Item 1. Financial Statements
Item
1. Financial
Statements.
Electromed,
Inc.
Condensed
Balance Sheets
September 30, 2020
June 30, 2020
(Unaudited)
Assets
Current Assets
Cash
$ 11,143,181
$ 10,479,150
Accounts receivable (net of allowances for doubtful accounts of $45,000)
13,624,505
12,940,677
Contract assets
799,121
902,619
Inventories, net
3,065,043
3,084,620
Prepaid expenses and other current assets
487,361
353,318
Income tax receivable
218,225
262,155
Total current assets
29,337,436
28,022,539
Property and equipment, net
3,666,101
3,788,469
Finite-life intangible assets, net
626,747
598,389
Other assets
60,508
80,166
Deferred income taxes
700,000
755,000
Total assets
$ 34,390,792
$ 33,244,563
Liabilities and Shareholders’ Equity
Current Liabilities
Current maturities of other long-term liabilities
$ 55,324
$ 72,328
Accounts payable
766,197
555,510
Accrued compensation
1,761,523
1,404,497
Warranty reserve
750,000
740,000
Other accrued liabilities
195,731
214,045
Total current liabilities
3,528,775
2,986,380
Other long-term liabilities
6,001
8,868
Total liabilities
3,534,776
2,995,248
Commitments and Contingencies
Shareholders’ Equity
Common stock, $0.01 par value per share, 13,000,000 shares authorized; 8,606,180 and 8,567,834 shares issued and outstanding, respectively
86,062
85,678
Additional paid-in capital
16,551,189
16,480,134
Retained earnings
14,218,765
13,683,503
Total shareholders’ equity
30,856,016
30,249,315
Total liabilities and shareholders’ equity
$ 34,390,792
$ 33,244,563
See
Notes to Condensed Financial Statements (Unaudited).
1
Electromed,
Inc.
Condensed
Statements of Operations (Unaudited)
Three Months Ended September 30,
2020
2019
Net revenues
$ 8,004,171
$ 8,302,498
Cost of revenues
1,855,950
1,960,150
Gross profit
6,148,221
6,342,348
Operating expenses
Selling, general and administrative
5,004,179
4,894,806
Research and development
481,059
98,937
Total operating expenses
5,485,238
4,993,743
Operating income
662,983
1,348,605
Interest income, net
9,279
39,951
Net income before income taxes
672,262
1,388,556
Income tax expense
137,000
374,000
Net income
$ 535,262
$ 1,014,556
Income per share:
Basic
$ 0.06
$ 0.12
Diluted
$ 0.06
$ 0.12
Weighted-average common shares outstanding:
Basic
8,550,824
8,379,505
Diluted
8,964,937
8,651,891
See
Notes to Condensed Financial Statements (Unaudited).
2
Electromed,
Inc.
Condensed
Statements of Cash Flows (Unaudited)
Three Months Ended September 30,
2020
2019
Cash Flows From Operating Activities
Net income
$ 535,262
$ 1,014,556
Adjustments to reconcile net income to net cash provided by operating activities:
Depreciation
131,818
150,938
Amortization of finite-life intangible assets
31,609
29,963
Share-based compensation expense
191,103
209,954
Deferred income taxes Changes in operating assets
and liabilities:
55,000
3,000
Loss on disposal of property and equipment Changes
in operating assets and liabilities:
92
975
Changes in operating assets and liabilities:
Accounts receivable
(683,828 )
41,299
Contract assets
103,498
(11,966 )
Inventories
26,934
(118,519 )
Prepaid expenses and other assets
(114,385 )
(102,147 )
Income tax receivable
43,930
(50,489 )
Income tax payable
-
(288,511 )
Accounts payable and accrued liabilities
500,917
(250,011 )
Net cash provided by operating activities
821,950
629,042
Cash Flows From Investing Activities
Expenditures for property and equipment
(15,771 )
(404,773 )
Expenditures for finite-life intangible assets
(65,735 )
(10,707 )
Net cash used in investing activities
(81,506 )
(415,480 )
Cash Flows From Financing Activities
Issuance of common stock upon exercise of options
-
13,040
Taxes paid on stock options exercised, net
(76,413 )
-
Net cash provided by (used in) financing activities
(76,413 )
13,040
Net increase in cash
664,031
226,602
Cash
Beginning of period
10,479,150
7,807,928
End of period
$ 11,143,181
$ 8,034,530
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, 2019
8,408,351
$ 84,084
$ 16,127,826
$ 9,522,064
$ 25,733,974
Net income
–
–
–
1,014,556
1,014,556
Issuance of restricted stock
32,500
325
(325 )
–
–
Issuance of common stock upon exercise of options
5,000
50
12,990
–
13,040
Share-based compensation expense
–
–
209,954
–
209,954
Balance at September 30, 2019
8,445,851
84,459
16,350,445
10,536,620
26,971,524
Total
Common Stock
Additional Paid-
Retained
Shareholders’
Shares
Amount
in Capital
Earnings
Equity
Balance at June 30, 2020
8,567,834
$ 85,678
$ 16,480,134
$ 13,683,503
$ 30,249,315
Net income
–
–
–
535,262
535,262
Issuance (forfeiture) of restricted stock
19,090
191
(191 )
–
–
Issuance of common stock upon exercise of options
19,256
193
(193 )
–
–
Taxes paid on stock option exercised on a net basis
–
–
(119,664 )
–
(119,664 )
Share-based compensation expense
–
–
191,103
–
191,103
Balance at September 30, 2020
8,606,180
86,062
16,551,189
14,218,765
30,856,016
See
Notes to Condensed Financial Statements (Unaudited).
4
Electromed,
Inc.
Notes to Condensed Financial Statements
(Unaudited)
Note 1.
Interim Financial Reporting
Basis
of presentation: 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 approximately $84,000 and $66,000 for the three months ended September 30, 2020 and 2019, respectively. Since its inception,
the Company has operated in a single industry segment: developing, manufacturing and marketing medical equipment.
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, 2020 (“fiscal 2020”).
Potential
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 its 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 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 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.
A
summary of the Company’s significant accounting policies follows:
Use
of estimates. Management uses estimates and assumptions in preparing the 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 Condensed Financial Statements include revenue recognition and the related estimation of variable consideration, allowance
for doubtful accounts, inventory obsolescence, share-based compensation and its warranty liability.
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 was 48,500 and 446,350 for the three months ended September 30, 2020 and 2019, respectively.
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 non-cash consideration, consideration paid or payable
to 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.
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. Revenue disaggregated by market is approximately the following:
For
the three months ended September 30,
2020
2019
Home Care
$ 7,464,000
$ 7,491,000
Institutional
278,000
625,000
Home Care Distributor
178,000
120,000
International
84,000
66,000
Total
$ 8,004,000
$ 8,302,000
Home
care revenue disaggregated by payer type is approximately the following:
For
the three months ended September 30,
2020
2019
Commercial
$ 2,726,000
$ 2,885,000
Medicare
4,383,000
3,669,000
Medicaid
188,000
688,000
Other
167,000
249,000
Total
$ 7,464,000
$ 7,491,000
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 sales recognized
at a point in time upon shipment or delivery as well as revenues recognized over time under operating leases.
6
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:
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.
7
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 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 the 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 30 days.
• Rentals
– Under these transactions, the customer obtains a right to use the product for
a period of time in exchange for consideration as usage occurs. These transactions are
treated as operating leases and revenue is recognized ratably over the applicable rental
period. Lease revenue recognized during the three months ended September 30, 2020 and
2019 were approximately zero and $3,000, respectively.
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. Accounts receivable include amounts billed to customers and third-party payers, for which only the passage of
time is required before payment of consideration is due. Amounts due are stated at their net estimated realizable value.
8
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.
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 expense sales incentives
as incurred. These costs are included in selling, general and administrative expenses in the Company’s statements of operations.
Contract
balances. The following table provides information about accounts receivable and contracts assets from contracts with customers:
September
30, 2020
June
30, 2020
Receivables,
included in “Accounts receivable, net of allowance for doubtful accounts”
$ 13,625,000
$ 12,941,000
Contract assets
$ 799,000
$ 903,000
Significant
changes in contract assets during the period are as follows:
Three
Months Ended
September 30, 2020
Fiscal
Year Ended
June 30, 2020
Increase
(decrease)
Increase
(decrease)
Contract
assets, beginning
$ 903,000
$ 996,000
Reclassification of
contract assets to accounts receivable
(396,000 )
(1,858,000 )
Contract assets recognized
285,000
1,734,000
Increase
as a result of changes in the estimate of amounts to be realized from payers, excluding amounts transferred to receivables
during the period
7,000
31,000
Contract assets,
ending
$ 799,000
$ 903,000
Note 3.
Inventories
The
components of inventory were approximately as follows:
September
30, 2020
June
30, 2020
Parts inventory
$ 2,228,000
$ 2,271,000
Work in process
100,000
127,000
Finished goods
873,000
827,000
Estimated inventory
to be returned
154,000
150,000
Less:
Reserve for obsolescence
(290,000 )
(290,000 )
Total
$ 3,065,000
$ 3,085,000
Note
4. Finite-life Intangible Assets
The
carrying value of patents and trademarks includes the original cost of obtaining the patents, periodic renewal fees and other
costs associated with maintaining and defending patent and trademark rights. Patents and trademarks are amortized over their estimated
useful lives, generally 15 and 12 years, respectively. Accumulated amortization was approximately $1,151,000 and $1,119,000 at
September 30, 2020 and June 30, 2020, respectively.
9
The
activity and balances of finite-life intangible assets were approximately as follows:
Three
Months Ended
Fiscal
Year Ended
September
30, 2020
June
30, 2020
Balance,
beginning
$ 598,000
$ 581,000
Additions
60,000
139,000
Amortization
expense
(31,000 )
(122,000 )
Balance, ending
$ 627,000
$ 598,000
Note
5. Warranty Liability
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 liability 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 liability and adjusts
the amounts as necessary.
Changes
in the Company’s warranty liability were approximately as follows:
Three
Months Ended
Fiscal
Year Ended
September
30, 2020
June
30, 2020
Beginning
warranty reserve
$ 740,000
$ 810,000
Accrual
for products sold
54,000
79,000
Expenditures
and costs incurred for warranty claims
(44,000 )
(149,000 )
Ending warranty
reserve
$ 750,000
$ 740,000
Note
6. Income Taxes
On
a quarterly basis, the Company estimates its effective tax rate for the full fiscal year and records a quarterly income tax provision
based on the anticipated rate. As the year progresses, the Company refines its estimate based on the facts and circumstances by
each applicable tax jurisdiction. Income tax expense was estimated at approximately $137,000 and the effective tax rate was 20.4%
for the three months ended September 30, 2020. Estimated income tax expense for the three months ended September 30, 2020 includes
a discrete current tax benefit of approximately $39,000 related to the excess tax benefit of non-qualified stock options exercised.
Income tax expense was estimated at approximately $374,000, and the effective tax rate was 26.9% for the three months ended September
30, 2019.
Note
7. Financing Arrangements
The
Company has a credit facility that provides for a revolving line of credit and a term loan. Effective December 18,
2019, the Company renewed its $2,500,000 revolving line of credit. There was no outstanding principal balance on the line of credit
as of September 30, 2020 or June 30, 2020. Interest on borrowings under the line of credit, if any, accrues at the prime rate
(3.25% at September 30, 2020) 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, 2020, if
not renewed. At September 30, 2020, 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
8. Share-Based Compensation
The
Company’s share-based compensation plans are described in Note 8 of our annual report on Form 10-K for the year ended June
30, 2020. Share-based compensation expense was approximately $191,000 and $210,000 for the three months ended September 30, 2020
and 2019, respectively. This expense is included in selling, general and administrative expense. As of September 30, 2020, approximately
$1,267,000 of total unrecognized compensation expense related to non-vested equity awards was expected to be recognized over a
weighted-average period of approximately 0.9 years.
10
Stock
Options
Stock
option transactions during the three months ended September 30, 2020 are summarized as follows:
Number
of Shares
Weighted
Average Exercise Price per Share
Outstanding at June 30, 2020
590,780
$ 4.34
Granted
55,800
$ 14.53
Exercised
(48,084 )
$ 4.93
Cancelled
or Forfeited
(56,898 )
$ 6.56
Outstanding at
September 30, 2020
541,598
$ 5.10
The
following assumptions were used to estimate the fair value of stock options granted:
Three
Months Ended September 30, 2020
Three
Months Ended September 30, 2019
Risk-free
interest rate
0.31%
- 0.39 %
1.85 %
Expected
term (years)
6.0
6.0
Expected
volatility
283.05%
- 334.15 %
190.1 %
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, 2020, the weighted average remaining contractual term for all outstanding stock options was 6.7 years and their aggregate
intrinsic value was approximately $3,071,000. Outstanding at September 30, 2020 were 541,598 stock options issued to employees,
of which 401,571 were exercisable and had an aggregate intrinsic value of approximately $2,609,000.
Restricted
Stock
During
the three months ended September 30, 2020, the Company issued restricted stock awards to employees totaling 30,756 shares of common
stock, with a vesting term of two to three years and a weighted average fair value of $14.68 per share. There were 53,255 shares
of unvested restricted stock with a weighted average fair value per share of $11.06 as of September 30, 2020.
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, related notes thereto included in Part I, Item 8 and Part II, Item 7 of our Annual
Report on Form 10-K for the fiscal year ended June 30, 2020 (“fiscal 2020”).
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.
11
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 our fiscal quarter ended March 31, 2014. In the fourth quarter of our fiscal year ended June 30,
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.
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 Policies and 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 2020.
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. 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, allowance for doubtful accounts,
inventory obsolescence, share-based compensation and warranty liability.
Potential
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 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.
The
COVID-19 pandemic has created significant volatility, uncertainty and economic disruption and has negatively impacted business
in our industry since March 2020. In particular, certain healthcare facilities and clinics restricted access to their clinicians,
reducing patient consultations and treatments, or closed temporarily due to the COVID-19 pandemic, which reduced home care referrals
and resulted in certain institutional orders being postponed. We believe that these and other responses by healthcare systems
have had a negative impact on our operating results and cash flows during the first quarter of our fiscal year ending June 30,
2021 (“fiscal 2021”), although to a lesser extent as compared to the fourth quarter of fiscal 2020. During the
first quarter of fiscal 2021, as state and local government restrictions began to ease in jurisdictions in which we operate, we
observed increased patient face-to-face re-engagement with clinicians and an increased number of clinics allowing face-to-face
access by our sales team. Our sales team continues to utilize a hybrid sales process of virtual and face-to-face clinician interaction
with strict adherence to specific clinic and healthcare system safety protocols.
12
We
estimate that institutional revenue has been negatively impacted since the onset of the COVID-19 pandemic as hospitals and long-term
care facilities have adjusted their operating protocols and procurement management.
We
believe that the impact of the COVID-19 pandemic on our home care and institutional business will likely continue to decrease
during the remainder of fiscal 2021 and subsequent periods; however, if COVID-19 rates increase and federal, state and local restrictions
on commerce, stay-at-home orders or other restrictions on businesses are reinstated, then such measures could have a material
adverse effect on our business.
We
believe that the COVID-19 pandemic’s adverse impact on our operating results, cash flows and financial condition will be
primarily driven by: the severity and duration of the pandemic; its impact on the U.S. healthcare system and economy; and the
timing, scope and effectiveness of U.S. governmental responses to the pandemic.
While
we have not experienced adverse impacts on our supply chain, it is possible the COVID-19 pandemic could have an adverse impact
on our supply chain in the future, including impacts associated with preventive and precautionary measures that other businesses
and applicable governments are taking. A reduction or interruption in any of our manufacturing processes could have a material
adverse effect on our business.
In
response to the negative impacts of the COVID-19 pandemic on our business, in April 2020, we initiated cost-containment measures,
which included reducing discretionary and variable spend, such as travel, and the use of contractors, consultants, temporary help
and employee furloughs in our manufacturing and general and administrative functions due to lower near-term demand for our products.
Employee furloughs continued through early August 2020, at which time we returned to full employment in both our manufacturing
and general and administrative functions.
We
have also taken measures to ensure the safety of our employees and to comply with applicable governmental orders. We consider
our business to be essential under applicable orders due primarily to our role in manufacturing and supplying needed medical devices
to patients with respiratory related issues and have therefore continued to operate during the government restrictions put in
place in response to the pandemic.
In
response to the COVID-19 pandemic and the U.S. federal government’s declaration of a public health emergency, the Center
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 are retroactively effective to 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 during such
period. The CMS waiver has been recently extended in conjunction with the extension of the public health emergency for an
additional 90-day period beginning on October 23, 2020.
13
Results of Operations
Net Revenues
Net revenues for the three months ended
September 30, 2020 and 2019 are summarized in the table below (dollar amounts in thousands).
Three Months Ended September 30,
2020
2019
Increase (Decrease)
Home care
$ 7,464
$ 7,491
$ (27 )
(0.4 %)
Institutional
278
625
(347 )
(55.5 %)
Home care distributor
178
120
58
48.3 %
International
84
66
18
27.3 %
Total
$ 8,004
$ 8,302
$ (298 )
(3.6 %)
Home care revenue. Home care revenue
for the three months ended September 30, 2020 was approximately $7,464,000, representing a decrease of approximately $27,000, or
0.4%, compared to the same period in fiscal 2020. The decrease was primarily due to a lower average allowable, partially offset
by an increase in referrals as compared to the prior year period. Home care revenue growth continued to be impacted by healthcare
facilities and clinics restricting access to sales representatives, reduced patient consultations and treatments, and patient safety
concerns with face-to-face visits. Home care revenue for the three months ended September 30, 2020 increased approximately $1,136,000,
or 17.9%, compared to home care revenue for the three months ended June 30, 2020. The increase was driven primarily by state and
local government restrictions beginning to ease, increasing patient face-to-face re-engagement with clinicians and an increasing
number of clinics allowing face-to-face access by our sales team. The home care business has also continued to benefit from the
CMS waiver, which has increased the number of referrals and the approval percentage for non-covered diagnosis and accelerated the
approval timeline for covered diagnosis.
Institutional revenue. Institutional
revenue for the three months ended September 30, 2020 was approximately $278,000, representing a decrease of approximately $347,000,
or 55.5%, compared to the same period in fiscal 2020. The decrease in the current year period was primarily due to a decrease in
the volume of devices and disposable wraps sold due to continued impact of COVID-19 on hospital purchasing activity. Institutional
revenue increased approximately $5,000, or 1.9%, compared to the three months ended June 30, 2020. The increase was due primarily
to higher disposable wrap volumes, offset by lower capital sales. Institutional includes sales to group purchasing organization
(“GPO”) members, medical equipment rental companies that rent to long-term care facilities and other institutions.
Home care distributor revenue. Home
care distributor revenue for the three months ended September 30, 2020 was approximately $178,000, representing an increase of
approximately $58,000, or 48.3%, compared to the same period in fiscal 2020. We began selling to home medical equipment distributors
during fiscal 2020, who in turn sell our SmartVest System in the U.S. home care market.
International revenue. International
revenue for the three months ended September 30, 2020 was approximately $84,000, representing an increase of approximately $18,000,
or 27.3%, compared to the same period in fiscal 2020. International sales are affected by the timing of distributor purchases that
can cause significant fluctuations in reported revenue on a quarterly basis.
Gross profit
Gross profit decreased to approximately
$6,148,000, or 76.8% of net revenues, for the three months ended September 30, 2020, from approximately $6,342,000, or 76.4% of
net revenues, in the same period in fiscal 2020. The decrease in gross profit dollars for the three months ended September 30,
2020 was primarily related to lower institutional revenue. The increase in gross profit as a percentage of net revenue was driven
by a higher mix of home care revenue.
14
Operating expenses
Selling, general and administrative
expenses. Selling, general and administrative (“SG&A”) expenses were approximately $5,004,000 for the
three months ended September 30, 2020, representing an increase of approximately $109,000, or 2.2%, compared to the same period
in the prior year.
Payroll and compensation-related expenses
were approximately $3,299,000 for the three months ended September 30, 2020, representing an increase of approximately $161,000,
or 5.1%, compared to the same period in the prior year. The increase in the current year period was primarily due to a higher average
number of employees in sales and marketing roles.
Travel, meals and entertainment expenses
were approximately $364,000 for the three months ended September 30, 2020, representing a decrease of approximately $221,000, or
37.8%, compared to the same period in the prior year. The decrease in the current year period was primarily due to travel reductions
in connection with COVID-19.
Direct Marketing costs were approximately
$142,000 for the three months ended September 30, 2020, representing an increase of $95,000, or 198.7%, compared to the same period
in the prior year. The increase in the current year period was primarily due to a direct-to-consumer marketing campaign that began
in May 2020.
Professional fees for the three months
ended September 30, 2020 were approximately $454,000, an increase of approximately $42,000, or 10.1%, compared to the same period
in the prior year. The increase in the current year period was primarily due to a new human resources platform that we implemented
in December 2019. Professional fees are primarily for services related to legal costs, shareowner services and reporting requirements,
information technology (“IT”) technical support and consulting fees.
Research and development expenses. Research
and development (“R&D”) expenses were approximately $481,000 for the three months ended September 30, 2020, representing
an increase of approximately $382,000 compared to the same period in the prior year. R&D expenses for the three months ended
September 30, 2020 were 6.0% of revenue compared to 1.2% of revenue for the same period in the prior year. The increase in the
current year period was primarily due to next generation platform development activities.
Interest income, net
Net
interest income for the three months ended September 30, 2020 was approximately $9,000 compared to approximately $40,000 in the
comparable prior year period. The decrease in the current year period was primarily driven by lower rates earned on our cash deposits.
Income tax expense
Income tax expense was estimated at approximately
$137,000 and $374,000 and the effective tax rate was 20.4% and 26.9% for the three months ended September 30, 2020 and 2019, respectively.
The estimated income tax expense for the three months ended September 30, 2020 includes a discrete tax benefit of $39,000 related
to stock options exercised by current and former employees.
Net income
Net income for the three months ended September
30, 2020 was approximately $535,000 compared to $1,015,000 for the same period in the prior year. The decrease in the current year
period was primarily due to increased R&D expense associated with our next generation platform development, lower institutional
revenue and higher average headcount in sales and marketing.
Liquidity and Capital Resources
Cash Flows and Sources of Liquidity
Cash Flows from Operating Activities
For the three months ended September 30,
2020, net cash provided by operating activities was approximately $822,000. Cash flows provided by operating activities consisted
of net income of approximately $535,000, an increase in accounts payable and accrued liabilities of $501,000, non-cash expenses
of $410,000, a decrease in contract assets of $103,000, a decrease in income tax receivable of $44,000 and a decrease in inventory
of $27,000. These cash flows from operating activities were partially offset by an increase in accounts receivable of $684,000
and an increase in prepaid expenses and other assets of $114,000.
15
Cash Flows from Investing Activities
For the three months ended September 30,
2020, cash used in investing activities was approximately $82,000. Cash used in investing activities consisted of approximately
$16,000 in expenditures for property and equipment and $66,000 in payments for patent costs.
Cash Flows from Financing Activities
For the three months ended September 30,
2020, cash used in financing activities was approximately $76,000, which consisted of taxes paid on stock options exercised on
a net basis.
Adequacy of Capital Resources
Our primary working capital requirements
relate to adding employees to our sales force and support functions, continuing R&D efforts, 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 approximately $25,809,000 and available borrowings under
our existing credit facility will provide adequate liquidity during fiscal 2021.
Effective December 18, 2019, we renewed
our credit facility, which provides us with a revolving line of credit. Interest on borrowings on the line of credit accrues at
the prime rate (3.25% at September 30, 2020) less 1.00% and is payable monthly. There was no outstanding principal balance on the
line of credit as of September 30, 2020 or June 30, 2020. 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, 2020, if not
renewed. At September 30, 2020, 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.
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,
2020 and 2019, we spent approximately $16,000 and $405,000, 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.
Off-Balance Sheet Arrangements
As of September 30, 2020, we had no off-balance
sheet arrangements.
16
Cautionary Note 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; the expected
impact of the COVID-19 pandemic on our business; and our anticipated revenues, expenses, capital requirements and liquidity. Words
such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,”
“goal,” “intend,” “may,” “ongoing,” “plan,” “potential,”
“project,” “should,” “target,” “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;
● the competitive nature of our market;
● changes to Medicare, Medicaid, or private insurance reimbursement policies;
● changes to state and federal health care laws;
● changes affecting the medical device industry;
● our ability to develop new sales channels for our products such as the home care distributor channel;
● our need to maintain regulatory compliance and to gain future regulatory approvals and clearances;
● new drug or pharmaceutical discoveries;
● general economic and business conditions;
● our ability to renew our line of credit or obtain additional credit as necessary;
● our ability to protect and expand our intellectual property portfolio; and
● the risks associated with expansion into international markets.
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 and subsequent reports we file with the SEC. 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.
17
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.