Attached files
| file | filename |
|---|---|
| EX-99.1 - PRESS RELEASE - SANUWAVE Health, Inc. | snwv_ex991.htm |
| 8-K - CURRENT REPORT - SANUWAVE Health, Inc. | snwv_8k.htm |
Exhibit 99.2
SANUWAVE HEALTH, INC.
CONFERENCE CALL TO DISCUSS THIRD QUARTER 2018
AND PROVIDE A BUSINESS UPDATE
Thursday, November 15, 2018
10:00 a.m. Eastern Time
Operator
Greetings,
and welcome to SANUWAVE Health Incorporated’s Third Quarter
Business Update. At this time all participants are in a listen-only
mode. [Operator instructions].
I would
now like to turn the conference over to your host, Kevin
Richardson, CEO.
Kevin Richardson – CEO
Thank
you. Good morning. We appreciate your interest in SANUWAVE and in
today's call. SANUWAVE will provide a business update on our most
recent activities. If you would like to be added to the company's
distribution list, please call SANUWAVE at 770-419-7525, or go to
the Investor Relations section of our website at
www.sanuwave.com.
Before
we begin, I would like to caution that comments made during the
conference call by management will contain forward-looking
statements that involve risks and uncertainties regarding the
operations and future results of SANUWAVE. We encourage you to
review the Company's filings with the Securities and Exchange
Commission, including without limitation our Forms 10-K and 10-Q,
which identify specific factors that may cause actual results or
events to differ materially from those described in the
forward-looking statements.
Furthermore,
the content of this conference call contains time-sensitive
information that is accurate only as of the day of the live
broadcast, November 15, 2018. SANUWAVE undertakes no obligation to
revise or update any statements to reflect events or circumstances
after the date of this conference call.
We last
updated you in August on our Q2 2018 progress. Today we'll provide
a brief update on third quarter 2018 and on a number of initiatives
we are undertaking to ensure our success as we roll out dermaPACE
in the US and internationally. Our goal, as we have stated, is to
have a device anywhere in the US a DFU is treated, and then to
drive device usage with the growth in the number of treatable
indications and our ability to combine with other treatment
modalities.
This
introduction may sound like I'm repeating myself, but that's
because I am. I plan to repeat a lot of what we have said in the
past nine months because it is that laser focus by our experienced
team that will lead us to achieving our goal of a device everywhere
in the US that a DFU is treated. Also, we want to note we have not
filed our 10-Q as we are working on Rev Rec 606 with regards to the
FKS transaction which occurred in Q2 2018. Once we get clarity and
comfort around exactly how this revenue is to be recognized under
this new accounting policy, the 10-Q will be filed and we will host
a call to discuss the financials and have an open Q&A session
with management. Today we will not be taking Q&A at the end of
the call.
Just to
be clear, FKS paid us an exclusivity fee in cash in the second
quarter. In the second quarter we recognized it ratably over five
months, which was the term of the contract, and just last week the
JV was incorporated. Business with FKS is moving along ahead of
plan at this point in time. How we recognize that exclusivity fee
according to Rev Rec 606 is what's holding up the filing of the
10-Q.
Third
quarter results will show SANUWAVE is making great strides to have
this vision become a reality, that we've established five goals for
2018, along with our priorities to support these goals, which will
allow us to show continued strong growth through 2018, and more
importantly, lay the groundwork to achieve market penetration and
massive top line growth in 2019 and beyond. Let me spend a second
to review each of the goals: initial revenue in the US, expand
senior management in the US wound market, enter in the
international markets, begin support of clinical work, and expand
our Board of Directors and Science Advisory Board. At this point in
time all five of these goals have been met and will be
achieved.
Page |
1
Looking
at the third quarter achievements, it is clear we are executing on
the business plan. As you know now, we generated revenue from sales
to Premier earlier in the year. Premier has begun to penetrate
their vertical markets, Indian Health and the Veterans
Administration, VA. It's important to note we also treated our
first US patients which are not tied to Premier during the quarter.
The program was established to place devices with key opinion
leaders, KOLs, and allow them to begin treating patients prior to
our reimbursement tracking codes kicking in on January 1, 2019.
We've had great success with this program to-date and look forward
to rolling it out further as we finish 2018.
With
regard to Premier Shockwave and the channels they represent, Q3 was
significant in that they began to launch their web-based marketing
campaign to VA and Indian Health physicians. This launch also
includes implementation of a HIPAA compliant web portal for
physicians’ back offices to complete the reimbursement
process. This will also be shared with SANUWAVE in 2019. They made
close to 20 in-service calls where they used the device in the
proper setting. All this activity, along with the numerous trade
shows, has led to them placing devices for use in the fourth
quarter at IHS tribal hospitals, military treatment facilities and
achieving medical board approvals for roll out in the western US in
2019. The pace of activity is picking up, and the installs and
training are currently strong for the remainder of the
year.
Internationally,
after announcing we entered into a total of 15, now 17 countries
this year, we began following our method to drive revenue in those
regions. It starts with identifying the KOLs in the region, allow
them to perform case studies, showcase the case studies at an
industry trade show, and then target high need either by volume or
severity of wound markets and then start selling. During this past
quarter and through October, we have presented our studies at
industry trade shows in Malaysia, Philippines, Singapore,
Australia, Canada, South Korea, Italy, and the highlight being the
SAWC and Desert Foot Conferences here in the US. This has been
followed by diligent follow up with the leads generated at those
events, and then turning them into training and sales
opportunities.
In
Europe, the team presented at the Pisa Conference. Pisa is the
Who's Who of wound care industry in Europe, where they highlight
new and up and coming technologies. We were a feature of the show,
and from this we anticipate orders in Italy to be up dramatically
in 2019.
In
Asia, we received our JV certification in Singapore November
7th, which
now allows for the real fun to begin with FKS. We had our newest
Science Advisor, Dr. Perry Mayer—who we discussed last
quarter—present at the Wounds Malaysia Conference to a room
of 200 practitioners. Orders and shipping have begun in that region
and based on current budgeting we expect them to exceed our
expectations in 2019. The largest markets will be Malaysia,
Indonesia, Taiwan and the Philippines.
They
are also starting two clinical studies that we're very excited
about. Dr. Han is a world-renowned microvascular surgeon who
specializes in very difficult reattachments, and it is really
pretty amazing stuff that he can do. He's going to see how
dermaPACE can affect such surgeries. Dr. Kuo, who is working in
Taiwan, will be working on perfusion studies, and we are also
looking forward to Dr. Han’s perfusion study coming out of
South Korea with 100 patients, showing how our device improves
perfusion in patients.
We also
anticipate one or two more countries and/or regions to come on
before the end of the year. As we've said before, it takes about 12
to 24 months to identify the right partner, 6 to 12 months to bring
in the revenue. Luckily, the process was started a few years ago,
and now we are benefiting from the pipeline of fruit growing in
these initiatives.
On our
goals for the year, we are executing on what we said we needed to
do, what we said we will deliver, but the truth is most investors
in SANUWAVE want to know about the US market, that's where the $1
billion opportunity exists. We introduced you to Shri last quarter,
Shri will provide much more detail about the US market on our next
conference call in the near future, but the quick preview is the
buzz from the conferences has been overwhelming and the number of
wound clinics and hospitals wanting to work with us and our device
is higher than we would have expected.
Shri
Parikh, our President, will go into detail on the next call
regarding clinical, reimbursement and sales. Needless to say, we've
already identified KOLs for initial placements, they have begun
using the device and will begin working reimbursement starting in
January when our tracking code goes into effect. We have great
expectations for success in 2019 and beyond, and Shri will be
leading the charge to achieve the goal of having a dermaPACE device
placed wherever DFU is treated in the US.
Lastly,
I want to thank our shareholders and investors who have helped us
get to where we are today. If anyone has any questions at this
point in time, please reach out to us and we'll try to answer as
best we can. Also, we encourage those in the area to stop by, meet
the team and see what we're working on and where the company is
headed. Thank you. And with that, the call will be
concluded.
Operator
Thank
you. You may disconnect your lines at this time and thank you for
your participation.
Page |
2