Attached files
| file | filename |
|---|---|
| EX-99.2 - CONFERENCE CALL - SANUWAVE Health, Inc. | sanu_ex992.htm |
| 8-K - CURRENT REPORT - SANUWAVE Health, Inc. | sanu_8k.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
SANUWAVE HEALTH REPORTS 2017 FINANCIAL RESULTS
AND PROVIDES A BUSINESS UPDATE
SUWANEE, GA, March 29, 2018 – SANUWAVE Health, Inc. (OTCQB:
SNWV) reported financial
results for the year ended December 31, 2017 with the SEC on
Thursday, March 29, 2018 and provided a business update. The
Company will also host a conference call today, March 29, 2018 at
9:00 a.m. Eastern Time.
Highlights of 2017:
●
Received de novo clearance from the FDA December 28, 2017 for use
of the dermaPACE® System in treating Diabetic Foot Ulcers
(DFU’s).
●
Signed
Brazilian JV with MundiMed worth north of $25 million in net
present value during fourth quarter of 2017.
●
International
footprint expanded from 5 active countries to 10 during
2017.
●
Hired André Mouton as Vice President of International Sales
and Relations in February 2017.
●
Added
experienced international health care expert to the Board of
Directors member Dr. Maj-Britt Kaltloff, Head of Business
Development, Danish State Serum Institute, Danish Ministry of
Health.
●
Added
Senior military doctor, Col. Pat Sesto (ret.) formally of the
Charlie Norwood VA Hospital, Augusta, GA to the science advisory
board.
●
Hosted
first annual Sanuwave Symposium in December with over 20
representatives from 5 countries.
●
Received three
patents as follows:
o
US
patent 9,522,011 titled “Shock Wave Applicator with Movable
Electrode”
o
US
patent 9,566,209 titled “Shock Wave Electrodes with Fluid
Holes”
o
US
patent 9,840,313 titled “Cleaning and Grooming Water
Submerged Structures Using Acoustic Pressure Shock
Waves”
●
Launched
numerous international clinical studies to support growth. These
studies have been or will be published during 2018 and/or featured
at various conferences.
●
Launched
the Blog “Shock This” which has gotten tremendous
industry response. 2017 focus was on education of the shock
wave.
●
Exhibitor
at MEDICA Conference and participated at SAWC (Symposium of
Advanced Wound Care) spring and fall conferences.
With the recent FDA clearance, we can now begin to develop and
implement a platform for rolling out the dermaPACE System for
treating DFU’s in the US. We are taking a methodical approach
to the roll out to ensure we will ultimately achieve our goal - The
delivery of a dermaPACE System to any location in the US that will
be treating DFU’s. This will enable the company to reach
thousands of locations in the next few years. To be successful in
this implementation the company is following a strategy that can
support such growth. This will involve following our playbook for
success:
–
Developing
relations with the Key Opinion Leaders (KOL’s) as we expand
our clinical work
–
Having
the proper equipment financing in place
–
Selecting
the right partners to manage the various channels
–
Continuing
extensive clinical work to support the gold standard study that was
part of the FDA approval
–
Extending
the number of wound indications beyond DFU
–
Adding
more wound care experience at the board of director and science
advisor level
–
Hiring
the driven people in several key positions
–
Developing
a service driven culture that can meet the needs of the
practitioners, payors, and patients
Internationally we have seen demand pick up since our FDA
announcement. We anticipate adding at least four new countries this
year with at least two being similar to the Brazilian deal in
nature. Our presence at EWMA, with four podium presentations, will
be a key part of our relaunching efforts in Europe and beyond. We
will also begin to see the first shipments of devices to the
Brazilian joint venture during 2018.
2017 was a year filled with milestones setting the stage for rapid
growth in the wound care market. 2018 will be about building the
proper base and game plan to implement and execute the growth
needed to achieve our stated goal of a device anywhere and
everywhere a DFU is treated.
2017 Financial Results
Year Ended December 31, 2017 Financial Results
Revenues
for the year ended December 31, 2017 were $738,527, compared to
$1,376,063 for the same period in 2016, a decrease of $637,536, or
46%. Revenue resulted primarily from sales in Europe, Asia, and
Asia/Pacific of our orthoPACE devices and related applicators and
upfront distribution fee from our Brazilian distribution agreement
with MundiMed. The decrease in revenue for 2017 is primarily due to
a decrease in sales of orthoPACE devices in Asia/Pacific and the
European Community, as compared to the prior year, as well as lower
sales of new and refurbished applicators.
Operating
expenses for the year ended December 31, 2017 were $4,321,403,
compared to $4,127,433 for the prior year, an increase of
$193,970. Research and development expenses increased by $163,891,
primarily as a result of costs associated with the responses to
questions from the FDA regarding the dermaPACE de novo submission
and hiring of an independent consultant to perform software
updates. In addition, a medical device
and separate technical audit was performed related to our ISO
certification in 2017. General and administrative expenses
increased by $331,030, primarily due to increase in cost associated
with investor relations consultants, costs associated with
symposium hosted in December 2017 and increased non-cash stock
compensation related to stock option and stock warrants issued in
2017. These increases are partially
offset by decrease in amortization expense of $306,756, as our
intangible assets were fully amortized as of December 31,
2016.
Net loss for 2017 was $5,537,936, or ($0.04) per share, compared
with a net loss of $6,439,040, or ($0.06) per share in 2016, which
is a decrease in the net loss of $901,104, or 14%. The decrease in
the net loss for 2017 was a result of decreased loss on warrant
valuation that is partially offset by increase in operating
expenses discussed above.
On
December 31, 2017, the Company has cash and cash equivalents of
$730,184 compared to $133,571 as of December 31, 2016, an increase
of $596,613. For the years ended December 31, 2017 and 2016, net
cash used by operating activities was $1,528,971 and $3,199,453,
respectively, a decrease of $1,670,482, or 52%. The decrease was
primarily due to increase in accounts receivable of $250,678 and in
accounts payable and accrued expenses of $1,082,071. Net cash used
by investing activities in 2017 was $0 as compared to net cash used
by investing activities in 2016 of $8,770 from the purchase of
property and equipment. 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. Net cash provided
by financing activities for the year ended December 31, 2016 was
$3,207,771, which primarily consisted of the net proceeds from 2016
Public Offering of $1,596,855, 2016 Private Placement of
$1,528,200, and proceeds from warrant exercises of $67,466. Cash
and cash equivalents increased by $596,613 for the year ended
December 31, 2017 and cash and cash equivalents decreased by
$19,359 for the year ended December 31, 2016.
Conference Call
The Company will host a conference call on Thursday, March 29,
2018, beginning at 9AM Eastern Time to discuss the 2017 financial
results, provide a business update and answer
questions.
Shareholders and other interested parties can participate in the
conference call by dialing 877-407-8033 (U.S.) or 201-689-8033
(international) or via webcast at http://www.investorcalendar.com/event/27265.
A replay of the conference call will be available beginning two
hours after its completion through April 5, 2018, by dialing
877-481-4010 (U.S.) and entering PIN 27265 and a replay of the
webcast will be available at http://www.investorcalendar.com/event/27265
until June 29,
2018.
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 has received FDA’s
de novo clearance 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.
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
(FINANCIAL TABLES FOLLOW)
|
SANUWAVE
HEALTH, INC. AND SUBSIDIARIES
|
|
CONSOLIDATED
BALANCE SHEETS
|
|
December
31, 2017 and 2016
|
|
|
2017
|
2016
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$730,184
|
$133,571
|
|
Accounts
receivable, net of allowance for doubtful accounts
|
152,520
|
460,799
|
|
Inventory,
net
|
231,532
|
231,953
|
|
Prepaid
expenses
|
90,288
|
87,823
|
|
TOTAL CURRENT
ASSETS
|
1,204,524
|
914,146
|
|
|
|
|
|
PROPERTY AND
EQUIPMENT, net
|
60,369
|
76,938
|
|
|
|
|
|
OTHER
ASSETS
|
13,917
|
13,786
|
|
TOTAL
ASSETS
|
$1,278,810
|
$1,004,870
|
|
|
|
|
|
LIABILITIES
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts
payable
|
$1,496,523
|
$712,964
|
|
Accrued
expenses
|
673,600
|
375,088
|
|
Accrued employee
compensation
|
1,680
|
64,860
|
|
Advances from
related and unrelated parties
|
310,000
|
-
|
|
Line of credit,
related parties
|
370,179
|
-
|
|
Convertible
promissory notes, net
|
455,606
|
-
|
|
Interest payable,
related parties
|
685,907
|
109,426
|
|
Short term loan,
net
|
-
|
47,440
|
|
Warrant
liability
|
1,943,883
|
1,242,120
|
|
Notes payable,
related parties, net
|
5,222,259
|
5,364,572
|
|
TOTAL CURRENT
LIABILITIES
|
11,159,637
|
7,916,470
|
|
|
|
|
|
TOTAL
LIABILITIES
|
11,159,637
|
7,916,470
|
|
|
|
|
|
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 2017 and
2016
|
-
|
-
|
|
|
|
|
|
PREFERRED STOCK,
SERIES B CONVERTIBLE, par value $0.001,
|
|
|
|
293 authorized; 293
shares issued and 0 shares outstanding
|
|
|
|
in 2017 and 2016,
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;
|
|
|
|
139,300,122 and
137,219,968 issued and outstanding in 2017 and
|
|
|
|
2016,
respectively
|
139,300
|
137,220
|
|
|
|
|
|
ADDITIONAL PAID-IN
CAPITAL
|
94,995,040
|
92,436,697
|
|
|
|
|
|
ACCUMULATED
DEFICIT
|
(104,971,384)
|
(99,433,448)
|
|
|
|
|
|
ACCUMULATED OTHER
COMPREHENSIVE LOSS
|
(43,783)
|
(52,069)
|
|
TOTAL STOCKHOLDERS'
DEFICIT
|
(9,880,827)
|
(6,911,600)
|
|
TOTAL LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
$1,278,810
|
$1,004,870
|
|
SANUWAVE
HEALTH, INC. AND SUBSIDIARIES
|
|
CONSOLIDATED
STATEMENTS OF COMPREHENSIVE LOSS
|
|
Years
Ended December 31, 2017 and 2016
|
|
|
2017
|
2016
|
|
|
|
|
|
REVENUES
|
$738,527
|
$1,376,063
|
|
|
|
|
|
COST OF REVENUES
(exclusive of depreciation and amortization shown
below)
|
241,970
|
565,129
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
Research and
development
|
1,292,531
|
1,128,640
|
|
General and
administrative
|
3,004,403
|
2,673,773
|
|
Depreciation
|
24,069
|
19,858
|
|
Amortization
|
-
|
306,756
|
|
Gain of sale of
assets, property and equipment
|
-
|
(1,594)
|
|
TOTAL OPERATING
EXPENSES
|
4,321,003
|
4,127,433
|
|
|
|
|
|
OPERATING
LOSS
|
(3,824,446)
|
(3,316,499)
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
Loss on warrant
valuation adjustment and conversion
|
(568,729)
|
(2,223,718)
|
|
Interest expense,
net
|
(1,139,711)
|
(886,494)
|
|
Loss on foreign
currency exchange
|
(5,050)
|
(12,329)
|
|
TOTAL OTHER INCOME
(EXPENSE), NET
|
(1,713,490)
|
(3,122,541)
|
|
|
|
|
|
NET
LOSS
|
(5,537,936)
|
(6,439,040)
|
|
|
|
|
|
OTHER COMPREHENSIVE
INCOME (LOSS)
|
|
|
|
Foreign currency
translation adjustments
|
8,286
|
(18,907)
|
|
TOTAL COMPREHENSIVE
LOSS
|
$(5,529,650)
|
$(6,457,947)
|
|
|
|
|
|
LOSS PER
SHARE:
|
|
|
|
Net loss - basic
and diluted
|
$(0.04)
|
$(0.06)
|
|
|
|
|
|
Weighted average
shares outstanding - basic and diluted
|
138,838,602
|
107,619,869
|
|
SANUWAVE
HEALTH, INC. AND SUBSIDIARIES
|
|
CONSOLIDATED
STATEMENTS OF CASH FLOWS
|
|
Years
Ended December 31, 2017 and 2016
|
|
|
2017
|
2016
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES
|
|
|
|
Net
loss
|
$(5,537,936)
|
$(6,439,040)
|
|
Adjustments
to reconcile loss from continuing operations
|
|
|
|
to
net cash used by operating activities
|
|
|
|
Amortization
|
-
|
306,756
|
|
Depreciation
|
24,069
|
19,858
|
|
Change in allowance
for doubtful accounts
|
57,601
|
26,233
|
|
Stock-based
compensation - employees, directors and advisors
|
768,105
|
547,842
|
|
Loss on warrant
valuation adjustment
|
568,729
|
2,223,718
|
|
Amortization of
debt issuance costs
|
431,087
|
225,786
|
|
Warrants issued for
services
|
182,856
|
186,410
|
|
Amortization of
debt discount
|
110,247
|
31,514
|
|
Stock issued for
consulting services
|
8,000
|
43,540
|
|
Loss on conversion
option of promissory notes payable
|
-
|
75,422
|
|
Stock issued with
convertible debenture
|
-
|
50,100
|
|
Gain on sale of
asset, property and equipment
|
-
|
(1,594)
|
|
Changes in assets -
(increase)/decrease
|
|
|
|
Accounts
receivable - trade
|
250,678
|
(412,578)
|
|
Inventory
|
(7,079)
|
(29,249)
|
|
Prepaid
expenses
|
(2,465)
|
36,165
|
|
Other
|
(131)
|
(2,689)
|
|
Changes in
liabilities - increase/(decrease)
|
|
|
|
Accounts
payable
|
783,559
|
203,698
|
|
Accrued
expenses
|
298,512
|
15,714
|
|
Accrued
employee compensation
|
(63,180)
|
(176,682)
|
|
Accrued
interest
|
21,896
|
-
|
|
Interest
payable, related parties
|
576,481
|
(130,377)
|
|
NET CASH USED BY
OPERATING ACTIVITIES
|
(1,528,971)
|
(3,199,453)
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES
|
|
|
|
Proceeds from sale
of property and equipment
|
-
|
1,594
|
|
Purchases of
property and equipment
|
-
|
(10,364)
|
|
NET CASH USED BY
INVESTING ACTIVITIES
|
-
|
(8,770)
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES
|
|
|
|
Proceeds from
convertible promissory notes, net
|
1,384,232
|
106,000
|
|
Proceeds from line
of credit, related party
|
370,000
|
-
|
|
Advances from
related parties
|
310,000
|
-
|
|
Proceeds from
warrant exercise
|
93,066
|
67,466
|
|
Proceeds from 2016
Public Offering, net
|
-
|
1,596,855
|
|
Proceeds from 2016
Private Offering, net
|
-
|
1,528,200
|
|
Proceeds from
convertible debenture, net
|
-
|
175,000
|
|
Proceeds from short
term loan
|
-
|
100,000
|
|
Payment of short
term loan
|
(40,000)
|
-
|
|
Payment of
convertible promissory notes
|
-
|
(155,750)
|
|
Payment of
convertible debenture
|
-
|
(210,000)
|
|
NET CASH PROVIDED
BY FINANCING ACTIVITIES
|
2,117,298
|
3,207,771
|
|
|
|
|
|
EFFECT OF EXCHANGE
RATES ON CASH
|
8,286
|
(18,907)
|
|
|
|
|
|
NET INCREASE
(DECREASE) IN CASH AND CASH EQUIVALENTS
|
596,613
|
(19,359)
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD
|
133,571
|
152,930
|
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD
|
$730,184
|
$133,571
|
|
|
|
|
|
SUPPLEMENTAL
INFORMATION
|
|
|
|
Cash paid for
interest, related parties
|
$-
|
$630,549
|
|
|
|
|
|
NONCASH INVESTING
AND FINANCING ACTIVITIES
|
|
|
|
Stock issued with
convertible debenture
|
$-
|
$50,100
|
|
|
|
|
|
Stock issued for
services
|
$8,000
|
$43,540
|
|
|
|
|
|
Loss on warrant
conversion to stock
|
$-
|
$888,418
|
|
|
|
|
|
Beneficial
conversion feature on convertible promissory notes
|
820,681
|
66,331
|
|
Beneficial
conversion feature on convertible debenture
|
-
|
124,900
|
|
Beneficial
conversion feature on convertible debt
|
$820,681
|
$191,231
|
|
|
|
|
|
Warrants issued for
services
|
$182,856
|
$186,410
|
|
|
|
|
|
Warrants issued
with convertible promissory note
|
$620,748
|
$-
|
|
Warrants issued for
short tem loan
|
-
|
58,400
|
|
Warrants issued for
debt
|
$620,748
|
$58,400
|