0001104659-16-156770.txt : 20161114 0001104659-16-156770.hdr.sgml : 20161111 20161114134820 ACCESSION NUMBER: 0001104659-16-156770 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 46 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161114 DATE AS OF CHANGE: 20161114 FILER: COMPANY DATA: COMPANY CONFORMED NAME: RETRACTABLE TECHNOLOGIES INC CENTRAL INDEX KEY: 0000946563 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 752599762 STATE OF INCORPORATION: TX FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 001-16465 FILM NUMBER: 161993377 BUSINESS ADDRESS: STREET 1: 511 LOBO LANE CITY: LITTLE ELM STATE: TX ZIP: 75068-0009 BUSINESS PHONE: 9722941010 MAIL ADDRESS: STREET 1: 511 LOBO LANE CITY: LITTLE ELM STATE: TX ZIP: 75068-0009 10-Q 1 a16-17129_110q.htm 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 September 30, 2016

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

For the transition period from to

Commission file number: 001-16465

Retractable Technologies, Inc.

(Exact name of registrant as specified in its charter)

Texas		75-2599762
(State or other jurisdiction of incorporation or organization)		(I.R.S. Employer Identification No.)

511 Lobo Lane
Little Elm, Texas		75068-5295
(Address of principal executive offices)		(Zip Code)

(972) 294-1010

(Registrant’s telephone number, including area code)

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

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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 o		Smaller reporting company x
(Do not check if a smaller reporting company)

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 No o

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: 29,654,754 shares of Common Stock, no par value, outstanding on November 1, 2016.

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RETRACTABLE TECHNOLOGIES, INC.

FORM 10-Q

For the Quarterly Period Ended September 30, 2016

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
NOTES TO CONDENSED FINANCIAL STATEMENTS		4

Item 2.	Management’s Discussion and Analysis of Financial Condition and Results of Operations	11

Item 3.	Quantitative and Qualitative Disclosures About Market Risk	16

Item 4.	Controls and Procedures	16

	PART II—OTHER INFORMATION

Item 1.	Legal Proceedings	17

Item 1A.	Risk Factors	17

Item 2.	Unregistered Sales of Equity Securities and Use of Proceeds	17

Item 3.	Defaults Upon Senior Securities	17

Item 6.	Exhibits	18

SIGNATURES		19

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PART I—FINANCIAL INFORMATION

Item 1. Financial Statements.

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED BALANCE SHEETS

		September 30, 2016
		(unaudited)		December 31, 2015
ASSETS
Current assets:
Cash and cash equivalents	$	15,218,714	$	18,045,044
Accounts receivable, net		5,161,441		4,900,997
Inventories, net		7,204,724		6,296,625
Other current assets		229,410		1,568,032
Total current assets		27,814,289		30,810,698

Property, plant, and equipment, net		12,472,192		11,468,061
Intangible and other assets, net		258,375		262,105
Total assets	$	40,544,856	$	42,540,864

LIABILITIES AND STOCKHOLDERS’ EQUITY
Current liabilities:
Accounts payable	$	4,709,270	$	5,697,518
Current portion of long-term debt		259,336		249,349
Accrued compensation		618,743		763,576
Dividends payable		55,113		55,414
Accrued royalties to shareholder		680,287		631,145
Other accrued liabilities		926,043		690,535
Income taxes payable		10,893		8,176
Total current liabilities		7,259,685		8,095,713

Long-term debt, net of current maturities		3,220,066		3,417,471
Total liabilities		10,479,751		11,513,184

Commitments and contingencies — see Note 6

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		59,026,550		58,268,036
Retained deficit		(29,742,890	)	(28,021,801	)
Total stockholders’ equity		30,065,105		31,027,680
Total liabilities and stockholders’ equity	$	40,544,856	$	42,540,864

See accompanying notes to condensed financial statements

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RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

		Three Months Ended September 30, 2016			Three Months Ended September 30, 2015		Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015

Sales, net	$	8,840,134		$	9,482,866		22,337,169		$	22,376,912
Cost of sales
Cost of manufactured product		4,900,072			5,489,151		12,400,679			12,307,440
Royalty expense to shareholders		680,287			770,197		1,868,064			1,846,438
Total cost of sales		5,580,359			6,259,348		14,268,743			14,153,878
Gross profit		3,259,775			3,223,518		8,068,426			8,223,034

Operating expenses:
Sales and marketing		1,058,029			954,955		2,953,773			2,826,224
Research and development		117,939			125,780		389,712			409,764
General and administrative		2,165,246			2,342,165		6,306,085			7,321,847
Total operating expenses		3,341,214			3,422,900		9,649,570			10,557,835
Loss from operations		(81,439	)		(199,382	)	(1,581,144	)		(2,334,801	)

Litigation proceeds		—			—		—			7,724,826

Interest and other income		8,609			4,916		19,822			20,836
Interest expense, net		(51,994	)		(58,316	)	(158,327	)		(165,269	)
Net income (loss) before income taxes		(124,824	)		(252,782	)	(1,719,649	)		5,245,592
Provision for income taxes		480			2,044		1,440			6,133
Net income (loss)		(125,304	)		(254,826	)	(1,721,089	)		5,239,459
Preferred stock dividend requirements		(176,249	)		(227,499	)	(528,747	)		(682,802	)
Earnings (loss) applicable to common shareholders	$	(301,553	)	$	(482,325	)	(2,249,836	)	$	4,556,657

Basic earnings (loss) per share	$	(0.01	)	$	(0.02	)	(0.08	)	$	0.16

Diluted earnings (loss) per share	$	(0.01	)	$	(0.02	)	(0.08	)	$	0.15

Weighted average common shares outstanding:
Basic		29,649,874			27,873,447		29,252,652			27,759,333
Diluted		29,649,874			27,873,447		29,252,652			29,436,008

See accompanying notes to condensed financial statements

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RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

		Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015
Cash flows from operating activities
Net income (loss)	$	(1,721,089	)	$	5,239,459
Adjustments to reconcile net income (loss) to net cash used by operating activities:
Provision for doubtful accounts		92,000			141,000
Share-based compensation		84,651			—
Depreciation and amortization		672,000			645,038
(Increase) decrease in assets:
Inventories		(908,099	)		(1,447,486	)
Accounts receivable		(352,444	)		474,048
Other current assets		1,338,622			419,238
Other assets		(750	)		—
Increase (decrease) in liabilities:
Accounts payable		(988,248	)		(36,989	)
Litigation proceeds subject to stipulation		—			(7,724,826	)
Other accrued liabilities		139,817			321,124
Income taxes payable		2,717			(2,885	)
Net cash used by operating activities		(1,640,823	)		(1,972,279	)

Cash flows from investing activities
Purchase of property, plant, and equipment		(1,671,649	)		(1,263,296	)
Change in restricted cash		—			600,897
Net cash used by investing activities		(1,671,649	)		(662,399	)

Cash flows from financing activities
Repayments of long-term debt and notes payable		(187,418	)		(123,602	)
Proceeds from the exercise of stock options		839,200			283,933
Proceeds from long-term debt		—			276,495
Payment of Preferred Stock dividends		(165,640	)		(227,180	)
Net cash provided by financing activities		486,142			209,646

Net decrease in cash and cash equivalents		(2,826,330	)		(2,425,032	)

Cash and cash equivalents at:
Beginning of period		18,045,044			22,128,977
End of period	$	15,218,714		$	19,703,945

Supplemental schedule of cash flow information:
Interest paid	$	158,325		$	165,269
Income taxes paid	$	2,025		$	9,017

Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	$	55,113		$	56,363

See accompanying notes to condensed financial statements

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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 small diameter tube adapter; the blood collection tube holder; 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 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 30, 2016 for the year ended December 31, 2015.

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 unrestricted 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.

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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 5, 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 market, with cost being determined using actual average cost. The Company compares the average cost to the market price and records the lower value. 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.

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 income.

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
Automobiles	7 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 of the underlying assets.

The Company’s property, plant, and equipment primarily consist of buildings, land, assembly equipment for syringes, molding machines, molds, office equipment, furniture, and fixtures.

Intangible assets

Intangible assets are stated at cost and consist primarily of intellectual property which is amortized using the straight-line method over 17 years.

Financial instruments

The Company estimates the fair market 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 market 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. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

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Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, 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 three and nine months of 2016 and 2015:

	Three Months ended September 30, 2016	Three Months ended September 30, 2015	Nine Months ended September 30, 2016	Nine Months ended September 30, 2015
Number of significant customers	2	2	1	2
Aggregate dollar amount of net sales to significant customers	$3.5 million	$5.1 million	$7.1 million	$10.3 million
Percentage of net sales to significant customers	39.3%	53.5%	31.6%	46.0%

The Company manufactures syringes in Little Elm, Texas as well as utilizing manufacturers in China. The Company purchases most of its product components from single suppliers, including needle adhesives and packaging materials. There are multiple sources of these materials. The Company obtained roughly 85.1% and 78.2% of its VanishPoint® syringes in the first nine months of 2016 and 2015, respectively, from its primary Chinese manufacturer. Purchases from this Chinese manufacturer aggregated 92.7% and 82.4% of VanishPoint® syringes in the three month periods ended September 30, 2016 and 2015, respectively. In the event that the Company becomes unable to purchase products from its primary Chinese manufacturer, the Company would need to find an alternate manufacturer for its 0.5mL insulin syringe, its 2mL, 5mL, and 10mL syringes and its autodisable syringe, and increase domestic production for 1mL and 3mL syringes.

Revenue recognition

Revenue is recognized for sales when title and risk of ownership passes to the customer, generally upon shipment. 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 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 Balance Sheets and deducted from revenues in the Statements of Operations. Accounts payable included estimated contractual allowances for $3,998,904 and $3,733,199 as of September 30, 2016 and December 31, 2015, 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. Any product shipped or distributed for evaluation purposes is expensed.

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Certain distributors have taken rebates to which they are not entitled, such as utilizing a rebate for products not purchased directly from the Company. Major customers said they have ceased the practices resulting in claiming non-contractual rebates. Rebates can only be claimed on purchases made directly from the Company. The Company has established a reserve for the collectability of these non-contractual rebate amounts. The expense for the reserve is recorded in Operating expense, General and administrative. The reserve for such non-contractual deductions is included in the allowance for doubtful accounts. There has been no change to the reserve for contractual rebates in the periods currently presented.

The Company’s domestic return policy is set forth in its standard Distribution Agreement. This 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 will not accept returned goods without a returned goods authorization number. The Company may refund the customer’s money or replace the 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.

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.

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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 670,338 and 674,042 shares of Common Stock underlying issued and outstanding stock options for the three months and nine months ended September 30, 2016, respectively, as their effect was antidilutive. The potential dilution, if any, is shown on the following schedule:

		Three Months Ended September 30, 2016			Three Months Ended September 30, 2015			Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015
Net income (loss)	$	(125,304	)	$	(254,826	)	$	(1,721,089	)	$	5,239,459
Preferred dividend requirements		(176,249	)		(227,499	)		(528,747	)		(682,802	)
Earnings (loss) applicable to common shareholders after assumed conversions	$	(301,553	)	$	(482,325	)	$	(2,249,836	)	$	4,556,657
Average common shares outstanding		29,649,874			27,873,447			29,252,652			27,759,333
Average common and common equivalent shares outstanding – assuming dilution		29,649,874			27,873,447			29,252,652			29,436,008
Basic earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.16
Diluted earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.15

Shipping and handling costs

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

Research and development costs

Research and development costs are expensed as incurred.

Share-based compensation

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

Recent Pronouncements

In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”. This ASU addresses several aspects of the accounting for share-based compensation transactions including: (a) income tax consequences when awards vest or are settled, (b) classification of awards as either equity or liabilities, (c) a policy election to account for forfeitures as they occur rather than on an estimated basis and (d) classification of excess tax impacts on the statement of cash flows. The updated guidance is effective for the Company’s quarter ending March 31, 2017, with early adoption permitted. The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and related disclosures.

In February 2016, the FASB issued ASU No. 2016-02, Leases (topic 842). Under the new ASU, 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 new guidance lessor accounting is largely unchanged. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. This ASU is effective for public companies for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of this standard.

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In July 2015, the FASB issued ASU No. 2015-11, “Inventory (Topic 330) Simplifying the Measurement of Inventory,” which is part of the FASB’s Simplification Initiative. Inventory, including inventory measured at average cost, would be valued at the lower of cost or net realizable value. Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. ASU 2015-11 is effective for the Company’s annual periods and interim periods within those annual periods beginning January 1, 2017. Amendments in this ASU should be applied prospectively with earlier application permitted at the beginning of an interim or annual reporting period. The Company is currently assessing the potential impact of this ASU on its financial statements.

In May 2014, FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers”, which provides guidance for revenue recognition. This ASU’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects consideration to which the company expects to be entitled in exchange for those goods or services. This ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract. ASU No. 2014-09 allows for either full retrospective or modified retrospective adoption. In July 2015, the FASB voted to delay the effective date of this ASU by one year. The ASU will now be effective commencing with the Company’s quarter ending March 31, 2018. Early adoption of this ASU is allowed no sooner than the original effective date. The Company is currently assessing the potential impact of this ASU on its financial statements.

3. INVENTORIES

Inventories consist of the following:

		September 30, 2016			December 31, 2015
Raw materials	$	1,614,476		$	1,664,241
Finished goods		6,448,066			5,313,778
		8,062,542			6,978,019
Inventory reserve		(857,818	)		(681,394	)
	$	7,204,724		$	6,296,625

4. INCOME TAXES

The Company’s effective tax rate on the net earnings (loss) before income taxes was (0.1)% and 0.1% for the nine months ended September 30, 2016 and September 30, 2015, respectively. For the three months ended September 30, 2016 and September 30, 2015, the Company’s effective tax rate on the net earnings (loss) before income taxes was (0.4)% and (0.8)%, respectively.

5. OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

		September 30, 2016		December 31, 2015
Prepayments from customers	$	357,396	$	395,396
Accrued property taxes		327,602		—
Accrued professional fees		213,952		274,252
Other accrued expenses		27,093		20,887
	$	926,043	$	690,535

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6. COMMITMENTS AND CONTINGENCIES

In May 2010, the Company and an officer’s suit 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. The trial commenced on September 9, 2013, in the U.S. District Court for the Eastern District of Texas, Tyler Division, and the jury found that BD illegally engaged in anticompetitive conduct with the intent to acquire or maintain monopoly power in the safety syringe market and engaged in false advertising under the Lanham Act. The jury awarded the Company $113,508,014 in damages, which was trebled pursuant to statute. The Court granted injunctive relief to take effect January 15, 2015. In doing so, the Court found that BD’s business practices limited innovation, including false advertisements that suppressed sales of the VanishPoint®. The specific injunctive relief includes: (1) enjoining BD’s use of “World’s Sharpest Needle” or any similar assertion of superior sharpness; (2) requiring notification to all customers who purchased BD syringe products from July 2, 2004 to date that BD wrongfully claimed that its syringe needles were sharper and that its statement that it had “data on file” was false and misleading; (3) requiring notification to employees, customers, distributors, GPOs, and government agencies that the deadspace of the VanishPoint® has been within ISO standards since 2004 and that BD overstated the deadspace of the VanishPoint® to represent that it was higher than some of BD’s syringes when it was actually less, and that BD’s statement that it had “data on file” was false and misleading, and, in addition, posting this notice on its website for a period of three years; (4) enjoining BD from advertising that its syringe products save medication as compared to VanishPoint® products for a period of three years; (5) requiring notification to all employees, customers, distributors, GPOs, and government agencies that BD’s website, cost calculator, printed materials, and oral representations alleging BD’s syringes save medication as compared to the VanishPoint® were based on false and inaccurate measurement of the VanishPoint®, and, in addition, posting this notice on its website for a period of three years; and (6) requiring the implementation of a comprehensive training program for BD employees and distributors that specifically instructs them not to use old marketing materials and not to make false representations regarding VanishPoint® syringes. Final judgment was entered on January 15, 2015, awarding the Company $340,524,042 in damages and $11,722,823 in attorneys’ fees, as well as granting injunctive relief consistent with the orders as indicated above. The parties stipulated that the amount of litigation costs recoverable by the Company is $295,000. On January 14, 2015, the District Court stayed the portion of the injunctive relief that requires BD to notify end-user customers but also ordered BD to comply with internal correction activities as well as mandatory disclosures as set out above to its employees, customers, distributors and Group Purchasing Organizations. BD filed an appeal of that ruling with the 5th Circuit Court of Appeals and that appeal was denied on February 3, 2015. On February 12, 2015, BD filed a motion to amend the judgment directed most specifically to the issue of award of prejudgment interest. On April 23, 2015, the Court entered an Amended Final Judgment that removed prejudgment interest but kept all other monetary and injunctive relief the same as was granted in the original Final Judgment. BD filed its brief in the appeal on July 20, 2015. The Company filed its responsive brief on September 18, 2015, and BD filed its brief in reply on October 19, 2015, to complete the briefing. Oral argument occurred on Monday, February 29, 2016. There is no set time limit for the 5th Circuit Court of Appeals to issue its decision.

In September 2007, BD and MDC Investment Holdings, Inc. (“MDC”) sued the Company in the United States 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. BD and MDC seek injunctive relief and unspecified damages. The Company counterclaimed for declarations of non-infringement, invalidity, and unenforceability of the asserted patents. The plaintiffs subsequently dropped allegations with regard to patent no. 7,090,656 and the Company subsequently dropped its counterclaims for unenforceability of the asserted patents. On June 30, 2015, the Court ordered that further proceedings in this matter be stayed and that this case remain administratively closed until resolution of all appeals in the case detailed in the first paragraph of this Note 6.

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7. BUSINESS SEGMENTS

		Three Months Ended September 30, 2016		Three Months Ended September 30, 2015		Nine Months Ended September 30, 2016		Nine Months Ended September 30, 2015
U.S. sales	$	7,303,015	$	6,152,873	$	19,750,504	$	17,423,389
North and South America sales (excluding U.S.)		1,406,720		3,065,507		2,058,594		4,345,044
Other international sales		130,399		264,486		528,071		608,479
Total sales	$	8,840,134	$	9,482,866	$	22,337,169	$	22,376,912

	September 30, 2016		December 31, 2015

Long-lived assets
U.S.	$	12,304,416	$	11,282,192
International	$	167,776	$	185,869

The Company does not operate in separate reportable segments. The Company has minimal long-lived assets in foreign countries. 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.

8. DIVIDENDS

The Company declared dividends in 2015 in the amounts of $12,313 and $43,101 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on February 1, 2016. The Company declared dividends in the first quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on April 21, 2016. The Company declared dividends in the second quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on July 28, 2016. The Company declared dividends in the third quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on October 20, 2016.

9. STOCK OPTIONS

On September 9, 2016, the Compensation and Benefits Committee approved grants of incentive stock options to the Company’s employees under the First Amended 2008 Stock Option Plan with exercise prices at fair market value ($2.75 per share), a ten-year term, and one-year vesting period, except to the extent that such vesting period would violate the First Amended 2008 Stock Option Plan. In total, once vested, the stock options will be exercisable into 500,400 shares of Common Stock. The value of an option for the purchase of one underlying common share is valued at $2.03, using the Black Scholes Option Pricing Model using a risk-free rate of 1.61% and a volatility factor of 67.6%.

10. SUBSEQUENT EVENTS

On November 1, 2016, the Compensation and Benefits Committee approved a grant of a stock option to the chief executive officer for the purchase of 3,000,000 shares of Common Stock, not pursuant to any existing stock option plan, which will require shareholder approval prior to effectiveness. The total value of this option using the Black Scholes Option Pricing Model using a risk-free rate of 1.84% and a volatility factor of 66.9% is $5.9 million.

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

FORWARD-LOOKING STATEMENT WARNING

Certain statements included by reference in this filing containing the words “could,” “may,” “believes,” “anticipates,” “intends,” “expects,” and similar such words constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Any forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among others, our ability to maintain liquidity, our maintenance of patent protection, the impact of current and future Court decisions regarding current litigation, our ability to maintain favorable third party manufacturing and supplier arrangements and relationships, 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

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production costs, our ability to continue to finance research and development as well as operations and expansion of production, the continuing interest 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. Safety syringes comprised 93.4% of our sales in the first nine months of 2016. We also manufacture and market the 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 resulting from catheter hub contamination.

In the second quarter of 2016, we began selling a new product, the EasyPoint® needle. The EasyPoint® is a retractable needle that can be used with Luer lock syringes, Luer slip syringes, and prefill syringes to give injections. The EasyPoint® needle can also be used to aspirate fluids and blood collection. A March 2016 article published in Medical Design Technology details the benefits of the EasyPoint® needle as well as the existing VanishPoint® syringe. The article states that when the EasyPoint® needle becomes available, “for the first time, clinicians will be able to change needles and have the safety of automated needle retraction.” The article is available on the Article Archives tab of our website at www.vanishpoint.com.

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

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 alternate care 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.

We have reported in the past that our progress is limited principally due to the marketing practices engaged in by BD, the dominant maker and seller of disposable syringes. In our litigation against BD alleging anticompetitive conduct and false advertising, a final judgment for $352 million plus post-judgment interest and costs as well as some injunctive relief has been granted by the District Court. We have not received any of the amounts indicated by the District Court in its final judgment. BD is currently under court order to make certain disclosures regarding its exclusionary conduct to a specified class of distributors and customers. BD has appealed to the United States Court of Appeals for the Fifth Circuit. Oral argument was heard on February 29, 2016, and no order has been issued.

In 2014, the Company took steps to decrease non-litigation legal costs by approximately $1.1 million. In 2014 and 2015, the Company reduced its workforce to cut costs. In the future, if such cost cutting measures prove insufficient, we may reduce other operating expenses, further reduce the workforce, further reduce the salaries of officers as well as other employees, and/or defer royalty payments.

The Consolidated Appropriations Act, 2016 (Pub. L. 114-113), signed into law on December 18, 2015, includes a two year moratorium on the medical device excise tax imposed by Internal Revenue Code section 4191. Thus, the medical device excise tax was suspended beginning on January 1, 2016 and ending on December 31, 2017. The impact of this tax was $360,000 in 2015.

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We exchanged 728 thousand shares of our Common Stock for 200 thousand shares of our Series IV Class B Convertible Preferred Stock as of November 30, 2015 pursuant to an agreement with a shareholder. Such shareholder agreed to waive all unpaid dividends in arrears associated with the tendered preferred stock, equaling $3.1 million. Future dividend requirements of $200 thousand per year are avoided as a result of this transaction.

Product purchases from our primary Chinese manufacturer have enabled us to increase manufacturing capacity with little capital outlay and have provided a competitive manufacturing cost. In the first nine months of 2016, our primary Chinese manufacturer produced approximately 85.1% of our VanishPoint® syringes. In the event that we become unable to purchase products from our primary Chinese manufacturer, we would need to find an alternate manufacturer for the 0.5mL insulin syringe, the 0.5mL autodisable syringe, and the 2mL, 5mL, and 10mL syringes and we would increase domestic production for the 1mL and 3mL syringes.

In 1995, we entered into a license agreement with Thomas J. Shaw for the exclusive right to manufacture, market, and distribute products utilizing automated retraction 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.

On April 5, 2016, Thomas J. Shaw exercised the remaining portion the stock option granted to him in 2009. The Company issued 1,000,000 shares of Common Stock to him at an exercise price of $0.81 per share (aggregate consideration of $810,000). On November 1, 2016, Mr. Shaw was granted another stock option with a ten-year term, an exercise price of $2.66 per share, and exercisable upon shareholder approval for 3,000,000 shares of Common Stock. The total value of this option using the Black Scholes Option Pricing Model using a risk-free rate of 1.84% and a volatility factor of 66.9% is $5.9 million.

With increased volumes of units manufactured, our manufacturing unit costs have generally tended to decline. During this period of manufacturing, unit production decreased, resulting in a higher unit cost due to fixed costs spread over fewer units. Factors that could affect our unit costs include 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.

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 September 30, 2016 or 2015.

RESULTS OF OPERATIONS

Comparison of Three Months Ended September 30, 2016 and September 30, 2015

Sales

Domestic sales accounted for 82.6% and 64.9% of the revenues for the three months ended September 30, 2016 and 2015, respectively. Domestic revenues increased 18.7% principally due to higher average prices and higher volumes. Domestic unit sales increased 9.3%. Domestic unit sales were 72.8% of total unit sales for the three months ended September 30, 2016. International revenue and unit sales decreased 55.4% and 53.8%, respectively, due to lower volumes. Our international orders may be subject to significant fluctuation over time. Overall unit sales decreased 21.6%.

Gross Profit and Cost of Sales

The Cost of manufactured product decreased by 10.7% due to lower volumes mitigated by higher unit cost. Royalty expense decreased 11.7% due to lower gross revenues.

Gross profit increased 1.1% primarily due to higher average prices.

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Operating Expenses

Operating expenses decreased $82 thousand. The decrease was primarily due to the suspension of the medical device excise tax and lower professional fees, mitigated by higher compensation and travel costs.

Loss from Operations

Our operating loss was $81 thousand compared to a loss from operations of $199 thousand for the same period last year due primarily to slightly higher gross profit and reduced operating expenses.

Income Taxes

Our effective tax rate on the net earnings (loss) before income taxes was (0.4)% and (0.8)% for the three months ended September 30, 2016 and September 30, 2015, respectively.

Comparison of Nine Months Ended September 30, 2016 and September 30, 2015

Sales

Domestic sales accounted for 88.4% and 77.9% of the revenues for the nine months ended September 30, 2016 and 2015, respectively. Domestic revenues increased 13.4% principally due to higher sales volume and somewhat lower average prices. Domestic unit sales increased 15.6%. Domestic unit sales were 83.0% of total unit sales for the nine months ended September 30, 2016. International revenue and unit sales decreased 47.8% and 53.3%, respectively, due to lower sales volumes and was somewhat offset by higher average sales prices. Our international orders may be subject to significant fluctuation over time. Overall unit sales decreased 7.5%.

Gross Profit and Cost of Sales

The Cost of manufactured product increased by 0.8% principally due to higher unit costs offset by lower volumes. 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 1.2% due to higher gross revenues. Rebates have a significant impact on the ratio of gross sales to net sales.

Gross profit decreased 1.9% primarily due to higher cost of manufacturing and slightly lower revenues.

Operating Expenses

Operating expenses decreased 8.6%. The decrease was due to suspension of the medical device excise tax, reduced donations of product, severance benefits not incurred in 2016, and lower bad debt accruals.

Litigation Proceeds

A non-recurring recognition of $7,724,826 received from BD in the second quarter of 2015 pursuant to a patent infringement case had a significant impact on income for the nine months ended September 30, 2015.

Loss from Operations

Our operating loss was $1.6 million compared to an operating loss for the same period last year of $2.3 million due primarily to lower operating expenses.

Income Taxes

Our effective tax rate on the net earnings (loss) before income taxes was (0.1)% and 0.1% for the nine months ended September 30, 2016 and September 30, 2015, respectively.

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Discussion of Balance Sheet and Statement of Cash Flow Items

Cash makes up 37.5% of total assets. Working capital was $20.6 million at September 30, 2016, a decrease of $2.2 million from December 31, 2015.

Approximately $1.6 million in cash flow in the nine months ended September 30, 2016 was used by operating activities.

LIQUIDITY

At the present time, Management does not intend to raise equity capital. Due to the 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. Our ability to obtain additional funds through loans is uncertain. Our financial statements do not reflect a 2015 judgment in our favor for $352 million plus post-judgment interest.

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.

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 22.2%) of our products in the U.S. 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. Typically, large international sales of VanishPoint® syringes are shipped directly from China to the customer. Purchases of product manufactured in China usually decrease the average cost of manufacture for all units. 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.

Fluctuations in the cost of oil (since our products are petroleum based) and transportation and the volume of units purchased from our Chinese manufacturers may have an impact on the unit costs of our product. Increases in such costs may not be recoverable through price increases of our products. Reductions in oil prices may not quickly affect petroleum product prices.

Seasonality

Historically, unit sales have increased during the flu season.

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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 non-litigation legal costs and we continue to evaluate these costs. Additionally, since the beginning of 2014, we have reduced our workforce. In the future, if such cost cutting measures prove insufficient, we may reduce the number of units being produced, further reduce the workforce, further reduce the salaries of officers and other employees, and/or defer royalty payments.

External Sources of Liquidity

We have obtained several loans from 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 sale of equity.

In our litigation against BD alleging anticompetitive conduct and false advertising, a final judgment for $352 million plus post-judgment interest and costs as well as some injunctive relief has been granted by the District Court. We have not received any of the amounts indicated by the District Court in its final judgment. BD is currently under court order to make certain disclosures regarding its exclusionary conduct to a specified class of distributors and customers. BD has appealed to the United States Court of Appeals for the Fifth Circuit. Oral argument was heard on February 29, 2016, and no order has been issued.

CAPITAL RESOURCES

In the second quarter of 2016, we placed orders for additional injection molding machines and additional molds for use in the manufacture of the EasyPoint™ needle. The expenditure for this equipment was approximately $1.4 million.

CONTRACTUAL OBLIGATIONS

We have purchased manufacturing equipment and molds in the amount of $1.4 million. We have obtained a lease from Deutsche Leasing USA, Inc. for the financing of certain molding machines in the amount of approximately $530 thousand.

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, Douglas W. Cowan (the “CFO”), acting in their capacities as our principal executive and principal financial officers, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. The term disclosure controls and procedures means controls and other procedures that are designed to ensure that information required to be disclosed by us in our periodic reports is: i) recorded, processed, summarized, and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms; and ii) accumulated and communicated to our Management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based upon this evaluation, the CEO and CFO concluded that, as of September 30, 2016, our disclosure controls and procedures were not effective, as discussed below.

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We reported a material weakness in our Annual Report on Form 10-K for the year ended December 31, 2015, filed on March 30, 2016, in connection with the accounting for raw materials. As disclosed in the Annual Report and previous Quarterly Reports, we plan to remedy this weakness by transitioning to an improved Oracle inventory accounting process. As we are currently implementing this improvement, we cannot yet state that our disclosure controls and procedures are effective. During the third quarter of 2016, we began running our improved Oracle process in tandem with the process currently in use and the testing produced favorable results. We will continue testing and plan on implementation in the first half of 2017.

Changes in Internal Control Over Financial Reporting

There have been no changes during the third quarter of 2016 or subsequent to September 30, 2016 in our internal control over financial reporting that has materially affected or is reasonably likely to materially affect our internal control over financial reporting.

PART II—OTHER INFORMATION

Item 1. Legal Proceedings.

Please refer to Note 6 to the financial statements for a complete description of all legal proceedings.

Item 1A. Risk Factors.

There were no material changes in the Risk Factors applicable to the Company as set forth in our Form 10-K annual report for 2015 which was filed on March 30, 2016, and which is available on EDGAR.

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

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 October 20, 2016.

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.

Item 3. Defaults Upon Senior Securities.

Series I Class B Convertible Preferred Stock

For the nine months ended September 30, 2016, no dividends were in arrears.

Series II Class B Convertible Preferred Stock

For the nine months ended September 30, 2016, no dividends were in arrears.

Series III Class B Convertible Preferred Stock

For the nine months ended September 30, 2016, the amount of dividends in arrears was $96,934 and the total arrearage was $3,984,000 as of September 30, 2016.

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Series IV Class B Convertible Preferred Stock

For the nine months ended September 30, 2016, the amount of dividends in arrears was $256,875 and the total arrearage was $5,713,000 as of September 30, 2016.

Series V Class B Convertible Preferred Stock

For the nine months ended September 30, 2016, the amount of dividends in arrears was $9,600 and the total arrearage was $980,000 as of September 30, 2016.

Item 6. Exhibits.

Exhibit No.		Description of Document

31.1		Certification of Principal Executive Officer

31.2		Certification of Principal Financial Officer

32		Certification Pursuant to 18 U.S.C. Section 1350

101		The following materials from Retractable Technologies, Inc.’s Form 10-Q for the quarter ended September 30, 2016, formatted in XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets as of September 30, 2016 and December 31, 2015, (ii) Condensed Statements of Operations for the nine months and three months ended September 30, 2016 and 2015, (iii) Condensed Statements of Cash Flows for the nine months ended September 30, 2016 and 2015 and (iv) Notes to Condensed Financial Statements

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SIGNATURES

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

DATE: November 14, 2016	RETRACTABLE TECHNOLOGIES, INC.
	(Registrant)



	BY:	/s/ DOUGLAS W. COWAN
		DOUGLAS W. COWAN VICE PRESIDENT, CHIEF FINANCIAL OFFICER, AND CHIEF ACCOUNTING OFFICER

EX-31.1 2 a16-17129_1ex31d1.htm EX-31.1

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

Exhibit 31.1

I, Thomas J. Shaw, certify that:

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

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

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

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

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

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

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

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

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

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

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

Date: November 14, 2016

/s/ THOMAS J. SHAW
THOMAS J. SHAW
PRESIDENT, CHAIRMAN, AND
CHIEF EXECUTIVE OFFICER

EX-31.2 3 a16-17129_1ex31d2.htm EX-31.2

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

Exhibit 31.2

I, Douglas W. Cowan, certify that:

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

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

Date: November 14, 2016

/s/ DOUGLAS W. COWAN
DOUGLAS W. COWAN
VICE PRESIDENT,
CHIEF FINANCIAL OFFICER,
AND CHIEF ACCOUNTING OFFICER

EX-32 4 a16-17129_1ex32.htm EX-32

Exhibit 32

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Solely in connection with the filing of the Quarterly Report of Retractable Technologies, Inc. (the “Company”) on Form 10-Q for the period ended September 30, 2016, 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 Douglas W. Cowan, Chief Financial Officer, do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

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

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

Date: November 14, 2016

	/s/ THOMAS J. SHAW
	THOMAS J. SHAW
	PRESIDENT, CHAIRMAN, AND
	CHIEF EXECUTIVE OFFICER


	/s/ DOUGLAS W. COWAN
	DOUGLAS W. COWAN
	VICE PRESIDENT, CHIEF FINANCIAL OFFICER,
	AND CHIEF ACCOUNTING OFFICER

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us-gaap:CustomerConcentrationRiskMember 2015-01-01 2015-09-30 0000946563 us-gaap:CostOfGoodsProductLineMember us-gaap:SupplierConcentrationRiskMember 2015-01-01 2015-09-30 0000946563 2015-09-30 0000946563 2014-12-31 0000946563 2016-07-01 2016-09-30 0000946563 2015-07-01 2015-09-30 0000946563 rvp:BDAndMDCInvestmentHoldingsIncCaseMember 2007-09-30 0000946563 rvp:BectonDickinsonAndCompanyCaseMember 2015-01-15 2015-01-15 0000946563 rvp:BectonDickinsonAndCompanyCaseMember 2016-01-01 2016-09-30 0000946563 2015-01-01 2015-09-30 0000946563 2016-09-30 0000946563 2015-12-31 0000946563 2016-11-01 0000946563 2016-01-01 2016-09-30 iso4217:USD xbrli:shares xbrli:pure rvp:customer rvp:item iso4217:USD xbrli:shares false --12-31 Q3 2016 2016-09-30 10-Q 0000946563 29654754 Yes Smaller Reporting Company RETRACTABLE TECHNOLOGIES INC 3733199 3998904 <div> <div>   8.      DIVIDENDS   The Company declared dividends in 2015 in the amounts of $12,313 and $43,101 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on February 1, 2016.  The Company declared dividends in the first quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on April 21, 2016.  The Company declared dividends in the second quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on July 28, 2016.  The Company declared dividends in the third quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on October 20, 2016.   <div /></div> </div> -7724826 0 262105 258375 P3Y P3Y 295000 2 0 2 2 1 2 0.01 2 P12M P10D <div> <div>   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 86.00%;margin-left:72pt;"> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Production equipment </td> <td valign="top" style="width:45.20%;padding:0pt;"> 3 to 13 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Office furniture and equipment </td> <td valign="top" style="width:45.20%;padding:0pt;"> 3 to 10 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Buildings </td> <td valign="top" style="width:45.20%;padding:0pt;"> 39 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Building improvements </td> <td valign="top" style="width:45.20%;padding:0pt;"> 15 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Automobiles </td> <td valign="top" style="width:45.20%;padding:0pt;"> 7 years </td> </tr> </table></div>   <div /></div> </div>

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<div> <div>   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 of the underlying assets.   The Company’s property, plant, and equipment primarily consist of buildings, land, assembly equipment for syringes, molding machines, molds, office equipment, furniture, and fixtures.   <div /></div> </div>

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<div> <div>     <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 94.00%;margin-left:27.35pt;"> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2016 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2016 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Net income (loss) </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(125,304 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(254,826 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(1,721,089 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>5,239,459 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Preferred dividend requirements </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(176,249 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(227,499 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(528,747 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(682,802 </td> <td valign="bottom" style="width:01.02%;"> ) </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Earnings (loss) applicable to common shareholders after assumed conversions </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(301,553 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(482,325 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(2,249,836 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>4,556,657 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Average common shares outstanding </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,649,874 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,873,447 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,252,652 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,759,333 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Average common and common equivalent shares outstanding – assuming dilution </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,649,874 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,873,447 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,252,652 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,436,008 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Basic earnings (loss) per share </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.01 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.02 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.08 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>0.16 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Diluted earnings (loss) per share </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.01 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.02 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.08 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>0.15 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> </table></div>   <div /></div> </div>

<div> <div>     <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 94.00%;margin-left:27.45pt;"> <tr> <td valign="bottom" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2016 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2015 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2016 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> U.S. sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>7,303,015  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>6,152,873  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>19,750,504  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>17,423,389  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> North and South America sales (excluding U.S.) </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>1,406,720  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>3,065,507  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>2,058,594  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>4,345,044  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> Other international sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>130,399  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>264,486  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>528,071  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>608,479  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> Total sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>8,840,134  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>9,482,866  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>22,337,169  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>22,376,912  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> </table></div>     <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 93.00%;margin-left:27.35pt;"> <tr> <td valign="bottom" style="width:57.26%;padding:0pt;">   </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> September 30, 2016 </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> December 31, 2015 </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;">   </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;padding:0pt;">   </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;padding:0pt;">   </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> Long-lived assets </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;padding:0pt;">   </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;padding:0pt;">   </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> U.S. </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.12%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>12,304,416  </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td valign="bottom" style="width:02.30%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.34%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>11,282,192  </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> International </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.12%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>167,776  </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td valign="bottom" style="width:02.30%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.34%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>185,869  </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> </table></div>   <div /></div> </div>

<div> <div>   7.      BUSINESS SEGMENTS   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 94.00%;margin-left:27.45pt;"> <tr> <td valign="bottom" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2016 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2015 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2016 </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> U.S. sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>7,303,015  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>6,152,873  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>19,750,504  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>17,423,389  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> North and South America sales (excluding U.S.) </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>1,406,720  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>3,065,507  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>2,058,594  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>4,345,044  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> Other international sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>130,399  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>264,486  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>528,071  </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>608,479  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;"> Total sales </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>8,840,134  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>9,482,866  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.86%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>22,337,169  </td> <td valign="bottom" style="width:02.62%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.88%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>22,376,912  </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:20.98%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.86%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:02.62%;padding:0pt;">   </td> <td valign="bottom" style="width:16.88%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.06%;padding:0pt;">   </td> </tr> </table></div>   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 93.00%;margin-left:27.35pt;"> <tr> <td valign="bottom" style="width:57.26%;padding:0pt;">   </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> September 30, 2016 </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> December 31, 2015 </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;">   </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;padding:0pt;">   </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;padding:0pt;">   </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> Long-lived assets </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.62%;padding:0pt;">   </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td colspan="2" valign="bottom" style="width:18.64%;padding:0pt;">   </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> U.S. </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.12%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>12,304,416  </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td valign="bottom" style="width:02.30%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.34%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>11,282,192  </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:57.26%;padding:0pt;"> International </td> <td valign="bottom" style="width:02.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.12%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>167,776  </td> <td valign="bottom" style="width:02.40%;padding:0pt;">   </td> <td valign="bottom" style="width:02.30%;padding:0pt;"> $ </td> <td valign="bottom" style="width:16.34%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>185,869  </td> <td valign="bottom" style="width:00.94%;padding:0pt;">   </td> </tr> </table></div>   The Company does not operate in separate reportable segments.  The Company has minimal long-lived assets in foreign countries.  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.   <div /></div> </div>

2826224

954955

2953773

1058029

84651

P1Y

P10Y

0.0161

0.0184

0.676

0.669

500400

2.03

3000000

2.75

<div> <div>   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 unrestricted 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 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 5, 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 market, with cost being determined using actual average cost.  The Company compares the average cost to the market price and records the lower value.  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.   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 income.   Depreciation and amortization are calculated using the straight-line method over the following useful lives:   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 86.00%;margin-left:72pt;"> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Production equipment </td> <td valign="top" style="width:45.20%;padding:0pt;"> 3 to 13 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Office furniture and equipment </td> <td valign="top" style="width:45.20%;padding:0pt;"> 3 to 10 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Buildings </td> <td valign="top" style="width:45.20%;padding:0pt;"> 39 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Building improvements </td> <td valign="top" style="width:45.20%;padding:0pt;"> 15 years </td> </tr> <tr> <td valign="top" style="width:54.80%;padding:0pt;"> Automobiles </td> <td valign="top" style="width:45.20%;padding:0pt;"> 7 years </td> </tr> </table></div>   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 of the underlying assets.   The Company’s property, plant, and equipment primarily consist of buildings, land, assembly equipment for syringes, molding machines, molds, office equipment, furniture, and fixtures.   Intangible assets   Intangible assets are stated at cost and consist primarily of intellectual property which is amortized using the straight-line method over 17 years.   Financial instruments   The Company estimates the fair market 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 market 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.  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, 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 three and nine months of 2016 and 2015:   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 94.00%;margin-left:27.35pt;"> <tr> <td valign="bottom" style="width:26.26%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months ended September 30, 2016 </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months ended September 30, 2015 </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months ended September 30, 2016 </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months ended September 30, 2015 </td> </tr> <tr> <td valign="top" style="width:26.26%;padding:0pt;"> Number of significant customers </td> <td valign="top" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>2  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>2  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>1  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>2  </td> </tr> <tr> <td valign="top" style="width:26.26%;padding:0pt;"> Aggregate dollar amount of net sales to significant customers </td> <td valign="top" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;padding:0pt;"> $3.5 million </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;padding:0pt;"> $5.1 million </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;padding:0pt;"> $7.1 million </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;padding:0pt;"> $10.3 million </td> </tr> <tr> <td valign="top" style="width:26.26%;padding:0pt;"> Percentage of net sales to significant customers </td> <td valign="top" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>39.3%  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>53.5%  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>31.6%  </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>46.0%  </td> </tr> </table></div>   The Company manufactures syringes in Little Elm, Texas as well as utilizing manufacturers in China.  The Company purchases most of its product components from single suppliers, including needle adhesives and packaging materials.  There are multiple sources of these materials.  The Company obtained roughly 85.1% and 78.2% of its VanishPoint®  syringes in the first nine months of 2016 and 2015, respectively, from its primary Chinese manufacturer.  Purchases from this Chinese manufacturer aggregated 92.7% and 82.4% of VanishPoint®  syringes in the three month periods ended September 30, 2016 and 2015, respectively.  In the event that the Company becomes unable to purchase products from its primary Chinese manufacturer, the Company would need to find an alternate manufacturer for its 0.5mL insulin syringe, its 2mL, 5mL, and 10mL syringes and its autodisable syringe, and increase domestic production for 1mL and 3mL syringes.   Revenue recognition   Revenue is recognized for sales when title and risk of ownership passes to the customer, generally upon shipment.  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 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 Balance Sheets and deducted from revenues in the Statements of Operations.  Accounts payable included estimated contractual allowances for $3,998,904 and $3,733,199 as of September 30, 2016 and December 31, 2015, 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.  Any product shipped or distributed for evaluation purposes is expensed.   Certain distributors have taken rebates to which they are not entitled, such as utilizing a rebate for products not purchased directly from the Company.  Major customers said they have ceased the practices resulting in claiming non-contractual rebates.  Rebates can only be claimed on purchases made directly from the Company. The Company has established a reserve for the collectability of these non-contractual rebate amounts.  The expense for the reserve is recorded in Operating expense, General and administrative.  The reserve for such non-contractual deductions is included in the allowance for doubtful accounts.  There has been no change to the reserve for contractual rebates in the periods currently presented.   The Company’s domestic return policy is set forth in its standard Distribution Agreement.  This 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 will not accept returned goods without a returned goods authorization number.  The Company may refund the customer’s money or replace the 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.   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 670,338 and 674,042 shares of Common Stock underlying issued and outstanding stock options for the three months and nine months ended September 30, 2016, respectively, as their effect was antidilutive.  The potential dilution, if any, is shown on the following schedule:   <div style="width:100%;"><table cellpadding="0" cellspacing="0" style="border-collapse:collapse;width: 94.00%;margin-left:27.35pt;"> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2016 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Three Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2016 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;"> Nine Months Ended September 30, 2015 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Net income (loss) </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(125,304 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(254,826 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(1,721,089 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>5,239,459 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Preferred dividend requirements </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(176,249 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(227,499 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(528,747 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(682,802 </td> <td valign="bottom" style="width:01.02%;"> ) </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Earnings (loss) applicable to common shareholders after assumed conversions </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(301,553 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(482,325 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(2,249,836 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>4,556,657 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Average common shares outstanding </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,649,874 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,873,447 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,252,652 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,759,333 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:1pt solid #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Average common and common equivalent shares outstanding – assuming dilution </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,649,874 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>27,873,447 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,252,652 </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>29,436,008 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Basic earnings (loss) per share </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.01 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.02 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.08 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>0.16 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;"> Diluted earnings (loss) per share </td> <td valign="bottom" style="width:02.64%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.01 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.02 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>(0.08 </td> <td valign="bottom" style="width:01.50%;"> ) </td> <td valign="bottom" style="width:01.50%;padding:0pt;"> $ </td> <td valign="bottom" style="width:15.80%;;font-family:Times New Roman,Times,serif;font-size:10pt;text-align:right;" nowrap="nowrap"><div style="float:left"></div>0.15 </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> <tr> <td valign="top" style="width:24.12%;padding:0pt;">   </td> <td valign="bottom" style="width:02.64%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:01.50%;padding:0pt;">   </td> <td valign="bottom" style="width:15.80%;border-top:1pt none #D9D9D9 ;border-left:1pt none #D9D9D9 ;border-bottom:2pt double #000000 ;border-right:1pt none #D9D9D9 ;padding:0pt;">   </td> <td valign="bottom" style="width:01.02%;padding:0pt;">   </td> </tr> </table></div>   Shipping and handling costs   The Company classifies shipping and handling costs as part of Cost of sales in the Condensed Statements of Operations.   Research and development costs   Research and development costs are expensed as incurred.   Share-based compensation   The Company’s share-based payments are accounted for using the fair value method.  The Company records share-based compensation expense on a straight-line basis over the requisite service period.   Recent Pronouncements   In March 2016, the FASB issued ASU 2016-09, “Compensation - Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting”.  This ASU addresses several aspects of the accounting for share-based compensation transactions including: (a) income tax consequences when awards vest or are settled, (b) classification of awards as either equity or liabilities, (c) a policy election to account for forfeitures as they occur rather than on an estimated basis and (d) classification of excess tax impacts on the statement of cash flows.  The updated guidance is effective for the Company’s quarter ending March 31, 2017, with early adoption permitted.  The Company is currently assessing the impact that adoption of this guidance will have on its financial statements and related disclosures.   In February 2016, the FASB issued ASU No. 2016-02, Leases (topic 842). Under the new ASU, 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 new guidance lessor accounting is largely unchanged. The new lease guidance simplified the accounting for sale and leaseback transactions primarily because lessees must recognize lease assets and lease liabilities. Lessees (for capital and operating leases) and lessors (for sales-type, direct financing, and operating leases) must apply a modified retrospective transition approach for leases existing at, or entered into after, the beginning of the earliest comparative period presented in the financial statements. The modified retrospective approach would not require any transition accounting for leases that expired before the earliest comparative period presented. This ASU is effective for public companies for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years, with early adoption permitted. The Company is currently evaluating the impact of this standard.   In July 2015, the FASB issued ASU No. 2015-11, “Inventory (Topic 330) Simplifying the Measurement of Inventory,” which is part of the FASB’s Simplification Initiative.  Inventory, including inventory measured at average cost, would be valued at the lower of cost or net realizable value.  Net realizable value is the estimated selling prices in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation.  ASU 2015-11 is effective for the Company’s annual periods and interim periods within those annual periods beginning January 1, 2017.  Amendments in this ASU should be applied prospectively with earlier application permitted at the beginning of an interim or annual reporting period.  The Company is currently assessing the potential impact of this ASU on its financial statements.   In May 2014, FASB issued ASU No. 2014-09, “Revenue from Contracts with Customers”, which provides guidance for revenue recognition.  This ASU’s core principle is that a company will recognize revenue when it transfers promised goods or services to customers in an amount that reflects consideration to which the company expects to be entitled in exchange for those goods or services.  This ASU also requires additional disclosure about the nature, amount, timing and uncertainty of revenue and cash flows arising from customer contracts, including significant judgments and changes in judgments, and assets recognized from costs incurred to obtain or fulfill a contract.  ASU No. 2014-09 allows for either full retrospective or modified retrospective adoption.  In July 2015, the FASB voted to delay the effective date of this ASU by one year.  The ASU will now be effective commencing with the Company’s quarter ending March 31, 2018.  Early adoption of this ASU is allowed no sooner than the original effective date.  The Company is currently assessing the potential impact of this ASU on its financial statements.   <div /></div> </div>

5900000

31027680

30065105

<div> <div>   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.   <div /></div> </div>

29436008

27873447

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27759333

27873447

29252652

29649874

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Document and Entity Information - shares	9 Months Ended
Document and Entity Information - shares	Sep. 30, 2016	Nov. 01, 2016
Document and Entity Information
Entity Registrant Name	RETRACTABLE TECHNOLOGIES INC
Entity Central Index Key	0000946563
Document Type	10-Q
Document Period End Date	Sep. 30, 2016
Amendment Flag	false
Current Fiscal Year End Date	--12-31
Entity Current Reporting Status	Yes
Entity Filer Category	Smaller Reporting Company
Entity Common Stock, Shares Outstanding		29,654,754
Document Fiscal Year Focus	2016
Document Fiscal Period Focus	Q3

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CONDENSED BALANCE SHEETS - USD ($)	Sep. 30, 2016	Dec. 31, 2015
Current assets:
Cash and cash equivalents	$ 15,218,714	$ 18,045,044
Accounts receivable, net	5,161,441	4,900,997
Inventories, net	7,204,724	6,296,625
Other current assets	229,410	1,568,032
Total current assets	27,814,289	30,810,698
Property, plant, and equipment, net	12,472,192	11,468,061
Intangible and other assets, net	258,375	262,105
Total assets	40,544,856	42,540,864
Current liabilities:
Accounts payable	4,709,270	5,697,518
Current portion of long-term debt	259,336	249,349
Accrued compensation	618,743	763,576
Dividends payable	55,113	55,414
Accrued royalties to shareholder	680,287	631,145
Other accrued liabilities	926,043	690,535
Income taxes payable	10,893	8,176
Total current liabilities	7,259,685	8,095,713
Long-term debt, net of current maturities	3,220,066	3,417,471
Total liabilities	10,479,751	11,513,184
Commitments and contingencies - see Note 6
Preferred stock $1 par value:
Common Stock, no par value
Additional paid-in capital	59,026,550	58,268,036
Retained deficit	(29,742,890)	(28,021,801)
Total stockholders' equity	30,065,105	31,027,680
Total liabilities and stockholders' equity	40,544,856	42,540,864
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

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CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares	Sep. 30, 2016	Dec. 31, 2015
CONDENSED BALANCE SHEETS
Preferred stock, par value (in dollars per share)	$ 1	$ 1
Common stock, par value (in dollars per share)	$ 0	$ 0

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CONDENSED STATEMENTS OF OPERATIONS - USD ($)	3 Months Ended		9 Months Ended
CONDENSED STATEMENTS OF OPERATIONS - USD ($)	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
CONDENSED STATEMENTS OF OPERATIONS
Sales, net	$ 8,840,134	$ 9,482,866	$ 22,337,169	$ 22,376,912
Cost of sales
Cost of manufactured product	4,900,072	5,489,151	12,400,679	12,307,440
Royalty expense to shareholders	680,287	770,197	1,868,064	1,846,438
Total cost of sales	5,580,359	6,259,348	14,268,743	14,153,878
Gross profit	3,259,775	3,223,518	8,068,426	8,223,034
Operating expenses:
Sales and marketing	1,058,029	954,955	2,953,773	2,826,224
Research and development	117,939	125,780	389,712	409,764
General and administrative	2,165,246	2,342,165	6,306,085	7,321,847
Total operating expenses	3,341,214	3,422,900	9,649,570	10,557,835
Loss from operations	(81,439)	(199,382)	(1,581,144)	(2,334,801)
Litigation proceeds				7,724,826
Interest and other income	8,609	4,916	19,822	20,836
Interest expense, net	(51,994)	(58,316)	(158,327)	(165,269)
Net income (loss) before income taxes	(124,824)	(252,782)	(1,719,649)	5,245,592
Provision for income taxes	480	2,044	1,440	6,133
Net income (loss)	(125,304)	(254,826)	(1,721,089)	5,239,459
Preferred stock dividend requirements	(176,249)	(227,499)	(528,747)	(682,802)
Earnings (loss) applicable to common shareholders	$ (301,553)	$ (482,325)	$ (2,249,836)	$ 4,556,657
Basic earnings (loss) per share (in dollars per share)	$ (0.01)	$ (0.02)	$ (0.08)	$ 0.16
Diluted earnings (loss) per share (in dollars per share)	$ (0.01)	$ (0.02)	$ (0.08)	$ 0.15
Weighted average common shares outstanding:
Basic (in shares)	29,649,874	27,873,447	29,252,652	27,759,333
Diluted (in shares)	29,649,874	27,873,447	29,252,652	29,436,008

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CONDENSED STATEMENTS OF CASH FLOWS - USD ($)	9 Months Ended
CONDENSED STATEMENTS OF CASH FLOWS - USD ($)	Sep. 30, 2016	Sep. 30, 2015
Cash flows from operating activities
Net income (loss)	$ (1,721,089)	$ 5,239,459
Adjustments to reconcile net income (loss) to net cash used by operating activities:
Provision for doubtful accounts	92,000	141,000
Share based compensation	84,651
Depreciation and amortization	672,000	645,038
(Increase) decrease in assets:
Inventories	(908,099)	(1,447,486)
Accounts receivable	(352,444)	474,048
Other current assets	1,338,622	419,238
Other assets	(750)
Increase (decrease) in liabilities:
Accounts payable	(988,248)	(36,989)
Litigation proceeds subject to stipulation		(7,724,826)
Other accrued liabilities	139,817	321,124
Income taxes payable	2,717	(2,885)
Net cash used by operating activities	(1,640,823)	(1,972,279)
Cash flows from investing activities
Purchase of property, plant, and equipment	(1,671,649)	(1,263,296)
Change in restricted cash		600,897
Net cash used by investing activities	(1,671,649)	(662,399)
Cash flows from financing activities
Repayments of long-term debt and notes payable	(187,418)	(123,602)
Proceeds from the exercise of stock options	839,200	283,933
Proceeds from long-term debt		276,495
Payment of Preferred Stock dividends	(165,640)	(227,180)
Net cash provided by financing activities	486,142	209,646
Net decrease in cash and cash equivalents	(2,826,330)	(2,425,032)
Cash and cash equivalents at:
Beginning of period	18,045,044	22,128,977
End of period	15,218,714	19,703,945
Supplemental schedule of cash flow information:
Interest paid	158,325	165,269
Income taxes paid	2,025	9,017
Supplemental schedule of noncash investing and financing activities:
Preferred dividends declared, not paid	$ 55,113	$ 56,363

XML 16 R6.htm IDEA: XBRL DOCUMENT

BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION	9 Months Ended
BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION	Sep. 30, 2016
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 small diameter tube adapter; the blood collection tube holder; 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 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 30, 2016 for the year ended December 31, 2015.

XML 17 R7.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

9 Months Ended

Sep. 30, 2016

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

Cash and cash equivalents

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

Accounts receivable

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

Inventories

Property, plant, and equipment

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
Automobiles	7 years

Long-lived assets

The Company’s property, plant, and equipment primarily consist of buildings, land, assembly equipment for syringes, molding machines, molds, office equipment, furniture, and fixtures.

Intangible assets

Intangible assets are stated at cost and consist primarily of intellectual property which is amortized using the straight-line method over 17 years.

Financial instruments

Concentration risks

The following table reflects our significant customers for the first three and nine months of 2016 and 2015:

	Three Months ended September 30, 2016	Three Months ended September 30, 2015	Nine Months ended September 30, 2016	Nine Months ended September 30, 2015
Number of significant customers	2	2	1	2
Aggregate dollar amount of net sales to significant customers	$3.5 million	$5.1 million	$7.1 million	$10.3 million
Percentage of net sales to significant customers	39.3%	53.5%	31.6%	46.0%

Revenue recognition

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

Income taxes

Earnings per share

		Three Months Ended September 30, 2016			Three Months Ended September 30, 2015			Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015
Net income (loss)	$	(125,304	)	$	(254,826	)	$	(1,721,089	)	$	5,239,459
Preferred dividend requirements		(176,249	)		(227,499	)		(528,747	)		(682,802	)

Earnings (loss) applicable to common shareholders after assumed conversions	$	(301,553	)	$	(482,325	)	$	(2,249,836	)	$	4,556,657

Average common shares outstanding		29,649,874			27,873,447			29,252,652			27,759,333

Average common and common equivalent shares outstanding – assuming dilution		29,649,874			27,873,447			29,252,652			29,436,008

Basic earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.16

Diluted earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.15

Shipping and handling costs

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

Research and development costs

Research and development costs are expensed as incurred.

Share-based compensation

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

Recent Pronouncements

XML 18 R8.htm IDEA: XBRL DOCUMENT

INVENTORIES

9 Months Ended

Sep. 30, 2016

INVENTORIES

INVENTORIES

3. INVENTORIES

Inventories consist of the following:

		September 30, 2016			December 31, 2015
Raw materials	$	1,614,476		$	1,664,241
Finished goods		6,448,066			5,313,778

		8,062,542			6,978,019
Inventory reserve		(857,818	)		(681,394	)

	$	7,204,724		$	6,296,625

XML 19 R9.htm IDEA: XBRL DOCUMENT

INCOME TAXES	9 Months Ended
INCOME TAXES	Sep. 30, 2016
INCOME TAXES
INCOME TAXES	4. INCOME TAXES The Company’s effective tax rate on the net earnings (loss) before income taxes was (0.1)% and 0.1% for the nine months ended September 30, 2016 and September 30, 2015, respectively. For the three months ended September 30, 2016 and September 30, 2015, the Company’s effective tax rate on the net earnings (loss) before income taxes was (0.4)% and (0.8)%, respectively.

XML 20 R10.htm IDEA: XBRL DOCUMENT

OTHER ACCRUED LIABILITIES

9 Months Ended

Sep. 30, 2016

OTHER ACCRUED LIABILITIES

OTHER ACCRUED LIABILITIES

5. OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

		September 30, 2016		December 31, 2015
Prepayments from customers	$	357,396	$	395,396
Accrued property taxes		327,602		—
Accrued professional fees		213,952		274,252
Other accrued expenses		27,093		20,887

	$	926,043	$	690,535

XML 21 R11.htm IDEA: XBRL DOCUMENT

COMMITMENTS AND CONTINGENCIES	9 Months Ended
COMMITMENTS AND CONTINGENCIES	Sep. 30, 2016
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES	6. COMMITMENTS AND CONTINGENCIES In May 2010, the Company and an officer’s suit 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. The trial commenced on September 9, 2013, in the U.S. District Court for the Eastern District of Texas, Tyler Division, and the jury found that BD illegally engaged in anticompetitive conduct with the intent to acquire or maintain monopoly power in the safety syringe market and engaged in false advertising under the Lanham Act. The jury awarded the Company $113,508,014 in damages, which was trebled pursuant to statute. The Court granted injunctive relief to take effect January 15, 2015. In doing so, the Court found that BD’s business practices limited innovation, including false advertisements that suppressed sales of the VanishPoint®. The specific injunctive relief includes: (1) enjoining BD’s use of “World’s Sharpest Needle” or any similar assertion of superior sharpness; (2) requiring notification to all customers who purchased BD syringe products from July 2, 2004 to date that BD wrongfully claimed that its syringe needles were sharper and that its statement that it had “data on file” was false and misleading; (3) requiring notification to employees, customers, distributors, GPOs, and government agencies that the deadspace of the VanishPoint® has been within ISO standards since 2004 and that BD overstated the deadspace of the VanishPoint® to represent that it was higher than some of BD’s syringes when it was actually less, and that BD’s statement that it had “data on file” was false and misleading, and, in addition, posting this notice on its website for a period of three years; (4) enjoining BD from advertising that its syringe products save medication as compared to VanishPoint® products for a period of three years; (5) requiring notification to all employees, customers, distributors, GPOs, and government agencies that BD’s website, cost calculator, printed materials, and oral representations alleging BD’s syringes save medication as compared to the VanishPoint® were based on false and inaccurate measurement of the VanishPoint®, and, in addition, posting this notice on its website for a period of three years; and (6) requiring the implementation of a comprehensive training program for BD employees and distributors that specifically instructs them not to use old marketing materials and not to make false representations regarding VanishPoint® syringes. Final judgment was entered on January 15, 2015, awarding the Company $340,524,042 in damages and $11,722,823 in attorneys’ fees, as well as granting injunctive relief consistent with the orders as indicated above. The parties stipulated that the amount of litigation costs recoverable by the Company is $295,000. On January 14, 2015, the District Court stayed the portion of the injunctive relief that requires BD to notify end-user customers but also ordered BD to comply with internal correction activities as well as mandatory disclosures as set out above to its employees, customers, distributors and Group Purchasing Organizations. BD filed an appeal of that ruling with the 5th Circuit Court of Appeals and that appeal was denied on February 3, 2015. On February 12, 2015, BD filed a motion to amend the judgment directed most specifically to the issue of award of prejudgment interest. On April 23, 2015, the Court entered an Amended Final Judgment that removed prejudgment interest but kept all other monetary and injunctive relief the same as was granted in the original Final Judgment. BD filed its brief in the appeal on July 20, 2015. The Company filed its responsive brief on September 18, 2015, and BD filed its brief in reply on October 19, 2015, to complete the briefing. Oral argument occurred on Monday, February 29, 2016. There is no set time limit for the 5th Circuit Court of Appeals to issue its decision. In September 2007, BD and MDC Investment Holdings, Inc. (“MDC”) sued the Company in the United States 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. BD and MDC seek injunctive relief and unspecified damages. The Company counterclaimed for declarations of non-infringement, invalidity, and unenforceability of the asserted patents. The plaintiffs subsequently dropped allegations with regard to patent no. 7,090,656 and the Company subsequently dropped its counterclaims for unenforceability of the asserted patents. On June 30, 2015, the Court ordered that further proceedings in this matter be stayed and that this case remain administratively closed until resolution of all appeals in the case detailed in the first paragraph of this Note 6.

XML 22 R12.htm IDEA: XBRL DOCUMENT

BUSINESS SEGMENTS

9 Months Ended

Sep. 30, 2016

BUSINESS SEGMENTS

BUSINESS SEGMENTS

7. BUSINESS SEGMENTS

		Three Months Ended September 30, 2016		Three Months Ended September 30, 2015		Nine Months Ended September 30, 2016		Nine Months Ended September 30, 2015
U.S. sales	$	7,303,015	$	6,152,873	$	19,750,504	$	17,423,389
North and South America sales (excluding U.S.)		1,406,720		3,065,507		2,058,594		4,345,044
Other international sales		130,399		264,486		528,071		608,479

Total sales	$	8,840,134	$	9,482,866	$	22,337,169	$	22,376,912

	September 30, 2016		December 31, 2015

Long-lived assets
U.S.	$	12,304,416	$	11,282,192
International	$	167,776	$	185,869

- Definition

The entire disclosure for reporting segments including data and tables. Reportable segments include those that meet any of the following quantitative thresholds a) it's reported revenue, including sales to external customers and intersegment sales or transfers is 10 percent or more of the combined revenue, internal and external, of all operating segments b) the absolute amount of its reported profit or loss is 10 percent or more of the greater, in absolute amount of 1) the combined reported profit of all operating segments that did not report a loss or 2) the combined reported loss of all operating segments that did report a loss c) its assets are 10 percent or more of the combined assets of all operating segments.

+ References

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Reference 2: http://www.xbrl.org/2003/role/presentationRef
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Reference 3: http://www.xbrl.org/2003/role/presentationRef
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Reference 4: http://www.xbrl.org/2003/role/presentationRef
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Reference 7: http://www.xbrl.org/2003/role/presentationRef
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-Publisher FASB
-Name Accounting Standards Codification
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+ Details

XML 23 R13.htm IDEA: XBRL DOCUMENT

DIVIDENDS	9 Months Ended
DIVIDENDS	Sep. 30, 2016
DIVIDENDS
DIVIDENDS	8. DIVIDENDS The Company declared dividends in 2015 in the amounts of $12,313 and $43,101 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on February 1, 2016. The Company declared dividends in the first quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on April 21, 2016. The Company declared dividends in the second quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on July 28, 2016. The Company declared dividends in the third quarter of 2016 in the amounts of $12,313 and $42,800 paid to Series I Class B and Series II Class B Preferred Stockholders, respectively, on October 20, 2016.

XML 24 R14.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS	9 Months Ended
STOCK OPTIONS	Sep. 30, 2016
STOCK OPTIONS
STOCK OPTIONS	9. STOCK OPTIONS On September 9, 2016, the Compensation and Benefits Committee approved grants of incentive stock options to the Company’s employees under the First Amended 2008 Stock Option Plan with exercise prices at fair market value ($2.75 per share), a ten-year term, and one-year vesting period, except to the extent that such vesting period would violate the First Amended 2008 Stock Option Plan. In total, once vested, the stock options will be exercisable into 500,400 shares of Common Stock. The value of an option for the purchase of one underlying common share is valued at $2.03, using the Black Scholes Option Pricing Model using a risk-free rate of 1.61% and a volatility factor of 67.6%.

XML 25 R15.htm IDEA: XBRL DOCUMENT

SUBSEQUENT EVENTS	9 Months Ended
SUBSEQUENT EVENTS	Sep. 30, 2016
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS	10. SUBSEQUENT EVENTS On November 1, 2016, the Compensation and Benefits Committee approved a grant of a stock option to the chief executive officer for the purchase of 3,000,000 shares of Common Stock, not pursuant to any existing stock option plan, which will require shareholder approval prior to effectiveness. The total value of this option using the Black Scholes Option Pricing Model using a risk-free rate of 1.84% and a volatility factor of 66.9% is $5.9 million.

XML 26 R16.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)

9 Months Ended

Sep. 30, 2016

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

Accounting estimates

Cash and cash equivalents

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

Accounts receivable

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

Inventories

Property, plant, and equipment

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
Automobiles	7 years

Long-lived assets

The Company’s property, plant, and equipment primarily consist of buildings, land, assembly equipment for syringes, molding machines, molds, office equipment, furniture, and fixtures.

Intangible assets

Intangible assets are stated at cost and consist primarily of intellectual property which is amortized using the straight-line method over 17 years.

Financial instruments

Concentration risks

The following table reflects our significant customers for the first three and nine months of 2016 and 2015:

	Three Months ended September 30, 2016	Three Months ended September 30, 2015	Nine Months ended September 30, 2016	Nine Months ended September 30, 2015
Number of significant customers	2	2	1	2
Aggregate dollar amount of net sales to significant customers	$3.5 million	$5.1 million	$7.1 million	$10.3 million
Percentage of net sales to significant customers	39.3%	53.5%	31.6%	46.0%

Revenue recognition

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

Income taxes

Earnings per share

		Three Months Ended September 30, 2016			Three Months Ended September 30, 2015			Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015
Net income (loss)	$	(125,304	)	$	(254,826	)	$	(1,721,089	)	$	5,239,459
Preferred dividend requirements		(176,249	)		(227,499	)		(528,747	)		(682,802	)

Earnings (loss) applicable to common shareholders after assumed conversions	$	(301,553	)	$	(482,325	)	$	(2,249,836	)	$	4,556,657

Average common shares outstanding		29,649,874			27,873,447			29,252,652			27,759,333

Average common and common equivalent shares outstanding – assuming dilution		29,649,874			27,873,447			29,252,652			29,436,008

Basic earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.16

Diluted earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.15

Shipping and handling costs

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

Research and development costs

Research and development costs are expensed as incurred.

Share-based compensation

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

Recent Pronouncements

XML 27 R17.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)

9 Months Ended

Sep. 30, 2016

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
Automobiles	7 years

Schedule of significant customers

	Three Months ended September 30, 2016	Three Months ended September 30, 2015	Nine Months ended September 30, 2016	Nine Months ended September 30, 2015
Number of significant customers	2	2	1	2
Aggregate dollar amount of net sales to significant customers	$3.5 million	$5.1 million	$7.1 million	$10.3 million
Percentage of net sales to significant customers	39.3%	53.5%	31.6%	46.0%

Schedule of earnings per share

		Three Months Ended September 30, 2016			Three Months Ended September 30, 2015			Nine Months Ended September 30, 2016			Nine Months Ended September 30, 2015
Net income (loss)	$	(125,304	)	$	(254,826	)	$	(1,721,089	)	$	5,239,459
Preferred dividend requirements		(176,249	)		(227,499	)		(528,747	)		(682,802	)

Earnings (loss) applicable to common shareholders after assumed conversions	$	(301,553	)	$	(482,325	)	$	(2,249,836	)	$	4,556,657

Average common shares outstanding		29,649,874			27,873,447			29,252,652			27,759,333

Average common and common equivalent shares outstanding – assuming dilution		29,649,874			27,873,447			29,252,652			29,436,008

Basic earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.16

Diluted earnings (loss) per share	$	(0.01	)	$	(0.02	)	$	(0.08	)	$	0.15

XML 28 R18.htm IDEA: XBRL DOCUMENT

INVENTORIES (Tables)

9 Months Ended

Sep. 30, 2016

INVENTORIES

Schedule of inventories

		September 30, 2016			December 31, 2015
Raw materials	$	1,614,476		$	1,664,241
Finished goods		6,448,066			5,313,778

		8,062,542			6,978,019
Inventory reserve		(857,818	)		(681,394	)

	$	7,204,724		$	6,296,625

XML 29 R19.htm IDEA: XBRL DOCUMENT

OTHER ACCRUED LIABILITIES (Tables)

9 Months Ended

Sep. 30, 2016

OTHER ACCRUED LIABILITIES

Schedule of other accrued liabilities

		September 30, 2016		December 31, 2015
Prepayments from customers	$	357,396	$	395,396
Accrued property taxes		327,602		—
Accrued professional fees		213,952		274,252
Other accrued expenses		27,093		20,887

	$	926,043	$	690,535

XML 30 R20.htm IDEA: XBRL DOCUMENT

BUSINESS SEGMENTS (Tables)

9 Months Ended

Sep. 30, 2016

BUSINESS SEGMENTS

Schedule of sales and long-lived assets by geographical areas

		Three Months Ended September 30, 2016		Three Months Ended September 30, 2015		Nine Months Ended September 30, 2016		Nine Months Ended September 30, 2015
U.S. sales	$	7,303,015	$	6,152,873	$	19,750,504	$	17,423,389
North and South America sales (excluding U.S.)		1,406,720		3,065,507		2,058,594		4,345,044
Other international sales		130,399		264,486		528,071		608,479

Total sales	$	8,840,134	$	9,482,866	$	22,337,169	$	22,376,912

	September 30, 2016		December 31, 2015

Long-lived assets
U.S.	$	12,304,416	$	11,282,192
International	$	167,776	$	185,869

XML 31 R21.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property, Plant and Equipment (Details)	9 Months Ended
	Sep. 30, 2016 item
Accounts receivable
Number of products consigned to customers	0
Maximum
Intangible assets
Useful lives of intellectual property	17 years
Production equipment \| Minimum
Property, plant, and equipment
Useful lives	3 years
Production equipment \| Maximum
Property, plant, and equipment
Useful lives	13 years
Office furniture and equipment \| Minimum
Property, plant, and equipment
Useful lives	3 years
Office furniture 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
Automobiles
Property, plant, and equipment
Useful lives	7 years

XML 32 R22.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration of Risk (Details)	3 Months Ended		9 Months Ended
	Sep. 30, 2016 USD ($) customer	Sep. 30, 2015 USD ($) customer	Sep. 30, 2016 USD ($) customer item	Sep. 30, 2015 USD ($) customer	Dec. 31, 2015 USD ($)
Concentration risks
Number of significant customers \| customer	2	2	1	2
Aggregate dollar amount of net sales to significant customers	$ 8,840,134	$ 9,482,866	$ 22,337,169	$ 22,376,912
Revenue recognition
Estimated contractual allowance	3,998,904		3,998,904		$ 3,733,199
Change to reserve regarding non-contractual rebates			$ 0
Period for return of incorrect shipments			10 days
Number of times overstocking returns are limited \| item			2
Period for return of product due to overstock			12 months
Maximum percentage of distributor's total purchase for the prior 12-month period			1.00%
Sales \| Customer Concentration Risk
Concentration risks
Aggregate dollar amount of net sales to significant customers	$ 3,500,000	$ 5,100,000	$ 7,100,000	$ 10,300,000
Percentage of net sales to significant customers (as a percent)	39.30%	53.50%	31.60%	46.00%
Syringes \| Supplier Concentration Risk
Concentration risks
Percentage of net sales to significant customers (as a percent)	92.70%	82.40%	85.10%	78.20%

XML 33 R23.htm IDEA: XBRL DOCUMENT

SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings Per Share (Details) - USD ($)	3 Months Ended		9 Months Ended
	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
Earnings per share
Stock options excluded from calculation of diluted EPS	670,338		674,042
Net income (loss)	$ (125,304)	$ (254,826)	$ (1,721,089)	$ 5,239,459
Preferred dividend requirements	(176,249)	(227,499)	(528,747)	(682,802)
Earnings (loss) applicable to common shareholders	$ (301,553)	$ (482,325)	$ (2,249,836)	$ 4,556,657
Average common shares outstanding	29,649,874	27,873,447	29,252,652	27,759,333
Average common and common equivalent shares outstanding - assuming dilution	29,649,874	27,873,447	29,252,652	29,436,008
Basic earnings (loss) per share (in dollars per share)	$ (0.01)	$ (0.02)	$ (0.08)	$ 0.16
Diluted earnings (loss) per share (in dollars per share)	$ (0.01)	$ (0.02)	$ (0.08)	$ 0.15

- Definition

The amount of net income (loss) for the period per each share of common stock or unit outstanding during the reporting period.

+ References + Details

- Definition

The portion of profit or loss for the period, net of income taxes, which is attributable to the parent.

+ References + Details

XML 34 R24.htm IDEA: XBRL DOCUMENT

INVENTORIES (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
INVENTORIES
Raw materials	$ 1,614,476	$ 1,664,241
Finished goods	6,448,066	5,313,778
Inventory, gross	8,062,542	6,978,019
Inventory reserve	(857,818)	(681,394)
Inventory, net	$ 7,204,724	$ 6,296,625

XML 35 R25.htm IDEA: XBRL DOCUMENT

INCOME TAXES (Details)	3 Months Ended		9 Months Ended
INCOME TAXES (Details)	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015
INCOME TAXES
Effective tax rate (as a percent)	(0.40%)	(0.80%)	(0.10%)	0.10%

XML 36 R26.htm IDEA: XBRL DOCUMENT

OTHER ACCRUED LIABILITIES (Details) - USD ($)	Sep. 30, 2016	Dec. 31, 2015
OTHER ACCRUED LIABILITIES
Prepayments from customers	$ 357,396	$ 395,396
Accrued property taxes	327,602
Accrued professional fees	213,952	274,252
Other accrued expenses	27,093	20,887
Other accrued liabilities	$ 926,043	$ 690,535

XML 37 R27.htm IDEA: XBRL DOCUMENT

COMMITMENTS AND CONTINGENCIES (Details)			9 Months Ended
COMMITMENTS AND CONTINGENCIES (Details)	Jan. 15, 2015 USD ($)	Sep. 09, 2013 USD ($)	Sep. 30, 2016	Sep. 30, 2007 item
Becton Dickinson and Company Case
COMMITMENTS AND CONTINGENCIES
Value of damages awarded	$ 340,524,042	$ 113,508,014
Length of time required to post corrected product information on its website			3 years
Length of time required to modify its advertising messages			3 years
Attorney fees	11,722,823
Litigation costs recoverable	$ 295,000
BD and MDC Investment Holdings Inc Case
COMMITMENTS AND CONTINGENCIES
Number of U.S. patents infringed upon \| item				2

XML 38 R28.htm IDEA: XBRL DOCUMENT

BUSINESS SEGMENTS (Details) - USD ($)	3 Months Ended		9 Months Ended
BUSINESS SEGMENTS (Details) - USD ($)	Sep. 30, 2016	Sep. 30, 2015	Sep. 30, 2016	Sep. 30, 2015	Dec. 31, 2015
Sales by geographical areas
Total sales	$ 8,840,134	$ 9,482,866	$ 22,337,169	$ 22,376,912
U.S.
Sales by geographical areas
Total sales	7,303,015	6,152,873	19,750,504	17,423,389
Long-lived assets
Long-Lived assets	12,304,416		12,304,416		$ 11,282,192
North and South America sales (excluding U.S.)
Sales by geographical areas
Total sales	1,406,720	3,065,507	2,058,594	4,345,044
Other international sales
Sales by geographical areas
Total sales	130,399	$ 264,486	528,071	$ 608,479
International
Long-lived assets
Long-Lived assets	$ 167,776		$ 167,776		$ 185,869

XML 39 R29.htm IDEA: XBRL DOCUMENT

DIVIDENDS (Details) - USD ($)					9 Months Ended
DIVIDENDS (Details) - USD ($)	Oct. 20, 2016	Jul. 28, 2016	Apr. 21, 2016	Feb. 01, 2016	Sep. 30, 2016	Sep. 30, 2015
Dividends
Preferred dividends declared					$ 55,113	$ 56,363
Series I, Class B
Dividends
Preferred dividends declared	$ 12,313	$ 12,313	$ 12,313	$ 12,313
Series II, Class B
Dividends
Preferred dividends declared	$ 42,800	$ 42,800	$ 42,800	$ 43,101

XML 40 R30.htm IDEA: XBRL DOCUMENT

STOCK OPTIONS (Details) - Employee Stock Option	Sep. 09, 2016 $ / shares shares
STOCK OPTIONS
Exercise price (in dollars per share)	$ (2.75)
Term of option plan	10 years
Vesting period	1 year
Exercisable (in shares) \| shares	500,400
Exercisable (in dollars per share)	$ 2.03
Risk-free rate (as a percent)	1.61%
Volatility factor (as a percent)	67.60%

XML 41 R31.htm IDEA: XBRL DOCUMENT

SUBSEQUENT EVENTS (Details) - Employee Stock Option - USD ($) $ in Millions	Nov. 01, 2016	Sep. 09, 2016
SUBSEQUENT EVENTS
Risk-free rate (as a percent)		1.61%
Volatility factor (as a percent)		67.60%
Subsequent events \| Chief Executive Officer
SUBSEQUENT EVENTS
Granted (in shares)	3,000,000
Risk-free rate (as a percent)	1.84%
Volatility factor (as a percent)	66.90%
Fair value of options granted	$ 5.9

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