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RVP Retractable Technologies Inc

0.62
0.005 (0.81%)
29 Nov 2024 - Closed
Delayed by 15 minutes
Share Name Share Symbol Market Type
Retractable Technologies Inc AMEX:RVP AMEX Common Stock
  Price Change % Change Share Price High Price Low Price Open Price Shares Traded Last Trade
  0.005 0.81% 0.62 0.644 0.6126 0.63 13,432 21:36:59

Form 10-Q - Quarterly report [Sections 13 or 15(d)]

14/08/2024 7:22pm

Edgar (US Regulatory)


0000946563--12-312024Q2falseRETRACTABLE TECHNOLOGIES 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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM  10-Q

(Mark One)

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

For the quarterly period ended June 30, 2024

or

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

For the transition period from          to          

Commission file number: 001-16465

Retractable Technologies, Inc.

(Exact name of registrant as specified in its charter)

Texas

    

75-2599762

(State or other jurisdiction of
incorporation or organization)

(I.R.S. Employer Identification No.)

511 Lobo Lane

Little Elm, Texas

75068-5295

(Address of principal executive offices)

(Zip Code)

(972) 294-1010

(Registrant’s telephone number, including area code)

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

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

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock

RVP

NYSE American

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

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

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

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

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

APPLICABLE ONLY TO ISSUERS INVOLVED IN BANKRUPTCY

PROCEEDINGS DURING THE PRECEDING FIVE YEARS:

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

APPLICABLE ONLY TO CORPORATE ISSUERS

Indicate the number of shares outstanding of each of the issuer’s classes of common stock, as of the latest practicable date: 29,937,159 shares of Common Stock outstanding, excluding 4,087,145 treasury shares, on August 1, 2024.

RETRACTABLE TECHNOLOGIES, INC.

FORM 10-Q

For the Quarterly Period Ended June 30, 2024

TABLE OF CONTENTS

PART I – FINANCIAL INFORMATION

Item 1.

Financial Statements

   

1

CONDENSED BALANCE SHEETS

1

CONDENSED STATEMENTS OF OPERATIONS

2

CONDENSED STATEMENTS OF CASH FLOWS

3

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

4

NOTES TO CONDENSED FINANCIAL STATEMENTS

5

Item 2.

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

17

Item 3.

Quantitative and Qualitative Disclosures About Market Risk

21

Item 4.

Controls and Procedures

21

PART II—OTHER INFORMATION

Item 1.

Legal Proceedings

22

Item 1A.

Risk Factors

22

Item 5.

Other Information

22

Item 6.

Exhibits

22

SIGNATURES

23

PART I—FINANCIAL INFORMATION

Item 1.Financial Statements.

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED BALANCE SHEETS

(unaudited)

    

June 30, 2024

    

December 31, 2023

ASSETS

Current assets:

Cash and cash equivalents

$

6,853,067

$

12,667,550

Accounts receivable, net

 

4,690,228

 

10,671,721

Investments in debt and equity securities, at fair value

35,051,499

34,621,213

Inventories

 

22,018,265

 

17,581,368

Income taxes receivable

1,078,117

1,155,077

Other current assets

 

877,335

 

952,668

Total current assets

 

70,568,511

 

77,649,597

Property, plant, and equipment, net

 

90,049,927

 

93,478,521

Deferred tax asset

8,392,030

Other assets

 

125,982

 

152,064

Total assets

$

160,744,420

$

179,672,212

LIABILITIES AND STOCKHOLDERS’ EQUITY

Current liabilities:

Accounts payable

$

3,114,068

$

4,779,035

Current portion of long-term debt

 

317,991

 

303,991

Accrued compensation

 

936,137

 

865,105

Dividends payable

 

1,417,437

 

1,417,437

Accrued royalties to shareholder

 

596,203

 

1,376,555

Other accrued liabilities

 

1,037,693

 

630,571

Income taxes payable

 

3,311

 

4,802

Total current liabilities

 

7,422,840

 

9,377,496

Other long-term liabilities

66,813,843

69,773,538

Long-term debt, net of current maturities

 

1,070,556

 

1,233,519

Total liabilities

 

75,307,239

 

80,384,553

Commitments and contingencies – see Note 10

Stockholders’ equity:

Preferred stock, $1 par value:

Class B; authorized: 5,000,000 shares

Series II, Class B

 

156,200

 

156,200

Series III, Class B

 

74,245

 

74,245

Common Stock, no par value

 

 

Additional paid-in capital

 

73,160,333

 

73,160,333

Retained earnings

 

24,935,081

 

38,785,559

Common stock in treasury – at cost

(12,888,678)

(12,888,678)

Total stockholders’ equity

 

85,437,181

 

99,287,659

Total liabilities and stockholders’ equity

$

160,744,420

$

179,672,212

See accompanying notes to condensed unaudited financial statements

1

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF OPERATIONS

(unaudited)

Three Months

Three Months

Six Months

Six Months

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Sales, net

$

6,029,364

$

7,971,280

$

13,628,727

$

18,972,382

Cost of sales:

Cost of manufactured product

 

5,853,085

 

6,940,895

 

10,902,131

 

14,302,759

Royalty expense to shareholder

 

596,203

 

653,478

 

1,245,591

 

1,423,187

Total cost of sales

 

6,449,288

 

7,594,373

 

12,147,722

 

15,725,946

Gross profit (loss)

 

(419,924)

 

376,907

 

1,481,005

 

3,246,436

Operating expenses:

Sales and marketing

 

1,474,600

 

1,545,453

 

2,909,342

 

2,895,624

Research and development

 

199,093

 

138,761

 

341,355

 

268,518

General and administrative

 

3,669,189

 

3,725,463

 

6,979,251

 

7,855,487

Total operating expenses

 

5,342,882

 

5,409,677

 

10,229,948

 

11,019,629

Loss from operations

 

(5,762,806)

 

(5,032,770)

 

(8,748,943)

 

(7,773,193)

Other income - TIA

1,475,075

1,474,019

2,959,695

3,031,798

Unrealized loss on debt and equity securities

(1,779,814)

(6,251,650)

(47,165)

(4,759,639)

Gain on sale of equity securities

4,828,529

5,574,791

Interest and other income

 

244,518

 

218,651

 

561,839

 

428,466

Interest expense

 

(31,817)

 

(37,469)

 

(65,300)

 

(81,024)

Loss before income taxes

 

(5,854,844)

 

(4,800,690)

 

(5,339,874)

 

(3,578,801)

Provision (benefit) for income taxes

 

8,309,796

 

(932,122)

 

8,395,382

 

(701,205)

Net loss

 

(14,164,640)

 

(3,868,568)

 

(13,735,256)

 

(2,877,596)

Preferred Stock dividend requirements

 

(57,611)

 

(58,111)

 

(115,222)

 

(116,222)

Net loss applicable to common shareholders

$

(14,222,251)

$

(3,926,679)

$

(13,850,478)

$

(2,993,818)

Basic loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Diluted loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Weighted average common shares outstanding:

Basic

 

29,937,159

 

29,937,159

 

29,937,159

 

29,937,159

Diluted

 

29,937,159

 

30,169,604

 

29,937,159

 

30,169,604

See accompanying notes to condensed unaudited financial statements

2

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CASH FLOWS

(unaudited)

Six Months

Six Months

Ended

Ended

    

June 30, 2024

    

June 30, 2023

Cash flows from operating activities

Net loss

$

(13,735,256)

$

(2,877,596)

Adjustments to reconcile net loss to net cash from operating activities:

Depreciation and amortization

 

3,776,694

 

3,884,970

Net unrealized loss on investments

47,165

4,759,639

Realized gain on investments

(5,574,791)

Accreted interest

9,157

Bond amortization

(505)

Deferred taxes

8,392,031

(701,205)

Provision for credit losses

 

427,487

 

370,573

Net realizable value inventory adjustment

1,872

143,290

Other income - TIA

(2,959,695)

(3,031,798)

(Increase) decrease in operating assets:

Accounts receivable

 

5,554,005

 

(2,758,677)

Inventories

 

(4,438,769)

 

(373,901)

Other current assets

 

75,333

 

(35,220)

Income taxes receivable

76,960

1,424,723

Other assets

26,082

13,830

Increase (decrease) in operating liabilities:

Accounts payable

 

(1,664,967)

 

(2,823,502)

Accrued liabilities

 

(302,198)

 

700,711

Income taxes payable

 

(1,491)

 

(58,396)

Net cash used by operating activities

 

(4,725,252)

 

(6,928,193)

Cash flows from investing activities

Purchase of property, plant, and equipment

 

(348,100)

 

(556,385)

Purchase of debt and equity securities

(476,946)

(43,868,141)

Proceeds from the sales of debt and equity securities

34,567,513

Net cash used by investing activities

 

(825,046)

 

(9,857,013)

Cash flows from financing activities

Repayments of long-term debt

 

(148,963)

 

(139,146)

Proceeds from Technology Investment Agreement (TIA)

2,563,229

Payment of preferred stock repurchase payable

(1,101,110)

Payment of preferred stock dividends

 

(115,222)

 

(116,223)

Net cash provided (used) by financing activities

 

(264,185)

 

1,206,750

Net decrease in cash and cash equivalents

 

(5,814,483)

 

(15,578,456)

Cash and cash equivalents at:

Beginning of period

 

12,667,550

 

19,721,345

End of period

$

6,853,067

$

4,142,889

Supplemental schedule of cash flow information:

Interest paid

$

65,300

$

28,312

Income taxes paid (received)

$

(71,318)

$

Supplemental schedule of noncash investing and financing activities:

Preferred dividends declared, not paid

$

57,611

$

See accompanying notes to condensed unaudited financial statements

3

RETRACTABLE TECHNOLOGIES, INC.

CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS’ EQUITY

(unaudited)

The following shows the changes in stockholders’ equity for the three-month period ended June 30, 2024:

    

    

Series II

    

Series III

    

    

    

Class B

Class B

Additional

Treasury

Common

Preferred

Preferred

Paid-In

Retained

Stock –

Stock

Stock

Stock

Capital

Earnings

at cost

Total

Balance at March 31, 2024

$

$

156,200

$

74,245

$

73,160,333

$

39,157,332

$

(12,888,678)

$

99,659,432

Dividends

 

 

 

 

 

(57,611)

 

 

(57,611)

Net Loss

 

 

 

 

 

(14,164,640)

 

 

(14,164,640)

Balance at June 30, 2024

$

$

156,200

$

74,245

$

73,160,333

$

24,935,081

$

(12,888,678)

$

85,437,181

The following shows the changes in stockholders’ equity for the three-month period ended June 30, 2023:

    

    

Series II

    

Series III

    

    

    

Class B

Class B

Additional

Treasury

Common

Preferred

Preferred

Paid-In

Retained

Stock –

Stock

Stock

Stock

Capital

Earnings

at cost

Total

Balance at March 31, 2023

$

$

156,200

$

76,245

$

73,164,501

$

46,961,402

$

(12,888,678)

$

107,469,670

Dividends

 

 

 

 

 

(58,111)

 

(58,111)

Net Loss

 

 

 

 

 

(3,868,568)

 

(3,868,568)

Balance at June 30, 2023

$

$

156,200

$

76,245

$

73,164,501

$

43,034,723

$

(12,888,678)

$

103,542,991

The following shows the changes in stockholders’ equity for the six-month period ended June 30, 2024:

    

    

Series II

    

Series III

    

    

    

Class B

Class B

Additional

Treasury

Common

Preferred

Preferred

Paid-In

Retained

Stock –

Stock

Stock

Stock

Capital

Earnings

at cost

Total

Balance at December 31, 2023

$

$

156,200

$

74,245

$

73,160,333

$

38,785,559

$

(12,888,678)

$

99,287,659

Dividends

 

 

 

 

(115,222)

(115,222)

Net Loss

 

 

 

 

(13,735,256)

(13,735,256)

Balance at June 30, 2024

$

$

156,200

$

74,245

$

73,160,333

$

24,935,081

$

(12,888,678)

$

85,437,181

The following shows the changes in stockholders’ equity for the six-month period ended June 30, 2023:

    

    

Series II

    

Series III

    

    

    

Class B

Class B

Additional

Treasury

Common

Preferred

Preferred

Paid-In

Retained

Stock –

Stock

Stock

Stock

Capital

Earnings

at cost

Total

Balance at December 31, 2022

$

$

156,200

$

76,245

$

73,164,501

$

46,028,541

$

(12,888,678)

$

106,536,809

Dividends

 

 

 

(116,222)

(116,222)

Net Loss

 

 

 

(2,877,596)

(2,877,596)

Balance at June 30, 2023

$

$

156,200

$

76,245

$

73,164,501

$

43,034,723

$

(12,888,678)

$

103,542,991

4

RETRACTABLE TECHNOLOGIES, INC.

NOTES TO CONDENSED FINANCIAL STATEMENTS

(unaudited)

1.    BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION

Business of the Company

Retractable Technologies, Inc. (the “Company”) was incorporated in Texas on May 9, 1994, and designs, develops, manufactures, and markets safety syringes and other safety medical products for the healthcare profession.  The Company began to develop its manufacturing operations in 1995.  The Company’s manufacturing and administrative facilities are located in Little Elm, Texas.  The Company’s products are the VanishPoint® 0.5mL insulin syringe; 1mL tuberculin, insulin, and allergy antigen syringes; 0.5mL, 1mL, 2mL, 3mL, 5mL, and 10mL syringes; the blood collection tube holder; the EasyPoint® blood collection tube holder with needle; 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 29, 2024 for the year ended December 31, 2023.  

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 credit losses is primarily determined by review of specific trade receivables based on historical collection rates and specific knowledge regarding the current creditworthiness of the customers.  Those

5

accounts that are doubtful of collection are included in the allowance.  The Company considers historical experience, the current economic environment, customer credit ratings or bankruptcies, legal disputes, collections on past due amounts, pricing discrepancies, and reasonable and supportable forecasts to develop its allowance for credit losses. Management reviews these factors quarterly to determine if any adjustments are needed to the allowance. 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 credit losses was $817 thousand and $891 thousand as of June 30, 2024 and December 31, 2023, 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. The Company recorded $2 thousand and $101 thousand lower of cost or net realizable value inventory adjustment associated with the VanishPoint® 3mL and EasyPoint® needle product segments as of June 30, 2024 and December 31, 2023, respectively.  

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 written down to their net realizable value.

Investments in debt and equity securities

The Company holds mutual funds, debt, and equity securities as investments.  These assets are held as trading securities and are carried at fair value as of the date of the Condensed Balance Sheets. Net unrealized and realized gains or losses on these investments are reflected separately on the Condensed Statements of Operations. Realized gains or losses on investments are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment are stated at cost less accumulated depreciation. 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 costs associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

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

Production equipment

    

3 to 13 years

Office furniture and equipment

 

3 to 10 years

Buildings

 

39 years

Building improvements

 

15 years

6

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 debt and equity securities consist primarily of individual equity securities and mutual funds and are reported at their fair value based upon quoted prices in active markets. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in 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. Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the three-month and six-month periods ended June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Number of significant customers

 

4

 

3

 

3

 

3

 

Aggregate dollar amount of net sales to significant customers

$

3.8

million

$

4.4

million

$

7.3

million

$

10.2

million

Percentage of net sales to significant customers

63.0%

55.0%

53.6%

53.9%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained 91% and 89% of its products in the first six months of 2024 and 2023, respectively, from its

7

Chinese manufacturers.  Purchases from Chinese manufacturers aggregated 92% and 84% of products in the second quarter of 2024 and 2023, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company may need to find an alternate manufacturer for its blood collection set, EasyPoint® blood collection tube holder with needle, 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.

On May 14, 2024, President Biden directed the Office of the U.S. Trade Representative (“USTR”) to increase tariffs on certain goods imported from China under Section 301 of the Trade Act of 1974.  Among those products included were syringes and needles, at a rate of 50%.  As noted above, for the first six months of 2024, 91% of the products the Company sold were purchased from our manufacturers in China, most of which would be impacted by the contemplated tariffs.  On July 30, 2024, the USTR announced that, in response to more than 1,100 public comments received regarding the modifications, it would continue reviewing the comments and expects its final determination will be issued in August, and that the modifications slated for 2024 will take effect approximately two weeks after its final determination.  In the event that the tariffs affecting syringes and needles are enacted, the resulting increase in costs could have a material impact to the Company’s results of operations and financial position.  The Company is working to evaluate options to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint® needles to its domestic manufacturing facility.

Revenue recognition

The Company recognizes revenue when control of performance obligations passes to the customer, generally when the product ships.  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 $1.3 million and $2.2 million as of June 30, 2024 and December 31, 2023, 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 has not historically incurred significant returns.

8

On February 5, 2024, the Company initiated a voluntary recall of its EasyPoint Needle lot number K220402 which was shipped within the U.S. between July 20, 2022 and September 20, 2023. The Company shipped 477,600 units of the products into the market and is working with customers and distributors to determine how many of the units remain unused and subject to the recall. The recall is due to the possible detachment of the needle cannula from the needle holder, which could result in serious injury. The Company has advised its customers and distributors to review their inventory for the affected products, segregate and quarantine the affected products, discontinue any distribution of the affected products, inform all personnel not to use the affected products, and report and return remaining inventory to the Company. The Company submitted a Removal Report with the U.S. Food and Drug Administration and has continued to provide monthly updates.  The estimated time for the completion of the recall is September 1, 2024.  The Company estimates that the potential expense related to the recall is approximately $116 thousand.

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

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

The Company periodically recognizes revenue from licensing agreements of its intellectual property. Such licensing agreements provide licensee with right to use the Company’s intellectual property.  The Company accounts for revenue generated under these licensing agreements in accordance with ASC 606.  A license may be perpetual or time limited in its application. The Company has concluded that its licensing agreement is distinct as the customer can benefit from the license on their own. In accordance with ASC 606, the licensing agreement is considered functional as it is without professional services, updates and technical support. The Company has determined the current licensing agreement is sales-based or usage-based as defined in ASC 606.  In accordance with ASC 606, the Company recognizes revenue from sales-based or usage-based license at the later of a) subsequent sale or usage occurrence or b) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).  The Company recognized $90 thousand and $189 thousand in licensing fees for the three and six months ended June 30, 2024.  No licensing fees were recognized for the three and six months ended June 30, 2023.  If the Company licenses its products for sale and the customers of the sublicensee are not known to the Company, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, fifty percent (50%) 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 June 30, 2024:

    

    

Blood 

    

    

    

Total 

Collection 

EasyPoint®

Other 

Product

Geographic Segment

Syringes

Products

Needles

Products

 Sales

U.S. sales

$

4,631,773

333,389

42,561

5,848

$

5,013,571

North and South America sales (excluding U.S.)

 

601,000

 

 

59,040

 

6,240

 

666,280

Other international sales

 

256,133

 

400

 

87,680

 

5,300

 

349,513

Total

$

5,488,906

$

333,789

$

189,281

$

17,388

$

6,029,364

9

For the three months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

5,780,080

$

346,297

$

1,165,634

$

8,665

7,300,676

North and South America sales (excluding U.S.)

 

210,232

 

 

 

210,232

Other international sales

 

366,312

 

1,748

 

87,612

 

4,700

460,372

Total

$

6,356,624

$

348,045

$

1,253,246

$

13,365

$

7,971,280

For the six months ended June 30, 2024:

    

    

Blood 

    

    

    

Collection 

EasyPoint®

Other 

Total

Geographic Segment

Syringes

Products

Needles

Products

Revenue

U.S. sales

$

10,185,082

700,998

755,432

13,226

$

11,654,738

North and South America sales (excluding U.S.)

 

755,537

96

59,040

6,240

 

820,913

Other international revenue

 

828,612

143,860

174,704

5,900

 

1,153,076

Total

$

11,769,231

$

844,954

$

989,176

$

25,366

$

13,628,727

For the six months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

10,583,166

$

744,673

$

1,378,121

$

18,164

$

12,724,124

North and South America sales (excluding U.S.)

 

4,771,512

 

 

 

212,040

 

4,983,552

Other international sales

 

871,854

 

213,948

 

174,204

 

4,700

 

1,264,706

Total

$

16,226,532

$

958,621

$

1,552,325

$

234,904

$

18,972,382

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.  As of June 30, 2024, Management has concluded that a $9.7 million valuation allowance is needed on the net deferred tax asset.  As of December 31, 2023, the valuation allowance for state net operating losses was $283 thousand.  

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the

10

common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

The calculation of diluted EPS under the treasury stock method included the following shares in the three and six month periods ending June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 20, 2023

June 30, 2024

    

June 30, 2023

Common stock underlying issued and outstanding stock options

1,524

 

16,033

5,007

 

22,041

1,524

 

16,033

5,007

 

22,041

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

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Net loss

$

(14,164,640)

$

(3,868,568)

$

(13,735,256)

$

(2,877,596)

Preferred stock dividend requirements

 

(57,611)

 

(58,111)

 

(115,222)

 

(116,222)

Loss applicable to common shareholders

$

(14,222,251)

$

(3,926,679)

$

(13,850,478)

$

(2,993,818)

Average common shares outstanding

 

29,937,159

 

29,937,159

 

29,937,159

 

29,937,159

Average common and common equivalent shares outstanding — diluted

 

29,937,159

 

30,169,604

 

29,937,159

 

30,169,604

Basic loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Diluted loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Shipping and handling costs

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

Share-based Compensation

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

Self-insured employee benefit costs

The Company self-insures certain health insurance benefits for its employees under certain policy limits. The Company has additional coverage provided by an insurance company for any individual with claims in excess of $100,000 and/or total plan claims in excess of $1.7 million for the plan year.

Research and development costs

Research and development costs are expensed as incurred.

Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in government funding for

11

expanding the Company’s domestic production of needles and syringes. At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  Under this agreement, the Company has made significant additions to its facilities which allows the Company to increase domestic production capacity.  For further explanation, please refer to Note 7 – Technology Investment Agreement.

As reimbursements were received from the U.S. government for expenditures under the TIA, the Company recorded a deferred liability. In 2021, the deferred liability began to be systematically amortized as a gain over the life of the related property, plant, and equipment and is presented as Other income – TIA on the Statements of Operations.  For any reimbursements received for expenditures not capitalized as property, plant, and equipment, Other income – TIA was recognized in the same period as the expense.  

Recently Issued Pronouncements

In March 2024, the FASB issued ASU 2024-02, “Codification Improvements — Amendments to Remove References to the Concepts Statements”, which amends the Codification to remove references to various concepts statements. In most instances, the references are extraneous and not required to understand or apply the guidance. In other instances, the references were used in prior Statements to provide guidance in certain topical areas.   ASU 2024-02 is effective for public business entities for fiscal periods beginning after December 15, 2024.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2025.  Early adoption is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued or made available for issuance.   The Company is evaluating the new guidance to determine the impact it may have, if any, on its financial statements.

In December of 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” The updated accounting guidance improves transparency of income tax disclosures, including the disaggregation of existing disclosures related to the effective tax rate reconciliation and income taxes paid. ASU No. 2023-09 is effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted.  For all other entities, it is effective for annual periods beginning after December 15, 2025.   Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.   Prospective application is required, with retrospective application permitted. The Company is evaluating the adoption of the amendments and the potential impact it may have, if any, on its financial statements.

In June 2022, the FASB issued ASU 2022-03, “Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”, intended to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.  The amendment also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction.  ASU No. 2022-03 is effective for public business entities for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2023.  Early adoption is permitted.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2024.  Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.  The adoption of the amendments is unlikely to have a material effect on the Company’s financial statements or disclosures.  

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3.    INVENTORIES

Inventories consist of the following:

    

June 30, 2024

    

December 31, 2023

Raw materials

$

4,119,134

$

4,349,029

Finished goods

17,899,131

13,232,339

$

22,018,265

$

17,581,368

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:

June 30, 2024

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,323,403

$

$

$

18,323,403

Mutual funds

16,059,428

16,059,428

Municipal bonds

668,668

668,668

$

35,051,499

$

$

$

35,051,499

December 31, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,282,556

$

$

$

18,282,556

Mutual funds

15,656,757

15,656,757

Municipal bonds

 

681,900

681,900

$

34,621,213

$

$

$

34,621,213

The investment assets are held as trading securities 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:

June 30, 2024

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,151,932

(5,828,529)

18,323,403

Mutual funds

15,975,653

83,775

16,059,428

Municipal bonds

635,929

32,739

668,668

$

40,763,514

$

116,514

$

(5,828,529)

$

35,051,499

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December 31, 2023

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,074,112

$

$

(5,791,556)

$

18,282,556

Mutual funds

15,576,527

80,230

15,656,757

Municipal bonds

 

635,425

46,475

681,900

$

40,286,064

$

126,705

$

(5,791,556)

$

34,621,213

Unrealized losses on investments in debt and equity securities were $47 thousand and $4.8 million for the six months ended June 30, 2024 and 2023, respectively.

5.    INCOME TAXES

The Company’s effective tax rate on the net loss before income taxes was (156.0)% and 19.4% for the three months ended June 30, 2024 and 2023, respectively.  The Company’s effective tax rate on the net income before income taxes was (157.6)% and 19.6% for the six months ended June 30, 2024 and 2023, respectively.

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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

U.S. statutory federal tax rate

 

21.0

%  

21.0

%  

 

State tax, net of federal tax

 

(0.1)

%  

0.1

%  

 

Change in valuation allowance

 

(178.0)

%  

%  

 

Stock options

%  

0.4

%  

Section 162(m); Limit on Compensation

(0.2)

%  

%  

Out of period adjustment

%  

(0.8)

%  

Other

(0.1)

%  

%  

Return-to-provision and other

 

(0.2)

%

(1.1)

%  

 

Effective tax rate

 

(157.6)

%

19.6

%

 

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. The Company reviewed the operating results, as well as all of the positive and negative evidence related to realization of such deferred tax assets, to evaluate the need for a valuation allowance.  As a result of this review, as of June 30, 2024, the Company concluded that a $9.7 million valuation is needed on the net deferred tax asset. As of December 31, 2023, the valuation allowance for state net operating losses was $283 thousand.

The effective tax rate for the six months ended June 30, 2024 was different from the federal statutory rate due primarily to the increase of the valuation allowance on the Company’s Deferred tax asset.

14

6.    OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

    

June 30, 2024

    

December 31, 2023

Prepayments from customers

$

300,268

$

201,492

Accrued property taxes

332,179

Accrued professional fees

316,254

320,899

Current portion – preferred stock repurchase

 

6,000

 

6,000

Other accrued expenses

 

82,992

 

102,180

Total

$

1,037,693

$

630,571

7.    TECHNOLOGY INVESTMENT AGREEMENT

Effective July 1, 2020, the Company entered into the Technology Investment Agreement (TIA) with the U.S. government to expand the Company’s manufacturing capacity for hypodermic safety needles in response to the worldwide COVID-19 global pandemic.  The award is an expenditure-type TIA, whereby the U.S. government has made payments to the Company for the Company’s expenditures for equipment and supplies related to the expansion.  The Company’s contributions under the terms of the TIA include providing facilities, technical expertise, labor and maintenance for the TIA-funded equipment for a ten-year term.  In May of 2021, the Company and the U.S. government amended the TIA agreement to include two additional assembly lines and additional controlled environment space.  

The Company has received all equipment, has completed all property construction required by the TIA, and all reimbursement requests have been submitted.  No further amounts for expansion under the TIA are expected to be submitted or collected.

At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements, and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  The successor agreement governs ongoing terms established by the TIA until June 30, 2030, which includes maintenance of equipment, availability of capacity, and US government preference in the event of a public health emergency.

Under the TIA, reimbursable amounts are reflected as Other long-term liabilities on the Balance Sheets until the time the deferred income can be systematically amortized over a period matching the useful life of the purchased assets.  Other long-term liabilities from the TIA were $66,813,843 and $72,965,630 at June 30, 2024 and 2023, respectively.

8.    COMMITMENTS AND CONTINGENCIES

On November 7, 2019, the Company filed a lawsuit in the 44th 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 alleged 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 September 2, 2022, the Company filed a Second Amended Petition alleging legal malpractice and negligence.  On February 20, 2024, the Defendants filed another Motion for Summary Judgment on the Company’s remaining claim of legal malpractice. A hearing on that Motion for Summary Judgment was held on April 18, 2024 and an order denying Defendants’ Motion was signed May 10, 2024.  A new trial date has been set for June 2, 2025.

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

15

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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

U.S. sales

$

5,013,571

$

7,300,676

$

11,654,738

$

12,724,124

North and South America sales (excluding U.S.)

 

666,280

 

210,232

 

820,913

 

4,983,552

Other international sales

 

349,513

 

460,372

 

1,153,076

 

1,264,706

Total sales

$

6,029,364

$

7,971,280

$

13,628,727

$

18,972,382

Long-lived assets by geography are as follows:

    

June 30, 2024

    

December 31, 2023

Long-lived assets

U.S.

$

85,966,745

$

89,237,030

International

4,083,182

4,241,491

Total

$

90,049,927

$

93,478,521

10.  DIVIDENDS

A payment of $39,050 was paid within one month of each quarter’s end in 2023 and in January, April, and July of 2024 to Series II preferred shareholders.  Series III preferred shareholders were paid a cash dividend of $19,061 within one month of each quarter’s end in 2023. A payment of $18,561 was made to Series III shareholders in January, April, and July of 2024.

In June 2021, the Board of Directors approved payments to its Series II, Series III, and former Series IV and Series V Class B Preferred Shareholders in the cumulative amount of $5,056,945 representing all current dividends, dividends in arrears, as well as dividends still owed to shareholders who converted their preferred stock in the past.  The dividends were paid on July 22, 2021 to all shareholders who had been contacted and confirmed as the rightful owner entitled to payment. The Company has not yet established contact with all former shareholders, most of whom converted their shares prior to 2001. The Company is continuing its efforts to establish contact with approximately 90 former shareholders who are entitled to approximately $1.4 million.  This, along with the current declared dividends, are reflected in Dividends payable on the Condensed Balance Sheets.

11.  PRIVATE EXCHANGES AND REDEMPTION

In 2020, the Company entered into several agreements with shareholders to purchase its outstanding Class B Convertible Preferred Stock.  The consideration for these purchases consisted of both cash and Common Stock.  In addition, in each such transaction, the preferred shareholder counterparty waived all rights to unpaid dividends in arrears.  The aggregate cash consideration equaled $3,786,000, of which $482,670 was paid in 2020.  The balance was paid in equal installments of $1,101,110 over a three-year period which began in February 2021 and the last payment was made in February 2023.

Effective November 2023, the Company entered into a privately negotiated transaction with a preferred shareholder to redeem 2,000 shares of Series III Class B Stock for a purchase price equal to approximately $6 thousand.

12.  TREASURY STOCK

Treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s balance sheets.

16

Of the 100 million authorized shares of Common Stock, 34,024,304 shares were issued and 29,937,159 shares outstanding as of both December 31, 2023 and June 30, 2024.

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

FORWARD-LOOKING STATEMENT WARNING

Certain statements included by reference in this filing containing the words “could,” “may,” “believes,” “anticipates,” “intends,” “expects,” and similar such words constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Any forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. Such factors include, among others: tariffs, material changes in demand; our ability to maintain liquidity; our maintenance of patent protection; our ability to maintain favorable third party manufacturing and supplier arrangements and relationships; foreign trade risk; our ability to access the market; production costs; the impact of larger market players in providing devices to the safety market; and any other factors referenced in Item 1A. Risk Factors in Part II. Given these uncertainties, undue reliance should not be placed on forward-looking statements.

MATERIAL CHANGES IN FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Overview

We have been manufacturing and marketing our products since 1997. Syringes comprised 86.4% of our sales in the first six months of 2024.  EasyPoint® products accounted for 7.3% and other products, including our IV safety catheter and blood collection products, were 6.4% of our sales in the first six months of 2024.

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

In 2020 and 2021, we were awarded significant orders and contracts by the U.S. government for safety syringes for COVID-19 vaccination efforts.  From 2020 through the first quarter of 2022, the U.S. government was a significant customer.  We cannot predict whether any future U.S. government orders may occur.

In 2020, we entered into a Technology Investment Agreement (“TIA”) with the U.S. government which provided significant government funding for expanding our domestic production of needles and syringes to meet ongoing and future U.S. COVID-19 medical countermeasures demands.  Recent additions of manufacturing equipment and facilities have increased our production capacity and our overhead costs.  There are currently no plans to further expand our production or administrative facilities, nor do we have material commitments for additional manufacturing equipment purchases. At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements, and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  The successor agreement governs ongoing terms established by the TIA until June 30, 2030, which includes maintenance of equipment, availability of capacity, and US government preference in the event of a public health emergency.

The U.S. government orders as well as the TIA are material events particular to the COVID-19 pandemic and are not indicative of future operations.

Over the past several years, we have experienced certain cost increases in raw materials, but those costs primarily affect our domestic manufacturing because the finished goods we purchased from China (being 91% of our products) are subject to a long-term fixed price contract.  Other factors that could affect our unit costs include increases in tariffs, supplier

17

cost increases, and changing production volumes.  Increases in costs may not be recoverable through price increases of our products.

We believe domestic customers have retained products provided for vaccination purposes in inventory, leading to a decrease in our 2023-2024 domestic sales.  Customers have reported that demand was diminished due to their remaining syringe inventory. It is difficult to estimate how much of the remaining inventory might still remain in the market.

As detailed in Note 4 to the financial statements, we held $35.1 million in debt and equity securities as of June 30, 2024, which represented 21.8% of our total assets.

Historically, unit sales have increased during the flu season. From approximately 2020-2022, the effect of flu season sales was less impactful due to the dramatic increase in sales attributable to COVID-19 vaccinations.  Seasonal trends may now be following pre-pandemic patterns.

Product purchases from our Chinese manufacturers have enabled us to increase manufacturing capacity with little capital outlay and have provided a competitive manufacturing cost. In the second quarter of 2024, our Chinese manufacturers produced approximately 92% of our products. In the event that we become unable to purchase products from our Chinese manufacturers, we may need to find an alternate manufacturer for the blood collection set, IV catheter, Patient Safe® syringe, 0.5mL insulin syringe, 0.5mL autodisable syringe, and 2mL, 5mL, and 10mL syringes, and we would increase domestic production for the 1mL and 3mL syringes and EasyPoint® needles.

On May 14, 2024, President Biden directed the Office of the U.S. Trade Representative (“USTR”) to increase tariffs on certain goods imported from China under Section 301 of the Trade Act of 1974.  Among those products included were syringes and needles, at a rate of 50%.  As noted in this report, for the first six months of 2024, 91% of our products were purchased from our manufacturers in China, most of which would be impacted by the contemplated tariffs.  On July 30, 2024, the USTR announced that, in response to more than 1,100 public comments received regarding the modifications, it would continue reviewing the comments and expects its final determination will be issued in August, and that the modifications slated for 2024 will take effect approximately two weeks after its final determination.  In the event that the tariffs affecting syringes and needles are enacted, the resulting increase in costs could have a material impact to our results of operations and financial position.  We are working to evaluate options to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint® needles to our domestic manufacturing facility.  While this shift to increase our domestic production of those products will not require additional capital outlays for equipment, we will most likely incur an increase in our headcount and associated employee costs for production staff.  The impact to our overall production staff costs will be dependent on our product mix and timing of implementation, but is expected to increase our overall wage expense.

A material portion of our net losses for the 2024 periods presented in this report is comprised of the approximately $8.3 million change in valuation allowance on the deferred tax asset which is included as a provision for income taxes on the Condensed Statements of Operations and additionally is reflected as a removal of that asset from the Condensed Balance Sheets.  In short, the devaluation of the deferred tax asset is related to our determination that, based on current information, it is more likely than not that we wouldn’t be in a position to use loss carryforwards against future taxable net income based on a variety of factors and accounting guidelines.  The expected implementation of tariffs on imported syringes from China was one of the factors considered in this determination.

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

Included in net sales for the second quarter of 2024 is $90 thousand in licensing fees recorded under a sublicensing agreement with one of our Chinese manufacturers.  Under the terms of our licensing agreement with Mr. Shaw, he is

18

entitled to receive 50% of this amount, which is recorded as royalty expense to shareholder in total cost of sales for the year.

RESULTS OF OPERATIONS

The following discussion may contain trend information and other forward-looking statements that involve a number of risks and uncertainties. Our actual future results could differ materially from our historical results of operations and those discussed in any forward-looking statements. All period references are to periods ended June 30, 2024 or 2023, as applicable. Dollar amounts have been rounded for ease of reading.

Comparison of Three Months Ended June 30, 2024 and June 30, 2023

Domestic sales accounted for 83.2% and 91.6% of the revenues for the three months ended June 30, 2024 and 2023, respectively.  Domestic revenues decreased 31.3% principally due to lower demand.  Domestic unit sales decreased 22.1%.  Domestic unit sales were 79.3% of total unit sales for the three months ended June 30, 2024.  International revenues increased approximately 51.5% or $345 thousand.  The increase in international revenues is primarily due to the timing of international shipments.  Overall unit sales decreased 13.6%. There is uncertainty as to the timing of future international orders.

Cost of manufactured product decreased 15.7% principally due to lower unit sales.  Royalty expense decreased 8.8% due to the associated decrease in gross sales.  

Operating expenses decreased 1.2% from the prior year due to a reduction of property tax expense as a result of newly enacted property tax exemption legislation relating to medical device property, offset by an increase in our allowance for anticipated credit losses.

The loss from operations was $5.8 million compared to a loss of $5.0 million for the same period last year.  The increased loss was due to lower gross profit for the current period, offset by a slight reduction in overall operating expenses.

The unrealized loss on debt and equity securities was $1.8 million due to the decreased market values of those securities.

The provision for income taxes was $8.3 million for the second quarter of 2024 as compared to a benefit for income taxes of $932 thousand in the second quarter of 2023.  The increase in income tax expense is primarily related to the valuation allowance against the Deferred tax asset.

Comparison of Six Months Ended June 30, 2024 and June 30, 2023

Domestic sales accounted for 85.5% and 67.1% of the revenues for the six months ended June 30, 2024 and 2023, respectively.  Domestic revenues decreased 8.4% principally due to lower demand.  Domestic unit sales decreased 4.6%.  Domestic unit sales were 82.8% of total unit sales for the six months ended June 30, 2024.  International revenues decreased approximately 68.4% predominately due to fewer international vaccination-related sales.  Overall unit sales decreased 35.8%. There is uncertainty as to the timing of future international orders.

Cost of manufactured product decreased 23.8% principally due to lower unit sales. Royalty expense decreased 12.5% due to the associated decrease in gross sales.  

Operating expenses decreased 7.2% from the prior year.  This is substantially due to a reduction of property tax expense as a result of newly enacted property tax exemption legislation relating to medical device property.

The loss from operations was $8.7 million compared to a loss of $7.8 million for the same period last year.  The increased loss was due to lower gross profit for the current period, offset by a slight reduction in overall operating expenses.

19

The provision for income taxes was $8.4 million for the first six months of 2024 as compared to a benefit for income taxes of $701 thousand in the first six months of 2023.  The year-to-date income tax provision is primarily related to the second quarter of 2024 as a result of fully reserving the Company’s Deferred tax asset.

Discussion of Balance Sheet and Cash Flow Items

Cash and investments comprise 26.1% of total assets.  Cash flow used by operations was $4.7 million for the six months ended June 30, 2024 due to a number of factors.  We recognized approximately $3.0 million in other income from the TIA during the first six months of 2024, offset by increase of $8.4 million in valuation allowance related to deferred tax assets which is material to the adjustments to total cash flow from operations. Changes in working capital also impacted cash flows from operating activities.  Accounts receivable decreased by $5.6 million, inventories increased by $4.4 million, and accounts payable decreased by $1.7 million.  

Cash flow used by investing activities was $825 thousand for the six months ended June 30, 2024 due to the purchase of assets and securities.

Cash flow used by financing activities was $264 thousand for the six months ended June 30, 2024 due to repayments of long-term debt and payment of preferred stock dividends.

LIQUIDITY AND CAPITAL RESOURCES

We have historically funded operations primarily from the proceeds from revenues, private placements, litigation settlements, and loans. We may fund operations going forward from revenues, cash reserves, and investments available for sale if the need to access those funds arises.

Margins

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

Cash Requirements

We believe we will have adequate means to meet our short-term needs to fund operations for at least 12 months from the date of issuance of the financial statements. Besides cash reserves and expected income from operations, we also have access to our investments which may be liquidated in the event that we need to access the funds for operations.  Expected short-term uses of cash include payroll and benefits, royalty expense, inventory purchases, contractual obligations, payment of income taxes, quarterly preferred stock dividends, and other operational priorities. Our liabilities are our bank debt as set forth as Long-term debt on our Condensed Balance Sheets and other liabilities detailed herein in Note 6 to the financial statements.  We believe we will have adequate means to meet our currently foreseeable long-term liquidity needs.  In the event that our long-term cash requirements exceed our current reserves and our ability to generate cash from operations, management would reduce our operational cash requirements.

20

Capital Resources

If new tariffs become effective and we determine to increase domestic production, we expect to spend approximately $1 million over the next six to eight months to improve and add to our domestic equipment in order to begin producing products we cannot currently produce at our U.S. facility.

CRITICAL ACCOUNTING ESTIMATES

We are responsible for developing estimates for amounts reported as assets and liabilities, and revenues and expenses in conformity with U.S. generally accepted accounting principles (“GAAP”).  Those estimates require that we develop assumptions of future events based on past experience and expectations of economic factors.  Among the more critical estimates management makes is the estimate for customer rebates.  The amount reported as a contractual allowance for rebates involves examination of past historical trends related to our sales to distributors and the related credits issued once our distributors have satisfied their contractual obligations.  The estimate includes consideration of historical redemption rates, discount rates, a combination of estimated distributor inventories based on tracking information provided by the distributors or if known, inventory turnover rates.  The establishment of a liability for future claims of rebates against sales in the current period requires that we have an understanding of the relevant sales with respect to product categories, sales distribution channels, and the likelihood of contractual obligations being satisfied.  We examine the results of estimates against actual results historically and use the determination to further develop our basis for assumptions in future periods, as well as the accuracy of past estimates.  Based on distributors purchasing and claiming rebates practices, we do not expect significant changes to the current inputs and assumption used in the estimate calculations.  While we believe that we have sufficient historical data, and a firm basis for establishing reserves for contractual obligations, there is an inherent risk that our estimates and the underlying assumptions may not reflect actual future results.  In the event that these estimates and/or assumptions are incorrect, adjustments to our reserves may have a material impact on future results. As of June 30, 2024, we estimate that the total potential future credits to be issued as a result of prior purchases which have not yet been claimed is $1.3 million.

Item 3.    Quantitative and Qualitative Disclosures About Market Risk.

Not applicable.

Item 4.    Controls and Procedures.

Disclosure Controls and Procedures

Pursuant to Rule 13a-15(b) of the Securities Exchange Act of 1934, Management, with the participation of our President, Chairman, and Chief Executive Officer, Thomas J. Shaw (the “CEO”), and our Vice President and Chief Financial Officer, John W. Fort III (the “CFO”), acting in their capacities as our principal executive and principal financial officers, evaluated the effectiveness of our disclosure controls and procedures, as defined in Rule 13a-15(e) under the Securities Exchange Act of 1934. The term disclosure controls and procedures means controls and other procedures that are designed to ensure that information required to be disclosed by us in our periodic reports is: i) recorded, processed, summarized, and reported, within the time periods specified in the Securities and Exchange Commission’s rules and forms; and ii) accumulated and communicated to our Management, including our principal executive and principal financial officers, as appropriate to allow timely decisions regarding required disclosure. Based upon this evaluation, the CEO and CFO concluded that, as of June 30, 2024, our disclosure controls and procedures were effective.

Changes in Internal Control Over Financial Reporting

There have been no changes during the second quarter of 2024 or subsequent to June 30, 2024 in our internal control over financial reporting that have materially affected or are reasonably likely to materially affect our internal control over financial reporting.

21

PART II—OTHER INFORMATION

Item 1.    Legal Proceedings.

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

Item 1A.    Risk Factors.

In addition to the risk factors disclosed in our most recent annual report which is available on EDGAR, the following additional risk factor has been identified.

On May 14, 2024, President Biden directed the Office of the U.S. Trade Representative (“USTR”) to increase tariffs on certain goods imported from China under Section 301 of the Trade Act of 1974.  Among those products included were syringes and needles, at a rate of 50%.  As noted in this report, for the first six months of 2024, 91% of our products were purchased from our manufacturers in China, most of which would be impacted by the contemplated tariffs.  On July 30, 2024, the USTR announced that, in response to more than 1,100 public comments received regarding the modifications, it would continue reviewing the comments and expects its final determination will be issued in August, and that the modifications slated for 2024 will take effect approximately two weeks after its final determination.  In the event that the tariffs affecting syringes and needles are enacted, the resulting increase in costs could have a material impact to our results of operations and financial position.  We are working to evaluate options to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint® needles to our domestic manufacturing facility.

Item 5.    Other Information.

No director or officer adopted or terminated a trading arrangement in the second quarter of 2024 of the type described by Item 408 of Regulation S-K.  As previously reported, on August 22, 2023, Thomas J. Shaw, President, Chairman, and Chief Executive Officer, adopted a written plan for the purchase of Retractable Technologies, Inc. common stock intended to satisfy the affirmative defense conditions of Rule 10b5–1(c).  In accordance with the plan, trading began on November 20, 2023 and may continue through November 19, 2024 if not earlier terminated.  During this period, the plan instructs a broker-dealer to purchase common stock for an aggregate purchase price of up to $800,000 within certain price parameters.  Mr. Shaw’s purchases pursuant to this plan are reported on forms filed with the SEC pursuant to Section 16(a) of the Securities Exchange Act of 1934.

Item 6.    Exhibits.

Exhibit No.

    

Description of Document 

31.1

Certification of Principal Executive Officer

31.2

Certification of Principal Financial Officer

32

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

101

The following materials from Retractable Technologies, Inc.’s Form 10-Q for the period ended June 30, 2024, formatted in inline XBRL (eXtensible Business Reporting Language): (i) Condensed Balance Sheets as of June 30, 2024 and December 31, 2023, (ii) Condensed Statements of Operations for the three  and six months ended June 30, 2024 and 2023, (iii) Condensed Statements of Cash Flows for the six  months ended June 30, 2024 and 2023, (iv) Condensed Statement of Changes in Stockholders’ Equity for the three and six months ended June 30, 2024 and 2023; and (v) Notes to Condensed Financial Statements

104

Interactive Data File (formatted Inline XBRL and contained in Exhibit 101)

22

SIGNATURES

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

DATE:   August 14, 2024

RETRACTABLE TECHNOLOGIES, INC.

(Registrant)

By:

/s/ John W. Fort III

JOHN W. FORT III
VICE PRESIDENT, CHIEF FINANCIAL OFFICER,
AND CHIEF ACCOUNTING OFFICER

23

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER

    

Exhibit 31.1

I, Thomas J. Shaw, certify that:

1.

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

2.

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

3.

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

4.

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

(a)

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

(b)

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

(c)

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

(d)

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

5.

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

(a)

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

(b)

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

Date: August 14, 2024

    

/s/ Thomas J. Shaw

THOMAS J. SHAW

PRESIDENT, CHAIRMAN, AND

CHIEF EXECUTIVE OFFICER


CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER

    

Exhibit 31.2

I, John W. Fort III, certify that:

1.

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

2.

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

3.

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

4.

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

(a)

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

(b)

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

(c)

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

(d)

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

5.

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

(a)

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

(b)

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

Date: August 14, 2024

    

 

/s/ John W. Fort III

JOHN W. FORT III

VICE PRESIDENT,

CHIEF FINANCIAL OFFICER,

AND CHIEF ACCOUNTING OFFICER


Exhibit 32

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

Solely in connection with the filing of the Quarterly Report of Retractable Technologies, Inc. (the “Company”) on Form 10-Q for the period ended June 30, 2024, as filed with the United States Securities and Exchange Commission on the date hereof (the “Report”), the undersigned Thomas J. Shaw, Chief Executive Officer, and John W. Fort III, Chief Financial Officer, do hereby certify, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

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

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

Date:

August 14, 2024

/s/ Thomas J. Shaw

 

 

 

THOMAS J. SHAW

PRESIDENT, CHAIRMAN, AND

CHIEF EXECUTIVE OFFICER

 

 

 

 

/s/ John W. Fort III

 

 

 

JOHN W. FORT III

VICE PRESIDENT, CHIEF FINANCIAL

OFFICER, AND CHIEF ACCOUNTING

OFFICER


v3.24.2.u1
Document and Entity Information - shares
6 Months Ended
Jun. 30, 2024
Aug. 01, 2024
Cover    
Document Type 10-Q  
Document Quarterly Report true  
Current Fiscal Year End Date --12-31  
Document Period End Date Jun. 30, 2024  
Document Transition Report false  
Securities Act File Number 001-16465  
Entity Registrant Name RETRACTABLE TECHNOLOGIES INC  
Entity Incorporation, State or Country Code TX  
Entity Tax Identification Number 75-2599762  
Entity Address, Address Line One 511 Lobo Lane  
Entity Address, City or Town Little Elm  
Entity Address, State or Province TX  
Entity Address, Postal Zip Code 75068-5295  
City Area Code 972  
Local Phone Number 294-1010  
Title of 12(b) Security Common Stock  
Trading Symbol RVP  
Security Exchange Name NYSEAMER  
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   29,937,159
Entity Central Index Key 0000946563  
Document Fiscal Year Focus 2024  
Document Fiscal Period Focus Q2  
Amendment Flag false  
v3.24.2.u1
CONDENSED BALANCE SHEETS - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Current assets:    
Cash and cash equivalents $ 6,853,067 $ 12,667,550
Accounts receivable, net 4,690,228 10,671,721
Investments in debt and equity securities, at fair value 35,051,499 34,621,213
Inventories 22,018,265 17,581,368
Income taxes receivable 1,078,117 1,155,077
Other current assets 877,335 952,668
Total current assets 70,568,511 77,649,597
Property, plant, and equipment, net 90,049,927 93,478,521
Deferred tax asset   8,392,030
Other assets 125,982 152,064
Total assets 160,744,420 179,672,212
Current liabilities:    
Accounts payable 3,114,068 4,779,035
Current portion of long-term debt 317,991 303,991
Accrued compensation 936,137 865,105
Dividends payable 1,417,437 1,417,437
Accrued royalties to shareholder 596,203 1,376,555
Other accrued liabilities 1,037,693 630,571
Income taxes payable 3,311 4,802
Total current liabilities 7,422,840 9,377,496
Other long-term liabilities 66,813,843 69,773,538
Long-term debt, net of current maturities 1,070,556 1,233,519
Total liabilities 75,307,239 80,384,553
Commitments and contingencies - see Note 10
Stockholders' equity:    
Common Stock, no par value
Additional paid-in capital 73,160,333 73,160,333
Retained earnings 24,935,081 38,785,559
Common stock in treasury - at cost (12,888,678) (12,888,678)
Total stockholders' equity 85,437,181 99,287,659
Total liabilities and stockholders' equity 160,744,420 179,672,212
Series II Class B    
Stockholders' equity:    
Preferred stock, $1 par value: Class B; authorized: 5,000,000 shares 156,200 156,200
Series III Class B    
Stockholders' equity:    
Preferred stock, $1 par value: Class B; authorized: 5,000,000 shares $ 74,245 $ 74,245
v3.24.2.u1
CONDENSED BALANCE SHEETS (Parenthetical) - $ / shares
Jun. 30, 2024
Dec. 31, 2023
Preferred stock, par value (in dollars per share) $ 1 $ 1
Common stock, par value (in dollars per share) $ 0 $ 0
Preferred Stock Class B    
Preferred stock, authorized shares 5,000,000 5,000,000
v3.24.2.u1
CONDENSED STATEMENTS OF OPERATIONS - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Sales, net $ 6,029,364 $ 7,971,280 $ 13,628,727 $ 18,972,382
Cost of sales:        
Total cost of sales 6,449,288 7,594,373 12,147,722 15,725,946
Gross profit (loss) (419,924) 376,907 1,481,005 3,246,436
Operating expenses:        
Sales and marketing 1,474,600 1,545,453 2,909,342 2,895,624
Research and development 199,093 138,761 341,355 268,518
General and administrative 3,669,189 3,725,463 6,979,251 7,855,487
Total operating expenses 5,342,882 5,409,677 10,229,948 11,019,629
Loss from operations (5,762,806) (5,032,770) (8,748,943) (7,773,193)
Other income - TIA 1,475,075 1,474,019 2,959,695 3,031,798
Unrealized loss on debt and equity securities (1,779,814) (6,251,650) (47,165) (4,759,639)
Gain on sale of equity securities   4,828,529   5,574,791
Interest and other income 244,518 218,651 561,839 428,466
Interest expense (31,817) (37,469) (65,300) (81,024)
Loss before income taxes (5,854,844) (4,800,690) (5,339,874) (3,578,801)
Provision (benefit) for income taxes 8,309,796 (932,122) 8,395,382 (701,205)
Net loss (14,164,640) (3,868,568) (13,735,256) (2,877,596)
Preferred Stock dividend requirements (57,611) (58,111) (115,222) (116,222)
Net loss applicable to common shareholders $ (14,222,251) $ (3,926,679) $ (13,850,478) $ (2,993,818)
Basic loss per share $ (0.48) $ (0.13) $ (0.46) $ (0.10)
Diluted loss per share $ (0.48) $ (0.13) $ (0.46) $ (0.10)
Weighted average common shares outstanding:        
Basic (in shares) 29,937,159 29,937,159 29,937,159 29,937,159
Diluted (in shares) 29,937,159 30,169,604 29,937,159 30,169,604
Cost of manufactured product        
Cost of sales:        
Total cost of sales $ 5,853,085 $ 6,940,895 $ 10,902,131 $ 14,302,759
Royalty expense to shareholder        
Cost of sales:        
Total cost of sales $ 596,203 $ 653,478 $ 1,245,591 $ 1,423,187
v3.24.2.u1
CONDENSED STATEMENTS OF CASH FLOWS - USD ($)
6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Cash flows from operating activities    
Net loss $ (13,735,256) $ (2,877,596)
Adjustments to reconcile net loss to net cash from operating activities:    
Depreciation and amortization 3,776,694 3,884,970
Net unrealized loss on investments 47,165 4,759,639
Realized gain on investments   (5,574,791)
Accreted interest   9,157
Bond amortization (505)  
Deferred taxes 8,392,031 (701,205)
Provision for credit losses 427,487 370,573
Net realizable value inventory adjustment 1,872 143,290
Other income - TIA (2,959,695) (3,031,798)
(Increase) decrease in operating assets:    
Accounts receivable 5,554,005 (2,758,677)
Inventories (4,438,769) (373,901)
Other current assets 75,333 (35,220)
Income taxes receivable 76,960 1,424,723
Other assets 26,082 13,830
Increase (decrease) in operating liabilities:    
Accounts payable (1,664,967) (2,823,502)
Accrued liabilities (302,198) 700,711
Income taxes payable (1,491) (58,396)
Net cash used by operating activities (4,725,252) (6,928,193)
Cash flows from investing activities    
Purchase of property, plant, and equipment (348,100) (556,385)
Purchase of debt and equity securities (476,946) (43,868,141)
Proceeds from the sales of debt and equity securities   34,567,513
Net cash used by investing activities (825,046) (9,857,013)
Cash flows from financing activities    
Repayments of long-term debt (148,963) (139,146)
Proceeds from Technology Investment Agreement (TIA)   2,563,229
Payment of preferred stock repurchase payable   (1,101,110)
Payment of preferred stock dividends (115,222) (116,223)
Net cash provided (used) by financing activities (264,185) 1,206,750
Net decrease in cash and cash equivalents (5,814,483) (15,578,456)
Cash and cash equivalents at:    
Beginning of period 12,667,550 19,721,345
End of period 6,853,067 4,142,889
Supplemental schedule of cash flow information:    
Interest paid 65,300 $ 28,312
Income taxes paid (received) (71,318)  
Supplemental schedule of noncash investing and financing activities:    
Preferred dividends declared, not paid $ 57,611  
v3.24.2.u1
CONDENSED STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY - USD ($)
Preferred Stock
Series II, Class B
Preferred Stock
Series III, Class B
Additional Paid-In Capital
Retained Earnings (Accumulated Deficit)
Treasury Stock - at cost
Total
Balance at Dec. 31, 2022 $ 156,200 $ 76,245 $ 73,164,501 $ 46,028,541 $ (12,888,678) $ 106,536,809
Increase (Decrease) in Stockholders' Equity            
Dividends       (116,222)   (116,222)
Net Income (Loss)       (2,877,596)   (2,877,596)
Balance at Jun. 30, 2023 156,200 76,245 73,164,501 43,034,723 (12,888,678) 103,542,991
Balance at Mar. 31, 2023 156,200 76,245 73,164,501 46,961,402 (12,888,678) 107,469,670
Increase (Decrease) in Stockholders' Equity            
Dividends       (58,111)   (58,111)
Net Income (Loss)       (3,868,568)   (3,868,568)
Balance at Jun. 30, 2023 156,200 76,245 73,164,501 43,034,723 (12,888,678) 103,542,991
Balance at Dec. 31, 2023 156,200 74,245 73,160,333 38,785,559 (12,888,678) 99,287,659
Increase (Decrease) in Stockholders' Equity            
Dividends       (115,222)   (115,222)
Net Income (Loss)       (13,735,256)   (13,735,256)
Balance at Jun. 30, 2024 156,200 74,245 73,160,333 24,935,081 (12,888,678) 85,437,181
Balance at Mar. 31, 2024 156,200 74,245 73,160,333 39,157,332 (12,888,678) 99,659,432
Increase (Decrease) in Stockholders' Equity            
Dividends       (57,611)   (57,611)
Net Income (Loss)       (14,164,640)   (14,164,640)
Balance at Jun. 30, 2024 $ 156,200 $ 74,245 $ 73,160,333 $ 24,935,081 $ (12,888,678) $ 85,437,181
v3.24.2.u1
BUSINESS OF THE COMPANY AND BASIS OF PRESENTATION
6 Months Ended
Jun. 30, 2024
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 EasyPoint® blood collection tube holder with needle; 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 29, 2024 for the year ended December 31, 2023.  

v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES
6 Months Ended
Jun. 30, 2024
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 credit losses is primarily determined by review of specific trade receivables based on historical collection rates and specific knowledge regarding the current creditworthiness of the customers.  Those

accounts that are doubtful of collection are included in the allowance.  The Company considers historical experience, the current economic environment, customer credit ratings or bankruptcies, legal disputes, collections on past due amounts, pricing discrepancies, and reasonable and supportable forecasts to develop its allowance for credit losses. Management reviews these factors quarterly to determine if any adjustments are needed to the allowance. 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 credit losses was $817 thousand and $891 thousand as of June 30, 2024 and December 31, 2023, 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. The Company recorded $2 thousand and $101 thousand lower of cost or net realizable value inventory adjustment associated with the VanishPoint® 3mL and EasyPoint® needle product segments as of June 30, 2024 and December 31, 2023, respectively.  

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 written down to their net realizable value.

Investments in debt and equity securities

The Company holds mutual funds, debt, and equity securities as investments.  These assets are held as trading securities and are carried at fair value as of the date of the Condensed Balance Sheets. Net unrealized and realized gains or losses on these investments are reflected separately on the Condensed Statements of Operations. Realized gains or losses on investments are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment are stated at cost less accumulated depreciation. 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 costs associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

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

Production equipment

    

3 to 13 years

Office furniture and equipment

 

3 to 10 years

Buildings

 

39 years

Building improvements

 

15 years

Long-lived assets

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

Fair value measurements

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

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information.  Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values.  Investments in debt and equity securities consist primarily of individual equity securities and mutual funds and are reported at their fair value based upon quoted prices in active markets. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in 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. Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the three-month and six-month periods ended June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Number of significant customers

 

4

 

3

 

3

 

3

 

Aggregate dollar amount of net sales to significant customers

$

3.8

million

$

4.4

million

$

7.3

million

$

10.2

million

Percentage of net sales to significant customers

63.0%

55.0%

53.6%

53.9%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained 91% and 89% of its products in the first six months of 2024 and 2023, respectively, from its

Chinese manufacturers.  Purchases from Chinese manufacturers aggregated 92% and 84% of products in the second quarter of 2024 and 2023, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company may need to find an alternate manufacturer for its blood collection set, EasyPoint® blood collection tube holder with needle, 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.

On May 14, 2024, President Biden directed the Office of the U.S. Trade Representative (“USTR”) to increase tariffs on certain goods imported from China under Section 301 of the Trade Act of 1974.  Among those products included were syringes and needles, at a rate of 50%.  As noted above, for the first six months of 2024, 91% of the products the Company sold were purchased from our manufacturers in China, most of which would be impacted by the contemplated tariffs.  On July 30, 2024, the USTR announced that, in response to more than 1,100 public comments received regarding the modifications, it would continue reviewing the comments and expects its final determination will be issued in August, and that the modifications slated for 2024 will take effect approximately two weeks after its final determination.  In the event that the tariffs affecting syringes and needles are enacted, the resulting increase in costs could have a material impact to the Company’s results of operations and financial position.  The Company is working to evaluate options to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint® needles to its domestic manufacturing facility.

Revenue recognition

The Company recognizes revenue when control of performance obligations passes to the customer, generally when the product ships.  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 $1.3 million and $2.2 million as of June 30, 2024 and December 31, 2023, 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 has not historically incurred significant returns.

On February 5, 2024, the Company initiated a voluntary recall of its EasyPoint Needle lot number K220402 which was shipped within the U.S. between July 20, 2022 and September 20, 2023. The Company shipped 477,600 units of the products into the market and is working with customers and distributors to determine how many of the units remain unused and subject to the recall. The recall is due to the possible detachment of the needle cannula from the needle holder, which could result in serious injury. The Company has advised its customers and distributors to review their inventory for the affected products, segregate and quarantine the affected products, discontinue any distribution of the affected products, inform all personnel not to use the affected products, and report and return remaining inventory to the Company. The Company submitted a Removal Report with the U.S. Food and Drug Administration and has continued to provide monthly updates.  The estimated time for the completion of the recall is September 1, 2024.  The Company estimates that the potential expense related to the recall is approximately $116 thousand.

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

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

The Company periodically recognizes revenue from licensing agreements of its intellectual property. Such licensing agreements provide licensee with right to use the Company’s intellectual property.  The Company accounts for revenue generated under these licensing agreements in accordance with ASC 606.  A license may be perpetual or time limited in its application. The Company has concluded that its licensing agreement is distinct as the customer can benefit from the license on their own. In accordance with ASC 606, the licensing agreement is considered functional as it is without professional services, updates and technical support. The Company has determined the current licensing agreement is sales-based or usage-based as defined in ASC 606.  In accordance with ASC 606, the Company recognizes revenue from sales-based or usage-based license at the later of a) subsequent sale or usage occurrence or b) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).  The Company recognized $90 thousand and $189 thousand in licensing fees for the three and six months ended June 30, 2024.  No licensing fees were recognized for the three and six months ended June 30, 2023.  If the Company licenses its products for sale and the customers of the sublicensee are not known to the Company, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, fifty percent (50%) 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 June 30, 2024:

    

    

Blood 

    

    

    

Total 

Collection 

EasyPoint®

Other 

Product

Geographic Segment

Syringes

Products

Needles

Products

 Sales

U.S. sales

$

4,631,773

333,389

42,561

5,848

$

5,013,571

North and South America sales (excluding U.S.)

 

601,000

 

 

59,040

 

6,240

 

666,280

Other international sales

 

256,133

 

400

 

87,680

 

5,300

 

349,513

Total

$

5,488,906

$

333,789

$

189,281

$

17,388

$

6,029,364

For the three months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

5,780,080

$

346,297

$

1,165,634

$

8,665

7,300,676

North and South America sales (excluding U.S.)

 

210,232

 

 

 

210,232

Other international sales

 

366,312

 

1,748

 

87,612

 

4,700

460,372

Total

$

6,356,624

$

348,045

$

1,253,246

$

13,365

$

7,971,280

For the six months ended June 30, 2024:

    

    

Blood 

    

    

    

Collection 

EasyPoint®

Other 

Total

Geographic Segment

Syringes

Products

Needles

Products

Revenue

U.S. sales

$

10,185,082

700,998

755,432

13,226

$

11,654,738

North and South America sales (excluding U.S.)

 

755,537

96

59,040

6,240

 

820,913

Other international revenue

 

828,612

143,860

174,704

5,900

 

1,153,076

Total

$

11,769,231

$

844,954

$

989,176

$

25,366

$

13,628,727

For the six months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

10,583,166

$

744,673

$

1,378,121

$

18,164

$

12,724,124

North and South America sales (excluding U.S.)

 

4,771,512

 

 

 

212,040

 

4,983,552

Other international sales

 

871,854

 

213,948

 

174,204

 

4,700

 

1,264,706

Total

$

16,226,532

$

958,621

$

1,552,325

$

234,904

$

18,972,382

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.  As of June 30, 2024, Management has concluded that a $9.7 million valuation allowance is needed on the net deferred tax asset.  As of December 31, 2023, the valuation allowance for state net operating losses was $283 thousand.  

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the

common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

The calculation of diluted EPS under the treasury stock method included the following shares in the three and six month periods ending June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 20, 2023

June 30, 2024

    

June 30, 2023

Common stock underlying issued and outstanding stock options

1,524

 

16,033

5,007

 

22,041

1,524

 

16,033

5,007

 

22,041

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

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Net loss

$

(14,164,640)

$

(3,868,568)

$

(13,735,256)

$

(2,877,596)

Preferred stock dividend requirements

 

(57,611)

 

(58,111)

 

(115,222)

 

(116,222)

Loss applicable to common shareholders

$

(14,222,251)

$

(3,926,679)

$

(13,850,478)

$

(2,993,818)

Average common shares outstanding

 

29,937,159

 

29,937,159

 

29,937,159

 

29,937,159

Average common and common equivalent shares outstanding — diluted

 

29,937,159

 

30,169,604

 

29,937,159

 

30,169,604

Basic loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Diluted loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Shipping and handling costs

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

Share-based Compensation

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

Self-insured employee benefit costs

The Company self-insures certain health insurance benefits for its employees under certain policy limits. The Company has additional coverage provided by an insurance company for any individual with claims in excess of $100,000 and/or total plan claims in excess of $1.7 million for the plan year.

Research and development costs

Research and development costs are expensed as incurred.

Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in government funding for

expanding the Company’s domestic production of needles and syringes. At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  Under this agreement, the Company has made significant additions to its facilities which allows the Company to increase domestic production capacity.  For further explanation, please refer to Note 7 – Technology Investment Agreement.

As reimbursements were received from the U.S. government for expenditures under the TIA, the Company recorded a deferred liability. In 2021, the deferred liability began to be systematically amortized as a gain over the life of the related property, plant, and equipment and is presented as Other income – TIA on the Statements of Operations.  For any reimbursements received for expenditures not capitalized as property, plant, and equipment, Other income – TIA was recognized in the same period as the expense.  

Recently Issued Pronouncements

In March 2024, the FASB issued ASU 2024-02, “Codification Improvements — Amendments to Remove References to the Concepts Statements”, which amends the Codification to remove references to various concepts statements. In most instances, the references are extraneous and not required to understand or apply the guidance. In other instances, the references were used in prior Statements to provide guidance in certain topical areas.   ASU 2024-02 is effective for public business entities for fiscal periods beginning after December 15, 2024.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2025.  Early adoption is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued or made available for issuance.   The Company is evaluating the new guidance to determine the impact it may have, if any, on its financial statements.

In December of 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” The updated accounting guidance improves transparency of income tax disclosures, including the disaggregation of existing disclosures related to the effective tax rate reconciliation and income taxes paid. ASU No. 2023-09 is effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted.  For all other entities, it is effective for annual periods beginning after December 15, 2025.   Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.   Prospective application is required, with retrospective application permitted. The Company is evaluating the adoption of the amendments and the potential impact it may have, if any, on its financial statements.

In June 2022, the FASB issued ASU 2022-03, “Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”, intended to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.  The amendment also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction.  ASU No. 2022-03 is effective for public business entities for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2023.  Early adoption is permitted.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2024.  Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.  The adoption of the amendments is unlikely to have a material effect on the Company’s financial statements or disclosures.  

v3.24.2.u1
INVENTORIES
6 Months Ended
Jun. 30, 2024
INVENTORIES  
INVENTORIES

3.    INVENTORIES

Inventories consist of the following:

    

June 30, 2024

    

December 31, 2023

Raw materials

$

4,119,134

$

4,349,029

Finished goods

17,899,131

13,232,339

$

22,018,265

$

17,581,368

v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS
6 Months Ended
Jun. 30, 2024
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:

June 30, 2024

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,323,403

$

$

$

18,323,403

Mutual funds

16,059,428

16,059,428

Municipal bonds

668,668

668,668

$

35,051,499

$

$

$

35,051,499

December 31, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,282,556

$

$

$

18,282,556

Mutual funds

15,656,757

15,656,757

Municipal bonds

 

681,900

681,900

$

34,621,213

$

$

$

34,621,213

The investment assets are held as trading securities 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:

June 30, 2024

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,151,932

(5,828,529)

18,323,403

Mutual funds

15,975,653

83,775

16,059,428

Municipal bonds

635,929

32,739

668,668

$

40,763,514

$

116,514

$

(5,828,529)

$

35,051,499

December 31, 2023

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,074,112

$

$

(5,791,556)

$

18,282,556

Mutual funds

15,576,527

80,230

15,656,757

Municipal bonds

 

635,425

46,475

681,900

$

40,286,064

$

126,705

$

(5,791,556)

$

34,621,213

Unrealized losses on investments in debt and equity securities were $47 thousand and $4.8 million for the six months ended June 30, 2024 and 2023, respectively.

v3.24.2.u1
INCOME TAXES
6 Months Ended
Jun. 30, 2024
INCOME TAXES  
INCOME TAXES

5.    INCOME TAXES

The Company’s effective tax rate on the net loss before income taxes was (156.0)% and 19.4% for the three months ended June 30, 2024 and 2023, respectively.  The Company’s effective tax rate on the net income before income taxes was (157.6)% and 19.6% for the six months ended June 30, 2024 and 2023, respectively.

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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

U.S. statutory federal tax rate

 

21.0

%  

21.0

%  

 

State tax, net of federal tax

 

(0.1)

%  

0.1

%  

 

Change in valuation allowance

 

(178.0)

%  

%  

 

Stock options

%  

0.4

%  

Section 162(m); Limit on Compensation

(0.2)

%  

%  

Out of period adjustment

%  

(0.8)

%  

Other

(0.1)

%  

%  

Return-to-provision and other

 

(0.2)

%

(1.1)

%  

 

Effective tax rate

 

(157.6)

%

19.6

%

 

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. The Company reviewed the operating results, as well as all of the positive and negative evidence related to realization of such deferred tax assets, to evaluate the need for a valuation allowance.  As a result of this review, as of June 30, 2024, the Company concluded that a $9.7 million valuation is needed on the net deferred tax asset. As of December 31, 2023, the valuation allowance for state net operating losses was $283 thousand.

The effective tax rate for the six months ended June 30, 2024 was different from the federal statutory rate due primarily to the increase of the valuation allowance on the Company’s Deferred tax asset.

v3.24.2.u1
OTHER ACCRUED LIABILITIES
6 Months Ended
Jun. 30, 2024
OTHER ACCRUED LIABILITIES  
OTHER ACCRUED LIABILITIES

6.    OTHER ACCRUED LIABILITIES

Other accrued liabilities consist of the following:

    

June 30, 2024

    

December 31, 2023

Prepayments from customers

$

300,268

$

201,492

Accrued property taxes

332,179

Accrued professional fees

316,254

320,899

Current portion – preferred stock repurchase

 

6,000

 

6,000

Other accrued expenses

 

82,992

 

102,180

Total

$

1,037,693

$

630,571

v3.24.2.u1
TECHNOLOGY INVESTMENT AGREEMENT
6 Months Ended
Jun. 30, 2024
TECHNOLOGY INVESTMENT AGREEMENT  
TECHNOLOGY INVESTMENT AGREEMENT

7.    TECHNOLOGY INVESTMENT AGREEMENT

Effective July 1, 2020, the Company entered into the Technology Investment Agreement (TIA) with the U.S. government to expand the Company’s manufacturing capacity for hypodermic safety needles in response to the worldwide COVID-19 global pandemic.  The award is an expenditure-type TIA, whereby the U.S. government has made payments to the Company for the Company’s expenditures for equipment and supplies related to the expansion.  The Company’s contributions under the terms of the TIA include providing facilities, technical expertise, labor and maintenance for the TIA-funded equipment for a ten-year term.  In May of 2021, the Company and the U.S. government amended the TIA agreement to include two additional assembly lines and additional controlled environment space.  

The Company has received all equipment, has completed all property construction required by the TIA, and all reimbursement requests have been submitted.  No further amounts for expansion under the TIA are expected to be submitted or collected.

At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements, and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  The successor agreement governs ongoing terms established by the TIA until June 30, 2030, which includes maintenance of equipment, availability of capacity, and US government preference in the event of a public health emergency.

Under the TIA, reimbursable amounts are reflected as Other long-term liabilities on the Balance Sheets until the time the deferred income can be systematically amortized over a period matching the useful life of the purchased assets.  Other long-term liabilities from the TIA were $66,813,843 and $72,965,630 at June 30, 2024 and 2023, respectively.

v3.24.2.u1
COMMITMENTS AND CONTINGENCIES
6 Months Ended
Jun. 30, 2024
COMMITMENTS AND CONTINGENCIES  
COMMITMENTS AND CONTINGENCIES

8.    COMMITMENTS AND CONTINGENCIES

On November 7, 2019, the Company filed a lawsuit in the 44th 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 alleged 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 September 2, 2022, the Company filed a Second Amended Petition alleging legal malpractice and negligence.  On February 20, 2024, the Defendants filed another Motion for Summary Judgment on the Company’s remaining claim of legal malpractice. A hearing on that Motion for Summary Judgment was held on April 18, 2024 and an order denying Defendants’ Motion was signed May 10, 2024.  A new trial date has been set for June 2, 2025.

v3.24.2.u1
BUSINESS SEGMENT
6 Months Ended
Jun. 30, 2024
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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

U.S. sales

$

5,013,571

$

7,300,676

$

11,654,738

$

12,724,124

North and South America sales (excluding U.S.)

 

666,280

 

210,232

 

820,913

 

4,983,552

Other international sales

 

349,513

 

460,372

 

1,153,076

 

1,264,706

Total sales

$

6,029,364

$

7,971,280

$

13,628,727

$

18,972,382

Long-lived assets by geography are as follows:

    

June 30, 2024

    

December 31, 2023

Long-lived assets

U.S.

$

85,966,745

$

89,237,030

International

4,083,182

4,241,491

Total

$

90,049,927

$

93,478,521

v3.24.2.u1
DIVIDENDS
6 Months Ended
Jun. 30, 2024
DIVIDENDS  
DIVIDENDS

10.  DIVIDENDS

A payment of $39,050 was paid within one month of each quarter’s end in 2023 and in January, April, and July of 2024 to Series II preferred shareholders.  Series III preferred shareholders were paid a cash dividend of $19,061 within one month of each quarter’s end in 2023. A payment of $18,561 was made to Series III shareholders in January, April, and July of 2024.

In June 2021, the Board of Directors approved payments to its Series II, Series III, and former Series IV and Series V Class B Preferred Shareholders in the cumulative amount of $5,056,945 representing all current dividends, dividends in arrears, as well as dividends still owed to shareholders who converted their preferred stock in the past.  The dividends were paid on July 22, 2021 to all shareholders who had been contacted and confirmed as the rightful owner entitled to payment. The Company has not yet established contact with all former shareholders, most of whom converted their shares prior to 2001. The Company is continuing its efforts to establish contact with approximately 90 former shareholders who are entitled to approximately $1.4 million.  This, along with the current declared dividends, are reflected in Dividends payable on the Condensed Balance Sheets.

v3.24.2.u1
PRIVATE EXCHANGES AND REDEMPTION
6 Months Ended
Jun. 30, 2024
PRIVATE EXCHANGES AND REDEMPTION  
PRIVATE EXCHANGES AND REDEMPTION

11.  PRIVATE EXCHANGES AND REDEMPTION

In 2020, the Company entered into several agreements with shareholders to purchase its outstanding Class B Convertible Preferred Stock.  The consideration for these purchases consisted of both cash and Common Stock.  In addition, in each such transaction, the preferred shareholder counterparty waived all rights to unpaid dividends in arrears.  The aggregate cash consideration equaled $3,786,000, of which $482,670 was paid in 2020.  The balance was paid in equal installments of $1,101,110 over a three-year period which began in February 2021 and the last payment was made in February 2023.

Effective November 2023, the Company entered into a privately negotiated transaction with a preferred shareholder to redeem 2,000 shares of Series III Class B Stock for a purchase price equal to approximately $6 thousand.

v3.24.2.u1
TREASURY STOCK
6 Months Ended
Jun. 30, 2024
TREASURY STOCK  
TREASURY STOCK

12.  TREASURY STOCK

Treasury share purchases are accounted for under the cost method and are included as a component of treasury stock in the Company’s balance sheets.

Of the 100 million authorized shares of Common Stock, 34,024,304 shares were issued and 29,937,159 shares outstanding as of both December 31, 2023 and June 30, 2024.

v3.24.2.u1
Pay vs Performance Disclosure - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Pay vs Performance Disclosure        
Net Income (Loss) $ (14,164,640) $ (3,868,568) $ (13,735,256) $ (2,877,596)
v3.24.2.u1
Insider Trading Arrangements
3 Months Ended
Jun. 30, 2024
Sep. 30, 2023
Trading Arrangements, by Individual    
Material Terms of Trading Arrangement   As previously reported, on August 22, 2023, Thomas J. Shaw, President, Chairman, and Chief Executive Officer, adopted a written plan for the purchase of Retractable Technologies, Inc. common stock intended to satisfy the affirmative defense conditions of Rule 10b5–1(c).  In accordance with the plan, trading began on November 20, 2023 and may continue through November 19, 2024 if not earlier terminated.  During this period, the plan instructs a broker-dealer to purchase common stock for an aggregate purchase price of up to $800,000 within certain price parameters.  Mr. Shaw’s purchases pursuant to this plan are reported on forms filed with the SEC pursuant to Section 16(a) of the Securities Exchange Act of 1934.
Rule 10b5-1 Arrangement Adopted false  
Non-Rule 10b5-1 Arrangement Adopted false  
Rule 10b5-1 Arrangement Terminated false  
Non-Rule 10b5-1 Arrangement Terminated false  
Thomas J Shaw [Member]    
Trading Arrangements, by Individual    
Name   Thomas J. Shaw
Title   President, Chairman, and Chief Executive Officer
Rule 10b5-1 Arrangement Adopted   true
Adoption Date   August 22, 2023
Expiration Date   November 19, 2024
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Policies)
6 Months Ended
Jun. 30, 2024
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 credit losses is primarily determined by review of specific trade receivables based on historical collection rates and specific knowledge regarding the current creditworthiness of the customers.  Those

accounts that are doubtful of collection are included in the allowance.  The Company considers historical experience, the current economic environment, customer credit ratings or bankruptcies, legal disputes, collections on past due amounts, pricing discrepancies, and reasonable and supportable forecasts to develop its allowance for credit losses. Management reviews these factors quarterly to determine if any adjustments are needed to the allowance. 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 credit losses was $817 thousand and $891 thousand as of June 30, 2024 and December 31, 2023, 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. The Company recorded $2 thousand and $101 thousand lower of cost or net realizable value inventory adjustment associated with the VanishPoint® 3mL and EasyPoint® needle product segments as of June 30, 2024 and December 31, 2023, respectively.  

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 written down to their net realizable value.

Investments in debt and equity securities

Investments in debt and equity securities

The Company holds mutual funds, debt, and equity securities as investments.  These assets are held as trading securities and are carried at fair value as of the date of the Condensed Balance Sheets. Net unrealized and realized gains or losses on these investments are reflected separately on the Condensed Statements of Operations. Realized gains or losses on investments are recognized using the specific identification method.

Property, plant, and equipment

Property, plant, and equipment

Property, plant, and equipment are stated at cost less accumulated depreciation. 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 costs associated with significant capital additions.  Gains or losses from disposals are included in Interest and other income.

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

Production equipment

    

3 to 13 years

Office furniture and equipment

 

3 to 10 years

Buildings

 

39 years

Building improvements

 

15 years

Long-lived assets

Long-lived assets

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

Fair value measurements

Fair value measurements

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

Financial instruments

Financial instruments

The Company estimates the fair value of financial instruments through the use of public market prices, quotes from financial institutions, and other available information.  Judgment is required in interpreting data to develop estimates of fair value and, accordingly, amounts are not necessarily indicative of the amounts that could be realized in a current market exchange.  Short-term financial instruments, including cash and cash equivalents, accounts receivable, accounts payable, and other liabilities, consist primarily of instruments without extended maturities, the fair value of which, based on Management's estimates, equals their recorded values.  Investments in debt and equity securities consist primarily of individual equity securities and mutual funds and are reported at their fair value based upon quoted prices in active markets. The fair value of long-term liabilities, based on Management’s estimates, approximates their reported values.

Concentration risks

Concentration risks

The Company’s financial instruments exposed to concentrations of credit risk consist primarily of cash, cash equivalents, certificates of deposit, exchange-traded and closed-end funds, mutual funds, equity securities, and accounts receivable. Cash balances, some of which exceed federally insured limits, are maintained in financial institutions; however, Management believes the institutions are of high credit quality. The Company assesses market risk in 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. Management considers any exposure from concentrations of credit risks to be limited.

The following table reflects our significant customers for the three-month and six-month periods ended June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Number of significant customers

 

4

 

3

 

3

 

3

 

Aggregate dollar amount of net sales to significant customers

$

3.8

million

$

4.4

million

$

7.3

million

$

10.2

million

Percentage of net sales to significant customers

63.0%

55.0%

53.6%

53.9%

The Company manufactures some of its products in Little Elm, Texas as well as utilizing manufacturers in China.  The Company obtained 91% and 89% of its products in the first six months of 2024 and 2023, respectively, from its

Chinese manufacturers.  Purchases from Chinese manufacturers aggregated 92% and 84% of products in the second quarter of 2024 and 2023, respectively.  In the event that the Company becomes unable to purchase products from its Chinese manufacturers, the Company may need to find an alternate manufacturer for its blood collection set, EasyPoint® blood collection tube holder with needle, 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.

On May 14, 2024, President Biden directed the Office of the U.S. Trade Representative (“USTR”) to increase tariffs on certain goods imported from China under Section 301 of the Trade Act of 1974.  Among those products included were syringes and needles, at a rate of 50%.  As noted above, for the first six months of 2024, 91% of the products the Company sold were purchased from our manufacturers in China, most of which would be impacted by the contemplated tariffs.  On July 30, 2024, the USTR announced that, in response to more than 1,100 public comments received regarding the modifications, it would continue reviewing the comments and expects its final determination will be issued in August, and that the modifications slated for 2024 will take effect approximately two weeks after its final determination.  In the event that the tariffs affecting syringes and needles are enacted, the resulting increase in costs could have a material impact to the Company’s results of operations and financial position.  The Company is working to evaluate options to lessen the financial impact of the tariffs, including shifting a larger portion of manufacturing of 1mL, 3mL, and EasyPoint® needles to its domestic manufacturing facility.

Revenue recognition

Revenue recognition

The Company recognizes revenue when control of performance obligations passes to the customer, generally when the product ships.  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 $1.3 million and $2.2 million as of June 30, 2024 and December 31, 2023, 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 has not historically incurred significant returns.

On February 5, 2024, the Company initiated a voluntary recall of its EasyPoint Needle lot number K220402 which was shipped within the U.S. between July 20, 2022 and September 20, 2023. The Company shipped 477,600 units of the products into the market and is working with customers and distributors to determine how many of the units remain unused and subject to the recall. The recall is due to the possible detachment of the needle cannula from the needle holder, which could result in serious injury. The Company has advised its customers and distributors to review their inventory for the affected products, segregate and quarantine the affected products, discontinue any distribution of the affected products, inform all personnel not to use the affected products, and report and return remaining inventory to the Company. The Company submitted a Removal Report with the U.S. Food and Drug Administration and has continued to provide monthly updates.  The estimated time for the completion of the recall is September 1, 2024.  The Company estimates that the potential expense related to the recall is approximately $116 thousand.

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

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

The Company periodically recognizes revenue from licensing agreements of its intellectual property. Such licensing agreements provide licensee with right to use the Company’s intellectual property.  The Company accounts for revenue generated under these licensing agreements in accordance with ASC 606.  A license may be perpetual or time limited in its application. The Company has concluded that its licensing agreement is distinct as the customer can benefit from the license on their own. In accordance with ASC 606, the licensing agreement is considered functional as it is without professional services, updates and technical support. The Company has determined the current licensing agreement is sales-based or usage-based as defined in ASC 606.  In accordance with ASC 606, the Company recognizes revenue from sales-based or usage-based license at the later of a) subsequent sale or usage occurrence or b) the performance obligation to which some or all of the sales-based or usage-based royalty has been allocated has been satisfied (or partially satisfied).  The Company recognized $90 thousand and $189 thousand in licensing fees for the three and six months ended June 30, 2024.  No licensing fees were recognized for the three and six months ended June 30, 2023.  If the Company licenses its products for sale and the customers of the sublicensee are not known to the Company, the Company is obligated to pay Thomas J. Shaw, the owner of certain patented technology, fifty percent (50%) 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 June 30, 2024:

    

    

Blood 

    

    

    

Total 

Collection 

EasyPoint®

Other 

Product

Geographic Segment

Syringes

Products

Needles

Products

 Sales

U.S. sales

$

4,631,773

333,389

42,561

5,848

$

5,013,571

North and South America sales (excluding U.S.)

 

601,000

 

 

59,040

 

6,240

 

666,280

Other international sales

 

256,133

 

400

 

87,680

 

5,300

 

349,513

Total

$

5,488,906

$

333,789

$

189,281

$

17,388

$

6,029,364

For the three months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

5,780,080

$

346,297

$

1,165,634

$

8,665

7,300,676

North and South America sales (excluding U.S.)

 

210,232

 

 

 

210,232

Other international sales

 

366,312

 

1,748

 

87,612

 

4,700

460,372

Total

$

6,356,624

$

348,045

$

1,253,246

$

13,365

$

7,971,280

For the six months ended June 30, 2024:

    

    

Blood 

    

    

    

Collection 

EasyPoint®

Other 

Total

Geographic Segment

Syringes

Products

Needles

Products

Revenue

U.S. sales

$

10,185,082

700,998

755,432

13,226

$

11,654,738

North and South America sales (excluding U.S.)

 

755,537

96

59,040

6,240

 

820,913

Other international revenue

 

828,612

143,860

174,704

5,900

 

1,153,076

Total

$

11,769,231

$

844,954

$

989,176

$

25,366

$

13,628,727

For the six months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

10,583,166

$

744,673

$

1,378,121

$

18,164

$

12,724,124

North and South America sales (excluding U.S.)

 

4,771,512

 

 

 

212,040

 

4,983,552

Other international sales

 

871,854

 

213,948

 

174,204

 

4,700

 

1,264,706

Total

$

16,226,532

$

958,621

$

1,552,325

$

234,904

$

18,972,382

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.  As of June 30, 2024, Management has concluded that a $9.7 million valuation allowance is needed on the net deferred tax asset.  As of December 31, 2023, the valuation allowance for state net operating losses was $283 thousand.  

Earnings per share

Earnings per share

The Company computes basic earnings per share (“EPS”) by dividing net earnings for the period (adjusted for any cumulative dividends for the period) by the weighted average number of common shares outstanding during the period. Diluted EPS includes the determinants of basic EPS and, in addition, reflects the dilutive effect, if any, of the

common stock deliverable pursuant to stock options and/or common stock issuable upon the conversion of convertible preferred stock.

The calculation of diluted EPS under the treasury stock method included the following shares in the three and six month periods ending June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 20, 2023

June 30, 2024

    

June 30, 2023

Common stock underlying issued and outstanding stock options

1,524

 

16,033

5,007

 

22,041

1,524

 

16,033

5,007

 

22,041

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

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Net loss

$

(14,164,640)

$

(3,868,568)

$

(13,735,256)

$

(2,877,596)

Preferred stock dividend requirements

 

(57,611)

 

(58,111)

 

(115,222)

 

(116,222)

Loss applicable to common shareholders

$

(14,222,251)

$

(3,926,679)

$

(13,850,478)

$

(2,993,818)

Average common shares outstanding

 

29,937,159

 

29,937,159

 

29,937,159

 

29,937,159

Average common and common equivalent shares outstanding — diluted

 

29,937,159

 

30,169,604

 

29,937,159

 

30,169,604

Basic loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Diluted loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Shipping and handling costs

Shipping and handling costs

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

Share-based Compensation

Share-based Compensation

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

Self-insured employee benefit costs

Self-insured employee benefit costs

The Company self-insures certain health insurance benefits for its employees under certain policy limits. The Company has additional coverage provided by an insurance company for any individual with claims in excess of $100,000 and/or total plan claims in excess of $1.7 million for the plan year.

Research and development costs

Research and development costs

Research and development costs are expensed as incurred.

Technology Investment Agreement (TIA)

Technology Investment Agreement (TIA)

Effective July 1, 2020, the Company entered into a Technology Investment Agreement (“TIA”) with the United States Government Department of Defense, U.S. Army Contracting Command-Aberdeen Proving Ground, Natick Contracting Division & Edgewood Contracting Division (ACC-APG, NCD & ECD) on behalf of the Biomedical Advanced Research and Development Authority (BARDA), as amended, for $81,029,518 in government funding for

expanding the Company’s domestic production of needles and syringes. At the request of the US government, the TIA was transferred to a successor agreement, identified as Other Transaction Agreement in April 2023.  Such agreement contains no additional requirements and, for the purposes of this report, the agreement shall continue to be referred to herein as the “TIA”.  Under this agreement, the Company has made significant additions to its facilities which allows the Company to increase domestic production capacity.  For further explanation, please refer to Note 7 – Technology Investment Agreement.

As reimbursements were received from the U.S. government for expenditures under the TIA, the Company recorded a deferred liability. In 2021, the deferred liability began to be systematically amortized as a gain over the life of the related property, plant, and equipment and is presented as Other income – TIA on the Statements of Operations.  For any reimbursements received for expenditures not capitalized as property, plant, and equipment, Other income – TIA was recognized in the same period as the expense.  

Recently Issued Pronouncement

Recently Issued Pronouncements

In March 2024, the FASB issued ASU 2024-02, “Codification Improvements — Amendments to Remove References to the Concepts Statements”, which amends the Codification to remove references to various concepts statements. In most instances, the references are extraneous and not required to understand or apply the guidance. In other instances, the references were used in prior Statements to provide guidance in certain topical areas.   ASU 2024-02 is effective for public business entities for fiscal periods beginning after December 15, 2024.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2025.  Early adoption is permitted for all entities, for any fiscal year or interim period for which financial statements have not yet been issued or made available for issuance.   The Company is evaluating the new guidance to determine the impact it may have, if any, on its financial statements.

In December of 2023, the FASB issued ASU 2023-09, “Income Taxes (Topic 740): Improvements to Income Tax Disclosures.” The updated accounting guidance improves transparency of income tax disclosures, including the disaggregation of existing disclosures related to the effective tax rate reconciliation and income taxes paid. ASU No. 2023-09 is effective for public business entities for annual periods beginning after December 15, 2024. Early adoption is permitted.  For all other entities, it is effective for annual periods beginning after December 15, 2025.   Early adoption is permitted for annual financial statements that have not yet been issued or made available for issuance.   Prospective application is required, with retrospective application permitted. The Company is evaluating the adoption of the amendments and the potential impact it may have, if any, on its financial statements.

In June 2022, the FASB issued ASU 2022-03, “Fair Value Measurement (Topic 820): Fair Value Measurement of Equity Securities Subject to Contractual Sale Restrictions”, intended to clarify that a contractual restriction on the sale of an equity security is not considered part of the unit of account of the equity security and, therefore, is not considered in measuring fair value.  The amendment also clarifies that an entity cannot, as a separate unit of account, recognize and measure a contractual sale restriction.  ASU No. 2022-03 is effective for public business entities for fiscal years, including interim periods within those fiscal years, beginning after December 15, 2023.  Early adoption is permitted.  For all other entities, it is effective for fiscal years, including interim periods within those fiscal years beginning after December 15, 2024.  Early adoption is permitted for both interim and annual financial statements that have not yet been issued or made available for issuance.  The adoption of the amendments is unlikely to have a material effect on the Company’s financial statements or disclosures.  

v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES (Tables)
6 Months Ended
Jun. 30, 2024
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES  
Schedule of estimated useful lives of property, plant and equipment

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

Schedule of significant customers

The following table reflects our significant customers for the three-month and six-month periods ended June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Number of significant customers

 

4

 

3

 

3

 

3

 

Aggregate dollar amount of net sales to significant customers

$

3.8

million

$

4.4

million

$

7.3

million

$

10.2

million

Percentage of net sales to significant customers

63.0%

55.0%

53.6%

53.9%

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

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

For the three months ended June 30, 2024:

    

    

Blood 

    

    

    

Total 

Collection 

EasyPoint®

Other 

Product

Geographic Segment

Syringes

Products

Needles

Products

 Sales

U.S. sales

$

4,631,773

333,389

42,561

5,848

$

5,013,571

North and South America sales (excluding U.S.)

 

601,000

 

 

59,040

 

6,240

 

666,280

Other international sales

 

256,133

 

400

 

87,680

 

5,300

 

349,513

Total

$

5,488,906

$

333,789

$

189,281

$

17,388

$

6,029,364

For the three months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

5,780,080

$

346,297

$

1,165,634

$

8,665

7,300,676

North and South America sales (excluding U.S.)

 

210,232

 

 

 

210,232

Other international sales

 

366,312

 

1,748

 

87,612

 

4,700

460,372

Total

$

6,356,624

$

348,045

$

1,253,246

$

13,365

$

7,971,280

For the six months ended June 30, 2024:

    

    

Blood 

    

    

    

Collection 

EasyPoint®

Other 

Total

Geographic Segment

Syringes

Products

Needles

Products

Revenue

U.S. sales

$

10,185,082

700,998

755,432

13,226

$

11,654,738

North and South America sales (excluding U.S.)

 

755,537

96

59,040

6,240

 

820,913

Other international revenue

 

828,612

143,860

174,704

5,900

 

1,153,076

Total

$

11,769,231

$

844,954

$

989,176

$

25,366

$

13,628,727

For the six months ended June 30, 2023:

    

    

Blood 

    

    

    

Total

Collection

EasyPoint®

Other 

Product 

Geographic Segment

Syringes

 Products

Needles

Products

Sales

U.S. sales

$

10,583,166

$

744,673

$

1,378,121

$

18,164

$

12,724,124

North and South America sales (excluding U.S.)

 

4,771,512

 

 

 

212,040

 

4,983,552

Other international sales

 

871,854

 

213,948

 

174,204

 

4,700

 

1,264,706

Total

$

16,226,532

$

958,621

$

1,552,325

$

234,904

$

18,972,382

Schedule of diluted EPS under the treasury stock method

The calculation of diluted EPS under the treasury stock method included the following shares in the three and six month periods ending June 30, 2024 and 2023:

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 20, 2023

June 30, 2024

    

June 30, 2023

Common stock underlying issued and outstanding stock options

1,524

 

16,033

5,007

 

22,041

1,524

 

16,033

5,007

 

22,041

Schedule of earnings per share

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

Three Months Ended

Three Months Ended

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

Net loss

$

(14,164,640)

$

(3,868,568)

$

(13,735,256)

$

(2,877,596)

Preferred stock dividend requirements

 

(57,611)

 

(58,111)

 

(115,222)

 

(116,222)

Loss applicable to common shareholders

$

(14,222,251)

$

(3,926,679)

$

(13,850,478)

$

(2,993,818)

Average common shares outstanding

 

29,937,159

 

29,937,159

 

29,937,159

 

29,937,159

Average common and common equivalent shares outstanding — diluted

 

29,937,159

 

30,169,604

 

29,937,159

 

30,169,604

Basic loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

Diluted loss per share

$

(0.48)

$

(0.13)

$

(0.46)

$

(0.10)

v3.24.2.u1
INVENTORIES (Tables)
6 Months Ended
Jun. 30, 2024
INVENTORIES  
Schedule of inventories

Inventories consist of the following:

    

June 30, 2024

    

December 31, 2023

Raw materials

$

4,119,134

$

4,349,029

Finished goods

17,899,131

13,232,339

$

22,018,265

$

17,581,368

v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS (Tables)
6 Months Ended
Jun. 30, 2024
FAIR VALUE OF FINANCIAL INSTRUMENTS  
Schedule of fair value of values of assets designated as Investments in equity securities

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

June 30, 2024

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,323,403

$

$

$

18,323,403

Mutual funds

16,059,428

16,059,428

Municipal bonds

668,668

668,668

$

35,051,499

$

$

$

35,051,499

December 31, 2023

    

Level 1

    

Level 2

    

Level 3

    

Total

Equity securities

$

18,282,556

$

$

$

18,282,556

Mutual funds

15,656,757

15,656,757

Municipal bonds

 

681,900

681,900

$

34,621,213

$

$

$

34,621,213

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

The investment assets are held as trading securities 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:

June 30, 2024

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,151,932

(5,828,529)

18,323,403

Mutual funds

15,975,653

83,775

16,059,428

Municipal bonds

635,929

32,739

668,668

$

40,763,514

$

116,514

$

(5,828,529)

$

35,051,499

December 31, 2023

Cumulative Unrealized

Aggregate

    

Cost

    

Gains

    

Losses

    

Fair Value

Equity securities

$

24,074,112

$

$

(5,791,556)

$

18,282,556

Mutual funds

15,576,527

80,230

15,656,757

Municipal bonds

 

635,425

46,475

681,900

$

40,286,064

$

126,705

$

(5,791,556)

$

34,621,213

v3.24.2.u1
INCOME TAXES (Tables)
6 Months Ended
Jun. 30, 2024
INCOME TAXES  
Schedule of reconciliation of the federal statutory corporate tax rate to the Company's effective tax rate

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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

U.S. statutory federal tax rate

 

21.0

%  

21.0

%  

 

State tax, net of federal tax

 

(0.1)

%  

0.1

%  

 

Change in valuation allowance

 

(178.0)

%  

%  

 

Stock options

%  

0.4

%  

Section 162(m); Limit on Compensation

(0.2)

%  

%  

Out of period adjustment

%  

(0.8)

%  

Other

(0.1)

%  

%  

Return-to-provision and other

 

(0.2)

%

(1.1)

%  

 

Effective tax rate

 

(157.6)

%

19.6

%

 

v3.24.2.u1
OTHER ACCRUED LIABILITIES (Tables)
6 Months Ended
Jun. 30, 2024
OTHER ACCRUED LIABILITIES  
Schedule of other accrued liabilities

Other accrued liabilities consist of the following:

    

June 30, 2024

    

December 31, 2023

Prepayments from customers

$

300,268

$

201,492

Accrued property taxes

332,179

Accrued professional fees

316,254

320,899

Current portion – preferred stock repurchase

 

6,000

 

6,000

Other accrued expenses

 

82,992

 

102,180

Total

$

1,037,693

$

630,571

v3.24.2.u1
BUSINESS SEGMENT (Tables)
6 Months Ended
Jun. 30, 2024
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

Six Months Ended

Six Months Ended

    

June 30, 2024

    

June 30, 2023

    

June 30, 2024

    

June 30, 2023

U.S. sales

$

5,013,571

$

7,300,676

$

11,654,738

$

12,724,124

North and South America sales (excluding U.S.)

 

666,280

 

210,232

 

820,913

 

4,983,552

Other international sales

 

349,513

 

460,372

 

1,153,076

 

1,264,706

Total sales

$

6,029,364

$

7,971,280

$

13,628,727

$

18,972,382

Long-lived assets by geography are as follows:

    

June 30, 2024

    

December 31, 2023

Long-lived assets

U.S.

$

85,966,745

$

89,237,030

International

4,083,182

4,241,491

Total

$

90,049,927

$

93,478,521

v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Accounts receivable (Details)
$ in Thousands
6 Months Ended
Jun. 30, 2024
USD ($)
customer
Dec. 31, 2023
USD ($)
Accounts receivable    
Number of products consigned to customers | customer 0  
Allowance for credit losses | $ $ 817 $ 891
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Inventories (Details) - USD ($)
$ in Thousands
6 Months Ended 12 Months Ended
Jun. 30, 2024
Dec. 31, 2023
VanishPoint 3mL and EasyPoint needle    
Inventories    
Lower of cost or net realizable value inventory adjustment $ 2 $ 101
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Property, plant and equipment (Details)
Jun. 30, 2024
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
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Concentration risks (Details)
3 Months Ended 6 Months Ended
May 14, 2024
Jun. 30, 2024
USD ($)
customer
Jun. 30, 2023
USD ($)
customer
Jun. 30, 2024
USD ($)
customer
Jun. 30, 2023
USD ($)
customer
Concentration risks          
Aggregate dollar amount of net sales   $ 6,029,364 $ 7,971,280 $ 13,628,727 $ 18,972,382
Net Sales | Customer Concentration Risk          
Concentration risks          
Number of significant customers | customer   4 3 3 3
Net Sales | Customer Concentration Risk | China          
Concentration risks          
Percentage of net sales to significant customers       91.00%  
Net Sales | Customer Concentration Risk | Significant customers          
Concentration risks          
Aggregate dollar amount of net sales   $ 3,800,000 $ 4,400,000 $ 7,300,000 $ 10,200,000
Percentage of net sales to significant customers   63.00% 55.00% 53.60% 53.90%
Cost of Sales, Manufacturing | Supplier Concentration Risk | China          
Concentration risks          
Percentage of net sales to significant customers   92.00% 84.00% 91.00% 89.00%
Percentage increase in tariffs for syringes and needles 50.00%        
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Revenue recognition (Details)
3 Months Ended 6 Months Ended 12 Months Ended
Sep. 01, 2024
USD ($)
Feb. 05, 2024
item
Jun. 30, 2024
USD ($)
Jun. 30, 2023
USD ($)
Jun. 30, 2024
USD ($)
item
Jun. 30, 2023
USD ($)
Dec. 31, 2023
USD ($)
Revenue recognition              
Estimated contractual allowances         $ 1,300,000   $ 2,200,000
License revenue payable to patent owner, as a percent         50.00%    
Sales, net     $ 6,029,364 $ 7,971,280 $ 13,628,727 $ 18,972,382  
Licensing fees              
Revenue recognition              
Sales, net     90,000 0 189,000 0  
Syringes              
Revenue recognition              
Sales, net     5,488,906 6,356,624 11,769,231 16,226,532  
Blood Collection Products              
Revenue recognition              
Sales, net     333,789 348,045 844,954 958,621  
EasyPoint Needles              
Revenue recognition              
Number of units subject to recall | item   477,600          
Sales, net     189,281 1,253,246 989,176 1,552,325  
EasyPoint Needles | Forecast              
Revenue recognition              
Estimated expense related to recall $ 116,000            
Other Products              
Revenue recognition              
Sales, net     17,388 13,365 25,366 234,904  
U.S.              
Revenue recognition              
Sales, net     5,013,571 7,300,676 11,654,738 12,724,124  
U.S. | Syringes              
Revenue recognition              
Sales, net     4,631,773 5,780,080 10,185,082 10,583,166  
U.S. | Blood Collection Products              
Revenue recognition              
Sales, net     333,389 346,297 700,998 744,673  
U.S. | EasyPoint Needles              
Revenue recognition              
Sales, net     42,561 1,165,634 755,432 1,378,121  
U.S. | Other Products              
Revenue recognition              
Sales, net     5,848 8,665 13,226 18,164  
North and South America (excluding U.S.)              
Revenue recognition              
Sales, net     666,280 210,232 820,913 4,983,552  
North and South America (excluding U.S.) | Syringes              
Revenue recognition              
Sales, net     601,000 210,232 755,537 4,771,512  
North and South America (excluding U.S.) | Blood Collection Products              
Revenue recognition              
Sales, net         96    
North and South America (excluding U.S.) | EasyPoint Needles              
Revenue recognition              
Sales, net     59,040   59,040    
North and South America (excluding U.S.) | Other Products              
Revenue recognition              
Sales, net     6,240   6,240 212,040  
Other international              
Revenue recognition              
Sales, net     349,513 460,372 1,153,076 1,264,706  
Other international | Syringes              
Revenue recognition              
Sales, net     256,133 366,312 828,612 871,854  
Other international | Blood Collection Products              
Revenue recognition              
Sales, net     400 1,748 143,860 213,948  
Other international | EasyPoint Needles              
Revenue recognition              
Sales, net     87,680 87,612 174,704 174,204  
Other international | Other Products              
Revenue recognition              
Sales, net     $ 5,300 $ 4,700 $ 5,900 $ 4,700  
U.S.              
Revenue recognition              
Period for return of incorrect domestic 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%    
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Income taxes (Details) - USD ($)
$ in Thousands
Jun. 30, 2024
Dec. 31, 2023
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES    
Valuation allowance $ 9,700 $ 283
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Earnings per share (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Earnings per share        
Common stock underlying issued and outstanding stock options 1,524 16,033 5,007 22,041
Diluted EPS calculated under the treasury stock method 1,524 16,033 5,007 22,041
Net Income (Loss) $ (14,164,640) $ (3,868,568) $ (13,735,256) $ (2,877,596)
Preferred stock dividend requirements (57,611) (58,111) (115,222) (116,222)
Loss applicable to common shareholders $ (14,222,251) $ (3,926,679) $ (13,850,478) $ (2,993,818)
Average common shares outstanding 29,937,159 29,937,159 29,937,159 29,937,159
Average common and common equivalent shares outstanding - diluted 29,937,159 30,169,604 29,937,159 30,169,604
Basic loss per share $ (0.48) $ (0.13) $ (0.46) $ (0.10)
Diluted loss per share $ (0.48) $ (0.13) $ (0.46) $ (0.10)
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Self-insured employee benefit costs (Details)
Jun. 30, 2024
USD ($)
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES  
Self-insured threshold for individual claims $ 100,000
Self-insured threshold for total plain claims for the year $ 1,700,000
v3.24.2.u1
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES - Technology Investment Agreement (TIA) (Details)
Jul. 01, 2020
USD ($)
Technology Investment Agreement (TIA)  
TECHNOLOGY INVESTMENT AGREEMENT  
Research and development agreement with government funding amount $ 81,029,518
v3.24.2.u1
INVENTORIES (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
INVENTORIES    
Raw materials $ 4,119,134 $ 4,349,029
Finished goods 17,899,131 13,232,339
Total Inventories $ 22,018,265 $ 17,581,368
v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS - Assets designated as Investments in debt and equity securities (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments $ 35,051,499 $ 34,621,213
Equity Securities    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 18,323,403 18,282,556
Mutual funds    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 16,059,428 15,656,757
Municipal bonds    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 668,668 681,900
Level 1    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 35,051,499 34,621,213
Level 1 | Equity Securities    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 18,323,403 18,282,556
Level 1 | Mutual funds    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments 16,059,428 15,656,757
Level 1 | Municipal bonds    
Fair value hierarchy of assets designated as Investments in debt and equity securities    
Fair value of investments $ 668,668 $ 681,900
v3.24.2.u1
FAIR VALUE OF FINANCIAL INSTRUMENTS - Unrealized gains and losses (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Cumulative unrealized gains and losses from Investments in debt and equity securities          
Cost $ 40,763,514   $ 40,763,514   $ 40,286,064
Gross Unrealized Gains 116,514   116,514   126,705
Gross Unrealized Losses (5,828,529)   (5,828,529)   (5,791,556)
Aggregate Fair Value 35,051,499   35,051,499   34,621,213
Unrealized loss on debt and equity securities (1,779,814) $ (6,251,650) (47,165) $ (4,759,639)  
Equity Securities          
Cumulative unrealized gains and losses from Investments in debt and equity securities          
Cost 24,151,932   24,151,932   24,074,112
Gross Unrealized Losses (5,828,529)   (5,828,529)   (5,791,556)
Aggregate Fair Value 18,323,403   18,323,403   18,282,556
Mutual funds          
Cumulative unrealized gains and losses from Investments in debt and equity securities          
Cost 15,975,653   15,975,653   15,576,527
Gross Unrealized Gains 83,775   83,775   80,230
Aggregate Fair Value 16,059,428   16,059,428   15,656,757
Municipal bonds          
Cumulative unrealized gains and losses from Investments in debt and equity securities          
Cost 635,929   635,929   635,425
Gross Unrealized Gains 32,739   32,739   46,475
Aggregate Fair Value $ 668,668   $ 668,668   $ 681,900
v3.24.2.u1
INCOME TAXES (Details) - USD ($)
$ in Thousands
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
Dec. 31, 2023
Reconciliation of the federal statutory corporate tax rate to the Company's effective tax rate (as a percent)          
U.S. statutory federal tax rate     21.00% 21.00%  
State tax, net of federal tax     (0.10%) 0.10%  
Change in valuation allowance     (178.00%)    
Stock options       0.40%  
Section 162(m); Limit on Compensation     (0.20%)    
Out of period adjustment       (0.80%)  
Other     (0.10%)    
Return-to-provision and other     (0.20%) (1.10%)  
Effective tax rate (156.00%) 19.40% (157.60%) 19.60%  
Valuation allowance $ 9,700   $ 9,700   $ 283
v3.24.2.u1
OTHER ACCRUED LIABILITIES (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
OTHER ACCRUED LIABILITIES    
Prepayments from customers $ 300,268 $ 201,492
Accrued property taxes 332,179  
Accrued professional fees 316,254 320,899
Current portion - preferred stock repurchase 6,000 6,000
Other accrued expenses 82,992 102,180
Total $ 1,037,693 $ 630,571
v3.24.2.u1
TECHNOLOGY INVESTMENT AGREEMENT (Details) - Technology Investment Agreement (TIA)
1 Months Ended
Jul. 01, 2020
May 31, 2021
item
Jun. 30, 2024
USD ($)
Jun. 30, 2023
USD ($)
TECHNOLOGY INVESTMENT AGREEMENT        
Technology investment agreement term 10 years      
Number of assembly lines added | item   2    
Long-term deferred liability - TIA | $     $ 66,813,843 $ 72,965,630
v3.24.2.u1
BUSINESS SEGMENT - Revenues by geography (Details) - USD ($)
3 Months Ended 6 Months Ended
Jun. 30, 2024
Jun. 30, 2023
Jun. 30, 2024
Jun. 30, 2023
BUSINESS SEGMENT        
Sales, net $ 6,029,364 $ 7,971,280 $ 13,628,727 $ 18,972,382
U.S.        
BUSINESS SEGMENT        
Sales, net 5,013,571 7,300,676 11,654,738 12,724,124
North and South America (excluding U.S.)        
BUSINESS SEGMENT        
Sales, net 666,280 210,232 820,913 4,983,552
Other international        
BUSINESS SEGMENT        
Sales, net $ 349,513 $ 460,372 $ 1,153,076 $ 1,264,706
v3.24.2.u1
BUSINESS SEGMENT - Long-lived assets (Details) - USD ($)
Jun. 30, 2024
Dec. 31, 2023
BUSINESS SEGMENT    
Long-lived assets $ 90,049,927 $ 93,478,521
U.S.    
BUSINESS SEGMENT    
Long-lived assets 85,966,745 89,237,030
International    
BUSINESS SEGMENT    
Long-lived assets $ 4,083,182 $ 4,241,491
v3.24.2.u1
DIVIDENDS (Details)
1 Months Ended 6 Months Ended
Jul. 31, 2024
USD ($)
Apr. 30, 2024
USD ($)
Jan. 31, 2024
USD ($)
Oct. 31, 2023
USD ($)
Jul. 31, 2023
USD ($)
Apr. 30, 2023
USD ($)
Jun. 30, 2021
USD ($)
Jun. 30, 2024
USD ($)
stockholder
DIVIDENDS                
Number of entitled shareholders | stockholder               90
Contingent liability former shareholders               $ 1,400,000
Series II, III, IV and V Class B                
DIVIDENDS                
Cumulative amount of dividends             $ 5,056,945  
Series II, Class B                
DIVIDENDS                
Cash dividends paid $ 39,050 $ 39,050 $ 39,050 $ 39,050 $ 39,050 $ 39,050    
Series III, Class B                
DIVIDENDS                
Cash dividends paid $ 18,561 $ 18,561 $ 18,561 $ 19,061 $ 19,061 $ 19,061    
v3.24.2.u1
PRIVATE EXCHANGES AND REDEMPTION (Details) - USD ($)
1 Months Ended 6 Months Ended 12 Months Ended
Nov. 30, 2023
Feb. 28, 2023
Feb. 28, 2022
Feb. 28, 2021
Jun. 30, 2023
Dec. 31, 2020
PRIVATE EXCHANGES AND REDEMPTION            
Amount paid for conversion of preferred stock into common stock         $ 1,101,110  
Preferred Class B [Member]            
PRIVATE EXCHANGES AND REDEMPTION            
Aggregate cash consideration           $ 3,786,000
Amount paid for conversion of preferred stock into common stock   $ 1,101,110 $ 1,101,110 $ 1,101,110   $ 482,670
Cash consideration payment period           3 years
Preferred Stock [Member] | Series III, Class B            
PRIVATE EXCHANGES AND REDEMPTION            
Number of preferred shares repurchased in private exchange transaction 2,000          
Aggregate cash consideration $ 6,000          
v3.24.2.u1
TREASURY STOCK (Details) - shares
Jun. 30, 2024
Dec. 31, 2023
TREASURY STOCK    
Common stock, authorized shares 100,000,000 100,000,000
Common stock, issued shares 34,024,304 34,024,304
Common stock, outstanding shares 29,937,159 29,937,159

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