# Electromed, Inc.: Form 10-Q for the period ended Dec 31, 2022

- Company: [Electromed, Inc.](/companies/elmd.md) (CIK 1488917)
- Form: 10-Q
- Filed: 2023-02-14
- Accepted by EDGAR: Feb 14, 2023, 16:10 ET
- Period: 2022-12-31
- Accession: 0000897101-23-000085
- Inline XBRL: yes
- Main document: https://www.sec.gov/Archives/edgar/data/1488917/000089710123000085/elmd230174_10q.htm
- All documents and exhibits: https://www.sec.gov/Archives/edgar/data/1488917/000089710123000085/

## Figures reported in this filing

Standardized XBRL line items for the period ended 2022-12-31.

| Line item | Period | Value | XBRL concept |
| --- | --- | ---: | --- |
| Revenue | 3 months, 2022-10-01 to 2022-12-31 | $11.7m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Revenue | 6 months, 2022-07-01 to 2022-12-31 | $22.4m | us-gaap:RevenueFromContractWithCustomerExcludingAssessedTax |
| Cost of revenue | 3 months, 2022-10-01 to 2022-12-31 | $3.0m | us-gaap:CostOfRevenue |
| Cost of revenue | 6 months, 2022-07-01 to 2022-12-31 | $5.4m | us-gaap:CostOfRevenue |
| Gross profit | 3 months, 2022-10-01 to 2022-12-31 | $8.7m | us-gaap:GrossProfit |
| Gross profit | 6 months, 2022-07-01 to 2022-12-31 | $17.0m | us-gaap:GrossProfit |
| Research and development | 3 months, 2022-10-01 to 2022-12-31 | $154.0k | us-gaap:ResearchAndDevelopmentExpense |
| Research and development | 6 months, 2022-07-01 to 2022-12-31 | $452.0k | us-gaap:ResearchAndDevelopmentExpense |
| Selling, general and administrative | 3 months, 2022-10-01 to 2022-12-31 | $7.3m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Selling, general and administrative | 6 months, 2022-07-01 to 2022-12-31 | $15.2m | us-gaap:SellingGeneralAndAdministrativeExpense |
| Operating income | 3 months, 2022-10-01 to 2022-12-31 | $1.3m | us-gaap:OperatingIncomeLoss |
| Operating income | 6 months, 2022-07-01 to 2022-12-31 | $1.3m | us-gaap:OperatingIncomeLoss |
| Income tax | 3 months, 2022-10-01 to 2022-12-31 | $304.0k | us-gaap:IncomeTaxExpenseBenefit |
| Income tax | 6 months, 2022-07-01 to 2022-12-31 | $271.0k | us-gaap:IncomeTaxExpenseBenefit |
| Net income | 3 months, 2022-10-01 to 2022-12-31 | $977.0k | us-gaap:NetIncomeLoss |
| Net income | 6 months, 2022-07-01 to 2022-12-31 | $1.1m | us-gaap:NetIncomeLoss |
| Diluted EPS | 3 months, 2022-10-01 to 2022-12-31 | $0.11 | us-gaap:EarningsPerShareDiluted |
| Diluted EPS | 6 months, 2022-07-01 to 2022-12-31 | $0.12 | us-gaap:EarningsPerShareDiluted |
| Basic EPS | 3 months, 2022-10-01 to 2022-12-31 | $0.12 | us-gaap:EarningsPerShareBasic |
| Basic EPS | 6 months, 2022-07-01 to 2022-12-31 | $0.13 | us-gaap:EarningsPerShareBasic |
| Diluted shares (weighted) | 3 months, 2022-10-01 to 2022-12-31 | 8,684,352 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Diluted shares (weighted) | 6 months, 2022-07-01 to 2022-12-31 | 8,685,184 shares | us-gaap:WeightedAverageNumberOfDilutedSharesOutstanding |
| Operating cash flow | 6 months, 2022-07-01 to 2022-12-31 | −$330.0k | us-gaap:NetCashProvidedByUsedInOperatingActivities |
| Capital expenditure | 6 months, 2022-07-01 to 2022-12-31 | $687.0k | us-gaap:PaymentsToAcquirePropertyPlantAndEquipment |
| Share repurchases | 3 months, 2022-10-01 to 2022-12-31 | $8.0k | us-gaap:PaymentsForRepurchaseOfCommonStock |
| Share repurchases | 6 months, 2022-07-01 to 2022-12-31 | $153.0k | us-gaap:PaymentsForRepurchaseOfCommonStock |
| Cash and equivalents | at 2022-12-31 | $6.9m | us-gaap:CashAndCashEquivalentsAtCarryingValue |
| Current assets | at 2022-12-31 | $34.2m | us-gaap:AssetsCurrent |
| Total assets | at 2022-12-31 | $41.4m | us-gaap:Assets |
| Current liabilities | at 2022-12-31 | $6.0m | us-gaap:LiabilitiesCurrent |
| Total liabilities | at 2022-12-31 | $6.0m | us-gaap:Liabilities |
| Shareholders' equity | at 2022-12-31 | $35.4m | us-gaap:StockholdersEquity |

## Management's discussion and analysis

As filed, 30,048 characters.

The following discussion and analysis of our financial condition and results of operations should be read in conjunction with our unaudited Condensed Financial Statements and related notes thereto included in Part I, Item 1 of this Quarterly Report on Form 10-Q, and our audited financial statements and related notes thereto included in Part II, Item 8 of our Annual Report on Form 10-K for the fiscal year ended June 30, 2022 (“fiscal 2022”).

Overview

Electromed, Inc. (“we,” “our,” “us,” “Electromed” or the “Company”) develops and provides innovative airway clearance products applying High Frequency Chest Wall Oscillation (“HFCWO”) technologies in pulmonary care for patients of all ages.

We manufacture, market and sell products that provide HFCWO, including the SmartVest® Airway Clearance System (“SmartVest System”) that includes our SmartVest SQL® and previous generation SV2100, and related products, to patients with compromised pulmonary function. The SmartVest SQL is smaller, quieter and lighter than our previous product, with enhanced programmability and ease of use. Our products are sold in both the home health care market and the institutional market for use by patients in hospitals, which we refer to as “institutional sales.” The SmartVest SQL has been sold in the domestic home care market since 2014. In 2015, we launched the SmartVest SQL into institutional and certain international markets. In June 2017, we announced the launch of the SmartVest SQL with SmartVest Connect™ wireless technology, which allows data connection between physicians and patients to track therapy performance and collaborate in treatment decisions. SmartVest Connect is currently available to pediatric and cystic fibrosis patients and was made available to certain targeted adult pulmonary clinics starting in November 2017. Since 2000, we have marketed the SmartVest System and its predecessor products to patients suffering from cystic fibrosis, bronchiectasis and repeated episodes of pneumonia. Additionally, we offer our products to a patient population that includes neuromuscular disorders such as cerebral palsy, muscular dystrophies, amyotrophic lateral sclerosis (“ALS”), the combination of emphysema and chronic bronchitis commonly known as chronic obstructive pulmonary disease (“COPD”), and patients with post-surgical complications or who are ventilator dependent or have other conditions involving excess secretion and impaired mucus transport.

In December 2022, we received 510(k) clearance of our newest generation SmartVest® Clearway® Airway Clearance System (“Clearway”) from the U.S. Food and Drug Administration and began a limited market release, with the expectation of a full product launch this year in our third fiscal quarter which ends March 31, 2023.

The SmartVest System is often eligible for reimbursement from major private insurance providers, health maintenance organizations (“HMOs”), state Medicaid systems, and the federal Medicare system, which we believe is an important consideration for patients considering an HFCWO course of therapy. For domestic sales, the SmartVest System may be reimbursed under the Medicare-assigned billing code (E0483) for HFCWO devices if the patient has cystic fibrosis, bronchiectasis (including chronic bronchitis or COPD that has resulted in a diagnosis of bronchiectasis), or any one of certain enumerated neuromuscular diseases, and can demonstrate that another less expensive physical or mechanical treatment did not adequately mobilize retained secretions. Private payers consider a variety of sources, including Medicare, as guidelines in setting their coverage policies and payment amounts.

Critical Accounting Estimates

For a description of our critical accounting policies, estimates and assumptions used in the preparation of our financial statements, including the unaudited Condensed Financial Statements in this Quarterly Report on Form 10-Q, see Note 1 to our unaudited Condensed Financial Statements included in Part I, Item 1 of this Quarterly Report on Form 10-Q and Part II, Item 7, and Note 1 to our audited financial statements included in Part II, Item 8, of our Annual Report on Form 10-K for fiscal 2022.

Some of our accounting policies require us to exercise significant judgment in selecting the appropriate assumptions for calculating financial statements. Such judgments are subject to an inherent degree of uncertainty and are based upon our historical experience, known trends in our industry, terms of existing contracts, other information from outside sources, as appropriate and other factors. Therefore, management discusses the development, selection and disclosures with the audit committee. Among other factors, these judgments are based upon our historical experience, known trends in our industry, terms of existing contracts and other information from outside sources, as appropriate. We believe the critical accounting policies that require the most significant estimates, assumptions and judgments in the preparation of our financial statements, including the unaudited Condensed Financial Statements contained in this Quarterly Report on Form 10-Q, include: revenue recognition and the estimation of variable consideration, inventory valuation, share-based compensation and warranty reserve.

Impacts of COVID-19 on Our Business and Operations

In March 2020, the World Health Organization designated COVID-19 as a global pandemic, and the U.S. Department of Health and Human Services designated COVID-19 as a public health emergency. The impact of the COVID-19 pandemic on our business remains uncertain, and its effects on our operational and financial performance will depend in part on future developments, which cannot be reasonably estimated at this time. Such future developments include, but are not limited to, the duration, scope and severity of the COVID-19 pandemic in geographic areas in which we operate or in which our patients live, actions taken to contain or mitigate its impact, the impact on governmental healthcare programs and budgets, the development and distribution of treatments or vaccines, and the resumption of widespread economic activity. Due to the inherent uncertainty of the unprecedented and evolving situation, we are unable to predict with confidence the likely impact of the COVID-19 pandemic on our future operations.

We believe that the impact of the COVID-19 pandemic on our home care and institutional business will likely continue through the remainder of fiscal 2023. Our home care and institutional revenue for the three months ended December 31, 2022 increased as compared to the three months ended December 31, 2021; however, if COVID-19 infection rates increase and federal, state and local restrictions on commerce, stay-at-home orders or other restrictions on businesses are reinstated, we believe that such measures could have a material adverse effect on our business.

In response to the COVID-19 pandemic and the U.S. federal government’s declaration of a public health emergency, the Centers for Medicare & Medicaid Services (“CMS”) implemented a number of temporary rule changes and waivers to allow prescribers to best treat patients during the period of the public health emergency. These waivers became effective on March 1, 2020. Clinical indications and documentation typically required will not be enforced for respiratory-related products, including the SmartVest System (solely with respect to Medicare patients). The minimum documentation now requires a valid order and documentation of a respiratory-related diagnosis. Face-to-face and in-person requirements for respiratory devices are being waived while the waiver is in place. The CMS waiver was recently extended in conjunction with the extension of the federal public health emergency for an additional 90-day period beginning January 11, 2023.

On January 30, 2023, the Biden administration announced that the COVID-19 national and public health emergency declarations will end on May 11, 2023 (the “PHE End Date”), one month after the current PHE was previously set to expire, or April 11, 2023. Without further action from the U.S. federal government, we expect the CMS waiver will terminate no later than the PHE End Date and we may experience a one-time delay in some percentage of our Medicare net revenue as we expect our average Medicare patient referral to approval timeframe will extend to pre-COVID-19 pandemic timeframes and referrals with diagnoses not covered pre-COVID-19 pandemic may be cancelled or need to be submitted to CMS for an appeal. We are executing our plans to mitigate the effects on our net revenue resulting from the likely termination of the CMS waiver by hiring additional employees to increase capacity and minimize the average timeframe to convert a Medicare patient referral to approval.

### Impacts of Certain Macro-Economic Conditions and the Supply Chain on Our Business and Operations

We observed increased lead times for certain components in our supply chain and increased material costs and shipping rates during the second half of fiscal 2022 and into the six months ended December 31, 2022. The changes to our supply chain lead times resulted in a temporary interruption that impacted product availability for certain customers beginning in September 2022 and continuing through December 2022. We anticipate that these increased lead times and temporary interruption of supply have the potential to continue through the second half of fiscal 2023. If we are unable to procure components to meet our demand or if we extend delivery lead-times to our customers, there may be an adverse impact to our revenue and, longer term, the potential of market share losses. We are taking actions to expedite components and to identify and qualify alternate suppliers for certain components to minimize any impact to our revenue and customer deliveries.

We expect that material costs and shipping rates will remain elevated during the second half of fiscal 2023 relating to supply chain availability and inflationary trends in electronic components and may extend to other components. In certain instances, we have purchased key electronic materials in advance to ensure adequate future supply and mitigate the risk of potential supply chain disruptions. It is possible that these macro-economic conditions and the COVID-19 pandemic could have a greater adverse impact on our supply chain in the future, including impacts associated with preventative and precautionary measures taken by other businesses and applicable governments. A reduction or further interruption in any of our manufacturing processes could have a material adverse effect on our business. Any significant increases to our raw material or shipping costs could reduce our gross margins.

Results of Operations

Net Revenues

Net revenues for the three and six months ended December 31, 2022 and 2021 are summarized in the table below.

|  | Three Months Ended December 31, 2022 | 2021 | Increase (Decrease) |  | Six Months Ended December 31, 2022 | 2021 | Increase (Decrease) |  |
| --- | ---: | ---: | ---: | ---: | ---: | ---: | ---: | ---: |
| Home care | $10,732,000 | $9,404,000 | $1,328,000 | 14.1% | $20,364,000 | $18,688,000 | $1,676,000 | 9.0% |
| Institutional | 589,000 | 333,000 | 256,000 | 76.9% | 980,000 | 782,000 | 198,000 | 25.3% |
| Home care distributor | 336,000 | 387,000 | (51,000) | (13.2%) | 890,000 | 543,000 | 347,000 | 63.9% |
| International | 72,000 | 124,000 | (52,000) | (41.9%) | 153,000 | 236,000 | (83,000) | (35.2%) |
| Total | $11,729,000 | $10,248,000 | $1,481,000 | 14.5% | $22,387,000 | $20,249,000 | $2,138,000 | 10.6% |

13

***Home care revenue.*** Home care revenue increased by $1,328,000, or 14.1%, for the three months ended December 31, 2022 compared to the same period in the prior year. For the six months ended December 31, 2022, home care revenue was $20,364,000, representing an increase of $1,676,000, or 9.0%, compared to the same period in the prior year. The increase was primarily due to an increase in referrals and approvals. The increase in referrals was due to an increase in direct sales representatives and was offset by a temporary interruption in supply chain and associated operations in the six months ended December 31, 2022.

The CMS waiver continues to benefit the non-commercial Medicare portion of our home care revenue by increasing the number of referrals and the approval percentage for non-covered diagnoses. We believe that our ongoing sales team execution, along with the continued 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 much of the impact of a CMS waiver expiration.

***Home care distributor revenue.*** Home care distributor revenue decreased by $51,000, or 13.2%, for the three months ended December 31, 2022 compared to the same period in the prior year. For the six months ended December 31, 2022, home care distributor revenue was $890,000, an increase of $347,000, or 63.9%, compared to the same period in the prior year. Home care distributor sales are affected by the timing of distributor purchases that can cause significant fluctuations in reported revenue on a quarterly basis. The year-to-date revenue increase was due to increased demand from one of our primary home care distribution partners.

***Institutional revenue.*** Institutional revenue was $589,000, an increase of $256,000, or 76.9%, for the three months ended December 31, 2022 compared to the same period in the prior year. For the six months ended December 31, 2022, institutional revenue was $980,000, an increase of $198,000, or 25.3%, compared to the same period in the prior year. The increase in the current year periods was primarily due to increased capital sales to institutional customers.

***International revenue.*** International revenue was $72,000, a decrease of $52,000, or 41.9%, for the three months ended December 31, 2022 compared to the same period in the prior year. For the six months ended December 31, 2022, international revenue was $153,000, a decrease of $83,000, or 35.2%, compared to the same period in the prior year.

Gross profit

Gross profit increased to $8,682,000, or 74.0% of net revenues, for the three months ended December 31, 2022, from $7,880,000, or 76.9% of net revenues, in the same period in the prior year. Gross profit increased to $17,013,000, or 76.0% of net revenues, for the six months ended December 31, 2022, from $15,581,000, or 76.9% of net revenues, in the same period in the prior year. The decrease in gross profit as a percentage of net revenues compared to the same period in the prior year was primarily due to increased material costs and higher shipping expenses to expedite inventory purchases.

Operating expenses

*Selling, general and administrative expenses.* Selling, general and administrative (“SG&A”) expenses were $7,254,000 and $15,243,000 for the three and six months ended December 31, 2022, respectively, representing increases of $779,000 and $1,981,000, or 12.0% and 14.9%, respectively, compared to the same periods in the prior year.

Payroll and compensation-related expenses were $4,940,000 and $9,884,000 for the three and six months ended December 31, 2022, respectively, representing increases of $614,000 and $1,292,000, or 14.2% and 15.0%, respectively, compared to the same periods in the prior year. The increase in the current year periods was primarily due to salaries and incentive compensation related to the higher average number of sales, sales support, marketing, and reimbursement personnel to process higher patient referrals. We have also continued to provide regular merit-based increases for our employees and are regularly benchmarking our compensation ranges for new and existing employees to ensure we can hire and retain the talent needed to drive growth in our business. Field sales employees totaled 57 as of December 31, 2022, 48 of which were direct sales representatives, compared to 48 field sales employees and 39 direct sales representatives as of December 31, 2021.

Travel, meals and entertainment expenses were $719,000 and $1,632,000 for the three and six months ended December 31, 2022, respectively, representing increases of $102,000 and $371,000, or 16.5% and 29.4%, respectively, compared to the same periods in the prior year. The increase in the current year periods was due to a higher average number of direct sales representatives as well as increases in airfare, lodging and inflationary expenses for our annual sales meeting in August 2022.

Total discretionary marketing expenses were $182,000 and $369,000 for the three and six months ended December 31, 2022, respectively, representing a decrease of $29,000 and an increase of $4,000, or a decrease of 13.7% and an increase of 1.1%, respectively, compared to the same periods in the prior year.

Professional fees were $1,031,000 and $2,462,000 for the three and six months ended December 31, 2022, respectively, representing increases of $94,000 and $264,000, or 10.0% and 12.0%, respectively, compared to the same periods in the prior year. Professional fees are primarily for services related to legal costs, shareowner services and reporting requirements, information technology technical support and consulting fees. The increase in the six months ended December 31, 2022 was primarily due to nonrecurring legal compliance fees of approximately $400,000 for a reimbursement-related project offset by a reduction in expenses related to shareholder activism incurred during the three months ended September 30, 2021, which concluded with a cooperation agreement that became effective in September 2021.

*Research and development expenses*. Research and development (“R&D”) expenses were $153,000 and $452,000 for the three and six months ended December 31, 2022, respectively, representing decreases of $176,000 and $253,000, or 53.5% and 35.9%, respectively, compared to the same periods in the prior year. The decrease was primarily due to reduced professional services costs associated with our next generation Clearway development. R&D expenses were 1.3% and 2.0% of revenue for the three and six months ended December 31, 2022, respectively.

Interest income, net

Net interest income for the three and six months ended December 31, 2022 was $7,000 and $11,000, respectively, compared to $6,000 and $15,000, respectively, for the same periods in the prior year.

Income tax expense

Income tax expense was estimated at $304,000 and $271,000, and the effective tax rate was 23.7% and 20.4%, for the three and six months ended December 31, 2022, respectively. Estimated income tax expense for the three and six months ended December 31, 2022 includes a discrete tax expense of $1,000 and a discrete tax benefit of $43,000, respectively, related to the exercise of stock options.

Income tax expense was estimated at $244,000 and $352,000, and the effective tax rate was 22.6% and 21.6%, for the three and six months ended December 31, 2021, respectively. Estimated income tax expense for the three and six months ended December 31, 2021 includes a discrete tax benefit of $1,000 and $21,000, respectively, related to the exercise of stock options.

Net income

Net income for the three and six months ended December 31, 2022 was $977,000 and $1,058,000, respectively, compared to $838,000 and $1,277,000 for the same periods in the prior year. The increase in net income in the three months ended December 31, 2022 was driven primarily by revenue growth while the decrease in net income in the six months ended December 31, 2022 was primarily due to increased SG&A expenses related to our sales and reimbursement investments in revenue growth partially offset by increased gross profit.

Liquidity and Capital Resources

Cash Flows and Sources of Liquidity

#### Cash Flows from Operating Activities

For six months ended December 31, 2022, net cash used in operating activities was $330,000. Cash flows provided by operating activities consisted of net income of $1,058,000, non-cash expenses of $645,000, a decrease in prepaid expenses and other assets of $176,000, and an increase in income tax payable of $79,000. These cash flows from operating activities were offset by a decrease in accrued compensation of $532,000, a decrease in accounts payable and other accrued liabilities of $711,000, an increase in accounts receivable of $503,000, an increase in inventory of $321,000, and an increase in contract assets of $221,000.

#### Cash Flows from Investing Activities

For the six months ended December 31, 2022, cash used in investing activities was $717,000. Cash used in investing activities consisted of $687,000 primarily related to our enterprise resource planning infrastructure investments and $30,000 in expenditures for intangible asset costs.

#### Cash Flows from Financing Activities

For the six months ended December 31, 2022, cash used in financing activities was $197,000. Cash used in financing activities consisted of $153,000 used for our share repurchase program and $60,000 for taxes paid on net share settlement of stock option exercises.

Adequacy of Capital Resources

Our primary working capital requirements relate to adding employees to our sales force and support functions, continuing infrastructure investments, and supporting general corporate needs, including financing equipment purchases and other capital expenditures incurred in the ordinary course of business. Based on our current operational performance, we believe our working capital of $28,153,000 and available borrowings under our existing credit facility will provide adequate liquidity during fiscal 2023.

Our credit facility provides us with a revolving line of credit. Interest on borrowings on the line of credit accrues at the prime rate (7.5% at December 31, 2022) less 1.00% and is payable monthly. There was no outstanding principal balance on the line of credit as of December 31, 2022 or June 30, 2022. The amount eligible for borrowing on the line of credit is limited to the lesser of $2,500,000 or 57.00% of eligible accounts receivable, and the line of credit expires on December 18, 2023, if not renewed. As of December 31, 2022, the maximum $2,500,000 was available under the line of credit. Payment obligations under the line of credit are secured by a security interest in substantially all of our tangible and intangible assets.

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

Any failure to comply with these covenants in the future may result in an event of default, which if not cured or waived, could result in the lender accelerating the maturity of our indebtedness, preventing access to additional funds under the line of credit, requiring prepayment of outstanding indebtedness, or refusing to renew the line of credit. If the maturity of the indebtedness is accelerated or the line of credit is not renewed, sufficient cash resources to satisfy the debt obligations may not be available and we may not be able to continue operations as planned. If we are unable to repay such indebtedness, the lender could foreclose on these assets.

For the six months ended December 21, 2022 and 2021, we spent $687,000 and $511,000, respectively, on property and equipment. We currently expect to finance planned equipment purchases with cash flows from operations or borrowings under our credit facility. We may need to incur additional debt if we have an unforeseen need for additional capital equipment or if our operating performance does not generate adequate cash flows.

While the impact of the COVID-19 pandemic and other factors such as inflation are difficult to predict, we believe our cash, cash equivalents and cash flows from operations will be sufficient to meet our working capital, capital expenditure, operational cash requirements for fiscal 2023 and the foreseeable future. We will continue to evaluate our projected expenditures relative to our available cash and evaluate financing alternatives in order to satisfy our working capital and other cash requirements.

Information Regarding Forward-Looking Statements

Statements contained in this Quarterly Report on Form 10-Q that are not statements of historical fact should be considered forward-looking statements within the meaning of the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Forward- looking statements include, but are not limited to, statements regarding: the expected impact of the COVID-19 pandemic on our business; our business strategy, including our intended level of investment in R&D and marketing activities; our expectations with respect to earnings, gross margins and sales growth, industry relationships, marketing strategies and international sales; estimated sizes of markets into which our products are or may be sold; our business strengths and competitive advantages; our ability to grow additional sales distribution channels; our intent to retain any earnings for use in operations rather than paying dividends; our expectation that our products will continue to qualify for reimbursement and payment under government and private insurance programs; our intellectual property plans and practices; the expected impact of applicable regulations on our business; our beliefs about our manufacturing processes; our expectations and beliefs with respect to our employees and our relationships with them; our belief that our current facilities are adequate to support our growth plans; our expectations with respect to ongoing compliance with the terms of our credit facility; our expectations regarding the ongoing availability of credit and our ability to renew our line of credit; enhancements to our products and services; expected excise tax exemption for the SmartVest System; and our anticipated revenues, expenses, capital requirements and liquidity. Words such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “project,” “goal,” “target,” “should,” “will,” “would,” and similar expressions, including the negative of these terms, are intended to identify forward-looking statements but are not the exclusive means of identifying such statements. Although we believe these forward-looking statements are reasonable, they involve risks and uncertainties that may cause actual results to differ materially from those projected by such statements. Such statements involve known and unknown risks, uncertainties and other factors that may cause our actual results or our industry’s actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements.

Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to, the following:

- ability to obtain reimbursement from Medicare, Medicaid, or private insurance payers for our products including potential adverse impact with an expiration of the CMS waiver for certain respiratory diseases;
- component or raw material shortages, changes to lead times or significant price increases;
- the risks associated with our anticipated launch of Clearway;
- adverse changes to state and federal health care regulations;
- our ability to maintain regulatory compliance and to gain future regulatory approvals and clearances;
- entry of new competitors including new drug or pharmaceutical discoveries;
- adverse economic and business conditions or intense competition;
- the risks associated with our planned sales force expansion;
- wage and component price inflation;
- technical problems with our research and products;
- 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 risks associated with cyberattacks, data breaches, computer viruses and other similar security threats;
- changes affecting the medical device industry;
- our ability to develop new sales channels for our products such as the home care distributor channel;
- adverse international health care regulation impacting current international business;
- our ability to renew our line of credit or obtain additional credit as necessary; and
- our ability to protect and expand our intellectual property portfolio.

This list of factors is not exhaustive, however, and these or other factors, many of which are outside of our control, could have a material adverse effect on us and our results of operations. Therefore, you should consider these risk factors with caution and form your own critical and independent conclusions about the likely effect of these risk factors on our future performance. Forward-looking statements speak only as of the date on which the statements are made, and we undertake no obligation, and expressly disclaim any such obligation, to update any forward-looking statement for any reason other than as required by law, even if new information becomes available or other events occur in the future. You should carefully review the disclosures and the risk factors described in this and other documents we file from time to time with the Securities and Exchange Commission (the “SEC”), including our Annual Report on Form 10-K for fiscal 2022. All forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the cautionary statements set forth herein.

## Controls and procedures

As filed, 1,091 characters.

### Evaluation of Disclosure Controls and Procedures

Our principal executive officer and principal financial officer evaluated the effectiveness of our disclosure controls and procedures, as defined in Rules 13a-15(e) and 15d-15(e) of the Exchange Act, as of the end of the period subject to this Quarterly Report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures were effective as of the date of such evaluation to provide reasonable assurance that information required to be disclosed by the Company in the reports that it files or submits under the Exchange Act is recorded, processed, summarized and reported within the time periods specified by the SEC’s rules and forms.

Changes to Internal Control Over Financial Reporting

There were no changes in our internal control over financial reporting that occurred during the quarter ended December 31, 2022 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

Filed Feb 14, 2023.
Source: SEC EDGAR, the filing index for accession 0000897101-23-000085. Last ingested by Listed: Oct 24, 2026, 15:08 ET. No prices; not investment advice.