Innovus 10-Q
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 10-Q
(Mark
One)
[X]
Quarterly Report Pursuant to Section 13 or 15(d) of the Securities
Exchange Act of 1934
For
the Quarterly Period ended June 30, 2017
or
[
] Transition Report Pursuant to Section 13 or 15(d) of the
Exchange Act.
For
the transition period from ___ to ____.
Commission
File Number: 000-52991
INNOVUS
PHARMACEUTICALS, INC.
(Exact
name of registrant as specified in its charter)
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Nevada
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90-0814124
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(State
or Other Jurisdiction of
Incorporation or
Organization)
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(IRS
Employer
Identification
No.)
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9171 Towne Centre Drive, Suite 440,
San Diego, CA
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92122
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(Address of
Principal Executive Offices)
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(Zip
Code)
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858-964-5123
(Registrant’s
telephone number, including area code)
Indicate
by check mark whether the registrant (1) has filed all reports
required to be filed by Section 13 or 15(d) of the Securities
Exchange Act of 1934 during the preceding 12 months (or 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
and posted on its corporate Web site, if any, every Interactive
Data File required to be submitted and posted pursuant Rule 405 of
Regulation S-T (Sec.232.405 of this chapter) during the preceding
12 months (or for such shorter period that the registrant was
required to submit and post such files). Yes ☒ No
☐
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a nonaccelerated filer, smaller reporting
company, or an emerging growth company. See the definitions of
“large accelerated filer,” “accelerated
filer,” “smaller reporting company,” and
“emerging growth company” in Rule 12b-2 of the Exchange
Act (Check one):
|
Large
accelerated filer
☐
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Accelerated
filer
☐
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Non-accelerated
filer
☐
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Smaller
reporting company ☒
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Emerging
growth company ☐
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Indicate
by check mark whether the registrant is a shell company (as defined
in Rule 12b-2 of the Exchange Act). Yes ☐ No
☒
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
the number of shares outstanding of each of the issuer's classes of
common stock, as of the latest practicable date:
As of August 11,
2017, the registrant had 151,303,679 shares of common stock
outstanding.
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37
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INNOVUS
PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
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ASSETS
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Assets:
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Cash
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$1,824,633
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$829,933
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Accounts receivable, net
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21,148
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33,575
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Prepaid expense and other current assets
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394,273
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863,664
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Inventories
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586,455
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599,856
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Total current
assets
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2,826,509
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2,327,028
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Property and
equipment, net
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32,197
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29,569
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Deposits
|
14,958
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14,958
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Goodwill
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952,576
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952,576
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Intangible assets,
net
|
4,588,049
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4,903,247
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Total
assets
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$8,414,289
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$8,227,378
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LIABILITIES AND
STOCKHOLDERS' EQUITY
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Liabilities:
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Accounts payable and accrued expense
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$1,256,551
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$1,210,050
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Accrued compensation
|
1,540,224
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767,689
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Deferred revenue and customer deposits
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46,769
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11,000
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Accrued interest payable
|
20,587
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47,782
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|
Derivative liabilities – embedded conversion
features
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-
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319,674
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Derivative liabilities – warrants
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90,206
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164,070
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Contingent consideration
|
75,699
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170,015
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Current portion of notes payable, net of debt discount of $104,788
and $216,403, respectively
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819,252
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626,610
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Convertible debentures, net of debt discount of $0 and $845,730,
respectively
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-
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714,192
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Total current
liabilities
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3,849,288
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4,031,082
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Accrued compensation – less current portion
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1,036,315
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1,531,904
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Notes payable, net of current portion and debt discount of $0 and
$468, respectively
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-
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54,517
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Contingent consideration – less current portion
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1,484,064
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1,515,902
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Total
non-current liabilities
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2,520,379
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3,102,323
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Total
liabilities
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6,369,667
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7,133,405
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Commitments and
contingencies
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Stockholders’
equity:
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Preferred stock: 7,500,000 shares authorized, at $0.001 par value,
no shares issued and outstanding at June 30, 2017 and December 31,
2016, respectively
|
-
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-
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Common stock: 292,500,000 shares authorized, at $0.001 par value,
151,027,774 and 121,694,293 shares issued and outstanding at June
30, 2017 and December 31, 2016, respectively
|
151,028
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121,694
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Additional paid-in capital
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34,709,180
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30,108,028
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Accumulated deficit
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(32,815,586)
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(29,135,749)
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Total
stockholders' equity
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2,044,622
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1,093,973
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Total liabilities
and stockholders’ equity
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$8,414,289
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$8,227,378
|
See
accompanying notes to these condensed consolidated financial
statements.
INNOVUS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Operations
(Unaudited)
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For
the
Three
Months Ended
June
30,
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For
the
Six
Months Ended
June
30,
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Net
revenue:
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Product sales, net
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$2,031,157
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$1,019,520
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$4,208,447
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$1,243,983
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License revenue
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7,500
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-
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7,500
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1,000
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Net
revenue
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2,038,657
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1,019,520
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4,215,947
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1,244,983
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Operating
expense:
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Cost of product sales
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408,579
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262,934
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849,055
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383,057
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Research and development
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15,063
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3,892
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18,246
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3,892
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Sales and marketing
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1,555,736
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249,515
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3,243,087
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285,011
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General and administrative
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1,182,235
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945,572
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2,886,898
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2,233,309
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Total
operating expense
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3,161,613
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1,461,913
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6,997,286
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2,905,269
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Loss from
operations
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(1,122,956)
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(442,393)
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(2,781,339)
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(1,660,286)
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Other income
(expense):
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Interest expense
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(110,130)
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(1,860,399)
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(667,609)
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(2,251,250)
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Loss on extinguishment of debt
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-
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-
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(304,828)
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-
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Other income (expense), net
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(206)
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111
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(822)
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1,876
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Fair value adjustment for contingent consideration
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98,979
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(16,750)
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126,154
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(22,334)
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Change in fair value of derivative liabilities
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3,463
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(2,040,909)
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(48,193)
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(1,983,315)
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Total other
expense, net
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(7,894)
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(3,917,947)
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(895,298)
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(4,255,023)
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Loss before
provision for income taxes
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(1,130,850)
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(4,360,340)
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(3,676,637)
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(5,915,309)
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Provision for
income taxes
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3,200
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-
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3,200
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-
|
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Net
loss
|
$(1,134,050)
|
$(4,360,340)
|
$(3,679,837)
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$(5,915,309)
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Net loss per share
of common stock – basic and diluted
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$(0.01)
|
$(0.05)
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$(0.02)
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$(0.08)
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Weighted average
number of shares of common stock outstanding – basic and
diluted
|
159,997,395
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85,395,846
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147,617,064
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70,271,333
|
See
accompanying notes to these condensed consolidated financial
statements.
INNOVUS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash Flows
(Unaudited)
|
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For
the
Six
Months Ended
June
30,
|
|
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Cash flows from
operating activities:
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Net
loss
|
$(3,679,837)
|
$(5,915,309)
|
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Adjustments to
reconcile net loss to net cash (used in) provided by operating
activities:
|
|
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Depreciation
|
5,420
|
7,370
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Allowance for
doubtful accounts
|
4,276
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5,708
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Common stock,
restricted stock units and stock options issued to employees, board
of directors and
consultants for compensation and services
|
742,301
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1,223,941
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Loss on
extinguishment of debt
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304,828
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-
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Fair value of
embedded conversion feature in convertible debentures in
excess of allocated
proceeds
|
-
|
938,840
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Change in fair
value of contingent consideration
|
(126,154)
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22,334
|
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Change in fair
value of derivative liabilities
|
48,193
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1,983,315
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Amortization of
debt discount
|
601,348
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1,161,131
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Amortization of
intangible assets
|
315,198
|
335,685
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Changes in
operating assets and liabilities, net of acquisition
amounts
|
|
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Accounts
receivable
|
8,151
|
55,242
|
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Prepaid expense and
other current assets
|
88,452
|
24,964
|
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Deposits
|
-
|
(37,460)
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Inventories
|
13,401
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32,006
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Accounts payable
and accrued expense
|
406,501
|
98,835
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Accrued
compensation
|
276,946
|
279,728
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Accrued interest
payable
|
(14,085)
|
56,147
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Deferred revenue
and customer deposits
|
35,769
|
(16,325)
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Net cash
(used in) provided by operating activities
|
(969,292)
|
256,152
|
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Cash flows used in
investing activities:
|
|
|
|
Purchase of
property and equipment
|
(8,048)
|
(6,565)
|
|
|
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Cash flows from
financing activities:
|
|
|
|
Repayments of line
of credit convertible debenture – related party
|
-
|
(119,000)
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|
Proceeds from
short-term loans payable
|
-
|
21,800
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Payments on
short-term loans payable
|
-
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(180,995)
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Proceeds from notes
payable and convertible debentures
|
150,000
|
416,500
|
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Payments on notes
payable
|
(138,958)
|
(226,660)
|
|
Proceeds from stock
option exercises
|
2,894
|
-
|
|
Financing costs in
connection with convertible debentures
|
-
|
(19,000)
|
|
Proceeds from sale
of common stock and warrants, net of offering costs
|
3,307,773
|
-
|
|
Payments on
convertible debentures
|
(1,222,422)
|
-
|
|
Prepayment penalty
on extinguishment of convertible debentures
|
(127,247)
|
-
|
|
Net cash
provided by (used in) financing activities
|
1,972,040
|
(107,355)
|
|
|
|
|
|
Net change in
cash
|
994,700
|
142,232
|
|
|
|
|
|
Cash at beginning
of period
|
829,933
|
55,901
|
|
|
|
|
|
Cash at end of
period
|
$1,824,633
|
$198,133
|
|
Supplemental
disclosures of cash flow information:
|
|
|
|
Cash paid for
income taxes
|
$5,600
|
$-
|
|
Cash paid for
interest
|
$80,344
|
$87,085
|
|
|
|
|
|
Supplemental
disclosures of non-cash investing and financing
activities:
|
|
|
|
Common stock issued
for conversion of convertible debentures and accrued
interest
|
$350,610
|
$1,515,635
|
|
Reclassification of
the fair value of the embedded conversion features from
derivative liability to
additional paid-in capital upon conversion
|
$203,630
|
$2,018,565
|
|
Relative fair value
of common stock issued in connection with notes payable
recorded as debt
discount
|
$44,217
|
$93,964
|
|
Proceeds from note
payable paid to seller in connection with acquisition
|
$-
|
$300,000
|
|
Financing costs
paid with proceeds from note payable
|
$-
|
$7,500
|
|
Cashless exercise
of warrants
|
$-
|
$3,194
|
|
Fair value of the
contingent consideration for acquisition
|
$-
|
$314,479
|
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Reclassification of
the fair value of the warrants from derivative liability to
additional paid-in capital upon cashless exercise
|
$-
|
$518,224
|
|
Relative fair value
of warrants issued in connection with convertible debentures
recorded as debt
discount
|
$-
|
$186,526
|
|
Relative fair value
of common stock subscribed but unissued in connection with
convertible
debentures recorded as debt discount
|
$-
|
$472,814
|
|
Fair value of
embedded conversion feature derivative liabilities recorded as debt
discount
|
$-
|
$470,824
|
|
Fair value of
warrants issued to placement agents in connection with convertible
debentures recorded as debt discount
|
$-
|
$140,836
|
|
Deferred financing
costs included in accounts payable and accrued expense
|
$-
|
$15,000
|
|
Net proceeds from
convertible debentures in escrow included in restricted
cash
|
$-
|
$1,305,000
|
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Fair value of
non-forfeitable common stock issued to consultant recorded as
prepaid expense and other
current assets
|
$-
|
$9,500
|
|
Fair value of
non-forfeitable common stock issued to consultant included in
accounts payable and accrued
expense
|
$360,000
|
$-
|
|
Issuance of shares
of common stock for vested restricted stock units
|
$92
|
$18,888
|
|
Fair value of
common stock issued for prepayment of future royalties due under
the CRI License Agreement
included in prepaid expense and other current assets
|
$44,662
|
$-
|
|
Fair value of
beneficial conversion feature on line of credit convertible
debenture – related
party
|
$-
|
$3,444
|
See
accompanying notes to these condensed consolidated financial
statements.
INNOVUS PHARMACEUTICALS, INC.
Notes to Condensed Consolidated
Financial Statements
June 30, 2017
(Unaudited)
NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
Organization
Innovus
Pharmaceuticals, Inc., together with its subsidiaries (collectively
referred to as “Innovus”, “we”,
“our”, “us” or the “Company”)
is a Nevada formed, San Diego, California-based emerging commercial
stage pharmaceutical company delivering over-the-counter medicines
and consumer care products for men’s and women’s health
and respiratory diseases.
We
generate revenue from 21 commercial products in the United States,
including six of these commercial products in multiple countries
around the world through our commercial partners. Our commercial
product portfolio includes (a) Beyond Human® Testosterone
Booster, (b) Beyond Human® Growth Agent, (c) Zestra® to
increase female arousal and desire, (d) EjectDelay® for
premature ejaculation, (e) Sensum+® for reduced penile
sensitivity, (f) Zestra Glide®, (g) Vesele® for promoting
sexual health, (h) Androferti® to support overall male
reproductive health and sperm quality, (i) RecalMax™ for
cognitive brain health, (j) Beyond Human® Green Coffee
Extract, (k) Beyond Human® Vision Formula, (l) Beyond
Human® Blood Sugar, (m) Beyond Human® Colon Cleanse, (n)
Beyond Human® Ketones, (o) Beyond Human® Krill Oil, (p)
Beyond Human® Omega 3 Fish Oil, (q) UriVarx™ for bladder
health, (r) ProstaGorx™ for prostate health, (s)
AllerVarx™ for
management of allergy symptoms, (t) Apeaz™ indicated for
arthritis pain relief, and (u) ArthriVarx™ for joint health.
While we generate revenue from the sale of our commercial products,
most revenue is currently generated by Vesele®, Zestra®,
Zestra® Glide, RecalMax™, Sensum+®, UriVarx™,
ProstaGorx™, AllerVarx™, Apeaz™,
ArthriVarx™ and Beyond Human® Testosterone
Booster.
Pipeline Products
FlutiCare™
(fluticasone propionate nasal spray). FlutiCare™ is our nationally branded Over-the-Counter
(“OTC”) fluticasone
propionate nasal spray, United States Pharmacopeia
(“USP”) 50 mcg per spray, which is indicated to treat
individuals with allergic rhinitis, or more commonly referred to as
“allergies”. Allergic rhinitis is one of the most
common ailments in the western world and is continuing to grow as
there are approximately 50 million suffers in the U.S. alone
according to GlobalData. We expect to launch our
FlutiCare™ OTC product in the U.S. in the fourth quarter of
2017 (see Note 3).
PEVarx™. This
product is designed and tested in over 600 men to extend the length
of sexual intercourse and enhance male sexual performance and
stamina. We expect to launch this product in the second half of
2017.
Xyralid™. Xyralid™ is an OTC FDA
monograph compliant drug containing the active drug ingredient
lidocaine and indicated for the relief of the pain and symptoms
caused by hemorrhoids. We expect to launch this product in the
second half of 2017.
Urocis™ XR.
Urocis™ XR is a proprietary extended release of
Vaccinium Marcocarpon (cranberry) shown to provide 24-hour coverage
in the body in connection with urinary tract infections in women.
We expect to launch this product in the second half of
2017.
AndroVit™. AndroVit™ is a
proprietary supplement to support overall prostate and male sexual
health. AndroVit™ was specifically formulated with
ingredients known to support normal prostate health and vitality
and male sexual health. We expect to launch this product in the
second half of 2017.
Basis of Presentation and Principles of Consolidation
The
condensed consolidated balance sheet as of December 31, 2016, which
has been derived from audited consolidated financial statements,
and these unaudited condensed consolidated financial statements
have been prepared by management in accordance with accounting
principles generally accepted in the United States (“U.S.
GAAP”), and include all assets, liabilities, revenues and
expenses of the Company and its wholly owned subsidiaries: FasTrack
Pharmaceuticals, Inc., Semprae Laboratories, Inc.
(“Semprae”) and Novalere, Inc.
(“Novalere”). All material intercompany transactions
and balances have been eliminated. These interim unaudited
condensed consolidated financial statements and notes thereto
should be read in conjunction with Management’s Discussion
and Analysis of Financial Condition and Results of Operations and
the audited consolidated financial statements and notes thereto
included in the Company’s Annual Report on Form 10-K for the
year ended December 31, 2016. Certain information required by U.S.
GAAP has been condensed or omitted in accordance with the rules and
regulations of the U.S. Securities and Exchange Commission
(“SEC”). The results for the period ended June 30,
2017, are not necessarily indicative of the results to be expected
for the entire fiscal year ending December 31, 2017 or for any
future period. Certain items have been reclassified to
conform to the current year presentation.
Use of Estimates
The
preparation of these condensed consolidated financial statements in
conformity with U.S. GAAP requires management to make
estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and
liabilities at the dates of the condensed consolidated financial
statements and the reported amounts of revenues and expenses during
the reporting periods. Such management estimates include the
allowance for doubtful accounts, sales returns and chargebacks,
realizability of inventories, valuation of deferred tax assets,
goodwill and intangible assets, valuation of contingent acquisition
consideration, recoverability of long-lived assets and goodwill,
fair value of derivative liabilities and the valuation of
equity-based instruments and beneficial conversion
features. We base our estimates on historical experience and
various other assumptions that we believe to be reasonable under
the circumstances. Actual results could differ from these
estimates under different assumptions or conditions.
Liquidity
Our
operations have been financed primarily through proceeds from
convertible debentures and notes payable, sales of our common stock
and revenue generated from our products domestically and
internationally by our partners. These funds have provided us
with the resources to operate our business, sell and support our
products, attract and retain key personnel and add new products to
our portfolio. We have experienced net losses and negative
cash flows from operations each year since our inception. As
of June 30, 2017, we had an accumulated deficit of $32,815,586 and
a working capital deficit of $1,022,779.
In
March 2017, we raised net cash proceeds of $3,307,773 from the sale
of common stock and warrants in a registered public offering (see
Note 7) and, in January 2017 and December 2016, we raised $650,000
in gross proceeds from the issuance of notes payable to three
investors (see Note 5). We have also issued equity instruments in
certain circumstances to pay for services from vendors and
consultants.
As of
June 30, 2017, we had $1,824,633 in cash. During the six months
ended June 30, 2017, we had net cash used in operating activities
of $969,292. We expect that our existing capital resources, revenue
from sales of our products and upcoming sales milestone payments
from the commercial partners signed for our products will be
sufficient to allow us to continue our operations, commence the
product development process and launch selected products
through at least the next 12 months. In addition, our CEO, who is
also a significant shareholder, has deferred the remaining payment
of his salary earned thru June 30, 2016 totaling $1,036,315 for at
least the next 12 months. Our actual needs will depend on numerous
factors, including timing of introducing our products to the
marketplace, our ability to attract additional international
distributors for our products and our ability to in-license in
non-partnered territories and/or develop new product candidates.
Although no assurances can be given, we may raise additional
capital through the sale of debt or equity securities to provide
additional working capital, pay for further expansion and
development of our business, and to meet current obligations. Such
capital may not be available to us when we need it or on terms
acceptable to us, if at all.
Fair Value Measurement
Our
financial instruments are cash, accounts receivable, accounts
payable, accrued liabilities, derivative liabilities, contingent
consideration and debt. The recorded values of cash, accounts
receivable, accounts payable and accrued liabilities approximate
their fair values based on their short-term nature. The fair values
of the warrant derivative liabilities and embedded conversion
feature derivative liabilities are based upon the Black Scholes
Option Pricing Model (“Black-Scholes”) and the
Path-Dependent Monte Carlo Simulation Model calculations,
respectively, and are a Level 3 measurement (see Note 8). The fair
value of the contingent acquisition consideration is based upon the
present value of expected future payments under the terms of the
agreements and is a Level 3 measurement (see Note
3). Based on borrowing rates currently available to us,
the carrying values of the notes payable approximate their
respective fair values.
We
follow a fair value hierarchy that prioritizes the inputs to
valuation techniques used to measure fair value. The hierarchy
gives the highest priority to unadjusted quoted prices in active
markets for identical assets and liabilities (Level 1) and
the lowest priority to measurements involving significant
unobservable inputs (Level 3). The three levels of the fair
value hierarchy are as follows:
●
Level
1 measurements are quoted prices (unadjusted) in active markets for
identical assets or liabilities that we have the ability to access
at the measurement date.
●
Level
2 measurements are inputs other than quoted prices included in
Level 1 that are observable either directly or
indirectly.
●
Level
3 measurements are unobservable inputs.
Concentration of Credit Risk, Major Customers and Segment
Information
Financial
instruments that potentially subject us to significant
concentrations of credit risk consist primarily of cash and
accounts receivable. Cash held with financial institutions may
exceed the amount of insurance provided by the Federal Deposit
Insurance Corporation on such deposits. Accounts receivable
consist primarily of sales of Zestra® to U.S. based retailers
and Ex-U.S. partners. We also require a percentage of payment in
advance for product orders with our larger partners. We perform
ongoing credit evaluations of our customers and generally do not
require collateral.
Revenues
consist primarily of product sales and licensing rights to market
and commercialize our products. We have no customers
that accounted for 10% or more of our total net revenue during the
three and six months ended June 30, 2017 and 2016 and two customers
accounted for 60% of total net accounts receivable as of June 30,
2017. We had three customers that accounted for 62% of total net
accounts receivable as of December 31, 2016.
Over
95% of our sales are currently within the United States and Canada.
The balance of the sales are to various other countries, none of
which is 10% or greater.
We
operate our business on the basis of a single reportable segment,
which is the business of delivering over-the-counter medicines and
consumer care products for men’s and women’s health and
respiratory diseases. Our chief operating decision-maker is the
Chief Executive Officer, who evaluates us as a single operating
segment.
Revenue Recognition and Deferred Revenue
We
generate revenue from product sales and the licensing of the rights
to market and commercialize our products.
We
recognize revenue in accordance with Financial Accounting Standards
Board (“FASB”) Accounting Standards Codification
(“ASC”) 605, Revenue
Recognition. Revenue is recognized when all of the following
criteria are met: (1) persuasive evidence of an arrangement
exists; (2) title to the product has passed or services have
been rendered; (3) price to the buyer is fixed or determinable
and (4) collectability is reasonably assured.
Product Sales: We ship products directly to consumers
pursuant to phone or online orders and to our wholesale and retail
customers pursuant to purchase agreements or sales
orders. Revenue from sales transactions where the buyer has
the right to return the product is recognized at the time of sale
only if (1) the seller’s price to the buyer is
substantially fixed or determinable at the date of sale,
(2) the buyer has paid the seller, or the buyer is obligated
to pay the seller and the obligation is not contingent on resale of
the product, (3) the buyer’s obligation to the seller
would not be changed in the event of theft or physical destruction
or damage of the product, (4) the buyer acquiring the product
for resale has economic substance apart from that provided by the
seller, (5) the seller does not have significant obligations
for future performance to directly bring about resale of the
product by the buyer and (6) the amount of future returns can
be reasonably estimated.
License Revenue: The license agreements we enter into
normally generate three separate components of revenue: 1) an
initial payment due on signing or when certain specific conditions
are met; 2) royalties that are earned on an ongoing basis as
sales are made or a pre-agreed transfer price and 3) sales-based
milestone payments that are earned when cumulative sales reach
certain levels. Revenue from the initial payments or licensing fee
is recognized when all required conditions are met. Royalties are
recognized as earned based on the licensee’s sales. Revenue
from the sales-based milestone payments is recognized when the
cumulative revenue levels are reached. The achievement of the
sales-based milestone underlying the payment to be received
predominantly relates to the licensee’s performance of future
commercial activities. FASB ASC 605-28, Milestone Method, (“ASC
605-28”) is not used by us as these milestones do not meet
the definition of a milestone under ASC 605-28 as they are
sales-based and similar to a royalty and the achievement of the
sales levels is neither based, in whole or in part, on our
performance, a specific outcome resulting from our performance, nor
is it a research or development deliverable.
Sales Allowances
We
accrue for product returns, volume rebates and promotional
discounts in the same period the related sale is
recognized.
Our
product returns accrual is primarily based on estimates of future
product returns over the period customers have a right of return,
which is in turn based in part on estimates of the remaining
shelf-life of products when sold to customers. Future product
returns are estimated primarily based on historical sales and
return rates. We estimate our volume rebates and promotional
discounts accrual based on its estimates of the level of inventory
of our products in the distribution channel that remain subject to
these discounts. The estimate of the level of products in the
distribution channel is based primarily on data provided by our
customers.
In all
cases, judgment is required in estimating these reserves. Actual
claims for rebates and returns and promotional discounts could be
materially different from the estimates.
We
provide a customer satisfaction warranty on all of our products to
customers for a specified amount of time after product
delivery. Estimated return costs are based on historical
experience and estimated and recorded when the related sales are
recognized. Any additional costs are recorded when incurred or
when they can reasonably be estimated.
The
estimated reserve for sales returns and allowances, which is
included in accounts payable and accrued expense, was approximately
$51,000 and $61,000 at June 30, 2017 and December 31, 2016,
respectively.
Advertising Expense
Advertising costs, which primarily includes print and online media
advertisements, are expensed as incurred and are included in sales
and marketing expense in the accompanying condensed consolidated
statements of operations. Advertising costs were approximately
$1,253,000 and $169,000 and $2,611,000 and $180,000 for the three
and six months ended June 30, 2017 and 2016,
respectively.
Debt Extinguishment
Any
gain or loss associated with debt extinguishment is recorded in the
period in which the debt is considered extinguished. Third party
fees incurred in connection with a debt restructuring accounted for
as an extinguishment are capitalized. Fees paid to third parties
associated with a term debt restructuring accounted for as a
modification are expensed as incurred. Third party and creditor
fees incurred in connection with a modification to a line of credit
or revolving debt arrangements are considered to be associated with
the new arrangement and are capitalized.
Net Loss per Share
Basic
net loss per share is computed by dividing net loss by the weighted
average number of common shares outstanding and vested but deferred
RSUs during the period presented. Diluted net loss per share
is computed using the weighted average number of common shares
outstanding and vested but deferred RSUs during the periods plus
the effect of dilutive securities outstanding during the
periods. For the three and six months ended June 30, 2017 and
2016, basic net loss per share is the same as diluted net loss per
share as a result of our common stock equivalents being
anti-dilutive. See Note 7 for more details.
Recent Accounting Pronouncements
In July
2017, the FASB issued ASU No. 2017-11, Earnings Per Share (Topic 260); Distinguishing
Liabilities from Equity (Topic 480); Derivatives and Hedging (Topic
815): (Part I) Accounting for Certain Financial Instruments with
Down Round Features. The amendments in Part I of this ASU
change the classification analysis of certain equity-linked
financial instruments (or embedded features) with down round
features. When determining whether certain financial instruments
should be classified as liabilities or equity instruments, a down
round feature no longer precludes equity classification when
assessing whether the instrument is indexed to an entity’s
own stock. As a result, a freestanding equity-linked financial
instrument (or embedded conversion option) no longer would be
accounted for as a derivative liability at fair value as a result
of the existence of a down round feature. For freestanding equity
classified financial instruments, the amendments require entities
that present earnings per share to recognize the effect of the down
round feature when it is triggered. That effect is treated as a
dividend and as a reduction of income available to common
shareholders in basic earnings per share. For public business
entities, the amendments are effective for fiscal years beginning
after December 15, 2018, including interim periods within those
fiscal years. Early adoption is permitted
in any interim or annual period, with any adjustments reflected as
of the beginning of the fiscal year of adoption. The
amendments should be applied retrospectively to outstanding
financial instruments with down round features by means of either a
cumulative-effect adjustment to the consolidated statement of
financial position as of the beginning of the first fiscal year and
interim period of adoption or retrospectively to each prior
reporting period presented in accordance with the guidance on
accounting changes. We are currently in the process of evaluating
the effect this standard will have on our derivative liabilities
and the impact on our condensed consolidated financial position and
results of operation.
In
August 2016, the FASB issued ASU No. 2016-15, Statement of Cash Flows (Topic 230) –
Classification of Certain Cash Receipts and Cash Payments.
This ASU provides clarification regarding how certain cash receipts
and cash payments are presented and classified in the statement of
cash flows. This ASU addresses eight specific cash flow issues with
the objective of reducing the existing diversity in practice. The
issues addressed in this ASU that will affect us is classifying
debt prepayments or debt extinguishment costs and contingent
consideration payments made after a business combination. This
update is effective for annual and interim periods beginning after
December 15, 2017, and interim periods within that reporting period
and is to be applied using a retrospective transition method to
each period presented. Early adoption is permitted. We have elected
to early adopt ASU 2016-15 as of January 1, 2017 and, as a result,
the prepayment penalty of $127,247 in connection with the
extinguishment of the 2016 Notes (see Note 5) in March 2017 is
classified as a financing cash outflow in the accompanying
condensed consolidated statement of cash flows for the six months
ended June 30, 2017. The adoption of this ASU did not have a
material impact on our condensed consolidated financial position,
results of operations and related disclosures and had no other
impact to the accompanying condensed consolidated statement of cash
flows for the six months ended June 30, 2017 and 2016.
In March 2016, the FASB issued ASU No.
2016-09, Improvements
to Employee Share-Based Payment Accounting, which amends ASC Topic
718, Compensation
- Stock Compensation. The ASU involves
several aspects of the accounting for share-based payment
transactions, including the income tax consequences, forfeitures,
classification of awards as either equity or liabilities and
classification on the statement of cash flows. Certain of these
changes are required to be applied retrospectively, while other
changes are required to be applied prospectively. ASU 2016-09 is effective
for public business entities for annual reporting periods beginning
after December 15, 2016, and interim periods within that reporting
period. Early adoption will be permitted in any interim or annual
period, with any adjustments reflected as of the beginning of the
fiscal year of adoption. As a result of the adoption of this ASU as
of January 1, 2017, we have made an entity-wide accounting policy
election to account for forfeitures when they occur. There is no
cumulative-effect adjustment as a result of the adoption of this
ASU as our estimated forfeiture rate prior to adoption of this ASU
was 0%. The adoption of this ASU did not have a material impact on
our condensed consolidated financial statements and related
disclosures.
NOTE 2 – LICENSE AGREEMENTS
CRI In-License Agreement
On
April 19, 2013, the Company and Centric Research Institute
(“CRI”) entered into an asset purchase agreement (the
“CRI Asset Purchase Agreement”) pursuant to which we
acquired:
●
All of
CRI’s rights in past, present and future Sensum+®
product formulations and presentations, and
●
An
exclusive, perpetual license to commercialize Sensum+®
products in all territories except for the United
States.
On June
9, 2016, the Company and CRI amended the CRI Asset Purchase
Agreement (“Amended CRI Asset Purchase Agreement”) to
provide us commercialization rights for Sensum+® in the U.S.
through our Beyond Human® marketing platform through December
31, 2016. On January 1, 2017, the Company and CRI agreed to extend
the term of the Amended CRI Asset Purchase Agreement to December
31, 2017. In connection with the extension, we issued restricted
shares of common stock totaling 225,000 to CRI as a prepayment of
royalties due on net profit of Sensum+® in the U.S. in 2017.
The royalty prepayment amount is $44,662 as the number of shares of
common stock issued was based on the closing price of our common
stock on December 30, 2016. If CRI does not earn royalties larger
than the prepaid amount of $44,662 in 2017, the term of the Amended
CRI Asset Purchase Agreement is automatically extended one
additional year to December 31, 2018.
The CRI
Asset Purchase Agreement also requires us to pay to CRI up to $7.0
million in cash milestone payments based on first achievement of
annual Ex-U.S. net sales targets plus a royalty based on annual
Ex-U.S. net sales. The obligation for these payments expires
on April 19, 2023 or the expiration of the last of CRI’s
patent claims covering the product or its use outside the U.S.,
whichever is sooner. No sales milestone obligations have been
met and no royalties are owed to CRI under this agreement during
the three and six months ended June 30, 2017 and 2016.
In
consideration for the Amended CRI Asset Purchase Agreement, we are
required to pay CRI a percentage of the monthly net profit, as
defined in the agreement, from our sales of Sensum+® in the
U.S. through our Beyond Human® marketing platform. During the
three and six months ended June 30, 2017 and 2016, no amounts have
been earned by CRI under the Amended CRI Asset Purchase
Agreement.
Densmore Pharmaceutical International Agreement
On
April 24, 2017, we entered into an exclusive ten-year license
agreement with Densmore Pharmaceutical International, a Monaco
company (“Densmore”), under which we granted to
Densmore an exclusive license to market and sell our topical
treatment for Female Sexual Interest/Arousal Disorder
(“FSI/AD”) Zestra® in France and Belgium. Under
the agreement, we received a non-refundable upfront payment of
$7,500 which was recognized as revenue in the accompanying
condensed consolidated statement of operations for the three and
six months ended June 30, 2017. We believe the amount of the
upfront payment received is reasonable compared to the amounts to
be received upon obtainment of future minimum order quantities.
Densmore is obligated to order certain minimum annual quantities of
Zestra® at a pre-negotiated transfer price per unit during the
term of the agreement. During the three and six months ended June
30, 2017, we did not recognize any revenue for the sale of products
related to this agreement but we did receive a deposit of $46,769
for Densmore’s initial order of approximately $95,000 which
is included in deferred revenue and customer deposits in the
accompanying condensed consolidated balance sheet as of June 30,
2017.
In July
2017, we entered into an amendment to the agreement with Densmore
to expand the product territory to Singapore and
Vietnam.
Luminarie Pty Ltd. Agreement
On May
16, 2017, we entered into an exclusive ten-year license agreement
with Luminarie Pty Ltd., a Australia company
(“Luminarie”), under which we granted to Luminarie an
exclusive license to market and sell our topical treatment for
FSI/AD Zestra® and Zestra Glide® in Australia, New
Zealand and the Philippines. Luminarie received approval for
Zestra® as a Class I Medical Device in Australia in July 2017.
Luminarie is obligated to order certain minimum annual quantities
of Zestra® and Zestra Glide® at a pre-negotiated transfer
price per unit during the term of the agreement. During the three
and six months ended June 30, 2017, we did not recognize any
revenue for the sale of products related to this
agreement.
J&H Co. LTD Agreement
On
November 9, 2016, we entered into an exclusive ten-year license
agreement with J&H Co. LTD, a South Korea company
(“J&H”), under which we granted to J&H an
exclusive license to market and sell our topical treatment for
Female Sexual Interest/Arousal Disorder (“FSI/AD”)
Zestra® and Zestra Glide® in South Korea. Under the
agreement, J&H is obligated to order minimum annual quantities
of Zestra® and Zestra Glide® totaling $2.0 million at a
pre-negotiated transfer price per unit. The minimum annual order
quantities by J&H are to be made over a 12-month period
following the approval of the product by local authorities and
beginning upon the completion of the first shipment of product. Our
partner recently received the approval to import the product and
placed its first order in March 2017. During the three and six
months ended June 30, 2017, we recognized $0 and $60,000 in revenue
for the sale of products related to this agreement.
Sothema Laboratories Agreement
On
September 23, 2014, we entered into an exclusive license agreement
with Sothema Laboratories, SARL, a Moroccan publicly traded company
(“Sothema”), under which we granted to Sothema an
exclusive license to market and sell Zestra® (based on the
latest Canadian approval of the indication) and Zestra Glide®
in several Middle Eastern and African countries (collectively the
“Territory”).
Under
the agreement, we received an upfront payment of $200,000 and are
eligible to receive additional consideration upon and subject to
the achievement of sales milestones based on cumulative supplied
units of the licensed products in the Territory, plus a
pre-negotiated transfer price per unit. We believe the amount of
the upfront payment received is reasonable compared to the amounts
to be received upon obtainment of future sales-based
milestones.
As the
sales-based milestones do not meet the definition of a milestone
under ASC 605-28, we will recognize the revenue from the milestone
payments when the cumulative supplied units’ volume is met.
During the three and six months ended June 30, 2017 and 2016, we
recognized $0 and $2,563 and $0 and $11,563, respectively, in net
revenue for the sales of products related to this agreement, and no
revenue was recognized for the sales-based milestones of the
agreement.
Orimed Pharma Agreement
On
September 18, 2014, we entered into a twenty-year exclusive license
agreement with Orimed Pharma (“Orimed”), an affiliate
of JAMP Pharma, under which we granted to Orimed an exclusive
license to market and sell in Canada Zestra®, Zestra
Glide®, our topical treatment for premature ejaculation
EjectDelay® and our product Sensum+® to increase penile
sensitivity.
Under
the agreement, we received an upfront payment of $100,000 and are
eligible to receive additional consideration upon and subject to
the achievement of sales milestones based on cumulative gross sales
in Canada by Orimed plus double-digit tiered royalties based on
Orimed’s cumulative net sales in Canada. We believe the
amount of the upfront payment received is reasonable compared to
the amounts to be received upon obtainment of future sales-based
milestones.
As the
sales-based milestones do not meet the definition of a milestone
under ASC 605-28, we will recognize the revenue from the milestone
payments when the cumulative gross sales volume is met. We will
recognize the revenue from the royalty payments on a quarterly
basis when the cumulative net sales have been
met. During the three and six months ended June 30, 2017
and 2016, under this agreement we recognized $20,942 and $7,483 and
$20,942 and $63,586, respectively, in net revenue for the sales of
products and no revenue was recognized for the sales-based
milestones.
NOTE 3 – BUSINESS AND ASSET ACQUISITIONS
Acquisition of Assets of Beyond Human in 2016
On
February 8, 2016, we entered into an Asset Purchase Agreement
(“APA”), pursuant to which we agreed to purchase
substantially all of the assets of Beyond Human® (the
“Acquisition”) for a total cash payment of up to
$662,500 (the “Purchase Price”). The Purchase Price was
payable in the following manner: (1) $300,000 in cash at
the closing of the Acquisition (the “Initial Payment”),
(2) $100,000 in cash four months from the closing upon the
occurrence of certain milestones as described in the APA, (3)
$100,000 in cash eight months from the closing upon the occurrence
of certain milestones as described in the APA, and (4) $130,000 in
cash in twelve months from the closing upon the occurrence of
certain milestones as described in the APA. An
additional $32,500 in cash is due if certain milestones occur
twelve months from closing. The transaction closed on
March 1, 2016. On September 6, 2016, the Company and the sellers
entered into an agreement in which we agreed to pay the sellers
$150,000 to settle the contingent consideration payments totaling
up to $362,500 under the APA. The settlement agreement was not
contemplated at the time of the acquisition and the fair value of
the contingent consideration on the date of settlement was
$330,000. As a result, we recorded a non-cash gain on contingent
consideration of $180,000 during the year ended December 31,
2016.
Acquisition of Novalere in 2015
On
February 5, 2015 (the “Closing Date”), Innovus, Innovus
Pharma Acquisition Corporation, a Delaware corporation and a
wholly-owned subsidiary of Innovus (“Merger Subsidiary
I”), Innovus Pharma Acquisition Corporation II, a Delaware
corporation and a wholly-owned subsidiary of Innovus (“Merger
Subsidiary II”), Novalere FP, Inc., a Delaware corporation
(“Novalere FP”) and Novalere Holdings, LLC, a Delaware
limited liability company (“Novalere Holdings”), as
representative of the shareholders of Novalere (the “Novalere
Stockholders”), entered into an Agreement and Plan of Merger
(the “Merger Agreement”), pursuant to which Merger
Subsidiary I merged into Novalere and then Novalere merged with and
into Merger Subsidiary II (the “Merger”), with Merger
Subsidiary II surviving as a wholly-owned subsidiary of Innovus.
Pursuant to the articles of merger effectuating the Merger, Merger
Subsidiary II changed its name to Novalere, Inc.
With
the Merger, we acquired the worldwide rights to market and
sell the FlutiCare™ brand (fluticasone propionate nasal
spray) and the related third-party manufacturing agreement for the
manufacturing of FlutiCare™ (“Acquisition
Manufacturer”) from Novalere FP. The OTC Abbreviated New Drug
Application (“ANDA”) for fluticasone propionate nasal
spray was filed at the end of 2014 by our third-party manufacturer
and partner, who is currently selling the prescription version of
the drug, with the FDA and the OTC ANDA is still subject to
FDA approval. An ANDA is an application for a U.S. generic drug
approval for an existing licensed medication or approved drug. A
prescription ANDA (“RX ANDA”) is for a generic version
of a prescription pharmaceutical and an OTC ANDA is for a generic
version of an OTC pharmaceutical.
Due to
the delay in approval of the Acquisition Manufacturer’s OTC
ANDA by the FDA, in May 2017, we announced a commercial
relationship with a different third-party manufacturer (West-Ward
Pharmaceuticals International Limited or “WWPIL”) who
has an FDA approved OTC ANDA for fluticasone propionate nasal spray
under which they have agreed to manufacture our FlutiCare™
OTC product for sale in the U.S. (see Note 9). We currently still
anticipate that the OTC ANDA filed in November 2014 by the
Acquisition Manufacturer with the FDA may be approved in 2017.
As we hold the worldwide rights to market and sell FlutiCare™
under the manufacturing agreement with the Acquisition
Manufacturer, we believe the agreement with the Acquisition
Manufacturer will still provide us with the opportunity to market
and sell FlutiCare™ ex-U.S. and, if the OTC ANDA is approved
by the FDA, a second source of supply within the U.S., if ever
needed.
The
Novalere Stockholders are entitled to receive, if and when earned,
earn-out payments (the “Earn-Out Payments”). For every
$5.0 million in Net Revenue (as defined in the Merger Agreement)
realized from the sales of FlutiCare™ through the
manufacturing agreement with the Acquisition Manufacturer, the
Novalere Stockholders will be entitled to receive, on a pro rata
basis, $500,000, subject to cumulative maximum Earn-Out Payments of
$2.5 million. The Novalere Stockholders are only entitled to the
Earn-Out Payments from the Acquisition Manufacturer’s OTC
ANDA under review by the FDA and have no earn-out rights to the
sales of FlutiCare™ supplied by WWPIL under the commercial
agreement entered into in May 2017.
During
the three and six months ended June 30, 2017, there was an increase
(decrease) in the estimated fair value of the remaining 138,859
ANDA consideration shares totaling $400 and ($19,707) which is
included in fair value adjustment for contingent consideration in
the accompanying condensed consolidated statement of operations.
The remaining 138,859 ANDA consideration shares not issuable yet
will be issued upon FDA approval of the ANDA filed by the
Acquisition Manufacturer and the estimated fair value of such
remaining shares of $12,509 is included in contingent consideration
in the accompanying condensed consolidated balance sheet at June
30, 2017. There was no change to the estimated fair value of the
future earn-out payments of $1,248,124 during the three and six
months ended June 30, 2017 and there was no change to the estimated
fair value of the contingent consideration during the three and six
months ended June 30, 2016.
Purchase of Semprae Laboratories, Inc. in 2013
On
December 24, 2013 (the “Semprae Closing Date”), we,
through Merger Sub, obtained 100% of the outstanding shares of
Semprae in exchange for the issuance of 3,201,776 shares of our
common stock, which shares represented 15% of our total issued and
outstanding shares as of the close of business on the Closing Date,
whereupon Merger Sub was renamed Semprae Laboratories, Inc. We
agreed to pay the former shareholders an annual royalty
(“Royalty”) equal to 5% of the net sales from
Zestra® and Zestra Glide® and any second generation
products derived primarily therefrom (“Target
Products”) up until the time that a generic version of such
Target Product is introduced worldwide by a third
party.
The
agreement to pay the annual Royalty resulted in the recognition of
a contingent consideration, which is recognized at the inception of
the transaction, and subsequent changes to estimate of the amounts
of contingent consideration to be paid will be recognized as
charges or credits in the consolidated statement of operations. The
fair value of the contingent consideration is based on preliminary
cash flow projections, growth in expected product sales and other
assumptions. During the three and six months ended June 30, 2017
and 2016, no amounts have been paid under this
arrangement. The fair value of the expected royalties to
be paid was decreased by $99,379 and $0 and $106,447 and $0 during
the three and six months ended June 30, 2017 and 2016,
respectively, which is included in the fair value adjustment for
contingent consideration in the accompanying condensed consolidated
statements of operations. The fair value of the contingent
consideration was $299,130 and $405,577 at June 30, 2017 and
December 31, 2016, respectively, based on the new estimated fair
value of the consideration.
NOTE 4 – ASSETS AND LIABILITIES
Inventories
Inventories
consist of the following:
|
|
|
|
|
|
|
|
|
Raw materials and
supplies
|
$107,973
|
$85,816
|
|
Work in
process
|
135,834
|
48,530
|
|
Finished
goods
|
342,648
|
465,510
|
|
Total
|
$586,455
|
$599,856
|
Intangible Assets
Amortizable
intangible assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent &
Trademarks
|
$417,597
|
$(108,005)
|
$309,592
|
7 – 15
|
|
Customer
Contracts
|
611,119
|
(218,984)
|
392,135
|
10
|
|
Sensum+®
License (from CRI)
|
234,545
|
(95,736)
|
138,809
|
10
|
|
Vesele®
Trademark
|
25,287
|
(8,627)
|
16,660
|
8
|
|
Beyond Human®
Website and Trade Name
|
222,062
|
(52,514)
|
169,548
|
5 – 10
|
|
Novalere
Manufacturing Contract
|
4,681,000
|
(1,121,490)
|
3,559,510
|
10
|
|
Other Beyond
Human® Intangible Assets
|
4,730
|
(2,935)
|
1,795
|
1 – 3
|
|
Total
|
$6,196,340
|
$(1,608,291)
|
$4,588,049
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent &
Trademarks
|
$417,597
|
$(91,201)
|
$326,396
|
7 – 15
|
|
Customer
Contracts
|
611,119
|
(188,428)
|
422,691
|
10
|
|
Sensum+®
License (from CRI)
|
234,545
|
(84,009)
|
150,536
|
10
|
|
Vesele®
Trademark
|
25,287
|
(7,047)
|
18,240
|
8
|
|
Beyond Human®
Website and Trade Name
|
222,062
|
(32,821)
|
189,241
|
5 – 10
|
|
Novalere
Manufacturing Contract
|
4,681,000
|
(887,440)
|
3,793,560
|
10
|
|
Other Beyond
Human® Intangible Assets
|
4,730
|
(2,147)
|
2,583
|
1 – 3
|
|
Total
|
$6,196,340
|
$(1,293,093)
|
$4,903,247
|
|
Amortization
expense for the three and six months ended June 30, 2017 and 2016
was $157,473 and $178,083 and $315,198 and $335,685, respectively.
The following table summarizes the approximate expected future
amortization expense as of June 30, 2017 for intangible
assets:
|
Remainder of
2017
|
$314,000
|
|
2018
|
630,000
|
|
2019
|
629,000
|
|
2020
|
629,000
|
|
2021
|
600,000
|
|
2022
|
592,000
|
|
Thereafter
|
1,194,000
|
|
|
$4,588,000
|
Prepaid Expense and Other Current Assets
Prepaid
expense and other current assets consist of the
following:
|
|
|
|
|
|
|
|
|
Prepaid
insurance
|
$16,391
|
$69,976
|
|
Prepaid
inventory
|
133,937
|
20,750
|
|
Merchant net
settlement reserve receivable
|
-
|
221,243 -
|
|
Prepaid consulting
and other expense
|
94,283
|
21,094
|
|
Prepaid CRI
royalties (see Note 2)
|
44,662
|
-
|
|
Prepaid consulting
and other service stock-based compensation expense (see Note
7)
|
105,000
|
530,601
|
|
Total
|
$394,273
|
$863,664
|
Accounts Payable and Accrued Expense
Accounts
payable and accrued expense consist of the following:
|
|
|
|
|
|
|
|
|
Accounts
payable
|
$989,040
|
$647,083
|
|
Accrued credit card
balances
|
36,348
|
31,654
|
|
Accrued
royalties
|
115,802
|
73,675
|
|
Sales returns and
allowances
|
50,632
|
60,853
|
|
Accrual for stock
to be issued to consultants (see Note 7)
|
-
|
360,000
|
|
Accrued
other
|
64,729
|
36,785
|
|
Total
|
$1,256,551
|
$1,210,050
|
NOTE 5 – NOTES PAYABLE AND DEBENTURES – NON-RELATED
PARTIES
Notes Payable
The
following table summarizes the outstanding notes payable at June
30, 2017 and December 31, 2016:
|
|
|
|
|
Notes
payable:
|
|
|
|
February 2016 Note
Payable
|
$209,040
|
$347,998
|
|
December 2016 and
January 2017 Notes Payable
|
715,000
|
550,000
|
|
Total
notes payable
|
924,040
|
897,998
|
|
Less: Debt
discount
|
(104,788)
|
(216,871)
|
|
Carrying value
|
819,252
|
681,127
|
|
Less: Current
portion
|
(819,252)
|
(626,610)
|
|
Notes
payable, net of current portion
|
$-
|
$54,517
|
The
following table summarizes the future minimum payments as of June
30, 2017 for the notes payable:
|
Remainder of
2017
|
$869,005
|
|
2018
|
54,985
|
|
|
$924,040
|
February 2016 Note Payable
On
February 24, 2016, the Company and SBI Investments, LLC, 2014-1
(“SBI”) entered into an agreement in which SBI loaned
us gross proceeds of $550,000 pursuant to a purchase agreement, 20%
secured promissory note and security agreement (“February
2016 Note Payable”), all dated February 19, 2016
(collectively, the “Finance Agreements”), to purchase
substantially all of the assets of Beyond Human® (see Note
3). Of the $550,000 gross proceeds, $300,000 was paid
into an escrow account held by a third party bank and was released
to Beyond Human® upon closing of the transaction, $242,500 was
provided directly to us for use in building the Beyond Human®
business and $7,500 was provided for attorneys’
fees. The attorneys’ fees were recorded as a
discount to the carrying value of the February 2016 Note
Payable.
Pursuant
to the Finance Agreements, the principal amount of the February
2016 Note Payable is $550,000 and the interest rate thereon is 20%
per annum. We began to pay principal and interest on the
February 2016 Note Payable on a monthly basis beginning on March
19, 2016 for a period of 24 months and the monthly mandatory
principal and interest payment amount thereunder is $28,209. The
monthly amount shall be paid by us through a deposit account
control agreement with a third-party bank in which SBI shall be
permitted to take the monthly mandatory payment amount from all
revenue received by us from the Beyond Human® assets in the
transaction. The maturity date for the February 2016
Note Payable is February 19, 2018.
The
February 2016 Note Payable is secured by SBI through a first
priority secured interest in all of the Beyond Human® assets
acquired by us in the transaction including all revenue received by
us from these assets
December 2016 and January 2017 Notes Payable
On
December 5, 2016 and January 19, 2017, we entered into a securities
purchase agreement with three unrelated third-party investors in
which the investors loaned us gross proceeds of $500,000 in
December 2016 and $150,000 in January 2017 pursuant to a 5%
promissory note (“December 2016 & January 2017 Notes
Payable”). The notes have an Original Issue
Discount (“OID”) of $65,000 and require payment of
$715,000 in principal upon maturity. The December 2016 &
January 2017 Notes Payable bear interest at the rate of 5% per
annum and the principal amount and interest are payable at maturity
on October 4, 2017 and November 18, 2017 for those received in
December 2016 and January 2017, respectively.
In
connection with the December 2016 & January 2017 Notes Payable,
we issued the investors restricted shares of common stock totaling
1,111,111 in December 2016 and 330,000 in January
2017. The fair value of the restricted shares of common
stock issued was based on the market price of our common stock on
the date of issuance of the December 2016 & January 2017 Notes
Payable. The allocation of the proceeds received to the
restricted shares of common stock based on their relative fair
value and the OID resulted in us recording a debt discount of
$182,203 in December 2016 and $44,217 in January 2017. The discount
is being amortized to interest expense using the effective interest
method over the term of the December 2016 & January 2017 Notes
Payable.
Interest Expense
We
recognized interest expense on notes payable of $21,656 and $77,550
and $46,713 and $88,915 for the three and six months ended June 30,
2017 and 2016, respectively. Amortization of the debt
discount to interest expense during the three and six months ended
June 30, 2017 and 2016 totaled $88,474 and $94,902 and $171,300 and
$95,371, respectively.
Convertible Debentures
2016 Financing
The
following table summarizes the outstanding 2016 convertible
debentures at June 30, 2017 and December 31, 2016:
|
|
|
|
|
|
|
|
|
Convertible
debentures
|
$-
|
$1,559,922
|
|
Less: Debt
discount
|
-
|
(845,730)
|
|
Carrying value
|
-
|
714,192
|
|
Less: Current
portion
|
-
|
(714,192)
|
|
Convertible debentures, net of current portion
|
$-
|
$-
|
In the
second and third quarter of 2016, we entered into Securities
Purchase Agreements with eight accredited investors (the
“Investors”), pursuant to which we received aggregate
gross proceeds of $3.0 million (net of OID) pursuant to which we
sold:
Nine
convertible promissory notes of the Company totaling $3,303,889
(each a “2016 Note” and collectively the “2016
Notes”) (the 2016 Notes were sold at a 10% OID and we
received an aggregate total of $2,657,500 in funds thereunder after
debt issuance costs of $342,500). The 2016 Notes and accrued
interest were convertible into shares of our common stock at a
conversion price of $0.25 per share, with certain adjustment
provisions. The maturity date of the 2016 Notes issued on June 30,
2016 and July 15, 2016 was July 30, 2017 and the maturity date of
the 2016 Notes issued on July 25, 2016 was August 25, 2017. The
2016 Notes bore interest on the unpaid principal amount at the rate
of 5% per annum from the date of issuance until the same became due
and payable, whether at maturity or upon acceleration or by
prepayment or otherwise. We had the ability to prepay the 2016
Notes at any time on the terms set forth in the 2016 Notes at the
rate of 110% of the then outstanding balance of the 2016
Notes.
The
fair value of the restricted shares of common stock issued to
Investors in 2016 was based on the market price of our common stock
on the date of issuance of the 2016 Notes. The
allocation of the proceeds to the warrants and restricted shares of
common stock based on their relative fair values resulted in us
recording a debt discount. We also determined that the embedded
conversion features in the 2016 Notes were a derivative instrument
which was required to be bifurcated from the debt host contract and
recorded at fair value as a derivative liability. The
fair value of the embedded conversion features was determined using
a Path-Dependent Monte Carlo Simulation Model (see Note 8 for
assumptions used to calculate fair value). The initial fair value
of the embedded conversion features was recorded as a debt discount
with the amount in excess of the proceeds allocated to the debt,
after the allocation of debt proceeds to the debt issuance costs,
being immediately expensed and recorded as interest expense in
2016.
During
the six months ended June 30, 2017, certain of the 2016 Notes
holders elected to convert principal and interest outstanding of
$350,610 into 1,402,440 shares of common stock at a conversion
price of $0.25 per share (see Note 7). As a result of
the conversion of the principal and interest balance into shares of
common stock, the fair value of the embedded conversion feature
derivative liabilities of $203,630 on the date of conversion was
reclassified to additional paid-in capital (see Note 8) and the
amortization of the debt discount was accelerated for the amount
converted and recorded to interest expense during the six months
ended June 30, 2017.
As a
result of the completion of a public equity offering in March 2017
(see Note 7), we were required to prepay the outstanding principal
and accrued interest balance of the 2016 Notes with the cash
proceeds received from such offering. The outstanding principal and
accrued interest balance of $1,272,469 was repaid in March 2017, as
well as, a 10% prepayment penalty of $127,247. Due to the
acceleration of repayment of the 2016 Notes as a result of the
public equity offering, the transaction was recorded as a debt
extinguishment and the 10% prepayment penalty of $127,247 and the
remaining unamortized debt discount as of the date of repayment of
$415,682 were recorded as a loss on debt extinguishment in the
accompanying condensed consolidated statement of operations for the
six months ended June 30, 2017. The repayment of the outstanding
principal and accrued interest balance of the 2016 Notes resulted
in the extinguishment of the embedded conversion feature derivative
liability and thus the fair value as of the date of repayment of
$238,101 was recorded as a reduction to the loss on debt
extinguishment in the accompanying condensed consolidated statement
of operations for the six months ended June 30, 2017.
Interest Expense
We
recognized interest expense on the 2016 Notes for the six months
ended June 30, 2017 of $19,544. The debt discount recorded for the
2016 Notes were being amortized as interest expense over the term
of the 2016 Notes using the effective interest
method. Total amortization of the debt discount on the
2016 Notes to interest expense for the six months ended June 30,
2017 was $430,048.
NOTE 6 – RELATED PARTY TRANSACTIONS
Accrued Compensation – Related Party
Accrued
compensation includes accruals for employee wages, vacation pay and
target-based bonuses. The components of accrued compensation
as of June 30, 2017 and December 31, 2016 are as
follows:
|
|
|
|
|
Wages
|
$1,431,686
|
$1,455,886
|
|
Vacation
|
302,663
|
261,325
|
|
Bonus
|
693,431
|
449,038
|
|
Payroll taxes on
the above
|
148,759
|
133,344
|
|
Total
|
2,576,539
|
2,299,593
|
|
Classified as
long-term
|
(1,036,315)
|
(1,531,904)
|
|
Accrued
compensation
|
$1,540,224
|
$767,689
|
Accrued
employee wages at June 30, 2017 and December 31, 2016 are entirely
related to wages owed to our President and Chief Executive
Officer. Under the terms of his employment agreement, wages
are to be accrued but no payment made for so long as payment of
such salary would jeopardize our ability to continue as a going
concern. The President and Chief Executive Officer started to
receive payment of salary in July 2016. In the second quarter of
2017, it was determined by our Board of Directors that deferred
salary of $463,167 would be paid to our current President and Chief
Executive Officer to assist in paying the statutory personal tax
withholding on the shares of common stock he received in 2016 for
his vested restricted stock units. As a result, the deferred salary
amount and related employer taxes totaling $495,589 has been
classified as current. The payment of such deferred salary would
not jeopardize our ability to continue as a going concern, and the
payment has not been made as of the date of filing of this
quarterly report. Our President and Chief Executive Officer has
agreed to not receive payment on the remaining accrued wages and
related payroll tax amounts within the next 12 months and thus the
remaining balance is classified as a long-term liability. In April
2017, our Board of Directors approved for payment the accrued
fiscal year 2016 bonus of $33,442 to our former Executive Vice
President and Chief Financial Officer in accordance with his
employment agreement and the bonus amount was paid upon his
departure. The fiscal year 2016 bonus for our President and Chief
Executive Officer has not yet been approved by our Board of
Directors but is included in accrued compensation in the
accompanying condensed consolidated balance sheets as of June 30,
2017 and December 31, 2016.
NOTE 7 – STOCKHOLDERS’ EQUITY
Issuances of Common Stock
Public Equity Offering
On
March 21, 2017, we completed a sale of common stock and warrants
under a registered public offering. The gross proceeds to us from
the offering were $3,850,000, before underwriting discounts and
commissions and other offering expenses ($3,307,773 after
underwriting discounts, commissions and expenses).
The
public offering price per share of common stock sold was $0.15.
Each investor who purchased a share of common stock in the offering
received a five-year warrant to purchase one share of common stock
at an exercise price of $0.15 per share (“Series A
Warrants”) and a one-year warrant to purchase one share of
common stock at an exercise price of $0.15 per share (“Series
B Warrants”). Under the terms of the offering, we issued
25,666,669 shares of common stock, Series A Warrants to purchase up
to an aggregate of 25,666,669 shares of common stock and Series B
Warrants to purchase up to an aggregate of 25,666,669 shares of
common stock. The Series A Warrants and Series B Warrants are
exercisable immediately. We allocated the net proceeds received of
$3,307,773 to the shares of common stock, Series A Warrants and
Series B Warrants sold in the offering based on their relative fair
values. The fair value of the Series A Warrants and Series B
Warrants was determined using Black-Scholes. Based on their
relative fair values, we allocated net of proceeds of $1,593,233 to
the shares of common stock, $1,075,995 to the Series A Warrants and
$638,545 to the Series B Warrants.
In
connection with this offering, we issued to H.C. Wainwright &
Co. (“HCW”), the underwriter in the offering, a warrant
to purchase up to 1,283,333 shares of common stock and HCW received
total cash consideration, including the reimbursement of public
offering-related expenses, of $443,000. If such warrant is
exercised, each share of common stock may be purchased at $0.1875
per share (125% of the price of the common stock sold in the
offering), commencing on March 21, 2017 and expiring March 21,
2022. The fair value of the warrants issued to HCW totaled $129,755
and was determined using Black-Scholes. The fair value of the
warrants was recorded as an offering cost but has no net impact to
additional paid-in capital in stockholders’ equity in the
accompanying condensed consolidated balance sheet.
In
connection with this offering, the Company incurred $99,227 in
other offering costs that have been offset against the proceeds
from this offering.
Other Stock Issuances and Related Stock-Based
Compensation
On August 23, 2016, we entered into a consulting agreement with a
third party pursuant to which we agreed to issue 1,600,000
restricted shares of common stock, payable in four equal
installments, in exchange for services to be rendered over the
agreement which ends on August 23, 2017. The shares were
considered fully-vested and non-refundable at the execution of the
agreement. In 2016, we issued 800,000 shares of common stock and
during the six months ended June 30, 2017, we issued a total of
800,000 shares of common stock under the agreement. The fair value
of the shares issued during 2017 of $360,000 was based on the
market price of our common stock on the date of agreement. There
are no more shares of common stock to be issued under this service
agreement as of June 30, 2017. During the three and six months
ended June 30, 2017, we recognized $180,000 and $360,000,
respectively, in general and administrative expense in the
accompanying condensed consolidated statements of operations and
the remaining unamortized expense of $105,000 is included in
prepaid expense and other current assets in the accompanying
condensed consolidated balance sheet at June 30,
2017.
On
September 1, 2016, we entered into a service agreement with a third
party pursuant to which we agreed to issue, over the term of the
agreement, 2,000,000 shares of common stock in exchange for
services to be rendered. During the six months ended June 30,
2017, we issued 670,000 shares under the agreement related to
services provided and recognized the fair value of the shares
issued of $123,615 in general and administrative expense in the
accompanying condensed consolidated statement of operations. The
670,000 shares of common stock vested on the date of issuance and
the fair value of the shares of common stock was based on the
market price of our common stock on the date of vesting. There are
no more shares of common stock to be issued under this service
agreement as of June 30, 2017.
On November 17, 2016, we entered into a service agreement with a
third party and in connection with the agreement issued 275,000
fully-vested shares for services to be provided over the term of
the service agreement through May 17, 2017. The fair value of the
shares issued of $69,575 was based on the market price of our
common stock on the date of vesting. During the three and six
months ended June 30, 2017, we recognized $17,394 and $52,181,
respectively, in general and administrative expense in the
accompanying condensed consolidated statements of
operations.
On
December 16, 2016, we amended a consulting agreement with a third
party to extend the term of the agreement to June 16, 2017 and in
connection with the amendment issued 80,000 fully-vested shares for
services to be provided over the remaining term of the amended
agreement. The fair value of the shares issued of $14,640 was based
on the market price of our common stock on the date of vesting. On
January 19, 2017, we further amended the agreement to expand the
scope of service performed by the consultant and as a result issued
an additional 78,947 shares of fully vested common stock for
services to be provided through June 16, 2017. The fair value of
the shares issued of $15,000 was based on the market price of our
common stock on the date of vesting. During the three and six
months ended June 30, 2017, we recognized $13,600 and $28,420,
respectively, in general and administrative expense in the
accompanying condensed consolidated statements of
operations.
In January 2017 and April 2017, we issued a total of 28,425 shares
of common stock for services and recorded an expense of $2,000 and
$4,000 for the three and six months ended June 30, 2017,
respectively, which is included in general and administrative
expense in the accompanying condensed consolidated statements of
operations. The 28,425 shares of common stock vested on the date of
issuance and the fair value of the shares of common stock was based
on the market price of our common stock on the date of
vesting.
In
January 2017, we issued 225,000 shares of common stock to CRI
pursuant to the Amended CRI Asset Purchase Agreement (see Note 2)
for the prepayment of future royalties due on net profit of
Sensum+® in the U.S. in 2017. The fair value of the
restricted shares of common stock of $44,662 was based on the
market price of our common stock on the date of issuance and is
included in prepaid expense and other current assets in the
accompanying condensed consolidated balance sheet at June 30,
2017.
In
January 2017, we issued 330,000 shares of restricted common stock
to a note holder in connection with their note
payable. The relative fair value of the shares of
restricted common stock issued was determined to be $44,217 and was
recorded as a debt discount (see Note 5).
In
March 2017, certain 2016 Notes holders elected to convert $350,610
in principal and interest into 1,402,440 shares of common stock
(see Note 5). Upon conversion, the fair value of the embedded
conversion feature derivative liability on the date of conversion
was reclassified to additional paid-in capital (see Note
8).
In
March 2017, we issued shares of common stock totaling 40,000 upon
the exercise of stock options for total cash proceeds of
$2,894.
In June
2017, we issued
92,000 shares of common stock in exchange for vested restricted
stock units.
2013 Equity Incentive Plan
We have issued common stock, restricted stock units and stock
option awards to employees, non-executive directors and outside
consultants under the 2013 Equity Incentive Plan (“2013
Plan”), which was approved by our Board of Directors in
February of 2013. The 2013 Plan allows for the issuance of up
to 10,000,000 shares of our common stock to be issued in the form
of stock options, stock awards, stock unit awards, stock
appreciation rights, performance shares and other share-based
awards. As of June 30, 2017, 31,000 shares were available
under the 2013 Plan.
2014 Equity Incentive Plan
We have issued common stock, restricted stock units and stock
options to employees, non-executive directors and outside
consultants under the 2014 Equity Incentive Plan (“2014
Plan”), which was approved by our Board of Directors in
November 2014. The 2014 Plan allows for the issuance of up to
20,000,000 shares of our common stock to be issued in the form of
stock options, stock awards, stock unit awards, stock appreciation
rights, performance shares and other share-based awards. As of
June 30, 2017, 58,367 shares were available under the 2014
Plan.
2016 Equity Incentive Plan
On March 21, 2016, our Board of Directors approved the adoption of
the 2016 Equity Incentive Plan and on October 20, 2016 adopted the
Amended and Restated 2016 Equity Incentive Plan (“2016
Plan”). The 2016 Plan was then approved by our
stockholders in November 2016. The 2016 Plan allows for the
issuance of up to 20,000,000 shares of our common stock to be
issued in the form of stock options, stock awards, stock unit
awards, stock appreciation rights, performance shares and other
share-based awards. The 2016 Plan includes an evergreen
provision in which the number of
shares of common stock authorized for issuance and available for
future grants under the 2016 Plan will be increased each January 1
after the effective date of the 2016 Plan by a number of shares of
common stock equal to the lesser of: (a) 4% of the number of shares
of common stock issued and outstanding on a fully-diluted basis as
of the close of business on the immediately preceding December 31,
or (b) a number of shares of common stock set by our Board of
Directors. In March 2017, our Board of Directors approved an
increase of 5,663,199 shares of common stock to the shares
authorized under the 2016 Plan in accordance with the evergreen
provision in the 2016 Plan. As of June 30, 2017, 21,291,727 shares
were available under the 2016 Plan.
Stock Options
For
the six months ended June 30, 2017 and 2016, the following weighted
average assumptions were utilized for the calculation of the fair
value of the stock options granted during the period using
Black-Scholes:
|
|
|
|
|
Expected life (in
years)
|
8.6
|
10.0
|
|
Expected
volatility
|
217.0%
|
227.9%
|
|
Average risk-free
interest rate
|
2.28%
|
1.77%
|
|
Dividend
yield
|
0%
|
0%
|
|
Grant date fair
value
|
$0.19
|
$0.16
|
The
dividend yield of zero is based on the fact that we have never paid
cash dividends and has no present intention to pay cash
dividends. Expected volatility is based on the historical
volatility of our common stock over the period commensurate with
the expected life of the stock options. Expected life in years
is based on the “simplified” method as permitted by ASC
Topic 718. We believe that all stock options issued under its
stock option plans meet the criteria of “plain vanilla”
stock options. We use a term equal to the term of the stock
options for all non-employee stock options. The risk-free
interest rate is based on average rates for treasury notes as
published by the Federal Reserve in which the term of the rates
correspond to the expected term of the stock options.
The
following table summarizes the number of stock options outstanding
and the weighted average exercise price:
|
|
|
Weighted
average exercise price
|
Weighted
remaining contractual life (years)
|
Aggregate
intrinsic value
|
|
Outstanding at
December 31, 2016
|
237,500
|
$0.22
|
8.6
|
$14,293
|
|
Granted
|
28,000
|
0.19
|
-
|
-
|
|
Exercised
|
(40,000)
|
0.07
|
-
|
-
|
|
Cancelled
|
(40,000)
|
0.24
|
-
|
-
|
|
Forfeited
|
-
|
-
|
-
|
-
|
|
Outstanding at June
30, 2017
|
185,500
|
$0.24
|
8.2
|
$2,466
|
|
|
|
|
|
|
|
Vested at June 30,
2017
|
185,500
|
$0.24
|
8.2
|
$2,466
|
The
aggregate intrinsic value is calculated as the difference between
the exercise price of all outstanding stock options and the quoted
price of our common stock at June 30, 2017. During the
three and six months ended June 30, 2017 and 2016, the Company
recognized stock-based compensation from stock options of $1,028
and $5,406 and $4,000 and $9,500, respectively. The intrinsic value
of the stock options exercised during the six months ended June 30,
2017 on the date of exercise was $5,306.
Restricted Stock Units
The
following table summarizes the restricted stock unit activity
for the six months ended June 30, 2017:
|
|
|
|
Outstanding at
December 31, 2016
|
12,874,848
|
|
Granted
|
2,670,547
|
|
Exchanged
|
(92,000)
|
|
Cancelled
|
(2,500,000)
|
|
Outstanding at June
30, 2017
|
12,953,395
|
|
|
|
|
Vested at June 30,
2017
|
9,203,395
|
The
vested restricted stock units at June 30, 2017 have not settled and
are not showing as issued and outstanding shares of ours but are
considered outstanding for earnings per share
calculations. Settlement of these vested restricted stock
units will occur on the earliest of (i) the date of termination of
service of the employee or consultant, (ii) change of control of
us, or (iii) 10 years from date of issuance. Settlement of
vested restricted stock units may be made in the form of (i) cash,
(ii) shares, or (iii) any combination of both, as determined by the
board of directors and is subject to certain criteria having been
fulfilled by the recipient.
We calculate the fair value of the restricted stock units based
upon the quoted market value of the common stock at the date of
grant. The grant date fair value of restricted stock units issued
during the six months ended June 30, 2017 was $491,500. For the
three and six months ended June 30, 2017 and 2016, we recognized
$(52,115) and $168,679 and $107,885 and $627,018, respectively, of
stock-based compensation expense for the vested units. The credit
for the three months ended June 30, 2017 was a result of the
reversal of the expense previously recognized on the RSUs granted
to our former Chief Financial Officer that were cancelled prior to
their initial vesting date upon his departure in April 2017. As of
June 30, 2017, compensation expense related to unvested shares not
yet recognized in the condensed consolidated statement of
operations was approximately $655,000 and will be recognized over a
remaining weighted-average term of 2.4
years.
Warrants
During
the year ended December 31, 2014, we issued warrants in connection
with notes payable (which were repaid in 2013). The remaining
warrants of 135,816 have an exercise price of $0.10 and expire
December 6, 2018.
In
January 2015, we issued 250,000 warrants with an exercise price of
$0.30 per share to a former executive in connection with the
January 2015 debenture. The warrants expire on January 21, 2020.
The warrants contain anti-dilution protection, including protection
upon dilutive issuances. In connection with the convertible
debentures issued in 2015, the exercise price of these warrants was
reduced to $0.0896 per share and an additional 586,705 warrants
were issued per the anti-dilution protection afforded in the
warrant agreement during the year ended December 31,
2015.
In
connection with the convertible debentures in 2015, we issued
warrants with an exercise price of $0.30 per share and expire in
2020 to investors and placement agents. Warrants to purchase
774,533 shares of common stock remain outstanding as of June 30,
2017.
In
connection with the 2016 Notes, we issued warrants to the Investors
and placement agents with an exercise price of $0.40 per share and
expire in 2021. Warrants to purchase 4,220,000 shares of common
stock remain outstanding as of June 30, 2017.
In
connection with the public equity offering in March 2017, we issued
Series A Warrants to purchase 25,666,669 shares of common stock at
$0.15 per share and Series B Warrants to purchase 25,666,669 shares
of common stock at $0.15 per share. The Series A Warrants expire in
2022 and the Series B Warrants expire in 2018. We also issued
warrants to purchase 1,283,333 shares of common stock to our
placement agent with an exercise price of $0.1875 per share and
expire in 2022.
For
the six months ended June 30, 2017, the following weighted average
assumptions were utilized for the calculation of the fair value of
the warrants issued during the period using
Black-Scholes:
|
|
|
|
Expected life (in
years)
|
3.1
|
|
Expected
volatility
|
203.3%
|
|
Average risk-free
interest rate
|
1.49%
|
|
Dividend
yield
|
0%
|
At June
30, 2017, there are 58,583,725 fully vested warrants outstanding.
The weighted average exercise price of outstanding warrants at June
30, 2017 is $0.17 per share, the weighted average remaining
contractual term is 2.9 years and the aggregate intrinsic value of
the outstanding warrants is $20,621.
Net Loss per Share
Restricted
stock units that are vested but the issuance and delivery of the
shares are deferred until the employee or director resigns are
included in the basic and diluted net loss per share
calculations.
The
weighted average shares of common stock outstanding used in the
basic and diluted net loss per share calculation for the three and
six months ended June 30, 2017 and 2016 was 150,713,121 and
138,587,767 and 77,455,497 and 62,335,408,
respectively.
The
weighted average restricted stock units vested but issuance of the
common stock is deferred until there is a change in control, a
specified date in the agreement or the employee or director resigns
used in the basic and diluted net loss per share calculation for
the three and six months ended June 30, 2017 and 2016 was 9,284,274
and 9,029,297 and 7,940,349 and 7,935,925,
respectively.
The
total weighted average shares outstanding used in the basic and
diluted net loss per share calculation for the three and six months
ended June 30, 2017 and 2016 was 159,997,395 and 147,617,064 and
85,395,846 and 70,271,333, respectively.
The
following table shows the anti-dilutive shares excluded from the
calculation of basic and diluted net loss per common share as of
June 30, 2017 and 2016:
|
|
|
|
|
|
|
|
Gross
number of shares excluded:
|
|
|
|
Restricted stock
units – unvested
|
3,750,000
|
1,893,753
|
|
Stock
options
|
185,500
|
254,500
|
|
Convertible
debentures and accrued interest
|
-
|
6,600,000
|
|
Warrants
|
58,583,725
|
5,206,011
|
|
Total
|
62,519,225
|
13,954,264
|
The
above table does not include the ANDA Consideration Shares related
to the Novalere acquisition totaling 138,859 and 12,947,655 at June
30, 2017 and 2016, respectively, as they are considered
contingently issuable (see Note 3).
NOTE 8 – DERIVATIVE LIABILITIES
The
warrants issued in connection with the January 2015 Non-Convertible
Debenture to a former executive are measured at fair value and
classified as a liability because these warrants contain
anti-dilution protection and therefore, cannot be considered
indexed to our own stock which is a requirement for the scope
exception as outlined under FASB ASC 815. The estimated fair value
of the warrants was determined using the Probability Weighted
Black-Scholes Model. The fair value will be affected by changes in
inputs to that model including our stock price, expected stock
price volatility, the contractual term and the risk-free interest
rate. We will continue to classify the fair value of the warrants
as a liability until the warrants are exercised, expire or are
amended in a way that would no longer require these warrants to be
classified as a liability, whichever comes first. The anti-dilution
protection for the warrants survives for the life of the warrants
which ends in January 2020.
The
derivative liabilities are a Level 3 fair value measure in the fair
value hierarchy and the assumptions for the Probability Weighted
Black-Scholes Option-Pricing Model for the six months ended June
30, 2017 are represented in the table below:
|
|
|
June 30, 2017
|
|
Expected life (in years)
|
|
2.56 – 2.97
|
|
Expected volatility
|
|
179% – 187%
|
|
Average risk-free interest rate
|
|
1.44% – 1.50%
|
|
Dividend yield
|
|
0%
|
We have
determined the embedded conversion features of the 2016 Notes (see
Note 5) to be derivative liabilities because the terms of the
embedded conversion features contained anti-dilution protection and
therefore, could not be considered indexed to our own stock which
was a requirement for the scope exception as outlined under FASB
ASC 815. The embedded conversion features were to be
measured at fair value and classified as a liability with
subsequent changes in fair value recorded in earnings at the end of
each reporting period. We have determined the fair value
of the derivative liabilities using a Path-Dependent Monte Carlo
Simulation Model. The fair value of the derivative
liabilities using such model was affected by changes in inputs to
that model and was based on the individual characteristics of the
embedded conversion features on the valuation date as well as
assumptions for volatility, remaining expected life, risk-free
interest rate, credit spread, probability of default by us and
acquisition of us. During the six months ended June 30,
2017, the 2016 Notes were either converted into shares of common
stock or repaid in full. The conversion of the 2016 Notes during
the six months ended June 30, 2017 resulted in the fair value of
the embedded conversion feature derivative liability on the dates
of conversion of $203,630 to be reclassified to additional paid-in
capital (see Note 7). Upon repayment of the remaining
2016 Notes in March 2017 (see Note 5), the fair value of the
embedded conversion features on date of repayment of $238,101 was
extinguished and included in loss on debt extinguishment in the
accompanying condensed consolidated statement of
operations.
The
derivative liabilities are a Level 3 fair value measurement in the
fair value hierarchy and a summary of quantitative information with
respect to valuation methodology and significant unobservable
inputs used for our embedded conversion feature derivative
liabilities that are categorized within Level 3 of the fair value
hierarchy during the six months ended June 30, 2017 is as
follows:
|
|
|
June 30, 2017
|
|
Stock
price
|
|
$0.103
– $0.305
|
|
Strike
price
|
|
$0.25
|
|
Expected
life (in years)
|
|
0.36
– 0.43
|
|
Expected
volatility
|
|
130%
– 168%
|
|
Average
risk-free interest rate
|
|
0.78%
– 0.87%
|
|
Dividend
yield
|
|
–
|
At
June 30, 2017, the estimated Level 3 fair value of the warrant
derivative liabilities measured on a recurring basis is as
follows:
|
|
|
|
|
|
|
|
Warrant derivative
liabilities
|
$90,206
|
$-
|
$-
|
$90,206
|
$90,206
|
The
following table presents the activity for the Level 3 embedded
conversion feature and warrant derivative liabilities measured at
fair value on a recurring basis for the six months ended June 30,
2017:
Fair
Value Measurements Using Level 3 Inputs
|
Warrant
derivative liabilities:
|
|
|
Beginning balance
December 31, 2016
|
$164,070
|
|
Change in fair
value
|
(73,864)
|
|
Ending balance June
30, 2017
|
$90,206
|
|
|
|
|
Embedded
conversion feature derivative liabilities:
|
|
|
Beginning balance
December 31, 2016
|
$319,674
|
|
Reclassification of
fair value of embedded conversion feature derivative liability
to additional paid-in
capital upon conversions of 2016 Notes
|
(203,630)
|
|
Extinguishment of
embedded conversion feature upon repayment of 2016
Notes
|
(238,101)
|
|
Change in fair
value
|
122,057
|
|
Ending balance June
30, 2017
|
$-
|
NOTE 9 – COMMITMENTS AND CONTINGENCIES
In May 2017, we entered into a
commercial agreement with West-Ward Pharmaceuticals International
Limited (“WWPIL”), a wholly-owned subsidiary of Hikma
Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai:
HIK) (OTC: HKMPY). Pursuant to the commercial agreement, WWPIL will
provide us with the rights to launch our branded, fluticasone
propionate nasal spray USP, 50 mcg per spray
(FlutiCare™), under WWPIL’s FDA approved ANDA
No. 207957 in the U.S. in the fourth quarter of 2017. The initial
term of the commercial agreement is for two years, and upon
expiration of the initial term, the agreement will automatically
renew for subsequent one-year terms unless either party notifies
the other party in writing of its desire not to renew at least 90
days prior to the end of the then current term. The agreement
requires us to meet certain minimum product batch purchase
requirements in order for the agreement to continue to be in
effect.
NOTE 10 – SUBSEQUENT EVENTS
In July
2017, we issued 44,405 shares of common stock to a consultant for
services rendered. The fair value of the common stock issued was
$5,000.
On July
20, 2017, we entered into a service agreement with a third party
pursuant to which we agreed to issue, over the term of the
agreement through December 31, 2017, 1,200,000 shares of common
stock in exchange for services to be rendered. Upon execution
of the agreement, we issued 200,000 shares to the third party with
a fair value of the shares issued of $24,200.
In July
2017, we issued shares of common stock totaling 31,500 upon the
exercise of stock options for total cash proceeds of
$1,985.
We
have evaluated subsequent events through the filing date of this
Form 10-Q and determined that no additional subsequent events have
occurred that would require recognition in the condensed
consolidated financial statements or disclosures in the notes
thereto other than as disclosed in the accompanying notes to the
condensed consolidated financial statements.
|
ITEM 2.
|
MANAGEMENT'S DISCUSSION
AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF
OPERATIONS
|
Innovus Pharmaceuticals, Inc., together with its subsidiaries, are
collectively referred to as “Innovus”, the
“Company”, “us”, “we”, or
“our”. The following information should be read in
conjunction with the condensed consolidated financial statements
and notes thereto appearing elsewhere in this report. For
additional context with which to understand our financial condition
and results of operations, see the discussion and analysis included
in Part II, Item 7 of our Annual Report on Form 10-K for the year
ended December 31, 2016, filed with the Securities and Exchange
Commission (“SEC”) on March 9, 2017, as well as the
consolidated financial statements and related notes contained
therein.
Forward Looking Statements
Certain
statements in this report, including information incorporated by
reference, are “forward-looking statements” within the
meaning of Section 27A of the Securities Act of 1933, as amended,
Section 21E of the Securities Exchange Act of 1934, as amended, and
the Private Securities Litigation Reform Act of 1995, as amended.
Forward-looking statements reflect current views about future
events and financial performance based on certain assumptions. They
include opinions, forecasts, intentions, plans, goals, projections,
guidance, expectations, beliefs or other statements that are not
statements of historical fact. Words such as “may,”
“should,” “could,” “would,”
“expects,” “plans,” “believes,”
“anticipates,” “intends,”
“estimates,” “approximates,”
“predicts,” or “projects,” or the negative
or other variation of such words, and similar expressions may
identify a statement as a forward-looking statement. Any statements
that refer to projections of our future financial performance, our
anticipated growth and trends in our business, our goals,
strategies, focus and plans, and other characterizations of future
events or circumstances, including statements expressing general
optimism about future operating results and the development of our
products, are forward-looking statements.
Although
forward-looking statements in this Quarterly Report on Form 10-Q
reflect the good faith judgment of our management, such statements
can only be based on facts and factors currently known by us.
Consequently, forward-looking statements are inherently subject to
risks and uncertainties and actual results and outcomes may differ
materially from the results and outcomes discussed in or
anticipated by the forward-looking statements. Factors that could
cause or contribute to such differences in results and outcomes
include, without limitation, those specifically addressed under the
heading “Risks Factors” below, as well as those
discussed elsewhere in this Quarterly Report on Form 10-Q. Readers
are urged not to place undue reliance on these forward-looking
statements, which speak only as of the date of this Quarterly
Report on Form 10-Q. We file reports with the SEC. You can read and
copy any materials we file with the SEC at the SEC's Public
Reference Room at 100 F Street, NE, Washington, DC 20549. You can
obtain additional information about the operation of the Public
Reference Room by calling the SEC at 1-800-SEC-0330. In addition,
the SEC maintains an Internet site (www.sec.gov) that contains
reports, proxy and information statements, and other information
regarding issuers that file electronically with the SEC, including
us.
Overview
We are
an emerging over-the-counter ("OTC") consumer goods and specialty
pharmaceutical company engaged in the commercialization, licensing
and development of safe and effective non-prescription medicine and
consumer care products to improve men’s and women’s
health and vitality and respiratory diseases. We deliver
innovative and uniquely presented and packaged health solutions
through our (a) OTC medicines and consumer and health products,
which we market directly, (b) commercial partners to primary care
physicians, urologists, gynecologists and therapists, and (c)
directly to consumers through our print media, on-line channels,
retailers and wholesalers. We are dedicated to being a leader in
developing and marketing new OTC and branded Abbreviated New Drug
Application (“ANDA”) products. We are actively pursuing
opportunities where existing prescription drugs have recently, or
are expected to, change from prescription (or Rx) to OTC. These
“Rx-to-OTC switches” require Food and Drug
Administration (“FDA”) approval through a process
initiated by the New Drug Application (“NDA”)
holder.
Our business model leverages our ability to (a) develop and build
our current pipeline of products, and (b) to also acquire outright
or in-license commercial products that are supported by scientific
and/or clinical evidence, place them through our existing supply
chain, retail and on-line (including Amazon®-based
business platform) channels to tap new markets and drive demand for
such products and to establish physician relationships. We
currently have 21 products marketed in the U.S. with six of those
being marketed and sold in multiple countries around the world
through some of our 15 commercial partners. We currently expect to
launch an additional five products in the U.S. in the second half
of 2017 and we currently have approvals to launch certain of our
already marketed products in 33 additional
countries.
Our Strategy
Our
corporate strategy focuses on two primary objectives:
1.
Developing a
diversified product portfolio of exclusive, unique and patented
non-prescription OTC and branded ANDA drugs and consumer health
products through: (a) the introduction of line extensions and
reformulations of either our or third-party currently marketed
products; and (b) the acquisition of products or obtaining
exclusive licensing rights to market such products;
and
2.
Building an
innovative, U.S. and global sales and marketing model through
direct to consumer approaches such as our proprietary Beyond
Human® sales and marketing platform, the addition of new
online platforms such as Amazon® and commercial partnerships
with established international complimentary partners that: (a)
generates revenue, and (b) requires a lower cost structure compared
to traditional pharmaceutical companies thereby increasing our
gross margins.
Our Products
We
currently generate revenue from 21 products in the U.S. and six in
international countries, as follows:
1.
Vesele® for
promoting sexual health (U.S. and U.K.);
2.
Zestra® for
female arousal (U.S., U.K., Denmark, Canada, Morocco, the UAE and
South Korea);
3.
Zestra
Glide® (U.S, Canada and the MENA countries);
4.
UriVarx™ for
bladder health;
5.
Sensum+® to
alleviate reduced penile sensitivity (U.S., U.K. and
Morocco);
6.
ProstaGorx™
for prostate health;
7.
AllerVarx™
for the management of allergy symptoms;
8.
Apeaz™ for
arthritis related pain;
9.
ArthriVarx™
for joint health;
10
EjectDelay®
indicated for the treatment of premature ejaculation (U.S. and
Canada);
11.
RecalMax™
for brain health;
12.
Androferti®
(U.S. and Canada) for the support of overall male reproductive
health and sperm quality;
13.
Beyond
Human® Testosterone Booster;
14.
Beyond
Human® Ketones;
15.
Beyond
Human® Krill Oil;
16.
Beyond
Human® Omega 3 Fish Oil;
17.
Beyond
Human® Vision Formula;
18.
Beyond
Human® Blood Sugar;
19.
Beyond
Human® Colon Cleanse;
20.
Beyond
Human® Green Coffee Extract; and
21.
Beyond
Human® Growth Agent.
In
addition, we currently expect to launch in the U.S. the following
products in the second half of 2017, subject to the applicable
regulatory approvals, if required:
1.
FlutiCare™
for allergic rhinitis;
2.
Xyralid™ for
the relief of the pain and symptoms caused by
hemorrhoids;
3.
PEVarx™ for
extension of sexual intercourse time;
4.
AndroVit™
for men's health; and
5.
Urocis™ XR
for urinary tract infections.
Sales and Marketing Strategy U.S. and Internationally
Our
sales and marketing strategy is based on (a) the use of direct to
consumer advertisements in print and online media through our
proprietary Beyond Human® sales and marketing infrastructure
acquired in March 2016, (b) working with direct commercial channel
partners in the U.S. and also directly marketing the products
ourselves to physicians, urologists, gynecologists and therapists
and to other healthcare providers, and (c) working with exclusive
commercial partners outside of the U.S. that would be responsible
for sales and marketing in those territories. We have now fully
integrated most of our existing line of products such as
Vesele®, Sensum+®, UriVarx™, Zestra®,
RecalMax™, ProstaGorx™ and AllerVarx™ into the
Beyond Human® sales and marketing platform. We plan to
integrate Apeaz™, ArthriVarx™, Xyralid™,
AndroVit™, Urocis™ XR; and FlutiCare™ upon their
expected commercial launches in 2017. We also market and distribute
our products in the U.S. through retailers, wholesalers and other
online channels. Our strategy outside the U.S. is to partner with
companies who can effectively market and sell our products in their
countries through their direct marketing and sales teams. The
strategy of using our partners to commercialize our products is
designed to limit our expenses and fix our cost structure, enabling
us to increase our reach while minimizing our incremental
spending.
Our
current OTC monograph, Rx-to-OTC ANDA switch drugs and consumer
care products marketing strategy is to focus on four main U.S.
markets: (1) sexual health (male sexual dysfunction and health);
(2) urology (bladder and prostate health); (3) respiratory disease;
and (4) migraines and brain health. We will focus our current
efforts on these four markets and will seek to develop, acquire or
license products that we can sell through our sales channels in
these fields.
In May
2017, we entered into a commercial agreement with West-Ward
Pharmaceuticals International Limited (“WWPIL”).
Pursuant to the commercial agreement, WWPIL will provide us with
the rights to launch our branded, fluticasone propionate nasal
spray USP, 50 mcg per spray (FlutiCare™), under WWPIL’s
FDA approved ANDA No. 207957 in the U.S. in the fourth quarter of
2017. Upon launch of FlutiCare™, it will be the third
national branded OTC fluticasone propionate nasal spray in the
allergic rhinitis market. Our current sales and marketing strategy
for the launch of the product consists of the
following:
1.
Finalizing
agreements with wholesalers, retail stores in which we are a vendor
of record and independent pharmacies;
2.
Provide sampling
to the top prescribers of fluticasone propionate;
3.
Implement direct
sampling and coupon programs to consumers to continue to build
brand awareness;
4.
Launch
under our Beyond Human® sales and marketing platform through
print and online media; and
5.
Launch
through our online platforms including our website, email
subscriber lists and Amazon®.
Results of Operations for the Three and Six Months Ended June 30,
2017 Compared with the Three and Six Months Ended June 30,
2016
|
|
Three Months Ended
June 30,
2017
|
Three Months Ended
June 30,
2016
|
|
|
|
NET
REVENUE:
|
|
|
|
|
|
Product
sales, net
|
$2,031,157
|
$1,019,520
|
$1,011,637
|
99.2%
|
|
License
revenue
|
7,500
|
-
|
7,500
|
100.0%
|
|
Net revenue
|
2,038,657
|
1,019,520
|
1,019,137
|
100.0%
|
|
|
|
|
|
|
|
OPERATING
EXPENSE:
|
|
|
|
|
|
Cost
of product sales
|
408,579
|
262,934
|
145,645
|
55.4%
|
|
Research
and development
|
15,063
|
3,892
|
11,171
|
287.0%
|
|
Sales
and marketing
|
1,555,736
|
249,515
|
1,306,221
|
523.5%
|
|
General
and administrative
|
1,182,235
|
945,572
|
236,663
|
25.0%
|
|
Total
operating expense
|
3,161,613
|
1,461,913
|
1,699,700
|
116.3%
|
|
LOSS
FROM OPERATIONS
|
(1,122,956)
|
(442,393)
|
(680,563)
|
153.8%
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
Interest
expense
|
(110,130)
|
(1,860,399)
|
1,750,269
|
(94.1)%
|
|
Loss
on extinguishment of debt
|
-
|
-
|
-
|
-%
|
|
Other
income (expense), net
|
(206)
|
111
|
(317)
|
(285.6)%
|
|
Fair
value adjustment for contingent consideration
|
98,979
|
(16,750)
|
115,729
|
(690.9)%
|
|
Change
in fair value of derivative liabilities
|
3,463
|
(2,040,909)
|
2,044,372
|
(100.2)%
|
|
Total
other expense, net
|
(7,894)
|
(3,917,947)
|
3,910,053
|
(99.8)%
|
|
LOSS
BEFORE PROVISION FOR INCOME TAXES
|
(1,130,850)
|
(4,360,340)
|
3,229,490
|
(74.1)%
|
|
Provision
for income taxes
|
3,200
|
-
|
3,200
|
100.0%
|
|
NET
LOSS
|
$(1,134,050)
|
$(4,360,340)
|
(3,226,290)
|
(74.0)%
|
|
|
Six Months Ended
June 30,
2017
|
Six Months Ended
June 30,
2016
|
|
|
|
NET
REVENUE:
|
|
|
|
|
|
Product
sales, net
|
$4,208,447
|
$1,243,983
|
$2,964,464
|
238.3%
|
|
License
revenue
|
7,500
|
1,000
|
6,500
|
650.0%
|
|
Net revenue
|
4,215,947
|
1,244,983
|
2,970,964
|
238.6%
|
|
|
|
|
|
|
|
OPERATING
EXPENSE:
|
|
|
|
|
|
Cost
of product sales
|
849,055
|
383,057
|
465,998
|
121.7%
|
|
Research
and development
|
18,246
|
3,892
|
14,354
|
100.0%
|
|
Sales
and marketing
|
3,243,087
|
285,011
|
2,958,076
|
1,037.9%
|
|
General
and administrative
|
2,886,898
|
2,233,309
|
653,589
|
29.3%
|
|
Total
operating expense
|
6,997,286
|
2,905,269
|
4,092,017
|
140.8%
|
|
LOSS
FROM OPERATIONS
|
(2,781,339)
|
(1,660,286)
|
(1,121,053)
|
67.5%
|
|
OTHER
INCOME (EXPENSE):
|
|
|
|
|
|
Interest
expense
|
(667,609)
|
(2,251,250)
|
1,583,641
|
(70.3)%
|
|
Loss
on extinguishment of debt
|
(304,828)
|
-
|
(304,828)
|
100.0%
|
|
Other
income (expense), net
|
(822)
|
1,876
|
(2,698)
|
(143.8)%
|
|
Fair
value adjustment for contingent consideration
|
126,154
|
(22,334)
|
148,488
|
(664.9)%
|
|
Change
in fair value of derivative liabilities
|
(48,193)
|
(1,983,315)
|
1,935,122
|
(97.6)%
|
|
Total other expense, net
|
(895,298)
|
(4,255,023)
|
3,359,725
|
(79.0)%
|
|
LOSS
BEFORE PROVISION FOR INCOME TAXES
|
(3,676,637)
|
(5,915,309)
|
2,238,672
|
(37.8)%
|
|
Provision
for income taxes
|
3,200
|
-
|
3,200
|
100.0%
|
|
NET
LOSS
|
$(3,679,837)
|
$(5,915,309)
|
2,235,472
|
(37.8)%
|
Net Revenue
We
recognized net revenue of approximately $2.0 million and $4.2
million for the three and six months ended June 30, 2017,
respectively, compared to $1.0 million and $1.2 million for the
three and six months ended June 30, 2016, respectively. The
increase in revenue in 2017 was primarily the result of the product
sales generated through the sales and marketing platform acquired
in the Beyond Human® asset acquisition in March 2016. The
increase was also due to the launch of UriVarx™ at the end of
the fourth quarter 2016 and ProstaGorx™. These new product
launches generated net revenue of approximately $973,000 and $1.5
million during the three and six months ended June 30, 2017. The
increase was also attributed to an increase in sales of
Vesele® and Sensum+®, which generated net revenue of
approximately $639,000 and $1.6 million for Vesele®, and
$185,000 and $554,000 for Sensum+® during the three and six
months ended June 30, 2017, respectively, compared to approximately
$573,000 for Vesele® and $8,000 for Sensum+® during the
three and six months ended June 30, 2016, respectively. The
increase in net revenue from the sale of products through the
Beyond Human® sales and marketing platform was offset by
decreases in our other existing product sales channels to major
retailers and wholesalers as we concentrated our sales efforts and
resources on integrating our existing products into the Beyond
Human® sales and marketing platform to increase our gross
margin. The decreases in existing product sales channels resulted
in net revenue from the Zestra® products decreasing
approximately $5,000 and $61,000 during the three and six months
ended June 30, 2017, respectively, when compared to the same period
in 2016. We signed an exclusive license and distribution agreement
in November 2016 for the sale of Zestra® and Zestra
Glide® in South Korea and, in March 2017, we shipped the
initial order under such agreement resulting in net revenue of
$60,000 during the six months ended June 30, 2017. In the second
quarter of 2017, we entered into two additional exclusive license
and distribution agreements which we expect will lead to an
increase in product sales of Zestra® and Zestra Glide®
through our Ex-U.S. sales channel in 2017.
Cost of Product Sales
We
recognized cost of product sales of approximately $409,000 and
$849,000 for the three and six months ended June 30, 2017,
respectively, compared to $263,000 and $383,000 for the three and
six months ended June 30, 2016, respectively. The cost of product
sales includes the cost of inventory, shipping and royalties. The
increase in cost of product sales is a result of higher shipping
costs due to an increase in the number of units
shipped. The increase in the gross margin to 80% in 2017
compared to 69% in 2016 is due to the higher margins earned on the
increased volume of our product sales through the Beyond
Human® sales and marketing platform. The increased margin in
2017 is also due to fewer sales when compared to 2016 through our
retail and wholesale sales channels, which have lower
margins.
Research and Development
We
recognized research and development expense of approximately
$15,000 and $18,000 for the three and six months ended June 30,
2017, respectively, compared to $4,000 for the three and six months
ended June 30, 2016. The research and development expense includes
salary and the related health benefits for an employee who was
terminated in January 2017, as well as, costs for stability testing
and other development related costs for our products.
Sales and Marketing
We
recognized sales and marketing expense of approximately $1.6
million and $3.2 million for the three and six months ended June
30, 2017, respectively, compared to $250,000 and $285,000 for the
three and six months ended June 30, 2016, respectively. Sales and
marketing expense during the six months ended June 30, 2017 consist
primarily of print advertisements and sales and marketing support.
The increase in sales and marketing expense during the three and
six months ended June 30, 2017 when compared to the same period in
2016 is due to the increase in the number of products integrated
into the Beyond Human® sales and marketing platform, the
increase in print and online media advertisements of our existing
products through the Beyond Human® platform, as well as, the
costs of our third-party customer service call center due to the
higher volume of sales orders received as a result of the Beyond
Human® asset acquisition.
General and Administrative
We
recognized general and administrative expense of approximately $1.2
million and $2.9 million for the three and six months ended June
30, 2017, respectively, compared to $946,000 and $2.2 million for
the three and six months ended June 30, 2016. General and
administrative expense consists primarily of investor relation
expense, legal, accounting, public reporting costs and other
infrastructure expense related to the launch of our products.
Additionally, our general and administrative expense includes
professional fees, insurance premiums and general corporate
expense. The increase is primarily due to the increase in merchant
processing fees due to increased credit card sales volume and
increased payroll and related costs due to the increase in
headcount when compared to 2016. The increase was offset by a
decrease in stock-based compensation to employees, directors and
consultants of approximately $322,000 and $482,000, respectively,
during the three and six months ended June 30, 2017 compared to
2016.
Other Income and Expense
We
recognized interest expense of approximately $110,000 and $668,000
for the three and six months ended June 30, 2017, respectively,
compared to $1.9 million and $2.3 million for the three and six
months ended June 30, 2016, respectively. Interest expense
primarily includes interest related to our debt and amortization of
debt discounts (see Note 5 to the accompanying condensed
consolidated financial statements included elsewhere in this
Quarterly Report). Due to the shares, warrants and cash discounts
provided to our lenders, the effective interest rate is
significantly higher than the coupon rate. The decrease in
interest expense during the three and six months ended June 30,
2017 is due to the larger amount of debt discount amortization in
2016 compared to 2017 as a result of the convertible debt and note
payable financings completed in 2016 and the repayment of the
convertible debt in March 2017.
We
recognized a loss on extinguishment of debt of approximately
$305,000 during the six months ended June 30, 2017. The loss on
debt extinguishment was the result of the required prepayment of
the 2016 Notes from the cash proceeds received through the public
equity offering in March 2017. Under the terms of the 2016 Notes,
we were required to prepay the outstanding principal and interest
of the convertible debentures with the cash proceeds received from
an equity offering with an offering price less than the current
conversion price of the debentures of $0.25 per share, as well as
incur a 10% prepayment penalty. As a result of the prepayment, the
remaining unamortized debt discount of approximately $416,000, the
prepayment penalty of $127,000 and the extinguishment of the
embedded conversion feature derivative liability of $238,000 were
recorded as a loss on debt extinguishment during the six months
ended June 30, 2017.
We
recognized a gain from the fair value adjustment for contingent
consideration of approximately $99,000 and $126,000 for the three
and six months ended June 30, 2017, respectively, compared to a
loss of $17,000 and $22,000 for the three and six months ended June
30, 2016, respectively. Fair value adjustment for contingent
consideration consists primarily of the decrease in the fair value
of the remaining contingent ANDA shares of common stock issuable to
individual members of Novalere Holdings, LLC in connection with our
acquisition in 2015 totaling approximately $20,000 and the decrease
in the royalty contingent consideration to Semprae of approximately
$106,000 (see Note 3 to the accompanying condensed consolidated
financial statements included elsewhere in this Quarterly
Report).
We
recognized a gain (loss) from the change in fair value of
derivative liabilities of approximately $3,000 and $(48,000) for
the three and six months ended June 30, 2017, respectively,
compared a loss from the change in fair value of derivative
liabilities of $2,041,000 and $1,983,000 for the three and six
months ended June 30, 2016, respectively. Change in fair value of
derivative liabilities primarily includes the change in the fair
value of the warrants and embedded conversion features classified
as derivative liabilities. The loss on change in fair value of
derivative liabilities during the six months ended June 30, 2017 is
primarily due to the increase in our stock price from December 31,
2016 through the date of conversion of certain of the convertible
debentures in 2017, which resulted in the fair value of the
embedded conversion features at the conversion date to be higher
than the fair value at December 31, 2016.
Net Loss
Net
loss for the three and six months ended June 30, 2017 was
approximately $(1.1 million) or $(0.01) basic and diluted net loss
per share and $(3.7 million) or $(0.02) basic and diluted net loss
per share, respectively, compared to a net loss for the same
periods in 2016 of $(4.4 million) or $(0.05) basic and diluted net
loss per share and $(5.9 million) or $(0.08) basic and diluted net
loss per share, respectively.
Liquidity and Capital Resources
Historically,
we have funded losses from operations through the sale of equity
and the issuance of debt instruments. Combined with revenue, these
funds have provided us with the capital to operate our business, to
sell and support our products, attract and retain key personnel,
and add new products to our portfolio. To date, we have experienced
net losses each year since our inception. As of June 30, 2017, we
had an accumulated deficit of approximately $32.8 million and a
working capital deficit of $1.0 million.
As of
June 30, 2017, we had approximately $1.8 million in cash. Although
no assurances can be given, we may raise additional capital through
the sale of equity or debt securities. We expect, however, that our
existing capital resources, revenue from sales of our products and
upcoming new product launches and sales milestone payments from the
commercial partners signed for our products, and equity instruments
available to pay certain vendors and consultants, will be
sufficient to allow us to continue our operations, commence the
product development process and launch selected products
through at least the next 12 months. In addition, our CEO, who is
also a significant shareholder, has deferred the remaining payment
of his salary earned thru June 30, 2016 totaling $1,036,315 for at
least the next 12 months.
Our
actual needs will depend on numerous factors, including timing of
introducing our products to the marketplace, our ability to attract
additional Ex-U.S. distributors for our products and our ability to
in-license in non-partnered territories and/or develop new product
candidates. In addition, we continue to seek new licensing
agreements from third-party vendors to commercialize our products
in territories outside the U.S., which could result in upfront,
milestone, royalty and/or other payments.
We may
raise additional capital through the sale of debt or equity
securities to provide additional working capital, for further
expansion and development of our business, and to meet current
obligations, although no assurances can be given. If we issue
equity or convertible debt securities to raise additional funds,
our existing stockholders may experience substantial dilution, and
the newly issued equity or debt securities may have more favorable
terms or rights, preferences and privileges senior to those of our
existing stockholders. If we raise funds by incurring additional
debt, we may be required to pay significant interest expense and
our leverage relative to our earnings or to our equity
capitalization may increase. Obtaining commercial loans, assuming
they would be available, would increase our liabilities and future
cash commitments and may impose restrictions on our activities,
such as financial and operating covenants. Further, we may incur
substantial costs in pursuing future capital and/or financing
transactions, including investment banking fees, legal fees,
accounting fees, printing and distribution expense and other costs.
We may also be required to recognize non-cash expense in connection
with certain securities we may issue, such as convertible notes and
warrants, which would adversely impact our financial results. We
may be unable to obtain financing when necessary as a result of,
among other things, our performance, general economic conditions,
conditions in the pharmaceuticals industries, or our operating
history. In addition, the fact that we are not and have never been
profitable could further impact the availability or cost to us of
future financings. As a result, sufficient funds may not be
available when needed from any source or, if available, such funds
may not be available on terms that are acceptable to us. If we are
unable to raise funds to satisfy our capital needs when needed,
then we may need to forego pursuit of potentially valuable
development or acquisition opportunities, we may not be able to
continue to operate our business pursuant to our business plan,
which would require us to modify our operations to reduce spending
to a sustainable level by, among other things, delaying, scaling
back or eliminating some or all of our ongoing or planned
investments in corporate infrastructure, business development,
sales and marketing and other activities, or we may be forced to
discontinue our operations entirely.
The
Company’s principle debt instruments include the
following:
February 2016 Note Payable
On
February 24, 2016, the Company and SBI Investments, LLC, 2014-1
(“SBI”) entered into an agreement in which SBI loaned
us gross proceeds of $550,000 pursuant to a purchase agreement, 20%
secured promissory note and security agreement (“February
2016 Note Payable”), all dated February 19, 2016
(collectively, the “Finance Agreements”). Pursuant to
the Finance Agreements, the principal amount of the February 2016
Note Payable was $550,000 and the interest rate thereon is 20% per
annum. We began to pay principal and interest on the
February 2016 Note Payable on a monthly basis beginning on March
19, 2016 for a period of 24 months and the monthly mandatory
principal and interest payment amount thereunder is $28,209. The
monthly amount shall be paid by us through a deposit account
control agreement with a third-party bank in which SBI shall be
permitted to take the monthly mandatory payment amount from all
revenue received by us from the Beyond Human® assets in the
transaction. The maturity date for the February 2016
Note Payable is February 19, 2018. The February 2016 Note Payable
is secured by SBI through a first priority secured interest in all
of the Beyond Human® assets acquired by us in the transaction
including all revenue received by us from these assets. The
principal balance of the February 2016 Note Payable as of June 30,
2017 is $209,040.
December 2016 and January 2017 Notes Payable
On
December 5, 2016 and January 19, 2017, we entered into a securities
purchase agreement with three unrelated third-party investors in
which the investors loaned us gross proceeds of $650,000 pursuant
to 5% promissory notes. The notes have an OID of $65,000
and requires payment of $715,000 in principal upon maturity. The
notes bear interest at the rate of 5% per annum and the principal
amount and interest are payable at maturity on October 4, 2017 and
November 18, 2017. In connection with the notes, we issued the
investors restricted shares of common stock totaling
1,441,111. The fair value of the restricted shares of
common stock issued was based on the market price of our common
stock on the date of issuance of the notes.
Net Cash Flows
|
|
Six
Months Ended June 30, 2017
|
Six
Months Ended June 30, 2016
|
|
Net cash (used in)
provided by operating activities
|
$(969,292)
|
$256,152
|
|
Net cash used in
investing activities
|
(8,048)
|
(6,565)
|
|
Net cash provided
by (used in) financing activities
|
1,972,040
|
(107,355)
|
|
Net change in
cash
|
994,700
|
142,232
|
|
Cash at beginning
of period
|
829,933
|
55,901
|
|
Cash at end of
period
|
$1,824,633
|
$198,133
|
Operating Activities
For the
six months ended June 30, 2017, cash used in operating activities
was approximately $969,000, consisting primarily of the net loss
for the period of approximately $3.7 million, which was primarily
offset by non-cash common stock, restricted stock units and stock
options issued for services and compensation of approximately
$742,000, amortization of debt discount of $601,000, loss on debt
extinguishment of $305,000, change in fair value of derivative
liabilities of $48,000, and amortization of intangible assets of
$315,000. The non-cash expense was offset with the gain on change
in fair value of contingent consideration of approximately
$126,000. Additionally, working capital changes consisted of cash
increases of approximately $815,000 related to a decrease in
accounts receivable from cash collections from customers of
approximately $8,000, $277,000 related to an increase in accrued
compensation, $407,000 related to an increase in accounts payable
and accrued expense, $88,000 related to a decrease in prepaid
expense and other current assets, $36,000 related to an increase in
deferred revenue and customer deposits and $13,000 related to a
decrease in inventories, partially offset by a cash decrease
related to accrued interest of $14,000. The increase in net cash
used in operating activities from 2016 was mainly due to expanding
our operations, including hiring additional personnel,
commercialization and marketing activities related to our existing
products and those acquired in 2016.
Investing Activities
For the
six months ended June 30, 2017, cash used in investing activities
was approximately $8,000 which consisted of the purchase of
property and equipment for our corporate office location compared
to $7,000 for 2016.
Financing Activities
For the
six months ended June 30, 2017, cash provided by financing
activities was approximately $2.0 million, consisting primarily of
the net proceeds from the public equity offering of $3.3 million
and notes payable of $150,000, offset by the repayment of
convertible debentures of approximately $1.2 million, notes payable
of $139,000, and the prepayment penalty on the repayment of the
convertible debentures of $127,000. Cash used in financing
activities in 2016 was primarily related to net proceeds from notes
payable and convertible debentures of approximately $417,000 and
proceeds from short-term loans payable of $22,000, offset by the
repayment of notes payable and short-term loans payable of
$408,000, payment of financing costs in connection with convertible
debentures of $19,000, and the repayment of the related-party line
of credit convertible debenture of $119,000.
Critical Accounting Policies and Estimates
On
January 1, 2017, the Company adopted Financial Accounting Standards
Board (“FASB”) Accounting Standards Update
(“ASU”) No. 2016-15, Statement of Cash Flows (Topic 230) –
Classification of Certain Cash Receipts and Cash Payments.
We elected to early adopt ASU 2016-15 and, as a result, the
prepayment penalty of $127,247 in connection with the
extinguishment of the 2016 Notes (see Note 5 in the accompanying
condensed consolidated financial statements) in March 2017 is
classified as a financing cash outflow in the accompanying
condensed consolidated statement of cash flows for the six months
ended June 30, 2017. The adoption of this ASU did not have a
material impact on our condensed consolidated financial position,
results of operations and related disclosures and had no other
impact to the accompanying condensed consolidated statement of cash
flows for the six months ended June 30, 2017 and 2016.
For
the six months ended June 30, 2017, there were no other material
changes to the “Critical Accounting Policies” discussed
in Part II, Item 7 (Management’s Discussion and Analysis of
Financial Condition and Results of Operations) of our Annual Report
on Form 10-K for the year ended December 31 2016.
Off- Balance Sheet Arrangements
None.
Recent Accounting Pronouncements
See
Note 1 to our condensed consolidated financial statements included
in this Quarterly Report.
|
ITEM 3.
|
QUANTITATIVE AND
QUALITATIVE DISCLOSURES ABOUT MARKET RISK
|
Not
applicable.
Evaluation of disclosure controls and procedures.
As of
June 30, 2017, we evaluated, with the participation of our
principal executive officer and principal financial officer, the
effectiveness of our disclosure controls and procedures (as defined
in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act
of 1934, as amended (the "Exchange Act")).
Based
on that evaluation, our principal executive officer and principal
financial officer concluded that, as of June 30, 2017, our
disclosure controls and procedures are designed at a reasonable
assurance level and are effective to provide reasonable assurance
that information we are required to disclose in reports that we
file or submit under the Exchange Act is recorded, processed,
summarized and reported within the time periods specified in SEC
rules and forms, and that such information is accumulated and
communicated to our management, including chief executive officer
and vice president, finance, as appropriate to allow timely
decisions regarding required disclosure. In designing and
evaluating our disclosure controls and procedures, management
recognized that disclosure controls and procedures, no matter how
well conceived and operated, can provide only reasonable, but not
absolute, assurance that the objectives of the disclosure controls
and procedures are met. The design of any disclosure control and
procedure also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any
design will succeed in achieving its stated goals under all
potential future conditions.
Changes in internal control over financial reporting.
During
the quarter ended June 30, 2017, there were no changes in our
internal control over financial reporting that have materially
affected, or are reasonably likely to materially affect, our
internal control over financial reporting.
PART II—OTHER INFORMATION
In the
normal course of business, we may be a party to legal
proceedings. We are not currently a party to any legal
proceedings.
The
risks described in Part
I, Item 1A, Risk Factors, in our Annual Report on
Form 10-K for the fiscal year ended December 31, 2016, could
materially and adversely affect our business, financial condition
and results of operations. These risk factors do not identify all
of the risks that we face. Our business, financial condition and
results of operations could also be affected by factors that are
not presently known to us or that we currently consider to be
immaterial. There have been no material changes to the “Risk
Factors” section included in our Annual Report on Form 10-K
for the fiscal year ended December 31, 2016.
|
ITEM 2.
|
UNREGISTERED SALES OF
EQUITY SECURITIES AND USE OF PROCEEDS
|
Unregistered Sales of Equity Securities
For
the three months ended June 30, 2017, we issued 418,349 shares of
our common stock valued at $182,000 in exchange for services under
existing consulting and service agreements with third
parties.
Each
of the securities were offered and sold in transactions exempt from
registration under the Securities Act, in reliance on Section
4(a)(2) thereof and Rule 506 of Regulation D thereunder and/or
Section 3(a)(9) of the Securities Act. Each of the investors
represented that it was an "accredited investor" as defined in
Regulation D under the Securities Act.
Use of Proceeds from the Sale of Registered Securities
On
March 15, 2017, our registration statement on Form S-1 (File
No. 333-215851) was declared effective by the SEC for our
public offering pursuant to which we sold an aggregate of
25,666,669 shares of our common stock at an offering price of $0.15
per share. There has been no material change in our use of
proceeds from our public offering as described in our final
prospectus filed with the SEC on March 17, 2017 pursuant to
Rule 424(b).
|
ITEM 3.
|
DEFAULTS UPON SENIOR SECURITIES
|
None.
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
Not
applicable.
None.
See
the Exhibit Index immediately following the signature page of this
report.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the
registrant has duly caused this report to be signed on its behalf
by the undersigned thereunto duly authorized.
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Innovus
Pharmaceuticals, Inc.
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(Registrant)
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Date:
August 14, 2017
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/s/ Bassam
Damaj
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Bassam
Damaj, Ph.D.
President,
Chief Executive Officer and Director
(Principal
Executive Officer)
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/s/ Rauly
Gutierrez
Rauly Gutierrez,
CPA
Vice President,
Finance
(Principal
Financial Officer)
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Exhibit No.
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Description
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Form
of Securities Purchase Agreement filed as Exhibit 4.1 to the
Registrant's report on Amendment No. 1 to Form S-1 filed with the
SEC on March 13, 2017 and incorporated herein by
reference.
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Form
of Series A and Series B Warrant filed as Exhibit 4.2 to the
Registrant's report on Amendment No. 1 to Form S-1 filed with the
SEC on March 13, 2017 and incorporated herein by
reference.
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Form
of Placement Agent Warrant filed as Exhibit 4.3 to the
Registrant's report on Amendment No. 1 to Form S-1 filed with the
SEC on March 13, 2017 and incorporated herein by
reference.
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Employment
Agreement, dated as of September 23, 2016 by and between Innovus
Pharmaceuticals, Inc. and Rauly Gutierrez (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed April 14, 2017).
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Certification
of Bassam Damaj, Ph.D., principal executive officer, pursuant to
Rule 13-a-14(a) or 15d-14(a) of the Securities and Exchange Act of
1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002.
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Certification
of Rauly Gutierrez, CPA, principal financial officer, pursuant to
Rule 13-a-14(a) or 15d-14(a) of the Securities and Exchange Act of
1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act
of 2002.
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Certification
of Bassam Damaj, Ph.D., principal executive officer, and Rauly
Gutierrez, CPA, principal financial officer, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
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101.INS*
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XBRL
Instance Document
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101.SCH*
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XBRL
Taxonomy Extension Schema Document
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101.CAL*
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XBRL
Taxonomy Extension Calculation Linkbase Document
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101.DEF*
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XBRL
Taxonomy Extension Definition Linkbase Document
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101.LAB*
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XBRL
Taxonomy Extension Label Linkbase Document
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101.PRE*
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XBRL
Taxonomy Extension Presentation Linkbase Document
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**
This certification is being furnished solely to
accompany this report pursuant to 18 U.S.C. Section 1350, as
adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
and is not being filed for purposes of Section 18 of the Securities
Exchange Act of 1934 and is not to be incorporated by reference
into any filing of the Registrant, whether made before or after the
date hereof, regardless of any general incorporation by reference
language of such filing.