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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 29, 2022

TACTILE SYSTEMS TECHNOLOGY, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

 

001-37799

 

41-1801204

(State or other jurisdiction of

 

(Commission

 

(I.R.S. Employer

incorporation)

 

File Number)

 

Identification No.)

3701 Wayzata Blvd, Suite 300, Minneapolis, MN 55416

(Address of principal executive offices) (Zip Code)

(612) 355-5100

(Registrant’s telephone number, including area code)

 

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:

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, Par Value $0.001 Per Share

TCMD

The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). 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 7.01. Regulation FD Disclosure.

Tactile Systems Technology, Inc. will be posting an updated version of its investor presentation on its website. A copy of the presentation is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2 of Form 8-K, the information in this Current Report on Form 8-K, including Exhibit 99.1, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liability of that section, and shall not be incorporated by reference into any registration statement or other document filed under the Securities Act of 1933 or the Securities Exchange Act of 1934, except as shall be expressly set forth by specific reference in that filing.

Item 9.01. Financial Statements and Exhibits.

 

(d) Exhibits

EXHIBIT INDEX

Exhibit
No.

 

Description

 

 

 

99.1

 

Investor Presentation, November 2022

104

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

TACTILE SYSTEMS TECHNOLOGY, INC.

Date: November 29, 2022

By:

/s/ Brent A. Moen

Brent A. Moen

Chief Financial Officer

Exhibit 99.1

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November 2022Investor PresentationNASDAQ: TCMD

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TACTILE MEDICAL | 2Thispresentationcontainsforward-lookingstatements.Forward-lookingstatementsaregenerallyidentifiablebytheuseofwordslike“may,”“will,”“should,”“could,”“expect,”“anticipate,”“estimate,”“believe,”“intend,”“continue,”“confident,”“outlook,”“guidance,”“project,”“goals,”“lookforward,”“poised,”“designed,”“plan,”“return,”“focused,”“positioned,”“prospects,”or“remain”orthenegativeofthesewordsorothervariationsonthesewordsorcomparableterminology.Allstatementsotherthanstatementsofhistoricalorcurrentfactare,ormaybedeemedtobe,forward-lookingstatements.Thereaderiscautionednottoputunduerelianceontheseforward-lookingstatements,asthesestatementsarebaseduponthecurrentbeliefsandexpectationsofmanagementandaresubjecttonumerousrisksanduncertaintiesoutsideoftheCompany’scontrolthatcancauseactualoutcomesandresultstodiffermaterially.Theserisksanduncertaintiesinclude,butarenotlimitedto:theimpactsoftheCOVID-19pandemicontheCompany’sbusiness,financialconditionandresultsofoperations,andtheCompany’sinabilitytomitigatesuchimpacts;theadequacyoftheCompany’sliquiditytopursueitsbusinessobjectives;theCompany’sabilitytoobtainreimbursementfromthirdpartypayersforitsproducts;lossorretirementofkeyexecutives,includingpriortoidentifyingasuccessor;adverseeconomicconditionsorintensecompetition;lossofakeysupplier;entryofnewcompetitorsandproducts;adversefederal,stateandlocalgovernmentregulation;technologicalobsolescenceoftheCompany’sproducts;technicalproblemswiththeCompany’sresearchandproducts;theCompany’sabilitytoexpanditsbusinessthroughstrategicacquisitions;theCompany’sabilitytointegrateacquisitionsandrelatedbusinesses;wageandcomponentpriceinflation;theeffectsofcurrentandfutureU.S.andforeigntradepolicyandtariffactions;ortheinabilitytocarryoutresearch,developmentandcommercializationplans.Inaddition,otherfactorsthatcouldcauseactualresultstodiffermateriallyarediscussedintheCompany’sfilingswiththeSEC.InvestorsandsecurityholdersareurgedtoreadthesedocumentsfreeofchargeontheSEC'swebsiteathttp ://www.sec.gov.TheCompanyundertakesnoobligationtopubliclyupdateorreviseitsforward-lookingstatementsasaresultofnewinformation,futureeventsorotherwise.Forward-Looking Statements Disclosure

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TACTILE MEDICAL | 3Thispresentationincludesthenon-GAAPfinancialmeasuresofAdjustedEBITDA,AdjustedEBITDAmarginandfreecashflow,whichdifferfromfinancialmeasurescalculatedinaccordancewithU.S.generallyacceptedaccountingprinciples(“GAAP”).Thesenon-GAAPfinancialmeasuresarepresentedbecausewebelievetheyareusefulindicatorsofouroperatingperformance.Managementusesthesemeasuresprincipallyasmeasuresofouroperatingperformanceandforplanningpurposes,includingthepreparationofourannualoperatingbudgetandfinancialprojections.Webelievethesenon-GAAPfinancialmeasuresareusefultoinvestorsassupplementalinformationbecausetheyarefrequentlyusedbyanalysts,investorsandotherinterestedpartiestoevaluatecompaniesinourindustry.Webelievethesenon-GAAPfinancialmeasuresareusefulasmeasuresofcomparativeoperatingperformancefromperiodtoperiod.Inaddition,AdjustedEBITDAisusedasaperformancemetricinourcompensationprogram.SetforthintheAppendixtothispresentation,wehaveprovidedreconciliationsofhistoricalAdjustedEBITDAtonetincome(loss),themostdirectlycomparableGAAPfinancialmeasure.InvestorsandotherreadersareencouragedtoreviewtherelatedGAAPfinancialmeasuresandthereconciliationsofthenon-GAAPmeasurestotheirmostdirectlycomparableU.S.GAAPmeasuressetforthintheAppendix.GuidanceforAdjustedEBITDAforfiscalyear2022andthegoalsforAdjustedEBITDAandAdjustedEBITDAmarginforfiscalyear2025areforward-lookingandwecannotreconcilethesenon-GAAPmeasurestoexpectednetincome(loss)andnetincome(loss)marginwithoutunreasonableeffortbecausecertainitemsthatimpactnetincome(loss)andotherreconcilingmetricsareoutofourcontroland/orcannotbereasonablypredictedatthistime,whichunavailableinformationcouldhaveasignificantimpactonourGAAPfinancialresults.Inaddition,ourgoalforcumulativefreecashflow,whichiscashflowsfromoperationslesscapitalexpenditures,cumulativeoverthethree-yearperiodendedDecember31,2025,cannotbereconciledtoexpectedcashflowsfromoperationswithoutunreasonableeffortbecausecertainitemsthatimpactsuchmetricandotherreconcilingmetricsareoutofourcontroland/orcannotbereasonablepredictedatthistime,whichunavailableinformationcouldhaveasignificantimpactonourfinancialresults.Investorsandotherreadersshouldconsidernon-GAAPmeasuresonlyassupplementsto,andnotassubstitutesfororassuperiormeasuresto,themeasuresoffinancialperformancepreparedinaccordancewithGAAP. Use of Non-GAAP Financial Measures

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TACTILE MEDICAL | 4Tactile Medical At a Glance FOUNDED 1995 HEADQUARTERS Minneapolis TOTAL EMPLOYEES 1,000+ 2021 REVENUE $208M PATIENTS SERVED IN 2021 >65,000 2021 GROSS MARGIN 71% Our Mission: To reveal and treat patients with underserved chronic conditions and help them care for themselves at home

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TACTILE MEDICAL | BRONCHIECTASISLYMPHEDEMA500K4Diagnosed bronchiectasis1.4M1Diagnosedlymphedema2,320M+Undiagnosed in the U.S. 5,64.4MUndiagnosed in the U.S. $5B+Current addressable market Total $10B+U.S. current addressable market $5B+Current addressable market5At a Glance 1. Data on file at Tactile Medical. 2. Includes data on breast, head and neck-related and other cancers, phlebolymphedema, primary lymphedema and lymphedema/lipedema. 3. Dean S, Valenti E, Hock K, Leffler J, Compston A, Abraham W, The clinical characteristics of lower extremity lymphedema in 440 patients. Jour of Vasc Surg: Venous & Lymph Disorders. ePublished Feb 2020. 4. Weycker, D. et al. Prevalence and Incidence of Non-cystic Fibrosis BE Among US Adults in 2013. Chron Respir Dis 2017;14(4):377–384. 5. Kosmas, E. et al. Bronchiectasis in Patients with COPD: An Irrelevant Imaging Finding or a Clinically Important Phenotype? CHEST. 2016; 150(4):894A. 6. Lambert AA, Dransfield MT. COPD Overlap Syndromes: Asthma and Beyond.Chronic Obstr Pulm Dis. 2016;3(1):459-465. Published 2016 Jan 15. doi:10.15326/jcopdf.3.1.2015.0176

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TACTILE MEDICAL | Aging population Growing awareness of the disease states The Affordable Care Act penalizes for readmission of patients within certain timeframes after discharge Healthcare reform driving greater accountability through moving from fee-for-service to fee-for-outcomes Trend toward preventative healthcare Treatment moving to lower cost sites of care6Key Market DriversDrivers for continued expansion in both lymphedema and bronchiectasis include:

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TACTILE MEDICAL | 7Strong Revenue Growth $62.9 $84.5 $109.3 $143.8 $189.5 $187.1 $208.1 $4.6 $7.0 $9.9 $17.3 $25.3 $16.0 $17.7 20152016201720182019202020212022 Revenues (000) Adj. EBITDA (000) Updated 2022 guidance16-18% y/y growth$242-$245Updated 2022 guidance$15-16(In $ millions)Trailing 6 yr. CAGR from FY’15 to FY’21* Includes COVID-19 impacted FY’20 and FY’21(1) Non-GAAP measure. See Appendix for a reconciliation to the directly comparable GAAP measure.21%*REVENUE CAGR(1)

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TACTILE MEDICAL | Major accomplishments and milestones: 8Significant Recent Progress Achieved2021 Treated >65,000 patients Crossed $200M revenue threshold Initiated largest-ever Head and Neck-related lymphedema Randomized Clinical Trial Completed largest acquisition in company history Bolstered leadership teamYTD 2022Enhanced board experience/diversity AffloVest integration completed Launch of ComfortEaseTMgarments New IP protecting Head and Neck therapy Launch of KyleeTMmobile application 

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TACTILE MEDICAL | Portfolio OptimizationPatient centric, connected and digital 1Improve Payor PolicySimplify coverage criteria 2Operational EfficiencyCreate leverageable infrastructure 3Clear priorities to optimize business performanceStrategies to Unlock Profitable Growth + Strong Cash Generation9FY 2025 GOALS$350M+ REVENUE3-year CAGR of 13%*$50M+ ADJ. EBITDA14%+ Adj. EBITDA Margin$75M+ CUMULATIVE FREE CASH FLOW**Strengthening balance sheet *Implied 3-year revenue CAGR based on FY’25 revenue vs. FY’22 revenue guidance range of $242 -$245 million. **Non-GAAP measure. Free Cash Flow defined as cash flow from operations less capital expenditures. Cumulative free cash flow generation target based on 3-year period ending 12/31/2025.

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TACTILE MEDICAL | 10Portfolio OptimizationCONNECTIVITYLaunch patient engagement app to provide educational content and improve user experience during order process, onboarding and therapy usage. 2 1Continuous product innovation that fits easily into thepatient’s lifestyle. PATIENT CENTERED DESIGN 3Develop digital and therapeutic solutions that lead to earlier patient engagement and optimized experience and outcomes.DIGITAL PLATFORM

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TACTILE MEDICAL | IMPROVE PATIENT ACCESS 2GOAL: 1CONTINUE INVESTMENTS IN CLINICAL RESEARCHMore than 275 million US lives have coverage for our therapies but barriers to access still existFocused on simplifying these coverages to ensure our patients have access Complete enrollment of our Head & Neck RCT Publish Therapist/Flexitouch comparative pressure studySupport investigator initiated studiesStreamline the order process to improve efficiency to shorten the time it takes for a patient to begin therapyFocus on billing and collections process improvement to improve days outstanding and cash collections 3ENHANCE PROCESSImprove Payor PolicyPRIORITY: 11

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TACTILE MEDICAL | 12Operational EfficiencyYields better patient, provider, and business outcomes while lowering our cost to serve OPERATIONSPROGRESS TOWARD DESIRED STATE ORDER PROCESS Low/no touch automated processing, ease of referral for clinicians, and informed patient experiencePATIENT SUPPORT Digital patient engagement, with omni-channel and self-serve optionsPATIENT EDUCATION & TRAINING Patient driven training experience, highly virtual, supported with digital tools, and new productsTECHNOLOGY Flow enabled, supported by AI, ML, automated payer policies, reduced manual intervention

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TACTILE MEDICAL | 13Lymphedema: Chronic, Progressive, Underserved Market The lymphatic system enables the transport of fluids containing infection-fighting white blood cells that rid the body of toxins and waste throughout the body.Sources of lymphedema include chronic venous insufficiency, cancer treatment, obesity, trauma, surgery and infection. Lymphedema symptoms and consequences include:Cellulitis FibrosisSwellingHard-to-heal woundsLimb heavinessFibrosis Skin changesDysphagiaPain & tightnessAbility to swallowLimited range of motion

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TACTILE MEDICAL | 14Lymphedema: Growing Body of Clinical Evidence ESTABLISHED SUPPORT 20 clinical studies28 peer reviewed articles37% reduction in total lymphedema-related costs per a study of 718 lymphedema patients published in (JAMA) Dermatology, Oct. 2015>HCPCS code (E0651/E0652)NEW/EMERGING SUPPORT“The American Venous Forum, American Vein and Lymphatic Society and the Society for Vascular Medicine Expert Opinion Consensus on Lymphedema Diagnosis and Treatment;” published in Phlebology, May 2022“Advanced Pneumatic Compression for Treatment of Lymphedema of the Head and Neck:a Randomized Wait-List Controlled Trial;” published in Supportive Care in Cancer, June 2020

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TACTILE MEDICAL | 15Lymphedema: Positioned to Win CLINICALLY PROVEN FLEXITOUCH AND ENTRE PNEUMATIC COMPRESSION DEVICES EXPANDING CLINICAL EVIDENCEDIRECT SALES FORCE BACK OFFICE SUPPORT BROAD INSURANCECOVERAGE275M U.S. LIVES UNDER COVERAGE #1MARKETSHARE$5B+ TOTAL ADDRESSABLE MARKET

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TACTILE MEDICAL | 16Bronchiectasis: Chronic, Progressive, Underserved Market Bronchiectasis (BE) is permanent scarring and dilation of the airways with excessive mucus productionRecurring lung infections, pneumonias, lead to progressive damage of airway wallBronchiectasis identified in nearly 1 in 4 (23%)smokers11. Cai Q, TriphuridetN, Zhu Y, et al. Bronchiectasis in Low-Dose CT Screening for Lung Cancer [published online ahead of print, 2022 Apr 19]. Radiology. 2022;212547. doi:10.1148/radiol.212547

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TACTILE MEDICAL | LEFT UNTREATEDCommonly missed diagnosis due to overlap with COPD; BE occurs in up to 42% of COPD patients.1,2Inability to clear mucus leads to a cycle of infection, inflammation and worsening damage 117Current Treatment Paradigm BASIC APPROACH Antibiotics for commonly-occurring infectionsAirway clearance foundational; common methods:•Huff coughing•PEP devices 2 STANDARD OF CARE Chest physiotherapy (CPT)Administered by care provider with manual positioning and clapping the lungs to thin and mobilize secretions 3 AFFLOVEST®High frequency chest walloscillation (HFCWO)Mimics manual CPTCan be used with other treatments, independent of a caregiverFully mobile during use; designed to improve adherence 41.Kosmas E. et al., Bronchiectasis in Patients with COPD: An Irrelevant Imaging Finding or a Clinically Important Phenotype? CHEST. 2016;150(4):894A.2.Aksamit, T. et al., Bronchiectasis and Chronic Airway Disease: It Is Not Just About Asthma and COPD. CHEST. 2018;154(4):737-739.

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TACTILE MEDICAL | Airway Clearance: Positioned to Win PORTABLE DESIGN BROAD DME CHANNEL REACH MEETS RESPIRATORY PATIENTS’ COMPLEX NEEDS STRONG REIMBURSEMENTCOMPELLING ECONOMICS FOR DME PARTNERS #2MARKETSHARE(based on units)$5B+ TOTAL ADDRESSABLE MARKET 18

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TACTILE MEDICAL | Long Term Objectives For Profitable GrowthFUTURE: FY 2025 GOALS*Implied 3-year revenue CAGR based on FY’25 revenue vs. FY’22 revenue guidance range of $242 -$245 million. **Non-GAAP measure. Free Cash Flow defined as cash flow from operations less capital expenditures. Cumulative free cash flow generation target based on 3-year period ending 12/31/2025. 19KEY DRIVERS Growing, underserved markets with enhanced product portfolio Creating a leverageable infrastructure enabled by improved payor policy and digital strategy Continuous improvement to capital efficiency and working capital requirements $350M+ REVENUE3-year CAGR of 13%*$50M+ ADJ. EBITDA14%+ Adj. EBITDA Margin$75M+ CUMULATIVE FREE CASH FLOW**Strengthening balance sheet

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TACTILE MEDICAL | 20Compelling Investment HighlightsATTRACTIVE END MARKETSLarge, growing and underserved patient segmentsBroad payer adoptionExpanding clinical education/awarenessUNIQUE ASSETSClinically proven therapiesLarge, well-developed distribution channelsComprehensive back-office capabilitiesDevelopment focused on innovation and digital roadmapVALUE CREATIONBuilding a more leverageable and efficient infrastructureGross margins >70% Improving profitability and strong free cash flow* generation *Non-GAAP measure. Free Cash Flow defined as cash flow from operations less capital expenditures.

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TACTILE MEDICAL | Thank You21

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TACTILE MEDICAL | 22Q3’22 Financial Results and FY’22 Financial Outlook Three months ended September 30Nine months ended September 30$ Millions2022202120222021Lymphedema products$54.2$51.6$146.5$145.5Airway clearance products$11.0$0.9$26.4$0.9Total revenues$65.3$52.5$172.9$146.3Gross profit$46.8$37.0$123.9$103.4Gross margin71.7%70.4%71.7%70.7%Non-GAAP gross margin72.2%71.8%72.2%71.2%Total operating expenses$48.4$38.3$144.5$108.9Operating income/(loss)($1.6)($1.4)($20.6)($5.5)Net income/(loss)($2.3)($3.4)($22.5)($4.3)Adjusted EBITDA*$7.2$4.1$6.2$8.2UPDATED FULL-YEAR 2022 FINANCIAL OUTLOOK:REVENUE ~$242–$245MADJ EBITDA ~$15–16M *Non-GAAP measure. See Appendix for a reconciliation to the directly comparable GAAP measure.

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TACTILE MEDICAL | 23Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA ($ Millions) Net (loss) income$(11.8) $(0.6) $11.0 $6.6 $5.9 $2.9 $1.4 Interest expense (income), net0.5 (0.1) (0.3) (0.4) (0.4) (0.0) 0.2 Income tax (benefit) expense9.5 (1.6) 0.2 (3.1) (1.7) 1.4 1.9 Depreciation and amortization3.7 2.8 3.5 3.7 1.8 0.8 0.8 Stock-based compensation10.2 10.7 9.8 8.0 4.2 1.9 0.3 Loss on termination of lease— — 1.1 — — — — Impairment charges and inventory write-offs0.6 4.0 — 2.5 — — — Acquisition costs1.1 — — — — — — CARES Act funding— (1.2) — — — — — Change in fair value of earn-out(0.2) — — — — — — Litigation defense costs3.7 1.0 — — — — — Executive transition costs0.5 1.0 — — — — — Adjusted EBITDA$17.7 $ 16.0 $ 25.3 $ 17.3 $ 9.9 $ 7.0 $ 4.6 2016 2015 Years ended December 31 2021 2020 2019 2018 2017

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TACTILE MEDICAL | 24Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA (Dollars in Millions) Net loss $(2.3) $(3.4) $1 (32) %$(22.5) $(4.3) $(18) N.M.% Interest expense, net0.7 0.1 1 N.M.%1.8 0.1 2 N.M.% Income tax (benefit) expense(0.1) 1.9 (2) (104) %0.1 (1.4) 1 (108) % Depreciation and amortization1.7 0.9 1 92 %4.7 2.2 3 117 % Stock-based compensation2.6 2.6 (0) (1) %7.7 7.7 (0) (0) % Impairment charges and inventory write-offs— 0.6 (1) (100) %— 0.6 (1) (100) % Acquisition costs— 0.8 (1) (100) %— 0.8 (1) (100) % Change in fair value of earn-out3.3 — 3 — 10.9 — 11 — Litigation defense costs0.9 0.6 0 47 %3.3 2.4 1 39 % Executive transition costs0.3 — 0 — %0.3 0.2 0 56 % Adjusted EBITDA$7.2 $4.1 $3.1 74 %$6.2 $8.2 $(2.0) (25) % $ % September 30, (Decrease) September 30, (Decrease) 2022 2021 $ % 2022 2021 Three Months Ended Increase Nine Months Ended Increase