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Item 2.
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Management's
Discussion and Analysis of Financial Condition and Results of Operations
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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 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 actually 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, medical products, and proprietary specialty industrial products.
All of the products that the Company manufactures, with the exception of Renacidin®, are produced at its facility
in Hauppauge, New York, and are marketed through marketing partners, distributors, wholesalers, direct advertising, mailings,
and trade exhibitions. Its most important product line is its Lubrajel® line of water-based moisturizing and lubricating
gels, which are used primarily as ingredients in cosmetic products, as well as medical lubricants. The Company’s research
and development department is actively working on the development of new products to expand the Company’s line of personal
care products. Over the years the Company has relied on both patent protection and trade secret protection to protect its proprietary
manufacturing processes and other intellectual property. There are no active patents at the current time.
The Company’s personal care
products are marketed worldwide by six marketing partners, the largest of which is U.S.-based ASI. The Company also sells two pharmaceutical
products for urological uses. Those products are sold primarily in the United States through the major drug wholesalers, which
in turn sell the products to pharmacies, hospitals, nursing homes and other long-term care facilities, and to government agencies,
primarily the United States Department of Veterans Affairs.
The Company’s non-pharmaceutical
medical products (referred to hereinafter as “medical products”), such as its catheter lubricants, as well as its specialty
industrial products, are sold directly by the Company to the end users or to contract manufacturers utilized by the end users,
although they are available for sale on a non-exclusive basis by its marketing partners as well.
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 products
are shipped, title and risk of loss pass to the customers, persuasive evidence of a sales arrangement exists, and 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 a number of registered trademarks, the
two most important of which are “Lubrajel” and “Renacidin”. However, in regard to 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 practical protection they
afford, and the difficulty and expense of enforcing them. 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.
Critical
Accounting Policies
As
disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2018, 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, 2018, 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, 2018, and a comparison of the results of operations for the three and nine months ended September 30, 2019 and September 30,
2018. This discussion and analysis should be read in conjunction with "Management's Discussion and Analysis or Plan of Operation"
included in the Company's Annual Report on Form 10-K for the year ended December 31, 2018.
The Company recognizes revenue from
sales of its personal care, 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. 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 its pharmaceutical products.
RESULTS
OF OPERATIONS
Sales
Sales for the third quarter of 2019 decreased by $27,004
(less than 1%) when compared with the same period in 2018. Sales for the first nine months of 2019 decreased by $889,439 (8%) as
compared with the corresponding period in 2018. The decrease in sales for both the third quarter of 2019 and the first nine months
of 2019 were attributable to changes in sales of the following product lines:
Personal care products:
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a)
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Third
quarter sales: For the third quarter of 2019, the Company’s sales of
personal care products decreased by $394,313 (21%) when compared with the third quarter
of 2018. The decrease in third quarter sales was due primarily to a decrease of $330,572
(22%) in sales of the Company’s personal care products to ASI. This was primarily
the result of a decrease in demand for some of the Company’s products in China
in 2019 compared with 2018. Based on information provided to the Company by ASI, the
Company’s marketing partners in China, the reduced sales were the result of both
a softening of the market in China for a particular line of cosmetic products in which
the Company’s products were being used, as well as continuing competition from
lower-priced Asian competitors. The Company continues to work closely with ASI to price
the Company’s products as competitively as possible in order to better compete
with lower-cost Asian competitors, and it recently provided ASI with reduced pricing
on some of its products, which it hopes will enable it to recover some of the business
it has lost to some of the lower-cost competitors.
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Third quarter sales to the Company’s five other marketing
partners, as well as to three small direct personal care customers, decreased by $63,741 (19%) compared with the third quarter
of 2018, with sales to the Company’s marketing partners in the UK, Switzerland and France decreasing by $82,300 (33%), and
sales to the Company’s marketing partners in Korea and Italy and the three direct personal care customers increasing by a
total of $18,559 (71%). The Company believes that the decline in sales in Europe has been due primarily to increased competition
from Asian competitors selling similar, although not necessarily identical, products at lower prices, but sales have also been
negatively impacted by the economic conditions in some parts of Europe.
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b)
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Nine-month
sales: For the first nine months of 2019 the Company’s sales of personal
care products decreased by $1,756,487 (28%) when compared with the same period in 2018.
This decrease was due primarily to a decrease of $1,355,465 (27%) in shipments of the
Company's extensive line of personal care products to ASI. The primary reason for the
decrease in sales for the nine-month period was the same as for the sales decrease in
the third quarter, with lower sales to ASI resulting from the reduction in demand in
China.
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Sales for the first nine months of the year of the Company’s personal care products to the Company’s five other marketing
partners, as well as to the three direct personal care customers, decreased by $401,022 (33%) compared with the same period in
2018. Nine-month sales to the Company’s marketing partners in Korea decreased by $177,272 (67%), while combined sales to
the Company’s four marketing partners in Europe, as well to the three direct personal care product customers, decreased by
$223,750 (23%).
The Company’s sales in Korea over the past year have
declined significantly, and, as a result, the Company has notified its Korean marketing partner that it will be terminating that
distributor’s marketing rights in Korea effective as of the end of this year. The Company has contracted with ASI to take
over responsibility for marketing the Company’s products in Korea, and those marketing efforts by ASI began in October. The
Company’s current marketing partner is cooperating with the Company in making this change, and the Company is working closely
with both ASI and its current marketing partner in Korea to assure a smooth transition. ASI has expressed confidence that ASI will
be able to increase the Company’s sales in Korea, and the Company is hopeful that this change will enable the Company to
recover some of the sales it has lost in Korea, despite the challenging business environment there.
Pharmaceuticals:
For the third quarter of 2019 sales of the Company’s
pharmaceutical products increased by $200,081 (21%) when compared with the third quarter of 2018. For the nine-month period ended
September 30, 2019 sales of the Company’s pharmaceutical products increased by $446,561 (17%) when compared with the first
nine months of 2018, primarily due to gross sales of Renacidin increasing by $155,142 (15%) for the third quarter and by $468,027
(16%) for the nine-month period. The Company believes that this increase was the result of its increased marketing efforts for
Renacidin, primarily through its launch of a website dedicated to Renacidin and its initiation of internet advertising.
Medical
(non-pharmaceutical) products:
Sales of the Company’s medical products increased
by $162,733 (31%) for the third quarter of 2019, and by $417,085 (25%) for the nine-month period ended September 30, 2019, compared
with the comparable periods in 2018. The increase in medical product sales for both periods was primarily attributable to the increase
in sales in one of the Company’s medical-grade Lubrajel products.
Industrial
and other products:
Sales of the Company's industrial products, as well as
other miscellaneous products, increased by $4,495 (10%) and by $3,402 (3%) for the three and nine months, respectively, ended September
30, 2019, when compared to the corresponding periods in 2018. These changes are primarily attributable to customer ordering patterns.
Although pharmaceutical sales for the three-month period
ended September 30, 2019 increased, there was a decrease of $44,321 in the Company’s provision for rebates, sales returns,
and allowances, compared with the comparable period in 2018. While these provisions are primarily related to pharmaceutical sales,
the decrease for the three-month period was due to a decrease in allowances for outdated material returns and distribution fees.
For the nine-month period ended September 30, 2019, this provision increased by $35,083 compared with the corresponding period
in 2018. This increase was due primarily to (a) increases in VA rebates due to increased sales of the Company’s pharmaceutical
products to the VA; and (b) increases in Medicare and Medicaid rebates paid to various states in connection with the sale of the
Company’s pharmaceutical products.
Cost of Sales
Cost of sales as a percentage of sales increased from 36%
in the third quarter of 2018 to 42% in the third quarter of 2019. For the first nine months of 2019, cost of sales as a percentage
of sales increased from 38% to 42% compared with the first nine months of 2018. The increases in both periods were the result of
an increase in sales of Renacidin, one of the Company’s pharmaceutical products, which carries a higher production cost than
most of the Company’s other products. In addition, there were decreases in sales volumes of some of the Company’s more
profitable personal care products in both the third quarter and first nine months of 2019.
Operating Expenses
Operating expenses, consisting of selling and general
and administrative expenses, increased by $24,846 (5%) for the third quarter of 2019, and by $15,368 (1%) for the first nine months
of 2019, compared with comparable periods in 2018. The increases in operating expenses were primarily attributable to an increase
in IT expenses and advertising expenses. Operating expenses are expected to remain relatively consistent for the remainder of the
year.
Research and Development
Expenses
Research and development expenses increased by $6,499
(7%) for the third quarter of 2019, and by $6,054 (2%) for the first nine months of 2019 compared with the comparable periods in
2018. The increases for both periods were mainly due to an increase in payroll and payroll related expenses.
Investment Income
Investment income increased by $9,272 (24%) for the
third quarter of 2019 compared with the third quarter of 2018, and decreased by $1,179 (less than 1%) for the first nine months
of 2019 compared with the same period in 2018. The increase in the third quarter of 2019 was due to increased interest income recognized
on U.S Treasury Bills that matured during the third quarter of 2019 compared to the same period in 2018. During 2019, the Company
divested a portion of its stock and bond mutual funds and reinvested in U.S. Treasury Bills.
Net gain (loss) on
marketable securities
Net gain (loss) on marketable securities decreased by
$73,646 for the third quarter of 2019 compared with the same period in 2018. Net gain (loss) on marketable securities increased
by $423,803 for the nine months ended September 30, 2019 compared with the same period in 2018. The decrease for the third quarter
was due to the Company recognizing lower gains (both realized and unrealized) on its stock and bond mutual funds compared to the
same period in 2018. The increase for the nine-month period ended September 30, 2019 was due to the Company recognizing increased
gains (both realized and unrealized) compared to the same period in 2018.
Provision for income
taxes
The Company's effective income tax rate was approximately
21% for the first nine months of 2019 and 2018. The Company’s tax rate is expected to remain at 21% for the current fiscal
year.
LIQUIDITY
AND CAPITAL RESOURCES
Working capital increased from $10,320,949 at December
31, 2018 to $11,171,564 at September 30, 2019, an increase of $850,615. The current ratio decreased from 8.6 to 1 at December 31,
2018 to 8.3 to 1 at September 30, 2019. The increase in working capital was primarily due to an increase in cash and marketable
securities. The decrease in the current ratio was primarily due to a decrease in inventories and an increase in accounts 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 2019.
The Company generated cash from operations of $3,627,013
and $3,908,470 for the nine months ended September 30, 2019 and September 30, 2018, respectively. The decrease in cash from operations
was primarily due to a decrease in net income.
Cash provided by investing activities for the nine-month
period ended September 30, 2019 was $142,381. Cash used in investing activities for the nine-month period ended September 30, 2018
was $1,616,477. The increase was primarily due to the increase in U.S. Treasury Bill maturities during the nine-month period in
2019 and increased marketable security purchases when compared to sales in the comparable period in 2018.
Cash used in financing activities was $2,524,946 and
$2,291,294 for the nine months ended September 30, 2019 and September 30, 2018, respectively. The increase was due to an increase
in the dividends paid per share from $0.55 per share in 2019 to $0.50 per share in 2018.
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 are in the best interest
of the Company and its shareholders, should they arise.
OFF BALANCE SHEET ARRANGEMENTS
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.
CONTRACTUAL
OBLIGATIONS AND COMMITMENTS
The information to be reported under
this item is not required of smaller reporting companies.