10-Q

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 10-Q

(Mark One)

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

For the quarterly period ended March 31, 2019

or

oTRANSITION 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)

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 x    No o

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 x No o

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

Large accelerated filer o	Accelerated filer o
Non-accelerated filer x	Smaller reporting company x
	Emerging growth company o

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. o

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).

Yes o No x

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 o Noo

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

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: 32,674,954 shares of Common Stock, no par value, issued and outstanding on May 1, 2019.

RETRACTABLE TECHNOLOGIES, INC.

FORM 10-Q

For the Quarterly Period Ended March 31, 2019

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	15
Item 3.	Quantitative and Qualitative Disclosures About Market Risk	18
Item 4.	Controls and Procedures	18
	PART II—OTHER INFORMATION
Item 1.	Legal Proceedings	19
Item 1A.	Risk Factors	19
Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	19
Item 3.	Defaults Upon Senior Securities	19
Item 6.	Exhibits	20
SIGNATURES		20

PART I—FINANCIAL INFORMATION

Item 1.Financial Statements.

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

		March 31, 2019		December 31, 2018
ASSETS
Current assets:
Cash and cash equivalents	$	4,228,624	$	9,647,292
Accounts receivable, net		4,648,428		4,912,356
Investments in equity securities, at fair value		4,558,714		—
Held-to-maturity securities, at amortized cost		997,176		996,233
Inventories, net		7,414,102		7,545,094
Income taxes receivable		100,887		100,887
Other current assets		718,095		644,803
Total current assets		22,666,026		23,846,665
Property, plant, and equipment, net		10,667,900		10,851,747
Held-to-maturity securities, at amortized cost (non-current)		1,991,119		1,989,923
Income taxes receivable		100,835		100,835
Other assets		145,441		165,856
Total assets	$	35,571,321	$	36,955,026
LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	4,847,357	$	5,369,677
Current portion of long-term debt		302,355		406,361
Accrued compensation		597,457		540,852
Dividends payable		55,113		55,113
Accrued royalties to shareholder		665,411		769,324
Other accrued liabilities		962,210		1,467,935
Income taxes payable		10,025		10,025
Total current liabilities		7,439,928		8,619,287
Other long-term liabilities		60,794		82,359
Long-term debt, net of current maturities		2,641,199		2,639,647
Total liabilities		10,141,921		11,341,293
Commitments and contingencies — see Note 8
Stockholders’ equity:
Preferred stock, $1 par value:
Series I, Class B		98,500		98,500
Series II, Class B		171,200		171,200
Series III, Class B		129,245		129,245
Series IV, Class B		342,500		342,500
Series V, Class B		40,000		40,000
Common stock, no par value		—		—
Additional paid-in capital		61,816,644		61,871,756
Accumulated deficit		(37,168,689	)	(37,039,468	)
Total stockholders’ equity		25,429,400		25,613,733
Total liabilities and stockholders’ equity	$	35,571,321	$	36,955,026

See accompanying notes to condensed unaudited financial statements

1

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

		Three Months Ended March 31, 2019			Three Months Ended March 31, 2018
Sales, net	$	7,932,474		$	7,672,801
Cost of sales
Cost of manufactured product		4,776,744			4,181,010
Royalty expense to shareholder		665,411			632,195
Total cost of sales		5,442,155			4,813,205
Gross profit		2,490,319			2,859,596
Operating expenses
Sales and marketing		875,546			1,165,461
Research and development		127,456			144,227
General and administrative		1,662,095			1,706,881
Total operating expenses		2,665,097			3,016,569
Loss from operations		(174,778	)		(156,973	)
Interest and other income		91,432			28,151
Interest expense		(45,875	)		(50,392	)
Loss before income taxes		(129,221	)		(179,214	)
Provision for income taxes		—			70
Net loss		(129,221	)		(179,284	)
Preferred stock dividend requirements		(176,249	)		(176,249	)
Loss applicable to common shareholders	$	(305,470	)	$	(355,533	)
Basic loss per share	$	(0.01	)	$	(0.01	)
Diluted loss per share	$	(0.01	)	$	(0.01	)
Weighted average common shares outstanding:
Basic		32,666,454			32,666,454
Diluted		32,666,454			32,666,454

See accompanying notes to condensed unaudited financial statements

2

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

		Three Months Ended March 31, 2019			Three Months Ended March 31, 2018
Cash flows from operating activities
Net loss	$	(129,221	)	$	(179,284	)
Adjustments to reconcile net loss to net cash provided (used) by operating activities:
Depreciation and amortization		211,754			229,807
Unrealized gain on investments		(43,102	)		—
(Increase) decrease in assets:
Accounts receivable		263,928			1,639,349
Inventories		130,992			(603,916	)
Other current assets		(73,290	)		(24,446	)
Increase (decrease) in liabilities:
Accounts payable		(522,320	)		(698,127	)
Other accrued liabilities		(554,745	)		234,068
Insurance proceeds		—			(149,792	)
Income taxes payable		—			11,477
Net cash provided (used) by operating activities		(716,004	)		459,136
Cash flows from investing activities
Purchase of property, plant, and equipment		(29,485	)		(76,294	)
Investments		(4,515,612	)		—
Net cash used by investing activities		(4,545,097	)		(76,294	)
Cash flows from financing activities
Repayments of long-term debt		(102,454	)		(111,370	)
Payment of preferred stock dividends		(55,113	)		(55,113	)
Net cash used by financing activities		(157,567	)		(166,483	)
Net increase (decrease) in cash and cash equivalents		(5,418,668	)		216,359
Cash and cash equivalents at:
Beginning of period		9,647,292			14,877,899
End of period	$	4,228,624		$	15,094,258
Supplemental schedule of cash flow information:
Interest paid	$	45,875		$	50,391
Income taxes paid	$	—		$	—
Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	$	55,113		$	55,113

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 March 31, 2019:

	Common Stock			Series I Class B Preferred Stock		Series II Class B Preferred Stock		Series III Class B Preferred Stock		Series IV Class B Preferred Stock		Series V Class B Preferred Stock		Additional Paid-In Capital			Accumulated Deficit			Total
Balance at December 31, 2018	$	—	$	98,500	$	171,200	$	129,245	$	342,500	$	40,000	$	61,871,756		$	(37,039,468	)	$	25,613,733
Dividends	—			—		—		—		—		—		(55,112	)		—			(55,112)
Net Loss	—			—		—		—		—		—		—			(129,221	)		(129,221)
Balance at March 31, 2019	$	—	$	98,500	$	171,200	$	129,245	$	342,500	$	40,000	$	61,816,644		$	(37,168,689	)	$	25,429,400

The following shows the changes in stockholders’ equity for the three month period ended March 31, 2018:

	Common Stock			Series I Class B Preferred Stock		Series II Class B Preferred Stock		Series III Class B Preferred Stock		Series IV Class B Preferred Stock		Series V Class B Preferred Stock		Additional Paid-In Capital			Accumulated Deficit			Total
Balance at December 31, 2017	$	—	$	98,500	$	171,200	$	129,245	$	342,500	$	40,000	$	62,092,206		$	(35,699,525	)	$	27,174,126
Dividends	—			—		—		—		—		—		(55,112	)		—			(55,112)
Net Loss	—			—		—		—		—		—		—			(179,284	)		(179,284)
Balance at March 31, 2018	$	—	$	98,500	$	171,200	$	129,245	$	342,500	$	40,000	$	62,037,094		$	(35,878,809	)	$	26,939,730

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.  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 28, 2019 for the year ended December 31, 2018.

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.

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 $146 thousand and $150 thousand as of March 31, 2019 and December 31, 2018, respectively.

5

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 7, Other Accrued Liabilities.

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

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.  A reserve is established for any excess or obsolete inventories or they may be written off.

Investments in Equity Securities

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

Investments – Held-to-Maturity Securities

The Company holds high-grade debt securities.  Since Management has the intent and ability to hold these securities until they mature, these investments have been accounted for as held-to-maturity investments.  The investments are carried at amortized cost.  Premiums and discounts on investments in debt securities are amortized over the contractual lives of these securities.  The method of amortization results in a constant effective yield on these securities.

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 property disposals are included in operations.

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.

6

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 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 U.S. Treasury Notes are classified as held-to-maturity and are presented at their amortized cost, net of discounts and premiums. 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, U.S. Treasury Notes, 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 majority of accounts receivable are due from companies which are well-established entities.  As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the first quarters of 2019 and 2018:

	Three Months Ended March 31, 2019	Three Months Ended March 31, 2018
Number of significant customers	3	4
Aggregate dollar amount of net sales to significant customers	$3.9 million	$4.9 million
Percentage of net sales to significant customers	48.6%	63.3%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 76.1% and 83.9% of its products in the first three months of 2019 and 2018, respectively, from its Chinese manufacturers.  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.

7

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.  Rebates are recorded when issued and 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 $3,413,037 and $3,896,341 as of March 31, 2019 and December 31, 2018, 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 within 30 to 60 days of receipt at the time product is shipped.

8

Disaggregated information of revenue recognized from contracts with customers is as follows:

		For the three months ended March 31, 2019:
Geographic Segment		Syringes		Blood Collection Products		EasyPoint® Needles		Other Products		Total Product Sales
U.S. sales	$	5,625,387	$	451,077	$	48,472	$	14,975	$	6,139,911
North and South America sales (excluding U.S.)		1,330,330		3,863		252		925		1,335,370
Other international sales		241,243		210,700		—		5,250		457,193
Total	$	7,196,960	$	665,640	$	48,724	$	21,150	$	7,932,474

		For the three months ended March 31, 2018:
Geographic Segment		Syringes		Blood Collection Products		EasyPoint® Needles		Other Products		Total Product Sales
U.S. sales	$	6,264,189	$	235,085	$	83,285	$	14,421	$	6,596,980
North and South America sales (excluding U.S.)		1,024,204		6,055		252		900		1,031,411
Other international sales		41,300		2,760		—		350		44,410
Total	$	7,329,693	$	243,900	$	83,537	$	15,671	$	7,672,801

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.  The Company has established a valuation allowance for its net deferred tax asset as future taxable income cannot be reasonably assured.  Penalties and interest related to income tax are classified as General and administrative expense and Interest expense, respectively, in the Condensed Statements of Operations.

9

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 or common stock issuable upon the conversion of convertible preferred stock.  The calculation of diluted EPS excluded 26 thousand shares of Common Stock underlying issued and outstanding stock options at March 31, 2018 as their effect was antidilutive.  The potential dilution, if any, is shown on the following schedule:

		Three Months Ended March 31, 2019			Three Months Ended March 31, 2018
Net loss	$	(129,221	)	$	(179,284	)
Preferred stock dividend requirements		(176,249	)		(176,249	)
Loss applicable to common shareholders	$	(305,470	)	$	(355,533	)
Weighted average common shares outstanding		32,666,454			32,666,454
Weighted average common and common equivalent shares outstanding — assuming dilution		32,666,454			32,666,454
Basic loss per share	$	(0.01	)	$	(0.01	)
Diluted loss per share	$	(0.01	)	$	(0.01	)

Shipping and handling costs

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

Self-insured employee benefit plan costs

The Company self-insures health insurance benefits for its employees under certain policy limits.  The Company has additional coverage provided by an insurance company.  The Company accrues for the cost of such benefits based on known claims and an estimate of incurred but not reported claims.

Research and development costs

Research and development costs are expensed as incurred.

Leases

The Company adopted ASU 2016-02, Leases (Topic 842), as amended January 1, 2019, effective for the quarter ended March 31, 2019.  The Company elected the comparative reporting relief practical expedient, which allows for the application of transition adjustments as of the adoption date rather than the beginning of the earliest period presented.

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in other assets, other current 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.  The Company did not elect to separate lease and non-lease components at the transition date. The Company elected the package of practical expedients permitted under the transition guidance, which among other things, allows the Company to carry forward the historical lease classification and elect hindsight to determine certain lease terms for existing leases.

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Recently Adopted Pronouncements

In August 2018, the Securities and Exchange Commission (SEC) adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, “Disclosure Update and Simplification”. The amendments were effective November 5, 2018.  The amendments eliminate or revise several redundant or duplicative requirements between SEC rules and GAAP, including the elimination of the disclosure of the ratio of earnings to fixed charges and the presentation of dividends per share on the face of the statement of operations for interim periods.  Among the amendments is the requirement to present the changes in shareholders’ equity in the interim financial statements (either in a separate statement or footnote) in quarterly reports on Form 10-Q. The amendments are effective for all filings made on or after November 5, 2018. In light of the timing of effectiveness of the amendments and proximity of effectiveness to the filing date for most filers’ quarterly reports, the SEC staff indicated that it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its Form 10-Q for the quarter that begins after the effective date of the amendments.  The Company elected to adopt the provisions of Securities Act Release No. 33-10532 for the quarter ended September 30, 2018.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, as well as several subsequently issued clarifying amendments. Under the ASU, as amended, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee’s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the guidance, lessor accounting is largely unchanged. The lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. In July 2018, the FASB issued ASU 2018-10, “Codification Improvements to Topic 842, Leases”. This amendment clarifies Topic 842 and corrected unintended application of guidance and is effective concurrent with Topic 842 or upon issuance if Topic 842 was early adopted.  In August 2018, the FASB issued ASU 2018-11, “Leases (Topic 842):  Targeted Improvements”. This amendment provides additional transition options allowing entities to recognize a cumulative effect adjustment to the opening balance of retained earnings in the period of adoption rather than the earliest period presented and provides a practical expedient to lessors to elect, by class of underlying assets, to account for non-lease and lease components as a single arrangement.  The Company adopted the provisions of ASU 2018-11 through a cumulative effect adjustment.  Topic 842, and its subsequent amendments, was effective for the Company’s quarter ended March 31, 2019. The Company has completed evaluating the various accounting policy elections associated with this ASU, as amended, including transition methods and practical expedients, identifying contracts for evaluation, and reviewing contracts to determine if they contain leases.  The Company completed evaluating the timing and impact of adopting ASU 2016-02, as amended, and recorded lease assets and liabilities of $163,007 on its Balance Sheets, with no impact to its accumulated deficit.

The following table summarizes the impact of the adoption of ASU 2016-02 to the previously reported results:

Balance Sheet as of December 31, 2018		As Previously Reported			New Lease Standard Adjustment			As Restated
Other assets	$		2,849	$		163,007	$		165,856
Other current liabilities		1,387,287			80,648			1,467,935
Other long-term liabilities		—			82,359			82,359

Recently Issued Pronouncements

In June 2016, the FASB issued Accounting Standards Update 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments.  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 today will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  This ASU is effective for the Company’s quarter ending March 31, 2020 with early application permitted for the Company’s quarter ending March 31, 2019.  The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and related disclosures.

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In August 2018, the FASB issued 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)”.  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.  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 amendment is effective for annual periods beginning after December 15, 2019 and interim periods within those annual periods.  The Company is currently assessing the impact that adoption of this ASU will have on its financial statements and related disclosures.

3.INVENTORIES

Inventories consist of the following:

		March 31, 2019			December 31, 2018
Raw materials	$	1,492,331		$	1,399,543
Finished goods		6,218,979			6,442,759
		7,711,310			7,842,302
Inventory reserve		(297,208	)		(297,208	)
	$	7,414,102		$	7,545,094

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 our assets designated as Investments in equity securities:

		March 31, 2019
		Level 1		Level 2		Level 3		Total
Investments in equity securities	$	4,558,714	$	—	$	—	$	4,558,714

		December 31, 2018
		Level 1		Level 2		Level 3		Total
Investments in equity securities	$	—	$	—	$	—	$	—

The Company holds high-grade exchange-traded and closed-end funds (ETFs) and mutual funds as investments.  These assets are readily marketable and are carried at market value as of the date of the Condensed Balance Sheets. The Company intends to hold these assets for possible future investment income.

	March 31, 2019
			Gross Unrealized				Aggregate
	Cost		Gains		Losses		Fair Value
$	4,515,612	$	43,102	$	—	$	4,558,714

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5.HELD-TO-MATURITY DEBT SECURITIES

The Company’s investment securities classified as held-to maturity consist of high-grade debt securities and certificates of deposit.  These investments are carried at amortized cost.  Gross unrecognized gains and losses and fair value of these securities at March 31, 2019 are as follows:

		March 31, 2019
				Gross Unrecognized
		Amortized Cost		Gains		Losses		Aggregate Fair Value
Current	$	997,176	$	167	$	—	$	997,343
Long-Term		1,991,119		5,545		—		1,996,664
Total	$	2,988,295	$	5,712	$	—	$	2,994,007

The fair value of investments in held-to maturity securities is valued under the market approach through the use of quoted prices.

6.INCOME TAXES

The Company’s effective tax rate on the net loss before income taxes was 0.0% for both the three months ended March 31, 2019 and March 31, 2018.

7.OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

		March 31, 2019		December 31, 2018
Prepayments from customers	$	377,837	$	860,926
Accrued property taxes		114,000		170,568
Accrued professional fees		317,185		294,903
Other accrued expenses		153,188		141,538
	$	962,210		1,467,935

8.COMMITMENTS AND CONTINGENCIES

In May 2010, the Company and an officer’s suit, initiated in 2007, against Becton, Dickinson and Company (“BD”) in the U.S. District Court for the Eastern District of Texas, Marshall Division alleging violations of antitrust acts, false advertising, product disparagement, tortious interference, and unfair competition was reopened.  After a series of appeals, this case was ultimately settled by the Settlement Agreement and Release (the “Settlement Agreement”) among the Company, an officer of the Company, BD, and MDC Investment Holdings, Inc. (“MDC”) whereby the Company and an officer and other affiliates (together, the “RTI Releasors”) released all claims arising prior to May 3, 2019 against BD and MDC and their affiliates (together, the “BD Releasors”).  Likewise, pursuant to the Settlement Agreement, the BD Releasors released all claims arising prior to May 3, 2019 against the RTI Releasors.  As a result of the Settlement Agreement, on May 6, 2019, the Company and an officer filed in the U.S. Court of Appeals for the Fifth Circuit a withdrawal of a petition for rehearing en banc filed on April 23, 2019, effectively leaving the take-nothing judgment of that court intact and ending further proceedings.

In September 2007, BD and MDC sued the Company in the U.S. District Court for the Eastern District of Texas, Texarkana Division, initially alleging that the Company is infringing two U.S. patents of MDC (6,179,812 and 7,090,656) that are licensed to BD.  This case, which had been stayed since 2015, was settled pursuant to the Settlement Agreement referenced in the preceding paragraph.  As a result of the Settlement Agreement, on May 6, 2019, BD, MDC, and the Company filed a stipulation with the U.S. District Court for the Eastern District of Texas, Texarkana Division that the claims in this action should be dismissed with prejudice without costs or attorneys’ fees to any of the parties.

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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 March 31, 2019		Three Months Ended March 31, 2018
U.S. sales	$	6,139,911	$	6,596,980
North and South America sales (excluding U.S.)	1,335,370		1,031,411
Other international sales	457,193		44,410
Total sales	$	7,932,474	$	7,672,801

Long-lived assets by geography are as follows:

	March 31, 2019		December 31, 2018
Long-lived assets
U.S.	$	10,560,437	$	10,738,253
International		107,463		113,494
Total	$	10,667,900	$	10,851,747

10.DIVIDENDS

The Board declared and the Company paid dividends in 2018 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on January 19, 2018, April 24, 2018, July 20, 2018, and October 23, 2018.  The Board declared and the Company paid dividends in 2019 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on January 18, 2019 and April 22, 2019.

11.LEASES

The Company has operating leases for a corporate office and equipment.  The leases have remaining lease terms of one to two years. The Company currently has no finance leases. The ROU asset is determined based on the lease liability adjusted for lease incentives received. Lease expense is recognized on a straight-line basis over the lease term. The leases may include various expenses incidental to the use of the property, such as common area maintenance, property taxes and insurance. These costs are separate from the minimum rent payment and are not considered in the determination of the lease liability and ROU asset. The Company has not noted any material instances in its leases where these costs were combined with the minimum rent payment and has therefore elected the policy to not separate lease from non-lease components if they are combined with the minimum rent payment. The option periods are not included in the determination of the lease liability and ROU asset as the Company is not reasonably certain if it will extend at the time of lease commencement.

The operating lease cost component of the lease expense was $19,854 at March 31, 2019.  The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $19,854 for the three months ended March 31, 2019.

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

		March 31, 2019		December 31, 2018
OPERATING LEASES
Other assets	$	143,153	$	163,007
Other accrued liabilities	$	82,359	$	80,648
Other long-term liabilities		60,794		82,359
Total operating lease liabilities	$	143,153	$	163,007

The weighted average remaining lease term is 1.73 years and the weighted average discount rate is 4.04%.

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Future minimum payments under non-cancelable operating leases and financing leases consist of the following at March 31, 2019:

Year ended December 31,
2019	$	64,308
2020		84,155
Total		148,463
Less imputed interest		5,310
Total	$	143,153

12.SUBSEQUENT EVENTS

Effective May 3, 2019, the Company and an officer settled litigation with both BD and MDC, whereby BD and MDC released the Company and its officer from claims arising prior to May 3, 2019.  Likewise, pursuant to the settlement, the Company and its officer released BD and MDC from claims arising prior to May 3, 2019.  This settlement effectively disposed of an antitrust and false advertising lawsuit by the Company and an officer against BD, as well as a suit by BD and MDC against the Company for patent infringement.  See Note 8.

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, 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 quickly increase capacity in response to an increase in demand, our ability to access the market, our ability to maintain or lower production costs, our ability to continue to finance research and development as well as operations and expansion of production, the impact of larger market players, specifically Becton, Dickinson and Company (“BD”), in providing devices to the safety market, and 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 90.7% of our sales in the first quarter of 2019.  We also manufacture and market the EasyPoint® needle, blood collection tube holder, IV safety catheter, and VanishPoint® Blood Collection Set.  We currently provide other safety medical products in addition to safety products utilizing retractable technology.  One such product is the Patient Safe® syringe, which is uniquely designed to reduce the risk of bloodstream infections associated with catheter hub contamination.

In the second quarter of 2016, we began selling the EasyPoint® needle.  EasyPoint® needles made up 10.3% of revenues for the year ended December 31, 2018 and 0.6% of revenues in the first quarter of 2019.  The EasyPoint® is a retractable needle that can be used with Luer lock syringes, Luer slip syringes, and prefilled syringes to give injections.  The EasyPoint® needle can also be used to aspirate fluids and collect blood.  Based on industry-wide trends, we anticipate that demand may increase for the EasyPoint® needle.

Historically, unit sales have increased in the latter part of the year due, in part, to the demand for syringes during the flu season.

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Our products have been and continue to be distributed nationally and internationally through numerous distributors.  Although we have made limited progress in some areas, such as the alternate care market, our volumes are not as high as they should be given the nature and quality of our products and the federal and state legislation requiring the use of safe needle devices. The alternate care market is composed of facilities that provide long-term nursing and out-patient surgery, emergency care, physician services, health clinics, and retail pharmacies.

We continue to pursue various strategies to have better access to the hospital market, as well as other markets, including attempting to gain access to the market through our sales efforts, our innovative technology, introduction of new products, and, when necessary, litigation.

Effective May 3, 2019, we settled and released all past claims against BD and MDC in return for a settlement and release of past claims against us from BD and MDC.  On May 6, 2019, filings were made with the U.S. Court of Appeals for the Fifth Circuit to cease further proceedings in our antitrust and false advertising suit against BD and in the U.S. District Court for the Eastern District of Texas to dismiss BD and MDC’s suit against us for patent infringement.

In November 2018, we terminated 19 employees earning total annual compensation of approximately $1.12 million.  Some of these positions may be filled in the future.  Severance costs associated with the 2018 terminations were $244 thousand.

In January 2018, Congress imposed another two-year moratorium on the 2.3% medical device excise tax imposed by Internal Revenue Code section 4191.  Thus, the medical device excise tax is not expected to go into effect until January 1, 2020.

We received approximately $1 million from our insurance carrier in the second quarter of 2017 and used these funds to repair our buildings from earlier storm damage.  The remaining proceeds of $261 thousand were recognized as Insurance proceeds in the fourth quarter of 2018.

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 quarter of 2019, our Chinese manufacturers produced approximately 76.1% 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.

With increased volumes, our manufacturing unit costs have generally tended to decline.  Factors that could affect our unit costs include possible tariffs, increases in costs by third party manufacturers, changing production volumes, costs of petroleum products, and transportation costs.  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.  Dollar amounts have been rounded for ease of reading.  All period references are to the periods ended March 31, 2019 or 2018.

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Comparison of Three Months Ended March 31, 2019 and March 31, 2018

Domestic sales accounted for 77.4% and 86.0% of our revenues for the three months ended March 31, 2019 and 2018, respectively.  Domestic revenues decreased 6.9% principally due to lower volumes and lower average selling prices.  Domestic unit sales decreased 0.9%.  Domestic unit sales were 69.1% of total unit sales for the three months ended March 31, 2019.  International unit sales and revenues increased 45.3% and 66.6%, respectively, due to higher volumes and higher average selling prices.  Our international orders may be subject to significant fluctuation over time.  Overall unit sales increased 9.9%.

Gross profit decreased 12.9% primarily due to higher cost of manufactured product.

The average cost of manufactured products sold per unit increased by 4.0% due to an increase in international units sold as a percentage of total units.  Profit margins can fluctuate depending upon, among other things, the cost of manufactured product and the capitalized cost of product recorded in inventory, as well as product sales mix.  Royalty expense increased 5.3% due to increased gross sales.

Operating expenses decreased 11.7% or $351 thousand.  The decrease was primarily due to a reduction in payroll costs as a result of a workforce reduction in the fourth quarter of 2018.

Our operating loss was $175 thousand compared to an operating loss of $157 thousand for the same period last year.  The increase was due primarily to the higher cost of manufactured products.

Our effective tax rate on the net loss before income taxes was 0.0% for both the three months ended March 31, 2019 and March 31, 2018.

Discussion of Balance Sheet and Statement of Cash Flow Items

Cash comprises 11.9% of total assets.  Working capital was $15.2 million at March 31, 2019, essentially unchanged from December 31, 2018.

Cash used by operations was $716 thousand for the three months ended March 31, 2019 due primarily to a decrease in accounts payable and other accrued liabilities, partially offset by a decrease in accounts receivable.

LIQUIDITY

At the present time, Management does not intend to publicly raise equity capital.  Due to the funds received from prior litigation and direct purchases of our stock, we have sufficient cash reserves and intend to rely on operations, cash reserves, and debt financing, when available, as the primary ongoing sources of cash. Our ability to obtain additional funds through loans is uncertain.

In the first quarter of 2019, we invested approximately $4.5 million in exchange-traded and closed-end funds (ETFs) and mutual funds.  These investments significantly decreased our cash accounts as of the date of the Condensed Balance Sheets.  However, we believe that these investments, along with our investment of approximately $3.0 million in debt securities with maturities of one to three years made in the fourth quarter of 2018, may increase our investment income in the future.

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 and Market Access

To routinely achieve positive or break even quarters, we need increased access to hospital markets which has been difficult to obtain.  We will continue to attempt to gain access to the market through our sales efforts, innovative technology, the introduction of new products, and, when necessary, litigation.

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We continue to focus on methods of upgrading our manufacturing capability and efficiency in order to reduce costs.

Fluctuations in the cost and availability of raw materials and inventory and our ability to maintain favorable manufacturing arrangements and relationships could result in the need to manufacture all (as opposed to 23.9%) of our products in the U.S. or find other manufacturers.  This could temporarily increase unit costs as we ramp up domestic production.

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.  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.

Seasonality

Historically, unit sales have increased during the flu season.

Cash Requirements

Due to funds received from prior litigation, we have sufficient cash reserves and intend to rely on operations, cash reserves, and debt financing, when available, as the primary ongoing sources of cash.  We have taken steps to decrease our legal costs and we continue to evaluate these costs.  We terminated 19 employees in the fourth quarter of 2018 which may reduce future costs, although some of the positions may be filled in the future.  In the future, if such cost cutting measures prove insufficient, we may reduce the number of units being produced, further reduce the workforce, reduce the salaries of officers and other employees, and/or defer royalty payments.

External Sources of Liquidity

We have obtained several loans since our inception, which have, together with the proceeds from the sales of equities and litigation efforts, enabled us to pursue development and production of our products.  Our ability to obtain additional funds through loans is uncertain.  Due to the current market price of our Common Stock, it is unlikely we would choose to raise funds by the public sale of equity.

CAPITAL RESOURCES

There were no material commitments for capital expenditures in the first quarter of 2019.

Item 3.Quantitative and Qualitative Disclosures About Market Risk.

No update.

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 March 31, 2019, our disclosure controls and procedures were effective.

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Changes in Internal Control Over Financial Reporting

There have been no changes during the first quarter of 2019 or subsequent to March 31, 2019 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.

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

None.

Item 3.Defaults Upon Senior Securities.

Working Capital Restrictions and Limitations on the Payment of Dividends

The Company declared a dividend to the Series I Class B and Series II Class B Convertible Preferred Shareholders in the aggregate amount of $55,113.  This dividend was paid on April 22, 2019.

The certificates of designation for each 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 and generally no junior preferred stock may be redeemed.  However, under certain conditions, and for certain Series of Class B Convertible Preferred Stock, we may purchase junior stock when dividends are in arrears.

Series I Class B Convertible Preferred Stock

For the three months ended March 31, 2019, no dividends were in arrears.

Series II Class B Convertible Preferred Stock

For the three months ended March 31, 2019, no dividends were in arrears.

Series III Class B Convertible Preferred Stock

For the three months ended March 31, 2019, the amount of dividends in arrears was $32,311 and the total arrearage was approximately $4,307,000 as of March 31, 2019.

Series IV Class B Convertible Preferred Stock

For the three months ended March 31, 2019, the amount of dividends in arrears was $85,625 and the total arrearage was approximately $6,569,000 as of March 31, 2019.

Series V Class B Convertible Preferred Stock

For the three months ended March 31, 2019, the amount of dividends in arrears was $3,200 and the total arrearage was approximately $1,012,000 as of March 31, 2019.

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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 March 31, 2019, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets as of March 31, 2019 and December 31, 2018, (ii) Condensed Statements of Operations for the three months ended March 31, 2019 and 2018, (iii) Condensed Statements of Cash Flows for the three months ended March 31, 2019 and 2018, (iv) Condensed Statement of Changes in Stockholders’ Equity for the three months ended March 31, 2019 and 2018; and (v) Notes to Condensed Financial Statements

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:    May 15, 2019	RETRACTABLE TECHNOLOGIES, INC.
	(Registrant)
	By:	/s/ John W. Fort III
		JOHN W. FORT III
		VICE PRESIDENT, CHIEF FINANCIAL OFFICER,
		AND CHIEF ACCOUNTING OFFICER

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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:May 15, 2019

/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:      May 15, 2019

/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 March 31, 2019, 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:May 15, 2019	/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	3 Months Ended
	Mar. 31, 2019	May 01, 2019
Document and Entity Information
Entity Registrant Name	RETRACTABLE TECHNOLOGIES INC
Entity Central Index Key	0000946563
Document Type	10-Q
Document Period End Date	Mar. 31, 2019
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Non-accelerated Filer
Trading Symbol	RVP
Entity Small Business	true
Entity Emerging Growth Company	false
Entity Common Stock, Shares Outstanding		32,674,954
Document Fiscal Year Focus	2019
Document Fiscal Period Focus	Q1

XML

CONDENSED BALANCE SHEETS - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Current assets:
Cash and cash equivalents	$ 4,228,624	$ 9,647,292
Accounts receivable, net	4,648,428	4,912,356
Investments in equity securities	4,558,714
Held-to-maturity securities, at amortized cost	997,176	996,233
Inventories, net	7,414,102	7,545,094
Income taxes receivable	100,887	100,887
Other current assets	718,095	644,803
Total current assets	22,666,026	23,846,665
Property, plant, and equipment, net	10,667,900	10,851,747
Held-to-maturity securities, at amortized cost (non-current)	1,991,119	1,989,923
Income taxes receivable	100,835	100,835
Other assets	145,441	165,856
Total assets	35,571,321	36,955,026
Current liabilities:
Accounts payable	4,847,357	5,369,677
Current portion of long-term debt	302,355	406,361
Accrued compensation	597,457	540,852
Dividends payable	55,113	55,113
Accrued royalties to shareholder	665,411	769,324
Other accrued liabilities	962,210	1,467,935
Income taxes payable	10,025	10,025
Total current liabilities	7,439,928	8,619,287
Other long-term liabilities	60,794	82,359
Long-term debt, net of current maturities	2,641,199	2,639,647
Total liabilities	10,141,921	11,341,293
Commitments and contingencies - See Note 8
Preferred stock, $1 par value:
Additional paid-in capital	61,816,644	61,871,756
Accumulated deficit	(37,168,689)	(37,039,468)
Total stockholders' equity	25,429,400	25,613,733
Total liabilities and stockholders' equity	35,571,321	36,955,026
Series I, Class B
Preferred stock, $1 par value:
Preferred stock	98,500	98,500
Series II, Class B
Preferred stock, $1 par value:
Preferred stock	171,200	171,200
Series III, Class B
Preferred stock, $1 par value:
Preferred stock	129,245	129,245
Series IV, Class B
Preferred stock, $1 par value:
Preferred stock	342,500	342,500
Series V, Class B
Preferred stock, $1 par value:
Preferred stock	$ 40,000	$ 40,000

XML

CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Mar. 31, 2019	Dec. 31, 2018
BALANCE SHEETS
Preferred stock, par value (in dollars per share)	$ 1	$ 1
Common stock, par value (in dollars per share)	$ 0	$ 0

XML

CONDENSED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Sales, net	$ 7,932,474	$ 7,672,801
Cost of sales
Total cost of sales	5,442,155	4,813,205
Gross profit	2,490,319	2,859,596
Operating expenses
Sales and marketing	875,546	1,165,461
Research and development	127,456	144,227
General and administrative	1,662,095	1,706,881
Total operating expenses	2,665,097	3,016,569
Loss from operations	(174,778)	(156,973)
Interest and other income	91,432	28,151
Interest expense	(45,875)	(50,392)
Loss before income taxes	(129,221)	(179,214)
Provision for income taxes		70
Net loss	(129,221)	(179,284)
Preferred Stock dividend requirements	(176,249)	(176,249)
Loss applicable to common shareholders	$ (305,470)	$ (355,533)
Basic loss per share (in dollars per share)	$ (0.01)	$ (0.01)
Diluted loss per share (in dollars per share)	$ (0.01)	$ (0.01)
Weighted average common shares outstanding:
Basic (in shares)	32,666,454	32,666,454
Diluted (in shares)	32,666,454	32,666,454
Costs of manufactured product
Cost of sales
Total cost of sales	$ 4,776,744	$ 4,181,010
Royalty expense to shareholder
Cost of sales
Total cost of sales	$ 665,411	$ 632,195

XML

CONDENSED STATEMENTS OF CASH FLOWS - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Cash flows from operating activities:
Net loss	$ (129,221)	$ (179,284)
Adjustments to reconcile net loss to net cash provided (used) by operating activities:
Depreciation and amortization	211,754	229,807
Unrealized gain on investments	(43,102)
(Increase) decrease in assets:
Accounts receivable	263,928	1,639,349
Inventories	130,992	(603,916)
Other current assets	(73,290)	(24,446)
Increase (decrease) in liabilities:
Accounts payable	(522,320)	(698,127)
Other accrued liabilities	(554,745)	234,068
Insurance proceeds		(149,792)
Income taxes payable		11,477
Net cash provided (used) by operating activities	(716,004)	459,136
Cash flows from investing activities:
Purchase of property, plant, and equipment	(29,485)	(76,294)
Investments	(4,515,612)
Net cash used by investing activities	(4,545,097)	(76,294)
Cash flows from financing activities:
Repayments of long-term debt	(102,454)	(111,370)
Payment of Preferred Stock dividends	(55,113)	(55,113)
Net cash used by financing activities	(157,567)	(166,483)
Net increase (decrease) in cash and cash equivalents	(5,418,668)	216,359
Cash and cash equivalents at:
Beginning of period	9,647,292	14,877,899
End of period	4,228,624	15,094,258
Supplemental schedule of cash flow information:
Interest paid	45,875	50,391
Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	$ 55,113	$ 55,113

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, Class B	Preferred Stock Series V, Class B	Additional Paid-in Capital	Accumulated Deficit	Total
Balance at Dec. 31, 2017	$ 98,500	$ 171,200	$ 129,245	$ 342,500	$ 40,000	$ 62,092,206	$ (35,699,525)	$ 27,174,126
Increase (Decrease) in Stockholders' Equity
Dividends						(55,112)		(55,112)
Net Loss							(179,284)	(179,284)
Balance at Mar. 31, 2018	98,500	171,200	129,245	342,500	40,000	62,037,094	(35,878,809)	26,939,730
Balance at Dec. 31, 2018	98,500	171,200	129,245	342,500	40,000	61,871,756	(37,039,468)	25,613,733
Increase (Decrease) in Stockholders' Equity
Dividends						(55,112)		(55,112)
Net Loss							(129,221)	(129,221)
Balance at Mar. 31, 2019	$ 98,500	$ 171,200	$ 129,245	$ 342,500	$ 40,000	$ 61,816,644	$ (37,168,689)	$ 25,429,400

XML

BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

3 Months Ended

Mar. 31, 2019

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.  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 28, 2019 for the year ended December 31, 2018.

XML

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

3 Months Ended

Mar. 31, 2019

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.

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 $146 thousand and $150 thousand as of March 31, 2019 and December 31, 2018, 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 7, Other Accrued Liabilities.

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

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.  A reserve is established for any excess or obsolete inventories or they may be written off.

Investments in Equity Securities

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

Investments – Held-to-Maturity Securities

The Company holds high-grade debt securities.  Since Management has the intent and ability to hold these securities until they mature, these investments have been accounted for as held-to-maturity investments.  The investments are carried at amortized cost.  Premiums and discounts on investments in debt securities are amortized over the contractual lives of these securities.  The method of amortization results in a constant effective yield on these securities.

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 property disposals are included in operations.

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 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 U.S. Treasury Notes are classified as held-to-maturity and are presented at their amortized cost, net of discounts and premiums. 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, U.S. Treasury Notes, 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 majority of accounts receivable are due from companies which are well-established entities.  As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the first quarters of 2019 and 2018:

	Three Months Ended			Three Months Ended
	March 31, 2019			March 31, 2018
Number of significant customers		3			4
Aggregate dollar amount of net sales to significant customers	$	3.9	million	$	4.9	million
Percentage of net sales to significant customers		48.6	%		63.3	%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 76.1% and 83.9% of its products in the first three months of 2019 and 2018, respectively, from its Chinese manufacturers.  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.  Rebates are recorded when issued and 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 $3,413,037 and $3,896,341 as of March 31, 2019 and December 31, 2018, 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 within 30 to 60 days of receipt at the time product is shipped.

Disaggregated information of revenue recognized from contracts with customers is as follows:

	For the three months ended March 31, 2019:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	5,625,387	$	451,077	$	48,472	$	14,975	$	6,139,911
North and South America sales (excluding U.S.)		1,330,330		3,863		252		925		1,335,370
Other international sales		241,243		210,700		—		5,250		457,193
Total	$	7,196,960	$	665,640	$	48,724	$	21,150	$	7,932,474

	For the three months ended March 31, 2018:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	6,264,189	$	235,085	$	83,285	$	14,421	$	6,596,980
North and South America sales (excluding U.S.)		1,024,204		6,055		252		900		1,031,411
Other international sales		41,300		2,760		—		350		44,410
Total	$	7,329,693	$	243,900	$	83,537	$	15,671	$	7,672,801

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.  The Company has established a valuation allowance for its net deferred tax asset as future taxable income cannot be reasonably assured.  Penalties and interest related to income tax are classified as General and administrative expense and Interest expense, respectively, in the Condensed Statements of Operations.

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 or common stock issuable upon the conversion of convertible preferred stock.  The calculation of diluted EPS excluded 26 thousand shares of Common Stock underlying issued and outstanding stock options at March 31, 2018 as their effect was antidilutive.  The potential dilution, if any, is shown on the following schedule:

	Three Months Ended		Three Months Ended
	March 31, 2019		March 31, 2018
Net loss	$	(129,221)	$	(179,284)
Preferred stock dividend requirements		(176,249)		(176,249)
Loss applicable to common shareholders	$	(305,470)	$	(355,533)
Weighted average common shares outstanding		32,666,454		32,666,454
Weighted average common and common equivalent shares outstanding — assuming dilution		32,666,454		32,666,454
Basic loss per share	$	(0.01)	$	(0.01)
Diluted loss per share	$	(0.01)	$	(0.01)

Shipping and handling costs

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

Self-insured employee benefit plan costs

The Company self-insures health insurance benefits for its employees under certain policy limits.  The Company has additional coverage provided by an insurance company.  The Company accrues for the cost of such benefits based on known claims and an estimate of incurred but not reported claims.

Research and development costs

Research and development costs are expensed as incurred.

Leases

The Company adopted ASU 2016-02, Leases (Topic 842), as amended January 1, 2019, effective for the quarter ended March 31, 2019.  The Company elected the comparative reporting relief practical expedient, which allows for the application of transition adjustments as of the adoption date rather than the beginning of the earliest period presented. 

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in other assets, other current 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.  The Company did not elect to separate lease and non-lease components at the transition date. The Company elected the package of practical expedients permitted under the transition guidance, which among other things, allows the Company to carry forward the historical lease classification and elect hindsight to determine certain lease terms for existing leases.

Recently Adopted Pronouncements

In August 2018, the Securities and Exchange Commission (SEC) adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, “Disclosure Update and Simplification”. The amendments were effective November 5, 2018.  The amendments eliminate or revise several redundant or duplicative requirements between SEC rules and GAAP, including the elimination of the disclosure of the ratio of earnings to fixed charges and the presentation of dividends per share on the face of the statement of operations for interim periods.  Among the amendments is the requirement to present the changes in shareholders’ equity in the interim financial statements (either in a separate statement or footnote) in quarterly reports on Form 10-Q. The amendments are effective for all filings made on or after November 5, 2018. In light of the timing of effectiveness of the amendments and proximity of effectiveness to the filing date for most filers’ quarterly reports, the SEC staff indicated that it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its Form 10-Q for the quarter that begins after the effective date of the amendments.  The Company elected to adopt the provisions of Securities Act Release No. 33-10532 for the quarter ended September 30, 2018.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, as well as several subsequently issued clarifying amendments. Under the ASU, as amended, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee‘s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the guidance, lessor accounting is largely unchanged. The lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. In July 2018, the FASB issued ASU 2018-10, “Codification Improvements to Topic 842, Leases”. This amendment clarifies Topic 842 and corrected unintended application of guidance and is effective concurrent with Topic 842 or upon issuance if Topic 842 was early adopted.  In August 2018, the FASB issued ASU 2018-11, “Leases (Topic 842):  Targeted Improvements”. This amendment provides additional transition options allowing entities to recognize a cumulative effect adjustment to the opening balance of retained earnings in the period of adoption rather than the earliest period presented and provides a practical expedient to lessors to elect, by class of underlying assets, to account for non-lease and lease components as a single arrangement.  The Company adopted the provisions of ASU 2018-11 through a cumulative effect adjustment.  Topic 842, and its subsequent amendments, was effective for the Company’s quarter ended March 31, 2019. The Company has completed evaluating the various accounting policy elections associated with this ASU, as amended, including transition methods and practical expedients, identifying contracts for evaluation, and reviewing contracts to determine if they contain leases.  The Company completed evaluating the timing and impact of adopting ASU 2016-02, as amended, and recorded lease assets and liabilities of $163,007 on its Balance Sheets, with no impact to its accumulated deficit.

The following table summarizes the impact of the adoption of ASU 2016-02 to the previously reported results:

			New Lease
	As Previously		Standard		As
Balance Sheet as of December 31, 2018	Reported		Adjustment		Restated
Other assets	$	2,849	$	163,007	$	165,856
Other current liabilities		1,387,287		80,648		1,467,935
Other long-term liabilities		—		82,359		82,359

Recently Issued Pronouncements

In June 2016, the FASB issued Accounting Standards Update 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments.  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 today will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  This ASU is effective for the Company’s quarter ending March 31, 2020 with early application permitted for the Company’s quarter ending March 31, 2019.  The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and related disclosures.

In August 2018, the FASB issued 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)”.  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.  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 amendment is effective for annual periods beginning after December 15, 2019 and interim periods within those annual periods.  The Company is currently assessing the impact that adoption of this ASU will have on its financial statements and related disclosures.

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INVENTORIES

3 Months Ended

Mar. 31, 2019

INVENTORIES

INVENTORIES

3.    INVENTORIES

Inventories consist of the following:

	March 31, 2019		December 31, 2018
Raw materials	$	1,492,331	$	1,399,543
Finished goods		6,218,979		6,442,759
		7,711,310		7,842,302
Inventory reserve		(297,208)		(297,208)
	$	7,414,102	$	7,545,094

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FAIR VALUE OF FINANCIAL INSTRUMENTS

3 Months Ended

Mar. 31, 2019

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 our assets designated as Investments in equity securities:

	March 31, 2019
	Level 1		Level 2		Level 3		Total
Investments in equity securities	$	4,558,714	$	—	$	—	$	4,558,714

	December 31, 2018
	Level 1		Level 2		Level 3		Total
Investments in equity securities	$	—	$	—	$	—	$	—

The Company holds high-grade exchange-traded and closed-end funds (ETFs) and mutual funds as investments.  These assets are readily marketable and are carried at market value as of the date of the Condensed Balance Sheets. The Company intends to hold these assets for possible future investment income.

March 31, 2019
		Gross Unrealized				Aggregate
Cost		Gains		Losses		Fair Value
$	4,515,612	$	43,102	$	—	$	4,558,714

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HELD-TO-MATURITY DEBT SECURITIES

3 Months Ended

Mar. 31, 2019

HELD-TO-MATURITY DEBT SECURITIES

HELD-TO-MATURITY DEBT SECURITIES

5.    HELD-TO-MATURITY DEBT SECURITIES

The Company’s investment securities classified as held-to maturity consist of high-grade debt securities and certificates of deposit.  These investments are carried at amortized cost.  Gross unrecognized gains and losses and fair value of these securities at March 31, 2019 are as follows:

	March 31, 2019
			Gross Unrecognized				Aggregate
	Amortized Cost		Gains		Losses		Fair Value
Current	$	997,176	$	167	$	—	$	997,343
Long-Term		1,991,119		5,545		—		1,996,664
Total	$	2,988,295	$	5,712	$	—	$	2,994,007

The fair value of investments in held-to maturity securities is valued under the market approach through the use of quoted prices.

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INCOME TAXES

3 Months Ended

Mar. 31, 2019

INCOME TAXES

INCOME TAXES

6.    INCOME TAXES

The Company’s effective tax rate on the net loss before income taxes was 0.0% for both the three months ended March 31, 2019 and March 31, 2018.

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OTHER ACCRUED LIABILITIES

3 Months Ended

Mar. 31, 2019

OTHER ACCRUED LIABILITIES

OTHER ACCRUED LIABILITIES

7.    OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

	March 31, 2019		December 31, 2018
Prepayments from customers	$	377,837	$	860,926
Accrued property taxes		114,000		170,568
Accrued professional fees		317,185		294,903
Other accrued expenses		153,188		141,538
	$	962,210		1,467,935

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COMMITMENTS AND CONTINGENCIES

3 Months Ended

Mar. 31, 2019

COMMITMENTS AND CONTINGENCIES

COMMITMENTS AND CONTINGENCIES

8.    COMMITMENTS AND CONTINGENCIES

In May 2010, the Company and an officer's suit, initiated in 2007, against Becton, Dickinson and Company (“BD”) in the U.S. District Court for the Eastern District of Texas, Marshall Division alleging violations of antitrust acts, false advertising, product disparagement, tortious interference, and unfair competition was reopened.  After a series of appeals, this case was ultimately settled by the Settlement Agreement and Release (the “Settlement Agreement”) among the Company, an officer of the Company, BD, and MDC Investment Holdings, Inc. (“MDC”) whereby the Company and an officer and other affiliates (together, the “RTI Releasors”) released all claims arising prior to May 3, 2019 against BD and MDC and their affiliates (together, the “BD Releasors”).  Likewise, pursuant to the Settlement Agreement, the BD Releasors released all claims arising prior to May 3, 2019 against the RTI Releasors.  As a result of the Settlement Agreement, on May 6, 2019, the Company and an officer filed in the U.S. Court of Appeals for the Fifth Circuit a withdrawal of a petition for rehearing en banc filed on April 23, 2019, effectively leaving the take-nothing judgment of that court intact and ending further proceedings.

In September 2007, BD and MDC sued the Company in the U.S. District Court for the Eastern District of Texas, Texarkana Division, initially alleging that the Company is infringing two U.S. patents of MDC (6,179,812 and 7,090,656) that are licensed to BD.  This case, which had been stayed since 2015, was settled pursuant to the Settlement Agreement referenced in the preceding paragraph.  As a result of the Settlement Agreement, on May 6, 2019, BD, MDC, and the Company filed a stipulation with the U.S. District Court for the Eastern District of Texas, Texarkana Division that the claims in this action should be dismissed with prejudice without costs or attorneys’ fees to any of the parties.

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BUSINESS SEGMENT

3 Months Ended

Mar. 31, 2019

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
	March 31, 2019		March 31, 2018
U.S. sales	$	6,139,911	$	6,596,980
North and South America sales (excluding U.S.)		1,335,370		1,031,411
Other international sales		457,193		44,410
Total sales	$	7,932,474	$	7,672,801

Long-lived assets by geography are as follows:

	March 31, 2019		December 31, 2018
Long-lived assets
U.S.	$	10,560,437	$	10,738,253
International		107,463		113,494
Total	$	10,667,900	$	10,851,747

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DIVIDENDS

3 Months Ended

Mar. 31, 2019

DIVIDENDS

DIVIDENDS

10.  DIVIDENDS

The Board declared and the Company paid dividends in 2018 in the amounts of $12,313 and $42,800  paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on January 19, 2018, April 24, 2018, July 20, 2018, and October 23, 2018.  The Board declared and the Company paid dividends in 2019 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on January 18, 2019 and April 22, 2019.

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LEASES

3 Months Ended

Mar. 31, 2019

LEASES

LEASES

11.  LEASES

The Company has operating leases for a corporate office and equipment.  The leases have remaining lease terms of one to two years. The Company currently has no finance leases. The ROU asset is determined based on the lease liability adjusted for lease incentives received. Lease expense is recognized on a straight-line basis over the lease term. The leases may include various expenses incidental to the use of the property, such as common area maintenance, property taxes and insurance. These costs are separate from the minimum rent payment and are not considered in the determination of the lease liability and ROU asset. The Company has not noted any material instances in its leases where these costs were combined with the minimum rent payment and has therefore elected the policy to not separate lease from non-lease components if they are combined with the minimum rent payment. The option periods are not included in the determination of the lease liability and ROU asset as the Company is not reasonably certain if it will extend at the time of lease commencement.

The operating lease cost component of the lease expense was $19,854  at March 31, 2019.  The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $19,854 for the three months ended March 31, 2019.

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

	March 31, 2019		December 31, 2018
OPERATING LEASES
Other assets	$	143,153	$	163,007
Other accrued liabilities	$	82,359	$	80,648
Other long-term liabilities		60,794		82,359
Total operating lease liabilities	$	143,153	$	163,007

The weighted average remaining lease term is 1.73 years and the weighted average discount rate is 4.04%.

Future minimum payments under non-cancelable operating leases and financing leases consist of the following at March 31, 2019:

Year ended December 31,
2019	$	64,308
2020		84,155
Total		148,463
Less imputed interest		5,310
Total	$	143,153

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SUBSEQUENT EVENTS

3 Months Ended

Mar. 31, 2019

SUBSEQUENT EVENTS

SUBSEQUENT EVENTS

12.  SUBSEQUENT EVENTS

Effective May 3, 2019, the Company and an officer settled litigation with both BD and MDC, whereby BD and MDC released the Company and its officer from claims arising prior to May 3, 2019.  Likewise, pursuant to the settlement, the Company and its officer released BD and MDC from claims arising prior to May 3, 2019.  This settlement effectively disposed of an antitrust and false advertising lawsuit by the Company and an officer against BD, as well as a suit by BD and MDC against the Company for patent infringement.  See Note 8.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

3 Months Ended

Mar. 31, 2019

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.

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 $146 thousand and $150 thousand as of March 31, 2019 and December 31, 2018, 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 7, Other Accrued Liabilities.

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

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.  A reserve is established for any excess or obsolete inventories or they may be written off.

Investments in Equity Securities

Investments in Equity Securities

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

Investments - Held-to-Maturity Securities

Investments – Held-to-Maturity Securities

The Company holds high-grade debt securities.  Since Management has the intent and ability to hold these securities until they mature, these investments have been accounted for as held-to-maturity investments.  The investments are carried at amortized cost.  Premiums and discounts on investments in debt securities are amortized over the contractual lives of these securities.  The method of amortization results in a constant effective yield on these securities.

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 property disposals are included in operations.

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 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 U.S. Treasury Notes are classified as held-to-maturity and are presented at their amortized cost, net of discounts and premiums. 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, U.S. Treasury Notes, 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 majority of accounts receivable are due from companies which are well-established entities.  As a consequence, Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the first quarters of 2019 and 2018:

	Three Months Ended			Three Months Ended
	March 31, 2019			March 31, 2018
Number of significant customers		3			4
Aggregate dollar amount of net sales to significant customers	$	3.9	million	$	4.9	million
Percentage of net sales to significant customers		48.6	%		63.3	%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained roughly 76.1% and 83.9% of its products in the first three months of 2019 and 2018, respectively, from its Chinese manufacturers.  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.  Rebates are recorded when issued and 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 $3,413,037 and $3,896,341 as of March 31, 2019 and December 31, 2018, 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 within 30 to 60 days of receipt at the time product is shipped.

Disaggregated information of revenue recognized from contracts with customers is as follows:

	For the three months ended March 31, 2019:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	5,625,387	$	451,077	$	48,472	$	14,975	$	6,139,911
North and South America sales (excluding U.S.)		1,330,330		3,863		252		925		1,335,370
Other international sales		241,243		210,700		—		5,250		457,193
Total	$	7,196,960	$	665,640	$	48,724	$	21,150	$	7,932,474

	For the three months ended March 31, 2018:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	6,264,189	$	235,085	$	83,285	$	14,421	$	6,596,980
North and South America sales (excluding U.S.)		1,024,204		6,055		252		900		1,031,411
Other international sales		41,300		2,760		—		350		44,410
Total	$	7,329,693	$	243,900	$	83,537	$	15,671	$	7,672,801

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.  The Company has established a valuation allowance for its net deferred tax asset as future taxable income cannot be reasonably assured.  Penalties and interest related to income tax are classified as General and administrative expense and Interest expense, respectively, in the Condensed Statements of Operations.

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 or common stock issuable upon the conversion of convertible preferred stock.  The calculation of diluted EPS excluded 26 thousand shares of Common Stock underlying issued and outstanding stock options at March 31, 2018 as their effect was antidilutive.  The potential dilution, if any, is shown on the following schedule:

	Three Months Ended		Three Months Ended
	March 31, 2019		March 31, 2018
Net loss	$	(129,221)	$	(179,284)
Preferred stock dividend requirements		(176,249)		(176,249)
Loss applicable to common shareholders	$	(305,470)	$	(355,533)
Weighted average common shares outstanding		32,666,454		32,666,454
Weighted average common and common equivalent shares outstanding — assuming dilution		32,666,454		32,666,454
Basic loss per share	$	(0.01)	$	(0.01)
Diluted loss per share	$	(0.01)	$	(0.01)

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.

Self-insured employee benefit plan costs

Self-insured employee benefit plan costs

The Company self-insures health insurance benefits for its employees under certain policy limits.  The Company has additional coverage provided by an insurance company.  The Company accrues for the cost of such benefits based on known claims and an estimate of incurred but not reported claims.

Research and development costs

Research and development costs

Research and development costs are expensed as incurred.

Leases

Leases

The Company adopted ASU 2016-02, Leases (Topic 842), as amended January 1, 2019, effective for the quarter ended March 31, 2019.  The Company elected the comparative reporting relief practical expedient, which allows for the application of transition adjustments as of the adoption date rather than the beginning of the earliest period presented. 

The Company determines if an arrangement is a lease at inception.  Operating and finance leases are included in other assets, other current 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.  The Company did not elect to separate lease and non-lease components at the transition date. The Company elected the package of practical expedients permitted under the transition guidance, which among other things, allows the Company to carry forward the historical lease classification and elect hindsight to determine certain lease terms for existing leases.

Recently Adopted Pronouncements and Recently Issued Pronouncements

Recently Adopted Pronouncements

In August 2018, the Securities and Exchange Commission (SEC) adopted amendments to certain disclosure requirements in Securities Act Release No. 33-10532, “Disclosure Update and Simplification”. The amendments were effective November 5, 2018.  The amendments eliminate or revise several redundant or duplicative requirements between SEC rules and GAAP, including the elimination of the disclosure of the ratio of earnings to fixed charges and the presentation of dividends per share on the face of the statement of operations for interim periods.  Among the amendments is the requirement to present the changes in shareholders’ equity in the interim financial statements (either in a separate statement or footnote) in quarterly reports on Form 10-Q. The amendments are effective for all filings made on or after November 5, 2018. In light of the timing of effectiveness of the amendments and proximity of effectiveness to the filing date for most filers’ quarterly reports, the SEC staff indicated that it would not object if the filer’s first presentation of the changes in shareholders’ equity is included in its Form 10-Q for the quarter that begins after the effective date of the amendments.  The Company elected to adopt the provisions of Securities Act Release No. 33-10532 for the quarter ended September 30, 2018.

In February 2016, the FASB issued ASU No. 2016-02, “Leases (Topic 842)”, as well as several subsequently issued clarifying amendments. Under the ASU, as amended, lessees will be required to recognize the following for all leases (with the exception of short-term leases) at the commencement date: (1) a lease liability, which is a lessee‘s obligation to make lease payments arising from a lease, measured on a discounted basis; and (2) a right-of-use asset, which is an asset that represents the lessee’s right to use, or control the use of, a specified asset for the lease term. Under the guidance, lessor accounting is largely unchanged. The lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. In July 2018, the FASB issued ASU 2018-10, “Codification Improvements to Topic 842, Leases”. This amendment clarifies Topic 842 and corrected unintended application of guidance and is effective concurrent with Topic 842 or upon issuance if Topic 842 was early adopted.  In August 2018, the FASB issued ASU 2018-11, “Leases (Topic 842):  Targeted Improvements”. This amendment provides additional transition options allowing entities to recognize a cumulative effect adjustment to the opening balance of retained earnings in the period of adoption rather than the earliest period presented and provides a practical expedient to lessors to elect, by class of underlying assets, to account for non-lease and lease components as a single arrangement.  The Company adopted the provisions of ASU 2018-11 through a cumulative effect adjustment.  Topic 842, and its subsequent amendments, was effective for the Company’s quarter ended March 31, 2019. The Company has completed evaluating the various accounting policy elections associated with this ASU, as amended, including transition methods and practical expedients, identifying contracts for evaluation, and reviewing contracts to determine if they contain leases.  The Company completed evaluating the timing and impact of adopting ASU 2016-02, as amended, and recorded lease assets and liabilities of $163,007 on its Balance Sheets, with no impact to its accumulated deficit.

The following table summarizes the impact of the adoption of ASU 2016-02 to the previously reported results:

			New Lease
	As Previously		Standard		As
Balance Sheet as of December 31, 2018	Reported		Adjustment		Restated
Other assets	$	2,849	$	163,007	$	165,856
Other current liabilities		1,387,287		80,648		1,467,935
Other long-term liabilities		—		82,359		82,359

Recently Issued Pronouncements

In June 2016, the FASB issued Accounting Standards Update 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments.  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 today will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses.  This ASU is effective for the Company’s quarter ending March 31, 2020 with early application permitted for the Company’s quarter ending March 31, 2019.  The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and related disclosures.

In August 2018, the FASB issued 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)”.  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.  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 amendment is effective for annual periods beginning after December 15, 2019 and interim periods within those annual periods.  The Company is currently assessing the impact that adoption of this ASU will have on its financial statements and related disclosures.

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

3 Months Ended

Mar. 31, 2019

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
	March 31, 2019			March 31, 2018
Number of significant customers		3			4
Aggregate dollar amount of net sales to significant customers	$	3.9	million	$	4.9	million
Percentage of net sales to significant customers		48.6	%		63.3	%

Schedule of disaggregated information of revenue recognized from contracts with customers

	For the three months ended March 31, 2019:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	5,625,387	$	451,077	$	48,472	$	14,975	$	6,139,911
North and South America sales (excluding U.S.)		1,330,330		3,863		252		925		1,335,370
Other international sales		241,243		210,700		—		5,250		457,193
Total	$	7,196,960	$	665,640	$	48,724	$	21,150	$	7,932,474

	For the three months ended March 31, 2018:
			Blood						Total
			Collection		EasyPoint®		Other		Product
Geographic Segment	Syringes		Products		Needles		Products		Sales
U.S. sales	$	6,264,189	$	235,085	$	83,285	$	14,421	$	6,596,980
North and South America sales (excluding U.S.)		1,024,204		6,055		252		900		1,031,411
Other international sales		41,300		2,760		—		350		44,410
Total	$	7,329,693	$	243,900	$	83,537	$	15,671	$	7,672,801

Schedule of earnings per share

	Three Months Ended		Three Months Ended
	March 31, 2019		March 31, 2018
Net loss	$	(129,221)	$	(179,284)
Preferred stock dividend requirements		(176,249)		(176,249)
Loss applicable to common shareholders	$	(305,470)	$	(355,533)
Weighted average common shares outstanding		32,666,454		32,666,454
Weighted average common and common equivalent shares outstanding — assuming dilution		32,666,454		32,666,454
Basic loss per share	$	(0.01)	$	(0.01)
Diluted loss per share	$	(0.01)	$	(0.01)

Summary of impact on adoption of ASU 2016-02 to previously reported results relating to balance sheet

			New Lease
	As Previously		Standard		As
Balance Sheet as of December 31, 2018	Reported		Adjustment		Restated
Other assets	$	2,849	$	163,007	$	165,856
Other current liabilities		1,387,287		80,648		1,467,935
Other long-term liabilities		—		82,359		82,359

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INVENTORIES (Tables)

3 Months Ended

Mar. 31, 2019

INVENTORIES

Schedule of inventories

	March 31, 2019		December 31, 2018
Raw materials	$	1,492,331	$	1,399,543
Finished goods		6,218,979		6,442,759
		7,711,310		7,842,302
Inventory reserve		(297,208)		(297,208)
	$	7,414,102	$	7,545,094

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FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)

3 Months Ended

Mar. 31, 2019

FAIR VALUE OF FINANCIAL INSTRUMENTS

Summary of value of assets designated as investments in equity securities

	March 31, 2019
	Level 1		Level 2		Level 3		Total
Investments in equity securities	$	4,558,714	$	—	$	—	$	4,558,714

	December 31, 2018
	Level 1		Level 2		Level 3		Total
Investments in equity securities	$	—	$	—	$	—	$	—

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

March 31, 2019
		Gross Unrealized				Aggregate
Cost		Gains		Losses		Fair Value
$	4,515,612	$	43,102	$	—	$	4,558,714

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HELD-TO-MATURITY DEBT SECURITIES (Tables)

3 Months Ended

Mar. 31, 2019

HELD-TO-MATURITY DEBT SECURITIES

Schedule of gross unrecognized gains and losses and fair value of securities

	March 31, 2019
			Gross Unrecognized				Aggregate
	Amortized Cost		Gains		Losses		Fair Value
Current	$	997,176	$	167	$	—	$	997,343
Long-Term		1,991,119		5,545		—		1,996,664
Total	$	2,988,295	$	5,712	$	—	$	2,994,007

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OTHER ACCRUED LIABILITIES (Tables)

3 Months Ended

Mar. 31, 2019

OTHER ACCRUED LIABILITIES

Schedule of other accrued liabilities

	March 31, 2019		December 31, 2018
Prepayments from customers	$	377,837	$	860,926
Accrued property taxes		114,000		170,568
Accrued professional fees		317,185		294,903
Other accrued expenses		153,188		141,538
	$	962,210		1,467,935

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BUSINESS SEGMENT (Tables)

3 Months Ended

Mar. 31, 2019

BUSINESS SEGMENT

Summary of sales and long-lived assets by geography

Revenues by geography are as follows:

	Three Months Ended		Three Months Ended
	March 31, 2019		March 31, 2018
U.S. sales	$	6,139,911	$	6,596,980
North and South America sales (excluding U.S.)		1,335,370		1,031,411
Other international sales		457,193		44,410
Total sales	$	7,932,474	$	7,672,801

Long-lived assets by geography are as follows:

	March 31, 2019		December 31, 2018
Long-lived assets
U.S.	$	10,560,437	$	10,738,253
International		107,463		113,494
Total	$	10,667,900	$	10,851,747

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LEASES (Tables)

3 Months Ended

Mar. 31, 2019

LEASES

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

	March 31, 2019		December 31, 2018
OPERATING LEASES
Other assets	$	143,153	$	163,007
Other accrued liabilities	$	82,359	$	80,648
Other long-term liabilities		60,794		82,359
Total operating lease liabilities	$	143,153	$	163,007

Schedule of future minimum payments under non-cancelable operating leases and financing leases

Year ended December 31,
2019	$	64,308
2020		84,155
Total		148,463
Less imputed interest		5,310
Total	$	143,153

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accounts receivable and Property, plant and equipment (Details) $ in Thousands	3 Months Ended
	Mar. 31, 2019 USD ($) item	Dec. 31, 2018 USD ($)
Accounts receivable
Number of products consigned to customers | item	0
Allowance for bad debt | $	$ 146	$ 150
Production equipment | Minimum
Property, plant, and equipment
Useful lives	3 years
Production equipment | Maximum
Property, plant, and equipment
Useful lives	13 years
Office furniture, fixtures, and equipment | Minimum
Property, plant, and equipment
Useful lives	3 years
Office furniture, fixtures, and equipment | Maximum
Property, plant, and equipment
Useful lives	10 years
Buildings
Property, plant, and equipment
Useful lives	39 years
Building Improvements
Property, plant, and equipment
Useful lives	15 years

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration risks (Details)	3 Months Ended
	Mar. 31, 2019 USD ($) customer	Mar. 31, 2018 USD ($) customer
Concentration risks
Number of significant customers | customer	3	4
Aggregate dollar amount of net sales to significant customers	$ 7,932,474	$ 7,672,801
Sales | Customer Concentration Risk
Concentration risks
Aggregate dollar amount of net sales to significant customers	$ 3,900,000	$ 4,900,000
Percentage of net sales to significant customers (as a percent)	48.60%	63.30%
Cost of Goods, Product Line | Supplier Concentration Risk
Concentration risks
Percentage of net sales to significant customers (as a percent)	76.10%	83.90%

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue recognition and Income taxes (Details)	3 Months Ended
	Mar. 31, 2019 USD ($) item	Mar. 31, 2018 USD ($)	Dec. 31, 2018 USD ($)
Revenue recognition
Estimated contractual allowance	$ 3,413,037		$ 3,896,341
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%
Total	$ 7,932,474	$ 7,672,801
Income taxes
Provision for income taxes		70
Minimum
Revenue recognition
Period of revenue recognition	30 days
Maximum
Revenue recognition
Period of revenue recognition	60 days
Syringes
Revenue recognition
Total	$ 7,196,960	7,329,693
Blood Collection Products
Revenue recognition
Total	665,640	243,900
Easy Point Needles
Revenue recognition
Total	48,724	83,537
Other Products
Revenue recognition
Total	21,150	15,671
UNITED STATES
Revenue recognition
Total	6,139,911	6,596,980
UNITED STATES | Syringes
Revenue recognition
Total	5,625,387	6,264,189
UNITED STATES | Blood Collection Products
Revenue recognition
Total	451,077	235,085
UNITED STATES | Easy Point Needles
Revenue recognition
Total	48,472	83,285
UNITED STATES | Other Products
Revenue recognition
Total	14,975	14,421
North and South America sales (excluding U.S.)
Revenue recognition
Total	1,335,370	1,031,411
North and South America sales (excluding U.S.) | Syringes
Revenue recognition
Total	1,330,330	1,024,204
North and South America sales (excluding U.S.) | Blood Collection Products
Revenue recognition
Total	3,863	6,055
North and South America sales (excluding U.S.) | Easy Point Needles
Revenue recognition
Total	252	252
North and South America sales (excluding U.S.) | Other Products
Revenue recognition
Total	925	900
Other international sales
Revenue recognition
Total	457,193	44,410
Other international sales | Syringes
Revenue recognition
Total	241,243	41,300
Other international sales | Blood Collection Products
Revenue recognition
Total	210,700	2,760
Other international sales | Other Products
Revenue recognition
Total	$ 5,250	$ 350

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
Earnings per share
Stock options excluded from calculation of diluted EPS		26,000
Net loss	$ (129,221)	$ (179,284)
Preferred stock dividend requirements	(176,249)	(176,249)
Loss applicable to common shareholders	$ (305,470)	$ (355,533)
Weighted average common shares outstanding	32,666,454	32,666,454
Weighted average common and common equivalent shares outstanding - assuming dilution	32,666,454	32,666,454
Basic loss per share (in dollars per share)	$ (0.01)	$ (0.01)
Diluted loss per share (in dollars per share)	$ (0.01)	$ (0.01)

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SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Recently Adopted Pronouncements (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Recently Adopted Pronouncements
Other assets	$ 145,441	$ 165,856
Other current liabilities	962,210	1,467,935
Other long-term liabilities	$ 60,794	82,359
ASU 2016-02 | As Previously Reported
Recently Adopted Pronouncements
Other assets		2,849
Other current liabilities		1,387,287
ASU 2016-02 | New Lease Standard Adjustment
Recently Adopted Pronouncements
Other assets		163,007
Other current liabilities		80,648
Other long-term liabilities		$ 82,359

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INVENTORIES (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
INVENTORIES
Raw materials	$ 1,492,331	$ 1,399,543
Finished goods	6,218,979	6,442,759
Inventory, gross	7,711,310	7,842,302
Inventory reserve	(297,208)	(297,208)
Inventory, net	$ 7,414,102	$ 7,545,094

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FAIR VALUE OF FINANCIAL INSTRUMENTS (Details)	3 Months Ended
	Mar. 31, 2019 USD ($)
Investments in equity securities
Investments in equity securities	$ 4,558,714
Gross Unrealized
Cost	4,515,612
Gains	43,102
Level 1
Investments in equity securities
Investments in equity securities	$ 4,558,714

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HELD-TO-MATURITY DEBT SECURITIES (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
HELD-TO-MATURITY DEBT SECURITIES
Amortized Cost	$ 997,176	$ 996,233
Gross Unrecognized Gains	167
Aggregate Fair Value	997,343
Amortized Cost	1,991,119	$ 1,989,923
Gross Unrecognized Gains	5,545
Aggregate Fair Value	1,996,664
Total
Amortized Cost	2,988,295
Gross Unrecognized Gains	5,712
Aggregate Fair Value	$ 2,994,007

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INCOME TAXES (Details)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018
INCOME TAXES
Effective tax rate (as a percent)	0.00%	0.00%

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OTHER ACCRUED LIABILITIES (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
OTHER ACCRUED LIABILITIES
Prepayments from customers	$ 377,837	$ 860,926
Accrued property taxes	114,000	170,568
Accrued professional fees	317,185	294,903
Other accrued expenses	153,188	141,538
Total	$ 962,210	$ 1,467,935

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COMMITMENTS AND CONTINGENCIES (Details)	Sep. 30, 2007 item
BD and MDC Investment Holdings Inc Case
COMMITMENTS AND CONTINGENCIES
Number of U.S. patents infringed upon	2

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BUSINESS SEGMENT (Details) - USD ($)	3 Months Ended
	Mar. 31, 2019	Mar. 31, 2018	Dec. 31, 2018
Sales by geography
Total	$ 7,932,474	$ 7,672,801
Long-lived assets
Long-lived assets	10,667,900		$ 10,851,747
UNITED STATES
Sales by geography
Total	6,139,911	6,596,980
Long-lived assets
Long-lived assets	10,560,437		10,738,253
North and South America sales (excluding U.S.)
Sales by geography
Total	1,335,370	1,031,411
Other international sales
Sales by geography
Total	457,193	$ 44,410
International
Long-lived assets
Long-lived assets	$ 107,463		$ 113,494

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DIVIDENDS (Details) - USD ($)							3 Months Ended
	Apr. 22, 2019	Jan. 18, 2019	Oct. 23, 2018	Jul. 20, 2018	Apr. 24, 2018	Jan. 19, 2018	Mar. 31, 2019	Mar. 31, 2018
Dividends
Preferred dividends declared							$ 55,113	$ 55,113
Series I, Class B
Dividends
Preferred dividends declared	$ 12,313	$ 12,313	$ 12,313	$ 12,313	$ 12,313	$ 12,313
Series II, Class B
Dividends
Preferred dividends declared	$ 42,800	$ 42,800	$ 42,800	$ 42,800	$ 42,800	$ 42,800

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LEASES (Details) - USD ($)	3 Months Ended
	Mar. 31, 2019	Dec. 31, 2018
LEASES
Operating lease cost	$ 19,854
Cash outflows related to leases	19,854
Assets and liabilities associated with these leases in Balance Sheets
Right-of use assets	$ 143,153	$ 163,007
Operating Lease, Right-of-Use Asset, Statement of Financial Position [Extensible List]	Other Assets	Other Assets
Operating lease liabilities current	$ 82,359	$ 80,648
Operating Lease, Liability, Current, Statement of Financial Position [Extensible List]	Other Accrued Liabilities, Current	Other Accrued Liabilities, Current
Operating lease liabilities non-current	$ 60,794	$ 82,359
Operating Lease, Liability, Noncurrent, Statement of Financial Position [Extensible List]	Other Liabilities, Noncurrent	Other Liabilities, Noncurrent
Total operating lease liabilities	$ 143,153	$ 163,007
Weighted average remaining lease term	1 year 8 months 23 days
Weighted average discount rate	4.04%
Minimum
LEASES
Remaining lease term	1 year
Maximum
LEASES
Remaining lease term	2 years

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LEASES - Future minimum payments (Details) - USD ($)	Mar. 31, 2019	Dec. 31, 2018
Operating Lease Liabilities, Payments Due [Abstract]
2019	$ 64,308
2020	84,155
Total	148,463
Less imputed interest	5,310
Total	$ 143,153	$ 163,007