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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON D.C. 20549

FORM 10-Q

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the quarterly period ended: June 30, 2021

OR

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from ___________ to ___________

Commission file number: 001-36278

NexGel, Inc.

(Exact name of registrant as specified in its charter)

Delaware

    

26-4042544

(State or other jurisdiction of incorporation or organization)

    

(I.R.S. Employer Identification Number)

 

    

 

2150 Cabot Blvd West, Suite B

Langhorne, PA

    

19047

(Address of principal executive office)

    

(Zip Code)

Registrant’s telephone number, including area code: (215) 702-8550

Securities registered pursuant to Section 12(b) of the Act: None.

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

None

None

None

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes   No

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes   No

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and "emerging growth company" in Rule 12b-2 of the Exchange Act.

Large accelerated filer

   

Accelerated filer

 

 

 

Non-accelerated filer

 

 

 

 

Smaller reporting company

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.

Indicate by check mark whether the registrant is a shell company (as defined by Rule 12b-2 of the Exchange Act). Yes  No

As of August 16, 2021, the registrant had 104,277,112 shares of common stock outstanding.

Table of Contents

nEXGEL, INC.

 

TABLE OF CONTENTS

 

PART I – FINANCIAL INFORMATION

ITEM 1.

Condensed Financial Statements (Unaudited)

3

 

Condensed Balance Sheets as of June 30, 2021 and December 31, 2020

3

 

Condensed Statements of Operations for the Three and Six Months Ended June 30, 2021 and 2020

4

 

Condensed Statements of Stockholders’ Equity for the Three and Six Months Ended June 30, 2021 and 2020

5

 

Condensed Statements of Cash Flows for the Six Months Ended June 30, 2021 and 2020

7

 

Notes to Condensed Financial Statements

8

ITEM 2.

Management’s Discussion and Analysis of Financial Condition and Results of Operations

28

ITEM 3.

Quantitative and Qualitative Disclosures About Market Risk

34

ITEM 4.

Controls and Procedures

34

PART II – OTHER INFORMATION

ITEM 1.

Legal Proceedings

35

ITEM 1A. 

Risk Factors

35

ITEM 2.

Unregistered Sales of Equity Securities and Use of Proceeds

35

ITEM 3.

Defaults Upon Senior Securities

35

ITEM 4.

Mine Safety Disclosures

35

ITEM 5. 

Other Information

35

ITEM 6.

Exhibits

36

Signatures

 

37

2

Table of Contents

PART I – FINANCIAL INFORMATION

ITEM 1. FINANCIAL STATEMENTS

NEXGEL, INC

CONDENSED BALANCE SHEETS

AS OF JUNE 30, 2021 AND DECEMBER 31, 2020

(in thousands, except share and per share data)

    

June 30, 

    

2021

December 31, 

(Unaudited)

2020

ASSETS:

 

  

 

  

Current Assets:

 

  

 

  

Cash

$

382

$

32

Accounts receivable, net

 

219

 

73

Inventory

 

226

 

233

Prepaid expenses and other current assets

 

82

 

25

Total current assets

 

909

 

363

Goodwill

 

311

 

311

Intangibles

40

47

Property and equipment, net

771

553

Operating lease - right of use asset

 

2,019

 

805

Other assets

 

60

 

178

Total assets

$

4,110

$

2,257

LIABILITIES AND STOCKHOLDERS' EQUITY

 

 

Current Liabilities:

 

 

Accounts payable

$

592

$

657

Accrued expenses and other current liabilities

70

90

Deferred Revenue

38

Convertible notes payable

511

59

Current portion of debt

 

18

 

10

Note payable – PPP

127

147

Warrant liability

245

123

Operating lease liability, current portion

207

207

Total current liabilities

 

1,770

 

1,331

Long-Term Liabilities:

Notes payable

253

256

Lease liability, long term

 

1,818

 

598

Total long-term liabilities

 

2,071

 

854

Total liabilities

3,841

 

2,185

Commitments and Contingencies

 

 

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, 750,000,000 shares authorized; 104,277,112 and 99,331,279 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively

 

104

 

99

Additional paid-in capital

 

4,197

 

2,474

Accumulated deficit

 

(4,032)

 

(2,502)

Total stockholders' equity

 

269

 

71

Total liabilities and stockholders' equity

$

4,110

$

2,256

The accompanying notes are an integral part of these condensed financial statements.

3

Table of Contents

NEXGEL, INC.

CONDENSED STATEMENTS OF OPERATIONS

FOR THE THREE AND SIX MONTHS ENDED June 30, 2021 AND 2020

(Unaudited)

(in thousands, except share and per share data)

Three Months Ended

Six Months Ended

June 30, 

June 30, 

    

2021

    

2020

    

2021

    

2020

Revenues, net

$

417

$

91

$

683

$

331

Cost of revenues

 

413

 

176

 

722

 

349

Gross (loss)/profit

 

4

 

(85)

 

(39)

 

(18)

Operating expenses

 

 

 

 

Selling, general and administrative

 

557

 

455

 

1,034

 

1,031

Total operating expenses

 

557

 

455

 

1,034

 

1,031

Loss from operations

 

(553)

(540)

(1,073)

(1,049)

Other income (expense)

 

Interest expense

 

(370)

(518)

(1)

Loss on debt extinguishment

(25)

Debt discount costs

(52)

(68)

Forgiveness of debt

147

147

Other income

8

8

Changes in fair value of warrant liability

 

2

2

8

4

Total other income (expense)

 

(273)

10

(456)

11

Loss before income taxes

(826)

(530)

(1,529)

(1,038)

Income tax expense

Net loss

$

(826)

$

(530)

(1,529)

(1,038)

Net loss per common share - basic

$

(0.01)

$

(0.01)

(0.01)

(0.01)

Net loss per common share - diluted

$

(0.01)

$

(0.01)

(0.01)

(0.01)

Weighted average shares used in computing net loss per common share - basic

102,894,279

76,338,541

102,156,565

70,445,816

Weighted average shares used in computing net loss per common share – diluted

102,894,279

76,338,541

102,156,565

70,445,816

The accompanying notes are an integral part of these condensed financial statements.

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NEXGEL, INC.

CONDENSED STATEMENTS OF STOCKHOLDERS’ EQUITY

FOR THE THREE AND SIX MONTHS ENDED JUNE 30, 2021 AND 2020

(Unaudited)

(in thousands, except share data)

Retained

Additional

Earnings

Total

Common Stock

 Paid-in

(Accumulated

Stockholders'

    

Shares

    

Amount

    

Capital

    

Deficit)

    

Equity (Deficit)

Balance, January 1, 2021

99,331,779

$

99

$

2,474

$

(2,502)

$

71

Stock-based compensation

69

69

Restricted stock vesting

 

 

 

21

 

 

21

Issuances of common stock, net of issuance costs

 

3,563,000

 

4

 

281

 

 

285

Warrants issued for debt issuance

(18)

(18)

Beneficial conversion and warrant features of convertible debt

1,276

1,276

Net loss

(704)

(704)

Balance, March 31, 2021

 

102,894,779

$

103

$

4,103

$

(3,206)

$

1,000

Stock-based compensation

74

74

Restricted stock vesting

1,383,333

1

20

21

Net loss

(826)

(826)

Balance, June 30, 2021

104,277,112

$

104

$

4,197

$

(4,032)

$

269

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Table of Contents

Retained

    

Additional

Earnings

Total

Common Stock

 Paid-in

(Accumulated

Stockholders'

    

Shares

    

Amount

    

Capital

    

Deficit)

    

Equity (Deficit)

Balance, January 1, 2020

57,505,208

$

57

$

561

$

(238)

$

380

Stock compensation

64

64

Issuance of common stock

 

15,500,000

 

16

 

604

 

 

620

Net loss

(508)

(508)

Balance, March 31, 2020

 

73,005,208

$

73

$

1,229

$

(746)

$

556

Stock compensation

40

40

Issuance of common stock for acquisition

9,375,000

9

366

375

Net loss

(530)

(530)

Balance, June 30, 2020

82,380,208

$

82

$

1,635

$

(1,276)

$

441

The accompanying notes are an integral part of these condensed financial statements.

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NEXGEL, INC.

CONDENSED STATEMENTS OF CASH FLOWS

FOR THE SIX MONTHS ENDED JUNE 30, 2021 AND 2020

(Unaudited)

(in thousands)

Six Months Ended June 30, 

    

2021

    

2020

Operating Activities

Net loss

$

(1,529)

$

(1,038)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

Depreciation and amortization

 

56

 

21

Share-based compensation

185

104

Changes in fair value of warrant liability

(8)

(4)

Amortization of deferred financing costs

528

Loss on extinguishment of debt

24

Forgiveness of debt

(148)

Beneficial conversion feature in excess of face value

51

Change in ROU asset and operating lease liability

6

Changes in operating assets and liabilities:

 

 

Accounts receivable

 

(146)

 

5

Inventory

 

7

 

(34)

Prepaid expenses and other assets

 

61

 

19

Accounts payable

 

(67)

 

(106)

Accrued expenses and other liabilities

 

(15)

 

53

Deferred revenue

(38)

Net Cash Used in Operating Activities

 

(1,033)

 

(980)

Investing Activities

 

 

  

Capital expenditures

(267)

(76)

Net Cash Used in Investing Activities

 

(267)

 

(76)

Financing Activities

 

 

Issuance of common stock, net of issuance costs

285

620

Proceeds from notes payable

15

408

Principle payment of notes payable

(15)

Proceeds from notes payable (PPP)

128

Proceeds from convertible notes

1,337

Principal payment on convertible notes

 

(100)

 

Net Cash Provided by Financing Activities

 

1,650

 

1,028

Net Increase in Cash

 

350

 

(28)

Cash – Beginning of period

 

32

 

261

Cash – End of period

$

382

$

233

Supplemental Disclosure of Cash Flows Information

 

 

Cash paid during the year for:

 

 

Interest

 

 

Taxes

Supplemental Non-cash Investing and Financing activities

Fair value of beneficial conversion and warrant features of Convertible Notes Payable

$

1,276

$

Original issue discounts recognized on Convertible Notes Payable

$

343

$

Warrants issued for debt and equity financing costs

$

130

$

Common shares issued for acquisition

$

$

375

Inventory acquired from acquisition

$

$

21

Accounts payable acquired from acquisition

$

$

13

The accompanying notes are an integral part of these condensed financial statements.

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NEXGEL, INC.

NOTES TO CONDENSED UNAUDITED FINANCIAL STATEMENTS

(in thousands, except share and per share data)

1.     Description of Business, the Spin-off and Basis of Presentation

Description of Business

NexGel, Inc. (the “Company” or “NexGel”) 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 its gels to third parties who incorporate them into their own products.  NexGel was previously known as AquaMed Technologies, Inc. (“AquaMed”) before changing its name to NexGel, Inc. on November 14, 2019.  The Company is implementing a new strategy to become a consumer products business focused on proprietary branded products and white label opportunities.

The Spin-Off

On June 21, 2019, NexGel became an independent company through the pro rata distribution (“Spin-Off”) by Adynxx, Inc. (“Adynxx” and the “Parent”) in connection with the closing of a reverse merger between Adynxx, Inc. and Alliqua BioMedical, Inc., (“Adynxx”) of NexGel’s common stock for common stock of Parent.  Adynxx, Inc. was previously known as Alliqua BioMedical, Inc. and subsequently changed its name to Adynxx, Inc. on May 3, 2019.  The terms and conditions of the Spin-Off provided that each record holder of Parent stock as of April 22, 2019, received one share of NexGel common stock in book-entry form and resulted in the distribution of 5,005,211 shares of common stock of NexGel. Following the distribution (“Capitalization”), all existing operations were distributed to NexGel with the exception of a corporate lease for property in Yardley, Pennsylvania which was retained by Adynxx, Inc.

Pursuant to the Spin-Off and in exchange for the 5,005,211 shares of common stock,NexGel assumed the following net assets and liabilities from Parent as of June 21, 2019 ($ in thousands):

Assets:

    

Cash

$

186

Accounts receivable, net

 

72

Inventory, net

 

140

Prepaid expenses and other current assets

 

101

Property and equipment, net

 

155

Operating lease - right of use asset

 

976

Other assets

 

178

Total assets

 

1,808

Liabilities:

Accounts payable

 

(496)

Accrued expenses and other current liabilities

 

(395)

Operating lease liability - current

 

(207)

Long-term operating lease liability

 

(769)

Total liabilities

 

(1,867)

Net liabilities assumed in Spin-Off on June 21, 2019

$

(59)

Basis of Presentation

The balance sheet as of June 30, 2021 and December 31, 2020 and the statements of operations, stockholders’ equity, and cash flows for the six months ended June 30, 2021 consists of the balances of NexGel as prepared on a stand-alone basis. Prior to the separation, these financial statements were derived from the consolidated financial statements and accounting records of Adynxx, Inc.

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Prior to the Spin-Off, Adynxx used a centralized approach to cash management and financing its operations, including the operations of the Company. Accordingly, none of the cash of Adynxx have been attributed to the Company in the financial statements. Transactions between Adynxx and the Company were accounted for through Parent’s Net Investment.

The expenses, including executive compensation, have been allocated by management based either on specific attribution of those expenses or, where necessary and appropriate, based on management’s best estimate of an appropriate proportional allocation.

These interim condensed financial statements have been prepared pursuant to the rules and regulations of the United States Securities and Exchange Commission (the "SEC"), which permit reduced disclosure for interim periods. The condensed balance sheet as of June 30, 2021 was derived from audited financial statements for the fiscal year then ended, but does not include all necessary disclosures required by generally accepted accounting principles in the United States of America ("GAAP") with respect to annual financial statements. In the opinion of management, the condensed financial statements include all adjustments, which are of a normal recurring nature, necessary to present fairly the Company’s financial position as of June 30, 2021 and results of operations and cash flows for the three months ended June 30, 2021 and 2020. These unaudited condensed financial statements should be read in conjunction with the audited financial statements and the notes thereto in the Company’s year-end financial statements for the years ended December 31, 2020 and 2019, which are included in the Company’s Form 10-K filed with SEC on June 30, 2021. Results for interim periods are not necessarily indicative of the results to be expected for a full fiscal year or for any future period.

Significant Accounting Policies and Estimates

The preparation of the condensed financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the condensed financial statements and accompanying notes.  These estimates and assumptions include allowance for doubtful accounts, 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.

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 doubtful accounts based on factors including the length of time the receivables are past due, the current business environment and the Company’s historical experience.  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 doubtful accounts was $4 thousand as of June 30, 2021 and $1 thousand as of December 31, 2020.

Inventory

Inventory 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 or 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 balance is made up of raw materials of $189 thousand and $190 thousand, work-in-progress of $23 thousand and $22 thousand, and finished goods of $14 thousand and $21 thousand on June 30, 2021 and December 31, 2020, respectively.

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.

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The carrying amounts of assets sold or retired and the related accumulated depreciation are eliminated in the period of disposal and the resulting gains and losses are included in the results of operations during the same period.

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 valued 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 acquisitions or annually as of December 1, 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.

Acquired identifiable intangible assets are amortized over the following periods:

Expected Life

Acquired intangible Asset

    

Amortization Basis

    

(years)

Technology-Related

 

Straight-line basis

 

3

Marketing-Related

 

Straight-line basis

 

4

Impairment of Long-Lived Assets

We review the recoverability of our long-lived assets, including equipment and right-of-use assets, when events or changes in circumstances occur that indicate that the carrying value of the asset, or asset group, may not be recoverable. Events or circumstances that might cause management to perform impairment testing include, but are not limited to, significant underperformance relative to historical or projected future operating results of the asset or asset group, significant changes in the manner or use of assets or the strategy for our overall business; and significant negative industry or economic trends. If indicators of potential impairment are present, management performs a recoverability test and, if necessary, records an impairment loss. If the total estimated future undiscounted cash flows to be generated from the use and ultimate disposition of an asset or asset group is less than its carrying value, an impairment loss is recorded in the Company’s results of operations, measured as the amount required to reduce the carrying value to fair value. Fair value is determined in accordance with the best available information per the hierarchy described under Fair Value Measurements below. For example, the Company would first seek to identify quoted prices or other observable market data. If observable data is not available, Management would apply the best available information under the circumstances to a technique such as a discounted cash flow model to estimate fair value. Impairment analysis involves estimates and the use of assumptions due to the inherently judgmental nature of forecasting long-term estimated inflows and outflows resulting from the use and ultimate disposition of an asset, and determining the ultimate useful lives of assets. Actual results may differ from these estimates using different assumptions, which could materially impact the results of an impairment assessment.

Prepaid expenses and other current assets

Prepaid expenses and other current assets is recorded at historical cost and is primarily made up of $26 thousand and $16 thousand of prepaid insurance, and $56 thousand and $9 thousand general prepaid expenses and other current assets in the period ended June 30, 2021 and December 31, 2020, respectively.

Other Assets

Other Assets is recorded at historical costs, and as of June 30, 2021 and December 31, 2020, the balance is entirely made up of spare parts for manufacturing equipment. Other assets are stated at cost and 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) in the 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 on March 11, 2021, February 3, 2021, December 24, 2020, March 18, 2020, September 10, 2019 and November 6, 2019. The fair values of the warrants are estimated as of the date of issuance and again at each period end using a Black-Scholes option valuation model. At issuance, the fair value of the warrant is 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 statements of operations.

Revenue recognition

On January 1, 2018, the Company adopted Accounting Standards Codification (“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 accounting principles generally accepted in the United States of America (“U.S. 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 adopted ASC 606 for all applicable contracts using the modified retrospective method, which would have required a cumulative-effect adjustment, if any, as of the date of adoption. The adoption of ASC 606 did not have a material impact on the Company’s financial statements as of the date of adoption. As a result, a cumulative-effect adjustment was not required.

The Company recognizes revenue predominately from three types of revenue, contract manufacturing, custom and white label manufacturing and proprietary branded products. Revenue from contract manufacturing is 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 it ships the product to the customer.

The Company’s customers consist of other life sciences companies and revenues are 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:

    

Six Months Ended

June 30,

    

2021

    

2020

Contract manufacturing

$

379

$

331

Custom and white label finished goods manufacturing

 

194

 

Nexgel branded consumer products

 

110

 

Total

$

683

$

331

As of June 30, 2021, the Company did not have any contract assets or contract liabilities from contracts with customers. As of June 30, 2021, there were no remaining performance obligations that the Company had not satisfied.

Share-based compensation

On August 28, 2019, the Company adopted the 2019 Long-Term Incentive Plan (the “2019 Plan”). 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 initial reserved a total of 2,000,000 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 2,000,000 shares of common stock to 17,000,000 shares of common stock and from 17,000,000 shares of common stock to 20,000,000 shares of common stock, all of which may be delivered pursuant to incentive stock options. 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 500,000 shares of common stock.

The Company’s 2019 Long-Term Incentive 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 statements of operations on a straight-line basis over the requisite service period, which is generally the vesting period required to obtain full vesting. Forfeitures are accounted for when they occur.

In June 2018, the FASB issued Accounting Standards Update (“ASU”) No. 2018-07, Compensation - Stock Compensation (Topic 718) - Improvements to Nonemployee Share-Based Payment Accounting. These amendments expand the scope of Topic 718, Compensation - Stock Compensation, to include share-based payments issued to nonemployees for goods or services. Consequently, the accounting for share-based payments to nonemployees and employees will be substantially aligned.  This new standard is effective for the Company on January 1, 2020.  The Company early adopted this new standard in the third quarter of 2019 and it did not have material impact to its condensed financial statements.

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.

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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 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 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.

Segment reporting

The Company operates in one business segment as a contract manufacturer of aqueous polymer hydrogels. As a result, the Company’s operations are a single reportable segment, which is consistent with the Company’s internal management reporting.

Comprehensive loss

Comprehensive loss consists of net loss and changes in equity during a 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 Adopted Accounting Standards

In August 2020, the FASB issued ASU No. 2020-06, Debt with Conversion and Other Options (Subtopic 470-20) and Derivatives and Hedging—Contracts in Entity’s Own Equity (Subtopic 815-40) which simplifies the accounting for convertible instruments. The guidance removes certain accounting models which separate the embedded conversion features from the host contract for convertible instruments. Either a modified retrospective method of transition or a fully retrospective method of transition is permissible for the adoption of this standard. Update No. 2020-06 is effective for fiscal years beginning after December 15, 2021, including interim periods within those fiscal years. Early adoption is permitted no earlier than the fiscal year beginning after December 15, 2020. The Company does not expect this ASU to have a material impact on its consolidated results of operations, cash flows and financial position.

Recently Issued Accounting Standards

From time to time, new accounting pronouncements are issued by the Financial Accounting Standards Board, or 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 financial position or results of operations upon adoption.

Fair Value Measurement—Disclosure Framework

In August 2018, the FASB issued ASU No. 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework — Changes to the Disclosure Requirements for Fair Value Measurement (“ASU 2018-13”), which amends ASC Topic 820, Fair Value Measurements. ASU 2018-13 modifies the disclosure requirements for fair value measurements by removing, modifying, or adding certain disclosures. The effective date is the first quarter of fiscal year 2021, with early adoption permitted for the removed disclosures and delayed adoption permitted until fiscal year 2021 for the new disclosures. The removed and modified disclosures will be adopted on a retrospective basis and the new disclosures will be adopted on a prospective basis. The Company has not yet adopted ASU 2018-13 and currently assessing the impact of this new standard on its financial statements.

2.     Going Concern

As of June 30, 2021, the Company had a cash balance of $382,000. For the six months ended June 30, 2021, the Company incurred a net loss of $1,529,000 and had a net usage of cash in operating activities of $1.03 million. In addition, the Company had a working capital deficit of $860,000 as of June 30, 2021.

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The Company expects to continue incurring losses for the foreseeable future and will need to raise additional capital to support ongoing operations. The ability of the Company to continue to operate as a going concern is dependent upon its ability to raise additional capital and to ultimately achieve profitable operations. Management is evaluating various options to raise capital to fund the Company’s working capital requirements through equity offerings. There can be no assurances, however, that management will be able to obtain sufficient additional funds when needed, or that such funds, if available, will be obtained on terms satisfactory to the Company. These factors raise substantial doubt as to the Company’s ability to continue as a going concern. The condensed financial statements do not include any adjustments relating to the recoverability and classification of recorded assets and liabilities that might be necessary should the Company be unable to continue as a going concern.

3.     Net Loss Per Common Share

Basic loss per share data is computed using the weighted-average number of shares of common stock outstanding during the period. Diluted loss per share data is computed using the weighted-average number of common and dilutive common-equivalent shares outstanding during the period. Dilutive common-equivalent shares consist of shares that would be issued upon the exercise of stock options and other common stock equivalents, computed using the treasury stock method. The number of shares that may be issued for share-based payment awards under the Company’s 2019 Long-Term Incentive Plan are excluded from the calculation of weighted average dilutive common shares for the three months ended June 30, 2021 and 2020, to the extent they are issued and outstanding, because their effect would be anti-dilutive.

4.     Acquisition

On May 29, 2020, the Company entered into a Membership Interest Purchase Agreement (the "Purchase Agreement") whereby the Company purchased all of the outstanding equity securities of Sport Defense LLC, a Delaware limited liability company ("Sports Defense"), from the members of Sport Defense (the "Sellers"). Subsequent to the Closing Date, Sport Defense is a wholly-owned subsidiary of the Company.

Sport Defense is a marketing and distribution company that leverages the unique benefits of ultra-gentle, high-water content hydrogels, manufactured by the Company, to build brands that treat various ailments of the skin caused by athletic training, such as blisters, turf burns, scrapes and skin irritations.

Under the terms of the Purchase Agreement, the purchase price paid to the Sellers was an aggregate of $375 thousand (the "Purchase Price") which was paid by the Company through the issuance of an aggregate of 9,375,000 shares of the Company's common stock, par value $0.001 (the "Shares"), which equates to a per share purchase price of $0.04. The Shares are "restricted securities" as such term is defined by Rule 144 promulgated under the Securities Act of 1933, as amended.

Adam Levy, the Company's Chief Executive Officer and Chief Financial Officer, and Nachum Stein, a member of the Company's Board of Directors (the "Board"), were each members of Sport Defense and part of the Sellers. Mr. Levy received 1,546,875 of the Shares and Mr. Stein received 3,187,500 of the Shares. Due to the potential conflict of interest that existed because of Messrs. Levy and Stein's partial ownership of Sport Defense, the Board obtained an independent investment bank to prepare a valuation report with respect to Sport Defense. This valuation report supported the Purchase Price. Also, Mr. Stein recused himself from the vote of the Board regarding the approval to purchase Sport Defense.

The Purchase Agreement and the Sport Defense acquisition were not subject to approval by the shareholders of the Company. The Purchase Agreement contained minimal representations and warranties regarding Sport Defense and certain limited representations and warranties regarding the Company and the Sellers.

The provisional fair value of the purchase consideration issued to the Seller was allocated to the net tangible assets acquired. The Company accounted for the Sports Defense 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 consolidated with those of the Company. The fair value of the net assets acquired was approximately $375 thousand. The excess of the aggregate fair value of the net tangible assets has been allocated to goodwill.

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The Company is currently in the process of completing the preliminary purchase price allocation as an acquisition of certain assets. The final purchase price allocation for Sports Defense's will be included in the Company's financial statements in future periods. The table below shows preliminary analysis for the Sports Defense acquisition:

Provisional Purchase Consideration at preliminary fair value:

    

  

Purchase price

$

375

Amount of consideration

$

375

Assets acquired and liabilities assumed at preliminary fair value

 

  

Inventories

 

21

Product/Technology related intangibles

31

Marketing related intangibles

8

Customer related intangibles

17

Accounts payable and accrued expenses

 

(13)

Other liabilities

 

Net tangible assets acquired

$

64

Total net assets acquired

$

64

Consideration paid

 

375

Preliminary goodwill

$

311

The unaudited pro-forma results of operations are presented for information purposes only. The unaudited pro-forma results of operations are not intended to present actual results that would have been attained had the Sports Defense acquisition been completed as of January 1, 2019 or to project potential operating results as of any future date or for any future periods.

    

For the Six Months Ended

June 30,

    

2021

    

2020

Revenues, net

$

683

$

348

Net loss allocable to common shareholders

$

(1,529)

$

(1,029)

Net loss per share

$

(0.01)

$

(0.01)

Weighted average number of shares outstanding

 

102,156,565

 

78,258,316

5.     Leases

The Company has one operating lease for a commercial manufacturing facility and administrative offices located in Langhorne, Pennsylvania that expired in January 2026. On April 14, 2021, the Company extended the term of the lease for an additional five years commencing on February 1, 2026 and continuing through January 31, 2031.

The right-of-use asset and lease liability from this operating lease were recognized in the opening balance sheet as of January 1, 2019 and are based on the present value of remaining lease payments over the lease term using the Company’s incremental borrowing rate.

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The following table presents information about the amount and timing of the liability arising from the Company’s operating lease as of June 30, 2021 ($ in thousands):

Operating

Lease

Maturity of Lease Liability

Liability

2021 (remainder of year)

    

$

104

2022

 

207

2023

 

207

2024

207

2025

 

207

Thereafter

1,428

Total undiscounted operating lease payments

$

2,360

Less: Imputed interest

 

(335)

Present value of operating lease liability

$

2,025

Weighted average remaining lease term

9.6 years

Weighted average discount rate

3.0

%

Total operating lease expense for the three months ended June 30, 2021 and 2020 was $103 thousand and $6 thousand related to the lease extension, and is recorded in cost of goods sold and selling, general and administrative expenses on the statement of operations under Accounting Standards Codification Topic 840, Leases.

Supplemental cash flows information related to leases was as follows ($ in thousands):

June 30, 

    

2021

Cash paid for amounts included in the measurement of lease liability:

Operating cash flows from operating lease

$

109

Change in right-of-use asset/liability due to lease amendments

$

1,275

6.    Inventory

Inventory consists of the following ($ in thousands):

    

June 30, 

    

December 31, 

2021

2020

Raw materials

$

189

$

190

Work-in-progress

23

22

Finished goods

14

21

226

233

Less: Inventory reserve for excess and slow moving inventory

 

 

Total

$

226

$

233

As a contract manufacturer, the Company builds its products based on customer orders and immediately ships the products upon completion of the production process.

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7.    Property and Equipment, Net

Property and equipment consist of the following ($ in thousands):

    

Useful Life

    

June 30, 

    

December 31, 

(Years)

2021

2020

Machinery and equipment

3 - 10

$

940

$

2,894

Office furniture and equipment

 

3 - 10

 

49

 

49

Leasehold improvements

 

6

 

228

 

228

Construction in progress

N/A

461

 

 

1,217