8-K
SANUWAVE Health, Inc. (SNWV)
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) | October 13, 2022 | |
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| SANUWAVE Health, Inc. | ||
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| (Exact name of registrant as specified in its charter) | ||
| Nevada | 000-52985 | 20-1176000 |
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| (State or other jurisdiction of incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
| 3360 Martin Farm Road, Suite 100, Suwanee, Georgia | 30024 | |
| --- | --- | |
| (Address of principal executive offices) | (Zip Code) | |
| Registrant’s telephone number, including area code | (770) 419-7525 | |
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| N/A | ||
| --- | ||
| (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 (see General Instruction A.2. below):
| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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Securities registered pursuant to Section 12(b) of the Act:
| Title of each class | Trading Symbol(s) | Name of each exchange on which<br><br> <br>registered |
|---|---|---|
| N/A | N/A | N/A |
Indicate by check mark whether the registration 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 7.01. | Regulation FD Disclosure. |
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On October 13, 2022, SANUWAVE Health, Inc. (the “Company”) will present at the Microcap Rodeo presents The Windy City Roundup 2022 conference, which is being held on October 12-13, 2022. A copy of the Company’s presentation is furnished as Exhibit 99.1 to this report.
The information in this Item 7.01, and Exhibit 99.1 attached hereto, is being furnished and 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, regardless of any general incorporation language in such filing.
| Item 9.01 | Financial Statements and Exhibits. |
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(d) Exhibits.
| Exhibit<br><br> <br>No. | Description |
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| 99.1 | Investor Presentation, dated October 12, 2022 |
| 104 | Cover Page Interactive Data File––the cover page XBRL tags are 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.
| SANUWAVE HEALTH, INC. | ||
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| Date: October 13, 2022 | By: | /s/ Kevin A. Richardson, II |
| Kevin A. Richardson, II | ||
| Chief Executive Officer |
Exhibit 99.1
Investor Presentation October, 2022
Forward Looking Statements This presentation may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 that reflect the Company’s current views with respect to certain current and future events and financial performance. Forward-looking statements include all statements that are not statements of historical fact regarding intent, belief or current expectations of the Company, its directors or its officers. Such forward-looking statements, include, without limitation, any statements regarding expected benefits of the transaction and its impact on the Company, expected sales, marketing and other synergies of the combined company, cost savings opportunities, cross-selling opportunities, new revenue channels and product lines, the Company’s pro forma sales coverage and organization, sales force growth, international market opportunities and sales model, and growth strategy. Words such as “expects,” “anticipates,” “projects,” “intends,” “plans,” “believes,” “estimates,” variations of such words, and similar expressions are also intended to identify such forward-looking statements. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, many of which are beyond the Company’s ability to control. Actual results may differ materially from those projected in the forward-looking statements. These risks and uncertainties include, without limitation, risks associated with the Company’s ability to successfully integrate the UltraMist business, that the transaction may not result in the expected benefits to the Company, risks associated with the regulatory approval and marketing of the Company’s product candidates and products, unproven pre-clinical and clinical development activities, regulatory oversight, the Company’s ability to manage its capital resource issues, competition, and other factors discussed in detail in the Company’s periodic filings with the Securities and Exchange Commission. The Company undertakes no obligation to update any forward-looking statement.
Introduction 2 FDA Approved Products: SANUWAVE is a commercial stage medical device company in the $45 billion US wound care space Wound care is undergoing a major transition to evidence based medicine This transition is being driven by payors who have assessed efficacy and restructured reimbursement These changes have de-emphasized skin substitutes and grafts and improved payouts for directed energy treatments This favors SANUWAVE’s product portfolio for device and consumable sales Strong and broad IP portfolio with many applications outside wound care Rapid growth despite supply constraint New funding will allow for increases in production to serve customers and accelerate growth Transitioning to profitability Seek to uplist to NASDAQ H1 2023 UltraMIST dermaPACE 3
Market Opportunity Growth Drivers Centers for Medicare and Medicaid Services (CMS) and commercial providers increasingly classifying regenerative technology products as medically necessary Aging population Increase in obesity, diabetes, cancers and autoimmune disorders Trend to move “care to the edge” and away from hospital settings Rice et al. Diabetes care 2014;37. 651-658. 2Rice et. al J Med Econ 2014;17 (5): 347-356. (National Pressure Ulcer Advisory Panel (NPUAP). Treatment Opportunity in the U.S. 2,200 Wound care centers 10,000 Physician offices 15,000 Skilled nursing facilities 28,900 Assisted living facilities ~$18 Billion Venous Leg Ulcers (VLUs)2 Annual treatment costs Inpatient only, all payers Targeting a ~$45 Billion Market in the US Estimated Annual Wound Care Costs in the United States ~$12 Billion Pressure Ulcers (PUs)3 Annual treatment costs Inpatient only, all payers ~$15 Billion Diabetic Foot Ulcers (DFUs)1 Annual treatment costs All care settings, all payers
Transition to Evidence Based Medicine The Wound Care Market is Transitioning to Evidence Based Medicine 1. “Noncontact low-frequency ultrasound therapy in the treatment of chronic wounds: A meta-analysis,” 2011 Driver et al Improved Outcomes Clinical Evidence Improved Reimbursement Increased Usage Concerns about the efficacy of several common treatment practices such as skin substitutes, grafts, and hyperbaric have led to payor reassessment of reimbursement. In meta study (Driver et al) non-contact low frequency ultrasound showed 72% greater healing rate at 12 weeks than standard of care.1 Reducing or terminating reimbursement for numerous modalities. Increased reimbursement for energy-based treatments UltraMIST is the only energy product that currently qualifies for a schedule one code.
The only 2 FDA approved directed energy devices for wound healing have been consolidated into SANUWAVE UltraMIST 931 ACTIVE UNITS IN FIELD Both units have established reimbursement and CPT codes Strong IP protection: 65 (UltraMIST) and 100+ (DermaPACE) US and international patents granted and filed covering method of use and use in specific indications related to advanced wound care. SANUWAVE Advantage 6 dermaPACE 52 ACTIVE UNITS IN FIELD
UltraMIST Therapy System ® 95% of current SANUWAVE revenues are UltraMIST Indications for use FDA Approved Diabetic Foot Ulcers Pressure Ulcers Venous Leg Ulcers Deep Tissue Pressure Injuries Surgical Wounds A low-frequency, non-contact ultrasound energy delivered through a fluid mist Device never touches the wound surface making it pain-free Promotes wound healing below the surface by modulating cell membranes to drive increased blood flow and capillary formation. Enhances macrophage mediated VEGF and PDGF release to enhance removal of damaged tissue by neutrophils. Reduces pro-inflammatory cytokines Kills bacteria by lysing cell walls. 3 to 20 minute treatment time with simple, self-contained system Highly portable: weighs only 7 pounds.
dermaPACE System ® Great potential for market expansion as data drives wider reimbursement Non-invasive acoustic wave device utilizing proprietary form of high-energy, focused shockwave technology for the repair and regeneration of skin, musculoskeletal tissue and vascular structures Promotes wound healing by increasing capillary perfusion and arteriogenesis. Encourages transmission of white cells to wound bed tissue improving healing and reducing inflammation. Causes growth factor upregulation. Kills bacteria by lysing cell walls. 5 to 7 minute treatment time Indications for use FDA Approved Diabetic Foot Ulcers International Diabetic Foot Ulcers Post-Operative Wound Healing Defects Post-Traumatic Wounds Deep-Partial Thickness Burns Decubitus Ulcers Arterial Leg Ulcers Venous Leg Ulcers
Per CMS prices at 8.2 week treatment time 2. Graphic from “Effects of non contact low-frequency ultrasound on healing of suspected deep tissue injury: a retrospective analysis” Jeremy S Honaker et al; Int wound J 2012 Recurrence: ~50% of Diabetic Foot Ulcers recur with standard of care. Energy treatment is cure, not symptom relief. Cost to treat: $8,000 $129,000 Payor Economics Cost to Close wound in hospital: Energy: $4,5001 VS Skin Substitutes: $14.3k1 Heal time: 16 weeks drops to 8.2 weeks Stage 2: partial dermal thickness Stage 3: full dermal thickness Stage 4: visible bone, muscle, tendon Unstageable: full thickness obscured with slough and/or eschar SDTI: severe sub dermal wound without surface opening 18% UltraMist patients: 80% resolve at Stage 2 or less vs 22% Std of Care <$8k to Treat Std of care patients: 70% progress to Unstageable or SDTI vs 14% for UltraMist >$129k to Treat Wound/Ulcer Progression from Deep Tissue Injury in ICU UltraMIST vs Standard of Care Percentage of treatment group reaching stage before wound resolution
Schedule 1: Reimbursed under CPT code 97610: “low frequency, non-contact, non-thermal ultrasound, including topical application(s), when performed, wound assessment, and instruction(s) for ongoing care, per day” Schedule 3: Reimbursed under CPT code 0512T “extracorporeal shockwave for integumentary wound healing, high energy, including topical application and dressing; initial wound.” No other approved product currently qualifies for this code One of 2 devices that currently qualifies for this code* Reimbursement = $420-500/procedure in physician office 100% Medicare reimbursement, significant private Reimbursement = $420 in physician office ~80% Medicare reimbursement, very little private Consumable costs = ~$100/procedure Consumable costs = ~$50/procedure Can be used by Nurse Practitioner Can be used by Nurse Practitioner 3 to 20 minute treatment time 5 to 7 minute treatment time ~85 procedures to pay for device ~128 procedures to pay for device * Other device is TRT ortho gold. Doctor Economics dermaPACE UltraMIST
dermaPACE Unit Price $47,500 Applicators Per Patient Price $37.50 Wound Kit (Sleeves & Gel) Single Use kits Price $10.40 UltraMIST Unit Price $30,000 Applicators Single Use Price $101.16 TOTAL ESTIMATED GROSS MARGIN: * Pricing reflects manufacturer's suggested retail price (MSRP) 75% Unit Economics 11
6/30/2021 3/30/2022 6/30/2022 Quarter Variation March-June 2022 YTD Variation 2021-2022 *Trials 44 66 94 42% +113% Trial value $1,510,000 $1,922,500 $3,133,380 63% +108% W2 sales reps 15 12 10 *Awaiting Trial 0 - 96 Value Potential 0 - $3,009,000 Backlog 94 An increase of 113% year-over-year. Manufacturing Capacity SANUWAVE has been capital and production constrained. August 2022 funding alleviates this. Q2 was 110% of manufacturing capacity Move manufacturing to Minnesota Move to Dual Source Expand unit production capacity from 240 to 600 over next 12 months Expand consumables production capacity from 5,400 applicators/wk to 24,000 applicators/wk over next 12 months Meet existing backlog and support an increase in sales outreach.
Company Financials Q2 2021 Q1 2022 Q2 2022 YoY growth REVENUE $2.9mm $3.2mm $3.9mm +34% GROSS MARGIN 64% 72% 72% +800bp OPERATING INCOME - $4.1mm - $1.9mm - $2.2mm* 46% reduction in loss *includes ~$1mm in one-time costs from audit compliance, consultants, relocation, and system upgrades 2022 REVENUE GUIDANCE: $18 Million (vs $13 Million 2021, +39%) Unbounded Upside: 1% market share in US wound market = $450 million Break Even $2.1mm/mo Gross Margin 72% Opex $1.5mm/mo
Wound care is undergoing a payor led shift to evidence based medicine and reimbursement. This has aligned incentives for Patients, Payors, and Providers. SANUWAVE is in a prime position to benefit: Approved products protected by strong IP Strong existing reimbursement with room to improve Strong, focused sales force Now able to meet demand with expanded manufacturing Summary Rapid growth poised to accelerate and bring company to profitability.
Appendix
Cosmetic/Aesthetic: (UM/DP) Scar treatment, post surgical, C-section Acne Post Laser peel, Inflamation reduction from facials Applications Outside of Wound Care GI Lesions Cardiovascular Orthopedic: (DP) Joint pain, deep tissue, chiropractic Men’s Health: (DP) Treatment of ED
Kevin A. Richardson, II CEO Kevin A. Richardson, II, joined SANUWAVE as chairman of the board of directors in August of 2005 and CEO in 2018. The previous year, he founded Prides Capital LLC and Prides Capital Partners LLC, where he is the managing director. From 1999 to 2003, Richardson was a partner at Blum Capital Partners, a $2.5 billion investment firm, where he was the lead public partner on 18 investments. Prior to Blum Capital, he worked with Tudor Investment Corporation and Fidelity Management and Research, where he managed funds in aerospace and defense and performed research in a variety of technical, financial, healthcare, and IT industries. Richardson is also on the boards of publicly traded multichannel distributor As Seen On TV, Inc., and travel technology company Pegasus Solutions. Previously, he served on the boards of Healthtronics and QC Holdings. Richardson received an undergraduate degree from Babson College and an MBA from Kenan-Flagler Business School at the University of North Carolina. Management Team Pete Stegagno Chief Operation Officer Peter Stegagno joined SANUWAVE® as Vice President, Operations in March 2006. Stegagno has nearly 30 years of experience in the medical device market, encompassing manufacturing, design and development, quality assurance and international, and domestic regulatory affairs. He has been instrumental in the development and deployment of international operational processes for leading medical device companies. Prior to joining SANUWAVE, Stegagno served as Vice President of Quality and Regulatory Affairs for Elekta and director level roles in medical device companies including Genzyme Biosurgery. Before focusing on the medical field, he enjoyed a successful career in production roles in the space industry, including avionics guidance systems for military applications and control computers for the space shuttle. Stegagno graduated from Tufts University with a B.S. degree in Chemical Engineering. Toni Rinow, Ph.D. MBA Chief Financial Officer Dr. Toni Rinow joined SANUWAVE® as Chief Financial Officer in August, 2022. Dr. Rinow is a transformational finance and business leader with over 20 years of experience and a proven track record in international corporate development. Prior to joining SANUWAVE Toni served in a NASDAQ traded wellness company raising over $130 million in capital expansion financing and executed acquisitions securing a Morgan Stanley capital-backed portfolio. Toni led healthcare organizations as General Manager at global nuclear medicine leader Jubilant Draximage Inc and as Chief Operating Officer at Isologic Innovative Radiopharmaceuticals. Her professional career includes leadership roles in both public and private pharmaceutical and healthcare organizations, where she spearheaded acquisitions across Canada, Latin America, Europe, India, and USA and supported the transition of biotechnology companies to an initial public offering. Toni has successfully facilitated the negotiation of international corporate alliances valued at over $100M and overseen a life science investment portfolio with $400M under management. Dr. Rinow holds an MBA and a Master’s in Accounting from McGill University, as well as a chemical engineer degree from ERASMUS European Higher Institute of Chemistry in Strasbourg, France, and a Ph.D. in Biophysics and Chemistry from the University of Montreal. She is trained in artificial intelligence at MIT Massachusetts Institute of Technology. Dr. Rinow believes in giving back to the community and sat on the Board of Directors in several non-for-profit organizations. Iulian Cioanta, Ph.D. Chief Science and Technology Officer Dr. Iulian Cioanta joined SANUWAVE® in June 2007 as director of research and development. In 2009, he was promoted to vice president of research and development and, in 2018, to chief science and technology officer. Prior to joining SANUWAVE, Dr. Cioanta served as business unit manager with Cordis Endovascular, a Johnson & Johnson company; director of development engineering with Kensey Nash Corporation; research manager at ArgoMed Inc., and project manager and scientist with the Institute for the Design of Research Apparatuses. He has 20+ years of experience in the medical device industry. Dr. Cioanta also worked in academia at Polytechnic University of Bucharest in Romania, Leicester University in the United Kingdom, and Duke University in the United States. He received a B.S. degree in Engineering and Management of Technological Systems and Business Management and an M.S. degree in Engineering and Management of Technological Systems from the Polytechnic University of Bucharest, and he earned his Ph.D. in Biomedical Engineering from Duke University in the field of extracorporeal shockwave lithotripsy. Jack Schlechtweg Chief Revenue Officer An award-winning executive who has led sales and marketing teams in the biotech, pharmaceutical and medical device industries for over 15 years, Jack serves as SANUWAVE’s chief revenue officer and vice president of sales. In those roles, Jack not only leads a team of 130 employees and contractors, but also drives revenue growth on a national scale. Jack has held senior roles at companies such as Celularity, Alliqua, Shire Regenerative Medicine, Accelecare, Organogenesis Inc., and Merck Schering-Plough. He achieved 235% of goal for a startup operation. Throughout his career, Jack has established relationships with key opinion leaders and led national accounts; throughout, he served as a catalyst for positive change and transformation management. A hands-on executive, Jack recently spearheaded a $24 million asset acquisition. Jack earned his MBA from Southern Connecticut State University as an honors graduate and holds a B.A. from Utica College of Syracuse University.
165+ patents including broad foundational patents in technology for forming penetrating shockwaves and in medical use cases. Cover reflector/electrode commination and structure and application to wounds, lungs, bacterial cleansing, and other applications including software, personalized treatment algorithms, and direct consumables links to billing. Intellectual Property
Consumables Consumables Active Accounts 527 Applicators 25.3 Top 100 Accounts 102.0 Remaining Accounts 7.4 Per Account per Month Per Account per Month Per Account per Month
UltraMIST dermaPACE Pain free, contact free Treats wound bed Treatments 3X/week Focus on captive patients, hospital and managed care settings, skilled nursing Highly portable device Why use UltraMist vs. dermaPACE? Contact system Treats wound bed and deeper peri-wound area around wound bed Treatments 1X/week Focus on ambulatory treatment, wound centers Somewhat portable device (cart, not carry) Deeper, higher power treatment The two are complimentary, not competitive. Some sites using both on same patients.
ACUTE WOUND CARE CHRONIC / ADVANCED WOUND CARE Wound Discovery Primary Care Physician Specialist Referral Specialist Treatment Wound Closure Weeks 1-2 Weeks 2-4 Weeks 3-5 Weeks 4-6 Weeks 5-12+ Home Treatment Standard of Care Initial Visit & Treatment Continue Treatment Treatment & Closure Self-cleaning and wound dressing Clinical exam, cleaning, debridement, wound dressing, offload pressure Diagnostics, debridement, advanced therapy Physician assessment, advanced therapy Cleaning, advanced therapy, wound closure OTC & Prescription cleaners, gels, films, foams, antibiotics Debridement Prescription gels, films, foams, antibiotics Hyperbaric Hyperbaric Negative Pressure Hyperbaric Wound dressings Wound dressings Walking boot Negative Pressure Extracellular Matrix Negative Pressure Compression SANUWAVE’s ENERGY FIRST products added to standard of care. Advanced Wound Care Continuum SANUWAVE