SUWANEE, GA / ACCESSWIRE / November 8, 2016 / SANUWAVE Health, Inc. (OTCQB: SNWV), today reported financial results for the
three and nine months ended September 30, 2016 and provided a business update. The Company will host a conference call at 10AM
Eastern Time on Wednesday, November 9, 2016.
Highlights of the third quarter and recent weeks:
- Private Offering: The Company raised $1.7M and issued 28.3M shares of
common stock in a private offering. - Revenue growth: Year to date revenue at $728K is 23% above revenue for the same time period
in 2015. - Participation at MEDICA in Dusseldorf, Germany: SANUWAVE will exhibit, in conjunction with Ortho-Medico, a member of
B&Co, at MEDICA in Dusseldorf, Germany on 14 -17 November, 2016. SANUWAVE and Ortho-Medico cordially invites you to our booth
17D61 in Hall 17. MEDICA is the world's leading trade fair for the medical industry. SANUWAVE is using this occasion to announce
SANUWAVE's expanded cooperation with Ortho-Medico to strengthen and expand our business in Europe.
"We have had another productive quarter, maintaining steady revenue growth over 2015 and acquiring funds to finance operations
as we prepare for the fourth quarter and beyond," stated Kevin A. Richardson, II, Chairman of the board of SANUWAVE. "We continue
to explore opportunities to expand our distribution of dermaPACE and orthoPACE to other countries around the world."
"We look forward to a positive response in the first quarter of 2017 from the FDA in support of our dermaPACE to treat diabetic
foot ulcers. We will continue our search for a partner in a joint venture or partnership for commercialization on the product upon
approval while also planning for a launch of the product on our own. We continue to work on a number of non-medical initiatives,
which we will keep shareholders abreast of as they occur," concluded Mr. Richardson.
Third Quarter Financial Results
Revenues for the three months ended September 30, 2016 were $255,652, compared to $143,605 for the same period in 2015, an
increase of $112,047, or 78%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and
related applicators. The increase in revenues for 2016 was due to higher sales of new orthoPACE devices and applicators in Europe
and Asia/Pacific in 2016, there were seven new devices sold in 2016 and one new device sold in 2015.
Research and development expenses for the three months ended September 30, 2016 were $266,473, compared to $569,134 for the same
period in 2015, a decrease of $302,661, or 53%. Research and development expenses decreased in 2016 due to lower payments to third
party clinical sites participating in the dermaPACE clinical study as the patient enrollment was completed in 2015 and lower
consulting related costs as the data results were also completed in 2015.
General and administrative expenses for the three months ended September 30, 2016 were $645,864, as compared to $778,679 for the
same period in 2015, a decrease of $132,815, or 17%. The decrease in general and administrative expenses is primarily due to
reduced salary and related costs due to reduction in headcount in July 2015 and lower legal and investor relations fees and is
partially offset by higher consulting fees related to preparation of taking dermaPACE to market upon possible FDA approval.
Net loss for the three months ended September 30, 2016 was $1,139,810, or ($0.01) per basic and diluted share, compared to a net
loss of $1,026,844, or ($0.02) per basic and diluted share, for the same period in 2015, an increase in the net loss of $112,966,
or 11%. The increase in the net loss for 2016 was primarily due to a loss on warrant valuations, increase in interest expense and
offset by lower operating expenses as noted above.
Nine Months Ended September 30, 2016 Financial Results
Revenues for the nine months ended September 30, 2016 were $728,382, compared to $594,040 for the same period in 2015, an
increase of $134,342, or 23%. Revenues resulted primarily from sales in Europe, Asia and Asia/Pacific of our orthoPACE device and
related applicators. The increase in revenues for 2016 was due to higher sales of orthoPACE devices, there were thirteen new and
two demonstration devices sold in 2016 and eight new devices sold in 2015. In addition, sales of new applicators, refurbishment of
applicators and wound kits were higher as compared to 2015.
Research and development expenses for the nine months ended September 30, 2016 were $1,052,595, compared to $1,660,546 for the
same period in 2015, a decrease of $607,951, or 37%. Research and development expenses decreased in 2016 due to lower payments to
third party clinical sites participating in the dermaPACE clinical study as the patient enrollment was completed in 2015 and lower
consulting related costs as the data results were also completed in 2015, and higher consulting expenses related to the
pre-submission package to the FDA in 2016. This is partially offset by stock based compensation for options issued in July 2016 and
higher travel and entertainment expense.
General and administrative expenses for the nine months ended September 30, 2016 were $1,734,891, as compared to $1,981,541 for
the same period in 2015, a decrease of $246,650, or 12%. The decrease in general and administrative expenses is primarily due to
reduced salary and related costs due to of reduction in headcount in July 2015 and lower legal and investor relations fees and is
partially offset by higher consulting fees related to preparation of taking dermaPACE to market upon possible FDA approval.
Net loss for the nine months ended September 30, 2016 was $3,986,509, or ($0.04) per basic and diluted share, compared to a net
loss of $3,707,492, or ($0.06) per basic and diluted share, for the same period in 2015, an increase in the net loss of $279,017,
or 8%. The increase in the net loss for 2016 was primarily due to the loss on the Series A warrant conversion which is partially
offset by lower operating expenses as noted above.
Conference Call
The Company will also host a conference call on Wednesday, November 9, 2016, beginning at 10AM Eastern Time to discuss the third
quarter financial results, provide a business update and answer questions. Shareholders and other interested parties can
participate in the conference call by dialing 866-320-0174 (U.S. and Canada) or 785-424-1631 (International) or via a simultaneous
webcast at http://www.investorcalendar.com/IC/CEPage.asp?ID=175440.
A replay of the conference call will be available beginning two hours after its completion through November 23, 2016, by dialing
877-481-4010 (U.S. and Canada) or 919-882-2331 (International) and entering Conference ID 10136.
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. 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.
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
SANUWAVE HEALTH,
INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED) September 30, December 31, 2016 2015 ASSETS CURRENT ASSETS
Cash and cash equivalents $ 504,404 $ 152,930 Accounts receivable, net of allowance for doubtful accounts 141,297 74,454 Inventory
266,986 284,908 Prepaid expenses 123,233 123,988 TOTAL CURRENT ASSETS 1,035,920 636,280 PROPERTY AND EQUIPMENT, at cost, less
accumulated depreciation 8,879 4,228 OTHER ASSETS 13,940 11,097 INTANGIBLE ASSETS, at cost, less accumulated amortization 76,689
306,756 TOTAL ASSETS $ 1,135,428 $ 958,361 LIABILITIES CURRENT LIABILITIES Accounts payable $ 376,093 $ 509,266 Accrued expenses
417,243 359,374 Accrued employee compensation 451,007 241,542 Interest payable, related parties - 239,803 Warrant liability 147,300
138,100 TOTAL CURRENT LIABILITIES 1,391,643 1,488,085 NON-CURRENT LIABILITIES Notes payable, related parties 5,357,446 5,348,112
TOTAL LIABILITIES 6,749,089 6,836,197 COMMITMENTS AND CONTINGENCIES STOCKHOLDERS' DEFICIT PREFERRED STOCK, SERIES A CONVERTIBLE,
par value $0.001, 6,175 authorized; 6,175 shares issued and 0 shares outstanding in 2016 and 2015 - - PREFERRED STOCK, SERIES B
CONVERTIBLE, par value $0.001, 293 authorized; 293 shares issued and 293 and 0 shares outstanding in 2016 and 2015, respectively -
- PREFERRED STOCK - UNDESIGNATED, par value $0.001, 4,993,532 shares authorized; no shares issued and outstanding - - COMMON STOCK,
par value $0.001, 350,000,000 shares authorized; 136,659,125 and 63,056,519 issued and outstanding in 2016 and 2015, respectively
136,659 63,057 ADDITIONAL PAID-IN CAPITAL 91,268,738 87,086,677 ACCUMULATED DEFICIT (96,980,916 ) (92,994,408 ) ACCUMULATED OTHER
COMPREHENSIVE LOSS (38,142 ) (33,162 ) TOTAL STOCKHOLDERS' DEFICIT (5,613,661 ) (5,877,836 ) TOTAL LIABILITIES AND STOCKHOLDERS'
DEFICIT $ 1,135,428 $ 958,361
SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (UNAUDITED)
Three Months Ended
Three Months Ended Nine Months Ended Nine Months Ended September 30, September 30, September 30, September 30, 2016 2015 2016 2015
REVENUES $ 255,652 $ 143,605 $ 728,382 $ 594,040 COST OF REVENUES 98,678 38,752 249,847 173,349 GROSS PROFIT 156,974 104,853
478,535 420,691 OPERATING EXPENSES Research and development 266,473 569,134 1,052,595 1,660,546 General and administrative 645,863
778,679 1,734,891 1,981,541 Depreciation 1,554 926 3,227 2,775 Amortization 76,689 76,689 230,067 230,068 TOTAL OPERATING EXPENSES
990,579 1,425,428 3,020,780 3,874,930 OPERATING LOSS (833,605 ) (1,320,575 ) (2,542,245 ) (3,454,239 ) OTHER INCOME (EXPENSE) Gain
on sale of assets held for sale - 100,000 - 100,000 Gain on sale of property and equipment - - 1,000 - Gain(loss) on warrant
valuation adjustment and conversion (43,536 ) 302,300 (812,983 ) (70,985 ) Interest expense, net (225,252 ) (105,830 ) (489,996 )
(266,810 ) Amortization of debt issuance costs (26,974 ) - (114,522 ) - Amortization of debt discount (7,076 ) - (18,548 ) - Loss
on foreign currency exchange (3,367 ) (2,739 ) (9,215 ) (15,458 ) TOTAL OTHER INCOME (EXPENSE) (306,205 ) 293,731 (1,444,264 )
(253,253 ) NET LOSS (1,139,810 ) (1,026,844 ) (3,986,509 ) (3,707,492 ) OTHER COMPREHENSIVE LOSS Foreign currency translation
adjustments (2,268 ) (345 ) (4,980 ) (13,831 ) TOTAL COMPREHENSIVE LOSS $ (1,142,078 ) $ (1,027,189 ) $ (3,991,489 ) $ (3,721,323 )
LOSS PER SHARE: Net loss - basic and diluted $ (0.01 ) $ (0.02 ) $ (0.04 ) $ (0.06 ) Weighted average shares outstanding - basic
and diluted 115,528,604 63,056,519 97,798,261 63,014,763
SANUWAVE HEALTH, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Nine Months Ended Nine
Months Ended September 30, September 30, 2016 2015 CASH FLOWS FROM OPERATING ACTIVITIES Net loss $ (3,986,509 ) $ (3,707,492 )
Adjustments to reconcile loss from continuing operations to net cash used by operating activities Amortization 230,067 230,068
Depreciation 3,227 2,775 Change in allowance for doubtful accounts 15,376 (9,186 ) Stock-based compensation - employees, directors
and advisors 116,550 146,385 Loss on warrant valuation adjustment 812,982 70,985 Amortization of debt issuance costs 114,522 - Loss
on conversion option of promissory notes payable 75,422 - Loss on conversion option of convertible debenture 50,100 - Stock issued
for consulting services 43,540 - Amortization of debt discount 18,548 6,658 Gain on sale of property and equipment (1,000 ) - Gain
on sale of assets - (100,000 ) Changes in assets - (increase)/decrease Accounts receivable - trade (82,219 ) 63,582 Inventory
17,922 (19,483 ) Prepaid expenses 755 (23,711 ) Other (2,843 ) (54 ) Changes in liabilities - increase/(decrease) Accounts payable
(133,173 ) 83,811 Accrued expenses 60,369 31,032 Accrued employee compensation 209,465 198,581 Interest payable, related parties
(239,803 ) 18,259 Promissory notes payable - accrued interest (32,271 ) - NET CASH USED BY OPERATING ACTIVITIES (2,708,973 )
(3,007,790 ) CASH FLOWS FROM INVESTING ACTIVITIES Proceeds from sale of property and equipment 1,000 100,000 Purchases of property
and equipment (7,878 ) - NET CASH PROVIDED (USED) BY INVESTING ACTIVITIES (6,878 ) 100,000 CASH FLOWS FROM FINANCING ACTIVITIES
Proceeds from 2016 Public Offering, net 1,596,855 - Proceeds from 2016 Private Offering, net 1,528,200 - Proceeds from convertible
promissory notes, net 106,000 - Proceeds from convertible debenture, net 175,000 - Proceeds from warrant exercise 32,000 - Payment
of convertible promissory notes (155,750 ) - Payment of convertible debenture (210,000 ) - NET CASH PROVIDED BY FINANCING
ACTIVITIES 3,072,305 - EFFECT OF EXCHANGE RATES ON CASH (4,980 ) (13,831 ) NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS
351,474 (2,921,621 ) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD 152,930 3,547,071 CASH AND CASH EQUIVALENTS, END OF PERIOD $
504,404 $ 625,450 SUPPLEMENTAL INFORMATION Cash paid for interest, related parties $ 630,549 $ 242,904
SOURCE: SANUWAVE Health, Inc.
