Guardion Health Sciences, Inc. (“Guardion” or the “Company”)
(NASDAQ: GHSI), ), a specialty health sciences company that
develops medical foods and medical devices in the ocular health
space and nutraceutical products that the Company believes provide
supportive health benefits to consumers, reported financial results
for the three months and six months ended June 30, 2020.
Fiscal 2020 Financial Highlights (Unaudited) (all dollar
amounts rounded to the nearest ‘000)
Three Months Ended June 30, 2020
- Total revenue was $1,191,000 for
the three months ended June 30, 2020, as compared to total revenue
of $261,000 for the three months ended June 30, 2019, an increase
of 356%, due to shipment of a large nutraceutical initial test
order to Malaysian distributor
- Completed shipment and cash
collection of $890,000 for nutraceutical initial test order to
Malaysian distributor
- Medical foods sales up 26% year
over year
- Medical devices sales were down 75%
year over year, primarily as a result of medical facility closures
due to COVID-19 “Stay at Home” orders
- Review and rationalization of
product lines, resulting in the decision to wind-down the
Trans-Cranial Doppler business unit at June 30, 2020
- Net loss for the three months ended
June 30, 2020 was ($707,000) or ($0.01) per share, as compared to a
net loss of ($3,048,000) or ($0.14) per share for the three months
ended June 30, 2019
- Warrant exercises netted $999,000
in cash during the three months ended June 30, 2020
- Ending cash balance at June 30,
2020 was $11,600,000
- Recently published research shows
an absorption rate three to four times higher, and thus similarly
increased bioavailability, of Lumega-Z ® versus AREDS2 gel
caps
Six Months Ended June 30,
2020
- Total revenue was $1,437,000 for
the six months ended June 30, 2020, as compared to total revenue of
$504,000 for the six months ended June 30, 2019, an increase of
185%, due to shipment of a large nutraceutical initial test order
to Malaysian distributor
- Medical foods sales were up 33%
year over year
- Medical devices sales were down 57%
as a result of medical facility closures due to COVID-19 “Stay at
Home” orders
- Net loss for the six months ended
June 30, 2020 was ($3,054,000) or ($0.04) per share, as compared to
a net loss of ($4,437,000) or ($0.21) per share for the six months
ended June 30, 2019
- Warrant exercises netted $4,549,000
in cash during the six months ended June 30, 2020
Management Commentary
Robert N. Weingarten, Guardion’s recently
appointed Chairman of the Board of Directors, commented, “The last
few months have seen major changes in the executive leadership of
Guardion Health Sciences, Inc., changes that the board believes are
necessary to focus the Company on effective deployment of its
capital and maximization of shareholder value. These ongoing
changes, some of which will take some time to develop and
implement, include new research studies, development and roll-out
of an e-commerce platform, enhanced trade promotion, and other
programs and strategies that the Company expects will generate
value over the long term, are being made to pave the way for a
better and brighter future for Guardion and its
shareholders.”
Mr. Weingarten added, “The Board of Directors is
working closely with Dr. David Evans, Ph.D., MBA, Guardion’s Chief
Science Officer and Interim President and Interim Chief Executive
Officer, and with Andrew Schmidt, who was recently appointed as
Chief Financial Officer of the Company, to finalize plans to take
advantage of the market and commercialization opportunities for the
Company’s proprietary products and technologies. The Company
is focusing on expanding its product lines with unique formulas
under a comprehensive branding strategy that is expected, over
time, to result in a sustainable improvement in the operating
performance of our business units.”
Dr. David Evans, Ph.D., MBA, Guardion’s Chief
Science Officer and Interim President and Interim Chief Executive
Officer, commented, “I am encouraged by our strong second quarter
revenues and the market opportunities that such sales in Asia
indicate. We are engaged in a wide-ranging series of
discussions with existing and potential new distributors to
identify additional business opportunities, both domestically and
internationally. The new leadership team and I are focused on
implementing initiatives across our core product lines to continue
this positive momentum through the rest of the year and beyond,
particularly in light of signs that many doctors’ offices are
reopening and patients are beginning to return for eye health
care.”
Dr. Evans concluded, “From a scientific
perspective, we are pleased with the newly published peer-review
research demonstrating the superiority of our medical foods over
the competition, as well as the commencement of new research
studies to collect and publish data showing the excellent efficacy
of our medical food products, which we believe will further
validate the technology-based health benefits of our products.”
Andrew Schmidt, Guardion’s newly-appointed Chief
Financial Officer, commented, “My financial team and I are focused
on supporting the Company’s efforts to improve revenue growth and
operational performance in the near-term. I am looking
forward to working with Dr. Evans and the rest of the Guardion
management team to expand the distribution of our proprietary
products and technologies through different channels, including by
building an on-line commercial presence, as well as expanding
international
distribution.”
Three Months Ended June 30, 2020 Financial
Results
Total revenue for the second quarter of fiscal
2020 increased 356% to $1,191,000, as compared to $261,000 for the
second fiscal quarter of 2019. This increase was due to a
large initial test order of a nutraceutical product placed by a
Malaysian distributor and increased sales of medical food product
lines, partially offset by a decrease in medical device sales which
were affected by the impact of COVID-19 closures.
Operating expenses for the second quarter of
fiscal 2020 of $1,255,000 were significantly lower than operating
expenses for the second quarter of fiscal 2019 of $2,976,000,
primarily due to a one-time gain of $1,402,000 related to a
reversal of stock-based compensation as a result of the resignation
of the Company’s former President and Chief Executive Officer in
June 2020.
Operating loss for the second quarter of fiscal
2020 was ($708,000), a decrease of $2,104,000 from the operating
loss of ($2,812,000) for the second quarter of fiscal 2019.
Net loss for the second quarter of fiscal 2020 was
($707,000), or ($0.01) per share, as compared with a net loss of
($3,048,000), or ($0.14) per share, for the second quarter of
fiscal 2019.
Six Months Ended June 30, 2020 Financial
Results
Total revenue for the six months ended June 30,
2020 increased 185% to $1,437,000, as compared to $504,000 for the
six months ended 2019. This increase was due to a large
initial test order of a nutraceutical product placed by a Malaysian
distributor and increased sales of medical food product lines,
partially offset by a decrease in medical device sales which were
affected by the impact of COVID-19 closures.
Operating expense for the six months ended June
30, 2020 of $3,727,000 was lower than operating expense for the for
the six months ended June 30, 2019 of $4,310,000, primarily due to
a reduction of $965,000 in stock compensation expense, related to a
reversal of stock-based compensation as a result of the resignation
of the Company’s former President and Chief Executive Officer in
June 2020.
Operating loss the six months ended June 30,
2020 was ($3,044,000), a decrease of $953,000 from the operating
loss of ($3,997,000) for the six months ended June 30, 2019. Net
loss for the six months ended June 30, 2020 was ($3,054,000), or
($0.04) per share, as compared with a net loss of ($4,437,000), or
($0.21) per share, for the six months ended June 30, 2019.
Earnings Conference Call
Guardion will conduct a conference call and
webcast today at 4:30 p.m. Eastern Time (1:30pm Pacific Time) to
discuss its fiscal 2020 second quarter results. To access the
live call, dial 800-353-6461 (United States and Canada) or +1
334-323-0501 (International) and give the participant passcode
7353998. In addition, a live and archived webcast of the
conference call will be accessible on the Investor Relations
section of the Company’s website at www.guardionhealth.com.
In addition, a phone replay will be available approximately
two hours following the end of the call and will remain available
for one week. To access the call replay dial-in information,
please click here.
About Guardion Health Sciences, Inc.
Guardion is a specialty health sciences company
that develops (i) medical foods and medical devices for the ocular
health marketplace, and (ii) nutraceutical products that the
Company believes provide supportive health benefits to consumers.
Information and risk factors with respect to Guardion and its
business, including its ability to successfully develop and
commercialize its proprietary products and technologies, may be
obtained in the Company’s filings with the SEC at www.sec.gov.
About VectorVision®
VectorVision® specializes in the standardization
of contrast sensitivity, glare sensitivity, low contrast acuity,
and ETDRS acuity vision testing. Its patented standardization
system provides the practitioner or researcher the ability to
delineate very small changes in visual capability, either as
compared to the population or from visit to visit.
VectorVision’s® patented technology is considered the standard of
care for clinical trials. VectorVision® is a wholly owned
subsidiary of Guardion.
About NutriGuard™
NutriGuard™ formulates high-quality
nutraceuticals which are designed to supplement consumers’
diets. NutriGuard uses industry standards to establish the
safety and efficacy of the products it develops and markets,
maintains that commitment through prudent manufacturing and quality
assurance programs, and only uses manufacturers who comply with FDA
current Good Manufacturing Practices (cGMP) requirements.
Guardion plans to increase NutriGuard’s existing customer base and
build on its product platform by making NutriGuard products
available to patients directly and through recommendations by their
physicians.
Forward-Looking Statement Disclaimer
With the exception of the historical information
contained in this news release, the matters described herein may
contain forward-looking statements within the meaning of Section
27A of the Securities Act of 1933, as amended, and Section 21E of
the Securities Exchange Act of 1934, as amended. Statements
preceded by, followed by or that otherwise include the words
“believes,” “expects,” “anticipates,” “intends,” “projects,”
“estimates,” “plans” and similar expressions or future or
conditional verbs such as “will,” “should,” “would,” “may” and
“could” are generally forward-looking in nature and not historical
facts, although not all forward-looking statements include the
foregoing. These statements involve unknown risks and
uncertainties that may individually or materially impact the
matters discussed herein for a variety of reasons that are outside
the control of the Company, including, but not limited to, the
Company’s ability to raise sufficient financing to implement its
business plan, the impact of the COVID-19 pandemic on the Company’s
business, operations and the economy in general, and the Company’s
ability to successfully develop and commercialize its proprietary
products and technologies. Readers are cautioned not to place undue
reliance on these forward- looking statements, as actual results
could differ materially from those described in the forward-looking
statements contained herein. Readers are urged to read the
risk factors set forth in the Company’s filings with the SEC, which
are available at the SEC’s website (www.sec.gov). The Company
disclaims any intention or obligation to update or revise any
forward-looking statements, whether as a result of new information,
future events or otherwise.
Investor Relations MKR Investor Relations, Inc.
Todd Kehrli ghsi@mkr-group.com
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Guardion
Health Sciences, Inc. |
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Condensed
Consolidated Balance Sheets |
|
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|
June
30, |
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|
December
31, |
|
|
|
2020 |
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2019 |
|
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(Unaudited) |
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Assets |
|
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Current assets |
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Cash |
|
$ |
11,603,459 |
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$ |
11,115,502 |
|
Accounts receivable |
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|
34,180 |
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|
78,337 |
|
Inventories |
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|
1,235,052 |
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|
310,941 |
|
Prepaid expenses |
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|
274,140 |
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|
362,938 |
|
Equipment held for sale |
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|
24,500 |
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|
- |
|
|
|
|
|
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|
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|
Total current assets |
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|
13,171,331 |
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|
11,867,718 |
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|
|
|
|
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|
Deposits |
|
|
11,751 |
|
|
|
11,751 |
|
Property and
equipment, net |
|
|
304,534 |
|
|
|
374,638 |
|
Right of use
asset, net |
|
|
496,387 |
|
|
|
572,714 |
|
Intangible
assets |
|
|
50,000 |
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
|
Total assets |
|
$ |
14,034,003 |
|
|
$ |
12,876,821 |
|
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|
|
|
|
|
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|
Liabilities and Stockholders’ Equity |
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Current liabilities |
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|
Accounts payable |
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$ |
332,787 |
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|
$ |
70,291 |
|
Accrued expenses |
|
|
162,461 |
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|
|
175,052 |
|
Due to former officer |
|
|
311,458 |
|
|
|
- |
|
Derivative warrant liability |
|
|
19,411 |
|
|
|
13,323 |
|
Lease liability – current |
|
|
157,119 |
|
|
|
151,568 |
|
Total current liabilities |
|
|
983,236 |
|
|
|
410,234 |
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|
|
|
|
|
|
|
|
Lease
liability – long term |
|
|
355,127 |
|
|
|
434,747 |
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|
|
|
|
|
|
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|
Total liabilities |
|
|
1,338,363 |
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|
|
844,981 |
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|
Commitments and contingencies |
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Stockholders’ Equity |
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|
Preferred
stock, $0.001 par value; 10,000,000 shares authorized, no shares
issued and outstanding |
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|
- |
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|
- |
|
Common
stock, $0.001 par value; 250,000,000 shares authorized; 88,309,962
and 74,982,562 shares issued and outstanding at June 30, 2020 and
December 31, 2019, respectively |
|
|
88,310 |
|
|
|
74,983 |
|
Additional
paid-in capital |
|
|
61,173,074 |
|
|
|
57,468,528 |
|
Accumulated
deficit |
|
|
(48,565,744 |
) |
|
|
(45,511,671 |
) |
|
|
|
|
|
|
|
|
|
Total stockholders’ equity |
|
|
12,695,640 |
|
|
|
12,031,840 |
|
|
|
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|
|
|
|
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|
Total liabilities and stockholders’ equity |
|
$ |
14,034,003 |
|
|
$ |
12,876,821 |
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|
Guardion
Health Sciences, Inc. |
|
Condensed
Consolidated Statements of Operations |
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Three Months
Ended |
|
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Six Months
Ended |
|
June 30, |
June 30, |
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|
2020 |
|
|
2019 |
|
|
2020 |
|
|
2019 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Medical foods and nutraceuticals |
|
$ |
1,152,894 |
|
|
$ |
104,448 |
|
|
$ |
1,304,028 |
|
|
$ |
204,382 |
|
Medical devices |
|
|
35,315 |
|
|
|
150,222 |
|
|
|
126,505 |
|
|
|
292,826 |
|
Other |
|
|
2,700 |
|
|
|
6,300 |
|
|
|
6,100 |
|
|
|
6,300 |
|
Total revenue |
|
|
1,190,909 |
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|
|
260,970 |
|
|
|
1,436,633 |
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|
|
503,508 |
|
|
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|
|
|
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|
|
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|
Cost
of goods sold |
|
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|
|
|
|
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|
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|
|
|
Medical foods and nutraceuticals |
|
|
628,205 |
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|
|
40,681 |
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|
695,291 |
|
|
|
78,953 |
|
Medical devices |
|
|
15,278 |
|
|
|
53,816 |
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|
|
55,920 |
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|
|
109,036 |
|
Other |
|
|
1,096 |
|
|
|
2,559 |
|
|
|
2,477 |
|
|
|
2,559 |
|
Total cost of goods sold |
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|
644,579 |
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|
|
97,056 |
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|
753,688 |
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|
|
190,548 |
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|
Gross profit |
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|
546,330 |
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|
|
163,914 |
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|
|
682,945 |
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|
312,960 |
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|
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
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|
|
Research and development |
|
|
44,581 |
|
|
|
77,688 |
|
|
|
75,769 |
|
|
|
106,716 |
|
Sales and marketing |
|
|
519,067 |
|
|
|
409,409 |
|
|
|
1,007,913 |
|
|
|
764,028 |
|
General and administrative |
|
|
1,712,183 |
|
|
|
2,489,011 |
|
|
|
3,228,698 |
|
|
|
3,439,633 |
|
Costs related to resignation of former officer (including the
reversal of previously recognized stock compensation expense of
$1,401,582 and $965,295 during the three and six months ended June
30, 2020, respectively) |
|
|
(1,052,223 |
) |
|
|
- |
|
|
|
(615,936 |
) |
|
|
- |
|
Impairment loss on equipment held for sale |
|
|
30,948 |
|
|
|
- |
|
|
|
30,948 |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses |
|
|
1,254,556 |
|
|
|
2,976,108 |
|
|
|
3,727,392 |
|
|
|
4,310,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
|
(708,226 |
) |
|
|
(2,812,194 |
) |
|
|
(3,044,447 |
) |
|
|
(3,997,417 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Other (income) expense: |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense |
|
|
1,790 |
|
|
|
234,065 |
|
|
|
3,538 |
|
|
|
251,637 |
|
Finance cost upon issuance of warrants |
|
|
- |
|
|
|
229,921 |
|
|
|
- |
|
|
|
415,955 |
|
Change in fair value of derivative warrants |
|
|
(2,856 |
) |
|
|
(227,832 |
) |
|
|
6,088 |
|
|
|
(227,832 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total other (income) expense |
|
|
(1,066 |
) |
|
|
236,154 |
|
|
|
9,626 |
|
|
|
439,760 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net
loss |
|
$ |
(707,160 |
) |
|
$ |
(3,048,348 |
) |
|
$ |
(3,054,073 |
) |
|
$ |
(4,437,177 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per
common share – basic and diluted |
|
$ |
(0.01 |
) |
|
$ |
(0.14 |
) |
|
$ |
(0.04 |
) |
|
$ |
(0.21 |
) |
Weighted
average common shares outstanding – basic and diluted |
|
|
86,567,215 |
|
|
|
22,537,943 |
|
|
|
82,598,791 |
|
|
|
21,628,758 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guardion
Health Sciences, Inc. |
|
Unaudited
Segment Reporting Details |
|
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|
|
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|
|
|
For the Three Months Ended June 30, 2020 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
2,700 |
|
|
$ |
1,152,894 |
|
|
$ |
35,315 |
|
|
$ |
1,190,909 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold |
|
|
1,096 |
|
|
|
628,205 |
|
|
|
15,278 |
|
|
|
644,579 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
1,604 |
|
|
|
524,689 |
|
|
|
20,037 |
|
|
|
546,330 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
88,428 |
|
|
|
1,072,508 |
|
|
|
93,620 |
|
|
|
1,254,556 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
$ |
(86,824 |
) |
|
$ |
(547,819 |
) |
|
$ |
(73,583 |
) |
|
$ |
(708,226 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Three Months Ended June 30, 2019 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
6,300 |
|
|
$ |
104,448 |
|
|
$ |
150,222 |
|
|
$ |
260,970 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold |
|
|
2,559 |
|
|
|
40,681 |
|
|
|
53,816 |
|
|
|
97,056 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
3,741 |
|
|
|
63,767 |
|
|
|
96,406 |
|
|
|
163,914 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
72,021 |
|
|
|
2,643,725 |
|
|
|
260,362 |
|
|
|
2,976,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
$ |
(68,280 |
) |
|
$ |
(2,579,958 |
) |
|
$ |
(163,956 |
) |
|
$ |
(2,812,194 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30, 2020 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
6,100 |
|
|
$ |
1,304,028 |
|
|
$ |
126,505 |
|
|
$ |
1,436,633 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold |
|
|
2,477 |
|
|
|
695,291 |
|
|
|
55,920 |
|
|
|
753,688 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
3,623 |
|
|
|
608,737 |
|
|
|
70,585 |
|
|
|
682,945 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
172,911 |
|
|
|
3,344,411 |
|
|
|
210,070 |
|
|
|
3,727,392 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
$ |
(169,288 |
) |
|
$ |
(2,735,674 |
) |
|
$ |
(139,485 |
) |
|
$ |
(3,044,447 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
For the Six Months Ended June 30, 2019 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
6,300 |
|
|
$ |
204,382 |
|
|
$ |
292,826 |
|
|
$ |
503,508 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost
of goods sold |
|
|
2,559 |
|
|
|
78,953 |
|
|
|
109,036 |
|
|
|
190,548 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross profit |
|
|
3,741 |
|
|
|
125,429 |
|
|
|
183,790 |
|
|
|
312,960 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating expenses |
|
|
120,783 |
|
|
|
3,719,338 |
|
|
|
470,256 |
|
|
|
4,310,377 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss
from operations |
|
$ |
(117,042 |
) |
|
$ |
(3,593,909 |
) |
|
$ |
(286,466 |
) |
|
$ |
(3,997,417 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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