Attached files
| file | filename |
|---|---|
| EX-99.2 - TRANSCRIPT - SANUWAVE Health, Inc. | snwv_ex992.htm |
| 8-K - CURRENT REPORT - SANUWAVE Health, Inc. | snwv_8k.htm |
Exhibit 99.1
FOR IMMEDIATE RELEASE
SANUWAVE HEALTH REPORTS FIRST QUARTER FINANCIAL
RESULTS
AND PROVIDES A BUSINESS UPDATE
SUWANEE, GA, May 16, 2018 – SANUWAVE Health, Inc. (OTCQB:
SNWV) reported financial
results for the three months ended March 31, 2018 with the SEC on
Tuesday, May 15, 2018 and will provide a business update on a
conference call today, May 16, 2018 at 9:00 a.m. Eastern
Time.
Highlights:
●
Revenue
for the first quarter of 2018 was $344,272 up 130% from the first
quarter of 2017.
●
Shipped first US dermaPACE®
devices in February
2018.
●
Entered into an exclusive agreement for purchase
and sale of dermaPACE®
Systems to certain governmental
healthcare facilities with Premier Shockwave Wound Care, Inc. and
Premier Shockwave, Inc. The contract includes a minimum purchase of
100 units over 3 years.
●
Entered
into a Master Equipment Lease with NFS Leasing Inc. to provide
financing for equipment placements.
●
Added
Dr. Perry Mayer, Medical Director and principal at The Mayer
Institute “TMI” in Hamilton, Ontario, Canada to the
science advisory board.
●
Exhibitor
at EWMA, CAET and Wounds Canada Spring conferences in May 2018 and
SAWC (Symposium of Advanced Wound Care) in April 2018.
With the FDA clearance, we have begun 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.
Recap of SANUWAVE Attendance at Four Global Wound Care
Conferences
SANUWAVE
is excited to recap the worldwide participation and unprecedented
user interest over the past three weeks at four significant global
wound care conferences. SANUWAVE executives were able to
divide and conquer around
the globe to ensure the display of the dermaPACE®
System at all four critical exhibitions.
“We
are elated and humbled by the outpouring of interest, support for
the dermaPACE®
System,” stated Kevin A. Richardson II, Chief Executive
Officer of SANUWAVE. “SANUWAVE met with hundreds of doctors,
nurses and global healthcare professionals while receiving over
four hundred leads for interest in device leasing, ownership and
continued clinical study work. Our global objective of Healing
Today, Curing Tomorrow may yield results sooner than we
think.”
4 conferences in attendance:
✓
2018 SAWC (Symposium on Advanced Wound
Care) Conference in Charlotte, NC on April 25 – 29. In
addition to the exhibitor’s session, SANUWAVE was selected to
present the dermaPACE®
System at the new product showcase.
✓
2018 CAET (Canadian Association for
Enterostomal Therapy) 37th National Conference Educational Program
“Turn Knowledge into Action” on May 3 – 6, 2018
in Victoria, British Columbia. In addition to the exhibitor’s
session, SANUWAVE was selected for the Shockwaves used for Disruption of
Biofilm poster presentation.
✓
2018 EWMA (European Wound Management
Association) Conference in Krakow, Poland on May 9 -
11.
✓
2018 Wounds Canada Spring Conference
“Sharing Solutions, Shaping the Future” on May
11–12, 2018 at the RBC Convention Centre in Winnipeg,
Manitoba.
Later
this year, SANUWAVE looks forward to attending other major
conferences and the growing interest in the product. We plan to be
at SAWC in Las Vegas, NV on November 2-4 and the Wounds Canada Fall
conference in London on November 8-11.
First Quarter Financial Results
Revenues
for the three months ended March 31, 2018 were $344,272, compared
to $149,569 for the same period in 2017, an increase of $194,703,
or 130%. Revenues resulted primarily from sales in the United
States and Europe of our dermaPACE®
and orthoPACE®
devices and related applicators. The increase in revenues for 2018
was due to first sale of dermaPACE®
devices and applicators in the United States after obtaining FDA
approval and slight increase in refurbishment applicator
sales.
Operating
expenses for the three months ended March 31, 2018 were $1,300,066,
compared to $718,064 for the prior period, an increase of
$582,002. Research and development expenses increased by $89,106,
as a result of hiring of a full-time software engineer, accrual of
bonus for 2018 and a grant given to a university for clinical work
to be performed. General and
administrative expenses increased by $497,000, due to hiring of a
human resources director, higher travel costs, accrual of bonus for
2018, recruiting fees for open positions, higher legal and
accounting fees related to SEC filings and higher consultant fees
related to the commercialization of dermaPACE®.
Net loss for the three months ended March 31, 2018 was $5,856,655,
or ($0.04) per share, compared with a net loss of $493,532, or
($0.00) per share for the same period in 2017, which is an increase
in the net loss of $5,363,123. The increase in the net loss for
2018 was a result of higher interest expense related to convertible
promissory notes, an increased loss on warrant valuation, and
increase in operating expenses discussed above.
On
March 31, 2018, the Company has cash and cash equivalents of
$154,205 compared to $730,184 as of December 31, 2017, a decrease
of $575,979. For the three months ended March 31, 2018 and 2017,
net cash used by operating activities was $1,848,553 and $114,884
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 three
months ended March 31, 2018, as compared to the same period for
2017, of $1,733,669 was primarily due to the increased operating
expenses and decreased payables in 2018. Net cash used by investing
activities for the three months ended March 31, 2018 consisted of
purchase of property and equipment of $7,720. Net cash provided by
financing activities for the three months ended March 31, 2018 was
$1,279,371 which consisted of $1,159,785 from the issuance of
convertible promissory notes, $94,058 net from note payable,
product, $13,528 from the exercise of warrants and $12,000 from the
advances from related parties for exercise of warrants. Net cash
provided by financing activities for the three months ended March
31, 2017 was $77,066 from exercise of warrants.
“The
first quarter reflects the beginning of our investment in the
future with new hires and increase in exposure on a world wide
basis with our participation in multiple tradeshows,” stated
Kevin A. Richardson II, Chairman of the Board of SANUWAVE.
“We expect continued growth over last year as we continue to
market our products both domestically and abroad,” concluded
Mr. Richardson.
Conference Call
The Company will host a conference call on Wednesday, May 16, 2018,
beginning at 9:00AM Eastern Time to discuss the first quarter
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/29632.
A replay of the conference call will be available beginning two
hours after its completion through May 30, 2018, by dialing
877-481-4010 (U.S.) or 919-882-2331 (international) and entering
Conference ID 29632 and a
replay of the webcast will be available at http://www.investorcalendar.com/event/29632
until August 16,
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
|
||
|
CONDENSED
CONSOLIDATED BALANCE SHEETS
|
||
|
(UNAUDITED)
|
||
|
|
|
|
|
|
March
31,
|
December
31,
|
|
|
2018
|
2017
|
|
ASSETS
|
|
|
|
CURRENT
ASSETS
|
|
|
|
Cash and cash
equivalents
|
$154,205
|
$730,184
|
|
Accounts
receivable, net of allowance for doubtful accounts
|
151,684
|
152,520
|
|
Contract
assets
|
55,700
|
-
|
|
Inventory,
net
|
264,266
|
231,532
|
|
Prepaid
expenses
|
200,960
|
90,288
|
|
TOTAL CURRENT
ASSETS
|
826,815
|
1,204,524
|
|
|
|
|
|
PROPERTY AND
EQUIPMENT, net
|
63,073
|
60,369
|
|
|
|
|
|
OTHER
ASSETS
|
17,253
|
13,917
|
|
TOTAL
ASSETS
|
$907,141
|
$1,278,810
|
|
|
|
|
|
LIABILITIES
|
|
|
|
CURRENT
LIABILITIES
|
|
|
|
Accounts
payable
|
$822,760
|
$1,496,523
|
|
Accrued
expenses
|
608,856
|
673,600
|
|
Accrued employee
compensation
|
70,502
|
1,680
|
|
Contract
liabilities
|
35,840
|
-
|
|
Advances from
related and unrelated parties
|
12,000
|
310,000
|
|
Line of credit,
related parties
|
375,729
|
370,179
|
|
Convertible
promissory notes, net
|
2,004,541
|
455,606
|
|
Note payable,
product, related party
|
94,058
|
-
|
|
Interest payable,
related parties
|
685,907
|
685,907
|
|
Warrant
liability
|
4,798,727
|
1,943,883
|
|
Notes payable,
related parties, net
|
5,260,243
|
5,222,259
|
|
TOTAL CURRENT
LIABILITIES
|
14,769,163
|
11,159,637
|
|
|
|
|
|
NON-CURRENT
LIABILITIES
|
|
|
|
Contract
liabilities
|
73,374
|
-
|
|
TOTAL NON-CURRENT
LIABILITIES
|
73,374
|
-
|
|
TOTAL
LIABILITIES
|
14,842,537
|
11,159,637
|
|
|
|
|
|
COMMITMENTS AND
CONTINGENCIES (Note 16)
|
|
|
|
|
|
|
|
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;
|
|
|
|
141,050,550 and
139,300,122 issued and outstanding in 2018 and
|
|
|
|
2017,
respectively
|
141,051
|
139,300
|
|
|
|
|
|
ADDITIONAL PAID-IN
CAPITAL
|
96,794,440
|
94,995,040
|
|
|
|
|
|
ACCUMULATED
DEFICIT
|
(110,828,039)
|
(104,971,384)
|
|
|
|
|
|
ACCUMULATED OTHER
COMPREHENSIVE LOSS
|
(42,848)
|
(43,783)
|
|
TOTAL STOCKHOLDERS'
DEFICIT
|
(13,935,396)
|
(9,880,827)
|
|
TOTAL LIABILITIES
AND STOCKHOLDERS' DEFICIT
|
$907,141
|
$1,278,810
|
|
SANUWAVE HEALTH, INC.
AND SUBSIDIARIES
|
||
|
CONDENSED
CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS
|
||
|
(UNAUDITED)
|
||
|
|
|
|
|
|
|
|
|
|
Three
Months Ended
|
Three
Months Ended
|
|
|
March
31,
|
March
31,
|
|
|
2018
|
2017
|
|
|
|
|
|
REVENUES
|
$344,272
|
$149,569
|
|
|
|
|
|
COST OF
REVENUES (exclusive of depreciation shown
below)
|
165,466
|
55,144
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
Research and
development
|
349,444
|
260,338
|
|
General and
administrative
|
945,606
|
448,606
|
|
Depreciation
|
5,016
|
6,120
|
|
TOTAL OPERATING
EXPENSES
|
1,300,066
|
715,064
|
|
|
|
|
|
OPERATING
LOSS
|
(1,121,260)
|
(620,639)
|
|
|
|
|
|
OTHER INCOME
(EXPENSE)
|
|
|
|
(Loss) gain on
warrant valuation adjustment
|
(2,973,682)
|
323,223
|
|
Interest expense,
net
|
(1,744,967)
|
(192,738)
|
|
Loss on foreign
currency exchange
|
(16,746)
|
(3,378)
|
|
TOTAL OTHER INCOME
(EXPENSE), NET
|
(4,735,395)
|
127,107
|
|
|
|
|
|
NET
LOSS
|
(5,856,655)
|
(493,532)
|
|
|
|
|
|
OTHER COMPREHENSIVE
INCOME
|
|
|
|
Foreign currency
translation adjustments
|
935
|
1,785
|
|
TOTAL COMPREHENSIVE
LOSS
|
$(5,855,720)
|
$(491,747)
|
|
|
|
|
|
LOSS PER
SHARE:
|
|
|
|
Net loss - basic
and diluted
|
$(0.04)
|
$-
|
|
|
|
|
|
Weighted average
shares outstanding - basic and diluted
|
139,754,044
|
138,042,070
|
|
SANUWAVE HEALTH, INC.
AND SUBSIDIARIES
|
||
|
CONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
||
|
(UNAUDITED)
|
||
|
|
|
|
|
|
Three
Months Ended
|
Three
Months Ended
|
|
|
March
31,
|
March
31,
|
|
|
2018
|
2017
|
|
|
|
|
|
CASH FLOWS FROM
OPERATING ACTIVITIES
|
|
|
|
Net
loss
|
$(5,856,655)
|
$(493,532)
|
|
Adjustments
to reconcile loss from continuing operations
|
|
|
|
to
net cash used by operating activities
|
|
|
|
Depreciation
|
5,016
|
6,120
|
|
Change in allowance
for doubtful accounts
|
(19,613)
|
5,152
|
|
Loss (gain) on
warrant valuation adjustment
|
2,973,682
|
(323,223)
|
|
Amortization of
debt issuance costs
|
1,473,872
|
-
|
|
Amortization of
debt discount
|
37,984
|
55,900
|
|
Stock issued for
consulting services
|
79,000
|
-
|
|
Changes in assets -
(increase)/decrease
|
|
|
|
Accounts
receivable - trade
|
20,449
|
4,278
|
|
Inventory
|
(32,734)
|
29,074
|
|
Prepaid
expenses
|
(110,672)
|
(27,554)
|
|
Contract
assets
|
(55,700)
|
|
|
Other
|
(3,336)
|
(55)
|
|
Changes in
liabilities - increase/(decrease)
|
|
|
|
Accounts
payable
|
(553,763)
|
320,377
|
|
Accrued
expenses
|
(64,744)
|
171,741
|
|
Accrued
employee compensation
|
68,822
|
-
|
|
Contract
liabilties
|
109,214
|
-
|
|
Accrued
interest
|
80,613
|
-
|
|
Interest
payable, related parties
|
-
|
136,838
|
|
NET CASH USED BY
OPERATING ACTIVITIES
|
(1,848,565)
|
(114,884)
|
|
|
|
|
|
CASH FLOWS FROM
INVESTING ACTIVITIES
|
|
|
|
Purchases of
property and equipment
|
(7,720)
|
-
|
|
NET CASH USED BY
INVESTING ACTIVITIES
|
(7,720)
|
-
|
|
|
|
|
|
CASH FLOWS FROM
FINANCING ACTIVITIES
|
|
|
|
Proceeds from
convertible promissory notes, net
|
1,159,785
|
-
|
|
Proceeds from note
payable, product
|
96,708
|
-
|
|
Proceeds from
warrant exercise
|
13,528
|
77,066
|
|
Advances from
related parties
|
12,000
|
-
|
|
Payments on note
payable, product
|
(2,650)
|
-
|
|
NET CASH PROVIDED
BY FINANCING ACTIVITIES
|
1,279,371
|
77,066
|
|
|
|
|
|
EFFECT OF EXCHANGE
RATES ON CASH
|
935
|
1,785
|
|
|
|
|
|
NET DECREASE IN
CASH AND CASH EQUIVALENTS
|
(575,979)
|
(36,033)
|
|
|
|
|
|
CASH AND CASH
EQUIVALENTS, BEGINNING OF PERIOD
|
730,184
|
133,571
|
|
CASH AND CASH
EQUIVALENTS, END OF PERIOD
|
$154,205
|
$97,538
|
|
|
|
|
|
SUPPLEMENTAL
INFORMATION
|
|
|
|
Cash paid for
interest, related parties
|
$151,227
|
$-
|
|
Cash paid for note
payable, product
|
$2,650
|
$-
|
|
|
|
|
|
NONCASH INVESTING
AND FINANCING ACTIVITIES
|
|
|
|
Stock issued for
services
|
$79,000
|
$-
|
|
|
|
|
|
Cashless exercise
of warrants
|
$118,838
|
$56,740
|
|
|
|
|
|
Advances from
related and unrelated parties converted to Convertible promissory
notes
|
$310,000
|
$-
|
|
|
|
|
|
Accounts payable
converted to Convertible promissory notes
|
$120,000
|
$-
|
|
|
|
|
|
Beneficial
conversion feature on 10% convertible promissory notes
|
709,827
|
-
|
|
Beneficial
conversion feature on convertible promissory note
|
35,396
|
-
|
|
Beneficial
conversion feature on convertible debt
|
$745,223
|
$-
|
|
|
|
|
|
Warrants issued
with 10% convertible promissory notes
|
$808,458
|
$-
|
|
Warrants issued
with convertible promissory note
|
36,104
|
-
|
|
Warrants issued for
debt
|
$844,562
|
$-
|