SALT
LAKE CITY, May 9, 2024 /PRNewswire/ --
Co-Diagnostics, Inc. (NASDAQ: CODX) ("Co-Dx," or the "Company"), a
molecular diagnostics company with a unique, patented platform for
the development of molecular diagnostic tests, today announced
financial results for the quarter ended March 31, 2024.
First Quarter 2024 Financial Results:
- Revenue of $0.5 million, down
from $0.6 million during the prior
year. Grant revenue totaled $0.2
million while product revenue totaled $0.3 million
- Operating expenses of $10.5
million increased by 4.4% from the prior year due to an
increase in research and development costs incurred for the
development of tests currently in our pipeline
- Operating loss of $10.3 million
compared to operating loss of $10.0
million in Q1 2023
- Net loss of $9.3 million,
compared to net loss of $5.8 million
in the prior year, representing a loss of $0.31 per fully diluted share, compared to a loss
of $0.20 per fully diluted share in
the prior year
- Adjusted EBITDA loss of $8.4
million compared to $7.2
million in Q1 2023
- Cash, cash equivalents, and marketable securities of
$50.0 million as of March 31, 2024
First Quarter and Recent 2024 Business Highlights:
- Appointed Richard Abbott as
President of Co-Diagnostics. Also appointed David Nielsen as Chief Operations Officer (COO),
Christopher Thurston as Chief
Technology Officer (CTO), and Seth
Egan as Chief Commercialization Officer (CCO)
- Inaugurated a new manufacturing facility in South Salt Lake to manufacture our patented
Co-Primers® oligonucleotides, the Co-Dx™ PCR Pro™ instrument, and
test cups for the new Co-Dx PCR platform
- Delivered a keynote address at the 5th Annual
MarketsandMarkets conference in London, which included an update of continued
expansion of the CoSara manufacturing facility in India to enable greater capacity for in-house
manufacturing of reagents, equipment and consumables, along with
the ability to manufacture Co-Primers
"We are extremely encouraged by our first quarter progress and
believe that we are well positioned to meet our 2024 goals," said
Dwight Egan, Co-Diagnostics' Chief
Executive Officer. "Co-Diagnostics was pleased to announce the
opening of our new manufacturing facility in Salt Lake and
continued facility expansion in India, which will soon enable in-house
Co-Primers, instrument, and test manufacturing at a low cost. We
remain committed to delivering a 510(k) submission to the FDA for
our new instrument and COVID-19 test kit in the near future and
driving development of our TB, multiplex respiratory, and HPV tests
throughout the remainder of the year."
"This is an exciting time for Co-Diagnostics and we truly
believe in the disruptive and unique nature of our new platform. We
look forward to beginning clinical evaluations for our multiplex
test later this year and plan to provide updates on our new
platform and pipeline progress as they come," said Brian Brown, Co-Diagnostics' Chief Financial
Officer.
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.co-dx.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://co-dx.com.
*The Co-Dx PCR 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 yet available for
sale. The Co-Dx PCR Pro instrument and Co-Dx COVID-19 Test are
currently under review by the FDA.
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, realized gains on investments, and stock-based
compensation. 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 that our expansion in India will soon enable in-house manufacturing
at a low cost, our commitment to deliver a 510(k) submission to the
FDA for our new instrument and COVID-19 test kit in the near
future, and our plan to begin clinical evaluations for our
multiplex test later 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 14,
2024, 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,
2024
|
|
|
December 31,
2023
|
|
Assets
|
|
|
|
|
|
|
|
|
Current
assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
23,099,251
|
|
|
$
|
14,916,878
|
|
Marketable investment
securities
|
|
|
26,864,435
|
|
|
|
43,631,510
|
|
Accounts receivable,
net
|
|
|
434,868
|
|
|
|
303,926
|
|
Inventory,
net
|
|
|
1,549,812
|
|
|
|
1,664,725
|
|
Income taxes
receivable
|
|
|
-
|
|
|
|
26,955
|
|
Prepaid expenses and
other current assets
|
|
|
1,750,467
|
|
|
|
1,597,114
|
|
Total current
assets
|
|
|
53,698,833
|
|
|
|
62,141,108
|
|
Property and equipment,
net
|
|
|
3,183,116
|
|
|
|
3,035,729
|
|
Operating lease
right-of-use asset
|
|
|
2,758,757
|
|
|
|
2,966,774
|
|
Intangible assets,
net
|
|
|
26,328,000
|
|
|
|
26,403,667
|
|
Investment in joint
venture
|
|
|
702,427
|
|
|
|
773,382
|
|
Total assets
|
|
$
|
86,671,133
|
|
|
$
|
95,320,660
|
|
Liabilities and
stockholders' equity
|
|
|
|
|
|
|
|
|
Current
liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
2,027,607
|
|
|
$
|
1,482,109
|
|
Accrued
expenses
|
|
|
1,324,779
|
|
|
|
2,172,959
|
|
Operating lease
liability, current
|
|
|
859,912
|
|
|
|
838,387
|
|
Contingent
consideration liabilities, current
|
|
|
750,877
|
|
|
|
891,666
|
|
Deferred
revenue
|
|
|
306,477
|
|
|
|
362,449
|
|
Total current
liabilities
|
|
|
5,269,652
|
|
|
|
5,747,570
|
|
Long-term
liabilities
|
|
|
|
|
|
|
|
|
Income taxes
payable
|
|
|
679,018
|
|
|
|
659,186
|
|
Operating lease
liability
|
|
|
1,931,164
|
|
|
|
2,152,180
|
|
Contingent
consideration liabilities
|
|
|
438,638
|
|
|
|
748,109
|
|
Total long-term
liabilities
|
|
|
3,048,820
|
|
|
|
3,559,475
|
|
Total
liabilities
|
|
|
8,318,472
|
|
|
|
9,307,045
|
|
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, 2024 and December 31, 2023,
respectively
|
|
|
-
|
|
|
|
-
|
|
Common stock, $0.001
par value; 100,000,000 shares authorized; 36,127,096 shares issued
and 31,278,418 shares outstanding as of March 31, 2024 and
36,108,346 shares issued and 31,259,668 shares outstanding as of
December 31, 2023
|
|
|
36,127
|
|
|
|
36,108
|
|
Treasury stock, at
cost; 4,848,678 shares held as of March 31, 2024 and December 31,
2023, respectively
|
|
|
(15,575,795)
|
|
|
|
(15,575,795)
|
|
Additional paid-in
capital
|
|
|
98,379,651
|
|
|
|
96,808,436
|
|
Accumulated other
comprehensive income
|
|
|
226,555
|
|
|
|
146,700
|
|
Accumulated earnings
(deficit)
|
|
|
(4,713,877)
|
|
|
|
4,598,166
|
|
Total stockholders'
equity
|
|
|
78,352,661
|
|
|
|
86,013,615
|
|
Total liabilities and
stockholders' equity
|
|
$
|
86,671,133
|
|
|
$
|
95,320,660
|
|
CO-DIAGNOSTICS, INC.
AND SUBSIDIARIES
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE INCOME
(LOSS)
(Unaudited)
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2024
|
|
|
2023
|
|
Product
revenue
|
|
$
|
252,745
|
|
|
$
|
601,957
|
|
Grant
revenue
|
|
|
215,109
|
|
|
|
-
|
|
Total
revenue
|
|
|
467,854
|
|
|
|
601,957
|
|
Cost of
revenue
|
|
|
234,505
|
|
|
|
502,241
|
|
Gross profit
|
|
|
233,349
|
|
|
|
99,716
|
|
Operating
expenses
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
|
1,563,682
|
|
|
|
1,706,331
|
|
General and
administrative
|
|
|
2,918,803
|
|
|
|
3,013,965
|
|
Research and
development
|
|
|
5,679,678
|
|
|
|
5,014,060
|
|
Depreciation and
amortization
|
|
|
330,573
|
|
|
|
316,010
|
|
Total operating
expenses
|
|
|
10,492,736
|
|
|
|
10,050,366
|
|
Loss from
operations
|
|
|
(10,259,387)
|
|
|
|
(9,950,650)
|
|
Other income,
net
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
362,733
|
|
|
|
202,372
|
|
Realized gain on
investments
|
|
|
228,070
|
|
|
|
418,082
|
|
Gain on remeasurement
of acquisition contingencies
|
|
|
450,260
|
|
|
|
1,037,672
|
|
Gain (loss) on equity
method investment in joint venture
|
|
|
(70,955)
|
|
|
|
277,322
|
|
Total other income,
net
|
|
|
970,108
|
|
|
|
1,935,448
|
|
Loss before income
taxes
|
|
|
(9,289,279)
|
|
|
|
(8,015,202)
|
|
Income tax provision
(benefit)
|
|
|
22,764
|
|
|
|
(2,259,811)
|
|
Net loss
|
|
$
|
(9,312,043)
|
|
|
$
|
(5,755,391)
|
|
Other comprehensive
loss
|
|
|
|
|
|
|
|
|
Change in net
unrealized gains on marketable securities, net of tax
|
|
|
79,855
|
|
|
|
178,621
|
|
Total other
comprehensive income
|
|
$
|
79,855
|
|
|
$
|
178,621
|
|
Comprehensive
loss
|
|
$
|
(9,232,188)
|
|
|
$
|
(5,576,770)
|
|
|
|
|
|
|
|
|
|
|
Loss per common
share:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
$
|
(0.31)
|
|
|
$
|
(0.20)
|
|
Weighted average shares
outstanding:
|
|
|
|
|
|
|
|
|
Basic and
diluted
|
|
|
29,842,874
|
|
|
|
29,483,540
|
|
CO-DIAGNOSTICS, INC.
AND SUBSIDIARIES
GAAP AND NON-GAAP
MEASURES
(Unaudited)
|
|
Reconciliation of
net loss to adjusted EBITDA:
|
|
|
|
Three Months Ended
March 31,
|
|
|
|
2024
|
|
|
2023
|
|
Net loss
|
|
$
|
(9,312,043)
|
|
|
$
|
(5,755,391)
|
|
Interest
income
|
|
|
(362,733)
|
|
|
|
(202,372)
|
|
Realized gain on
investments
|
|
|
(228,070)
|
|
|
|
(418,082)
|
|
Depreciation and
amortization
|
|
|
330,573
|
|
|
|
316,010
|
|
Change in fair value of
contingent consideration
|
|
|
(450,260)
|
|
|
|
(1,037,672)
|
|
Stock-based
compensation expense
|
|
|
1,571,234
|
|
|
|
2,168,742
|
|
Income tax provision
(benefit)
|
|
|
22,764
|
|
|
|
(2,259,811)
|
|
Adjusted
EBITDA
|
|
$
|
(8,428,535)
|
|
|
$
|
(7,188,576)
|
|
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SOURCE Co-Diagnostics