SANUWAVE Health, Inc. - Quarter Report: 2020 June (Form 10-Q)
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark One)
☒
|
QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For the quarterly period ended June 30, 2020
☐
|
TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
|
For the transition period from ________ to
Commission File Number 000-52985
SANUWAVE Health, Inc.
(Exact name of registrant as specified in its charter)
Nevada
|
20-1176000
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S. Employer
Identification No.)
|
|
|
3360 Martin Farm Road, Suite 100
Suwanee, GA
|
30024
|
(Address
of principal executive offices)
|
(Zip Code)
|
(770) 419-7525
(Registrant's telephone number, including area code)
Indicate by check mark whether the registrant: (1) has filed
all reports required to be filed by Section 13 or 15(d) of the
Securities Exchange Act of 1934 during the preceding 12 months (or
for such shorter period that the registrant was required to file
such reports), and (2) has been subject to such filing
requirements for the past 90 days. ☒ Yes ☐ No
Indicate by check mark whether the registrant has submitted
electronically every Interactive Data File required to be submitted
pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period
that the registrant was required to submit such
files). ☒ Yes ☐ No
Indicate by check mark whether the registrant is a large
accelerated filer, an accelerated filer, a non-accelerated filer,
smaller reporting company, or an emerging growth company. See the
definitions of “large accelerated filer,”
“accelerated filer,” “smaller reporting
company,” and “emerging growth company” in Rule
12b-2 of the Exchange Act (Check one):
Large accelerated filer ☐
|
Accelerated filer
☐
|
Non-accelerated filer ☒
|
Smaller reporting company
☒
|
|
Emerging growth company ☐
|
If an emerging growth company, indicate by check mark if the
registrant has elected not to use the extended transition period
for complying with any new or revised financial accounting
standards provided pursuant to Section 13(a) of the Exchange
Act. ☐
Indicate by check mark whether the registrant is a shell company
(as defined in Rule 12b-2 of the Exchange
Act). ☐
Yes ☒ No
Securities registered pursuant to Section 12(b) of the Exchange
Act: None
Title of each class
|
Trading Symbol(s)
|
Name of each exchange on which registered
|
Common Stock, par value $0.001
|
SNWV
|
OTCQB
|
As of August 13, 2020, there were issued and outstanding
326,619,428 shares of the registrant’s common stock, $0.001
par value.
SANUWAVE Health,
Inc.
Table of Contents
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28
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Special Note Regarding Forward-Looking Statements
Except as otherwise indicated by the context, references in this
Quarterly Report on Form 10-Q to “we,” “us”
and “our” are to the consolidated business of the
Company.
PART I — FINANCIAL
INFORMATION
Item 1. FINANCIAL
STATEMENTS
SANUWAVE HEALTH, INC. AND
SUBSIDIARIES
CONDENSED CONSOLIDATED BALANCE SHEETS
|
June
30,
|
December
31,
|
|
2020
|
2019
|
ASSETS
|
(Unaudited)
|
|
CURRENT
ASSETS
|
|
|
Cash
and cash equivalents
|
$430,606
|
$1,760,455
|
Accounts
receivable, net of allowance for doubtful accounts
|
|
|
of
$255,503 in 2020 and $72,376 in 2019
|
110,501
|
75,543
|
Inventory
|
651,344
|
542,955
|
Prepaid
expenses and other current assets
|
227,086
|
125,405
|
TOTAL
CURRENT ASSETS
|
1,419,537
|
2,504,358
|
|
|
|
PROPERTY
AND EQUIPMENT, net
|
591,064
|
512,042
|
|
|
|
RIGHT
OF USE ASSETS, net
|
243,251
|
323,661
|
|
|
|
DEPOSITS
|
1,110,000
|
-
|
|
|
|
OTHER
ASSETS
|
43,096
|
41,931
|
TOTAL
ASSETS
|
$3,406,948
|
$3,381,992
|
LIABILITIES
|
|
|
CURRENT
LIABILITIES
|
|
|
Accounts
payable
|
$1,799,630
|
$1,439,413
|
Accrued
expenses
|
1,221,214
|
1,111,109
|
Accrued
employee compensation
|
2,010,610
|
1,452,910
|
Contract
liabilities
|
551,755
|
66,577
|
Operating
lease liability
|
179,524
|
173,270
|
Finance
lease liability
|
181,371
|
121,634
|
Convertible
promissory notes, net
|
705,980
|
-
|
SBA
Loans
|
142,514
|
-
|
Line
of credit, related parties
|
222,164
|
212,388
|
Short
term notes payable
|
210,000
|
587,233
|
Advances
from related parties
|
-
|
18,098
|
Notes
payable, related parties, net
|
5,372,743
|
5,372,743
|
Accrued
interest, related parties
|
2,229,713
|
1,859,977
|
TOTAL
CURRENT LIABILITIES
|
14,827,218
|
12,415,352
|
|
|
|
NON-CURRENT
LIABILITIES
|
|
|
Contract
liabilities
|
53,782
|
573,224
|
SBA
loans
|
471,821
|
-
|
Operating
lease liability
|
92,889
|
185,777
|
Finance
lease liability
|
333,771
|
271,240
|
TOTAL
NON-CURRENT LIABILITIES
|
952,263
|
1,030,241
|
TOTAL
LIABILITIES
|
15,779,481
|
13,445,593
|
|
|
|
COMMITMENTS
AND CONTINGENCIES
|
|
|
|
|
|
REDEEMABLE PREFERRED STOCK, SERIES C CONVERTIBLE, par value
$0.001,
|
|
|
90
designated; 90 shares issued and outstanding in 2020
|
2,250,000
|
-
|
|
|
|
REDEEMABLE PREFERRED STOCK, SERIES D CONVERTIBLE, par value
$0.001,
|
|
|
8
designated; 8 shares issued and outstanding in 2020
|
200,000
|
-
|
|
|
|
|
|
|
STOCKHOLDERS'
DEFICIT
|
|
|
PREFERRED
STOCK, par value $0.001, 5,000,000
|
|
|
shares
authorized; 6,175 and 293 shares designated Series A
and
|
-
|
-
|
Series
B, respectively
|
|
|
|
|
|
COMMON
STOCK, par value $0.001, 600,000,000 shares authorized (See Note
18);
|
|
|
302,119,428
and 293,780,400 issued and outstanding in 2020 and
|
|
|
2019,
respectively
|
302,119
|
293,781
|
|
|
|
ADDITIONAL
PAID-IN CAPITAL
|
117,326,629
|
115,457,808
|
|
|
|
ACCUMULATED
DEFICIT
|
(132,387,124)
|
(125,752,956)
|
|
|
|
ACCUMULATED
OTHER COMPREHENSIVE LOSS
|
(64,157)
|
(62,234)
|
TOTAL
STOCKHOLDERS' DEFICIT
|
(14,822,533)
|
(10,063,601)
|
TOTAL
LIABILITIES, MEZZANINE EQUITY AND STOCKHOLDERS'
DEFICIT
|
$3,406,948
|
$3,381,992
|
The
accompanying notes to condensed consolidated financial
statements
are an integral part of these statements.
4
SANUWAVE
HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF
COMPREHENSIVE LOSS
(UNAUDITED)
|
Three
Months Ended
|
Three
Months Ended
|
Six
Months Ended
|
Six
Months Ended
|
|
June
30,
|
June
30,
|
June
30,
|
June
30,
|
|
2020
|
2019
|
2020
|
2019
|
|
|
|
|
|
REVENUES
|
|
|
|
|
Product
|
$69,341
|
$220,667
|
$143,900
|
$285,232
|
License
fees
|
-
|
66,808
|
10,000
|
173,058
|
Other
revenue
|
13,960
|
29,501
|
77,993
|
36,649
|
TOTAL
REVENUES
|
83,301
|
316,976
|
231,893
|
494,939
|
|
|
|
|
|
COST
OF REVENUES
|
|
|
|
|
Product
|
24,825
|
178,458
|
103,740
|
243,570
|
Other
|
1,522
|
7,423
|
11,484
|
36,164
|
TOTAL
COST OF REVENUES
|
26,347
|
185,881
|
115,224
|
279,734
|
|
|
|
|
|
GROSS
MARGIN
|
56,954
|
131,095
|
116,669
|
215,205
|
|
|
|
|
|
OPERATING
EXPENSES
|
|
|
|
|
Research
and development
|
264,907
|
307,273
|
551,661
|
567,922
|
Selling
and marketing
|
433,151
|
407,477
|
1,041,001
|
565,559
|
General
and administrative
|
2,566,793
|
1,426,405
|
4,474,710
|
2,943,860
|
Depreciation
|
64,766
|
9,455
|
117,789
|
17,812
|
TOTAL
OPERATING EXPENSES
|
3,329,617
|
2,150,610
|
6,185,161
|
4,095,153
|
|
|
|
|
|
OPERATING
LOSS
|
(3,272,663)
|
(2,019,515)
|
(6,068,492)
|
(3,879,948)
|
|
|
|
|
|
OTHER
INCOME (EXPENSE)
|
|
|
|
|
Gain
on warrant valuation adjustment
|
-
|
195,310
|
-
|
227,669
|
Interest
expense
|
(168,941)
|
(790,178)
|
(187,673)
|
(938,439)
|
Interest
expense, related party
|
(187,172)
|
(112,984)
|
(369,736)
|
(332,671)
|
Loss
on foreign currency exchange
|
(4,244)
|
(7,064)
|
(8,267)
|
(8,359)
|
TOTAL
OTHER INCOME (EXPENSE), NET
|
(360,357)
|
(714,916)
|
(565,676)
|
(1,051,800)
|
|
|
|
|
|
NET
LOSS
|
(3,633,020)
|
(2,734,431)
|
(6,634,168)
|
(4,931,748)
|
|
|
|
|
|
OTHER
COMPREHENSIVE INCOME (LOSS)
|
|
|
|
|
Foreign
currency translation adjustments
|
(6,551)
|
1,489
|
(1,923)
|
(909)
|
TOTAL
COMPREHENSIVE LOSS
|
$(3,639,571)
|
$(2,732,942)
|
$(6,636,091)
|
$(4,932,657)
|
|
|
|
|
|
LOSS
PER SHARE:
|
|
|
|
|
Net
loss - basic and diluted
|
$(0.01)
|
$(0.02)
|
$(0.02)
|
$(0.03)
|
|
|
|
|
|
Weighted
average shares outstanding - basic and diluted
|
299,497,960
|
174,730,747
|
297,856,870
|
165,921,811
|
The
accompanying notes to condensed consolidated financial
statements
are an integral part of these statements.
5
SANUWAVE
HEALTH, INC. AND SUBSIDIARIES
CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS'
DEFICIT
(UNAUDITED)
|
Preferred
Stock
|
Common
Stock
|
|
|
|
|
||
|
Number
of
Shares
Issued
and Outstanding
|
Par
Value
|
Number
of Shares
Issued
and Outstanding
|
Par
Value
|
Additional
Paid-in
Capital
|
Accumulated
Deficit
|
Accumulated
Other
Comprehensive
Loss
|
Total
|
|
|
|
|
|
|
|
|
|
Balances
as of Janaury 1, 2019
|
-
|
$-
|
155,665,138
|
$155,665
|
$101,153,882
|
$(116,602,778)
|
$(62,868)
|
$(15,356,099)
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(2,197,317)
|
-
|
(2,197,317)
|
Cashless
warrant exercises
|
-
|
-
|
704,108
|
704
|
(704)
|
-
|
-
|
-
|
Proceeds
from warrant exercise
|
-
|
-
|
620,000
|
620
|
52,580
|
-
|
-
|
53,200
|
Conversion
of short term notes and convertible notes payable
|
-
|
-
|
3,333,334
|
3,334
|
263,333
|
-
|
-
|
266,667
|
Reclassification
of warrant liability to equity due to adoption of ASU
2017-11
|
-
|
-
|
-
|
-
|
262,339
|
1,279,661
|
-
|
1,542,000
|
Foreign
currency translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
(2,398)
|
(2,398)
|
|
|
|
|
|
|
|
|
|
Balances
as of March 31, 2019
|
-
|
$-
|
160,322,580
|
$160,323
|
$101,731,430
|
$(117,520,434)
|
$(65,266)
|
$(15,693,947)
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(2,734,431)
|
-
|
(2,734,431)
|
Cashless
warrant exercises
|
-
|
-
|
2,997,375
|
2,997
|
13,003
|
-
|
-
|
16,000
|
Proceeds
from warrant exercise
|
-
|
-
|
17,051,769
|
17,052
|
1,333,005
|
-
|
-
|
1,350,057
|
Other
warrant exercise
|
-
|
-
|
5,804,167
|
5,804
|
451,697
|
|
|
457,501
|
Conversion
of short term notes and convertible notes payable
|
-
|
-
|
2,475,000
|
2,475
|
177,525
|
-
|
-
|
180,000
|
Stock-based
compensation
|
-
|
-
|
-
|
-
|
31,758
|
-
|
-
|
31,758
|
Warrants
issued for consulting services
|
-
|
-
|
-
|
-
|
36,067
|
-
|
-
|
36,067
|
Foreign
currency translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
1,489
|
1,489
|
|
|
|
|
|
|
|
|
|
Balances
as of June 30, 2019
|
-
|
$-
|
188,650,891
|
$188,651
|
$103,774,485
|
$(120,254,865)
|
$(63,777)
|
$(16,355,506)
|
|
|
|
|
|
|
|
|
|
Balances
as of Janaury 1, 2020
|
-
|
$-
|
293,780,400
|
$293,781
|
$115,457,808
|
$(125,752,956)
|
$(62,234)
|
$(10,063,601)
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(3,001,148)
|
-
|
(3,001,148)
|
Proceeds
from warrant exercise
|
-
|
-
|
1,000,000
|
1,000
|
9,000
|
-
|
-
|
10,000
|
Shares
issued for services
|
-
|
-
|
1,000,000
|
1,000
|
199,000
|
-
|
-
|
200,000
|
Stock-based
compensation
|
-
|
-
|
-
|
-
|
21,900
|
-
|
-
|
21,900
|
Conversion
of short term notes
|
-
|
-
|
1,820,461
|
1,820
|
262,164
|
-
|
-
|
263,984
|
Conversion
of advances from related parties
|
-
|
-
|
62,811
|
63
|
2,035
|
-
|
-
|
2,098
|
Foreign
currency translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
4,826
|
4,826
|
|
|
|
|
|
|
|
|
|
Balances
as of March 31, 2020
|
-
|
$-
|
297,663,672
|
$297,664
|
$115,951,907
|
$(128,754,104)
|
$(57,408)
|
$(12,561,941)
|
Net
loss
|
-
|
-
|
-
|
-
|
-
|
(3,633,020)
|
-
|
(3,633,020)
|
Proceeds
from PIPE
|
-
|
-
|
1,071,428
|
1,071
|
148,929
|
-
|
-
|
150,000
|
Proceeds
from stock option exercise
|
-
|
-
|
225,000
|
225
|
44,025
|
-
|
-
|
44,250
|
Beneficial
conversion feature on convertible debt
|
-
|
-
|
-
|
-
|
560,682
|
-
|
-
|
560,682
|
Shares
issued for services
|
-
|
-
|
2,200,000
|
2,200
|
515,300
|
-
|
-
|
517,500
|
Conversion
of short term notes
|
-
|
-
|
759,328
|
759
|
89,986
|
-
|
-
|
90,745
|
Conversion
of advances from related parties
|
-
|
-
|
200,000
|
200
|
15,800
|
-
|
-
|
16,000
|
Foreign
currency translation adjustment
|
-
|
-
|
-
|
-
|
-
|
-
|
(6,749)
|
(6,749)
|
|
|
|
|
|
|
|
|
|
Balances
as of June 30, 2020
|
-
|
$-
|
302,119,428
|
$302,119
|
$117,326,629
|
$(132,387,124)
|
$(64,157)
|
$(14,822,533)
|
The
accompanying notes to condensed consolidated financial
statements
are an integral part of these
statements.
6
|
Six Months
Ended
|
Six Months
Ended
|
|
June
30,
|
June
30,
|
|
2020
|
2019
|
|
|
|
CASH
FLOWS FROM OPERATING ACTIVITIES
|
|
|
Net
loss
|
$(6,634,168)
|
$(4,931,748)
|
Adjustments
to reconcile net loss
|
|
|
to
net cash used by operating activities
|
|
|
Depreciation
|
117,789
|
17,812
|
Bad
debt expense
|
183,127
|
25,248
|
Share-based
payment
|
739,400
|
67,825
|
Amortization
of debt issuance costs
|
69,862
|
-
|
Accrued
interest
|
84,072
|
936,658
|
Interest
payable, related parties
|
369,736
|
332,671
|
Amortization
of operating leases
|
(6,224)
|
(3,471)
|
Waived
proceeds from warrant exercise
|
-
|
16,000
|
Gain
on warrant valuation adjustment
|
-
|
(227,669)
|
Changes
in operating assets and liabilities
|
|
|
Accounts
receivable - trade
|
(218,085)
|
34,485
|
Inventory
|
(108,389)
|
(66,112)
|
Prepaid
expenses
|
(101,681)
|
(126,505)
|
Due
from related parties
|
-
|
1,228
|
Other
assets
|
(1,165)
|
(7,070)
|
Operating
leases
|
-
|
44,623
|
Accounts
payable
|
360,217
|
(135,916)
|
Accrued
expenses
|
110,105
|
106,178
|
Accrued
employee compensation
|
557,700
|
525,487
|
Contract
liabilties
|
(34,264)
|
3,642
|
NET
CASH USED BY OPERATING ACTIVITIES
|
(4,511,968)
|
(3,386,634)
|
|
|
|
CASH
FLOWS FROM INVESTING ACTIVITIES
|
|
|
|
(1,110,000)
|
-
|
Purchases
of property and equipment
|
(4,855)
|
(25,839)
|
NET
CASH USED BY INVESTING ACTIVITIES
|
(1,114,855)
|
(25,839)
|
|
|
|
CASH
FLOWS FROM FINANCING ACTIVITIES
|
|
|
Proceeds
from sale of convertible preferred stock
|
2,450,000
|
-
|
Proceeds
from convertible promissory note
|
1,100,000
|
-
|
Proceeds
from SBA loan
|
614,335
|
-
|
Proceeds
from PIPE offering
|
150,000
|
-
|
Proceeds
from stock option exercise
|
44,250
|
-
|
Proceeds
from short term note
|
-
|
1,215,000
|
Proceeds
from warrant exercise
|
10,000
|
1,403,257
|
Advances
from related parties
|
-
|
585,022
|
Payments
of principal on finance leases
|
(69,688)
|
-
|
NET
CASH PROVIDED BY FINANCING ACTIVITIES
|
4,298,897
|
3,203,279
|
|
|
|
EFFECT
OF EXCHANGE RATES ON CASH
|
(1,923)
|
(909)
|
|
|
|
NET
DECREASE IN CASH AND CASH EQUIVALENTS
|
(1,329,849)
|
(210,103)
|
|
|
|
CASH
AND CASH EQUIVALENTS, BEGINNING OF PERIOD
|
1,760,455
|
364,549
|
CASH
AND CASH EQUIVALENTS, END OF PERIOD
|
$430,606
|
$154,446
|
|
|
|
NONCASH
INVESTING AND FINANCING ACTIVITIES
|
|
|
Conversion
of short term notes payable to equity
|
$354,729
|
$724,168
|
|
|
|
|
|
|
Conversion
of advances from related parties to equity
|
$18,098
|
$180,000
|
|
|
|
|
|
|
Additions
to right of use assets from new finance lease
liabilities
|
$127,611
|
$-
|
|
|
|
|
|
|
Beneficial
conversion feature on convertible debt
|
$560,682
|
$-
|
|
|
|
|
|
|
Reclassification
of warrant liability to equity
|
$-
|
$262,339
|
The
accompanying notes to condensed consolidated financial
statements
are an integral part of these
statements.
7
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2020
1. Nature of
the Business
SANUWAVE Health,
Inc. and Subsidiaries (the “Company”) is a shock wave technology company using a patented
system of noninvasive, high-energy, acoustic shock waves for
regenerative medicine and other applications. The Company’s
initial focus is regenerative medicine – utilizing
noninvasive, acoustic shock waves to produce a biological response
resulting in the body healing itself through the repair and
regeneration of tissue, musculoskeletal and vascular structures.
The Company’s lead regenerative product in the United States
is the dermaPACE®
device, used for treating diabetic
foot ulcers, which was subject to two double-blinded, randomized
Phase III clinical studies. On December 28, 2017, the U.S.
FDA granted the Company’s request to classify the dermaPACE
System as a Class II device via the de novo process. As a result of
this decision, the Company was able to immediately market the
product for the treatment of Diabetic Foot Ulcers (DFU) as
described in the De Novo request, subject to the general control
provisions of the FD&C Act and the special controls identified
in this order.
The Company’s portfolio of healthcare
products and product candidates activate biologic signaling and
angiogenic responses, including new vascularization and
microcirculatory improvement, helping to restore the body’s
normal healing processes and regeneration. The Company is marketing
its dermaPACE System for treatment usage in the United States and
is able to generate revenue from sales of the European
Conformity Marking (CE Mark) devices and accessories in Europe,
Canada, Asia, and Asia/Pacific. The Company generates revenue
streams from dermaPACE treatments, product sales, licensing
transactions and other activities.
In
March 2020, the World Health Organization characterized COVID-19 as
a pandemic and the President of the United States declared the
COVID-19 outbreak a national emergency. Since then, the COVID-19
pandemic has rapidly spread across the globe and has already
resulted in significant volatility, uncertainty and economic
disruption. The primary impact of the COVID-19 pandemic has been
seen in our dermaPACE System placements in the United States as our
treatment is not widely recognized as an “essential”
service. In addition, stay-at-home policies deployed to combat the
spread of COVID-19 has greatly constrained visits to wound care
centers, doctor’s offices and hospitals since late March 2020
and continuing as of this filing and have therefore delayed
placements of new devices that were included in our revenue
forecast. The future impacts of the pandemic and any resulting
economic impact are largely unknown and rapidly evolving. It is
difficult at this time to predict the impact that COVID-19 will
have on the Company’s business, financial position and
operating results in future periods due to numerous uncertainties.
The Company is closely monitoring the impact of the pandemic on all
aspects of its business and operations.
On
August 6, 2020 the Company entered into an asset purchase agreement
with Celularity Inc.(“Celularity”) pursuant to which
the Company acquired Celularity’s UltraMIST assets, as more
fully described in Note 18 to the Company’s condensed
consolidated financial statements.
Basis of Presentation
The accompanying unaudited condensed consolidated
financial statements of the Company have been prepared in
accordance with accounting principles generally accepted in the
United States of America for interim financial information and
with the instructions to Form 10-Q and Article 8-03 of
Regulation S-X. Accordingly, these condensed
consolidated financial statements do not include all the
information and footnotes required by U.S. GAAP for complete
financial statements. The financial information as of
June 30, 2020 and for the three and
six months ended June 30, 2020 and 2019 is unaudited; however, in the opinion of
management, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been
included. Operating results for the three and six months ended June
30, 2020 are not necessarily indicative of the results that may be
expected for any other interim period or for the year ending
December 31, 2020.
The
condensed consolidated balance sheet at December 31, 2019 has
been derived from the audited consolidated financial statements at
that date but does not include all of the information and footnotes
required by U.S. GAAP for complete financial statements. These
financial statements should be read in conjunction with the
Company’s Form 10-K filed with the Securities and Exchange
Commission on March 30, 2020 (the “2019 Annual
Report”).
2. Going Concern
The Company does
not currently generate significant recurring revenue and will
require additional capital during 2020. As of June 30, 2020, the
Company had cash and cash equivalents
of $430,606. For the six months ended June 30, 2020, the net
cash used by operating activities was $4,511,968. The Company
incurred a net loss of $6,634,168 for the six months ended June 30,
2020. The operating losses and the events of default on the
Company’s short term notes payable (see Note 6) and the notes
payable, related parties (see Note 9) raised substantial doubt
about the Company’s ability to continue as a going concern
for a period of at least twelve months from the filing of this
report. Management is currently evaluating the impact on cash flows
of the Company’s acquisition of certain assets of Celularity
Inc., as more fully described in Note 18.
The continuation of the Company’s business
is dependent upon raising additional capital to fund operations.
Management’s plans are to obtain additional capital through
investments by strategic partners for market opportunities, which
may include strategic partnerships or licensing arrangements, or
raise capital through the issuance of common or preferred stock,
securities convertible into common stock, or secured or unsecured
debt. These possibilities, to the extent available, may be on terms
that result in significant dilution to the Company’s existing
shareholders. Although no assurances can be given,
management of the Company believes that potential additional
issuances of equity or other potential financing transactions as
discussed above should provide the necessary funding for the
Company to continue as a going concern. If these efforts are unsuccessful, the Company may
be forced to seek relief through a filing under the U.S. Bankruptcy
Code. The condensed consolidated financial statements do not
include any adjustments that might be necessary if the Company is
unable to continue as a going concern.
8
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2020
3.
Summary
of Significant Accounting Policies
The
significant accounting policies followed by the Company are
summarized below and should be read in conjunction with the 2019
Annual Report:
Principles of
consolidation - The condensed consolidated financial
statements include the accounts of the Company and its wholly-owned
subsidiaries. All significant intercompany accounts and
transactions have been eliminated.
Estimates –
These condensed consolidated financial statements have been
prepared in accordance with U.S. GAAP. Because a precise
determination of assets and liabilities, and correspondingly
revenues and expenses, depend on future events, the preparation of
condensed consolidated financial statements for any period
necessarily involves the use of estimates and assumptions. Actual
amounts may differ from these estimates. These condensed
consolidated financial statements have, in management’s
opinion, been properly prepared within reasonable limits of
materiality and within the framework of the accounting policies
summarized herein. Significant estimates include the recording of
allowances for doubtful accounts, estimate of the net realizable
value of inventory, the determination of the valuation allowances
for deferred taxes, and the estimated fair value of stock-based
compensation, debt discounts and warrants.
Inventory -
Inventory consists of finished medical equipment and parts and is
stated at the lower of cost, which is valued using the first in,
first out (“FIFO”) method, or net realizable value less
allowance for selling and distribution expenses. The Company analyzes its inventory
levels and writes down inventory that has, or is expected to,
become obsolete. As of June 30, 2020, inventory consists of goods
of $367,988 and parts of $283,356 for a total inventory of
$651,344. As of December 31, 2019, inventory consisted of goods of
$357,264 and parts of $185,691 for a total inventory of
$542,955.
Preferred stock
– The Company evaluates Preferred Stock issuances for
liability or equity classification in accordance with the
provisions of ASC 480, Distinguishing Liabilities from Equity,
and determines appropriate equity or liability accounting
treatment. Additionally, the Company determines, if classified as
equity, whether it would be recorded as permanent or temporary
equity.
Sequencing policy
– The Company has granted certain options and warrants which,
upon settlement, may exceed the limit on the authorized number of
shares of common stock. The Company follows a sequencing policy for
which in the event partial reclassifications of contracts subject
to ASC 815-40-25 is necessary, due to the Company’s inability
to demonstrate it has sufficient authorized shares, shares will be
allocated on the basis of earliest issuance date of potentially
dilutive instruments with the earliest grants receiving first
allocation of shares. The Company evaluated such instruments and
determined that there was no impact to the Company’s
condensed consolidated financial statements.
4.
Accrued
expenses
Accrued
expenses consist of the following:
|
June
30,
2020
|
December
31,
2019
|
|
|
|
Accrued board of
director's fees
|
$416,667
|
$400,000
|
Accrued legal and
professional fees
|
200,000
|
134,970
|
Accrued executive
severance
|
313,000
|
154,000
|
Accrued
travel
|
120,000
|
120,000
|
Accrued outside
services
|
106,233
|
108,033
|
Accrued
inventory
|
50,275
|
167,050
|
Accrued clinical
study expenses
|
13,650
|
13,650
|
Accrued
other
|
1,389
|
13,406
|
|
$1,221,214
|
$1,111,109
|
9
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
June 30, 2020
5.
Contract
liabilities
As of
June 30, 2020, the Company has contract assets and liabilities from
contracts with customers (see Note 14).
Contract
liabilities consist of the following:
|
June 30,
2020
|
December 31,
2019
|
|
|
|
Service
agreement
|
$91,746
|
$133,510
|
License
fees
|
500,000
|
500,000
|
Other
|
13,791
|
6,291
|
Total
Contract liabilities
|
605,537
|
639,801
|
Non-Current
|
(551,755)
|
(573,224)
|
Total
Current
|
$53,782
|
$66,577
|
The
timing of the Company’s revenue recognition may differ from
the timing of payment by its customers. A receivable is recorded
when revenue is recognized prior to payment and the Company has an
unconditional right to payment. Alternatively, when payment
precedes the satisfaction of performance obligations, the Company
records a contract liability (deferred revenue) until the
performance obligations are satisfied. Of the aggregate contract
liability balances as of June 30, 2020, the Company expects to
satisfy its remaining performance obligations associated with
$551,755 and $53,782 of contract liability balances within the next
twelve months and following thirty-two months, respectively. Of the
aggregate contract liability balances as of December 31, 2019, the
Company expects to satisfy its remaining performance obligations
associated with $66,577 and $573,224 of contract liability balances
within the next twelve months and following thirty-eight months,
respectively.
6.
Short
term notes payable
During
the six months ended June 30, 2020, the Company converted $354,729
of the short-term notes payable into 2,579,789 shares of
Company common stock, $0.001 par value
(the “Common Stock”).
7.
Convertible
promissory note
On June
5, 2020, the Company entered into a Securities Purchase Agreement
with investor LGH Investments LLC (the “Investor”) for
(i) a Promissory Note (the “Convertible Promissory
Note”) in the original principal amount of $1,210,000,
convertible into shares of Common Stock, (ii) warrants entitling
the Investor to acquire 1,000,000 shares of Common Stock (the
“Warrants”) and (iii) 200,000 restricted common shares
in the Company as an inducement grant (the “Inducement
Shares”). Such note contained certain default provisoins, as
defined. As part of the Securities Purchase Agreement, the
Company established a reserve of shares of its authorized but
unissued and unreserved Common Stock in the amount of 11,000,000
shares for purposes of exercise of the Warrant or conversion of the
Convertible Promissory Note.
The
Company recorded a debt discount and original issuance discount
aggregating $670,682 to be amortized over the life of the
Convertible Promissory Note.
The
Convertible Promissory Note had an aggregate outstanding principal
balance of $705,980, net of $600,820 beneficial conversion feature,
warrant discount and original issuance discount costs at June 30,
2020. As of the date of this report, the note was repaid in
full (See Note 18).
Interest expense on
the Convertible Promissory Note totaled $166,663 for the six months
ended June 30, 2020.
10
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
8.
SBA
Loans
All or a portion of the PPP Loan may be forgiven
by the U.S. Small Business Administration (“SBA”) upon
application by the Company beginning 60 days but not later than 120
days after loan approval and upon documentation of expenditures in
accordance with the SBA requirements. The
ultimate forgiveness of the PPP Loan is also predicated upon
regulatory authorities concurring with management’s good
faith assessment that the current economic uncertainty made the
loan request necessary to support ongoing operations. If, despite
the Company’s good-faith belief that given the circumstances
the Company satisfied all eligibility requirements for the PPP
Loan, the Company is later determined to have violated any
applicable laws or regulations or it is otherwise determined that
the Company was ineligible to receive the PPP Loan, the
Company may be required to repay the PPP Loan in its entirety
and/or be subject to additional penalties. In the event the
PPP Loan, or any portion thereof, is forgiven pursuant to the
PPP, the amount forgiven is applied to outstanding
principal.
Under
the terms of the PPP Loan, the Company may be eligible for full or
partial loan forgiveness in the third quarter of 2020, however, no
assurance is provided that the Company will apply for,
or obtain forgiveness for, any portion of the PPP
Loan.
As
of June 30, 2020, $132,514 is classified as current and $321,821 as
non-current.
On
June 10, 2020, the Company secured a loan offered by the U.S. Small
Business Administration (SBA) under its Economic Injury Disaster
Loan (“EIDL”) assistance program in light of the impact
of COVID-19 pandemic on the Company’s business. The principal
amount of this loan of $150,000. Interest accrues at the rate of
3.75% per annum. Installment payments, including principal and
interest, are due monthly beginning June 10, 2021. The balance of
principal and interest is payable 30 years from the date of the
EIDL. The EIDL is secured by a security interest on all of the
Company’s assets (See Note 9).
As
of June 30, 2020, $150,000 is classified as
non-current.
9.
Notes
payable, related parties
The
notes payable, related parties as amended were issued in
conjunction with the Company’s purchase of the orthopedic
division of HealthTronics, Inc. The notes payable, related parties
bear interest at 8% per annum, as amended. All remaining unpaid
accrued interest and principal was due on December 31, 2018, as
amended. HealthTronics, Inc. is a related party because it is a
shareholder in the Company and has a security agreement with the
Company detailed below.
The Company is a party to a security
agreement with HealthTronics, Inc. to provide a first security
interest in the assets of the Company. During any period when
an Event of Default occurs, the applicable interest rate shall
increase by 2% per annum. An Event of Default under the notes
payable, related parties occurred on December 31, 2016
(“Default”). As a result of the Default, the notes
payable, related parties have been accruing interest at the rate of
10% per annum since January 2, 2017 and continue to accrue interest
at such rate. The Company will be required to make mandatory
prepayments of principal on the notes payable, related parties
equal to 20% of the proceeds received by the Company through the
issuance or sale of any equity securities in cash or through the
licensing of the Company’s patents or other intellectual
property rights. For the three months
ended June 30, 2020, additional mandatory prepayments of principal
and interest on the notes payable, related parties were due on June
30, 2020. The Company has not made the mandatory prepayments of
principal to HealthTronics, Inc. on the notes payable, related
parties as amended from proceeds received through the issuance or
sale of any equity securities in cash through June 30,
2020.
The
notes payable, related parties had an aggregate outstanding
principal balance of $5,372,743 at June 30, 2020 and December 31,
2019.
Accrued
interest, related parties currently payable totaled $2,229,713 at
June 30, 2020 and $1,859,977 at December 31, 2019. Interest expense
on notes payable, related parties totaled $187,172 and $112,984 for
the three months ended June 30, 2020 and 2019, respectively and
$369,736 and $332,671 for the six months ended June 30, 2020 and
2019, respectively.
As
of June 30, 2020, we are in default under the notes, as amended,
and as a result HealthTronics, Inc. could, among other rights and
remedies, exercise its rights under its first priority security
interest in our assets. The
Company entered into a letter agreement with HealthTronics, Inc.,
pursuant to which the Company paid off all outstanding debt due and
owed to HealthTronics (see Note 18).
11
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
10.
Preferred
Stock
On
February 6, 2020, the Company entered into a Series C Preferred
Stock Purchase Agreement (the “Series C Purchase
Agreement”) with certain accredited investors for the sale by
the Company in a private placement of an aggregate of 90 shares of
the Company’s Series C Convertible Preferred Stock, par value
$0.001 per share at a stated value equal to $25,000 per share (the
“Series C Preferred Stock”), for an aggregate total
purchase price of $2,250,000.
On
January 31, 2020, the Company filed a Certificate of Designation of
Preferences, Right and Limitations of Series C Convertible
Preferred Stock of the Company with the Nevada Secretary of State
which amended our Articles of Incorporation to designate 90 shares
of our preferred stock as Series C Convertible Preferred Stock. On
May 14, 2020, the Company entered into a Series D Preferred Stock
Purchase Agreement (the “Series D Purchase Agreement”)
with certain accredited investors for the sale by the Company in a
private placement of an aggregate of eight shares of the
Company’s Series D Convertible Preferred Stock, par value
$0.001 per share at a stated value equal to $25,000 per share (the
“Series D Preferred Stock”), for an aggregate total
purchase price of $200,000. On May 14, 2020, the Company filed a
Certificate of Designation of Preferences, Right and Limitations of
Series D Convertible Preferred Stock of the Company with the Nevada
Secretary of State which amended our Articles of Incorporation to
designate eight shares of our preferred stock as Series D
Convertible Preferred Stock.
Subject
to the terms of the Certificates of Designation, each share of
Series C Preferred Stock and Series D Preferred Stock is
convertible into shares of Common Stock of the Company at a rate
equal to the stated value of such share of Series C Preferred Stock
and Series D Preferred Stock of $25,000, divided by the conversion
price of $0.14 per share (subject to adjustment from time to time
upon the occurrence of certain events as described in the
Certificate of Designation). The Certificates of Designation became
effective upon filing with the Secretary of State of the State of
Nevada. If all outstanding shares of Series C Preferred Stock and
Series D Preferred Stock were converted into Common Stock at the
original conversion rate, such shares would convert into an
aggregate of 17,500,000 shares of Common Stock.
Notwithstanding the
foregoing, the Series C Preferred Stock and Series D Preferred
Stock is not currently convertible into shares of Common Stock
because the Company does not currently have sufficient authorized
and unissued shares of its Common Stock to permit conversion in
full of all issued and outstanding shares of Series C Preferred
Stock and Series D Preferred Stock. Accordingly, the Certificate of
Designation provides that the Series C Preferred Stock and Series D
Preferred Stock is only convertible into Common Stock once the
Company amends its Articles of Incorporation to increase its
authorized and unissued Common Stock to an amount sufficient to
permit such conversion of the Series C Preferred Stock and Series D
Preferred Stock. Each investor has agreed in the Purchase Agreement
that such investor will, within five business days following such
amendment to the Articles of Incorporation, convert all of such
investor’s shares of Series C Preferred Stock and Series D
Preferred Stock into shares of Common Stock.
The
Certificate of Designation provides that if the Company has not
obtained the approval of its shareholders to amend the
Company’s Articles of Incorporation to increase the
authorized shares of Common Stock sufficient to permit such
conversion, or if such amendment has not otherwise been filed with
the Nevada Secretary of State on or before December 31, 2020
(either such event, an “Authorization Failure”), then
the Company shall be required to redeem all outstanding shares of
Series C Preferred Stock and Series D Preferred Stock for a
per-share redemption price, payable in cash in a single installment
not later than thirty (30) days following the date of such
Authorization Failure, equal to the greater of (a) two hundred
percent (200%) of the stated value of such share, and (b)(i) the
volume-weighted average sale price of a share of Common Stock
reported on the trading market on which the Common Stock is then
traded for the thirty (30) consecutive trading days immediately
preceding the date of such Authorization Failure, multiplied by
(ii) the number of shares of Common Stock such share of Series C
Preferred Stock and Series D Preferred Stock would otherwise be
convertible into as of such date had such Authorization Failure not
occurred. The closing of the private placements occurred on
February 6, 2020 and May 14, 2020, respectively, and the preferred
stock was recorded in temporary equity on the related condensed
consolidated balance sheet at an aggregate value of $2,250,000 and
$200,000 respectively. Ninety shares of the Series C Preferred
Stock and eight shares of Series D Preferred Stock have been issued
as of June 30, 2020. The Company has
obtained the approval of its shareholders to amend the
Company’s Articles of Incorporation to increase the
authorized shares of Common Stock and effected such increase
subsequent to June 30, 2020 (see Note 18).
12
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
11.
Equity
transactions
Warrant Exercises
During the three and six months ended June
30, 2020, the Company issued 1,000,000
shares of Common Stock upon the exercise of 1,000,000 Class P
Warrants to purchase shares of stock and an exercise price of $0.01
per share under the terms of the respective warrant
agreement.
Conversion of liabilities
During
the six months ended June 30, 2020, the Company issued 2,579,789
shares of Common Stock upon the conversion of short term notes
payable in the principal and accrued interest amount of $354,729
with the receipt of notices of Class L warrant exercises, all
pursuant to the terms of the short term notes payable.
Conversion of advances from related parties
During
the six months ended June 30, 2020, the Company issued 262,811
shares of Common Stock upon the conversion of advances from related
parties in the amount of $18,098 with the receipt of notice of
Series A Warrant exercise to purchase shares of stock under the
terms of the respective warrant agreement.
Consulting Agreement
In
January 2020, the Company entered into a six month consulting
agreement for which the fee for the services was to be paid with
Common Stock. The number of shares to be paid with Common Stock was
1,000,000 earned upon signing and an additional 1,000,000 upon
agreement by both consultant and the Company no later than May 1,
2020. The Company issued 1,000,000 shares in March 2020 and
1,000,000 shares in April 2020. The fair value of the shares of
$380,000 was recorded as a non-cash general and administrative
expense during the six months ended June 30, 2020.
The
consulting agreement was extended to November 30, 2020 with an
additional 2,000,000 Common Stock shares to be issued for services.
The Company issued 1,000,000 shares to the consultant in June 2020.
The fair value of the shares of $287,500 was recorded as a non-cash
general and administrative expense during the six months ended June
30, 2020.
13
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
11.
Equity
transactions (continued)
PIPE Offering
On
December 11, 2019, the Company entered into a Common Stock Purchase
Agreement with certain investors for the sale by the Company in a
private placement of an aggregate of up to 21,071,143 shares of its
common stock at a purchase price of $0.14 per share.
During
the six months ended June 30, 2020, the Company issued 1,071,428
shares of Common Stock in conjunction with this offering and
received $150,000 in cash proceeds.
Stock Option Exercise
During the six months ended June 30,
2020, the Company issued 225,000
shares of Common Stock upon the exercise of stock options resulting
in net proceeds of $44,250.
Litigation Settlement
During the six months ended June 30,
2020, the Company issued 200,000
shares of restricted Common Stock upon the settlement of
outstanding litigation. The fair value of the shares of
$50,000 was recorded as a non-cash general and administrative
expense during the six months ended June 30, 2020.
12.
Warrants
A
summary of the warrant activity during the six months ended June
30, 2020 is presented as follows:
Warrant class
|
Outstanding as
of
December 31,
2019
|
Issued
|
Exercised
|
Expired
|
Outstanding as
of
June 30, 2020
|
|
|
|
|
|
|
Class K
Warrants
|
7,200,000
|
-
|
-
|
-
|
7,200,000
|
Class O
Warrants
|
909,091
|
-
|
-
|
-
|
909,091
|
Class P
Warrants
|
1,365,000
|
-
|
(1,000,000)
|
(100,000)
|
265,000
|
Common Stock
Purchase Warrants
|
-
|
1,000,000
|
-
|
-
|
1,000,000
|
|
9,474,091
|
1,000,000
|
(1,000,000)
|
(100,000)
|
9,374,091
|
A
summary of the warrant exercise price per share and expiration date
is presented as follows:
|
Exercise
price/share
|
Expiration date
|
|
|
|
Class K
Warrants
|
$0.08
|
June 2025
|
Class K
Warrants
|
$0.11
|
August 2027
|
Class O
Warrants
|
$0.11
|
January2022
|
Class P
Warrants
|
$0.20
|
June 2024
|
Common Stock
Purchase Warrants
|
$0.35
|
June 2025
|
The
fair value of the Common Stock Purchase Warrants is estimated on
the date of grant using the Black-Scholes
option pricing model which approximates the binomial model using
the following weighted average assumptions for the six months ended
June 30, 2020:
|
June 30,
2020
|
|
|
Weighted average
contractual terms in years
|
2.5 |
Weighted average
risk free interest rate
|
0.47% |
Weighted average
volatility
|
107.12% |
14
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
13.
Commitments
and contingencies
Operating Leases
The
Company is a party to certain operating leases. The Company has
entered into a lease agreement, as amended, for office space for
office, research and development, quality control, production and
warehouse space which expires on December 31, 2021. Under the terms
of the lease, the Company pays monthly rent of $14,651, subject to
a 3% adjustment on an annual basis.
For
leases where the Company is the lessee, ROU assets represent the
Company’s right to use an underlying asset for the lease term
and lease liabilities represent an obligation to make lease
payments arising from the lease. ROU assets and lease liabilities
are recognized at the lease commencement date (except we used the
practical expedients and recorded the outstanding operating lease
at January 1, 2019) based on the present value of lease payments
over the lease term. As the Company’s lease did not provide
an implicit interest rate, the Company used the equivalent
borrowing rate for a secured financing with the term of that equal
to the remaining life of the lease at inception. The lease terms
used to calculate the ROU asset and related lease liability did not
include options to extend or termination of the lease; there are
none and there is no reasonable certainty that the Company would
extend the lease at expiration. Lease expense for operating leases
is recognized on a straight-line basis over the lease term as an
operating expense. The Company has lease agreements which require
payments for lease and non-lease components and has elected to
account for these as separate lease components. Non-leasing
components are not included in the ROU asset.
Right
of use assets and Lease liability – right of use consist of
the following:
|
June 30,
2020
|
|
|
Right of use
assets
|
$243,251
|
|
June 30,
2020
|
Lease liability -
right of use
|
|
Current
portion
|
$173,270
|
Long
term portion
|
99,142
|
|
$272,412
|
As of
June 30, 2020, the maturities of the Company’s lease
liability – right of use which have initial or remaining
lease terms in excess of one year consist of the
following:
Year ending
December 31,
|
Amount
|
2020
(remainder)
|
$97,041
|
2021
|
197,462
|
Total
lease payments
|
294,503
|
Less: Present value
adjustment
|
(22,090)
|
Lease liability -
right of use
|
$272,413
|
As of
June 30, 2020, the Company’s operating lease had a weighted
average remaining lease term of 1.5 years and a weighted average
discount rate of 7%.
Rent
expense for the three months ended June 30, 2020 and 2019 was $52,346 and
$54,698, respectively, and for the six months ended June 30, 2020
and 2019 was $117,876 and $107,536, respectively.
Financing Lease
For
leases where the Company is the lessee, ROU assets represent the
Company’s right to use an underlying asset for the lease term
and lease liabilities represent an obligation to make lease
payments arising from the lease. ROU assets and lease liabilities
are recognized at the lease commencement date based on the present
value of lease payments over the lease term. The present value of
the lease payment exceeds 90% of the sales price of the equipment,
therefore this lease will be considered a financing lease is
included in Property and equipment, net on our Condensed
Consolidated Balance Sheets. Lease expense will be recognized as
payment of financing lease, depreciation expense and interest
expense.
15
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
13.
Commitments
and contingencies (continued)
Right
of use assets and Lease liability – right of use consist of
the following:
|
June 30,
2020
|
Right of use
assets
|
$515,551
|
|
June 30,
2020
|
Lease liability -
right of use
|
|
Current
portion
|
$181,371
|
Long
term portion
|
333,771
|
|
$515,141
|
As of
June 30, 2020, the maturities of the Company’s lease
liability – right of use which have initial or remaining
lease terms in excess of one year consist of the
following:
Year ending
December 31,
|
Amount
|
2020
(remainder)
|
$117,297
|
2021
|
234,593
|
2022
|
199,793
|
2023
|
18,388
|
Total
|
$570,071
|
As of
June 30, 2020, the Company’s financing leases had a weighted
average remaining lease term of 2.44 years based on annualized base
payments expiring through 2023 and a weighted average discount rate
of 13.2%.
As of
June 30, 2020, the Company did not have additional operating or
financing leases that have yet commenced.
Litigation
From time to time, the Company is subject to various legal actions,
claims and proceedings arising in the ordinary course of business,
including claims related to breach of contracts and intellectual
property matters resulting from our business activities. As with
most actions such as these, an estimation of any possible and/or
ultimate liability cannot always be determined. The Company
believes that all pending claims, if adversely decided, would not
have a material adverse effect on our business, financial position
or results of operations.
16
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
14.
Revenue
The
Company accounts for revenue in accordance with ASC
606.
Disaggregation of Revenue
The
disaggregation of revenue is based on geographical region. The
following table presents revenue from contracts with customers for
the three and six months ended June 30, 2020 and 2019:
|
Three months ended June 30,
2020
|
Three months ended June 30,
2019
|
||||
|
United States
|
International
|
Total
|
United States
|
International
|
Total
|
|
|
|
|
|
|
|
Product
|
$63,076
|
$6,265
|
$69,341
|
$120,488
|
$100,179
|
$220,667
|
License
fees
|
-
|
-
|
-
|
6,250
|
60,558
|
66,808
|
Other
Revenue
|
711
|
13,249
|
13,960
|
-
|
29,501
|
29,501
|
|
$63,787
|
$19,514
|
$83,301
|
$126,738
|
$190,238
|
$316,976
|
|
Six months ended June 30,
2020
|
Six months ended June 30,
2019
|
||||
|
United States
|
International
|
Total
|
United States
|
International
|
Total
|
|
|
|
|
|
|
|
Product
|
$96,730
|
$47,170
|
$143,900
|
$138,167
|
$147,065
|
$285,232
|
License
fees
|
10,000
|
-
|
10,000
|
12,500
|
160,558
|
173,058
|
Other
Revenue
|
1,252
|
76,741
|
77,993
|
-
|
36,649
|
36,649
|
|
$107,982
|
$123,911
|
$231,893
|
$150,667
|
$344,272
|
$494,939
|
Management
routinely assesses the financial strength of its customers and, as
a consequence, believes accounts receivable are stated at the net
realizable value and credit risk exposure is limited. One
distributor accounted for 86% of revenue for the six months ended
June 30, 2020 and 72% of accounts receivable at June 30, 2020.
Three distributors accounted for 72% of revenues for the six months
ended June 30, 2019 and 49%, 0% and 25% of accounts receivable at
June 30, 2019.
15.
Related
party transactions
During
the three and six months ended June 30, 2020 and 2019, the Company
recorded $13,105 and $17,678, respectively, and $26,210 and
$138,167 respectively, in revenue from an entity owned by A.
Michael Stolarski, a member of the Company’s board of
directors and an existing shareholder of the Company. Contract
liabilities includes a balance at June 30, 2020 and 2019 of $90,943
and $102,899, respectively from this related party.
16.
Stock-based
compensation
During
the six months ended June 30, 2020, an employee exercised stock
options to buy 175,000 shares at an exercise price of $0.21 per
share and 50,000 shares at an exercise price of $0.15 per share of
the Company’s
common
stock totaling 225,000 shares.
During
the six months ended June 30, 2020, 10,000 stock options to
purchase the Company’s common stock were forfeited due to
termination.
The
range of exercise prices for options was $0.04 to $2.00 for options
outstanding at June 30, 2020 and December 31, 2019, respectively.
The aggregate intrinsic value for all vested and exercisable
options was $3,034,841 and $2,085,866 at June 30, 2020 and December
31, 2019, respectively.
17
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
June 30, 2020
16.
Stock-based
compensation (continued)
The
weighted average remaining contractual term for outstanding
exercisable stock options was 6.1 and 6.6 years as of June 30, 2020
and December 31, 2019, respectively.
17.
Earnings
(loss) per share
Basic
net loss per share is computed by dividing the net loss
attributable to common stockholders by the weighted average number
of shares of common stock outstanding for the
period. Diluted net loss per share reflects the
potential dilution that could occur if securities or other
instruments to issue common stock were exercised or converted into
common stock. Potentially dilutive securities are excluded from the
computation of diluted net loss per share as their inclusive would
be anti-dilutive and consist of the following:
|
June 30,
2020
|
June 30,
2019
|
|
|
|
Stock
options
|
34,168,385
|
32,183,385
|
Preferred stock
conversion
|
17,500,000
|
-
|
Warrants
|
9,374,091
|
68,357,635
|
Convertible
promissory notes
|
5,227,200
|
26,004,347
|
Short term notes
payable
|
2,250,000
|
-
|
Anti-dilutive equity
securities
|
68,519,676
|
126,545,367
|
18.
Subsequent
events
On July
23, 2020, in connection with the Company’s 2020 Annual
Meeting of Stockholders, the Company’s stockholders approved,
among other matters, the following;
●
An amendment to the
Company’s Articles of Incorporation to increase the number of
authorized shares of Common Stock from 355,000,000 to 605,000,000;
and
● To
grant the board of directors the authority to effect a reverse
split of the Company’s outstanding Common Stock at an
exchange rate of between 1-for-10 and 1-for-50, with the exact
ratio to be determined by the board of directors in its sole
discretion.
On July
23, 2020, in connection with the Company’s 2020 Annual
Meeting of Stockholders, the Company’s stockholders approved,
among other matters, the following;
●
An amendment to the
Company’s Articles of Incorporation to increase the number of
authorized shares of Common Stock from 355,000,000 to 605,000,000;
and
● To
grant the board of directors the authority to effect a reverse
split of the Company’s outstanding Common Stock at an
exchange rate of between 1-for-10 and 1-for-50, with the exact
ratio to be determined by the board of directors in its sole
discretion.
The
amendment to the Company’s Articles of Incorporation to
effect the increase in the number of authorized shares of Common
Stock was filed with the Secretary of State of Nevada on August 3,
2020. An amendment to the Company’s Articles of Incorporation
to effect the reverse stock split have not yet been filed with the
Secretary of State of Nevada.
On
August 6, 2020, the Company entered into an asset purchase
agreement with Celularity Inc. pursuant to which the Company
acquired Celularity’s UltraMIST assets. The aggregate
consideration paid for the assets was $24,000,000, which consisted
of (i) a cash payment of $18,890,000, (ii) the issuance of a
promissory note to Celularity in the principal amount of
$4,000,000, and (iii) a credit of $1,110,000 for the previous
payment made by the Company to Celularity pursuant to that certain
letter of intent between the Company and Celularity dated June 7,
2020. The closing of the transaction occurred on August 6,
2020.
In
connection with the asset purchase agreement, on August 6, 2020,
the Company entered into a license and marketing agreement with
Celularity pursuant to which Celularity granted to the Company a
license to the Celularity wound care biologic products,
Biovance® and Interfyl®. The license agreement provides
the Company with an exclusive license to use, market, distribute
and sell Biovance® in the Field (as defined in the License
Agreement) in the Territory (as defined in the License Agreement),
and a non-exclusive license to use, market, distribute and sell
Interfyl® in the Field in the Territory. The License Agreement
has an initial five year term, after which it automatically renews
for additional one year periods, unless either party gives written
notice at least 180 days prior to the expiration of the current
term.
On August 6, 2020, the Company entered into a Securities Purchase
Agreement with certain accredited investors for the sale by the
Company in a private placement of an aggregate of 119,125,000
shares of Common Stock and accompanying Class E Warrants to
purchase up to an additional 119,125,000 shares of Common Stock, at
a purchase price of $0.20 per share and accompanying warrant. The
warrants have an exercise price of $0.25 per share and a three year
term. The closing of the private placement occurred on August 6,
2020. On August 13, 2020, 24,500,000 shares of Common Stock were
issued for next cash proceeds of $4,900,000.
In connection with the Private Placement, H.C.
Wainwright & Co., LLC, as exclusive placement agent for the
Private Placement, received warrants to purchase up to 8,934,375
shares of Common Stock on the same terms
as the
Warrants, a cash fee and certain
expenses.
On
August 6, 2020, the Company entered into a Note and Warrant
Purchase and Security Agreement (the “NWPSA”), with the
noteholder party thereto and NH Expansion Credit Fund Holdings LP,
as agent. The NWPSA provides for (i) the sale and purchase of
secured notes in an aggregate original principal amount of $15
million and (ii) the issuance of warrants equal to 2.0% of the
fully-diluted Common Stock of the Company as of the issue date. The
warrant has an exercise price of $0.01 per share and a 10 year
term.
On
August 6, 2020, the Company entered into a letter agreement (the
“HealthTronics Agreement”) with HealthTronics, Inc.
(“HealthTronics”), pursuant to which the Company paid
off all outstanding debt due and owed to HealthTronics. Pursuant to
the HealthTronics Agreement, as consideration for the
extinguishment of the debt due and owed to HealthTronics, (i) the
Company paid to HealthTronics an amount in cash equal to
$4,000,000, (ii) HealthTronics exercised all of its outstanding
Class K Warrants to purchase 7,200,000 shares of Common Stock,
(iii) the Company issued to HealthTronics a convertible promissory
note in the principal amount of $1,372,743, and (iv) the Company
and HealthTronics entered into a Securities Purchase Agreement
dated August 6, 2020 pursuant to which the Company issued to
HealthTronics an aggregate of 8,275,235 shares of Common Stock and
an accompanying warrant to purchase up to an additional 8,275,235
shares of Common Stock. The warrant has an exercise price of $0.25
per share and a three year term.
On
August 6, 2020, the Company repaid all amounts owing to LGH
Investments, LLC pursuant to that certain promissory note issued by
the Company to LGH Investments, LLC dated June 5, 2020 in the
original principal amount of $1,210,000 (the “LGH
Note”). As a result, all obligations of the Company under the
LGH Note have been terminated. The Warrants issued to LGH
Investments, as more fully described in Note 7 to our condensed
consolidated financial statements, contain certain anti-dilution
adjustment provisions with respect to subsequent issuances of
securities by the Company at a price below the exercise price of
such warrants. As a result of certain dilutive issuances of
securities by the Company during the third quarter of 2020, the
exercise price of the Warrants decreased to $0.20 per share and the
number of shares subject to the Warrants increased to 1,750,000
shares as of September 30, 2020.
On August 6, 2020, the Company terminated that
certain line of credit agreement with A. Michael Stolarski, a
member of the Company’s board of directors, dated December
29, 2017 and as amended November 12, 2018, in the amount of
$1,000,000 (the “Stolarski Line of Credit”). As
consideration for the termination of the Stolarski Line of Credit,
the Company issued to A. Michael Stolarski a convertible promissory
note in the principal amount of $223,511 (the “Stolarski
Note”).
The
Stolarski Note has a maturity date of August 6, 2021 and accrues
interest at a rate equal to 12.0% per annum. In the event that the
Stolarski Note has not been repaid prior to January 1, 2021, the
holder may elect to convert the outstanding principal amount plus
any accrued by unpaid interest thereon into shares of Common Stock
at a conversion price of $0.10 per share.
The
Company has evaluated its subsequent events from June 30, 2020
through the date these condensed consolidated financial statements
were issued, and has determined that there are no additional
subsequent events required to be disclosed.
Item 2. MANAGEMENT’S
DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
You should read the following discussion and analysis of our
financial condition and results of operations together with our
unaudited condensed consolidated financial statements and the
related notes appearing elsewhere in this report, and together with
our audited consolidated financial statements, related notes and
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations” as of and for the year
ended December 31, 2019 included in our Annual Report on Form
10-K, filed with the SEC on March 30, 2020 (the “2019 Annual
Report”).
Overview
We are
a shock wave technology company using a patented system of
noninvasive, high-energy, acoustic shock waves for regenerative
medicine and other applications. Our initial focus is regenerative
medicine utilizing noninvasive, acoustic shock waves to produce a
biological response resulting in the body healing itself through
the repair and regeneration of tissue, musculoskeletal, and
vascular structures. Our lead regenerative product in the United
States is the dermaPACE® device, used
for treating diabetic foot ulcers, which was subject to two
double-blinded, randomized Phase III clinical studies. On December
28, 2017, the U.S. FDA granted the Company’s request to
classify the dermaPACE System as a Class II device via the
de novo process. As a
result of this decision, the Company was able to immediately market
the product for the treatment of Diabetic Foot Ulcers (DFU) as
described in the De Novo request, subject to the general control
provisions of the FD&C Act and the special controls identified
in this order.
Our
portfolio of healthcare products and product candidates activate
biologic signaling and angiogenic responses, including new
vascularization and microcirculatory improvement, helping to
restore the body’s normal healing processes and regeneration.
We intend to apply our Pulsed Acoustic Cellular Expression
(PACE®) technology in
wound healing, orthopedic, plastic/cosmetic and cardiac conditions.
The Company is marketing its dermaPACE
System for treatment usage in the United States and will continue
to generate revenue from sales of the European Conformity
Marking (CE Mark) devices and accessories in Europe, Canada, Asia,
and Asia/Pacific. The Company generates revenue streams from
dermaPACE treatments, product sales, licensing transactions and
other activities.
Our
lead product candidate for the global wound care market, dermaPACE,
has received FDA clearance for commercial use to treat diabetic
foot ulcers in the United States and the CE Mark allowing for
commercial use on acute and chronic defects of the skin and
subcutaneous soft tissue. We believe we have demonstrated that our
patented technology is safe and effective in stimulating healing in
chronic conditions of the foot and the elbow through our United
States FDA Class III Premarket Approvals ("PMAs") approved
OssaTron® device, and in the stimulation of bone and chronic
tendonitis regeneration in the musculoskeletal environment through
the utilization of our OssaTron, Evotron®, and orthoPACE®
devices in Europe and Asia.
We
are focused on developing our Pulsed Acoustic Cellular Expression
(PACE) technology to activate healing in:
●
wound
conditions, including diabetic foot ulcers, venous and arterial
ulcers, pressure sores, burns and other skin eruption
conditions;
●
orthopedic
applications, such as eliminating chronic pain in joints from
trauma, arthritis or tendons/ligaments inflammation, speeding the
healing of fractures (including nonunion or delayed-union
conditions), improving bone density in osteoporosis, fusing bones
in the extremities and spine, and other potential sports injury
applications;
●
plastic/cosmetic
applications such as cellulite smoothing, graft and transplant
acceptance, skin tightening, scarring and other potential aesthetic
uses; and
●
cardiac
applications for removing plaque due to atherosclerosis improving
heart muscle performance.
In
addition to healthcare uses, our high-energy, acoustic pressure
shock waves, due to their powerful pressure gradients and localized
cavitational effects, may have applications in secondary and
tertiary oil exploitation, for cleaning industrial waters and food
liquids and finally for maintenance of industrial installations by
disrupting biofilms formation. Our business approach will be
through licensing and/or partnership opportunities.
In
March 2020, the World Health Organization characterized COVID-19 as
a pandemic and the President of the United States declared the
COVID-19 outbreak a national emergency. Since then, the COVID-19
pandemic has rapidly spread across the globe and has already
resulted in significant volatility, uncertainty and economic
disruption. While the COVID-19 pandemic has not had a material
adverse financial impact on the Company’s operations to date,
the pandemic has resulted in the decreased demand for a broad
variety of products, including from our customers, and will also
disrupt supply channels and marketing activities for an unknown
period of time until the disease is contained. Future impacts of
the pandemic and any resulting economic impact are largely unknown
and rapidly evolving. It is difficult at this time to predict the
impact that COVID-19 will have on the Company’s business,
financial position and operating results in future periods due to
numerous uncertainties. The Company is closely monitoring the
impact of the pandemic on all aspects of its business and
operations. We have received funds for disaster relief loans
through the SBA to help minimize the impact on our
business.
We
were formed as a Nevada corporation in 2004. We maintain a public
internet site at www.sanuwave.com. The information on our websites
is not part of this Form 10-Q.
Recent Clinical Highlights and Updates
A
dosage study has been developed for launch in Poland to optimize
dermaPACE system treatment dosage for producing a more rapid
reduction in size of a diabetic foot ulcer
(“DFU”). The focus will be on increasing the
number of shock waves delivered per treatment, as a function of
DFUs area. To determine the dosage necessary, three new
distinctive regimens will be assessed during the study. This
study started in April 2019 and is expected to be finalized in the
fourth quarter of 2020, depending on availability of patients due
to the COVID-19 pandemic.
A
post-market pilot study to evaluate the effects of high energy
acoustic shock wave therapy on local skin perfusion and healing of
DFUs will be conducted at two sites: one in New Jersey and one in
California. The intent of this trial is to quantify the level of
increased perfusion and oxygenation during and after treatment with
the dermaPACE system. This study started in April 2019 and is
expected to be finalized in the fourth quarter of 2020, depending
on availability of patients due to the COVID-19
pandemic.
19
Financial Overview
Since
our inception, our operations have primarily been funded from the
sale of capital stock, notes payable, and convertible debt
securities. We expect to devote substantial resources for the
commercialization of the dermaPACE System and will continue to
research and develop the non-medical uses of the PACE technology,
both of which will require additional capital resources. We
incurred a net loss of $3,633,020 and $2,734,431 for the three
months ended June 30, 2020 and June 30, 2019, respectively, and
$6,634,168 and $4,931,748 for the six months ended June 30, 2020
and the June 30, 2019, respectively. These factors, and the events
of default on the notes payable to HealthTronics, Inc. and our
short term notes payable, create substantial doubt about our
ability to continue as a going concern for a period of at least
twelve months from the financial statement issuance date. Although
no assurances can be given, we believe that potential additional
issuances of equity, debt or other potential financing will provide
the necessary funding for us to continue as a going concern for the
next year. See “Liquidity and Capital Resources” for
further information regarding our financial condition.
We
cannot reasonably estimate the nature, timing and costs of the
efforts necessary to complete the development and approval of, or
the period in which material net cash flows are expected to be
generated from, any of our products, due to the numerous risks and
uncertainties associated with developing and marketing products,
including the uncertainty of:
●
the scope, rate of
progress and cost of our clinical trials;
●
future clinical
trial results;
●
the cost and timing
of regulatory approvals;
●
the establishment
of successful marketing, sales and distribution channels and
partnerships, including our efforts to expand our marketing, sales
and distribution reach through joint ventures and other contractual
arrangements;
●
the cost and timing
associated with establishing reimbursement for our
products;
●
the effects of
competing technologies and market developments; and
●
the industry demand
and patient wellness behavior.
Any
failure to complete the development of our product candidates in a
timely manner, or any failure to successfully market and
commercialize our product candidates, would have a material adverse
effect on our operations, financial position and liquidity. A
discussion of the risks and uncertainties associated with us and
our business are set forth under the section entitled “Risk
Factors – Risks Related to Our Business” in our 2019
Annual Report.
On
March 27, 2020, Congress enacted the Coronavirus Aid, Relief, and
Economic Security Act (15 U.S.C. 636(a)(36)) (the “CARES
Act”) to provide certain relief as a result of the COVID-19
pandemic. The CARES Act provides numerous tax provisions and other
stimulus measures, including temporary changes regarding the prior
and future utilization of net operating losses, temporary changes
to the prior and future limitations on interest deductions,
temporary suspension of certain payment requirements for the
employer portion of Social Security taxes, technical corrections
from prior tax legislation for tax depreciation of certain
qualified improvement property, and the creation of certain
refundable employee retention credits.
On
May 29, 2020, the Company received the proceeds from a loan in the
amount of approximately $460,000 (the “PPP Loan”) from
Truist Bank, as lender, pursuant to the Paycheck Protection Program
(“PPP”) of under the CARES Act. The PPP Loan matures on
May 28, 2022 and bears interest at a rate of 1% per annum.
Commencing December 12, 2020, the Company is required to pay the
lender equal monthly payments of principal and interest. The PPP
Loan is evidenced by a promissory note dated May 28, 2020, which
contains customary events of default relating to, among other
things, payment defaults and breaches of representations,
warranties and covenants. The PPP Loan may be prepaid by the
Company at any time prior to maturity with no prepayment penalties.
Under the terms of the PPP Loan, the Company may be eligible for
full or partial loan forgiveness in the third quarter of 2020,
however, no assurance is provided that the Company will apply
for, or obtain forgiveness for, any portion of the PPP
Loan.
Critical Accounting Policies and Estimates
Management’s
Discussion and Analysis of Financial Condition and Results of
Operations is based on our condensed consolidated financial
statements, which have been prepared in accordance with United
States generally accepted accounting principles. The preparation of
our condensed consolidated financial statements requires us to make
estimates and assumptions that affect the reported amounts of
assets, liabilities, revenues and expenses.
On an ongoing basis, we evaluate our estimates and judgments,
including those related to the recording of the allowances for
doubtful accounts, estimated reserves for inventory, estimated
useful life of property and equipment, the determination of the
valuation allowance for deferred taxes, the estimated fair value of
the warrant liability, and the estimated fair value of stock-based
compensation. We base our estimates on authoritative literature and
pronouncements, historical experience and on various other
assumptions that we believe are reasonable under the circumstances,
the results of which form the basis for making judgments about the
carrying value of assets and liabilities that are not readily
apparent from other sources. Our actual results may differ from
these estimates under different assumptions or conditions. The
results of our operations for any historical period are not
necessarily indicative of the results of our operations for any
future period.
Our
significant accounting policies are more fully described in Note 2
to our consolidated financial statements filed with our 2019 Annual
Report. For a description of recent accounting policies and the
impact on our financial statements, refer to Note 3 in the
condensed consolidated financial statements in this 10-Q
filing.
20
Results of Operations for the Three Months ended June 30, 2020 and
2019
Revenues and Cost of Revenues
Revenues for the
three months ended June 30, 2020 were $83,301, compared to $316,976
for the same period in 2019, a decrease of $233,675, or 74%.
Revenue resulted primarily from sales in Europe of our orthoPACE
devices, related applicators and spare parts for refurbishment
services performed by our Italian distributor. The decrease in
revenue for 2020 is primarily due to lower upfront international
distribution fees, as compared to the prior year. This is partially
offset by higher sales of spare parts for refurbishment of
applicators.
Cost of
revenues for the three months ended June 30, 2020 were $26,347
compared to $185,881 for the same period in 2019. Gross profit as a
percentage of revenues was 68% for the three months ended June 30,
2020, compared to 41% for the same period in 2019. The increase in
gross profit as a percentage of revenues in 2020 was primarily due
to decrease in sales and refurbishment of applicators and increase
in high margin treatment fees.
Research and Development Expenses
Research and
development expenses for the three months ended June 30, 2020 were
$264,907, compared to $307,273 for the same period in 2019, a
decrease of $42,366, or 14%. The decrease in research and
development expenses in 2020, as compared to 2019, was due to lower
salary and related costs as a result of lower headcount and lower
clinical and research costs due to the COVID-19
pandemic.
Selling and Marketing Expenses
Selling
and marketing expenses for the three months ended June 30, 2020
were $433,151, compared to $407,477 for the same period in 2019, an
increase of $25,674, or 6%. The increase in selling and marketing
expenses in 2020, as compared to 2019, was due to an increase in
hiring of clinical account managers and salespeople for placement
and training related to the commercialization of
dermaPACE.
General and Administrative Expenses
General and
administrative expenses for the three months ended June 30, 2020
were $2,566,793, as compared to $1,426,405 for the same period in
2019, an increase of $1,140,388, or 80%. The increase in general
and administrative expenses in 2020, as compared to 2019, was due
to engagement of specialists to assist with distribution partner
searches, increase in severance of $150,000 due to a separation of
an officer, increase in legal and consulting fees related to merger
and acquisition opportunities and increased director and officer
insurance which was partially offset by lower investor relations
costs and lower travel costs.
Depreciation
Depreciation for
the three months ended June 30, 2020 was $64,766, compared to
$9,455 for the same period in 2019, an increase of $55,311 or 585%.
The increase was due to the higher depreciation related to increase
in fixed assets and leased dermaPACE devices.
Other Income (Expense)
Other
income (expense) was a net expense of $360,357 for the three months
ended June 30, 2020 as compared to a net expense of $714,916 for
the same period in 2019, a decrease of $354,559, or 50% The
decrease was primarily due to decreased interest expense. This is
partially offset by a non-cash gain for valuation adjustment on
outstanding warrants of $0, as compared to $195,310 for the same
period in 2019.
Net Loss
Net
loss for the three months ended June 30, 2020 was $3,633,020, or
($0.01) per basic and diluted share, compared to a net loss of
$2,734,431, or ($0.02) per basic and diluted share, for the same
period in 2019, an increase in the net loss of $898,589, or
33%.
Results of Operations for the Six Months ended June 30, 2020 and
2019
Revenues and Cost of Revenues
Revenues for the
six months ended June 30, 2020 were $231,893, compared to $494,939
for the same period in 2019, a decrease of $263,046, or 53%.
Revenue resulted primarily from sales in Europe of our orthoPACE
devices, related applicators and spare parts for refurbishment
services performed by our Italian distributor. The decrease in
revenue for 2020 is primarily due to lower upfront international
distribution fees, as compared to the prior year. This is partially
offset by higher sales of spare parts for refurbishment of
applicators.
21
Cost of
revenues for the six months ended June 30, 2020 were $115,224,
compared to $279,734 for the same period in 2019. Gross profit as a
percentage of revenues was 50% for the six months ended June 30,
2020, compared to 43% for the same period in 2019. The increase in
gross profit as a percentage of revenues in 2020 was primarily due
to decrease in sales and refurbishment of applicators and increase
in high margin treatment fees.
Research and Development Expenses
Research and
development expenses for the six months ended June 30, 2020 were
$559,981, compared to $567,922 for the same period in 2019, a
decrease of $7,941, or 1%. The decrease in research and development
expenses in 2020, as compared to 2019, was due to decreased study
expenses related to our new dosage study in Poland due to COVID-19
pandemic.
Selling and Marketing Expenses
Selling
and marketing expenses for the six months ended June 30, 2019 were
$1,041,001, compared to $565,559 for the same period in 2019, an
increase of $475,442, or 84%. The increase in sales and marketing
expenses in 2020, as compared to 2019, was due to an increase in
hiring of trainers and salespeople and increased travel expenses
for placement and training related to the commercialization of
dermaPACE. There was a slow down in the commercialization of
dermaPACE in the second quarter of 2020 due to the COVID
pandemic.
General and Administrative Expenses
General
and administrative expenses for the six months ended June 30, 2020
were $4,474,710, as compared to $2,943,860 for the same period in
2019, an increase of $1,530,850, or 66%. The increase in general
and administrative expenses in 2020, as compared to 2019, was due
to engagement of specialists to assist with distribution partner
searches, increase in legal and consulting fees related to merger
and acquisition opportunities and increased director and officer
insurance which was partially offset by lower investor relations
costs and lower travel costs.
Depreciation
Depreciation for
the six months ended June 30, 2020 was $117,789, compared to
$17,812 for the same period in 2019, an increase of $99,977, or
561%. The increase was due to the higher depreciation related to
leased dermaPACE devices.
Other Income (Expense)
Other
income (expense) was a net expense of $565,676 for the six months
ended June 30, 2020 as compared to a net expense of $1,051,800 for
the same period in 2019, a decrease of $486,124, or 46%, in the net
expense. The decrease was primarily due to decreased interest
expense. In addition, the net expense in 2019 included a non-cash
gain for valuation adjustment on outstanding warrants of
$227,669.
Net Loss
Net
loss for the six months ended June 30, 2020 was $6,634,168, or
($0.02) per basic and diluted share, compared to a net loss of
$4,931,748, or ($0.03) per basic and diluted share, for the same
period in 2019, an increase in the net loss of $1,702,420, or 35%.
The increase in the net loss was primarily a result of an increase
in general and administrative expense and decrease in other income
as described above.
Liquidity and Capital Resources
We
expect to devote substantial resources for the commercialization of
the dermaPACE System and will continue to research and develop the
next generation of our technology as well as the non-medical uses
of the PACE technology, both of which will require additional
capital resources. We incurred a net loss of $6,634,168 and
$4,931,748 for the six months ended June 30, 2020 and June 30,
2019, respectively. These factors and the events of default on the
notes payable to HealthTronics, Inc. and the Company’s short
term notes payable create substantial doubt about the
Company’s ability to continue as a going concern for a period
of at least twelve months from the financial issuance date.
Management
is currently evaluating the impact on cash flows of the
Company’s acquisition of certain assets of Celularity Inc.,
as more fully described in Note 18 to the Company’s condensed
consolidated financial statements in this
report.
Since
inception in 2005, our operations have primarily been funded from
the sale of capital stock, notes payable, and convertible debt
securities.
22
The
continuation of our business is dependent upon raising additional
capital to fund operations. Management expects the cash used in
operations for the Company will be approximately $300,000 to
$375,000 per month for the second half of 2020 as resources are
devoted to the commercialization of the dermaPACE product including
hiring of new employees, expansion of our international business
and continued research and development of next generation of our
technology as well as non-medical uses of our technology.
Management’s plans are to obtain additional capital in 2020
through investments by strategic partners for market opportunities,
which may include strategic partnerships or licensing arrangements,
or raise capital through the issuance of common or preferred stock,
securities convertible into common stock, or secured or unsecured
debt. These possibilities, to the extent available, may be on terms
that result in significant dilution to our existing shareholders.
Although no assurances can be given, management believes that
potential additional issuances of equity or other potential
financing transactions as discussed above should provide the
necessary funding for us. If these efforts are unsuccessful, we may
be required to significantly curtail or discontinue operations or
obtain funds through financing transactions with unfavorable terms.
The accompanying condensed consolidated financial statements have
been prepared in conformity with accounting principles generally
accepted in the United States of America, which contemplate
continuation of the Company as a going concern and the realization
of assets and satisfaction of liabilities in the normal course of
business. The carrying amounts of assets and liabilities presented
in the financial statements do not necessarily purport to represent
realizable or settlement values. The condensed consolidated
financial statements do not include any adjustment that might
result from the outcome of this uncertainty. Our condensed
consolidated financial statements do not include any adjustments
relating to the recoverability of assets and classification of
assets and liabilities that might be necessary should we be unable
to continue as a going concern.
On
January 31, 2020, the Company filed a Certificate of Designation of
Preferences, Right and Limitations of Series C Convertible
Preferred Stock of the Company with the Nevada Secretary of State,
which amended our Articles of Incorporation to designate 90 shares
of our preferred stock as Series C Convertible Preferred Stock. On
May 14, 2020, the Company filed a Certificate of Designation of
Preferences, Rights and Limitations of Series D Convertible
Preferred Stock of the Company with the Nevada Secretary of State,
which amended our Articles of Incorporation to designate 8 shares
of our preferred stock as Series D Convertible Preferred Stock. As
of June 30, 2020, there were 98 shares of our preferred stock
issued and outstanding. The Certificates of Designation became
effective upon filing with the Secretary of State of the State of
Nevada. If all outstanding shares of Series C Preferred Stock and
Series D Preferred Stock were converted into Common Stock at the
original conversion rate, such shares would convert into an
aggregate of 17,499,999 shares of Common Stock.
We may
also attempt to raise additional capital if there are favorable
market conditions or other strategic considerations even if we have
sufficient funds for planned operations. To the extent that we
raise additional funds by issuance of equity securities, our
shareholders will experience dilution and we may be required to use
some or all of the net proceeds to repay our indebtedness, and debt
financings, if available, may involve restrictive covenants or may
otherwise constrain our financial flexibility. To the extent that
we raise additional funds through collaborative arrangements, it
may be necessary to relinquish some rights to our intellectual
property or grant licenses on terms that are not favorable to us.
In addition, payments made by potential collaborators or licensors
generally will depend upon our achievement of negotiated
development and regulatory milestones. Failure to achieve these
milestones would harm our future capital position.
For the six months
ended June 30, 2020 and 2019, net cash used by operating activities
was $4,511,968 and $3,386,634, 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 six months ended June 30, 2020, as
compared to the same period for 2019, was primarily due to an
increase in accrued expenses of $106,178 an increase in prepaid
expenses of $126,505, a decrease in accounts payable of $135,916,
an increase of accrued employee compensation and accrued expenses
of $354,032 and increase in interest payable, related parties of
$135,916. Net cash used by investing activities for the six months
ended June 30, 2020 was $1,114,855 as compared to net cash used by
investing activities for the same period in 2019 of $25,839. The
increase in cash used by investing activities is due to increase in
deposits paid offset by decrease in purchasing of property and
equipment. Net cash provided by financing activities for the six
months ended June 30, 2020 was $4,298,897, which primarily
consisted of $2,450,000 proceeds from purchase of preferred stock,
$1,100,000 from convertible notes, and $614,335 from SBA Loans (see
Note 8). Net cash provided by financing activities for the six
months ended June 30, 2019 was $3,203,279, which primarily
consisted of $1,215,000 of proceeds from short term note,
$1,403,257 of proceeds from exercise of warrants and $585,022 of
proceeds from advances from related parties. Cash and cash
equivalents decreased by $1,329,849 for the six months ended June
30, 2020.
Segment and Geographic Information
We have
determined that we have one operating segment. Our revenues are
generated from sales in United States, Europe, Canada, Asia and
Asia/Pacific. All significant expenses are generated in the United
States and all significant assets are located in the United
States.
Contractual Obligations
Our
major outstanding contractual obligations relate to our operating
lease for our facility, purchase and supplier obligations for
product component materials and equipment, and our notes payable,
related parties. We have disclosed these obligations in our 2019
Annual Report.
23
Off-Balance Sheet Arrangements
Since
inception, we have not engaged in any off-balance sheet activities,
including the use of structured finance, special purpose entities
or variable interest entities.
Effects of Inflation
Due to
the fact that our assets are, to an extent, liquid in nature, they
are not significantly affected by inflation. However, the rate of
inflation affects such expenses as employee compensation, office
space leasing costs and research and development charges, which may
not be readily recoverable during the period of time that we are
bringing the product candidates to market. To the extent inflation
results in rising interest rates and has other adverse effects on
the market, it may adversely affect our condensed consolidated
financial condition and results of operations.
Item 3. QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
Not
required under Regulation S-K for “smaller reporting
companies”.
Item 4. CONTROLS AND
PROCEDURES
Evaluation of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures, as defined in Rule
13a-15(e) and 15d-15(e) promulgated under the Securities Exchange
Act of 1934, as amended (the “Exchange Act”), that are
designed to provide reasonable assurance that information required
to be disclosed by us in the reports that we file or submit under
the Exchange Act is recorded, processed, summarized and reported
within the time periods specified in the SEC’s rules and
forms. Disclosure controls and procedures include, without
limitation, controls and procedures designed to ensure that
information required to be disclosed by the Company in the reports
that it files or submits under the Exchange Act is accumulated and
communicated to the Company’s management, including its
principal executive and principal financial officers, or persons
performing similar functions, as appropriate to allow timely
decisions regarding required disclosure.
We carried out an evaluation under the supervision
and with the participation of our management, including our Chief
Executive Officer (principal executive officer) and Chief Financial
Officer (principal financial officer and accounting officer), of
the effectiveness of the design and operation of our disclosure
controls and procedures as of June 30, 2020. Based on this evaluation, the Chief Executive
Officer and Chief Financial Officer concluded that our disclosure
controls and procedures were not operating effectively as of
June 30, 2020. Our disclosure controls
and procedures were not effective because of the “material
weakness” described below under “Management’s
Annual Report on Internal Control over Financial
Reporting.”
Management’s Annual Report on Internal Control over Financial
Reporting
Management
is responsible for establishing and maintaining adequate internal
control over financial reporting (as defined in
Rules 13a-15(f) and 15d-15(f) under the Exchange Act) for the
Company. The Company’s internal control over financial
reporting is a process designed to provide reasonable assurance
regarding the reliability of financial reporting and the
preparation of financial statements for external purposes in
accordance with U.S. GAAP.
Because
of its inherent limitations, internal control over financial
reporting may not prevent or detect misstatements. Therefore, even
those systems determined to be effective can provide only
reasonable assurance of achieving their control
objectives.
Management,
with the participation of the Chief Executive Officer (principal
executive officer) and the Chief Financial Officer (principal
financial and accounting officer), evaluated the effectiveness of
the Company’s internal control over financial reporting as of
June 30, 2020. In making this assessment, management used the
criteria set forth by the Committee of Sponsoring Organizations of
the Treadway Commission in Internal Control — Integrated
Framework (2013).
We
previously reported three material weaknesses in our internal
control over financial reporting process resulting from a lack of
internal expertise and resources to analyze and properly apply
generally accepted accounting principles to complex and non-routine
transactions such as complex financial instruments and derivatives
and complex sales distribution agreements, a lack of internal
resources to analyze and properly apply generally accepted
accounting principles to accounting for equity components of
service agreements with select vendors and cybersecurity breaches
from email spoofing. As a result, management concluded that our
internal control over reporting was not effective as of June 30,
2020.
24
Management’s Plan to Remediate Material
Weaknesses
Beginning
in 2019 and continuing in 2020, we engaged external consultants
with appropriate experience applying GAAP technical accounting
guidance, and we have hired additional accounting personnel. We
engaged external consultants to review revenue recognition for new
products, lease agreements, internal controls and related
procedures and review of documentation of internal controls in
addition to new equity and debt financing arrangements. Accounting
memos were produced for all technical issues during 2019 and
reviewed with management. All internal controls were reviewed, in
addition to new controls created and documented. We hired an
accounting manager in April 2019 to enhance the accounting
knowledge and abilities of the department. The accounting
manager’s skill set includes restructuring of accounting
procedure, preparation of budgets and key analytical reports and
managing all accounting functions. We also contracted with an
external financial reporting consultant in 2020. Adding an
additional members to the accounting team also enabled some
segregation of duties and additional review
procedures.
We
have also implemented cybersecurity training for all employees and
redesign of procedures that cyber security breaches may impact and
worked with our third party IT vendor to develop a training plan
for all existing and new employees related to cyber and implemented
related controls around information technology infrastructure. In
addition, an additional employee was hired to assist with the
management of IT controls and enhance internal IT resources. Going
forward, this employee will monitor our third party IT
vendor’s testing and monitoring efforts and where necessary
implement new controls as the Company grows. These internal
controls have been documented and procedures
implemented.
There
is no assurance that the measures described above will be
sufficient to remediate the previously identified material
weaknesses.
Changes in Internal Control over Financial Reporting
There
have been no changes in our internal control over financial
reporting that occurred during the period covered by this report
that materially affect, or are reasonably likely to materially
affect, our internal control over financial reporting. Management
is in the process of designing updated changes to its controls as
discussed above in “Management’s Plan to Remediate
Material Weaknesses.”
25
PART II — OTHER
INFORMATION
Item 1. LEGAL
PROCEEDINGS.
None.
Item 1A. RISK
FACTORS.
As a
“smaller reporting company” as defined by Item 10 of
Regulation S-K, we are not required to provide the information
required under this item.
Item 2. UNREGISTERED SALES OF EQUITY
SECURITIES AND USE OF PROCEEDS.
On June 5, 2020,
the Company entered into a Securities Purchase Agreement with
investor LGH Investments LLC (the “Investor”) for (i) a
Promissory Note (the “Convertible Promissory Note”) in
the original principal amount of $1,210,000, convertible into
shares of Common Stock, (ii) warrants entitling the Investor to
acquire 1,000,000 shares of Common Stock (the
“Warrants”) and (iii) two hundred thousand (200,000)
restricted common shares in the Company as an inducement grant (the
“Inducement Shares”). The issuance of the
Convertible Note, Warrants and Inducement Shares were offered and sold in a transaction exempt from
registration under the Securities Act of 1933, as amended, in
reliance on Section 4(a)(2) thereof.
Item 3. DEFAULTS UPON SENIOR
SECURITIES.
Not
applicable.
Item 4. MINE SAFETY DISCLOSURES.
Not
applicable.
Item 5. OTHER INFORMATION.
Not
applicable.
26
Item 6.
EXHIBITS
Exhibit
No.
|
Description
|
Certificate of Designation of Preferences, Rights
and Limitations of Series D ConvertiblePreferred Stock of the Company dated May 14, 2020
(Incorporated by reference to the Form 8-K filed with the SEC on
May 20, 2020).
|
|
|
|
Convertible
Promissory Note, dated as of June 5, 2020, issued by the Company to
LGH Investments, LLC (Incorporated by reference to the Form 8-K
filed with the SEC on June 11, 2020).
|
|
|
|
Common
Stock Purchase Warrant, dated as of June 5, 2020, issued by the
Company to LGH Investments, LLC (Incorporated by reference to the
Form 8-K filed with the SEC on June 11, 2020).
|
|
|
|
Series
D Preferred Stock Purchase Agreement, by and among the Company and
the accredited investors party thereto, dated May 14, 2020
(Incorporated by reference to the Form 8-K filed with the SEC on
May 20, 2020).
|
|
|
|
10.2*
|
Shareholders
Agreement by and between the Company and with Universus Global
Advisors LLC, Versani Health Consulting Consultoria em Gestão
de Negócios EIRELI, and IDIC Participações Ltda.,
dated April 17, 2020.
|
|
|
10.3Ꚙ
|
Separation
Agreement and General Release, dated as of May 14, 2020 by and
between the Company and Shri P. Parikh (Incorporated by reference
to the Form 8-K filed with the SEC on May 18, 2020).
|
|
|
Promissory
Note by and between the Company and Truist Bank, dated May 28, 2020
(Incorporated by reference to the Form 8-K filed with the SEC on
June 1, 2020).
|
|
|
|
10.5*
|
Option
Agreement by and between the Company and Celularity Inc., dated
June 7, 2020.
|
|
|
Securities
Purchase Agreement, dated as of June 5, 2020, by and between the
Company and LGH Investments, LLC (Incorporated by reference to the
Form 8-K filed with the SEC on June 11, 2020).
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of the Principal Executive
Officer.
|
|
|
|
Rule
13a-14(a)/15d-14(a) Certification of the Chief Financial
Officer.
|
|
|
|
Section
1350 Certification of the Principal Executive Officer.
|
|
|
|
Section
1350 Certification of the Chief Financial Officer.
|
|
|
|
101.INS*†
|
XBRL
Instance.
|
|
|
101.SCH*†
|
XBRL
Taxonomy Extension Schema.
|
|
|
101.CAL*†
|
XBRL
Taxonomy Extension Calculation.
|
|
|
101.DEF*†
|
XBRL
Taxonomy Extension Definition.
|
|
|
101.LAB*†
|
XBRL
Taxonomy Extension Labels.
|
|
|
101.PRE*†
|
XBRL
Taxonomy Extension Presentation.
|
______________________________________
Ꚙ Indicates management
contract or compensatory plan or arrangement.
*
Filed herewith.
**
Furnished herewith.
† XBRL-related documents are not deemed filed for purposes of
section 11 of the Securities Act of 1933, as amended, section 18 of
the Securities Exchange Act of 1934, as amended, or otherwise
subject the liabilities of these sections, and are not part of any
registration statement to which they relate.
27
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
|
SANUWAVE HEALTH, INC. |
|
|
|
|
|
|
Date: August 14, 2020
|
By:
|
/s/ Kevin A.
Richardson, II
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Name: Kevin A.
Richardson, II
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Title:
Chief
Executive Officer
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Pursuant
to the requirements of the Securities Exchange Act of 1934, this
report has been signed below by the following persons on behalf of
the registrant and in the capacities and on the dates
indicated:
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Signatures
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Capacity
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Date
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By: /s/ Kevin A. Richardson,
II
Name:
Kevin A. Richardson, II
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Chief Executive Officer and Chairman of the Board of
Directors
(principal executive officer)
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August
14, 2020
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By: /s/ Lisa E.
Sundstrom
Name:
Lisa E. Sundstrom
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Chief Financial Officer (principal financial and accounting
officer)
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August
14, 2020
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28