N
OTES TO UNAUDITED CONDENSED
CONSOLIDATED FINANCIAL STATEMENTS
March 31, 2019
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. Food and Drug Administration (the
“FDA”) notified the Company to permit the marketing of
the dermaPACE System for the treatment of diabetic foot ulcers in
the United States.
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 intends to
apply its Pulsed Acoustic Cellular Expression
(PACE
®
)
technology in wound healing, orthopedic, plastic/cosmetic and
cardiac conditions. In 2019, the Company has been marketing the
dermaPACE System for sale in the United States and the European
Conformity Marking (CE Mark) devices and accessories in Europe,
Canada, Asia and Asia/Pacific. The Company generates revenues
streams from product sales, licensing transactions and other
activities.
Basis of Presentation
The
accompanying unaudited condensed consolidated financial statements
of the Company have been prepared in accordance with United States
generally accepted accounting principles (“U.S. GAAP”)
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 GAAP for
complete financial statements. The financial information as of
March 31, 2019 and for the three months ended March 31, 2019 and
2018 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 months ended
March 31, 2019 are not necessarily indicative of the results that
may be expected for any other interim period or for the year ending
December 31, 2019.
The
condensed consolidated balance sheet at December 31, 2018 has
been derived from the audited consolidated financial statements at
that date but does not include all of the information and footnotes
required by 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
April 1, 2019 ("the 2018 Annual Report").
2. Going Concern
The
Company does not currently generate significant recurring revenue
and will require additional capital during 2019. As of March 31,
2019, the Company had an accumulated deficit of $117,520,434 and
cash and cash equivalents of
$98,946
. For the three months ended March 31, 2019 and 2018,
the net cash used by operating activities was $1,285,551 and
$1,848,565, respectively. The Company incurred a net loss of
$2,197,317 for the three months ended March 31, 2019. The operating
losses and the events of default on the Company’s short term
notes payable (see Note 7), the Company’s convertible
promissory notes and the notes payable, related parties (see Note
8) indicate 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.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
2. Going Concern (continued)
The continuation of the Company’s business
is dependent upon raising additional capital during the final three
quarters of 2019 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 conversion of outstanding warrants, 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.
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 2018 Annual
Report:
Principles of
consolidation
- The 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 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 consolidated financial
statements for any period necessarily involves the use of estimates
and assumptions. Actual amounts may differ from these estimates.
These 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, estimated reserves for inventory, valuation of
derivatives, the determination of the valuation allowances for
deferred taxes, estimated fair value of stock-based compensation,
and estimated fair value of warrants.
Reclassifications
–
Certain accounts in the prior period consolidated
financial statements have been reclassified for comparison purposes
to conform to the presentation of the current period consolidated
financial statements. These reclassifications had no effect on the
previously reported net loss.
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 March 31, 2019, inventory consists of
goods of $242,032 and parts of $195,814, net of reserve of $109,462
for total inventory of $328,384.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
3
.
Summary
of Significant Accounting Policies (continued)
Recently Issued or Adopted Accounting Standards
In
February 2016, the
Financial
Accounting Standards Board (“
FASB
”)
issued
Accounting Standards Update
(“
ASU
”)
2016-02,
Leases (Topic
842).
Subsequent to the issuance of Topic 842, the FASB
clarified the guidance through several ASUs; hereinafter the
collection of lease guidance is referred to as “ASC
842”. The Company, using the modified retrospective approach
with a cumulative-effect adjustment, recognized a right to use
("ROU") asset at the beginning of the period of adoption (January
1, 2019). Therefore, the Company recognized and measured operating
leases on the condensed consolidated balance sheet without revising
comparative period information or disclosure. The Company elected
the package of practical expedients permitted under the transition
guidance within the standard, which eliminates the reassessment of
past leases, classification and initial direct costs and treats
short term leases of less than a year outside of a ROU asset. The
Company has no financing leases. The adoption did not materially
impact the Company’s Condensed Consolidated Statements of
Operations or Cash Flows. Refer to Note
11
, Commitments and Contingencies, for
additional disclosures required by ASC 842. The Company determines
if an arrangement is a lease at inception. 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; there were no finance leases at this time which
would be recognized as depreciation expense and interest expense.
The Company has lease agreements which require payments for lease
and non-lease components and has elected to account for these as a
separate lease components. Non-leasing components are not included
in the ROU asset.
In
May 2017, the FASB issued ASU
No. 2017-09,
Compensation - Stock Compensation (Topic 718):
Scope of Modification Accounting
, which clarifies what
constitutes a modification of a share-based payment award.
The ASU is intended to provide clarity and reduce both diversity in
practice and cost and complexity when applying the guidance in
Topic 718 to a change to the terms or conditions of a share-based
payment award. ASU 2017-09 is effective for public entities
for annual periods beginning after December 15, 2017, and
interim periods within those fiscal years. The adoption of
ASU 2017-09 did have a material impact on the Company's financial
condition or results of operations.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
3
.
Summary
of Significant Accounting Policies (continued)
In July
2017, the FASB issued ASU No. 2017-11,
Earnings Per Share (Topic 260); Distinguishing
Liabilities from Equity (Topic 480): Derivatives and Hedging (Topic
815): (Part I) Accounting for Certain Financial Instruments with
Down Round Features, (Part II) Replacement of the Indefinite
Deferral for Mandatorily Redeemable Financial Instruments of
Certain Nonpublic Entities and Certain Mandatorily Redeemable
Noncontrolling Interests with a Scope Exception.
Part I of
this ASU addresses the complexity and reporting burden associated
with the accounting for freestanding and embedded instruments with
down round features as liabilities subject to fair value
measurement. Part II of this ASU addresses the difficulty of
navigating Topic 480. Part I of this ASU will be effective for
fiscal years beginning after December 15, 2018. Early adoption is
permitted for an entity in an interim or annual period. The Company
has elected to apply ASU 2017-11 using a modified-retrospective
approach by means of a cumulative-effect adjustment to its
financial statements as of the beginning of the first fiscal year
for which the account standard applies (or January 1, 2019), as
allowed under ASU 2017-11. Since the adoption of ASU 2017-11 would
have classified the warrants effected as equity at inception, the
cumulative-effect adjustment should (i) record the issuance date
value of the warrants as if they had been equity classified at the
issuance date, (ii) reverse the effects of changes in the fair
value of the warrants that had been recorded in the statement of
comprehensive loss of each period, and (iii) eliminate the
derivative liabilities form the balance sheet. The Company
calculated (i) at $262,339 and recorded an increase to additional
paid-in capital, (ii) at $1,279,661 and recorded an increase to
retained earnings and (iii) at $1,542,000 and decreased the warrant
liability.
In June 2018, the FASB issued ASU 2018-07,
Compensation
– Stock Compensation (Topic 718) – Improvements to
Nonemployee Share-Based Payment Accounting
. This ASU simplifies the accounting for
share-based payments to nonemployees by aligning it with the
accounting for share-based payments to employees. As a result,
share-based payments issued to nonemployees related to the
acquisition of goods and services will be accounted for similarly
to the accounting for share-based payments to employees, with
certain exceptions. This ASU is effective for fiscal years
beginning after December 15, 2018, including interim periods within
such fiscal years. Early adoption is permitted if financial
statements have not yet been issued. The adoption of ASU 2018-07
had no impact on the Company’s financial
statements.
In July 2018, the FASB issued ASU No.
2018-09,
Codification
Improvements
(“ASU
2018-09”). These amendments provide clarifications and
corrections to certain ASC subtopics including the following:
Income Statement - Reporting Comprehensive Income – Overall
(Topic 220-10), Debt - Modifications and Extinguishments (Topic
470-50), Distinguishing Liabilities from Equity – Overall
(Topic 480-10), Compensation - Stock Compensation - Income Taxes
(Topic 718-740), Business Combinations - Income Taxes (Topic
805-740), Derivatives and Hedging – Overall (Topic 815- 10),
and Fair Value Measurement – Overall (Topic 820-10). The
majority of the amendments in ASU 2018-09 will be effective in
annual periods beginning after December 15, 2018. The Company is
currently evaluating and assessing the impact this guidance will
have on its condensed consolidated financial
statements.
In August 2018, the FASB issued ASU No.
2018-13,
Fair Value Measurement (Topic
820): Disclosure Framework—Changes to the Disclosure
Requirements for Fair Value Measurement
(“ASU 2018-13”). The amendments in ASU
2018-13 modify the disclosure requirements associated with fair
value measurements based on the concepts in the Concepts Statement,
including the consideration of costs and benefits. The amendments
on changes in unrealized gains and losses, the range and weighted
average of significant unobservable inputs used to develop Level 3
fair value measurements, and the narrative description of
measurement uncertainty should be applied prospectively for only
the most recent interim or annual period presented in the initial
fiscal year of adoption. All other amendments should be applied
retrospectively to all periods presented upon their effective date.
The amendments are effective for all entities for fiscal years
beginning after December 15, 2019, and interim periods within those
fiscal years. Early adoption is permitted, including adoption in an
interim period. The Company is currently evaluating ASU 2018-13 and
its impact on its consolidated financial
statements.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
Accrued
expenses consist of the following:
|
|
|
|
|
|
|
|
|
Accrued board of
directors' fees
|
$
250,000
|
$
200,000
|
Accrued outside
services
|
148,576
|
115,118
|
Accrued executive
severance
|
140,500
|
136,000
|
Accrued related
party advances
|
102,370
|
101,137
|
Accrued
travel
|
58,993
|
58,993
|
Deferred
rent
|
-
|
44,623
|
Accrued legal
fees
|
38,098
|
-
|
Accrued clinical
study expenses
|
13,650
|
13,650
|
Accrued computer
equipment
|
-
|
8,752
|
Accrued
other
|
1,207
|
11,007
|
|
$
753,394
|
$
689,280
|
As of
March 31, 2019, the Company has contract assets and liabilities
from contracts with customers (see Note 12).
Contract
liabilities consist of the following:
|
|
|
|
|
|
|
|
|
Deposit on
product
|
$
82,950
|
$
92,950
|
Service
agreement
|
53,787
|
57,365
|
Other
|
35,139
|
28,218
|
Total
Contract liabilities
|
171,876
|
178,533
|
Non-Current
|
(42,612
)
|
(46,736
)
|
Total
Current
|
$
129,264
|
$
131,797
|
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 $171,876 of
contract liability balances as of March 31, 2019, the Company
expects to satisfy its remaining performance obligations associated
with $129,264 and $42,612 of contract liability balances within the
next twelve months and following twelve months, respectively. Of
the aggregate $178,533 of contract liability balances as of
December 31, 2018, the Company expects to satisfy its remaining
performance obligations associated with $131,797 and $46,736 of
contract liability balances within the next twelve months and
following twelve months, respectively.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
6.
Advances
from related parties
During
the three months ended March 31, 2019, the Company has received
$26,200 for warrant exercises. Due to the timing of receipt of cash
and issuance of the Company’s common stock the funds have
been recorded as advances from related parties and will be properly
recorded as equity when the common stock is issued.
7.
Short
term notes payable
During
the three months ended March 31, 2019, the Company entered into
short term notes payable in the total principal amount of $965,000
with an interest rate of 5% per annum. The total principal and
accrued interest of short term notes payable was $2,611,731 as of
March 31, 2019 and are due and payable six months from the date of
issuance of the respective notes.
On
December 26, 2018, the Company defaulted on the short term notes
payable issued on June 26, 2018 and began accruing interest at the
default interest rate of 10%. On January 2, 2019, the Company
defaulted on the short term notes payable issued on July 2, 2018
and began accruing interest at the default interest rate of 10%. On
January 30, 2019, the Company defaulted on the short term notes
payable issued on July 30, 2018 and began accruing interest at the
default interest rate of 10%.
8.
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 they are a
shareholder in the Company and have 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. Events of Default under the notes
payable, related parties have occurred and are continuing on
account of the failure of SANUWAVE, Inc., a Delaware corporation, a
wholly owned subsidiary of the Company and the borrower under the
notes payable, related parties, to make the required payments of
interest which were due on December 31, 2016, March 31, 2017, June
30, 2017, September 30, 2017, December 31, 2017, June 30, 2018,
September 30, 2018, December 31, 2018 and March 31, 2019
(collectively, the “Defaults”). As a result of the
Defaults, 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.
The
notes payable, related parties had an aggregate outstanding
principal balance of $5,372,743 at March 31, 2019 and December 31,
2018.
Accrued
interest, related parties currently payable totaled $1,391,469 at
March 31, 2019 and $1,171,782 at December 31, 2018. Interest
expense on notes payable, related parties totaled $219,687 and
$189,211 for the three months ended March 31, 2019 and 2018,
respectively.
Warrant Exercise
During
the three months ended March 31, 2019, the Company issued 620,000
shares of Common Stock upon the exercise of 620,000
Class
L Warrants and Class O Warrants to purchase shares of stock under
the terms of the respective warrant agreements.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
9.
Equity
transactions (continued)
Cashless Warrant Exercise
During
the three months ended March 31, 2019, the Company issued 704,108
shares of Common Stock upon the cashless exercise of 1,313,258
Class N Warrants and Class L Warrants to purchase shares of stock
under the terms of the respective warrant agreements.
Conversion of short term notes payable to equity
During
the three months ended March 31, 2019, the Company issued 3,333,334
shares of Common Stock upon the conversion of short term note
payable in the principal amount of $266,667 with the receipt of
notice of Class L warrant exercise of 3,333,334 Class L Warrants
under the terms of the short term note payable.
A
summary of the warrant activity during the three months ended March
31, 2019, is presented as follows:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Warrant
class
|
|
|
|
|
|
|
|
|
|
|
|
Class K
Warrants
|
7,200,000
|
-
|
-
|
-
|
7,200,000
|
Class L
Warrants
|
57,258,339
|
-
|
(4,100,001
)
|
-
|
53,158,338
|
Class N
Warrants
|
30,451,815
|
-
|
(1,046,591
)
|
-
|
29,405,224
|
Class O
Warrants
|
7,929,091
|
-
|
(120,000
)
|
-
|
7,809,091
|
Series A
Warrants
|
1,155,682
|
-
|
-
|
-
|
1,155,682
|
|
103,994,927
|
-
|
(5,266,592
)
|
-
|
98,728,335
|
A
summary of the warrant exercise price per share and expiration date
is presented as follows:
|
|
Expiration
|
|
|
date
|
|
|
|
Class K
Warrants
|
$
0.08
|
June
2025
|
Class K
Warrants
|
$
0.11
|
August
2027
|
Class L
Warrants
|
$
0.08
|
May
2019
|
Class N
Warrants
|
$
0.11
|
June
2019
|
Class O
Warrants
|
$
0.11
|
June
2019
|
Series A
Warrants
|
$
0.03
|
May
2019
|
The
exercise price of the Class K Warrants and the Series A Warrants
are subject to a “down-round” anti-dilution adjustment
if the Company issues or is deemed to have issued certain
securities at a price lower than the then applicable exercise price
of the warrants. Accordingly, the Company has classified such
warrants as derivative liabilities. The Class K Warrants may be
exercised on a physical settlement or on a cashless basis.
The Series A Warrants may be exercised on a physical settlement
basis if a registration statement underlying the warrants is
effective. If a registration statement is not effective (or
the prospectus contained therein is not available for use) for the
resale by the holder of the Series A Warrants, then the holder may
exercise the warrants on a cashless basis.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
The
Class K Warrants and the Series A Warrants are derivative financial
instruments. The estimated fair value of the Class K Warrants at
the date of grant was $36,989 and recorded as debt discount, which
is accreted to interest expense through the maturity date of the
related notes payable, related parties. The estimated fair values
of the Series A Warrants and the Series B Warrants at the date of
grant were $557,733 for the warrants issued in conjunction with the
2014 Private Placement and $47,974 for the warrants issued in
conjunction with the 18% Convertible Promissory Notes. The fair
value of the Series A Warrants and Series B Warrants were recorded
as equity issuance costs in 2014, a reduction of additional paid-in
capital. The Series B Warrants expired unexercised in March
2015.
The
estimated fair values were determined using a binomial option
pricing model based on various assumptions. The
Company’s derivative liabilities have been classified as
Level 3 instruments and are adjusted to reflect estimated fair
value at each period end, with any decrease or increase in the
estimated fair value being recorded in other income or expense
accordingly, as adjustments to the fair value of derivative
liabilities. Various factors are considered in the pricing
models the Company uses to value the warrants, including the
Company's current common stock price, the remaining life of the
warrants of 0.085 years, the volatility of the Company's
common stock price of 102%, and the risk-free interest rate of
2.43%. In addition, as of the valuation dates, management
assessed the probabilities of future financing and other re-pricing
events in the binominal valuation models.
A
summary of the changes in the warrant liability during the three
months ended March 31, 2019, is presented as follows:
|
|
|
|
|
|
|
|
|
|
|
|
Warrant liability
as of December 31, 2018
|
$
1,542,000
|
$
227,669
|
$
1,769,669
|
Issued
|
-
|
-
|
-
|
Exercised
|
-
|
-
|
-
|
Change in fair
value
|
-
|
(32,359
)
|
(32,359
)
|
Reclassification
due to adoption of ASU 2017-11 (see Note 3)
|
(1,542,000
)
|
-
|
(1,542,000
)
|
Warrant liability
as of March 31, 2019
|
$
-
|
$
195,310
|
$
195,310
|
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
11.
Commitments
and contingencies
Operating Leases
The Company is a
party to certain operating leases. In August 2016, we entered
into a lease agreement for 7,500 square feet of office space for
office, research and development, quality control, production and
warehouse space which expires on December 31, 2021. On February 1,
2018, we entered into an amendment to the lease agreement for an
additional 380 square feet of office space for storage which
expires on December 31, 2021. On January 2, 2019, we entered into a
second amendment to the lease agreement for an additional 2,297
square feet of office space for office space which expires on
December 31, 2021. Under the terms of the lease, we pay monthly
rent of $14,651, subject to a 3% adjustment on an annual
basis.
Right
of use assets and Lease liability - right of use consist of the
following:
|
|
|
|
Right of use
assets
|
$
437,363
|
|
|
Lease liability -
right of use
|
|
Current portion
|
$
164,521
|
Long term portion
|
315,730
|
Total Lease
liability - right of use
|
$
480,251
|
Cash paid for
amounts included in the measurement of lease liabilities for the
three months ended March 31, 2019 was $4,222 and were included in
Net cash used in operating activities in it condensed consolidated
statement of cash flows. Upon adoption of ASC 842 on January 1,
2019, the Company increased non-cash balances of right of use
assets and lease liability – right of use by $476,029 and
$520,652, respectively.
As of
March 31, 2019, the maturities of the Company's Lease liability -
right of use consist of the following:
Year ending
December 31,
|
|
2019
(remainder)
|
$
140,173
|
2020
|
191,713
|
2021
|
197,462
|
Total
lease payments
|
529,348
|
Less: Present
value adjustment
|
(49,097
)
|
Total Lease
liability - right of use
|
$
480,251
|
As required, the
following disclosure is provided for periods prior to adoption.
Minimum future lease payments that have initial or remaining lease
terms in excess of one year consist of the
following:
Year ending
December 31,
|
|
2019
(remainder)
|
$
140,173
|
2020
|
191,713
|
2021
|
197,462
|
Total
|
$
529,348
|
Rent
expense for the three months ended March 31, 2019 and 2018 was
$52,838 and $35,882, respectively.
As of
March 31, 2019, the Company had no leases that were classified as a
financing lease. As of March 31, 2019, the Company did not have
additional operating or financing leases that have not yet
commenced.
Litigation
The
Company is a defendant in 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. We believe that all
pending claims, if adversely decided, would not have a material
adverse effect on our business, financial position or results of
operations.
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
Disaggregation of Revenue
The
disaggregation of revenue is based on geographical region. The
following table presents revenue from contracts with customers for
the three months ended March 31, 2019 and 2018:
|
Three
months ended March 31, 2019
|
Three
months ended March 31, 2018
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Product
|
$
17,678
|
$
46,887
|
$
64,565
|
$
116,447
|
$
122,121
|
$
238,568
|
License
fees
|
6,250
|
100,000
|
106,250
|
6,250
|
77,866
|
84,116
|
Other
Revenue
|
-
|
7,148
|
7,148
|
-
|
21,588
|
21,588
|
|
$
23,928
|
$
154,035
|
$
177,963
|
$
122,697
|
$
221,575
|
$
344,272
|
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
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. Three
distributors accounted for 58%, 11% and 10% of revenues for the
three months ended March 31, 2019 and 39%, 5% and 0% of accounts
receivable at March 31, 2019.
Four
distributors accounted for 4%, 27%, 18% and 34% of revenues for the
three months ended March 31, 2018.
Three distributors and
partners accounted for 24%, 60% and 7% of accounts receivable at
December 31, 2018.
13.
Related
party transactions
During
the three months ended March 31, 2019 and 2018, the Company
recorded $17,678 and $116,447, 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 March 31,
2019 and 2018, of $138,887 and $48,553, respectively and the
Accrued expenses balance includes a balance at March 31, 2019 and
2018, of $0 and $10,000, respectively from this related
party.
14.
Stock-based
compensation
The
Company recognized as compensation cost for all outstanding stock
options granted to employees, directors and advisors, $0 for each
of the three months ended March 31, 2019 and 2018.
The
range of exercise prices for options was $0.04 to $2.00 for options
outstanding at March 31, 2019 and December 31, 2018, respectively.
The aggregate intrinsic value for all vested and exercisable
options was $1,456,116 and $2,085,866 at March 31, 2019 and
December 31, 2018, respectively.
The
weighted average remaining contractual term for outstanding
exercisable stock options was 7.15 and 7.4 years as of March 31,
2019 and December 31, 2018, respectively.
15.
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:
|
|
|
|
|
|
|
|
|
Options
|
31,703,385
|
21,593,385
|
Warrants
|
98,728,335
|
110,581,275
|
Convertible
promissory notes
|
25,058,432
|
-
|
|
155,490,152
|
132,174,660
|
SANUWAVE HEALTH, INC. AND SUBSIDIARIES
NOTES TO UNAUDITED CONDENSED CONSOLIDATED FINANCIAL
STATEMENTS
March 31, 2019
The
Company evaluates events that have occurred after the balance sheet
date but before the financial statements are issued.
Warrant Exercise
Subsequent
to March 31, 2019, the Company issued 13,693,435 shares of Common
Stock upon the exercise of 13,693,435 Series A Warrants, Class L
Warrants and Class O Warrants to purchase shares of stock under the
terms of the respective warrant agreements.
Cashless Warrant Exercise
Subsequent
to March 31, 2019, the Company issued 234,632 shares of Common
Stock upon the cashless exercise of 251,356 Series A Warrants to
purchase shares of stock under the terms of the warrant
agreement.
Warrant Exercise – Line of credit, related
parties
Subsequent
to March 31, 2019, the Company issued 2,475,000 shares of Common
Stock upon the exercise of 2,250,000 Class L Warrants converting
funds from line of credit, related parties to purchase shares of
stock under the terms of the warrant agreement.
Warrant Exercise – Short term notes payable
Subsequent
to March 31, 2019, the Company issued 137,500 shares of Common
Stock upon the exercise of 125,000 Series A Warrants converting
funds from short term notes payable to purchase shares of stock
under the terms of the warrant agreement.
Non-Cash Warrant Exercise
Subsequent
to March 31, 2019, the Company issued 200,000 shares of Common
Stock upon the exercise of 200,000 Class L Warrants to purchase
shares of stock under the terms of the warrant agreement. The cash
for this exercise was wired to an incorrect bank account due to the
cyber security breach at the Company. The Company issued the shares
of stock to the investor in lieu of the funds being
received.
Accrued related party advances
On
May 13, 2019, the Company repaid in full the outstanding balance
with interest of $102,918 to Shri Parikh, the President of the
Company.
Short term notes payable
Subsequent to March
31, 2019, the Company entered into short term notes payable with
individuals in the total principal amount of $250,000 with an
interest rate of 5% per annum. The principal and accrued interest
are due and payable six months from the date of issuance or receipt
of notice of warrant exercise.
Advances from related parties
Subsequent
to March 31, 2019, the Company collected $345,696 for the exercise
of Series A Warrants and Class L Warrants. The shares of Common
Stock for the exercise of the Series A Warrants and Class L
Warrants will be issued by the transfer agent upon receipt of
authorized documentation.
I
tem 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, 2018 included in our Annual Report on Form
10-K, filed with the SEC on April 1, 2019.
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 and was
cleared by the U.S. Food and Drug Administration ("FDA") on
December 28, 2017.
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.
In 2018, we started marketing our dermaPACE System for sale 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.
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 PMA approved OssaTron
®
device, and in
the stimulation of bone and chronic tendonitis regeneration in the
musculoskeletal environment through the utilization of our
orthoPACE
®
, OssaTron, and
Evotron
®
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.
Clinical Trials and Marketing
The FDA
granted approval of our Investigational Device Exemption (IDE) to
conduct two double-blinded, randomized clinical trials utilizing
our lead device product for the global wound care market, the
dermaPACE device, in the treatment of diabetic foot
ulcers.
The
dermaPACE system was evaluated using two studies under IDE G070103.
The studies were designed as prospective, randomized, double-blind,
parallel-group, sham-controlled, multi-center 24-week studies at 39
centers. A total of 336 subjects were enrolled and treated with
either dermaPACE plus conventional therapy or conventional therapy
(a.k.a. standard of care) alone. Conventional therapy included, but
was not limited to, debridement, saline-moistened gauze, and
pressure reducing footwear. The objective of the studies was to
compare the safety and efficacy of the dermaPACE device to
sham-control application. The prospectively defined primary
efficacy endpoint for the dermaPACE studies was the incidence of
complete wound closure at 12 weeks post-initial application of the
dermaPACE system (active or sham). Complete wound closure was
defined as skin re-epithelialization without drainage or dressing
requirements, confirmed over two consecutive visits within
12-weeks. If the wound was considered closed for the first time at
the 12 week visit, then the next visit was used to confirm closure.
Investigators continued to follow subjects and evaluate wound
closure through 24 weeks.
The dermaPACE device completed its initial Phase
III, IDE clinical trial in the United States for the treatment of
diabetic foot ulcers in 2011 and a PMA application was filed with
the FDA in July 2011.
The patient enrollment for the second,
supplemental clinical trial began in June 2013. We completed
enrollment for the 130 patients in this second trial in November
2014 and suspended further enrollment at that time.
The
only significant difference between the two studies was the number
of applications of the dermaPACE device. Study one (DERM01; n=206)
prescribed four (4) device applications/treatments over a two-week
period, whereas, study two (DERM02; n=130) prescribed up to eight
(8) device applications (4 within the first two weeks of
randomization, and 1 treatment every two weeks thereafter up to a
total of 8 treatments over a 10-week period). If the wound was
determined closed by the PI during the treatment regimen, any
further planned applications were not performed.
Between
the two studies there were over 336 patients evaluated, with 172
patients treated with dermaPACE and 164 control group subjects with
use of a non-functional device (sham). Both treatment groups
received wound care consistent with the standard of care in
addition to device application. Study subjects were enrolled using
pre-determined inclusion/exclusion criteria in order to obtain a
homogenous study population with chronic diabetes and a diabetic
foot ulcer that has persisted a minimum of 30 days and its area is
between 1cm
2
and 16cm
2
, inclusive. Subjects
were enrolled at Visit 1 and followed for a run-in period of two
weeks. At two weeks (Visit 2 – Day 0), the first treatment
was applied (either dermaPACE or Sham Control application).
Applications with either dermaPACE or Sham Control were then made
at Day 3 (Visit 3), Day 6 (Visit 4), and Day 9 (Visit 5) with the
potential for 4 additional treatments in Study 2. Subject progress
including wound size was then observed on a bi-weekly basis for up
to 24 weeks at a total of 12 visits (Weeks 2-24; Visits
6-17).
A total
of 336 patients were enrolled in the dermaPACE studies at 37 sites.
The patients in the studies were followed for a total of 24 weeks.
The studies’ primary endpoint, wound closure, was defined as
“successful” if the skin was 100% re-epithelialized at
12 weeks without drainage or dressing requirements confirmed at two
consecutive study visits.
A
summary of the key study findings were as follows:
●
Patients treated
with dermaPACE showed a strong positive trend in the primary
endpoint of 100% wound closure. Treatment with dermaPACE increased
the proportion of diabetic foot ulcers that closed within 12 weeks,
although the rate of complete wound closure between dermaPACE and
sham-control at 12 weeks in the intention-to-treat (ITT) population
was not statistically significant at the 95% confidence level used
throughout the study (p=0.320). There were 39 out of 172 (22.67%)
dermaPACE subjects who achieved complete wound closure at 12 weeks
compared with 30 out of 164 (18.29%) sham-control
subjects.
●
In addition to the
originally proposed 12-week efficacy analysis, and in conjunction
with the FDA agreement to analyze the efficacy analysis carried
over the full 24 weeks of the study, we conducted a series of
secondary analyses of the primary endpoint of complete wound
closure at 12 weeks and at each subsequent study visit out to 24
weeks. The primary efficacy endpoint of complete wound closure
reached statistical significance at 20 weeks in the ITT population
with 61 (35.47%) dermaPACE subjects achieving complete wound
closure compared with 40 (24.39%) of sham-control subjects
(p=0.027). At the 24 week endpoint, the rate of wound closure in
the dermaPACE® cohort was 37.8% compared to 26.2% for the
control group, resulting in a p-value of 0.023.
●
Within 6 weeks
following the initial dermaPACE treatment, and consistently
throughout the 24-week period, dermaPACE significantly reduced the
size of the target ulcer compared with subjects randomized to
receive sham-control (p<0.05).
●
The proportion of
patients with wound closure indicate a statistically significant
difference between the dermaPACE and the control group in the
proportion of subjects with the target-ulcer not closed over the
course of the study (p-value=0.0346). Approximately 25% of
dermaPACE® subjects reached wound closure per the study
definition by day 84 (week 12). The same percentage in the control
group (25%) did not reach wound closure until day 112 (week 16).
These data indicate that in addition to the proportion of subjects
reaching wound closure being higher in the dermaPACE® group,
subjects are also reaching wound closure at a faster rate when
dermaPACE is applied.
●
dermaPACE
demonstrated superior results in the prevention of wound expansion
(≥ 10% increase in wound size), when compared to the control,
over the course of the study at 12 weeks (18.0% versus 31.1%;
p=0.005, respectively).
●
At 12 and 24 weeks,
the dermaPACE group had a higher percentage of subjects with a 50%
wound reduction compared to the control (p=0.0554 and p=0.0899,
respectively). Both time points demonstrate a trend towards
statistical significance.
●
The mean wound
reduction for dermaPACE subjects at 24 weeks was 2.10cm2 compared
to 0.83cm2 in the control group. There was a statistically
significant difference between the wound area reductions of the two
cohorts from the 6 week follow-up visit through the end of the
study.
●
Of the subjects who
achieved complete wound closure at 12 weeks, the recurrence rate at
24 weeks was only 7.7% in the dermaPACE group compared with 11.6%
in the sham-control group.
●
Importantly, there
were no meaningful statistical differences in the adverse event
rates between the dermaPACE treated patients and the sham-control
group. There were no issues regarding the tolerability of the
treatment which suggests that a second course of treatment, if
needed, is a clinically viable option.
We
retained Musculoskeletal Clinical Regulatory Advisers, LLC (MCRA)
in January 2015 to lead the Company’s interactions and
correspondence with the FDA for the dermaPACE, which have already
commenced. MCRA has successfully worked with the FDA on numerous
Premarket Approvals (PMAs) for various musculoskeletal, restorative
and general surgical devices since 2006.
Working
with MCRA, we submitted to FDA a
de novo
petition on July 23, 2016. Due
to the strong safety profile of our device and the efficacy of the
data showing statistical significance for wound closure for
dermaPACE subjects at 20 weeks, we believe that the dermaPACE
device should be considered for classification into Class II as
there is no legally marketed predicate device and there is not an
existing Class III classification regulation or one or more
approved PMAs (which would have required a reclassification under
Section 513(e) or (f)(3) of the FD&C Act). On December 28,
2017, the FDA determined that the criteria at section 513(a)(1)(A)
of (B) of the FD&C Act were met and granted the
de novo
clearance classifying dermaPACE
as Class II and available to be marketed immediately.
Finally, our
dermaPACE device has received the European CE Mark approval to
treat acute and chronic defects of the skin and subcutaneous soft
tissue, such as in the treatment of pressure ulcers, diabetic foot
ulcers, burns, and traumatic and surgical wounds. The dermaPACE is
also licensed for sale in Canada, Australia, New Zealand and South
Korea.
We are
actively marketing the dermaPACE to the European Community, Canada
and Asia/Pacific, utilizing distributors in select
countries.
Clinical Studies
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 late in
the third quarter of 2019.
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. Enrollment and first patient treatment
started in April 2019.
Financial Overview
Since
our inception, we have incurred losses from operations each year.
As of March 31, 2019, we had an accumulated deficit of
$117,520,434. Although the size and timing of our future operating
losses are subject to significant uncertainty, we anticipate that
our operating losses will continue over the next few years as we
incur expenses related to commercialization of our dermaPACE system
for the treatment of diabetic foot ulcers in the United States. If
we are able to successfully commercialize, market and distribute
the dermaPACE system, we hope to partially or completely offset
these losses in the future.
Our
operating losses create substantial doubt about our ability to
continue as a going concern. 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 Annual
Report on Form 10-K for the year ended December 31, 2018, filed
with the SEC on April 1, 2019.
Critical Accounting Policies and Estimates
The
discussion and analysis of our financial condition and results of
operations are 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.
While
our significant accounting policies are more fully described in
Note 2 to our consolidated financial statements filed with our
Annual Report on Form 10-K for the year ended December 31, 2018,
filed with the SEC on April 1, 2019, we believe that the following
accounting policies relating to revenue recognition, liabilities
related to warrants issued, and stock-based compensation are
significant and; therefore, they are important to aid you in fully
understanding and evaluating our reported financial
results.
Revenue Recognition
Sales
of medical devices, including related applicators and applicator
kits, are recognized when shipped to the customer. Shipments under
agreements with distributors are invoiced at a fixed price, are not
subject to return, and payment for these shipments is not
contingent on sales by the distributor. We recognize revenues on
shipments to distributors in the same manner as with other
customers. The initial warranty and extended warranty on the sale
of medical devices will be deferred and recognized over time as the
performance obligation is satisfied. Fees from services performed
are recognized when the service is performed. License fee for
refurbishment of applicators will be recognized at the time the
customer is granted the license to refurbish the applicators.
Revenue will be calculated using the transaction price that
represents the most likely consideration to be received for the
license times the number of licenses issued. Fees for upfront
distribution license agreements will be recognized on a straight
line basis based on the payment schedule in the
contract.
Liabilities Related to Warrants Issued
We
record certain common stock warrants we issued at fair value and
recognize the change in the fair value of such warrants as a gain
or loss, which we report in the Other Income (Expense) section in
our Consolidated Statements of Comprehensive Loss. We report these
warrants at fair value and they are classified as liabilities
because they contain certain down-round provisions allowing for
reduction of their exercise price. We estimate the fair value of
these warrants using a binomial options pricing model.
Stock-based Compensation
The
Stock Incentive Plan provides that stock options, and other equity
interests or equity-based incentives, may be granted to key
personnel, directors and advisors at the fair value of the common
stock at the time the option is granted, which is approved by our
board of directors. The maximum term of any option granted pursuant
to the Stock Incentive Plan is ten years from the date of
grant.
The
fair value of each option award is estimated on the date of grant
using the Black-Scholes option pricing model. The expected terms of
options granted represent the period of time that options granted
are estimated to be outstanding and are derived from the
contractual terms of the options granted. We amortize the fair
value of each option over each option’s vesting
period.
Results of Operations for the Three Months ended March 31, 2019 and
2018
Revenues and Cost of Revenues
Revenues for the
three months ended March 31, 2019 were $177,963, compared to
$344,272 for the same period in 2018, a decrease of $166,309, or
48%. Revenue resulted primarily from sales in Europe of our
orthoPACE devices and related applicators, sales in the United
States of our dermaPACE applicators and upfront distribution fee
from our Southeast Asia distribution agreement with Johnfk Medical
Inc. ("FKS"). The decrease in revenue for 2019 is primarily due to
a decrease in sales of orthoPACE devices in Asia/Pacific and the
European Community, as compared to the prior year, as well as lower
sales of new applicators.
Cost of
revenues for the three months ended March 31, 2019 were $93,853,
compared to $165,466 for the same period in 2018. Gross profit as a
percentage of revenues was 47% for the three months ended March 31,
2019, compared to 52% for the same period in 2018. The decrease in
gross profit as a percentage of revenues in 2019 was primarily due
to cost of new and refurbished dermaPACE applicators in the United
States as a result of placements. This was partially offset by
increased revenue for refurbishment license and upfront
distribution fee which have little or no related cost, as compared
to 2018.
Research and Development Expenses
Research and
development expenses for the three months ended March 31, 2019 were
$261,002, compared to $238,477 for the same period in 2018, an
increase of $22,525, or 9%. The increase in research and
development expenses in 2019, as compared to 2018, was due to an
increase in contracting for temporary services and increased study
expenses related to our new dosage study in
Poland.
Selling and Marketing Expenses
Selling
and marketing expenses for the three months ended March 31, 2019
were $158,083, compared to $51,959 for the same period in
2018, an increase of $106,124, or 204%. The increase in sales and
marketing expenses in 2019, as compared to 2018, 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.
General and Administrative Expenses
General and
administrative expenses for the three months ended March 31, 2019
were $1,517,101, as compared to $1,004,614 for the same period in
2018, an increase of $512,487, or 51%. The increase in general and
administrative expenses in 2019, as compared to 2018, was due to an
increase in salary, bonus and benefits related to new hires in
2018, increased legal costs of associated with SEC filings and
patent issuance and maintenance, increased consulting expenses of
related to our insurance reimbursement strategy for the
commercialization of dermaPACE and one-time expense related to
email spoofing cyber security breach.
Depreciation
Depreciation for
the three months ended March 31, 2019 was $8,357, compared to
$5,016 for the same period in 2018, an increase of $3,341, or 67%.
The increase was due to the higher depreciation related to increase
in fixed assets.
Other Income (Expense)
Other
income (expense) was a net expense of $336,885 for the three months
ended March 31, 2019 as compared to a net expense of
$4,735,395 for the same period in 2018, a decrease of
$4,398,510, or 93%, in the net expense. The decrease was primarily
due to decreased interest expense, beneficial conversion discount
and debt discount related to the convertible promissory notes
issued in the fourth quarter of 2017 and first quarter of 2018. In
addition, the net expense in 2019 included a non-cash gain for
valuation adjustment
on outstanding warrants of $32,359, as compared to a non-cash loss
for valuation adjustment on outstanding warrants of $2,973,682 in
2018.
Net Loss
Net loss for the
three months ended March 31, 2019 was $2,197,317, or ($0.01) per
basic and diluted share, compared to a net loss of $5,856,655, or
($0.04) per basic and diluted share, for the same period in 2018, a
decrease in the net loss of $3,659,338, or 62%. The decrease in the
net loss was primarily a result of a decrease in other income
(expense), partially offset by an increase in our operating
expenses as described above.