UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-Q
(Mark
One)
☑
QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the quarterly period ended September 30, 2022
☐
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
For
the transition period from to .
Commission
File No.: 001-34839
Electromed, Inc.
(Exact
Name of Registrant as Specified in its Charter)
Minnesota
41-1732920
(State
or other jurisdiction of incorporation or organization)
(I.R.S.
Employer Identification No.)
500
Sixth Avenue NW
New Prague , Minnesota
56071
(Address
of principal executive offices)
(Zip
Code)
( 952 )
758-9299
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Common
Stock, $0.01 par value
ELMD
NYSE
American LLC
(Title
of each class)
(Trading
Symbol(s))
(Name
of each exchange on which registered)
Indicate
by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange
Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports),
and (2) has been subject to such filing requirements for the past 90 days. Yes ☑ No ☐
Indicate
by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant
to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that
the registrant was required to submit such files). Yes ☑ No ☐
Indicate
by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting
company or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,”
“smaller reporting company” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
Large
accelerated filer ☐
Accelerated
filer ☐
Non-accelerated
filer ☑
Smaller
reporting company ☑
Emerging
growth company ☐
If
an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for
complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate
by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes ☐ No ☑
There
were 8,485,064
shares of Electromed, Inc. common stock, par
value $0.01 per share, outstanding as of the close of business on November 4, 2022.
Electromed,
Inc.
Index
to Quarterly Report on Form 10-Q
Page
PART I – FINANCIAL INFORMATION
Item 1. Financial Statements
1
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations
11
Item 3. Quantitative and Qualitative Disclosures About Market Risk
17
Item 4. Controls and Procedures
17
PART II – OTHER INFORMATION
Item 1. Legal Proceedings
17
Item 1A. Risk Factors
18
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
18
Item 3. Defaults Upon Senior Securities
18
Item 4. Mine Safety Disclosures
18
Item 5. Other Information
18
Item 6. Exhibits
19
PART
I – FINANCIAL INFORMATION
Item
1. Financial
Statements.
Electromed,
Inc.
Condensed
Balance Sheets
September 30, 2022
June 30, 2022
(Unaudited)
Assets
Current Assets
Cash and cash equivalents
$ 5,998,000
$ 8,153,000
Accounts receivable (net of allowances for doubtful accounts of $ 45,000 )
20,957,000
21,052,000
Contract assets
453,000
286,000
Inventories
3,673,000
3,178,000
Prepaid expenses and other current assets
2,015,000
1,870,000
Income taxes receivable
124,000
-
Total current assets
33,220,000
34,539,000
Property and equipment, net
4,682,000
4,568,000
Finite-life intangible assets, net
600,000
599,000
Other assets
100,000
120,000
Deferred income taxes
1,532,000
1,538,000
Total assets
$ 40,134,000
$ 41,364,000
Liabilities and Shareholders’ Equity
Current Liabilities
Accounts payable
$ 1,265,000
$ 1,261,000
Accrued compensation
1,610,000
2,742,000
Income tax payable
-
51,000
Warranty reserve
1,354,000
1,256,000
Other accrued liabilities
1,724,000
1,840,000
Total current liabilities
5,953,000
7,150,000
Other long-term liabilities
37,000
41,000
Total liabilities
5,990,000
7,191,000
Commitments and Contingencies
Shareholders’ Equity
Common stock, $ 0.01 par value per share, 13,000,000 shares authorized; 8,485,864 and 8,475,438 shares issued and outstanding, as of September 30, 2022 and June 30, 2022, respectively
85,000
85,000
Additional paid-in capital
18,343,000
18,308,000
Retained earnings
15,716,000
15,780,000
Total shareholders’ equity
34,144,000
34,173,000
Total liabilities and shareholders’ equity
$ 40,134,000
$ 41,364,000
See
Notes to Condensed Financial Statements (Unaudited).
1
Electromed,
Inc.
Condensed
Statements of Operations (Unaudited)
Three Months Ended
September 30,
2022
2021
Net revenues
$ 10,658,000
$ 10,001,000
Cost of revenues
2,327,000
2,300,000
Gross profit
8,331,000
7,701,000
Operating expenses
Selling, general and administrative
7,989,000
6,787,000
Research and development
298,000
376,000
Total operating expenses
8,287,000
7,163,000
Operating income
44,000
538,000
Interest income, net
4,000
9,000
Net income before income taxes
48,000
547,000
Income tax (benefit) expense
( 33,000 )
108,000
Net income
$ 81,000
$ 439,000
Income per share:
Basic
$ 0.01
$ 0.05
Diluted
$ 0.01
$ 0.05
Weighted-average common shares outstanding:
Basic
8,445,893
8,559,219
Diluted
8,689,377
8,884,493
See
Notes to Condensed Financial Statements (Unaudited).
2
Electromed,
Inc.
Condensed
Statements of Cash Flows (Unaudited)
Three Months Ended September 30,
2022
2021
Cash Flows From Operating Activities
Net income
$ 81,000
$ 439,000
Adjustments to reconcile net income to net cash provided
by (used in) operating activities:
Depreciation
134,000
106,000
Amortization of finite-life intangible assets
20,000
52,000
Share-based compensation expense
95,000
249,000
Deferred income taxes
6,000
32,000
Changes in operating assets and liabilities:
Accounts receivable
95,000
( 1,331,000 )
Contract assets
( 167,000 )
74,000
Inventories
( 500,000 )
91,000
Prepaid expenses and other assets
( 125,000 )
( 186,000 )
Income tax payable, net
( 175,000 )
( 498,000 )
Accounts payable and accrued liabilities
( 26,000 )
( 455,000 )
Accrued compensation
( 1,132,000 )
851,000
Net cash used in operating activities
( 1,694,000 )
( 576,000 )
Cash Flows From Investing Activities
Expenditures for property and equipment
( 241,000 )
( 225,000 )
Expenditures for finite-life intangible assets
( 15,000 )
( 45,000 )
Net cash used in investing activities
( 256,000 )
( 270,000 )
Cash Flows From Financing Activities
Issuance of common stock upon exercise of options
-
1,000
Taxes paid on net share settlement of stock option exercises
( 60,000 )
( 64,000 )
Repurchase of common stock
( 145,000 )
-
Net cash used in financing activities
( 205,000 )
( 63,000 )
Net decrease in cash
( 2,155,000 )
( 909,000 )
Cash
Beginning of period
8,153,000
11,889,000
End of period
$ 5,998,000
$ 10,980,000
Supplemental Disclosures of Cash Flow Information
Cash paid for income taxes
$ 135,000
$ 574,000
Supplemental Disclosures of Noncash Investing and Financing Activities
Property and equipment acquisitions in accounts payable
$ 46,000
$ 2,000
Intangible asset acquisitions in accounts payable
$ 9,000
$ 7,000
Lease assets obtained in exchange for new operating lease liabilities
$ -
$ 53,000
Demonstration equipment returned to inventory
$ 5,000
$ 1,000
See
Notes to Condensed Financial Statements (Unaudited).
3
Electromed,
Inc.
Condensed
Statements of Shareholders’ Equity (Unaudited)
Total
Common Stock
Additional Paid-
Retained
Shareholders’
Shares
Amount
in Capital
Earnings
Equity
Balance at June 30, 2021
8,533,209
$ 85,000
$ 17,409,000
$ 14,922,000
$ 32,416,000
Net income
–
–
–
439,000
439,000
Issuance of restricted stock
25,900
–
–
–
–
Issuance of common stock upon exercise of options
10,530
1,000
–
–
1,000
Taxes paid on stock options exercised on a net basis
–
–
( 64,000 )
–
( 64,000 )
Share-based compensation expense
–
–
249,000
–
249,000
Balance at September 30, 2021
8,569,639
$ 86,000
$ 17,594,000
$ 15,361,000
$ 33,041,000
Total
Common Stock
Additional Paid-
Retained
Shareholders’
Shares
Amount
in Capital
Earnings
Equity
Balance at June 30, 2022
8,475,438
$ 85,000
$ 18,308,000
$ 15,780,000
$ 34,173,000
Net income
–
–
–
81,000
81,000
Issuance of restricted stock
27,400
–
–
–
–
Forfeiture of restricted stock
( 14,166 )
–
–
–
–
Issuance of common stock upon exercise of options
11,760
–
–
–
–
Taxes paid on stock options exercised on a net basis
–
–
( 60,000 )
–
( 60,000 )
Share-based compensation expense
–
–
95,000
–
95,000
Repurchase of common stock
( 14,568 )
–
–
( 145,000 )
( 145,000 )
Balance at September 30, 2022
8,485,864
$ 85,000
$ 18,343,000
$ 15,716,000
$ 34,144,000
See
Notes to Condensed Financial Statements (Unaudited).
4
Electromed,
Inc.
Notes
to Condensed Financial Statements
(Unaudited)
Note
1. Interim Financial Reporting
Nature
of business: Electromed, Inc. (the “Company”) develops, manufactures and markets innovative airway clearance
products that apply High Frequency Chest Wall Oscillation (“HFCWO”) therapy in pulmonary care for patients of all
ages. The Company markets its products in the U.S. to the home health care and institutional markets for use by patients in
personal residences, hospitals and clinics. The Company also sells internationally both directly and through distributors.
International sales were $ 81,000 and $ 112,000 for the three months ended September 30, 2022 and 2021, respectively. Since its
inception, the Company has operated in a single industry segment: developing, manufacturing and marketing medical
equipment.
Impacts
of COVID-19 on the Company’s business:
The
impact of the COVID-19 pandemic on the Company’s business remains uncertain, and its effects on our operational and financial
performance will depend in large part on future developments, which cannot be reasonably estimated at this time. Such future developments
include, but are not limited to, the duration, scope and severity of the COVID-19 pandemic in geographic areas where the Company
operates or in which its patients live, actions taken to contain or mitigate its impact, the impact on governmental healthcare
programs and budgets, the development and distribution of treatments or vaccines, and the resumption of widespread economic activity.
Due to the inherent uncertainty of the unprecedented and rapidly evolving situation, the Company is unable to predict with confidence
the likely impact of the COVID-19 pandemic on its future operations. For a more detailed discussion, see “Management’s
Discussion and Analysis of Financial Condition and Results of Operations” in Part I, Item 2 of this Quarterly Report on
Form 10-Q.
Basis
of presentation: The accompanying unaudited Condensed Financial Statements of the Company have been prepared in accordance
with U.S. generally accepted accounting principles (“U.S. GAAP”) for interim financial statements and pursuant to
the rules and regulations of the U.S. Securities and Exchange Commission. In the opinion of management, the accompanying unaudited
Condensed Financial Statements reflect all adjustments consisting of normal recurring adjustments necessary for a fair presentation
of the Company’s financial position and results of operations as required by Regulation S-X. Interim results of operations
are not necessarily indicative of the results that may be achieved for the full year. The financial statements and related notes
do not include all information and footnotes required by U.S. GAAP for annual reports. This interim report should be read in conjunction
with the financial statements included in the Company’s Annual Report on Form 10-K for the fiscal year ended June 30, 2022
(“fiscal 2022”).
A
summary of the Company’s significant accounting policies follows:
Use
of estimates . Management uses estimates and assumptions in preparing the unaudited Condensed Financial Statements in accordance
with U.S. GAAP. Those estimates and assumptions affect the reported amounts of assets and liabilities, the disclosure of contingent
assets and liabilities, and the reported revenues and expenses. Actual results could vary from the estimates that were used. The
Company believes the critical accounting policies that require the most significant assumptions and judgments in the preparation
of its unaudited Condensed Financial Statements include revenue recognition and the related estimation of variable consideration,
inventory valuation, share-based compensation and warranty reserve.
Net
income per common share . Net income is presented on a per share basis for both basic and diluted common shares. Basic net
income per common share is computed using the weighted average number of common shares outstanding during the period, excluding
any restricted stock awards which have not vested. The diluted net income per common share calculation includes outstanding restricted
stock grants and assumes that all stock options were exercised and converted into common stock at the beginning of the period
unless their effect would be anti-dilutive. Common stock equivalents excluded from the calculation of diluted earnings per share
because their impact was anti-dilutive were 212,023 and 110,752 for the three months ended September 30, 2022 and 2021, respectively.
Recently
Issued Accounting Standards
In
June 2016, the Financial Accounting Board issued Accounting Standards Update (“ASU”) 2016-13, Financial Instruments
-- Credit Losses: Measurement of Credit Losses on Financial Instruments, which was subsequently amended by ASU 2018-19, ASU
2019-04, 2019-05, 2019-10, 2019-11, and 2020-02. The standard introduces new accounting guidance for credit losses on financial
instruments within its scope, including trade receivables. This new guidance adds an impairment model that is based on expected
losses rather than incurred losses. It is effective for interim and annual reporting periods beginning after December 15, 2022,
with early adoption permitted. The adoption of the standard is not expected to have an impact on the Company’s consolidated
results of operations and financial condition.
5
Note
2. Revenues
Revenue
is measured based on consideration specified in the contract with a customer, adjusted for any applicable estimates of variable
consideration and other factors affecting the transaction price, including consideration paid or payable from customers and significant
financing components. Revenue from all customers is recognized when a performance obligation is satisfied by transferring control
of a distinct good or service to a customer, as further described below under Performance obligations and transaction price .
Individual
promised goods and services in a contract are considered a performance obligation and accounted for separately if the individual
good or service is distinct (i.e., the customer can benefit from the good or service on its own or with other resources that are
readily available to the customer and the good or service is separately identifiable from other promises in the arrangement).
If an arrangement includes multiple performance obligations, the consideration is allocated between the performance obligations
in proportion to their estimated standalone selling price, unless discounts or variable consideration is attributable to one or
more but not all the performance obligations. Costs related to products delivered are recognized in the period incurred, unless
criteria for capitalization of costs under Accounting Standards Codification (“ASC”) 340-40, “Other Assets and
Deferred Costs” (“ASC 340”), or other applicable guidance are met.
The
Company includes shipping and handling fees in net revenues. Shipping and handling costs associated with the shipment of the Company’s
SmartVest® Airway Clearance System (“SmartVest System”) after control has transferred to a customer are accounted
for as a fulfillment cost and are included in cost of revenues in the Condensed Statements of Operations.
The
timing of revenue recognition, billings and cash collections results in accounts receivable on the Condensed Balance Sheets as
further described below under Accounts receivable and Contract assets .
Disaggregation
of revenues. In the following table, net revenues are disaggregated by market:
Schedule of disaggregated revenue
Three Months Ended September 30,
2022
2021
Home care
$ 9,632,000
$ 9,284,000
Institutional
391,000
449,000
Home care distributor
554,000
156,000
International
81,000
112,000
Total
$ 10,658,000
$ 10,001,000
In
the following table, net home care revenue is disaggregated by payer type:
Three Months Ended September 30,
2022
2021
Commercial
$ 3,879,000
$ 3,784,000
Medicare
5,382,000
5,176,000
Medicaid
154,000
174,000
Other
217,000
150,000
Total
$ 9,632,000
$ 9,284,000
Revenues
in the Company’s home care, home care distributor, and international markets are recognized at a point in time when control
passes to the customer upon product shipment or delivery. Revenues in the Company’s institutional market include revenue
recognized at a point in time upon shipment or delivery as well as revenue recognized over time under operating leases.
Performance
obligations and transaction price. A performance obligation is a promise in a contract to transfer a distinct good or service
to the customer and is the unit of account under ASC 606, “Revenue From Contracts With Customers” (“ASC 606”).
A contract’s transaction price is allocated to each distinct performance obligation in proportion to the standalone selling
price for each and recognized as revenue when, or as, the performance obligation is satisfied. The Company’s performance
obligations and the timing or method of revenue recognition in each of the Company’s markets are discussed below:
6
Home
care market . In the Company’s home care market, its customers are patients who use the SmartVest System. The various
models of the SmartVest System are comprised of three main components – a generator, a vest and a connecting hose –
that are sold together as an integrated unit. Accordingly, in contracts within the home care market, the Company regards the SmartVest
System to be a single performance obligation.
The
Company makes available to its home care patients limited post-sale services that are not material in the context of the contracts,
either individually or taken together, and therefore does not consider them to be performance obligations. The costs associated
with the services are accrued and expensed when the related revenues are recognized. As such, transactions in the home care market
consist of a single performance obligation: the SmartVest System.
Home
care patients generally will rely on third-party payers, including commercial payers and governmental payers such as Medicare,
Medicaid and the U.S. Department of Veterans Affairs to cover and reimburse all or part of the cost of the SmartVest System. The
third-party payers’ reimbursement programs fall into three types, distinguished by the differences in the timing of payments
from the payer, consisting of either (i) outright sale, in which payment is received from the payer based on standard terms, (ii)
capped installment sale, under which the SmartVest System is sold for a series of payments that are capped not to exceed a prescribed
or negotiated amount over a period of time or (iii) installment sale, under which the SmartVest System is paid for over a period
of several months as long as the patient continues to use the SmartVest System.
Regardless
of the type of transaction, provided criteria for an enforceable contract are met, it is the Company’s long-standing business
practice to regard all home care agreements as transferring control to the patient upon shipment or delivery, in spite of possible
payment cancellation under government or commercial programs where the payer is controlling the payment over specified time periods.
For home care sales that feature installment payments, the ultimate amount of consideration received from Medicare, Medicaid or
commercial payers can be significantly less than expected if the contract is terminated due to changes in the patient’s
status, including insurance coverage, hospitalization, death or otherwise becoming unable to use the SmartVest System. However,
once delivered to a patient who needs the SmartVest System, the patient is under no obligation to return the SmartVest System
should payments be terminated as a result of the described contingencies. As a result, the Company’s product sales qualify
for point in time revenue recognition. Control transfers to the patient, and revenue is recognized, upon shipment of the SmartVest
System. At this point, physical possession and the significant risks and rewards of ownership are transferred to the patient and
either a current or future right to payment is triggered, as further discussed under Accounts receivable and Contract
assets below.
The
Company’s contractually stated transaction prices in the home care market are generally set by the terms of the contracts
negotiated with insurance companies or by government programs. The transaction price for the Company’s products may be further
impacted by variable consideration. ASC 606 requires the Company to adjust the transaction price at contract inception and throughout
the contract duration for the estimated value of payments to be received from insurance payers based on historical experience
and other available information, subject to the constraint on estimates of variable consideration. Transactions requiring estimates
of variable consideration primarily include (i) capped installment payments, which are subject to the third-party payer’s
termination due to changes in insurance coverage, death or the patient’s discontinued use of the SmartVest System, (ii)
contracts under appeal and (iii) patient responsibility amounts for deductibles, coinsurance, copays and other similar payments.
Although
estimates may be made on a contract-by-contract basis, whenever possible, the Company uses all available information, including
historical collection patterns, to estimate variable consideration for portfolios of contracts. The Company’s estimates
of variable consideration consist of amounts it may receive from insurance providers in excess of its initial revenue estimate
due to patients meeting deductibles or coinsurance during the payment duration, changes to a patient’s insurance status,
changes in an insurance allowable, claims in appeals with Medicare and amounts received directly from patients for their allowable
or coinsurance. The Company believes it has representative historical information to estimate the amount of variable consideration
in relevant portfolios considering the significant experience it has with each portfolio and the similarity of patient accounts
within a portfolio. The analysis includes steps to ensure that revenue recognized on a portfolio basis does not result in a material
difference when compared with an individual contract approach. The Company also leverages its historical experience and all available
relevant information for each portfolio of contracts to minimize the risk its estimates used to arrive at the transaction price
will result in a significant reversal in the amount of cumulative revenue recognized when the uncertainty associated with the
variable consideration is subsequently resolved. Variable consideration is included in the transaction price if, in the Company’s
judgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.
For
example, for contracts in which the Company believes the criteria for reimbursement under government or commercial payer contracts
have been met but for which coverage is unconfirmed or payments are under appeal, the Company has significant observable evidence
of relatively consistent claims recovery experience over the prior three to five years. The Company believes the low volatility
in historical claims approval rates for populations of patients whose demographics are similar to those of current patients provides
reliable predictive value in arriving at estimates of variable consideration in such contracts. Similarly, historical payment
trends for recovery of claims subject to payer installments and payments from patients have remained relatively consistent over
the past five years. No significant changes in patient demographics or other relevant factors have occurred that would limit the
predictive value of such payment trends in estimating variable consideration for current contracts. As a result, the Company believes
its estimates of variable consideration are generally not subject to the risk of significant revenue reversal.
7
For
each type of variable consideration discussed above, there are a large number of contracts with similar characteristics with a
wide range of possible transaction prices. For that reason, the Company uses the probability-weighted expected value method provided
under ASC 606 to estimate variable consideration.
The
Company often receives payment from third-party payers for SmartVest System sales over a period of time that may exceed one year.
Despite these extended payment terms, no significant financing component is deemed to exist because the purpose of such terms
is not to provide financing to the patient, the payer or the Company. Rather, the extended payment terms are mandated by the government
or commercial insurance programs; the fundamental purpose of which is to avoid paying the full purchase price of equipment that
may potentially be used by the patient for only a short period of time.
Home
care distributors. Sales to distributors, who sell direct to patients, are made at fixed contract prices and may include
tiered pricing structures or volume-based rebates which offer more favorable pricing once certain volumes are achieved per the
negotiated contract. The distributor’s purchases accumulate to give the distributor a right to a higher discount on purchases
in excess of the specified level within the contract period. As a result, to the extent the Company expects the distributor to
exceed the specified volume of purchases in the annual period, it recognizes revenue at a blended rate based on estimated total
annual volume and sales revenue. This effectively defers a portion of the transaction price on initial purchases below the specified
volumes for recognition when the higher discount is earned on purchases in excess of specified volumes. Transfer of control of
the products occurs upon shipment or delivery to the distributor, as applicable.
Institutional
market. The Company’s institutional sales are made to hospitals and home health care centers, pulmonary rehabilitation
centers and other clinics. Sales to these institutions are negotiated with the individual institution or with group purchasing
organizations, with payments received directly from the institution. No insurance reimbursement is involved. Generators are either
sold or leased to the institutions and associated hoses and wraps (used in institutional settings rather than vests) are sold
separately. Accordingly, each product is distinct and considered a separate performance obligation in sales to institutional customers.
The agreements with institutions fall into two main types, distinguished by differences in the timing of transfer of control and
timing of payments:
● Outright
sale – Under these transactions, the Company sells its products for a prescribed
or negotiated price. Transfer of control of the product, and associated revenue recognition,
occurs at the time of shipment and payment is made within normal credit terms, usually
within thirty days.
● Wrap
usage agreements – Under these transactions, the Company provides a generator device
at no cost to the hospital in return for a fixed annual commitment to purchase consumable
wraps. These agreements are cancellable upon at least sixty days prior written notice
by either party. If cancelled, the generator is returned to the Company, where it can
be refurbished and used again at a later date. Revenue for the consumable wraps is recognized
when control transfers to the customer.
International
market. Sales to international markets are made directly to a number of independent distributors at fixed contract prices
that are not subject to further adjustments for variable consideration. Transfer of control of the products occurs upon shipment
or delivery to the distributor, as applicable.
Product
warranty. The Company offers warranties on its products. These warranties are assurance-type warranties not sold on a standalone
basis or are otherwise considered immaterial in the context of the contract, and therefore are not considered distinct performance
obligations under ASC 606. The Company estimates the costs that may be incurred under its warranties and records a liability in
the amount of such costs at the time the product is sold.
Accounts
receivable. The Company’s accounts receivable balance is comprised of amounts due from individuals, institutions and
distributors. Balances due from individuals are typically remitted to the Company by third-party reimbursement agencies such as
Medicare, Medicaid and private insurance companies. Accounts receivable are carried at amounts estimated to be received from patients
under reimbursement arrangements with third-party payers. Accounts receivable are also net of an allowance for doubtful accounts.
Management determines the allowance for doubtful accounts by regularly evaluating individual customer receivables and considering
a customer’s financial condition and credit history. Receivables are written off when deemed uncollectible.
Contract
assets. Contract assets include amounts recognized as revenue that are estimates of variable consideration for Medicare appeals
where the final determination of the insurance coverage amount is dependent on future approval of an appeal, or when the consideration
due to the Company is dependent on a future event such as the patient meeting a deductible prior to the Company’s claim
being processed by the payer. Contract assets are classified as current as amounts will turn into accounts receivable and be collected
during the Company’s normal business operating cycle. Contract assets are reclassified to accounts receivable when the right
to receive payment is unconditional.
8
Contract
balances. The following table provides information about contract assets from contracts with customers:
Schedule of contract assets
Three Months Ended
September 30, 2022
Fiscal Year Ended
June 30, 2022
Increase (decrease)
Increase (decrease)
Contract assets, beginning
$ 286,000
$ 393,000
Reclassification of contract assets to accounts receivable
( 305,000 )
( 833,000 )
Contract assets recognized
471,000
784,000
Increase (decrease) as a result of changes in the estimate of amounts to be realized from
payers, excluding amounts transferred to receivables during the period
1,000
( 58,000 )
Contract assets, ending
$ 453,000
$ 286,000
Incremental
costs to obtain a contract. Sales incentives paid to sales representatives are eligible for capitalization as they are incremental
costs that would not have been incurred without entering into a specific sales arrangement and are recoverable through the expected
margin on the transaction. However, the recovery period is less than one year as the performance obligation is satisfied upon
shipment or delivery. Consequently, the Company applies the practical expedient provided by ASC 340 and expenses sales incentives
as incurred. These costs are included in selling, general and administrative expenses in the Condensed Statements of Operations.
Note
3. Inventories
The
components of inventory were as follows:
Schedule of components of inventories
September 30, 2022
June 30, 2022
Parts inventory
$ 2,968,000
$ 2,672,000
Work in process
361,000
100,000
Finished goods
317,000
469,000
Estimated inventory to be returned
251,000
228,000
Less: Reserve for obsolescence
( 224,000 )
( 291,000 )
Total
$ 3,673,000
$ 3,178,000
Note
4. Warranty Reserve
The
Company provides a lifetime warranty on its products to the prescribed patient for sales within the U.S. and a three-year warranty
for all institutional sales and sales to individuals outside the U.S. The Company estimates the costs that may be incurred under
its warranty and records a liability in the amount of such costs at the time the product is shipped. Factors that affect the Company’s
warranty reserve include the number of units shipped, historical and anticipated rates of warranty claims, the product’s
useful life and cost per claim. The Company periodically assesses the adequacy of its recorded warranty reserve and adjusts the
amounts as necessary.
Changes
in the Company’s warranty reserve were as follows:
Schedule of changes in warranty liability
Three Months Ended
September 30, 2022
Fiscal Year Ended
June 30, 2022
Warranty reserve, beginning
$ 1,256,000
$ 940,000
Accrual for products sold
172,000
494,000
Expenditures and costs incurred for warranty claims
( 74,000 )
( 178,000 )
Warranty reserve, ending
$ 1,354,000
$ 1,256,000
9
Note
5. Income Taxes
Income
tax benefit was estimated at $ 33,000 , and the effective tax rate was ( 68.8 %) for the three months ended September 30, 2022. Estimated
income tax expense for the three months ended September 30, 2022 includes a discrete current tax benefit of $ 44,000 related to
the exercise of stock options.
Income
tax expense was estimated at $ 108,000 , and the effective tax rate was 19.7 % for the three months ended September 30, 2021. Estimated
income tax expense for the three months ended September 30, 2021 included a discrete current tax benefit of $ 20,000 related to
the exercise of stock options.
The
Company is subject to U.S. federal and state income tax in multiple jurisdictions. With limited exceptions, years prior to the
Company’s fiscal year ended June 30, 2019 are no longer open to U.S. federal, state or local examinations by taxing authorities.
The Company is not under any current income tax examinations by any federal, state or local taxing authority. If any issues addressed
in the Company’s tax audits are resolved in a manner not consistent with management’s expectations, the Company could
be required to adjust its provision for income taxes in the period such resolution occurs.
Note
6. Financing Arrangements
The
Company has a credit facility that provides for a $ 2,500,000 revolving line of credit. There was no outstanding principal balance
on the line of credit as of September 30, 2022 or June 30, 2022. Interest on borrowings under the line of credit, if any, accrues
at the prime rate ( 6.25 % at September 30, 2022) less 1.00 % and is payable monthly. The amount eligible for borrowing on the line
of credit is limited to the lesser of $ 2,500,000 or 57.00 % of eligible accounts receivable and the line of credit expires on December
18, 2023 , if not renewed before such date. At September 30, 2022, the maximum $ 2,500,000 was eligible for borrowing. Payment obligations
under the line of credit, if any, are secured by a security interest in substantially all of the tangible and intangible assets
of the Company.
The
documents governing the line of credit contain certain financial and nonfinancial covenants that include a minimum tangible net
worth covenant of not less than $ 10,125,000 and restrictions on the Company’s ability to incur certain additional indebtedness
or pay dividends.
Note
7. Common Stock
Authorized
shares: The Company’s Articles of Incorporation, as amended, have established 15,000,000 authorized shares
of capital stock consisting of 13,000,000 shares of common stock, par value $ 0.01 per share, and 2,000,000 shares
of undesignated stock.
On
May 26, 2021, the Company’s Board of Directors (the “Board”) approved a stock repurchase authorization. Under
the authorization, the Company was originally able to repurchase up to $ 3.0 million of shares of common stock through
May 26, 2022. On May 26, 2022, the Board removed the date limitation. As of September 30, 2022, a total of 239,195 shares
have been repurchased and retired under this authorization for a total cost of $ 2,717,000 , or $ 11.36 per share. Repurchased
shares have been retired and constitute authorized but unissued shares.
Note
8. Share-Based Compensation
The
Company’s share-based compensation plans are described in Note 8 to the financial statements included in the Company’s
Annual Report on Form 10-K for fiscal 2022. Share-based compensation expense was $ 95,000 and $ 249,000 for the three months ended
September 30, 2022 and 2021, respectively. This expense is included in selling, general and administrative expense in the Condensed
Statements of Operations.
Stock
Options
Stock
option transactions during the three months ended September 30, 2022 are summarized as follows:
Number of Shares
Weighted-Average
Exercise Price per
Share
Outstanding at June 30, 2022
502,084
$ 5.82
Granted
101,500
$ 9.90
Exercised
( 20,000 )
$ 1.75
Cancelled or Forfeited
( 7,799 )
$ 11.95
Outstanding at September 30, 2022
575,785
$ 6.60
10
The
following assumptions were used to estimate the fair value of stock options granted:
Three Months Ended
September 30, 2022
Fiscal Year Ended
June 30, 2022
Risk-free interest rate
2.88 %
0.89 - 2.52 %
Expected term (years)
6
6
Expected volatility
55 %
55 - 64 %
The
intrinsic value of an option is the amount by which the fair value of the underlying stock exceeds its exercise price. At September
30, 2022, the weighted average remaining contractual term for all outstanding stock options was 6.0 years and the aggregate intrinsic
value of the options was $ 2,345,567 . Outstanding at September 30, 2022 were 575,785 stock options issued to employees, of which
413,222 were vested and exercisable and had an aggregate intrinsic value of $ 2,309,189 . As of September 30, 2022, $ 643,858 of
total unrecognized compensation expense related to stock options is expected to be recognized over a weighted-average period of
approximately 2.5 years.
Restricted
Stock
During
the three months ended September 30, 2022, the Company issued restricted stock awards to employees totaling 27,400 shares of common
stock, with a vesting term of three years and a weighted average fair value of $ 9.90 per share. There were 42,918 shares of unvested
restricted stock with a weighted average fair value of $ 10.75 per share outstanding as of September 30, 2022. As of September
30, 2022, $ 304,373 of total unrecognized compensation expense related to restricted stock awards is expected to be recognized
over a weighted-average period of approximately 2.4 years.
Note
9. Commitments and Contingencies
The
Company is occasionally involved in claims and disputes arising in the ordinary course of business. The Company insures certain
business risks where possible to mitigate the financial impact of individual claims and establishes reserves for an estimate of
any probable cost of settlement or other disposition.
On
September 8, 2021, a state court putative class action lawsuit was filed in Minnesota against the Company asserting injury resulting
from the previously announced data breach that impacted the Company’s customer protected health information and employee
personal information and seeking compensatory damages, equitable relief, and attorneys’ fees and costs. On October 6, 2021,
the proceeding was removed to the District of Minnesota. The Company believes the plaintiff was not injured as a result of the
data privacy incident and, as a result, the claims are without merit. Accordingly, on November
11, 2021, the Company moved to dismiss the complaint in its entirety. Prior to the hearing on the motion to dismiss, the parties
agreed in principle to settle the case. The parties have executed a settlement agreement and submitted a motion to settle
the class action in the near future. If the court does not grant the motion for settlement, the Company will continue to
vigorously defend the lawsuit. At this time, the Company is unable to determine the ultimate outcome or potential exposure to
loss, if any.
Item
2. Management’s
Discussion and Analysis of Financial Condition and Results of Operations.
The
following discussion and analysis of our financial condition and results of operations should be read in conjunction with our
unaudited Condensed Financial Statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form
10-Q, and our audited financial statements and related notes thereto included in Part II, Item 8 of our Annual Report on Form
10-K for the fiscal year ended June 30, 2022 (“fiscal 2022”).
Overview
Electromed,
Inc. (“we,” “our,” “us,” “Electromed” or the “Company”) develops and
provides innovative airway clearance products applying High Frequency Chest Wall Oscillation (“HFCWO”) technologies
in pulmonary care for patients of all ages.
We
manufacture, market and sell products that provide HFCWO, including the SmartVest® Airway Clearance System (“SmartVest
System”) that includes our newest generation SmartVest SQL® and previous generation SV2100, and related products, to
patients with compromised pulmonary function. The SmartVest SQL is smaller, quieter and lighter than our previous product, with
enhanced programmability and ease of use. Our products are sold in both the home health care market and the institutional market
for use by patients in hospitals, which we refer to as “institutional sales.” The SmartVest SQL has been sold in the
domestic home care market since 2014. In 2015, we launched the SmartVest SQL into institutional and certain international markets.
In June 2017, we announced the launch of the SmartVest SQL with SmartVest Connect™ wireless technology, which allows data
connection between physicians and patients to track therapy performance and collaborate in treatment decisions. SmartVest Connect
is currently available to pediatric and cystic fibrosis patients and was made available to certain targeted adult pulmonary clinics
starting in November 2017. Since 2000, we have marketed the SmartVest System and its predecessor products to patients suffering
from cystic fibrosis, bronchiectasis and repeated episodes of pneumonia. Additionally, we offer our products to a patient population
that includes neuromuscular disorders such as cerebral palsy, muscular dystrophies, amyotrophic lateral sclerosis (“ALS”),
the combination of emphysema and chronic bronchitis commonly known as chronic obstructive pulmonary disease (“COPD”),
and patients with post-surgical complications or who are ventilator dependent or have other conditions involving excess secretion
and impaired mucus transport.
11
The
SmartVest System is often eligible for reimbursement from major private insurance providers, health maintenance organizations
(“HMOs”), state Medicaid systems, and the federal Medicare system, which we believe is an important consideration
for patients considering an HFCWO course of therapy. For domestic sales, the SmartVest System may be reimbursed under the Medicare-assigned
billing code (E0483) for HFCWO devices if the patient has cystic fibrosis, bronchiectasis (including chronic bronchitis or COPD
that has resulted in a diagnosis of bronchiectasis), or any one of certain enumerated neuromuscular diseases, and can demonstrate
that another less expensive physical or mechanical treatment did not adequately mobilize retained secretions. Private payers consider
a variety of sources, including Medicare, as guidelines in setting their coverage policies and payment amounts.
Critical
Accounting Estimates
For
a description of our critical accounting policies, estimates and assumptions used in the preparation of our financial statements,
including the unaudited Condensed Financial Statements in this Quarterly Report on Form 10-Q, see Note 1 to our unaudited Condensed
Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q and Part II, Item 7, and Note 1 to our audited
financial statements included in Part II, Item 8, of our Annual Report on Form 10-K for fiscal 2022.
Some
of our accounting policies require us to exercise significant judgment in selecting the appropriate assumptions for calculating
financial statements. Such judgments are subject to an inherent degree of uncertainty and are based upon our historical experience,
known trends in our industry, terms of existing contracts, other information from outside sources, as appropriate and other factors.
Therefore, management discusses the development, selection and disclosures with the audit committee. Among other factors, these
judgments are based upon our historical experience, known trends in our industry, terms of existing contracts and other information
from outside sources, as appropriate. We believe the critical accounting policies that require the most significant assumptions
and judgments in the preparation of our financial statements, including the unaudited Condensed Financial Statements contained
in this Quarterly Report on Form 10-Q, include: revenue recognition and the estimation of variable consideration, inventory valuation,
share-based compensation and warranty reserve.
Impacts
of COVID-19 on Our Business and Operations
In
March 2020, the World Health Organization designated COVID-19 as a global pandemic, and the U.S. Department of Health and Human
Services designated COVID-19 as a public health emergency. The impact of the COVID-19 pandemic on our business remains uncertain,
and its effects on our operational and financial performance will depend in part on future developments, which cannot be reasonably
estimated at this time. Such future developments include, but are not limited to, the duration, scope and severity of the COVID-19
pandemic in geographic areas in which we operate or in which our patients live, actions taken to contain or mitigate its impact,
the impact on governmental healthcare programs and budgets, the development and distribution of treatments or vaccines, and the
resumption of widespread economic activity. Due to the inherent uncertainty of the unprecedented and evolving situation, we are
unable to predict with confidence the likely impact of the COVID-19 pandemic on our future operations.
12
We
believe that the impact of the COVID-19 pandemic on our home care and institutional business will likely continue during the first
half of our fiscal year ending June 30, 2023 (“fiscal 2023”). Our home care and institutional revenue for the three
months ended September 30, 2022 increased as compared to the three months ended September 30, 2021; however, if COVID-19 infection
rates increase and federal, state and local restrictions on commerce, stay-at-home orders or other restrictions on businesses
are reinstated, we believe that such measures could have a material adverse effect on our business.
We
observed increased changes to our supply chain timelines and increased material and shipping rates during the second half of fiscal
2022 and into the three months ended September 30, 2022. The changes to our supply chain timelines resulted in a temporary
interruption that impacted product availability for certain customers in September 2022. We do not anticipate this will have an
effect on our fiscal 2023 revenue. We expect that material and shipping rates will remain elevated during fiscal 2023 relating to
supply chain availability and inflationary trends in electronic components and may extend to other components. In certain instances,
we have purchased key electronic materials in advance to ensure adequate future supply and mitigate the risk of potential supply
chain disruptions. It is possible that the COVID-19 pandemic could have a greater adverse impact on our supply chain in the future,
including impacts associated with preventative and precautionary measures taken by other businesses and applicable governments. A
reduction or further interruption in any of our manufacturing processes could have a material adverse effect on our business. Any
significant increases to our raw material or shipping costs could reduce our gross margins.
In
response to the COVID-19 pandemic and the U.S. federal government’s declaration of a public health emergency, the Centers
for Medicare & Medicaid Services (“CMS”) implemented a number of temporary rule changes and waivers to allow prescribers
to best treat patients during the period of the public health emergency. These waivers became effective on March 1, 2020. Clinical
indications and documentation typically required will not be enforced for respiratory-related products including the SmartVest
System (solely with respect to Medicare patients). The minimum documentation now requires a valid order and documentation of a
respiratory-related diagnosis. Face-to-face and in-person requirements for respiratory devices are being waived while the waiver
is in place. The CMS waiver was recently extended in conjunction with the extension of the federal public health emergency for
an additional 90-day period beginning October 13, 2022.
Results
of Operations
Net
Revenues
Net
revenues for the three months ended September 30, 2022 and 2021 are summarized in the table below.
Three Months Ended September 30,
2022
2021
Increase (Decrease)
Home Care Revenue
$ 9,632,000
$ 9,284,000
$ 348,000
3.7 %
Home Care Distributor Revenue
554,000
156,000
398,000
255.1 %
Institutional Revenue
391,000
449,000
(58,000 )
(12.9 %)
International Revenue
81,000
112,000
(31,000 )
(27.7 %)
Total Revenue
$ 10,658,000
$ 10,001,000
$ 657,000
6.6 %
Home
care revenue . Home care revenue increased by $348,000, or 3.7%, for the three months ended September 30, 2022 compared
to the same period in fiscal 2022. The increase was primarily due to an increase in referrals and approvals. The increase in referrals
was due to an increase in direct sales representatives. The increase was slightly offset by
a temporary interruption in supply chain and associated operations in September 2022.
The
CMS waiver continues to benefit the non-commercial Medicare portion of our home care revenue by increasing the number of referrals
and the approval percentage for non-covered diagnoses. We believe that our ongoing sales team execution, along with the expected
return to pre-COVID-19 levels of patient face-to-face engagement with physicians and clinic access for our sales team, has the
potential to mitigate the impact of a CMS waiver expiration, which is currently effective until January 2023.
13
Home
care distributor revenue . Home care distributor revenue increased by $398,000, or 255.1%, for the three months
ended September 30, 2022 compared to the same period in fiscal 2022. The revenue increase was due to increased demand from one
of our primary home care distribution partners.
Institutional
revenue. Institutional revenue decreased by $58,000, or 12.9%, for the three months ended September 30, 2022 compared
to the same period in fiscal 2022.
International
revenue . International revenue decreased by $31,000, or 27.7%, for the three months ended September 30, 2022 compared
to the same period in fiscal 2022.
Gross
profit
Gross
profit increased to $8,331,000, or 78.2% of net revenues, for the three months ended September 30, 2022, from $7,701,000, or 77.0%
of net revenues, in the same period in fiscal 2022. The increase in gross profit dollars and percentage for the three months ended
September 30, 2022 was primarily due to increased revenue and operational efficiencies
partially offset by increased direct expenses and patient training related expenses due to increased face-to-face trainings.
Operating
expenses
Selling,
general and administrative expenses. Selling, general and administrative (“SG&A”) expenses were $7,989,000
for the three months ended September 30, 2022, representing an increase of $1,202,000 or 17.7%, compared to the same period in
the prior year.
Payroll
and compensation-related expenses increased by $671,000, or 15.9%, to $4,884,000 for the three months ended September 30, 2022,
compared to the same period in the prior year. The increase was primarily due salaries and incentive compensation related to the
higher average number of sales, sales support and marketing personnel, and reimbursement personnel to process higher patient
referrals. We have also continued to provide regular merit-based
increases for our employees and are regularly benchmarking our compensation ranges for new and existing employees to ensure we can
hire and retain the talent needed to drive growth in our business. Field sales employees totaled 53 as of September 30, 2022, 44 of
which were direct sales representatives, compared to 51 field sales employees and 41 direct sales representatives as of September
30, 2021.
Travel,
meals and entertainment expenses increased $253,000, or 39.5%, to $894,000 for the three months ended September 30, 2022, compared
to the same period in the prior year. The increase was primarily due to airfare, lodging and inflationary expenses for our annual
sales meeting as well a higher average number of direct sales representatives.
Total
discretionary marketing expenses increased $80,000, or 46.2%, to $253,000 for the three months ended September 30, 2022, compared
to the same period in the prior year. The increase was primarily due to an investment in direct-to-consumer and direct-to-physician
marketing.
Professional
fees increased $75,000, or 5.5%, to $1,431,000 for the three months ended September 30, 2022, compared to the same period in the
prior year. Professional fees are primarily for services related to legal costs, shareowner services and reporting requirements,
information technology technical support and consulting fees. The increase was primarily due to nonrecurring legal compliance fees
of approximately $400,000 incurred for a reimbursement-related project offset by a reduction in expenses related to
shareholder activism incurred during the three months ended September 30, 2021, which concluded with a cooperation agreement that
became effective in September 2021.
Research
and development expenses. Research and development (“R&D”) expenses decreased $78,000, or 20.7%, to
$298,000 for the three months ended September 30, 2022 compared to the same period in the prior year. The decrease was
primarily due to reduced professional services costs associated with our next generation platform development. R&D
expenses for the three months ended September 30, 2022 were 2.8% of revenue compared to 3.8% of revenue for the same period
in the prior year.
Interest
income, net
Net
interest income decreased $5,000, or 55.6%, to $4,000 for the three months ended September 30, 2022, compared to the same period
in the prior year.
14
Income
tax expense
Income
tax benefit was estimated at $33,000 for the three months ended September 30, 2022 and the income tax expense was estimated at
$108,000 for the three months ended September 30, 2021. The effective tax rate was (68.8%) and 19.7% for the three months ended
September 30, 2022 and 2021, respectively. Estimated income tax benefit for the three months ended September 30, 2022 included
a $44,000 discrete tax benefit related to the exercise of stock options. The net impact of this discrete event created an income
tax benefit. The income tax expense for the three months ended September 30, 2021 included a discrete tax benefit of $20,000 related
to the exercise of stock options.
Net
income
Net
income for the three months ended September 30, 2022 was $81,000 compared to $439,000 for the same period in the prior year. The
decrease in net income was primarily due to increased S&GA expenses related to our sales and reimbursement related investments
in revenue growth partially offset by increased gross profit.
Liquidity
and Capital Resources
Cash
Flows and Sources of Liquidity
Cash
Flows from Operating Activities
For
the three months ended September 30, 2022, net cash used in operating activities was $1,694,000. Cash flows provided by operating
activities consisted of net income of $81,000, an increase in non-cash expenses of $255,000, and a decrease in accounts receivable
of $95,000. These cash flows from operating activities were offset by a decrease in accrued compensation of $1,132,000, a decrease
in accounts payable and other accrued liabilities of $26,000, an increase in inventory of $500,000, an increase in contract assets
of $167,000, an increase in prepaid expenses and other assets of $125,000, and an increase in income tax receivable of $175,000. The
decrease in accrued compensation was primarily due to the payment of annual incentives.
Cash
Flows from Investing Activities
For
the three months ended September 30, 2022, cash used in investing activities was $256,000. Cash used in investing activities consisted
of $241,000 primarily related to our enterprise resource planning infrastructure investments and $15,000 in expenditures for intangible
asset costs.
Cash
Flows from Financing Activities
For
the three months ended September 30, 2022, cash used in financing activities was $205,000, which consisted of $145,000 used for
our share repurchase program and $60,000 for taxes paid on net share settlement of stock option exercises.
Adequacy
of Capital Resources
Our
primary working capital requirements relate to adding employees to our sales force and support functions, continuing infrastructure
investments, and supporting general corporate needs, including financing equipment purchases and other capital expenditures incurred
in the ordinary course of business. Based on our current operational performance, we believe our working capital of $27,267,000
and available borrowings under our existing credit facility will provide adequate liquidity during fiscal 2023.
Our
credit facility provides us with a revolving line of credit. Interest on borrowings on the line of credit accrues at the prime
rate (6.25% at September 30, 2022) less 1.00% and is payable monthly. There was no outstanding principal balance on the line of
credit as of September 30, 2022 or June 30, 2022. The amount eligible for borrowing on the line of credit is limited to the lesser
of $2,500,000 or 57.00% of eligible accounts receivable, and the line of credit expires on December 18, 2023, if not renewed.
As of September 30, 2022, the maximum $2,500,000 was available under the line of credit. Payment obligations under the line of
credit are secured by a security interest in substantially all of our tangible and intangible assets.
The
documents governing our line of credit contain certain financial and nonfinancial covenants that include a minimum tangible net
worth of not less than $10,125,000 and restrictions on our ability to incur certain additional indebtedness or pay dividends.
15
Any
failure to comply with these covenants in the future may result in an event of default, which if not cured or waived, could result
in the lender accelerating the maturity of our indebtedness, preventing access to additional funds under the line of credit, requiring
prepayment of outstanding indebtedness, or refusing to renew the line of credit. If the maturity of the indebtedness is accelerated
or the line of credit is not renewed, sufficient cash resources to satisfy the debt obligations may not be available and we may
not be able to continue operations as planned. If we are unable to repay such indebtedness, the lender could foreclose on these
assets.
For
the three months ended September 30, 2022 and 2021, we spent $241,000 and $225,000, respectively, on property and equipment. We
currently expect to finance planned equipment purchases with cash flows from operations or borrowings under our credit facility.
We may need to incur additional debt if we have an unforeseen need for additional capital equipment or if our operating performance
does not generate adequate cash flows.
While
the impact of the COVID-19 pandemic and other factors such as inflation are difficult to predict, we believe our cash, cash equivalents
and cash flows from operations will be sufficient to meet our working capital, capital expenditure, operational cash requirements for
fiscal 2023 and the foreseeable future. We will continue to evaluate our projected expenditures relative to our available
cash and evaluate financing alternatives in order to satisfy our working capital and other cash requirements.
Information
Regarding Forward-Looking Statements
Statements
contained in this Quarterly Report on Form 10-Q that are not statements of historical fact should be considered forward-looking
statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section
21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward-looking statements include,
but are not limited to, statements regarding: the expected impact of the COVID-19 pandemic on our business; our business strategy,
including our intended level of investment in R&D and marketing activities; our expectations with respect to earnings, gross
margins and sales growth, industry relationships, marketing strategies and international sales; estimated sizes of markets into
which our products are or may be sold; our business strengths and competitive advantages; our ability to grow additional sales
distribution channels; our intent to retain any earnings for use in operations rather than paying dividends; our expectation that
our products will continue to qualify for reimbursement and payment under government and private insurance programs; our intellectual
property plans and practices; the expected impact of applicable regulations on our business; our beliefs about our manufacturing
processes; our expectations and beliefs with respect to our employees and our relationships with them; our belief that our current
facilities are adequate to support our growth plans; our expectations with respect to ongoing compliance with the terms of our
credit facility; our expectations regarding the ongoing availability of credit and our ability to renew our line of credit; enhancements
to our products and services; expected excise tax exemption for the SmartVest System; and our anticipated revenues, expenses,
capital requirements and liquidity. Words such as “anticipate,” “believe,” “continue,” “could,”
“estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,”
“potential,” “project,” “goal,” “target,” “should,” “will,”
“would,” and similar expressions, including the negative of these terms, are intended to identify forward-looking
statements but are not the exclusive means of identifying such statements. Although we believe these forward-looking statements
are reasonable, they involve risks and uncertainties that may cause actual results to differ materially from those projected by
such statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results
or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information
expressed or implied by the forward-looking statements.
Factors
that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited
to, the following:
● the
duration, extent and severity of the COVID-19 pandemic, including its effects on our
business, operations and employees as well as its impact on our customers and distribution
channels and on economies and markets more generally;
● ability
to obtain reimbursement from Medicare, Medicaid, or private insurance payers for our
products including potential adverse impact with an expiration of the CMS waiver for
certain respiratory diseases;
● component
or raw material shortages, changes to lead times or significant price increases;
● adverse
changes to state and federal health care regulations;
● our
ability to develop new sales channels for our products such as the home care distributor
channel;
● our
ability to maintain regulatory compliance and to gain future regulatory approvals and
clearances;
16
● entry
of new competitors including new drug or pharmaceutical discoveries;
● adverse
economic and business conditions or intense competition;
● wage
and component price inflation;
● technical
problems with our research and products;
● changes
affecting the medical device industry;
● adverse
international health care regulation impacting current international business;
● our
ability to renew our line of credit or obtain additional credit as necessary;
● our
ability to protect and expand our intellectual property portfolio;
● the
risks associated with cyberattacks, data breaches, computer viruses and other similar
security threats; and
● the
risks associated with our planned sales force expansion.
This
list of factors is not exhaustive, however, and these or other factors, many of which are outside of our control, could have a
material adverse effect on us and our results of operations. Therefore, you should consider these risk factors with caution and
form your own critical and independent conclusions about the likely effect of these risk factors on our future performance. Forward-looking
statements speak only as of the date on which the statements are made, and we undertake no obligation, and expressly disclaim
any such obligation, to update any forward-looking statement for any reason other than as required by law, even if new information
becomes available or other events occur in the future. You should carefully review the disclosures and the risk factors described
in this and other documents we file from time to time with the Securities and Exchange Commission (the “SEC”), including
our Annual Report on Form 10-K for fiscal 2022. All forward-looking statements attributable to us or persons acting on our behalf
are expressly qualified in their entirety by the cautionary statements set forth herein.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk.
As
a smaller reporting company, we are not required to provide disclosure pursuant to this Item.
Item
4. Controls
and Procedures.
Evaluation
of Disclosure Controls and Procedures
Our
principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures,
as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, as of the end of the period subject to this Quarterly Report
on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure
controls and procedures were effective as of the date of such evaluation to provide reasonable assurance that information required
to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized
and reported within the time periods specified by the SEC’s rules and forms.
Changes
to Internal Control Over Financial Reporting
There
were no changes in our internal control over financial reporting that occurred during the quarter ended September 30, 2022 that
have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.
PART
II – OTHER INFORMATION
Item
1. Legal
Proceedings.
The
disclosure regarding legal proceedings set forth in Note 9 to our unaudited Condensed Financial Statements in Part I, Item 1 of
this Quarterly Report on Form 10-Q is incorporated herein by reference. Occasionally, we may be party to legal actions, proceedings,
or claims in the ordinary course of business, including claims based on assertions of patent and trademark infringement. Corresponding
costs are accrued when it is probable that loss will be incurred and the amount can be precisely or reasonably estimated. We are
not aware of any undisclosed actual or threatened litigation that would have a material adverse effect on our financial condition
or results of operations.
17
Item
1A. Risk Factors.
As
a smaller reporting company, we are not required to provide disclosure pursuant to this Item.
Item
2. Unregistered
Sales of Equity Securities and Use of Proceeds.
On
May 26, 2021, our Board of Directors (the “Board”) approved a stock repurchase authorization. Under the authorization,
we were originally able to repurchase up to $3.0 million of outstanding shares of our common stock through May 26, 2022. On May
26, 2022, the Board removed the date limitation. The shares of our common stock may be repurchased on the open market or in privately
negotiated transactions subject to applicable securities laws and regulations. The following table sets forth information concerning
purchases of shares of our common stock for three months ended September 30, 2022:
Period
Total Number of Shares Purchased
Average
Price Paid
per Share
Total Number of Shares Purchased as Part of Publicly Announced Plans or Programs
Approximate Dollar Value of Shares that May Yet be Purchased Under the Plans or Programs
July 1 to July
31, 2022
-
$ -
-
$ 427,000
August 1 to August 31, 2022
1,700
$ 9.72
1,700
$ 411,000
September 1 to September 30, 2022
12,868
$ 9.93
12,868
$ 283,000
Total
14,568
$ 9.91
14,568
Item
3. Defaults
Upon Senior Securities.
None.
Item
4. Mine
Safety Disclosures.
None.
Item
5. Other
Information.
None.
18
Item
6. Exhibits.
Exhibit
Number
Description
Method
of Filing
3.1
Composite Articles of Incorporation, as amended through November 8, 2010 (incorporated by reference to Exhibit 3.1 to Annual Report on Form 10-K for the fiscal year ended June 30, 2015)
Incorporated
by Reference
3.2
Amended and Restated Bylaws, effective September 29, 2020 (incorporated by reference to Exhibit 3.1 to Current Report on Form 8-K filed September 29, 2020)
Incorporated
by Reference
10.1
Cooperation Agreement, dated July 25, 2022, by and among Electromed, Inc. and Summer Value Partners LLC and certain of its affiliates signatory thereto (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed July 25, 2022)
Incorporated
by Reference
31.1
Certification Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
Filed
Electronically
31.2
Certification Pursuant
to Section 302 of the Sarbanes-Oxley Act of 2002
Filed
Electronically
32.1
Certification Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002
Furnished
Electronically
32.2
Certification Pursuant
to Section 906 of the Sarbanes-Oxley Act of 2002
Furnished
Electronically
101
Financial
statements from the Quarterly Report on Form 10-Q for the period ended September 30, 2022, formatted in inline XBRL: (i) Condensed
Balance Sheets, (ii) Condensed Statements of Operations, (iii) Condensed Statements of Cash Flows, (iv) Condensed Statements
of Shareholders’ Equity, and (v) Notes to Condensed Financial Statements
Filed
Electronically
104
Cover
Page Interactive Data File (embedded within the inline XBRL Document)
Filed
Electronically
19
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
ELECTROMED, INC.
Date:
November
8, 2022
/s/
Kathleen S. Skarvan
Kathleen S. Skarvan, President and Chief Executive Officer
(duly authorized officer)
Date:
November
8, 2022
/s/
Michelle C. Wirtz
Michelle
C. Wirtz, Interim Chief Financial Officer
(principal
financial officer and principal accounting officer)
Text extracted from the filing as submitted to EDGAR. Formatting, tables and exhibits are simplified for reading; the original document is authoritative for anything you rely on.