Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the
“Company”), a clinical nutrition and diagnostics company that
develops clinically supported nutrition, medical foods, supplements
and medical devices, announced financial results for the three
months ended March 31, 2021 and is also providing a corporate
update for shareholders.
Effective March 1, 2021, the Company effectuated
a 1-for-6 reverse split of its outstanding common stock.
Accordingly, all share and per share amounts included herein have
been retroactively adjusted to reflect the reverse stock split for
all periods presented.
Financial highlights for the quarter ended March 31, 2021
include the following:
- Total revenue of
$233,297 for the quarter ended March 31, 2021, as compared to
$245,723 for the quarter ended March 31, 2020, a decrease of
approximately 5%.
- Net loss for the
quarter ended March 31, 2021 of $(2,669,525) or $(0.13) per share,
as compared to a net loss of $(2,346,913) or $(0.18) per share for
the quarter ended March 31, 2020.
-
Cash balance of $43,329,674 and net working capital of $43,012,927
at March 31, 2021.
Corporate highlights for the quarter ended March
31, 2021 and subsequently include the following:
-
Bret Scholtes joined the Company as President and Chief Executive
Officer, and as a member of the Board of Directors. Mr. Scholtes is
a veteran of the nutritional products industry who also has
experience leading an NYSE listed public company.
-
The Company initiated a placebo-controlled clinical trial to study
the impact on visual function, as measured by visual field
sensitivity, in patients with glaucoma after a 12-week regimen of
the Company’s GlaucoCetin® product.
-
The Company completed equity financings that generated gross
proceeds of $35,000,000, before commissions and other costs, and
generated additional proceeds from the exercise of warrants of
$3,568,415.
-
Ho Wah Genting Berhad (HWGB), Guardion’s exclusive distributor in
Malaysia, advised the Company that Astramern Astra H (formerly
Astramern Nutra H), an immune support dietary supplement designed
and produced by the Company, has been granted product registration
approval by the Malaysian National Pharmaceutical Regulatory Agency
(“NPRA”). The Company’s vitamin formulation, Astramern Nutra V, had
previously received product approval from the NPRA in August 2020.
These immune support dietary supplements are designed to be
packaged together for sale by HWGM in Malaysia.
Bret Scholtes, Guardion’s President and Chief
Executive Officer, commented, “I joined Guardion as CEO in early
January 2021. During the first quarter of 2021, I am pleased that
we were able to implement and complete several major initiatives.
Of particular note, were able to accomplish Guardion’s transition
from financial uncertainty to financial stability through the
successful capital raises. We completed a reverse stock split to
maintain our listing on the Nasdaq Capital
Market.”
“I am excited for the future and the role we can
play in addressing the health needs of consumers. Our strategy is
to build Guardion into a leading clinical nutrition company, with
the objective that Guardion becomes a leader in our target markets.
We are also continuing to assess and evaluate our business, core
fundamentals and capabilities, and market opportunities for the
Company’s products and services.”
“At certain stages of our lives, and as we age,
our ability to obtain essential nutrients from our diets, declines.
These nutrients support critical metabolic pathways. Our clinical
studies aim to demonstrate that the correct supply of these
nutrients can restore certain functions in the body. The Centers
for Disease Control and Prevention estimates that approximately 12
million people 40 years of age in the United States have vision
impairment. The Company believes that specific and targeted
nutrition strategies can help to offset vision loss in many of
these eye conditions. Consumers with eye disease, as well as other
age-related conditions, represents significant and underserved
markets. We utilize our understanding of particular markets and our
scientific knowledge to conduct clinical studies that demonstrate
the impact of clinical nutrition to help offset the impact of these
conditions, such as supporting visual function in certain types of
eye disease. This type of investment underpins our strategy of
supporting our scientifically developed brands with strong clinical
evidence. We can provide valuable and differentiated solutions to
healthcare professionals and their patients that make meaningful
contribution to the quality of life.”
“The process for creating long-term sustainable
value involves analyzing areas of consumer needs and interest,
seeking out market gaps, and then designing clinical studies to
focus on these areas. We are committed to developing brands and
products that are differentiated by science and can generate
compelling product claims, and then executing detailed marketing
plans that implement an omni-channel marketing and sales effort. We
are also in the process of establishing our nascent brands and
identifying core customer bases where we can accelerate our
marketing efforts once our clinical support and scientific evidence
is in place.”
Mr. Scholtes concluded, “Over the long-term, the
key to our success will be our ability to create value for
well-differentiated and robust brands that are based on strong,
clinically proven claims that address consumer needs in growing
markets, both domestically and internationally. We are committed to
bringing compelling products to market under these brands that are
supported by strong scientific evidence. We appreciate the support
of our shareholders as we focus on the Company’s evolution during
2021.”
Financial
ResultsQuarter Ended March 31, 2021
Total revenue for the quarter ended March 31,
2021 decreased by approximately 5% to $233,297, as compared total
revenue for the quarter ended March 31, 2020 of $245,723. The
relatively flat overall performance reflects a combination of
improved sales of medical foods and nutraceuticals, offset by a
decrease in medical device sales primarily due to the impact of
COVID-19 office closures for many in our customer base. In
addition, the Company sold one MapcatSF device in the quarter ended
March 31, 2020 for approximately $25,000. There have been no
further sales of MapcatSF devices.
Operating expenses for the quarter ended March
31, 2021 were $2,769,807, as compared to operating expenses for the
quarter ended March 31, 2020 of $2,472,837, an increase of
approximately 12%.
Net loss for the quarter ended March 31, 2021
was $(2,669,525), as compared to net loss for the quarter ended
March 31, 2020 of $(2,346,913), an increase of approximately
14%.
About Guardion Health Sciences,
Inc.
Guardion Health Sciences, Inc. (Nasdaq: GHSI),
is a clinical nutrition and diagnostics company. Guardion’s
portfolio of science-based, clinically supported nutrition, medical
foods, and diagnostic products support healthcare professionals,
their patients, and consumers in achieving health goals. Guardion’s
commercial and developmental initiatives are supported by equally
impressive scientific and medical advisory boards, led by seasoned
business executives and physicians with many years of experience.
This combination of expertise and scientific knowledge forms the
foundation of Guardion’s growing position within the eye care
industry and the clinical nutrition marketplace. 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 U.S. Securities and Exchange Commission
(the “SEC”) at www.sec.gov.
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 Contact:
CORE IRScott Arnold516-222-2560scotta@coreir.com
Media Relations Contact:
Jules AbrahamDirector of Public RelationsCORE
IR917-885-7378julesa@coreir.com
Guardion Health Sciences,
Inc.Condensed Consolidated Balance
Sheets
|
March 31, |
|
|
December 31, |
|
2021 |
|
|
2020 |
|
(Unaudited) |
|
|
|
Assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
assets |
|
|
|
|
|
|
|
Cash |
$ |
43,329,674 |
|
|
$ |
8,518,732 |
|
Accounts receivable |
|
64,897 |
|
|
|
11,248 |
|
Inventories |
|
288,527 |
|
|
|
384,972 |
|
Prepaid expenses |
|
312,523 |
|
|
|
179,931 |
|
|
|
|
|
|
|
|
|
Total current
assets |
|
43,995,621 |
|
|
|
9,094,883 |
|
|
|
|
|
|
|
|
|
Deposits |
|
11,751 |
|
|
|
11,751 |
|
Property and equipment,
net |
|
265,978 |
|
|
|
285,676 |
|
Right of use asset, net |
|
379,120 |
|
|
|
418,590 |
|
Intangible assets |
|
50,000 |
|
|
|
50,000 |
|
|
|
|
|
|
|
|
|
Total
assets |
$ |
44,702,470 |
|
|
$ |
9,860,900 |
|
|
|
|
|
|
|
|
|
Liabilities and
Stockholders’ Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Current
liabilities |
|
|
|
|
|
|
|
Accounts payable |
$ |
230,403 |
|
|
$ |
608,313 |
|
Accrued expenses |
|
518,826 |
|
|
|
127,637 |
|
Payable to former officer |
|
67,708 |
|
|
|
148,958 |
|
Derivative warrant liability |
|
- |
|
|
|
25,978 |
|
Operating lease liability – current |
|
165,757 |
|
|
|
162,845 |
|
Total current
liabilities |
|
982,694 |
|
|
|
1,073,731 |
|
|
|
|
|
|
|
|
|
Operating lease liability –
long term |
|
229,430 |
|
|
|
271,903 |
|
|
|
|
|
|
|
|
|
Total
liabilities |
|
1,212,124 |
|
|
|
1,345,634 |
|
|
|
|
|
|
|
|
|
Commitments and
contingencies |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stockholders’
Equity |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Preferred stock, $0.001 par
value; 10,000,000 shares authorized, no shares issued and
outstanding |
|
- |
|
|
|
- |
|
Common stock, $0.001 par
value; 250,000,000 shares authorized; 24,426,993 and 15,170,628
shares issued and outstanding at March 31, 2021 and December 31,
2020, respectively |
|
24,427 |
|
|
|
15,171 |
|
Additional paid-in
capital |
|
100,192,794 |
|
|
|
62,583,423 |
|
Accumulated deficit |
|
(56,726,875 |
) |
|
|
(54,083,328 |
) |
|
|
|
|
|
|
|
|
Total stockholders’
equity |
|
43,490,346 |
|
|
|
8,515,266 |
|
|
|
|
|
|
|
|
|
Total liabilities and
stockholders’ equity |
$ |
44,702,470 |
|
|
$ |
9,860,900 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Guardion Health Sciences, Inc.Condensed
Consolidated Statements of Operations
|
|
Three Months EndedMarch 31, |
|
|
|
2021 |
|
|
2020 |
|
|
|
(Unaudited) |
|
|
(Unaudited) |
|
Revenue |
|
|
|
|
|
|
|
|
Medical foods |
|
$ |
162,143 |
|
|
$ |
139,789 |
|
Medical devices |
|
|
71,154 |
|
|
|
91,190 |
|
Other |
|
|
- |
|
|
|
14,744 |
|
Total
revenue |
|
|
233,297 |
|
|
|
245,723 |
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold |
|
|
|
|
|
|
|
|
Medical foods |
|
|
84,917 |
|
|
|
66,196 |
|
Medical devices |
|
|
48,098 |
|
|
|
40,642 |
|
Other |
|
|
- |
|
|
|
2,270 |
|
Total cost of goods
sold |
|
|
133,015 |
|
|
|
109,108 |
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
100,282 |
|
|
|
136,615 |
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
|
|
|
|
|
|
Research and development |
|
|
20,608 |
|
|
|
31,188 |
|
Sales and marketing |
|
|
457,727 |
|
|
|
488,846 |
|
General and administrative |
|
|
2,291,472 |
|
|
|
1,952,803 |
|
|
|
|
|
|
|
|
|
|
Total operating
expenses |
|
|
2,769,807 |
|
|
|
2,472,837 |
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
|
(2,669,525 |
) |
|
|
(2,336,222 |
) |
|
|
|
|
|
|
|
|
|
Other
expenses: |
|
|
|
|
|
|
|
|
Interest expense |
|
|
- |
|
|
|
(1,747 |
) |
Change in fair value of derivative liability |
|
|
- |
|
|
|
(8,944 |
) |
|
|
|
|
|
|
|
|
|
Total other
expenses |
|
|
- |
|
|
|
(10,691 |
) |
|
|
|
|
|
|
|
|
|
Net loss |
|
$ |
(2,669,525 |
) |
|
$ |
(2,346,913 |
) |
|
|
|
|
|
|
|
|
|
Net loss per common share –
basic and diluted |
|
$ |
(0.13 |
) |
|
$ |
(0.18 |
) |
Weighted average common shares
outstanding – basic and diluted |
|
|
21,351,380 |
|
|
|
13,105,061 |
|
|
|
For the Three Months Ended March 31, 2021 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
- |
|
|
$ |
162,143 |
|
|
$ |
71,154 |
|
|
$ |
233,297 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold |
|
|
- |
|
|
|
84,917 |
|
|
|
48,098 |
|
|
|
133,015 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
- |
|
|
|
77,226 |
|
|
|
23,056 |
|
|
|
100,282 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation
expense |
|
|
387,615 |
|
|
|
- |
|
|
|
- |
|
|
|
387,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
1,150,600 |
|
|
|
1,176,127 |
|
|
|
55,465 |
|
|
|
2,382,192 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
$ |
(1,538,215 |
) |
|
$ |
(1,098,901 |
) |
|
$ |
(32,409 |
) |
|
$ |
(2,669,525 |
) |
|
|
For the Three Months Ended March 31, 2020 |
|
|
|
Corporate |
|
|
Medical Foods and Nutraceuticals |
|
|
Medical Devices |
|
|
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Revenue |
|
$ |
14,744 |
|
|
$ |
139,789 |
|
|
$ |
91,190 |
|
|
$ |
245,723 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Cost of goods
sold |
|
|
- |
|
|
|
78,439 |
|
|
|
30,669 |
|
|
|
109,108 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Gross
profit |
|
|
14,744 |
|
|
|
61,350 |
|
|
|
60,521 |
|
|
|
136,615 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock compensation
expense |
|
|
503,893 |
|
|
|
- |
|
|
|
- |
|
|
|
503,893 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Operating
expenses |
|
|
915,552 |
|
|
|
937,123 |
|
|
|
116,269 |
|
|
|
1,968,944 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Loss from
operations |
|
$ |
(1,404,701 |
) |
|
$ |
(875,773 |
) |
|
$ |
(55,748 |
) |
|
$ |
(2,336,222 |
) |
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