023
|
|
|
2022
|
|
Net income
(loss)
|
|
$
|
(5,755,391)
|
|
|
$
|
11,714,595
|
|
Interest
income
|
|
|
(202,372)
|
|
|
|
(11,393)
|
|
Realized gain on
investments
|
|
|
(418,082)
|
|
|
|
-
|
|
Depreciation and
amortization
|
|
|
316,010
|
|
|
|
247,264
|
|
Transaction
costs
|
|
|
-
|
|
|
|
133
|
|
Change in fair value of
contingent consideration
|
|
|
(1,037,672)
|
|
|
|
-
|
|
Stock-based
compensation expense
|
|
|
2,168,742
|
|
|
|
1,375,097
|
|
Income tax
provision
|
|
|
(2,259,811)
|
|
|
|
1,386,087
|
|
Adjusted
EBITDA
|
|
$
|
(7,188,576)
|
|
|
$
|
14,711,783
|
|
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SOURCE Co-Diagnostics