Item 1. Financial Statements
ITEM
1. FINANCIAL STATEMENTS
NEXGEL,
INC
CONDENSED
CONSOLIDATED BALANCE SHEETS
AS
OF JUNE 30, 2024 AND DECEMBER 31, 2023
(Unaudited)
(in
thousands, except share and per share data)
June
30, 2024
December
31, 2023
ASSETS:
Current Assets:
Cash
$ 1,069
$ 2,700
Accounts receivable, net
605
633
Inventory
1,446
1,319
Prepaid expenses and other current assets
468
400
Total current assets
3,588
5,052
Goodwill
1,128
1,128
Intangibles, net
855
326
Property and equipment, net
2,368
1,499
Operating lease - right of use asset
1,742
1,855
Other assets
95
95
Total assets
$ 9,776
$ 9,955
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current Liabilities:
Accounts payable
$ 1,245
$ 1,233
Accrued expenses and other current liabilities
284
398
Deferred revenue
179
20
Current portion of note payable
87
80
Warrant liability
176
146
Contingent consideration liability
370
439
Financing lease liability, current portion
55
-
Operating lease liabilities, current portion
237
233
Total current liabilities
2,633
2,549
Operating lease liabilities, net of current portion
1,632
1,727
Financing lease liability, net of current portion
339
-
Notes payable, net of current portion
645
513
Total liabilities
5,249
4,789
Commitments and Contingencies (Note 16)
Preferred stock, par value $ 0.001 per share, 5,000,000 shares authorized, no shares issued and outstanding
-
-
Common stock, par value $ 0.001 per share, 25,000,000 shares authorized; 6,324,266 and 5,741,838 shares issued and outstanding as of June 30, 2024 and December 31, 2023, respectively
6
6
Additional paid-in capital
20,614
19,406
Accumulated deficit
( 16,453 )
( 14,715 )
Total NexGel stockholders’ equity
4,167
4,697
Non-controlling interest in joint venture
360
469
Total stockholders’ equity
4,527
5,166
Total liabilities and stockholders’ equity
$ 9,776
$ 9,955
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF OPERATIONS
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
(in
thousands, except share and per share data)
2024
2023
2024
2023
Three Months Ended
Six Months Ended
June 30,
June 30,
2024
2023
2024
2023
Revenues, net
$ 1,440
$ 1,167
$ 2,706
$ 1,786
Cost of revenues
1,030
992
2,019
1,669
Gross profit
410
175
687
117
Operating expenses
Research and development
76
55
78
84
Selling, general and administrative
1,388
882
2,534
1,679
Total operating expenses
1,464
937
2,612
1,763
Loss from operations
( 1,054 )
( 762 )
( 1,925 )
( 1,646 )
Other income (expense)
Interest expense
( 30 )
( 9 )
( 46 )
( 10 )
Interest income
1
2
2
2
Loss on sale of assets
( 4 )
-
( 4 )
-
Other income
6
-
6
4
Gain on investments
23
116
57
124
Changes in fair value of warrant liability
79
11
26
77
Total other income, net
75
120
41
197
Loss before income taxes
( 979 )
( 642 )
( 1,884 )
( 1,449 )
Income tax expense
-
-
-
-
Net loss
$ ( 979 )
$ ( 642 )
( 1,884 )
( 1,449 )
Less: Income attributable to non-controlling interest in joint venture
94
( 53 )
146
( 60 )
Net loss attributable to NexGel stockholders
( 885 )
( 695 )
( 1,738 )
( 1,509 )
Net loss per common share - basic
$ ( 0.14 )
$ ( 0.12 )
( 0.28 )
( 0.27 )
Net loss per common share - diluted
$ ( 0.14 )
$ ( 0.12 )
( 0.28 )
( 0.27 )
Weighted average shares used in computing net loss per common share - basic
6,254,659
5,662,338
6,118,212
5,624,275
Weighted average shares used in computing net loss per common share – diluted
6,254,659
5,662,338
6,118,212
5,624,275
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
(in
thousands, except share data)
Shares
Amount
Capital
Interest
Deficit
Equity
Common Stock
Additional
Paid-in
Non-
controlling
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Interest
Deficit
Equity
Balance, January 1, 2024
5,741,838
$ 6
$ 19,406
$ 469
$ ( 14,715 )
$ 5,166
Share-based compensation and restricted stock vesting
—
—
54
—
—
54
Equity offering proceeds, net of expenses
485,786
—
946
—
—
946
Issuance of placement agent warrants in conjunction with the equity offering
—
—
( 56 )
—
—
( 56 )
Net loss
—
—
—
( 52 )
( 853 )
( 905 )
Balance, March 31, 2024
6,227,624
$ 6
$ 20,350
$ 417
$ ( 15,568 )
$ 5,205
Share-based compensation and restricted stock vesting
1,750
—
55
—
—
55
Shares issued in acquisition
89,892
—
200
—
—
200
Issuance of shares for services
5,000
—
9
—
—
9
Non-controlling interest contribution
—
—
—
37
—
37
Net loss
—
—
—
( 94 )
( 885 )
( 979 )
Balance, June 30, 2024
6,324,266
$ 6
$ 20,614
$ 360
$ ( 16,453 )
$ 4,527
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR
THE THREE AND SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
(in
thousands, except share data)
Common Stock
Additional
Paid-in
Non-
controlling
Accumulated
Total
Stockholders’
Shares
Amount
Capital
Interest
Deficit
Equity
Balance, January 1, 2023
5,577,916
$ 6
$ 19,189
$ -
$ ( 11,558 )
$ 7,637
Restricted stock vesting
5,682
-
24
-
-
24
Exercise of warrants
30,430
-
-
-
-
-
Non-controlling interest in JV
-
-
-
500
-
500
Non-controlling interest
-
-
-
500
-
500
Net income (loss)
-
-
-
7
( 814 )
( 807 )
Balance, March 31, 2023
5,614,028
$ 6
$ 19,213
$ 507
$ ( 12,372 )
$ 7,354
Balance
5,614,028
$ 6
$ 19,213
$ 507
$ ( 12,372 )
$ 7,354
Stock-based compensation
-
-
29
-
-
29
Exercise of warrants
82,036
-
-
-
-
-
Net income (loss)
-
-
-
53
( 695 )
( 642 )
Balance, June 30, 2023
5,696,064
$ 6
$ 19,242
$ 560
$ ( 13,067 )
$ 6,741
Balance
5,696,064
$ 6
$ 19,242
$ 560
$ ( 13,067 )
$ 6,741
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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NEXGEL,
INC.
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
FOR
THE SIX MONTHS ENDED JUNE 30, 2024 AND 2023
(Unaudited)
(in
thousands)
2024
2023
Six Months Ended
June 30,
2024
2023
Operating Activities
Net loss
$ ( 1,738 )
$ ( 1,509 )
Adjustments to reconcile net loss to net cash used in operating activities:
Income (loss) attributable to non-controlling interest in joint venture
( 146 )
60
Depreciation and amortization
144
68
Changes in ROU asset and operating lease liability
22
21
Share-based compensation and restricted stock vesting
118
53
Gain on investment in marketable securities
( 57 )
124
Changes in fair value of warrant liability
( 26 )
( 77 )
Changes in operating assets and liabilities:
Accounts receivable
28
( 728 )
Inventory
( 127 )
( 577 )
Prepaid expenses and other assets
( 68 )
( 226 )
Accounts payable
12
793
Accrued expenses and other current liabilities
( 113 )
—
Deferred revenue
159
72
Net Cash Used in Operating Activities
( 1,792 )
( 1,926 )
Investing Activities
Proceeds from sales of marketable securities
57
4,772
Capital expenditures
( 361 )
( 253 )
Net cash paid for Asset acquisition
( 400 )
-
Net Cash Provided by (Used in) Investing Activities
( 704 )
4,519
Financing Activities
Proceeds from equity offering, net of expenses
946
—
Investment by joint venture partner
37
—
Principal payment on financing lease liability
( 22 )
—
Change in contingent consideration liability
( 69 )
—
Principal payments of notes payable
( 27 )
( 3 )
Net Cash Provided by (Used in) Financing Activities
865
( 3 )
Net Decrease in Cash
( 1,631 )
2,590
Cash – Beginning of period
2,700
1,101
Cash – End of period
$ 1,069
$ 3,691
Supplemental Disclosure of Cash Flows Information
Cash paid during the year for:
Interest
$ 27
$ —
Taxes
$ —
$ —
Supplemental Non-cash Investing and Financing activities
Shares issued in conjunction with asset acquisition
$ 200
$ —
Property and equipment financed under notes payable
$ 165
$ —
Property and equipment financed under financing leases
$ 416
$ —
Property and equipment contributed as capital investment to JV
$ —
$ 500
ROU asset and operating lease liabilities recognized upon consolidation of JV
$ —
$ 334
The
accompanying notes are an integral part of these condensed consolidated financial statements.
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NEXGEL,
INC.
NOTES
TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(in
thousands, except share and per share data)
1.
Description of Business, Stock Split and Basis of Presentation
NexGel,
Inc. (“NexGel” or the “Company”) manufactures high water content, electron beam cross-linked, aqueous polymer
hydrogels, or gels, used for wound care, medical diagnostics, transdermal drug delivery and cosmetics. The Company specializes in custom
gels by capitalizing on proprietary manufacturing technologies. The Company has historically served as a contract manufacturer, supplying
our gels to third parties who incorporate them into their own products. Beginning in 2020, we created two new lines of business for the
Company. First, we launched our own line of branded consumer products sold direct to consumers. Second, we expanded into custom and white
label opportunities, which focuses on combining our gels with proprietary branded products and white label opportunities. All of our
gel products are manufactured using proprietary and non-proprietary mixing, coating and cross-linking technologies. Together, these technologies
enable us to produce gels that can satisfy rigid tolerance specifications with respect to a wide range of physical characteristics (e.g.,
thickness, water content, adherence, absorption, moisture vapor transmission rate [a measure of the passage of water vapor through a
substance] and release rate) while maintaining product integrity. Additionally, we have the manufacturing ability to offer broad choices
in the selection of liners onto which the gels are coated. Consequently, the Company and its customers are able to determine tolerances
in moisture vapor transmission rate and active ingredient release rates while personalizing color and texture.
NexGel
was previously known as AquaMed Technologies, Inc. (“AquaMed”) before changing its name to NexGel, Inc. on November 14, 2019.
On
May 15, 2024, the Company purchased assets from Semmens Online Pty Ltd as Trustee for Semmens Business Trust (the “SG Seller”)
related to the SG Seller’s eyeliner, fake eyelashes, lash growth serum and mascara business operating under the tradename “Silly
George” (collectively, the “Silly George Business”).
On
December 1, 2023, the Company purchased substantially all of the assets Olympus Trading Company, LLC (the “Kenkoderm Seller”)
related to the Kenkoderm Seller’s skincare line focused on reducing symptoms associated with psoriasis operating under the tradename
“Kenkoderm” (“Kenkoderm acquisition”).
On
March 1, 2023, the Company acquired a
50 % interest in a newly formed joint venture (“JV”), CG Converting and Packaging, LLC (“CGN”), with
C.G. Laboratories Inc. (“CG Labs”) for its converting and packaging business. The JV is effective March 1, 2023. As
a result of this transaction, the Company owns 50 %
of the JV, with the remaining 50 %
held by CG Labs.
On January 6, 2023, the Company acquired a 50 % interest in a newly formed JV (“Enigma”) to pursue branded
consumer product retail opportunities and the development of new patch products. The JV agreement is effective January 6, 2023. As a
result of this transaction, the Company owns 50 % of the JV, with the remaining 50 % held by Moiety.
Basis
of Presentation
The
accompanying unaudited condensed consolidated financial statements and footnotes of NexGel have been prepared in accordance with
generally accepted accounting principles in the United States of America (“GAAP”) for interim financial information and the
instructions to Rule 10-01 of Regulation S-X of the Securities and Exchange Commission (“SEC”). Accordingly, they do not
include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, these
unaudited condensed consolidated financial statements contain all adjustments, consisting of normal recurring adjustments, considered
necessary for a fair presentation of the results of the interim periods, but are not necessarily indicative of the results of
operations to be anticipated for the full year ending December 31, 2024 . These condensed consolidated financial statements should
be read in conjunction with the audited consolidated financial statements and the notes thereto included in the Company’s Annual
Report on Form 10-K for the year ended December 31, 2023.
Principles
of Consolidation
The
accompanying condensed consolidated financial statements include the accounts of the Company and its condensed consolidated wholly-owned
subsidiary, NexGelRx, Inc. and the fifty percent ( 50 %) owned JV’s (see Note 5).
2.
Going Concern
As
of June 30, 2024, the Company had a cash balance of $ 1.1 million. For the six months ended June 30, 2024, the Company incurred a net
loss of $ 1.7 million and had a net usage of cash in operating activities of $ 1.8 million. In addition, the Company had a working
capital of $ 1.0 million as of June 30, 2024. Additionally, we believe we have sufficient cash to operate our
business plan into 2025.
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On
August 8, 2024, the Company, entered into subscription agreements with investors, certain members of its board of directors for a registered
direct offering (“RDO”) of the Company’s common stock. The RDO sold an aggregate 222,000
units at a price to the public of $ 5.00
per unit, with each
unit consisting of two shares of the Company’s common stock, and a warrant to purchase one share of common stock at an exercise
price of $ 4.25
per
share. The gross proceeds to the Company from the RDO
were $ 1.1
million, before deducting the placement agent’s
fees and other estimated offering expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the warrants.
The Company intends to use the net proceeds from the RDO for working capital and for general corporate purposes (discussed further within Note 19).
Management
is exploring new product channel sales in adjacent industries, such as cosmetics, athletic products, and proprietary medical devices.
The Company has increased focus on sales and developing a sales pipeline for potential customers. This customer base expansion will enable
us to provide financial stability for the foreseeable future, expand our current processes, and position us for long-term shareholder
value creation.
We
have sufficient capital to maintain as a going concern due to the recent capital raises. We intend to maintain and attempt to grow our
existing contract manufacturing business. We also plan to continue building and developing our catalog of consumer products for sale
to branding partners and to use our in-house capabilities to create and test market additional branded products. These products will
be target marketed and sold online through social media, television and online marketplaces. Furthermore, the Company plans to develop
its own proprietary medical devices and explore drug delivery programs for its technology. Additionally, the Company continues to evaluate
strategic initiatives (e.g., acquisitions) and additional capital raises through debt or equity may be necessary to achieve these objectives.
We
expect to continue incurring losses for the near-term future. Our ability to continue to operate as a going concern in the long-term
is dependent upon our ability to manage and grow our current products and to ultimately achieve profitable operations. Management may
consider various options to raise capital to fund potential acquisitions through equity or debt offerings. There can be no assurances,
however, that management will be able to obtain sufficient additional funds, if needed, or that such funds, if available, will be obtained
on terms satisfactory to us. The condensed consolidated financial statements do not include any adjustments relating to the recoverability
and classification of recorded assets and liabilities that might be necessary should we be unable to continue as a going concern. Additionally,
it is reasonably possible that estimates made in the condensed consolidated financial statements have been, or will be, materially and
adversely impacted in the near term as a result of these conditions, including the recoverability of long-lived assets.
3.
Significant Accounting Policies and Estimates
Use
of Estimates
The
preparation of the condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions
that affect the amounts reported in the condensed consolidated financial statements and accompanying notes. These estimates and assumptions
include allowances for credit losses, inventory reserves, deferred taxes, share-based compensation and related valuation allowances and
fair value of long-lived assets. Actual results could differ from the estimates.
Reclassifications
We
have reclassified, combined or separately disclosed certain amounts in the prior years’ consolidated financial statements and accompanying
footnotes to conform with the current year’s presentation.
Segment
Reporting
The
Financial Accounting Standards Board (“FASB”) Accounting Standard Codification (“ASC”) Topic 280, Segment
Reporting , requires that an enterprise report selected information about reportable segments in its financial reports issued to its
stockholders. The Company has two reportable segments - the NexGel segment and the “CGN” segment.
The
NexGel segment is comprised of the manufacturing of ultra-gentle, high-water-content hydrogel products for healthcare and consumer
applications, which is based in Langhorne, Pennsylvania. The NexGel segment includes the Kenkoderm and Silly George recent
acquisitions and the Enigma JV.
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The
“CGN” segment is comprised of the JV used for the Company’s converting and packaging business, which is based in
Granbury, Texas.
Cash
Cash
is comprised of cash in banks and highly liquid investments, including U.S. treasury bills purchased with an original maturity of three
months or less as well as investments in money market funds for which the carrying amount approximates fair value, due to the short maturities
of these investments.
Margin
Line of Credit
The
Company has a brokerage account through which it can buy and sell U.S. treasury bills. The provisions of the account allow us to borrow
on certain securities held in the account and to purchase additional securities based on the account equity (including cash). Amounts
borrowed are collateralized by the securities held in the account and bear interest at a negotiated rate payable monthly. Securities
pledged to secure margin balances cannot be specifically identified as a portion of all securities held in a brokerage account are used
as collateral. As of December 31, 2023, there was $ 245 thousand outstanding under this short-term credit line which is included in accrued
expenses and other current liabilities within the accompanying condensed consolidated balance sheet (see Note 11). The margin line credit
line was repaid in January 2024 and there is no outstanding balance under the credit line as of June 30, 2024.
Accounts
Receivable, net
Trade
accounts receivable are stated at the amount the Company expects to collect and do not bear interest. The Company evaluates the collectability
of accounts receivable and records a provision to the allowance for credit losses based on factors including the length of time the receivables
are past due, the customer’s payment history, the credit quality of the customer and other factors that may affect the customers’
ability to pay. Provisions to the allowances for doubtful accounts are recorded in selling, general and administrative expenses. Account
balances are charged off against the allowance when it is probable that the receivable will not be recovered. The allowance for credit
losses was $ 18 thousand as of June 30, 2024 and $ 11 thousand as of December 31, 2023.
Inventory
and Cost of Revenues
The
inventory balance is stated at the lower of cost, the value determined by the first-in, first-out method, or net realizable value. The
Company evaluates inventories for excess quantities, obsolescence, and shelf-life expiration. This evaluation includes an analysis of
historical sales levels by product, projections of future demand, the risk of technological or competitive obsolescence for products,
general market conditions, and a review of the shelf-life expiration dates for products. These factors determine when, and if, the Company
adjusts the carrying value of inventory to estimated net realizable value.
The
Company produces proprietary branded products and white label opportunities in our manufacturing of consumer products. In our contract
manufacturing, the Company builds its products based on customer orders and immediately ships the products upon completion of the production
process.
The
inventory balance is made up of raw materials, work-in-progress, and finished goods. Inventory is maintained at the Company’s warehouses
and at fulfilment centers owned by Amazon, Walmart and CVS.
The
“Cost of revenues” line item in the condensed consolidated statements of operations is comprised of the book value of inventory
sold to customers during the reporting period. When circumstances dictate that we use net realizable value as the basis for recording
inventory, we base our estimates on expected future selling prices less expected disposal costs.
Research
and Development
Our
research and development activities focus on new and innovative products designed to support revenue growth. Research and development
expenses consist primarily of contracted development and testing efforts associated with development of products.
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Shipping
and Handling Revenue and Expense
Shipping
and handling revenue and expense are included in our condensed consolidated statements of operations in revenues and cost of revenues,
respectively. Shipping revenue and expense are primarily generated through the Amazon marketplace.
Property
and Equipment, net
Property
and equipment is recorded at historical cost, net of accumulated depreciation and amortization. Depreciation is provided over the assets’
useful lives on a straight-line basis. Leasehold improvements are amortized on a straight-line basis over the shorter of their estimated
useful lives or lease terms. Repairs and maintenance costs are expensed as incurred.
Management
periodically assesses the estimated useful life over which assets are depreciated or amortized. If the analysis warrants a change in
the estimated useful life of property and equipment, management will reduce the estimated useful life and depreciate or amortize the
carrying value prospectively over the shorter remaining useful life.
The
carrying amounts of assets sold or retired and the related accumulated depreciation are eliminated in the year of disposal and any resulting
gains and losses are included in the results of operations during the same year.
Impairment
of Long-Lived Assets
The
Company reviews its property and equipment and any identifiable intangibles for impairment whenever events or changes in circumstances
indicate that the carrying amount of an asset may not be recoverable. Recoverability of assets to be held and used is measured by a comparison
of the carrying amount of an asset to the future undiscounted operating cash flow expected to be generated by the asset. If such assets
are considered to be impaired, the impairment to be recognized is measured by the amount by which the carrying amount of the asset exceeds
the fair value of the asset. Long-lived assets to be disposed of are reported at the lower of carrying amount or fair value less costs
to sell.
Goodwill
and Intangible Assets
In
applying the acquisition method of accounting, amounts assigned to identifiable assets and liabilities acquired were based on estimated
fair values as of the date of acquisition, with the remainder recorded as goodwill. Identifiable intangible assets are initially recorded
at fair value using generally accepted valuation methods appropriate for the type of intangible asset. Identifiable intangible assets
with definite lives are amortized over their estimated useful lives and are reviewed for impairment if indicators of impairment arise.
Intangible assets with indefinite lives are tested for impairment within one year of the acquisition date or annually as of December
31, and whenever indicators of impairment exist. The fair value of intangible assets is compared with their carrying values, and an impairment
loss would be recognized for the amount by which a carrying amount exceeds its fair value.
The
Company performed the annual assessment and concluded it is more likely than not that the fair value exceeds the carrying value and no
impairments were recognized in the year ended December 31, 2023.
Prepaid
Expenses and Other Current Assets
Prepaid
expenses and other current assets are recorded at historical cost and are primarily made up of $ 10
thousand and $ 64
thousand of prepaid insurance, and $ 458 thousand
and $ 336
thousand general prepaid expenses and other current assets as of June 30, 2024 and December 31, 2023, respectively.
Other
Assets
Other
assets are recorded at historical costs, and as of June 30, 2024 and December 31, 2023, the balance is primarily comprised of spare parts
for manufacturing equipment. Spare parts are not subject to depreciation until such time that they are placed into service and the part
that is being replaced is disposed.
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Fair
Value Measurements
The
Company utilizes the fair value hierarchy to apply fair value measurements. The fair value hierarchy is based on inputs to valuation
techniques that are used to measure fair values that are either observable or unobservable. Observable inputs reflect assumptions market
participants would use in pricing an asset or liability based on market data obtained from independent sources, while unobservable inputs
reflect a reporting entity’s pricing based upon its own market assumptions. The basis for fair value measurements for each level
within the hierarchy is described below:
Level
1 —Quoted prices for identical assets or liabilities in active markets.
Level
2 —Quoted prices for similar assets or liabilities in active markets; quoted prices for identical or similar assets or liabilities
in markets that are not active; or model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level
3 —Valuations derived from valuation techniques in which one or more significant inputs to the valuation model are unobservable.
The
Company considers the carrying amounts of its financial instruments (cash, accounts receivable and accounts payable, notes payable and
convertible notes payable) in the condensed consolidated balance sheet to approximate fair value because of the short-term or highly
liquid nature of these financial instruments.
Warrant
Liability
Warrants
to purchase common stock were issued in connection with equity financing raises, which occurred during 2019 through 2024. The fair values
of the warrants are estimated as of the date of issuance and again at each year end using a Black-Scholes option valuation model. At
issuance, the fair values of the warrant are recognized as an equity issuance cost within additional paid-in-capital. Fair value adjustments
to the warrant liability are recognized in other income (expense) in the condensed consolidated statements of operations.
Revenue
Recognition
The
Company records revenue in accordance with ASC Topic 606, Revenue from Contracts with Customers (“ASC 606”). The core
principle of ASC 606 requires that an entity recognize revenue to depict the transfer of promised goods or services to customers in an
amount that reflects the consideration to which the Company expects to be entitled in exchange for those goods or services. ASC 606 defines
a five-step process to achieve this core principle and, in doing so, it is possible more judgment and estimates may be required within
the revenue recognition process than required under existing GAAP including identifying performance obligations in the contract, estimating
the amount of variable consideration to include in the transaction price and allocating the transaction price to each separate performance
obligation.
The
Company currently recognizes revenue predominately from three sources, contract manufacturing, custom and white label finished goods
manufacturing and our branded products. Revenues from manufactured products are recognized at the point where the customer obtains control
of the goods and the Company satisfies its performance obligation, which generally is at the time the customer receives the product.
The
Company’s customers consist of other life sciences companies and Amazon retail customers. Revenues are entirely concentrated in
the United States. Payment terms vary by the type and location of customer and may differ by jurisdiction and customer but payment is
generally required in a term ranging from 30 to 60 days from date of shipment.
Estimates
for product returns, allowances and discounts are recorded as a reduction of revenue and are established at the time of sale. Returns
are estimated through a comparison of historical return data and are determined for each product and adjusted for known or expected changes
in the marketplace specific to each product, when appropriate. Historically, sales return provisions have not been material. Amounts
accrued for sales allowances and discounts are based on estimates of amounts that are expected to be claimed on the related sales and
are based on historical data. Payments for allowances and discounts have historically been immaterial.
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Disaggregated
revenue by sales type ($ in thousands):
Schedule
of Disaggregated Revenue by Sales Type
2024
2023
Three months ended
June 30,
2024
2023
Contract manufacturing
$ 425
$ 887
Custom and white label finished goods manufacturing
11
—
Branded consumer products
968
259
Other
36
21
Total
$ 1,440
$ 1,167
2024
2023
Six months ended
June 30,
2024
2023
Contract manufacturing
$ 1,026
$ 1,267
Custom and white label finished goods manufacturing
42
4
Branded consumer products
1,585
493
Other
53
22
Total
$ 2,706
$ 1,786
As
of June 30, 2024 and December 31, 2023, the Company did not have any contract assets or contract liabilities from contracts with customers
and there were no remaining performance obligations that the Company had not satisfied except for deferred revenue of $ 179 thousand and
$ 20 thousand at June 30, 2024 and December 31, 2023, respectively, that the Company had not satisfied as of the end of the respective
period.
The
Company has four distinct lines of business; Contract Manufacturing, Custom and White Label, Branded Consumer Products,
and Medical Devices/Other.
Contract
Manufacturing
Customers
order rolls of gel (“rollstock”). The rollstock is shipped to our customers, which they package into finished goods. Historically,
this has been the Company’s primary source of revenue.
Custom
and White Label
These
products often infuse various ingredients into our base gel to develop unique product offerings to satisfy market demand (e.g. aloe infused
into the gel for a beauty mask). The rollstock is converted and packaged into saleable units. The finished goods are shipped to the customer,
who is ultimately responsible for product distribution. Frequently these products started as development deals, in which the customer
paid the Company a small fee to develop a specific product. Once completed, the customer places a large order for newly developed product.
Branded
Consumer Products
These
products are finished goods marketed and sold directly to the customer by the Company through online and retail channels. The Company
is responsible for sales, marketing, and distribution. These products carry the Company’s brand names, which include Medagel, Lumagel
Beauty, Kenkoderm and Silly George.
Medical
Devices
Medical
Devices are a hybrid business, combining elements of Custom and White Label and Branded Consumer Products. Medical Devices, which
are not yet marketed, are expected to be distributed through strategic partnerships. The Company will manufacture and possibly
convert/package the device while the strategic partner brings the product to market. Small market Medical Devices could be launched
by the Company, but also be offered to a distributor to reach the full scale of the market.
Share-based
Compensation
On
August 28, 2019, the Company adopted the 2019 Long-Term Incentive Plan, as amended (the “2019 Plan”). See Note 13 below for
further details regarding the 2019 Plan.
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The
2019 Plan provides certain employees, contractors, and outside directors with share-based compensation in the form of incentive stock
options, nonqualified stock options, stock appreciation rights, restricted stock, restricted stock units, performance awards, dividend
equivalent rights and other awards. The fair values of incentive stock option award grants are estimated as of the date of grant using
a Black-Scholes option valuation model. Compensation expense is recognized in the condensed consolidated statements of operations on
a straight-line basis over the requisite service period, which is generally the vesting period.
Income
Taxes
Income
taxes are accounted for using an asset and liability approach that requires the recognition of deferred tax assets and liabilities for
the expected future tax consequences of temporary differences between the financial statement and tax bases of assets and liabilities
at the applicable tax rates. Deferred tax assets are reduced by a valuation allowance when it is more likely than not that some portion
or all of the deferred tax assets will not be realized. Deferred tax assets and liabilities are adjusted for the effects of changes in
tax laws and rates.
Tax
benefits are recognized from an uncertain tax position only if it is more likely than not that the tax position will be sustained upon
examination by a tax authority and based upon the technical merits of the tax position. The tax benefit recognized in the condensed consolidated
financial statements for a particular tax position is based on the largest benefit that is more likely than not to be realized upon settlement.
An unrecognized tax benefit, or a portion thereof, is presented in the condensed consolidated financial statements as a reduction to
a deferred tax asset for a net operating loss carryforward, a similar tax loss, or a tax credit carryforward if such settlement is required
or expected in the event the uncertain tax position is disallowed.
Leases
ASC
842, Leases, requires recognition of leases on the condensed consolidated balance sheets as right-of-use (“ROU”) assets and
lease liabilities. ROU assets represent the Company’s right to use underlying assets for the lease terms and lease liabilities
represent the Company’s obligation to make lease payments arising from the leases. Operating lease ROU assets and operating lease
liabilities are recognized based on the present value and future minimum lease payments over the lease term at commencement date. As
the Company’s leases do not provide an implicit rate, the Company used its estimated incremental borrowing rate based on the information
available at commencement date in determining the present value of lease payments. A number of the lease agreements contain options to
renew and options to terminate the leases early. The lease term used to calculate ROU assets and lease liabilities only includes renewal
and termination options that are deemed reasonably certain to be exercised.
The
Company recognized lease liabilities, with corresponding ROU assets, based on the present value of unpaid lease payments for existing
operating leases longer than twelve months. The ROU assets were adjusted per ASC 842 transition guidance for existing lease-related balances
of accrued and prepaid rent, and unamortized lease incentives provided by lessors. Operating lease cost is recognized as a single lease
cost on a straight-line basis over the lease term and is recorded in selling, general and administrative expenses. Variable lease payments
for common area maintenance, property taxes and other operating expenses are recognized as expense in the year when the changes in facts
and circumstances on which the variable lease payments are based occur. The Company has elected not to separate lease and non-lease components
for all property leases for the purposes of calculating ROU assets and lease liabilities.
Variable
Interest Entity
The
Company reviews each legal entity formed by parties related to the Company to determine whether or not the Company has a variable interest
in the entity and whether or not the entity would meet the definition of a variable interest entity (“VIE”) in accordance
with ASC Topic 810, Consolidation . In assessing whether the Company has a variable interest in the entity as a whole, the Company
considers and makes judgements regarding the purpose and design of the entity, the value of the licensed assets to the entity, the value
of the entity’s total assets and the significant activities of the entity. If the Company has a variable interest in the entity
as a whole, the Company assesses whether or not the Company is a primary beneficiary of that VIE, based on a number of factors, including:
(i) which party has the power to direct the activities that most significantly affect the VIE’s economic performance, (ii) the
parties’ contractual rights and responsibilities pursuant to the collaboration agreement, and (iii) which party has the obligation
to absorb losses of or the right to receive benefits from the VIE that could be significant to the VIE.
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If
the Company determines that it is the primary beneficiary of a VIE at the onset of the collaboration, the collaboration is treated as
a business combination and the Company consolidates the financial statements of the VIE into the Company’s condensed consolidated
financial statements. As of December 31, 2023, and on a quarterly basis thereafter, the Company will evaluate whether it continues to
be the primary beneficiary of the consolidated VIE. If the Company determines that it is no longer the primary beneficiary of a consolidated
VIE, it deconsolidates the VIE in the period in which the determination is made.
Assets
and liabilities recorded as a result of consolidating the financial results of the VIE into the Company’s condensed consolidated
balance sheet do not represent additional assets that could be used to satisfy claims against the Company’s general assets or liabilities
for which creditors have recourse to the Company’s general assets.
Comprehensive
loss
Comprehensive
loss consists of net loss and changes in equity during the period from transactions and other equity and circumstances generated from
non-owner sources. The Company’s net loss equals comprehensive loss for all periods presented.
Recently
Issued Accounting Standards
From
time to time, new accounting pronouncements are issued by the FASB, or other standard setting bodies and adopted by us as of the specified
effective date. Unless otherwise discussed, the impact of recently issued standards that are not yet effective will not have a material
impact on our condensed consolidated financial position or results of operations upon adoption.
In
June 2016, the FASB issued Accounting Standards Update (“ASU’) 2016-13, Financial Instruments – Credit Losses (Topic
326): Measurement of Credit Losses on Financial Instruments . ASU 2016-13 significantly changes the impairment model for most financial
assets and certain other instruments. ASU 2016-13 will require immediate recognition of estimated credit losses expected to occur over
the remaining life of many financial assets, which will generally result in earlier recognition of allowances for credit losses on loans
and other financial instruments. ASU 2016-13 is effective for the Company’s fiscal year beginning January 1, 2023 and subsequent
interim periods. The Company adopted this new standard during the year ended December 31, 2023 and it did not have a material impact
to its condensed consolidated financial statements.
Accounting
Pronouncements Issued But Not Yet Adopted
In
December 2023, the FASB issued ASU 2023-09 , Income Taxes (Topic 740): Improvements to Income Tax Disclosures . The ASU requires
that an entity disclose specific categories in the effective tax rate reconciliation as well as reconciling items that meet a quantitative
threshold. Further, the ASU requires additional disclosures on income tax expense and taxes paid, net of refunds received, by jurisdiction.
The new standard is effective for annual periods beginning after December 15, 2024 on a prospective basis with the option to apply it
retrospectively. Early adoption is permitted. The adoption of this guidance will result in the Company being required to include enhanced
income tax related disclosures. The Company is currently evaluating the impact this standard will have on its condensed consolidated
financial statements.
In
November 2023, the FASB issued ASU 2023-07 , Segment Reporting (Topic 280): Improvements to Reportable Segment Disclosures . This
ASU includes amendments that expand the existing reportable segment disclosure requirements and requires disclosure of (i) significant
expense categories and amounts by reportable segment as well as the segment’s profit or loss measure(s) that are regularly provided
to the chief operating decision maker (the “CODM”) to allocate resources and assess performance; (ii) how the CODM uses each
reported segment profit or loss measure to allocate resources and assess performance; (iii) the nature of other segment balances contributing
to reported segment profit or loss that are not captured within segment revenues or expenses; and (iv) the title and position of the
individual or name of the group or committee identified as the CODM. This guidance requires retrospective application to all prior periods
presented in the financial statements and is effective for fiscal years beginning after December 15, 2023 and interim periods within
fiscal years beginning after December 15, 2024. Early adoption is permitted. The adoption of this guidance will result in the Company
being required to include enhanced disclosures relating to its reportable segments. The Company is currently evaluating the impact this
standard will have on its condensed consolidated financial statements.
15
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4.
Business Segments
The
Company’s CODM evaluates the financial performance of the Company’s segments based upon segment adjusted operating income
or (loss) as the profitability measure. Items outside of adjusted operating income or (loss) are not reported by segment, since they
are excluded from the single measure of segment profitability reviewed by the CODM.
Summarized
financial information concerning the Company’s reportable segments for each of the quarters ended June 30, 2024 and 2023 is presented
below.
Schedule
of Reportable Segments
For
Quarter Ended June 30, 2024 ($ in thousands)
NexGel
CGN JV
Total
Revenue
Contract Manufacturing
$ 78
$ 347
$ 425
Custom and White Label Finished Goods
11
-
11
Branded Consumer Products
968
-
968
Other income
33
3
36
Total revenue
1,090
350
1,440
Cost of sales
705
325
1,030
Operating expenses
1,322
142
1,464
Loss from operations
$ ( 937 )
$ ( 117 )
$ ( 1,054 )
For
Quarter Ended June 30, 2023 ($ in thousands)
NexGel
CGN JV
Total
Revenue
Contract Manufacturing
$ 291
$ 596
$ 887
Custom and White Label Finished Goods
-
-
-
Branded Consumer Products
259
-
259
Other income
18
3
21
Total revenue
568
599
1,167
Cost of sales
558
434
992
Operating expenses
884
53
937
Loss from operations
$ ( 874 )
$ 112
$ ( 762 )
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For
the Six Months Ended June 30, 2024 ($ in thousands)
NexGel
CGN JV
Total
Revenue
Contract Manufacturing
$ 269
$ 757
$ 1,026
Custom and White Label Finished Goods
42
-
42
Branded Consumer Products
1,585
-
1,585
Other income
45
8
53
Total revenue
1,941
765
2,706
Cost of sales
1,348
671
2,019
Operating expenses
2,309
303
2,612
Loss from operations
$ ( 1,716 )
$ ( 209 )
$ ( 1,925 )
For
the Six Months Ended June 30, 2023 ($ in thousands)
NexGel
CGN JV
Total
Revenue
Contract Manufacturing
$ 479
$ 788
$ 1,267
Custom and White Label Finished Goods
4
-
4
Branded Consumer Products
493
-
493
Other income
19
3
22
Total revenue
995
791
1,786
Cost of sales
1,081
588
1,669
Operating expenses
1,677
86
1,763
Loss from operations
$ ( 1,763 )
$ 117
$ ( 1,646 )
As
of June 30, 2024 ($ in thousands)
NexGel
CGN JV
Total
Assets:
Current assets:
Cash
$ 1,026
$ 43
$ 1,069
Accounts receivable, net
111
494
605
Inventory
931
515
1,446
Prepaid expenses and other current assets
447
21
468
Total current assets
2,515
1,073
3,588
Goodwill
1,128
-
1,128
Intangibles, net
688
167
855
Property and equipment, net
852
1,516
2,368
Operating lease – right of use asset
1,444
298
1,742
Other assets
95
-
95
Total Assets
$ 6,722
$ 3,054
$ 9,776
Liabilities
Current liabilities:
Accounts payable
$ 578
$ 667
$ 1,245
Accrued expenses and other current liabilities
233
51
284
Deferred revenue
-
179
179
Current portion of note payable
12
75
87
Warrant liability
176
-
176
Contingent consideration liability
370
-
370
Financing lease liability, current portion
-
55
55
Operating lease liabilities, current portion
208
29
237
Total current liabilities
1,577
1,056
2,633
Financing lease liability, net of current portion
-
339
339
Operating lease liabilities, net of current portion
1,358
274
1,632
Notes payable, net of current portion
274
371
645
Total liabilities
$ 3,209
$ 2,040
$ 5,249
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As
of December 31, 2023 ($ in thousands)
NexGel
CGN JV
Total
Assets:
Current assets:
Cash
$ 2,458
$ 242
$ 2,700
Accounts receivable, net
26
607
633
Inventory
622
697
1,319
Prepaid expenses and other current assets
312
88
400
Total current assets
3,418
1,634
5,052
Goodwill
1,128
-
1,128
Intangibles, net
122
204
326
Property and equipment, net
898
601
1,499
Operating lease – right of use asset
1,543
312
1,855
Other assets
95
-
95
Total Assets
$ 7,204
$ 2,751
$ 9,955
Liabilities
Current liabilities:
Accounts payable
$ 509
$ 724
$ 1,233
Accrued expenses and other current liabilities
137
261
398
Deferred revenue
20
-
20
Current portion of note payable
6
74
80
Warrant liability
146
-
146
Contingent consideration liability
439
-
439
Operating lease liability, current portion
207
26
233
Total current liabilities
1,464
1,085
2,549
Operating lease liability, net of current portion
1,438
289
1,727
Notes payable, net of current portion
272
241
513
Total liabilities
$ 3,174
$ 1,615
$ 4,789
5.
Acquisition
Silly
George Acquisition
On
May 15, 2024, the Company entered into and closed a transaction related to an Asset Purchase Agreement dated May 15, 2024 (the
“SG Purchase Agreement”) with Semmens Online Pty Ltd as Trustee for Semmens Business Trust, an Australian proprietary
limited, whereby the Company purchased the Silly George Business. The Company believes the acquisition will be accretive and synergistic to its existing health and beauty customer
product brands.
Under
the terms of the Purchase Agreement and on the Closing Date, the Company paid the SG Seller a cash payment of $ 400,000
and issued $ 200,000
in shares of the Company’s common stock based on the 10-Day VWAP (as defined in the SG Purchase Agreement), or 89,892
of shares of the Company’s common Stock. Additionally, the Company shall pay the Seller a cash earn-out based on 20 %
of the Net Profit (as defined in the SG Purchase Agreement) related to the SG Assets for the fiscal quarterly period beginning June
30, 2024 and ending on June 30, 2028. Per the scope exception under ASC 815, the Company has not accrued the contingent consideration.
Schedule of Business Acquisitions
Provisional purchase consideration at preliminary fair value:
Purchase price
$ 600
Contingent consideration liability
-
Co nsideration paid
$ 600
Assets acquired and liabilities assumed at preliminary fair value
Inventory
56
Fixed assets
213
Product/technology related intangibles
77
Trademark related intangibles
600
Net tangible assets acquired
$ 600
Kenkoderm
Acquisition
On
December 1, 2023, the Company closed a transaction related to an Asset Purchase Agreement dated November 30, 2023 with Olympus Trading Company, LLC, a Virginia limited liability company,
whereby the Company purchased all assets related to the Kenkoderm Seller’s skincare line focused on reducing symptoms associated
with psoriasis operating under the tradename “Kenkoderm” (“Kenkoderm acquisition”). The Company believes the Kenkoderm brand fits its health and wellness lines of product.
Under
the terms of the Kenkoderm Purchase Agreement, the Company paid the Kenkoderm Seller a cash payment of $ 546,500 on December 1, 2023.
Additionally, the Company shall pay the Kenkoderm Seller a cash earn-out of the same amount each quarter, payable in the subsequent month
following quarter end, of $ 136,625 , subject to adjustment. The cash earn-out can fluctuate higher or lower based on the quarterly results
of the Kenkoderm business during 2024 according to the formula contained in the Purchase Agreement.
The
provisional fair value of the purchase consideration issued to the Kenkoderm Seller was allocated to the net tangible assets acquired.
The Company accounted for the Kenkoderm acquisition as the purchase of a business under GAAP under the acquisition method of accounting,
and the assets and liabilities acquired were recorded as of the acquisition date, at their respective fair values and condensed consolidated
with those of the Company. The fair value of the net assets acquired was approximately $ 169 thousand. The excess of the aggregate fair
value of the net tangible assets has been allocated to goodwill.
18
Table of Contents
The
table below shows a preliminary analysis for the Kenkoderm acquisition ($ in thousands):
Schedule of Business Acquisitions
Provisional purchase consideration at preliminary fair value:
Purchase price
$ 547
Contingent consideration liability
439
Amount of consideration
$ 986
Assets acquired and liabilities assumed at preliminary fair value
Inventory
56
Product/technology related intangibles
77
Marketing related intangibles
36
Net tangible assets acquired
$ 169
Total net assets acquired
$ 169
Consideration paid
986
Preliminary goodwill
$ 817
Non-controlling
Interest in Joint Venture – CGN
On
March 1, 2023, the Company acquired a 50 % interest in
the JV (see Note 1). The JV is owned 50 % by the Company and 50 % by CG Labs. CG Labs contributed its existing converting and packaging
division to the JV, including, but not limited to, its facilities, equipment, employees, and customers. The Company will contribute $ 500,000
to the JV, on a schedule to be determined, to be used for equipment and facility upgrades as well as general corporate purposes for the
JV.
The
JV is considered to be a VIE and we have consolidated the JV because we believe we are the primary beneficiary because
we meet the Power and the Economics
Criteria, as laid out in ASC 323.
The
recorded assets acquired and liabilities assumed in connection with the formation of the JV based on their estimated fair values as of
the March 1, 2023. The purchase price allocation is as follow ($ in thousands):
Schedule of Business Acquisitions
Purchase consideration at fair value:
Cash contributed by the Company
$ 500
Noncontrolling interest portion of CG Labs contributed business
500
C onsideration Paid
$ 1,000
Assets acquired and liabilities assumed at fair value
Cash contributed by the Company
500
Fixed assets
213
Product/technology related intangibles
217
Marketing related intangibles
70
Net tangible assets acquired
$ 1,000
Non-controlling Interest in Joint Venture –
Enigma
On January 6, 2023, the Company acquired a 50 % interest
in a newly formed JV (“Enigma”) to pursue branded consumer product retail opportunities and the development of new patch products.
The JV agreement is effective January 6, 2023. As a result of this transaction, the Company owns 50 % of the JV, with the remaining 50 %
held by Moiety. As of June 30, 2024, the Company has contributed $ 20 thousand and $ 37 thousand has been contributed by the non-controlling
interest portion of Enigma contributed business.
The
JV is considered to be a VIE and we have consolidated the JV because we believe we are the primary beneficiary because we meet the
Power and the Economics Criteria, as laid out in ASC 323.
The
allocation of the purchase price to identifiable assets is based on the preliminary valuations performed to determine the fair value
of the net assets as of the acquisition date. The measurement period for the valuation of net assets acquired ends as soon as information
on the facts and circumstances that existed as of the acquisition dates becomes available, but not to exceed 12 months following the
acquisition date. Adjustments in purchase price allocations may require a change in the amounts allocated to net assets acquired during
the periods in which the adjustments are determined.
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Table of Contents
The
unaudited pro-forma condensed consolidated results of operations are presented for information purposes only. The unaudited
pro-forma condensed consolidated results of operations are not intended to present actual results that would have been attained had
the Kenkoderm and Silly George acquisitions and the CGN JV and Enigma JV been completed as of January 1, 2023 or to project
potential operating results as of any future date or for any future periods ($ in thousands except share and per share
amounts):
Schedule of Unaudited Pro-Forma Results of Operations
2024
2023
June 30,
June 30,
2024
2023
Revenues, net
$ 3,280
$ 5,239
Net loss allocable to common shareholders
$ ( 1,780 )
$ ( 980 )
Net loss per share
$ ( 0.29 )
$ ( 0.17 )
Weighted average number of shares outstanding
6,208,104
5,714,167
6.
Operating Leases
The
Company has an operating lease for a commercial manufacturing facility and administrative offices located in Langhorne, Pennsylvania
that runs through January 2031. There are two options that can extend the lease term for five years each . The exercise of the lease options
to renew is solely at the Company’s discretion.
The
Company also has a sublease for office and manufacturing space in Granbury, Texas that runs through February 2028. There is an option
that can extend the lease term for an additional five years through February 2033 . The exercise of the lease options to renew is solely
at the Company’s discretion.
The
following table presents information about the amount and timing of the liability arising from the Company’s operating lease as
of June 30, 2024 ($ in thousands):
Schedule of Future Minimum Operating Lease Payments
Maturity of Lease Liability
Operating
Lease
Liabilities
2024 (Remainder of year)
$ 122
2025
245
2026
301
2027
315
2028
324
Thereafter
790
Total undiscounted operating lease payments
2,097
Less: Imputed interest
( 228 )
Present value of operating lease liabilities
$ 1,869
Weighted average remaining lease term
6.9 years
Weighted average discount rate
3.0 %
Total
operating lease expense for the six months ended June 30, 2024 and 2023, was $ 143 thousand and $ 136 thousand, respectively, and is recorded
in cost of goods sold and selling, general and administrative expenses in the accompanying condensed consolidated statements of operations.
Supplemental
cash flows information related to leases was as follows:
Schedule of Supplemental Cash Flows Information Related to Leases
June 30,
2024
Cash paid for amounts included in the measurement of lease liability ($ in thousands):
Operating cash flows from operating lease
$ 122
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7.
Financing Lease
In
February 2024, the CGN JV entered into a lease agreement for certain equipment under separate non-cancelable equipment loan and
security agreements. The agreement matures in January 2030. The agreements require monthly payments of principal and interest
through maturity and are secured by the assets under the lease. As of June 30, 2024, $ 394
thousand is included in the property and equipment on the balance sheet. The weighted average interest rate was 9.1 %
at June 30, 2024.
The
following table presents information about the amount and timing of the liability arising from the Company’s financing lease as
of June 30, 2024 ($ in thousands):
Schedule of Future Minimum Financing Lease Payments
Maturity of Lease Liability
Operating
Lease
Liability
2024 (Remainder of year)
$ 45
2025
90
2026
91
2027
91
2028
91
Thereafter
98
Total undiscounted operating lease payments `
506
Less: Imputed interest
( 112 )
Present value of operating lease liability
$ 394
Weighted average remaining lease term
5.6 years
Weighted average discount rate
9.1 %
8.
Inventory
Inventory
consists of the following ($ in thousands):
Schedule of Inventory
June 30,
December 31,
2024
2023
Raw materials
$ 945
$ 899
Work-in-progress
59
12
Finished goods
442
408
Inventory, gross
1,446
1,319
Less: Inventory reserve for excess and slow moving inventory
-
-
Total
$ 1,446
$ 1,319
Inventory
is maintained at the Company’s warehouses and at fulfillment centers owned by Amazon, Walmart and CVS. The Company builds its contract
manufacturing products based on customer orders and immediately ships the products upon completion of the production process.
9.
Property and Equipment, Net
Property
and equipment consist of the following ($ in thousands):
Schedule of Property and Equipment
Useful Life
June 30,
December 31,
(Years)
2024
2023
Machinery and equipment
3 - 10
$ 1,378
$ 1,280
Office furniture and equipment
3 - 10
184
139
Leasehold improvements
6
664
419
Construction in progress
N/A
944
387
Property and equipment, gross
3,170
2,225
Less: accumulated depreciation and amortization
( 802 )
( 726 )
Property and equipment, net
$ 2,368
$ 1,499
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Depreciation
expense for the six months ended June 30, 2024 and 2023 was $ 76 and $ 61 , respectively.
10.
Intangible Assets
The
following provides a breakdown of identifiable intangible assets as of June 30, 2024 and December 31, 2023 ($ in thousands):
Schedule of Breakdown of Identifiable Intangible Assets
Useful Life
June 30,
December 31,
(Years)
2024
2023
Product/Technology Related
Identifiable intangible assets, gross
3
$ 325
$ 325
Accumulated amortization
( 142 )
( 98 )
Product/technology related identifiable intangible assets, net
183
227
Marketing Related
Customer related intangible asset, gross
10
17
17
Tradename related intangible asset, gross
4
113
113
Trademark related intangibles
Indefinite
600
-
Accumulated amortization
( 58 )
( 31 )
Marketing related identifiable intangible assets, net
672
99
Total identifiable intangible assets, net
$ 855
$ 326
In
connection with the May 29, 2020 acquisition of Sports Defense, the Company identified intangible assets of $ 55 thousand representing
technology related and customer related intangibles.
In
connection with the March 1, 2023 CGN JV, the Company identified intangible assets of $ 287
thousand representing technology related and customer related intangibles.
In
connection with the December 1, 2023 acquisition of Kenkoderm, the Company identified intangible assets of $ 113 thousand representing
technology related and customer related intangibles.
In
connection with the May 15, 2024 acquisition of Silly George, the Company identified intangible assets of $ 600 thousand representing
trademark related intangibles with indefinite lives. Intangible assets with indefinite lives are tested for impairment within one year of the acquisition date or annually
as of December 31, and whenever indicators of impairment exist.
These
assets are being amortized on a straight-line basis over their weighted average estimated useful life of 4.5 years and amortization expense
amounted to $ 72 and $ 4 thousand for the six months ended June 30, 2024 and 2023, respectively.
As
of June 30, 2024, the estimated annual amortization expense for each of the next five fiscal years is as follows ($ in thousands):
Schedule of Estimated Annual Amortization Expense
2024 (remainder of the year)
$ 48
2025
126
2026
64
2027
13
2028
2
Thereafter
2
Subtotal
255
Indefinite lived intangible assets subject to impairment
600
Total
$
855
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11.
Accrued Expenses and Other Current Liabilities
Accrued
expenses and other current liabilities consist of the following ($ in thousands):
Schedule of Accrued Expenses and Other Current Liabilities
June 30,
December 31,
2024
2023
Salaries, benefits, and incentive compensation
$ 98
$ 61
Margin line of credit
-
245
Other
186
92
Total accrued expenses and other current liabilities
$ 284
$ 398
12.
Common Stock
At
June 30, 2024, the Company has reserved common stock for issuance in relation to the following:
Schedule of Reserved Common Stock For Issued Securities in Relation
Share-based compensation plan
546,364
Warrants to purchase common stock
3,713,519
Restricted stock units
84,284
On
June 6, 2024, Company issued 5,000 common shares to a consultant valued at $ 9 thousand.
On
February 15, 2024 (the “Closing Date”), the Company, entered into subscription agreements with investors, the Company’s
Chief Financial Officer and certain members of its board of directors for a RDO of the Company’s common stock. The RDO sold an
aggregate 242,891 units at a price to the public of $ 4.22 per unit, with each unit consisting of two shares of the Company’s common
stock, and a warrant to purchase one share of common stock at an exercise price of $ 4.00 per share. The $ 4.22 purchase price equals two
times the last reported sale price of $ 2.11 per share of the Company’s common stock on February 15, 2024 on The Nasdaq Capital
Market. The Company issued 485,782 shares of common stock and warrants to purchase up to 242,891 shares of common stock.
Subject
to certain ownership limitations, each of the warrants became exercisable on the Closing Date, with an exercise price of $ 4.00 per share
and will expire five years after the Closing Date. The warrants may only be exercised on a cashless basis if there is no registration
statement registering, or the prospectus contained in the registration statement is not available for, the issuance or resale of shares
of common stock underlying the warrants to or by the holder. The holder of a warrant is prohibited from exercising of any such warrants
to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates
exceeding 4.99 % of the total number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage
may be increased or decreased at the holder’s election not to exceed 9.99 %.
The
net proceeds to the Company from the RDO were $ 0.9 million, after deducting the placement agent’s fees and other estimated offering
expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the warrants. The Company intends to use the
net proceeds from the RDO for working capital and for general corporate purposes.
The
Company retained Alere Financial Partners, LLC (A division of Cova Capital Partners, LLC) to act as the placement agent for the RDO.
The Company paid the placement agent a cash fee of 6 % of the aggregate gross proceeds in the RDO received from non-affiliates of the
Company and 3 % of the aggregate gross proceeds in the RDO received from affiliates of the Company. Additionally, on the Closing Date,
the Company issued to the placement agent warrants exercisable for a period of five years to purchase up to 6 % of the number of shares
sold in this offering, or up to 27,725 shares, at a per share exercise price of $ 4.00 .
13.
Share-based Compensation
The
2019 Plan provides for the granting of incentive stock options, nonqualified stock options, restricted stock, stock appreciation rights
(“SARs”), restricted stock units, performance awards, dividend equivalent rights and other awards, which may be granted singly,
in combination, or in tandem, and which may be paid in cash, shares of common stock of the Company or a combination of cash and shares
of common stock of the Company. The Company initially reserved a total of 57,143 shares of the Company’s common stock for awards
under the 2019 Plan. Effective as of May 26, 2020 and May 3, 2021, respectively, the Board approved an increase of the number of authorized
shares of common stock reserved under the 2019 Plan from 57,143 shares of common stock to 485,715 and from 485,715 shares of common stock
to 571,429 shares of common stock, all of which may be delivered pursuant to incentive stock options.
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On
March 23, 2023, the Board approved an additional 300,000 shares of common stock to be reserved under the 2019 Plan, such that total of
number of shares underlying the Plan is 871,429 of which 609,687 shares have already been awarded or exercised. Subject to adjustments
pursuant to the 2019 Plan, the maximum number of shares of common stock with respect to which stock options or SARs may be granted to
an executive officer during any calendar year is 14,286 shares of common stock.
The
following table contains information about the 2019 Plan as of June 30, 2024:
Schedule of Information about Incentive Plan
Awards
Awards
Awards
Reserved for
Issued &
Awards
Available for
Issuance
Outstanding
Exercised
Grant
2019 Plan (1)
871,429
607,551
19,541
244,337
Awards issued in excess of 2019 Plan (2)
-
70,623
48,401
-
(1)
Includes
incentive stock options and restricted stock units discussed below.
(2)
Includes
shares of restricted common stock granted outside of the 2019 Plan to our Chief Executive Officer, Adam Levy.
Incentive
stock options
The
following table summarizes the Company’s incentive stock option activity and related information for the period ended June 30,
2024:
Schedule of Incentive Stock Option Activity
Weighted
Weighted
Average
Average
Contractual
Number of
Exercise
Term in
Options
Price
Years
Outstanding at January 1, 2024
560,650
$ 2.350742
7.95
Granted
—
—
—
Exercised
—
—
—
Forfeited
—
—
—
Cancelled
—
—
—
Expired
( 14,286 )
5.25
—
Outstanding at June 30, 2024
546,364
$ 2.274933
7.45
Exercisable at June 30, 2024
421,364
$ 1.733517
7.06
As
of June 30, 2024 and 2023, vested outstanding stock options had $ 207
thousand and $ 129
thousand of intrinsic value as the exercise price is greater than the estimated fair value of the underlying common stock,
respectively. As of June 30, 2024, there were no
unrecognized share-based compensation related to unvested stock options, excluding options fully contingent upon certain sales-based milestones being achieved within 18
to 36
months of commercial release.
Restrictive
stock awards
Effective
as of January 1, 2024, the Company granted an aggregated restricted stock award of 22,222 shares of the Company’s common stock
to Adam Levy for his service as our Chief Executive Officer pursuant to the terms of his Executive Employment Agreement dated December
31, 2023. The shares vested monthly from April 1, 2024 through December 31, 2024. Under ASC 718, Compensation—Stock
Compensation, the Company has measured the value of the 22,222 shares granted based on the closing price of the Company’s stock
at the grant date of the RSU Grant ($ 2.25 per share).
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Schedule of Restricted Stock Units Granted
Weighted
Average
Number of
Grant Date
Units
Fair Value
Outstanding at January 1, 2024
64,562
$ 1.82
Granted
22,222
2.25
Exercised and converted to common shares
( 2,000 )
1.82
Forfeited
( 1,750 )
1.82
Outstanding at June 30, 2024
82,534
$ 1.93
Exercisable at June 30, 2024
35,595
$ 1.91
Compensation
expense will be recognized ratably over the total vesting schedule. The Company will periodically adjust the cumulative compensation
expense for forfeited awards. Stock based compensation of $ 118 thousand and $ 53 thousand has been recorded for the six months ended June
30, 2024 and 2023, respectively. As of June 30, 2024, there was $ 77 thousand unrecognized share-based compensation related to unvested
RSUs, which the Company expects to recognize through December 2025.
Warrants
The
following table shows a summary of common stock warrants through June 30, 2024:
Schedule of Common Stock Warrants
Weighted
Weighted
Average
Average
Number of
Exercise
Contractual
Warrants
Price
Term in Years
Outstanding at January 1, 2024
3,442,904
$ 5.414793
2.87
Granted
270,615
4.00
5.00
Exercised
—
—
—
Forfeited
—
—
—
Cancelled
—
—
—
Expired
—
—
—
Outstanding at June 30, 2024
3,713,519
$ 5.311694
2.79
Exercisable at June 30, 2024
3,713,519
$ 5.311694
2.79
As
of June 30, 2024 and 2023, vested outstanding warrants had no intrinsic value as the exercise price is greater than the estimated fair
value of the underlying common stock.
14.
Notes Payable
CGN
JV Notes Payable
The
CGN JV has entered into a $ 231
thousand promissory note agreement for certain equipment. The equipment was installed in December 2023. The promissory note has a
term of five
years beginning on March 13, 2024. The promissory note accrues interest at 8 %
and requires interest only payments through March 13, 2024 and monthly payments of $ 4
thousand thereafter. The principal balance amounted
to $ 218
thousand and $ 231
thousand as of June 30, 2024 and December 31, 2023, respectively.
The
CGN JV has entered into a $ 237
thousand promissory note agreement for certain equipment. The funding advances of $ 153
thousand and $ 84
thousand have been issued in February 2024 and December 2023, respectively. The promissory note has a term of five
years beginning on March 13, 2024. The promissory note accrues interest at 8 %
and requires interest only payments through March 13, 2024 and monthly payments of $ 5
thousand thereafter. The principal balance amounted
to $ 228
thousand and $ 84
thousand as of June 30, 2024 and December 31, 2023, respectively.
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NexGel
The
Company has entered into a $ 13
thousand promissory note agreement for certain leasehold improvements. The leasehold improvements were installed
in February 2024. The promissory note has a term of two
years beginning on February 11, 2024. The promissory note accrues interest at 0 %
and requires monthly payments of $ 545 . The
principal balance amounted to $ 11
thousand as of June 30, 2024.
Economic
Injury Disaster Loan
On
May 28, 2020, the Company entered into the standard loan documents required for securing a loan (the “EIDL Loan”) from the
SBA under its Economic Injury Disaster Loan (“EIDL”) assistance program in light of the impact of the COVID-19 pandemic on
the Company’s business. Pursuant to that certain Loan Authorization and Agreement (the “SBA Loan Agreement”), the principal
amount of the EIDL Loan is up to $ 260,500 , with proceeds to be used for working capital purposes. Interest accrues at the rate of 3.75 %
per annum. Installment payments, including principal and interest, are due monthly beginning May 28, 2021 (twelve months from the date
of the SBA Note) in the amount of $ 1,270 . The balance of principal and interest is payable thirty years from the date of the SBA Note.
In connection therewith, the Company received an $ 8 thousand advance, which does not have to be repaid. On March 26, 2021, the SBA announced
that all EIDL loans issued in 2020 will start repayment 24 months from the date of the SBA Note. The SBA has since extended the repayment
start to 30 months from the date of the SBA Note. The Company made its first payment in December 2022. The balances of the principal
and accrued interest amounted to $ 275 and $ 279 thousand as of June 30, 2024 and December 31, 2023, respectively.
The
future annual principal amounts and accrued interest to be paid as of June 30, 2024 are as follows:
Schedule of Debt Instruments
Amount
For the year ending December 31 ($ in thousands):
2024
$ 49
2025
96
2026
96
2027
103
2028
111
Thereafter
277
Total
$ 732
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15. Warrant
Liability
On
February 21, 2024, September 2, 2021, March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10, 2019, and
November 6, 2019, the Company issued 27,725 , 22,019 , 34,285 , 7,429 , 7,286 , 44,286 , 35,714
and 114,286
warrants, respectively, as equity issuance consideration, in connection with equity offering of the Company’s common stock.
The warrants entitle the holder to purchase one share of our common stock at an exercise price equal to $ 0.49
to $ 5.25
per share at any time on or after their issuance date and on or prior to the close of business three years after the issuance date
(the “Termination Date”). The Company determined that these warrants are free standing financial instruments that are
legally detachable and separately exercisable from the common stock included in the public share offering. Management also
determined that the warrants required classification as a liability pursuant to ASC 815, Derivatives and Hedging . In
accordance with the accounting guidance, the outstanding warrants are recognized as a warrant liability on the balance sheet and are
measured at their inception date fair value and subsequently re-measured at each reporting period with changes being recorded as a
component of other income (expense) in the condensed consolidated statements of operations.
The
warrants outstanding and fair values at each of the respective valuation dates are summarized below:
Schedule of Warrant Liability
Warrant Liability
Warrants Outstanding
Fair Value per Share
Fair Value
Fair value as of year ended 12/31/2023
71,019
$ 146
Fair value at initial measurement date
27,725
$ 2.01
56
Change in fair value of warrant liability
-
( 26 )
Fair value as of year ended 6/30/2024
98,744
$ 176
The
following assumptions were used to calculate the warrant liability for six months ended June 30, 2024 and 2023:
Schedule of Assumptions Used in Warrant Liability
2024
2023
Exercise price
$ 2.80 to $ 5.25
$ 0.49 - $ 5.25
Share price
$ 1.99 - $ 2.73
$ 1.28
Volatility
113.39 % - 283.32 %
137.02 - 287.87 %
Risk-free interest rate
4.21 % - 5.09 %
3.81 % - 4.74 %
Dividend yield
0.0 %
0.0 %
Expected term
1.2 to 5.0 years
0.1 to 3.4 years
The
warrant liabilities are considered Level 3 liabilities on the fair value hierarchy as the determination of fair value includes various
assumptions about of future activities and the Company’s stock prices and historical volatility of Guideline Public Companies as
inputs.
16.
Commitments and Contingencies
Litigation
The
Company may be subject to legal proceedings and claims that arise in the ordinary course of business. Management is not currently aware
of any matters that will have a material effect on the condensed consolidated financial position, results of operations, or cash flows
of the Company.
Service
Agreement
On
March 21, 2023, the Company entered into a Services Agreement with GlaxoSmithKline Consumer Healthcare Holdings (US) LLC (“Haleon”)
to supply material for a consumer product to be developed and released in the future. There can be no guaranty that a consumer product
will be released or, if released, that it will be successful.
17.
Concentrations of Risk
The
Company’s revenues are concentrated in a small group of customers with some individually having more than 10% of total revenues.
Revenues from one customer that exceeded 10% of total revenues for the six months ended June 30, 2024, was 15 %.
The accounts receivable from the top customer was 58 %
as well as 14 %
from one other customer of the total accounts receivable as of June 30, 2024.
Revenues
from two customers that exceeded 10% of total revenues for the six months ended June 30, 2023, were 40 % and 14 %. The accounts receivable
from those top two customers were 0 % and 22 % as well as 13 %, 15 %, and 16 % from three other customers of the total accounts receivable
as of June 30, 2023.
The
Company’s financial instruments that are exposed to concentrations of credit risk consist primarily of cash, cash equivalents and
marketable securities. Cash balances are maintained principally at major U.S. financial institutions and are insured by the Federal Deposit
Insurance Corporation (“FDIC”) up to regulatory limits. Such cash balances are currently in excess of the FDIC insurance
limit of $ 250 thousand. As of June 30, 2024, the Company did not have any balances that exceeded the FDIC insurance limit, however the Company had approximately $82
thousand in cash in non FDIC insured entities at June 30, 2024. The Company has not experienced
any credit losses associated with its cash balances in the past. The Company invests its cash equivalents in U.S. treasury bills with
original maturities of three months or less.
Marketable
securities are comprised of U.S. treasury bills with original maturities greater than three months. The Company has not experienced any
losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash, cash equivalents, and marketable
securities and performs periodic evaluations of the credit standing of such institutions.
18.
Related Party Transactions
Advances
Dr.
Jerome Zeldis, a member of the Company board of directors, has an outstanding balance due of $ 25,000 for services as of June 30, 2024
and December 31, 2023, which is included in accounts payable in the accompanying condensed consolidated balance sheets.
19.
Subsequent Events
Management
of the Company has performed a review of events and transactions occurring after the condensed consolidated balance sheet date to determine
if there were any such events or transactions requiring adjustment to or disclosure in the accompanying condensed consolidated financial
statements, noting no such events or transactions except as set forth below:
On August 8, 2024, the Company
entered into subscription agreements with investors, certain members of its board of directors, and management for the sale by the Company of an aggregate of 222,000
units at a price to the public of $ 5.00
per unit (the “August Offering”), with each
unit consisting of two shares of the Company’s common stock and a warrant to purchase one share of common stock at an exercise
price of $ 4.25
per share (the “August Warrants”) . The
closing of the August Offering is subject to customary closing conditions and is expected to occur on or about August 14, 2024 (the
“August Closing Date”). On or about the August Closing Date, the Company expects to issue 444,000
shares of common stock and issue August Warrants to purchase up to 222,000
shares of common stock
Subject to certain ownership limitations, each of
the August Warrants will become exercisable on the August Closing Date, will have an exercise price of $ 4.25 per share and will expire
five years after the August Closing Date. The August Warrants may only be exercised on a cashless basis if there is no registration statement
registering, or the prospectus contained in the registration statement is not available for, the issuance or resale of shares of common
stock underlying the August Warrants to or by the holder. The holder of an August Warrant is prohibited from exercising of any such warrants
to the extent that such exercise would result in the number of shares of common stock beneficially owned by such holder and its affiliates
exceeding 4.99% of the total number of shares of common stock outstanding immediately after giving effect to the exercise, which percentage
may be increased or decreased at the holder’s election not to exceed 9.99%.
Certain members of the Company’s board of directors
and management have agreed to purchase an aggregate of 27,000 units in the August Offering. In connection with the August Offering, the
members of board of directors and management purchasing units in the August Offering have agreed not to offer, issue, sell, contract to
sell, encumber, grant any option for the sale of or otherwise dispose of any of securities relating to the units for a period of 180 days
following the date of the prospectus used in the August Offering.
The gross proceeds to the Company from the August
Offering are expected to be approximately $ 1.110 million, before deducting the placement agent’s fees and other estimated offering
expenses payable by the Company, and excluding the proceeds, if any, from the exercise of the August Warrants. The Company intends to
use the net proceeds from the August Offering for working capital and for general corporate purposes.
The Company retained Alere Financial
Partners, LLC (a division of Cova Capital Partners, LLC) to act as the placement agent (the “Placement Agent”) for the
August Offering. The Company agreed to pay the Placement Agent a cash fee of 8 %
of the aggregate gross proceeds in the August Offering received from non-affiliates of the Company and 4 %
of the aggregate gross proceeds in the August Offering received from affiliates of the Company. Additionally, and upon the closing
of the August Offering, the Company agreed to issue to the Placement Agent warrants exercisable for a period of five
years to purchase up to 8 %
of the number of shares sold in August Offering, or up to 33,360
shares, at a per share exercise price of $ 4.25 .
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Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.