U.S. SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

 

(Mark One)

 

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

 

             For the quarterly period ended September 30, 2021 .

For the quarterly period ended June 30, 2022

        

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

 

             For the transition period from ________ to ________

For the transition period from ________ to ________

 

COMMISSION FILE NUMBER: 1-10526

 

UNITED-GUARDIAN, INC..

(Exact Name of Registrant as Specified in Its Charter)

 

Delaware11-1719724
(State or Other Jurisdiction of Incorporation or Organization)(I.R.S. Employer Identification No.)

 

230 Marcus Boulevard, Hauppauge, New York 11788

(Address of Principal Executive Offices)

 

(631) 273-0900

(Registrants Telephone Number)

 

N/A

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

 

Cover Page 1 of 2

 

 

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

 

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, $0.10 par value per share

UG

NASDAQ Global Market

 

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 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 
 Non-accelerated filerSmaller reporting company
Emerging growth company

 

If an emerging growth company, indicate by checkmark 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

 

Indicate the number of shares outstanding of each of the issuers classes of common stock, as of the latest practicable date:

 

As of NovemberAugust 1, 2021,2022, the Registrant had issued and outstanding 4,594,319 shares of Common Stock, $.10 par value per share ("Common Stock").

 

 

Cover Page 2 of 2

 

 

UNITED-GUARDIAN, INC.

INDEX TO FINANCIAL STATEMENTS

PageNo.

Page No.

Part I. FINANCIAL INFORMATION

 
  

Item 1 - Condensed Financial Statements (unaudited unless indicated otherwise)

 
  

Statements of Income - Three and NineSix Months ended SeptemberJune 30, 20212022 and 20202021

2

  

Balance Sheets – SeptemberJune 30, 20212022 (unaudited) and December 31, 20202021 (audited)

3-4

  

Statements of Changes in Stockholders’ Equity – Three and NineSix Months ended SeptemberJune 30, 20212022 and 20202021

5

  

Statements of Cash Flows - Nine– Six Months ended SeptemberJune 30, 20212022 and 20202021

6

  

Notes to Condensed Financial Statements

7-15

  

Item 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations

15-22

  

Item 3 - Quantitative and Qualitative Disclosures About Market Risk

22

  

Item 4 - Controls and Procedures

2322

  

Part II. OTHER INFORMATION

 
  

Item 1 - Legal Proceedings

23

  

Item 1A - Risk Factors

23-2423

  

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

2423

  

Item 3 - Defaults Upon Senior Securities

2423

  

Item 4 - Mine Safety Disclosures

2423

  

Item 5 - Other Information

2423

  

Item 6 - Exhibits

2523

  

Signatures

2524

 

 

Page 1 of 2524

 

UNITED-GUARDIAN, INC.

 

Part I. FINANCIAL INFORMATION

 

ITEM 1. Condensed Financial Statements

STATEMENTS OF INCOME
(UNAUDITED)(unaudited)

 

  

THREE MONTHS ENDED
SEPTEMBER 30,

  

NINE MONTHS ENDED

SEPTEMBER 30,

 
  

2021

  

2020

  

2021

  

2020

 
                 

Net Sales

 $3,179,746  $2,336,360  $10,268,592  $8,613,918 
                 

Costs and expenses:

                

Cost of sales

  1,320,509   974,763   4,180,912   3,634,528 

Operating expenses

  458,582   493,204   1,428,721   1,520,114 

Research and development

  130,742   114,836   349,053   331,134 

Total costs and expenses

  1,909,833   1,582,803   5,958,686   5,485,776 

Income from operations

  1,269,913   753,557   4,309,906   3,128,142 
                 

Other Income:

                

Investment income

  38,747   38,932   124,147   131,318 

Net (loss) gain on marketable securities

  (25,108)  113,248   40,419   143,832 

Total other income

  13,639   152,180   164,566   275,150 

Income before provision for income taxes

  1,283,552   905,737   4,474,472   3,403,292 
                 

Provision for income taxes

  267,046   188,205   932,240   708,842 

Net Income

 $1,016,506  $717,532  $3,542,232  $2,694,450 
                 

Earnings per common share (Basic and Diluted)

 $0.22  $0.16  $0.77  $0.59 
                 

Weighted average shares basic and diluted

  4,594,319   4,594,319   4,594,319   4,594,319 

See Notes to Condensed Financial Statements

2 of 25

UNITED-GUARDIAN, INC.

BALANCE SHEETS

ASSETS

  

SEPTEMBER 30, DECEMBER 31,

 
  

2021

  2020 
  

(UNAUDITED)

  (AUDITED) 

Current assets:

        

Cash and cash equivalents

 $691,921  $591,444 

Marketable securities

  8,893,454   7,591,381 

Accounts receivable, net of allowance for doubtful accounts of $27,296 at September 30, 2021 and $14,017 at December 31, 2020

  1,930,183   1,387,698 

Inventories, net

  1,287,234   1,415,773 

Prepaid expenses and other current assets

  159,361   161,208 

Prepaid income taxes

  ---   99,107 

Total current assets

  12,962,153   11,246,611 
         

Net property, plant, and equipment:

        

Land

  69,000   69,000 

Factory equipment and fixtures

  4,571,364   4,516,335 

Building and improvements

  2,853,718   2,848,585 

Total property, plant, and equipment

  7,494,082   7,433,920 

Less: Accumulated depreciation

  6,830,549   6,760,255 

Total property, plant, and equipment, net

  663,533   673,665 
         

TOTAL ASSETS

 $13,625,686  $11,920,276 
  

THREE MONTHS ENDED JUNE 30,

  

SIX MONTHS ENDED JUNE 30,

 
  

2022

  

2021

  

2022

  

2021

 
                 

Net sales

 $3,626,177  $3,657,978  $7,518,535  $7,088,846 
                 

Costs and expenses:

                

Cost of sales

  1,693,753   1,499,390   3,403,870   2,860,403 

Operating expenses

  620,229   513,012   1,166,978   970,139 

Research and development expense

  112,266   130,025   243,932   218,311 

Total costs and expenses

  2,426,248   2,142,427   4,814,780   4,048,853 

Income from operations

  1,199,929   1,515,551   2,703,755   3,039,993 
                 

Other (expense) income:

                

Investment income

  58,860   45,640   99,410   85,400 

Net (loss) gain on marketable securities

  (460,278

)

  137,574   (853,938

)

  65,527 

Total other (expense) income

  (401,418

)

  183,214   (754,528

)

  150,927 

Income before provision for income taxes

  798,511   1,698,765   1,949,227   3,190,920 
                 

Provision for income taxes

  165,187   354,241   404,438   665,194 

Net income

 $633,324  $1,344,524  $1,544,789  $2,525,726 
                 

Earnings per common share (basic and diluted)

 $0.14  $0.29  $0.34  $0.55 
                 

Weighted average shares (basic and diluted)

  4,594,319   4,594,319   4,594,319   4,594,319 

 

See Notes to Condensed Financial Statements

 

Page 2 of 24

UNITED-GUARDIAN, INC.

BALANCE SHEETS

  

JUNE 30,

  

DECEMBER 31,

 
  

2022

  

2021

 
  

(unaudited)

  

(audited)

 

Current assets:

        

Cash and cash equivalents

 $355,572  $531,213 

Marketable securities

  6,410,082   7,635,463 

Accounts receivable, net of allowance for doubtful accounts of $28,398 at June 30, 2022 and $20,252 December 31, 2021

  2,106,537   1,813,346 

Inventories, net

  1,728,204   1,410,789 

Prepaid expenses and other current assets

  247,001   192,579 

Prepaid income taxes

  231,405   --- 

Total current assets

  11,078,801   11,583,390 
         

Net property, plant, and equipment:

        

Land

  69,000   69,000 

Factory equipment and fixtures

  4,610,582   4,605,742 

Building and improvements

  2,861,171   2,853,718 

Total property, plant, and equipment

  7,540,753   7,528,460 

Less: Accumulated depreciation

  6,938,109   6,869,598 

Total property, plant, and equipment, net

  602,644   658,862 

TOTAL ASSETS

 $11,681,445  $12,242,252 

See Notes to Condensed Financial Statements

Page 3 of 2524

 

UNITED-GUARDIAN, INC.

 

BALANCE SHEETS

(continued)

 

LIABILITIES ANDSTOCKHOLDERS EQUITY

 

 

SEPTEMBER 30, DECEMBER 31,

  

JUNE 30,

 

DECEMBER 31,

 
 

2021

  

2020

  

2022

  

2021

 
 (UNAUDITED) (AUDITED)  

(unaudited)

 

(audited)

 

Current liabilities:

 

 

 

 

     

Accounts payable

 $87,158  $31,800  $416,442  $410,894 

Accrued expenses and other current liabilities

 1,542,760  1,363,457  1,545,858  1,627,390 

Deferred revenue

 ---  190,164 

Income taxes payable

 57,614  ---  ---  88,738 

Dividends payable

  19,685   19,028   21,082   20,575 

Total current liabilities

  1,707,217   1,414,285   1,983,382   2,337,761 
  

Deferred income taxes

  227,203   151,684 

Deferred income taxes, net

  31,903   83,222 
  

Commitments and contingencies

                  
  

Stockholders equity:

        

Common stock (at $.10 par value) (10,000,000 shares authorized; 4,594,319 shares issued and outstanding at September 30, 2021 and December 31, 2020, respectively)

 459,432  459,432 

Common stock $.10 par value; 10,000,000 shares authorized; 4,594,319 shares issued and outstanding at June 30, 2022 and December 31, 2021, respectively

 459,432  459,432 

Retained earnings

  11,231,834   9,894,875   9,206,728   9,361,837 

Total stockholders equity

  11,691,266   10,354,307   9,666,160   9,821,269 
  

TOTAL LIABILITIES AND STOCKHOLDERS EQUITY

 $13,625,686  $11,920,276  $11,681,445  $12,242,252 

 

See Notes to Condensed Financial Statements

 

Page 4 of 2524

 

 

UNITED-GUARDIAN, INC.

 

STATEMENTS OF CHANGES IN STOCKHOLDERS' EQUITY

(unaudited)

THREE AND NINESIX MONTHS ENDED SEPTEMBERJUNE 30, 2022

   Common stock   Retained     
   Shares   Amount   Earnings   Total 

Balance, January 1, 2022

  4,594,319  $459,432  $9,361,837  $9,821,269 

Net income

  ---   ---   911,465   911,465 

Balance, March 31, 2022

  4,594,319  $459,432  $10,273,302  $10,732,734 

Net income

  ---   ---   633,324   633,324 

Dividends declared and paid ($0.37 per share)

  ---   ---   (1,699,392)  (1,699,392)

Dividends declared but not paid ($0.37 per share)

  ---   ---   (506)  (506)

Balance, June 30, 2022

  4,594,319  $459,432  $9,206,728  $9,666,160 

THREE AND SIX MONTHS ENDED JUNE 30, 2021

 

   Common stock   Retained     
   Shares    Amount   Earnings   Total 

Balance, January 1, 2021

  4,594,319  $459,432  $9,894,875  $10,354,307 

Net income

  ---   ---   1,181,202   1,181,202 

Balance, March 31, 2021

  4,594,319  $459,432  $11,076,077  $11,535,509 

Net income

  ---   ---   1,344,524   1,344,524 

Dividends declared and paid ($0.48 per share)

  ---   ---   (2,204,616

)

  (2,204,616

)

Dividends declared, not paid ($0.48 per share)

  ---   ---   (657

)

  (657

)

Balance, June 30, 2021

  4,594,319  $459,432  $10,215,328  $10,674,760 

Net income

  ---   ---   1,016,506   1,016,506 

Balance, September 30, 2021

  4,594,319  $459,432  $11,231,834  $11,691,266 

THREE AND NINE MONTHS ENDED SEPTEMBER 30, 2020

   Common stock   Retained     
   Shares   Amount   Earnings   Total 

Balance, January 1, 2020

  4,594,319  $459,432  $10,173,466  $10,632,898 

Net income

  ---   ---   790,307   790,307 

Balance, March 31, 2020

  4,594,319  $459,432  $10,963,773  $11,423,505 

Net income

  ---   ---   1,186,611   1,186,611 

Dividends declared and paid ($0.42 per share)

  ---   ---   (1,928,969

)

  (1,928,969

)

Dividends declared, not paid ($0.42 per share)

  ---   ---   (645

)

  (645

)

Balance, June 30, 2020

  4,594,319  $459,432  $10,220,770  $10,680,202 

Net income

  ---   ---   717,532   717,532 

Balance, September 30, 2020

  4,594,319  $459,432  $10,938,302  $11,397,734 
  

Common stock

  

 

Retained  

 

 
   Shares   Amount   Earnings   Total 

Balance, January 1, 2021

  4,594,319  $459,432  $9,894,875  $10,354,307 

Net income

  ---   ---   1,181,202   1,181,202 

Balance, March 31, 2021

  4,594,319  $459,432  $11,076,077  $11,535,509 

Net income

  ---   ---   1,344,524   1,344,524 

Dividends declared and paid ($0.48 per share)

  ---   ---   (2,204,616)  (2,204,616)

Dividends declared but not paid ($0.48 per share)

  ---   ---   (657)  (657)

Balance, June 30, 2021

  4,594,319  $459,432  $10,215,328  $10,674,760 

 

See Notes to Condensed Financial Statements

 

Page 5 of 2524

 

 

UNITED-GUARDIAN, INC.



STATEMENTS OF CASH FLOWS
(UNAUDITED)(unaudited)

 

 

NINE MONTHS ENDED

  

SIX MONTHS ENDED

 
 

SEPTEMBER 30,

  

June 30,

 
 

2021

  

2020

  

2022

  

2021

 

Cash flows from operating activities:

        

Net income

 $3,542,232  $2,694,450  $1,544,789  $2,525,726 

Adjustments to reconcile net income to net cash provided by operating activities:

  

Depreciation and amortization

 106,928  121,669  68,511  70,025 

Net gain on marketable securities

 (40,419

)

 (143,832

)

Gain on sale of asset

 (14,799

)

 --- 

Net loss (gain) on marketable securities

 853,938  (65,527

)

Allowance for doubtful accounts

 13,279  (992

)

 8,146  9,678 

Deferred income taxes

 75,519  (155,127

)

 (51,319

)

 149,454 

(Increase) decrease in operating assets:

  

Accounts receivable

 (555,764

)

 815,808  (301,337

)

 (586,995

)

Inventories

 128,539  (327,542

)

 (317,415

)

 497,487 

Prepaid expenses and other current assets

 1,847  4,185  (54,421

)

 (33,751

)

Prepaid income taxes

 99,107  38,969  (231,405

)

 15,740 

Increase (decrease) in operating liabilities:

  

Accounts payable

 55,358  (30,460

)

 5,548  (5,797

)

Accrued expenses and other current liabilities

 179,303  29,233 

Accrued expenses

 (81,532

)

 41,268 

Deferred revenue

 (190,164

)

 --- 

Income taxes payable

 57,614  ---   (88,738

)

  --- 

Dividends payable

  ---   (124,657

)

 

Net cash provided by operating activities

  3,648,744   2,921,704   1,164,601   2,617,308 
  

Cash flows from investing activities:

    

Cash flows from investing activities:

    

Acquisition of property, plant and equipment

 (81,997

)

 (25,437

)

 (12,293

)

 (38,758

)

Proceeds from sale of marketable securities

 1,832,829  3,802,205  1,658,292  1,832,827 

Purchases of marketable securities

  (3,094,483

)

  (4,932,754

)

Net cash used in investing activities

  (1,343,651

)

  (1,155,986

)

Purchase of marketable securities

  (1,286,849

)

  (2,053,744

)

Net cash provided by (used in) investing activities

  359,150   (259,675

)

  

Cash flows from financing activities:

    

Cash flows from financing activities:

    

Dividends paid

  (2,204,616

)

  (1,928,969

)

  (1,699,392

)

  (2,204,616

)

Net cash used in financing activities

  (2,204,616

)

  (1,928,969

)

  (1,699,392

)

  (2,204,616

)

Net increase (decrease) in cash and cash equivalents

 100,477  (163,251

)

  

Net (decrease) increase in cash and cash equivalents

 (175,641

)

 153,017 

Cash and cash equivalents at beginning of period

  591,444   1,048,311   531,213   591,444 

Cash and cash equivalents at end of period

 $691,921  $885,060  $355,572  $744,461 
 

Supplemental disclosure of cash flow information:

    
Supplemental disclosure of cash flow information        

Taxes paid

 $700,000  $825,000  $350.000  $300,000 

Supplemental disclosure of non-cash items:

    

Dividends payable

 $657  $645 

Trade-in received from sale of asset

 $29,000  $--- 

Supplemental disclosure of non-cash dividends payable

 $507  $657 

 

See Notes to Condensed Financial Statements

 

Page 6 of 2524

 

UNITED-GUARDIAN, INC.

 

NOTES TO CONDENSED FINANCIAL STATEMENTS
(UNAUDITED)(unaudited)

 

 

1.        Nature of Business

 

United-Guardian, Inc. (the “Company”) is a Delaware corporation that, through its Guardian Laboratories division, conducts research, product development, manufacturing and marketing of cosmetic ingredients, pharmaceuticals, medical products, and proprietary specialty industrial products. The Company’s research and development department modifies, refines, and expands the uses for existing products for additional uses and markets. It also develops new products using natural and environmentally friendlyenvironmentally-friendly raw materials, which is important to many of the Company's cosmetic customers.

 

 

2.        Basis of Presentation

 

Interim condensed financial statements of the Company are prepared in accordance with generally accepted accounting principles in the United States Generally Accepted Accounting Principlesof America (“US GAAP”) for interim financial information, pursuant to the requirements for reporting on Form 10-Q and Regulation S-X. In the opinion of management, all adjustments including normal recurring accruals, considered necessary for the fair presentation of financial statements for the interim periods have been included. The results of operations for the three and ninesix months ended SeptemberJune 30, 20212022 (also referred to as the "third"second quarter of 2021"2022" and the "first nine monthshalf of 2021"2022", respectively) are not necessarily indicative of results that ultimately may be achieved for any other interim period or for the year ending December 31, 2021.2022. The interim unaudited condensed financial statements and notes thereto should be read in conjunction with the audited financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2020.2021.

 

 

3.        Impact of Coronavirus (COVID-19)

 

While the coronavirus pandemic (“pandemic”) continues to impact certain areas of the Company’s operations, the substantialcurrent impact on the pandemic had on Company sales in 2020 significantly lessened in the firstnine months of 2021. The current impactCompany’s financial performance is coming primarily from supply chain disruptions,higher raw material costs and increased shipping costs, which had an impact on the Company’s gross profit margins in the second quarter of 2022 and may continue to have resulteda future impact on the Company’s gross profit margins in increased packagingupcoming quarters. In addition, during the first half of 2022 it was more difficult to ship the Company’s products due to a shortage of truck drivers and limited availability of shipping vessels. This situation began to gradually improve during the second quarter of 2022. The shortage of truck drivers and shipping costs, and increases invessels is expected to continue to improve as the costyear progresses, but this will be at least partially contingent upon the extent to which the impact of some raw materials, although itthe pandemic lessens globally. The Company has been able to minimize the impact on customers by making them aware of longer lead times that may be necessary as a result of these issues.

The pandemic has not significantly affected the ability of the Company to obtain raw materials. Itmaterials, but has however, resulted increated longer lead times for some shipping delays dueof them. In response to the shortage of truck drivers. Therising raw material prices the Company has been ableinstituted price increases on many of its products, which will help to maintain production throughoutreduce the pandemic.impact on the Company’s gross margins in the future.

 

Page 7 of 24

SalesAs a result of the Company’s non-pharmaceutical medical products (“medical products”) had also been negatively impacted by the pandemic in 2020, but those impacts have lessened as well in the firstthree quarters of 2021. Saleslingering effects of the Company’s pharmaceutical products were not impacted by thecoronavirus pandemic in 2020 or in the firstnine months of 2021.

Thereas described above, there continues to be some uncertainty in regard to the future potential impact of the pandemic on the Company’s operations or financial results and as a resultresults. The Company believes that it is difficult for the Companystill unable to provide an accurate estimate or projection as to what the future impact of the pandemic will be on the Company’s future operations or financial results. The Company does not expect the carrying value of its assets or its liquidity to be impaired by the coronavirus pandemic.

7 of 25

 

 

4.        Use of Estimates

 

In preparing financial statements in conformity with US GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, andas well as revenues and expenses during the reporting period. Actual results could differ from those estimates. Such estimated items include the allowance for bad debts, reserve for inventory obsolescence, accrued distribution fees, outdated material returns, possible impairment of marketable securities, and the allocation of overhead.

 

 

5.        Cash and Cash Equivalents

 

For financial statement purposes, the Company considers as cash equivalents all highly liquid investments with an original maturity of three months or less at the time of purchase.inception. The Company deposits cash and cash equivalents with high credit quality financial institutions and believes that any amounts in excess of insurance limitations to be at minimal risk. Cash and cash equivalents held in these accounts are currently insured by the Federal Deposit Insurance Corporation (“FDIC”) up to a maximum of $250,000. At SeptemberJune 30, 20212022 and December 31, 2020,2021, approximately $806,000$395,000 and $653,000$410,000, respectively, exceeded the FDIC limit.

 

 

6.        Revenue Recognition

 

The Company records revenue in accordance with ASC Topic 606 “Revenue from Contracts with Customers.” Under this guidance, revenue is recognized when a customer obtains control of promised goods or services, in an amount that reflects the consideration expected to be received in exchange for those goods or services. The Company’s principal source of revenue is product sales.

 

The Company’s sales, as reported, are subject to a variety of deductions, some of which are estimated. These deductions are recorded in the same period in whichthat the revenue isrevenues are recognized. Such deductions, primarily related to the sale of the Company’s pharmaceutical products, include chargebacks from the United States Department of Veterans Affairs (‘VA”), rebates in connection with the Company’s current participation in Medicare programs and its past participation in Medicaid programs, distribution fees, discounts, and outdated product returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these revenue deductions on sales for a reporting period.

 

During 20212022 and 2020,2021, the Company participated in various government drug rebate programs related to the sale of Renacidin®, its most important pharmaceutical product. These programs include the Veterans Affairs Federal Supply Schedule (FSS), and the Medicare Part D Coverage Gap Discount Program (CGDP). These programs require the Company to sell its product at a discounted price. In addition, during 2020, the Company also participated in the Medicaid Drug Rebate Program (MDRP), which required the Company to pay a significant rebate to the various states where Renacidin was provided to Medicaid patients, as well as the Section 340B Drug Pricing Program (340B), which required the Company to sell Renacidin at a deeply discounted price. Due to the overly burdensome nature of the Medicaid rebates, and the deeply discounted pricing associated with the 340B Program, the Company terminated its participation in the MDRP and the 340B Programs, effective December 31, 2020. The Company’s sales, as reported, are net of these product rebates and discounts, some of which are estimated and are recorded in the same period that the revenue is recognized.

 

Page 8 of 2524

 

The Company recognizes revenue from sales of its cosmetic ingredients, medical, and industrial products when those products are shipped, as long as a valid purchase order has been received and future collection of the sale amount is reasonably assured. These products are shipped “Ex-Works” from the Company’s facility in Hauppauge, NY, and it is at this time that risk of loss and responsibility for the shipment passes to the customer and the Company’s performance obligation is satisfied. Sales of these products are deemed final, and there is no obligation on the part of the Company to repurchase or allow the return of these goods unless they are defective.

 

The Company’s pharmaceutical products are shipped via common carrier upon receipt of a valid purchase order, with, in most cases, the Company paying the shipping costs. Sales of pharmaceutical products are final, and revenue is recognized at the time of shipment, which is when the risk of loss and responsibility for the shipment passes to the customer, and the performance obligation of the Company is satisfied. Pharmaceutical products are returnable only at the discretion of the Company unless (a) they are found to be defective; (b) the product is damaged in shipping; or (c) the product is outdated (but not more than one year after theirits expiration date, which is a return policy which conforms to standard pharmaceutical industry practice). The Company estimates an allowance for outdated material returns based on prior year historical returns of its pharmaceutical products.

 

The Company does not make sales on consignment, and the collection of the proceeds of the sale of any of the Company’s products is not contingent upon the customer being able to sell the goods to a third party.

 

Any allowances for returns are taken as a reduction of sales within the same period the revenue is recognized. Such allowances are determined based on historical experience under ASC Topic 606-10-32-8. The Company has not experienced significant fluctuations between estimated allowances and actual activity.

 

The timing between recognition of revenue for product sales and the receipt of payment is not significant. The Company’s standard credit terms, which vary depending on the customer, range between 30 and 60 days. The Company uses its judgment on a case-by-case basis to determine its ability to collect outstanding receivables and provides allowances for any receivables for which collection has become doubtful. As of SeptemberJune 30, 20212022 and December 31, 2020,2021, the allowance for doubtful accounts receivable was $27,296$28,398 and $14,017,$20,252, respectively. Prompt-pay discounts are offered to some customers; however, due to the uncertainty of the customers taking the discounts, the discounts are recorded when they are taken.

At September 30, 2021, the Company recorded an advance payment from one of its customers in the amount of $128,636. The related performance obligation associated with this payment had not been satisfied as of the balance sheet date. The deferred revenue related to this payment is included in accrued expenses and other current liabilities.

 

The Company has distribution fee contracts with certain distributors of its pharmaceutical products that entitles them to distribution and service-related fees. The Company records distribution fees and estimates distribution fees as offsets to revenue.

 

Page 9 of 2524

 

Disaggregated sales by product class are as follows:

 

  Three months ended September 30,  Nine months ended September 30, 
  2021  2020  2021  2020 

Cosmetic Ingredients

 $1,578,650  $550,177  $5,065,022  $3,358,956 

Pharmaceutical

  1,216,747   1,232,586   3,509,235   3,463,738 

Medical

  343,884   517,036   1,580,657   1,683,682 

Industrial products

  40,465   36,561   113,678   107,542 

Total Sales

 $3,179,746  $2,336,360  $10,268,592  $8,613,918 
  Three months ended   Six months ended 
  June 30,   June 30, 
  2022   2021   2022   2021 

Cosmetic ingredients

 $1,393,963  $1,855,776  $3,471,878  $3,486,372 

Pharmaceuticals

  1,238,384   1,149,179   2,463,597   2,292,487 

Medical products

  962,080   620,748   1,519,875   1,236,774 

Industrial products

  31,750   32,275   63,185   73,213 

Total Net Sales

 $3,626,177  $3,657,978  $7,518,535  $7,088,846 

 

The Company’s cosmetic ingredients are marketed worldwide by five marketing partners, of which U.S.-based Ashland Specialty Ingredients (“ASI”) purchases the largest volume. Approximately 16%35% of the Company’s total sales in the thirdsecond quarter of 20212022 were to customers located outside of the United States, compared with approximately 22%24% in the thirdsecond quarter of 2020.2021. For the ninesix months ended SeptemberJune 30, 2021,2022, approximately 21%28% of the Company’s total sales were to customers located outside of the United States, compared with approximately 20%23% for the ninesix months ended SeptemberJune 30, 2020.2021.

 

Disaggregated sales by geographic region are as follows:

 

 

Three months ended

 

Six months ended

 
 Three months ended September 30, Nine months ended September 30,  

June 30,

 

June 30,

 
 2021  2020  2021  2020  

2022

  

2021

  

2022

  

2021

 

United States*

 $2,670,515  $1,819,084  $8,115,145  $6,887,726  $2,353,952  $2,773,242  $5,433,846  $5,444,629 

Other countries

  509,231   517,276   2,153,447   1,726,192   1,272,225   884,736   2,084,689   1,644,217 

Total Sales

 $3,179,746  $2,336,360  $10,268,592  $8,613,918  $3,626,177  $3,657,978  $7,518,535  $7,088,846 

 

* Since substantially all purchases by ASI are shipped to ASI’s warehouses in the U.S., all sales to ASI are reported as U.S. sales for financial reporting purposes, even though a significant quantity of those purchases will be shipped by ASI to foreign customers. ASI has reported to the Company that approximately 76%75% of its sales of the Company’s products in the thirdsecond quarter of 20212022 were to foreign customers, compared with 69% for the same period in 2020,with China representing approximately 29% of those foreign sales46%. For the same time period in the third quarter of 2021, comparedapproximately 72% of ASI’s sales of the Company’s products were to foreign customers, with China representing approximately 30% in the third quarter of 2020.43%.

 

For the ninesix months ended SeptemberJune 30, 20212022 approximately 72%73% of ASI’s sales of the Company’s products were to customers in other countries, with China accounting for approximately 35%43% of ASI’s sales of the Company’s products, as compared with approximately 69% of ASI’s sales going to customers in other countries for the ninesix months ended SeptemberJune 30, 2020,2021, with China accounting for approximately 33%40% of ASI’s sales of the Company’s products during that period.

 

 

7.        Marketable Securities

 

Marketable securities include investments in fixed income and equity mutual funds and U.S. Government securities with maturities greater than 3 months, all of which are reported at their fair values.

 

Page 10 of 2524

 

The disaggregated net gains and losses on the marketable securities that were recognized inon the income statements for the three and ninesix months ended SeptemberJune 30, 2022 and June 30, 2021 and 2020, respectively, arewere as follows:

 

 

Three months ended September 30,

 

Nine months ended September 30,

  

THREE MONTHS ENDED
JUNE 30,

 

SIX MONTHS ENDED
JUNE 30,

 
 

2021

  

2020

  

2021

  

2020

  

2022

  

2021

  

2022

  

2021

 

Net (losses) gains recognized during the period on marketable securities

 $(25,108

)

 $113,248  $40,419  $143,832  $(460,278) $137,574  $(853,938) $65,527 

Less: Net gains recognized during the period on marketable securities sold during the period

  ---   25,062   112,180   29,918 

Less: Net (losses) gains recognized on marketable securities sold during during the period

  (207,936)  112,180   (207,936)  112,180 

Unrealized (losses) gains recognized during the reporting period on marketable securities still held at the reporting date

 $(25,108

)

 $88,186  $(71,761

)

 $113,914  $(252,342) $25,394  $(646,002) $(46,653)

 

The fair values of the Company’s marketable securities are determined in accordance with US GAAP, with fair value being defined as the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. As such, fair value is a market-based measurement that should be determined based on assumptions that market participants would use in pricing an asset or liability. As a basis for considering such assumptions, the Company utilizes the three-tier value hierarchy, as prescribed by US GAAP, which prioritizes the inputs used in measuring fair value as follows:

 

•    Level 1 - inputs to the valuation methodology are quoted prices (unadjusted) for identical assets or liabilities in active markets.

 

•    Level 2 - inputs to the valuation methodology include quoted prices for similar assets and liabilities in active markets, and inputs that are observable for the asset or liability, either directly or indirectly, for substantially the full term of the financial instrument.

 

•    Level 3 – inputs to the valuation methodology are unobservable and significant to the fair value measurement.

 

The Company’s marketable equity securities, which are considered available for sale securities, are re-measured to fair value on a recurring basis and are valued using Level 1 inputs using quoted prices (unadjusted) for identical assets in active markets.

 

The following tables summarize the Company’s investments:

 

SeptemberJune 30, 2022 (unaudited)

   Cost   Fair value   Unrealized
(loss)gain
 
Equity Securities            

Fixed income mutual funds

 $6,214,590  $5,722,563  $(492,027

)

Equity and other mutual funds

  672,199   687,519   15,320 

Total equity securities

  6,886,789   6,410,082   (476,707

)

Total marketable securities

 $6,886,789  $6,410,082  $(476,707

)

December 31, 2021(Unaudited) (audited)

 

Equity Securities Cost  Fair Value  Unrealized Gain       

Fixed income mutual funds

 $8,050,443  $8,172,762  $122,319  $6,814,420  $6,873,333  $58,913 

Equity and other mutual funds

  610,542   720,692   110,150   651,748   762,130   110,382 

Total equity securities

  8,660,985   8,893,454   232,469   7,466,168   7,635,463   169,295 

Total marketable securities

 $8,660,985  $8,893,454  $232,469  $7,466,168  $7,635,463  $169,295 

 

Page 11 of 2524

 

December 31, 2020(Audited)

Equity Securities Cost  Fair Value  Unrealized Gain 

Fixed income mutual funds

 $6,703,107  $6,907,270  $204,163 

Equity and other mutual funds

  584,044   684,111   100,067 

Total equity securities

  7,287,151   7,591,381   304,230 

Total marketable securities

 $7,287,151  $7,591,381  $304,230 

Investment income is recognized when earned and consists principally of interest income from fixed income mutual funds and U.S. Treasury Bills and dividend income from equity and otherfixed income mutual funds. Realized gains and losses on sales of investments are determined on a specific identification basis.

 

Proceeds from the sale and redemption of marketable securities amounted to $1,832,829$1,658,292 for the ninefirst months endedhalf of September 30, 2021, 2022,which includedincludes realized gainslosses of $112,180.$207,936. Proceeds from the sale and redemption of marketable securities amounted to $3,802,205$1,832,827 for the ninefirst months endedhalf of September 30, 2020, 2021,which included realized gains on sales of $29,918.$112,180.

 

 

8.        Inventories

 

September 30,

 

December 31,

  

June 30,

 

December 31,

 
 

2021

  

2020

  

2022

  

2021

 
 

(UNAUDITED)

 

(AUDITED)

  

(unaudited)

 

(audited)

 

Inventories consist of the following:

  

Raw materials

 $434,178  $415,415  $582,458  $494,348 

Work in process

 75,716  59,258  165,263  119,069 

Finished products

  777,340   941,100   980,483   797,372 

Total inventories

 $1,287,234  $1,415,773  $1,728,204  $1,410,789 

 

Inventories are valued at the lower of cost and net realizable value. Cost is determined using the average cost method, which approximates cost determined by the first-in, first-out (“FIFO”) method. Finished product inventories at SeptemberJune 30, 20212022 and December 31, 20202021 are stated net of a reserve of $35,000 for slow moving and obsolete inventory. At September 30, 2021 and December 31, 2020, the Company had allowances of $311,311 and $302,713 respectively, for possible outdated material returns, which is included in accrued expenses.

As of the date of this report, the Covid-19 pandemic has not materially impacted the valuation of the Company’s finished products, work in process, or raw material inventories, but increases in the cost of some raw materials may impact future inventory valuations.

 

 

9.        Income Taxes

 

The Company’s tax provision is based on its estimated annual effective tax rate. The Company continues to fully recognize its tax benefits, and as of SeptemberJune 30, 20212022 and December 31, 2020,2021, the Company did not have any unrecognized tax benefits. The Company’s provision for income taxes for the three and ninesix months ended SeptemberJune 30, 2022 comprisesand 2021, included the following:

 

   Three months ended   Six months ended 
   June 30,   June 30, 
   2022   2021   2022   2021 

Provision for federal income taxes - current

 $331,161  $266,780  $455,657  $515,640 

Provision for state income taxes - current

  ---   ---   100   100 

(Benefit) provision for federal income taxes - deferred

  (165,974

)

  87,461   (51,319

)

  149,454 

Total provision for Income taxes

 $165,187  $354,241  $404,438  $665,194 

Page 12 of 2524

  

Three months ended September 30,

  Nine months ended September 30, 
  2021  2020  2021  2020 

Provision for federal income taxes - current

 $340,981  $81,323  $856,621  $863,819 

Provision for state income taxes - current

  ---   ---   100   150 

(Benefit from) provision for federal income taxes – deferred

  (73,935

)

  106,882   75,519   (155,127

)

Total provision for income taxes

 $267,046  $188,205  $932,240  $708,842 

 

 

10.      Defined Contribution Plan

 

The Company sponsors a 401(k) defined contribution plan (“DC Plan”) that provides for a dollar-for-dollar employer matching contribution of the first 4% of each employee’s pay that is deferred by the employee. Employees become fully vested in employer matching contributions after one year of employment.immediately.

 

The Company also makes discretionary contributions to each employee's account based on a "pay-to-pay" safe-harbor formula that qualifies the 401(k) Plan under current IRS regulations. Employees become vested in the discretionary contributions as follows: 20% after two years of employment, and 20% for each year of employment thereafter until the employee becomes fully vested after six years of employment. The Company accrued $87,000$54,500 and $65,000 in contributions to the DC Plan for the ninesix months ended SeptemberJune 30, 2021,2022 and $108,750 for2021, respectively. In the ninefirstsix months endedof September 30, 2020. 2022, the Company made discretionary contributions of $109,000 to the DC Plan. This payment represented the Company’s 2021 discretionary contribution. For the first three quartershalf of 2021, and 2020, the Company did not make any discretionary contributions to the DC Plan.

 

 

11.      Related-Party TransactionsOther Information

 

During the three months ended September 30, 2021, there were 0 payments made to related parties. For the nine months ended September 30, 2021, the Company made payments of $9,500, to the accounting firm PKF O’Connor Davies (“PKF”) for accounting and tax services. For the three and nine months ended September 30, 2020, the Company made payments of $9,500 for accounting and tax services to Bonamassa, Maietta and Cartelli, LLP “Bonamassa”). Lawrence Maietta, a partner at PKF O’Connor Davies, and previously a partner at Bonamassa before its combination with PKF, is a director of the Company.

  

 

June 30,  

 

December 31, 

 

 

 

2022  

 

2021 
Accrued Expenses  (unaudited)   (audited) 

Bonuses

 $196,500  $348,000 

Distribution fees

  379,719   359,550 

Payroll and related expenses

  296,688   292,560 

Reserve for outdated material

  331,943   313,904 

Company 401(k) contribution

  54,500   109,000 

Audit fee

  38,000   61,500 

Annual report expenses

  50,373   64,038 

Sales rebates

  169,203   56,857 

Other

  28,932   21,981 

Total accrued expenses

 $1,545,858  $1,627,390 

 

 

12.     Other Information

Accrued Expenses and Other Current Liabilities

    Accrued expenses and other current liabilities consist of the following:

13 of 25

 

 

 

September 30,

2021

  

December 31,

2020

 
Accrued Expenses (Unaudited)  (Audited) 
         

Bonuses

 $237,000  $210,000 

Distribution fees

  362,315   325,792 

Payroll and related expenses

  225,328   245,521 

Reserve for outdated material

  311,311   302,713 

Company 401(k) contribution

  87,000   --- 

Deferred revenue

  128,636   --- 

Audit fee

  57,875   50,500 

Annual report expenses

  46,462   63,432 

Sales rebates

  51,428   149,346 

Other

  35,405   16,153 

Total Accrued Expenses

 $1,542,760  $1,363,457 

13.      Recent Accounting Pronouncements

 

On January 1, 2021, the Company adopted Accounting Standards Update (ASU) 2019-12, “Simplifying the Accounting for Income Taxes.” This standard modified ASU 740, and simplifies the accounting for income taxes. The Company has determined that these modifications did not have an impact on its financial statements.

 

In June 2016, the FASB issued ASU-2016-13 “Financial Instruments – Credit Losses”. This guidance affects organizations that hold financial assets and net investments in leases that are not accounted for at fair value with changes in fair value reported in net income. The guidance requires organizations to measure all expected credit losses for financial instruments at the reporting date based on historical experience, current conditions, and reasonable and supportable forecasts. In November 2019, the FASB amended the effective date of implementation of this standard for smaller reporting companies. The new effective date is for fiscal years beginning after December 15, 2022. The Company is currently evaluating if this pronouncement will have a potential impact on its financial statements.

 

Page 13 of 24

 

14.13.      Concentrations of Credit Risk

 

Customer concentrationConcentration -: Accounts receivable potentially exposes the Company to concentrations of credit risk. The Company monitors the amount of credit it allows each of its customers, using the customer’s prior payment history and its overall credit worthiness to determine how much credit to allow or whether any credit should be given at all. It is the Company’s policy to discontinue shipments to any customer that is substantially past due on its payments. The Company sometimes requires payment in advance from customers whose payment record is questionable. As a result of its monitoring of the outstanding credit allowed for each customer, as well as the fact that the majority of the Company’s sales are to customers whose satisfactory credit and payment record has been established over a long period of time, the Company believes that its credit risk from accounts receivable is low.

 

ForDuring the three months ended SeptemberJune 30, 2021,2022, one1 of the Company’s cosmetic ingredient marketing partners, and threealong with 3 of its pharmaceutical distributors, together accountedwere responsible for 86%69% of the Company’s sales, and 79%accounted for 68% of its outstanding accounts receivable at SeptemberJune 30, 2021.2022. During the three months ended SeptemberJune 30, 2020,2021, the same marketing partner and three3 distributors together were responsible for 79%75% of the Company’s sales, and 70%accounted for 73% of its outstanding accounts receivable at SeptemberJune 30, 2020.2021.

 

14 of 25

ForDuring the ninesix months ended SeptemberJune 30, 2021,2022, one1 of the Company’s cosmetic ingredient marketing partners, andalong with three of its pharmaceutical distributors, together accountedwere responsible for 79%74% of the Company’s sales, and 79%accounted for 68% of its outstanding accounts receivable at SeptemberJune 30, 2021.2022. During the ninesix months-month period ended SeptemberJune 30, 2020,2021, the same marketing partner and three3 distributors together were responsible for 79%76% of the Company’s sales, and 70%accounted for 73% of its outstanding accounts receivable at SeptemberJune 30, 2020.2021.

 

 

15.14.      Earnings Per Share

 

Basic earnings per share is computed by dividing net income available to common shareholders by the weighted-average number of shares of common stock outstanding during the period. Diluted earnings per share is computed by dividing income available to common shareholders by the weighted-average number of shares of common stock outstanding during the period, increased to include the number of additional shares of common stock that would have been outstanding if the potentially dilutive securities had been issued.

 

Per share basic and diluted earnings were $0.22amounted to $0.14 and $0.16$0.29 for the three months ended SeptemberJune 30, 20212022 and 2020,2021, respectively, and $0.77$0.34 and $0.59$0.55 for the ninesix months ended SeptemberJune 30, 20212022 and 2020,2021, respectively.

 

 

17.15.      Subsequent EventsOther Items

 

On January 25, 2022, the Company announced that its Board of Directors had launched a formal review process to explore strategic alternatives. The purpose of the review was to ensure that value was being maximized for shareholders, and that the Company has evaluated all subsequent events from the datesufficient scale and financial resources to take advantage of potential growth opportunities available. These alternatives could include, among others, an outright sale of the financial statements through the dateCompany, possible joint ventures, strategic partnerships or alliances, or other possible transactions.

Page 14 of this report.  As detailed in Note 324 above, the Covid-

On 19June 14, 2022, pandemic is an ongoing event, and as such, the Company isannounced that it had completed the formal review process of exploring strategic alternatives and concluded that there were notno ableopportunities presented to projectthe Company that the Board of Directors believed would be in the best interests of the Company or quantifyits stockholders. While the impact of this event onactive efforts will be suspended, the Company will continue to explore opportunities to grow the Company’s future operationscore businesses and financial results.will consider any opportunities that would be in the best interests of the Company and its stockholders.

 

 

Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsOperations.

 

The following discussion and analysis covers material changes in the financial condition of the Company since the year ended December 31, 2021, and a comparison of the results of operations for the second quarter of 2022 and 2021 and the first half of 2022 and 2021. This discussion and analysis should be read in conjunction with "Management's Discussion and Analysis of Financial Condition and Results of Operations included in the Company's Annual Report on Form 10-K for the year ended December 31, 2021. All references in this quarterly report to “sales” or “Sales” shall mean “net sales” unless specifically identified as “gross sales”.

FORWARD-LOOKING STATEMENTS

 

Statements made in this Form 10-Q which are not purely historical are forward-looking statements with respect to the goals, plans, objectives, intentions, expectations, financial condition, results of operations, future performance and business of the Company. Forward-looking statements may be identified by the use of such words as “believes”, “may”, “will”, “should”, “intends”, “plans”, “estimates”, “anticipates”, or other similar expressions.

Forward-looking statements involve inherent risks and uncertainties, and important factors (many of which are beyond the Company’s control) could cause actual results to differ materially from those set forth in the forward-looking statements. In addition to those specific risks and uncertainties set forth in the Company's reports currently on file with the SEC, some other factors that may affect the future results of operations of the Company are: the development of products that may be superior to those of the Company; changes in the quality or composition of the Company's products; lack of market acceptance of the Company's products; the Company's ability to develop new products; general economic or industry conditions; changes in intellectual property rights; changes in interest rates; new legislation or regulatory requirements; conditions of the securities markets; the Company's ability to raise capital; changes in accounting principles, policies or guidelines; financial or political instability; acts of war or terrorism; and other economic, competitive, governmental, regulatory and technical factors that may affect the Company's operations, products, services and prices. Accordingly, results achieved may differ materially from those anticipated as a result of such forward-looking statements, and those statements speak only as of the date they are made.

The Company does not undertake, and specifically disclaims, any obligation to update any forward-looking statements to reflect events or circumstances occurring after the date of such statements.

 

Page 15 of 2524

 

OVERVIEW

 

The Company is a Delaware corporation that, through its Guardian Laboratories division, conducts research, product development, manufacturing, and marketing of cosmetic ingredients, personal and health care products, pharmaceuticals, non-pharmaceutical medical products, and proprietary specialty industrial products. All the products that the Company markets, with the exception ofexcept for Renacidin, are produced at its facility in Hauppauge, New York. Renacidin, a urological product, is manufactured for the Company by an outside contract manufacturer.

 

The Company’s most important product line is its Lubrajel® line of water-based moisturizing and lubricating gels, which are used primarily as ingredients in cosmetic products butand are also used in medical products, primarily catheter lubricants. These products are marketed worldwide for cosmetic uses by five marketing partners, each handling a different geographic area, with the largest being U.S.-based ASI. The Company’s research and development department is actively working on the development of new products to expand the Company’s line of cosmetic ingredients. Many of the Company’s products use proprietary manufacturing processes, and the company relies primarily on trade secret protection to protect its intellectual property.

 

Renacidin and the Company’s other pharmaceutical product, Clorpactin®, which is also used primarily in urology, are distributed through full-line drug wholesalers and marketed only in the United States. Those wholesalers in turn sell the products to pharmacies, hospitals, nursing homes, and other long-term care facilities, and to government agencies, primarily the VA. The Company promotes Renacidin through internet advertising as well as a dedicated website. Clorpactin and some of the Company’s other products are marketed through information provided on the Company’s corporate website.

 

The Company’s non-pharmaceutical medical products, such as its catheter lubricants, as well as its specialty industrial products, are sold directly to end-users,end users, or to contract manufacturers utilized by those end-users.end users. They are also available for marketing on a non-exclusive basis by the Company’s marketing partners.

 

While the Company does have competition in the marketplace for some of its products, particularly its cosmetic ingredients, some of its pharmaceutical and medical products have some unique characteristics, and do not have direct competitors. However, these products may have indirect competition from other products that are not marketed as direct competitors to the Company’s products but may have functionality or properties that are similar to the Company’s products.

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The Company recognizes revenue when all of the following requirements are satisfied: (a) persuasive evidence of a sales arrangement exists; (b) products are shipped, which is when the performance obligation is satisfied and title and risk of loss pass to the customers; and (c) collections are reasonably assured. An allowance for returns, based on historical experience, is taken as a reduction of sales within the same period the revenue is recognized.

 

Over the years the Company has been issued many patents and trademarks, and it still maintains several registered trademarks, the two most important of which are “Lubrajel” and “Renacidin.” However, regarding the protection of the Company’s proprietary formulations and manufacturing technology, the Company currently relies primarily on trade secret protection rather than patent protection due to the current disclosure requirements needed to obtain patents, the limited protection they afford, and the difficulty and expense of enforcing them globally. However, the Company may, from time to time, seek patent protection when it believes it would be in the Company’s best interest to do so. All of the Company’s previously issued patents have expired; however, the Company does not believe that the expiration of those patents has had, or will have, any material impact on its sales, since in recent years protection for the Company’s most important products has been based on trade secrets and proprietary manufacturing methods rather than patent protection.

 

Page 16 of 24

As discussed in Note 3 above, while the coronavirus pandemic (“pandemic”) continues to impact certain areas of the Company’s operations, the substantial impact the pandemic had on Company sales in 2020 significantly lessened in the first nine months of 2021. While the Company believes that sales of its cosmetic ingredients are still being negatively impacted, the sales situation has improved substantially, and the current impact on the Company’s financial performance is coming moreprimarily from increased shipping costs and some higher raw material costs and increased shipping costs, which could have somehad an impact on the Company’s gross profit margins in the second quarter of 2022 and may continue to have a future impact on the Company’s gross profit margins in upcoming quarters. It has also beenIn addition, during the first half of 2022 it was more difficult to ship the Company’s products due to a shortage of truck drivers which has meant some delays in having orders picked up, even thoughand limited availability of shipping vessels. This situation began to gradually improve during the Company’s products are available to ship.second quarter of 2022. The shortage of truck drivers and shipping vessels is expected to continue into 2022, andto improve as the year progresses, but this will be at least partially contingent upon the extent to which the impact of the pandemic lessens globally. The Company is doing what it canhas been able to minimize the impact on customers by making customersthem aware of some longer lead times due to the truckingthat may be necessary as a result of these issues.

Sales of the Company’s non-pharmaceutical medical products (referred to herein as “medical products”) had also been negatively impacted by the pandemic in 2020, but those impacts have lessened as well in the first three quarters of 2021. There continues to be some impact on shipping schedules, with the shipping of some customers’ orders being delayed due to the shortage of truck drivers.

Sales of the Company’s pharmaceutical products were not impacted by the pandemic in 2020 or in the first nine months of 2021. However, the Company is beginning to see a small decrease in gross pharmaceutical sales due the termination of its participation in the Medicaid Drug Rebate Program. Please refer to the pharmaceutical sales section of the MD&A for further discussion.

 

The pandemic has not significantly affected the ability of the Company to obtain raw materials, but it has madecreated longer lead times for some of those materials more expensive,them. In response to the rising raw material prices the Company has instituted price increases on many of its products, which couldwill help to reduce the impact on the Company’s gross profit margins in the future. The Company has been able to maintain production throughout the pandemic.

 

ThereAs a result of the lingering effects of the coronavirus pandemic as described above, there continues to be uncertainty in regard to the future potential impact of the pandemic on the Company’s operations or financial results. While the impact on the Company’s’ sales lessened considerably in 2021, theThe Company believes that it is still unable to provide an accurate estimate or projection as to what the future impact of the pandemic will be on the Company’s future operations or financial results. The Company does not expect the carrying value of its assets or its liquidity to be impaired by the coronavirus pandemic.

 

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CRITICAL ACCOUNTING POLICIES

 

As disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2020,2021, the discussion and analysis of the Company’s financial condition and results of operations are based on its financial statements, which have been prepared in conformity with US GAAP. The preparation of those financial statements required the Company to make estimates and assumptions that affect the carrying value of assets, liabilities, revenues and expenses reported in those financial statements. Those estimates and assumptions can be subjective and complex, and consequently actual results could differ from those estimates and assumptions. The Company’s most critical accounting policies relate to revenue recognition, concentration of credit risk, investments, inventory, and income taxes. Since December 31, 2020,2021, there have been no significant changes to the assumptions and estimates related to those critical accounting policies.

 

The following discussion and analysis covers material changes in the financial condition of the Company since the year ended December 31, 2020,2021, and a comparison of the results of operations for the third quarter of 2021six months ended June 30, 2022 and 2020 and the first nine months of 2021 and 2020.June 30, 2021. This discussion and analysis should be read in conjunction with "Management's“Management’s Discussion and Analysis or Plan of Operation"Financial Condition and Results of Operations” included in the Company'sCompany’s Annual Report on Form 10-K for the year ended December 31, 2020.2021. All references in this quarterly report to “sales” or “Sales” shall mean “net sales”Net Sales unless specifically identified as “gross sales”.specified otherwise.

Page 17 of 24

 

The Company recognizes revenue from sales of its cosmetic ingredients, medical products, and industrial products when all of the following requirements are satisfied: (a) a valid purchase order has been received; (b) products are shipped, which is when the performance obligation is satisfied and title and risk of loss pass to the customers; and (c) future collection of the sale amount is reasonably assured. These products are shipped “Ex-Works” from the Company’s facility in Hauppauge, NY, and it is at this time that risk of loss and responsibility for the shipment passes to the customer. Sales of these products are deemed final, and there is no obligation on the part of the Company to repurchase or allow the return of these goods unless they are defective.

 

The Company’s pharmaceutical products are shipped via common carrier upon receipt of a valid purchase order, with, in most cases, the Company paying the shipping costs. The Company assumes responsibility for the shipment arriving at its intended destination. Sales of pharmaceutical products are final and revenue is recognized at the time of shipment.shipment, which is when the performance obligation is satisfied. Pharmaceutical products are returnable only at the discretion of the Company unless (a) they are found to be defective; (b) the product is damaged in shipping; or (c) the product is outdated (but not more than one year after theirits expiration date, which is a return policy which conforms to standard pharmaceutical industry practice). The Company estimates an allowance for outdated material returns based on gross sales of its pharmaceutical products.

 

RESULTS OF OPERATIONS

 

Net Sales

 

SalesNet sales for the thirdsecond quarter of 2021 increased2022 decreased by $843,386 (36%$31,801 (less than 1%) when compared with the same period in 2020. Sales2021. Net sales for the first nine monthshalf of 20212022 increased by $1,654,674 (19%$429,689 (6%) as compared with the corresponding period in 2020.2021. The decrease and increase in sales for both the thirdsecond quarter of 20212022 and the first nine monthshalf of 20212022 were attributable to changes in sales of the following product lines:

 

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1.Cosmetic ingredients:

 

a)

Third quarter sales: For the third quarter of 2021, the Company’s sales of cosmetic ingredients increased by $1,028,473 (187%) when compared with the third quarter of 2020. The increase in third quarter sales was due primarily to an increase of $983,466 (308%) in sales of the Company’s personal care products to ASI. Based on information provided to the Company by ASI, the Company’s marketing partner in China, the increase was due primarily to the continued increase in shipments of the Company’s products to China by ASI.

Thirda)     Second quarter sales to: For the second quarter of 2022, the Company’s four other marketing partners, as well as to four small directsales of cosmetic ingredient customers, had a net increase of $45,007 (20%ingredients decreased by $461,813 (25%) when compared with the thirdsecond quarter of 2020. Sales to the Company’s marketing partners2021. The decrease in the United Kingdom, Switzerland, and Italy increased bysecond quarter sales was due primarily to a totalnet decrease of $117,448 (112%$487,820 (34%), while sales to the Company’s marketing partner in France and foursales of the Company’s small direct cosmetic customers decreased by $72,440 (58%).ingredients to ASI. The net decrease in sales to ASI was due to two main factors: 1) in the second quarter of 2021, ASI resumed shipments of the Company’s cosmetic ingredients to China due to improving COVID-19 pandemic conditions, and sales for that period represented a significant increase in order to compensate for the lack of sales during the height of the pandemic in 2020; and 2) in the second quarter of 2022 the Company provided pricing rebates in the amount of $129,600 to ASI for new business it acquired.

 

b)

Nine-month

Second quarter sales: For the first nine months of 2021, the Company’s sales of cosmetic ingredients increased by $1,706,066 (51%) when compared with the same period in 2020. This increase was due primarily to an increase of $1,486,664 (58%) in shipments of the Company's extensive line of cosmetic ingredients to ASI. The primary reason for the increase in sales to ASI during the first nine months of 2021 was the same as for the increase in sales in the third quarter, which was due to the continued increase in shipments of the Company’s products to China by ASI.

Cosmetic ingredient sales for the first nine months of the year to the Company’s four other marketing partners, as well as to the four direct cosmetic ingredient customers, increased by a net of $219,402 (28%)$26,007 compared with the samesecond quarter of 2021. The increase was attributable to a sales increase of $168,028 to the Company’s marketing partner in the UK and an increase of $535 in sales to four direct cosmetic ingredient customers. These increases were offset by a decrease of $126,708 to the Company’s marketing partners in France, a decrease of $770 in Switzerland and a decrease of $15,078 in sales to the Company’s marketing partner in Italy.

Page 18 of 24

b) Six-month sales: For the first half of 2022 the Company’s sales of cosmetic ingredients decreased by $14,494 (less than 1%) when compared with the corresponding period in 2020. Nine-month2021. This decrease was due primarily to a net decrease in sales to ASI of $105,905 (4%), which includes a rebate of $129,600 to ASI in connection with new business that ASI acquired. That decrease was fully offset by a net increase in sales of $106,064 to the Company’s four other marketing partners, with sales to the Company’s marketing partners in the UK, France, SwitzerlandUnited Kingdom and Italy increasedincreasing by $240,985 (32%), whilea combined net of $121,691, and sales to the Company’s marketing partners in France and Switzerland decreasing by a combined net of $15,622. Sales to the Company’s four direct cosmetic ingredient customers decreased by $21,583 (52%).$14,658.

 

The Company believes that the increase in sales of the Company’s cosmetic ingredients in Europe was, at least in part, the result of global pandemic conditions improving.

2.Pharmaceuticals:Pharmaceuticals:

 

Because there are fees, rebates and allowances associated with sales of the Company’s two pharmaceutical products, Renacidin and Clorpactin, discussion of the Company’s pharmaceutical sales includes references to both gross sales (before fees, rebates and allowances) and net sales (after fees, rebates and allowances). Gross sales of the Company’s pharmaceutical products for the three- and nine-monthsix-month periods ended SeptemberJune 30, 2021 decreased2022 increased by $92,405 (6%$112,599 (8%) and $178,459 (4%$162,882 (6%), respectively, compared with the corresponding periods in 2020.2021. These decreasesincreases were due primarily to decreasesincreases of $86,751 (6%$88,962 (7%) and $232,493 (6%$128,009 (5%) in gross sales of Renacidin for the three- and nine-monthsix-month periods, respectively, ended SeptemberJune 30, 2021. The decrease2022. These increases were accompanied by increases of $23,637 (14%) and $34,873 (11%) in both periods was primarily due to the Company having terminated its participation in the Medicaid Drug Rebate Program on December 31, 2020. Grossgross sales of the Company’s other pharmaceutical product, Clorpactin, decreased by $5,654 (3%) for the three-month period ended September 30, 2021,same three- and increased by $54,034 (12%) forsix-month periods, respectively, which the nine-month period ended September 30, 2021, compared with the corresponding periods in 2020. The Company believes the changes in sales of Clorpactin werewas most likely due to normal fluctuations in the sales of that product.Clorpactin.

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The decreaseincrease in gross sales for the three- and nine-monthsix-month periods ended SeptemberJune 30, 20212022 was partially offset by a decreasean increase in pharmaceutical relatedpharmaceutical-related fees, rebates and allowances of $76,567 (22%$23,393 (11%) and $223,957 (23%$8,228 (2%), respectively. The decreasesincrease in these fees, rebates and allowances wereis the result of the Company’s termination of its participation indirect relationship between the Medicaid Drug Rebate Program at the end of 2020. Due to the overly burdensome nature of the Medicaid rebates that the Company had to pay under this program, the Company determined that it was no longer profitable for the Company to continue to participate. Accordingly, on October 30, 2020 the Company informed the Centers for Medicare & Medicaid Services (CMS) of its intention to terminate its Medicaid Drug Rebate Agreement and its participation in the Medicaid Program, effective December 31, 2020. As the Company had anticipated, the discontinuation of its participation in this program resulted in the loss of some Renacidin sales, but that loss was more than offset by the elimination of the rebate payments, which resulted in an increase in net income from these sales.

As sales of the Company’s pharmaceutical products fluctuate there is typically a corresponding direct relationship inand the related allowances, such as for distribution fees, VA chargebacks, Medicare rebates, sales rebates and discounts, outdated material returns, and Medicaid rebates. For the three- and nine-month periods ended September 30, 2021, these allowances decreased by $74,116 (21%) and $226,932 (24%), respectively, compared with the same periods in 2020. This was primarily the result of the Company’s termination of its participation in the Medicaid Program. Although the Company will no longer be incurring Medicaid-related rebate costs, it will continue to incur costs related to other allowances, including Medicare rebates, distribution fees, chargebacks on VA sales, and outdated material returns.those product sales.

 

3.Medical (non-pharmaceutical) products:

 

Sales of the Company’s medical products decreased by $173,152 (33%) for the third quarter of 2021,three and six-month periods ended June 30, 2022, increased by $103,025 (6%$341,332 (55%) for the nine-month period ended September 30, 2021,and $283,101 (23%), respectively, compared with the same periods in 2020.2021. The decreaseincrease in sales for the three-month period was primarily due to two factors: 1) at March 31, 2022, the Company had medical product orders of approximately $240,000 that were waiting to be shipped but were delayed due to a shortage of truck drivers and limited availability of shipping vessels. These orders were subsequently shipped in the second quarter of 2022, and 2) The Company has seen a significant increase in orders from one of its larger customers in China. For the six-month period ended June 30, 2022, the increase in medical product sales for both periods was primarily attributable to the loss of one of the Company’s domestic medical product customers in 2020 due to the reformulation of its product, combined with a decrease in orders from two of the Company’s larger direct medical product customers located in China and India, which was partially the result of shipping delays. The Company believes that the other decreases were related to the impact of the coronavirus pandemic.

Industrial products:

Sales of the Company's industrial products increased by $3,904 (11%) and by $6,136 (6%) for the three and nine months, respectively, ended September 30, 2021, when compared with the corresponding periods in 2020.The increase in sales for both the three- and nine-month periods was primarily due to an increase in orders from one of the Company’s industrial productforeign customers, particularly customers located in the northeastern United States.China, which began to place larger orders than they had in 2021.

 

20Page 19 of 2524

4.Industrial and other products:

Sales of the Company's industrial products, as well as other miscellaneous products, for the three-month and six-month periods ended June 30, 2022, decreased by $525 and $10,028, respectively, when compared with the corresponding periods in 2021. The decrease in sales for both periods was primarily due to the loss of one of the Company’s larger domestic customers due to a reformulation of one of that customer’s products.

 

Cost of Sales

 

Cost of sales as a percentage of net sales remainedincreased to 47% in the same for both the thirdsecond quarter of 2021 and 2020, at 42%.2022 from 41% in the second quarter of 2021. For the first ninesix months of 2021,2022, cost of sales as a percentage of sales increased to 45% compared with 40% for the first six months of 2021. The increases in both periods were the result of an increase in certain raw material costs, combined with the recording of $129,600 in rebates payable to one of the Company’s marketing partners in the second quarter of 2022. In addition, the Company recorded a one-time Employee Retention Credit (ERC) in the first six months of 2021, which decreased from 42% in 2020 to 41% in 2021.the cost of sales for that period.

 

Operating Expenses

 

Operating expenses, consisting of selling and general and administrative expenses, decreasedincreased by $34,622 (7%$107,217 ( 21%) for the thirdsecond quarter of 2021, and2022 compared with the equivalent period in 2021. Operating expenses increased by $91,393 (6%$196,839 (20%) for the first ninesix months of 2022, compared with comparable period in 2021. The increase in operating expenses for the second quarter of 2022 was primarily due to increases in insurance expense and consulting and legal fees. In addition, during the second quarter there was an increase in fees to the independent members of the Company’s Board of Directors, which related to the review process of exploring strategic alternatives for the Company. The increase in operating expenses for the first 6 months of 2022 was primarily due to the recording of an ERC in the first 6 months of 2021, which decreased the Company’s operating expenses. After taking into account the effect of the ERC, the Company’s operating expenses increased by (7%) in the first six months of 2022 compared with the same periodsperiod in 2020. The decreases2021, which was due primarily to increases in the same expenses noted above. Due to the current inflationary environment, the Company expects to see a minor increase in operating expenses for both periods were primarily attributable to a decrease in payroll and payroll related expenses, combined with the recognition of a gain on the sale of an asset during the third quarter of 2021. Operating expenses are expected to remain relatively consistent for the remainder of the year.

 

Research and Development Expenses

 

Research and development expenses increaseddecreased by $15,906$17,759 (14%) for the thirdsecond quarter of 2022 compared with the second quarter of 2021, and increased by $17,919 (5%$25,621 (12%) for the first ninesix months of 20212022 compared with the same periodsfirst six months of 2021. The decrease in 2020. The increases for both periods were mainlythe second quarter of 2022 was due primarily to an increasea decrease in payroll and payroll related expenses. The increase for the first six months of 2022 was due to the recording of the ERC in 2021. After taking the effect of the ERC into account, research and development expenses for the six-month period ending June 30, 2022 decreased by less than 1%.

Page 20 of 24

 

Investment Income

 

Investment income decreasedincreased by $185 (less than 1%$13,220 (29%) for the thirdsecond quarter of 2022 compared with the second quarter of 2021, compared with the third quarter of 2020 and decreasedincreased by $7,171 (5%$14,010 (16%) for the first nine monthshalf of 20212022 compared with the same period in 2020.2021. The decreasesincrease in both periods werewas due to decreased interest income from U.S. Treasury Bills combined with loweran increase in dividend income from stock and bond mutual fundsfunds.

Net (loss) gain on Marketable Securities

The net loss on marketable securities increased by $597,852 and $919,465 for the three and six-month periods ended June 30, 2022 compared towith the same periods in 2020.

Net gain on marketable securities

Net gain on2021. Approximately 90% of the Company’s marketable securities decreased by $138,356 (122%) forportfolio is composed of fixed income mutual funds. The Company intentionally weighted its portfolio as such in an effort to minimize significant stock market fluctuations. However, given the third quartercurrent inflationary environment and the rise of 2021 compared with the same period in 2020. The reason forinterest rates, management believes that the decrease was a combinationin the market value of 1) a decreasethe Company’s fixed income mutual funds will be temporary. The Company’s management and Board of Directors are continuing to closely monitor the Company's investment portfolio and will make any adjustments they believe may be necessary or appropriate in realized gainsorder to minimize the future impact on the sales of marketable securities duringCompany’s financial position that the third quarter of 2021 compared with the same period in 2020 (the Company did not sell any securities during the equivalent three-month period in 2021) and 2) in the third quarter of 2020, the market began its recovery after the significant market value decline that occurred in the first and second quarters of 2020 due to the pandemic.

For the first nine months of 2021, the net gain on marketable securities decreased by $103,413 (72%) compared with the same period in 2020. The primary reason for the decrease was that during the first nine months of 2020 the Company recognized unrealized gains of $113,914, which represented the upward market adjustment due to improved economic conditions after the significant decline that occurred during the first partvolatility of the year due to the pandemic.global financial markets may have.

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Provision for income taxesIncome Taxes

 

The Company's effective income tax rate was approximately 21% for the first nine monthshalves and second quarters of 20212022 and 2020.2021. The Company’s tax rate is expected to remain at 21% for the current fiscal year.

 

LIQUIDITY AND CAPITAL RESOURCES

 

Working capital increaseddecreased from $9,832,326$9,245,629 at December 31, 20202021 to $11,254,936$9,095,419 at SeptemberJune 30, 2021, an increase2022, a decrease of $1,422,610.$150,210. The current ratio decreasedincreased from 8.05.0 to 1 at December 31, 20202021 to 7.65.6 to 1 at SeptemberJune 30, 2021.2022. The increasedecrease in working capital was primarily due to an increasea decrease in marketable securities and accounts receivable.cash. The decreaseincrease in the current ratio was due primarily due to decreases in prepaiddeferred revenue and income taxes and inventory, and an increase in accrued expenses.payable.

 

The Company believes that its working capital is, and will continue to be, sufficient to support its operating requirements for at least the next twelve months. The Company does not expect to incur any significant capital expenditures for the remainder of 2021.2022. The Company intends to utilize its available cash and assets primarily for its continued organic growth and potential future strategic transactions, as well as to mitigate the potential impact of COVID-19 and inflation on the Company's business.

 

The Company generated cash from operations of $3,648,744$1,164,601 and $2,921,704$2,617,308 for the nine months ended September 30,first half of 2022 and 2021, and September 30, 2020, respectively. The increase in cashdecrease from operations2021 to 2022 was primarily due to an increasethe decrease in net income.

 

Cash used inprovided by investing activities was $359,150 in the first half of 2022, compared with cash used by investing activities of $259,675 for the nine-month period ended September 30, 2021 was $1,343,651. Cash used in investing activities for the nine-month period ended September 30, 2020 was $1,155,986.first half of 2021. The increase was primarily due to an increasethe Company purchasing less marketable securities in the purchasesfirst half of property, plant and equipment, and an increase in fixed income mutual fund purchases.2022 compared to 2021.

Page 21 of 24

 

Cash used in financing activities was $2,204,616$1,699,392 and $1,928,969$2,204,616 for the nine months ended September 30,first half of 2022 and 2021, and September 30, 2020, respectively. The increasedecrease was due to an increasea decrease in the dividends paid per share from $0.42 per share in 2020 to $0.48 per share in 2021.2021 to $0.37 per share in 2022.

 

The Company expects to continue to use its cash to make dividend payments, to purchase marketable securities, and to take advantage of other opportunities that may arise that are in the best interest of the Company and its shareholders.

 

OFF BALANCE-SHEET ARRANGEMENTS

 

The Company has no off balance-sheet transactions that have, or are reasonably likely to have, a current or future effectimpact on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.

 

CONTRACTUAL OBLIGATIONS AND COMMITMENTS

 

The information to be reported under this item is not required of smaller reporting companies.

 

Item 3. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK.RISK.

 

The information to be reported under this item is not required of smaller reporting companies.

 

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Item 4. CONTROLS AND PROCEDURESPROCEDURES.

 

 

(a)

DISCLOSURE CONTROLS AND PROCEDURES 

The Company’s management, including its Principal Executive Officer and Chief Financial Officer, has evaluated the design, operation, and effectiveness of the Company’s disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934 (the “Exchange Act”). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives. Based upon the evaluation performed by the Company’s management, including its Principal Executive Officer and Chief Financial Officer, it was determined that, as of the end of the period covered by this quarterly report, the Company’s disclosure controls and procedures were effective in providing reasonable assurance that information required to be disclosed in the reports filed or submitted pursuant to the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding disclosures.

The Company’s management, including its Principal Executive Officer and Chief Financial Officer, has evaluated the design, operation, and effectiveness of the Company’s disclosure controls and procedures pursuant to Rule 13a-15 under the Securities Exchange Act of 1934 (the “Exchange Act”). There are inherent limitations to the effectiveness of any system of disclosure controls and procedures, including the possibility of human error and the circumvention or overriding of the controls and procedures. Accordingly, even effective disclosure controls and procedures can only provide reasonable assurance of achieving their control objectives. Based upon the evaluation performed by the Company’s management, including its Principal Executive Officer and Chief Financial Officer, it was determined that, as of the end of the period covered by this quarterly report, the Company’s disclosure controls and procedures were effective in providing reasonable assurance that information required to be disclosed in the reports filed or submitted pursuant to the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the rules and forms of the SEC, and that such information is accumulated and communicated to the Company’s management, including its Principal Executive Officer and Chief Financial Officer, or persons performing similar functions, as appropriate, to allow timely decisions regarding disclosures.

 

 

(b)

CHANGES IN INTERNAL CONTROL OVER FINANCIAL REPORTING

The Company's Principal Executive Officer and Chief Financial Officer have determined that, during the period covered by this quarterly report, there were no changes in the Company's internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. They have also concluded that there were no significant changes in the Company’s internal controls after the date of the evaluation.

The Company's Principal Executive Officer and Chief Financial Officer have determined that, during the period covered by this quarterly report, there were no changes in the Company's internal control over financial reporting that materially affected, or are reasonably likely to materially affect, the Company’s internal control over financial reporting. They have also concluded that there were no significant changes in the Company’s internal controls after the date of the evaluation.

Page 22 of 24

 

PART II - OTHER INFORMATION

ITEM 1.             LEGAL PROCEEDINGSPROCEEDINGS.

 

NONE

 

ITEM 1A.RISK FACTORSFACTORS.

 

IMPACT OF COVID-19

As a result of the pandemic, global consumer purchases of cosmetic products declined significantly in 2020, which resulted in a significant decline in sales of the Company’s cosmetic ingredients in the last three quarters of 2020. Sales of these products were particularly impacted in China, where prior to the pandemic the Company had significant sales. This resulted in an excess inventory situation in China, which severely impacted sales, and which was not resolved until the end of 2020.

23 of 25

The impact of the pandemic on the Company’s sales significantly lessened in 2021. Sales of its cosmetic ingredients in the first quarter of 2021 were slightly lower than in the first quarter of 2020 because the pandemic didn’t begin to significantly impact sales of the Company’s cosmetic ingredients until the latter part of the second quarter of 2020, and that impact continued into the first quarter of 2021.

With the pandemic beginning to abate, sales in the third quarter of 2021 increased significantly compared with the third quarter of 2020. While it is still too soon to predict what the impact of the pandemic will be on future sales, it is likely that there will continue to be some impact on sales of the Company’s cosmetic ingredients, but to a lesser degree than in 2020. The current impact of the pandemic is coming primarily from supply chain disruptions, which have resulted in increased packaging and shipping costs, and increases in the cost of some raw materials. Due to the uncertainty surrounding the duration of the pandemic and its impact in the various countries in which the Company does business, it is difficult for the Company to provide an accurate estimate or projection as to what the future impact of the pandemic will be on the Company’s future operations or financial results. Although the pandemic had some impact on sales of some of the Company’s medical products, it has not impacted sales of its pharmaceutical products.

The Company does not anticipate that the pandemic will affect its ability to obtain raw materials and maintain production, and the Company has multiple sources for many of its raw materials. However, some of the Company’s raw materials have experienced price increases, which could impact the manufacturing cost of some of the Company’s products in the future. The Company may or may not be able to pass along and recoup these price increases, depending on the product. The Company expects to be able to maintain production levels sufficient to ship orders on a timely basis, but the timely shipping of the Company’s products may continue to be impacted by the current shortage of truck drivers.NONE

 

ITEM 2.             UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDSPROCEEDS.

 

NONE

 

ITEM 3.            DEFAULTS UPON SENIOR SECURITIESSECURITIES.

 

NONE

 

ITEM 4.            MINE SAFETY DISCLOSURESDISCLOSURES.

 

NONE

 

ITEM 5.            OTHER INFORMATIONINFORMATION.

 

NONE

24 of 25

 

ITEM 6.            EXHIBITSEXHIBITS.

 

31.1*

Certification of Ken Globus, President and Principal Executive Officer of the Company, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

  

31.2*

Certification of Andrea Young, Chief Financial Officer of the Company, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

  

32*

Certifications of the Principal Executive Officer and Chief Financial Officer of the Company, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.

  

101.INS*

101.INS*

Inline XBRL Instance Document – The instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the inline XBRL document.

101.SCH*

101.SCH*

Inline XBRL Taxonomy Extension Schema Document.

101.CAL*

101.CAL*

Inline XBRL Taxonomy Extension Calculation Linkbase Document.

101.DEF*

101.DEF*

Inline XBRL Taxonomy Extension Definition Linkbase Document.

101.LAB*

101.LAB*

Inline XBRL Taxonomy Extension Label Linkbase Document.

101.PRE*

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase Document.

104*

104*

Cover Page Interactive Data File (Embedded within the inline XBRL document and included in Exhibit 101.1).

* Filed herewith

* Filed herewith

Page 23 of 24

 

SIGNATURES

 

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

 

Date: November 9, 2021UNITED-GUARDIAN, INC. 
 (Registrant)
 
   
 By:  /S/ KEN GLOBUS 
 Ken Globus 
 President  
   
 
By:/S/ ANDREA YOUNG 
Date: August 12, 2022Andrea Young 
 Chief Financial Officer 

 

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