ITEM 1. Condensed Financial Statements.
UNITED-GUARDIAN, INC.
STATEMENTS OF INCOME
(UNAUDITED)
| | | THREE MONTHS ENDED MARCH 31, | |
| | | | | | | | | |
| | | 2022 | | | 2021 | |
| | | | | | | | | |
| Net Sales | | $ | 3,892,358 | | | $ | 3,430,868 | |
| | | | | | | | | |
| Costs and expenses: | | | | | | | | |
| Cost of sales | | | 1,710,117 | | | | 1,361,013 | |
| Operating expenses | | | 546,749 | | | | 457,127 | |
| Research and development | | | 131,666 | | | | 88,286 | |
| Total costs and expenses | | | 2,388,532 | | | | 1,906,426 | |
| Income from operations | | | 1,503,826 | | | | 1,524,442 | |
| | | | | | | | | |
| Other (expense) income: | | | | | | | | |
| Investment income | | | 40,550 | | | | 39,760 | |
| Net loss on marketable securities | | | (393,660 | ) | | | (72,047 | ) |
| Total other (expense) income | | | (353,110 | ) | | | (32,287 | ) |
| Income before provision for income taxes | | | 1,150,716 | | | | 1,492,155 | |
| | | | | | | | | |
| Provision for income taxes | | | 239,251 | | | | 310,953 | |
| | | | | | | | | |
| Net income | | $ | 911,465 | | | $ | 1,181,202 | |
| | | | | | | | | |
| Earnings per common share (basic and diluted) | | $ | 0.20 | | | $ | 0.26 | |
| | | | | | | | | |
| Weighted average shares – basic and diluted | | | 4,594,319 | | | | 4,594,319 | |
See notes to condensed financial statements
UNITED-GUARDIAN, INC.
BALANCE SHEETS
| ASSETS | | MARCH 31, | | | DECEMBER 31, | |
| | | 2022 | | | | 2021 | |
| | | (UNAUDITED) | | | (AUDITED) | |
| Current assets: | | | | | | | | |
| Cash and cash equivalents | | $ | 511,500 | | | $ | 531,213 | |
| Marketable securities | | | 7,284,091 | | | | 7,635,463 | |
| Accounts receivable, net of allowance for doubtful accounts of $27,055 at March 31, 2022 and $20,252 at December 31, 2021 | | | 2,550,822 | | | | 1,813,346 | |
| Inventories (net) | | | 1,497,640 | | | | 1,410,789 | |
| Prepaid expenses and other current assets | | | 255,922 | | | | 192,579 | |
| Prepaid income taxes | | | 211,666 | | | | --- | |
| Total current assets | | | 12,311,641 | | | | 11,583,390 | |
| | | | | | | | | |
| | | | | | | | | |
| Property, plant and equipment: | | | | | | | | |
| Land | | | 69,000 | | | | 69,000 | |
| Factory equipment and fixtures | | | 4,610,582 | | | | 4,605,742 | |
| Building and improvements | | | 2,853,718 | | | | 2,853,718 | |
| Total property, plant and equipment | | | 7,533,300 | | | | 7,528,460 | |
| Less: accumulated depreciation | | | 6,903,854 | | | | 6,869,598 | |
| Total property, plant and equipment (net) | | | 629,446 | | | | 658,862 | |
| | | | | | | | | |
| | | | | | | | | |
| TOTAL ASSETS | | $ | 12,941,087 | | | $ | 12,242,252 | |
See notes to condensed financial statements
UNITED-GUARDIAN, INC.
BALANCE SHEETS
(continued)
LIABILITIES AND STOCKHOLDERS’ EQUITY
| | | MARCH 31, | | | DECEMBER 31, | |
| | | 2022 | | | 2021 | |
| Current liabilities: | | (UNAUDITED) | | | (AUDITED) | |
| Accounts payable | | $ | 367,815 | | | $ | 410,894 | |
| Accrued expenses | | | 1,533,532 | | | | 1,627,390 | |
| Deferred revenue | | | 88,554 | | | | 190,164 | |
| Income taxes payable | | | --- | | | | 88,738 | |
| Dividends payable | | | 20,575 | | | | 20,575 | |
| Total current liabilities | | | 2,010,476 | | | | 2,337,761 | |
| | | | | | | | | |
| Deferred income taxes (net) | | | 197,877 | | | | 83,222 | |
| | | | | | | | | |
| Commitments and contingencies | | | | | | | | |
| | | | | | | | | |
| Stockholders’ equity: | | | | | | | | |
| Common stock $.10 par value; 10,000,000 shares authorized; 4,594,319 shares issued and outstanding at March 31, 2022 and December 31, 2021 | | | 459,432 | | | | 459,432 | |
| Retained earnings | | | 10,273,302 | | | | 9,361,837 | |
| Total stockholders’ equity | | | 10,732,734 | | | | 9,821,269 | |
| | | | | | | | | |
| TOTAL LIABILITIES AND STOCKHOLDERS’ EQUITY | | $ | 12,941,087 | | | $ | 12,242,252 | |
See notes to condensed financial statements
UNITED-GUARDIAN, INC.
STATEMENTS OF CHANGES IN
STOCKHOLDERS’ EQUITY
(UNAUDITED)
THREE MONTHS ENDED MARCH 31, 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 | |
THREE MONTHS ENDED MARCH 31, 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 | |
See notes to condensed financial statements
UNITED-GUARDIAN, INC.
STATEMENTS OF CASH FLOWS
(UNAUDITED)
| | | THREE MONTHS ENDED | |
| | | MARCH 31, | |
| | | 2022 | | | 2021 | |
| Cash flows from operating activities: | | | | | | | | |
| Net income | | $ | 911,465 | | | $ | 1,181,202 | |
| Adjustments to reconcile net income to net cash provided by operating activities: | | | | | | | | |
| Depreciation | | | 34,256 | | | | 34,900 | |
| Net loss on marketable securities | | | 393,660 | | | | 72,047 | |
| Bad debt expense | | | 6,803 | | | | 5,275 | |
| Deferred income taxes | | | 114,655 | | | | 61,993 | |
| (Increase) decrease in operating assets: | | | | | | | | |
| Accounts receivable | | | (744,279 | ) | | | (521,314 | ) |
| Inventories | | | (86,851 | ) | | | 82,938 | |
| Prepaid expenses and other current assets | | | (63,343 | ) | | | (132,389 | ) |
| Prepaid income taxes | | | (211,666 | ) | | | 48,960 | |
| (Decrease) increase in operating liabilities: | | | | | | | | |
| Accounts payable | | | (43,079 | ) | | | 25,904 | |
| Accrued expenses and other current liabilities | | | (93,858 | ) | | | 130,690 | |
| Deferred revenue | | | (101,610 | ) | | | | |
| Income taxes payable | | | (88,738 | ) | | | --- | |
| Net cash provided by operating activities | | | 27,415 | | | | 990,206 | |
| | | | | | | | | |
| Cash flows from investing activities: | | | | | | | | |
| Acquisition of property, plant, and equipment | | | (4,840 | ) | | | (28,156 | ) |
| Purchase of marketable securities | | | (42,288 | ) | | | (691,445 | ) |
| Net cash used in investing activities | | | (47,128 | ) | | | (719,601 | ) |
| | | | | | | | | |
| Net (decrease) increase in cash and cash equivalents | | | (19,713 | ) | | | 270,605 | |
| Cash and cash equivalents at beginning of period | | | 531,213 | | | | 591,444 | |
| Cash and cash equivalents at end of period | | $ | 511,500 | | | $ | 862,049 | |
| | | | | | | | | |
| Supplemental disclosure of cash flow information | | | | | | | | |
| Taxes paid | | $ | 425,000 | | | $ | 200,000 | |
See notes to condensed financial statements
UNITED-GUARDIAN, INC.
NOTES TO CONDENSED FINANCIAL STATEMENTS
(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 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 of 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 considered necessary for the fair presentation of financial statements for the interim periods have been included. The results of operations for the three months ended March 31, 2022 (also referred to as the “first quarter of 2022”) are not necessarily indicative of results that ultimately may be achieved for any other interim period or for the year ending December 31, 2022. The interim unaudited condensed financial statements and notes thereto should be read in conjunction with the audited condensed financial statements and notes thereto contained in our Annual Report on Form 10-K for the year ended December 31, 2021.
3. Impact of the Coronavirus (COVID-19)
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 during 2021 and in the first quarter of 2022. While the Company believes that sales of its cosmetic ingredients have rebounded to pre-pandemic levels, the current impact on the Company’s financial performance is coming more from increased shipping costs and higher raw material costs, which may have some future impact on the Company’s profit margins in upcoming quarters. In addition, during 2021 and the first quarter 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 created some delays in having orders picked up, even though the Company’s products were available to ship. At March 31, 2022, the Company had approximately $240,000 worth of medical products ready to ship, but were unable to do so due to a lack of vessel availability. The shortage of truck drivers and shipping vessels is expected to continue well into 2022 but is also expected to improve as the as the year progresses and the impact of the 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.
Sales of the Company’s non-pharmaceutical medical products (“medical products”) had also been negatively impacted by the pandemic in 2020, but those impacts lessened in 2021 and in the first quarter of 2022. Sales of the Company’s pharmaceutical products have not been impacted by the pandemic.
The pandemic has not significantly affected the ability of the Company to obtain raw materials, but it has made some of those materials more expensive and created longer lead times for some of them. The increased cost of some of these raw materials has impacted the Company’s gross profit margins in the first quarter of 2022 and may continue to impact the gross profit margins in the future on certain products. In response to the rising raw material prices, the Company has instituted price increases on many of its products, which will reduce the impact on the Company’s gross margins in the future.
As 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 and in the first quarter of 2022, the 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.
4. Use of Estimates
In preparing financial statements in accordance with US GAAP, management is required to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements, and 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. The Company deposits cash and cash equivalents with financially strong, FDIC-insured financial institutions, and believes that any amounts above FDIC insurance limitations are 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 March 31, 2022, approximately $274,000 exceeded the FDIC limit, compared with $410,000 at December 31, 2021.
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 that the revenues are recognized. Such deductions, primarily related to sales of the Company’s pharmaceutical products, include chargebacks from the United States Department of Veterans Affairs (“VA”), rebates in connection with the Company’s participation in Medicare 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 2022 and 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. 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.
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 their 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 March 31, 2022 and December 31, 2021, the allowance for doubtful accounts receivable was $27,055 and $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 only after they have been taken.
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.
Disaggregated revenue by product class is as follows:
| | | Three months ended March 31, | |
| | | 2022 | | | 2021 | |
| Cosmetic ingredients | | $ | 2,077,916 | | | $ | 1,630,597 | |
| Pharmaceutical | | | 1,225,212 | | | | 1,143,307 | |
| Medical | | | 557,795 | | | | 616,026 | |
| Industrial and other | | | 31,435 | | | | 40,938 | |
| Net Sales | | $ | 3,892,358 | | | $ | 3,430,868 | |
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 21% of the Company’s total sales were to customers located outside of the United States in the first quarter of 2022, compared with approximately 22% in the first quarter of 2021.
Disaggregated revenue by geographic region is as follows:
| | | Three months ended March 31, | |
| | | 2022 | | | 2021 | |
| United States* | | $ | 3,079,896 | | | $ | 2,671,387 | |
| Other countries | | | 812,462 | | | | 759,481 | |
| Net Sales | | $ | 3,892,358 | | | $ | 3,430,868 | |
*Since all purchases by ASI are shipped to ASI’s warehouses in the U.S. they are reported as U.S. sales for financial reporting purposes. However, ASI has reported to the Company that in the first quarter of 2022, approximately 71% of ASI’s sales of the Company’s products were to customers in other countries, with China representing approximately 40% of ASI’s sales of the Company’s products. In the first quarter of 2021, approximately 67% of ASI’s sales of the Company’s products were to customers in other countries, with China representing approximately 36% of ASI’s sales of the Company’s products.
7. Marketable Securities
Marketable securities include investments in fixed income and equity mutual funds which are reported at their fair values.
The disaggregated net gains and losses on the marketable securities recognized in the statements of income for the three months ended March 31, 2022 and 2021 are as follows:
| | | Three months ended March 31, | |
| | | 2022 | | | 2021 | |
| Net loss recognized during the period on marketable securities | | $ | (393,660 | ) | | $ | (72,047 | ) |
| Less: Net gains (losses) realized on marketable securities sold during the period | | | --- | | | | --- | |
| Net unrealized loss recognized during the reporting period on marketable securities still held at the reporting date | | $ | (393,660 | ) | | $ | (72,047 | ) |
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:
March 31, 2022 (unaudited)
| | | Cost | | | Fair Value | | | Unrealized
(Loss) Gain | |
| Equity Securities | | | | | | | | | | | | |
| Fixed-income mutual funds | | $ | 6,853,475 | | | $ | 6,539,521 | | | $ | (313,954 | ) |
| Equity and other mutual funds | | | 654,981 | | | | 744,570 | | | | 89,589 | |
| Total equity securities | | | 7,508,456 | | | | 7,284,091 | | | | (224,365 | ) |
| Total marketable securities | | $ | 7,508,456 | | | $ | 7,284,091 | | | $ | (224,365 | ) |
December 31, 2021 (audited)
| | | Cost | | | Fair Value | | | Unrealized
Gain | |
| Equity Securities | | | | | | | | | | | | |
| Fixed-income mutual funds | | $ | 6,814,420 | | | $ | 6,873,333 | | | $ | 58,913 | |
| Equity and other mutual funds | | | 651,748 | | | | 762,130 | | | | 110,382 | |
| Total equity securities | | | 7,466,168 | | | | 7,635,463 | | | | 169,295 | |
| Total marketable securities | | $ | 7,466,168 | | | $ | 7,635,463 | | | $ | 169,295 | |
Investment income is recognized when earned and consists principally of dividend income from equity and fixed income mutual funds. Realized gains and losses on sales of investments are determined on a specific identification basis.
There were no proceeds from the redemption of marketable securities in the first quarter of 2022 or 2021.
8. Inventories
| | | March 31, | | | December 31, | |
| | | 2022 | | | 2021 | |
| Inventories consist of the following: | | (Unaudited) | | | (Audited) | |
| Raw materials | | $ | 639,385 | | | $ | 494,348 | |
| Work in process | | | 136,872 | | | | 119,069 | |
| Finished products | | | 721,383 | | | | 797,372 | |
| Total inventories | | $ | 1,497,640 | | | $ | 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 March 31, 2022 and December 31, 2021 are stated net of a reserve of $35,000 for slow-moving and obsolete inventory.
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 March 31, 2022 and December 31, 2021, the Company did not have any unrecognized tax benefits. The Company’s provision for income taxes for the three months ended March 31 comprises the following:
| | | Three months ended March 31 | |
| | | 2022 | | | 2021 | |
| | | | | | | | | |
| Provision for federal income taxes – current | | $ | 124,496 | | | $ | 248,860 | |
| Provision for state income taxes – current | | | 100 | | | | 100 | |
| Provision for federal income taxes – deferred | | | 114,655 | | | | 61,993 | |
| Total provision for income taxes | | $ | 239,251 | | | $ | 310,953 | |
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 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 $27,250 in contributions to the DC Plan for the three months ended March 31, 2022, and $32,500 for the three months ended March 31, 2021. In the first quarter of 2022, the Company made discretionary contributions of $109,000 to the DC Plan. This payment represented the Company’s 2021 discretionary contribution. In the first quarter of 2021, the Company did not make any discretionary contributions to the DC Plan, as that contribution was made in the fourth quarter of 2020.
11. Other Information
Accrued expenses:
| | | March 31, 2022 | | | December 31, 2021 | |
| | | (unaudited) | | | (audited) | |
| Bonuses | | $ | 491,397 | | | $ | 348,000 | |
| Distribution fees | | | 361,936 | | | | 359,550 | |
| Payroll and related expenses | | | 246,128 | | | | 292,560 | |
| Reserve for outdated material | | | 317,105 | | | | 313,904 | |
| Audit fee | | | 23,750 | | | | 61,500 | |
| Annual report expenses | | | 32,206 | | | | 64,038 | |
| Company 401K contribution | | | 27,250 | | | | 109,000 | |
| Sales rebates | | | 8,000 | | | | 56,857 | |
| Other | | | 25,760 | | | | 21,981 | |
| Total accrued expenses | | $ | 1,533,532 | | | $ | 1,627,390 | |
12. 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 which 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. It is effective 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.
13. Concentrations of Credit Risk
Customer concentration: 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 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, the Company believes that its credit risk from accounts receivable has been reduced.
For the three months ended March 31, 2022, three of the Company’s pharmaceutical distributors and one of its cosmetic ingredients marketing partners together accounted for 79% of the Company’s net sales, and 78% of its outstanding accounts receivable at March 31, 2022. During the three months ended March 31, 2021, the same three distributors and marketing partner together were responsible for a total of approximately 77% of the Company’s net sales. They also accounted for 67% of the Company’s outstanding accounts receivable at March 31, 2021.
14. Earnings Per Share
Basic 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. 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.
Basic and diluted earnings per share amounted to $0.20 and $0.26 for the three months ended March 31, 2022 and 2021, respectively.
15. Subsequent Events
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 is to ensure that value is being maximized for shareholders, and that the Company has sufficient scale and financial resources to take advantage of potential growth opportunities available. These alternatives could include, among others, an outright sale of the Company, possible joint ventures, strategic partnerships or alliances, or other possible transactions.
In furtherance of this goal, the Company retained Capstone Partners, a Denver- and Boston-based financial advisory and investment banking company to assist it with this endeavor. The Company paid a non-refundable fee of $75,000 to Capstone in connection with the work it would be performing on behalf of the Company. The Company also retained the Denver-based law firm of Brownstein Hyatt Farber Schreck, LLP to assist with the legal aspects of any possible transactions that might result from the efforts of Capstone.
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
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 using such words as “believes,” “may,” “will,” “should,” “intends,” “plans,” “estimates,” or “anticipates” or other similar expressions.
Forward-looking statements involve inherent risks and uncertainties, and important factors (many of which are beyond our 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.
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, except 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 but 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, as well as 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, or to contract manufacturers utilized by those 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.
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.
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 during 2021 and in the first quarter of 2022. While the Company believes that sales of its cosmetic ingredients have rebounded to pre-pandemic levels, the current financial impact is coming more from increased shipping costs and higher raw material costs, which may have some future impact on the Company’s profit margins in upcoming quarters. In addition, during 2021 and the first quarter 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 created some delays in having orders picked up, even though the Company’s products were available to ship. At March 31, 2022, the Company had approximately $240,000 worth of its medical products ready to ship, but were unable to do so due to lack of vessel availability. The shortage of truck drivers and shipping vessels is expected to continue well into 2022 but is also expected to improve as the year progresses and the impact of the 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.
Sales of the Company’s non-pharmaceutical medical products (“medical products”) had also been negatively impacted by the pandemic in 2020, but those impacts lessened in 2021 and in the first quarter of 2022. Sales of the Company’s pharmaceutical products have not been impacted by the pandemic.
The pandemic has not significantly affected the ability of the Company to obtain raw materials, but it has made some of those materials more expensive and created longer lead times for some of them. The increased costs of some of these raw materials has impacted the Company’s gross profit margins in the first quarter of 2022 and may continue to impact the gross profit margins in the future on certain products. In response to the rising raw material prices, the Company has instituted price increases on many of its products and hopes to minimize the impact on the gross margins in the future.
With the continuing uncertainty as to what the duration and future impact of the pandemic will be, the Company is unable to provide an accurate estimate or projection as to what the continuing impact of the pandemic will be on the Company’s operations or its financial results in the future. The Company does not expect the carrying value of its assets or its liquidity to be impaired by the coronavirus pandemic.
CRITICAL ACCOUNTING POLICIES
As disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 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, 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, 2021, and a comparison of the results of operations for the three months ended March 31, 2022 and March 31, 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 specified otherwise.
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. 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 their 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 their pharmaceutical products.
RESULTS OF OPERATIONS
Net Sales
Net sales for the first quarter of 2022 increased by $461,490 (approximately 13%) as compared with the first quarter of 2021. The increase in sales for the first quarter of 2022 was primarily attributable to an increase in sales of the Company’s cosmetic ingredients and pharmaceutical products, which was partially offset by a decrease in sales of the Company’s medical and industrial products. The changes in the sales of the products in the Company’s different products lines were as follows:
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(a) |
Cosmetic Ingredients: Sales of the Company’s cosmetic ingredients increased by $447,319 (approximately 27%) in the first quarter of 2022 compared with the same period in 2021. The increase was primarily attributable to an increase in purchases of the Company’s cosmetic ingredients by ASI, whose purchases increased by $381,915 (approximately 29%) compared with the same period in 2021, In addition, sales to the Company’s four other marketing partners increased by a net of $80,598 (approximately 27%), while sales to three direct cosmetic ingredient customers in the United States decreased by $15,194 (approximately 87%). |
The increase in sales attributable to the Company’s four other marketing partners was primarily due to significant sales increases to the Company’s marketing partners in France and Germany, both of whose sales increased over 100% compared with the same period in 2021. The Company believes this increase was due to improving global economic conditions.
Based on information received from ASI, the Company believes that the increase in sales to ASI was primarily due to increased demand for the Company’s Lubrajel products in China.
Since the Company’s cosmetic ingredients are marketed globally by its marketing partners in many different countries, and since the virus continues to impact countries at different times and to very different extents, it is difficult to project the future impact of the coronavirus pandemic on the Company’s global cosmetic ingredient sales. However, based on sales in the first quarter of 2022, the Company believes that sales of its cosmetic ingredients have significantly improved and will continue to improve during 2022 as long as the global pandemic situation continues to improve.
In addition to the impact of the pandemic on sales of the Company’s cosmetic ingredients, there also continues to be significant global competition from Asian and European competitors selling products that are chemically similar to, and competitive with, those sold by the Company, some of which are marketed at lower prices than the products manufactured by the Company. The Company continues to work closely with its marketing partners to price its products as competitively as possible and, when appropriate, to offer additional volume discounts and more aggressive pricing to maintain and increase sales and bring in new customers. However, the Company expects the Asian and European markets to remain very competitive based on the continuing competition from lower-cost competitors, and for that reason it is concentrating its research and development (“R&D”) efforts on developing new and unique products that other companies do not have.
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(b) |
Pharmaceutical Products: 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). Net sales of the Company’s two pharmaceutical products, Renacidin and Clorpactin, together increased from $1,143,307 in the first quarter of 2021 to $1,225,212 in the first quarter of 2022, (approximately 7%). Gross sales of both products increased from $1,383,594 in the first quarter of 2021 to $1,433,877 in the first quarter of 2022 (approximately 4%). |
The difference in the net sales increase compared with the gross sales increase for these products is due to a combination of an increase in gross sales of those products, combined with a decrease in pharmaceutical sales allowances of $31,621 (approximately 13%), compared with the same period in 2021. The decrease in sales allowances was primarily due to a decrease in VA chargebacks.
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(c) |
Medical Products: Sales of the Company’s non-pharmaceutical medical products decreased by $58,231 (approximately 9%) for the first quarter of 2022 when compared with the same period in 2021. The decrease was primarily due to the inability of certain foreign customers to secure vessels to transport the Company’s products. At March 31, 2022, customer orders totaling approximately $240,000 were ready to ship, but there were delays in having these orders picked up from the Company’s facility due to the difficulty customers were having securing transport vessels. The Company has, in fact, seen an increase in medical product orders from its customers in both China and India, and is hopeful that the steady increase will continue throughout the year. |
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(d) |
Specialty Industrial Products: Sales of the Company’s specialty industrial products, as well as other miscellaneous products, decreased by $9,503 (approximately 23%) for the first quarter of 2022 compared with the same period in 2021. The decrease 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 increased to approximately 44% for the first quarter of 2022, up from approximately 40% for the first quarter in 2021. The increase was primarily the result of an increase in the price of some of the Company’s raw materials. The Company has experienced increased raw material costs over the past year; however, it has been able to lock in pricing on crucial raw materials and has also seen prices start to decline on certain products compared to prices last year. In addition, in the first quarter of 2021, the Company recorded a one-time employee-retention credit from the Internal Revenue Service, which offset and reduced some labor costs in that quarter.
In an effort to offset rising raw material costs, the Company instituted price increases on most of its products, some of which took effect in the latter part of 2021, while others took effect at the beginning of the second quarter of 2022.
Operating Expenses
Operating expenses, consisting of selling, general, and administrative expenses, increased by $89,622 (approximately 20%) for the first quarter of 2022 compared with the first quarter of 2021. The increase was mainly due to the Company recording a one-time employee retention credit in the first quarter of 2021, combined with an increase in payroll, payroll related costs and consulting fees in the first quarter of 2022.
Research and Development Expenses
R&D expenses increased by $43,380 (approximately 49%) for the first quarter of 2022 compared with the first quarter of 2021. The increase was primarily due to an increase in payroll and payroll related costs combined with the fact that in the first quarter of 2021 the Company recorded a one-time employee-retention credit that reduced its payroll and payroll related costs in that quarter.
Investment Income
Investment income increased by $790 (approximately 2%) for the first quarter of 2022 compared with the first quarter of 2021.
Net Loss on Marketable Securities
The net loss on marketable securities increased by $321,613 (approximately 446%) for the first quarter of 2022 compared with the first quarter of 2021. Approximately 90% of the Company’s marketable securities portfolio 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 current inflationary environment and the rise of interest rates, management believes that the decrease in the market value of the 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 order to minimize the future impact on the Company’s financial position that the volatility of the global financial markets may have.
Provision for Income Taxes
The Company's effective income tax rate was approximately 21% for the first quarter of 2022 and 2021, and is expected to remain at 21% for the current fiscal year.
LIQUIDITY AND CAPITAL RESOURCES
Working capital increased by $1,055,536 to $10,301,165 at March 31, 2022, up from $9,245,629 at December 31, 2021. The current ratio increased to 6.1 to 1 at March 31, 2022, up from 5.0 to 1 at December 31, 2021. The increases in working capital and the current ratio were primarily due to an increase accounts receivable and prepaid income taxes.
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’s long-term liquidity position will be dependent on its ability to generate sufficient cash flow from profitable operations.
The Company has no material commitments for future capital expenditures and no material cash requirements of immediate concern.
The Company has no off balance-sheet transactions that have, or are reasonably likely to have, a current or future effect on the Company’s financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures, or capital resources.
The Company generated cash from operations of $27,415 and $990,206 for the three months ended March 31, 2022 and March 31, 2021, respectively. The decrease was due primarily to an increase in accounts receivable and prepaid income taxes.
Cash used in investing activities for the three months ended March 31, 2022 was $47,128 compared with $719,601 for the three months ended March 31, 2021. The decrease was primarily due to a decrease in purchases of marketable securities in the first quarter of 2022.
There was no cash used in financing activities for the first quarters of 2022 and 2021.
The Company expects to continue to use its cash to make dividend payments, purchase marketable securities, and take advantage of other market opportunities that may arise that are in the best interests of the Company and its shareholders.
CONTRACTUAL OBLIGATIONS AND COMMITMENTS
The information to be reported under this item is not required of smaller reporting companies.