Sanara MedTech Inc. - Quarter Report: 2020 June (Form 10-Q)
U.S. SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 10-Q
(Mark
One)
[X]
QUARTERLY REPORT UNDER SECTION 13 OR 15(d) OF THE SECURITIES
EXCHANGE ACT OF 1934
For the quarterly period ended: June 30, 2020
or
[
] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE
SECURITIES EXCHANGE ACT OF 1934
Commission
File No. 0-11808
SANARA MEDTECH INC.
(Exact name of registrant as specified in its charter)
Texas
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59-2219994
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(State
or other jurisdiction of incorporation or
organization)
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(I.R.S.
Employer Identification Number)
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1200 Summit Ave, Suite 414, Fort Worth, Texas 76102
(Address of principal executive offices)
(817) 529-2300
(Registrant’s telephone number, including area
code)
Securities
registered pursuant to Section 12(b) of the Act: None
Title of each class
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Trading Symbol(s)
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Name of each exchange on which registered
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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, a 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
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☐
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Accelerated filer
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☐
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Non-accelerated
filer
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☒
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Smaller reporting company
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☒
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Emerging
growth company
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☐
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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 ☒
As of
August 13, 2020, the Company had 6,203,214 shares of Common Stock,
$.001 par value per share outstanding.
SANARA MEDTECH INC. AND SUBSIDIARIES
Form 10-Q
Quarter Ended June 30, 2020
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Page
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Part I – Financial Information
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19
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Part II. Other Information
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23
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23
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2
Part I – Financial Information
Item 1. Financial Statements
Sanara MedTech Inc. and Subsidiaries
Consolidated Balance Sheets
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(Unaudited)
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June 30,
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December 31,
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Assets
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2020
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2019
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Current assets
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Cash
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$3,305,281
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$6,611,928
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Accounts
receivable, net of allowance for bad debt of $80,029 and
$60,012
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1,368,371
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1,285,165
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Royalty
receivable
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49,344
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50,250
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Inventory,
net of allowance for obsolescence of $93,944 and
$43,650
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862,692
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746,519
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Prepaid
other - related party
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50,970
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-
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Prepaid
and other assets
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472,568
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161,902
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Total current assets
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6,109,226
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8,855,764
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Long-term assets
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Property,
plant and equipment, net of accumulated depreciation of $91,424 and
$60,694
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227,002
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204,953
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Right
of use assets – operating leases
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527,371
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585,251
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Intangible
assets, net of accumulated amortization of $698,079 and
$603,580
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3,226,696
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1,471,194
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Total long-term assets
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3,981,069
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2,261,398
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Total assets
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$10,090,295
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$11,117,162
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Liabilities and Shareholders' Equity
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Current liabilities
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Accounts
payable
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$139,795
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$337,504
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Accounts
payable – related party
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752,322
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68,668
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Accrued
royalties and expenses
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861,792
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528,060
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Accrued
bonus and commissions
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1,519,736
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1,588,056
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Operating
lease liability - current
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122,750
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117,533
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Short-term
debt
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190,433
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-
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Accrued
interest
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1,101
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-
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Total current liabilities
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3,587,929
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2,639,821
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Long-term liabilities
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Operating
lease liability – long term
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419,054
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481,384
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Convertible
notes payable – related party
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-
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1,500,000
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Long-term
debt
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392,567
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-
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Accrued
interest - related party
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-
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103,557
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Other
long-term liabilities
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77,092
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-
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Total long-term liabilities
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888,713
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2,084,941
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Total liabilities
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4,476,642
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4,724,762
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Shareholders' equity
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Series
F Convertible Preferred Stock: $10 par value, 1,200,000 shares
authorized; none issued and outstanding as of June 30, 2020 and
1,136,815 issued and outstanding as of December 31,
2019
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-
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11,368,150
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Common
Stock: $0.001 par value, 20,000,000 shares authorized; 6,203,402
issued and outstanding as of June 30, 2020 and 3,571,001 issued and
outstanding as of December 31, 2019
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6,203
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3,571
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Additional
paid-in capital
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11,475,511
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(2,081,829)
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Accumulated
deficit
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(5,638,523)
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(2,675,802)
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Total Sanara MedTech shareholders' equity
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5,843,191
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6,614,090
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Equity attributable
to noncontrolling interest
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(229,538)
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(221,690)
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Total shareholders' equity
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5,613,653
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6,392,400
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Total liabilities and stockholders' equity
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$10,090,295
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$11,117,162
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The accompanying notes are an integral part of these unaudited
consolidated financial statements.
3
Sanara MedTech Inc. and Subsidiaries
Consolidated Statements of Operations
(unaudited)
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Three Months Ended
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Six Months Ended
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June 30,
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June 30,
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2020
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2019
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2020
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2019
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Revenues
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$2,967,183
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$3,017,489
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$6,491,514
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$5,504,385
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Cost of goods sold
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348,675
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334,829
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678,863
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624,169
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Gross profit
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2,618,508
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2,682,660
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5,812,651
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4,880,216
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Operating expenses
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Selling,
general and administrative expenses
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3,624,027
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2,983,248
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8,530,565
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5,333,611
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Depreciation
and amortization
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74,221
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22,542
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127,726
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26,882
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Bad
debt expense
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-
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-
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30,000
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-
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Total operating expenses
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3,698,248
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3,005,790
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8,688,291
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5,360,493
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Operating loss
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(1,079,740)
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(323,130)
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(2,875,640)
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(480,277)
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Other expense
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Other
expense
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(48,716)
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145
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(85,474)
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145
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Interest
expense
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(1,101)
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(29,486)
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(9,455)
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(34,911)
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Total other expense
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(49,817)
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(29,341)
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(94,929)
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(34,766)
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Net loss
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(1,129,557)
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(352,471)
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(2,970,569)
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(515,043)
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Less:
Net loss attributable to noncontrolling interest
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(3,793)
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(1,054)
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(7,848)
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(1,054)
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Net loss attributable to Sanara MedTech common
shareholders
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$(1,125,764)
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$(351,417)
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$(2,962,721)
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$(513,989)
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Basic
loss per share of common stock
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$(0.18)
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$(0.15)
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$(0.54)
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$(0.37)
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Diluted
loss per share of common stock
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$(0.18)
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$(0.15)
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$(0.54)
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$(0.37)
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Weighted
average number of common shares outstanding basic
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6,203,577
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2,366,288
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5,477,759
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1,398,867
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Weighted
average number of common shares outstanding diluted
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6,203,577
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2,366,288
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5,477,759
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1,398,867
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The accompanying notes are an integral part of these unaudited
consolidated financial statements.
4
Sanara MedTech Inc. and Subsidiaries
Consolidated Statements of Changes in Shareholders’ Equity (Deficit)
(unaudited)
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Preferred Stock
Series F
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Common
Stock
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Additional
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Total
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$10 par
value
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$0.001 par
value
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Paid-In
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Treasury
Stock
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Accumulated
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Noncontrolling
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Shareholders'
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Shares
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Amount
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Shares
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Amount
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Capital
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Shares
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Amount
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Income/
(Deficit)
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Interest
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Equity
(Deficit)
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Balance at December 31,
2018
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1,136,815
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$11,368,150
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-
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$-
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$(10,919,639)
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-
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$-
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$138,286
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$-
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$586,797
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Reverse
recapitalization
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-
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-
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2,366,465
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2,366
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(1,159,929)
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(41)
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-
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-
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-
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(1,157,563)
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Net loss
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-
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-
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-
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-
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-
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-
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(162,572)
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-
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(162,572)
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Balance at March 31,
2019
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1,136,815
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$11,368,150
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2,366,465
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$2,366
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$(12,079,568)
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(41)
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$-
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$(24,286)
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$-
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$(733,338)
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Treasury stock
retirement
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-
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-
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(41)
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-
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-
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41
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-
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-
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-
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-
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Repurchase and cancellation of
fractional shares
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-
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-
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(243)
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-
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(1,061)
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-
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-
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-
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-
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(1,061)
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Net loss
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-
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-
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-
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-
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-
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-
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(351,417)
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(1,054)
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(352,471)
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Balance at June 30,
2019
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1,136,815
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$11,368,150
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2,366,181
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$2,366
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$(12,080,629)
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-
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$-
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$(375,703)
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$(1,054)
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$(1,086,870)
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|
Preferred Stock
Series F
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Common
Stock
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Additional
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Total
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|||
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$10 par
value
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$0.001 par
value
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Paid-In
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Treasury
Stock
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Accumulated
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Noncontrolling
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Shareholders'
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|||
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Shares
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Amount
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Shares
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Amount
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Capital
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Shares
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Amount
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Income/
(Deficit)
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Interest
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Equity
(Deficit)
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Balance at December 31,
2019
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1,136,815
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$11,368,150
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3,571,001
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$3,571
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$(2,081,829)
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-
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$-
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$(2,675,802)
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$(221,690)
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$6,392,400
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Conversion of Preferred Shares to
Common
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(1,136,815)
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(11,368,150)
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2,273,630
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2,274
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11,365,876
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-
|
-
|
-
|
-
|
-
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Conversion of Promissory Note to
Common
|
-
|
-
|
179,101
|
179
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1,611,732
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-
|
-
|
-
|
-
|
1,611,911
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Stock Grants
|
-
|
-
|
180,100
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180
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(180)
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-
|
-
|
-
|
-
|
-
|
Share-based
compensation
|
-
|
-
|
-
|
-
|
393,740
|
-
|
-
|
-
|
-
|
393,740
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Net loss
|
-
|
-
|
-
|
-
|
|
-
|
-
|
(1,836,957)
|
(4,055)
|
(1,841,012)
|
Balance at March 31,
2020
|
-
|
$-
|
6,203,832
|
$6,204
|
$11,289,339
|
-
|
$-
|
$(4,512,759)
|
$(225,745)
|
$6,557,039
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Stock Grants
|
|
|
(430)
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(1)
|
1
|
-
|
-
|
-
|
-
|
-
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Share-based
compensation
|
|
|
|
|
186,171
|
-
|
-
|
-
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-
|
186,171
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Net income
(loss)
|
-
|
-
|
-
|
-
|
|
-
|
-
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(1,125,764)
|
(3,793)
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(1,129,557)
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Balance at June 30,
2020
|
-
|
$-
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6,203,402
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$6,203
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$11,475,511
|
-
|
$-
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$(5,638,523)
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$(229,538)
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$5,613,653
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The accompanying notes are an integral part of these unaudited
consolidated financial statements.
5
Sanara MedTech Inc. and Subsidiaries
Consolidated Statements of Cash Flows
(unaudited)
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Six Months Ended
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June 30,
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2020
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2019
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Cash flows from operating activities:
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Net
loss
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$(2,970,569)
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$(515,043)
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Adjustments
to reconcile net loss to net cash used in operating
activities
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Depreciation
and amortization
|
127,726
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26,882
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Interest expense on
convertible debt
|
8,354
|
22,585
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Interest expense on
PPP loan
|
1,101
|
-
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Loss on disposal of
asset
|
2,180
|
13,581
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Bad debt
expense
|
30,000
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-
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Inventory
obsolescence
|
75,422
|
85,838
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Share-based
compensation
|
491,069
|
-
|
Changes
in assets and liabilities:
|
|
|
(Increase)
decrease in accounts receivable
|
(112,301)
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(259,342)
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(Increase)
decrease in inventory
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(191,595)
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(15,109)
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(Increase)
decrease in prepaid - related parties
|
(50,970)
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(144,587)
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(Increase)
decrease in prepaid and other assets
|
(252,786)
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(758,132)
|
Increase
(decrease) in accounts payable
|
(197,709)
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(217,299)
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Increase
(decrease) in accounts payable related parties
|
(66,346)
|
55,243
|
Increase
(decrease) in accrued royalties and expenses
|
333,731
|
166,379
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Increase
(decrease) in accrued liabilities
|
40,502
|
299,440
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Net cash used in operating activities
|
(2,732,191)
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(1,239,564)
|
|
|
|
Cash flows from investing activities:
|
|
|
Purchase of
property and equipment
|
(57,456)
|
(25,606)
|
Cash received in
reverse acquisition
|
-
|
508,973
|
Repurchase and
cancellation of fractional shares
|
-
|
(1,061)
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Purchase of
intangible assets
|
(1,100,000)
|
-
|
Net cash flows provided by (used in) investing
activities
|
(1,157,456)
|
482,306
|
|
|
|
Cash flows from financing activities:
|
|
|
Draw on line of
credit
|
-
|
1,000,000
|
Proceeds from PPP
Loan
|
583,000
|
-
|
Net cash provided by financing activities
|
583,000
|
1,000,000
|
|
|
|
Net increase (decrease) in cash
|
(3,306,647)
|
242,742
|
Cash and cash equivalents, beginning of period
|
6,611,928
|
176,421
|
Cash and cash equivalents, end of period
|
$3,305,281
|
$419,163
|
|
|
|
Cash paid during the period for:
|
|
|
Interest
|
$-
|
$7,465
|
Income
taxes
|
-
|
-
|
|
|
|
Supplemental non-cash investing and financing
activities:
|
|
|
Common stock issued
for conversion of Series F Preferred Stock
|
11,368,150
|
-
|
Common stock issued
for conversion of Related Party debt and interest
|
1,611,911
|
-
|
Common stock
issuable in payment of intangible asset
|
750,000
|
-
|
Common stock issued
in reverse capitalization; less cash received of
$508,973
|
-
|
1,666,537
|
The accompanying notes are an integral part of these unaudited
consolidated financial statements.
6
Sanara MedTech Inc. and Subsidiaries
Notes to Unaudited Consolidated
Financial Statements
NOTE 1 – SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Background and Basis of Presentation
The
terms “Sanara MedTech,” “Sanara,”
“we,” “the Company,” “SMTI,”
“our,” and “us” as used in this report
refer to Sanara MedTech Inc. and its subsidiaries. The accompanying
unaudited consolidated balance sheet as of June 30, 2020, and
unaudited consolidated statements of operations for the six-months
ended June 30, 2020 and
2019, have been prepared in accordance with generally accepted
accounting principles for interim financial information and with
the instructions to Form 10-Q and Article 10 of Regulation S-X.
Accordingly, they do not include all of the information and
footnotes required by U.S. generally accepted accounting principles
for complete financial statements. In the opinion of management of
the Company, all adjustments (consisting of normal recurring
accruals) considered necessary for a fair presentation have been
included. Operating results for the six-month period ended June 30,
2020, are not necessarily indicative of the results that may be
expected for the year ending December 31, 2020, or any other
period. These financial statements and notes should be read in
conjunction with the financial statements for each of the two years
ended December 31, 2019, and December 31, 2018, included in the
Company’s Annual Report on Form 10-K.
On
August 28, 2018, the Company consummated definitive agreements that
continued the Company’s operations to market its principal
products, CellerateRX® Surgical Activated Collagen®
Peptides and CellerateRX® Hydrolyzed Collagen wound fillers
(“CellerateRX”), through a 50% ownership interest in a
newly formed Texas limited liability company, Cellerate, LLC which
began operations on September 1, 2018. The remaining 50% ownership
interest was held by an affiliate of The Catalyst Group, Inc.
(“Catalyst”), which acquired an exclusive world-wide
license to distribute CellerateRX products. Cellerate, LLC conducts
operations with an exclusive sublicense from the Catalyst affiliate
to distribute CellerateRX products into the wound care and surgical
markets in the United States, Canada and Mexico.
On
March 15, 2019, the Company acquired Catalyst’s 50% interest
in Cellerate, LLC (“the Cellerate Acquisition”) in
exchange for 1,136,815 shares of the Company’s newly created
Series F Convertible Preferred Stock. Each share of Series F
Convertible Preferred Stock was convertible at the option of the
holder, at any time, into 2 shares of common stock, adjusted for
the 1-for-100 reverse stock split of the Company’s common
stock which became effective on May 10, 2019. Additionally, each
holder of Series F Convertible Preferred Stock was entitled to vote
on all matters submitted for a vote of the Company’s
shareholders with votes equal to the number of shares of common
stock into which such holder’s Series F shares could then be
converted. Based on the closing price of the Company’s common
stock on March 15, 2019 and the conversion ratio of the Series F
Preferred Stock, the fair value of the preferred shares issued to
Catalyst was approximately $12.5 million. Following the closing of
this transaction, Mr. Ronald T. Nixon, Founder and Managing Partner
of Catalyst, was elected to the Company’s Board of Directors
effective March 15, 2019.
The
Cellerate Acquisition was accounted for as a reverse merger and
recapitalization because, immediately following the completion of
the transaction, Catalyst could obtain effective control of the
Company upon exercise of its convertible preferred stock and
promissory note, both of which could occur at Catalyst’s
option. Additionally, Cellerate, LLC’s officers and senior
executive positions continued on as management of the combined
entity after consummation of the Cellerate Acquisition. For
accounting purposes, Cellerate, LLC was deemed to be the accounting
acquirer in the transaction and, consequently, the transaction was
treated as a recapitalization of Sanara MedTech. As part of the reverse merger and
recapitalization, the net liabilities existing in the Company as of
the date of the merger totaling approximately $1,666,537, which
included $508,973 of cash, were converted to equity as part of this
transaction. No step-up in basis or intangible assets or
goodwill was recorded in this transaction.
On May
9, 2019, the Company organized Sanara Pulsar, LLC, a Texas limited
liability company, which is owned 60% by the Company’s wholly
owned subsidiary Cellerate, LLC, and 40% owned by Wound Care
Solutions, Limited, an unaffiliated company registered in the
United Kingdom (“WCS”). Net profits and losses and
distributions are shared by the members in proportion to their
respective membership interests. The Company consolidates the
operations and financial position of Sanara Pulsar.
On June
9, 2020, the Company organized United Wound and Skin Solutions,
LLC, a Delaware limited liability company. United Wound and Skin
Solutions is a 100% owned subsidiary of the Company. The Company
intends to utilize the UWSS entity to invest in future partnerships
and technology that offer proprietary, efficacious solutions for
wound and skin care.
Principles of Consolidation
The
unaudited consolidated financial statements include the accounts of
Sanara MedTech Inc. and its wholly owned subsidiaries, Wound Care
Innovations, LLC, a Nevada limited liability company, Cellerate,
LLC, a Texas limited liability company, and United Wound and Skin
Solutions, LLC. The consolidated financial statements also include
the accounts of Sanara Pulsar, LLC, a Texas limited liability
company which is owned 60% by the Company’s wholly owned
subsidiary Cellerate, LLC, and 40% owned by Wound Care Solutions,
Limited.
7
Revenue Recognition
The Company recognizes revenue in accordance with Accounting
Standards Codification (“ASC”) Topic 606, Revenue
from Contracts with Customers, which was adopted on January 1, 2018
using the modified retrospective method. Revenues are recognized
when control of the promised goods or services is transferred to
the customer in an amount that reflects the consideration the
Company expects to be entitled to receive in exchange for
transferring those goods or services. Revenue is recognized based
on the following five step model:
- Identification of the contract with a customer
- Identification of the performance obligations in the
contract
- Determination of the transaction price
- Allocation of the transaction price to the performance
obligations in the contract
- Recognition of revenue when, or as, the Company satisfies a
performance obligation
Details of this five-step process are as follows:
Identification of the contract with a customer
Customer purchase orders are generally considered to be contracts
under ASC 606. Purchase orders typically identify specific terms of
products to be delivered, create the enforceable rights and
obligations of both parties, and result in commercial substance. No
other forms of contract revenue recognition, such as the completed
contract or percentage of completion methods, were utilized by the
Company in either 2019 or 2020.
Performance obligations
The Company’s performance obligation is generally limited to
delivery of the requested items to its customers at the agreed upon
quantities and prices.
Determination and allocation of the transaction price
The Company has established prices for its products. These prices
are effectively agreed to when customers place purchase orders with
the Company. Rebates and discounts, if any, are recognized in full
at the time of sale as a reduction of net revenue. Allocation of
transaction prices is not necessary where one performance
obligation exists.
Recognition of revenue as performance obligations are
satisfied
Product revenues are recognized when the products are delivered,
and title passes to the customer.
Disaggregation of Revenue
Revenue
streams from product sales and royalties are summarized below for
the six months ended June 30, 2020 and 2019. All revenue was
generated in the United States; therefore, no geographical
disaggregation is necessary.
|
Six Months Ended
|
|
|
June 30,
|
|
|
2020
|
2019
|
Product
sales revenue
|
$6,391,014
|
$5,445,760
|
Royalty
revenue
|
100,500
|
58,625
|
Total Revenue
|
$6,491,514
|
$5,504,385
|
The Company recognizes royalty revenue from a licensing agreement
between BioStructures, LLC and the Company. The Company records
revenue each calendar quarter as earned per the terms of the
agreement which stipulates the Company will receive quarterly
royalty payments of at least $50,250. Under the terms of the
development and license agreement the Company executed with
BioStructures, LLC in 2011, royalties of 2.0% are recognized on
sales of products containing the Company’s patented
resorbable bone hemostasis. The minimum annual royalty due to the
Company is $201,000 per year throughout the life of the patent
which expires in 2023. These royalties are payable in quarterly
installments of $50,250. To date, royalties related to this
licensing agreement have not exceeded the annual minimum of
$201,000 ($50,250 per quarter).
8
Contract Assets and Liabilities
The Company does not have any contract assets or contract
liabilities.
Inventories
Inventories
are stated at the lower of cost or net realizable value, with cost
computed on a first-in, first-out basis. Inventories consist of
finished goods and related packaging components. The Company
recorded inventory obsolescence expense of $75,422 for the six
months ended June 30, 2020, compared to $85,838 for the six months
ended June 30, 2019. The allowance for obsolete and slow-moving
inventory had a balance of $93,944 at June 30, 2020, and $43,650 at
December 31, 2019. The Company considered the impact of COVID-19 on
its recorded value of inventory and determined no adjustment was
necessary.
Allowance for Doubtful Accounts
The
Company establishes an allowance for doubtful accounts to ensure
accounts receivable are not overstated due to uncollectible
accounts. The Company recorded bad debt expense of
$30,000 during the six
months ended June 30, 2020, and $0 during the six months ended June
30, 2019. The allowance for doubtful accounts at June 30, 2020 was
$80,029 and $60,012 at
December 31, 2019. Bad debt reserves are maintained based on a
variety of factors, including the length of time receivables are
past due and a detailed review of certain individual customer
accounts. If circumstances related to customers change, estimates
of the recoverability of receivables would be further adjusted. The
Company considered the impact of COVID-19 in its analysis of
receivables and determined that allowance for doubtful accounts was
appropriate at June 30, 2020.
Use of Estimates
The preparation of financial statements in conformity with
generally accepted accounting principles requires management to
make estimates and assumptions that affect amounts reported in the
financial statements and accompanying notes. The extent to which
the COVID-19 pandemic may directly or indirectly impact our
business, financial condition, and results of operations is highly
uncertain and subject to change. We considered the potential impact
of the COVID-19 pandemic on our estimates and assumptions and
determined there was not a material impact to our consolidated
financial statements as of and for the six months ended June 30, 2020; however, actual results could differ from those
estimates and there may be changes to our estimates in future
periods.
Impairment of Long-Lived Assets
Long-lived
assets, including certain identifiable intangibles held and to be
used by the Company, are reviewed for impairment whenever events or
changes in circumstances, including the COVID-19 pandemic, indicate
that the carrying amount of such an asset may not be recoverable.
The Company continuously evaluates the recoverability of its
long-lived assets based on estimated future cash flows and the
estimated liquidation value of such long-lived assets and provides
for impairment if such undiscounted cash flows are insufficient to
recover the carrying amount of the long-lived assets. If impairment
exists, an adjustment is made to write the asset down to its fair
value, and a loss is recorded as the difference between the
carrying value and fair value. Fair values are determined based on
quoted market values, undiscounted cash flows or internal and
external appraisals, as applicable. Assets to be disposed of are
carried at the lower of carrying value or estimated net realizable
value. No impairment was recorded during the six months ended June
30, 2020 and 2019.
Fair Value Measurements
As
defined in ASC Topic 820, fair value is the price that would be
received to sell an asset or paid to transfer a liability in an
orderly transaction between market participants at the measurement
date (exit price). The Company utilizes market data or assumptions
that market participants would use in pricing the asset or
liability, including assumptions about risk and the risks inherent
in the inputs to the valuation technique. These inputs can be
readily observable, market corroborated, or generally unobservable.
ASC 820 establishes a fair value hierarchy that prioritizes the
inputs used to measure fair value. The hierarchy gives the highest
priority to unadjusted quoted prices in active markets for
identical assets or liabilities (level 1 measurement) and the
lowest priority to unobservable inputs (level 3 measurement). This
fair value measurement framework applies at both initial and
subsequent measurement.
9
The
three levels of the fair value hierarchy defined by ASC Topic 820
are as follows:
Level 1
– Quoted prices are available in active markets for identical
assets or liabilities as of the reporting date. Active markets are
those in which transactions for the asset or liability occur in
sufficient frequency and volume to provide pricing information on
an ongoing basis. Level 1 primarily consists of financial
instruments such as exchange-traded derivatives, marketable
securities and listed equities.
Level
2 – Pricing inputs are other than quoted prices in active
markets included in Level 1, which are either directly or
indirectly observable as of the reported date. Level 2 includes
those financial instruments that are valued using models or other
valuation
methodologies.
These models are primarily industry-standard models that consider
various assumptions, including quoted forward prices for
commodities, time value, volatility factors, and current market and
contractual prices for the underlying instruments, as well as other
relevant economic measures. Substantially all of these assumptions
are observable in the marketplace throughout the full
term
of the
instrument, can be derived from observable data or are supported by
observable levels at which transactions are executed in the
marketplace. Instruments in this category generally include
non-exchange-traded derivatives such as commodity swaps, interest
rate swaps, options and collars.
Level 3
– Pricing inputs include significant inputs that are
generally less observable from objective sources. These inputs may
be used with internally developed methodologies that result in
management’s best estimate of fair value.
Our
intangible assets have been valued using the fair value accounting
treatment. A description of the methodology used, including the
valuation category, is described in Note 8 – Intangible
Assets.
Income Per Share
The
Company computes income per share in accordance with ASC Topic 260,
“Earnings per Share,” which requires the Company to
present basic and dilutive income per share when the effect is
dilutive. Basic income per share is computed by dividing income
available to common shareholders by the weighted average number of
common shares outstanding. Diluted income per share is computed
similar to basic income per share except that the denominator is
increased to include the number of additional common shares that
would have been outstanding if the potential common shares had been
issued and if the additional common shares were dilutive. All
convertible instruments were excluded from the current and prior
period calculations as their inclusion would have been
anti-dilutive during the six months ended June 30, 2020 and June
30, 2019.
The
following table summarizes the shares of common stock that were
potentially issuable but were excluded from the computation of
diluted net loss per share for the six months ended June 30, 2020
and 2019 as such shares would have had an anti-dilutive
effect:
|
As of June 30,
|
|
|
2020
|
2019
|
|
|
|
Stock
options
|
11,500
|
11,500
|
Convertible
debt
|
-
|
173,800
|
Preferred
shares
|
-
|
2,273,630
|
Recently Issued Accounting Pronouncements
In
February 2016, the FASB issued ASC Topic 842 Leases which is
effective for reporting periods beginning after December 15, 2018.
The Company adopted the pronouncement effective January 1, 2019.
In accordance with the transition
guidance of ASC 842, such arrangements are included in our balance
sheet as of January 1, 2019. All other leases are short-term leases
which for practical expediency the Company has elected to not
recognize as lease assets and lease liabilities. See Note 4
below for more information regarding the Company’s
leases.
On June
20, 2018, the FASB issued Accounting Standards Update (ASU)
2018-07, which simplifies the accounting for share-based payments
granted to nonemployees for goods and services. Under the ASU, most
of the guidance on such payments to nonemployees would be aligned
with the requirements for share-based payments granted to
employees. The Company adopted the pronouncement effective January
1, 2019, and the adoption did not have a material impact on the
Company’s financial position, operations or cash
flows.
10
NOTE 2 – NOTES PAYABLE
Convertible Notes Payable - Related Parties
As part
of the aforementioned transaction with a Catalyst affiliate to form
Cellerate, LLC, the Company issued a 30-month convertible
promissory note to Catalyst in the principal amount of $1,500,000,
bearing interest at a 5% annual interest rate, compounded
quarterly. Interest was payable quarterly but could be deferred at
the Company’s election to the maturity of the promissory
note. Outstanding principal and interest were convertible at
Catalyst’s option into shares of the Company’s common
stock at a conversion price of $9.00 per share.
On
February 7, 2020, Catalyst converted its $1,500,000 promissory
note, including accrued interest of $111,911, into 179,101 shares
of the Company’s common stock. As of June 30, 2020, there
were no related party promissory notes or accrued interest
outstanding.
Promissory Note - Paycheck Protection Program
On
April 22, 2020, the Company executed an unsecured promissory note
to Cadence Bank, N.A. (the “PPP Loan”) pursuant to the
Paycheck Protection Program (the “PPP”) under Division
A, Title I of the federal Coronavirus Aid, Relief, and Economic
Security (“CARES”) Act. The Company is using the PPP
Loan proceeds for covered payroll costs and other costs in
accordance with the relevant terms and conditions of the CARES
Act.
The PPP
Loan is in the principal amount of $583,000, bears interest at a
fixed rate of 1.00% per annum and matures on April 22, 2022. The
PPP Loan requires monthly payments of principal and interest in the
amount of $24,546 commencing on November 2, 2020 with a final
payment of $174,115 due on April 22, 2022. The PPP Loan may be
prepaid at any time prior to maturity without penalty. Under the
terms of the PPP, the Company may apply for forgiveness of the
amount due on the PPP Loan equal to the sum of payroll costs,
covered rent and covered utility payments incurred during the
8-week period commencing on the loan funding date of April 24,
2020. The foregoing summary is qualified in its entirety by
reference to the promissory note which is attached as Exhibit 10.1
to the Company’s Form 8-K filed on April 29, 2020. At June
30, 2020, the total outstanding note balance was $583,000 plus
accrued interest of $1,101.
NOTE 3 – COMMITMENTS AND CONTINGENCIES
LICENSE AGREEMENTS AND ROYALTIES
CellerateRX® Activated Collagen®
The
Company has an exclusive sublicense to distribute CellerateRX®
Activated Collagen® products into the wound care and surgical
markets in the United States, Canada and Mexico. The Company pays
specified royalties based on annual net sales of CellerateRX. The
term of the sublicense extends through August 2028, with automatic
one-year renewals through December 31, 2049, subject to termination
at the end of any renewal term by either party on six months'
notice. The Company pays royalties based on its annual net sales of
CellerateRX consisting of 3% of all collected net sales each year
up to $12,000,000, 4% of all collected net sales each year that
exceed $12,000,000 up to $20,000,000, and 5% of all collected net
sales each year that exceed $20,000,000. Minimum royalties of
$400,000 per year are payable for the first five years of the
sublicense agreement.
BIAKŌS™ Antimicrobial Wound Gel and BIAKŌS™
Antimicrobial Skin and Wound Cleanser
On July
7, 2019, the Company executed a license agreement with Rochal
Industries, LLC (“Rochal”) whereby the Company acquired
an exclusive world-wide license to market, sell and further develop
antimicrobial products for the prevention and treatment of microbes
on the human body utilizing certain Rochal patents and pending
patent applications (the “BIAKOS License Agreement”).
Currently, the products covered by the BIAKOS License Agreement are
BIAKŌS™ Antimicrobial Wound Gel, and BIAKŌS™
Antimicrobial Skin and Wound Cleanser. Both products are FDA
cleared. The Executive Chairman of the Company is also a director
of Rochal, and indirectly a significant shareholder of Rochal, and
through the potential exercise of warrants a majority shareholder
of Rochal. Another Company director is also a director and
significant shareholder of Rochal.
Future
commitments under the terms of the BIAKOS License Agreement
include:
1.
Subject to the
occurrence of specified the Company financing conditions by the end
of 2022, the Company will also pay Rochal $750,000, which at the
Company’s option, may be in cash or Sanara common stock; or a
combination of cash and Sanara common stock.
2.
The Company will
pay Rochal a royalty of:
a.
4% of net sales of
licensed products in countries in which patents are
registered
b.
2% of net sales of
licensed products in countries without patent
protection.
11
The
minimum annual royalty due to Rochal will be $100,000 beginning
with calendar year 2020. The annual minimum royalty will increase
by 10% each subsequent calendar year up to a maximum amount of
$150,000.
3.
The Company will
pay additional royalty annually based on specific net profit
targets from sales of the licensed products, subject to a maximum
of $1,000,000 during any calendar year.
Unless
previously terminated by the parties, the BIAKOS License Agreement
will expire with the related patents in December 2031.
The
foregoing summary does not purport to be complete and is qualified
in its entirety by reference to the BIAKOS License Agreement which
was filed as an exhibit to the Company’s Quarterly Report on
Form 10-Q filed with the SEC on August 14, 2019.
CuraShield™ Antimicrobial
Barrier Film and No Sting Skin
Protectant
On
October 1, 2019, the Company executed a license agreement with
Rochal whereby the Company acquired an exclusive world-wide license
to market, sell and further develop certain antimicrobial barrier
film and skin protectant products for use in the human health care
market utilizing certain Rochal patents and pending patent
applications (the “ABF License Agreement”). Currently,
the products covered by the ABF License Agreement are
CuraShield™ Antimicrobial Barrier Film and a no sting skin protectant
product.
Future
commitments under the terms of the ABF License Agreement
include:
1.
Subject to the
occurrence of specified Company financing conditions in 2020, the
Company will also pay Rochal $500,000, which at Rochal’s
option may be in cash or the Sanara common stock; or a combination
of cash and Sanara common stock.
2.
The
Company will pay Rochal a royalty of:
a.
4% of net sales of
licensed products in countries in which patents are
registered
b.
2% of net sales of
licensed products in countries without patent
protection.
The
minimum annual royalty due to Rochal will be $50,000 beginning with
the first full calendar year following the year in which first
commercial sales of the products occur (the “First Revenue
Year”). The annual minimum royalty will increase by 10% each
subsequent calendar year up to a maximum amount of
$75,000.
3.
The Company will
pay additional royalty annually based on specific net profit
targets from sales of the licensed products, subject to a maximum
of $500,000 during any calendar year.
Unless
previously terminated or extended by the parties, the ABF License
Agreement will terminate upon expiration of the last U.S. patent in
October 2033.
The
foregoing summary does not purport to be complete and is qualified
in its entirety by reference to the ABF License Agreement which was
filed as an exhibit to the Company’s Quarterly Report on Form
10-Q filed with the SEC on November 14, 2019.
Product License Agreement
On May
4, 2020, the Company executed a product license agreement (the
“Debrider License Agreement”) with Rochal whereby the
Company acquired an exclusive world-wide license to market, sell
and further develop an autolytic debrider for human medical use to
enhance skin condition or treat or relieve skin disorders,
excluding uses primarily for beauty, cosmetic, or toiletry
purposes.
Key
terms of the Debrider License Agreement include:
1.
The Company paid
Rochal $600,000 in cash and will pay $750,000 to Rochal at the
Company’s option in cash, Sanara common stock, or a
combination of cash and Sanara common stock.
Note:
The Company has elected to pay the $750,000 in Sanara common stock
which will be issued to Rochal in August 2020. Under the terms of
the agreement, the number of shares to be issued is determined by
dividing the amount to be paid ($750,000) by the closing sale price
of the Sanara’s common stock on the effective date of the
agreement. On May 4, 2020, the closing price of Sanara common stock
was $12.50 which will result in the issuance of 60,000 shares to
Rochal.
2.
At the time Rochal
issues a purchase order to its contract manufacturer for the first
good manufacturing practice run of the licensed products, the
Company will pay Rochal $600,000 in cash.
12
3.
Upon FDA clearance
of the licensed products, the Company will pay Rochal $500,000 in cash and $1,000,000
which at the Company’s option may be in cash or Sanara common
stock; or a combination of cash and Sanara common
stock.
4.
The Company will
pay Rochal a royalty of:
a.
4% of net sales of
licensed products in countries in which patents are
registered
b.
2% of net sales of
licensed products in countries without patent
protection.
c.
The minimum annual
royalty due to Rochal will be $100,000 beginning with the first
full calendar year following the year in which first commercial
sales of the licensed products occur and increase by 10% each
subsequent calendar year up to a maximum amount of
$150,000.
d.
The Company will
pay additional royalty annually based on specific net profit
targets from sales of the licensed products, subject to a maximum
of $1,000,000 during any calendar year
5.
The Debrider
License Agreement will expire in October 2034.
The
foregoing summary does not purport to be complete and is qualified
in its entirety by reference to the Debrider License Agreement
which was filed as an exhibit to the Company’s Quarterly
Report on Form 10-Q filed with the SEC on May 12,
2020.
Resorbable Bone Hemostat
The
Company acquired a patent in 2009 for a resorbable bone hemostat
and delivery system for orthopedic bone void fillers. This patent is not part of the Company’s
long-term strategic focus. The Company subsequently licensed
the patent to a third party to market a bone void filler product
for which the Company receives a 3% royalty on product sales over
the life of the patent, which expires in 2023 with annual minimum
royalties of $201,000. The Company pays two unrelated third parties
a combined royalty equal to eight percent (8%) of the
Company’s net revenues or minimum royalties generated from
products that utilize the Company's acquired patented bone hemostat
and delivery system. To date,
royalties received by the Company related to this licensing
agreement have not exceeded the annual minimum of $201,000 ($50,250
per quarter). Therefore, the Company’s annual royalty
obligation under the terms of the license agreement has been
$16,080 ($4,020 per quarter).
OTHER COMMITMENTS
At the
time of the formation of Sanara Pulsar, it and WCS entered into a
supply agreement whereby Sanara Pulsar became the exclusive
distributor in the United States of certain wound care products
that utilize intellectual property developed and owned by WCS. In
2019, the Company advanced to WCS $200,000 and recorded the payment
as a reduction of non-controlling interests. In the event
WCS’s Form K-l from Sanara Pulsar for the year 2020 does not
allocate to WCS net income of at least $200,000 ("Target Net
Income"), then Cellerate. LLC will, within 30 days after such
determination, pay WCS the amount of funds representing the
difference between Target Net Income and the actual amount of net
income shown on WCS’s Form K-1 for the year 2020. For the
years 2021 through 2024 Target Net Income will increase by 10% each
year and in the event WCS’s Form K-1 for any of those years
does not allocate to WCS net income in an amount at least equal to
Target Net Income for such year, then Cellerate, LLC will, within
30 days after such determination, pay WCS the amount of funds
representing the difference between Target Net Income and the
actual amount of net income shown on WCS’s Form K-1 for the
applicable year. All other distributions made by Sanara Pulsar to
its members, not including tax distributions, will be made
exclusively to Cellerate, LLC until such time as Cellerate, LLC has
received an amount of distributions equal to all such advances to
WCS.
NOTE 4 – LEASES
The
Company periodically enters into operating lease contracts for
office space and equipment. Arrangements are evaluated at inception
to determine whether such arrangements constitute a lease. In
accordance with the transition guidance of ASC 842, such
arrangements are included in our balance sheet as of January 1,
2019.
Right
of use assets, which we refer to as “ROU assets,”
represent the right to use an underlying asset for the lease term,
and lease
liabilities represent the obligation to make lease payments arising
from the lease. Operating lease ROU assets and liabilities were
recognized at the transition date based on the present value of
lease payments over the respective lease term, with the office
space ROU asset adjusted for deferred rent
liability.
13
The Company has two operating leases: an office space lease with a
remaining lease term of 48 months
and a copier lease with a remaining lease term
of 13 months
as of June 30, 2020. In
accordance with the transition guidance of ASC 842, such
arrangements are included in our balance sheet as of January 1,
2019.
All other leases are
short-term leases which for practical expediency the Company has
elected to not recognize as lease assets and lease
liabilities.
In
March 2017, and as amended in March 2018, the Company executed a
new office lease effective April 1, 2019 for office space located
at 1200 Summit Ave., Suite 414, Fort Worth, TX 76102. On July 1,
2019, the Company amended the office lease agreement which became
effective on August 22, 2019 upon completion by the landlord of
certain leasehold improvements. Under the terms of the amended
lease agreement, the Company leased an additional 1,682 rentable
square feet of office space which brought the total square footage
leased to 5,877. The amended lease agreement extends the original
term of the lease for a period of 36 months through June 30, 2024.
The monthly base rental payments under the amended lease agreement
are as follows:
|
|
Monthly
|
From
|
Through
|
Base Rental
|
August
22, 2019
|
June
30, 2020
|
$12,243.75
|
July
1, 2020
|
June
30, 2021
|
$12,488.63
|
July
1, 2021
|
June
30, 2022
|
$12,488.63
|
July
1, 2022
|
June
30, 2023
|
$12,733.50
|
July
1, 2023
|
June
30, 2024
|
$12,978.38
|
As the implicit rate in the leases is not determinable, the
discount rate applied to determine the present value of lease
payments is the Company’s incremental borrowing rate of
6.25%. The office space lease agreement contains no renewal terms,
so no lease liability is recorded beyond the termination date. The
copier lease can be automatically renewed but no lease liability is
recorded beyond the initial termination date as exercising this
option is not reasonably certain.
In
accordance with ASC Topic 842, the Company has recorded lease
assets of $527,371 and a related lease liability of $541,804 as of
June 30, 2020. Cash paid in 2020 for amounts included in
measurement of operating lease liabilities as of June 30, 2020 was
$74,709. The present value of our operating lease liabilities is
shown below.
Maturity of Operating Lease Liabilities
|
June
30, 2020
|
Remainder
of 2020
|
$76,178
|
2021
|
151,317
|
2022
|
151,333
|
2023
|
154,271
|
2024
|
77,870
|
Thereafter
|
-
|
Total
lease payments
|
610,969
|
Less
imputed interest
|
(69,165)
|
Present
Value of Lease Liabilities
|
$541,804
|
As of
June 30, 2020, our operating leases have a weighted average
remaining lease term of 4.0 years and a weighted average discount
rate of 6.25%.
14
NOTE 5 – PROPERTY & EQUIPMENT
Property
and equipment are stated at cost, less accumulated depreciation.
Depreciation is recorded using the straight-line method over the
estimated useful lives of the related assets, ranging from three to
ten years. A summary is as follows:
|
June 30,
|
December 31,
|
|
2020
|
2019
|
Computers
|
$87,928
|
$87,310
|
Office
equipment
|
22,597
|
22,312
|
Furniture
and fixtures
|
205,871
|
153,995
|
Leasehold
improvements
|
2,030
|
2,030
|
|
318,426
|
265,647
|
Less
accumulated depreciation
|
(91,424)
|
(60,694)
|
|
|
|
Property
and equipment, net
|
$227,002
|
$204,953
|
Depreciation expense related to property and equipment was $33,227
for the six months ended June 30,2020, and $7,917 for the six
months ended June 30,2019.
The
Company considered the impact the COVID-19 pandemic may have had on
the carrying value of its property and equipment and determined
that no impairment loss had occurred. We will continue to assess
the COVID-19 pandemic's impact on our business including any
indicators of impairment of property and equipment.
NOTE 6 – SHAREHOLDERS’ EQUITY
Preferred Stock
On
March 13, 2019, the Company established a new series of preferred
stock consisting of 1,200,000 shares of Series F Convertible
Preferred Stock, par value of $10.00 per share. After
proportionally adjusting to reflect a subsequent 1-for-100 reverse
stock split of the common stock, each share of Series F Convertible
Preferred Stock was convertible at the option of the holder, at any
time, into 2 shares of common stock. Additionally, each holder of
Series F Convertible Preferred Stock was entitled to vote on all
matters submitted for a vote of the Company’s shareholders
with votes equal to the number of shares of common stock into which
such holder’s Series F Preferred shares could then be
converted. The Series F Convertible Preferred Stock ranked senior
to the Company’s common stock as to the payment of dividends
(if any) and the distribution of assets. Upon liquidation of the
Company, holders of Series F Convertible Preferred Stock were
entitled to a liquidation preference of $5 per share.
On
February 7, 2020, Catalyst converted its entire holdings of Sanara
MedTech Inc.’s 30-month $1,500,000 convertible promissory
note and 1,136,185 shares of Series F convertible preferred stock
into shares of Sanara common stock. The Company issued an aggregate
of 2,452,731 shares of common stock in the conversions. After the
conversions, Catalyst and its affiliates control the voting of a
total of 3,416,587 shares of common stock, which represents 55.1%
of the 6,203,402 shares of common stock currently outstanding. As
of June 30, 2020, there were no
shares of the Series F preferred stock issued and outstanding.
Common Stock
On May
10, 2019 the Company effected a 1-for-100 reverse stock split of
the Company’s issued and outstanding shares of common stock.
Concurrent with the reverse stock split, the Company changed its
corporate name from Wound Management Technologies, Inc. to Sanara
MedTech Inc.
The
reverse stock split was previously approved by shareholders of a
majority of the Company’s outstanding voting stock on March
21, 2019. On May 10, 2019, the Company’s common stock began
trading on the OTCQB market under the symbol “WNDMD”
and traded under that symbol until June 6, 2019, at which time the
Company changed its trading symbol to “SMTI”. The
post-split common stock is traded under a new CUSIP number
79957L100. In connection with the reverse stock split, the Company
also made a corresponding adjustment to the Company’s
authorized capital stock to reduce the authorized common stock to
20,000,000 shares and the authorized preferred stock to 2,000,000
shares, effective May 10, 2019.
The
reverse stock split did not change a shareholder’s ownership
percentage of the Company's common stock, except for the small
effect where the reverse stock split would result in a shareholder
owning a fractional share. No fractional shares were issued as a
result of the reverse split. Shareholders who were otherwise
entitled to receive a fractional share received a cash payment
based on the market price of a share of the common stock on May 13,
2019.
On
October 15, 2019, Company closed a private placement offering of
1,204,820 shares of its common stock at a price of $8.30 per share.
All shares sold by the Company were newly issued shares. The
purchasers in the offering were related party entities to three
members of the Company’s Board of Directors.
15
On
February 21, 2020, the Company filed a Form S-8 registration
statement which registered an aggregate of 2,000,000 shares of its
common stock that may be issued under the Sanara MedTech Inc. 2014
Omnibus Long-Term Incentive Plan. Pursuant to Rule 416 of the
Securities Act of 1933, as amended, this registration statement
also covers such additional and indeterminate number of securities
as may become issuable pursuant to the provisions of the plan
relating to adjustments for changes resulting from a share
dividend, share split or similar change.
At the
Company’s Annual Meeting of Shareholders held on July 9,
2020, the Company approved the Restated 2014 Omnibus Long Term
Incentive Plan as amended (the “Plan”) in which the
Company’s directors, officers, employees and consultants are
eligible to participate. For a brief description of the Plan, see
the section entitled “Item 2, Approval of the Restated 2014
Omnibus Long Term Incentive Plan” in the Company’s
definitive Proxy Statement filed with the Securities and Exchange
Commission on June 25, 2020, which section is incorporated by
reference herein.
Restricted Stock Awards
During
the first quarter of 2020, the Company issued a total of 180,100
shares of restricted common stock to Company employees, directors,
and certain consultants of the Company. The restricted share awards
were issued under the Company’s 2014 Long Term Incentive Plan
and are subject to certain vesting provisions and other terms and
conditions set forth in each recipient’s restricted stock
agreement. During the second quarter of 2020, the Company issued an
additional 1,000 shares of restricted common stock to an officer of
the Company. Restricted shares forfeited during the second quarter
totaled 1,430.
The
fair value of each award is based on the closing price of the
Company’s common stock on the respective grant dates. The
Company recognizes compensation expense for stock awards on a
straight-line basis over the vesting period of the award.
Share-based compensation expense of $491,069 was recognized in
selling, general and administrative expenses during the six months
ended June 30, 2020. No share-based expense was recognized during
the six months ended June 30, 2019.
Below
is a summary of restricted stock activity for the six months ended
June 30, 2020:
|
For the Six Months Ended
|
|
|
June 30, 2020
|
|
|
Shares
|
Weighted Average
Grant
Date Fair Value |
Non-vested
at beginning of period
|
-
|
$-
|
Granted
|
181,100
|
11.50
|
Vested
|
(25,580)
|
11.16
|
Forfeited
|
(1,430)
|
11.15
|
Non-vested
at June 30, 2020
|
154,090
|
$11.57
|
At June 30, 2020 there was $1,488,058 of total unrecognized
share-based compensation expense related to unvested share-based
compensation awards. Unrecognized share-based compensation expense
is expected to be recognized over a weighted-average period of 2.3
years.
Stock Options
On
December 31, 2017, the Company granted a total of 11,500 options to
five employees. The aggregate fair value of the awards was
determined to be $61,322 and was to be expensed over a three-year
vesting period. On April 13, 2018, the Company granted a total of
2,000 options to one employee and one contractor. The aggregate
fair value of the awards was determined to be $8,943 and was to be
expensed over a three-year vesting period. The aggregate fair value
of the awards was determined to be $16,405 and was to be expensed
over a three-year vesting period.
The
Company’s stock option agreements include a provision whereby
all outstanding options vest immediately if the Company consummates
a transaction resulting in a change in control of the Company, as
defined in the stock option agreements. The Cellerate Acquisition
on March 15, 2019 (see Note 1 for more information) represented a
change in control of the Company for purposes of the stock option
agreements. Accordingly, all outstanding stock options fully vested
on March 15, 2019.
16
A
summary of the status of the stock options at June 30, 2020 and
changes during the six-month period then ended is presented
below:
|
For the Six Months Ended
June
30, 2020 |
||
|
|
Weighted Average
|
Weighted
Average
Remaining
|
|
Options
|
Exercise Price
|
Contract Life
|
Outstanding
at beginning of period
|
11,500
|
$6.00
|
|
Granted
|
-
|
-
|
|
Exercised
|
-
|
-
|
|
Forfeited
|
-
|
-
|
|
Expired
|
-
|
-
|
|
Outstanding at June
30, 2020
|
11,500
|
$6.00
|
2.5
|
|
|
|
|
Exercisable at June
30, 2020
|
11,500
|
$6.00
|
2.5
|
NOTE 7 – DEBT AND CREDIT FACILITIES
In
December 2018, Cellerate, LLC executed agreements with Cadence
Bank, N.A. (“Cadence”) which provided Cellerate, LLC
access to a revolving line of credit up to a maximum principal
amount of $1,000,000. The line of credit supports short-term
working capital requirements of Cellerate, LLC. The line of credit
is secured by substantially all of the assets of Cellerate, LLC.
The interest rate per annum under this loan is the “Prime
Rate” as it varies from time to time and designated in the
“Money Rates” section of the Wall Street Journal plus
0.75%.
On June
21, 2019, the Company modified the Cadence revolving line of credit
to increase the maximum principal amount from $1,000,000 to
$2,500,000. Most terms of the modification agreement, including
security and interest rate, were unchanged from the original loan
agreement. Significant changes under the terms of the modification
agreement include extending the maturity date from December 16,
2019 to June 19, 2020, and the addition of a financial covenant
requiring the Company to sell additional equity securities in an
amount of at least $5,000,000 no later than December 31,
2019.
On
October 16, 2019, the Company paid down the entire $2,200,000
balance of the revolving line of credit with cash proceeds received
through a private placement stock offering. The total outstanding
line of credit balance and accrued interest were $0 at June 30,
2020.
The
Company’s revolving line of credit with Cadence matured on
June 19, 2020. The Company is considering other financing options
including a new revolving line of credit with Cadence.
NOTE 8 – INTANGIBLE ASSETS
The
carrying values of the Company’s finite-lived intangible
assets are as follows:
|
June 30, 2020
|
December 31,
2019
|
||||
|
|
Accumulated
|
|
|
Accumulated
|
|
|
Cost
|
Amortization
|
Net
|
Cost
|
Amortization
|
Net
|
Patent
|
$510,310
|
$(510,310)
|
$-
|
$510,310
|
$(510,310)
|
$-
|
Product
Licenses
|
3,350,000
|
(139,627)
|
3,210,373
|
1,500,000
|
(48,876)
|
1,451,124
|
Software
and Other
|
64,464
|
(48,141)
|
16,323
|
64,464
|
(44,394)
|
20,070
|
Total
|
$3,924,774
|
$(698,078)
|
$3,226,696
|
$2,074,774
|
$(603,580)
|
$1,471,194
|
During
the first quarter of 2020, the Company paid a $500,000 milestone
payment to Rochal Industries, LLC (“Rochal”) upon FDA
clearance of BIAKŌS™ Antimicrobial Wound Gel pursuant to
the terms of the July 8, 2019 license agreement with Rochal. The
milestone payment was recorded as an addition to intangible assets.
During the second quarter of 2020, the Company signed a new product
license agreement which required an initial payment of $1,350,000
to Rochal which included $600,000 in cash and $750,000 payable at
the Company’s option in cash, Sanara common stock, or a
combination of cash and Sanara common stock. The initial payment
was recorded as an addition to intangible assets.
17
As of
June 30, 2020, the weighted-average amortization period for all
intangible assets is12.8 years. Amortization expense related to
intangible assets was $94,499 for the six months ended June 30,2020
and $18,965 for the six months ended June 30,2019. The estimated
remaining amortization expense as of June 30, 2020 is as
follows:
Remainder
of 2020
|
$129,030
|
2021
|
258,059
|
2022
|
255,645
|
2023
|
250,564
|
2024
|
250,564
|
Thereafter
|
2,082,834
|
Total
|
$3,226,696
|
During the second quarter of 2020, the Company reviewed the
carrying value of intangible assets due to the events and
circumstances surrounding the COVID-19 pandemic. The Company
does not believe the impact of COVID-19 has created an impairment loss on the Company’s intangible
assets. Accordingly, there was no impairment loss recognized
on the Company’s intangible assets during the six
months ended June 30,
2020.
NOTE 9 –RELATED PARTIES
Payables to Related Parties
The
Company had outstanding payables to related parties totaling
$752,322 at June 30, 2020, and $68,668 at December 31, 2019. The
outstanding payable at June 30, 2020 was primarily related to a
$750,000 payment due to Rochal under the terms of the product
license agreement dated May 4, 2020. The $750,000 amount due to
Rochal will be paid in Sanara common stock in August of
2020.
Prepaid other - related party
In the
normal course of business, the Company may advance payments to its
suppliers, inclusive of Rochal, a related party. As of June 30,
2020, the Company prepaid $50,970 to Rochal for a finished goods
inventory order. At December 31, 2019, there were no prepaid
balances to related parties.
18
Item
2. Management’s Discussion
and Analysis of Financial Condition and Results of
Operations
The following discussion of our financial condition and results of
operations should be read in conjunction with the
“Management’s Discussion and Analysis of Financial
Condition and Results of Operations” section and audited
consolidated financial statements and related notes thereto
included in our Annual Report on Form 10-K for the year ended
December 31, 2019 and with the unaudited consolidated financial
statements and related notes thereto presented in this Quarterly
Report on Form 10-Q.
Forward-Looking Statements
This Quarterly Report on Form 10-Q contains forward-looking
statements concerning the impact of the COVID-19 pandemic among
other matters. These statements may discuss expectations as to
future trends, plans, events, results of operations or financial
condition, or state other information relating to the Company.
Forward-looking statements generally will be accompanied by words
such as “anticipate,” “believe,”
“could,” “estimate,” “expect,”
“forecast,” “guidance,”
“intend,” “may,” “possible,”
“potential,” “predict,”
“project” or other similar words, phrases or
expressions. These statements should be used with caution and are
subject to various risks and uncertainties, many of which are
outside of the Company’s control. The following factors could
cause actual results to differ materially from those in the
forward-looking statements: unanticipated changes in the markets
for the Company’s business; unanticipated downturns in
business relationships with customers or their purchases from us;
the potential effects on our businesses from natural disasters; the
availability of credit to customers and suppliers; competitive
pressures on sales and pricing; unanticipated changes in the cost
of inventory and other operating costs; the introduction of
competing products; unexpected technical or marketing difficulties;
unexpected claims, charges, litigation or dispute resolutions; new
laws and governmental regulations; stock market and currency
fluctuations; war, civil or political unrest or terrorism; the
course of the COVID-19 pandemic and government responses thereto;
and unanticipated deterioration of economic and financial
conditions in the United States and around the world. The Company
does not assume any obligation to update these forward-looking
statements.
The
following discussion and analysis of our financial condition is as
of June 30, 2020. The discussion of our results of
operations and cash flows should be read in conjunction with our
unaudited financial statements and notes thereto included elsewhere
in this report and the audited financial statements and the notes
thereto included in our Annual Report on Form 10-K for the year
ended December 31, 2019.
Impact of the COVID-19 Pandemic
Beginning
in March 2020, many states issued orders suspending elective
surgeries in order to free-up hospital resources to treat COVID-19
patients. This resulted in a substantial reduction in demand for
the Company’s surgical products beginning primarily in the
second half of March 2020. Additionally, most states limited access
to skilled nursing facilities to only resident caregivers, which
impeded the Company’s ability to provide education and
product training to the clinicians who use our products in these
facilities. These restrictions resulted in an overall decline in
sales for the second quarter. As the second quarter progressed, the
Company saw a strong rebound in product sales as restrictions on
elective surgeries eased and the Company expanded the use of its
virtual training platform. During the second quarter, the Company
generated approximately $2.9 million of product sales revenue
including approximately $0.60 million in April, $0.86 million in
May, and $1.46 million in June (a record month for the
Company).
With
many states recently experiencing a spike in COVID-19 cases and
consequently reinstating recently relaxed restrictions, the Company
may again experience swings in monthly sales if surgeries are
postponed and subsequently rescheduled. Based on the
Company’s second quarter experience, management continues to
believe that the majority of postponed surgeries will ultimately be
performed.
As a
result of the COVID-19 pandemic, the Company has significantly
reduced costs in areas such as payroll, consulting, business
travel, and other discretionary spending. The duration of the
pandemic is uncertain, however, management believes that elective
surgical procedures will continue to be performed with the
exception of future geographic hotspots. We will continue to closely monitor the COVID-19
pandemic in order to ensure the safety of our people and our
ability to serve our customers and patients.
Business Overview
The Company was organized on December 14, 2001, as a Texas
corporation. The Company’s business is developing,
marketing, and distributing wound and skin care products to
physicians, hospitals, clinics and post-acute care settings. Our
products are primarily sold in the North American advanced wound
care and surgical tissue repair markets. Sanara MedTech products
include CellerateRX® Surgical Activated Collagen®
Adjuvant (CellerateRX); HYCOL™ Hydrolyzed Collagen (HYCOL);
BIAKŌS™ Antimicrobial Skin & Wound Cleanser
(BIAKŌS AWC); and PULSAR II™ Advanced Wound Irrigation
System (AWI™).
19
Products
CellerateRX
products are primarily purchased by hospitals and ambulatory
surgical centers for use by surgeons on surgical wounds. HYCOL
products are used in skilled nursing facilities, wound care clinics
and other medical facilities, and are intended for the management
of full and partial thickness wounds including pressure ulcers,
venous and arterial leg ulcers and diabetic foot ulcers. HYCOL is
currently approved for reimbursement under Medicare Part B. We
believe CellerateRX and HYCOL products are unique in composition,
superior to other products in clinical performance, and demonstrate
the ability to reduce costs associated with the standards of care
for their intended uses.
BIAKŌS
AWC is an FDA cleared, patented product that effectively disrupts
extracellular polymeric substances to eradicate biofilm microbes.
BIAKŌS AWC also provides mechanical removal of debris, dirt,
foreign materials, and microorganisms from wounds including stage
I-IV pressure ulcers, diabetic foot ulcers, post-surgical wounds,
first and second-degree burns as well as grafted and donor sites.
BIAKŌS AWC is effective in killing free-floating microbes,
immature and mature bacterial biofilms and fungal biofilms. In
addition, BIAKŌS AWC safety studies show that it is
non-cytotoxic, non-irritating, and non-sensitizing to healthy skin
and assists in the normal wound healing process. First sales of
BIAKŌS AWC occurred in July 2019
PULSAR
II™ Advanced Wound Irrigation System (AWI™) is a
portable, no touch, painless, selective hydro-mechanical
debridement system that effectively removes bacteria and necrotic
tissue from wounds without disrupting healthy tissue.
New Products, Markets and Services
The
Company received notification of FDA clearance for
BIAKŌS™ Antimicrobial Wound Gel in February 2020 and
expects to launch the product in 2020 to complement its
BIAKŌS™ AWC. Both products are effective against
planktonic microbes as well as immature and mature biofilms. When
used together, the cleanser can be used initially to clean a wound
and disrupt biofilms (removing 99% in 10 minutes). The gel can then
be applied and will remain in the wound for up to 72 hours,
eliminating biofilms between normal dressing changes.
Marketing, Sales and Distribution
The
Company’s CellerateRX Surgical products are attracting
increased business from hospitals and surgery centers due to their
recognized benefits including efficacy and economic value. The
surgical products are used in specialty areas such as spine,
orthopedics, trauma, vascular, general, plastic, podiatry and
reconstructive surgeries. The surgical products are sold through a
growing network of surgical specialty distributors and Company
representatives who are credentialed to demonstrate the products in
surgical settings.
The
Company’s advanced wound care products are primarily
distributed to post-acute care settings, including long-term care
facilities, home health, wound care centers, and professional
medical offices. We believe our products are unique in composition,
superior to other products in clinical performance, and demonstrate
the ability to reduce costs associated with standard wound
management. Our wound care products are sold by Company
representatives supplemented by major medical-surgical
distributors, independent distributors, and durable medical
equipment (DME) distributors.
The
Company currently employees 16 surgical regional sales managers
(“RSMs”) and 5 wound care RSMs. The company is
constantly evaluating new markets and opportunities to add to this
team as warranted.
Corporate Infrastructure
The
Company has significantly invested in corporate infrastructure in
2020 with the hiring of a Chief Commercialization and Regulatory
Officer. This position directs the Company’s efforts related
to product development, commercialization, procurement, quality and
regulatory matters associated with new and existing products. In
early 2020, the Company retained a Compliance Officer to oversee
the Company's ongoing compliance program focusing on policy
development, training and compliance with the Company’s Code
of Ethics.
Competition
The
wound care market is served by a number of large, multi-product
line companies as well as a number of small companies. Our products
compete with primary dressings, advanced wound care products,
collagen matrices and other biopharmaceutical products.
Manufacturers and distributors of competitive products include
Smith & Nephew plc, Acelity L.P. Inc. (acquired by 3M Company
in October 2019), Medline Industries, Inc., ACell Inc., and Integra
LifeSciences Holdings Corporation. Many of our competitors are
significantly larger than we are and have greater financial and
personnel resources. We believe our products outperform our
competitors’ currently available products by providing
greater efficacy, reducing the cost of patient care, and replacing
numerous products with a single primary dressing.
20
Liquidity and Capital Resources
Historically,
we have financed our operations primarily from the sale of equity
securities. During 2019 and 2020, our principal sources of
liquidity have been our cash generated from operations, cash
provided through a bank line of credit, and a $10,000,000 private
placement offering in October 2019. Cash consists of cash on
deposit with banks.
As a
result of the COVID-19 pandemic, the Company has significantly
reduced costs in areas such as payroll, consulting, business
travel, and other discretionary spending. We will continue to
monitor our cash flow and will make additional expenditure
adjustments as necessary. The Company will be applying for
forgiveness of the loan received under Paycheck Protection Program.
The Company believes the full amount of the loan ($583,000) will be
forgiven. If appropriate, we may pursue additional financing
including issuing additional stock and incurring additional debt.
If we are unable to obtain additional funding for operations at any
time in the future, we may not be able to continue operations as
currently planned which would require us to modify various aspects
of our operations.
For the
six months ended June 30, 2020, net cash used in operating activities was $2,732,191 compared to $1,239,564 used in operating activities during the
first six months of 2019. The higher use of cash in 2020 was due
primarily to the Company’s investment in sales force
expansion and corporate infrastructure.
For the
six months ended June 30, 2020, net cash used in investing
activities was $1,157,456 , compared to $482,306 provided by
investing activities during the first six months of 2019. The cash
used in investing activities during the first six months of 2020
was primarily due to the May 4, 2020 acquisition of the debrider
product license agreement from Rochal which included a $600,000
initial payment. In addition, a $500,000 milestone payment was made
to Rochal during the first quarter of 2020 as a result of FDA
clearance of BIAKŌS™ Antimicrobial Wound
Gel.
For the
six months ended June 30, 2020, net cash provided by financing activities was
$583,000 as compared to
$1,000,000 provided for
the six months ended June 30, 2019. The cash provided in 2020 were
proceeds from the Paycheck Protection Program loan.
Results of Operations
Revenues. The
Company generated revenue of $2,967,183 for the three months ended
June 30, 2020, compared to revenue of $3,017,489 for the three
months ended June 30, 2019, representing a 2% decrease in revenue
from the prior year. The lower second quarter revenue was due to
the suspension of elective surgeries and restricted access to
patient facilities throughout most parts of the United States as a
result of the COVID-19 pandemic. For the six months ended June 30,
2020, revenue totaled $6,491,514, compared to revenue of $5,504,385
for the six months ended June 30, 2019, yielding an 18% increase
from the prior year. The higher
revenue in 2020 was primarily due to strong revenue growth during
the first quarter as well as the month of June resulting from the
execution of the Company’s strategy to expand its sales force
and independent distribution network in both new and existing U.S.
markets.
Cost of goods sold.
Cost of goods sold for the three months ended June 30, 2020, was
$348,675, compared to costs of goods sold of $334,829 for the three
months ended June 30, 2019. Cost of goods sold for the six months
ended June 30, 2020, was $678,863, compared to costs of goods sold
of $624,169 for the six months ended June 30, 2019. The increase
over the prior year was primarily due to higher sales
volume.
Selling, general and administrative expenses
(“SG&A"). SG&A
expenses for the three months ended June 30, 2020, were $3,624,027,
as compared to $2,983,248 for the three months ended June 30, 2019.
SG&A expenses for the six months ended June 30, 2020, were
$8,530,565, as compared to $5,333,611 for the six months ended June
30, 2019. The higher SG&A expenses in 2020 were primarily due
to increased payroll costs resulting from sales force expansion and
operational support, and higher sales commission expense as a
result of higher product sales. Direct selling costs represented
the vast majority of the increase in total SG&A costs as we
increased the size of our field sales organization from nine in
June 2019 to twenty-one in June of 2020.
The
higher SG&A expenses are consistent with the Company's strategy
of building out a larger sales force and independent distribution
network. New sales representatives generally take six to twelve
months to begin generating significant revenue. The Company expects
SG&A expenses to decline as a percentage of revenue in the next
two years as revenue generated by new sales representatives begins
to offset the cost of the sales force expansion.
Interest expense. Interest expense was $1,101 for
the three months ended June 30, 2020, as compared to $29,486 for
the three months ended June 30, 2019. Interest expense was $9,455
for the six months ended June 30, 2020, as compared to $34,911 for
the six months ended June 30, 2019. The lower interest expense was
primarily due to not using our revolving line of credit in
2020.
21
Net income / loss. The Company had a net loss of $1,129,557
for the three months ended June 30, 2020, compared to net loss of
$352,471 for the three months ended June 30, 2019. The Company had
a net loss of $2,970,569 for the six months ended June 30, 2020,
compared to net loss of $515,043 for the six months ended June 30,
2019. The net loss was due to higher SG&A costs described
above, which were driven by the Company’s strategy to grow
top-line revenue through significant investments in sales force
expansion and related sales support infrastructure. The Company
expects SG&A expenses to decline as a percentage of revenue in
the next two years as the revenue generated by its new sales force
begins to offset the sales force expansion expense.
Off-Balance Sheet Arrangements
None.
Item 3. Quantitative and Qualitative
Disclosures About Market Risk
As a
smaller reporting company, we are not required to provide this
information.
Item 4. Controls and
Procedures
Disclosure Controls and Procedures
We maintain disclosure controls and procedures that are designed to
ensure that information required to be disclosed by us in the
reports that we file or submit to the Securities and Exchange
Commission under the Securities Exchange Act of 1934, as amended,
is recorded, processed, summarized and reported within the time
periods specified by the Securities and Exchange Commission’s
rules and forms, and that information is accumulated and
communicated to our management, including our principal executive
and principal financial officers (whom we refer to in this periodic
report as our Certifying Officer), as appropriate to allow timely
decisions regarding required disclosure. Our management evaluated,
with the participation of our Certifying Officer, the effectiveness
of our disclosure controls and procedures as of June 30, 2020,
pursuant to Rule 13a-15(b) under the Securities Exchange Act.
Based upon that evaluation, our Certifying Officer concluded that,
as of June 30, 2020, our disclosure controls and procedures were
effective.
Remediation of Previously Reported Material Weakness
As reported in Item 9A on Form 10-K for the year ended December 31,
2019, the Company’s management concluded that our internal
control over financial reporting was not effective due to the small
size of the Company and limited segregation of duties.
Notwithstanding such material weakness, management has concluded
that our financial statements for the periods included in this
Quarterly Report on Form 10-Q are fairly stated in all material
respects in accordance with generally accepted accounting
principles for each of the periods presented herein.
The Company has formally documented its system of internal control
and implemented additional controls including the hiring of an
additional full-time accounting professional in January 2020 which
enabled the Company to properly segregate such duties. The Company
has concluded that the material weakness previously noted has been
remediated as of June 30, 2020.
Changes in Internal Control over Financial Reporting
Except
as noted above, there were no changes in our internal control over
financial reporting that
occurred during our most recently completed fiscal quarter that
have materially affected, or are reasonably likely to materially
affect, our internal control over financial
reporting. We will continue to evaluate the
effectiveness of internal controls and procedures on an on-going
basis.
22
Part II — Other Information
Item 1. Legal
Proceedings
As of
June 30, 2020, and as of this filing date, the Company has no
outstanding legal proceedings.
Item 1a. Risk
Factors
The COVID-19 pandemic in the United States and other parts of the
world may negatively impact our business, financial condition and
results of operations.
An
epidemic of COVID-19 is ongoing in the United States and most of
the world. On January 30, 2020, the World Health Organization
declared a global emergency, and since that time governments have
instituted measures to attempt to contain spread of the virus,
including temporary limitations on non-essential business
activities and elective surgical procedures in medical
facilities.
A
majority of our revenue is currently generated from the sale of
products in connection with surgical procedures. If extensive
limitations are put on these procedures and/or our sales personnel
are restricted from entering patient facilities, it could adversely
affect our sales and operating results. Additionally, we obtain our
products from manufacturers in the United States, and any
disruptions in those manufacturing sites or the shipment of the
products could impact our sales and operations.
The
extent to which these events impact our business will depend on
future developments regarding the rate of infection of the virus
and the further or lessening of current or new restrictions put in
place to contain the pandemic.
Item 2. Unregistered Sales of Equity
Securities and Use of Proceeds
None.
Item 3. Defaults Upon Senior
Securities
None.
Item 4. Mine Safety
Disclosure
This
item is not applicable.
Item 5. Other
Information
None.
Item 6. Exhibits
The
following documents are filed as part of this Report:
Exhibit
No.
|
|
Description
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31.1*
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Certification of Principal
Executive Officer in accordance with 18 U.S.C. Section 1350, as
adopted by Section 302 of the Sarbanes-Oxley Act of
2002*
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|
|
|
31.2*
|
|
Certification of Principal
Financial Officer in accordance with 18 U.S.C. Section 1350, as
adopted by Section 302 of the Sarbanes-Oxley Act of
2002*
|
|
|
|
32.1*
|
|
Certification of Principal
Executive Officer in accordance with 18 U.S.C. Section 1350, as
adopted by Section 906 of the Sarbanes-Oxley Act of
2002*
|
|
|
|
32.2*
|
|
Certification of Principal
Financial Officer in accordance with 18 U.S.C. Section 1350, as
adopted by Section 906 of the Sarbanes-Oxley Act of
2002*
|
|
|
|
101
|
|
Interactive Data Files pursuant to
Rule 405 of Regulation S-T.
|
* Filed herewith
Signatures
Pursuant to the
requirements of the Exchange Act of 1934, the registrant has caused
this report to be signed on its behalf by the undersigned thereunto
duly authorized.
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Sanara MedTech Inc.
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August
13, 2020
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By:
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/s/ Michael
McNeil
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Michael
McNeil
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|
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Chief
Financial Officer
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23