8-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

Date of report (Date of earliest event reported): November 10, 2023

ELECTROMED, INC.

(Exact Name of Registrant as Specified in Its Charter)

Minnesota	001-34839	41-1732920
(State or Other Jurisdiction of Incorporation)	(Commission File Number)	(I.R.S. Employer Identification Number)

500 Sixth Avenue NW

New Prague, MN 56071

(Address of Principal Executive Offices) (Zip Code)

(952) 758-9299

(Registrant’s Telephone Number, Including Area Code)

Not Applicable

(Former Name or Former Address, if Changed Since Last Report)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐	Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
☐	Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
☐	Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
☐	Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:

Common Stock, $0.01 par value	ELMD	NYSE American LLC
(Title of each class)	(Trading Symbol)	(Name of each exchange on which registered)

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 or Rule 12b-2 of the Securities Exchange Act of 1934.

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. ☐

Item 5.07 Submission of Matters to a Vote of Security Holders. 

At the annual meeting of shareholders of Electromed, Inc. (the “Company”) held on November 10, 2023, the following proposals, each as described in further detail in the definitive proxy statement filed on September 26, 2023, were voted upon by our shareholders as set forth below:

1. The following individuals designated by our Board of Directors (the “Board”) as nominees for director were elected for a one-year term or until a successor has been elected and qualified, thereby setting the number of directors at eight, with voting as follows:

Name	For	Withheld	Broker Non-Votes
James L. Cunniff	4,043,526	23,776	1,282,424
Stan K. Erickson	3,934,581	132,721	1,282,424
Gregory J. Fluet	3,886,683	180,619	1,282,424
Joseph L. Galatowitsch	4,036,919	30,383	1,282,424
Kathleen S. Skarvan	4,026,909	40,393	1,282,424
Andrew J. Summers	3,308,087	759,215	1,282,424
Kathleen A. Tune	3,416,625	650,677	1,282,424
Andrea M. Walsh	3,928,188	139,114	1,282,424

2. Our shareholders approved the Electromed, Inc. 2023 Equity Incentive Plan with voting as follows:

For	Against	Abstain	Broker Non-Votes
3,900,794	146,689	19,819	1,282,424

3. Our shareholders ratified the appointment of RSM US LLP as our independent registered public accounting firm for the fiscal year ending June 30, 2024, with voting as follows:

For	Against	Abstain
5,256,837	44,804	48,085

4. Our shareholders approved, on a non-binding and advisory basis, our executive compensation, with voting as follows:

For	Against	Abstain	Broker Non-Votes
3,990,197	54,887	22,218	1,282,424

Item 7.01 Regulation FD Disclosure.

The Company has updated its investor presentation, a copy of which is furnished as Exhibit 99.1 to this Current Report on Form 8-K and incorporated by reference herein. The Company intends to use the presentation in whole or in part, in one or more meetings with investors and analysts.

The information contained in this Item 7.01, including Exhibit 99.1, shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities of that Section, and shall not be incorporated by reference into any registration statement pursuant to the Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such filing.

Item 9.01 Financial Statements and Exhibits.

(d) Exhibits:

Exhibit Number	Description
99.1	Company Investor Presentation dated November 15, 2023
104	Cover Page Interactive Data File (embedded in the cover page and formatted in inline XBRL)

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 hereunto duly authorized.

	ELECTROMED, INC.
Date:  November 15, 2023	By: /s/ Bradley M. Nagel
	Name:	Bradley M. Nagel
	Title:	Chief Financial Officer

EX-99.1

Exhibit 99.1

 

Electromed, Inc. Investor Presentation November 2023 NYSE American: ELMDINNOVATION LEADER IN AIRWAY CLEARANCE TECHNOLOGIES

 

Forward Looking Statements Certain statements in this press release constitute forward-looking statements as defined in the US Private Securities Litigation Reform Act of 1995. Forward-looking statements can generally be identified by words such as ?anticipate,? ?believe,? ?estimate,? ?expect,? ?intend,? ?may,? ?plan,? ?potential,? ?should,? ?will,? and similar expressions, including the negative of these terms, but they are not the exclusive means of identifying such statements. Forward-looking statements cannot be guaranteed, and actual results may vary materially due to the uncertainties and risks, known or unknown associated with such statements. Examples of risks and uncertainties for the Company include, but are not limited to 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 homecare 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; the risks associated with expansion into international markets, as well as other factors we may describe from time to time in the Company?s reports filed with the Securities and Exchange Commission (including the Company?s most recent Annual Report on Form 10-K, as amended from time to time, and subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K). Investors should not consider any list of such factors to be an exhaustive statement of all of the risks, uncertainties or potentially inaccurate assumptions investors should take into account when making investment decisions. Shareholders and other readers should not place undue reliance on ?forward-looking statements,? as such statements speak only as of the date of this press release. We undertake no obligation to update them in light of new information or future events. Investor Presentation |2

 

Key Stats:Electromed, Inc. is a growing medical device company focused on airway management to help people around the world breathe better, stay healthier, and lead active and fulfilling lives.Headquarters: New Prague, MNAnnual Revenue: $48.1MTicker: ELMDMarket Cap: $90MEstablished: 1992Share Count: 8.6M#170 EmployeesManufacturing in MinnesotaHFCWO Market FocusAs of 10/31/2023Investor Presentation | 3

 

Electromed Overview Net Revenue ($M)1 $48.1 » » » Growing and profitable medical technology company A leader in the large and expanding airway clearance market SmartVest® High Frequency Chest Wall Oscillation (?HFCWO?) technology supported by clinical outcomes data with strong reimbursement » Attractive direct-to-patient and provider model » Strong financial profile with attractive historical gross margins and profitability, well capitalized balance sheet 1 Financials $41.7 $35.8 $31.3 $32.5 $28.3 FY'18 FY'19 FY'20 FY'21 FY'22 FY'23 Net Income ($M)1 $4.2 $3.2 $1.8 $2.0 FY'18 FY'19 FY'20 $2.4 $2.3 FY'21 FY'22 FY'23 under ASC 606 Investor Presentation |4

 

» An irreversible lung condition characterized by abnormal widening of one or more of the bronchi (airways) » End result of repeated episodes of pulmonary inflammation and infection » Damaged airways allow excess mucus to accumulate, increasing risk of infection » Mean prevalence of bronchiectasis in patients with COPD is 54%¹1Chalmers J. and Sethi S. Raising awareness of bronchiectasis in primary care: overview of diagnosis and management strategies in adults. NPJ Prim Care Respir Med. 2017;27:18 Investor Presentation | 5

 

Large, Growing and Underpenetrated MarketEstimated Net Bronchiectasis prevalence, DIAGNOSED1Estimated bronchiectasis prevalence, UNDIAGNOSED2Estimated HFCWO bronchiectasis penetration, treated population11Internal company estimates derived from GUIDEHOUSE 2023 NASM claims database 2Internal company estimates derived from GUIDEHOUSE 2023 literature review and 2023 CDC NHANES data| 6

 

Benefits of HFCWO TherapyInvestor Presentation | 7

 

Introduced Portable HFCWO DeviceIntroduced Programmable HFCWO DeviceIntroduced Reversible Wrap GarmentIntroduced SmartVest® ColorsIntroduced SmartVest SQL®Commenced Development of Wireless Connectivity Reporting Solution2000200120032007200820102013 201620172022Introduced Machine Washable Vest GarmentIntroduced Multi- Positional HFCWO DeviceIntroduced Expanded SmartVest® Garment and SQL® Generator ColorsIntroduced Touch Screen User Interface HFCWO Device - Clearway®Investor Presentation | 8

 

SmartVest Clearway® Only New HFCWO Device on the Market An enhanced patient experience! » Smaller, lighter and intuitive user interface for better patient adherence » Patient remote monitoring enabled » More portable and easier for travel » Expect to contribute to both top line and gross margin growth SmartVest® has a well-established reimbursement code from CMS ? E0483; Electromed has over 275M contracted lives in the US Investor Presentation |9

 

Providing Patient Outcomes and Treatment Progress to PhysiciansSmartNotes combine patient Quality of Life and Therapy Utilization data to provide physicians with extended views into disease management » TeleRespiratory Services: A team of Respiratory Therapists stay connected with patients and support their therapy utilization. » Outcomes Management: Easy-to-read report provides physicians with a comprehensive view of disease progression and therapy impact.| 10

 

Electromed has Published Studies Showing Effectiveness of HFCWO to Treat BronchiectasisTherapy with HFCWO demonstrated key health outcomes improved in post- compared to pre-index period: cough, all-cause hospitalizations, pneumonia and pulmonary hospitalizations. DeKoven (2022)Therapy with SmartVest® demonstrated anFewer hospitalizations Exacerbations requiring hospitalizations reduced with SmartVest®. Sievert (2016)Therapy with SmartVest® significantly decreased exacerbations requiring hospitalization, antibiotic use, and stabilizes lung function. Powner (2018)improvement in symptom scores and quality of life. Chakravorty (2011)Investor PresentationReduction in ER visits Longitudinal outcome-based study showed ER visits significantly reduce with SmartVest®. Sievert (2018)| 11

 

Net Revenue Breakdown, Fiscal Year 2023% of Net Revenue:Sales Points:Revenue Model:Investor Presentation| 12

 

Drives Attractive Margin ProfileInvestor Presentation| 13

 

By SettingHomecare By PayerHomecare By Referral VolumeHome Care¹ Hospitals InternationalMedicareCommercial / Other2MedicaidBronchiectasis Cystic Fibrosis Neuromuscular1Includes $1.5 million from home care distributor revenue2 Includes Managed Medicare and Managed MedicaidInvestor PresentationCOPD/COPD RelatedOther| 14

 

How Will Electromed Increase Market Share?• Continued sales force expansion along with complementary infrastructure investments • Direct-to-consumer and physician marketing to increase brand awareness and revenue • Best-in-class customer care and support • Develop and promulgate the body of bronchiectasis clinical evidence to increase physician adoption of the SmartVest® System for patients • Promote the best-in-class SmartVest Clearway® device| 15

 

Mid-teens revenue growth • Increase market share; deeper penetration of current SmartVest® prescribersOperating margin improvement • Operating leverage as revenue increases| 16

 

HFCWO Industry DriversAging populationHigher incidence of chronic lung diseasesGrowing physician awareness of diseases such as bronchiectasisThe Affordable Care Act penalizes for readmissionHealthcare reform moving to fee-for- outcomesTreatment moving to lower cost settings (homecare)Investor Presentation| 17

 

Unique Investment Opportunity ? Large, expanding bronchiectasis market supported by industry tailwinds ? Clinically proven therapy ? Well established reimbursement code with broad payer coverage ? Consistent double-digit organic revenue growth ? History of high gross margins, robust operating cash flow and increased operating leverage ? Attractive valuation at 1.8x EV/Revenue Investor Presentation | 18

 

Mgmt. Incentives Aligned w/Investors ? CEO incentive reward based on increasing total shareholder return. ? Management?s incentive compensation focused solely on delivering financial results. Investor Presentation | 19

 

Why Invest? Attractive Valuation and Operating Metrics (FY2023 Results) RUS ME Metric ELMD Sales Growth 15.4% > 3.7% EV / Revenue 1.8x > 4.6x Gross Margin 76.0% > 54.7% Operating Margin 8.3% > (9.1%) Investor Presentation | 20

 

Jim Cunniff, President & CEO (952) 758-9299 jcunniff@Electromed.comBrad Nagel, CFO (952) 758-9299 bnagel@Electromed.comMike Cavanaugh (617) 877-8641 mike.cavanaugh@westwicke.comCallie Conway (332) 242-4336 Callie.Conway@Westwicke.comInvestor Presentation| 21

 

APPENDIXInvestor Presentation | 22

 

Financial Summary (in $ millions, except shares amounts) Fiscal Year EndedJune 30, 2021 June 30, 2022 June 30, 2023 3 MonthSept 30, 2022 s EndedSept 30, 2023 Revenues 35.8 41.7 48.1 10.7 12.3 Gross Profit 27.3 31.4 36.5 8.3 9.5 Gross margin 76% 75% 76% 78% 77% Operating income 3.1 3.0 4.0 0.0 0.1 Operating margin 9% 7% 8% 0% 1% Net income 2.4 2.3 3.2 0.1 0.2 Diluted EPS $0.27 $0.26 $0.36 $0.01 $0.02 Diluted shares 8,911,842 8,768,703 8,700,833 8,689,377 8,782,824 Cash provided by operations $3.1 ($0.7) $1.3 ($1.7) ($0.2)Cash Provided by Operations$4.2(in millions)$3.1$1.3($0.7)FY'20 FY'21 FY'22 FY'23Investor Presentation| 23

 

Jim Cunniff – President & Chief Executive Officer • CEO of Electromed since July 2023 • 30+ years of executive leadership in MedTech and the broader healthcare industry • Track record of consistently growing revenue through innovative go-to market strategies • Former President, CEO, and Board Director of Provista as well as Leiters Health • Former Senior Vice President of Americas for Kinetic Concepts, Inc. • Former President, Stryker Corporation for the following divisions: Medical, Asia/Pacific and Emerging MarketsBrad Nagel – Chief Financial Officer • Chief Financial Officer at Electromed since November 2022 • 15+ years of financial leadership and strategic planning experience with Fortune 500 companies • Former Divisional Chief Financial Officer of Global Lung Health and Visualization at MedtronicKristine Owata – Vice President of Reimbursement & Payer Relations • VP of Reimbursement & Payer Relations at Electromed since October 2020 • 15+ years of diverse leadership experience in people management, client experience and process improvement • Former president and director of Intelligere, Inc., and former owner of W4P Revenue Cycle Solutions, where she implemented revenue cycle solutions for healthcare clientsDiane Kaufman – Vice President of Human Resources • VP of Human Resources at Electromed since July 2021 • 30+ years of experience leading global human resource functions aligning them with global business strategy and a champion of culture transformation • Former Sr. VP of Global Human Resources at Ergotron resulting in 65% employee referral rate, 100% candidate acceptance and hiring in 30 days, and reduced turnover from 23% to 3%Amy Yanta – Vice President of Regulatory Affairs, Quality Assurance & Compliance • VP of Regulatory, Quality & Compliance since September 2023 • 15+ years of experience in the MedTech industry specializing in Regulatory Affairs and Quality Assurance • Former RAQA leader at IMRIS, and former regulatory affair roles at Boston Scientific and Surmodics.| 24

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Cover	Nov. 10, 2023
Cover [Abstract]
Document Type	8-K
Amendment Flag	false
Document Period End Date	Nov. 10, 2023
Entity File Number	001-34839
Entity Registrant Name	ELECTROMED, INC.
Entity Central Index Key	0001488917
Entity Tax Identification Number	41-1732920
Entity Incorporation, State or Country Code	MN
Entity Address, Address Line One	500 Sixth Avenue NW
Entity Address, City or Town	New Prague
Entity Address, State or Province	MN
Entity Address, Postal Zip Code	56071
City Area Code	(952)
Local Phone Number	758-9299
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Soliciting Material	false
Pre-commencement Tender Offer	false
Pre-commencement Issuer Tender Offer	false
Title of 12(b) Security	Common Stock, $0.01 par value
Trading Symbol	ELMD
Security Exchange Name	NYSEAMER
Entity Emerging Growth Company	false
Entity Information, Former Legal or Registered Name	Not Applicable