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, Nov. 9, 2023 /PRNewswire/ --
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.
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
|
|
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multimedia:https://www.prnewswire.com/news-releases/co-diagnostics-inc-reports-third-quarter-2023-financial-results-301983486.html
SOURCE Co-Diagnostics