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 December 31, 2023
☐
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 8,605,227 shares of Electromed, Inc. common stock, par value $0.01 per share, outstanding as of the close of business on
February 8, 2024.
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
12
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
17
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds
17
Item 3. Defaults Upon Senior Securities
17
Item 4. Mine Safety Disclosures
18
Item 5. Other Information
18
Item 6. Exhibits
18
PART I – FINANCIAL
INFORMATION
Item 1. Financial Statements.
Electromed, Inc.
Condensed Balance Sheets
December 31, 2023
June 30, 2023
(Unaudited)
Assets
Current Assets
Cash and cash equivalents
$ 10,434,000
$ 7,372,000
Accounts receivable (net of allowances for doubtful accounts of $ 45,000 )
22,988,000
24,130,000
Contract assets
574,000
487,000
Inventories
4,760,000
4,221,000
Prepaid expenses and other current assets
509,000
1,577,000
Total current assets
39,265,000
37,787,000
Property and equipment, net
5,377,000
5,672,000
Finite-life intangible assets, net
616,000
605,000
Other assets
125,000
161,000
Deferred income taxes
1,581,000
1,581,000
Total assets
$ 46,964,000
$ 45,806,000
Liabilities and Shareholders’ Equity
Current Liabilities
Accounts payable
$ 1,041,000
$ 1,372,000
Accrued compensation
2,806,000
3,018,000
Income tax payable
253,000
336,000
Warranty reserve
1,483,000
1,378,000
Other accrued liabilities
990,000
1,949,000
Total current liabilities
6,573,000
8,053,000
Other long-term liabilities
49,000
86,000
Total liabilities
6,622,000
8,139,000
Commitments and Contingencies
Shareholders’ Equity
Common stock, $ 0.01 par value per share, 13,000,000 shares
authorized; 8,602,677 and 8,555,238 shares issued and outstanding, as of December 31, 2023 and June 30, 2023,
respectively
86,000
86,000
Additional paid-in capital
19,634,000
18,788,000
Retained earnings
20,622,000
18,793,000
Total shareholders’ equity
40,342,000
37,667,000
Total liabilities and shareholders’ equity
$ 46,964,000
$ 45,806,000
See Notes to Condensed Financial Statements (Unaudited).
1
Electromed, Inc.
Condensed Statements of Operations
(Unaudited)
Three
Months Ended
December 31,
Six
Months Ended
December 31,
2023
2022
2023
2022
Net revenues
$ 13,689,000
$ 11,729,000
$ 26,013,000
$ 22,387,000
Cost of revenues
3,144,000
3,047,000
5,970,000
5,374,000
Gross profit
10,545,000
8,682,000
20,043,000
17,013,000
Operating expenses
Selling, general and administrative
8,175,000
7,254,000
17,325,000
15,243,000
Research and development
107,000
154,000
313,000
452,000
Total operating expenses
8,282,000
7,408,000
17,638,000
15,695,000
Operating income
2,263,000
1,274,000
2,405,000
1,318,000
Interest income, net
96,000
7,000
173,000
11,000
Net income before income taxes
2,359,000
1,281,000
2,578,000
1,329,000
Income tax expense
685,000
304,000
749,000
271,000
Net income
$ 1,674,000
$ 977,000
$ 1,829,000
$ 1,058,000
Income per share:
Basic
$ 0.20
$ 0.12
$ 0.21
$ 0.13
Diluted
$ 0.19
$ 0.11
$ 0.21
$ 0.12
Weighted-average common shares outstanding:
Basic
8,545,120
8,442,939
8,541,254
8,442,684
Diluted
8,800,172
8,684,352
8,791,519
8,685,184
See
Notes to Condensed Financial Statements (Unaudited).
2
Electromed, Inc.
Condensed Statements of Cash
Flows (Unaudited)
Six Months Ended December 31,
2023
2022
Cash Flows From Operating Activities
Net income
$ 1,829,000
$ 1,058,000
Adjustments to reconcile net income to net cash provided by (used in) operating activities:
Depreciation
398,000
272,000
Amortization of finite-life intangible assets
25,000
47,000
Share-based compensation expense
791,000
316,000
Deferred income taxes
-
10,000
Changes in operating assets and liabilities:
Accounts receivable
1,142,000
( 503,000 )
Contract assets
( 87,000 )
( 221,000 )
Inventories
( 509,000 )
( 321,000 )
Prepaid expenses and other assets
1,104,000
176,000
Income tax payable, net
( 83,000 )
79,000
Accounts payable and accrued liabilities
( 1,171,000 )
( 711,000 )
Accrued compensation
( 212,000 )
( 532,000 )
Net cash provided by (used in) operating activities
3,227,000
( 330,000 )
Cash Flows From Investing Activities
Expenditures for property and equipment
( 180,000 )
( 687,000 )
Expenditures for finite-life intangible assets
( 40,000 )
( 30,000 )
Net cash used in investing activities
( 220,000 )
( 717,000 )
Cash Flows From Financing Activities
Issuance of common stock upon exercise of options
55,000
16,000
Taxes paid on net share settlement of stock option exercises
-
( 60,000 )
Repurchase of common stock
-
( 153,000 )
Net cash provided by (used in) financing activities
55,000
( 197,000 )
Net increase (decrease) in cash
3,062,000
( 1,244,000 )
Cash and cash equivalents
Beginning of period
7,372,000
8,153,000
End of period
$ 10,434,000
$ 6,909,000
Supplemental Disclosures of Cash Flow Information
Cash paid for income taxes
$ 833,000
$ 182,000
Supplemental Disclosures of Noncash Investing and Financing Activities
Property and equipment acquisitions in accounts payable
$ 13,000
$ 73,000
Intangible asset acquisitions in accounts payable
$ -
$ 5,000
Demonstration equipment returned to inventory
$ 30,000
$ 26,000
See
Notes to Condensed Financial Statements (Unaudited).
3
Electromed, Inc.
Condensed Statements of Shareholders’
Equity (Unaudited)
Common
Stock
Additional Paid-
Retained
Total
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
Net income
–
–
–
977,000
977,000
Issuance of restricted stock
26,000
–
–
–
–
Issuance of common stock upon exercise of options
3,100
–
16,000
–
16,000
Share-based compensation expense
–
–
221,000
–
221,000
Repurchase of common stock
( 800 )
–
–
( 8,000 )
( 8,000 )
Balance at December 31, 2022
8,514,164
$ 85,000
$ 18,580,000
$ 16,685,000
$ 35,350,000
Common
Stock
Additional Paid-
Retained
Total
Shareholders’
Shares
Amount
in
Capital
Earnings
Equity
Balance at June 30, 2023
8,555,238
$ 86,000
$ 18,788,000
$ 18,793,000
$ 37,667,000
Net income
–
–
–
155,000
155,000
Issuance of restricted stock
20,878
–
–
–
–
Issuance of common stock upon exercise of options
2,934
–
29,000
–
29,000
Share-based compensation expense
–
–
371,000
–
371,000
Balance at September 30, 2023
8,579,050
86,000
19,188,000
18,948,000
38,222,000
Net income
–
–
–
1,674,000
1,674,000
Issuance of restricted stock
21,000
–
–
–
–
Issuance of common stock upon exercise of options
2,627
–
26,000
–
26,000
Share-based compensation expense
–
–
420,000
–
420,000
Balance at December 31, 2023
8,602,677
$ 86,000
$ 19,634,000
$ 20,622,000
$ 40,342,000
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 for pulmonary care patients. The Company
markets its products in the U.S. to the home health care and hospital markets. The Company also sells internationally through
distributors.
Since
its inception, the Company has operated in a single industry segment: developing, manufacturing, and marketing medical equipment.
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, 2023 (“fiscal
2023”).
A
summary of the Company’s significant accounting policies and estimates 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 405,974 and 200,499 for the three months ended December 31, 2023, and 2022, respectively,
and were 404,973 and 206,261 for the six months ended December 31, 2023 and 2022, 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. The company adopted the standard effective July 1, 2023. The Company’s adoption of the
standard did not have a material impact on the financial statements.
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 .
5
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 December 31,
Six
Months Ended December 31,
2023
2022
2023
2022
Homecare
$ 12,668,000
$ 10,732,000
$ 23,821,000
$ 20,364,000
Hospital
619,000
589,000
1,126,000
980,000
Homecare distributor
280,000
336,000
853,000
890,000
International
122,000
72,000
213,000
153,000
Total
$ 13,689,000
$ 11,729,000
$ 26,013,000
$ 22,387,000
In
the following table, net homecare revenue is disaggregated by payer type:
Three
Months Ended December 31,
Six
Months Ended December 31,
2023
2022
2023
2022
Commercial
$ 5,945,000
$ 4,040,000
$ 11,710,000
$ 7,919,000
Medicare
4,893,000
4,964,000
8,841,000
9,209,000
Medicare Supplemental
1,287,000
1,266,000
2,270,000
2,403,000
Medicaid
314,000
336,000
607,000
490,000
Other
229,000
126,000
393,000
343,000
Total
$ 12,668,000
$ 10,732,000
$ 23,821,000
$ 20,364,000
Revenues
are recognized at a point in time when control passes to the customer upon product shipment or delivery.
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:
Homecare
market . In the Company’s homecare 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 homecare market, the Company regards the SmartVest
System to be a single performance obligation.
The
Company makes available to its homecare 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 homecare market
consist of a single performance obligation: the SmartVest System.
Homecare
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.
6
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 homecare agreements as transferring control to the patient upon shipment or delivery, despite possible
payment cancellation under government or commercial programs where the payer is controlling the payment over specified time periods.
For homecare 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 because 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 homecare 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.
For
each type of variable consideration discussed above, there are many 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.
7
Homecare
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 the right to a higher discount on purchases more
than 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.
Hospital
market. The Company’s hospital sales are made to hospitals and other clinics. Sales to these hospitals are negotiated
with the individual hospital or with group purchasing organizations, with payments received directly from the hospital. No insurance
reimbursement is involved. Generators are either sold or leased to the hospitals and associated hoses and wraps (used in hospital
settings rather than vests) are sold separately. Accordingly, each product is distinct and considered a separate performance obligation
in sales to hospital customers. The agreements with hospitals 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 later.
Revenue for the consumable wraps is recognized when control transfers to the customer.
International
market. Sales to international markets are made directly to several 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, hospitals 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 receivables 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 asset
Six Months Ended December 31, 2023
Fiscal Year Ended June 30, 2023
Increase (decrease)
Increase (decrease)
Contract assets, beginning
$ 488,000
$ 286,000
Reclassification of contract assets to accounts receivable
( 994,000 )
( 1,220,000 )
Contract assets recognized
1,340,000
1,351,000
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
( 260,000 )
71,000
Contract assets, ending
$ 574,000
$ 488,000
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:
December 31, 2023
June 30, 2023
Parts inventory
$ 3,666,000
$ 3,420,000
Work in process
507,000
470,000
Finished goods
708,000
323,000
Estimated inventory to be returned
261,000
265,000
Less: Reserve for obsolescence
( 382,000 )
( 257,000 )
Total
$ 4,760,000
$ 4,221,000
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 hospital 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:
Six Months Ended December 31, 2023
Fiscal Year Ended June 30, 2023
Warranty reserve, beginning
$ 1,378,000
$ 1,256,000
Accrual for products sold
296,000
416,000
Expenditures and costs incurred for warranty claims
( 191,000 )
( 294,000 )
Warranty reserve, ending
$ 1,483,000
$ 1,378,000
9
Note
5. Income Taxes
Income
tax expense was estimated at $ 685,000 and $ 749,000 , and the effective tax rate was 28.8 % and 28.9 % for the three and six months
ended December 31, 2023, respectively. Estimated income tax expense for the three and six months ended December 31, 2023, includes
a discrete current tax benefit of $ 1,000 and $ 1,000 , respectively, related to the exercise of stock options.
Income
tax expense was estimated at $ 304,000 and $ 271,000 , and the effective tax rate was 23.7 % and 20.4 % for the three and six months
ended December 31, 2022, respectively. Estimated income tax expense for the three and six months ended December 31, 2022, includes
a discrete current tax expense of $ 1,000 and discrete current tax benefit of $ 43,000 , respectively, 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, 2020, 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 through December 18, 2025 , if not renewed
before such date. There was no outstanding principal balance on the line of credit as of December 31, 2023, or June 30, 2023.
Interest on borrowings under the line of credit, if any, accrues at the prime rate ( 8.50 % on December 31, 2023) 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. On December 31, 2023, 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 the tangible and intangible assets of the
Company.
The
documents governing the line of credit contain certain financial and non-financial 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 December 31, 2023, a total of 239,995 shares
have been repurchased and retired under this authorization for a total cost of $ 2,725,000 , or $ 11.36 per share. Repurchased
shares have been retired and constitute authorized but unissued shares. There were no share repurchases for the three and six
months ended December 31, 2023.
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 2023. Share-based compensation expenses were $ 791,000 and $ 316,000 for the six months ended
December 31, 2023, and 2022, respectively. This expense is included in selling, general and administrative expense in the Condensed
Statements of Operations.
10
Stock
Options
Stock
option transactions during the six months ended December 31, 2023, are summarized as follows:
Number
of Shares
Weighted-Average
Exercise Price per Share
Outstanding at June 30, 2023
451,570
$ 6.93
Granted
262,062
$ 10.70
Exercised
( 5,563 )
$ 9.88
Cancelled or Forfeited
( 8,713 )
$ 11.02
Outstanding at December 31, 2023
699,356
$ 8.27
The
following assumptions were used to estimate the fair value of stock options granted:
Six
Months Ended
December 31, 2023
Fiscal
Year Ended
June 30, 2023
Risk-free
interest rate
4.07
- 4.64 %
2.88
– 4.23 %
Expected
term (years)
6
6
Expected
volatility
52
- 53 %
53
- 54 %
The
intrinsic value of an option is the amount by which the fair value of the underlying stock exceeds its exercise price. On December
31 2023, the weighted average remaining contractual term for all outstanding stock options was 6.7 years and the aggregate intrinsic
value of the options was $ 1,983,000 . Outstanding on December 31, 2023, were 699,356 stock options issued to employees, of which
371,402 were vested and exercisable and had an aggregate intrinsic value of $ 1,879,000 . As of December 31, 2023, $ 1,199,000 of
total unrecognized compensation expense related to stock options is expected to be recognized over a weighted-average period of
approximately 3.0 years.
Restricted
Stock
During
the six months ended December 31, 2023, the Company issued restricted stock awards to employees totaling 20,878 shares of common
stock, with a weighted average vesting term of 3.0 years and a weighted average fair value of $ 10.72 per share, and to directors
totaling 21,000 shares of common stock, with a vesting term of six months and a weighted average fair value of $ 10.44 per share.
There were 55,111 shares of unvested restricted stock with a weighted average fair value of $ 10.51 per share outstanding as of
December 31, 2023. As of December 31, 2023, $ 385,000 of total unrecognized compensation expense related to restricted stock awards
is expected to be recognized over a weighted-average period of approximately 1.4 years.
Performance-Based
Restricted Stock Units
The
Company granted 175,000 performance-based restricted stock units (“PSUs”) to our CEO in connection with his appointment
as CEO on July 1, 2023. The PSUs are to be earned based on the extent to which performance goals tied to Total Shareholder Return
(“TSR”) are achieved. The performance-based restricted stock units will be eligible to vest and settle into shares
of common stock on a 1-for-1 basis with respect to one-half of the shares upon achieving a total shareholder return of 50% and
the remaining shares upon a total shareholder return of 100%, in each case within four years of the date of grant. The grant date
fair value of the awards was determined using a Monte Carlo valuation model with an expected term of four years.
Stock
based compensation expense recognized for PSUs was $ 145,000 and $ 0 for the six months ended December 31, 2023, and 2022, respectively.
The weighted average grant date fair value per unit was $ 6.58 and as of December 31, 2023, there are 175,000 PSUs outstanding.
On December 31, 2023, there was approximately $ 1,006,000 of total unrecognized compensation expense related to outstanding PSUs
that is expected to be recognized over a period of 3.50 years.
11
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.
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, 2023 (“fiscal 2023”).
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.
We
manufacture, market, and sell products that provide HFCWO, including the SmartVest® Airway Clearance System (“SmartVest
System”) that includes our newest generation SmartVest Clearway® Airway Clearance System (“Clearway”), previous
generation SmartVest SQL®, and related garments and accessories to patients with compromised pulmonary function. The SmartVest
Clearway, which received 510(k) clearance from the U.S. Food and Drug Administration in December 2022, provides patients with
proven quality of life outcomes while offering a state-of-the-art patient experience with a simple touch screen user interface,
small footprint and lightest HFCWO generator on the market.
Our
products are sold in both the home health care market and the hospital market for inpatient use, which we refer to as “hospital
sales.” Since 2000, we have marketed the SmartVest System and its predecessor products to patients suffering from bronchiectasis,
cystic fibrosis, and other chronic pulmonary conditions which require external chest manipulation to enhance mucus transport.
Additionally, we offer our products to a patient population that includes neuromuscular disorders such as cerebral palsy, muscular
dystrophies, amyotrophic lateral sclerosis (“ALS”), patients with post-surgical complications or who are ventilator
dependent and patients who have other conditions involving excess secretion and impaired mucus transport.
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 myopathies 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 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 and Note 2 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 2023 .
There
were no material changes in our critical accounting estimates and assumptions since the filing of our Annual Report on Form 10-K
for fiscal 2023.
12
Results
of Operations
Net
Revenues
Net
revenues for the three and six months ended December 31, 2023 and 2022 are summarized in the table below.
Three Months Ended
December 31,
Six
Months Ended
December
31,
2023
2022
Increase (Decrease)
2023
2022
Increase (Decrease)
Homecare
$ 12,668,000
$ 10,732,000
$ 1,936,000
18.0 %
$ 23,821,000
$ 20,364,000
$ 3,457,000
17.0 %
Hospital
619,000
589,000
30,000
5.1 %
1,126,000
980,000
146,000
14.9 %
Homecare distributor
280,000
336,000
(56,000 )
(16.7 %)
853,000
890,000
(37,000 )
(4.2 %)
International
122,000
72,000
50,000
69.4 %
213,000
153,000
60,000
39.2 %
Total
$ 13,689,000
$ 11,729,000
$ 1,960,000
16.7 %
$ 26,013,000
$ 22,387,000
$ 3,626,000
16.2 %
Homecare
revenue . Homecare revenue increased by $1,936,000, or 18.0%, for the three months ended December 31, 2023, compared to the same period in the prior year. For the six months ended December 31, 2023, homecare revenue was $23,821,000, representing an increase of $3,457,000, or 17.0%, compared to the same period in the prior year. The increase in revenue was due to an increase in direct sales territories and efficiencies recognized within our reimbursement department as a result of recent investments made to streamline the claims process in the six months ended December 31, 2023.
Hospital
revenue. Hospital revenue was $619,000, an increase of $30,000, or 5.1%, for the three months ended December 31, 2023,
compared to the same period in the prior year. For the six months ended December 31, 2023, hospital revenue was $1,126,000, an
increase of $146,000, or 14.9%, compared to the same period in the prior year. The increases were primarily due to an increase
in sales representatives focused on the hospital market.
Homecare
distributor revenue . Homecare distributor revenue decreased by $56,000, or 16.7%, for the three months ended December
31, 2023, compared to the same period in the prior year. For the six months ended December 31, 2023, homecare distributor revenue
was $853,000, a decrease of $37,000, or 4.2%, compared to the same period in the prior year. The decreases in homecare distributor
sales were primarily a result of the timing of distributor purchases that can cause significant fluctuations in reported revenue
on a quarterly basis.
International
revenue . International revenue was $122,000, an increase of $50,000, or 69.4%, for the three months ended December
31, 2023, compared to the same period in the prior year. For the six months ended December 31, 2023, international revenue was
$213,000, an increase of $60,000, or 39.2% over the prior year primarily driven off the timing of international orders.
Gross
profit
Gross
profit increased to $10,545,000, or 77.0% of net revenues, for the three months ended December 31, 2023, from $8,682,000, or 74.0%
of net revenues, in the same period in the prior year. Gross profit increased to $20,043,000, or 77.1% of net revenues, for the
six months ended December 31, 2023, from $17,013,000, or 76.0% of net revenues, in the same period in the prior year. The increases
in gross profit as a percentage of net revenues compared to the same period in the prior year were primarily due to decreased
shipping expenses as well as increased material costs in the prior year to expedite inventory purchases which did not recur in
the current year.
Operating
expenses
Selling,
general and administrative expenses. Selling, general and administrative (“SG&A”) expenses were $8,175,000
and $17,325,000 for the three and six months ended December 31, 2023, respectively, representing increases of $921,000 and $2,082,000,
or 12.7% and 13.7%, respectively, compared to the same periods in the prior year.
13
Payroll
and compensation-related expenses were $5,625,000 and $11,390,000 for the three and six months ended December 31, 2023, respectively,
representing increases of $796,000 and $1,301,000, or 16.5% and 12.9%, respectively, compared to the same periods in the prior
year. The increases in the current year periods were primarily due to salaries and incentive compensation related to the higher
average number of sales, sales support, marketing, 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 58 as of December 31, 2023, 49 of which were direct sales representatives, compared to 57 field sales employees and 48
direct sales representatives as of December 31, 2022.
Travel,
meals and entertainment expenses were $745,000 and $1,693,000 for the three and six months ended December 31, 2023, respectively,
representing increases of $26,000 and $61,000, or 3.6% and 3.7%, respectively, compared to the same periods in the prior year.
The increases in the current year periods were due to higher travel costs and an increased number of sales territories.
Total
discretionary marketing expenses were $252,000 and $791,000 for the three and six months ended December 31, 2023, respectively,
representing an increase of $70,000 and $422,000, or 38.5% and 114.4%, respectively, compared to the same periods in the prior
year. The increases were primarily due to an investment in market research, direct-to-consumer and direct-to-physician marketing.
Professional
fees were $934,000 and $2,244,000 for the three and six months ended December 31, 2023, respectively, representing decreases of
$97,000 and $218,000, or 9.4% and 8.9%, respectively, compared to the same periods 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 decreases were primarily due to legal fees in fiscal 2023 related to a reimbursement project that did
not recur in fiscal 2024.
Research
and development expenses . Research and development (“R&D”) expenses were $107,000 and $313,000 for the three
and six months ended December 31, 2023, respectively, representing decreases of $47,000 and $139,000, or 30.5% and 30.8%, respectively,
compared to the same periods in the prior year. The decreases were primarily due to reduced costs associated with our SmartVest
Clearway platform development which has now been launched into the Homecare and hospital markets.
Interest
income, net
Net
interest income for the three and six months ended December 31, 2023, was $96,000 and $173,000, respectively, compared to $7,000
and $11,000, respectively, for the same periods in the prior year. The increases were primarily due to increased savings rates
on higher cash balances.
Income
tax expense
Income
tax expense was estimated at $685,000 and $749,000, and the effective tax rate was 28.8% and 28.9%, for the three and six months
ended December 31, 2023, respectively. Estimated income tax expense for the three and six months ended December 31, 2023 includes
a discrete tax expense of $1,000 and a discrete tax benefit of $1,000, respectively, related to the exercise of stock options.
Income
tax expense was estimated at $304,000 and $271,000, and the effective tax rate was 23.7% and 20.4%, for the three and six months
ended December 31, 2022, respectively. Estimated income tax expense for the three and six months ended December 31, 2022, includes
a discrete tax expense of $1,000 and a discrete tax benefit of $43,000, respectively, related to the exercise of stock options.
Net
income
Net
income for the three and six months ended December 31, 2023, was $1,674,000 and $1,829,000, respectively, compared to $977,000
and $1,058,000 for the same periods in the prior year. The increase in net income in the three months ended December 31, 2023,
and six months ended December 31, 2022, was driven primarily by homecare revenue growth, an increase in gross profit margin, and
an increase in interest income.
14
Liquidity
and Capital Resources
Cash
Flows and Sources of Liquidity
Cash
Flows from Operating Activities
For
six months ended December 31, 2023, net cash provided by operating activities was $3,227,000. Cash flows provided by operating
activities consisted of net income of $1,829,000, non-cash expenses of $1,214,000, a decrease in accounts receivable of $1,142,000,
and a decrease in prepaid expenses and other assets of $1,104,000. These cash flows from operating activities were offset by a
decrease in accounts payable and other accrued liabilities of $1,171,000, an increase in inventory of $509,000, a decrease in
accrued compensation of $212,000, an increase in contract assets of $87,000, and a decrease of taxes payable of $83,000.
The
decrease in accounts receivable is primarily due to an increased focus on cash receipts from our cash collections team. The decrease
in prepaid expenses and other assets, as well as the decrease in accounts payable and other accrued liabilities are primarily
due to a litigation settlement payment related to our previously disclosed cyber security breach. The payment to the settlement
fund during the first quarter of fiscal 2024 for the settlement amount of $825,000 was covered by insurance resulting in a reduction
in other current assets and other accrued liabilities.
Cash
Flows from Investing Activities
For
the six months ended December 31, 2023, cash used in investing activities was $220,000. Cash used in investing activities consisted
of $180,000 of expenditures for property and equipment and $40,000 in expenditures for intangible asset costs.
Cash
Flows from Financing Activities
For
the six months ended December 31, 2023, cash provided by financing activities was $55,000, consisting of cash received upon 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 $32,692,000
and available borrowings under our existing credit facility will provide sufficient liquidity to meet our anticipated working
capital and other liquidity needs for the next twelve months from the date of this report.
Our
credit facility provides us with a revolving line of credit. Interest on borrowings on the line of credit accrues at the prime
rate (8.50% on December 31, 2023) less 1.00% and is payable monthly. There was no outstanding principal balance on the line of
credit as of December 31, 2023, or June 30, 2023. 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 17, 2025, if not renewed.
As of December 31, 2023, 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 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.
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 six months ended December 21, 2023, and 2022, we spent $180,000 and $687,000, 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.
15
While
the impact of macroeconomic 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 2024 and the foreseeable future. We will continue to evaluate our projected expenditures relative to our available
cash and evaluate financing alternatives 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: 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:
● ability
to obtain reimbursement from Medicare, Medicaid, or private insurance payers for our
products including potential adverse impact with an expiration of the Centers for Medicare
and Medicaid Services 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 maintain regulatory compliance and to gain future regulatory approvals and
clearances;
● entry
of new competitors including new drug or pharmaceutical discoveries;
● adverse
economic and business conditions or intense competition;
● the
risks associated with our planned salesforce expansion;
● wage
and component price inflation;
● technical
problems with our research and products;
● the
risks associated with cyberattacks, data breaches, computer viruses and other similar
security threats;
● changes
affecting the medical device industry;
● our
ability to develop new sales channels for our products such as the homecare distributor
channel;
● adverse
international health care regulation impacting current international business;
● our
ability to renew our line of credit or obtain additional credit as necessary; and
● our
ability to protect and expand our intellectual property portfolio.
16
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 2023. 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 December 31, 2023, 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.
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. We are not party to any material pending legal proceedings.
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, Use of Proceeds, and Issuer Purchases of Equity Securities.
On
May 26, 2021, our Board of Directors (the “Board”) approved the repurchase of up to $3.0 million of outstanding shares
of our common stock. The shares of our common stock may be repurchased under the authorization on the open market or in privately
negotiated transactions subject to applicable securities laws and regulations. The current repurchase authorization does not expire
and the approximate dollar value of shares that may yet be purchased under the plan as of December 31, 2023, was approximately
$275,000.
Item
3. Defaults
Upon Senior Securities.
None.
17
Item
4. Mine
Safety Disclosures.
None.
Item
5. Other
Information.
During
the three months ended December 31, 2023, no director or officer of the Company adopted, modified or terminated a “Rule
10b5-1 trading arrangement” or “non-Rule 10b5-1 trading arrangement,” as each term is defined in Item 408(a)
of Regulation S-K.
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
Electromed,
Inc. 2023 Equity Incentive Plan (incorporated by reference to Exhibit 4.3 to Registration Statement on Form S-8 filed
November 30, 2023)*
Incorporated
by Reference
10.2
Rider
to Business Loan Agreement (Asset Based) with Choice Financial Group, dated December 13, 2023 (incorporated by references
to Exhibit 10.2 to Current Report on Form 8-K filed December 15, 2023)
Incorporated
by Reference
10.3
Form of Restricted Stock Agreement (Non-Employee Directors) under the 2023 Equity Incentive Plan*
Filed
Electronically
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 December 31, 2023, 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
*
Management compensatory contract or arrangement
18
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: February
13, 2024
/s/ James
L. Cunniff
James L. Cunniff, President
and Chief Executive Officer (duly authorized officer)
Date: February
13, 2024
/s/ Bradley
M. Nagel
Bradley M. Nagel, 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.