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, 20172020

 

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

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 valueELMDNYSE 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 and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted 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 and post 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 ☐
(Do not check if smaller reporting company)

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 8,286,4098,635,045 shares of Electromed, Inc. common stock, par value $0.01 per share, outstanding as of the close of business on February 12, 2018.5, 2021.

  

 

 

 

Electromed, Inc.

Index to Quarterly Report on Form 10-Q

Page

 

Page
PART I – FINANCIAL INFORMATION 
  
Item 1.Financial Statements1
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations912
Item 3.Quantitative and Qualitative Disclosures About Market Risk1418
Item 4.Controls and Procedures1418
   
PART II – OTHER INFORMATION 
  
Item 1.Legal Proceedings1518
Item 1A.Risk Factors1518
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds1518
Item 3.Defaults Upon Senior Securities1519
Item 4.Mine Safety Disclosures1519
Item 5.Other Information1519
Item 6.Exhibits1619

 

 

PART I – FINANCIAL INFORMATION

 

Item 1.Financial Statements.

 

Electromed, Inc.

Condensed Balance Sheets

 

 December 31, 2017 June 30, 2017  December 31, 2020  June 30, 2020 
  (Unaudited)     (Unaudited)  
Assets            
Current Assets                
Cash $6,840,237  $5,573,709  $11,742,115  $10,479,150 
Accounts receivable (net of allowances for doubtful accounts of $45,000)  9,680,369   9,949,759   15,395,124   12,940,677 
Inventories  2,393,639   2,559,485 
Contract assets  696,993   902,619 
Inventories, net  2,603,495   3,084,620 
Prepaid expenses and other current assets  379,713   393,319   381,763   353,318 
Income tax receivable  76,271   262,155 
Total current assets  19,293,958   18,476,272   30,895,761   28,022,539 
Property and equipment, net  3,215,369   3,303,233   3,583,374   3,788,469 
Finite-life intangible assets, net  674,704   721,276   622,697   598,389 
Other assets  102,577   99,868   43,792   80,166 
Deferred income taxes  417,000   460,000   678,000   755,000 
Total assets $23,703,608  $23,060,649  $35,823,624  $33,244,563 
                
Liabilities and Shareholders’ Equity                
Current Liabilities                
Current maturities of long-term debt, net of debt issuance costs $1,124,745  $50,703 
Current maturities of other long-term liabilities $40,455  $72,328 
Accounts payable  704,105   663,376   722,905   555,510 
Accrued compensation  835,907   946,623   1,823,742   1,404,497 
Income tax payable  84,110   156,524 
Warranty reserve  670,000   640,000   770,000   740,000 
Other accrued liabilities  360,538   438,748   128,859   214,045 
Total current liabilities  3,779,405   2,895,974   3,485,961   2,986,380 
Long-term debt, less current maturities and net of debt issuance costs     1,097,125 
Other long-term liabilities  3,929   8,868 
Total liabilities  3,779,405   3,993,099   3,489,890   2,995,248 
                
Commitments and Contingencies                
                
Shareholders’ Equity                
Common stock, $0.01 par value; authorized: 13,000,000 shares; 8,270,167 and 8,230,167 issued and outstanding at December 31, 2017 and June 30, 2017, respectively  82,702   82,302 
Common stock, $0.01 par value per share, 13,000,000 shares authorized; 8,635,045 and 8,567,834 shares issued and outstanding, respectively  86,350   85,678 
Additional paid-in capital  14,414,450   14,028,602   16,825,192   16,480,134 
Retained earnings  5,427,051   4,956,646   15,422,192   13,683,503 
Total shareholders’ equity  19,924,203   19,067,550   32,333,734   30,249,315 
Total liabilities and shareholders’ equity $23,703,608  $23,060,649  $35,823,624  $33,244,563 

 

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,

 
 2017 2016 2017 2016  

Three Months Ended 

December 31, 

 

Six Months Ended 

December 31, 

 
          2020 2019 2020 2019 
Net revenues $6,984,626  $6,372,243  $13,366,405  $11,917,606  $9,496,073  $8,546,942  $17,500,245  $16,849,440 
Cost of revenues  1,398,001   1,445,786   2,843,286   2,663,522   1,970,830   1,871,434   3,826,780   3,831,584 
Gross profit  5,586,625   4,926,457   10,523,119   9,254,084   7,525,243   6,675,508   13,673,465   13,017,856 
                                
Operating expenses                                
Selling, general and administrative  4,759,652   4,096,197   9,463,163   7,784,107   5,435,025   4,965,053   10,439,205   9,859,858 
Research and development  56,794   100,801   127,458   451,641   507,497   143,477   988,556   242,414 
Total operating expenses  4,816,446   4,196,998   9,590,621   8,235,748   5,942,522   5,108,530   11,427,761   10,102,272 
Operating income  770,179   729,459   932,498   1,018,336   1,582,721   1,566,978   2,245,704   2,915,584 
Interest expense, net of interest income of $8,888, $3,603, $18,517 and $6,969, respectively  4,894   15,598   9,093   32,304 
Interest income, net  9,706   37,078   18,985   77,028 
Net income before income taxes  765,285   713,861   923,405   986,032   1,592,427   1,604,056   2,264,689   2,992,612 
                                
Income tax expense  416,000   270,000   453,000   351,000   389,000   419,000   526,000   793,000 
                
Net income $349,285  $443,861  $470,405  $635,032  $1,203,427  $1,185,056  $1,738,689  $2,199,612 
                                
Income per share:                                
                
Basic $0.04  $0.05  $0.06  $0.08  $0.14  $0.14  $0.20  $0.26 
                
Diluted $0.04  $0.05  $0.05  $0.08  $0.13  $0.14  $0.19  $0.25 
                                
Weighted-average common shares outstanding:                                
Basic  8,200,167   8,167,112   8,200,167   8,167,112   8,570,313   8,390,125   8,560,590   8,384,807 
Diluted  8,648,866   8,426,996   8,645,987   8,440,698   8,924,861   8,759,143   8,926,182   8,698,168 

 

See Notes to Condensed Financial Statements (Unaudited).

 


 2

Electromed, Inc.

Condensed Statements of Cash Flows (Unaudited)

 

 Six Months Ended December 31,  Six Months Ended December 31, 
 2017  2016  2020 2019 
Cash Flows From Operating Activities                
Net income $470,405  $635,032  $1,738,689  $2,199,612 
Adjustments to reconcile net income to net cash provided by operating activities:                
Depreciation  329,719   312,075   250,489   318,982 
Amortization of finite-life intangible assets  56,610   60,963   65,074   60,219 
Amortization of debt issuance costs  4,394   9,216 
Share-based compensation expense  386,248   234,634   429,776   444,258 
Deferred income taxes  43,000   13,000   77,000   18,000 
Loss on disposal of intangible assets     111,497 
Loss on disposal of property and equipment  -   1,294 
Changes in operating assets and liabilities:                
Accounts receivable  269,390   (673,458)  (2,454,447)  41,822 
Contract assets  205,626   (194,963)
Inventories  183,617   (53,894)  490,430   (19,448)
Prepaid expenses and other assets  8,461   7,046   7,929   76,213 
Income tax receivable     189,789   185,884   (206,489)
Income tax payable  (72,414)     -   (288,511)
Accounts payable and accrued liabilities  (149,647)  (807,188)  494,429   (427,390)
Net cash provided by operating activities  1,529,783   38,712   1,490,879   2,023,599 
                
Cash Flows From Investing Activities                
Expenditures for property and equipment  (228,176)  (267,117)  (53,778)  (669,842)
Expenditures for finite-life intangible assets  (10,038)  (44,518)  (90,090)  (30,899)
Net cash used in investing activities  (238,214)  (311,635)  (143,868)  (700,741)
                
Cash Flows From Financing Activities                
Principal payments on long-term debt including capital lease obligations  (25,041)  (24,056)
Payment of deferred financing fees     (4,872)
Net cash used in financing activities  (25,041)  (28,928)
Net increase (decrease) in cash  1,266,528   (301,851)
        
Issuance of common stock upon exercise of options  45,669   75,936 
Taxes paid on net share settlement of stock option exercises  (129,715)  - 
Net cash provided by (used in) financing activities  (84,046)  75,936 
Net increase in cash  1,262,965   1,398,794 
Cash                
Beginning of period  5,573,709   5,123,355   10,479,150   7,807,928 
End of period $6,840,237  $4,821,504  $11,742,115  $9,206,722 

See Notes to Condensed Financial Statements (Unaudited).

 3

Electromed, Inc.

Condensed Statements of Shareholders’ Equity (Unaudited)

  Common Stock  Additional Paid-in Capital Retained Earnings  Total Shareholders’ Equity 
  Shares  Amount      
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 
                    
Net income          1,185,056   1,185,056 
Issuance of restricted stock  15,000   150   (150)     
Issuance of common stock upon exercise of options  17,597   175   62,721     62,896 
Share-based compensation expense        234,304     234,304 
Balance at December 31, 2019  8,478,448  $84,784  $16,647,320 $11,721,676  $28,453,780 

  Common Stock  Additional Paid-in Capital Retained Earnings  Total Shareholders’ Equity 
  Shares  Amount      
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 of restricted stock, net of forfeitures  19,090   191   (191)     
Issuance of common stock upon exercise of options  19,256   193   (193)     
Taxes paid on net share settlement of stock option exercises        (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 
                    
Net income          1,203,427   1,203,427 
Issuance of restricted stock  18,000   180   (180)     
Issuance of common stock upon exercise of options  10,865   108   45,561     45,669 
Taxes paid on net share settlement of stock option exercises        (10,051)    (10,051)
Share-based compensation expense        238,673     238,673 
Balance at December 31, 2020  8,635,045  $86,350  $16,825,192 $15,422,192  $32,333,734 

 

See Notes to Condensed Financial Statements (Unaudited).


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 $267,000$221,000 and $332,000$319,000 for the six months ended December 31, 20172020 and 2016,2019, respectively. Since its inception, the Company has operated in a single industry segment: developing, manufacturing and marketing medical equipment.

 

The accompanying unaudited condensed financial statementsCondensed 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 statementsCondensed 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, 20172020 (“fiscal 2017”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 and distribution of treatments or vaccines, and the resumption of widespread economic activity. Due to the inherent uncertainty of the unprecedented and rapidly evolving situation, the Company is unable to predict with confidence the likely impact of the COVID-19 pandemic on its future operations. For a more detailed discussion see “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in Part I, Item 2 of this Quarterly Report on Form 10-Q.

 

A summary of the Company’s significant accounting policies follows:

 

Use of estimates:estimates. Management uses estimates and assumptions in preparing the condensed financial statementsunaudited 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 statementsunaudited Condensed Financial Statements include revenue recognition and the related estimation of selling price adjustments,variable consideration, allowance for doubtful accounts, inventory obsolescence, share-based compensation income taxes and theits warranty reserve.liability.

 

Net income per common share: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 177,75046,800 and 196,500136,000 for the three months ended December 31, 2020 and 2019, respectively, and were 46,800 and 316,000 for the six months ended December 31, 20172020 and 2016,2019, respectively.

 


New accounting pronouncements: In May 2014,Note 2. Revenues

Revenue is measured based on consideration specified in the Financial Accounting Standards Board (“FASB”) issued guidance creatingcontract 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”) Section 606, “Revenue from Contracts340-40, “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 Customers.” The new section will replace ASC Section 605, “Revenue Recognition,” and creates modifications to various other revenue accounting standards for specialized transactions and industries. The section is intended to conform revenue accounting principlesthe shipment of the Company’s SmartVest® Airway Clearance System (“SmartVest System”) after control has transferred to a concurrently issued International Financial Reporting Standards with previously differing treatment between U.S. practicecustomer are accounted for as a fulfillment cost and thatare included in cost of muchrevenues in the Condensed Statements of Operations.

The timing of revenue recognition, billings and cash collections results in accounts receivable on the restCondensed Balance Sheets as further described below under Accounts receivable and Contract assets

Disaggregation of revenues. In the world,following table, net revenues are disaggregated by market:

  Three Months Ended December 31,  Six Months Ended December 31, 
  2020  2019  2020  2019 
Home Care $8,902,609  $7,669,107  $16,366,221  $15,160,762 
Institutional  308,563   493,525   586,686   1,118,349 
Home Care Distributor  148,519   131,035   326,530   251,369 
International  136,382   253,275   220,808   318,960 
Total $9,496,073  $8,546,942  $17,500,245  $16,849,440 

In the following table, net home care revenue is disaggregated by payer type:

  Three Months Ended December 31,  Six Months Ended December 31, 
  2020  2019  2020  2019 
Commercial $3,374,998  $3,103,518  $6,101,232  $5,988,130 
Medicare  5,218,814   3,788,173   9,602,061   7,463,673 
Medicaid  165,068   449,492   352,812   1,131,410 
Other  143,729   327,924   310,116   577,549 
Total $8,902,609  $7,669,107  $16,366,221  $15,160,762 

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.

Performance obligations and transaction price. A performance obligation is a promise in a contract to enhance disclosures relatedtransfer a distinct good or service to disaggregatedthe 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 information. Entities will havewhen, or as, the option to applyperformance obligation is satisfied. The Company’s performance obligations and the standard retrospectively to all prior periods presented (“full retrospective”),timing or to apply it retrospectively only to contracts existing at the effective date (“modified retrospective”), with the cumulative effectmethod of revenue recognition in each of the standard recorded as an adjustment to beginning retained earnings. The updated guidance will be effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within that year. The Company is currently evaluating which of the alternative approaches it will apply and the potential impact of adoption of the revised revenue standards on its financial statements. The Company intends to complete its evaluation during its fiscal year ending June 30, 2018 (“fiscal 2018”).Company’s markets are discussed below:

 


Home care market.In July 2015, FASB issued ASU 2015-11, “Inventory (Topic 330) Relatedthe 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 Simplifyingbe a single performance obligation.

The Company makes available to its home care patients limited post-sale services that are not material in the Measurementcontext of Inventory,”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 appliespayment 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 inventory excepthome 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 is measured using last-in, first-out (“LIFO”)are subject to the third-party payer’s termination due to changes in insurance coverage, death or the retail inventory method. Inventory measured using first-in, first-out (“FIFO”) or average cost is within the scopepatient’s discontinued use of the new guidanceSmartVest System, (ii) contracts under appeal and should be measured at the lower of cost(iii) patient responsibility amounts for deductibles, coinsurance, copays and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less reasonably predictable cost of completion, disposal, and transportation. Subsequent measurement is unchanged for inventory measured using LIFO or the retail inventory method. The amendments are effective for public business entities for fiscal years beginning after December 15, 2016, including interim periods within those fiscal years. The new guidance is applied prospectively, and earlier application is permitted as of the beginning of an interim or annual reporting period. The Company adopted ASU 2015-11 effective July 1, 2017, which had no material impact on its financial statements or financial statement disclosures.other similar payments.

 

In February 2016, FASB issued ASU 2016-02, “Leases (Topic 842).” This standard requiresAlthough estimates may be made on a contract-by-contract basis, whenever possible, the recognitionCompany uses all available information, including historical collection patterns, to estimate variable consideration for portfolios of all lease transactions with termscontracts. The Company’s estimates of variable consideration consist of amounts it may receive from insurance providers in excess of 12 monthsits 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 balance sheet asrisk its estimates used to arrive at the transaction price will result in a lease liability and a right-of-use asset (as definedsignificant reversal in the standard). ASU 2016-02 will be effective for fiscal years beginning after December 15, 2018, including interim periods within those fiscal years,amount of cumulative revenue recognized when the uncertainty associated with earlier application permitted.  Upon adoption, the lessee will apply the new standard retrospectively to all periods presented or retrospectively using a cumulative effect adjustmentvariable consideration is subsequently resolved. Variable consideration is included in the year of adoption. The Company has evaluated ASU 2016-02 and expects that it will have no material impact on its financial statements or financial statement disclosures upon adoption based on current facts and circumstances.

In March 2016, FASB issued ASU 2016-09, “Compensation—Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting,” which reduces complexity in accounting standards related to share-based payment transactions, including, among others, (1) accounting for income taxes, (2) classification of excess tax benefits on the statement of cash flow, (3) forfeitures, and (4) statutory tax withholding requirements.  ASU 2016-09 is effective for annual reporting periods beginning on or after December 15, 2016, and interim periods within those annual periods.  The Company adopted ASU 2016-09 effective July 1, 2017, which had no material impact on its previously reported financial statementstransaction price if, in the Company’s Annual Report on Form 10-Kjudgment, it is probable that a significant future reversal of cumulative revenue under the contract will not occur.

For example, for fiscal 2017.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 has electedbelieves the low volatility in historical claims approval rates for populations of patients whose demographics are similar to continuethose 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 recognize estimated forfeitures as stock-based compensation expense.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.

Rental – 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 six months ended December 31, 2020 and 2019 was zero and approximately $4,000, 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.

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 expenses sales incentives as incurred. These costs are included in selling, general and administrative expenses in the Condensed Statements of Operations.

Contract balances. The following table provides information about accounts receivable and contracts assets from contracts with customers:

  December 31,
2020
  June 30,
2020
 
Receivables, included in "Accounts receivable, net of allowance for doubtful accounts" $15,395,124  $12,940,677 
Contract assets $696,993  $902,619 

Significant changes in contract assets during the period are as follows:

  Six Months Ended December 31, 2020  Fiscal Year Ended June 30, 2020 
  Increase (decrease)  Increase (decrease) 
Contract assets, beginning $902,619  $995,847 
Reclassification of contract assets to accounts receivable  (806,550)  (1,857,818)
Contract assets recognized  608,445   1,733,835 
Increase as a result of changes in the estimate of amounts to be realized from payers, excluding amounts transferred to receivables during the period  (7,521)  30,755 
Contract assets, ending $696,993  $902,619 

Note 2.3. Inventories

 

The components of inventory were approximately as follows:

 

  December 31, 2017  June 30, 2017 
Parts inventory  $1,743,000  $1,789,000 
Work in process   377,000   205,000 
Finished goods   544,000   745,000 
Less: Reserve for obsolescence   (270,000)  (180,000)
Total  $2,394,000  $2,559,000 

  December 31,
2020
  June 30,
2020
 
Parts inventory $2,117,176  $2,270,766 
Work in process  111,227   126,726 
Finished goods  508,180   826,740 
Estimated inventory to be returned  166,912   150,388 
Less: Reserve for obsolescence  (300,000)  (290,000)
Total $2,603,495  $3,084,620 

 

Note 3.4. 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. There were no abandonments of domestic or foreign patents that occurred during the six months ended December 31, 2017. During fiscal 2017, the Company abandoned certain domestic and foreign patents with net values of approximately $133,000, which were included as an expense in selling, general and administrative expense on the statements of operations. The majority of the pending patents that were abandoned related to the initial development of the Company’s SQL SmartVest technology. During a review of the Company’s patent portfolio it was determined that certain patents proved redundant to a subsequent SQL patent filing and were therefore abandoned. A smaller portion of expense was related to patents that covered technology that management considered outdated, and was no longer in use. Accumulated amortization was $847,000approximately $1,183,000 and $790,000$1,119,000 at December 31, 20172020 and June 30, 2017,2020, respectively.

 


The activity and balances of finite-life intangible assets were approximately as follows:

 

  Six Months Ended
December 31, 2017
  Fiscal Year Ended
June 30, 2017
 
Balance, beginning   $721,000  $904,000 
Additions    10,000   68,000 
Abandonments      (133,000)
Amortization expense    (56,000)  (118,000)
Balance, ending   $675,000  $721,000 

  Six Months Ended December 31, 2020  Fiscal Year Ended June 30, 2020 
Balance, beginning $598,389  $581,413 
Additions  89,382   138,739 
Amortization expense  (65,074)  (121,763)
Balance, ending $622,697  $598,389 

 

Note 4.5. 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:

 

  Six Months Ended
December 31, 2017
  Fiscal Year Ended
June 30, 2017
 
Beginning warranty reserve  $640,000  $660,000 
Accrual for products sold   108,000   129,000 
Expenditures and costs incurred for warranty claims   (78,000)  (149,000)
Ending warranty reserve  $670,000  $640,000 

  Six Months Ended December 31, 2020  Fiscal Year Ended June 30, 2020 
Beginning warranty reserve $740,000  $810,000 
Accrual for products sold  114,000   79,000 
Expenditures and costs incurred for warranty claims  (84,000)  (149,000)
Ending warranty reserve $770,000  $740,000 

 

Note 5.6. Income Taxes

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act significantly revises future and ongoing U.S. corporate tax obligations by, among other things, lowering U.S. corporate income tax rates. Since the Company has a June 30 fiscal year-end, the lower corporate income tax rate will be phased in, resulting in a blended U.S. statutory federal rate of approximately 28% for fiscal 2018, and 21% for subsequent fiscal years. The Tax Act also eliminates the domestic production manufacturing deduction effective for the Company’s tax year beginning July 1, 2018. For the six months ended December 31, 2017, these changes under the Tax Act resulted in a net income tax expense of approximately $160,000.

 

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 $416,000$389,000 and $453,000, respectively,$526,000 and the effective tax rates were 54.4%rate was 24.4% and 49.1%, respectively,23.2% for the three and six months ended December 31, 2017.2020, respectively. Estimated income tax expense for the three and six months ended December 31, 20172020 includes a discrete deferredcurrent tax expense of approximately $160,000 as a result of re-measuring certain deferred tax assets and liabilities based on the rates at which they are expected to reverse in future periods under the Tax Act. Additionally, a discrete tax(expense) benefit of approximately $2,000$(7,000) and $27,000$32,000, respectively, related to the excess tax (expense) benefit of non-qualified stock options exercised. Income tax expense was recognized duringestimated at approximately $419,000 and $793,000 and the effective tax rate was 26.1% and 26.5% for the three and six months ended December 31, 2017, respectively, as a result of greater federal and state research and development tax credits than what was originally estimated in the Company’s tax provision for fiscal 2017. The net impact of these discrete events increased the effective tax rate by 20.6% and 14.4% during the three and six months ended December 31, 2017,2019, respectively.

Income tax expense was estimated at $351,000 and the effective tax rate was 35.6% for the six months ended December 31, 2016. Income tax expense for the six months ended December 31, 2016 included a recognized tax benefit of approximately $22,000 as a result of the lapse of the statute of limitations on uncertain tax positions, which reduced the effective tax rate for the period by 2.2%.


Note 6.7. Financing Arrangements

 

The Company has a credit facility that provides for a revolving line of credit and a term loan.  Effective December 18, 2017,2020, the Company renewed its $2,500,000 revolving line of credit. There was no outstanding principal balance on the line of credit as of December 31, 20172020 or June 30, 2017.2020. Interest on borrowings under the line of credit, if any, would accrueaccrues at the prime rate less 0.25% (4.25%(3.25% at December 31, 2017)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, 2018,2021, if not renewed. At December 31, 2017,2020, the maximum $2,500,000 was eligible for borrowing. ThePayment obligations under the line of credit, isif any, are secured by a security interest in substantially all of the tangible and intangible assets of the Company.

  

In connection with the credit facility, the Company also has a term loan, which had an outstanding principal balance of approximately $1,129,000 at December 31, 2017 and $1,154,000 as of June 30, 2017. The term loan was refinanced effective December 18, 2016, reducing the interest rate from 5.00% to 3.88%. The unamortized debt issuance cost associated with this debt was approximately $4,000 and $6,000 as of December 31, 2017 and June 30, 2017, respectively. The term loan bears interest at 3.88%, with monthly payments of principal and interest of approximately $7,900 and a final payment of principal and interest of approximately $1,085,000 due on the maturity date of December 18, 2018. Payment obligations under the term loan are secured by a mortgage on the Company’s real property. 

The documents governing the line of credit and term loan contain certain financial and nonfinancial covenants that include a minimum tangible net worth covenant of not less than $10,125,000 and restrictions on the Company’s ability to incur certain additional indebtedness or pay dividends.

 

Note 7. Stock-Based8. Share-Based Compensation

In November 2017, the Company’s shareholders approved the 2017 Omnibus Incentive Plan (the “2017 Plan”) which supersedes the 2014 Equity Incentive Plan (the “2014 Plan”). The 2017 Plan allows the Company’s Board of Directors to grant stock options, stock appreciation rights, restricted stock, restricted stock units and other stock-based awards, as well as cash incentive awards to all employees, non-employee directors, and advisors or consultants of the Company. The vesting schedule and term for each award are determined by the Board upon each grant. The maximum number of shares of common stock available for issuance under the 2017 Plan is 900,000. There were 918,300 options granted under the 2014 Plan and prior plans outstanding as of December 31, 2017. There were no options and 10,000 restricted shares issued under the 2017 Plan outstanding and 890,000 available for grant under the 2017 Plan as of December 31, 2017.

 

The Company recorded approximately $386,000 and $235,000Company’s share-based compensation plans are described in Note 8 of our annual report on Form 10-K for fiscal 2020. Share-based compensation expense related to currentwas approximately $430,000 and past grants of stock options and restricted stock$444,000 for the six months ended December 31, 20172020 and 2016,2019, respectively. This expense is included in selling, general and administrative expense.expense in the Condensed Statements of Operations. As of December 31, 2017,2020, approximately $1,026,000$1,192,000 of total unrecognized compensation expense related to non-vested equity awards iswas expected to be recognized over a weighted averageweighted-average period of approximately 0.90.8 years.

 

The Company recognizes compensation expense related to share-based paymentStock Options

Stock option transactions induring the financial statements based on the estimated fair value of the award issued. The fair value of each option is estimated using the Black-Scholes pricing model at the time of award grant. The Company estimates the expected life of options based on the expected holding period by the option holder. The risk-free interest rate is based upon observed U.S. Treasury interest rates for the expected term of the options. The Company makes assumptions with respect to expected stock price volatility based upon the volatility of its stock price. Forfeituressix months ended December 31, 2020 are estimated at the time of grant and revised in subsequent periods if actual forfeitures differ from initial estimates. Forfeitures are estimated based on the percentage of awards expected to vest, taking into consideration the seniority level of the award recipient.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  (64,484) $5.05 
Cancelled or Forfeited  (109,198) $6.24 
Outstanding at December 31, 2020  472,898  $5.00 

  

The following assumptions were used to estimate the fair value of stock options granted:

 

 Six Months Ended
December 31, 2017
 Fiscal Year Ended
June 30, 2017
Risk-free interest rate 1.77% - 2.07% 1.14% - 1.27%
Expected term (years) 6 6
Expected volatility 125.2% - 141.2% 100.5% - 105.8%


Stock Options

The Company issued 182,250 stock options pursuant to the 2014 Plan during the six months ended December 31, 2017. Stock option transactions during the six months ended December 31, 2017 are summarized as follows:

  Number of Shares  Weighted Average
Exercise Price per
Share
 
Outstanding at June 30, 2017   747,634  $2.91 
Granted   182,250  $5.64 
Exercised       
Cancelled or Forfeited   (11,584) $3.51 
Outstanding at December 31, 2017   918,300  $3.44 
  Six Months Ended December 31, 2020  

Fiscal Year Ended June 30, 2020 

 
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 December 31, 2017,2020, the weighted average remaining contractual term for all outstanding stock options was 5.706.3 years and their aggregate intrinsic value was approximately $2,817,000.$2,489,000. Outstanding at December 31, 20172020 were 918,300472,898 stock options issued to employees, of which 586,303341,104 were exercisable and had an aggregate intrinsic value of approximately $2,178,000.$2,112,000.

 

Restricted Stock

The 2017 Plan permits, and the 2014 Plan permitted, the grant of other stock-based awards. Historically, the Company makes restricted stock grants to key employees and non-employee directors that vest over six months to three years.

 

During the six months ended December 31, 2017,2020, the Company issued restricted stock awards to employees totaling 40,00030,756 shares of common stock, with a vesting term of onetwo to three years and a weighted average fair value of $5.59$14.68 per share and to directors totaling 18,000 shares of common stock, with a vesting term of six months and a weighted average fair value of $9.94 per share. TheThere were 71,255 shares of unvested restricted stock’sstock with a weighted average fair value of $10.80 per share represents the closing priceas of the Company’s common stock on the date the grants were made. Restricted stock transactions during the six months ended December 31, 2017 are summarized as follows:2020.

 

  Number of Shares  Weighted Average
Grant Date Fair
Value per Share
 
Unvested shares at June 30, 2017   29,998  $3.15 
Granted   40,000  $5.59 
Vested       
Forfeited       
Unvested at December 31, 2017   69,998  $4.54 

Note 8.9. Commitments and Contingencies

 

The Company is occasionally involved in claims and disputes arising in the ordinary course of business. The Company insures itscertain 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 condensedunaudited 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 Item 1 of Part I, of this Quarterly Report on Form 10-QItem 8 and the audited financial statements, related notes thereto and Management’s Discussion and AnalysisPart II, Item 7 of Financial Condition and Results of Operations contained in our Annual Report on Form 10-K for the fiscal year ended June 30, 2017, or “fiscal 2017.”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.

 

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 the fiscal quarter ended March 31, 2014. In the fourth quarter of our fiscal year ended June 30, 2015, we launched the SmartVest SQL into the institutional and certain international markets. During February 2017, we entered into an agreement with Monaghan Medical Corporation to distribute and sell the Aerobika® Oscillating Positive Expiratory Pressure (OPEP) Device in the U.S. home care market. 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 condensed financial statementsunaudited Condensed Financial Statements in this report,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, “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” and Note 1 to our audited financial statements included in Part II, Item 8, of our Annual Report on Form 10-K for fiscal 2017.2020.

 


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. TheseAmong 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 condensed financial statementsunaudited Condensed Financial Statements contained in this report,Quarterly Report on Form 10-Q, include: revenue recognition and the estimation of selling price adjustments,variable consideration, allowance for doubtful accounts, inventory obsolescence, share-based compensation income taxes 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 second quarter of our fiscal year ending June 30, 2021 (“fiscal 2021”), although to a lesser extent as compared to the prior two fiscal quarters.  During the first half 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.

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 during the remainder of fiscal 2021. We have experienced improvement in our home care referrals for the three months ended December 31, 2020 as compared to the three months ended September 30, 2020; however, if COVID-19 infection rates increase and federal, state and local restrictions on commerce, stay-at-home orders or other restrictions on businesses are reinstated, 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 governmental 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 was recently extended in conjunction with the extension of the public health emergency for an additional 90-day period beginning on January 21, 2021.


Results of Operations

 

Net Revenues

 

RevenueNet revenues for the three and six month periodsmonths ended December 31, 20172020 and 20162019 are summarized in the table below (dollar amounts in thousands).

                           
  Three Months Ended
December 31,
        Six Months Ended
December 31,
       
  2017 2016 Change  2017 2016 Change 
Total Revenue $6,985 $6,372 $613  9.6% $13,367 $11,918 $1,449  12.2%
Home Care Revenue  6,506  5,502  1,004  18.2%  12,486  10,635  1,851  17.4%
Institutional Revenue  313  605  (292) (48.3%)  614  951  (337) (35.4%)
International Revenue  166  265  (99) (37.4%)  267  332  (65) (19.6%)

 

  Three Months Ended December 31,           Six Months Ended December 31,          
  2020  2019  Change 20202019  Change  
Home care $8,903  $7,669  $1,234   16.1% $16,366  $15,161  $1,205   7.9% 
Institutional  309   494   (185)  (37.4%)  587   1,118   (531)  (47.5%) 
Home care distributor  149   131   18   13.7%  327   251   76   30.3% 
International  135   253   (118)  (46.6%)  220   319   (99)  (31.0%) 
Total $9,496  $8,547  $949   11.1% $17,500  $16,849  $651   3.9% 

Home Care Revenue.care revenue. Home care revenue for the three months ended December 31, 20172020 was approximately $6,506,000,$8,903,000, representing an increase of approximately $1,004,000 compared to the same period in fiscal 2017,$1,234,000, or 18.2%. For the six months ended December 31, 2017, home care revenue was approximately $12,486,000, an increase of approximately $1,851,000, or 17.4%16.1%, compared to the same period in fiscal 2017. During2020. For the threesix months ended December 31, 2016,2020, home care revenue was negatively impacted byapproximately $16,366,000, representing an increase of approximately $1,205,000, or 7.9%, compared to the retroactive repayment of previously collectedsame period in fiscal 2020. The revenue increase compared to the prior year periods was primarily due to an increase in referrals and recognized revenueapprovals. The increase in referrals compared to the prior year was due to the sales team adapting to a state Medicaid program totaling approximately $212,000. The repayment resulted fromhybrid virtual and face-to-face selling model implemented to combat clinic access limitations due to the state Medicaid program’s reinterpretationCOVID-19 pandemic, benefits of its reimbursement processthe CMS waiver on the non-commercial Medicare portion of our home care revenue, and a reductionan increase in its allowable payments. We believe that the repayment was a one-time event and is not reflective of other state Medicaid reimbursement processes.direct sales representatives.

 

After taking into consideration the negative impact of the retroactive repayment during the three months ended December 31, 2016, homeHome care revenue for the three months ended December 31, 20172020 increased predominantlyapproximately $1,439,000, or 19.3%, compared to the period ended September 30, 2020. The increase in revenue was also due to growthan increase in approvals as a result of continued improvementsreferrals and approvals. The increase in our reimbursement operations that led to a greater referral to approval percentage asreferrals compared to the prior year. Thequarter was primarily due to the success of our hybrid model, supplemented by increased patient face-to-face re-engagement with physicians, improved access to clinics for our sales staff, temporary pent up demand for SmartVest and an increase in direct sales reps.

The CMS waiver benefited the non-commercial Medicare portion of our home care revenue by increasing the number of referrals and the approval percentage for non-covered diagnoses. We believe that our ongoing sales team execution, along with the expected return to pre COVID-19 levels of patient face-to-face engagement with physicians and clinic access for our sales team, has the potential to mitigate the impact of a CMS waiver expiration, which is currently effective until April 2021.

Institutional revenue. Institutional revenue for the three months ended December 31, 2020 was approximately $309,000, representing a decrease of approximately $185,000, or 37.4%, compared to the same period in fiscal 2020. For the six months ended December 31, 20172020, institutional revenue was primarily driven byapproximately $587,000, a greater referral to approval percentage and a higher leveldecrease of referrals asapproximately $531,000, or 47.5%, compared to the prior year.same period in fiscal 2020. The increasedecrease in referralsthe current year periods was primarily due to growth in the numbercontinued impact of field sales employees as compared to the comparable prior year period.COVID-19 on hospital purchasing activity.

 

Institutional Revenue.Home care distributor revenue. InstitutionalHome care distributor revenue for the three andmonths ended December 31, 2020 was approximately $149,000, representing an increase of approximately $18,000, or 13.7%, compared to the same period in fiscal 2020. For the six months ended December 31, 20172020, home care distributor revenue was approximately $313,000 and $614,000, respectively, representing a decrease$327,000, an increase of approximately $292,000 and $337,000,$76,000, or 48.3% and 35.4%30.3%, compared to the same periodsperiod in fiscal 2017. The decrease in revenue for2020. We began selling to home medical equipment distributors during the three and six months ended December 31, 2017 was due to a decreaseSeptember 30, 2019, who in turn sell our SmartVest System in the number of units and single patient use garments sold compared to the same periods in the prior year. Institutional revenue includes sales to distributors, group purchasing organization (“GPO”) members and other institutions.U.S. home care market.

 

International Revenue.revenue. International revenue for the three months ended December 31, 20172020 was approximately $166,000,$135,000, representing a decrease of approximately $99,000,$118,000, or 37.4%46.6%, compared to the same period in fiscal 2017.2020. For the six months ended December 31, 2017,2020, international revenue was approximately $267,000,$220,000, a decrease of approximately $65,000,$99,000, or 19.6%31.0%, fromcompared to the same period in fiscal 2017.2020. 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 increased to approximately $5,587,000,$7,525,000, or 80.0%79.2% of net revenues, for the three months ended December 31, 2017,2020, from approximately $4,926,000,$6,676,000, or 78.1% of net revenues, in the same period in fiscal 2020. Gross profit increased to approximately $13,673,000, or 78.1% of net revenues, for the six months ended December 31, 2020, from approximately $13,018,000, or 77.3% of net revenues, in the same period in fiscal 2017. Gross profit increased to approximately $10,523,000, or 78.7% of net revenues, for the six months ended December 31, 2017, from approximately $9,254,000, or 77.7% of net revenues, in the same period in fiscal 2017.2020. The increase in gross profit for the three and six months ended December 31, 2017 was primarily related to increases in domestic home care revenue. The increase in gross profit as a percentage of net revenue was driven by a higher level of net revenue recognized per new device placement as compared to the prior year whichperiods was partially offset by the additional costs to manufacture the SmartVest SQL with SmartVest Connect ™ wireless technology. Additionally, gross profit for the three and six months ended December 31, 2016 was negatively impacted by the retroactive repayment of previously collected and recognized revenueprimarily due to a state Medicaid program totaling approximately $212,000.higher mix of home care revenue and a favorable mix of Medicare within the home care channel.


Operating expenses

 

Selling, general and administrative expenses. Selling, general and administrative (“SG&A”) expenses were approximately $4,760,000$5,435,000 and $9,463,000$10,439,000 for the three and six months ended December 31, 2017,2020, respectively, representing an increaseincreases of approximately $664,000$470,000 and $1,679,000,$579,000, or 16.2%9.5% and 21.6%5.9%, respectively, compared to the same periods in the prior year.

 

Payroll and compensation-related expenses were approximately $2,712,000$3,432,000 and $5,398,000$6,732,000 for the three and six months ended December 31, 2017,2020, respectively, representing an increaseincreases of approximately $362,000$396,000 and $1,011,000,$557,000, or 15.4%13.0% and 23.0%9.0%, respectively, compared to the same periods in the prior year. The increasesincrease in the current year periods werewas primarily due to additional employees inhigher incentive payments on stronger home care revenue, a higher average number of sales annual salary increases, higher share-based equity compensation expense, and additional sales incentives on higher revenue accruals.marketing personnel, and increased temporary resources to assist with systems infrastructure investments.

 

Professional feesTravel, meals and entertainment expenses were approximately $466,000 and $830,000 for the three and six months ended December 31, 2017 were approximately $516,000 and $1,016,000,2020, respectively, an increaserepresenting decreases of approximately $191,000$91,000 and $344,000,$312,000, or 58.8%16.3% and 51.2%27.3%, respectively, compared to the same periods in the prior year. TheseThe decrease in the current year periods was primarily due to travel reductions in connection with COVID-19.

Total discretionary marketing expenses were approximately $317,000 and $506,000 for the three and six months ended December 31, 2020, respectively, representing an increase of approximately $188,000 and $261,000, or 145.7% and 106.5%, respectively, compared to the same periods in the prior year. The increase in the current year periods was primarily due to a direct-to-consumer marketing campaign that began in May 2020.

Professional fees were approximately $533,000 and $987,000 for the three and six months ended December 31, 2020, respectively, representing an increase of approximately $47,000 and $90,000, or 9.7% and 10.0%, respectively, compared to the same periods in the prior year. The increase in the current year periods was primarily due to annual fees associated with a new human resources platform. Professional fees are primarily for services related to legal costs, shareowner services and reporting requirements, general and administrative temporary labor, information technology (“IT”) security and backup, and consulting fees for sales training. The increase in professional fees was primarily due to increases in general and administrative temporary labor, IT, legal coststechnical support and consulting fees.

 

Recruiting feesResearch and development expenses. Research and development (“R&D”) expenses were approximately $507,000 and $989,000 for the three and six months ended December 31, 2017 were approximately $133,000 and $298,000,2020, respectively, an increaserepresenting increases of approximately $46,000$364,000 and $140,000,$747,000, or 52.9%254.5% and 88.6%, respectively, compared to the same period in the prior year. The increase in recruiting fees was due primarily to adding more employees in sales and administrative roles as compared to the prior year.

Travel, meals and entertainment expenses were approximately $537,000 and $1,014,000 for the three and six months ended December 31, 2017, respectively, representing an increase of approximately $123,000 and $159,000, or 29.7% and 18.6%308.7%, respectively, compared to the same periods in the prior year. The increase in the current year periods was primarily due primarily to additional sales personnel.

SG&A expenses included a loss on the abandonment of certain domestic and foreign patents with net values of approximately $111,000 during both the three and six months ended December 31, 2016. No losses on the abandonment of patents were recognized during the three and six months ended December 31, 2017.

Research andnext generation platform development expenses.Research and development (“activities. R&D”)&D expenses were approximately $57,0005.3% and $127,0005.7% of revenue for the three and six months ended December 31, 2017,2020, respectively, representing an decreaseand we expect R&D investment to remain in a similar range for the duration of approximately $44,000 and $325,000 compared to the same periods in the prior year. R&D expensesfiscal 2021.

Interest income, net

Net interest income for the three and six months ended December 31, 2017 were 0.8%2020 was approximately $10,000 and 1.0% of revenue,$19,000, respectively, compared to 1.6%approximately $37,000 and 3.8% of revenue for the same periods$77,000, respectively, in the comparable prior year. During the fiscal year ended June 30, 2016, we began developing SmartVest Connect, a new wireless connectivity feature for our HFCWO device which allows data connection between physicians and patients. We believe SmartVest Connect will strengthen our patient and clinician partnerships, leading to greater therapy adherence and improved quality of life for individuals with compromised pulmonary function. We launched this feature in June 2017. As a percentage of net revenues, we expect spending on R&D expenses to remain consistent through the remainder of our fiscal year ending June 30, 2018. Certain expenses related to our innovation investments are not always captured in R&D expenses. These expenses may be included in cost of sales as in the case of depreciation of tooling, or for SG&A, in the case of professional fees or higher labor expenses, as we improve our internal processes or enhance our customer service.

Interest expense

Interest expense, net, was approximately $5,000 and $9,000 for the three and six months ended December 31, 2017, respectively, compared to $16,000 and $32,000 in the same periods in the prior year.periods. The decrease in net interest expense during both the three and six months ended December 31, 2017 as comparedcurrent year periods was primarily due to the prior year was driven by an increase in interest income, a lower effective interest raterates earned on outstanding borrowings, lower deferred financing costs and a lower level of debt as compared to the prior year.our cash deposits.


Income tax expense

 

Income tax expense was estimated at approximately $416,000$389,000 and $453,000$419,000 and the effective tax rates were 54.4%rate was 24.4% and 49.1%, respectively,26.1% for the three months ended December 31, 2020 and 2019, respectively. Income tax expense was estimated at approximately $526,000 and $793,000 and the effective tax rate was 23.2% and 26.5% for the six months ended December 31, 2017.2020 and 2019, respectively. Estimated income tax expense for the three and six months ended December 31, 20172020 includes a discrete deferredcurrent tax expense of approximately $160,000 as a result of re-measuring certain deferred tax assets and liabilities based on the rates at which they are expected to reverse in future periods under the Tax Cuts and Jobs Act (the “Tax Act”) that was enacted by the U.S. federal government on December 22, 2017. Additionally, a discrete tax(expense) benefit of approximately $2,000$(7,000) and $27,000 was recognized during$32,000, respectively, related to the three and six months ended December 31, 2017, respectively, as a result of greater federal and state R&Dexcess tax credits than what was originally estimated in our tax provision for fiscal 2017. The net impact of these discrete events increased the effective tax rate by 20.6% and 14.4% during the three and six months ended December 31, 2017, respectively.

Income tax expense was estimated at approximately $270,000 and $351,000 and the effective tax rates were 37.8% and 35.6%, respectively, for the three and six months ended December 31, 2016. Income tax expense during the six months ended December 31, 2016 includes a recognized tax(expense) benefit of approximately $22,000 as a result of the lapse of the statute of limitations on uncertain tax positions, which reduced the effective tax rate by 2.2% for that period.non-qualified stock options exercised.


Net income

 

Net income for the three and six months ended December 31, 20172020 was approximately $349,000$1,203,000 and $470,000,$1,739,000, respectively, compared to net income of approximately $444,000$1,185,000 and $635,000$2,200,000 for the same periods in the prior year. The year-over-year decrease in net incomeFor the three months ended December 31, 2020, the increase was driven primarily by higherstronger home care revenue, offset by increased strategic investments in SG&A expenses related to hiring additional new employees, which was partially offset by an increase in gross profit driven by higher revenue and lower R&D expenses as compared to&D. For the prior year. Additionally, net income for the three and six months ended December 31, 20172020, the decrease was affectedprimarily due to increased strategic investments in both R&D and SG&A, partially offset by discrete tax events including the $160,000 re-measurement of certain deferred tax assets and liabilities.stronger home care revenue performance.

 

Liquidity and Capital Resources

 

Cash Flows and Sources of Liquidity

 

Cash Flows from Operating Activities

 

For the six months ended December 31, 2017,2020, net cash provided by operating activities was approximately $1,530,000.$1,491,000. Cash flows provided by operating activities consisted of net income of approximately $470,000,$1,739,000, an increase in accounts payable and accrued liabilities of $494,000, non-cash expenses of $820,000$822,000, a decrease in contract assets of $206,000, a decrease in income tax receivable of $186,000, a decrease in inventory of $490,000 and decreasesa decrease in accounts receivable, inventory and prepaid expenses and other assets of $269,000, $184,000 and $9,000, respectively.$8,000. These cash flows from operating activities were partially offset by a decreasean increase in accounts payable and accrued liabilitiesreceivable of approximately $150,000 and$2,454,000. The increase in accounts receivable was primarily due to an increase in the Medicare portion of our home care business, which has a decrease in income tax payable of $72,000.13-month payment cycle.

Cash Flows from Investing Activities

 

For the six months ended December 31, 2016, net2020, cash provided by operatingused in investing activities was approximately $39,000.$144,000. Cash flows provided by operatingused in investing activities consisted of net income of approximately $635,000, non-cash expenses of $741,000, a decrease$54,000 in prepaid expensesexpenditures for property and other assets of $7,000equipment and a decreaseapproximately $90,000 in income tax receivable of $190,000. These cash flows from operating activities were offset by a decrease of approximately $807,000 in accounts payable and accrued liabilities, an increase in accounts receivable of $673,000 and an increase in inventory of $54,000.payments for patent costs.

 

Cash Flows from InvestingFinancing Activities

 

For the six months ended December 31, 2017, cash used in investing activities was approximately $238,000. Cash used in investing activities consisted of approximately $228,000 in expenditures for property and equipment and $10,000 in payments for patent costs.

For the six months ended December 31, 2016, cash used in investing activities was approximately $312,000. Cash used in investing activities consisted of approximately $267,000 in expenditures for property and equipment and $45,000 in payments for patent costs. The expenditures for property and equipment consisted primarily of costs associated with the development of software associated with SmartVest Connect.


Cash Flows from Financing Activities

For the six months ended December 31, 2017,2020, cash used in financing activities was approximately $25,000,$84,000, which consisted of principal paymentsapproximately $46,000 of cash provided from stock option exercises offset by approximately $130,000 of taxes paid on long-term debt.net share settlements of stock option exercises.

 

For the six months ended December 31, 2016, cash used in financing activities was approximately $29,000, which consisted of principal payments on long-term debt of $24,000 and payments of deferred financing fees of $5,000.

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 recentcurrent operational performance, we believe our working capital of approximately $15,515,000 as of December 31, 2017$27,410,000 and available borrowings under our existing credit facility will provide adequate liquidity for the next year.during fiscal 2021.

 

Effective December 18, 2017,2020, we renewed our credit facility, which provides us with a revolving line of credit and a term loan.credit. Interest on borrowings on the line of credit accrues at the prime rate (3.25% at December 31, 2020) less 0.25%1.00% and is payable monthly. There was no outstanding principal balance on the line of credit as of December 31, 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, 2018,2021, if not renewed. At December 31, 2017,2020, the maximum $2,500,000 was available under the line of credit and the applicable interest rate (the prime rate) was 4.50%.credit. Payment obligations under the line of credit are secured by a security interest in substantially all of our tangible and intangible assets.

 

In connection with the credit facility, we also have a term loan, which had an outstanding principal balance of approximately $1,129,000 at December 31, 2017 and $1,154,000 as of June 30, 2017. The term loan was refinanced effective December 18, 2016, reducing the interest rate from 5.00% to 3.88%. The unamortized debt issuance cost associated with this debt was approximately $4,000 and $6,000 as of December 31, 2017 and June 30, 2017, respectively. The term loan bears interest at 3.88%, with monthly payments of principal and interest of approximately $7,900 and a final payment of principal and interest of approximately $1,085,000 due on the maturity date of December 18, 2018. Payment obligations under the term loan are secured by a mortgage on our real property. 

The documents governing our line of credit and term loan 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. We were in compliance with these covenants as of December 31, 2017.

 


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, and/or term loan, requiring prepayment of outstanding indebtedness, under either arrangement, 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. The indebtedness under the line of credit and term loan are secured by a security interest in substantially all of our tangible and intangible assets and a mortgage on our real property, respectively. If we are unable to repay such indebtedness, the lender could foreclose on these assets.

 

For the six months ended December 31, 20172020 and 2016,2019, we spent approximately $228,000$54,000 and $267,000,$670,000, 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 December 31, 2017,2020, we had no off-balance sheet arrangements.


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, (the “Securities Act”), 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 regardingregarding: the following:expected impact of the COVID-19 pandemic on our business; our business strategy, including our intended level of investment in R&D and marketing activities; our expectations with respect to earnings, gross margins and sales growth, industry relationships, marketing strategies distribution agreements with third parties and international sales; estimated sizes of markets into which our products are or may be sold; our business strengths and competitive advantages; our plans and expectations with respectability to internationalgrow additional sales growth;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, including, but not limited to, the Tax Act;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 expansion and availability of our SmartVest Connect technology;System; 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: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.for fiscal 2020. 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) promulgated under 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 six monthsquarter ended December 31, 20172020 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. Corresponding costs are accrued when it is probable that loss will be incurred and the amount can be precisely or reasonably estimated. We are not aware of any undisclosed actual or threatened litigation that would have a material adverse effect on our financial condition or results of operations.

 

Item 1A.Risk Factors.

 

As a smaller reporting company, we are not required to provide disclosure pursuant to this Item.

 

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds.

 

None.

 


Item 3.Defaults Upon Senior Securities.

 

None.

 

Item 4.Mine Safety Disclosures.

 

None.

 

Item 5.Other Information.

 

None.


Item 6.Exhibits.

Unless otherwise indicated, all documents incorporated into this Quarterly Report on Form 10-Q by reference to a document filed with the SEC pursuant to the Exchange Act are located under SEC file number 001-34839.

  

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 CompositeAmended and Restated Bylaws, as amended through June 30, 2012effective September 29, 2020 (incorporated by reference to Exhibit 3.23.1 to AnnualCurrent Report on Form 10-K for the fiscal year ended June 30, 2015)8-K filed September 29, 2020)  Incorporated by Reference
     
10.1 Electromed, Inc. 2017 Omnibus Incentive Plan (incorporated by reference to Exhibit 99.1 to Registration Statement on Form S-8 filed December 4, 2017)Incorporated by Reference
10.2

Rider to Business Loan Agreement (Asset Based) with Venture Bank,Choice Financial Group, dated December 18, 2017 (incorporated by reference to Exhibit 10.1 to Current Report on Form 8-K filed December 12, 2017)

Incorporated by Reference
10.3

Change in Terms Agreement with Venture Bank, dated December 18, 201716, 2020 (incorporated by reference to Exhibit 10.2 to Current Report on Form 8-K filed December 12, 2017)

17, 2020)
 Incorporated by Reference
     
31.1 Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 Filed Electronically
     
31.2 Certification Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002 Filed Electronically
     
32.1 Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 FiledFurnished Electronically
     
32.2 Certification Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 FiledFurnished Electronically
     
101 Financial statements from the Quarterly Report on Form 10-Q for the period ended December 31, 2017,2020, formatted in XBRL: (i) Condensed Balance Sheets, (ii) Condensed Statements of Income,Operations, (iii) Condensed Statements of Cash Flows, (iv) Condensed Statements of Shareholders’ Equity, and (iv)(v) Notes to Condensed Financial Statements Filed Electronically

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, 20189, 2021/s/ Kathleen S. Skarvan
  Kathleen S. Skarvan, President and Chief Executive Officer
  (duly authorized officer)
   
Date:February 13, 20189, 2021/s/ Jeremy T. BrockMichael J. MacCourt
  Jeremy T. Brock,Michael J. MacCourt, Chief Financial Officer
  (principal financial officer and principal accounting officer)