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UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or Section 15(d) of the Securities Exchange Act of 1934
Date
of Report (Date of earliest event reported): November 13, 2023
GUARDION
HEALTH SCIENCES, INC.
(Exact
name of registrant as specified in its charter)
Delaware |
|
001-38861 |
|
47-4428421 |
(State
or other jurisdiction
of
incorporation) |
|
(Commission
File
Number) |
|
(I.R.S.
Employer
Identification
No.) |
2925
Richmond Avenue, Suite 1200
Houston,
Texas 77098
(Address
of principal executive offices, including zip code)
Registrant’s
telephone number, including area code: (800) 873-5141
Check
the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under
any of the following provisions:
☐ |
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
|
|
☐ |
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
|
|
☐ |
Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e -4(c)) |
Securities
registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, par value $0.001 per share |
|
GHSI |
|
The
Nasdaq Stock Market LLC |
Indicate
by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405
of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging
growth company ☒
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying
with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.
Item
2.02 Results of Operations and Financial Condition.
On
November 13, 2023, Guardion Health Sciences, Inc. (the “Company”) issued a press release
announcing financial results for the three months and nine months ended November 13, 2023. The text of the press release is furnished
as Exhibit 99.1 to this current report.
The
information in this Item 2.02 and Exhibit 99.1 hereto shall not be deemed “filed” for the purposes of or otherwise subject
to the liabilities under Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Unless expressly
incorporated into a filing of the Company under the Securities Act of 1933, as amended, or the Exchange Act, the information contained
in this Item 2.02 and Exhibit 99.1 hereto shall not be incorporated by reference into any Company filing, whether made before or after
the date hereof, regardless of any general incorporation language in such filing.
Item
9.01 Financial Statements and Exhibits
(d)
Exhibits.
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by
the undersigned hereunto duly authorized.
|
GUARDION
HEALTH SCIENCES, INC. |
Date:
November 13, 2023 |
|
|
|
By: |
/s/
Jan Hall |
|
Name: |
Jan
Hall |
|
Title: |
Chief
Executive Officer |
Exhibit
99.1
Guardion
Health Sciences Announces Financial Results
for
the Three Months and Nine Months Ended September 30, 2023
Viactiv®
Generated Net Revenues of Approximately $3.3 Million for the Three Months Ended September 30, 2023, an increase of 27% over the
Three Months Ended September 30, 2022
HOUSTON,
TEXAS – November 13, 2023 (GLOBE NEWSWIRE) – Guardion Health Sciences, Inc. (Nasdaq: GHSI) (“Guardion” or the
“Company”), a clinical nutrition company that offers a portfolio of science-based,
clinically-supported products designed to support the health needs of consumers, healthcare professionals and providers and their patients,
announced its financial results for the three months and nine months ended September 30, 2023. The Company also provided a corporate
update to stockholders.
Financial
highlights for the three months ended September 30, 2023 include the following:
|
● |
Total
revenue was $3,337,190 for the three months ended September 30, 2023, as compared to $2,663,550 for the three months ended September
30, 2022, an increase of $673,640 or 25.3%. The increase in total revenue was driven primarily by sales growth of the Viactiv®
product line, which accounted for approximately 97.5% and 96.2% of the Company’s total revenue for the three
months ended September 30, 2023 and 2022, respectively. Drivers of the sales increase included resolution of the short-term impact
of a third-party warehouse expansion which had resulted in carry over of retail shipments from June into July 2023, in combination
with strong shipments to Amazon, plus additional distribution of the Company’s Omega Boost® product. |
|
|
|
|
● |
Gross
profit was $1,460,252 for the three months ended September 30, 2023, as compared to $1,088,184 for the three months ended September
30, 2022, an increase of $372,068 or 34.2%. The increase in gross profit was primarily attributable to the increase in sales from
the Viactiv® product line. |
|
|
|
|
● |
Gross
margin for the three months ended September 30, 2023 was 43.8%, as compared to 40.9% for the three months ended September 30, 2022,
an increase of 2.9 percentage points, which was driven by cost of goods favorability, such as lower transportation costs, and higher
sales in 2023. |
|
|
|
|
● |
Total
operating expenses for the three months ended September 30, 2023 were $2,233,166, as compared to $2,827,578 for the three months
ended September 30, 2022, a decrease of $594,412 or 21.0%. The variance was attributable to a combination of factors, including the
amortization of intangible assets in 2022 that was no longer occurring in 2023, reduced payroll expense, lower executive stock compensation
expense and lower consultant fees. |
|
● |
Loss
from operations for the three months ended September 30, 2023 decreased to $(772,914), as compared to $(1,739,394) for the three
months ended September 30, 2022, a reduction of $966,480 or 55.6%. |
|
|
|
|
● |
As
a result of the aforementioned factors, including the non-cash gain from the change in fair value of the warrant derivative liability
of $1,050,800 and $873,200 for the three months ended September 30, 2023 and 2022, respectively, net income was $372,633 for the
three months ended September 30, 2023, as compared to a net loss of $822,912 for the three months ended September 30, 2022. |
|
|
|
|
● |
Basic
and diluted net income for the three months ended September 30, 2023 was $0.29 per share, as compared to basic and diluted net loss
of $(0.67) per share for the three months ended September 30, 2022, based on 1,273,486 weighted average common shares outstanding
in 2023 and 1,232,016 weighted average common shares outstanding in 2022. |
|
|
|
|
● |
Cash
used in operations for the three months ended September 30, 2023 was $766,581, as compared to $1,282,141 for the three months ended
September 30, 2022. |
Financial
highlights for the nine months ended September 30, 2023 include the following:
|
● |
Total
revenue was $9,312,695 for the nine months ended September 30, 2023, as compared to $8,323,382 for the nine months ended September
30, 2022, an increase of $989,313 or 11.9%. The increase in total revenue was driven by increased sales of the Viactiv®
product line, which accounted for approximately 97.2% and 96.2% of the Company’s total revenue for the nine months
ended September 30, 2023 and 2022, respectively. Drivers of the sales increase included resolution of the short-term impact of a
third-party warehouse expansion which resulted in carry over of retail shipments from June into July 2023, in combination with strong
shipments to Amazon, plus additional distribution of the Company’s Omega Boost® product line. |
|
|
|
|
● |
Gross
profit was $4,044,821 for the nine months ended September 30, 2023, as compared to $3,584,185 for the nine months ended September
30, 2022, an increase of $460,636 or 12.9%. The increase in gross profit was primarily attributable to the increase in sales from
the Viactiv® product line. |
|
|
|
|
● |
Gross
margin for the nine months ended September 30, 2023 was 43.4%, as compared to 43.1% for the nine months ended September 30, 2022,
an increase of 0.3 percentage points, which was driven by cost of goods favorability, such as the realization of lower supply chain
transportation costs that began May 2023, and higher sales. |
|
|
|
|
● |
Total
operating expenses for the nine months ended September 30, 2023 were $7,294,388, as compared to $9,655,205 for the nine months ended
September 30, 2022, a decrease of $2,360,817 or 24.5%. The variance was attributable to a combination of factors, including including
the amortization of intangible assets in 2022, reduced payroll expense, insurance, and professional fees and consulting fees. |
|
● |
Loss
from operations for the nine months ended September 30, 2023 decreased to $(3,249,567), as compared to $(6,071,020) for the nine
months ended September 30, 2022, a reduction of $2,821,453 or 46.5%. |
|
|
|
|
● |
As
a result of the aforementioned factors, including the non-cash gain from the change in fair value of the warrant derivative liability
of $2,693,600 and $3,548,300 for the nine months ended September 30, 2023 and 2022, respectively, net loss was $266,687 for the nine
months ended September 30, 2023, as compared to a net loss of $2,468,262 for the nine months ended September 30, 2022. |
|
|
|
|
● |
Basic
and diluted net loss for the nine months ended September 30, 2023 was $(0.21) per share, as compared to basic and diluted net loss
of $(2.27) per share for the nine months ended September 30, 2022, based on 1,273,249 weighted average common shares outstanding
in 2023 and 1,083,924 weighted average common shares outstanding in 2022. |
|
|
|
|
● |
Cash
used in operations for the nine months ended September 30, 2023 was $3,052,293, as compared to $6,082,906 for the nine months ended
September 30, 2022. The decrease of $3,030,613 in cash used by operating activities was primarily due to a reduction in general and
administrative expenses. |
|
|
|
|
● |
As
of September 30, 2023, the Company had unrestricted cash and cash equivalents of $7,657,309 and net working capital of $11,407,975. |
Additional
significant events that occurred during the three months and nine months ended September 30, 2023, included the following:
|
● |
Alantra
LLC was retained as the Company’s exclusive financial advisor to implement a strategic review to solicit and evaluate alternatives
to maximize stockholder value in the near-term, which review is on-going. |
|
|
|
|
● |
Jan
Hall was appointed President and CEO, effective June 19, 2023, replacing Bret Scholtes. |
|
|
|
|
● |
Katie
Cox was appointed as Chief Accounting Officer, effective July 25, 2023, replacing Jeffrey Benjamin. |
Jan
Hall, Guardion’s President and Chief Executive Officer, commented, “We are pleased with the progress made during the quarter
which was driven by strong topline growth combined with improved operating margins and a reduced cash burn.”
“We
are continuing our efforts to build a clinical nutrition platform and the Viactiv® brand. We are also continuing
our strategic review process with Alantra, LLC (“Alantra”), our exclusive financial advisor, to evaluate opportunities to
maximize stockholder value in the near-term.
“In
the meantime, we believe our market position, consumer loyalty and the extendability of the Viactiv® brand,
combined with our current operating business strategy, provide us with a viable platform from which to leverage our resources to continue
our efforts to grow operations, improve financial performance and maximize stockholder value,” concluded Ms. Hall.”
Financial
Results
Additional
information with respect to the Company’s business, operations and financial condition as of and for the three months and nine
months ended September 30, 2023 is contained in the Company’s Quarterly Report on Form 10-Q for the quarterly period ended September
30, 2023, which has been filed with the U.S. Securities and Exchange Commission (the “SEC”) at www.sec.gov.
About
Guardion Health Sciences, Inc.
Guardion
Health Sciences, Inc. (Nasdaq: GHSI) is a clinical nutrition company that offers a portfolio of
science-based, clinically supported products designed to support the health needs of consumers, healthcare professionals and providers
and their patients. Information and risk factors with respect to Guardion and its business may be obtained in the Company’s
filings with 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. These forward-looking statements contain information about our expectations, beliefs, plans or intentions regarding
our product development and commercialization efforts, research and development efforts, business, financial condition, results of operations,
strategies or prospects, and other similar matters. Statements preceded by, followed by or that otherwise include the words “believes,”
“expects,” “anticipates,” “intends,” “projects,” “estimates,” “plans,”
“hopes” 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 are based on management’s current expectations and assumptions about future events, which are inherently subject to
uncertainties, risks and changes in circumstances that are difficult to predict, and 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 fund its business plan, the impact of the
Company’s exploration of strategic alternatives, any replacement and integration of new management team members, the implementation
of new financial, management, accounting and business software systems, the identification and integration of possible acquisition targets
and suitors, the impact of the COVID-19 pandemic, supply chain disruptions, inflation and a potential recession on the Company’s
business, operations and the economy in general, the Company’s ability to successfully develop and commercialize its proprietary
products and technologies, and the Company’s ability to maintain compliance with Nasdaq’s continued listing requirements.
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.
For
more information about Guardion Health Sciences, Inc., Contact:
investors@guardionhealth.com
Phone:
1-800 873-5141 Ext 208
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