EX-99.1 2 snwv_ex991.htm PRESS RELEASE Blueprint
  Exhibit 99.1
 
FOR IMMEDIATE RELEASE
SANUWAVE HEALTH REPORTS RECORD 2018 FINANCIAL RESULTS
FULL YEAR REVENUE INCREASED OVER 150%
 
SUWANEE, GA, March 29, 2019 – SANUWAVE Health, Inc. (OTCQB: SNWV) will report financial results for the year ended December 31, 2018 with the SEC on Monday, April 1, 2019. The Company will also host a conference call today, March 29, 2019 at 10:00 a.m. Eastern Time.
 
 
Highlights from 2018:
 
Hired Shri Parikh as President, Healthcare in May 2018.
 
Received insurance reimbursement tracking codes for Diabetic Foot Ulcer (DFU) procedure using ESWT.
 
Signed Premier Shockwave Wound Care, Inc. as the exclusive distributor of dermaPACE® for the Veteran’s Administration (VA), Indian Health Services (IHS) and Tribally-operated healthcare services.
 
First shipments of the dermaPACE system in the U.S. Market in first quarter of 2018.
 
Added Dr. Perry Mayer, Medial Director and Principal at The Mayer Institute (“TMI”) in Hamilton, Ontario, Canada to the science advisory board.
 
The Journal of Wound Care (JWC) published a peer review article on SANUWAVE’s 336 double blind study titled “Diabetic foot ulcer treatment with focused shockwave therapy: two multicenter prospective, controlled, double-blinded, randomized phase III clinical trials.”
 
Added 15 countries to international distribution.
 
Signed an agreement with NFS Leasing, Inc. to finance equipment growth.
 
Established a Joint Venture with FKS, a JohnFK Medical company in Southeast Asia, receiving upfront payments.
Expanded our patent portfolio as follows:
U.S. patent number US 10,053,376 entitled “Acoustic Pressure Shock Wave Devices and Methods for Fluids Processing”
U.S. patent number US 10,058,340 entitled “Extracorporeal Pressure Shock Wave Devices with Multiple Reflectors and Methods for Using These Devices”
European patent number EP 2,984,280 entitled “Apparatuses and Methods for Generating Shock Waves for Use in the Energy Industry”
European patent number EP 3,117,784 entitled “Usage of Intracorporeal Pressure Shock Waves in Medicine”
Exhibited at seven industry trade shows in 2018 and received a positive response.
 
Since receiving FDA clearance for the use of dermaPACE system for treating DFUs on December 28, 2017, we have spent much of 2018 preparing for the full-on launch of dermaPACE in the US. “Our preparations were well laid out and achieved throughout 2018 and included hiring the right people, gaining reimbursement tracking codes to allow hospitals to get paid for using the system, and establishing vested partners in channels and for financing the purchase of devices for distribution. On top of this, the seeds we have planted in the past led to record revenue and shipments in 2018 as well. Looking forward, the main focus in 2019 is about dermaPACE placements, primarily in 6 key markets we have prioritized based on research of the market. By achieving these goals in 2019, we expect revenue growth beginning later this year and continued growth ahead in the coming years,” stated Kevin Richardson, Chairman and CEO of the Company.
 
 
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Goals for 2019
 
 
100 US dermaPACE system placements and 300 certified users.
 
Finish the year with at least 10 million covered lives for insurance reimbursement.
 
Launch 2 - 3 domestic clinical studies.
 
Add 3 - 4 new countries.
 
Add additional advisors to our scientific board.
 
Add other key senior management positions.
 
2018 was filled with achievements meant to prepare SANUWAVE for rapid revenue growth beginning in 2019 and beyond. The stage is set and it is now dependent on our ability to execute the well developed plan of placing 100 dermaPACE devices in the US in 2019. Our vision is to be viewed by the world as a diverse, compassionate global family that provides positive impact on life and environment, one shock at a time. The goal for SANUWAVE remains unchanged and that is to have a dermaPACE device anywhere and everywhere a DFU is treated.
 
 
2018 Financial Results (Unaudited)
 
Revenues for the year ended December 31, 2018 were $1,850,060, compared to $738,527 for the same period in 2017, an increase of $1,111,533, or 151%. Revenue resulted primarily from sales in Europe and Asia/Pacific of our orthoPACE devices and related applicators, sales in the United States and Asia/Pacific of our dermaPACE devices and related applicators and upfront license fee from our Southeast Asia distribution agreement with FKS. The increase in revenue for 2018 is primarily due to initial sales of dermaPACE devices in the United States, an increase in sales of orthoPACE devices in Asia/Pacific and the European Community, as compared to the prior year, as well as higher sales of new applicators.
 
Operating expenses for the year ended December 31, 2018 were $8,336,654, compared to $4,321,003 for the same period in 2017, an increase of $4,015,651, or 93%. Research and development expenses increased by $371,307. The increase was due to an increase in salary and benefits of $263,628 as a result of hiring and contracting for temporary services and increased consulting expenses of $72,972 related to our insurance reimbursement strategy for the commercialization of dermaPACE. General and administrative expenses increased $3,646,081. The increase was due to an increase in salary and benefits and recruitment fees related to new hires of $1,062,594, increased legal costs of $196,845 associated with SEC filings and patent issuance and maintenance, increased travel of $156,986 related to tradeshows and joint venture with FKS, and increased non-cash stock based compensation related to stock option and stock warrants issued in 2018 to new and existing employees.
 
Net loss for the year ended December 31, 2018 was $11,631,394, or ($0.08) per basic and diluted share, compared to a net loss of $5,537,936, or ($0.04) per basic and diluted share, for the same period in 2017, an increase in the net loss of $6,093,458, or 110%. The increase in the net loss was primarily a result of increase in operating expenses and interest expense as explained above.
 
 
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For the years ended December 31, 2018 and 2017, net cash used by operating activities was $3,621,172 and $1,528,971, respectively, primarily consisting of compensation costs, research and development activities and general corporate operations. The increase in the use of cash for operating activities for the year ended December 31, 2018, as compared to the same period for 2017, of $2,092,201, or 137%, was primarily due to the increase in accounts payable, accrued employee compensation and accrued expenses of $797,673 and increase in interest payable, related parties of $485,875. Net cash used by investing activities in 2018 was $42,888 as compared to net cash used by investing activities in 2017 of $0. The increase in cash used by investing activities is due to the purchase of property and equipment. Net cash provided by financing activities for the year ended December 31, 2018 was $3,317,510, which primarily consisted of the proceeds from short term notes of $1,637,497, net proceeds from convertible promissory notes of $1,159,785, proceeds from related party line of credit of $480,000, proceeds from advances from related parties of $144,000 and proceeds from warrant exercises of $40,728 which was offset by payment on related party line of credit of $144,500. Net cash provided by financing activities for the year ended December 31, 2017 was $2,117,298, which primarily consisted of the net proceeds from convertible promissory notes of $1,384,232, proceeds from related party line of credit of $370,000, proceeds from advances from related parties of $310,000 and proceeds from warrant exercises of $93,066. Cash and cash equivalents decreased by $365,635 for the year ended December 31, 2018 and cash and cash equivalents increased by $596,613 for the year ended December 31, 2017.
 
Conference Call 
 
The Company will host a conference call on Friday, March 29, 2019, beginning at 10AM Eastern Time to discuss the 2018 financial results, provide a business update and answer questions.
 
Shareholders and other interested parties can participate in the conference call by dialing 844-602-0380 (U.S.) or 862-298-0970 (international) or via webcast at https://www.investornetwork.com/event/presentation/45543.
 
A replay of the conference call will be available beginning two hours after its completion through April 12, 2019, by dialing 877-481-4010 or 919-882-2331 and entering PIN #45443 and a replay of the webcast will be available at https://www.investornetwork.com/event/presentation/45543 until June 29, 2019.
 
About SANUWAVE Health, Inc.
SANUWAVE Health, Inc. (www.sanuwave.com) is a shock wave technology company initially focused on the development and commercialization of patented noninvasive, biological response activating devices for the repair and regeneration of skin, musculoskeletal tissue, and vascular structures.  SANUWAVE’s portfolio of regenerative medicine products and product candidates activate biologic signaling and angiogenic responses, producing new vascularization and microcirculatory improvement, which helps restore the body’s normal healing processes and regeneration. SANUWAVE applies its patented PACE technology in wound healing, orthopedic/spine, plastic/cosmetic and cardiac conditions. Its lead product candidate for the global wound care market, dermaPACE®, is CE Marked throughout Europe and has device license approval for the treatment of the skin and subcutaneous soft tissue in Canada, Australia, and New Zealand.  In the U.S., dermaPACE®, is currently under the FDA’s Premarket Approval (PMA) review process for the treatment of diabetic foot ulcers.  SANUWAVE researches, designs, manufactures, markets and services its products worldwide, and believes it has demonstrated that its technology is safe and effective in stimulating healing in chronic conditions of the foot (plantar fasciitis) and the elbow (lateral epicondylitis) through its U.S. Class III PMA approved OssaTron® device, as well as stimulating bone and chronic tendonitis regeneration in the musculoskeletal environment through the utilization of its OssaTron®, Evotron® and orthoPACE® devices in Europe, Asia, and Asia/Pacific.  In addition, there are license/partnership opportunities for SANUWAVE’s shock wave technology for non-medical uses, including energy, water, food, and industrial markets.
 
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, such as statements relating to financial results and plans for future business development activities, and are thus prospective. 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. 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. Among the key risks, assumptions and factors that may affect operating results, performance and financial condition are 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 the 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.
 
 
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For additional information about the Company, visit www.sanuwave.com.
 
Contact:
 
 
Millennium Park Capital LLC
 
 
Christopher Wynne
 
 
312-724-7845
 
 
cwynne@mparkcm.com
 
 
SANUWAVE Health, Inc.
 
 
Kevin Richardson II
 
 
Chairman of the Board
 
 
978-922-2447
 
 
investorrelations@sanuwave.com or Kevin.richardson@sanuwave.com
 
 
 
 
 
 
(FINANCIAL TABLES FOLLOW)
 
 
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES         
CONSOLIDATED BALANCE SHEETS         
December 31, 2018 and 2017          
UNAUDITED          
 
 
 
 
 
 
 
 
 
 
 
2018
 
 
2017
 
 ASSETS         
CURRENT ASSETS
 
 
 
 
 
 
 
Cash and cash equivalents
 
 $364,549 
 $730,184 
Accounts receivable, net of allowance for doubtful accounts
    
    
of $33,045 in 2018 and $92,797 in 2017
  234,774 
  152,520 
Due from related party
 
  1,228 
  - 
Inventory
 
  357,820 
  231,532 
Prepaid expenses and other current assets
  125,111 
  90,288 
TOTAL CURRENT ASSETS
 
  1,083,482 
  1,204,524 
 
    
    
PROPERTY AND EQUIPMENT, net
  77,755 
  60,369 
 
    
    
OTHER ASSETS
  16,491 
  13,917 
TOTAL ASSETS
 
 $1,177,728 
 $1,278,810 
 
    
    
LIABILITIES
CURRENT LIABILITIES
    
    
Accounts payable
 
 $1,592,643 
 $1,496,523 
Accrued expenses
 
  689,280 
  673,600 
Accrued employee compensation
 
  340,413 
  1,680 
Contract liabilities
 
  131,797 
  - 
Advances payable
 
  - 
  310,000 
Line of credit, related parties
 
  883,224 
  370,179 
Accrued interest, related parties
 
  1,171,782 
  685,907 
Short term notes payable
 
  1,883,163 
  - 
Convertible promissory notes, net
 
  2,652,377 
  455,606 
Notes payable, related parties, net
 
  5,372,743 
  5,222,259 
Warrant liability
 
  1,769,669 
  1,943,883 
TOTAL CURRENT LIABILITIES
 
  16,487,091 
  11,159,637 
 
    
    
NON-CURRENT LIABILITIES
    
    
Contract liabilities
 
  46,736 
  - 
TOTAL NON-CURRENT LIABILITIES
  46,736 
  - 
TOTAL LIABILITIES
 
  16,533,827 
  11,159,637 
 
    
    
STOCKHOLDERS' DEFICIT
PREFERRED STOCK, par value $0.001, 5,000,000
 
    
    
shares authorized; no shares issued and outstanding
  - 
  - 
 
    
    
 PREFERRED STOCK, SERIES A CONVERTIBLE, par value $0.001,
 
    
    
6,175 designated; 6,175 shares issued and 0 shares outstanding
    
    
in 2018 and 2017
 
  - 
  - 
 
    
    
PREFERRED STOCK, SERIES B CONVERTIBLE, par value $0.001,
 
    
    
293 designated; 293 shares issued and 0 shares outstanding
    
    
in 2018 and 2017
 
  - 
  - 
 
    
    
COMMON STOCK, par value $0.001, 350,000,000 shares authorized;
 
    
    
155,665,138 and 139,300,122 issued and outstanding in 2018 and
    
    
2017, respectively
 
  155,665 
  139,300 
 
    
    
ADDITIONAL PAID-IN CAPITAL
 
  101,153,882 
  94,995,040 
 
    
    
ACCUMULATED DEFICIT
 
  (116,602,778)
  (104,971,384)
 
    
    
ACCUMULATED OTHER COMPREHENSIVE LOSS
 
  (62,868)
  (43,783)
TOTAL STOCKHOLDERS' DEFICIT
  (15,356,099)
  (9,880,827)
TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT
 $1,177,728 
 $1,278,810 
 
 
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES    
 
 
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS  
 
 
Years Ended December 31, 2018 and 2017    
 
 
UNAUDITED    
 
 
 
     
 
 
 
2018
 
 
2017
 
 
 
 
 
 
 
 
REVENUES
 
 
 
 
 
 
Product
 $949,601 
 $456,765 
License fees
  819,696 
  235,878 
Other revenue
  80,763 
  45,884 
TOTAL REVENUES
  1,850,060 
  738,527 
 
    
    
COST OF REVENUES
    
    
Product
  525,216 
  129,512 
Other
  168,448 
  112,458 
TOTAL COST OF REVENUES
  693,664 
  241,970 
 
    
    
GROSS MARGIN
  1,156,396 
  496,557 
 
    
    
OPERATING EXPENSES
    
    
Research and development
  1,663,838 
  1,292,531 
General and administrative
  6,650,484 
  3,004,403 
Depreciation
  22,332 
  24,069 
TOTAL OPERATING EXPENSES
  8,336,654 
  4,321,003 
 
    
    
OPERATING LOSS
  (7,180,258)
  (3,824,446)
 
    
    
OTHER INCOME (EXPENSE)
    
    
Gain (loss) on warrant valuation adjustment
  55,376 
  (568,729)
Interest expense
  (4,496,148)
  (1,139,711)
Other income, net
  9,952 
  - 
Loss on foreign currency exchange
  (20,316)
  (5,050)
TOTAL OTHER INCOME (EXPENSE), NET
  (4,451,136)
  (1,713,490)
 
    
    
NET LOSS
  (11,631,394)
  (5,537,936)
 
    
    
OTHER COMPREHENSIVE INCOME (LOSS)
    
    
Foreign currency translation adjustments
  (19,085)
  8,286 
TOTAL COMPREHENSIVE LOSS
 $(11,650,479)
 $(5,529,650)
 
    
    
LOSS PER SHARE:
    
    
Net loss - basic and diluted
 $(0.08)
 $(0.04)
 
    
    
Weighted average shares outstanding - basic and diluted
  149,537,777 
  138,838,602 
 
 
 
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SANUWAVE HEALTH, INC. AND SUBSIDIARIES    
 
 
CONSOLIDATED STATEMENTS OF CASH FLOWS        
 
 
Years Ended December 31, 2018 and 2017        
 
 
UNAUDITED          
 
 
 
2018
 
 
2017
 
 
 
 
 
 
 
 
CASH FLOWS FROM OPERATING ACTIVITIES
 
 
 
 
 
 
Net loss
 $(11,631,394)
 $(5,537,936)
  Adjustments to reconcile loss from operations
    
    
    to net cash used by operating activities
    
    
Depreciation
  22,332 
  24,069 
Bad debt expense (recovery)
  (59,752)
  57,601 
Stock-based compensation
  2,480,970 
  768,105 
Loss (gain) on warrant valuation adjustment
  (55,376)
  568,729 
Amortization of debt issuance costs
  2,767,361 
  431,087 
Amortization of debt discount
  150,484 
  110,247 
Stock issued for consulting services
  181,500 
  8,000 
Warrants issued for consulting services
  828,690 
  182,856 
Accrued interest
  410,289 
  21,896 
     Interest payable, related parties
  485,875 
  576,481 
Changes in assets and liabilities
    
    
     Accounts receivable - trade
  (22,502)
  250,678 
     Inventory
  (123,118)
  (7,079)
     Prepaid expenses
  (34,823)
  (2,465)
     Other
  (3,802)
  (131)
     Accounts payable
  276,120 
  783,559 
     Accrued expenses
  188,708 
  298,512 
     Accrued employee compensation
  338,733 
  (63,180)
     Contract liabilties
  178,533 
  - 
NET CASH USED BY OPERATING ACTIVITIES
  (3,621,172)
  (1,528,971)
 
    
    
CASH FLOWS FROM INVESTING ACTIVITIES
    
    
Purchases of property and equipment
  (42,888)
  - 
NET CASH USED BY INVESTING ACTIVITIES
  (42,888)
  - 
 
    
    
CASH FLOWS FROM FINANCING ACTIVITIES
    
    
Proceeds from short term note
  1,637,497 
  - 
Proceeds from convertible promissory notes, net
  1,159,785 
  1,384,232 
Proceeds from line of credit, related party
  624,000 
  370,000 
Advances from related parties
  - 
  310,000 
Proceeds from note payable, product
  96,708 
  - 
Proceeds from warrant exercise
  40,728 
  93,066 
Payment on line of credit, related party
  (144,500)
  - 
Payments on note payable, product
  (96,708)
  - 
Payments on short term loan
  - 
  (40,000)
NET CASH PROVIDED BY FINANCING ACTIVITIES
  3,317,510 
  2,117,298 
 
    
    
EFFECT OF EXCHANGE RATES ON CASH
  (19,085)
  8,286 
 
    
    
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
  (365,635)
  596,613 
 
    
    
CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD
  730,184 
  133,571 
CASH AND CASH EQUIVALENTS, END OF PERIOD
 $364,549 
 $730,184 
 
    
    
SUPPLEMENTAL INFORMATION
    
    
Cash paid for interest, related parties
 $151,227 
 $- 
 
    
    
NONCASH INVESTING AND FINANCING ACTIVITIES
    
    
Reclassification of warrant liability to equity
 $118,838 
 $66,967 
 
    
    
Advances payable converted to convertible promissory notes
 $310,000 
 $- 
 
    
    
Accounts payable converted to convertible promissory notes
 $120,000 
 $- 
 
    
    
Beneficial conversion feature on convertible debt
 $745,223 
 $820,681 
 
    
    
Warrants issued with debt
 $844,562 
 $620,748 
 
    
    
Conversion of 10% convertible promissory notes
 $934,696 
 $- 
 

 
 
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