SEC Connect
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 September 30, 2016
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)
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 [X] 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
[X] No [ ]
Indicate
by check mark whether the registrant is a large accelerated filer,
an accelerated filer, a non-accelerated filer, or a smaller
reporting company.
Large
accelerated filer [ ]
|
Accelerated
filer [ ]
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Non-accelerated
filer [ ]
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Smaller
reporting company [X]
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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
[X]
Outstanding Shares
As
of November 10, 2016, the registrant had 106,080,636 shares of
common stock outstanding.
TABLE OF CONTENTS
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INNOVUS PHARMACEUTICALS, INC.
Condensed Consolidated Balance Sheets
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ASSETS
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CURRENT
ASSETS
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Cash
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$1,454,545
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$55,901
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Accounts receivable, net
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30,875
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83,097
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Prepaid expenses and other current assets
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1,179,212
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53,278
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Inventories
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396,772
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254,443
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Total
current assets
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3,061,404
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446,719
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PROPERTY
AND EQUIPMENT, NET
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32,235
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35,101
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OTHER
ASSETS
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Deposits
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14,958
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14,958
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Goodwill
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549,368
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549,368
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Intangible assets, net
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5,401,571
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5,300,859
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TOTAL
ASSETS
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$9,059,536
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$6,347,005
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LIABILITIES
AND STOCKHOLDERS' DEFICIT
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CURRENT
LIABILITIES
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Accounts payable and accrued expenses
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$1,623,547
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$155,503
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Accrued compensation
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517,846
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535,862
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Deferred revenue and customer deposits
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11,000
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24,079
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Accrued interest payable
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30,656
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79,113
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Short-term loans payable
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-
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230,351
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Derivative liabilities – embedded conversion
features
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1,091,544
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301,779
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Derivative liabilities – warrants
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239,049
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432,793
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Contingent consideration
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22,104
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-
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Current portion of note payable and non-convertible debenture, net
of debt discount of $3,750 and $0, respectively
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274,536
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73,200
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Line of credit convertible debenture and non-convertible debenture
– related parties, net of debt discount of $0 and
$17,720, respectively
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-
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391,472
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Convertible debentures, net of debt discount of $1,474,342 and
$1,050,041, respectively
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410,580
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407,459
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Total
current liabilities
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4,220,862
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2,631,611
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NON-CURRENT
LIABILITIES
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Accrued compensation – less current portion
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1,506,010
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906,928
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Note payable and non-convertible debenture, net of current portion
and debt discount of $1,405 and $0, respectively
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132,593
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-
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Line of credit convertible debenture and non-convertible debenture
– related
parties, net of current portion
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-
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25,000
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Contingent consideration – less current portion
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3,207,700
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3,229,804
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Total
non-current liabilities
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4,846,303
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4,161,732
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TOTAL
LIABILITIES
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9,067,165
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6,793,343
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COMMITMENTS
AND CONTINGENCIES
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STOCKHOLDERS'
DEFICIT
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Common stock: 150,000,000 shares authorized, at $0.001 par value,
104,164,880 and 47,141,230 shares issued and outstanding at
September 30, 2016 and December 31, 2015, respectively
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104,165
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47,141
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Additional paid-in capital
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25,663,922
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14,941,116
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Accumulated deficit
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(25,775,716)
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(15,434,595)
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Total
stockholders' deficit
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(7,629)
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(446,338)
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TOTAL
LIABILITIES AND STOCKHOLDERS' DEFICIT
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$9,059,536
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$6,347,005
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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
September 30,
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For the
Nine Months Ended
September 30,
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NET
REVENUES:
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Product sales, net
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$1,882,129
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$179,744
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$3,126,112
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$555,069
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License revenues
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-
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-
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1,000
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5,000
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Net
revenues
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1,882,129
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179,744
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3,127,112
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560,069
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OPERATING
EXPENSES:
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Cost of product sales
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331,227
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102,359
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714,284
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242,808
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Research and development
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43,775
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-
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47,667
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-
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Sales and marketing
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1,972,155
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80,682
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2,257,166
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132,778
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General and administrative
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1,779,048
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650,539
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4,012,357
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2,948,413
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Total
operating expenses
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4,126,205
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833,580
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7,031,474
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3,323,999
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LOSS
FROM OPERATIONS
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(2,244,076)
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(653,836)
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(3,904,362)
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(2,763,930)
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OTHER
INCOME AND (EXPENSES):
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Interest expense
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(3,727,168)
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(473,360)
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(6,000,752)
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(744,726)
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Loss on extinguishment of debt
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-
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-
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-
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(32,500)
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Other income, net
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194,744
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-
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196,620
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-
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Change in fair value of derivative liabilities
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1,350,688
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268,449
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(632,627)
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316,378
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Total
other expense, net
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(2,181,736)
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(204,911)
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(6,436,759)
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(460,848)
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NET
LOSS
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$(4,425,812)
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$(858,747)
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$(10,341,121)
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$(3,224,778)
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NET
LOSS PER SHARE OF COMMON STOCK - BASIC AND DILUTED
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$(0.04)
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$(0.02)
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$(0.12)
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$(0.06)
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WEIGHTED
AVERAGE NUMBER OF SHARES OF COMMON STOCK OUTSTANDING –
BASIC AND DILUTED
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104,972,645
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55,076,819
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86,498,234
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50,486,501
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See
accompanying notes to these condensed consolidated financial
statements.
INNOVUS PHARMACEUTICALS, INC.
Condensed Consolidated Statements of Cash
Flows
(Unaudited)
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For the
Nine Months Ended
September 30,
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CASH
FLOWS FROM OPERATING ACTIVITIES
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NET
LOSS
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$(10,341,121)
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$(3,224,778)
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Adjustments
to reconcile net loss to net cash used in operating
activities
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Depreciation
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9,431
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24,943
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Allowance
for doubtful accounts
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918
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-
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Common
stock, restricted stock units and stock options issued for services
and board compensation
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1,889,837
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1,288,993
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Loss
on extinguishment of debt
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-
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32,500
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Stock
issued for interest on debt amendment
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-
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48,000
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Gain
on return of shares of common stock issued in Semprae
merger
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-
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(115,822)
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Imputed
interest on contingent consideration
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30,302
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-
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Non-cash
gain on contingent consideration
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(194,781)
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-
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Change
in fair value of derivative liabilities
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632,627
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(316,378)
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Fair
value of embedded conversion feature in convertible debentures in
excess of
allocated proceeds
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2,756,899
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71,462
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Amortization
of debt discount
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2,997,061
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555,362
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Amortization
of intangible assets
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513,767
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387,011
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Changes
in operating assets and liabilities, net of acquisition
amounts
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Accounts
receivable
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51,304
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123,372
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Prepaid
expenses and other current assets
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(450,394)
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27,324
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Deposits
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-
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9,394
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Inventories
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(142,329)
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(45,245)
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Accounts
payable and accrued expenses
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928,044
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(53,794)
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Accrued
compensation
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581,066
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407,860
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Accrued
interest payable
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10,976
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11,254
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Deferred
revenue and customer deposits
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(13,079)
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(17,470)
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Net
cash used in operating activities
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(739,472)
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(786,012)
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CASH
FLOWS FROM INVESTING ACTIVITIES
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Purchase of property and equipment
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(6,565)
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(9,540)
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Purchase of intangible assets
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-
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(3,276)
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Payments on Beyond Human contingent consideration
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(150,000)
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-
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Net
cash used in investing activities
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(156,565)
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(12,816)
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CASH
FLOWS FROM FINANCING ACTIVITIES
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Proceeds from (repayments of) line of credit convertible debenture
– related party
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(409,192)
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114
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Proceeds from short-term loans payable
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21,800
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50,000
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Payments
on short-term loans payable
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(252,151)
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(23,811)
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Proceeds
from notes payable and convertible debentures
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3,074,000
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1,455,000
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Payments
on notes payable
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(384,916)
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(402,933)
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Proceeds
from warrant exercises
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310,140
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-
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Financing
costs in connection with convertible debentures
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(40,000)
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(82,500)
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Proceeds
from non-convertible debentures – related party
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-
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50,000
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Payments
on non-convertible debentures – related party
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(25,000)
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(105,000)
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Net
cash provided by financing activities
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2,294,681
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940,870
|
|
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NET
CHANGE IN CASH
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1,398,644
|
142,042
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CASH
AT BEGINNING OF PERIOD
|
55,901
|
7,479
|
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CASH
AT END OF PERIOD
|
$1,454,545
|
$149,521
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SUPPLEMENTAL
DISCLOSURES OF CASH FLOW INFORMATION:
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Cash paid for income taxes
|
$-
|
$-
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Cash paid for interest
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$205,456
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$-
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SUPPLEMENTAL
DISCLOSURES OF NON-CASH INVESTING AND FINANCING
ACTIVITIES:
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Common stock issued for conversion of notes payable, convertible
debentures and accrued
interest
|
$2,935,900
|
$167,000
|
Reclassification of the fair value of the embedded conversion
features from derivative liability
to additional paid-in capital upon conversion
|
$2,962,666
|
$-
|
Cashless exercise of warrants
|
$3,385
|
$-
|
Reclassification of the fair value of the warrants from derivative
liability to additional paid-in
capital upon cashless exercise
|
$518,224
|
$-
|
Common stock issued for acquisition
|
$-
|
$2,071,625
|
Relative fair value of common stock issued in connection with notes
payable recorded
as debt discount
|
$93,964
|
$-
|
Relative fair value of warrants issued in connection with
convertible debentures recorded
as debt discount
|
$445,603
|
$89,551
|
Relative fair value of common stock issued in connection with
convertible debentures recorded
as debt discount
|
$1,127,225
|
$374,474
|
Fair value of embedded conversion feature derivative liabilities
recorded as debt
discount
|
$687,385
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$830,322
|
Fair value of warrants issued to placement agents in connection
with convertible debentures
recorded as debt discount
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$357,286
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$68,419
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Fair value of the contingent consideration for
acquisition
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$314,479
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$2,862,300
|
Fair value of warrant derivative liabilities recorded as debt
discount
|
$-
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$226,297
|
Proceeds from note payable paid to seller in connection with
acquisition
|
$300,000
|
$-
|
Financing costs paid with proceeds from note payable
|
$7,500
|
$-
|
Fair value of unamortized non-forfeitable common stock issued to
consultant included in
prepaid expenses and other current assets
|
$135,540
|
$-
|
Fair value of non-forfeitable common stock to be issued to
consultant included in prepaid expenses
and other current assets and accounts payable and accrued
expenses
|
$540,000
|
$-
|
Issuance of shares of common stock for vested restricted stock
units
|
$19,229
|
$-
|
Return of shares of common stock related to license
agreement
|
$-
|
$38,000
|
Common stock issued in connection with debt amendment
|
$-
|
$48,000
|
Fair value of beneficial conversion feature on line of credit
convertible debenture – related
party
|
$3,444
|
$6,275
|
See
accompanying notes to these condensed consolidated financial
statements.
INNOVUS PHARMACEUTICALS, INC.
Notes to Condensed Consolidated
Financial Statements
September 30, 2016
(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” 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 revenues from sixteen 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) BTH® Testosterone
Booster, (b) BTH® Human Growth Agent, (c) Zestra® for
female arousal, (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)
BTH® GCBE (k) BTH® Vision Formula, (l) BTH® Blood
Sugar, (m) BTH® Colon Cleans, (n) BTH® Ketones, (o)
BTH® Krill Oil and (p) BTH® Omega 3 Fish Oil. While we
generate revenues from the sale of our commercial products, most
revenue is currently generated by Vesele®, Zestra®,
Zestra® Glide, RecalMax™, Sensum +® and BTH®
Testosterone Booster.
Pipeline Products
Fluticare™
(Fluticasone propionate nasal spray). Innovus acquired the worldwide rights to market
and sell the Fluticare™ brand (Fluticasone propionate
nasal spray) and the related manufacturing agreement from Novalere
FP in February 2015. The Over-the-Counter (“OTC”)
Abbreviated New Drug Application (“ANDA”) filed at the
end of 2014 by the manufacturer with the U.S. Food and Drug
Administration (“FDA”), subject to FDA approval, may
allow the Company to market and sell Fluticare™ OTC. An ANDA
is an application for a U.S. generic drug approval for an existing
licensed medication or approved drug.
UriVarx™.
On September 29, 2016, the Company
entered into a product license agreement with Seipel Group Pty Ltd.
(Australia) to in-license their Urox® formulation for the
indication of overactive bladders and urinary incontinence. The
Company is expected to commercialize this licensed product
formulation under the name UriVarx™ in the U.S. in November
2016.
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. The Company expects to commercialize this product
around the end of 2016.
Urocis®
XR. On October 27, 2015, the
Company entered into an exclusive distribution agreement with
Laboratorios Q Pharma (Spain) to distribute and commercialize
Urocis® XR in the U.S. and Canada. Urocis® XR is a
proprietary extended release of Vaccinium Marcocarpon (cranberry)
shown to provide 24 hour coverage in the body.
AndroVit®.
On October 27, 2015, the Company
entered into an exclusive distribution agreement with Laboratorios
Q Pharma (Spain) to distribute and commercialize AndroVit® in
the U.S. and Canada. AndroVit® is a proprietary supplement to
support overall prostate and male sexual health currently marketed
in Europe. AndroVit® was specifically formulated
with ingredients known to support normal prostate health and
vitality and male sexual health.
Change in Accounting Principle
On January 1, 2016, the Company retrospectively
adopted Financial Accounting Standards Board (“FASB”)
Accounting Standards Update (“ASU”) No. 2015-03,
Interest -
Imputation of Interest (Subtopic 835-30): Simplifying the
Presentation of Debt Issuance Costs. This ASU requires that debt issuance costs be
presented as a direct reduction from the carrying amount of debt.
As a result of the adoption of this ASU, the condensed consolidated
balance sheet at December 31, 2015 was adjusted to reflect the
reclassification of $97,577 from deferred financing costs, net to
convertible debentures, net. The adoption of this ASU
did not have an impact on the Company’s condensed
consolidated results of operations.
Basis of Presentation and Principles of Consolidation
The
condensed consolidated balance sheet as of December 31, 2015, which
has been derived from audited financial statements, and
these
unaudited condensed consolidated financial statements as of and for
the periods ended September 30, 2016 and 2015 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, 2015. 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 September 30,
2016, are not necessarily indicative of the results to be expected
for the entire fiscal year ending December 31, 2016 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 and sales return adjustments,
realizability of inventories, valuation of deferred tax assets,
goodwill and intangible assets, valuation of contingent acquisition
considerations, recoverability of long-lived assets and goodwill,
fair value of derivative liabilities and the valuation of
equity-based instruments and beneficial conversion
features. The Company bases its estimates on historical
experience and various other assumptions that the Company believes
to be reasonable under the circumstances. Actual results could
differ from these estimates under different assumptions or
conditions.
Liquidity
The
Company’s operations have been financed primarily through
proceeds from convertible debentures, revenues generated from the
launch of its products and commercial partnerships signed for the
sale and distribution of its products domestically and
internationally. These funds have provided the Company with
the resources to operate its business, sell and support its
products, attract and retain key personnel and add new products to
its portfolio. The Company has experienced net losses from
operations each year since its inception. As of September 30,
2016, the Company had an accumulated deficit of $25,775,716 and a
working capital deficit of $1,159,458.
The
Company has raised funds through the issuance of debt and the sale
of common stock. The Company has also issued equity instruments in
certain circumstances to pay for services from vendors and
consultants. In June and July 2016, the Company raised $3,000,000
in gross proceeds from the issuance of convertible debentures to
eight investors (see Note 5). In the event the Company does not pay
the convertible debentures upon their maturity, or after the remedy
period, the principal amount and accrued interest on the
convertible debentures is convertible at the Company’s option
to common stock at the lower of the fixed conversion price or 60%
of the volume weighted average price (“VWAP”) during
the ten consecutive trading day period preceding the date of
conversion. In February 2016, the Company also raised $550,000 in
funds from a note payable with net proceeds of $242,500 to the
Company, which was used to pay for the asset acquisition of Beyond
Human, LLC (see Note 5), a Texas limited liability company
(“Beyond Human”) and for working capital
purposes.
As
of November 8, 2016, we had approximately $0.9 million in cash and
approximately $296,000 of cash collections held by our third-party
merchant service provider. During the nine months ended
September 30, 2016 we had net cash used in operating activities of
$739,472 primarily from purchasing inventory to support our growing
revenues and certain prepayments of annual expenses. The Company
expects that its existing capital resources, revenues from sales of
its products and upcoming sales milestone payments from the
commercial partners signed for its products, and equity instruments
available to pay certain vendors and consultants, will be
sufficient to allow the Company to continue its operations,
commence the product development process and launch
selected products through at least the next 12 months. In
addition, the Company’s CEO, who is also a significant
shareholder, has deferred the payment of his salary earned thru
June 30, 2016 for at least the next 12 months. The Company’s
actual needs will depend on numerous factors, including timing of
introducing its products to the marketplace, its ability to attract
additional Ex-U.S. distributors for its products and its ability to
in-license in non-partnered territories and/or develop new product
candidates. The Company may also seek to raise capital, debt or
equity from outside sources to pay for further expansion and
development of its business and to meet current obligations. Such
capital may not be available to the Company when it needs it or on
terms acceptable to the Company, if at all.
Fair Value Measurement
The
Company’s 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 recorded fair value of the convertible
debentures, net of debt discount, is based upon the relative fair
value calculation of the common stock and warrants issued in
connection with the convertible debentures and the fair value of
the embedded conversion features. 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 9). 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 the Company, the carrying values of
the notes payable and convertible debentures approximate their
respective fair values.
The
Company follows 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 the Company has
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 and Major Customers
Financial
instruments that potentially subject the Company 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 online sales of Zestra® to U.S. based
retailers and Ex-U.S. partners. The Company also requires a
percentage of payment in advance for product orders with its larger
partners. The Company performs ongoing credit evaluations of its
customers and generally does not require
collateral.
Revenues
consist primarily of product sales and licensing rights to market
and commercialize our products. The Company had no
customers that accounted for 10% or greater of its total net
revenues during the three and nine months ended September 30, 2016.
Four customers accounted for 67% of total gross accounts receivable
as of September 30, 2016. The Company had three customers that
accounted for 43% of its total net revenues during the nine months
ended September 30, 2015 and had two customers that accounted for
38% of its total net revenues during the three months ended
September 30, 2015. Two customers accounted for 73% of gross
accounts receivable as of December 31, 2015.
Over
90% 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 percent or greater.
Debt Issuance Costs
Debt
issuance costs represent costs incurred in connection with the
issuance of the convertible debentures during the third quarter of
2015 and the note payable and convertible debentures during the
nine months ended September 30, 2016. Debt issuance costs related
to the issuance of the convertible debentures and note payable are
recorded as a reduction to the debt balances in the accompanying
condensed consolidated balance sheets. The debt issuance
costs are being amortized to interest expense over the term of the
financing instruments using the effective interest
method.
Derivative Liabilities
Certain
of the Company’s embedded conversion features on debt and
issued and outstanding common stock purchase warrants, which have
exercise price reset features and other anti-dilution protection
clauses, are treated as derivatives for accounting purposes. The
common stock purchase warrants were not issued with the intent of
effectively hedging any future cash flow, fair value of any asset,
liability or any net investment in a foreign operation. The
warrants do not qualify for hedge accounting, and as such, all
future changes in the fair value of these warrants are recognized
currently in earnings until such time as the warrants are
exercised, expire or the related rights have been waived. These
common stock purchase warrants do not trade in an active securities
market, and as such, the Company estimates the fair value of these
warrants using a Probability Weighted Black-Scholes Option-Pricing
Model and the embedded conversion features using a Path-Dependent
Monte Carlo Simulation Model (see Note 9).
Income Taxes
Income
taxes are provided for using the asset and liability method whereby
deferred tax assets and liabilities are recognized using current
tax rates on the difference between the consolidated financial
statement carrying amounts and the respective tax basis of the
assets and liabilities. The Company provides a valuation
allowance on deferred tax assets when it is more likely than not
that such assets will not be realized.
The
Company recognizes the consolidated financial statement benefit of
a tax position only after determining that the relevant tax
authority would more likely than not sustain the position following
an audit. For tax positions meeting this standard, the amount
recognized in the consolidated financial statements is the largest
benefit that has a greater than fifty percent likelihood of
being realized upon ultimate settlement with the relevant tax
authority. There were no uncertain tax positions at September
30, 2016 and December 31, 2015.
Revenue Recognition and Deferred Revenue
The
Company generates revenues from product sales and the licensing of
the rights to market and commercialize its products.
The Company recognizes revenue in accordance with
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: The Company ships
product to its wholesale and retail customers pursuant to purchase
agreements or 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
Revenues: The license
agreements the Company enters 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 the Company 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
The
Company accrues for product returns, volume rebates and promotional
discounts in the same period the related sale is
recognized.
The
Company’s 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. The Company estimates its volume rebates and
promotional discounts accrual based on its estimates of the level
of inventory of its 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 the Company’s 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.
The
Company provides a customer satisfaction warranty on all of its
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 expenses, was
approximately $104,000 and $5,000 at September 30, 2016 and
December 31, 2015, respectively.
Advertising Expenses
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 $1.4
million and $1.6 million for the three and nine months ended
September 30, 2016, respectively. Advertising costs for the three
and nine months ended September 30, 2015 were less than
$1,000.
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
restricted stock units during the period presented. Diluted
net loss per share is computed using the weighted average number of
common shares outstanding during the periods plus the effect of
dilutive securities outstanding during the periods. For the
three and nine months ended September 30, 2016 and 2015, basic net
loss per share is the same as diluted net loss per share as a
result of the Company’s common stock equivalents being
anti-dilutive. See Note 8 for more details.
Recent Accounting Pronouncements
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 the Company are
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. Early adoption is permitted. The Company is currently assessing the impact the
adoption of ASU 2016-15 will have on our condensed consolidated
financial statements.
In September 2015, the FASB issued ASU
2015-16, Simplifying the Accounting for
Measurement-Period Adjustments, which eliminates the requirement to
retrospectively adjust the consolidated financial statements for
measurement-period adjustments that occur in periods after a
business combination is consummated. Measurement period adjustments
are calculated as if they were known at the acquisition date, but
are recognized in the reporting period in which they are
determined. Additional disclosures are required about the impact on
current-period income statement line items of adjustments that
would have been recognized in prior periods if prior-period
information had been revised. The guidance is effective for annual
periods beginning after December 15, 2015 and is to be applied
prospectively to adjustments of provisional amounts that occur
after the effective date. Early application is permitted. The
adoption of this ASU during the nine months ended September 30,
2016 did not have a material impact on the Company’s
condensed consolidated financial position and results of
operations.
NOTE 2 – LICENSE AGREEMENTS
Seipel Group Pty Ltd. In-License Agreement
On
September 29, 2016, the Company and Seipel Group Pty Ltd.
(“SG”) entered into a license and purchase agreement
(“SG License Purchase Agreement”) pursuant to which the
Company acquired the rights to use, market and sell SG’s
proprietary dietary supplement formula known as Urox® for
bladder support in the U.S. and worldwide. Under this agreement,
the Company has agreed to certain minimum purchase order
requirements and is obligated to pay a brokerage fee of $200,000
which is included in sales and marketing expense in the
accompanying condensed consolidated statements of operations for
the three and nine months ended September 30, 2016 and accounts
payable and accrued expenses in the accompanying condensed
consolidated balance sheet at September 30, 2016.
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 the
Company 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 the Company commercialization rights for Sensum+® in
the United States through its Beyond Human marketing
platform.
In
consideration for the CRI Asset Purchase Agreement, the Company
issued 631,313 shares of common stock to CRI in 2013. The
Company recorded an asset totaling $250,000 related to the CRI
Asset Purchase Agreement and will amortize this amount over its
estimated useful life of 10 years. Under the CRI Asset
Purchase Agreement, the Company was required to issue to CRI shares
of the Company’s common stock valued at an aggregate
of $200,000 for milestones relating to additional clinical
data to be received. As a result of the Amended CRI Asset Purchase
Agreement, the Company and CRI agreed to settle the clinical
milestone payments with a payment of 100,000 shares of restricted
common stock. The fair value of the restricted shares of common
stock of $23,000 was based on the market price of the
Company’s common stock on the date of issuance and is
included in research and development expense in the accompanying
condensed consolidated statement of operations for the three and
nine months ended September 30, 2016.
The
CRI Asset Purchase Agreement also requires the Company to pay to
CRI up to $7 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 are considered owed to CRI under this agreement
during the three and nine months ended September 30, 2016 and 2015,
and royalties owed to CRI were immaterial and included in cost of
product sales.
In
consideration for the Amended CRI Asset Purchase Agreement, the
Company is required to pay CRI a percentage of the monthly net
profits, as defined in the agreement, from our sales of
Sensum+® in the U.S. through our Beyond Human marketing
platform. During the three and nine months ended September 30,
2016, no amounts are due to CRI under the Amended CRI Asset
Purchase Agreement.
Sothema Laboratories Agreement
On
September 23, 2014, the Company entered into an exclusive license
agreement with Sothema Laboratories, SARL, a Moroccan publicly
traded company (“Sothema”), under which Innovus granted
to Sothema an exclusive license to market and sell Innovus’
topical treatment for Female Sexual Interest/Arousal Disorder
(“FSI/AD”) (based on the latest Canadian approval of
the indication), Zestra® and its high viscosity low osmolality
water-based lubricant Zestra Glide® in the North African
countries of Egypt, Morocco, Algeria, Tunisia and Libya, the Middle
Eastern countries of Iraq, Jordan, Saudi Arabia and the United Arab
Emirates and the West African countries of Benin, Burkina Faso,
Cape Verde, Gambia, Ghana, Guinea, Guinea-Bissau, Ivory Coast,
Liberia, Mali, Niger, Nigeria, Senegal, Sierra Leone and Togo
(collectively the “Territory”).
Under
the agreement, Innovus received an upfront payment of $200,000 and
is eligible to receive up to approximately $171 million 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, the Company will recognize the revenue
from the milestone payments when the cumulative supplied units
volume is met. During the three and nine months ended September 30,
2016 and 2015, the Company recognized $666, $12,229, $0 and
$56,487, respectively, in 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, the Company entered into an exclusive license
agreement with Orimed Pharma (“Orimed”), an affiliate
of JAMP Pharma, under which Innovus granted to Orimed an exclusive
license to market and sell in Canada, Innovus’ (a) topical
treatment for FSI/AD, Zestra®, (b) topical treatment for
premature ejaculation, EjectDelay®, (c) product Sensum+™
to increase penile sensitivity and (d) high viscosity low
osmolality water-based lubricant, Zestra Glide®.
Under
the agreement, Innovus received an upfront payment of $100,000 and
is eligible to receive up to approximately CN $94.5 million ($72.2
million USD based on September 30, 2016 exchange rate) 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, the Company will recognize the revenue
from the milestone payments when the cumulative gross sales volume
is met. The Company will recognize the revenue from the royalty
payments on a quarterly basis when the cumulative net sales have
been met. During the three and nine months ended
September 30, 2016 and 2015, under this agreement the Company
recognized $0, $40,233, $0 and $49,376, respectively, in revenue
for the sales of products and no revenue was recognized for the
sales-based milestones. During the three and nine months ended
September 30, 2016, the Company recognized royalty payments of $538
and $844, respectively, and no royalty payments were recognized
during the three and nine months ended September 30,
2015.
BroadMed SAL Agreements
On
May 24, 2016, the Company entered into an exclusive license and
distribution agreement with BroadMed SAL, a Lebanese company,
(“BroadMed”) under which Innovus granted to BroadMed an
exclusive license to market and sell in Lebanon Innovus
Pharma’s EjectDelay® for treating premature ejaculation.
Under the agreement, the Company is eligible to receive up to $6.2
million in sales-based milestone payments. As the sales-based
milestones do not meet the definition of a milestone under ASC
605-28, the Company will recognize the revenue from the milestone
payments when the annual net sales volume is met. For the three and
nine months ended September 30, 2016, the Company did not recognize
revenue for the sales-based milestones of the
agreement.
In
April 2015, the Company entered into an exclusive license and
distribution agreement with BroadMed under which Innovus granted to
BroadMed an exclusive license to market and sell in Lebanon Innovus
Pharma’s Sensum+® to increase penile sensitivity. Under
the agreement, the Company received an upfront payment of $5,000
and is eligible to receive up to $11.1 million in annual
sales-based milestone payments plus double-digit tiered royalties
based on BroadMed’s cumulative net sales in Lebanon. 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, the Company will recognize the revenue
from the milestone payments when the annual net sales volume is
met. The Company will recognize the revenue from the royalty
payments on a quarterly basis when the cumulative net sales have
been met. For the nine months ended September 30, 2015, the Company
recognized the $5,000 upfront payment under this
agreement. No amounts were received or recognized during
the nine months ended September 30, 2016.
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 Innovus 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.
The
fair value of the contingent consideration is based on preliminary
cash flow projections and other assumptions for the milestone
payments and future changes in the estimate of such contingent
consideration will be recognized as a charge to other
expense. The amortization of imputed interest on the
contingent consideration is recorded to interest expense in the
accompanying condensed consolidated statement of
operations.
The
total purchase price is summarized as follows:
|
Cash
consideration
|
$300,000
|
Fair
value of future earn out payments
|
314,479
|
Total
|
$614,479
|
The
Company has preliminary recorded the purchase price of $614,479 as
an intangible asset on March 1, 2016 for the trademarks and domain
names associated with the Beyond Human products and marketing
platform acquired. The identifiable intangible assets
are being amortized over their estimated useful lives of five
years.
The
purchase price allocation is subject to completion of our analysis
of the fair value of the assets acquired from Beyond Human as of
the date of the acquisition. These adjustments could be material.
The final valuation is expected to be completed as soon as
practicable but no later than one year from the closing of the
transaction. The establishment of the fair value of the contingent
consideration, and the allocation to identifiable intangible assets
requires the extensive use of accounting estimates and management
judgment. The fair values assigned to the assets acquired are based
on estimates and assumptions from data currently
available.
On
September 6, 2016, the Company and the sellers entered into an
agreement in which the Company agreed to pay the sellers $150,000
to settle the contingent consideration payments totaling $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 $344,781. As a result,
the Company recorded a non-cash gain on contingent consideration of
$194,781, which is included in other income, net in the
accompanying condensed consolidated statement of operations for the
three and nine months ended September 30, 2016. During the three
and nine months ended September 30, 2016, the Company recorded
imputed interest expense of $7,968 and $30,302, respectively, which
is included in interest expense in the accompanying condensed
consolidated statement of operations.
Supplemental Pro Forma Information for Acquisition of Assets of
Beyond Human (unaudited)
The
following unaudited supplemental pro forma information for the nine
months ended September 30, 2016 and 2015 and the three months ended
September 30, 2015, assumes the asset acquisition of Beyond Human
had occurred as of January 1, 2016 and 2015, giving effect to
purchase accounting adjustments such as amortization of intangible
assets. The pro forma data is for informational purposes only and
may not necessarily reflect the actual results of operations had
the assets of Beyond Human been operated as part of the Company
since January 1, 2016 and 2015.
|
Nine Months Ended
September 30, 2016
|
Nine Months Ended
September 30, 2015
|
|
As Reported
|
|
|
|
Net
revenues
|
$3,119,126
|
$3,175,750
|
$555,069
|
$2,636,107
|
Net
loss
|
$(10,341,121)
|
$(10,354,157)
|
$(3,224,778)
|
$(3,029,008)
|
Net
loss per share of common stock – basic and
diluted
|
$(0.12)
|
$(0.12)
|
$(0.06)
|
$(0.06)
|
Weighted
average number of shares of common stock outstanding – basic
and diluted
|
86,498,234
|
86,498,234
|
50,486,501
|
50,486,501
|
|
Three Months Ended
September 30, 2015
|
|
As Reported
|
|
Net
revenues
|
$179,744
|
$772,337
|
Net
loss
|
$(858,747)
|
$(850,364)
|
Net
loss per share of common stock – basic and
diluted
|
$(0.02)
|
$(0.02)
|
Weighted
average number of shares of common stock outstanding – basic
and diluted
|
55,076,819
|
55,076,819
|
The
acquisition of the assets of Beyond Human was not individually
significant and the Company incurred approximately $70,000 in
expenses related to the Acquisition.
Acquisition of Novalere in 2015
On
February 5, 2015 (the “Closing Date”), the Company,
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 the Company
(“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 the Company. Pursuant to the articles of
merger effectuating the Merger, Merger Subsidiary II changed its
name to Novalere, Inc.
With
the Merger, the Company acquired the worldwide rights to market and
sell the Fluticare™ brand (Fluticasone propionate nasal
spray) and the related manufacturing agreement from Novalere FP.
The Company currently anticipates that the ANDA filed in November
2014 by the manufacturer with the FDA may be approved in the
fourth quarter of 2016, which, when and if approved, may allow the
Company to market and sell Fluticare™ OTC in
2017.
Under
the terms of the Merger Agreement, at the Closing Date, the
Novalere Stockholders received 50% of the Consideration Shares (the
“Closing Consideration Shares”) and the remaining 50%
of the Consideration Shares (the “ANDA Consideration
Shares”) will be delivered only if an ANDA of Fluticasone
Propionate Nasal Spray of Novalere Manufacturing Partners (the
“Target Product”) is approved by the FDA (the
“ANDA Approval”). A portion of the Closing
Consideration Shares and, if ANDA Approval was obtained prior to
the 18 month anniversary of the Closing Date, a portion of the ANDA
Consideration Shares, would have been held in escrow for a period
of 18 months from the Closing Date to be applied towards any
indemnification claims by the Company pursuant to the Merger
Agreement.
In
addition, the Novalere Stockholders are entitled to receive, if and
when earned, earn-out payments (the “Earn-Out
Payments”). For every $5 million in Net Revenue (as defined
in the Merger Agreement) realized from the sales of
Fluticare™, 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
closing price of the Company’s common stock on the Closing
Date was $0.20 per share. The Company issued 12,947,657 Closing
Consideration Shares of its common stock at the Closing Date, the
fair market value of the Closing Consideration Shares was
$2,071,625 as of the Closing Date.
The
establishment of the fair value of the consideration for the
Merger, and the allocation to identifiable tangible and intangible
assets and liabilities, requires the extensive use of accounting
estimates and management judgment. The fair values assigned to the
assets acquired and liabilities assumed were based on estimates and
assumptions. There has been no change to the estimated fair value
of the contingent consideration of $2,905,425 through September 30,
2016. On November 12,
2016, the Company entered into an Amendment and Supplement to the
Registration Rights and Stock Restriction Agreement with Novalere
Holdings in which the Company agreed to issue the ANDA
Consideration Shares of 12,947,655 (see Note
10).
Supplemental Pro Forma Information for Acquisition of Novalere
(unaudited)
The
following unaudited supplemental pro forma information for the nine
months ended September 30, 2015, assumes the acquisition of
Novalere had occurred as of January 1, 2015, giving effect to
purchase accounting adjustments such as amortization of intangible
assets. The pro forma data is for informational purposes only and
may not necessarily reflect the actual results of operations had
Novalere been operated as part of the Company since January 1,
2015.
|
Nine Months Ended
September 30, 2015
|
|
As Reported
|
|
Net
revenues
|
$555,069
|
$555,069
|
Net
loss
|
$(3,224,778)
|
$(3,540,908)
|
Net
loss per share of common stock – basic and
diluted
|
$(0.06)
|
$(0.07)
|
Weighted
average number of shares of common stock outstanding – basic
and diluted
|
50,486,501
|
52,193,884
|
Purchase of Semprae Laboratories, Inc. in 2013
On
December 24, 2013 (the “Semprae Closing Date”), the
Company, through Merger Sub obtained 100% of the outstanding shares
of Semprae in exchange for the issuance of 3,201,776 shares of the
Company’s common stock, which shares represented fifteen
percent of the total issued and outstanding shares of the Company
as of the close of business on the Closing Date, whereupon Merger
Sub was renamed Semprae Laboratories, Inc. Also, the Company agreed
to pay $343,500 to the New Jersey Economic Development Authority
(“NJEDA”) as settlement-in full for an outstanding loan
of approximately $640,000 owed by the former stockholder’s of
Semprae, in full satisfaction of the obligation to the NJEDA. In
addition, the Company agreed to pay the former shareholders an
annual royalty (“Royalty”) equal to five percent 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 condensed consolidated statements of
operations. The fair value of the contingent consideration is based
on preliminary cash flow projections, growth in expected product
sales and other assumptions. Based on the assumptions, the fair
value of the Royalty was determined to be $308,273 at the date of
acquisition. The fair value of the Royalty was determined by
applying the income approach, using several significant
unobservable inputs for projected cash flows and a discount rate of
40% commensurate with the Company’s cost of capital and
expectation of the revenue growth for products at their life cycle
stage. These inputs are considered Level 3 inputs under the fair
value measurements and disclosure guidance. During the nine months
ended September 30, 2016 and 2015 no amounts were paid under this
arrangement. There were no changes in the fair value of
the expected royalties to be paid during the nine months ended
September 30, 2016 and 2015. The fair value of contingent
consideration was $324,379 at September 30, 2016 and December 31,
2015, based on the new estimated fair value of the consideration,
net of the amounts to be returned to the Company as discussed
above.
NOTE 4 – ASSETS AND LIABILITIES
Inventories
Inventories
consist of the following:
|
|
|
|
|
|
Raw
materials and supplies
|
$99,492
|
$77,649
|
Work
in process
|
-
|
90,540
|
Finished
goods
|
297,280
|
86,254
|
Total
|
$396,772
|
$254,443
|
Intangible Assets
Amortizable
intangible assets consist of the following:
|
|
|
|
|
|
|
|
|
|
|
|
Patent
& Trademarks
|
$1,032,076
|
$(154,489)
|
$877,587
|
5 - 15
|
Customer
Contracts
|
611,119
|
(173,150)
|
437,969
|
10
|
Sensum+®
License (from CRI)
|
234,545
|
(78,145)
|
156,400
|
10
|
Vesele®
trademark
|
25,287
|
(6,257)
|
19,030
|
8
|
Novalere
Mfg. Contract
|
4,681,000
|
(770,415)
|
3,910,585
|
10
|
Total
|
$6,584,027
|
$(1,182,456)
|
$5,401,571
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Patent
& Trademarks
|
$417,597
|
$(57,593)
|
$360,004
|
7 - 15
|
Customer
Contracts
|
611,119
|
(127,316)
|
483,803
|
10
|
Sensum+®
License (from CRI)
|
234,545
|
(60,554)
|
173,991
|
10
|
Vesele®
trademark
|
25,287
|
(3,886)
|
21,401
|
8
|
Novalere
Mfg. Contract
|
4,681,000
|
(419,340)
|
4,261,660
|
10
|
Total
|
$5,969,548
|
$(668,689)
|
$5,300,859
|
|
Amortization
expense for the three and nine months ended September 30, 2016 and
2015 was $178,082, $513,767, $147,429 and $387,011, respectively.
The following table summarizes the approximate expected future
amortization expense as of September 30, 2016 for intangible
assets:
Remainder
of 2016
|
$178,000
|
2017
|
712,000
|
2018
|
712,000
|
2019
|
712,000
|
2020
|
712,000
|
2021
|
609,000
|
Thereafter
|
1,767,000
|
|
$5,402,000
|
Prepaid Expenses and Other Current Assets
Prepaid
expenses and other current assets consist of the
following:
|
|
|
|
|
|
Prepaid
insurance
|
$97,237
|
$27,816
|
Prepaid
inventory
|
127,000
|
-
|
Merchant
net settlement reserve receivable
|
228,855
|
-
|
Prepaid
consulting and other expenses
|
50,580
|
25,462
|
Prepaid
consulting and other service stock-based compensation expenses (see
Note 8)
|
675,540
|
-
|
Total
|
$1,179,212
|
$53,278
|
Accounts Payable and Accrued Expenses
Accounts
payable and accrued expenses consist of the following:
|
|
|
|
|
|
Accounts
payable
|
$649,785
|
$63,826
|
Accrued
credit card balances
|
55,391
|
91,037
|
Accrued
royalties
|
54,956
|
-
|
Sales
returns and allowances
|
103,533
|
-
|
Accrual
for stock to be issued to consultants (see Note 8)
|
540,000
|
-
|
Accrual
for amounts due under license agreement (see Note 2)
|
200,000
|
-
|
Accrued
other
|
19,882
|
640
|
Total
|
$1,623,547
|
$155,503
|
NOTE 5 – NOTES PAYABLE AND DEBENTURES – NON-RELATED
PARTIES
Short-Term Loans Payable
The
short-term non-convertible financings were from three funding
sources and all balances were guaranteed by the Company’s
CEO. The Company repaid these amounts in full in July
2016.
Note Payable and Non-Convertible Debentures
The
following table summarizes the outstanding note payable and
non-convertible debentures at September 30, 2016 and December 31,
2015:
|
|
|
Note
payable and non-convertible debenture:
|
|
|
February
2016 Note Payable
|
$412,284
|
$-
|
July
2015 Debenture (Amended August 2014 Debenture)
|
-
|
73,200
|
Total note payable and non-convertible debenture
|
412,284
|
73,200
|
Less:
Debt discount
|
(5,155)
|
-
|
Carrying value
|
407,129
|
73,200
|
Less:
Current portion
|
(274,536)
|
(73,200)
|
Note payable and non-convertible debenture, net of current
portion
|
$132,593
|
$-
|
The
following table summarizes the future minimum payments as of
September 30, 2016 for the note payable and non-convertible
debentures:
Remainder
of 2016
|
$64,286
|
2017
|
293,013
|
2018
|
54,985
|
|
$412,284
|
July 2015 Debenture (Amended August 2014 Debenture)
On
August 30, 2014, the Company issued an 8% debenture to an unrelated
third party investor in the principal amount of $40,000 (the
“August 2014 Debenture”). The August 2014 Debenture
bore interest at the rate of 8% per annum. The principal amount and
interest were payable on August 29, 2015. On July 21, 2015, the
Company received an additional $30,000 from the investor and
amended and restated this agreement to a new principal balance of
$73,200 (including accrued interest of $3,200 added to principal)
and a new maturity date of July 21, 2016. The note was
repaid in full in July 2016.
February 2016 Note Payable
On
February 24, 2016, the Company and SBI Investments, LLC, 2014-1
(“SBI”) entered into a closing statement in which SBI
loaned the Company 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 the Company 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 in accordance with ASU 2015-03.
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. The Company 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 the Company 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 revenues received by the Company 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 the Company in the transaction including all revenue
received by the Company from these assets.
May 2016 Debenture
On
May 4, 2016, the Company issued a 10% non-convertible debenture to
an unrelated third party investor in the principal amount of
$24,000 (the “May 2016 Debenture”). The May 2016
Debenture bore interest at the rate of 10% per annum. The principal
amount and interest were payable on May 4, 2017. The note was
repaid in full in July 2016.
May 2016 Notes Payable
On
May 6, 2016, the Company entered into a securities purchase
agreement with an unrelated third party investor in which the
investor loaned the Company gross proceeds of $50,000 pursuant to a
3% promissory note (“May 6, 2016 Note
Payable”). The May 6, 2016 Note Payable bore
interest at the rate of 3% per annum. The principal amount and
interest were payable on November 6, 2016. The note was repaid in
full in June 2016.
In
connection with the May 6, 2016 Note Payable, the Company issued
the investor restricted shares of common stock totaling
500,000. The fair value of the restricted shares of
common stock issued was based on the market price of the
Company’s common stock on the date of issuance of the May 6,
2016 Note Payable. The allocation of the proceeds
received to the restricted shares of common stock based on their
relative fair value resulted in the Company recording a debt
discount of $23,684. The discount was amortized in full to interest
expense during the nine months ended September 30,
2016.
On
May 20, 2016, the Company entered into a securities purchase
agreement with an unrelated third party investor in which the
investor loaned the Company gross proceeds of $100,000 pursuant to
a 3% promissory note (“May 20, 2016 Note
Payable”). The May 20, 2016 Note Payable bore
interest at the rate of 3% per annum. The principal amount and
interest were payable on February 21, 2017. The note was repaid in
full in June 2016.
In
connection with the May 20, 2016 Note Payable, the Company issued
the investor restricted shares of common stock totaling
750,000. The fair value of the restricted shares of
common stock issued was based on the market price of the
Company’s common stock on the date of issuance of the May 20,
2016 Note Payable. The allocation of the proceeds
received to the restricted shares of common stock based on their
relative fair value resulted in the Company recording a debt
discount of $70,280. The discount was amortized in full to interest
expense during the nine months ended September 30,
2016.
Interest Expense
The
Company recognized interest expense on the short-term loans payable
and non-related party note payable and non-convertible debentures
of $42,652, $131,567, $62,863, and $84,779 for the three and nine
months ended September 30, 2016 and 2015,
respectively. Amortization of the debt discount to
interest expense during the three and nine months ended September
30, 2016 and 2015 totaled $938, $96,309, $97,617, and $286,070,
respectively.
Convertible Debentures - Third Quarter 2015 Financing
The
following table summarizes the outstanding Third Quarter 2015
Convertible Debentures at December 31, 2015:
|
|
|
|
Convertible
debentures
|
$1,457,500
|
Less:
Debt discount
|
(1,050,041)
|
Carrying value
|
407,459
|
Less:
Current portion
|
(407,459)
|
Convertible debentures – long-term
|
$-
|
In
the third quarter of 2015, the Company entered into Securities
Purchase Agreements with three accredited investors (the
“Buyers”), pursuant to which the Company received
aggregate gross proceeds of $1,325,000 (net of OID) pursuant to
which it sold:
Six
convertible promissory notes of the Company totaling $1,457,500
(each a “Q3 2015 Note” and collectively the “Q3
2015 Notes”) (the Q3 2015 Notes were sold at a 10% OID and
the Company received an aggregate total of $1,242,500 in funds
thereunder after debt issuance costs of $82,500). The principal
amount due under the Q3 2015 Notes was $1,457,500. The Q3 2015
Notes and accrued interest were convertible into shares of common
stock of the Company (the “Common Stock”) beginning six
months from the date of execution, at a conversion price of $0.15
per share, with certain adjustment provisions noted below. The
maturity date of the first and second Q3 2015 Note was August 26,
2016. The third Q3 2015 Note had a maturity date of September 24,
2016, the fourth had a maturity date of September 26, 2016, the
fifth was October 20, 2016 and the sixth was October 29, 2016. The
Q3 2015 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.
Notwithstanding
the foregoing, upon the occurrence of an Event of Default, as
defined in such Q3 2015 Note, a Default Amount is equal to the sum
of (i) the principal amount, together with accrued interest due
thereon through the date of payment payable at the holder’s
option in cash or common stock and (ii) an additional amount equal
to the principal amount payable at the Company’s option in
cash or common stock. For purposes of payments in common stock, the
following conversion formula applied: the conversion price shall be
the lower of: (i) the fixed conversion price ($0.15) or (ii) 60%
multiplied by the volume weighted average price of the
Company’s common stock during the ten consecutive trading
days immediately prior to the later of the Event of Default or the
end of the applicable cure period. Certain other conversion rates
applied in the event of the sale or merger of the Company,
default and other defined events. The embedded conversion
feature of these notes contained anti-dilution protection,
therefore, were treated as derivative instruments (see Note
9).
The
Company could have prepaid the Q3 2015 Notes at any time on the
terms set forth in the Q3 2015 Notes at the rate of 115% of the
then outstanding balance of the Q3 2015 Notes. Under the terms of
the Q3 2015 Notes, the Company could not effect certain corporate
and business actions during the term of the Q3 2015 Notes, although
some could have been done with proper notice. Pursuant to the
Purchase Agreement, with certain exceptions, the Note holder had a
right of participation during the term of the Q3 2015 Notes;
additionally, the Company granted the Q3 2015 Note holder
registration rights for the shares of common stock underlying the
Q3 2015 Notes pursuant to Registration Rights
Agreements.
In
addition, a Registration Rights Agreement was signed and, as a
result, the Company filed a Form S-1 Registration Statement on
September 11, 2015, filed an Amended Form S–1 on October 26,
2015, November 12, 2015 and December 10, 2015 and the Amended Form
S-1 became effective December 18, 2015.
During
the nine months ended September 30, 2016, the Q3 2015 Notes holders
elected to convert all principal and interest outstanding of
$1,515,635 into 10,104,228 shares of common stock at a conversion
price of $0.15 per share (see Note 8). As a result of
the conversion of the outstanding principal and interest balance
into shares of common stock, the fair value of the embedded
conversion feature derivative liabilities of $2,018,565 on the date
of conversion was reclassified to additional paid-in capital (see
Note 9) and the remaining unamortized debt discount was amortized
to interest expense during the nine months ended September 30,
2016.
Convertible Debentures - 2016 Financing
The
following table summarizes the outstanding 2016 Convertible
Debentures at September 30, 2016:
|
|
|
|
Convertible
debentures
|
$1,884,922
|
Less:
Debt discount
|
(1,474,342)
|
Carrying value
|
410,580
|
Less:
Current portion
|
(410,580)
|
Convertible debentures – long-term
|
$-
|
In
the second and third quarter of 2016, the Company entered into
Securities Purchase Agreements with eight accredited investors (the
“Investors”), pursuant to which the Company received
aggregate gross proceeds of $3,000,000 (net of OID) pursuant to
which it 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 the
Company received an aggregate total of $2,657,500 in funds
thereunder after debt issuance costs of $342,500). The 2016 Notes
and accrued interest are convertible into shares of common stock of
the Company at a conversion price of $0.25 per share, with certain
adjustment provisions noted below. The maturity date of the 2016
Notes issued on June 30, 2016 and July 15, 2016 is July 30, 2017
and the maturity date of the 2016 Notes issued on July 25, 2016 is
August 25, 2017. The 2016 Notes bear interest on the unpaid
principal amount at the rate of 5% per annum from the date of
issuance until the same becomes due and payable, whether at
maturity or upon acceleration or by prepayment or
otherwise.
Notwithstanding
the foregoing, upon the occurrence of an Event of Default, as
defined in such 2016 Notes, a Default Amount is equal to the sum of
(i) the principal amount, together with accrued interest due
thereon through the date of payment payable at the holder’s
option in cash or common stock and (ii) an additional amount equal
to the principal amount payable at the Company’s option in
cash or common stock. For purposes of payments in common stock, the
following conversion formula shall apply: the conversion price
shall be the lower of: (i) the fixed conversion price ($0.25) or
(ii) 75% multiplied by the volume weighted average price of the
Company’s common stock during the ten consecutive trading
days immediately prior to the later of the Event of Default or the
end of the applicable cure period. For purposes of the Investors
request of repayment in cash but the Company is unable to do so,
the following conversion formula shall apply: the conversion price
shall be the lower of: (i) the fixed conversion price ($0.25) or
(ii) 60% multiplied by the lowest daily volume weighted average
price of the Company’s common stock during the ten
consecutive trading days immediately prior to the conversion.
Certain other conversion rates apply in the event of the sale or
merger of the Company, default and other defined
events.
The
Company may 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. Pursuant to the Securities Purchase
Agreements, with certain exceptions, the Investors have a right of
participation during the term of the 2016 Notes; additionally, the
Company granted the 2016 Note holders registration rights for the
shares of common stock underlying the 2016 Notes up to $1,000,000
pursuant to Registration Rights Agreements. The Company filed a
Form S-1 Registration Statement on August 9, 2016, filed an Amended
Form S–1 on August 23, 2016 and August 24, 2016 and the
Amended Form S-1 became effective August 25, 2016.
In
addition, bundled with the convertible debenture, the Company
sold:
1.
|
A common stock
purchase warrant to each Investor, which allows the Investors to
purchase an aggregate of 3,000,000 shares of common stock and the
placement agent to purchase 1,220,000 shares of common stock
(aggregating 4,220,000 shares of the Company’s common stock)
at an exercise price of $0.40 per share (see Note 8);
and
|
2.
|
7,500,000
restricted shares of common stock to the
Investors.
|
The
Company allocated the proceeds from the 2016 Notes to the
convertible debenture, warrants and restricted shares of common
stock issued based on their relative fair values. The
Company determined the fair value of the warrants using
Black-Scholes with the following range of
assumptions:
|
|
Expected
terms (in years)
|
5.00
|
Expected
volatility
|
229%
|
Risk-free
interest rate
|
1.01 - 1.15%
|
Dividend
yield
|
-
|
The
fair value of the restricted shares of common stock issued to
Investors was based on the market price of the Company’s
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 the Company recording a debt discount of
$445,603 and $1,127,225, respectively. The remaining
proceeds of $1,427,172 were initially allocated to the debt. The
Company 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 at issuance was determined using a
Path-Dependent Monte Carlo Simulation Model (see Note 9 for
assumptions used to calculate fair value). The initial
fair value of the embedded conversion features were $3,444,284, of
which, $687,385 is recorded as a debt discount. The
initial fair value of the embedded conversion feature derivative
liabilities in excess of the proceeds allocated to the debt, after
the allocation of debt proceeds to the debt issuance costs, was
$2,756,899, and was immediately expensed and recorded as
interest expense during the nine months ended September 30, 2016 in
the accompanying condensed consolidated statement of
operations. The 2016 Notes were also issued at an OID of
10% and the OID of $303,889 was recorded as an addition to the
principal amount of the 2016 Notes and a debt discount in the
accompanying condensed consolidated balance sheet.
Total
debt issuance costs incurred in connection with the 2016 Notes was
$739,787, of which, $357,286 is the fair value of the warrants to
purchase 1,220,000 shares of common stock issued to the placement
agents. The debt issuance costs have been recorded as a
debt discount and are being amortized to interest expense using the
effective interest method over the term of the 2016
Notes.
During
the nine months ended September 30, 2016, certain of the 2016 Notes
holders elected to convert principal and interest outstanding of
$1,420,265 into 5,681,060 shares of common stock at a conversion
price of $0.25 per share (see Note 8). 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 $944,101 on the date of conversion was
reclassified to additional paid-in capital (see Note 9) and the
amortization of the debt discount was accelerated for the amount
converted and recorded to interest expense during the nine months
ended September 30, 2016.
Interest Expense
The
Company recognized interest expense on the Q3 2015 Notes and 2016
Notes for the three and nine months ended September 30, 2016 and
2015 of $29,333, $60,714, $11,267 and $11,267, respectively. The
debt discount recorded for the 2016 Notes are 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 Q3 2015 Notes and 2016 Notes to interest
expense for the three and nine months ended September 30, 2016 and
2015 was $1,829,547, $2,879,588, $165,540 and $165,540,
respectively.
NOTE 6 – DEBENTURES – RELATED PARTY
The
following table summarizes the outstanding debentures to a related
party at December 31, 2015:
|
|
Line
of credit convertible debenture – related party
|
$409,192
|
2014
non-convertible debenture – related party
|
25,000
|
Total
|
434,192
|
Less
: Debt discount
|
(17,720)
|
Carrying
value
|
416,472
|
Less:
Current portion
|
(391,472)
|
Total
long-term debentures – related party
|
$25,000
|
Line of Credit Convertible Debenture
In
January 2013, the Company entered into a line of credit convertible
debenture with its CEO (the “LOC Convertible
Debenture”). Under the terms of its original issuance: (1)
the Company could request to borrow up to a maximum principal
amount of $250,000 from time to time; (2) amounts borrowed bore an
annual interest rate of 8%; (3) the amounts borrowed plus accrued
interest were payable in cash at the earlier of January 14, 2014 or
when the Company completed a Financing, as defined, and (4) the
holder had sole discretion to determine whether or not to make an
advance upon the Company’s request.
During
2013, the LOC Convertible Debenture was further amended to: (1)
increase the maximum principal amount available for borrowing to $1
million plus any amounts of salary or related payments paid to Dr.
Damaj prior to the termination of the funding commitment; and (2)
change the holder’s funding commitment to automatically
terminate on the earlier of either (a) when the Company completes a
financing with minimum net proceeds of at least $4 million, or (b)
July 1, 2016.
On
August 12, 2015, the principal amount that may be borrowed was
increased to $2,000,000 and the automatic termination date
described above was extended to October 1, 2016. The LOC
Convertible Debenture was not renewed upon expiration. The
conversion price was $0.16 per share, 80% times the quoted market
price of the Company’s common stock on the date of the
amendment.
During
the nine months ended September 30, 2016 and 2015, the Company
borrowed $0 and $114, respectively, under the LOC Convertible
Debenture and recorded a beneficial conversion feature of $3,444
and $6,275, respectively, for the amounts borrowed and accrued
interest. The Company repaid the LOC Convertible Debenture balance
and accrued interest in full during the nine months ended September
30, 2016.
2014 Non-Convertible Note – Related Party
On
January 29, 2014, the Company issued an 8% note, in the amount of
$25,000, to the Company’s CEO. The principal amount and
interest were payable on January 22, 2015. This note was amended to
extend the maturity date until January 22, 2017. The Company
repaid the principal note balance and accrued interest in full in
August 2016.
Interest Expense
The
Company recognized interest expense on the outstanding debentures
to a related party totaling $2,124, $17,430, $47,507, and $74,324
during the three and nine months ended September 30, 2016 and 2015,
respectively. Amortization of the debt discount to interest expense
during the three and nine months ended September 30, 2016 and 2015
totaled $5,445, $21,164, $71,788 and $103,752,
respectively.
NOTE 7 – RELATED PARTY TRANSACTIONS
Related Party Borrowings
There
were certain related party borrowings that were repaid in full
during the nine months ended September 30, 2016 which are described
in more detail in Note 6.
Accrued Compensation – Related Party
Accrued
compensation includes accruals for employee wages, vacation pay and
target-based bonuses. The components of accrued compensation
as of September 30, 2016 and December 31, 2015 are as
follows:
|
|
|
Wages
|
$1,407,486
|
$1,178,909
|
Vacation
|
215,279
|
170,371
|
Bonus
|
282,773
|
-
|
Payroll
taxes on the above
|
118,318
|
93,510
|
Total
|
2,023,856
|
1,442,790
|
Classified
as long-term
|
(1,506,010)
|
(906,928)
|
Accrued
compensation
|
$517,846
|
$535,862
|
Accrued
employee wages at September 30, 2016 and December 31, 2015 are
entirely related to wages owed to the Company’s
CEO. 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 the Company’s ability to continue as
a going concern. The CEO started to receive payment of salary in
July 2016. Under the third quarter 2015 financing agreement,
salaries prior to January 1, 2015 totaling $906,928 could not be
repaid until the debentures were repaid in full or otherwise
extinguished by conversion or other means and, accordingly, the
accrued compensation was shown as a long-term
liability. During the nine months ended September 30, 2016,
the Q3 2015 Notes were fully converted into shares of common stock.
The Company does not expect to pay the wages and related payroll
tax amounts within the next 12 months and thus is classified as a
long-term liability.
NOTE 8 – STOCKHOLDERS’ DEFICIT
Capital Stock
The
Company is authorized to issue 150,000,000 shares, all of which are
common stock with a par value of $0.001 per share.
Issuances of Common Stock
On
January 6, 2016 and April 5, 2016, the Company entered into a
consulting agreement with a third party pursuant to which the
Company agreed to issue, over the term of the agreements, an
aggregate of 1,560,000 shares of common stock in exchange for
services to be rendered. During the nine months ended
September 30, 2016, the Company issued 1,335,000 shares under the
agreement related to services provided and recognized the fair
value of the shares issued of $116,760 in general and
administrative expense in the accompanying condensed consolidated
statement of operations. The 1,335,000 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 the
Company’s common stock on the date of vesting.
In
January 2016, the Company issued 300,000 shares of common stock for
services and recorded an expense of $17,000, which is included in
general and administrative expense in the accompanying condensed
consolidated statement of operations. The 300,000 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 the
Company’s common stock on the date of vesting.
On
February 10, 2016, the Company entered into a service agreement
with a third party pursuant to which the Company agreed to issue,
over the term of the agreement, 3,000,000 shares of common stock in
exchange for services to be rendered. During the nine months
ended September 30, 2016, the Company issued 3,000,000 shares under
the agreement related to services provided and recognized the fair
value of the shares issued of $352,500 in general and
administrative expense in the accompanying condensed consolidated
statement of operations. The 3,000,000 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 the Company’s
common stock on the date of vesting.
On
February 19, 2016, the Company entered into a consulting agreement
with a third party, pursuant to which the Company agreed to issue,
over the term of the agreement, 1,750,000 shares of common stock in
exchange for services to be rendered. During the nine months
ended September 30, 2016, the Company issued 1,750,000 shares under
the agreement related to services provided in connection with the
acquisition of Beyond Human (see Note 3) and recognized the fair
value of the shares issued of $181,013 in general and
administrative expense in the accompanying condensed consolidated
statement of operations. The 1,750,000 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 the Company’s
common stock on the date of vesting.
In
April and August 2016, the Company issued an aggregate of 3,385,354
shares of common stock upon the cashless exercise of warrants to
purchase 5,042,881 shares of common stock. Upon exercise
of certain warrants in April 2016, the fair value of the warrant
derivative liability on the date of exercise was reclassified to
additional paid-in capital (see Note 9).
In
April, May and August 2016, the Company issued an aggregate of
785,714 shares of common stock for services and recorded an expense
of $126,543, which is included in general and administrative
expense in the accompanying condensed consolidated statement of
operations. The 785,714 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 the Company’s common stock on
the date of vesting.
On
April 27, 2016, the Company entered into a service agreement with a
third party pursuant to which the Company agreed to issue 300,000
shares of common stock in exchange for services to be rendered over
the 3 month term of the agreement. The shares of common stock
issued were non-forfeitable and the fair value of $28,500 was based
on the market price of the Company’s common stock on the date
of vesting. During the nine months ended September 30, 2016, the
Company recognized $28,500 in general and administrative expense in
the accompanying condensed consolidated statement of
operations.
In
May 2016, the Company issued 1,250,000 shares of restricted common
stock to certain note holders in connection with their notes
payable. The relative fair value of the shares of
restricted common stock issued was determined to be $93,964 and was
recorded as a debt discount (see Note 5).
In
May and June 2016, the Buyers of the Q3 2015 Notes elected to
convert $1,515,635 in principal and interest into 10,104,228 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
9).
On
June 16, 2016, the Company entered into a consulting agreement with
a third party pursuant to which the Company agreed to issue 250,000
restricted shares of common stock in exchange for services to be
rendered. In July 2016, the Company issued 250,000
fully-vested shares under the agreement related to services to be
provided over the term of the agreement which ends on December 16,
2016. The fair value of the shares issued of $47,500 was based on
the market price of the Company’s common stock on the date of
vesting. During the nine months ended September 30, 2016, the
Company recognized $27,710 in general and administrative expense in
the accompanying condensed consolidated statement of operations and
the remaining unamortized expense of $19,790 is included in prepaid
expenses and other current assets in the accompanying condensed
consolidated balance sheet at September 30, 2016.
In July 2016, the Company issued 100,000 shares of common stock to
CRI pursuant to the Amended CRI Asset Purchase Agreement (see Note
2). The fair value of the restricted shares of common
stock of $23,000 was based on the market price of the
Company’s common stock on the date of issuance and is
included in research and development expense in the accompanying
condensed consolidated statement of operations.
On
August 3, 2016, the Company entered into a service agreement with a
third party pursuant to which the Company issued 75,000
fully-vested restricted shares of common stock in exchange for
services to be rendered over the term of the agreement which ended
on November 10, 2016. The fair value of the shares issued of
$32,250 was based on the market price of the Company’s common
stock on the date of vesting. During the nine months ended
September 30, 2016, the Company recognized $21,500 in general and
administrative expense in the accompanying condensed consolidated
statement of operations and the remaining unamortized expense of
$10,750 is included in prepaid expenses and other current assets in
the accompanying condensed consolidated balance sheet at September
30, 2016.
On
August 23, 2016, the Company entered into a consulting agreement
with a third party pursuant to which the Company 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 September 2016, the Company issued 400,000 shares of
common stock under the agreement. The fair value of the shares
issued of $180,000 was based on the market price of the
Company’s common stock on the date of agreement. As a result
of the shares being fully-vested at the execution of the agreement
but payable in equal installments, the Company recorded a liability
for the fair value of the remaining 1,200,000 shares of common
stock to be issued of $540,000 which is included in accounts
payable and accrued expenses in the accompanying condensed
consolidated balance sheet at September 30, 2016. The fair value
was based on the market price of the Company’s common stock
on the date of the agreement. Upon issuance of the remaining
shares, the Company will reclassify the liability to common stock
and additional paid-in-capital. During the nine months ended
September 30, 2016, the Company recognized $75,000 in general and
administrative expense in the accompanying condensed consolidated
statement of operations and the remaining unamortized expense of
$645,000 is included in prepaid expenses and other current assets
in the accompanying condensed consolidated balance sheet at
September 30, 2016.
On
September 1, 2016, the Company entered into a service agreement
with a third party pursuant to which the Company 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 nine months
ended September 30, 2016, the Company issued 330,000 shares under
the agreement related to services provided and recognized the fair
value of the shares issued of $89,100 in general and administrative
expense in the accompanying condensed consolidated statement of
operations. The 330,000 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 the Company’s common stock on
the date of vesting.
During
the nine months ended September 30, 2016, the Company issued
215,000 shares of common stock for legal fees in connection with
the Semprae merger transaction and recognized the fair value of the
shares issued of $64,500 in general and administrative expense in
the accompanying condensed consolidated statement of
operations.
During
the nine months ended September 30, 2016, the Company issued
19,228,494 shares of common stock in exchange for vested restricted
stock units.
In
connection with the issuance of the 2016 Notes, the Company issued
restricted shares of common stock totaling 7,500,000 to the
Investors. The relative fair value of the restricted shares of
common stock totaling $1,127,225 was recorded as a debt discount
(see Note 5).
In
August and September 2016, certain 2016 Notes holders elected to
convert $1,420,265 in principal and interest into 5,681,060 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
9).
During
the nine months ended September 30, 2016, the Company received
notifications from five of its warrant holders on their intent
to exercise their warrants to purchase shares of common stock
totaling 1,033,800 at an exercise price of $0.30 per
share. The Company received gross cash proceeds of
$310,140.
2013 Equity Incentive Plan
The
Company has issued common stock, restricted stock units and stock
option awards to employees, non-executive directors and outside
consultants under the 2013 Equity Incentive Plan, which was
approved by the Company’s Board of Directors in February of
2013. The 2013 Equity Incentive Plan allows for the issuance
of up to 10,000,000 shares of the Company’s 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 exercise price for all equity awards
issued under the 2013 Equity Incentive Plan is based on the fair
market value of the common stock. Currently, because the
Company’s common stock is quoted on the OTCQB, the fair
market value of the common stock is equal to the last-sale price
reported by the OTCQB as of the date of determination, or if there
were no sales on such date, on the last date preceding such date on
which a sale was reported. Generally, each vested stock unit
entitles the recipient to receive one share of Company common stock
which is eligible for settlement at the earliest of their
termination, a change in control of the Company or a specified
date. Restricted stock units can vest according to a schedule
or immediately upon award. Stock options generally vest over a
three-year period, first year cliff vesting with quarterly vesting
thereafter on the three-year awards, and have a ten-year
life. Stock options outstanding are subject to time-based
vesting as described above and thus are not performance-based. As
of September 30, 2016, 119,516 shares were available under this
plan.
2014 Equity Incentive Plan
The
Company has issued common stock and restricted stock units to
employees and non-executive directors under the 2014 Equity
Incentive Plan, which was approved by the Company’s Board of
Directors in November 2014. The 2014 Equity Incentive Plan
allows for the issuance of up to 20,000,000 shares of the
Company’s 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
exercise price for all equity awards issued under the 2014 Equity
Incentive Plan is based on the fair market value of the common
stock. Generally, each vested stock unit entitles the
recipient to receive one share of Company common stock which is
eligible for settlement at the earliest of their termination, a
change in control of the Company or a specified
date. Restricted stock units can vest according to a schedule
or immediately upon award. Stock options generally vest over a
three-year period, first year cliff vesting with quarterly vesting
thereafter on the three-year awards and have a ten-year
life. Stock options outstanding are subject to time-based
vesting as described above and thus are not performance-based. As
of September 30, 2016, 950,001 shares were available under this
plan.
2016 Equity Incentive Plan
On
March 21, 2016, our Board of Directors approved the adoption of the
2016 Equity Incentive Plan. The 2016 Equity Incentive Plan
allows for the issuance of up to 20,000,000 shares of the
Company’s 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
exercise price for all equity awards issued under the 2016 Equity
Incentive Plan is based on the fair market value of the common
stock. Generally, each vested stock unit entitles the
recipient to receive one share of Company common stock which is
eligible for settlement at the earliest of their termination, a
change in control of the Company or a specified
date. Restricted stock units can vest according to a schedule
or immediately upon award. Stock options generally vest over a
three-year period, first year cliff vesting with quarterly vesting
thereafter on the three-year awards and have a ten-year
life. Stock options outstanding are subject to time-based
vesting as described above and thus are not performance-based. As
of September 30, 2016, 16,250,000 shares were available under this
plan.
Stock-Based Compensation
The
stock-based compensation expense for the three and nine months
ended September 30, 2016 and 2015 was $130,193, $766,711, $80,097
and $831,807, respectively, for the issuance of restricted stock
units and stock options to management, directors and
consultants. The Company calculates the fair value of the
restricted stock units based upon the quoted market value of the
common stock at the date of grant. The Company calculates the fair
value of each stock option award on the date of grant using
Black-Scholes.
Stock Options
For
the nine months ended September 30, 2016 and 2015, the following
weighted average assumptions were utilized for the stock options
granted during the period:
|
|
|
Expected
life (in years)
|
10.0
|
6.0
|
Expected
volatility
|
227.8%
|
219.3%
|
Average
risk-free interest rate
|
1.71%
|
1.54%
|
Dividend
yield
|
0%
|
0%
|
Grant
date fair value
|
$0.17
|
$0.12
|
The
dividend yield of zero is based on the fact that the Company has
never paid cash dividends and has no present intention to pay cash
dividends. Expected volatility is based on the historical
volatility of the Company’s 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. The Company believes that all stock options issued under
its stock option plans meet the criteria of “plain
vanilla” stock options. The Company uses 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, 2015
|
196,000
|
$0.31
|
9.0
|
-
|
Granted
|
82,500
|
$0.17
|
10.0
|
-
|
Exercised
|
-
|
-
|
-
|
-
|
Cancelled
|
(50,000)
|
$0.31
|
-
|
-
|
Forfeited
|
-
|
-
|
-
|
-
|
Outstanding
at September 30, 2016
|
228,500
|
$0.21
|
8.8
|
$27,060
|
|
|
|
|
|
Vested
at September 30, 2016
|
228,500
|
$0.21
|
8.8
|
$27,060
|
The
aggregate intrinsic value is calculated as the difference between
the exercise price of all outstanding stock options and the quoted
price of the Company’s common stock at September 30,
2016. During the three and nine months ended September
30, 2016 and 2015, the Company recognized stock-based compensation
from stock options of $8,638, $18,138, $4,000 and $6,711,
respectively.
Restricted Stock Units
The
following table summarizes the restricted stock unit activity
for the nine months ended September 30, 2016:
|
|
Outstanding
at December 31, 2015
|
17,554,736
|
Granted
|
14,593,247
|
Exchanged
|
(19,228,494)
|
Cancelled
|
-
|
Outstanding
at September 30, 2016
|
12,919,489
|
|
|
Vested
at September 30, 2016
|
7,906,990
|
The
vested restricted stock units at September 30, 2016 have not
settled and are not showing as issued and outstanding shares of the
Company 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
the Company, 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.
During
the nine months ended September 30, 2016, the Company issued
14,593,247 restricted stock units to employees and board members.
In 2016, 843,248 were from the 2013 Equity Incentive Plan and
vested immediately, 9,999,999 were from the 2014 Equity Incentive
Plan and 3,750,000 were from the 2016 Equity Incentive
Plan. A total of 6,000,001 of 9,999,999 restricted stock
units issued under the 2014 Equity Incentive Plan vested
immediately and the remaining 3,999,998 vested upon the closing of
the Beyond Human asset acquisition. The restricted stock units
issued under the 2016 Equity Incentive Plan vest as to 25% on the
one year anniversary from the date of grant and then in equal
quarterly installments for the next two years. The grant date fair
value of restricted stock units issued during the nine months ended
September 30, 2016 was $1,487,268. For the three and nine months
ended September 30, 2016 and 2015, the Company recognized $121,555,
$748,573, $76,097 and $825,096, respectively, of stock-based
compensation expense for the vested units. As of September 30,
2016, compensation expense related to unvested shares not yet
recognized in the condensed consolidated statement of operations
was approximately $1.2 million and will be recognized over a
remaining weighted-average term of 2.6 years.
Warrants
In
2014, the Company issued 380,973 warrants in connection with a note
payable. The warrants have an exercise price of $0.10 per share and
expire December 6, 2018. Warrants to purchase 245,157 shares of
common stock were exercised under the cashless exercise provisions
of the warrant agreement in July 2016, which resulted in the
issuance of 191,908 shares of common stock. The intrinsic value of
the warrants on the date of exercise was $86,359.
In
February 2014, the Company issued 250,000 warrants in connection
with a convertible debenture. The warrants had an exercise price of
$0.50 per share and were to expire on February 13, 2019. On
March 6, 2015 the Company entered into an agreement with the note
holder to extend the convertible debenture for six months. As
consideration for the extension, the Company issued the note holder
an additional 250,000 warrants, reduced the exercise price of the
warrants from $0.50 to $0.30 per share and extended the expiration
date to March 12, 2020. The warrants were also amended to include
certain anti-dilution protection, including protection upon
dilutive issuances. In connection with the third quarter 2015
convertible debenture financing, the exercise price of these
warrants was reduced to $0.0896 per share and an additional
1,173,410 warrants were issued per the anti-dilution protection
afforded in the warrant agreement during the year ended December
31, 2015. These warrants were exercised under the cashless exercise
provisions of the warrant agreement in April 2016. In
connection with the exercise of the warrants, the Company agreed to
reduce the exercise price of these warrants to $0.07 per share
which resulted in an additional 469,447 warrants being issued in
April 2016 prior to exercise. The warrants exercised
were classified as derivative liabilities and, upon exercise, the
fair value of the warrant derivative liability was reclassified to
additional paid-in capital (see Note 9). The intrinsic value of the
warrants on the date of exercise was $53,629.
In
January 2015, the Company issued 500,000 warrants in connection
with a non-convertible debenture. The warrants are exercisable for
five years from the closing date at an exercise price of $0.30 per
share of common stock or January 21, 2020. The warrants contain
anti-dilution protection, including protection upon dilutive
issuances. In connection with the third quarter 2015 convertible
debenture financing, the exercise price of these warrants was
reduced to $0.0896 per share and an additional 1,173,410 warrants
were issued per the anti-dilution protection afforded in the
warrant agreement during the year ended December 31, 2015. These
warrants were exercised under the cashless exercise provisions of
the warrant agreement in April 2016. In connection with
the exercise of the warrants, the Company agreed to reduce the
exercise price of these warrants to $0.0565 per share which
resulted in an additional 981,457 warrants being issued in April
2016 prior to exercise. The warrants exercised were
classified as derivative liabilities and, upon exercise, the fair
value of the warrant derivative liability was reclassified to
additional paid-in capital (see Note 9). The intrinsic value of the
warrants on the date of exercise was $99,121.
In
January 2015, the Company issued 250,000 warrants with an exercise
price of $0.30 per share to its former CFO in connection with a
non-convertible debenture. The warrants expire on January 21, 2020.
The warrants contain anti-dilution protection, including protection
upon dilutive issuances. In connection with the third quarter 2015
convertible debenture financing, 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 Q3 2015 Notes, the Company issued 1,808,333
warrants with an exercise price of $0.30 per share and expire in
2020. Warrants to purchase 1,033,800 shares of common stock were
exercised during the nine months ended September 30, 2016. The
intrinsic value of the warrants on the dates of exercise was
$150,200.
In
connection with the 2016 Notes, the Company issued 4,220,000
warrants to the Investors and placement agents with an exercise
price of $0.40 per share and expire in 2021.
At
September 30, 2016 and December 31, 2015, there are 5,967,054 and
6,372,831 fully vested warrants outstanding, respectively. The
weighted average exercise price of outstanding warrants at
September 30, 2016 is $0.34 per share, the weighted average
remaining contractual term is 4.4 years and the aggregate intrinsic
value of the outstanding warrants is $183,421.
Net Loss per Share
The
weighted average shares of common stock outstanding used in the
basic and diluted net loss per share calculation for the three and
nine months ended September 30, 2016 and 2015 was 97,222,394,
77,645,019, 42,453,051 and 39,440,755, 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 nine months ended September 30, 2016 and 2015 was
7,750,251, 8,853,215, 12,623,768 and 11,045,746,
respectively.
The
total weighted average shares outstanding used in the basic and
diluted net loss per share calculation for the three and nine
months ended September 30, 2016 and 2015 was 104,972,645,
86,498,234, 55,076,819 and 50,486,501, respectively.
The
following table shows the anti-dilutive shares excluded from the
calculation of basic and diluted net loss per common share as of
September 30, 2016 and 2015:
|
|
|
|
|
Gross number of shares excluded:
|
|
|
Restricted
stock units – unvested
|
5,012,499
|
4,623,333
|
Stock
options
|
228,500
|
164,500
|
Convertible
debentures and accrued interest
|
7,651,830
|
1,359,590
|
Warrants
|
5,967,054
|
3,439,306
|
Total
|
18,859,883
|
9,586,729
|
The
above table does not include the ANDA Consideration Shares related
to the Novalere acquisition, as they are considered contingently
issuable (see Note 3).
NOTE 9 – DERIVATIVE LIABILITIES
The
warrants issued in connection with certain previously outstanding
debentures are measured at fair value and classified as a liability
because these warrants contain anti-dilution protection and
therefore, cannot be considered indexed to the Company’s 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
Option-Pricing Model, resulting in a value of $226,297 at the date
of issuance. 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.
The Company 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. Certain of
these warrants were exercised under the cashless exercise
provisions of the warrant agreement in April 2016 and, as a result,
the fair value of the warrant derivative liability on the date of
exercise totaling $518,224 was reclassified to additional paid-in
capital (see Note 8).
The
assumptions for the Probability Weighted Black-Scholes
Option-Pricing Model for the nine months ended September 30, 2016
are represented in the table below.
|
|
Expected
life (in years)
|
3.31 - 3.95
|
Expected
volatility
|
206% - 230%
|
Average
risk-free interest rate
|
0.86% - 1.07%
|
Dividend
yield
|
0%
|
The
Company has determined the embedded conversion features of the Q3
2015 Notes and 2016 Notes (see Note 5) to be derivative liabilities
because the terms of the embedded conversion features contain
anti-dilution protection and therefore, cannot be considered
indexed to the Company’s own stock which is a requirement for
the scope exception as outlined under FASB ASC 815. The
embedded conversion features are 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. The Company has 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 will be affected by changes in inputs
to that model and is 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 the Company
and acquisition of the Company. The Company will
continue to classify the fair value of the embedded conversion
features as a liability until the conversion features are
exercised, expire or are amended in a way that would no longer
require these embedded conversion features to be classified as a
liability, whichever comes first. During the nine months
ended September 30, 2016, the Q3 2015 Notes were fully converted
and certain 2016 Notes were converted into shares of common stock
which resulted in the fair value of the embedded conversion feature
derivative liability on the dates of conversion of $2,962,666 to be
reclassified to additional paid-in capital (see Note
8). The anti-dilution protection for the embedded
conversion features survive the life of the 2016 Notes which mature
at July 30, 2017 and August 25, 2017.
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 the Company’s embedded conversion feature
derivative liabilities that are categorized within Level 3 of the
fair value hierarchy during the nine months ended September 30,
2016 is as follows:
|
|
Stock
price
|
$0.05 - $0.50
|
Strike
price
|
$0.15 - $0.25
|
Expected
life (in years)
|
0.26 - 1.08
|
Expected
volatilty
|
121% - 274%
|
Average
risk-free interest rate
|
0.28% - 0.62%
|
Dividend
yield
|
-
|
At
September 30, 2016, the estimated Level 3 fair values of the
embedded conversion feature and warrant derivative liabilities
measured on a recurring basis are as follows:
|
|
|
|
|
|
Embedded
conversion feature derivative liabilities
|
$1,091,544
|
$-
|
$-
|
$1,091,544
|
$1,091,544
|
Warrant
derivative liabilities
|
239,049
|
-
|
-
|
239,049
|
239,049
|
Total
|
$1,330,593
|
$-
|
$-
|
$1,330,593
|
$1,330,593
|
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 nine months ended September
30, 2016:
Fair Value Measurements Using
Level 3 Inputs
Warrant
derivative liabilities:
|
|
Beginning
balance December 31, 2015
|
$432,793
|
Reclassification
of fair value of warrant derivative liability to
additional paid-in capital upon cashless exercise of
warrants
|
(518,224)
|
Change
in fair value
|
324,480
|
Ending
balance September 30, 2016
|
$239,049
|
|
|
Embedded
conversion feature derivative liabilities:
|
|
Beginning
balance December 31, 2015
|
$301,779
|
Fair
value of 2016 Notes embedded conversion feature derivative
liability
|
3,444,284
|
Reclassification
of fair value of embedded conversion feature derivative liability
to additional
paid-in capital upon conversions of Q3 2015 Notes
|
(2,018,565)
|
Reclassification
of fair value of embedded conversion feature derivative liability
to additional
paid-in capital upon conversions of 2016 Notes
|
(944,101)
|
Change
in fair value
|
308,147
|
Ending
balance September 30, 2016
|
$1,091,544
|
NOTE 10 – SUBSEQUENT EVENTS
In October and November 2016, the Company issued
1,315,220 shares of common stock to certain 2016 Notes Investors
upon the conversion of outstanding principal and interest totaling
$328,805.
In
October 2016, the Company issued 556,786 shares of common stock to
various consultants for services rendered and the fair value of the
common stock issued was approximately $150,000.
In
October 2016, the Company issued 43,750 shares of common stock to
an employee in exchange for vested restricted stock
units.
On November 12,
2016, the Company entered into an Amendment and Supplement to a
Registration Rights and Stock Restriction Agreement (the
"Agreement") with Novalere Holdings pursuant to which the
Company agreed to issue 12,947,655 shares of the Company’s
common stock (the “Novalere Shares”) that were
issuable pursuant to agreement upon the approval of
Fluticare™ by the FDA. Management agreed to issue the
Novalere Shares due to its confidence that FlutiCare™ will be
approved by the FDA in the near future and the obligation of the
Company to issue and register for resale the Novalere Shares and
all other shares of common stock of the Company held by Novalere
Holdings. In connection with the issuance of the
Novalere Shares, Novalere Holdings also agreed to certain
restrictions, and to an extension in the date to register the
Novalere Shares and all other shares of common stock of the Company
held by Novalere Holdings until the second quarter of 2017.
Management believes that the issuance of the Novalere Shares
at this time is in the best interest of the Company and its
shareholders as it results in a restriction on the resale of all
shares of common stock of the Company held by Novalere Holdings,
including the Novalere Shares, until after the Company has achieved
certain milestones.
The
Company has evaluated subsequent events through the filing date of
this Form 10-Q and determined that no 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”, “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, 2015, filed with the Securities and Exchange
Commission (“SEC”) on March 30, 2016, 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 commercial stage pharmaceutical company delivering
over-the-counter medicines and consumer care products for
men’s and women’s health and respiratory
diseases. We market directly or through commercial
partners to primary care physicians, urologists, gynecologists and
therapists, and directly to consumers through on-line channels,
retailers and wholesalers. Our business model leverages our ability
to acquire and in-license commercial products that are supported by
scientific, and or clinical evidence, place them through our
existing supply chain, retail and on-line channels to tap new
markets and drive demand for such products and to establish
physician relationships. We currently market sixteen 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)
BTH® Testosterone Booster, (b) BTH® Human Growth Agent,
(c) Zestra® for female arousal, (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) BTH® GCBE (k) BTH® Vision
Formula, (l) BTH® Blood Sugar, (m) BTH® Colon Cleans, (n)
BTH® Ketones, (o) BTH® Krill Oil and (p) BTH® Omega
3 Fish Oil.
In
addition the Company has a pipeline of five additional product
candidates – FlutiCare™ Over-the-Counter
(“OTC”) for Allergic Rhinitis, if its Abbreviated New
Drug Application (“ANDA”) is approved by the U.S. Food
and Drug Administration (“FDA”), UriVarx™, a
proprietary formulation in-licensed through Seipel Group Pty Ltd.
for the indication of overactive bladders and urinary incontinence,
Xyralid®, a OTC FDA monograph compliant indicated drug
containing the active drug ingredient lidocaine and indicated for
the relief of the pain and symptoms caused by hemorrhoids,
Urocis® XR, a proprietary extended release of Vaccinium
Marcocarpon (cranberry) shown to provide 24-hour coverage in the
body to increase compliance of the use of the product to get full
benefit, and AndroVit®, a proprietary supplement to support
overall prostate and male sexual health currently marketed in
Europe. AndroVit® was specifically formulated with ingredients
known to support the normal prostate health and vitality and male
sexual health. The Company expects to commercialize UriVarx™
in November 2016 and Xyralid® around the end of
2016.
Strategy
Our
corporate strategy focuses on two primary objectives:
1.
Developing
a diversified product portfolio of exclusive, unique and patented
non-prescription pharmaceutical and consumer health products
through: (a) the acquisition of products or obtaining exclusive
rights to market such products and (b) the introduction of line
extensions and reformulations of currently marketed products;
and
2.
Building
an innovative, global sales and marketing model through commercial
partnerships with established complimentary partners that: (a)
generates revenue and (b) requires a lower cost structure compared
to traditional pharmaceutical companies.
We
believe that our proven ability to market, license, acquire and
develop brand name non-prescription pharmaceutical and consumer
health products uniquely positions us to commercialize our products
and grow in this market in a differentiated way. We believe this
strategy will enable us to meet our goal of profitability in
2017.
Sales and Marketing Strategy
Our
sales and marketing strategy is based on (a) the use of direct to
consumer advertisements in print and online media through the
proprietary sales and marketing infrastructure acquired from the
purchase of the Beyond Human assets 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+®, and
RecalMax™ into the Beyond Human sales and marketing platform
acquired. We plan to integrate Zestra® into this sales and
marketing platform in November 2016, as well as, UriVarx™ and
Xyralid® upon their commercial launches in the fourth quarter
of 2016. 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 the incremental spending impact on the
Company.
Results of Operations for the Three and Nine Months Ended September
30, 2016 Compared with the Three and Nine Months Ended September
30, 2015
|
Three Months Ended
September 30,
2016
|
Three Months Ended
September 30,
2015
|
|
|
NET
REVENUES:
|
|
|
|
|
Product
sales, net
|
$1,882,129
|
$179,744
|
$1,702,385
|
947.1%
|
License
revenues
|
-
|
-
|
-
|
-%
|
|
1,882,129
|
179,744
|
1,702,385
|
947.1%
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
Cost
of product sales
|
331,227
|
102,359
|
228,868
|
223.6%
|
Research
and development
|
43,775
|
-
|
43,775
|
100.0%
|
Sales
and marketing
|
1,972,155
|
80,682
|
1,891,473
|
2,344.4%
|
General
and administrative
|
1,779,048
|
650,539
|
1,128,509
|
173.5%
|
Total
operating expenses
|
4,126,205
|
833,580
|
3,292,625
|
395.0%
|
LOSS
FROM OPERATIONS
|
(2,244,076)
|
(653,836)
|
(1,590,240)
|
243.2%
|
|
|
|
|
|
Interest
expense
|
(3,727,168)
|
(473,360)
|
(3,253,808)
|
687.4%
|
Other
income, net
|
194,744
|
-
|
194,744
|
100.0%
|
Change
in fair value of derivative liabilities
|
1,350,688
|
268,449
|
1,082,239
|
403.1%
|
NET
LOSS
|
$(4,425,812)
|
$(858,747)
|
$(3,567,065)
|
415.4%
|
|
Nine Months Ended
September 30,
2016
|
Nine Months Ended
September 30,
2015
|
|
|
NET
REVENUES:
|
|
|
|
|
Product
sales, net
|
$3,126,112
|
$555,069
|
$2,571,043
|
463.2%
|
License
revenues
|
1,000
|
5,000
|
(4,000)
|
(80.0)%
|
|
3,127,112
|
560,069
|
2,567,043
|
458.3%
|
|
|
|
|
|
OPERATING
EXPENSES:
|
|
|
|
|
Cost
of product sales
|
714,284
|
242,808
|
471,476
|
194.2%
|
Research
and development
|
47,667
|
-
|
47,667
|
100.0%
|
Sales
and marketing
|
2,257,166
|
132,778
|
2,124,388
|
1,600.0%
|
General
and administrative
|
4,012,357
|
2,948,413
|
1,063,944
|
36.1%
|
Total
operating expenses
|
7,031,474
|
3,323,999
|
3,707,475
|
111.5%
|
LOSS
FROM OPERATIONS
|
(3,904,362)
|
(2,763,930)
|
(1,140,432)
|
41.3%
|
|
|
|
|
|
Interest
expense
|
(6,000,752)
|
(744,726)
|
(5,256,026)
|
705.8%
|
Loss
on extinguishment of debt
|
-
|
(32,500)
|
32,500
|
(100.0)%
|
Other
income, net
|
196,620
|
-
|
196,620
|
100.0%
|
Change
in fair value of derivative liabilities
|
(632,627)
|
316,378
|
(949,005)
|
(300.0)%
|
NET
LOSS
|
$(10,341,121)
|
$(3,224,778)
|
(7,116,343)
|
220.7%
|
Net
Revenues: The Company
recognized net revenues of $1,882,129 and $3,127,112 for the three
and nine months ended September 30, 2016 compared to $179,744 and
$560,069 for the three and nine months ended September 30,
2015. The increase in revenue for the three and
nine months ended September 30, 2016 was primarily the result
of the product sales generated through the sales and marketing
platform acquired in the Beyond Human asset acquisition. The
increase was also due to an increase in sales of Vesele® which
generated net revenues of approximately $1.1 million and $1.5
million during the three and nine months ended September 30, 2016,
respectively, compared to approximately $1,000 and $6,000 during
the three and nine months ended September 30, 2015, respectively.
The Company generated additional net revenues of approximately
$382,000 and $566,000 when selling Vesele® with other Beyond
Human products during the three and nine months ended September 30,
2016, respectively. The increase in net revenues from the sale of
products through the Beyond Human sales and marketing platform was
offset by decreases in our other existing product sales channels as
we concentrated our sales efforts and resources on integrating our
existing products into the Beyond Human sales and marketing
platform. The decreases in existing product sales channels resulted
in net revenues from the Zestra® products decreasing
approximately $120,000 and $224,000 during the three and nine
months September 30, 2016, respectively, when compared to the same
period in 2015. The Company is in the process of integrating
Zestra® into the Beyond Human sales and marketing platform and
is expecting an increase in product sales of Zestra® through
that sales channel in the fourth quarter of
2016.
Cost of
Product Sales: We recognized
cost of product sales of $331,227 and $714,284 for the three and
nine months ended September 30, 2016 compared to $102,359 and
$242,808 for the three and nine months ended September 30, 2015.
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 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 2016 is also due to fewer sales when compared
to 2015 through our retail and wholesale sales channels which have
lower margins.
Research
and Development: We recognized
research and development expenses of $43,775 and $47,667 for the
three and nine months ended September 30, 2016 compared to no
expenses for the three and nine months ended September 30, 2015.
The research and development expenses includes the fair value of
the shares of common stock issued to Centric Research Institute
totaling $23,000 for the settlement of certain clinical and
regulatory milestone payments due under the in-license agreement
for Sensum+®, as well as, clinical costs incurred related to
post marketing studies for Vesele® and BHT® Testosterone
Booster.
Sales and
Marketing: Sales and marketing
expenses of $1,972,155 and $2,257,166 during the three and nine
months ended September 30, 2016, respectively, consist primarily of
print advertisements and sales and marketing support. The increase
in sales and marketing expenses during the three and nine months
ended September 30, 2016 when compared to the same period in 2015
is due to the costs of integration of our existing products into
the Beyond Human sales and marketing platform and the increase in
the number of print and online media advertisements of our existing
products through the Beyond Human platform. The increase is also
attributable to increased costs in sales and marketing support
services due to the higher volume of sales orders received as a
result of the Beyond Human asset acquisition and the integration of
more products into this platform.
General and
Administrative: General and
administrative expenses consist primarily of investor relation
expenses, legal, accounting, public reporting costs and other
infrastructure expenses related to the launch of our
products. Additionally, our general and administrative
expenses include professional fees, insurance premiums and general
corporate expenses. General and administrative expenses were
$1,779,048 and $4,012,357 for the three and nine months ended
September 30, 2016 compared to $650,539 and $2,948,413 for the
three and nine months ended September 30, 2015. The increase is
primarily due to the increase in non-cash stock-based compensation
to consultants for services rendered, an increase in the
amortization of intangible assets as a result of the acquisitions
in 2016 and 2015 and increased payroll and related costs due to the
increase in headcount when compared to 2015.
Interest
Expense: Interest expense
primarily includes interest related to the Company’s debt,
amortization of debt discounts and the fair value of the embedded
conversion feature derivative liability in excess of the proceeds
allocated to the debt (see Notes 5, 6 and 9 to the accompanying
condensed consolidated financial statements). Due to the shares,
warrants and cash discounts provided to our lenders, the effective
interest rate is significantly higher than the coupon
rate. The increase in interest expense reflects the larger
amount of debt discount amortization of approximately $2.4 million
when compared to 2015 due to the convertible debt and note payable
financings completed in 2016 and 2015 and the increase in the fair
value in excess of the allocated proceeds of the embedded
conversion feature in the convertible debt financings in June and
July of 2016 of approximately $2.7 million.
Other
Income, Net: Other income, net
consists primarily of the non-cash gain on contingent consideration
of $194,781 as a result of the settlement agreement entered into
with the sellers of the Beyond Human assets in September 2016 (see
Note 3 in the accompanying condensed consolidated financial
statements).
Change in
Fair Value of Derivative Liabilities: 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 increase in the loss on change in fair value of derivative
liabilities during the nine months ended September 30, 2016 is due
to the increase in the Company’s stock price during that
period when compared to 2015. The increase in the gain on change in
fair value of derivative liabilities during the three months ended
September 30, 2016 is due to the decrease in the Company’s
stock price from the date of issuance of the 2016 convertible
debentures in June and July when compared to the stock price on the
date of conversion or the reporting period end.
Net
Loss: Net loss for the three
and nine months ended September 30, 2016 was $(4,425,812) and
$(10,341,121), or $(0.04) and $(0.12) basic and diluted net loss
per share, respectively, compared to a net loss for the same
periods in 2015 of $(858,747) and $(3,224,778), or $(0.02) and
$(0.06) 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 issuance of debt instruments. Combined with revenues, these
funds have provided us with the resources 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 September 30, 2016,
we had an accumulated deficit of $25,775,716 and a working capital
deficit of $1,159,458.
The
Company has raised funds through the issuance of debt and the sale
of common stock. The Company has also issued equity instruments in
certain circumstances to pay for services from vendors and
consultants. In June and July 2016, the Company raised $3,000,000
in gross proceeds from the issuance of convertible debentures to
eight investors (see Note 5 to the accompanying condensed
consolidated financial statements) for working capital purposes. In
the event the Company does not pay the convertible debentures upon
their maturity, or after the remedy period, the principal amount
and accrued interest on the convertible debentures is convertible,
at the Company’s option, to common stock at 60% of the volume
weighted average price (“VWAP”) during the ten
consecutive trading day period preceding the date of
conversion.
As
of November 8, 2016, we had approximately $0.9 million in cash and
approximately $296,000 of cash collections held by our third-party
merchant service provider. The Company expects that its existing
capital resources, revenues from sales of its products and upcoming
new product launches and sales milestone payments from the
commercial partners signed for its products, and equity instruments
available to pay certain vendors and consultants, will be
sufficient to allow the Company to continue its operations,
commence the product development process and launch
selected products through at least the next 12 months. In
addition, the Company’s CEO, who is also a significant
shareholder, has deferred the payment of his salary earned thru
June 30, 2016 for at least the next 12 months.
The
Company’s actual needs will depend on numerous factors,
including timing of introducing its products to the marketplace,
its ability to attract additional Ex-U.S. distributors for its
products and its ability to in-license in non-partnered territories
and/or develop new product candidates. The Company may also seek to
raise capital, debt or equity from outside sources to pay for
further expansion and development of its business and to meet
current obligations. Such capital may not be available to the
Company when it needs it on terms acceptable to the Company, if at
all.
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 a closing statement in which SBI
loaned the Company 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. 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 the Company for use in building the Beyond
Human business and $7,500 was provided for attorneys’
fees.
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. The Company 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 the Company 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 revenues received by the Company 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 the Company in the transaction including all revenue
received by the Company from these assets.
Convertible Debentures - 2016 Financing
In
the second and third quarter of 2016, the Company entered into
Securities Purchase Agreements with eight accredited investors (the
“Investors”), pursuant to which the Company received
aggregate gross proceeds of $3,000,000 (net of OID) pursuant to
which it 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 the
Company received an aggregate total of $2,657,500 in funds
thereunder after debt issuance costs of $342,500). The 2016 Notes
and accrued interest are convertible into shares of common stock of
the Company at a conversion price of $0.25 per share, with certain
adjustment provisions noted below. The maturity date of the 2016
Notes issued on June 30, 2016 and July 15, 2016 is July 30, 2017
and the maturity date of the 2016 Notes issued on July 25, 2016 is
August 25, 2017. The 2016 Notes bear interest on the unpaid
principal amount at the rate of 5% per annum from the date of
issuance until the same becomes due and payable, whether at
maturity or upon acceleration or by prepayment or
otherwise.
Notwithstanding
the foregoing, upon the occurrence of an Event of Default as
defined in such 2016 Notes, a Default Amount is equal to the sum of
(i) the principal amount, together with accrued interest due
thereon through the date of payment payable at the holder’s
option in cash or common stock and (ii) an additional amount equal
to the principal amount payable at the Company’s option in
cash or common stock. For purposes of payments in common stock, the
following conversion formula shall apply: the conversion price
shall be the lower of: (i) the fixed conversion price ($0.25) or
(ii) 75% multiplied by the volume weighted average price of the
Company’s common stock during the ten consecutive trading
days immediately prior to the later of the Event of Default or the
end of the applicable cure period. For purposes of the Investors
request of repayment in cash but the Company is unable to do so,
the following conversion formula shall apply: the conversion price
shall be the lower of: (i) the fixed conversion price ($0.25) or
(ii) 60% multiplied by the lowest daily volume weighted average
price of the Company’s common stock during the ten
consecutive trading days immediately prior to the conversion.
Certain other conversion rates apply in the event of the sale or
merger of the Company, default and other defined
events.
The
Company may 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. Under the terms of the 2016 Notes, the
Company shall not effect certain corporate and business actions
during the term of the 2016 Notes, although some may be done with
proper notice. Pursuant to the Securities Purchase Agreements, with
certain exceptions, the Investors have a right of participation
during the term of the 2016 Notes; additionally, the Company
granted the 2016 Note holders registration rights for the shares of
common stock underlying the 2016 Notes up to $1,000,000 pursuant to
Registration Rights Agreements.
Cash Flows
For
the nine months ended September 30, 2016, cash used in operating
activities was $739,472, consisting primarily of the net loss for
the period of $10,341,121, which was primarily offset by non-cash
common stock, restricted stock units and stock options issued for
services and compensation of $1,889,837, amortization of debt
discount of $2,997,061, change in fair value of derivative
liabilities of $632,627, fair value of the embedded conversion
feature in excess of allocated proceeds of $2,756,899 and
amortization of intangible assets of $513,767. The non-cash
expenses were offset with the non-cash gain on contingent
consideration of $194,781. Additionally, working capital changes
consisted of cash increases of $965,588 related to a decrease in
accounts receivable from cash collections from customers of
$51,304, $581,066 related to an increase in accrued compensation,
and $928,044 related to an increase in accounts payable and accrued
expenses, partially offset by a cash decrease related to the
increase in prepaid expenses and other current assets of $450,394
and inventories of $142,329.
For
the nine months ended September 30, 2016, cash used in investing
activities was $156,565 which consisted of purchases of property
and equipment of $6,565 and the contingent consideration payment of
$150,000 made to the seller of the Beyond Human
assets.
For
the nine months ended September 30, 2016, cash provided by
financing activities was $2,294,681, consisting primarily of the
net proceeds from notes payable and convertible debentures of
$3,074,000 and proceeds from warrant exercises of $310,140, offset
by the repayment of short-term loans payable of $252,151, notes
payable of $384,916 and the related party line of credit
convertible debenture of $409,192.
Critical Accounting Policies and Estimates
On January 1, 2016, the Company retrospectively
adopted Financial Accounting Standards Board (“FASB”)
Accounting Standards Update (“ASU”) No. 2015-03,
Interest -
Imputation of Interest (Subtopic 835-30): Simplifying the
Presentation of Debt Issuance Costs. This ASU requires that debt issuance costs be
presented as a direct reduction from the carrying amount of debt.
As a result of the adoption of this ASU, the condensed consolidated
balance sheet at December 31, 2015 was adjusted to reflect the
reclassification of $97,577 from deferred financing costs, net to
convertible debentures, net. The adoption of this ASU
did not have an impact on the Company’s condensed
consolidated results of operations.
For
the nine months ended September 30, 2016, 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
2015.
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.
(a) Evaluation of disclosure controls and procedures.
As
of September 30, 2016, 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 September 30, 2016, 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 chief financial officer, 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 September 30, 2016, 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. The Company has
expanded its financial and accounting department with the
employment of a new chief financial officer and a vice president of
finance to maintain the effectiveness of its internal
controls.
PART II—OTHER
INFORMATION
ITEM 1. LEGAL
PROCEEDINGS
In
the normal course of business, the Company may be a party to legal
proceedings. The Company is not currently a party to any
material legal proceedings.
ITEM 1A. RISK
FACTORS
Not
required under Regulation S-K for “smaller reporting
companies.”
ITEM 2. UNREGISTERED
SALES OF EQUITY SECURITIES AND USE OF PROCEEDS
For
the three months ended September 30, 2016, the Company issued
2,140,714 shares of its common stock valued at $638,743 in exchange
for services under the Company’s existing consulting and
service agreements with third parties.
For
the three months ended September 30, 2016, the Company issued
100,000 shares of its common stock valued at $23,000 for the
settlement of certain clinical and regulatory milestones under the
in-license agreement for Sensum+®.
For
the three months ended September 30, 2016, the Company issued
191,908 shares of its common stock upon the cashless exercise of
warrants to purchase 245,157 shares of common stock that were
previously issued in connection with a note payable.
In
the second and third quarter of 2016, the Company entered into
Securities Purchase Agreements with eight accredited investors (the
“Investors”), pursuant to which the Company received
aggregate gross proceeds of $3,000,000 (net of OID) pursuant to
which it 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 the Company received an aggregate total of
$2,657,500 in funds thereunder after debt issuance costs of
$342,500). The 2016 Notes and accrued interest are convertible into
shares of common stock of the Company at a conversion price of
$0.25 per share, with certain adjustment provisions noted herein.
The maturity date of the 2016 Notes issued on June 30, 2016 and
July 15, 2016 is July 30, 2017 and the maturity date of the 2016
Notes issued on July 25, 2016 is August 25, 2017. The 2016 Notes
bear interest on the unpaid principal amount at the rate of 5% per
annum from the date of issuance until the same becomes due and
payable, whether at maturity or upon acceleration or by prepayment
or otherwise.
For the
three months ended September 30, 2016, certain 2016 Notes holders elected to convert
$1,420,265 in principal and interest into 5,681,060 shares of
common stock.
All the
foregoing issuances of securities were made in reliance on the
exemption from registration provided by Section 4(a)(2) of the
Securities Act of 1933, as amended for transactions by an issuer
not involving a public offering, pursuant to Rule 506 of Regulation
D, or pursuant to benefit plans and contracts relating to
compensation as provided under Rule 701.
There
were no issuances of unregistered securities to report which were
sold or issued by the Company without the registration of these
securities under the Securities Act of 1933 in reliance on
exemptions from such registration requirements, within the period
covered by this report, which have not been previously included in
and Annual Report on Form 10-K, a Quarterly Report on Form 10-Q or
a Current Report on Form 8-K.
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.
|
Innovus
Pharmaceuticals, Inc.
|
|
|
|
|
|
Date: November 14,
2016
|
By:
|
/s/
Bassam
Damaj
|
|
|
|
Bassam
Damaj, Ph.D., President,
|
|
|
|
Chief
Executive Officer and Director
(Principal
Executive Officer)
|
|
|
Innovus
Pharmaceuticals, Inc.
|
|
|
|
|
|
Date: November 14,
2016
|
By:
|
/s/
Robert
E. Hoffman
|
|
|
|
Robert
E. Hoffman, Executive Vice President and Chief Financial
Officer
|
|
|
|
(Principal
Financial Officer)
|
|
INDEX TO EXHIBITS
Exhibit No.
|
|
Description
|
4.1
|
|
Form
of Securities Purchase Agreement, dated July 15, 2016 (incorporated
by reference to Exhibit 4.1 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
4.2
|
|
Form
of Convertible Promissory Note, dated July 15, 2016 (incorporated
by reference to Exhibit 4.2 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
4.3
|
|
Form
of Common Stock Purchase Warrant Agreement, dated July 15, 2016
(incorporated by reference to Exhibit 4.3 to the Company’s
Current Report on Form 8-K filed July 6, 2016)
|
4.4
|
|
Form
of Registration Rights Agreement, dated July 15, 2016 (incorporated
by reference to Exhibit 4.4 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
4.5
|
|
Form
of Securities Purchase Agreement, dated July 25, 2016 (Incorporated
by reference to Exhibit 4.1 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
4.6
|
|
Form
of Convertible Promissory Note, dated July 25, 2016 (incorporated
by reference to Exhibit 4.2 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
4.7
|
|
Form
of Common Stock Purchase Warrant Agreement, dated July 25, 2016
(incorporated by reference to Exhibit 4.3 to the Company’s
Current Report on Form 8-K filed July 6, 2016)
|
4.8
|
|
Form
of Registration Rights Agreement, dated July 25, 2016 (incorporated
by reference to Exhibit 4.4 to the Company’s Current Report
on Form 8-K filed July 6, 2016)
|
10.1
|
|
Employment
Agreement, dated as of September 6, 2016, by and between Innovus
Pharmaceuticals, Inc. and Robert E. Hoffman (incorporated by
reference to Exhibit 10.1 to the Company’s Current Report on
Form 8-K filed August 29, 2016)
|
10.2*
|
|
Amendment
and supplement to the Registration Rights an Stock Restriction
Agreement, dated November 12, 2016, by and between the Company and
Novalere Holdings, LLC
|
31.1*
|
|
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.
|
31.2*
|
|
Certification
of Robert E. Hoffman, 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.
|
32.1**
|
|
Certification
of Bassam Damaj, Ph.D., principal executive officer, and Robert E.
Hoffman, principal financial officer, pursuant to 18 U.S.C.
Section 1350, as adopted pursuant to Section 906 of the
Sarbanes-Oxley Act of 2002.
|
|
|
|
101.INS*
|
|
XBRL
Instance Document
|
101.SCH*
|
|
XBRL
Taxonomy Extension Schema Document
|
101.CAL*
|
|
XBRL
Taxonomy Extension Calculation Linkbase Document
|
101.DEF*
|
|
XBRL
Taxonomy Extension Definition Linkbase Document
|
101.LAB*
|
|
XBRL
Taxonomy Extension Label Linkbase Document
|
101.PRE*
|
|
XBRL
Taxonomy Extension Presentation Linkbase Document
|
**
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.