Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2021 | May 03, 2021 | |
Cover | ||
Entity Registrant Name | RETRACTABLE TECHNOLOGIES INC | |
Entity Central Index Key | 0000946563 | |
Document Type | 10-Q | |
Document Period End Date | Mar. 31, 2021 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Interactive Data Current | Yes | |
Entity Filer Category | Non-accelerated Filer | |
Entity Small Business | true | |
Entity Emerging Growth Company | false | |
Entity Shell Company | false | |
Entity Common Stock, Shares Outstanding | 34,004,104 | |
Document Fiscal Year Focus | 2021 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | RVP | |
Title of 12(b) Security | Common Stock | |
Security Exchange Name | NYSE |
CONDENSED BALANCE SHEETS
CONDENSED BALANCE SHEETS - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
Current assets: | ||
Cash and cash equivalents | $ 30,924,687 | $ 17,566,682 |
Accounts receivable, net | 34,364,259 | 32,910,919 |
Investments in debt and equity securities, at fair value | 13,763,887 | 8,081,833 |
Inventories, net | 8,946,051 | 10,234,646 |
Other current assets | 813,490 | 684,317 |
Total current assets | 88,812,374 | 69,478,397 |
Property, plant, and equipment, net | 43,216,851 | 30,816,504 |
Deferred tax asset | 6,370,001 | 4,631,206 |
Other assets | 31,723 | 44,567 |
Total assets | 138,430,949 | 104,970,674 |
Current liabilities: | ||
Accounts payable | 14,303,586 | 16,256,444 |
Current portion of long-term debt | 1,489,318 | 1,030,763 |
Accrued compensation | 1,303,568 | 826,762 |
Dividends payable | 39,050 | 49,091 |
Accrued royalties to shareholder | 2,921,597 | 1,973,781 |
Other accrued liabilities | 3,266,909 | 3,398,904 |
Income taxes payable | 12,699,408 | 4,365,770 |
Total current liabilities | 36,023,436 | 27,901,515 |
Other long-term liabilities | 32,383,550 | 24,478,697 |
Long-term debt, net of current maturities | 2,183,654 | 2,710,337 |
Total liabilities | 70,590,640 | 55,090,549 |
Commitments and contingencies - see Note 8 | ||
Preferred stock, $1 par value: | ||
Common stock, no par value | ||
Additional paid-in capital | 59,294,701 | 59,285,401 |
Retained earnings | 8,287,663 | (9,668,221) |
Total stockholders' equity | 67,840,309 | 49,880,125 |
Total liabilities and stockholders' equity | 138,430,949 | 104,970,674 |
Series II, Class B | ||
Preferred stock, $1 par value: | ||
Preferred stock | 156,200 | 156,200 |
Series III Preferred Stock | ||
Preferred stock, $1 par value: | ||
Preferred stock | $ 101,745 | $ 106,745 |
CONDENSED BALANCE SHEETS (Paren
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2021 | Dec. 31, 2020 |
CONDENSED BALANCE SHEETS | ||
Preferred stock, par value (in dollars per share) | $ 1 | $ 1 |
Common stock, par value (in dollars per share) | $ 0 | $ 0 |
CONDENSED STATEMENTS OF OPERATI
CONDENSED STATEMENTS OF OPERATIONS - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Sales, net | $ 50,073,725 | $ 11,202,217 |
Cost of sales | ||
Total cost of sales | 22,078,938 | 7,671,783 |
Gross profit | 27,994,787 | 3,530,434 |
Operating expenses: | ||
Sales and marketing | 931,231 | 1,135,980 |
Research and development | 149,283 | 138,537 |
General and administrative | 3,493,236 | 1,775,204 |
Total operating expenses | 4,573,750 | 3,049,721 |
Income from operations | 23,421,037 | 480,713 |
Interest and other income (loss) | 1,194,779 | (141,417) |
Interest expense | (65,095) | (33,849) |
Income before income taxes | 24,550,721 | 305,447 |
Provision (benefit) for income taxes | 6,594,837 | (17,326) |
Net income | 17,955,884 | 322,773 |
Preferred Stock dividend requirements | (64,938) | (174,143) |
Income applicable to common shareholders | $ 17,890,946 | $ 148,630 |
Basic earnings per share | $ 0.53 | $ 0 |
Diluted earnings per share | $ 0.52 | $ 0 |
Weighted average common shares outstanding: | ||
Basic (in shares) | 33,967,771 | 32,681,204 |
Diluted (in shares) | 34,378,683 | 32,745,972 |
Costs of manufactured product | ||
Cost of sales | ||
Total cost of sales | $ 19,157,341 | $ 6,802,675 |
Royalty expense to shareholder | ||
Cost of sales | ||
Total cost of sales | $ 2,921,597 | $ 869,108 |
CONDENSED STATEMENTS OF CASH FL
CONDENSED STATEMENTS OF CASH FLOWS - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Cash flows from operating activities | ||
Net income | $ 17,955,884 | $ 322,773 |
Adjustments to reconcile net income to net cash provided by operating activities: | ||
Depreciation and amortization | 210,683 | 210,369 |
Net unrealized (gain) loss on investments | (1,103,972) | 164,342 |
Accreted interest | 32,277 | |
Deferred taxes | (1,738,795) | |
Provision for doubtful accounts | 150,000 | 125,000 |
(Increase) decrease in operating assets: | ||
Accounts receivable | (7,904,815) | 1,245,531 |
Inventories | 1,288,595 | 1,077,460 |
Other current assets | (129,173) | (34,566) |
Other assets | 12,844 | 20,483 |
Increase (decrease) in operating liabilities: | ||
Accounts payable | (1,952,858) | (572,637) |
Accrued liabilities | 1,433,224 | (466,610) |
Income taxes payable | 8,333,638 | |
Net cash provided by operating activities | 16,587,532 | 2,092,145 |
Cash flows from investing activities | ||
Purchase of property, plant, and equipment | (12,611,028) | (186,030) |
Purchase of debt and equity securities | (4,578,082) | (41,763) |
Net cash used by investing activities | (17,189,110) | (227,793) |
Cash flows from financing activities | ||
Repayments of long-term debt | (68,128) | (64,167) |
Proceeds from TIA | 15,235,812 | |
Proceeds from the exercise of stock options | 43,350 | |
Payment of preferred stock redemption price payable | (101,250) | |
Payment of preferred stock repurchase payable | (1,101,110) | (75,000) |
Payment of preferred stock dividends | (49,091) | (54,800) |
Net cash provided (used) by financing activities | 13,959,583 | (193,967) |
Net increase in cash and cash equivalents | 13,358,005 | 1,670,385 |
Cash and cash equivalents at: | ||
Beginning of period | 17,566,682 | 5,934,749 |
End of period | 30,924,687 | 7,605,134 |
Supplemental schedule of cash flow information: | ||
Interest paid | 32,818 | 33,851 |
Supplemental schedule of noncash investing and financing activities: | ||
Preferred dividends declared, not paid | 39,050 | $ 54,800 |
Conversion of preferred stock to common stock | 5,000 | |
Amounts receivable under TIA | $ 5,477,603 |
CONDENSED STATEMENTS OF CHANGES
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($) | Preferred StockSeries I, Class B | Preferred StockSeries II, Class B | Preferred StockSeries III Preferred Stock | Preferred StockSeries IV Preferred Stock | Preferred StockSeries V Preferred Stock | Additional Paid-in Capital | Retained Earnings/Accumulated Deficit | Total |
Balance at Dec. 31, 2019 | $ 96,000 | $ 171,200 | $ 129,245 | $ 342,500 | $ 34,000 | $ 61,660,744 | $ (33,891,234) | $ 28,542,455 |
Increase (Decrease) in Stockholders' Equity | ||||||||
Exchange of Preferred Stock for Common Stock | (2,500) | (5,000) | (67,500) | (75,000) | ||||
Dividends | (54,800) | (54,800) | ||||||
Net income | 322,773 | 322,773 | ||||||
Balance at Mar. 31, 2020 | $ 96,000 | 171,200 | 126,745 | $ 337,500 | $ 34,000 | 61,538,444 | (33,568,461) | 28,735,428 |
Balance at Dec. 31, 2020 | 156,200 | 106,745 | 59,285,401 | (9,668,221) | 49,880,125 | |||
Increase (Decrease) in Stockholders' Equity | ||||||||
Conversion of Preferred Stock into Common Stock | (5,000) | 5,000 | ||||||
Stock Option Exercises | 43,350 | 43,350 | ||||||
Dividends | (39,050) | (39,050) | ||||||
Net income | 17,955,884 | 17,955,884 | ||||||
Balance at Mar. 31, 2021 | $ 156,200 | $ 101,745 | $ 59,294,701 | $ 8,287,663 | $ 67,840,309 |
BUSINESS OF THE COMPANY AND BAS
BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION | 3 Months Ended |
Mar. 31, 2021 | |
BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION | |
BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION | 1. BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION Business of the Company Retractable Technologies, Inc. (the “Company”) was incorporated in Texas on May 9, 1994, and designs, develops, manufactures, and markets safety syringes and other safety medical products for the healthcare profession. The Company began to develop its manufacturing operations in 1995. The Company’s manufacturing and administrative facilities are located in Little Elm, Texas. The Company’s products are the VanishPoint ® 0.5mL insulin syringe; 1mL tuberculin, insulin, and allergy antigen syringes; 0.5mL, 1mL, 2mL, 3mL, 5mL, and 10mL syringes; the blood collection tube holder; the small diameter tube adapter; the allergy tray; the IV safety catheter; the Patient Safe ® syringes; the Patient Safe ® Luer Cap; the VanishPoint ® Blood Collection Set; and the EasyPoint ® needle as well as a standard 3mL syringe packaged with an EasyPoint ® needle. The Company also sells VanishPoint ® autodisable syringes in the international market in addition to the Company’s other products . Basis of presentation The accompanying condensed financial statements are unaudited and, in the opinion of Management, reflect all adjustments that are necessary for a fair presentation of the financial position and results of operations for the periods presented. All such adjustments are of a normal and recurring nature. The results of operations for the periods presented are not necessarily indicative of the results to be expected for the entire year. The unaudited condensed financial statements should be read in conjunction with the financial statement disclosures contained in the Company’s audited financial statements incorporated into its Form 10-K filed on March 31, 2021 for the year ended December 31, 2020. |
SUMMARY OF SIGNIFICANT ACCOUNTI
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 3 Months Ended |
Mar. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | 2. SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES Accounting estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ significantly from those estimates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related to sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that the Company has an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied. Cash and cash equivalents For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with original maturities of three months or less. Accounts receivable The Company records trade receivables when revenue is recognized. No product has been consigned to customers. The Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables. Those accounts that are doubtful of collection are included in the allowance. This provision is reviewed to determine the adequacy of the allowance for doubtful accounts. Trade receivables are charged off when there is certainty as to their being uncollectible. Trade receivables are considered delinquent when payment has not been made within contract terms. The Allowance for bad debt was $352,217 and $205,822 as of March 31, 2021 and December 31, 2020, respectively. The Company requires certain customers to make a prepayment prior to beginning production or shipment of their order. Customers may apply such prepayments to their outstanding invoices or pay the invoice and continue to carry forward the deposit for future orders. Such amounts are included in Other accrued liabilities on the Condensed Balance Sheets and are shown in Note 6, Other Accrued Liabilities. The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales. Historically, returns have been insignificant. Inventories Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost. The Company compares the average cost to the net realizable value and records the lower value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, the shelf life of inventory, and current market conditions when determining excess or obsolete inventories. Once inventory items are deemed to be either excess or obsolete, they are excluded from the stated net realizable value. Investments in debt and equity securities The Company holds high-grade exchange-traded and closed-end funds (ETFs), mutual funds, equity securities, and debt securities as investments. These assets are readily marketable and are carried at fair value as of the date of the Condensed Balance Sheets. Net unrealized and realized gains or losses on investments in debt and equity securities are reflected as a component of Interest and other income (loss). Realized gains or losses on investments in debt and equity securities are recognized using the specific identification method. Property, plant, and equipment Property, plant, and equipment are stated at cost. Expenditures for maintenance and repairs are charged to operations as incurred. Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity and interest cost associated with significant capital additions. Gains or losses from disposals are included in operations. The Company's property, plant, and equipment primarily consist of buildings, land, assembly equipment, molding machines, molds, office equipment, furniture, and fixtures. Depreciation and amortization are calculated using the straight-line method over the following useful lives: Production equipment 3 to 13 years Office furniture and equipment 3 to 10 years Buildings 39 years Building improvements 15 years Long-lived assets The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash flows related to such assets. In the event that assets are found to be carried at amounts which are in excess of estimated gross future cash flows, the assets will be adjusted for impairment to a level commensurate with fair value determined using a discounted cash flow analysis or appraised values of the underlying assets. Fair value measurements For assets and liabilities that are measured using quoted prices in active markets, total fair value is the published market price per unit multiplied by the number of units held without consideration of transaction costs. Assets and liabilities that are measured using significant other observable inputs are valued by reference to similar assets or liabilities, adjusted for contract restrictions and other terms specific to that asset or liability. For these items, a significant portion of fair value is derived by reference to quoted prices of similar assets or liabilities in active markets. For all remaining assets and liabilities, fair value is derived using a fair value model, such as a discounted cash flow model or Black-Scholes model. Financial instruments The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information. Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange. Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values. Investments in equity securities consist primarily of individual equity securities, exchange-traded and closed-end funds and mutual funds and are reported at their fair value based upon quoted prices in active markets. Investments in U.S. Treasury Notes are reported at their fair value based upon quoted prices in active markets. Investments in certificates of deposit (CD) with original maturities of greater than three months are reported at their estimated fair value based upon the duration of the CD and the interest rate earned on the CD versus current interest rates of similar duration CDs. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values. Concentration risks The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, U.S. Treasury Notes, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in debt and equity securities through consultation with its outside investment advisors. Management is responsible for directing investment activity based on current economic conditions. The majority of accounts receivable are due from companies which are well-established entities. In the first quarter of 2021, a significant portion of the Company’s sales were to the U.S. government, which Management does not consider a credit risk. As a consequence, Management considers any exposure from concentrations of credit risks to be limited. The following table reflects significant customers for the first quarters of 2021 and 2020: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Number of significant customers 1 3 Aggregate dollar amount of net sales to significant customers $ 37.8 million $ 5.4 million Percentage of net sales to significant customers 75.5 % 48.2 % In the first quarter of 2021, approximately $37.8 million of the Company's sales were to the Department of Health and Human Services of the United States. Management expects the U.S. government to remain a significant customer through at least September 2021. There were no sales to the Department of Health and Human Services in the first quarter of 2020. The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China. The Company obtained roughly 90.3% and 80.3% of its products in the first three months of 2021 and 2020, respectively, from its Chinese manufacturers. In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company would need to find an alternate manufacturer for its blood collection set, IV catheter, Patient Safe ® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and would increase domestic production for the 1mL and 3mL syringes and EasyPoint ® needles. Revenue recognition The Company recognizes revenue when it has satisfied all performance obligations to the customer, generally when title and risk of loss pass to the customer. Payments from customers with approved credit terms are typically due 30 days from the invoice date. Under certain contracts, revenue is recorded on the basis of sales price to distributors, less contractual pricing allowances. Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among other things, the facility that purchased the products, and (ii) a provision for estimated contractual pricing allowances for products for which the Company has not received tracking reports. When rebates are issued, they are applied against the customer’s receivable balance. Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by a distributor to an entity that has no contract, there is a standard rebate (lower than a contracted rebate) given to the distributor. One of the purposes of the rebate is to encourage distributors to submit tracking reports to the Company. The provision for contractual pricing allowances is recognized in the period the related sales are recognized and is reviewed at the end of each quarter and adjusted for changes in levels of products for which there is no tracking report. Additionally, if it becomes clear that tracking reports will not be provided by individual distributors, the provision is further adjusted. The estimated contractual allowance is included in Accounts payable in the Condensed Balance Sheets and deducted from Revenues in the Condensed Statements of Operations. Accounts payable included estimated contractual allowances for $4,893,647 and $3,435,352 as of March 31, 2021 and December 31, 2020, respectively. The terms and conditions of contractual pricing allowances are governed by contracts between the Company and its distributors. Revenue for shipments directly to end-users is recognized when title and risk of ownership pass from the Company. End-users do not receive any contractual allowances on their purchases. Any product shipped or distributed for evaluation purposes is expensed. The Company provides product warranties that: i) the products are fit for medical use as generally defined within the boundaries of United States FDA approval; ii) the products are not defective; and iii) the products will conform to the descriptions set forth in their respective labeling, provided that they are used in accordance with such labeling and the Company’s written directions for use. The Company has historically not incurred significant warranty claims. The Company’s domestic return policy provides that a customer may return incorrect shipments within 10 days following arrival at the distributor’s facility. In all such cases, the distributor must obtain an authorization code from the Company and affix the code to the returned product. The Company’s domestic return policy also generally provides that a customer may return product that is overstocked. Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for the prior 12-month period. All product overstocks and returns are subject to inspection and acceptance by the Company. The Company’s international distribution agreements generally do not provide for any returns. The Company requires certain customers to pay in advance of product shipment. Such prepayments from customers are recorded in Other accrued liabilities and are generally recognized as revenue upon shipment of the product. The Company recognizes revenue from licensing agreements when collection of such amounts from third parties is reasonably assured. If the Company licenses its products for sale, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, a certain percentage of such revenue pursuant to the terms of the Technology License Agreement between the Company and Mr. Shaw. Disaggregated information of revenue recognized from contracts with customers and licensing fees recognized are as follows: For the three months ended March 31, 2021: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales (excluding U.S. government) $ 8,759,314 $ 574,008 $ 1,612,333 $ 15,536 $ 10,961,191 Sales to U.S. government 37,782,360 — — — 37,782,360 North and South America sales (excluding U.S.) 825,820 — 11,968 109,440 947,228 Other international sales 199,316 37,350 144,780 1,500 382,946 Total $ 47,566,810 $ 611,358 $ 1,769,081 $ 126,476 $ 50,073,725 For the three months ended March 31, 2020: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales $ 6,972,935 $ 580,123 $ 765,860 $ 17,879 $ 8,336,797 North and South America sales (excluding U.S.) 2,054,784 2,700 1,496 687,420 2,746,400 Other international sales 114,830 1,740 — 2,450 119,020 Total $ 9,142,549 $ 584,563 $ 767,356 $ 707,749 $ 11,202,217 Income taxes The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements based on whether it is “more-likely-than-not” that a tax position will be sustained based upon the technical merits of the position. Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on enacted rates expected to be in effect when such differences reverse in future periods. Deferred tax assets are periodically reviewed for realizability. In prior periods, the Company established a valuation allowance for its net deferred tax asset as future taxable income which could not be reasonably assured. During the quarter ended June 30, 2020, the Company released its valuation allowance based on available evidence supporting that its deferred tax assets will be realized in full. Earnings per share The Company computes basic earnings or loss 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. At March 31, 2021, the calculation of diluted EPS under the treasury stock method included 152,967 shares of Common Stock underlying issued and outstanding stock options. Common stock issuable upon the conversion of 257,945 convertible preferred shares is included in the calculation of diluted EPS for the three months ended March 31, 2021. Preferred stock was excluded from the calculation of diluted EPS for the period ended March 31, 2020 because the effect was antidilutive. The potential dilution, if any, is shown on the following schedule: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Net income $ 17,955,884 $ 322,773 Preferred stock dividend requirements (64,938) (174,143) Income applicable to common shareholders $ 17,890,946 $ 148,630 Average common shares outstanding 33,967,771 32,681,204 Average common and common equivalent shares outstanding — assuming dilution 34,378,683 32,745,972 Basic earnings per share $ 0.53 $ 0.00 Diluted earnings per share $ 0.52 $ 0.00 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. Leases The Company determines if an arrangement is a lease at inception. Operating and finance leases are included in Other assets, Other accrued liabilities, and Other long-term liabilities on the Condensed Balance Sheets. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the incremental borrowing rate based on information available at the commencement date was used in determining the present value of lease payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Leases with an initial term of twelve months or less are not recorded on the Condensed Balance Sheets; however, rent expense is recognized on a straight-line basis over the lease term. Technology Investment Agreement (TIA) Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) for $53,664,286 in Government funding for expanding the Company’s domestic production of needles and syringes. Pursuant to the terms of the TIA, the Company is expected to make significant additions to its facilities which should allow the Company to increase domestic production. As reimbursements are received from the U.S. government for such expenditures, the Company records a deferred liability. The deferred liability will be systematically amortized as a gain over the life of the related property, plant, and equipment as to offset the related depreciation expense of the assets acquired. The amortization will be presented separately from the depreciation expense on the Condensed Statements of Operations. Recently Adopted Pronouncements The Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments on January 1, 2020. Among other things, these amendments require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Many of the loss estimation techniques applied previously will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses. The adoption of ASU 2016-13, as well as the Targeted Transition Relief as provided by ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326) – Targeted Transition Relief” did not have a significant impact on the Company’s financial statements. The Company adopted ASU 2018-15, “Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract (a Consensus of the FASB Emerging Issues Task Force)" on January 1, 2020. This amendment requires that implemented costs incurred in a hosting arrangement that is a service contract should be accounted for in accordance with ASC 350-40 Internal-Use Software. Accordingly, costs incurred during the preliminary project and post-implementation stages are expensed and costs associated with the application development phase are capitalized. The amendment also requires that capitalized costs be amortized over the term of the hosting arrangement and that capitalized costs should be evaluated for impairment. The adoption of this ASU did not have a significant impact on the Company's financial statements or disclosures. In August 2018, the FASB issued ASU 2018-13 "Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement." The amendment modifies, among other things, disclosure requirements on fair value measurements and eliminates certain disclosures related to transfers and valuation levels of Level 3 fair value measurements. Additionally, the amendment requires disclosure of changes in unrealized gains and losses in other comprehensive income for Level 3 fair value measurements and certain qualitative factors related to significant unobservable inputs used in Level 3 valuations. The amendment was effective for annual periods beginning after December 15, 2019 and interim periods within the annual period. The adoption of ASU 2018-13 did not have a significant effect on the Company's financial statements , as the Company does not currently have any investments classified as Level 3 fair value measurements. In December 2019, the FASB issued ASU 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”. The new standard is intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within the annual period, with early adoption permitted. Adoption of the standard requires certain changes primarily be made prospectively, with some changes to be made retrospectively. The Company has determined that the adoption of ASU 2019-12 did not have a material impact on its financial statements. Recently Issued Pronouncement In March 2020, the FASB issued ASU No. 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting”, to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients for contracts that reference LIBOR, if certain criteria are met, that can be applied through December 31, 2022. As reference rate reform is still an ongoing process, the Company will continue to evaluate the timing and potential impact of adoption for optional expedients when deemed necessary. |
INVENTORIES
INVENTORIES | 3 Months Ended |
Mar. 31, 2021 | |
INVENTORIES | |
INVENTORIES | 3. INVENTORIES Inventories consist of the following: March 31, 2021 December 31, 2020 Raw materials $ 1,576,376 $ 1,358,552 Finished goods 7,666,883 9,243,259 Inventory reserve (297,208) (297,208) $ 8,946,051 $ |
FAIR VALUE OF FINANCIAL INSTRUM
FAIR VALUE OF FINANCIAL INSTRUMENTS | 3 Months Ended |
Mar. 31, 2021 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | 4. FAIR VALUE OF FINANCIAL INSTRUMENTS ASC 820, “Fair Value Measurements”, defines fair value, establishes a framework for measuring fair value and requires additional disclosures regarding certain fair value measurements. ASC 820 establishes a three-tier hierarchy for measuring fair value, as follows: · Level 1 – quoted market prices in active markets for identical assets and liabilities · Level 2 – inputs other than quoted prices that are directly or indirectly observable · Level 3 - unobservable inputs where there is little or no market activity The following tables summarize the values of assets designated as Investments in debt and equity securities: March 31, 2021 Level 1 Level 2 Level 3 Total Equity securities $ 9,647,668 $ — $ — $ 9,647,668 Mutual funds and exchange traded funds 4,039,440 — — 4,039,440 Certificates of deposit — 76,779 — 76,779 $ 13,687,108 $ 76,779 $ — $ 13,763,887 December 31, 2020 Level 1 Level 2 Level 3 Total Equity securities $ $ — $ — $ Mutual funds and exchange traded funds 4,013,956 — — Certificates of deposit — — $ $ $ — $ The Company holds high-grade ETFs, mutual funds, individual equity stocks, and debt securities as investments. These assets are readily marketable and are carried at fair value as of the date of the Condensed Balance Sheets. The Company intends to hold these assets for possible future operating requirements. The following table summarizes gross unrealized gains and losses from Investments in debt and equity securities: March 31, 2021 Gross Unrealized Aggregate Cost Gains Losses Fair Value Equity securities $ 6,636,822 $ 3,010,846 $ — $ 9,647,668 Mutual funds and exchange traded funds 3,948,768 95,899 (5,227) 4,039,440 Certificates of deposit 75,000 1,779 — 76,779 $ 10,660,590 $ 3,108,524 $ (5,227) $ 13,763,887 December 31, 2020 Gross Unrealized Aggregate Cost Gains Losses Fair Value Equity securities $ $ $ — $ Mutual funds and exchange traded funds — Certificates of deposit — $ $ $ — $ Unrealized gains (losses) on investments in debt and equity securities were $1,103,972 and $(164,342) for the three months ended March 31, 2021 and 2020, respectively. |
INCOME TAXES
INCOME TAXES | 3 Months Ended |
Mar. 31, 2021 | |
INCOME TAXES | |
INCOME TAXES | 5. INCOME TAXES The Company’s effective tax rate on the net income before income taxes was 26.9% and 0.2% for the three months ended March 31, 2021 and March 31, 2020, respectively. For the three months ended March 31, 2021 and 2020, the Company’s effective tax rate was determined based on the estimated annual effective income tax rate. A reconciliation of the federal statutory corporate tax rate to the Company’s effective tax rate is as follows: March 31, 2021 December 31, 2020 U.S. statutory federal tax rate 21.0 % 21.0 % Valuation Allowance — (21.0) % State taxes 5.9 % 0.2 % Effective tax rate 26.9 % 0.2 % The Company uses the recognition and measurement provisions of the FASB ASC Topic 740, Income Taxes (“Topic 740”), to account for income taxes. The provisions of Topic 740 require a company to record a valuation allowance when the “more likely than not” criterion for realizing net deferred tax assets cannot be met. Furthermore, the weight given to the potential effect of such evidence should be commensurate with the extent to which it can be objectively verified. As a result, we reviewed the operating results, as well as all of the positive and negative evidence related to realization of such deferred tax assets to evaluate the need for a valuation allowance at March 31, 2021 and 2020. The effective tax rate for the three months ended March 31,2021 was different from the federal statutory rate due primarily to the apportionment of earnings across various state jurisdictions. The Company determined that no valuation allowance should be recorded at March 31, 2021. The effective tax rate for the three months ended March 31, 2020 was different from the federal statutory rate due primarily to the valuation allowance recorded on net operating losses. |
OTHER ACCRUED LIABILITIES
OTHER ACCRUED LIABILITIES | 3 Months Ended |
Mar. 31, 2021 | |
OTHER ACCRUED LIABILITIES | |
OTHER ACCRUED LIABILITIES | 6. OTHER ACCRUED LIABILITIES Other accrued liabilities consist of the following: March 31, 2021 December 31, 2020 Prepayments from customers $ 1,566,167 $ Accrued property taxes 112,847 — Accrued professional fees 368,995 Current portion — preferred stock repurchase 1,058,935 Other accrued expenses 159,965 Total $ 3,266,909 $ 3,398,904 |
OTHER LONG-TERM LIABILITIES
OTHER LONG-TERM LIABILITIES | 3 Months Ended |
Mar. 31, 2021 | |
OTHER LONG-TERM LIABILITIES | |
OTHER LONG-TERM LIABILITIES | 7. OTHER LONG-TERM LIABILITIES Other long-term liabilities consists of the following: March 31, 2021 December 31, 2020 Technology Investment Agreement (TIA) $ 31,378,662 $ 22,444,324 Stock repurchase 1,004,888 2,034,373 Total $ 32,383,550 $ 24,478,697 The TIA provides for reimbursement to the Company for the purchase of equipment and supplies related to the expansion of the Company’s domestic production of needles and syringes. Under the TIA, reimbursable amounts will be reflected as a liability until the time its deferred income can be systematically amortized over a period matching the useful life of the purchased assets. The stock repurchase liability represents the long-term portion, at net present value, of $2,057,823 gross payable by the Company to former preferred shareholders as a result of private stock purchases in 2020 of 320,333 shares of Class B Series IV preferred stock and 25,000 shares of Class B Series V preferred stock. The purchase price is payable in three annual installments of $1,101,110. |
COMMITMENTS AND CONTINGENCIES
COMMITMENTS AND CONTINGENCIES | 3 Months Ended |
Mar. 31, 2021 | |
COMMITMENTS AND CONTINGENCIES | |
COMMITMENTS AND CONTINGENCIES | 8. COMMITMENTS AND CONTINGENCIES On November 7, 2019, the Company filed a lawsuit in the 44 th District Court of Dallas County, Texas (No. DC-19-17946) against Locke Lord, LLP and Roy Hardin in connection with their legal representation of the Company in its previous litigation against Becton, Dickinson and Company ("BD"). The Company alleges that the defendants breached their fiduciary duties, committed malpractice, and were negligent in their representation of the Company. The Company seeks actual and exemplary damages, disgorgement, costs, and interest. On October 6, 2020, the Court dismissed BD’s motion to dismiss. Such order was affirmed on April 20, 2021 by the Court of Appeals, Fifth District of Texas at Dallas. |
BUSINESS SEGMENT
BUSINESS SEGMENT | 3 Months Ended |
Mar. 31, 2021 | |
BUSINESS SEGMENT | |
BUSINESS SEGMENT | 9. BUSINESS SEGMENT The Company does not operate in separate reportable segments. Shipments to international customers generally require a prepayment either by wire transfer or an irrevocable confirmed letter of credit. The Company does extend credit to international customers on some occasions depending upon certain criteria, including, but not limited to, the credit worthiness of the customer, the stability of the country, banking restrictions, and the size of the order. All transactions are in U.S. currency. Revenues by geography are as follows: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 U.S. sales (excluding U.S. government) $ 10,961,191 $ 8,336,797 Sales to U.S. government 37,782,360 — North and South America sales (excluding U.S.) 947,228 2,746,400 Other international sales 382,946 119,020 Total sales $ 50,073,725 $ 11,202,217 Long-lived assets by geography are as follows: March 31, 2021 December 31, 2020 Long-lived assets U.S. $ 43,157,637 $ International 59,214 Total $ 43,216,851 $ 30,816,504 |
DIVIDENDS
DIVIDENDS | 3 Months Ended |
Mar. 31, 2021 | |
DIVIDENDS | |
DIVIDENDS | 10. The Board declared and the Company paid cash dividends to Series I and Series II Class B Preferred Shareholders within one month of the end of each quarter in 2020. Cumulatively, dividend payments of $48,000, and $168,642 were made to Series I and Series II preferred shareholders, respectively, in 2020 and one payment of $10,041, and $39,050 was made to Series I and Series II preferred shareholders, respectively, in January 2021. A cash dividend of $39,050 was paid in April 2021 to Series II preferred shareholders. |
LEASES
LEASES | 3 Months Ended |
Mar. 31, 2021 | |
LEASES | |
LEASES | 11. LEASES The Company has operating leases for a warehouse and equipment. The leases have a remaining lease term of less than one year. The Company currently has no finance leases. The ROU asset is determined based on the lease liability adjusted for lease incentives received. Lease expense is recognized on a straight-line basis over the lease term. The leases may include various expenses incidental to the use of the property, such as common area maintenance, property taxes and insurance. These costs are separate from the minimum rent payment and are not considered in the determination of the lease liability and ROU asset. The Company has not noted any material instances in its leases where these costs were combined with the minimum rent payment and has therefore elected the policy to not separate lease from non-lease components if they are combined with the minimum rent payment. The option periods are not included in the determination of the lease liability and right-of-use asset as the Company is not reasonably certain if it will extend at the time of lease commencement. The operating lease cost component of the lease expense was $12,843 for the three-month period ended March 31, 2021. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $12,843 for the three months ended March 31, 2021. The operating lease cost component of the lease expense was $20,283 at March 31, 2020. The cash paid for amounts included in the measurement of lease liabilities as a component of cash flows related to leases was $20,283 for the three months ended March 31, 2020. Assets and liabilities associated with these leases included in the Condensed Balance Sheets are as follows: March 31, 2021 December 31, 2020 OPERATING LEASES Other assets $ 26,049 $ Other accrued liabilities $ 26,049 $ Other long-term liabilities — — Total operating lease liabilities $ 26,049 $ The weighted average remaining lease term is 6 months and the weighted average discount rate is 3.75%. Future minimum payments under non-cancelable operating leases and financing leases consist of the following at March 31, 2021: Quarter ending March 31, 2021 $ 26,335 Less imputed interest (286) Total $ 26,049 |
EXCHANGE OF COMMON STOCK FOR PR
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK | 3 Months Ended |
Mar. 31, 2021 | |
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK | |
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK | 12. EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK In 2020, the Company entered into several agreements with shareholders to purchase its outstanding Class B Convertible Preferred Stock. The consideration for these purchases consisted of both cash and Common Stock. In addition, in each such transaction, the preferred shareholder counterparty waived their rights to unpaid dividends in arrears. The aggregate cash consideration equaled $3,786,000, of which $482,670 was paid in 2020 with the rest payable over a three-year period beginning February 2021. |
STOCK OPTIONS
STOCK OPTIONS | 3 Months Ended |
Mar. 31, 2021 | |
STOCK OPTIONS | |
STOCK OPTIONS | 13. STOCK OPTIONS Stock options were exercised by the Company’s employees and directors at various dates during the three months ended March 31, 2021, and, consequently, a total of 20,400 shares of Common Stock were issued for an aggregate payment to the Company of $43,350 to exercise such options. |
COVID-19
COVID-19 | 3 Months Ended |
Mar. 31, 2021 | |
COVID-19 | |
COVID-19 | 14. COVID-19 To date, the Company's manufacturing facility in Little Elm, Texas has continued to operate due to its status as an essential business. As a result of the COVID-19 pandemic, the Company has implemented certain safety precautions at its facility to reduce the risk of the potential spread of the novel coronavirus. The Company has implemented arrangements to reduce the number of office staff employees working on-site at the production facility, as well as instituting personal distancing policies and monitoring of essential production staff to minimize the risk of infection. The Company continues to monitor the evolving situation and will work to further mitigate risks to staff and to customers. The Company is continuing to evaluate the ever-changing circumstances surrounding this pandemic as it relates to its ability to continue to source materials and products, maintain a workforce, and operate its business effectively and efficiently. Despite the global disruption of the coronavirus pandemic, the Company has not experienced a significant disruption to its supply chain. During 2020 and 2021, the Company has experienced an increase in demand for its products and has been able to meet such demand with increased volumes despite the pandemic. The Company is unable to predict with certainty its ability to maintain its current operational functionality. |
TECHNOLOGY INVESTMENT AGREEMENT
TECHNOLOGY INVESTMENT AGREEMENT | 3 Months Ended |
Mar. 31, 2021 | |
TECHNOLOGY INVESTMENT AGREEMENT | |
TECHNOLOGY INVESTMENT AGREEMENT | 15. TECHNOLOGY INVESTMENT AGREEMENT Effective July 1, 2020, the Company entered into the TIA with the U.S. government. The principal purpose of the TIA is to fund the expansion of the Company’s manufacturing capacity for hypodermic safety needles and corresponding syringes in response to the worldwide COVID-19 global pandemic. The award is an expenditure-type TIA, whereby the U.S. government will make payments to the Company for the Company’s expenditures for equipment and supplies in carrying out the expansion of the Company’s domestic production. The Company’s contributions under the terms of the TIA to enhance domestic capacity of pandemic-essential technology include providing facilities, technical expertise, labor, and maintenance of the TIA-funded equipment for a ten-year term. As of March 31, 2021, the Company had negotiated contracts for the purchase of automated assembly equipment, molds, and molding equipment, as well as portions of auxiliary equipment, for approximately $50.6 million. The Company has substantially completed construction of expanded facilities consisting of approximately 27,800 square feet of additional controlled environment within existing properties and is expected to complete approximately 55,000 square feet of new warehouse space within the second quarter of 2021. The estimated cost of the controlled environment within existing properties is $6.5 million. The new warehouse space is estimated to cost $5.8 million. The cost of the controlled environment will be funded by the U.S. government under the TIA, while the cost of the new warehouse will be funded by the Company. |
PAYCHECK PROTECTION PROGRAM LOA
PAYCHECK PROTECTION PROGRAM LOAN | 3 Months Ended |
Mar. 31, 2021 | |
PAYCHECK PROTECTION PROGRAM LOAN | |
PAYCHECK PROTECTION PROGRAM LOAN | 16. PAYCHECK PROTECTION PROGRAM LOAN On April 17, 2020, the Company entered into a promissory note in the principal amount of $1,363,000 (the “PPP Loan”) in favor of Independent Bank pursuant to the Paycheck Protection Program (the “PPP”) of the Coronavirus Aid, Relief, and Economic Security Act (the “CARES Act”), administered by the U.S. Small Business Administration (“SBA”). The PPP Loan’s original maturity date was April 17, 2022 with an interest rate of 1.0% per annum. The PPP Loan had a prepayment option with no prepayment penalties. The PPP Loan was unsecured and was a non-recourse obligation. On May 13, 2021, the Company was informed that the SBA granted its request for loan forgiveness for the entire original principal amount of $1,363,000. Prior to loan forgiveness and as of March 31, 2021, the Company’s obligations under the PPP Loan were as follows: 2021 $ 755,907 2022 607,093 $ 1,363,000 |
SUBSEQUENT EVENTS
SUBSEQUENT EVENTS | 3 Months Ended |
Mar. 31, 2021 | |
SUBSEQUENT EVENTS | |
SUBSEQUENT EVENTS | 17. SUBSEQUENT EVENTS In April 2021, the Company received a preliminary notice from the U.S. Department of Health and Human Services, Office of the Assistant Secretary for Preparedness & Response (“DHHS/ASPR”) expressing its intent to exercise at least the first two one-month options under the February 2021 contract between DHHS/ASPR and the Company. Such option exercises would extend the July 14, 2021 base period expiration date to September 14, 2021. The two one-month option periods referenced by the preliminary notice would relate to an overall purchase price of approximately $23.5 million, including freight costs. As discussed in Note 16, on May 13, 2021, the Company was informed that the SBA granted its request for loan forgiveness for the PPP Loan for the entire original principal amount of $1,363,000. |
SUMMARY OF SIGNIFICANT ACCOUN_2
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies) | 3 Months Ended |
Mar. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Accounting estimates | Accounting estimates The preparation of financial statements in conformity with U.S. generally accepted accounting principles (“GAAP”) requires Management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ significantly from those estimates. The amount reported as a contractual allowance for rebates involves examination of past historical trends related to sales to customers and the related credits issued once contractual obligations of the customers have been met. The establishment of a liability for future claims of rebates against sales in the current period requires that the Company has an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied. |
Cash and cash equivalents | Cash and cash equivalents For purposes of reporting cash flows, cash and cash equivalents include cash, money market accounts, and investments with original maturities of three months or less. |
Accounts receivable | Accounts receivable The Company records trade receivables when revenue is recognized. No product has been consigned to customers. The Company’s allowance for doubtful accounts is primarily determined by review of specific trade receivables. Those accounts that are doubtful of collection are included in the allowance. This provision is reviewed to determine the adequacy of the allowance for doubtful accounts. Trade receivables are charged off when there is certainty as to their being uncollectible. Trade receivables are considered delinquent when payment has not been made within contract terms. The Allowance for bad debt was $352,217 and $205,822 as of March 31, 2021 and December 31, 2020, respectively. The Company requires certain customers to make a prepayment prior to beginning production or shipment of their order. Customers may apply such prepayments to their outstanding invoices or pay the invoice and continue to carry forward the deposit for future orders. Such amounts are included in Other accrued liabilities on the Condensed Balance Sheets and are shown in Note 6, Other Accrued Liabilities. The Company records an allowance for estimated returns as a reduction to Accounts receivable and Gross sales. Historically, returns have been insignificant. |
Inventories | Inventories Inventories are valued at the lower of cost or net realizable value, with cost being determined using actual average cost. The Company compares the average cost to the net realizable value and records the lower value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable costs of completion, disposal, and transportation. Management considers such factors as the amount of inventory on hand and in the distribution channel, estimated time to sell such inventory, the shelf life of inventory, and current market conditions when determining excess or obsolete inventories. Once inventory items are deemed to be either excess or obsolete, they are excluded from the stated net realizable value. |
Investments in debt and equity securities | Investments in debt and equity securities The Company holds high-grade exchange-traded and closed-end funds (ETFs), mutual funds, equity securities, and debt securities as investments. These assets are readily marketable and are carried at fair value as of the date of the Condensed Balance Sheets. Net unrealized and realized gains or losses on investments in debt and equity securities are reflected as a component of Interest and other income (loss). Realized gains or losses on investments in debt and equity securities are recognized using the specific identification method. |
Property, plant, and equipment | Property, plant, and equipment Property, plant, and equipment are stated at cost. Expenditures for maintenance and repairs are charged to operations as incurred. Cost includes major expenditures for improvements and replacements which extend useful lives or increase capacity and interest cost associated with significant capital additions. Gains or losses from disposals are included in operations. The Company's property, plant, and equipment primarily consist of buildings, land, assembly equipment, molding machines, molds, office equipment, furniture, and fixtures. Depreciation and amortization are calculated using the straight-line method over the following useful lives: Production equipment 3 to 13 years Office furniture and equipment 3 to 10 years Buildings 39 years Building improvements 15 years |
Long-lived assets | Long-lived assets The Company assesses the recoverability of long-lived assets using an assessment of the estimated undiscounted future cash flows related to such assets. In the event that assets are found to be carried at amounts which are in excess of estimated gross future cash flows, the assets will be adjusted for impairment to a level commensurate with fair value determined using a discounted cash flow analysis or appraised values of the underlying assets. |
Fair value measurements | Fair value measurements For assets and liabilities that are measured using quoted prices in active markets, total fair value is the published market price per unit multiplied by the number of units held without consideration of transaction costs. Assets and liabilities that are measured using significant other observable inputs are valued by reference to similar assets or liabilities, adjusted for contract restrictions and other terms specific to that asset or liability. For these items, a significant portion of fair value is derived by reference to quoted prices of similar assets or liabilities in active markets. For all remaining assets and liabilities, fair value is derived using a fair value model, such as a discounted cash flow model or Black-Scholes model. |
Financial instruments | Financial instruments The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information. Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange. Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values. Investments in equity securities consist primarily of individual equity securities, exchange-traded and closed-end funds and mutual funds and are reported at their fair value based upon quoted prices in active markets. Investments in U.S. Treasury Notes are reported at their fair value based upon quoted prices in active markets. Investments in certificates of deposit (CD) with original maturities of greater than three months are reported at their estimated fair value based upon the duration of the CD and the interest rate earned on the CD versus current interest rates of similar duration CDs. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values. |
Concentration risks | Concentration risks The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, U.S. Treasury Notes, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in debt and equity securities through consultation with its outside investment advisors. Management is responsible for directing investment activity based on current economic conditions. The majority of accounts receivable are due from companies which are well-established entities. In the first quarter of 2021, a significant portion of the Company’s sales were to the U.S. government, which Management does not consider a credit risk. As a consequence, Management considers any exposure from concentrations of credit risks to be limited. The following table reflects significant customers for the first quarters of 2021 and 2020: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Number of significant customers 1 3 Aggregate dollar amount of net sales to significant customers $ 37.8 million $ 5.4 million Percentage of net sales to significant customers 75.5 % 48.2 % In the first quarter of 2021, approximately $37.8 million of the Company's sales were to the Department of Health and Human Services of the United States. Management expects the U.S. government to remain a significant customer through at least September 2021. There were no sales to the Department of Health and Human Services in the first quarter of 2020. The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China. The Company obtained roughly 90.3% and 80.3% of its products in the first three months of 2021 and 2020, respectively, from its Chinese manufacturers. In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company would need to find an alternate manufacturer for its blood collection set, IV catheter, Patient Safe ® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and would increase domestic production for the 1mL and 3mL syringes and EasyPoint ® needles. |
Revenue recognition | Revenue recognition The Company recognizes revenue when it has satisfied all performance obligations to the customer, generally when title and risk of loss pass to the customer. Payments from customers with approved credit terms are typically due 30 days from the invoice date. Under certain contracts, revenue is recorded on the basis of sales price to distributors, less contractual pricing allowances. Contractual pricing allowances consist of: (i) rebates granted to distributors who provide tracking reports which show, among other things, the facility that purchased the products, and (ii) a provision for estimated contractual pricing allowances for products for which the Company has not received tracking reports. When rebates are issued, they are applied against the customer’s receivable balance. Distributors receive a rebate for the difference between the Wholesale Acquisition Cost and the appropriate contract price as reflected on a tracking report provided by the distributor to the Company. If product is sold by a distributor to an entity that has no contract, there is a standard rebate (lower than a contracted rebate) given to the distributor. One of the purposes of the rebate is to encourage distributors to submit tracking reports to the Company. The provision for contractual pricing allowances is recognized in the period the related sales are recognized and is reviewed at the end of each quarter and adjusted for changes in levels of products for which there is no tracking report. Additionally, if it becomes clear that tracking reports will not be provided by individual distributors, the provision is further adjusted. The estimated contractual allowance is included in Accounts payable in the Condensed Balance Sheets and deducted from Revenues in the Condensed Statements of Operations. Accounts payable included estimated contractual allowances for $4,893,647 and $3,435,352 as of March 31, 2021 and December 31, 2020, respectively. The terms and conditions of contractual pricing allowances are governed by contracts between the Company and its distributors. Revenue for shipments directly to end-users is recognized when title and risk of ownership pass from the Company. End-users do not receive any contractual allowances on their purchases. Any product shipped or distributed for evaluation purposes is expensed. The Company provides product warranties that: i) the products are fit for medical use as generally defined within the boundaries of United States FDA approval; ii) the products are not defective; and iii) the products will conform to the descriptions set forth in their respective labeling, provided that they are used in accordance with such labeling and the Company’s written directions for use. The Company has historically not incurred significant warranty claims. The Company’s domestic return policy provides that a customer may return incorrect shipments within 10 days following arrival at the distributor’s facility. In all such cases, the distributor must obtain an authorization code from the Company and affix the code to the returned product. The Company’s domestic return policy also generally provides that a customer may return product that is overstocked. Overstocking returns are limited to two times in each 12-month period up to 1% of distributor’s total purchase of products for the prior 12-month period. All product overstocks and returns are subject to inspection and acceptance by the Company. The Company’s international distribution agreements generally do not provide for any returns. The Company requires certain customers to pay in advance of product shipment. Such prepayments from customers are recorded in Other accrued liabilities and are generally recognized as revenue upon shipment of the product. The Company recognizes revenue from licensing agreements when collection of such amounts from third parties is reasonably assured. If the Company licenses its products for sale, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, a certain percentage of such revenue pursuant to the terms of the Technology License Agreement between the Company and Mr. Shaw. Disaggregated information of revenue recognized from contracts with customers and licensing fees recognized are as follows: For the three months ended March 31, 2021: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales (excluding U.S. government) $ 8,759,314 $ 574,008 $ 1,612,333 $ 15,536 $ 10,961,191 Sales to U.S. government 37,782,360 — — — 37,782,360 North and South America sales (excluding U.S.) 825,820 — 11,968 109,440 947,228 Other international sales 199,316 37,350 144,780 1,500 382,946 Total $ 47,566,810 $ 611,358 $ 1,769,081 $ 126,476 $ 50,073,725 For the three months ended March 31, 2020: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales $ 6,972,935 $ 580,123 $ 765,860 $ 17,879 $ 8,336,797 North and South America sales (excluding U.S.) 2,054,784 2,700 1,496 687,420 2,746,400 Other international sales 114,830 1,740 — 2,450 119,020 Total $ 9,142,549 $ 584,563 $ 767,356 $ 707,749 $ 11,202,217 |
Income taxes | Income taxes The Company evaluates tax positions taken or expected to be taken in a tax return for recognition in the financial statements based on whether it is “more-likely-than-not” that a tax position will be sustained based upon the technical merits of the position. Measurement of the tax position is based upon the largest amount of benefit that is greater than 50% likely of being realized upon ultimate settlement. The Company provides for deferred income taxes through utilizing an asset and liability approach for financial accounting and reporting based on the tax effects of differences between the financial statement and tax bases of assets and liabilities, based on enacted rates expected to be in effect when such differences reverse in future periods. Deferred tax assets are periodically reviewed for realizability. In prior periods, the Company established a valuation allowance for its net deferred tax asset as future taxable income which could not be reasonably assured. During the quarter ended June 30, 2020, the Company released its valuation allowance based on available evidence supporting that its deferred tax assets will be realized in full. |
Earnings per share | Earnings per share The Company computes basic earnings or loss 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. At March 31, 2021, the calculation of diluted EPS under the treasury stock method included 152,967 shares of Common Stock underlying issued and outstanding stock options. Common stock issuable upon the conversion of 257,945 convertible preferred shares is included in the calculation of diluted EPS for the three months ended March 31, 2021. Preferred stock was excluded from the calculation of diluted EPS for the period ended March 31, 2020 because the effect was antidilutive. The potential dilution, if any, is shown on the following schedule: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Net income $ 17,955,884 $ 322,773 Preferred stock dividend requirements (64,938) (174,143) Income applicable to common shareholders $ 17,890,946 $ 148,630 Average common shares outstanding 33,967,771 32,681,204 Average common and common equivalent shares outstanding — assuming dilution 34,378,683 32,745,972 Basic earnings per share $ 0.53 $ 0.00 Diluted earnings per share $ 0.52 $ 0.00 |
Shipping and handling costs | Shipping and handling costs The Company classifies shipping and handling costs as part of Cost of sales in the Condensed Statements of Operations. |
Research and development costs | Research and development costs Research and development costs are expensed as incurred. |
Leases | Leases The Company determines if an arrangement is a lease at inception. Operating and finance leases are included in Other assets, Other accrued liabilities, and Other long-term liabilities on the Condensed Balance Sheets. Right-of-use (“ROU”) assets represent the Company’s right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. Operating lease ROU assets and liabilities are recognized at the commencement date based on the present value of lease payments over the lease term. As the Company’s leases do not provide an implicit rate, the incremental borrowing rate based on information available at the commencement date was used in determining the present value of lease payments. The operating lease ROU asset also includes any lease payments made and excludes lease incentives. Lease terms may include options to extend or terminate the lease when it is reasonably certain that the Company will exercise that option. Lease expense for lease payments is recognized on a straight-line basis over the lease term. Leases with an initial term of twelve months or less are not recorded on the Condensed Balance Sheets; however, rent expense is recognized on a straight-line basis over the lease term. |
Technology Investment Agreement (TIA) | Technology Investment Agreement (TIA) Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA) for $53,664,286 in Government funding for expanding the Company’s domestic production of needles and syringes. Pursuant to the terms of the TIA, the Company is expected to make significant additions to its facilities which should allow the Company to increase domestic production. As reimbursements are received from the U.S. government for such expenditures, the Company records a deferred liability. The deferred liability will be systematically amortized as a gain over the life of the related property, plant, and equipment as to offset the related depreciation expense of the assets acquired. The amortization will be presented separately from the depreciation expense on the Condensed Statements of Operations. |
Recently Adopted Pronouncements and Recently Issued Pronouncement | Recently Adopted Pronouncements The Company adopted Financial Accounting Standards Board ("FASB") Accounting Standards Update ("ASU") 2016-13, “Financial Instruments — Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments,” as well as subsequent clarifying amendments on January 1, 2020. Among other things, these amendments require the measurement of all expected credit losses for financial assets held at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. Many of the loss estimation techniques applied previously will still be permitted, although the inputs to those techniques will change to reflect the full amount of expected credit losses. The adoption of ASU 2016-13, as well as the Targeted Transition Relief as provided by ASU 2019-05, “Financial Instruments – Credit Losses (Topic 326) – Targeted Transition Relief” did not have a significant impact on the Company’s financial statements. The Company adopted ASU 2018-15, “Intangibles—Goodwill and Other—Internal-Use Software (Subtopic 350-40): Customer’s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That is a Service Contract (a Consensus of the FASB Emerging Issues Task Force)" on January 1, 2020. This amendment requires that implemented costs incurred in a hosting arrangement that is a service contract should be accounted for in accordance with ASC 350-40 Internal-Use Software. Accordingly, costs incurred during the preliminary project and post-implementation stages are expensed and costs associated with the application development phase are capitalized. The amendment also requires that capitalized costs be amortized over the term of the hosting arrangement and that capitalized costs should be evaluated for impairment. The adoption of this ASU did not have a significant impact on the Company's financial statements or disclosures. In August 2018, the FASB issued ASU 2018-13 "Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement." The amendment modifies, among other things, disclosure requirements on fair value measurements and eliminates certain disclosures related to transfers and valuation levels of Level 3 fair value measurements. Additionally, the amendment requires disclosure of changes in unrealized gains and losses in other comprehensive income for Level 3 fair value measurements and certain qualitative factors related to significant unobservable inputs used in Level 3 valuations. The amendment was effective for annual periods beginning after December 15, 2019 and interim periods within the annual period. The adoption of ASU 2018-13 did not have a significant effect on the Company's financial statements , as the Company does not currently have any investments classified as Level 3 fair value measurements. In December 2019, the FASB issued ASU 2019-12, “Income Taxes: Simplifying the Accounting for Income Taxes”. The new standard is intended to simplify the accounting for income taxes by eliminating certain exceptions related to the approach for intraperiod tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. The new guidance also simplifies aspects of the accounting for franchise taxes and enacted changes in tax laws or rates and clarifies the accounting for transactions that result in a step-up in the tax basis of goodwill. The standard is effective for annual periods beginning after December 15, 2020 and interim periods within the annual period, with early adoption permitted. Adoption of the standard requires certain changes primarily be made prospectively, with some changes to be made retrospectively. The Company has determined that the adoption of ASU 2019-12 did not have a material impact on its financial statements. Recently Issued Pronouncement In March 2020, the FASB issued ASU No. 2020-04, “Reference Rate Reform (Topic 848): Facilitation of the Effects of Reference Rate Reform on Financial Reporting”, to ease the potential burden in accounting for reference rate reform. The new guidance provides optional expedients for contracts that reference LIBOR, if certain criteria are met, that can be applied through December 31, 2022. As reference rate reform is still an ongoing process, the Company will continue to evaluate the timing and potential impact of adoption for optional expedients when deemed necessary. |
SUMMARY OF SIGNIFICANT ACCOUN_3
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Schedule of estimated useful lives of property, plant and equipment | Production equipment 3 to 13 years Office furniture and equipment 3 to 10 years Buildings 39 years Building improvements 15 years |
Schedule of significant customers | Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Number of significant customers 1 3 Aggregate dollar amount of net sales to significant customers $ 37.8 million $ 5.4 million Percentage of net sales to significant customers 75.5 % 48.2 % |
Schedule of disaggregated information of revenue recognized from contracts with customers and licensing fees | For the three months ended March 31, 2021: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales (excluding U.S. government) $ 8,759,314 $ 574,008 $ 1,612,333 $ 15,536 $ 10,961,191 Sales to U.S. government 37,782,360 — — — 37,782,360 North and South America sales (excluding U.S.) 825,820 — 11,968 109,440 947,228 Other international sales 199,316 37,350 144,780 1,500 382,946 Total $ 47,566,810 $ 611,358 $ 1,769,081 $ 126,476 $ 50,073,725 For the three months ended March 31, 2020: Blood Total Collection EasyPoint ® Other Product Geographic Segment Syringes Products Needles Products Sales U.S. sales $ 6,972,935 $ 580,123 $ 765,860 $ 17,879 $ 8,336,797 North and South America sales (excluding U.S.) 2,054,784 2,700 1,496 687,420 2,746,400 Other international sales 114,830 1,740 — 2,450 119,020 Total $ 9,142,549 $ 584,563 $ 767,356 $ 707,749 $ 11,202,217 |
Schedule of earnings per share | Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 Net income $ 17,955,884 $ 322,773 Preferred stock dividend requirements (64,938) (174,143) Income applicable to common shareholders $ 17,890,946 $ 148,630 Average common shares outstanding 33,967,771 32,681,204 Average common and common equivalent shares outstanding — assuming dilution 34,378,683 32,745,972 Basic earnings per share $ 0.53 $ 0.00 Diluted earnings per share $ 0.52 $ 0.00 |
INVENTORIES (Tables)
INVENTORIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
INVENTORIES | |
Schedule of inventories | March 31, 2021 December 31, 2020 Raw materials $ 1,576,376 $ 1,358,552 Finished goods 7,666,883 9,243,259 Inventory reserve (297,208) (297,208) $ 8,946,051 $ |
FAIR VALUE OF FINANCIAL INSTR_2
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
FAIR VALUE OF FINANCIAL INSTRUMENTS | |
Summary of value of assets designated as investments in debt and equity securities | March 31, 2021 Level 1 Level 2 Level 3 Total Equity securities $ 9,647,668 $ — $ — $ 9,647,668 Mutual funds and exchange traded funds 4,039,440 — — 4,039,440 Certificates of deposit — 76,779 — 76,779 $ 13,687,108 $ 76,779 $ — $ 13,763,887 December 31, 2020 Level 1 Level 2 Level 3 Total Equity securities $ $ — $ — $ Mutual funds and exchange traded funds 4,013,956 — — Certificates of deposit — — $ $ $ — $ |
Schedule of unrealized gains (losses) on investments in equity securities | March 31, 2021 Gross Unrealized Aggregate Cost Gains Losses Fair Value Equity securities $ 6,636,822 $ 3,010,846 $ — $ 9,647,668 Mutual funds and exchange traded funds 3,948,768 95,899 (5,227) 4,039,440 Certificates of deposit 75,000 1,779 — 76,779 $ 10,660,590 $ 3,108,524 $ (5,227) $ 13,763,887 December 31, 2020 Gross Unrealized Aggregate Cost Gains Losses Fair Value Equity securities $ $ $ — $ Mutual funds and exchange traded funds — Certificates of deposit — $ $ $ — $ |
INCOME TAXES (Tables)
INCOME TAXES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
INCOME TAXES | |
Schedule of reconciliation of income taxes based on the federal statutory rate and the effective income tax rate | March 31, 2021 December 31, 2020 U.S. statutory federal tax rate 21.0 % 21.0 % Valuation Allowance — (21.0) % State taxes 5.9 % 0.2 % Effective tax rate 26.9 % 0.2 % |
OTHER ACCRUED LIABILITIES (Tabl
OTHER ACCRUED LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
OTHER ACCRUED LIABILITIES | |
Schedule of other accrued liabilities | March 31, 2021 December 31, 2020 Prepayments from customers $ 1,566,167 $ Accrued property taxes 112,847 — Accrued professional fees 368,995 Current portion — preferred stock repurchase 1,058,935 Other accrued expenses 159,965 Total $ 3,266,909 $ 3,398,904 |
OTHER LONG-TERM LIABILITIES (Ta
OTHER LONG-TERM LIABILITIES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
OTHER LONG-TERM LIABILITIES | |
Schedule of other long-term liabilities | March 31, 2021 December 31, 2020 Technology Investment Agreement (TIA) $ 31,378,662 $ 22,444,324 Stock repurchase 1,004,888 2,034,373 Total $ 32,383,550 $ 24,478,697 |
BUSINESS SEGMENT (Tables)
BUSINESS SEGMENT (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
BUSINESS SEGMENT | |
Schedule of company's sales and long-lived assets by geography | Revenues by geography are as follows: Three Months Ended Three Months Ended March 31, 2021 March 31, 2020 U.S. sales (excluding U.S. government) $ 10,961,191 $ 8,336,797 Sales to U.S. government 37,782,360 — North and South America sales (excluding U.S.) 947,228 2,746,400 Other international sales 382,946 119,020 Total sales $ 50,073,725 $ 11,202,217 Long-lived assets by geography are as follows: March 31, 2021 December 31, 2020 Long-lived assets U.S. $ 43,157,637 $ International 59,214 Total $ 43,216,851 $ 30,816,504 |
LEASES (Tables)
LEASES (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
LEASES | |
Schedule of assets and liabilities relating to leases included in the Condensed Balance Sheets | March 31, 2021 December 31, 2020 OPERATING LEASES Other assets $ 26,049 $ Other accrued liabilities $ 26,049 $ Other long-term liabilities — — Total operating lease liabilities $ 26,049 $ |
Schedule of future minimum payments under non-cancelable operating leases and financing leases | Future minimum payments under non-cancelable operating leases and financing leases consist of the following at March 31, 2021: Quarter ending March 31, 2021 $ 26,335 Less imputed interest (286) Total $ 26,049 |
PAYCHECK PROTECTION PROGRAM L_2
PAYCHECK PROTECTION PROGRAM LOAN (Tables) | 3 Months Ended |
Mar. 31, 2021 | |
PAYCHECK PROTECTION PROGRAM LOAN | |
Schedule of Company's obligations under the PPP Loan prior to loan forgiveness | Prior to loan forgiveness and as of March 31, 2021, the Company’s obligations under the PPP Loan were as follows: 2021 $ 755,907 2022 607,093 $ 1,363,000 |
SUMMARY OF SIGNIFICANT ACCOUN_4
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accounts receivable (Details) - USD ($) $ in Thousands | Mar. 31, 2021 | Dec. 31, 2020 |
Accounts receivable | ||
Allowance for bad debt | $ 352,217 | $ 205,822 |
SUMMARY OF SIGNIFICANT ACCOUN_5
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property, plant and equipment (Details) | 3 Months Ended |
Mar. 31, 2021 | |
Production equipment | Minimum | |
Property, plant, and equipment | |
Useful lives (in years) | 3 years |
Production equipment | Maximum | |
Property, plant, and equipment | |
Useful lives (in years) | 13 years |
Office furniture and equipment | Minimum | |
Property, plant, and equipment | |
Useful lives (in years) | 3 years |
Office furniture and equipment | Maximum | |
Property, plant, and equipment | |
Useful lives (in years) | 10 years |
Buildings | |
Property, plant, and equipment | |
Useful lives (in years) | 39 years |
Building Improvements | |
Property, plant, and equipment | |
Useful lives (in years) | 15 years |
SUMMARY OF SIGNIFICANT ACCOUN_6
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration risks (Details) | 3 Months Ended | |
Mar. 31, 2021USD ($)customer | Mar. 31, 2020USD ($)customer | |
Concentration risks | ||
Aggregate dollar amount of net sales to significant customers | $ 50,073,725 | $ 11,202,217 |
Customer Concentration Risk | ||
Concentration risks | ||
Number of significant customers | customer | 1 | 3 |
Aggregate dollar amount of net sales to significant customers | $ 37,800,000 | $ 5,400,000 |
Percentage of net sales to significant customers | 75.50% | 48.20% |
Supplier Concentration Risk | China | ||
Concentration risks | ||
Concentration risk, geographic | 90.3% | 80.3% |
Department of health and human | ||
Concentration risks | ||
Aggregate dollar amount of net sales to significant customers | $ 37,800,000 |
SUMMARY OF SIGNIFICANT ACCOUN_7
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue recognition (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021USD ($)item | Mar. 31, 2020USD ($) | Dec. 31, 2020USD ($) | |
Revenue recognition | |||
Estimated contractual allowance | $ 4,893,647 | $ 3,435,352 | |
Period for return of incorrect shipments | 10 days | ||
Number of times overstocking returns are limited | item | 2 | ||
Period for return of product due to overstock | 12 months | ||
Maximum percentage of distributor's total purchase for the prior 12-month period | 1.00% | ||
Sales, net | $ 50,073,725 | $ 11,202,217 | |
Syringes | |||
Revenue recognition | |||
Sales, net | 47,566,810 | 9,142,549 | |
Blood Collection Products | |||
Revenue recognition | |||
Sales, net | 611,358 | 584,563 | |
Easy Point Needles | |||
Revenue recognition | |||
Sales, net | 1,769,081 | 767,356 | |
Other Products | |||
Revenue recognition | |||
Sales, net | 126,476 | 707,749 | |
Department of health and human | |||
Revenue recognition | |||
Sales, net | 37,800,000 | ||
U.S. | |||
Revenue recognition | |||
Sales, net | 10,961,191 | 8,336,797 | |
U.S. | Syringes | |||
Revenue recognition | |||
Sales, net | 8,759,314 | 6,972,935 | |
U.S. | Blood Collection Products | |||
Revenue recognition | |||
Sales, net | 574,008 | 580,123 | |
U.S. | Easy Point Needles | |||
Revenue recognition | |||
Sales, net | 1,612,333 | 765,860 | |
U.S. | Other Products | |||
Revenue recognition | |||
Sales, net | 15,536 | 17,879 | |
U.S. government | |||
Revenue recognition | |||
Sales, net | 37,782,360 | ||
U.S. government | Syringes | |||
Revenue recognition | |||
Sales, net | 37,782,360 | ||
North and South America sales (excluding U.S.) | |||
Revenue recognition | |||
Sales, net | 947,228 | 2,746,400 | |
North and South America sales (excluding U.S.) | Syringes | |||
Revenue recognition | |||
Sales, net | 825,820 | 2,054,784 | |
North and South America sales (excluding U.S.) | Blood Collection Products | |||
Revenue recognition | |||
Sales, net | 2,700 | ||
North and South America sales (excluding U.S.) | Easy Point Needles | |||
Revenue recognition | |||
Sales, net | 11,968 | 1,496 | |
North and South America sales (excluding U.S.) | Other Products | |||
Revenue recognition | |||
Sales, net | 109,440 | 687,420 | |
Other international sales | |||
Revenue recognition | |||
Sales, net | 382,946 | 119,020 | |
Other international sales | Syringes | |||
Revenue recognition | |||
Sales, net | 199,316 | 114,830 | |
Other international sales | Blood Collection Products | |||
Revenue recognition | |||
Sales, net | 37,350 | 1,740 | |
Other international sales | Easy Point Needles | |||
Revenue recognition | |||
Sales, net | 144,780 | ||
Other international sales | Other Products | |||
Revenue recognition | |||
Sales, net | $ 1,500 | $ 2,450 |
SUMMARY OF SIGNIFICANT ACCOUN_8
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - USD ($) | 3 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | |
Earnings per share | ||
Additional stock options included in calculation of diluted EPS | 152,967 | |
Common stock issuable upon the conversion of convertible preferred shares | 257,945 | |
Net income | $ 17,955,884 | $ 322,773 |
Preferred stock dividend requirements | (64,938) | (174,143) |
Income applicable to common shareholders | $ 17,890,946 | $ 148,630 |
Average common shares outstanding | 33,967,771 | 32,681,204 |
Average common and common equivalent shares outstanding - assuming dilution | 34,378,683 | 32,745,972 |
Basic earnings per share | $ 0.53 | $ 0 |
Diluted earnings per share | $ 0.52 | $ 0 |
SUMMARY OF SIGNIFICANT ACCOUN_9
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Technology Investment Agreement (TIA) (Details) | 3 Months Ended |
Mar. 31, 2021USD ($) | |
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES | |
Research and development agreement with government funding amount | $ 53,664,286 |
INVENTORIES (Details)
INVENTORIES (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
INVENTORIES | ||
Raw materials | $ 1,576,376 | $ 1,358,552 |
Finished goods | 7,666,883 | 9,173,302 |
Inventory, gross | 9,243,259 | 10,531,854 |
Inventory reserve | (297,208) | (297,208) |
Inventory, net | $ 8,946,051 | $ 10,234,646 |
FAIR VALUE OF FINANCIAL INSTR_3
FAIR VALUE OF FINANCIAL INSTRUMENTS (Details) - USD ($) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | $ 13,763,887 | $ 8,081,833 | |
Gross Unrealized | |||
Cost | 10,660,590 | 6,082,508 | |
Gross Unrealized Gains | 3,108,524 | 1,999,325 | |
Gross Unrealized Losses | (5,227) | ||
Unrealized gains (loss) on investments in debt and equity securities | 1,103,972 | $ (164,342) | |
Level 1 | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 13,687,108 | 8,004,489 | |
Level 2 | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 76,779 | 77,344 | |
Equity securities | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 9,647,668 | 3,990,533 | |
Gross Unrealized | |||
Cost | 6,636,822 | 2,098,144 | |
Gross Unrealized Gains | 3,010,846 | 1,892,389 | |
Equity securities | Level 1 | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 9,647,668 | 3,990,533 | |
Mutual funds and exchange traded funds | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 4,039,440 | 4,013,956 | |
Gross Unrealized | |||
Cost | 3,948,768 | 3,909,364 | |
Gross Unrealized Gains | 95,899 | 104,592 | |
Gross Unrealized Losses | (5,227) | ||
Mutual funds and exchange traded funds | Level 1 | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 4,039,440 | 4,013,956 | |
Certificates of deposit | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | 76,779 | 77,344 | |
Gross Unrealized | |||
Cost | 75,000 | 75,000 | |
Gross Unrealized Gains | 1,779 | 2,344 | |
Certificates of deposit | Level 2 | |||
Investments in equity securities | |||
Investments in debt and equity securities, at fair value | $ 76,779 | $ 77,344 |
INCOME TAXES (Details)
INCOME TAXES (Details) | 3 Months Ended | 12 Months Ended | |
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Reconciliation of income taxes based on the federal statutory rate and the effective income tax rate | |||
U.S. statutory federal tax rate (as a percent) | 21.00% | 21.00% | |
Valuation Allowance (as a percent) | (21.00%) | ||
State taxes (as a percent) | 5.90% | 0.20% | |
Effective tax rate (as a percent) | 26.90% | 0.20% | 0.20% |
OTHER ACCRUED LIABILITIES (Deta
OTHER ACCRUED LIABILITIES (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
OTHER ACCRUED LIABILITIES | ||
Prepayments from customers | $ 1,566,167 | $ 1,686,868 |
Accrued property taxes | 112,847 | |
Accrued professional fees | 368,995 | 331,204 |
Current portion - preferred stock repurchase | 1,058,935 | 1,092,282 |
Other accrued expenses | 159,965 | 288,550 |
Total | $ 3,266,909 | $ 3,398,904 |
OTHER LONG-TERM LIABILITIES (De
OTHER LONG-TERM LIABILITIES (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 |
OTHER LONG-TERM LIABILITIES | ||
Technology Investment Agreement (TIA) | $ 31,378,662 | $ 22,444,324 |
Stock repurchase | 1,004,888 | 2,034,373 |
Total | $ 32,383,550 | $ 24,478,697 |
OTHER LONG-TERM LIABILITIES- Ad
OTHER LONG-TERM LIABILITIES- Additional information (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)shares | |
OTHER LONG-TERM LIABILITIES | |
Net present value | $ | $ 2,057,823 |
Purchase price is payable | $ | $ 1,101,110 |
Series IV Preferred Stock | |
OTHER LONG-TERM LIABILITIES | |
Preferred shareholders as a result of private stock purchases | shares | 320,333 |
Series V Preferred Stock | |
OTHER LONG-TERM LIABILITIES | |
Preferred shareholders as a result of private stock purchases | shares | 25,000 |
BUSINESS SEGMENT (Details)
BUSINESS SEGMENT (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Sales by geography | |||
Sales, net | $ 50,073,725 | $ 11,202,217 | |
Long-lived assets | |||
Long-lived assets | 43,216,851 | $ 30,816,504 | |
U.S. | |||
Sales by geography | |||
Sales, net | 10,961,191 | 8,336,797 | |
Long-lived assets | |||
Long-lived assets | 43,157,637 | 30,751,259 | |
U.S. government | |||
Sales by geography | |||
Sales, net | 37,782,360 | ||
North and South America sales (excluding U.S.) | |||
Sales by geography | |||
Sales, net | 947,228 | 2,746,400 | |
Other international sales | |||
Sales by geography | |||
Sales, net | 382,946 | $ 119,020 | |
International | |||
Long-lived assets | |||
Long-lived assets | $ 59,214 | $ 65,245 |
DIVIDENDS (Details)
DIVIDENDS (Details) - USD ($) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
Apr. 30, 2021 | Jan. 31, 2021 | Mar. 31, 2021 | Mar. 31, 2020 | Dec. 31, 2020 | |
Dividends | |||||
Dividends paid | $ 39,050 | $ 54,800 | |||
Series I, Class B | |||||
Dividends | |||||
Dividends paid | $ 10,041 | $ 48,000 | |||
Series II, Class B | |||||
Dividends | |||||
Dividends paid | $ 39,050 | $ 39,050 | $ 168,642 |
LEASES (Details)
LEASES (Details) - USD ($) | 3 Months Ended | |||
Mar. 31, 2021 | Mar. 31, 2020 | Jan. 31, 2021 | Dec. 31, 2020 | |
LEASES | ||||
Operating lease cost | $ 12,843 | $ 20,283 | ||
Cash outflows related to leases | 12,843 | 20,283 | ||
Assets and liabilities associated with these leases in Balance Sheets | ||||
Other assets | $ 26,049 | $ 38,892 | ||
Other assets [Extensible List] | us-gaap:OtherAssets | us-gaap:OtherAssets | ||
Other accrued liabilities | $ 26,049 | $ 38,892 | ||
Other accrued liabilities [Extensible List] | us-gaap:OtherAccruedLiabilitiesCurrent | us-gaap:OtherAccruedLiabilitiesCurrent | ||
Other long-term liabilities [Extensible List] | us-gaap:OtherLiabilitiesNoncurrent | us-gaap:OtherLiabilitiesNoncurrent | ||
Total operating lease liabilities | $ 26,049 | $ 26,049 | $ 38,892 | |
Weighted average remaining lease term | 6 months | |||
Weighted average discount rate | 3.75% | |||
Maximum | ||||
LEASES | ||||
Remaining lease term | 1 year |
LEASES - Future minimum payment
LEASES - Future minimum payments (Details) - USD ($) | Mar. 31, 2021 | Dec. 31, 2020 | Mar. 31, 2020 |
Future minimum payments under non-cancelable operating leases and financing leases | |||
Remainder of 2021 | $ 26,335 | ||
Less imputed interest | (286) | ||
Total operating lease liabilities | $ 26,049 | $ 38,892 | $ 26,049 |
EXCHANGE OF COMMON STOCK FOR _2
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK (Details) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2021 | Dec. 31, 2020 | |
EXCHANGE OF COMMON STOCK FOR PREFERRED STOCK | ||
Aggregate cash consideration | $ 3,786,000 | |
Payment for repurchase of stock | $ 482,670 | |
Cash consideration payment period | 3 years |
STOCK OPTIONS (Details)
STOCK OPTIONS (Details) | 3 Months Ended |
Mar. 31, 2021USD ($)shares | |
STOCK OPTIONS | |
Shares of Common Stock issued for exercises | shares | 20,400 |
Proceeds from the exercise of stock options | $ | $ 43,350 |
TECHNOLOGY INVESTMENT AGREEME_2
TECHNOLOGY INVESTMENT AGREEMENT (Details) $ in Millions | Jul. 01, 2020 | Mar. 31, 2021USD ($)ft² |
TECHNOLOGY INVESTMENT AGREEMENT | ||
Technology investment agreement term | 10 years | |
Purchase of automated assembly and auxiliary equipment | $ 50.6 | |
Area of land for existing properties | ft² | 27,800 | |
Area of land for new warehouse | ft² | 55,000 | |
Estimated cost of the controlled environment within existing properties | $ 6.5 | |
Estimated cost of the construction of the new warehouse | $ 5.8 |
PAYCHECK PROTECTION PROGRAM L_3
PAYCHECK PROTECTION PROGRAM LOAN (Details) - Paycheck Protection Program, CARES Act - USD ($) | May 13, 2021 | Apr. 17, 2020 |
Paycheck Protection Program | ||
Principal amount, COVID-19 | $ 1,363,000 | |
Interest rate (as a percent) | 1.00% | |
Subsequent Events | ||
Paycheck Protection Program | ||
Loan amount forgiveness, CARES Act | $ 1,363,000 |
PAYCHECK PROTECTION PROGRAM L_4
PAYCHECK PROTECTION PROGRAM LOAN - Future payments (Details) - Paycheck Protection Program, CARES Act | Mar. 31, 2021USD ($) |
Paycheck Protection Program | |
2021 | $ 755,907 |
2022 | 607,093 |
Long term debt total | $ 1,363,000 |
SUBSEQUENT EVENTS (Details)
SUBSEQUENT EVENTS (Details) - Subsequent Events - USD ($) | May 13, 2021 | Apr. 30, 2021 |
SUBSEQUENT EVENTS | ||
Preliminary notice, notice of intent to extend Government contract, purchase price | $ 23,500,000 | |
Paycheck Protection Program, CARES Act | ||
SUBSEQUENT EVENTS | ||
Loan amount forgiveness, CARES Act | $ 1,363,000 |