Attached files
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| EX-99.2 - TRANSCSRIPT - 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 RECORD THIRD QUARTER REVENUE
Total Revenue Increase of 269%;
Initial US treatments have begun, New President, Shri Parikh, to
Discuss on Conference Call at 10 am
SUWANEE, GA, November 20, 2018 – SANUWAVE Health, Inc.
(OTCQB: SNWV) reported financial results for the three months
ended September 30, 2018 with the SEC yesterday, November 19, 2018
and will provide a business update on a conference call today,
Tuesday, November 20, 2018 at 10:00 a.m. Eastern
Time.
Highlights of the third quarter and recent weeks:
●
Record
total revenue for the third quarter of 2018 was $595,789, up 269%
from the third quarter of 2017.
●
Initial
US treatments started in the third quarter.
●
Holistic Wellness Alliance PTE. LTD has been
incorporated in Singapore with Johnfk Medical Inc. (“FKS”) for
the manufacture, sale and distribution of the Company’s
dermaPACE® and
orthoPACE® devices
covering 11 countries in Southeast Asia.
●
Third
quarter medical conference attendance activity for the Company was
9 major medical shows with resounding success.
●
Social media launch by Premier Shockwave Wound
Care targeting dermaPACE® for VA, Military and I.H.S.
markets.
We began the year with the following stated goals for 2019:
accelerating growth through the year, establish partners in
specific channels, establish partners to help finance growth in
medical equipment placement, hire senior management to lead the
wound care team, add new countries to
our distribution platform, and prepare and be ready to
scale once our reimbursement tracking codes are in effect.
Through the third quarter we are on track to achieve
and exceed these goals. Our record revenue came from planting
the seeds for success in prior quarters and fortunately, we have
been planting more seeds so we feel confident we will
continue to see this growth continue. What is most exciting
is the wound industry buzz around the dermaPACE product.
Having attended 9 trade shows in the past few months, we
believe that we are becoming one of the hot new products in
the wound care space. This has the added benefit of
attracting talented industry professionals who want to be part
of SANUWAVE as we enter this next growth phase. We
have much work to do but are proud of the accomplishments
achieved year to date and feel confident in our growth plans
for the remainder of this year and entering
2019.
Conference Call
The Company will host a conference call on Tuesday, November 20,
2018, 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 877-407-8033 (U.S.) or 201-689-8033
(international) or via webcast at http://www.investorcalendar.com/event/41390.
A replay of the conference call will be available beginning two
hours after its completion through December 4, 2018, by dialing
877-481-4010 (U.S.) or 919-882-2331 and entering PIN #41390 and a
replay of the webcast will be available at http://www.investorcalendar.com/event/41390
until February 20,
2019.
Third Quarter Financial Results
Revenues for the
three months ended September 30, 2018 were $595,789, compared to
$161,585 for the same period in 2017, an increase of $434,204, or
269%. Revenues resulted primarily from higher sales in Southeast
Asia and Europe of our dermaPACE and orthoPACE devices and related
applicators. In addition, revenues for 2018 include revenue
recognized per Topic 606 from distribution licensing agreement in
Southeast Asia with our joint venture partner, FKS.
Research and
development expenses for the three months ended September 30, 2018
were $661,736, compared to $266,837 for the same period in
2017, an increase of $394,899, or 148%. Research and development
costs include payments to third parties that relate to our products
in clinical development and employee costs (salaries, payroll
taxes, benefits, and travel) for employees of the regulatory
affairs, quality assurance, and research and development
departments. The increase in research and development expenses was
due to higher salary and benefit expenses related to new hires,
accrual of bonus, stock-based compensation expense related to stock
options issued in September 2018 and higher travel
costs.
General
and administrative expenses for the three months ended September
30, 2018 were $2,415,106, as compared to $475,377 for the same
period in 2017, an increase of $1,939,729, or 408%. The increase in
general and administrative expenses was due to increased headcount,
stock-based compensation expense related to stock options issued in
September 2018, higher travel costs, accrual of bonus, and higher
consultant fees related to the commercialization of
dermaPACE.
Net
loss for the three months ended September 30, 2018 was $825,142, or
($0.01) per basic and diluted share, compared to a net loss of
$851,325, or ($0.01) per basic and diluted share, for the same
period in 2017, a decrease in the net loss of $26,183. The decrease
in the net loss for 2018 was primarily due to gain on warrant
valuation adjustment which was partially offset by higher general
and administrative expenses as noted above as well as higher
interest expense related to convertible promissory
notes.
Nine Months ended September 30, 2018 Financial Results
Revenues for the
nine months ended September 30, 2018 were $1,393,271, compared to
$422,199 for the same period in 2017, an increase of $971,072, or
230%. 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 the
higher sale of devices and both new and refurbished applicators in
the United States, Southeast Asia and Europe as compared to the
same period in 2017.
Research and
development expenses for the nine months ended September 30, 2018
were $1,379,517, compared to $965,084 for the same period in
2017, an increase of $414,433, or 43%. Research and development
costs include payments to third parties that relate to our products
in clinical development and employee costs (salaries, payroll
taxes, benefits, and travel) for employees of the regulatory
affairs, quality assurance, and research and development
departments. The increase in research and development expenses was
due to increased salary and benefits related to new hires,
stock-based compensation expense for stock options issued to new
hires and in September 2018, accrual of bonus, and consulting fees
related to reimbursement strategy which was partially offset by
lower consultant costs related to the FDA submission and follow
up.
General
and administrative expenses for the nine months ended September 30,
2018 were $5,391,511, as compared to $1,875,891 for the same period
in 2017, an increase of $3,515,620, or 187%. The increase in
general and administrative expenses was due to the hiring of a
president and human resources director and the related stock-based
compensation expense for stock options issued, stock-based
compensation for options issued in September 2018, higher travel
costs, accrual of bonus, 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 nine months ended September 30, 2018 was $9,570,056,
or ($0.06) per basic and diluted share, compared to a net loss of
$2,760,794, or ($0.02) per basic and diluted share, for the same
period in 2017, an increase in the net loss of $6,809,262. The
increase in the net loss for 2018 was primarily due to higher
general and administrative expenses as noted above as well as
higher interest expense related to convertible promissory
notes.
Cash and cash
equivalents decreased by $657,873 for the nine months ended
September 30, 2018 and decreased by $93,345 for the nine months
ended September 30, 2017. For the nine months ended September 30,
2018 and 2017, net cash used by operating activities was $2,271,566
and $944,831, respectively, primarily consisting of compensation
costs, research and development activities and general corporate
operations. The increase of $1,326,735 in the use of cash for
operating activities for the nine months ended September 30, 2018,
as compared to the same period for 2017, was primarily due to the
increased operating expenses and increased receivables in 2018. Net
cash used by investing activities for the nine months ended
September 30, 2018 consisted of purchase of property and equipment
of $32,171. Net cash provided by financing activities for the nine
months ended September 30, 2018 was $1,663,063, which consisted of
$1,159,785 from the issuance of convertible promissory notes,
$38,528 from the exercise of warrants, $136,000 net increase in
line of credit, $184,750 from the issuance of short term notes
payable and $144,000 from an advance from related party. Net cash
provided by financing activities for the nine months ended
September 30, 2017 was $844,683, which consisted of $751,616 from
advances from related parties and $93,067 from exercise of
warrants.
Quarterly Report on Form 10-Q for Q3 2018
On November 15, 2018, the Company filed a Notice of Late Filing
with regards to its Quarterly Report on Form 10-Q (the “Form
10-Q”) for its third quarter of fiscal 2018 with the
Securities and Exchange Commission (SEC). The compilation,
verification and review by management of the information and
disclosure required to be presented in the Form 10-Q requires
additional time, which renders the timely filing of the Form 10-Q
impracticable without undue hardship and expense to the Company.
The Company filed its Form 10-Q for the third quarter of 2018
today, November 19, 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®, received US FDA clearance in December 2017 for the
treatment of Diabetic Foot Ulcers. dermaPACE is the only
Extracorporeal Shockwave Technology (ESWT) device cleared or
approved in the US for the treatment of DFUs. Internationally,
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, and South Korea. 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, the filing by the Company of periodic reports with the
SEC, including its Quarterly Report on Form 10-Q for the
Company’s third quarter of fiscal 2018, and the timing
thereof, 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
CEO
& Chairman
978-922-2447
investorrelations@sanuwave.com