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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.
Cover Page Interactive Data File (embedded within the Inline XBRL document)
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
/s/ Brent A. Moen
Brent A. Moen
Chief Financial Officer
November 2022Investor PresentationNASDAQ: TCMD
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
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
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:
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)
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
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.
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
TACTILE MEDICAL | IMPROVE PATIENT ACCESS 2GOAL: 1CONTINUE INVESTMENTS IN CLINICAL RESEARCHMore than 275 million US lives have coverage for our therapies but barriers to access still existFocused on simplifying these coverages to ensure our patients have access Complete enrollment of our Head & Neck RCT Publish Therapist/Flexitouch comparative pressure studySupport investigator initiated studiesStreamline the order process to improve efficiency to shorten the time it takes for a patient to begin therapyFocus on billing and collections process improvement to improve days outstanding and cash collections 3ENHANCE PROCESSImprove Payor PolicyPRIORITY: 11
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
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 FibrosisSwellingHard-to-heal woundsLimb heavinessFibrosis Skin changesDysphagiaPain & tightnessAbility to swallowLimited range of motion
TACTILE MEDICAL | 14Lymphedema: Growing Body of Clinical Evidence ESTABLISHED SUPPORT 20 clinical studies28 peer reviewed articles37% 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
TACTILE MEDICAL | 15Lymphedema: Positioned to Win CLINICALLY PROVEN FLEXITOUCH AND ENTRE PNEUMATIC COMPRESSION DEVICES EXPANDING CLINICAL EVIDENCEDIRECT SALES FORCE BACK OFFICE SUPPORT BROAD INSURANCECOVERAGE275M U.S. LIVES UNDER COVERAGE #1MARKETSHARE$5B+ TOTAL ADDRESSABLE MARKET
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
TACTILE MEDICAL | LEFT UNTREATEDCommonly missed diagnosis due to overlap with COPD; BE occurs in up to 42% of COPD patients.1,2Inability to clear mucus leads to a cycle of infection, inflammation and worsening damage 117Current Treatment Paradigm BASIC APPROACH Antibiotics for commonly-occurring infectionsAirway 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 CPTCan be used with other treatments, independent of a caregiverFully 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.
TACTILE MEDICAL | Airway Clearance: Positioned to Win PORTABLE DESIGN BROAD DME CHANNEL REACH MEETS RESPIRATORY PATIENTS’ COMPLEX NEEDS STRONG REIMBURSEMENTCOMPELLING ECONOMICS FOR DME PARTNERS #2MARKETSHARE(based on units)$5B+ TOTAL ADDRESSABLE MARKET 18
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$75M+ CUMULATIVE FREE CASH FLOW**Strengthening balance sheet
TACTILE MEDICAL | 20Compelling Investment HighlightsATTRACTIVE END MARKETSLarge, growing and underserved patient segmentsBroad payer adoptionExpanding clinical education/awarenessUNIQUE ASSETSClinically proven therapiesLarge, well-developed distribution channelsComprehensive back-office capabilitiesDevelopment focused on innovation and digital roadmapVALUE CREATIONBuilding a more leverageable and efficient infrastructureGross margins >70% Improving profitability and strong free cash flow* generation *Non-GAAP measure. Free Cash Flow defined as cash flow from operations less capital expenditures.
TACTILE MEDICAL | Thank You21
TACTILE MEDICAL | 22Q3’22 Financial Results and FY’22 Financial Outlook Three months ended September 30Nine months ended September 30$ 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 ~$15–16M *Non-GAAP measure. See Appendix for a reconciliation to the directly comparable GAAP measure.
TACTILE MEDICAL | 23Reconciliation of GAAP Net Income to Non-GAAP Adjusted EBITDA ($ 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
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