SALT LAKE CITY, Aug. 13, 2020 /PRNewswire/
-- Co-Diagnostics, Inc. (Nasdaq: CODX), a molecular
diagnostics company with a unique, patented platform for the
development of molecular diagnostic tests, announced today the
filing of its operating results for the 3 month period ending
June 30, 2020 on SEC Form 10-Q, and
provided updates on Company developments.
Q2 2020 Highlights:
- Company continues COVID-19 test sales and reports $24.04 million of revenue in Q2;
- Net profit of $12.6 million in
quarter and net income per common share of $0.43;
- Stockholders' equity increased to $33.4
million compared to $1.7
million at the beginning of the year.
- Gross margins of 70% on sales of Logix Smart™ COVID-19 test
kits;
- CoSara Diagnostics, Company's India joint venture, receives authorization
from CDSCO in India to manufacture
and sell COVID-19 tests and records profit for the 2nd Quarter and
YTD;
- Received FDA Emergency Use Authorization for COVID-19 test kit
on April 3, 2020;
- Cash on hand was $18.6 million as
of June 30, 2020, an increase of
$17.7 million over 12/31/2019;
- Company is included in the Russell 2000® and Russell
3000® Index, widely used by investment managers and
institutional investors for index funds and as benchmarks for
active investment strategies.
Q3 2020 Mid-Quarter Highlights:
- Company records COVID-19 test and equipment sales orders
approaching $50 million YTD,
including joint venture sales in India, through mid-third quarter
(unaudited);
- Receives purchase orders from public and private organizations
in nearly 50 countries and over 25 states in the U.S. YTD;
- Company nears completion of principal design work and
verification for Flu A, Flu B, and COVID-19 multiplex panel with
anticipated deployment during Q3;
- Company announced that its partner Clinical Reference Lab has
received FDA Emergency Use Authorization for CRL Rapid Response™, a
saliva-based COVID-19 test that can be self-administered at home,
work or any other setting and then tested using Co-Diagnostics'
Logix Smart COVID-19 tests based on patented CoPrimer™
technology.
"In the last 4 months since Co-Diagnostics received emergency
use authorization from the FDA, the Company has successfully grown
our internationally recognized business and brand. With clients in
over 50 countries, 25 U.S. states, and validations of test accuracy
from regulatory bodies of numerous countries around the world,
Co-Diagnostics has established a distribution platform that we
believe will continue to support sales and profitability as our
tests have gained widespread acceptance in the market. We have
created a test menu and established the production capacity to meet
demand for tests as the nations of the world continue to battle the
pandemic, and believe these efforts will continue to bolster the
Company's durability in the months and years to come," said
Dwight Egan, Chief Executive
Officer.
The Company will host an earnings call at 4:30 pm EDT today. Participants can register for
access to the webcast here. The call will be recorded and later
made available on the Company's website.
About Emergency Use Authorization:
The Co-Diagnostics
SARS-CoV-2 Test has been made available under an emergency access
mechanism called an Emergency Use Authorization (EUA). The EUA is
supported by the Secretary of Health and Human Service's (HHS's)
declaration that circumstances exist to justify the use of in vitro
diagnostics (IVDs) under EUA for the detection and/or diagnosis of
COVID-19. An IVD made available under an EUA has not undergone the
same type of review as an FDA cleared IVD. However, based on the
totality of scientific evidence available, it is reasonable to
believe that this IVD may be effective in the detection of
COVID-19. The EUAs for these tests are in effect for the duration
of the COVID-19 emergency, unless terminated or revoked (after
which the tests may no longer be used). An FDA cleared IVD should
be used instead of an IVD under EUA, when applicable and
available.
About Co-Diagnostics, Inc.:
Co-Diagnostics, Inc., a
Utah corporation, is a molecular
diagnostics company that develops, manufactures and markets a new,
state-of-the-art diagnostics technology. The Company's technology
is 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 to locate
genetic markers for use in industries other than infectious disease
and license the use of those tests to specific customers.
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 the (i) use of funding proceeds, (ii) expansion of
product distribution, (iii) acceleration of initiatives in liquid
biopsy and SNP detection, (iv) use of the Company's liquid biopsy
tests by laboratories, (v) capital resources and runway needed to
advance the Company's products and markets, (vi) increased sales in
the near-term, (vii) flexibility in managing the Company's balance
sheet, (viii) anticipation of business expansion, and (ix) benefits
in research and worldwide accessibility of the CoPrimer technology
and its cost-saving and scientific advantages. 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. 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. CONDENSED CONSOLIDATED BALANCE
SHEETS (Unaudited)
|
|
|
|
June 30,
2020
|
|
|
December 31,
2019
|
|
ASSETS:
|
|
|
|
|
|
|
|
|
Current
Assets
|
|
|
|
|
|
|
|
|
Cash and cash
equivalents
|
|
$
|
18,550,437
|
|
|
$
|
893,138
|
|
Accounts receivables,
net
|
|
|
5,349,876
|
|
|
|
131,382
|
|
Inventory
|
|
|
10,110,786
|
|
|
|
197,168
|
|
Prepaid
expenses
|
|
|
521,180
|
|
|
|
362,566
|
|
Total current
assets
|
|
|
34,532,279
|
|
|
|
1,584,254
|
|
Other
Assets
|
|
|
|
|
|
|
|
|
Property and
equipment, net
|
|
|
473,376
|
|
|
|
196,832
|
|
Investment in joint
venture
|
|
|
1,416,480
|
|
|
|
434,240
|
|
Total other
assets
|
|
|
1,889,856
|
|
|
|
631,072
|
|
|
|
|
|
|
|
|
|
|
Total
assets
|
|
$
|
36,422,135
|
|
|
$
|
2,215,326
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND
STOCKHOLDERS' EQUITY:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
Liabilities
|
|
|
|
|
|
|
|
|
Accounts
payable
|
|
$
|
1,127,709
|
|
|
$
|
5,959
|
|
Accrued
expenses
|
|
|
691,385
|
|
|
|
200,788
|
|
Accrued expenses
(related party)
|
|
|
120,000
|
|
|
|
120,000
|
|
Deferred
revenue
|
|
|
1,045,548
|
|
|
|
1,323
|
|
Total current
liabilities
|
|
|
2,984,642
|
|
|
|
328,070
|
|
Long-term
Liabilities, net of current portion
|
|
|
|
|
|
|
|
|
Accrued
expenses-long-term (related party)
|
|
|
80,000
|
|
|
|
150,000
|
|
Total long-term
liabilities, net of current portion
|
|
|
80,000
|
|
|
|
150,000
|
|
Total
liabilities
|
|
|
3,064,642
|
|
|
|
478,070
|
|
|
|
|
|
|
|
|
|
|
STOCKHOLDERS'
EQUITY
|
|
|
|
|
|
|
|
|
Convertible preferred
stock, $0.001 par value; 5,000,000 shares authorized, 0 and 25,600
shares issued and outstanding as of June 30, 2020 and December 31,
2019, respectively
|
|
|
—
|
|
|
|
26
|
|
|
|
|
|
|
|
|
|
|
Common stock, $0.001
par value, 100,000,000 shares authorized; 27,991,042 and 17,342,922
shares issued and outstanding, as of June 30, 2020 and December 31,
2019, respectively.
|
|
|
27,991
|
|
|
|
17,343
|
|
Additional paid-in
capital
|
|
|
46,726,869
|
|
|
|
26,687,701
|
|
Accumulated
deficit
|
|
|
(13,397,367)
|
|
|
|
(24,967,814)
|
|
Total stockholders'
equity
|
|
|
33,357,493
|
|
|
|
1,737,256
|
|
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders' equity
|
|
$
|
36,422,135
|
|
|
$
|
2,215,326
|
|
CO – DIAGNOSTICS,
INC. CONDENSED CONSOLIDATED STATEMENTS OF
OPERATIONS (Unaudited)
|
|
|
|
For the Three
Months
Ended June 30,
|
|
|
For the Six
Months
Ended June 30,
|
|
|
|
2020
|
|
|
2019
|
|
|
2020
|
|
|
2019
|
|
Net
revenue
|
|
$
|
24,040,274
|
|
|
$
|
61,574
|
|
|
$
|
25,588,802
|
|
|
$
|
64,974
|
|
Cost of
revenue
|
|
|
8,344,674
|
|
|
|
38,809
|
|
|
|
8,826,414
|
|
|
|
39,261
|
|
Gross
profit
|
|
|
15,695,600
|
|
|
|
22,765
|
|
|
|
16,762,388
|
|
|
|
25,713
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Sales and
marketing
|
|
|
390,191
|
|
|
|
252,076
|
|
|
|
658,674
|
|
|
|
508,179
|
|
Administrative and
general
|
|
|
2,191,034
|
|
|
|
807,769
|
|
|
|
3,650,518
|
|
|
|
1,448,132
|
|
Research and
development
|
|
|
750,249
|
|
|
|
312,590
|
|
|
|
1,150,271
|
|
|
|
659,896
|
|
Depreciation and
amortization
|
|
|
25,218
|
|
|
|
16,094
|
|
|
|
45,966
|
|
|
|
29,762
|
|
Total operating
expenses
|
|
|
3,356,692
|
|
|
|
1,388,529
|
|
|
|
5,505,429
|
|
|
|
2,645,969
|
|
Income (loss) from
operations
|
|
|
12,338,908
|
|
|
|
(1,365,764)
|
|
|
|
11,256,959
|
|
|
|
(2,620,256)
|
|
Other
expense:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest
income
|
|
|
38,173
|
|
|
|
19,640
|
|
|
|
45,748
|
|
|
|
20,048
|
|
Interest
expense
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
(106,427)
|
|
Gain on disposition
of assets
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
850
|
|
Gain (loss) on equity
method investment in joint venture
|
|
|
258,559
|
|
|
|
1,728
|
|
|
|
267,740
|
|
|
|
(7,000)
|
|
Total other
expense
|
|
|
296,732
|
|
|
|
21,368
|
|
|
|
313,488
|
|
|
|
(92,529)
|
|
Income (loss) before
income taxes
|
|
|
12,635,640
|
|
|
|
(1,344,396)
|
|
|
|
11,570,447
|
|
|
|
(2,712,785)
|
|
Provision for income
taxes
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
|
|
—
|
|
Net income
(loss)
|
|
$
|
12,635,640
|
|
|
$
|
(1,344,396)
|
|
|
$
|
11,570,447
|
|
|
$
|
(2,712,785)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic income (loss)
per common share
|
|
$
|
0.46
|
|
|
$
|
(0.08)
|
|
|
$
|
0.42
|
|
|
$
|
(0.16)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Diluted income (loss)
per common share
|
|
$
|
0.43
|
|
|
$
|
(0.08)
|
|
|
$
|
0.40
|
|
|
$
|
(0.16)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding basic
|
|
|
27,582,229
|
|
|
|
17,017,964
|
|
|
|
27,605,137
|
|
|
|
16,544,926
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average
common shares outstanding diluted
|
|
|
29,152,222
|
|
|
|
17,017,964
|
|
|
|
29,094,475
|
|
|
|
16,544,926
|
|
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SOURCE Co-Diagnostics