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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:
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 |
|
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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