10-Q

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 September 30, 2021

or

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

For the transition period from          to          

Commission file number: 001-16465

Retractable Technologies, Inc.

(Exact name of registrant as specified in its charter)

Texas	75-2599762
(State or other jurisdiction of incorporation or organization)	(I.R.S. Employer Identification No.)
511 Lobo Lane
Little Elm, Texas	75068-5295
(Address of principal executive offices)	(Zip Code)

(972) 294-1010

(Registrant’s telephone number, including area code)

(Former name, former address, and former fiscal year, if changed since last report)

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common Stock	RVP	NYSE American

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 in Rule 12b-2 of the Exchange Act). Yes ☐  No ☑

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

Indicate by check mark whether the registrant has filed all documents and reports required to be filed by Sections 12, 13, or 15(d) of the Securities Exchange Act of 1934 subsequent to the distribution of securities under a plan confirmed by a court.  Yes ◻  No 

APPLICABLE ONLY TO CORPORATE ISSUERS

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 33,764,283 shares of Common Stock, no par value, issued and outstanding on November 1, 2021.

RETRACTABLE TECHNOLOGIES, INC.

FORM 10-Q

For the Quarterly Period Ended September 30, 2021

TABLE OF CONTENTS

	PART I – FINANCIAL INFORMATION
Item 1.	Financial Statements	1
	CONDENSED BALANCE SHEETS	1
	CONDENSED STATEMENTS OF OPERATIONS	2
	CONDENSED STATEMENTS OF CASH FLOWS	3
	CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY	4
	NOTES TO CONDENSED FINANCIAL STATEMENTS	5
Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	18
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	25
Item 4.	Controls and Procedures	25
	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	25
Item 1A.	Risk Factors	25
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	26
Item 3.	Defaults Upon Senior Securities	26
Item 6.	Exhibits	27
SIGNATURES		27

PART I—FINANCIAL INFORMATION

Item 1.Financial Statements.

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

	September 30, 2021		December 31, 2020
ASSETS
Current assets:
Cash and cash equivalents	$	16,363,163	$	17,566,682
Accounts receivable, net		30,040,562		21,131,841
Receivable from Technology Investment Agreement (TIA)		8,764,753		11,779,078
Investments in debt and equity securities, at fair value		13,583,943		8,081,833
Inventories		18,696,764		10,234,646
Other current assets		767,829		684,317
Total current assets		88,217,014		69,478,397
Property, plant, and equipment, net		76,625,980		30,816,504
Deferred tax asset		13,145,274		4,631,206
Other assets		5,675		44,567
Total assets	$	177,993,943	$	104,970,674
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	24,410,852	$	16,256,444
Current portion of long-term debt		285,519		1,030,763
Accrued compensation		841,290		826,762
Dividends payable		1,399,744		49,091
Accrued royalties to shareholder		2,297,527		1,973,781
Other accrued liabilities		4,422,865		3,398,904
Income taxes payable		2,545,692		4,365,770
Total current liabilities		36,203,489		27,901,515
Other long-term liabilities		60,306,784		24,478,697
Long-term debt, net of current maturities		1,886,271		2,710,337
Total liabilities		98,396,544		55,090,549
Commitments and contingencies – see Note 8
Stockholders’ equity:
Preferred stock, $1 par value:
Class B; authorized: 5,000,000 shares
Series II, Class B convertible; outstanding: 156,200 shares at September 30, 2021 and December 31, 2020		156,200		156,200
Series III, Class B convertible; outstanding: 80,245 and 106,745 shares at September 30, 2021 and December 31, 2020, respectively		80,245		106,745
Common Stock, no par value; authorized: 100,000,000 shares; outstanding: 33,764,283 and 33,957,204 at September 30, 2021 and December 31, 2020, respectively		—		—
Additional paid-in capital		61,863,653		59,285,401
Retained earnings (accumulated deficit)		20,336,627		(9,668,221)
Common stock in treasury – at cost		(2,839,326)		—
Total stockholders’ equity		79,597,399		49,880,125
Total liabilities and stockholders’ equity	$	177,993,943	$	104,970,674

See accompanying notes to condensed unaudited financial statements

1

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

	Three Months		Three Months		Nine Months		Nine Months
	Ended		Ended		Ended		Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Sales, net	$	36,356,047	$	27,091,064	$	128,926,716	$	49,867,126
Cost of sales:
Cost of manufactured product		20,663,651		11,580,674		60,074,349		25,331,916
Royalty expense to shareholder		2,297,527		1,681,885		7,819,529		3,502,525
Total cost of sales		22,961,178		13,262,559		67,893,878		28,834,441
Gross profit		13,394,869		13,828,505		61,032,838		21,032,685
Operating expenses:
Sales and marketing		1,020,244		1,160,412		3,398,905		3,148,290
Research and development		199,200		134,575		747,525		399,367
General and administrative		4,209,836		2,185,980		12,824,957		5,696,901
Total operating expenses		5,429,280		3,480,967		16,971,387		9,244,558
Income from operations		7,965,589		10,347,538		44,061,451		11,788,127
Gain on forgiveness of PPP loan		—		—		1,377,652		—
Interest and other income (loss)		(318,663)		(87,483)		1,014,348		881,316
Interest expense		(52,886)		(36,124)		(172,668)		(105,959)
Income before income taxes		7,594,040		10,223,931		46,280,783		12,563,484
Provision (benefit) for income taxes		1,072,155		1,598,180		11,140,889		(151,153)
Net income		6,521,885		8,625,751		35,139,894		12,714,637
Preferred Stock dividend requirements		(59,111)		(145,535)		(183,219)		(493,826)
Deemed contribution on extinguishment of preferred stock		—		2,525,848		—		2,519,124
Income applicable to common shareholders	$	6,462,774	$	11,006,064	$	34,956,675	$	14,739,935
Basic earnings per share	$	0.19	$	0.33	$	1.03	$	0.45
Diluted earnings per share	$	0.19	$	0.33	$	1.02	$	0.45
Weighted average common shares outstanding:
Basic		33,883,684		33,371,471		33,950,742		32,947,241
Diluted		34,262,681		33,984,934		34,330,967		33,071,652

See accompanying notes to condensed unaudited financial statements

2

`RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

	Nine Months		Nine Months
	Ended		Ended
	September 30, 2021		September 30, 2020
Cash flows from operating activities
Net income	$	35,139,894	$	12,714,637
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization		702,384		624,998
Net unrealized gain on investments		(816,150)		(559,543)
Realized gains on investments		—		(162,595)
Accreted interest		83,282		—
Deferred taxes		(8,514,068)		(804,357)
Provision for doubtful accounts		146,395		125,000
Share-based compensation		2,503,152		—
Gain on forgiveness of PPP loan		(1,377,652)		—
(Increase) decrease in operating assets:
Accounts receivable		(9,055,116)		(7,542,375)
Inventories		(8,462,118)		(301,951)
Other current assets		(83,512)		(18,053)
Other assets		38,892		10,125
Increase (decrease) in operating liabilities:
Accounts payable		8,154,409		2,272,302
Accrued liabilities		1,490,008		1,803,433
Income taxes payable		(1,820,078)		670,531
Net cash provided by operating activities		18,129,722		8,832,152
Cash flows from investing activities
Purchase of property, plant, and equipment		(46,511,859)		(9,478,182)
Purchase of debt and equity securities		(4,685,960)		(2,174,980)
Proceeds from the sales of debt and equity securities		—		3,965,329
Net cash used by investing activities		(51,197,819)		(7,687,833)
Cash flows from financing activities
Repayments of long-term debt		(206,310)		(194,985)
Proceeds of long-term debt		—		1,363,000
Proceeds from Technology Investment Agreement (TIA)		39,848,368		6,883,103
Proceeds from the exercise of stock options		48,600		851,012
Payment of preferred stock redemption price payable		(101,250)		—
Payment of preferred stock repurchase payable		(1,101,110)		(100,000)
Payment of preferred stock dividends		(3,784,394)		(164,400)
Repurchase of common stock		(2,839,326)		—
Net cash provided by financing activities		31,864,578		8,637,730
Net increase (decrease) in cash and cash equivalents		(1,203,519)		9,782,049
Cash and cash equivalents at:
Beginning of period		17,566,682		5,934,749
End of period	$	16,363,163	$	15,716,798
Supplemental schedule of cash flow information:
Interest paid	$	89,386	$	105,959
Income taxes paid	$	21,068,540	$	—
Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	$	1,399,744	$	52,242
Conversion of preferred stock to common stock	$	26,500	$	15,000
Amounts receivable under Technology Investment Agreement	$	(3,014,325)	$	—
Preferred stock repurchase payable	$	—	$	2,723,248

See accompanying notes to condensed unaudited financial statements

3

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(unaudited)

The following shows the changes in stockholders’ equity for the three-month period ended September 30, 2021:

			Series II		Series III
			Class B		Class B		Additional				Treasury
	Common		Preferred		Preferred		Paid-In		Retained		Stock –
	Stock		Stock		Stock		Capital		Earnings		at cost		Total
Balance at June 30, 2021	$	—	$	156,200	$	80,245	$	60,706,417	$	13,853,792	$	(154,424)	$	74,642,230
Dividends		—		—		—		—		(39,050)		—		(39,050)
Stock Option Compensation		—		—		—		1,157,236		—		—		1,157,236
Repurchase of Common Stock – at cost		—		—		—		—		—		(2,684,902)		(2,684,902)
Net Income		—		—		—		—		6,521,885		—		6,521,885
Balance at September 30, 2021	$	—	$	156,200	$	80,245	$	61,863,653	$	20,336,627	$	(2,839,326)	$	79,597,399

The following shows the changes in stockholders’ equity for the three-month period ended September 30, 2020:

			Series I		Series II		Series III		Series IV		Series V
			Class B		Class B		Class B		Class B		Class B		Additional
	Common		Preferred		Preferred		Preferred		Preferred		Preferred		Paid-In		Accumulated
	Stock		Stock		Stock		Stock		Stock		Stock		Capital		Deficit		Total
Balance at June 30, 2020	$	—	$	96,000	$	171,200	$	126,745	$	335,000	$	34,000	$	62,087,831	$	(29,802,348)	$	33,048,428
Exchange of Preferred Stock for Common Stock		—		—		—		—		(300,000)		—		(2,423,248)		—		(2,723,248)
Conversion		—		—		(15,000)		—		—		—		15,000		—		—
Stock Option Exercises		—		—		—		—		—		—		224,325		—		224,325
Dividends		—		—		—		—		—		—		(52,242)		—		(52,242)
Net Income		—		—		—		—		—		—		—		8,625,751		8,625,751
Balance at September 30, 2020	$	—	$	96,000	$	156,200	$	126,745	$	35,000	$	34,000	$	59,851,666	$	(21,176,597)	$	39,123,014

The following shows the changes in stockholders’ equity for the nine-month period ended September 30, 2021:

			Series II		Series III				Retained
			Class B		Class B		Additional		Earnings		Treasury
	Common		Preferred		Preferred		Paid-In		(Accumulated		Stock –
	Stock		Stock		Stock		Capital		Deficit)		at cost		Total
Balance at December 31, 2020	$	—	$	156,200	$	106,745	$	59,285,401	$	(9,668,221)	$	—	$	49,880,125
Conversion of Preferred Stock into Common Stock		—		—		(26,500)		26,500		—		—		—
Stock Option Exercises		—		—		—		48,600		—		—		48,600
Dividends		—		—		—		—		(5,135,046)		—		(5,135,046)
Stock Option Compensation		—		—		—		2,503,152		—		—		2,503,152
Repurchase of Common Stock – at cost		—		—		—		—		—		(2,839,326)		(2,839,326)
Net Income		—		—		—		—		35,139,894		—		35,139,894
Balance at September 30, 2021	$	—	$	156,200	$	80,245	$	61,863,653	$	20,336,627	$	(2,839,326)	$	79,597,399

The following shows the changes in stockholders’ equity for the nine-month period ended September 30, 2020:

			Series I		Series II		Series III		Series IV		Series V
			Class B		Class B		Class B		Class B		Class B		Additional
	Common		Preferred		Preferred		Preferred		Preferred		Preferred		Paid-In		Accumulated
	Stock		Stock		Stock		Stock		Stock		Stock		Capital		Deficit		Total
Balance at December 31, 2019	$	—	$	96,000	$	171,200	$	129,245	$	342,500	$	34,000	$	61,660,744	$	(33,891,234)	$	28,542,455
Exchange of Preferred Stock for Common Stock		—		—		—		(2,500)		(307,500)		—		(2,513,248)		—		(2,823,248)
Conversion		—		—		(15,000)		—		—		—		15,000		—		—
Stock Option Exercises		—		—		—		—		—		—		851,012		—		851,012
Dividends		—		—		—		—		—		—		(161,842)		—		(161,842)
Net Income		—		—		—		—		—		—		—		12,714,637		12,714,637
Balance at September 30, 2020	$	—	$	96,000	$	156,200	$	126,745	$	35,000	$	34,000	$	59,851,666	$	(21,176,597)	$	39,123,014

See accompanying notes to condensed unaudited financial statements

4

RETRACTABLE TECHNOLOGIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

1.    BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

Business of the Company

Retractable Technologies, Inc. (the “Company”) was incorporated in Texas on May 9, 1994, and designs, develops, manufactures, and markets safety syringes and other safety medical products for the healthcare profession.  The Company began to develop its manufacturing operations in 1995.  The Company’s manufacturing and administrative facilities are located in Little Elm, Texas.  The Company’s products are the VanishPoint^® 0.5mL insulin syringe; 1mL tuberculin, insulin, and allergy antigen syringes; 0.5mL, 1mL, 2mL, 3mL, 5mL, and 10mL syringes; the blood collection tube holder; the small diameter tube adapter; the allergy tray; the IV safety catheter; the Patient Safe^® syringes; the Patient Safe^® Luer Cap; the VanishPoint^® Blood Collection Set; and the EasyPoint^® needle as well as a standard 3mL syringe packaged with an EasyPoint^® needle. The Company also sells VanishPoint^® autodisable syringes in the international market in addition to the Company’s other products.

Basis of presentation

The accompanying condensed financial statements are unaudited and, in the opinion of Management, reflect all adjustments that are necessary for a fair presentation of the financial position and results of operations for the periods presented.  All such adjustments are of a normal and recurring nature.  The results of operations for the periods presented are not necessarily indicative of the results to be expected for the entire year.  The unaudited condensed financial statements should be read in conjunction with the financial statement disclosures contained in the Company’s audited financial statements incorporated into its Form 10-K filed on March 31, 2021 for the year ended December 31, 2020.  Certain amounts in the prior period Condensed Balance Sheets have been reclassified to conform to the presentation of the current period financial statements. These reclassifications had no effect on the previously reported total current assets or total assets.

2.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ significantly from those estimates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related to sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that the Company has an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied.

Cash and cash equivalents

For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with original maturities of three months or less.

Accounts receivable

The Company records trade receivables when revenue is recognized.  No product has been consigned to customers.  The Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables.  

5

Those accounts that are doubtful of collection are included in the allowance.  This provision is reviewed to determine the adequacy of the allowance for doubtful accounts. Trade receivables are charged off when there is certainty as to their being uncollectible. Trade receivables are considered delinquent when payment has not been made within contract terms. The Allowance for bad debt was $352,217 and $205,822 as of September 30, 2021 and December 31, 2020, respectively.

The Company requires certain customers to make a prepayment prior to beginning production or shipment of their order.  Customers may apply such prepayments to their outstanding invoices or pay the invoice and continue to carry forward the deposit for future orders.  Such amounts are included in Other accrued liabilities on the Condensed Balance Sheets and are shown in Note 6, Other Accrued Liabilities.

The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales.  Historically, returns have been insignificant.

Receivable from Technology Investment Agreement (TIA)

The amounts set forth as Receivable from Technology Investment Agreement (TIA) represent amounts receivable under a contractual agreement under the TIA. The amounts may represent advance requests or reimbursement requests for expenditures the Company makes or has made under its obligations with the federal government. For further explanation, please refer to Note 15 – Technology Investment Agreement.

Inventories

Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost.  The Company compares the average cost to the net realizable value and records the lower value.  Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.  Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, the shelf life of inventory, and current market conditions when determining excess or obsolete inventories. Once inventory items are deemed to be either excess or obsolete, they are excluded from the stated net realizable value.

Investments in debt and equity securities

The Company holds high-grade exchange-traded and closed-end funds (ETFs), mutual funds, equity securities, and debt securities as investments.  These assets are readily marketable and are carried at fair value as of the date of the Condensed  Balance Sheets. Net unrealized and realized gains or losses on investments in debt and equity securities are reflected as a component of Interest and other income (loss). Realized gains or losses on investments in debt and equity securities are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment are stated at cost. Expenditures for maintenance and repairs are charged to operations as incurred.  Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity and interest cost associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

The Company's property, plant, and equipment primarily consist of buildings, land, assembly equipment, molding machines, molds, office equipment, furniture, and fixtures.  Depreciation and amortization are calculated using the straight-line method over the following useful lives:

6

Production equipment	3 to 13 years
Office furniture and equipment	3 to 10 years
Buildings	39 years
Building improvements	15 years

Long-lived assets

The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash flows related to such assets.  In the event that assets are found to be carried at amounts which are in excess of estimated gross future cash flows, the assets will be adjusted for impairment to a level commensurate with fair value determined using a discounted cash flow analysis or appraised values of the underlying assets.

Fair value measurements

For assets and liabilities that are measured using quoted prices in active markets, total fair value is the published market price per unit multiplied by the number of units held without consideration of transaction costs. Assets and liabilities that are measured using significant other observable inputs are valued by reference to similar assets or liabilities, adjusted for contract restrictions and other terms specific to that asset or liability.  For these items, a significant portion of fair value is derived by reference to quoted prices of similar assets or liabilities in active markets.  For all remaining assets and liabilities, fair value is derived using a fair value model, such as a discounted cash flow model or Black-Scholes model.

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information.  Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values.  Investments in equity securities consist primarily of individual equity securities, exchange-traded and closed-end funds and mutual funds and are reported at their fair value based upon quoted prices in active markets.  Investments in certificates of deposit (CD) with original maturities of greater than three months are reported at their estimated fair value based upon the duration of the CD and the interest rate earned on the CD versus current interest rates of similar duration CDs. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in debt and equity securities through consultation with its outside investment advisors. Management is responsible for directing investment activity based on current economic conditions. The majority of accounts receivable are due from companies which are well-established entities. In the third quarter of 2021, a significant portion of the Company’s sales were to the U.S. government, which Management does not consider a credit risk. As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

7

The following table reflects significant customers for the three- and nine-month periods of 2021 and 2020:

	Three Months Ended			Three Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2021			September 30, 2020			September 30, 2021			September 30, 2020
Number of significant customers		2			2			1			2
Aggregate dollar amount of net sales to significant customers	$	22.6	million	$	16.4	million	$	83.6	million	$	21.7	million
Percentage of net sales to significant customers		62.1%			60.6%			64.8%			43.6%

In the first nine months of 2021, approximately $83.6 million of the Company's sales were to the Department of Health and Human Services of the United States. Management expects the U.S. government to remain a significant customer through at least March 2022.

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 90.9% and 82.2% of its products in the first nine months of 2021 and 2020, respectively, from its Chinese manufacturers. Purchases from Chinese manufacturers aggregated 91.9% and 80.5% of products in the three-month periods ended September 30, 2021 and 2020, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company would need to find an alternate manufacturer for its blood collection set, IV catheter, Patient Safe^® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and would increase domestic production for the 1mL and 3mL syringes and EasyPoint^® needles.

Revenue recognition

The Company recognizes revenue when it has satisfied all performance obligations to the customer, generally when title and risk of loss pass to the customer.  Payments from customers with approved credit terms are typically due 30 days from the invoice date. Under certain contracts, revenue is recorded on the basis of sales price to distributors, less contractual pricing allowances. Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among other things, the facility that purchased the products, and (ii) a provision for estimated contractual pricing allowances for products for which the Company has not received tracking reports.  When rebates are issued, they are applied against the customer’s receivable balance.  Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by a distributor to an entity that has no contract, there is a standard rebate (lower than a contracted rebate) given to the distributor.  One of the purposes of the rebate is to encourage distributors to submit tracking reports to the Company. The provision for contractual pricing allowances is recognized in the period the related sales are recognized and is reviewed at the end of each quarter and adjusted for changes in levels of products for which there is no tracking report.  Additionally, if it becomes clear that tracking reports will not be provided by individual distributors, the provision is further adjusted.  The estimated contractual allowance is included in Accounts payable in the Condensed Balance Sheets and deducted from Revenues in the Condensed Statements of Operations.  Accounts payable included estimated contractual allowances for $5,304,885 and $3,435,352 as of September 30, 2021 and December 31, 2020, respectively.  The terms and conditions of contractual pricing allowances are governed by contracts between the Company and its distributors. Revenue for shipments directly to end-users is recognized when title and risk of ownership pass from the Company.  End-users do not receive any contractual allowances on their purchases.  Any product shipped or distributed for evaluation purposes is expensed.

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The Company provides product warranties that: i) the products are fit for medical use as generally defined within the boundaries of United States FDA approval; ii) the products are not defective; and iii) the products will conform to the descriptions set forth in their respective labeling, provided that they are used in accordance with such labeling and the Company’s written directions for use.  The Company has historically not incurred significant warranty claims.

The Company’s domestic return policy provides that a customer may return incorrect shipments within 10 days following arrival at the distributor’s facility.  In all such cases, the distributor must obtain an authorization code from the Company and affix the code to the returned product.  The Company’s domestic return policy also generally provides that a customer may return product that is overstocked.  Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for the prior 12-month period.  All product overstocks and returns are subject to inspection and acceptance by the Company.

The Company’s international distribution agreements generally do not provide for any returns.

The Company requires certain customers to pay in advance of product shipment.  Such prepayments from customers are recorded in Other accrued liabilities and are generally recognized as revenue upon shipment of the product.

The Company periodically recognizes revenue from licensing agreements. If the Company licenses its products for sale, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, a certain percentage of such revenue pursuant to the terms of the Technology License Agreement between the Company and Mr. Shaw.

Disaggregated information of revenue recognized from contracts with customers and licensing fees recognized are as follows:

	For the three months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	11,033,291	$	560,065	$	4,048,292	$	11,399	$	15,653,047
Sales to U.S. government		18,420,480		—		—		—		18,420,480
North and South America sales (excluding U.S.)		670,602		4,800		26,400		—		701,802
Other international sales		1,389,226		900		189,992		600		1,580,718
Total	$	31,513,599	$	565,765	$	4,264,684	$	11,999	$	36,356,047

	For the three months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	8,241,161	$	791,961	$	3,581,723	$	9,210	$	12,624,055
Sales to U.S. government		12,898,080		—		—		—		12,898,080
North and South America sales (excluding U.S.)		1,295,080		450		—		—		1,295,530
Other international sales		198,440		73,019		235		1,705		273,399
Total	$	22,632,761	$	865,430	$	3,581,958	$	10,915	$	27,091,064

	For the nine months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	30,685,338	$	1,590,891	$	7,019,560	$	40,345	$	39,336,134
Sales to U.S. government		83,560,680		—		—		—		83,560,680
North and South America sales (excluding U.S.)		2,963,930		4,800		83,248		109,440		3,161,418
Other international sales		2,161,062		63,540		640,432		3,450		2,868,484
Total	$	119,371,010	$	1,659,231	$	7,743,240	$	153,235	$	128,926,716

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	For the nine months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	21,538,941		1,607,804		6,004,295		52,065	$	29,203,105
Sales to U.S. government		14,065,623		—		—		—		14,065,623
North and South America sales (excluding U.S.)		4,911,106		8,450		1,496		1,064,768		5,985,820
Other international sales		529,430		76,609		235		6,304		612,578
Total	$	41,045,100	$	1,692,863	$	6,006,026	$	1,123,137	$	49,867,126

Income taxes

The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements based on whether it is “more-likely-than-not” that a tax position will be sustained based upon the technical merits of the position.  Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.  

The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on enacted rates expected to be in effect when such differences reverse in future periods.  Deferred tax assets are periodically reviewed for realizability.  In prior periods, the Company established a valuation allowance for its net deferred tax asset as future taxable income which could not be reasonably assured.  During the quarter ended June 30, 2020, the Company released its valuation allowance based on available evidence supporting that its deferred tax assets will be realized in full.

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

For the three and nine months ended September 30, 2021, the calculation of diluted EPS under the treasury stock method included 142,552 and 143,780 shares, respectively, of Common Stock underlying issued and outstanding stock options. Common stock issuable upon the conversion of 236,445 convertible preferred shares is included in the calculation of diluted EPS for both the three and nine months ended September 30, 2021.

The calculation of diluted EPS under the treasury stock method included 226,150 shares of Common Stock underlying issued and outstanding stock options for both the three and nine months ended September 30, 2020, respectively. For these same periods, preferred stock was excluded from the calculation of diluted EPS because the effect was antidilutive.

The potential dilution, if any, is shown on the following schedule:

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	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Net income	$	6,521,885	$	8,625,751	$	35,139,894	$	12,714,637
Preferred stock dividend requirements		(59,111)		(145,535)		(183,219)		(493,826)
Deemed contribution on extinguishment of preferred stock		—		2,525,848		—		2,519,124
Income applicable to common shareholders	$	6,462,774	$	11,006,064	$	34,956,675	$	14,739,935
Average common shares outstanding		33,883,684		33,371,471		33,950,742		32,947,241
Average common and common equivalent shares outstanding — assuming dilution		34,262,681		33,984,934		34,330,967		33,071,652
Basic earnings per share	$	0.19	$	0.33	$	1.03	$	0.45
Diluted earnings per share	$	0.19	$	0.33	$	1.02	$	0.45

Shipping and handling costs

The Company classifies shipping and handling costs as part of Cost of sales in the Condensed Statements of Operations.

Share-based Compensation

The Company’s share-based payments are accounted for using the fair value method.  The Company records share-based compensation expense on a straight-line basis over the requisite service period.  The Company incurred the following share-based compensation costs:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Cost of Sales	$	—	$	—	$	—	$	—
Sales and Marketing		—		—		—		—
Research and development		—		—		—		—
General and administrative		1,157,236		—		2,503,152		—
	$	1,157,236	$	—	$	2,503,152	$	—

Research and development costs

Research and development costs are expensed as incurred.

Leases

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in Other assets, Other accrued liabilities, and Other long-term liabilities on the Condensed Balance Sheets. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.  Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.  As the Company’s leases do not provide an implicit rate, the incremental borrowing rate based on information available at the commencement date was used in determining the present value of lease payments.

The operating lease ROU asset also includes any lease payments made and excludes lease incentives.  Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.  Lease expense for lease payments is recognized on a straight-line basis over the lease term.  Leases with an initial term of twelve months or less are not recorded on the Condensed Balance Sheets; however, rent expense is recognized on a straight-line basis over the lease term.

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Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in Government funding for expanding the Company’s domestic production of needles and syringes. Pursuant to the terms of the TIA, the Company is expected to make significant additions to its facilities which should allow the Company to increase domestic production. As reimbursements are received from the U.S. government for such expenditures, the Company records a deferred liability. The deferred liability will be systematically amortized as a gain over the life of the related property, plant, and equipment as to offset the related depreciation expense of the assets acquired. The amortization will be presented separately from the depreciation expense on the Condensed Statements of Operations.

Recently Adopted Pronouncements

The Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments on January 1, 2020.  Among other things, these amendments require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts.  Many of the loss estimation techniques applied previously will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  The adoption of ASU 2016-13, as well as the Targeted Transition Relief as provided by ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326) – Targeted Transition Relief” did not have a significant impact on the Company’s financial statements.

The Company adopted ASU 2018-15, “Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):  Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract (a Consensus of the FASB Emerging Issues Task Force)" on January 1, 2020.  This amendment requires that implemented costs incurred in a hosting arrangement that is a service contract should be accounted for in accordance with ASC 350-40  Internal-Use Software.  Accordingly, costs incurred during the preliminary project and post-implementation stages are expensed and costs associated with the application development phase are capitalized.  The amendment also requires that capitalized costs be amortized over the term of the hosting arrangement and that capitalized costs should be evaluated for impairment. The adoption of this ASU did not have a significant impact on the Company's financial statements or disclosures.

In August 2018, the FASB issued ASU 2018-13 "Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement." The amendment modifies, among other things, disclosure requirements on fair value measurements and eliminates certain disclosures related to transfers and valuation levels of Level 3 fair value measurements. Additionally, the amendment requires disclosure of changes in unrealized gains and losses in other comprehensive income for Level 3 fair value measurements and certain qualitative factors related to significant unobservable inputs used in Level 3 valuations. The amendment was effective for annual periods beginning after December 15, 2019 and interim periods within the annual period. The adoption of ASU 2018-13 did not have a significant effect on the Company's financial statements, as the Company does not currently have any investments classified as Level 3 fair value measurements.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”.  The new standard is intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.  The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.  The standard is effective for annual periods beginning after December 15, 2020 and interim periods within the annual period, with early adoption permitted.  Adoption of the standard requires certain changes primarily be made prospectively, with some changes to be made retrospectively.  

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The Company has determined that the adoption of ASU 2019-12 did not have a material impact on its financial statements.

Recently Issued Pronouncement

In March 2020, the FASB issued ASU No. 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting”, to ease the potential burden in accounting for reference rate reform.  The new guidance provides optional expedients for contracts that reference LIBOR, if certain criteria are met, that can be applied through December 31, 2022.  As reference rate reform is still an ongoing process, the Company will continue to evaluate the timing and potential impact of adoption for optional expedients when deemed necessary.

3.    INVENTORIES

Inventories consist of the following:

	September 30, 2021		December 31, 2020
Raw materials	$	2,370,760	$	1,320,214
Finished goods		16,326,004		8,914,432
	$	18,696,764	$	10,234,646

4.    FAIR VALUE OF FINANCIAL INSTRUMENTS

ASC 820, “Fair Value Measurements”, defines fair value, establishes a framework for measuring fair value and requires additional disclosures regarding certain fair value measurements.  ASC 820 establishes a three-tier hierarchy for measuring fair value, as follows:

● Level 1 – quoted market prices in active markets for identical assets and liabilities

● Level 2 – inputs other than quoted prices that are directly or indirectly observable

● Level 3 – unobservable inputs where there is little or no market activity

The following tables summarize the values of assets designated as Investments in debt and equity securities:

	September 30, 2021
	Level 1		Level 2		Level 3		Total
Equity securities	$	9,357,931	$	—	$	—	$	9,357,931
Mutual funds and exchange traded funds		4,150,405		—		—		4,150,405
Certificates of deposit		—		75,607		—		75,607
	$	13,508,336	$	75,607	$	—	$	13,583,943

	December 31, 2020
	Level 1		Level 2		Level 3		Total
Equity securities	$	3,990,533	$	—	$	—	$	3,990,533
Mutual funds and exchange traded funds		4,013,956		—		—		4,013,956
Certificates of deposit		—		77,344		—		77,344
	$	8,004,489	$	77,344	$	—	$	8,081,833

The Company holds high-grade ETFs, mutual funds, individual equity stocks, and debt securities as investments.  These assets are readily marketable and are carried at fair value as of the date of the Condensed Balance Sheets. The Company intends to hold these assets for possible future operating requirements. The following table summarizes gross unrealized gains and losses from Investments in debt and equity securities:

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	September 30, 2021
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	6,698,032	$	2,659,899	$	—	$	9,357,931
Mutual funds and exchange traded funds		3,994,001		156,404		—		4,150,405
Certificates of deposit		75,000		607		—		75,607
	$	10,767,033	$	2,816,910	$	—	$	13,583,943

	December 31, 2020
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	2,098,144	$	1,892,389	$	—	$	3,990,533
Mutual funds and exchange traded funds		3,909,364		104,592		—		4,013,956
Certificates of deposit		75,000		2,344		—		77,344
	$	6,082,508	$	1,999,325	$	—	$	8,081,833

Unrealized gains on investments in debt and equity securities were $816,150 and $559,543 for the nine months ended September 30, 2021 and 2020, respectively.

5.    INCOME TAXES

The Company’s effective tax rate on the net income before income taxes was 14.1% and 24.1% for the three and nine months ended September 30, 2021, respectively.  The Company’s effective tax rate on the net income before income taxes was 15.6% and (1.2)% for the three and nine months ended September 30, 2020, respectively.

A reconciliation of the federal statutory corporate tax rate to the Company’s effective tax rate is as follows:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. statutory federal tax rate	21.0	%	21.0	%	21.0	%	21.0	%
Valuation Allowance	—	%	(8.8)	%	—	%	(24.8)	%
Stock options	0.1	%	—	%	(0.1)	%	—	%
Other	(12.4)	%	0.6	%	(1.8)	%	0.1	%
PPP loan	—	%	—	%	(0.8)	%	—	%
State taxes	5.4	%	2.8	%	5.8	%	2.5	%
Effective tax rate	14.1	%	15.6	%	24.1	%	(1.2)	%

The Company uses the recognition and measurement provisions of the FASB ASC Topic 740, Income Taxes (“Topic 740”), to account for income taxes. The provisions of Topic 740 require a company to record a valuation allowance when the “more likely than not” criterion for realizing net deferred tax assets cannot be met. Furthermore, the weight given to the potential effect of such evidence should be commensurate with the extent to which it can be objectively verified. As a result, the Company reviewed the operating results, as well as all of the positive and negative evidence related to realization of such deferred tax assets to evaluate the need for a valuation allowance at September 30, 2021 and 2020.

The effective tax rate for the nine months ended September 30, 2021 was different from the federal statutory rate due primarily to the apportionment of earnings across various state jurisdictions. The Company determined that no valuation allowance should be recorded at September 30, 2021.

The effective tax rate for the nine months ended September 30, 2020 was different from the federal statutory rate due primarily to the release of the valuation allowance recorded on net operating losses in earlier periods.

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6.    OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

	September 30, 2021		December 31, 2020
Prepayments from customers	$	2,609,684	$	1,686,868
Accrued property taxes		338,540		—
Accrued professional fees		228,204		331,204
Current portion – preferred stock repurchase		1,084,795		1,092,282
Other accrued expenses		161,642		288,550
Total	$	4,422,865	$	3,398,904

7.    OTHER LONG-TERM LIABILITIES

Other long-term liabilities consists of the following:

	September 30, 2021		December 31, 2020
Technology Investment Agreement (TIA)	$	59,278,368	$	22,444,324
Stock repurchase		1,028,416		2,034,373
Total	$	60,306,784	$	24,478,697

The TIA provides for reimbursement to the Company for the purchase of equipment and supplies related to the expansion of the Company’s domestic production of needles and syringes.  Under the TIA, reimbursable amounts will be reflected as a liability until the time its deferred income can be systematically amortized over a period matching the useful life of the purchased assets.

The stock repurchase liability represents the long-term portion, at net present value, of $2,107,212 gross payable by the Company to former preferred shareholders as a result of private stock purchases in 2020 of 320,333 shares of Class B Series IV preferred stock and 25,000 shares of Class B Series V preferred stock.  The purchase price is payable in three annual installments of $1,101,110.

8.    COMMITMENTS AND CONTINGENCIES

On November 7, 2019, the Company filed a lawsuit in the 44^th District Court of Dallas County, Texas (No. DC-19-17946) against Locke Lord, LLP and Roy Hardin in connection with their legal representation of the Company in its previous litigation against Becton, Dickinson and Company ("BD"). The Company alleges that the defendants breached their fiduciary duties, committed malpractice, and were negligent in their representation of the Company. The Company seeks actual and exemplary damages, disgorgement, costs, and interest. On October 6, 2020, the Court dismissed Locke Lord, LLP and Mr. Hardin’s motion to dismiss.  Such order was affirmed on April 20, 2021 by the Court of Appeals, Fifth District of Texas at Dallas.

9.    BUSINESS SEGMENT

The Company does not operate in separate reportable segments. Shipments to international customers generally require a prepayment either by wire transfer or an irrevocable confirmed letter of credit.  The Company does extend credit to international customers on some occasions depending upon certain criteria, including, but not limited to, the credit worthiness of the customer, the stability of the country, banking restrictions, and the size of the order.  All transactions are in U.S. currency.

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Revenues by geography are as follows:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. sales (excluding U.S. government)	$	15,653,047	$	12,624,055	$	39,336,134	$	29,203,105
Sales to U.S. government		18,420,480		12,898,080		83,560,680		14,065,623
North and South America sales (excluding U.S.)		701,802		1,295,530		3,161,418		5,985,820
Other international sales		1,580,718		273,399		2,868,484		612,578
Total sales	$	36,356,047	$	27,091,064	$	128,926,716	$	49,867,126

Long-lived assets by geography are as follows:

	September 30, 2021		December 31, 2020
Long-lived assets
U.S.	$	72,822,361	$	30,751,259
International		3,803,619		65,245
Total	$	76,625,980	$	30,816,504

10.  DIVIDENDS

The Board declared and the Company paid cash dividends  to Series I and Series II Class B Preferred Shareholders within one month of the end of each quarter in 2020. Cumulatively, dividend payments of $48,000, and $168,642 were made to Series I and Series II preferred shareholders, respectively, in 2020 and one payment of $10,041, and $39,050 was made to Series I and Series II preferred shareholders, respectively, in January 2021. A cash dividend of $39,050 was paid in April 2021 to Series II preferred shareholders.

In June 2021, the Board of Directors approved payments to its Series II, Series III, and former Series IV and Series V Class B Preferred Shareholders in the cumulative amount of $5,056,945 representing all current dividends, dividends in arrears, as well as dividends still owed to shareholders who converted their preferred stock in the past.  Of this amount, $39,050 was declared to Series II Class B Convertible Preferred shareholders, representing a dividend amount of $0.25 per share and cover amounts in arrears from April 1, 2021 though the date of conversion or June 30, 2021, whichever is applicable.  To Series III Class B Convertible Preferred shareholders, $4,086,704 was declared, representing a dividend amount of $1.00 per share per year and cover amounts in arrears from the date of purchase though the date of conversion or June 30, 2021, whichever is applicable.  To former Series IV Class B Convertible Preferred shareholders, $101,475 was declared, representing a dividend amount of $1.00 per share per year and cover amounts in arrears from the date of purchase though the date of conversion.  To former Series V Class B Convertible Preferred shareholders, $829,716 was declared, representing a dividend amount of $0.32 per share per year and cover amounts in arrears from the date of purchase though the date of conversion.  The dividends were paid on July 22, 2021 to all shareholders who had been contacted and confirmed as the rightful owner entitled to payment. The Company has not yet established contact with all former shareholders, most of whom converted their shares prior to 2001. As of November 5, 2021, the Company is continuing its efforts to establish contact with approximately 90 former shareholders who are entitled to approximately $1.4 million.

 A cash dividend of $39,050 was paid in October 2021 to Series II preferred shareholders.

11.  LEASES

The Company has no finance leases and its operating leases for a warehouse and equipment terminated on August 15, 2021. The ROU asset value was determined based on the lease liability adjusted for lease incentives received. Lease expense has been recognized on a straight-line basis over the lease term. Certain costs incidental to the use of the property were separate from the minimum rent payment and were not considered in the determination of the lease liability and ROU asset. The Company elected the policy to not separate lease from non-lease components if they are

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combined with the minimum rent payment. The option periods were not included in the determination of the lease liability and right-of-use asset.

The operating lease cost component of the lease expense was $38,892 for the nine-month period ended September 30, 2021. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $38,892 for the nine months ended September 30, 2021. The operating lease cost component of the lease expense was $69,689 for the nine-month period ended September 30, 2020. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $69,689 for the nine months ended September 30, 2020.

Assets and liabilities associated with these leases included in the Condensed Balance Sheets are as follows:

	September 30, 2021		December 31, 2020
OPERATING LEASES
Other assets	$	—	$	38,892
Other accrued liabilities	$	—	$	38,892
Other long-term liabilities		—		—
Total operating lease liabilities	$	—	$	38,892

12.  EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK

In 2020, the Company entered into several agreements with shareholders to purchase its outstanding Class B Convertible Preferred Stock.  The consideration for these purchases consisted of both cash and Common Stock.  In addition, in each such transaction, the preferred shareholder counterparty waived all rights to unpaid dividends in arrears.  The aggregate cash consideration equaled $3,786,000, of which $482,670 was paid in 2020. The balance is payable over a three-year period which began in February 2021.  In February 2021, the Company paid the first of three equal installments of $1,101,110.

13.  STOCK OPTIONS

Stock options were exercised by the Company’s employees and directors at various dates during the nine months ended September 30, 2021, and, consequently, a total of 25,400 shares of Common Stock were issued for an aggregate payment to the Company of $48,600 to exercise such options.

On March 16, 2021, the Company’s Board of Directors approved the 2021 Stock Option Plan (the “Plan”) and set aside and reserved 2,000,000 shares of Common Stock for issuance pursuant to the Plan. The Plan was approved by the Company’s shareholders at the May 11, 2021 shareholder meeting. The Plan provides for the granting of incentive stock options and non-qualified stock options at a price equal to at least 100% of the fair market value of the Company’s Common Stock as of the date of grant. Participants in the Plan may include employees, consultants, and non-employee Directors. On March 16, 2021, the Company’s Compensation and Benefits Committee approved option grants to purchase 1,000,000, 250,000, and 100,000 shares of Common Stock to the Company’s chief executive officer, general counsel, and chief financial officer, respectively. These shares will vest in their entirety three years from the grant date and have an exercise price of $13.00 per share.  The value of an option for the purchase of each underlying share of Common Stock is $10.21 using the Black-Scholes option pricing model with a risk-free rate of 1.20% and a volatility factor of 92.66%.

14. PAYCHECK PROTECTION PROGRAM LOAN

On April 17, 2020, the Company entered into a promissory note in the principal amount of $1,363,000 (the “PPP Loan”) in favor of Independent Bank pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), administered by the U.S. Small Business Administration (“SBA”). The PPP Loan’s original maturity date was April 17, 2022 with an interest rate of 1.0% per annum. The PPP Loan had a prepayment option with no prepayment penalties. The PPP Loan was unsecured and was a non-recourse obligation.

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On May 13, 2021, the Company was informed that the SBA granted its request for loan forgiveness for the entire original principal and accrued interest, for a total of $1,377,652. No payments were made prior to receiving forgiveness.

15.    TECHNOLOGY INVESTMENT AGREEMENT

Effective July 1, 2020, the Company entered into the TIA with the U.S. government. The principal purpose of the TIA is to fund the expansion of the Company’s manufacturing capacity for hypodermic safety needles and corresponding syringes in response to the worldwide COVID-19 global pandemic. The award is an expenditure-type TIA, whereby the U.S. government will make payments to the Company for the Company’s expenditures for equipment and supplies in carrying out the expansion of the Company’s domestic production. The Company’s contributions under the terms of the TIA to enhance domestic capacity of pandemic-essential technology include providing facilities, technical expertise, labor, and maintenance of the TIA-funded equipment for a ten-year term.

As of September 30, 2021, the Company had negotiated contracts for the purchase of automated assembly equipment, molds, and molding equipment, as well as portions of auxiliary equipment, for approximately $44.6 million.  The Company has received a temporary certificate of occupancy for both the approximately 27,800 square foot controlled environment and the approximately 55,000 square foot new warehouse space.  The final cost of the controlled environment within existing properties is $6.7 million.  The new warehouse space final cost is $5.9 million.  The cost of the controlled environment was funded by the U.S. government under the TIA, while the cost of the new warehouse was funded by the Company.  A May 2021 amendment to the TIA requires further expansion and new assembly lines.  As of September 30, 2021, the Company has issued purchase orders for approximately $16.7 million for the purchase of additional production and ancillary equipment in connection with the foregoing amendment.

16.    STOCK REPURCHASE PLAN

The Company entered into a repurchase plan (the “Plan”) dated June 4, 2021 with an independent broker for the purchase of up to $10 million of the Company’s Common Stock.  Under the Plan, open market purchases of the Company’s Common Stock commenced June 18, 2021 and 231,321 shares were purchased in the quarterly period ended September 30, 2021 for an aggregate purchase price of $2,684,902.  A total of 244,821 shares have been repurchased for $2,839,326 as of September 30, 2021.  These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s balance sheets.  The Plan terminates on the earliest of: June 18, 2022, the completion of all purchases contemplated by the Plan, termination by either party, the existence of a legal or regulatory restriction, certain fundamental business transactions, liquidation or reorganization, or failure of the Company to adhere to the representations and warranties in the Plan.  The Plan is structured to comply with Rules 10b5-1 and 10b-18 under the Securities Exchange Act of 1934. The purchases under the Plan are subject to Rule 10b-18 limitations as well as certain price and market volume constraints specified in the Plan.  As of November 10, 2021, 362,854 shares were purchased for a total of $4.0 million.

Item 2.    Management’s Discussion and Analysis of Financial Condition and Results of Operations.

FORWARD-LOOKING STATEMENT WARNING

Certain statements included by reference in this filing containing the words “could,” “may,” “believes,” “anticipates,” “intends,” “expects,” and similar such words constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Any forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among others: the impact of COVID-19 on all facets of logistics and operations as well as costs; our ability to complete capital improvements and produce products in response to government agreements; potential tariffs; our ability to maintain liquidity; our maintenance of patent protection; our ability to maintain favorable third party manufacturing and supplier arrangements and relationships; foreign trade risk; our ability to access the market; production costs; the impact of larger market players, specifically Becton, Dickinson and Company, in providing devices to the safety market; and any

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other factors referenced in Item 1A. Risk Factors in Part II. Given these uncertainties, undue reliance should not be placed on forward-looking statements.

MATERIAL CHANGES IN FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We have been manufacturing and marketing our products since 1997. VanishPoint^® syringes comprised 92.6% of our sales in the first nine months of 2021. EasyPoint^® products accounted for 6.0% of sales in the first nine months of 2021. We also manufacture and market a blood collection tube holder, IV safety catheter, and VanishPoint^® Blood Collection Set.

Our products have been and continue to be distributed nationally and internationally through numerous distributors.  Some of our popular syringe products provide low dead-space.  Low dead-space syringes reduce residual medication remaining in the syringe after the dose has been administered.  In some instances, the low dead-space allows for additional doses of medication to be obtained from the vials.  

On May 1, 2020, we were awarded a delivery order under an existing contract by the Department of Health and Human Services of the United States to supply automated retraction safety syringes for COVID-19 vaccination efforts, which order was in the amount of $83.8 million plus $10 million in expedited freight costs.  The period of performance for this order will end in March 2022.

The Department of Health and Human Services awarded us another contract on February 12, 2021 to supply low dead-space safety syringes for COVID-19 vaccination efforts. The base price for the contract and purchase order was $54.2 million for the five-month base period of performance (February 15, 2021 to July 14, 2021).  We have received notice that the contract would be extended for seven additional months beyond the base period of performance with a total contract price during such period of approximately $92.8 million. To date, we have received a commitment to exercise the first four option periods which extend through the end of December 2021. For each period, the freight reimbursement cost is included in total overall contract value and is estimated at approximately 25% of the overall price.

Our sales under both of the foregoing orders from the U.S. government were $83.6 million during the first nine months of 2021, representing 64.8% of our total sales for such period. Both of the above-mentioned orders as well as the TIA (as defined below) from the U.S. government are material events particular to the COVID-19 pandemic and may not be indicative of future operations. While the addition of manufacturing equipment and facilities will greatly increase our production capacity, we cannot be assured that there will be increased demand for our products once orders from the U.S. government have been filled. If future orders are not placed by the U.S. government and orders from new and existing customers do not materialize, we would have significant excess productive capabilities.

Effective July 1, 2020, we entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) for $53.7 million in government funding for expanding our domestic production of needles and syringes.  Effective May 12, 2021 we entered into an amendment to the TIA providing an additional $27.4 million in funding. The amendment calls for an increase in existing domestic manufacturing capabilities by a minimum of 50% in order to meet ongoing and future U.S. COVID-19 medical countermeasures demands.  In order to satisfy this new objective, we are required to further expand our facilities and add new assembly lines by January 31, 2022. As of September 30, 2021, we have negotiated contracts for the purchase of automated assembly equipment, molds, and molding equipment, as well as portions of auxiliary equipment, for approximately $44.6 million and have substantially completed the $6.7 million 27,800 square foot controlled environment which was funded by the U.S. government. We have also substantially completed the new $5.9 million 55,000 square foot warehouse space which is our financial responsibility.  In furtherance of the May 2021 amendment, we have issued purchase orders for approximately $16.7 million for the purchase of two additional assembly lines, the necessary molds and molding equipment to support the additional assembly lines, as well as some of the necessary accessory equipment.

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To date, our manufacturing facility in Little Elm, Texas has continued to operate due to its status as an essential business. As a result of the COVID-19 pandemic, we have implemented certain safety precautions at our facility to reduce the risk of the potential spread of the novel coronavirus. All of our employees are required to be vaccinated.  We continue to monitor the evolving situation and will work to further mitigate risks to staff and to customers. We are continuing to evaluate the ever-changing circumstances surrounding this pandemic as it relates to our ability to continue to source materials and products, maintain a workforce, and operate our business effectively and efficiently. We have faced and continue to deal with the logistical challenges of sourcing raw materials and finished goods, particularly finished goods from China.  We utilize multiple transportation providers to ensure we can meet our delivery schedules, but we are subject to the global supply chain and its complexities.

On April 17, 2020, we entered into the PPP Loan in the principal amount of $1.4 million in favor of Independent Bank pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act, administered by the U.S. Small Business Administration (“SBA”). On May 13, 2021, we were informed that the SBA granted our request for loan forgiveness for the entire original principal amount and accrued interest, for a total of $1.4 million.

We have engaged a construction company and architect to explore the possibility of expanding our existing administrative offices. We currently expect that the cost of expansion will be approximately $5.0 million and will be completed in the first half of 2022. To date, we have spent approximately $212 thousand.

As detailed in Note 4 to the financial statements, we held $13.6 million in debt and equity securities as of September 30, 2021, which represented 15.4% of our current assets. We continually monitor our invested balances.

In response to, among other factors, the global COVID-19 pandemic, our delivery orders from the U.S. government, and the TIA, employee headcount and related salary and benefits costs have increased significantly. As of September 30, 2021, the Company employed approximately 243 full-time, part-time, and temporary employees. This represents approximately a 35.0% increase in our workforce since September 2020.

On March 16, 2021, the Board approved the 2021 Stock Option Plan (the “Plan”) and set aside and reserved 2,000,000 shares of Common Stock for issuance pursuant to the Plan. The Plan was approved by the shareholders at the May 11, 2021 shareholder meeting. The Plan provides for the granting of incentive stock options and non-qualified stock options at a price equal to at least 100% of the fair market value of the Company’s Common Stock as of the date of grant. Participants in the Plan may include employees, consultants, and non-employee Directors. On March 16, 2021, the Compensation and Benefits Committee approved option grants to purchase 1,000,000, 250,000, and 100,000 shares of Common Stock to our chief executive officer, general counsel, and chief financial officer, respectively. These shares will vest in their entirety three years from the grant date.

On March 16, 2021, the Compensation and Benefits Committee modified the annual salaries of our chief executive officer, general counsel, and chief financial officer to $1,000,000, $400,000, and $300,000, respectively. Such salaries are retroactively effective as of January 1, 2021. On March 16, 2021, the Compensation and Benefits Committee also approved issuances of cash bonuses of $300,000, $100,000, and $100,000 to our chief executive officer, general counsel, and chief financial officer, respectively.

On June 4, 2021, the Board of Directors approved payment to Class B Convertible Preferred shareholders of all current dividends, dividends in arrears, as well as dividends still owed to shareholders who converted their preferred stock in the past.  The total amount authorized for dividends payable was $5.1 million.  The dividends were paid on July 22, 2021 to all shareholders who had been contacted and confirmed as the rightful owner entitled to payment. We have not yet established contact with all former shareholders, most of whom converted their shares prior to 2001. As of November 5, 2021, we are continuing to establish contact with approximately 90 former shareholders who are entitled to approximately $1.4 million.

Effective June 4, 2021, we entered into a repurchase plan (the “Plan”) for the purchase of up to $10 million of our Common Stock.  Under the Plan, open market purchases of our Common Stock commenced June 18, 2021 and 362,854 shares were purchased as of November 10, 2021 for an aggregate purchase price of approximately $4.0 million.

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Historically, unit sales have increased during the flu season. Seasonal trends in 2020 and the first nine months of 2021 have been less pronounced due to demand related to the COVID-19 vaccine.

Product purchases from our Chinese manufacturers have enabled us to increase manufacturing capacity with little capital outlay and have provided a competitive manufacturing cost. In the first nine months of 2021, our Chinese manufacturers produced approximately 90.9% of our products. In the event that we become unable to purchase products from our Chinese manufacturers, we would need to find an alternate manufacturer for the blood collection set, IV catheter, Patient Safe^® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes and we would increase domestic production for the 1mL and 3mL syringes and EasyPoint^® needles.

In 1995, we entered into a license agreement with Thomas J. Shaw for the exclusive right to manufacture, market, and distribute products utilizing his patented automated retraction technology and other patented technology.  This technology is the subject of various patents and patent applications owned by Mr. Shaw.  The license agreement generally provides for quarterly payments of a 5% royalty fee on gross sales of products subject to the license and he receives fifty percent (50%) of the royalties paid to us by certain sublicensees of the technology subject to the license.

We have experienced significant cost pressure with respect to transportation costs, particularly freight costs for importing products from our overseas manufacturers.  In addition, we have experienced an increase in raw materials costs, principally the cost of petroleum-based plastics used in our molded components.  These costs contribute significantly to the cost of manufactured products and have significantly reduced our gross margins for the 2021 periods presented.  With increased volumes, our manufacturing unit costs have generally tended to decline.  Other factors that could affect our unit costs include increases in tariffs, costs by third party manufacturers, and changing production volumes.  Increases in such costs may not be recoverable through price increases of our products.  

RESULTS OF OPERATIONS

The following discussion may contain trend information and other forward-looking statements that involve a number of risks and uncertainties. Our actual future results could differ materially from our historical results of operations and those discussed in any forward-looking statements. All period references are to periods ended September 30, 2021 or 2020. Dollar amounts have been rounded for ease of reading.

Comparison of Three Months Ended September 30, 2021 and September 30, 2020

Domestic sales, including sales to the U.S. government, accounted for 93.7% and 94.2% of the revenues for the three months ended September 30, 2021 and 2020, respectively.  Domestic revenues increased 33.5% principally due to increased volumes primarily attributable to orders from the U.S. government.  Domestic unit sales increased 34.1%.  Domestic unit sales were 90.6% of total unit sales for the three months ended September 30, 2021.  Domestic unit sales excluding the U.S. government rose approximately 32.6%.  International revenues increased approximately 45.5% due to an increase in products available for international shipment. Our international orders may be subject to significant fluctuation over time and may not be reflective of the full year’s sales.  Overall unit sales increased 34.2%.  Other than the U.S. government, our increased sales are predominantly attributable to existing customers as well as several new smaller customers who do not operate as distributors.  As discussed above, our gross margins were significantly impacted during the third quarter of 2021 due to the global demand for, and rising costs of, cargo freight transportation. Despite the increase in revenues for the third quarter of 2021, our gross profit decreased, both on a per unit basis and in the aggregate.

Cost of manufactured product increased 78.4% principally due to both an increase in units sold and higher materials and transportation costs.  Royalty expense increased 36.6% due to increased gross sales.  

Operating expenses increased 56.0% from the prior year.  This is substantially due to increased headcount and other employee-related expenses, as well as consulting expenses. Each of these is attributable to the larger volume of orders and the expansion activities required by the TIA. Included in the increased employee expenses were $1.2 million of share-based compensation expense and $338 thousand from general salary increases and larger headcount. Sales and marketing expenses decreased due to a reduction in marketing samples and bonus expense.

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Income from operations was $8.0 million compared to income from operations of $10.3 million for the same period last year.  The decrease was due to lower gross margins as mentioned above and an increase in general and administrative expenses.

Interest and other income (loss) was ($319) thousand for the quarter ended September 30, 2021 as compared to ($87) thousand for the same period last year principally due to a decrease in investment balances from unrealized losses from the prior quarter.  Interest expense for the third quarter of 2021 increased by approximately 46.4% from the same period in the prior year. The increase is primarily attributable to imputed interest associated with amounts payable for the repurchase of preferred stock from former shareholders. See Note 7 to the financial statements for further discussion of the repurchase terms.

Comparison of Nine Months Ended September 30, 2021 and September 30, 2020

Domestic sales, including sales to the U.S. government, accounted for 95.3% and 86.8% of the revenues for the nine months ended September 30, 2021 and 2020, respectively.  Domestic revenues increased 184.0% principally due to higher average pricing and increased volumes primarily attributable to orders from the U.S. government.  Domestic unit sales increased 160.9%.  Domestic unit sales were 92.7% of total unit sales for the nine months ended September 30, 2021.  Domestic unit sales excluding the U.S. government rose approximately 36.6%. International revenues decreased approximately 8.6%.  Our international orders may be subject to significant fluctuation over time and may not be reflective of the full year’s sales.  Overall unit sales increased 129.9%. As a result of product mix and customer base for the 2021 nine-month period, our average net revenue per unit sold increased by 12.5%. Other than the U.S. government, our increased sales are predominantly attributable to existing customers as well as several new smaller customers who do not operate as distributors.

Cost of manufactured product increased 137.1% principally due to an increase in overall units sold as well as higher inventory carrying costs.  Royalty expense increased 123.3% due to increased gross sales.  

An increase in operating expenses of 83.6% over the previous year is primarily attributable to an increase in headcount, employee-related expenses, and consulting fees.  These increases are due to the growth in order volume and expansion activities required by the TIA.  Included in the increased employee expenses were bonuses and retroactive salary increases for the named executive officers of approximately $650 thousand, $2.2 million in other employee bonuses, and $2.5 million of share-based compensation expense.  Sales and marketing expenses increased due to employee bonuses and an increase of GPO fees on the basis of the increase in sales.

Income from operations was $44.1 million compared to $11.8 million for the same period last year.  The increase was due to the increase in net revenues and resulting gross profit.

Interest and other income (loss) increased 15.1% for the nine months ended September 30, 2021 compared to the same period last year principally due to unrealized gains from our investments.  Interest expense for the first nine months of 2021 increased by approximately 63.0% from the same period in the prior year. The increase is primarily attributable to imputed interest associated with amounts payable for the repurchase of preferred stock from former shareholders. See Note 7 to the financial statements for further discussion of the repurchase terms.

The 2021 recognition of the gain from the forgiveness PPP Loan and the 2020 release of the valuation allowance for approximately $1.8 million in deferred tax assets affect the comparability of the nine-month periods ended September 30, 2021 and 2020.

Discussion of Balance Sheet and Cash Flow Items

Cash comprises 9.2% of total assets. Cash flow from operations was $18.1 million for the nine months ended September 30, 2021. Additionally, we have recorded deferred taxes of $8.5 million which is material to the adjustments to total cash flow from operations. The deferred tax asset represents amounts available to reduce income taxes payable on taxable income in future years.  Inventory levels have increased significantly since the end of last year due to higher

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volumes of raw materials on hand for production, as well as an increase in finished goods.  Overall values are up by approximately $8.5 million, including finished goods in transit from our overseas manufacturers.

During 2020, we engaged in private purchase agreements to purchase shares of outstanding preferred stock in exchange for cash consideration and the issuance of new common stock. In addition to payment in Common Stock, we paid cash consideration equaling $3,786,000, of which $482,670 was paid in 2020 with the remainder payable over a three-year period which began in February 2021. In February 2021, we paid the first of three installments of $1,101,110.  Amounts payable as the result of our purchase of preferred stock comprises a small portion of the long-term liabilities set forth on our Balance Sheets. Amounts related to reimbursements from the U.S. government in connection with the TIA make up most of the other long-term liabilities of $60.3 million.

Cash used by investing activities was $51.2 million for the nine months ended September 30, 2021 due primarily to the purchase of property, plant and equipment and the purchase of equity securities. The $46.5 million impact to cash from the purchase of fixed assets primarily reflects down payments on orders for certain assets as discussed in Note 15 to the financial statements. Of the $46.5 million, $3.8 million was spent on assembly equipment outside the TIA reimbursement provisions. Additionally, predominantly in the first quarter of 2021, we increased our invested cash position by approximately $4.7 million.

Cash provided by financing activities was $31.9 million for the nine months ended September 30, 2021. This was primarily due to proceeds from the government under the TIA for down payments on our orders for fixed assets but was offset by payments under the preferred stock repurchase agreements from 2020. While a total of $5.0 million was declared as dividends to current and former shareholders, only $3.4 million was paid during the third quarter of 2021. The remainder will be paid upon our successfully contacting certain former shareholders. As of the end of the third quarter of 2021, we had spent approximately $2.8 million for the repurchase of Common Stock, as previously discussed.

LIQUIDITY AND CAPITAL RESOURCES

Historical Sources of Liquidity

We have historically funded operations primarily from the proceeds from revenues, private placements, litigation settlements, and loans.

Internal Sources of Liquidity

Margins

The mix of domestic and international sales affects the average sales price of our products. Generally, the higher the ratio of domestic sales to international sales, the higher the average sales price will be. Some international sales of our products are shipped directly from China to the customer. The number of units produced by us versus manufactured in China can have a significant effect on the carrying costs of Inventory as well as Cost of sales. Generally, an overall increase in units sold can positively affect our margins. The cost of raw materials used in manufacturing and transportation costs can also significantly affect our margins. We will continue to evaluate the appropriate mix of products manufactured domestically and those manufactured in China to achieve economic benefits as well as to maintain our domestic manufacturing capability.

Cash Requirements

We have sufficient cash reserves, received the proceeds from a PPP Loan, and have begun to realize income from operations. We also have access to our investments which may be liquidated in the event that we need to access the funds for operations.

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Contracts with the U.S. Government

As discussed above, we were awarded a material delivery order by the Department of Health and Human Services of the United States in the total amount of approximately $83.8 million, plus certain expedited freight expenses.  In February 2021, we received another contract from the Department of Health and Human Services for additional safety syringes representing expected revenues and reimbursable freight costs of $54.2 million for a five-month period ending July 14, 2021 and approximately $92.8 million for seven monthly option periods. To date, we have received a commitment to exercise the first four option periods which extend through the end of December 2021.

As discussed above, we entered into a TIA with the U.S. government for a total value of approximately $81.0 million in government funding for expanding our domestic production of needles and syringes.  As of November 5, 2021, we have received approximately $54.8 million for down payments on the purchase of certain fixed assets.  As of November 5, 2021, we have contributed approximately $5.9 million towards the completion of the new 55,000 square foot warehouse as a portion of the cost sharing agreement. The Company will continue to fund the expansion efforts primarily through providing the necessary workforce to implement the addition of new assets, as well as provide the ongoing necessary support.

External Sources of Liquidity

We received a PPP Loan in the principal amount of $1.4 million.  On May 13, 2021, we were informed that the entire original principal amount of $1.4 million would be forgiven.  

We consider our investment portfolio a source of liquidity as well. As of September 30, 2021, $13.6 million was invested in third party securities.

Capital Resources

Since the execution of the TIA on July 1, 2020, we have begun construction for significant expansion to our facilities.  As of September 30, 2021, we had substantially completed initial construction of expanded facilities consisting of approximately 27,800 square feet of additional controlled environment within existing properties and 55,000 square feet of new warehouse space.  In August 2021, construction began on an additional 12,500 square feet of controlled environment space. As of November 5, 2021, we have negotiated contracts for the purchase of automated assembly equipment, molds, and molding equipment, as well as portions of auxiliary equipment, under the original TIA and the modification for approximately $61.4 million.  To fund the purchase of the automated assembly equipment, auxiliary equipment, and construction of the controlled environment, we are reimbursed by the U.S. government according to the terms in the TIA.  The TIA also allows us to request an advance of funds for larger purchases when necessary.  The expenditures which are not reimbursable from the U.S. government under the TIA are funded with cash from operations.  The capital assets funded by us under the TIA include the construction of the new warehouse as well as certain accessory equipment.

Additionally, we have engaged a construction company and architect to explore the possibility of expanding our existing administrative offices. We currently expect that the cost of expansion will be approximately $5.0 million and will be completed in the first half of 2022.  To date, we have spent approximately $212 thousand.

CRITICAL ACCOUNTING ESTIMATES

We are responsible for developing estimates for amounts reported as assets and liabilities, and revenues and expenses in conformity with U.S. generally accepted accounting principles (“GAAP”). Those estimates require that we develop assumptions of future events based on past experience and expectations of economic factors. Among the more critical estimates management makes is the estimate for customer rebates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related of our sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that we have an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied. We examine the results

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of estimates against actual results historically and use the determination to further develop our basis for assumptions in future periods, as well as the accuracy of past estimates.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

Item 4.    Controls and Procedures.

Disclosure Controls and Procedures

Pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, Management, with the participation of our President, Chairman, and Chief Executive Officer, Thomas J. Shaw (the “CEO”), and our Vice President and Chief Financial Officer, John W. Fort III (the “CFO”), acting in their capacities as our principal executive and principal financial officers, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. The term disclosure controls and procedures means controls and other procedures that are designed to ensure that information required to be disclosed by us in our periodic reports is: i) recorded, processed, summarized, and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms; and ii) accumulated and communicated to our Management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based upon this evaluation, the CEO and CFO concluded that, as of September 30, 2021, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

There have been no changes during the third quarter of 2021 or subsequent to September 30, 2021 in our internal control over financial reporting that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1.    Legal Proceedings.

Please refer to Note 8 to the financial statements for a complete description of all legal proceedings.

Item 1A.    Risk Factors.

There were no material changes in our Risk Factors as set forth in our most recent annual report which is available on EDGAR.

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Item 2.    Unregistered Sales of Equity Securities and Use of Proceeds.

Purchases of Equity Securities by the Issuer and Affiliated Purchasers

Issuer Purchases of Equity Securities

Period	Total Number of Shares (or Units) Purchased(1)	Average Price Paid Per Share (or Unit)	Total Number of Shares (or Units) Purchased as Part of Publicly Announced Plans or Programs	Maximum Number (or Approximate Dollar Value) of Shares (or Units) that May Yet Be Purchased Under the Plans or Programs
June 18, 2021 through June 30, 2021	13,500	$11.44	13,500	$9,845,576
July 1, 2021 through July 31, 2021	70,577	$11.08	70,577	$9,063,332
August 1, 2021 through August 31, 2021	78,947	$11.99	78,947	$8,116,667
September 1, 2021 through September 30, 2021	81,797	$11.69	81,797	$7,160,674
Total	231,321	$11.61	231,321

(1)These shares were purchased pursuant to our Common Stock repurchase plan structured to comply with Rules 10b5-1 and 10b-18 under the Securities Exchange Act of 1934, announced on June 7, 2021.  On June 4, 2021, the Board of Directors authorized the repurchase of up to $10 million of Common Stock subject to Rule 10b-18 limitations as well as certain market value constraints specified in the plan.  Notwithstanding the terms of the plan, the exact dollar amount and number of shares which may be purchased pursuant to the plan is difficult to predict.  The plan will expire on June 18, 2022 at the latest.

Item 3.    Defaults Upon Senior Securities.

Working Capital Restrictions and Limitations on the Payment of Dividends

The certificates of designation for both of the outstanding series of Class B Convertible Preferred Stock each currently provide that, if a dividend upon any shares of Preferred Stock is in arrears, no dividends may be paid or declared upon any stock ranking junior to such stock.  If Series II Class B preferred stock dividends are in arrears, Common Stock may generally not be purchased by the Company.  If Series III Class B preferred stock dividends are in arrears, the Company may generally purchase Common Stock if the funds used to purchase stock do not exceed 25% of the value of the prior period’s cash assets.

For the nine months ended September 30, 2021, the amount of dividends in arrears payable to Series III preferred shareholders was $20,061.

26

Item 6.    Exhibits.

Exhibit No.	Description of Document
31.1	Certification of Principal Executive Officer
31.2	Certification of Principal Financial Officer
32	Certification Pursuant to 18 U.S.C. Section 1350
101	The following materials from Retractable Technologies, Inc.’s Form 10-Q for the quarter ended September 30, 2021, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets as of September 30, 2021 and December 31, 2020, (ii) Condensed Statements of Operations for the three and nine months ended September 30, 2021 and 2020, (iii) Condensed Statements of Cash Flows for the nine months ended September 30, 2021 and 2020, (iv) Condensed Statement of Changes in Stockholders’ Equity for the three and nine months ended September 30, 2021 and 2020; and (v) Notes to Condensed Financial Statements
104	Interactive Data File (formatted Inline XBRL and contained in Exhibit 101)

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

DATE:   November 15, 2021	RETRACTABLE TECHNOLOGIES, INC.
	(Registrant)
	By:	/s/ John W. Fort III
		JOHN W. FORT III VICE PRESIDENT, CHIEF FINANCIAL OFFICER, AND CHIEF ACCOUNTING OFFICER

27

EX-31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER Exhibit 31.1

I, Thomas J. Shaw, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Retractable Technologies, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and

(b) Any fraud, whether or not material, that involves Management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 15, 2021

/s/ Thomas J. Shaw

THOMAS J. SHAW

PRESIDENT, CHAIRMAN, AND

CHIEF EXECUTIVE OFFICER

EX-31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER Exhibit 31.2

I, John W. Fort III, certify that:

1. I have reviewed this quarterly report on Form 10-Q of Retractable Technologies, Inc.;

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations, and cash flows of the registrant as of, and for, the periods presented in this report;

4. The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

(a) Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

(b) Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

(c) Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

(d) Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

5. The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

(a) All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize, and report financial information; and

(b) Any fraud, whether or not material, that involves Management or other employees who have a significant role in the registrant’s internal control over financial reporting.

Date: November 15, 2021

/s/ John W. Fort III

JOHN W. FORT III

VICE PRESIDENT,

CHIEF FINANCIAL OFFICER,

AND CHIEF ACCOUNTING OFFICER

EX-32

Exhibit 32

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Solely in connection with the filing of the Quarterly Report of Retractable Technologies, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2021, as filed with the United States Securities and Exchange Commission on the date hereof (the “Report”), the undersigned Thomas J. Shaw, Chief Executive Officer, and John W. Fort III, Chief Financial Officer, do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

(1)       The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

(2)       The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the issuer.

Date:	November 15, 2021	/s/ Thomas J. Shaw
		THOMAS J. SHAW PRESIDENT, CHAIRMAN, AND CHIEF EXECUTIVE OFFICER
		/s/ John W. Fort III
		JOHN W. FORT III VICE PRESIDENT, CHIEF FINANCIAL OFFICER, AND CHIEF ACCOUNTING OFFICER

XML

Document and Entity Information - shares	9 Months Ended
	Sep. 30, 2021	Nov. 01, 2021
Cover
Document Type	10-Q
Document Quarterly Report	true
Document Transition Report	false
Entity File Number	001-16465
Entity Registrant Name	Retractable Technologies, Inc.
Entity Central Index Key	0000946563
Document Period End Date	Sep. 30, 2021
Entity Address, State or Province	TX
Entity Tax Identification Number	75-2599762
Entity Address, Address Line One	511 Lobo Lane
Entity Address, City or Town	Little Elm
City Area Code	972
Local Phone Number	294-1010
Entity Address, Postal Zip Code	75068-5295
Entity Incorporation, State or Country Code	TX
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Interactive Data Current	Yes
Entity Filer Category	Non-accelerated Filer
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Shell Company	false
Entity Common Stock, Shares Outstanding		33,764,283
Document Fiscal Year Focus	2021
Document Fiscal Period Focus	Q3
Trading Symbol	RVP
Title of 12(b) Security	Common Stock
Security Exchange Name	NYSE

XML

CONDENSED BALANCE SHEETS - USD ($)	Sep. 30, 2021	Dec. 31, 2020
Current assets:
Cash and cash equivalents	$ 16,363,163	$ 17,566,682
Accounts receivable, net	30,040,562	21,131,841
Receivable from Technology Investment Agreement (TIA)	8,764,753	11,779,078
Investments in debt and equity securities, at fair value	13,583,943	8,081,833
Inventories	18,696,764	10,234,646
Other current assets	767,829	684,317
Total current assets	88,217,014	69,478,397
Property, plant, and equipment, net	76,625,980	30,816,504
Deferred tax asset	13,145,274	4,631,206
Other assets	5,675	44,567
Total assets	177,993,943	104,970,674
Current liabilities:
Accounts payable	24,410,852	16,256,444
Current portion of long-term debt	285,519	1,030,763
Accrued compensation	841,290	826,762
Dividends payable	1,399,744	49,091
Accrued royalties to shareholder	2,297,527	1,973,781
Other accrued liabilities	4,422,865	3,398,904
Income taxes payable	2,545,692	4,365,770
Total current liabilities	36,203,489	27,901,515
Other long-term liabilities	60,306,784	24,478,697
Long-term debt, net of current maturities	1,886,271	2,710,337
Total liabilities	98,396,544	55,090,549
Commitments and contingencies - see Note 8
Preferred stock, $1 par value:
Common stock, no par value	0	0
Additional paid-in capital	61,863,653	59,285,401
Retained earnings (accumulated deficit)	20,336,627	(9,668,221)
Common stock in treasury - at cost	(2,839,326)
Total stockholders' equity	79,597,399	49,880,125
Total liabilities and stockholders' equity	177,993,943	104,970,674
Series II, Class B
Preferred stock, $1 par value:
Preferred stock	156,200	156,200
Series III Class B
Preferred stock, $1 par value:
Preferred stock	$ 80,245	$ 106,745

XML

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2021	Dec. 31, 2020
Preferred stock, par value (in dollars per share)	$ 1	$ 1
Common stock, par value (in dollars per share)	$ 0	$ 0
Common Stock, authorized shares	100,000,000	100,000,000
Common Stock, outstanding shares	33,764,283	33,957,204
Preferred Class B
Preferred Stock, Shares Authorized	5,000,000	5,000,000
Series II, Class B
Preferred Stock, outstanding shares	156,200	156,200
Series III Class B
Preferred Stock, outstanding shares	80,245	106,745

XML

CONDENSED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Sales, net	$ 36,356,047	$ 27,091,064	$ 128,926,716	$ 49,867,126
Cost of sales
Cost of sales	22,961,178	13,262,559	67,893,878	28,834,441
Gross profit	13,394,869	13,828,505	61,032,838	21,032,685
Operating expenses:
Sales and marketing	1,020,244	1,160,412	3,398,905	3,148,290
Research and development	199,200	134,575	747,525	399,367
General and administrative	4,209,836	2,185,980	12,824,957	5,696,901
Total operating expenses	5,429,280	3,480,967	16,971,387	9,244,558
Income from operations	7,965,589	10,347,538	44,061,451	11,788,127
Gain on forgiveness of PPP loan			1,377,652
Interest and other income (loss)	(318,663)	(87,483)	1,014,348	881,316
Interest expense	(52,886)	(36,124)	(172,668)	(105,959)
Income before income taxes	7,594,040	10,223,931	46,280,783	12,563,484
Provision (benefit) for income taxes	1,072,155	1,598,180	11,140,889	(151,153)
Net income	6,521,885	8,625,751	35,139,894	12,714,637
Preferred Stock dividend requirements	(59,111)	(145,535)	(183,219)	(493,826)
Deemed contribution on extinguishment of preferred stock		2,525,848		2,519,124
Income applicable to common shareholders	$ 6,462,774	$ 11,006,064	$ 34,956,675	$ 14,739,935
Basic earnings per share	$ 0.19	$ 0.33	$ 1.03	$ 0.45
Diluted earnings per share	$ 0.19	$ 0.33	$ 1.02	$ 0.45
Weighted average common shares outstanding:
Basic (in shares)	33,883,684	33,371,471	33,950,742	32,947,241
Diluted (in shares)	34,262,681	33,984,934	34,330,967	33,071,652
Costs of manufactured product
Cost of sales
Cost of sales	$ 20,663,651	$ 11,580,674	$ 60,074,349	$ 25,331,916
Royalty expense to shareholder
Cost of sales
Cost of sales	$ 2,297,527	$ 1,681,885	$ 7,819,529	$ 3,502,525

XML

CONDENSED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020
Cash flows from operating activities
Net income	$ 35,139,894	$ 12,714,637
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation and amortization	702,384	624,998
Net unrealized gain on investments	(816,150)	(559,543)
Realized gains on investments		(162,595)
Accreted interest	83,282
Deferred taxes	(8,514,068)	(804,357)
Provision for doubtful accounts	146,395	125,000
Share-based compensation	2,503,152
Gain on forgiveness of PPP loan	(1,377,652)
(Increase) decrease in operating assets:
Accounts receivable	(9,055,116)	(7,542,375)
Inventories	(8,462,118)	(301,951)
Other current assets	(83,512)	(18,053)
Other assets	38,892	10,125
Increase (decrease) in operating liabilities:
Accounts payable	8,154,409	2,272,302
Accrued liabilities	1,490,008	1,803,433
Income taxes payable	(1,820,078)	670,531
Net cash provided by operating activities	18,129,722	8,832,152
Cash flows from investing activities
Purchase of property, plant, and equipment	(46,511,859)	(9,478,182)
Purchase of debt and equity securities	(4,685,960)	(2,174,980)
Proceeds from the sales of debt and equity securities		3,965,329
Net cash used by investing activities	(51,197,819)	(7,687,833)
Cash flows from financing activities
Repayments of long-term debt	(206,310)	(194,985)
Proceeds of long-term debt		1,363,000
Proceeds from Technology Investment Agreement (TIA)	39,848,368	6,883,103
Proceeds from the exercise of stock options	48,600	851,012
Payment of preferred stock redemption price payable	(101,250)
Payment of preferred stock repurchase payable	(1,101,110)	(100,000)
Payment of preferred stock dividends	(3,784,394)	(164,400)
Repurchase of common stock	(2,839,326)
Net cash provided by financing activities	31,864,578	8,637,730
Net increase (decrease) in cash and cash equivalents	(1,203,519)	9,782,049
Cash and cash equivalents at:
Beginning of period	17,566,682	5,934,749
End of period	16,363,163	15,716,798
Supplemental schedule of cash flow information:
Interest paid	89,386	105,959
Income taxes paid	21,068,540
Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	1,399,744	52,242
Conversion of preferred stock to common stock	26,500	15,000
Amounts receivable under Technology Investment Agreement	$ (3,014,325)
Preferred stock repurchase payable		$ 2,723,248

XML

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)	Preferred Stock Series I, Class B	Preferred Stock Series II, Class B	Preferred Stock Series III Class B	Preferred Stock Series IV Preferred Stock	Preferred Stock Series V Preferred Stock	Additional Paid-in Capital	Retained Earnings/Accumulated Deficit	Treasury Stock	Total
Balance at Dec. 31, 2019	$ 96,000	$ 171,200	$ 129,245	$ 342,500	$ 34,000	$ 61,660,744	$ (33,891,234)		$ 28,542,455
Increase (Decrease) in Stockholders' Equity
Exchange of Preferred Stock for Common Stock			(2,500)	(307,500)		(2,513,248)			(2,823,248)
Conversion of Preferred Stock into Common Stock		(15,000)				15,000
Stock Option Exercises						851,012			851,012
Dividends						(161,842)			(161,842)
Net income							12,714,637		12,714,637
Balance at Sep. 30, 2020	96,000	156,200	126,745	35,000	34,000	59,851,666	(21,176,597)		39,123,014
Balance at Jun. 30, 2020	96,000	171,200	126,745	335,000	34,000	62,087,831	(29,802,348)		33,048,428
Increase (Decrease) in Stockholders' Equity
Exchange of Preferred Stock for Common Stock				(300,000)		(2,423,248)			(2,723,248)
Conversion of Preferred Stock into Common Stock		(15,000)				15,000
Stock Option Exercises						224,325			224,325
Dividends						(52,242)			(52,242)
Net income							8,625,751		8,625,751
Balance at Sep. 30, 2020	$ 96,000	156,200	126,745	$ 35,000	$ 34,000	59,851,666	(21,176,597)		39,123,014
Balance at Dec. 31, 2020		156,200	106,745			59,285,401	(9,668,221)		49,880,125
Increase (Decrease) in Stockholders' Equity
Conversion of Preferred Stock into Common Stock			(26,500)			26,500
Stock Option Exercises						48,600			48,600
Dividends							(5,135,046)		(5,135,046)
Stock option compensation						2,503,152			2,503,152
Repurchase of Common Stock								$ (2,839,326)	(2,839,326)
Net income							35,139,894		35,139,894
Balance at Sep. 30, 2021		156,200	80,245			61,863,653	20,336,627	(2,839,326)	79,597,399
Balance at Jun. 30, 2021		156,200	80,245			60,706,417	13,853,792	(154,424)	74,642,230
Increase (Decrease) in Stockholders' Equity
Dividends							(39,050)		(39,050)
Stock option compensation						1,157,236			1,157,236
Repurchase of Common Stock								(2,684,902)	(2,684,902)
Net income							6,521,885		6,521,885
Balance at Sep. 30, 2021		$ 156,200	$ 80,245			$ 61,863,653	$ 20,336,627	$ (2,839,326)	$ 79,597,399

XML

BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

9 Months Ended

Sep. 30, 2021

BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

1.    BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

Business of the Company

Retractable Technologies, Inc. (the “Company”) was incorporated in Texas on May 9, 1994, and designs, develops, manufactures, and markets safety syringes and other safety medical products for the healthcare profession.  The Company began to develop its manufacturing operations in 1995.  The Company’s manufacturing and administrative facilities are located in Little Elm, Texas.  The Company’s products are the VanishPoint^® 0.5mL insulin syringe; 1mL tuberculin, insulin, and allergy antigen syringes; 0.5mL, 1mL, 2mL, 3mL, 5mL, and 10mL syringes; the blood collection tube holder; the small diameter tube adapter; the allergy tray; the IV safety catheter; the Patient Safe^® syringes; the Patient Safe^® Luer Cap; the VanishPoint^® Blood Collection Set; and the EasyPoint^® needle as well as a standard 3mL syringe packaged with an EasyPoint^® needle. The Company also sells VanishPoint^® autodisable syringes in the international market in addition to the Company’s other products.

Basis of presentation

The accompanying condensed financial statements are unaudited and, in the opinion of Management, reflect all adjustments that are necessary for a fair presentation of the financial position and results of operations for the periods presented.  All such adjustments are of a normal and recurring nature.  The results of operations for the periods presented are not necessarily indicative of the results to be expected for the entire year.  The unaudited condensed financial statements should be read in conjunction with the financial statement disclosures contained in the Company’s audited financial statements incorporated into its Form 10-K filed on March 31, 2021 for the year ended December 31, 2020.  Certain amounts in the prior period Condensed Balance Sheets have been reclassified to conform to the presentation of the current period financial statements. These reclassifications had no effect on the previously reported total current assets or total assets.

XML

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2.     SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ significantly from those estimates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related to sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that the Company has an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied.

Cash and cash equivalents

For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with original maturities of three months or less.

Accounts receivable

The Company records trade receivables when revenue is recognized.  No product has been consigned to customers.  The Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables.  

Those accounts that are doubtful of collection are included in the allowance.  This provision is reviewed to determine the adequacy of the allowance for doubtful accounts. Trade receivables are charged off when there is certainty as to their being uncollectible. Trade receivables are considered delinquent when payment has not been made within contract terms. The Allowance for bad debt was $352,217 and $205,822 as of September 30, 2021 and December 31, 2020, respectively.

The Company requires certain customers to make a prepayment prior to beginning production or shipment of their order.  Customers may apply such prepayments to their outstanding invoices or pay the invoice and continue to carry forward the deposit for future orders.  Such amounts are included in Other accrued liabilities on the Condensed Balance Sheets and are shown in Note 6, Other Accrued Liabilities.

The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales.  Historically, returns have been insignificant.

Receivable from Technology Investment Agreement (TIA)

The amounts set forth as Receivable from Technology Investment Agreement (TIA) represent amounts receivable under a contractual agreement under the TIA. The amounts may represent advance requests or reimbursement requests for expenditures the Company makes or has made under its obligations with the federal government. For further explanation, please refer to Note 15 – Technology Investment Agreement.

Inventories

Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost.  The Company compares the average cost to the net realizable value and records the lower value.  Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.  Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, the shelf life of inventory, and current market conditions when determining excess or obsolete inventories. Once inventory items are deemed to be either excess or obsolete, they are excluded from the stated net realizable value.

Investments in debt and equity securities

The Company holds high-grade exchange-traded and closed-end funds (ETFs), mutual funds, equity securities, and debt securities as investments.  These assets are readily marketable and are carried at fair value as of the date of the Condensed  Balance Sheets. Net unrealized and realized gains or losses on investments in debt and equity securities are reflected as a component of Interest and other income (loss). Realized gains or losses on investments in debt and equity securities are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment are stated at cost. Expenditures for maintenance and repairs are charged to operations as incurred.  Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity and interest cost associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

The Company's property, plant, and equipment primarily consist of buildings, land, assembly equipment, molding machines, molds, office equipment, furniture, and fixtures.  Depreciation and amortization are calculated using the straight-line method over the following useful lives:

Production equipment	3 to 13 years
Office furniture and equipment	3 to 10 years
Buildings	39 years
Building improvements	15 years

Long-lived assets

The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash flows related to such assets.  In the event that assets are found to be carried at amounts which are in excess of estimated gross future cash flows, the assets will be adjusted for impairment to a level commensurate with fair value determined using a discounted cash flow analysis or appraised values of the underlying assets.

Fair value measurements

For assets and liabilities that are measured using quoted prices in active markets, total fair value is the published market price per unit multiplied by the number of units held without consideration of transaction costs. Assets and liabilities that are measured using significant other observable inputs are valued by reference to similar assets or liabilities, adjusted for contract restrictions and other terms specific to that asset or liability.  For these items, a significant portion of fair value is derived by reference to quoted prices of similar assets or liabilities in active markets.  For all remaining assets and liabilities, fair value is derived using a fair value model, such as a discounted cash flow model or Black-Scholes model.

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information.  Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values.  Investments in equity securities consist primarily of individual equity securities, exchange-traded and closed-end funds and mutual funds and are reported at their fair value based upon quoted prices in active markets.  Investments in certificates of deposit (CD) with original maturities of greater than three months are reported at their estimated fair value based upon the duration of the CD and the interest rate earned on the CD versus current interest rates of similar duration CDs. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in debt and equity securities through consultation with its outside investment advisors. Management is responsible for directing investment activity based on current economic conditions. The majority of accounts receivable are due from companies which are well-established entities. In the third quarter of 2021, a significant portion of the Company’s sales were to the U.S. government, which Management does not consider a credit risk. As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects significant customers for the three- and nine-month periods of 2021 and 2020:

	Three Months Ended			Three Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2021			September 30, 2020			September 30, 2021			September 30, 2020
Number of significant customers		2			2			1			2
Aggregate dollar amount of net sales to significant customers	$	22.6	million	$	16.4	million	$	83.6	million	$	21.7	million
Percentage of net sales to significant customers		62.1%			60.6%			64.8%			43.6%

In the first nine months of 2021, approximately $83.6 million of the Company's sales were to the Department of Health and Human Services of the United States. Management expects the U.S. government to remain a significant customer through at least March 2022.

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 90.9% and 82.2% of its products in the first nine months of 2021 and 2020, respectively, from its Chinese manufacturers. Purchases from Chinese manufacturers aggregated 91.9% and 80.5% of products in the three-month periods ended September 30, 2021 and 2020, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company would need to find an alternate manufacturer for its blood collection set, IV catheter, Patient Safe^® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and would increase domestic production for the 1mL and 3mL syringes and EasyPoint^® needles.

Revenue recognition

The Company recognizes revenue when it has satisfied all performance obligations to the customer, generally when title and risk of loss pass to the customer.  Payments from customers with approved credit terms are typically due 30 days from the invoice date. Under certain contracts, revenue is recorded on the basis of sales price to distributors, less contractual pricing allowances. Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among other things, the facility that purchased the products, and (ii) a provision for estimated contractual pricing allowances for products for which the Company has not received tracking reports.  When rebates are issued, they are applied against the customer’s receivable balance.  Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by a distributor to an entity that has no contract, there is a standard rebate (lower than a contracted rebate) given to the distributor.  One of the purposes of the rebate is to encourage distributors to submit tracking reports to the Company. The provision for contractual pricing allowances is recognized in the period the related sales are recognized and is reviewed at the end of each quarter and adjusted for changes in levels of products for which there is no tracking report.  Additionally, if it becomes clear that tracking reports will not be provided by individual distributors, the provision is further adjusted.  The estimated contractual allowance is included in Accounts payable in the Condensed Balance Sheets and deducted from Revenues in the Condensed Statements of Operations.  Accounts payable included estimated contractual allowances for $5,304,885 and $3,435,352 as of September 30, 2021 and December 31, 2020, respectively.  The terms and conditions of contractual pricing allowances are governed by contracts between the Company and its distributors. Revenue for shipments directly to end-users is recognized when title and risk of ownership pass from the Company.  End-users do not receive any contractual allowances on their purchases.  Any product shipped or distributed for evaluation purposes is expensed.

The Company provides product warranties that: i) the products are fit for medical use as generally defined within the boundaries of United States FDA approval; ii) the products are not defective; and iii) the products will conform to the descriptions set forth in their respective labeling, provided that they are used in accordance with such labeling and the Company’s written directions for use.  The Company has historically not incurred significant warranty claims.

The Company’s domestic return policy provides that a customer may return incorrect shipments within 10 days following arrival at the distributor’s facility.  In all such cases, the distributor must obtain an authorization code from the Company and affix the code to the returned product.  The Company’s domestic return policy also generally provides that a customer may return product that is overstocked.  Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for the prior 12-month period.  All product overstocks and returns are subject to inspection and acceptance by the Company.

The Company’s international distribution agreements generally do not provide for any returns.

The Company requires certain customers to pay in advance of product shipment.  Such prepayments from customers are recorded in Other accrued liabilities and are generally recognized as revenue upon shipment of the product.

The Company periodically recognizes revenue from licensing agreements. If the Company licenses its products for sale, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, a certain percentage of such revenue pursuant to the terms of the Technology License Agreement between the Company and Mr. Shaw.

Disaggregated information of revenue recognized from contracts with customers and licensing fees recognized are as follows:

	For the three months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	11,033,291	$	560,065	$	4,048,292	$	11,399	$	15,653,047
Sales to U.S. government		18,420,480		—		—		—		18,420,480
North and South America sales (excluding U.S.)		670,602		4,800		26,400		—		701,802
Other international sales		1,389,226		900		189,992		600		1,580,718
Total	$	31,513,599	$	565,765	$	4,264,684	$	11,999	$	36,356,047

	For the three months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	8,241,161	$	791,961	$	3,581,723	$	9,210	$	12,624,055
Sales to U.S. government		12,898,080		—		—		—		12,898,080
North and South America sales (excluding U.S.)		1,295,080		450		—		—		1,295,530
Other international sales		198,440		73,019		235		1,705		273,399
Total	$	22,632,761	$	865,430	$	3,581,958	$	10,915	$	27,091,064

	For the nine months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	30,685,338	$	1,590,891	$	7,019,560	$	40,345	$	39,336,134
Sales to U.S. government		83,560,680		—		—		—		83,560,680
North and South America sales (excluding U.S.)		2,963,930		4,800		83,248		109,440		3,161,418
Other international sales		2,161,062		63,540		640,432		3,450		2,868,484
Total	$	119,371,010	$	1,659,231	$	7,743,240	$	153,235	$	128,926,716

	For the nine months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	21,538,941		1,607,804		6,004,295		52,065	$	29,203,105
Sales to U.S. government		14,065,623		—		—		—		14,065,623
North and South America sales (excluding U.S.)		4,911,106		8,450		1,496		1,064,768		5,985,820
Other international sales		529,430		76,609		235		6,304		612,578
Total	$	41,045,100	$	1,692,863	$	6,006,026	$	1,123,137	$	49,867,126

Income taxes

The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements based on whether it is “more-likely-than-not” that a tax position will be sustained based upon the technical merits of the position.  Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.  

The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on enacted rates expected to be in effect when such differences reverse in future periods.  Deferred tax assets are periodically reviewed for realizability.  In prior periods, the Company established a valuation allowance for its net deferred tax asset as future taxable income which could not be reasonably assured.  During the quarter ended June 30, 2020, the Company released its valuation allowance based on available evidence supporting that its deferred tax assets will be realized in full.

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

For the three and nine months ended September 30, 2021, the calculation of diluted EPS under the treasury stock method included 142,552 and 143,780 shares, respectively, of Common Stock underlying issued and outstanding stock options. Common stock issuable upon the conversion of 236,445 convertible preferred shares is included in the calculation of diluted EPS for both the three and nine months ended September 30, 2021.

The calculation of diluted EPS under the treasury stock method included 226,150 shares of Common Stock underlying issued and outstanding stock options for both the three and nine months ended September 30, 2020, respectively. For these same periods, preferred stock was excluded from the calculation of diluted EPS because the effect was antidilutive.

The potential dilution, if any, is shown on the following schedule:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Net income	$	6,521,885	$	8,625,751	$	35,139,894	$	12,714,637
Preferred stock dividend requirements		(59,111)		(145,535)		(183,219)		(493,826)
Deemed contribution on extinguishment of preferred stock		—		2,525,848		—		2,519,124
Income applicable to common shareholders	$	6,462,774	$	11,006,064	$	34,956,675	$	14,739,935
Average common shares outstanding		33,883,684		33,371,471		33,950,742		32,947,241
Average common and common equivalent shares outstanding — assuming dilution		34,262,681		33,984,934		34,330,967		33,071,652
Basic earnings per share	$	0.19	$	0.33	$	1.03	$	0.45
Diluted earnings per share	$	0.19	$	0.33	$	1.02	$	0.45

Shipping and handling costs

The Company classifies shipping and handling costs as part of Cost of sales in the Condensed Statements of Operations.

Share-based Compensation

The Company’s share-based payments are accounted for using the fair value method.  The Company records share-based compensation expense on a straight-line basis over the requisite service period.  The Company incurred the following share-based compensation costs:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Cost of Sales	$	—	$	—	$	—	$	—
Sales and Marketing		—		—		—		—
Research and development		—		—		—		—
General and administrative		1,157,236		—		2,503,152		—
	$	1,157,236	$	—	$	2,503,152	$	—

Research and development costs

Research and development costs are expensed as incurred.

Leases

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in Other assets, Other accrued liabilities, and Other long-term liabilities on the Condensed Balance Sheets. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.  Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.  As the Company’s leases do not provide an implicit rate, the incremental borrowing rate based on information available at the commencement date was used in determining the present value of lease payments.

The operating lease ROU asset also includes any lease payments made and excludes lease incentives.  Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.  Lease expense for lease payments is recognized on a straight-line basis over the lease term.  Leases with an initial term of twelve months or less are not recorded on the Condensed Balance Sheets; however, rent expense is recognized on a straight-line basis over the lease term.

Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in Government funding for expanding the Company’s domestic production of needles and syringes. Pursuant to the terms of the TIA, the Company is expected to make significant additions to its facilities which should allow the Company to increase domestic production. As reimbursements are received from the U.S. government for such expenditures, the Company records a deferred liability. The deferred liability will be systematically amortized as a gain over the life of the related property, plant, and equipment as to offset the related depreciation expense of the assets acquired. The amortization will be presented separately from the depreciation expense on the Condensed Statements of Operations.

Recently Adopted Pronouncements

The Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments on January 1, 2020.  Among other things, these amendments require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts.  Many of the loss estimation techniques applied previously will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  The adoption of ASU 2016-13, as well as the Targeted Transition Relief as provided by ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326) – Targeted Transition Relief” did not have a significant impact on the Company’s financial statements.

The Company adopted ASU 2018-15, “Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):  Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract (a Consensus of the FASB Emerging Issues Task Force)" on January 1, 2020.  This amendment requires that implemented costs incurred in a hosting arrangement that is a service contract should be accounted for in accordance with ASC 350-40  Internal-Use Software.  Accordingly, costs incurred during the preliminary project and post-implementation stages are expensed and costs associated with the application development phase are capitalized.  The amendment also requires that capitalized costs be amortized over the term of the hosting arrangement and that capitalized costs should be evaluated for impairment. The adoption of this ASU did not have a significant impact on the Company's financial statements or disclosures.

In August 2018, the FASB issued ASU 2018-13 "Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement." The amendment modifies, among other things, disclosure requirements on fair value measurements and eliminates certain disclosures related to transfers and valuation levels of Level 3 fair value measurements. Additionally, the amendment requires disclosure of changes in unrealized gains and losses in other comprehensive income for Level 3 fair value measurements and certain qualitative factors related to significant unobservable inputs used in Level 3 valuations. The amendment was effective for annual periods beginning after December 15, 2019 and interim periods within the annual period. The adoption of ASU 2018-13 did not have a significant effect on the Company's financial statements, as the Company does not currently have any investments classified as Level 3 fair value measurements.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”.  The new standard is intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.  The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.  The standard is effective for annual periods beginning after December 15, 2020 and interim periods within the annual period, with early adoption permitted.  Adoption of the standard requires certain changes primarily be made prospectively, with some changes to be made retrospectively.  

The Company has determined that the adoption of ASU 2019-12 did not have a material impact on its financial statements.

Recently Issued Pronouncement

In March 2020, the FASB issued ASU No. 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting”, to ease the potential burden in accounting for reference rate reform.  The new guidance provides optional expedients for contracts that reference LIBOR, if certain criteria are met, that can be applied through December 31, 2022.  As reference rate reform is still an ongoing process, the Company will continue to evaluate the timing and potential impact of adoption for optional expedients when deemed necessary.

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INVENTORIES

9 Months Ended

Sep. 30, 2021

INVENTORIES

INVENTORIES

3.    INVENTORIES

Inventories consist of the following:

	September 30, 2021		December 31, 2020
Raw materials	$	2,370,760	$	1,320,214
Finished goods		16,326,004		8,914,432
	$	18,696,764	$	10,234,646

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FAIR VALUE OF FINANCIAL INSTRUMENTS

9 Months Ended

Sep. 30, 2021

FAIR VALUE OF FINANCIAL INSTRUMENTS

FAIR VALUE OF FINANCIAL INSTRUMENTS

4.    FAIR VALUE OF FINANCIAL INSTRUMENTS

ASC 820, “Fair Value Measurements”, defines fair value, establishes a framework for measuring fair value and requires additional disclosures regarding certain fair value measurements.  ASC 820 establishes a three-tier hierarchy for measuring fair value, as follows:

● Level 1 – quoted market prices in active markets for identical assets and liabilities

● Level 2 – inputs other than quoted prices that are directly or indirectly observable

● Level 3 – unobservable inputs where there is little or no market activity

The following tables summarize the values of assets designated as Investments in debt and equity securities:

	September 30, 2021
	Level 1		Level 2		Level 3		Total
Equity securities	$	9,357,931	$	—	$	—	$	9,357,931
Mutual funds and exchange traded funds		4,150,405		—		—		4,150,405
Certificates of deposit		—		75,607		—		75,607
	$	13,508,336	$	75,607	$	—	$	13,583,943

	December 31, 2020
	Level 1		Level 2		Level 3		Total
Equity securities	$	3,990,533	$	—	$	—	$	3,990,533
Mutual funds and exchange traded funds		4,013,956		—		—		4,013,956
Certificates of deposit		—		77,344		—		77,344
	$	8,004,489	$	77,344	$	—	$	8,081,833

The Company holds high-grade ETFs, mutual funds, individual equity stocks, and debt securities as investments.  These assets are readily marketable and are carried at fair value as of the date of the Condensed Balance Sheets. The Company intends to hold these assets for possible future operating requirements. The following table summarizes gross unrealized gains and losses from Investments in debt and equity securities:

	September 30, 2021
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	6,698,032	$	2,659,899	$	—	$	9,357,931
Mutual funds and exchange traded funds		3,994,001		156,404		—		4,150,405
Certificates of deposit		75,000		607		—		75,607
	$	10,767,033	$	2,816,910	$	—	$	13,583,943

	December 31, 2020
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	2,098,144	$	1,892,389	$	—	$	3,990,533
Mutual funds and exchange traded funds		3,909,364		104,592		—		4,013,956
Certificates of deposit		75,000		2,344		—		77,344
	$	6,082,508	$	1,999,325	$	—	$	8,081,833

Unrealized gains on investments in debt and equity securities were $816,150 and $559,543 for the nine months ended September 30, 2021 and 2020, respectively.

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INCOME TAXES

9 Months Ended

Sep. 30, 2021

INCOME TAXES

INCOME TAXES

5.    INCOME TAXES

The Company’s effective tax rate on the net income before income taxes was 14.1% and 24.1% for the three and nine months ended September 30, 2021, respectively.  The Company’s effective tax rate on the net income before income taxes was 15.6% and (1.2)% for the three and nine months ended September 30, 2020, respectively.

A reconciliation of the federal statutory corporate tax rate to the Company’s effective tax rate is as follows:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. statutory federal tax rate	21.0	%	21.0	%	21.0	%	21.0	%
Valuation Allowance	—	%	(8.8)	%	—	%	(24.8)	%
Stock options	0.1	%	—	%	(0.1)	%	—	%
Other	(12.4)	%	0.6	%	(1.8)	%	0.1	%
PPP loan	—	%	—	%	(0.8)	%	—	%
State taxes	5.4	%	2.8	%	5.8	%	2.5	%
Effective tax rate	14.1	%	15.6	%	24.1	%	(1.2)	%

The Company uses the recognition and measurement provisions of the FASB ASC Topic 740, Income Taxes (“Topic 740”), to account for income taxes. The provisions of Topic 740 require a company to record a valuation allowance when the “more likely than not” criterion for realizing net deferred tax assets cannot be met. Furthermore, the weight given to the potential effect of such evidence should be commensurate with the extent to which it can be objectively verified. As a result, the Company reviewed the operating results, as well as all of the positive and negative evidence related to realization of such deferred tax assets to evaluate the need for a valuation allowance at September 30, 2021 and 2020.

The effective tax rate for the nine months ended September 30, 2021 was different from the federal statutory rate due primarily to the apportionment of earnings across various state jurisdictions. The Company determined that no valuation allowance should be recorded at September 30, 2021.

The effective tax rate for the nine months ended September 30, 2020 was different from the federal statutory rate due primarily to the release of the valuation allowance recorded on net operating losses in earlier periods.

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OTHER ACCRUED LIABILITIES

9 Months Ended

Sep. 30, 2021

OTHER ACCRUED LIABILITIES

OTHER ACCRUED LIABILITIES

6.    OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

	September 30, 2021		December 31, 2020
Prepayments from customers	$	2,609,684	$	1,686,868
Accrued property taxes		338,540		—
Accrued professional fees		228,204		331,204
Current portion – preferred stock repurchase		1,084,795		1,092,282
Other accrued expenses		161,642		288,550
Total	$	4,422,865	$	3,398,904

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OTHER LONG-TERM LIABILITIES

9 Months Ended

Sep. 30, 2021

OTHER LONG-TERM LIABILITIES

OTHER LONG-TERM LIABILITIES

7.    OTHER LONG-TERM LIABILITIES

Other long-term liabilities consists of the following:

	September 30, 2021		December 31, 2020
Technology Investment Agreement (TIA)	$	59,278,368	$	22,444,324
Stock repurchase		1,028,416		2,034,373
Total	$	60,306,784	$	24,478,697

The TIA provides for reimbursement to the Company for the purchase of equipment and supplies related to the expansion of the Company’s domestic production of needles and syringes.  Under the TIA, reimbursable amounts will be reflected as a liability until the time its deferred income can be systematically amortized over a period matching the useful life of the purchased assets.

The stock repurchase liability represents the long-term portion, at net present value, of $2,107,212 gross payable by the Company to former preferred shareholders as a result of private stock purchases in 2020 of 320,333 shares of Class B Series IV preferred stock and 25,000 shares of Class B Series V preferred stock.  The purchase price is payable in three annual installments of $1,101,110.

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COMMITMENTS AND CONTINGENCIES

9 Months Ended

Sep. 30, 2021

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

8.    COMMITMENTS AND CONTINGENCIES

On November 7, 2019, the Company filed a lawsuit in the 44^th District Court of Dallas County, Texas (No. DC-19-17946) against Locke Lord, LLP and Roy Hardin in connection with their legal representation of the Company in its previous litigation against Becton, Dickinson and Company ("BD"). The Company alleges that the defendants breached their fiduciary duties, committed malpractice, and were negligent in their representation of the Company. The Company seeks actual and exemplary damages, disgorgement, costs, and interest. On October 6, 2020, the Court dismissed Locke Lord, LLP and Mr. Hardin’s motion to dismiss.  Such order was affirmed on April 20, 2021 by the Court of Appeals, Fifth District of Texas at Dallas.

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BUSINESS SEGMENT

9 Months Ended

Sep. 30, 2021

BUSINESS SEGMENT

BUSINESS SEGMENT

9.    BUSINESS SEGMENT

The Company does not operate in separate reportable segments. Shipments to international customers generally require a prepayment either by wire transfer or an irrevocable confirmed letter of credit.  The Company does extend credit to international customers on some occasions depending upon certain criteria, including, but not limited to, the credit worthiness of the customer, the stability of the country, banking restrictions, and the size of the order.  All transactions are in U.S. currency.

Revenues by geography are as follows:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. sales (excluding U.S. government)	$	15,653,047	$	12,624,055	$	39,336,134	$	29,203,105
Sales to U.S. government		18,420,480		12,898,080		83,560,680		14,065,623
North and South America sales (excluding U.S.)		701,802		1,295,530		3,161,418		5,985,820
Other international sales		1,580,718		273,399		2,868,484		612,578
Total sales	$	36,356,047	$	27,091,064	$	128,926,716	$	49,867,126

Long-lived assets by geography are as follows:

	September 30, 2021		December 31, 2020
Long-lived assets
U.S.	$	72,822,361	$	30,751,259
International		3,803,619		65,245
Total	$	76,625,980	$	30,816,504

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DIVIDENDS

9 Months Ended

Sep. 30, 2021

DIVIDENDS

DIVIDENDS

10.  DIVIDENDS

The Board declared and the Company paid cash dividends  to Series I and Series II Class B Preferred Shareholders within one month of the end of each quarter in 2020. Cumulatively, dividend payments of $48,000, and $168,642 were made to Series I and Series II preferred shareholders, respectively, in 2020 and one payment of $10,041, and $39,050 was made to Series I and Series II preferred shareholders, respectively, in January 2021. A cash dividend of $39,050 was paid in April 2021 to Series II preferred shareholders.

In June 2021, the Board of Directors approved payments to its Series II, Series III, and former Series IV and Series V Class B Preferred Shareholders in the cumulative amount of $5,056,945 representing all current dividends, dividends in arrears, as well as dividends still owed to shareholders who converted their preferred stock in the past.  Of this amount, $39,050 was declared to Series II Class B Convertible Preferred shareholders, representing a dividend amount of $0.25 per share and cover amounts in arrears from April 1, 2021 though the date of conversion or June 30, 2021, whichever is applicable.  To Series III Class B Convertible Preferred shareholders, $4,086,704 was declared, representing a dividend amount of $1.00 per share per year and cover amounts in arrears from the date of purchase though the date of conversion or June 30, 2021, whichever is applicable.  To former Series IV Class B Convertible Preferred shareholders, $101,475 was declared, representing a dividend amount of $1.00 per share per year and cover amounts in arrears from the date of purchase though the date of conversion.  To former Series V Class B Convertible Preferred shareholders, $829,716 was declared, representing a dividend amount of $0.32 per share per year and cover amounts in arrears from the date of purchase though the date of conversion.  The dividends were paid on July 22, 2021 to all shareholders who had been contacted and confirmed as the rightful owner entitled to payment. The Company has not yet established contact with all former shareholders, most of whom converted their shares prior to 2001. As of November 5, 2021, the Company is continuing its efforts to establish contact with approximately 90 former shareholders who are entitled to approximately $1.4 million.

 A cash dividend of $39,050 was paid in October 2021 to Series II preferred shareholders.

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LEASES

9 Months Ended

Sep. 30, 2021

LEASES

LEASES

11.  LEASES

The Company has no finance leases and its operating leases for a warehouse and equipment terminated on August 15, 2021. The ROU asset value was determined based on the lease liability adjusted for lease incentives received. Lease expense has been recognized on a straight-line basis over the lease term. Certain costs incidental to the use of the property were separate from the minimum rent payment and were not considered in the determination of the lease liability and ROU asset. The Company elected the policy to not separate lease from non-lease components if they are

combined with the minimum rent payment. The option periods were not included in the determination of the lease liability and right-of-use asset.

The operating lease cost component of the lease expense was $38,892 for the nine-month period ended September 30, 2021. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $38,892 for the nine months ended September 30, 2021. The operating lease cost component of the lease expense was $69,689 for the nine-month period ended September 30, 2020. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $69,689 for the nine months ended September 30, 2020.

Assets and liabilities associated with these leases included in the Condensed Balance Sheets are as follows:

	September 30, 2021		December 31, 2020
OPERATING LEASES
Other assets	$	—	$	38,892
Other accrued liabilities	$	—	$	38,892
Other long-term liabilities		—		—
Total operating lease liabilities	$	—	$	38,892

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EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK

9 Months Ended

Sep. 30, 2021

EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK

EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK

12.  EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK

In 2020, the Company entered into several agreements with shareholders to purchase its outstanding Class B Convertible Preferred Stock.  The consideration for these purchases consisted of both cash and Common Stock.  In addition, in each such transaction, the preferred shareholder counterparty waived all rights to unpaid dividends in arrears.  The aggregate cash consideration equaled $3,786,000, of which $482,670 was paid in 2020. The balance is payable over a three-year period which began in February 2021.  In February 2021, the Company paid the first of three equal installments of $1,101,110.

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STOCK OPTIONS

9 Months Ended

Sep. 30, 2021

STOCK OPTIONS

STOCK OPTIONS

13.  STOCK OPTIONS

Stock options were exercised by the Company’s employees and directors at various dates during the nine months ended September 30, 2021, and, consequently, a total of 25,400 shares of Common Stock were issued for an aggregate payment to the Company of $48,600 to exercise such options.

On March 16, 2021, the Company’s Board of Directors approved the 2021 Stock Option Plan (the “Plan”) and set aside and reserved 2,000,000 shares of Common Stock for issuance pursuant to the Plan. The Plan was approved by the Company’s shareholders at the May 11, 2021 shareholder meeting. The Plan provides for the granting of incentive stock options and non-qualified stock options at a price equal to at least 100% of the fair market value of the Company’s Common Stock as of the date of grant. Participants in the Plan may include employees, consultants, and non-employee Directors. On March 16, 2021, the Company’s Compensation and Benefits Committee approved option grants to purchase 1,000,000, 250,000, and 100,000 shares of Common Stock to the Company’s chief executive officer, general counsel, and chief financial officer, respectively. These shares will vest in their entirety three years from the grant date and have an exercise price of $13.00 per share.  The value of an option for the purchase of each underlying share of Common Stock is $10.21 using the Black-Scholes option pricing model with a risk-free rate of 1.20% and a volatility factor of 92.66%.

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PAYCHECK PROTECTION PROGRAM

9 Months Ended

Sep. 30, 2021

Paycheck Protection Program

Paycheck Protection Program

14. PAYCHECK PROTECTION PROGRAM LOAN

On April 17, 2020, the Company entered into a promissory note in the principal amount of $1,363,000 (the “PPP Loan”) in favor of Independent Bank pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), administered by the U.S. Small Business Administration (“SBA”). The PPP Loan’s original maturity date was April 17, 2022 with an interest rate of 1.0% per annum. The PPP Loan had a prepayment option with no prepayment penalties. The PPP Loan was unsecured and was a non-recourse obligation.

On May 13, 2021, the Company was informed that the SBA granted its request for loan forgiveness for the entire original principal and accrued interest, for a total of $1,377,652. No payments were made prior to receiving forgiveness.

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TECHNOLOGY INVESTMENT AGREEMENT

9 Months Ended

Sep. 30, 2021

TECHNOLOGY INVESTMENT AGREEMENT

TECHNOLOGY INVESTMENT AGREEMENT

15.    TECHNOLOGY INVESTMENT AGREEMENT

Effective July 1, 2020, the Company entered into the TIA with the U.S. government. The principal purpose of the TIA is to fund the expansion of the Company’s manufacturing capacity for hypodermic safety needles and corresponding syringes in response to the worldwide COVID-19 global pandemic. The award is an expenditure-type TIA, whereby the U.S. government will make payments to the Company for the Company’s expenditures for equipment and supplies in carrying out the expansion of the Company’s domestic production. The Company’s contributions under the terms of the TIA to enhance domestic capacity of pandemic-essential technology include providing facilities, technical expertise, labor, and maintenance of the TIA-funded equipment for a ten-year term.

As of September 30, 2021, the Company had negotiated contracts for the purchase of automated assembly equipment, molds, and molding equipment, as well as portions of auxiliary equipment, for approximately $44.6 million.  The Company has received a temporary certificate of occupancy for both the approximately 27,800 square foot controlled environment and the approximately 55,000 square foot new warehouse space.  The final cost of the controlled environment within existing properties is $6.7 million.  The new warehouse space final cost is $5.9 million.  The cost of the controlled environment was funded by the U.S. government under the TIA, while the cost of the new warehouse was funded by the Company.  A May 2021 amendment to the TIA requires further expansion and new assembly lines.  As of September 30, 2021, the Company has issued purchase orders for approximately $16.7 million for the purchase of additional production and ancillary equipment in connection with the foregoing amendment.

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STOCK REPURCHASE PLAN

9 Months Ended

Sep. 30, 2021

STOCK REPURCHASE PLAN

Stock Repurchase Plan

16.    STOCK REPURCHASE PLAN

The Company entered into a repurchase plan (the “Plan”) dated June 4, 2021 with an independent broker for the purchase of up to $10 million of the Company’s Common Stock.  Under the Plan, open market purchases of the Company’s Common Stock commenced June 18, 2021 and 231,321 shares were purchased in the quarterly period ended September 30, 2021 for an aggregate purchase price of $2,684,902.  A total of 244,821 shares have been repurchased for $2,839,326 as of September 30, 2021.  These treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s balance sheets.  The Plan terminates on the earliest of: June 18, 2022, the completion of all purchases contemplated by the Plan, termination by either party, the existence of a legal or regulatory restriction, certain fundamental business transactions, liquidation or reorganization, or failure of the Company to adhere to the representations and warranties in the Plan.  The Plan is structured to comply with Rules 10b5-1 and 10b-18 under the Securities Exchange Act of 1934. The purchases under the Plan are subject to Rule 10b-18 limitations as well as certain price and market volume constraints specified in the Plan.  As of November 10, 2021, 362,854 shares were purchased for a total of $4.0 million.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

Accounting estimates

The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period.  Actual results could differ significantly from those estimates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related to sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that the Company has an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied.

Cash and cash equivalents

Cash and cash equivalents

For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with original maturities of three months or less.

Accounts receivable

Accounts receivable

The Company records trade receivables when revenue is recognized.  No product has been consigned to customers.  The Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables.  

Those accounts that are doubtful of collection are included in the allowance.  This provision is reviewed to determine the adequacy of the allowance for doubtful accounts. Trade receivables are charged off when there is certainty as to their being uncollectible. Trade receivables are considered delinquent when payment has not been made within contract terms. The Allowance for bad debt was $352,217 and $205,822 as of September 30, 2021 and December 31, 2020, respectively.

The Company requires certain customers to make a prepayment prior to beginning production or shipment of their order.  Customers may apply such prepayments to their outstanding invoices or pay the invoice and continue to carry forward the deposit for future orders.  Such amounts are included in Other accrued liabilities on the Condensed Balance Sheets and are shown in Note 6, Other Accrued Liabilities.

The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales.  Historically, returns have been insignificant.

Receivable from Technology Investment Agreement (TIA)

The amounts set forth as Receivable from Technology Investment Agreement (TIA) represent amounts receivable under a contractual agreement under the TIA. The amounts may represent advance requests or reimbursement requests for expenditures the Company makes or has made under its obligations with the federal government. For further explanation, please refer to Note 15 – Technology Investment Agreement.

Inventories

Inventories

Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost.  The Company compares the average cost to the net realizable value and records the lower value.  Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.  Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, the shelf life of inventory, and current market conditions when determining excess or obsolete inventories. Once inventory items are deemed to be either excess or obsolete, they are excluded from the stated net realizable value.

Investments in debt and equity securities

Investments in debt and equity securities

The Company holds high-grade exchange-traded and closed-end funds (ETFs), mutual funds, equity securities, and debt securities as investments.  These assets are readily marketable and are carried at fair value as of the date of the Condensed  Balance Sheets. Net unrealized and realized gains or losses on investments in debt and equity securities are reflected as a component of Interest and other income (loss). Realized gains or losses on investments in debt and equity securities are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment

Property, plant, and equipment are stated at cost. Expenditures for maintenance and repairs are charged to operations as incurred.  Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity and interest cost associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

The Company's property, plant, and equipment primarily consist of buildings, land, assembly equipment, molding machines, molds, office equipment, furniture, and fixtures.  Depreciation and amortization are calculated using the straight-line method over the following useful lives:

Production equipment	3 to 13 years
Office furniture and equipment	3 to 10 years
Buildings	39 years
Building improvements	15 years

Long-lived assets

Long-lived assets

The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash flows related to such assets.  In the event that assets are found to be carried at amounts which are in excess of estimated gross future cash flows, the assets will be adjusted for impairment to a level commensurate with fair value determined using a discounted cash flow analysis or appraised values of the underlying assets.

Fair value measurements

Fair value measurements

For assets and liabilities that are measured using quoted prices in active markets, total fair value is the published market price per unit multiplied by the number of units held without consideration of transaction costs. Assets and liabilities that are measured using significant other observable inputs are valued by reference to similar assets or liabilities, adjusted for contract restrictions and other terms specific to that asset or liability.  For these items, a significant portion of fair value is derived by reference to quoted prices of similar assets or liabilities in active markets.  For all remaining assets and liabilities, fair value is derived using a fair value model, such as a discounted cash flow model or Black-Scholes model.

Financial instruments

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information.  Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values.  Investments in equity securities consist primarily of individual equity securities, exchange-traded and closed-end funds and mutual funds and are reported at their fair value based upon quoted prices in active markets.  Investments in certificates of deposit (CD) with original maturities of greater than three months are reported at their estimated fair value based upon the duration of the CD and the interest rate earned on the CD versus current interest rates of similar duration CDs. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in debt and equity securities through consultation with its outside investment advisors. Management is responsible for directing investment activity based on current economic conditions. The majority of accounts receivable are due from companies which are well-established entities. In the third quarter of 2021, a significant portion of the Company’s sales were to the U.S. government, which Management does not consider a credit risk. As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects significant customers for the three- and nine-month periods of 2021 and 2020:

	Three Months Ended			Three Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2021			September 30, 2020			September 30, 2021			September 30, 2020
Number of significant customers		2			2			1			2
Aggregate dollar amount of net sales to significant customers	$	22.6	million	$	16.4	million	$	83.6	million	$	21.7	million
Percentage of net sales to significant customers		62.1%			60.6%			64.8%			43.6%

In the first nine months of 2021, approximately $83.6 million of the Company's sales were to the Department of Health and Human Services of the United States. Management expects the U.S. government to remain a significant customer through at least March 2022.

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 90.9% and 82.2% of its products in the first nine months of 2021 and 2020, respectively, from its Chinese manufacturers. Purchases from Chinese manufacturers aggregated 91.9% and 80.5% of products in the three-month periods ended September 30, 2021 and 2020, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company would need to find an alternate manufacturer for its blood collection set, IV catheter, Patient Safe^® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and would increase domestic production for the 1mL and 3mL syringes and EasyPoint^® needles.

Revenue recognition

Revenue recognition

The Company recognizes revenue when it has satisfied all performance obligations to the customer, generally when title and risk of loss pass to the customer.  Payments from customers with approved credit terms are typically due 30 days from the invoice date. Under certain contracts, revenue is recorded on the basis of sales price to distributors, less contractual pricing allowances. Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among other things, the facility that purchased the products, and (ii) a provision for estimated contractual pricing allowances for products for which the Company has not received tracking reports.  When rebates are issued, they are applied against the customer’s receivable balance.  Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by a distributor to an entity that has no contract, there is a standard rebate (lower than a contracted rebate) given to the distributor.  One of the purposes of the rebate is to encourage distributors to submit tracking reports to the Company. The provision for contractual pricing allowances is recognized in the period the related sales are recognized and is reviewed at the end of each quarter and adjusted for changes in levels of products for which there is no tracking report.  Additionally, if it becomes clear that tracking reports will not be provided by individual distributors, the provision is further adjusted.  The estimated contractual allowance is included in Accounts payable in the Condensed Balance Sheets and deducted from Revenues in the Condensed Statements of Operations.  Accounts payable included estimated contractual allowances for $5,304,885 and $3,435,352 as of September 30, 2021 and December 31, 2020, respectively.  The terms and conditions of contractual pricing allowances are governed by contracts between the Company and its distributors. Revenue for shipments directly to end-users is recognized when title and risk of ownership pass from the Company.  End-users do not receive any contractual allowances on their purchases.  Any product shipped or distributed for evaluation purposes is expensed.

The Company provides product warranties that: i) the products are fit for medical use as generally defined within the boundaries of United States FDA approval; ii) the products are not defective; and iii) the products will conform to the descriptions set forth in their respective labeling, provided that they are used in accordance with such labeling and the Company’s written directions for use.  The Company has historically not incurred significant warranty claims.

The Company’s domestic return policy provides that a customer may return incorrect shipments within 10 days following arrival at the distributor’s facility.  In all such cases, the distributor must obtain an authorization code from the Company and affix the code to the returned product.  The Company’s domestic return policy also generally provides that a customer may return product that is overstocked.  Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for the prior 12-month period.  All product overstocks and returns are subject to inspection and acceptance by the Company.

The Company’s international distribution agreements generally do not provide for any returns.

The Company requires certain customers to pay in advance of product shipment.  Such prepayments from customers are recorded in Other accrued liabilities and are generally recognized as revenue upon shipment of the product.

The Company periodically recognizes revenue from licensing agreements. If the Company licenses its products for sale, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, a certain percentage of such revenue pursuant to the terms of the Technology License Agreement between the Company and Mr. Shaw.

Disaggregated information of revenue recognized from contracts with customers and licensing fees recognized are as follows:

	For the three months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	11,033,291	$	560,065	$	4,048,292	$	11,399	$	15,653,047
Sales to U.S. government		18,420,480		—		—		—		18,420,480
North and South America sales (excluding U.S.)		670,602		4,800		26,400		—		701,802
Other international sales		1,389,226		900		189,992		600		1,580,718
Total	$	31,513,599	$	565,765	$	4,264,684	$	11,999	$	36,356,047

	For the three months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	8,241,161	$	791,961	$	3,581,723	$	9,210	$	12,624,055
Sales to U.S. government		12,898,080		—		—		—		12,898,080
North and South America sales (excluding U.S.)		1,295,080		450		—		—		1,295,530
Other international sales		198,440		73,019		235		1,705		273,399
Total	$	22,632,761	$	865,430	$	3,581,958	$	10,915	$	27,091,064

	For the nine months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	30,685,338	$	1,590,891	$	7,019,560	$	40,345	$	39,336,134
Sales to U.S. government		83,560,680		—		—		—		83,560,680
North and South America sales (excluding U.S.)		2,963,930		4,800		83,248		109,440		3,161,418
Other international sales		2,161,062		63,540		640,432		3,450		2,868,484
Total	$	119,371,010	$	1,659,231	$	7,743,240	$	153,235	$	128,926,716

	For the nine months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	21,538,941		1,607,804		6,004,295		52,065	$	29,203,105
Sales to U.S. government		14,065,623		—		—		—		14,065,623
North and South America sales (excluding U.S.)		4,911,106		8,450		1,496		1,064,768		5,985,820
Other international sales		529,430		76,609		235		6,304		612,578
Total	$	41,045,100	$	1,692,863	$	6,006,026	$	1,123,137	$	49,867,126

Income taxes

Income taxes

The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements based on whether it is “more-likely-than-not” that a tax position will be sustained based upon the technical merits of the position.  Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement.  

The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on enacted rates expected to be in effect when such differences reverse in future periods.  Deferred tax assets are periodically reviewed for realizability.  In prior periods, the Company established a valuation allowance for its net deferred tax asset as future taxable income which could not be reasonably assured.  During the quarter ended June 30, 2020, the Company released its valuation allowance based on available evidence supporting that its deferred tax assets will be realized in full.

Earnings per share

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

For the three and nine months ended September 30, 2021, the calculation of diluted EPS under the treasury stock method included 142,552 and 143,780 shares, respectively, of Common Stock underlying issued and outstanding stock options. Common stock issuable upon the conversion of 236,445 convertible preferred shares is included in the calculation of diluted EPS for both the three and nine months ended September 30, 2021.

The calculation of diluted EPS under the treasury stock method included 226,150 shares of Common Stock underlying issued and outstanding stock options for both the three and nine months ended September 30, 2020, respectively. For these same periods, preferred stock was excluded from the calculation of diluted EPS because the effect was antidilutive.

The potential dilution, if any, is shown on the following schedule:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Net income	$	6,521,885	$	8,625,751	$	35,139,894	$	12,714,637
Preferred stock dividend requirements		(59,111)		(145,535)		(183,219)		(493,826)
Deemed contribution on extinguishment of preferred stock		—		2,525,848		—		2,519,124
Income applicable to common shareholders	$	6,462,774	$	11,006,064	$	34,956,675	$	14,739,935
Average common shares outstanding		33,883,684		33,371,471		33,950,742		32,947,241
Average common and common equivalent shares outstanding — assuming dilution		34,262,681		33,984,934		34,330,967		33,071,652
Basic earnings per share	$	0.19	$	0.33	$	1.03	$	0.45
Diluted earnings per share	$	0.19	$	0.33	$	1.02	$	0.45

Shipping and handling costs

Shipping and handling costs

The Company classifies shipping and handling costs as part of Cost of sales in the Condensed Statements of Operations.

Share-based compensation

Share-based Compensation

The Company’s share-based payments are accounted for using the fair value method.  The Company records share-based compensation expense on a straight-line basis over the requisite service period.  The Company incurred the following share-based compensation costs:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Cost of Sales	$	—	$	—	$	—	$	—
Sales and Marketing		—		—		—		—
Research and development		—		—		—		—
General and administrative		1,157,236		—		2,503,152		—
	$	1,157,236	$	—	$	2,503,152	$	—

Research and development costs

Research and development costs

Research and development costs are expensed as incurred.

Leases

Leases

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in Other assets, Other accrued liabilities, and Other long-term liabilities on the Condensed Balance Sheets. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease.  Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term.  As the Company’s leases do not provide an implicit rate, the incremental borrowing rate based on information available at the commencement date was used in determining the present value of lease payments.

The operating lease ROU asset also includes any lease payments made and excludes lease incentives.  Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option.  Lease expense for lease payments is recognized on a straight-line basis over the lease term.  Leases with an initial term of twelve months or less are not recorded on the Condensed Balance Sheets; however, rent expense is recognized on a straight-line basis over the lease term.

Technology Investment Agreement (TIA)

Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in Government funding for expanding the Company’s domestic production of needles and syringes. Pursuant to the terms of the TIA, the Company is expected to make significant additions to its facilities which should allow the Company to increase domestic production. As reimbursements are received from the U.S. government for such expenditures, the Company records a deferred liability. The deferred liability will be systematically amortized as a gain over the life of the related property, plant, and equipment as to offset the related depreciation expense of the assets acquired. The amortization will be presented separately from the depreciation expense on the Condensed Statements of Operations.

Recently Adopted Pronouncements and Recently Issued Pronouncement

Recently Adopted Pronouncements

The Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments on January 1, 2020.  Among other things, these amendments require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts.  Many of the loss estimation techniques applied previously will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  The adoption of ASU 2016-13, as well as the Targeted Transition Relief as provided by ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326) – Targeted Transition Relief” did not have a significant impact on the Company’s financial statements.

The Company adopted ASU 2018-15, “Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40):  Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract (a Consensus of the FASB Emerging Issues Task Force)" on January 1, 2020.  This amendment requires that implemented costs incurred in a hosting arrangement that is a service contract should be accounted for in accordance with ASC 350-40  Internal-Use Software.  Accordingly, costs incurred during the preliminary project and post-implementation stages are expensed and costs associated with the application development phase are capitalized.  The amendment also requires that capitalized costs be amortized over the term of the hosting arrangement and that capitalized costs should be evaluated for impairment. The adoption of this ASU did not have a significant impact on the Company's financial statements or disclosures.

In August 2018, the FASB issued ASU 2018-13 "Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement." The amendment modifies, among other things, disclosure requirements on fair value measurements and eliminates certain disclosures related to transfers and valuation levels of Level 3 fair value measurements. Additionally, the amendment requires disclosure of changes in unrealized gains and losses in other comprehensive income for Level 3 fair value measurements and certain qualitative factors related to significant unobservable inputs used in Level 3 valuations. The amendment was effective for annual periods beginning after December 15, 2019 and interim periods within the annual period. The adoption of ASU 2018-13 did not have a significant effect on the Company's financial statements, as the Company does not currently have any investments classified as Level 3 fair value measurements.

In December 2019, the FASB issued ASU 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”.  The new standard is intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences.  The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill.  The standard is effective for annual periods beginning after December 15, 2020 and interim periods within the annual period, with early adoption permitted.  Adoption of the standard requires certain changes primarily be made prospectively, with some changes to be made retrospectively.  

The Company has determined that the adoption of ASU 2019-12 did not have a material impact on its financial statements.

Recently Issued Pronouncement

In March 2020, the FASB issued ASU No. 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting”, to ease the potential burden in accounting for reference rate reform.  The new guidance provides optional expedients for contracts that reference LIBOR, if certain criteria are met, that can be applied through December 31, 2022.  As reference rate reform is still an ongoing process, the Company will continue to evaluate the timing and potential impact of adoption for optional expedients when deemed necessary.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2021

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Schedule of estimated useful lives of property, plant and equipment

Production equipment	3 to 13 years
Office furniture and equipment	3 to 10 years
Buildings	39 years
Building improvements	15 years

Schedule of significant customers

	Three Months Ended			Three Months Ended			Nine Months Ended			Nine Months Ended
	September 30, 2021			September 30, 2020			September 30, 2021			September 30, 2020
Number of significant customers		2			2			1			2
Aggregate dollar amount of net sales to significant customers	$	22.6	million	$	16.4	million	$	83.6	million	$	21.7	million
Percentage of net sales to significant customers		62.1%			60.6%			64.8%			43.6%

Schedule of disaggregated information of revenue recognized from contracts with customers and licensing fees

	For the three months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	11,033,291	$	560,065	$	4,048,292	$	11,399	$	15,653,047
Sales to U.S. government		18,420,480		—		—		—		18,420,480
North and South America sales (excluding U.S.)		670,602		4,800		26,400		—		701,802
Other international sales		1,389,226		900		189,992		600		1,580,718
Total	$	31,513,599	$	565,765	$	4,264,684	$	11,999	$	36,356,047

	For the three months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	8,241,161	$	791,961	$	3,581,723	$	9,210	$	12,624,055
Sales to U.S. government		12,898,080		—		—		—		12,898,080
North and South America sales (excluding U.S.)		1,295,080		450		—		—		1,295,530
Other international sales		198,440		73,019		235		1,705		273,399
Total	$	22,632,761	$	865,430	$	3,581,958	$	10,915	$	27,091,064

	For the nine months ended September 30, 2021:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	30,685,338	$	1,590,891	$	7,019,560	$	40,345	$	39,336,134
Sales to U.S. government		83,560,680		—		—		—		83,560,680
North and South America sales (excluding U.S.)		2,963,930		4,800		83,248		109,440		3,161,418
Other international sales		2,161,062		63,540		640,432		3,450		2,868,484
Total	$	119,371,010	$	1,659,231	$	7,743,240	$	153,235	$	128,926,716

	For the nine months ended September 30, 2020:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales (excluding U.S. government)	$	21,538,941		1,607,804		6,004,295		52,065	$	29,203,105
Sales to U.S. government		14,065,623		—		—		—		14,065,623
North and South America sales (excluding U.S.)		4,911,106		8,450		1,496		1,064,768		5,985,820
Other international sales		529,430		76,609		235		6,304		612,578
Total	$	41,045,100	$	1,692,863	$	6,006,026	$	1,123,137	$	49,867,126

Schedule of earnings per share

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Net income	$	6,521,885	$	8,625,751	$	35,139,894	$	12,714,637
Preferred stock dividend requirements		(59,111)		(145,535)		(183,219)		(493,826)
Deemed contribution on extinguishment of preferred stock		—		2,525,848		—		2,519,124
Income applicable to common shareholders	$	6,462,774	$	11,006,064	$	34,956,675	$	14,739,935
Average common shares outstanding		33,883,684		33,371,471		33,950,742		32,947,241
Average common and common equivalent shares outstanding — assuming dilution		34,262,681		33,984,934		34,330,967		33,071,652
Basic earnings per share	$	0.19	$	0.33	$	1.03	$	0.45
Diluted earnings per share	$	0.19	$	0.33	$	1.02	$	0.45

Schedule of share-based compensation costs

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
Cost of Sales	$	—	$	—	$	—	$	—
Sales and Marketing		—		—		—		—
Research and development		—		—		—		—
General and administrative		1,157,236		—		2,503,152		—
	$	1,157,236	$	—	$	2,503,152	$	—

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INVENTORIES (Tables)

9 Months Ended

Sep. 30, 2021

INVENTORIES

Schedule of inventories

	September 30, 2021		December 31, 2020
Raw materials	$	2,370,760	$	1,320,214
Finished goods		16,326,004		8,914,432
	$	18,696,764	$	10,234,646

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FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)

9 Months Ended

Sep. 30, 2021

FAIR VALUE OF FINANCIAL INSTRUMENTS

Summary of value of assets designated as investments in debt and equity securities

	September 30, 2021
	Level 1		Level 2		Level 3		Total
Equity securities	$	9,357,931	$	—	$	—	$	9,357,931
Mutual funds and exchange traded funds		4,150,405		—		—		4,150,405
Certificates of deposit		—		75,607		—		75,607
	$	13,508,336	$	75,607	$	—	$	13,583,943

	December 31, 2020
	Level 1		Level 2		Level 3		Total
Equity securities	$	3,990,533	$	—	$	—	$	3,990,533
Mutual funds and exchange traded funds		4,013,956		—		—		4,013,956
Certificates of deposit		—		77,344		—		77,344
	$	8,004,489	$	77,344	$	—	$	8,081,833

Schedule of unrealized gains (losses) on investments in equity securities

	September 30, 2021
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	6,698,032	$	2,659,899	$	—	$	9,357,931
Mutual funds and exchange traded funds		3,994,001		156,404		—		4,150,405
Certificates of deposit		75,000		607		—		75,607
	$	10,767,033	$	2,816,910	$	—	$	13,583,943

	December 31, 2020
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
Equity securities	$	2,098,144	$	1,892,389	$	—	$	3,990,533
Mutual funds and exchange traded funds		3,909,364		104,592		—		4,013,956
Certificates of deposit		75,000		2,344		—		77,344
	$	6,082,508	$	1,999,325	$	—	$	8,081,833

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INCOME TAXES (Tables)

9 Months Ended

Sep. 30, 2021

INCOME TAXES

Schedule of reconciliation of income taxes based on the federal statutory rate and the effective income tax rate

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. statutory federal tax rate	21.0	%	21.0	%	21.0	%	21.0	%
Valuation Allowance	—	%	(8.8)	%	—	%	(24.8)	%
Stock options	0.1	%	—	%	(0.1)	%	—	%
Other	(12.4)	%	0.6	%	(1.8)	%	0.1	%
PPP loan	—	%	—	%	(0.8)	%	—	%
State taxes	5.4	%	2.8	%	5.8	%	2.5	%
Effective tax rate	14.1	%	15.6	%	24.1	%	(1.2)	%

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OTHER ACCRUED LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2021

OTHER ACCRUED LIABILITIES

Schedule of other accrued liabilities

	September 30, 2021		December 31, 2020
Prepayments from customers	$	2,609,684	$	1,686,868
Accrued property taxes		338,540		—
Accrued professional fees		228,204		331,204
Current portion – preferred stock repurchase		1,084,795		1,092,282
Other accrued expenses		161,642		288,550
Total	$	4,422,865	$	3,398,904

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OTHER LONG-TERM LIABILITIES (Tables)

6 Months Ended

Jun. 30, 2021

OTHER LONG-TERM LIABILITIES

Schedule of other long-term liabilities

	September 30, 2021		December 31, 2020
Technology Investment Agreement (TIA)	$	59,278,368	$	22,444,324
Stock repurchase		1,028,416		2,034,373
Total	$	60,306,784	$	24,478,697

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BUSINESS SEGMENT (Tables)

9 Months Ended

Sep. 30, 2021

BUSINESS SEGMENT

Schedule of company's sales and long-lived assets by geography

Revenues by geography are as follows:

	Three Months Ended		Three Months Ended		Nine Months Ended		Nine Months Ended
	September 30, 2021		September 30, 2020		September 30, 2021		September 30, 2020
U.S. sales (excluding U.S. government)	$	15,653,047	$	12,624,055	$	39,336,134	$	29,203,105
Sales to U.S. government		18,420,480		12,898,080		83,560,680		14,065,623
North and South America sales (excluding U.S.)		701,802		1,295,530		3,161,418		5,985,820
Other international sales		1,580,718		273,399		2,868,484		612,578
Total sales	$	36,356,047	$	27,091,064	$	128,926,716	$	49,867,126

Long-lived assets by geography are as follows:

	September 30, 2021		December 31, 2020
Long-lived assets
U.S.	$	72,822,361	$	30,751,259
International		3,803,619		65,245
Total	$	76,625,980	$	30,816,504

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LEASES (Tables)

6 Months Ended

Jun. 30, 2021

LEASES

Schedule of assets and liabilities relating to leases included in the Condensed Balance Sheets

	September 30, 2021		December 31, 2020
OPERATING LEASES
Other assets	$	—	$	38,892
Other accrued liabilities	$	—	$	38,892
Other long-term liabilities		—		—
Total operating lease liabilities	$	—	$	38,892

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accounts receivable (Details) - USD ($) $ in Thousands	Sep. 30, 2021	Dec. 31, 2020
Accounts receivable
Allowance for bad debt	$ 352,217	$ 205,822

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property, plant and equipment (Details)	9 Months Ended
	Sep. 30, 2021
Production equipment | Minimum
Property, plant, and equipment
Useful lives (in years)	3 years
Production equipment | Maximum
Property, plant, and equipment
Useful lives (in years)	13 years
Office furniture and equipment | Minimum
Property, plant, and equipment
Useful lives (in years)	3 years
Office furniture and equipment | Maximum
Property, plant, and equipment
Useful lives (in years)	10 years
Buildings
Property, plant, and equipment
Useful lives (in years)	39 years
Building Improvements
Property, plant, and equipment
Useful lives (in years)	15 years

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration risks (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Concentration risks
Aggregate dollar amount of net sales to significant customers	$ 36,356,047	$ 27,091,064	$ 128,926,716	$ 49,867,126
Department of health and human
Concentration risks
Aggregate dollar amount of net sales to significant customers			$ 83,600,000
Supplier Concentration Risk | China
Concentration risks
Concentration risk, geographic	91.9%	80.5%	90.9%	82.2%

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue recognition (Details)	3 Months Ended		9 Months Ended		12 Months Ended
	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Sep. 30, 2021 USD ($) item	Sep. 30, 2020 USD ($)	Dec. 31, 2020 USD ($)
Revenue recognition
Estimated contractual allowance			$ 5,304,885		$ 3,435,352
Period for return of incorrect shipments			10 days
Number of times overstocking returns are limited | item			2
Period for return of product due to overstock			12 months
Maximum percentage of distributor's total purchase for the prior 12-month period			1.00%
Sales, net	$ 36,356,047	$ 27,091,064	$ 128,926,716	$ 49,867,126
Syringes
Revenue recognition
Sales, net	31,513,599	22,632,761	119,371,010	41,045,100
Blood Collection Products
Revenue recognition
Sales, net	565,765	865,430	1,659,231	1,692,863
Easy Point Needles
Revenue recognition
Sales, net	4,264,684	3,581,958	7,743,240	6,006,026
Other Products
Revenue recognition
Sales, net	11,999	10,915	153,235	1,123,137
Department of health and human
Revenue recognition
Sales, net			83,600,000
U.S.
Revenue recognition
Sales, net	15,653,047	12,624,055	39,336,134	29,203,105
U.S. | Syringes
Revenue recognition
Sales, net	11,033,291	8,241,161	30,685,338	21,538,941
U.S. | Blood Collection Products
Revenue recognition
Sales, net	560,065	791,961	1,590,891	1,607,804
U.S. | Easy Point Needles
Revenue recognition
Sales, net	4,048,292	3,581,723	7,019,560	6,004,295
U.S. | Other Products
Revenue recognition
Sales, net	11,399	9,210	40,345	52,065
U.S. government
Revenue recognition
Sales, net	18,420,480	12,898,080	83,560,680	14,065,623
U.S. government | Syringes
Revenue recognition
Sales, net	18,420,480	12,898,080	83,560,680	14,065,623
North and South America sales (excluding U.S.)
Revenue recognition
Sales, net	701,802	1,295,530	3,161,418	5,985,820
North and South America sales (excluding U.S.) | Syringes
Revenue recognition
Sales, net	670,602	1,295,080	2,963,930	4,911,106
North and South America sales (excluding U.S.) | Blood Collection Products
Revenue recognition
Sales, net	4,800	450	4,800	8,450
North and South America sales (excluding U.S.) | Easy Point Needles
Revenue recognition
Sales, net	26,400		83,248	1,496
North and South America sales (excluding U.S.) | Other Products
Revenue recognition
Sales, net			109,440	1,064,768
Other international sales
Revenue recognition
Sales, net	1,580,718	273,399	2,868,484	612,578
Other international sales | Syringes
Revenue recognition
Sales, net	1,389,226	198,440	2,161,062	529,430
Other international sales | Blood Collection Products
Revenue recognition
Sales, net	900	73,019	63,540	76,609
Other international sales | Easy Point Needles
Revenue recognition
Sales, net	189,992	235	640,432	235
Other international sales | Other Products
Revenue recognition
Sales, net	$ 600	$ 1,705	$ 3,450	$ 6,304

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020
Earnings per share
Additional stock options included in calculation of diluted EPS	142,552	226,150	143,780	226,150
Common stock issuable upon the conversion of convertible preferred shares	236,445		236,445
Net income	$ 6,521,885	$ 8,625,751	$ 35,139,894	$ 12,714,637
Preferred stock dividend requirements	(59,111)	(145,535)	(183,219)	(493,826)
Deemed contribution on extinguishment of preferred stock		2,525,848		2,519,124
Income applicable to common shareholders	$ 6,462,774	$ 11,006,064	$ 34,956,675	$ 14,739,935
Average common shares outstanding	33,883,684	33,371,471	33,950,742	32,947,241
Average common and common equivalent shares outstanding - assuming dilution	34,262,681	33,984,934	34,330,967	33,071,652
Basic earnings per share	$ 0.19	$ 0.33	$ 1.03	$ 0.45
Diluted earnings per share	$ 0.19	$ 0.33	$ 1.02	$ 0.45

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Share-based compensation (Details) - USD ($)	3 Months Ended	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2021
Share-based compensation expense	$ 1,157,236	$ 2,503,152
General and administrative
Share-based compensation expense	$ 1,157,236	$ 2,503,152

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Technology Investment Agreement (TIA) (Details)	9 Months Ended
	Sep. 30, 2021 USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
Research and development agreement with government funding amount	$ 81,029,518

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INVENTORIES (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
INVENTORIES
Raw materials	$ 2,370,760	$ 1,320,214
Finished goods	16,326,004	8,914,432
Inventory, net	$ 18,696,764	$ 10,234,646

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FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - USD ($)	9 Months Ended		12 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Investments in equity securities
Investments in debt and equity securities, at fair value	$ 13,583,943		$ 8,081,833
Gross Unrealized
Cost	10,767,033		6,082,508
Gross Unrealized Gains	2,816,910		1,999,325
Unrealized gains (loss) on investments in debt and equity securities	816,150	$ 559,543
Level 1
Investments in equity securities
Investments in debt and equity securities, at fair value	13,508,336		8,004,489
Level 2
Investments in equity securities
Investments in debt and equity securities, at fair value	75,607		77,344
Equity securities
Investments in equity securities
Investments in debt and equity securities, at fair value	9,357,931		3,990,533
Gross Unrealized
Cost	6,698,032		2,098,144
Gross Unrealized Gains	2,659,899		1,892,389
Equity securities | Level 1
Investments in equity securities
Investments in debt and equity securities, at fair value	9,357,931		3,990,533
Mutual funds and exchange traded funds
Investments in equity securities
Investments in debt and equity securities, at fair value	4,150,405		4,013,956
Gross Unrealized
Cost	3,994,001		3,909,364
Gross Unrealized Gains	156,404		104,592
Mutual funds and exchange traded funds | Level 1
Investments in equity securities
Investments in debt and equity securities, at fair value	4,150,405		4,013,956
Certificates of deposit
Investments in equity securities
Investments in debt and equity securities, at fair value	75,607		77,344
Gross Unrealized
Cost	75,000		75,000
Gross Unrealized Gains	607		2,344
Certificates of deposit | Level 2
Investments in equity securities
Investments in debt and equity securities, at fair value	$ 75,607		$ 77,344

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INCOME TAXES (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021 USD ($)	Sep. 30, 2020
Tax effects of temporary differences that give rise to significant portions of the deferred tax assets and liabilities
Increase (decrease) in valuation allowance			$ 0
Reconciliation of income taxes based on the federal statutory rate and the effective income tax rate
U.S. statutory federal tax rate (as a percent)	21.00%	21.00%	21.00%	21.00%
Tax Rate (as a percentage)		15.6		(1.2)
Valuation Allowance (as a percent)		(8.80%)		(24.80%)
Incentive stock options (as a percent)	0.10%		(0.10%)
Other (as a percent)	(12.40%)	0.60%	(1.80%)	0.10%
PPP loan			(0.80%)
State taxes (as a percent)	5.40%	2.80%	5.80%	2.50%
Effective tax rate (as a percent)	14.10%	15.60%	24.10%	(1.20%)

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OTHER ACCRUED LIABILITIES (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
OTHER ACCRUED LIABILITIES
Prepayments from customers	$ 2,609,684	$ 1,686,868
Accrued property taxes	338,540
Accrued professional fees	228,204	331,204
Current portion - preferred stock repurchase	1,084,795	1,092,282
Other accrued expenses	161,642	288,550
Total	$ 4,422,865	$ 3,398,904

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OTHER LONG-TERM LIABILITIES (Details) - USD ($)	Sep. 30, 2021	Dec. 31, 2020
OTHER LONG-TERM LIABILITIES
Technology Investment Agreement (TIA)	$ 59,278,368	$ 22,444,324
Stock repurchase	1,028,416	2,034,373
Total	$ 60,306,784	$ 24,478,697

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OTHER LONG-TERM LIABILITIES- Additional information (Details)	9 Months Ended	12 Months Ended
	Sep. 30, 2021 USD ($) installment	Dec. 31, 2020 shares
OTHER LONG-TERM LIABILITIES
Net present value | $	$ 2,107,212
Number of annual installment payments | installment	3
Purchase price is payable | $	$ 1,101,110
Series IV Preferred Stock
OTHER LONG-TERM LIABILITIES
Preferred shareholders as a result of private stock purchases | shares		320,333
Series V Preferred Stock
OTHER LONG-TERM LIABILITIES
Preferred shareholders as a result of private stock purchases | shares		25,000

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BUSINESS SEGMENT (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
Sales by geography
Sales, net	$ 36,356,047	$ 27,091,064	$ 128,926,716	$ 49,867,126
Long-lived assets
Long-lived assets	76,625,980		76,625,980		$ 30,816,504
U.S.
Sales by geography
Sales, net	15,653,047	12,624,055	39,336,134	29,203,105
Long-lived assets
Long-lived assets	72,822,361		72,822,361		30,751,259
U.S. government
Sales by geography
Sales, net	18,420,480	12,898,080	83,560,680	14,065,623
North and South America sales (excluding U.S.)
Sales by geography
Sales, net	701,802	1,295,530	3,161,418	5,985,820
Other international sales
Sales by geography
Sales, net	1,580,718	$ 273,399	2,868,484	$ 612,578
International
Long-lived assets
Long-lived assets	$ 3,803,619		$ 3,803,619		$ 65,245

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DIVIDENDS (Details)		1 Months Ended				9 Months Ended		12 Months Ended
	Nov. 05, 2021 USD ($) stockholder	Oct. 31, 2021 USD ($)	Jun. 30, 2021 USD ($) $ / shares	Apr. 30, 2021 USD ($)	Jan. 31, 2021 USD ($)	Sep. 30, 2021 USD ($)	Sep. 30, 2020 USD ($)	Dec. 31, 2020 USD ($)
Dividends
Cumulative annual payments			$ 5,056,945
Dividends paid						$ 1,399,744	$ 52,242
Number of entitled shareholders | stockholder	90
Contingent liability former shareholders	$ 1,400,000
Series I, Class B
Dividends
Cumulative annual payments					$ 10,041			$ 48,000
Series II, Class B
Dividends
Cumulative annual payments			$ 39,050	$ 39,050	$ 39,050			$ 168,642
Dividends paid		$ 39,050
Dividend (per share) | $ / shares			$ 0.25
Series III Class B
Dividends
Cumulative annual payments			$ 4,086,704
Dividend (per share) | $ / shares			$ 1.00
Series IV Preferred Stock
Dividends
Cumulative annual payments			$ 101,475
Dividend (per share) | $ / shares			$ 1.00
Series V Preferred Stock
Dividends
Cumulative annual payments			$ 829,716
Dividend (per share) | $ / shares			$ 0.32

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LEASES (Details) - USD ($)	9 Months Ended
	Sep. 30, 2021	Sep. 30, 2020	Dec. 31, 2020
LEASES
Operating lease cost	$ 38,892	$ 69,689
Cash outflows related to leases	$ 38,892	$ 69,689
Assets and liabilities associated with these leases in Balance Sheets
Other assets			$ 38,892
Other assets [Extensible List]	Other Assets		Other Assets
Other accrued liabilities			$ 38,892
Other accrued liabilities [Extensible List]	Other Accrued Liabilities, Current		Other Accrued Liabilities, Current
Other long-term liabilities [Extensible List]	Other Liabilities, Noncurrent		Other Liabilities, Noncurrent
Total operating lease liabilities			$ 38,892

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LEASES - Future minimum payments (Details)	Dec. 31, 2020 USD ($)
Future minimum payments under non-cancelable operating leases and financing leases
Total operating lease liabilities	$ 38,892

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EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK (Details)	1 Months Ended	9 Months Ended	12 Months Ended
	Feb. 28, 2021 USD ($)	Sep. 30, 2021	Dec. 31, 2020 USD ($)
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK
Installments	3
Cash consideration	$ 1,101,110
Aggregate cash consideration			$ 3,786,000
Payment for repurchase of stock			$ 482,670
Cash consideration payment period		3 years

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STOCK OPTIONS (Details) - USD ($)		9 Months Ended
	Mar. 16, 2021	Sep. 30, 2021	Sep. 30, 2020
Stock options
Shares of Common Stock issued for exercises		25,400
Proceeds from the exercise of stock options		$ 48,600	$ 851,012
Shares authorized	2,000,000
Term (in years)	3 years
Exercise price (per share)	$ 13.00
Fair value (per share)	$ 10.21
Risk-free rate (as a percent)	1.20%
Volatility (as a percent)	92.66%
Chief executive officer
Stock options
Shares issued (in shares)	1,000,000
General Counsel
Stock options
Shares issued (in shares)	250,000
Chief financial officer
Stock options
Shares issued (in shares)	100,000

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PAYCHECK PROTECTION PROGRAM (Details) - USD ($)	May 13, 2021	Apr. 17, 2020
Debt Instrument [Line Items]
Loan amount forgiveness, CARES Act	$ 1,377,652
Promissory note | Paycheck Protection Program Loan
Debt Instrument [Line Items]
Principal amount		$ 1,363,000
Interest rate (as a percent)		1.00%

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TECHNOLOGY INVESTMENT AGREEMENT (Details) $ in Millions		9 Months Ended
	Jul. 01, 2020	Sep. 30, 2021 USD ($)
TECHNOLOGY INVESTMENT AGREEMENT
Technology investment agreement term	10 years
Purchase of automated assembly and auxiliary equipment		$ 44.6
Area of land for existing properties		27,800
Area of land for new warehouse		55,000
Estimated cost of the controlled environment within existing properties		$ 6.7
Increase cost of controlled environment within manufacturing equipment		5.9
Estimated cost of the construction of the new warehouse		$ 16.7

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STOCK REPURCHASE PLAN (Details) - USD ($)	Nov. 10, 2021	Jun. 18, 2021	Sep. 30, 2021
Obligation with Joint and Several Liability Arrangement [Line Items]
Proceeds from sale of common stock		$ 2,684,902
Treasury Stock, Common, Value			$ 2,839,326
Repurchase Plan
Obligation with Joint and Several Liability Arrangement [Line Items]
Value of shares under repurchase plans			$ 10,000,000
Shares issued (in shares)	362,854	231,321	244,821
Proceeds from sale of common stock	$ 4,000,000.0
Treasury Stock, Common, Value			$ 2,839,326