Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

 (Mark One)

[X]  Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the Quarterly Period ended June 30, 2019

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

 

90-0814124

(State or Other Jurisdiction of

Incorporation or Organization)

 

(IRS Employer

Identification No.)

 

 

 

8845 Rehco Road

San Diego, CA

 

92121

(Address of Principal Executive Offices)

 

(Zip Code)

 

858-964-5123

(Registrant’s telephone number, including area code)

 

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days.  Yes ☒  No ☐

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted 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 such files).  Yes ☒  No ☐

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a nonaccelerated filer, smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act:

 

Large accelerated filer ☐

Accelerated filer ☐

Non-accelerated filer ☒

Smaller reporting company ☒

Emerging growth company ☐     

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act).  Yes ☐ No ☒

 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

 

Securities registered pursuant to Section 12(b) of the Act: none

 

Securities registered pursuant to Section 12(g) of the Act: 

Title of each class

Trading Symbol(s)

Name of each exchange on which registered

Common Stock, par value $0.001 per share

INNV

OTCQB Marketplace

 

Indicate the number of shares outstanding of each of the issuer's classes of common stock, as of the latest practicable date:

 

As of August 6, 2019, the registrant had 2,604,476 shares of common stock outstanding.

 

 

 

TABLE OF CONTENTS

 

 

 

 

Page

 

 

 

 

 

 

PART I—FINANCIAL INFORMATION

 

 

 

 

 

 

 

 

 

Item 1.

Financial Statements

 

 

1

 

 

 

 

 

 

 

 

Condensed Consolidated Balance Sheets at June 30, 2019 (Unaudited) and December 31, 2018

 

 

1

 

 

 

 

 

 

 

 

Condensed Consolidated Statements of Operations (Unaudited) for the Three and Six Months Ended June 30, 2019 and 2018

 

 

2

 

 

 

 

 

 

 

  Condensed Consolidated Statement of Changes in Stockholders' Equity (Unaudited) for the Six Months Ended June 30, 2019 and 2018     3  
           

 

Condensed Consolidated Statements of Cash Flows (Unaudited) for the Six Months Ended June 30, 2019 and 2018

 

 

4

 

 

 

 

 

 

 

 

Notes to Condensed Consolidated Financial Statements (Unaudited)

 

 

5

 

 

 

 

 

 

 

Item 2.

Management's Discussion and Analysis of Financial Condition and Results of Operations

 

 

16

 

 

 

 

 

 

 

Item 3.

Quantitative and Qualitative Disclosures about Market Risk

 

 

23

 

 

 

 

 

 

 

Item 4.

Controls and Procedures

 

 

23

 

 

 

 

 

 

 

PART II—OTHER INFORMATION

 

 

 

 

 

 

 

 

 

Item 1.

Legal Proceedings

 

 

24

 

 

 

 

 

 

 

Item 1A.

Risk Factors

 

 

24

 

 

 

 

 

 

 

Item 2.

Unregistered Sales of Equity Securities and Use of Proceeds

 

 

24

 

 

 

 

 

 

 

Item 3.

Defaults Upon Senior Securities

 

 

25

 

 

 

 

 

 

 

Item 4.

Mine Safety Disclosures

 

 

25

 

 

 

 

 

 

 

Item 5.

Other Information

 

 

25

 

 

 

 

 

 

 

Item 6.

Exhibits

 

 

25

 

 

 

 

 

 

 

 

Signatures

 

 

26

 

 

 

 

 

PART I - FINANCIAL INFORMATION

Item 1. Financial Statements

 

  INNOVUS PHARMACEUTICALS, INC.

Condensed Consolidated Balance Sheets

(In thousands, except share amounts)

 

   

June 30, 2019

   

December 31, 2018

 
   

(Unaudited)

         

ASSETS

               

Assets:

               

Cash

  $ 1,574     $ 1,248  

Accounts receivable, net

    319       282  

Prepaid expense and other current assets

    1,711       1,116  

Inventories

    1,853       2,370  

Total current assets

    5,457       5,016  
                 

Property and equipment, net

    227       247  
                 

Deposits

    21       21  

Operating lease right-of-use asset

    622       -  

Goodwill

    953       953  

Intangible assets, net

    3,557       3,890  

Total assets

  $ 10,837     $ 10,127  
                 

LIABILITIES AND STOCKHOLDERS' EQUITY

               
                 

Liabilities:

               

Accounts payable and accrued expense

  $ 2,949     $ 2,622  
Operating lease liability     155       -  

Accrued compensation

    1,648       1,252  

Deferred revenue and customer deposits

    83       108  

Accrued interest payable

    38       32  

Short-term loan payable

    681       266  

Notes payable, net of debt discount of $813 and $1,008, respectively

    2,321       3,073  

Total current liabilities

    7,875       7,353  
                 

Deferred Rent

    -       181  

Operating lease liability, net of current portion

    634       -  

Accrued compensation, net of current portion

    1,032       1,228  

Contingent consideration

    1,250       1,256  

Total non-current liabilities

    2,916       2,665  
                 

Total liabilities

    10,791       10,018  
                 

Commitments and contingencies

               
                 

Stockholders’ equity:

               

Preferred stock: 7,500,000 shares authorized, at $0.001 par value, no shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively

    -       -  

Common stock: 292,500,000 shares authorized, at $0.001 par value, 2,578,476 and 2,103,071 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively

    2       2  

Additional paid-in capital

    47,652       43,967  

Accumulated deficit

    (47,608 )     (43,860 )

Total stockholders' equity

    46       109  
                 

Total liabilities and stockholders’ equity

  $ 10,837     $ 10,127  

 

See accompanying notes to these condensed consolidated financial statements.

 

 

 

INNOVUS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Operations

(Unaudited)

(in thousands, except weighted average share and per share amounts)

 

   

For the Three Months Ended June 30,

   

For the Six Months Ended June 30,

 
   

2019

   

2018

   

2019

   

2018

 

Net revenue:

                               

Product sales, net

  $ 6,594     $ 6,970     $ 11,783     $ 11,512  

Service revenue

    56       156       156       156  

Cooperative marketing revenue

    91       183       162       184  

License revenue

    107       3       110       5  

Net revenue

    6,848       7,312       12,211       11,857  
                                 

Cost of product sales

    2,356       1,339       4,134       2,203  

Gross Profit

    4,492       5,973       8,077       9,654  
                                 

Operating expense:

                               

Research and development

    91       23       148       34  

Sales and marketing

    2,858       5,529       5,453       8,831  

General and administrative

    2,724       1,919       5,158       3,615  

Total operating expense

    5,673       7,471       10,759       12,480  
                                 

Loss from operations

    (1,181 )     (1,498 )     (2,682 )     (2,826 )
                                 

Other income (expense):

                               

Interest expense

    (486 )     (326 )     (976 )     (568 )

Loss on extinguishment of debt

    (125 )     (38 )     (125 )     (294 )
Other income (expense), net     29       -       29       -  

Fair value adjustment for contingent consideration

    4       22       6       19  

Total other expense, net

    (578 )     (342 )     (1,066 )     (843 )
                                 

Net loss

  $ (1,759 )   $ (1,840 )   $ (3,748 )   $ (3,669 )
                                 

Net loss per share of common stock – basic and diluted

  $ (0.66 )   $ (0.94 )   $ (1.47 )   $ (1.96 )
                                 

Weighted average number of shares of common stock outstanding – basic and diluted

    2,660,435       1,953,400       2,553,212       1,867,338  

 

See accompanying notes to these condensed consolidated financial statements.

 

 

 

 

INNOVUS PHARMACEUTICALS, INC.

Condensed Consolidated Statement of Stockholder's Equity

(Unaudited)

For the Months Ended June 30, 2019 and 2018

(In thousands, except share amounts)

 

                   

Additional

                 
   

Common Stock

   

Paid-in

   

Accumulated

   

Stockholders'

 
   

Shares

   

Amount

   

Capital

   

Deficit

   

Equity

 
                                         

Balance at December 31, 2017

    1,596,574     $ 2     $ 36,541     $ (35,640 )   $ 903  
                                         

Common stock issued for services

    2,444       -       21       -       21  

Stock-based compensation

    -       -       95       -       95  

Exercise of warrants, net of offering costs

    180,247       -       2,657       -       2,657  

Common stock issued upon conversion of debt and interest

    21,429       -       385       -       385  

Common stock issued in connection with debt

    26,355       -       292       -       292  

Fair value of shares of common stock issued as financing fees in connection with notes payable

    8,916       -       122       -       122  

Reclassification of warrant derivative liability upon adoption of ASU 2017-11

    -       -       -       59       59  

Net loss

    -       -       -       (1,829 )     (1,829 )
                                         
Balances at March 31, 2018     1,835,965     $ 2     $ 40,113     $ (37,410 )   $ 2,705  
                                         

Common stock issued for services

    159       -       2       -       2  

Stock-based compensation

    -       -       108       -       108  
Common stock issued upon conversion of debt and interest     14,041       -       196       -       196  
Common stock issued for vested RSUs     6,797       -       -       -       -  

Net loss

    -       -       -       (1,840 )     (1,840 )
                                         

Balances at June 30, 2018

    1,856,962     $ 2     $ 40,419     $ (39,250 )   $ 1,171  
                                         
                                         

Balance at December 31, 2018

    2,103,071     $ 2     $ 43,967     $ (43,860 )   $ 109  
                                         
Stock-based compensation     -       -       138       -       138  

Relative fair value of shares of restricted common stock issued in connection with notes payable

    18,000       -       61       -       61  

Sales of common stock and warrants, net of offering costs

    230,853       -       2,714       -       2,714  
Fair value of shares of common stock issued as financing fees in connection with notes payable     5,600       -       28       -       28  
Net loss     -       -       -       (1,989 )     (1,989 )
                                         
Balances at March 31, 2019     2,357,524     $ 2     $ 46,908     $ (45,849 )   $ 1,061  
                                         
Common stock issued for services     36,916       -       106       -       106  
Stock-based compensation     -       -       137       -       137  
Common stock issued upon conversion of debt and interest     100,000       -       300       -       300  
Relative fair value of shares of restricted common stock issued in connection with notes payable     74,000       -       173       -       173  
Fair value of shares of common stock issued as financing fees in connection with notes payable     10,036       -       28       -       28  
Net loss     -       -       -       (1,759 )     (1,759 )
                                         

Balances at June 30, 2019

    2,578,476     $ 2     $ 47,652     $ (47,608 )   $ 46  

 

See accompanying notes to these condensed consolidated financial statements.

 

 

 

INNOVUS PHARMACEUTICALS, INC.

Condensed Consolidated Statements of Cash Flows

(Unaudited)

(In thousands)

 

   

For the Six Months Ended June 30,

 
   

2019

   

2018

 
                 

Cash flows from operating activities:

               

Net loss

  $ (3,748 )   $ (3,669 )

Adjustments to reconcile net loss to net cash used in operating activities:

               

Depreciation

    35       19  

Recovery of allowance for doubtful accounts

    (11 )     -  

Common stock, restricted stock units and stock options issued to employees, board of directors and consultants for compensation and services

    275       225  

Loss on extinguishment of debt

    125       294  

Change in fair value of contingent consideration

    (6 )     (19 )

Amortization of debt discount

    908       534  

Amortization of intangible assets

    363       315  

Changes in operating assets and liabilities, net of acquisition amounts

               

Accounts receivable

    (27 )     (219 )

Prepaid expense and other current assets

    (596 )     (331 )

Inventories

    830       (503 )

Operating lease right-of-use asset and liability, net

    (14 )     -  

Accounts payable and accrued expense

    301       474  

Accrued compensation

    201       (677 )

Accrued interest payable

    33       23  

Deferred revenue and customer deposits

    (25 )     73  

Net cash used in operating activities

    (1,356 )     (3,461 )
                 

Cash flows used in investing activities:

               

Purchase of property and equipment

    (16 )     (135 )

Asset acquisition

    (343 )     -  

Net cash used in investing activities

    (359 )     (135 )
                 

Cash flows from financing activities:

               

Payments on short-term loans payable

    (664 )     (58 )

Proceeds from short-terms loans payable

    1,053       125  

Proceeds from notes payable

    1,650       1,873  

Payments on notes payable

    (2,712 )     (1,133 )

Proceeds from sale of common stock and warrants, net of offering costs

    2,714       -  

Proceeds from stock option and warrant exercises

    -       2,839  

Net cash provided by financing activities

    2,041       3,646  
                 

Net change in cash

    326       50  
                 

Cash at beginning of period

    1,248       1,565  
                 

Cash at end of period

  $ 1,574     $ 1,615  
                 

Supplemental disclosures of cash flow information:

               

Cash paid for interest

  $ 29     $ 2  
                 

Supplemental disclosures of non-cash investing and financing activities:

               

Common stock issued for conversion of convertible debentures, notes payable and accrued interest

  $ 300     $ 167  

Relative fair value of common stock issued in connection with notes payable recorded as debt discount

  $ 367     $ 292  
Fair value of common stock issued to consultants for services   $ 106     $ -  

Offering costs in connection with warrant exercises included in accounts payable and accrued expense

  $ -     $ 181  

Cumulative adjustment to accumulated deficit for the fair value of the warrant derivative liability upon adoption of ASU 2017-11 on January 1, 2018

  $ -     $ 59  

Fair value of common stock issued as financing fees in connection with notes payable recorded as debt discount

  $ 56     $ 123  

 

See accompanying notes to these condensed consolidated financial statements.

 

 

INNOVUS PHARMACEUTICALS, INC.

Notes to Condensed Consolidated Financial Statements

June 30, 2019

(Unaudited)

 

 

NOTE 1 – ORGANIZATION AND SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Organization

 

Innovus Pharmaceuticals, Inc., a Nevada incorporated and San Diego-based company, together with its subsidiaries as follows (collectively referred to as “Innovus” or the “Company”): Semprae Laboratories, Inc., a Delaware corporation (“Semprae”); FasTrack Pharmaceuticals, Inc., a Delaware corporation (“FasTrack”); Novalere, Inc., a Delaware corporation (“Novalere”); Supplement Hunt, Inc., a Nevada corporation (“Supplement Hunt”); and Prime Savings Club, Inc., a Nevada corporation (“Prime Savings Club”), is an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine, consumer care products, supplements and certain related devices to improve men’s and women’s health and vitality, urology, brain health, pain, respiratory diseases, among others. The Company delivers innovative and uniquely presented and packaged health solutions through its (a) OTC medicines, devices, consumer and health products, and clinical supplements, which we market directly, (b) commercial retail and wholesale partners, and (c) directly to consumers through the Company’s proprietary Beyond Human® Sales & Marketing Platform including print media, on-line channels, websites, retailers and wholesalers. The Company is dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products, supplements and certain related devices. Innovus actively pursues opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC. These “Rx-to-OTC switches” require Food and Drug Administration (“FDA”) approval through a process initiated by the New Drug Application (“NDA”) holder.

 

The Company’s business model leverages its ability to (a) develop and build its current pipeline of proprietary products, and (b) to also acquire outright or in-license commercial products that are supported by scientific and/or clinical evidence, place them through the Company’s existing supply chain, retail and on-line (including our Amazon®, eBay®, Wish.com®, Walmart.com®, and Walgreens.com® on-line stores and other e-commerce business platforms) channels to tap new markets and drive demand for such products and to establish physician relationships. The Company currently sells its products direct to consumer primarily in the United States and Canada and sells to international commercial partners in multiple countries around the world.

 

Basis of Presentation and Principles of Consolidation

 

The condensed consolidated balance sheet as of December 31, 2018, which has been derived from audited consolidated financial statements, and these unaudited condensed consolidated financial statements have been prepared by management in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”), and include all assets, liabilities, revenues and expenses of the Company and its wholly-owned subsidiaries. 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 our Annual Report on Form 10-K for the year ended December 31, 2018. Certain information required by U.S. GAAP has been condensed or omitted in accordance with the rules and regulations of the U.S. Securities and Exchange Commission (“SEC”). The results for the period ended June 30, 2019 are not necessarily indicative of the results to be expected for the entire fiscal year ending December 31, 2019, or for any future period. 

 

Use of Estimates

 

The preparation of these condensed consolidated financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Such management estimates include the allowance for doubtful accounts, sales returns and chargebacks, realizability of inventories, valuation of deferred tax assets, goodwill and intangible assets, valuation of contingent acquisition consideration, recoverability of long-lived assets and goodwill and the valuation of equity-based instruments. We base our estimates on historical experience and various other assumptions that we believe to be reasonable under the circumstances. Actual results could differ from these estimates under different assumptions or conditions.

 

Liquidity

 

The Company’s operations have been financed primarily through proceeds from convertible debentures and notes payable, sales of its common stock and revenue generated from its products domestically and internationally through the Company’s marketing platform and by its partners. These funds have provided Innovus with the resources to operate its business, sell and support its products, attract and retain key personnel and add new products to the Company’s portfolio. The Company has experienced net losses and negative cash flows from operations each year since its inception. As of June 30, 2019, the Company had an accumulated deficit of $47.6   million and a working capital deficit of $2.4 million.

As of June 30, 2019, we had $1.6 million  in cash and $0.7 million  held by merchant processors reported in other current assets for a total of $2.3 million and as of August 9 , 2019 we had $1.5  million  in cash and $0.6 million  held by merchant processors. During the six months ended June 30, 2019, we had net cash used in operating activities of $1.4 million. We expect that our existing capital resources, together with revenue from sales of our products and upcoming sales milestone payments from the commercial partners signed for our products, will be sufficient to allow us to continue our operations, commence the product development process and launch selected products through at least the next 12 months.

In addition, our CEO, who is also a significant shareholder, has deferred the remaining payment of his salary earned through June 30, 2016, with a current balance totaling $1.0 million, and has agreed to refrain from receipt of any funds which may jeopardize the ability of the Company to operate. During 2019, the Company has paid the CEO approximately $195,000 of the deferred salary balance. Our actual needs will depend on numerous factors, including timing of introducing our new products to the marketplace, our ability to attract additional international distributors for our products and our ability to in-license in non-partnered territories and/or develop new product candidates. Although no assurances can be given, we currently intend to raise additional capital through the sale of debt or equity securities to provide additional working capital, pay for further expansion and development of our business, and to meet current obligations. Such capital may not be available to us when we need it or on terms acceptable to us, if at all.

 

 

Fair Value Measurement
 

Our financial instruments are cash, accounts receivable, accounts payable, accrued liabilities, contingent consideration and debt. The recorded values of cash, accounts receivable, accounts payable and accrued liabilities approximate their fair values based on their short-term nature. The fair 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.  Based on borrowing rates currently available to us, the carrying values of the notes payable and short-term loans payable approximate their respective fair values.  

 

We follow a fair value hierarchy that prioritizes the inputs to valuation techniques used to measure fair value. The hierarchy gives the highest priority to unadjusted quoted prices in active markets for identical assets and liabilities (Level 1) and the lowest priority to measurements involving significant unobservable inputs (Level 3). The three levels of the fair value hierarchy are as follows:

 

 

Level 1 measurements are quoted prices (unadjusted) in active markets for identical assets or liabilities that we have the ability to access at the measurement date.

 

 

Level 2 measurements are inputs other than quoted prices included in Level 1 that are observable either directly or indirectly.

 

 

Level 3 measurements are unobservable inputs.

 

Revenue Recognition

 

The Company generates revenue from product sales and the licensing of the rights to market and commercialize our products.

 

Revenue is measured based on consideration specified in a contract with a customer. A contract with a customer exists when the Company enters into an enforceable contract with a customer. The contract is based on either the acceptance of standard terms and conditions on the websites for e-commerce customers and via telephone with our third-party call center for our print media and direct mail customers, or the execution of terms and conditions contracts with retailers and wholesalers. These contracts define each party’s rights, payment terms and other contractual terms and conditions of the sale. Consideration is typically paid prior to shipment via credit card or check when products are sold direct to consumers or approximately 30 days from the time control is transferred when sold to wholesalers, distributors and retailers. The Company applies judgment in determining the customer’s ability and intention to pay, which is based on a variety of factors including the customer’s historical payment experience and, in some circumstances, published credit and financial information pertaining to the customer.

 

A performance obligation is a promise in a contract to transfer a distinct product to the customer, which for the Company is transfer of over-the-counter drug and consumer care products to its customers. Performance obligations promised in a contract are identified based on the goods that will be transferred to the carrier who takes control of the product that are both capable of being distinct and are distinct in the context of the contract, whereby the transfer of the goods is separately identifiable from other promises in the contract. 

 

The transaction price of a contract is allocated to each distinct performance obligation and recognized as revenue when or as the customer receives the benefit of the performance obligation. The transaction price is determined based on the consideration to which we will be entitled to receive in exchange for transferring goods to the customer. We issue refunds to e-commerce and print media customers, upon request, within 30-90 days of delivery. We estimate the amount of potential refunds at each reporting period using a portfolio approach of historical data, adjusted for changes in expected customer experience, including seasonality and changes in economic factors. For retailers, distributors and wholesalers, we do not offer a right of return or refund and revenue is recognized at the time products are shipped to customers. In all cases, judgment is required in estimating these reserves. Actual claims for returns could be materially different from the estimates. The estimated reserve for sales returns and allowances, which is included in accounts payable and accrued expense, was approximately $191,000 and $194,000 at June 30, 2019 and December 31, 2018, respectively.

 

The Company recognizes revenue when we satisfy a performance obligation in a contract by transferring control over a product to a customer when product is shipped. Taxes assessed by a governmental authority that are both imposed on and concurrent with a specific revenue-producing transaction, that are collected by us from a customer, are excluded from revenue. Shipping and handling costs associated with outbound freight after control over a product has transferred to a customer are accounted for as a fulfillment cost and are included in cost of product sales.

 

The Company enters into exclusive distributor and license agreements that are within the scope of ASC Topic 606. The license agreements we enter into normally generate three separate components of revenue: (1) an initial nonrefundable 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 nonrefundable payments or licensing fee is recognized when all required conditions are met. If the consideration for the initial license fee is for the right to sell the licensed product in the respective territory with no other required conditions to be met, such type of nonrefundable license fee arrangement for the right to sell the licensed product in the territory is recognized ratably over the term of the license agreement. For arrangements with licenses that include sales-based royalties, including sales-based milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, we recognize royalty revenue and sales-based milestones at the later of (i) when the related sales occur, or (ii) when the performance obligation to which the royalty has been allocated has been satisfied. The achievement of the sales-based milestone underlying the payment to be received predominantly relates to the licensee’s performance of future commercial activities.

 

Advertising Expense

 

Advertising costs, which primarily includes print and online media advertisements, are expensed as incurred and are included in sales and marketing expense in the accompanying condensed consolidated statements of operations. Advertising costs were approximately $ 2.1  million and $4.5 million and $ 4.1 million  and $7.2 million for the three and six months ended June 30, 2019 and 2018, respectively.

 

 

Net Loss per Share

 

Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding and vested but deferred RSUs during the period presented. Diluted net loss per share is computed using the weighted average number of common shares outstanding and vested plus deferred RSUs during the periods plus the effect of dilutive securities outstanding during the periods. For the three and six months ended June 30, 2019 and 2018, basic net loss per share is the same as diluted net loss per share as a result of our common stock equivalents being anti-dilutive.  See Note 7 for more details.

 

Recently Adopted Accounting Pronouncements

 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) . The update requires lessees to recognize most leases on the balance sheet as lease liabilities with corresponding right-of-use assets and to disclose key information about leasing arrangements. We adopted Topic 842 on its effective date in the first quarter of 2019 using a modified retrospective approach. We elected the available package of practical expedients upon adoption, which allowed us to carry forward our historical assessment of whether existing agreements contained a lease and the classification of our existing operating leases. We continue to report our financial position as of December 31, 2018 under the former lease accounting standard (Topic 840) in our condensed consolidated balance sheet. The adoption impact resulted in the recognition of an operating lease liability with a corresponding right-of-use asset based on the present value of our remaining minimum lease payments which offset the previously reported deferred rent balance.

 

The following table summarizes the impact of Topic 842 on our condensed consolidated balance sheet upon adoption on January 1, 2019 (in thousands):

 

 

   

January 1, 2019

   

(unaudited

   

Pre-adoption

   

Adoption Impact

   

Post-adoption

Assets

               

Operating lease right-of-use asset

 

$ -

   

$ 675

   

$ 675

Total assets

 

$ -

   

$ 675

   

$ 675

Liabilities and Stockholders' Equity

               

Accrued Liabilities

 

$ -

   

$ 140

   

$ 140

Deferred Rent

 

181

   

$ (181)

   

-

Operating lease liabilities, net of current portion

 

-

   

$ 716

   

716

Total liabilities and stockholders' equity

 

$ 181

   

$ 675

   

$ 856

 

In June 2018, the FASB issued ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . The update aligns the accounting for share-based payment awards issued to nonemployees with those issued to employees. Under the new guidance, the nonemployee awards will be measured on the grant date and compensation costs will be recognized when achievement of the performance condition is probable. This new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The adoption of the new guidance does not have a material impact on the Company’s consolidated financial statements.

 

Recent Accounting Pronouncements

 

In January 2017, the FASB issued ASU 2017-04,  Intangibles - Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment . The update simplifies how an entity is required to test goodwill for impairment by eliminating Step 2 from the goodwill impairment test. Step 2 measures a goodwill impairment loss by comparing the implied fair value of a reporting unit’s goodwill with the carrying amount. This update is effective for annual and interim periods beginning after December 15, 2019, and interim periods within that reporting period. While the Company is still in the process of completing our analysis on the impact this guidance will have on the consolidated financial statements and related disclosures, the Company does not expect the impact to be material.

In August 2018, the FASB issued ASU 2018-13, Fair Value Measurement (Topic 820): Disclosure Framework- Changes to the Disclosure Requirements for Fair Value Measurement . The update modifies the disclosure requirements for recurring and nonrecurring fair value measurements, primarily those surrounding Level 3 fair value measurements and transfers between Level 1 and Level 2. The new standard is effective for fiscal years beginning after December 15, 2019, including interim periods within that reporting period. The Company is currently evaluating the new guidance and does not expect it to have a material impact on its consolidated financial statements.

In August 2018, the FASB issued ASU 2018-15,  Customer s Accounting for Implementation Costs Incurred in a Cloud Computing Arrangement That Is a Service Contract , which aligns the requirements for capitalizing implementation costs incurred in a hosting arrangement that is a service contract with the requirements for capitalizing implementation costs incurred to develop or obtain internal-use software (and hosting arrangements that include an internal-use software license). This ASU also requires the entity to expense the capitalized implementation costs of a hosting arrangement that is a service contract over the term of the hosting arrangement, which includes reasonably certain renewals. This ASU becomes effective for the Company in the year ending December 31, 2020 and early adoption is permitted. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements.

 

In November 2018, the FASB issued ASU 2018-18,  Clarifying the Interaction Between Topic 808 and Topic 606 , which clarifies when transactions between participants in a collaborative arrangement are within the scope of the FASB’s revenue standard, Topic 606. This ASU becomes effective for the Company in the year ending December 31, 2020 and early adoption is permitted. The Company is currently assessing the impact that this ASU will have on its consolidated financial statements.

 

 

 

NOTE 2 – REVENUE

 

Disaggregation of Revenue

 

Our revenue is primarily from distinct fixed-price product sales in the over-the-counter drug and consumer care products market, to similar customers and channels utilizing similar types of contracts that are short term in nature (less than one year). We do not sell service agreements or goods over a period of time and do not sell or utilize customer financing arrangements or time-and-material contracts.

 

The following is a table that presents product sales, net by geographical area:

 

   

For the Three Months Ended June 30,

   

For the Six Months Ended June 30,

 
   

2019

   

2018

   

2019

   

2018

 

United States

  $ 4,690     $ 5,919     $ 9,199     $ 10,103  

Canada

    1,693       892       2,369       1,246  

All Other

    211       159       215       163  

Product sales, net

  $ 6,594     $ 6,970     $ 11,783     $ 11,512  

All Other consists of Europe, Australia, Asia, and the Middle East.

 

Contract Balances

 

We do not have any contract assets such as work-in-process but do have certain contract liabilities such as customer advances for product sales under its license agreements. As of June 30, 2019, we had customer advances totaling $ 35,000  included in deferred revenue and customer deposits in the accompanying condensed consolidated balance sheet for advance payments on the future sale of Zestra® and Zestra Glide® products to Sothema under their license agreement.

 

 

NOTE 3 – BUSINESS AND ASSET ACQUISITIONS

 

Acquisition of Prime Consultants, LLC Assets

 

On January 1, 2019, the Company entered into an Asset Purchase Agreement, pursuant to which the Company acquired substantially all of the assets of Prime Consultants, LLC (“Prime Consultants”) in exchange for $343,000 in cash. The assets acquired include the established Amazon seller platform and inventory totaling $313,000. Prime Consultants is an e-commerce business with sales of products primarily through the Amazon® platform which generated $2.4 million in sales in 2018. The Company recorded intangible assets totaling $30,000.  The Company believes this business complements its existing business while providing an additional sales platform to add to the Company's existing revenue channels.

 

 

Acquisition of Novalere in 2015

 

On February 5, 2015, the Company acquired the worldwide rights to market and sell the FlutiCare® brand (fluticasone propionate nasal spray) and the related third-party manufacturing agreement for the manufacturing of FlutiCare® (“Acquisition Manufacturer”) from Novalere FP. The OTC ANDA for fluticasone propionate nasal spray was filed at the end of 2014 by our third-party manufacturer and partner, who is currently selling the prescription version of the drug, with the FDA and the OTC ANDA was approved in April 2019. An ANDA is an application for a U.S. generic drug approval for an existing licensed medication or approved drug. A prescription ANDA (“RX ANDA”) is for a generic version of a prescription pharmaceutical and an OTC ANDA is for a generic version of an OTC pharmaceutical.

 

Due to the delay in approval of the Acquisition Manufacturer’s OTC ANDA by the FDA, in May 2017, we announced a commercial relationship with a different third-party manufacturer (West-Ward Pharmaceuticals International Limited or “WWPIL”) who has an FDA approved OTC ANDA for fluticasone propionate nasal spray under which they have agreed to manufacture our FlutiCare® OTC product for sale in the U.S. (see Note 8). As we hold the worldwide rights to market and sell FlutiCare® under the manufacturing agreement with the Acquisition Manufacturer, we believe the agreement with the Acquisition Manufacturer will still provide us with the opportunity to market and sell FlutiCare® ex-U.S. and, with the approval of the OTC ANDA in April 2019, a second source of supply within the U.S. is available to Innovus.

 

The Novalere Stockholders are entitled to receive, if and when earned, earn-out payments (“Earn-Out Payments”). For every $5.0 million in net revenue realized from the sales of FlutiCare® through the manufacturing agreement with the Acquisition Manufacturer, the Novalere's stockholders will be entitled to receive, on a pro rata basis, $500,000, subject to cumulative maximum earn-out payments of $2.5 million. The Novalere's stockholders are only entitled to the earn-out payments from the Acquisition Manufacturer’s OTC ANDA under review by the FDA and have no earn-out rights to the sales of FlutiCare® supplied by WWPIL under the commercial agreement entered into in May 2017. As of June 30, 2019, there were no earn-out payments accrued for or paid to the Novalere's stockholders.

 

During the three and six months ended June 30, 2019 and 2018, there was an (decrease) increase in the estimated fair value of the remaining 1,323 ANDA consideration shares totaling $ (4,000)  and $(1,000) and $ (6,000) and $3,000, respectively, which is included in fair value adjustment for contingent consideration in the accompanying condensed consolidated statements of operations. The fair value of the contingent consideration was $ 1.3  million and $1.3 million as of June 30, 2019 and December 31, 2018, respectively. 

 

 

NOTE 4 – INVENTORY

 

Inventories consist of the following:

 

 

   

June 30,

   

December 31,

 
   

2019

   

2018

 

Raw materials and supplies

  $ 240     $ 238  

Work in process

    4       96  

Finished goods

    1,609       2,036  

Total

  $ 1,853     $ 2,370  

 

 

NOTE 5 – INTANGIBLE ASSETS AND GOODWILL

 

Intangible Assets

 

Amortizable intangible assets consist of the following:

 

   

June 30, 2019

 
   

Amount

   

Accumulated Amortization

   

Net Amount

   

Useful Lives (years)

 
                                 

Patent & Trademarks

  $ 684     $ (223 )   $ 461       7 – 15  

Customer Contracts

    625       (345 )     280       10  

Sensum+® License (from CRI)

    234       (142 )     92       10  

Vesele® Trademark

    25       (15 )     10       8  

Beyond Human® Website and Trade Name

    222       (131 )     91       5 – 10  

Novalere Manufacturing Contract

    4,681       (2,058 )     2,623       10  

Other Beyond Human® Intangible Assets

    5       (5 )     -       1 – 3  

Total

  $ 6,476     $ (2,919 )   $ 3,557          

 

 

   

December 31, 2018

 
   

Amount

   

Accumulated Amortization

   

Net Amount

   

Useful Lives (years)

 
                                 

Patent & Trademarks

  $ 654     $ (161 )   $ 493       7 – 15  

Customer Contracts

    625       (311 )     314       10  

Sensum+® License (from CRI)

    234       (131 )     103       10  

Vesele® Trademark

    25       (12 )     13       8  

Beyond Human® Website and Trade Name

    222       (112 )     110       5 – 10  

Novalere Manufacturing Contract

    4,681       (1,824 )     2,857       10  

Other Beyond Human® Intangible Assets

    5       (5 )     -       1 – 3  

Total

  $ 6,446     $ (2,556 )   $ 3,890          

 

Amortization expense for the three and six months ended June 30, 2019 and 2018 was $ 179,000  and $157,000 and $363,000 and $315,000, respectively. The following table summarizes the approximate expected future amortization expense as of June 30, 2019 for intangible assets:

 

Remainder of 2019

  $ 357  

2020

    714  

2021

    657  

2022

    614  

2023

    578  

Thereafter

    637  

Total Amortization Expense

  $ 3,557  

 

 

NOTE 6 – NOTES PAYABLE AND SHORT-TERM LOANS PAYABLE

 

Notes Payable

 

The following table summarizes the outstanding notes payable at June 30, 2019 and December 31, 2018:

 

   

2019

   

2018

 

Notes payable:

               

January and March 2018 Notes Payable

  $ -     $ 112  

February and March 2018 5% Notes Payable

    -       250  

July 2018 5% Notes Payable

    -       550  

August 2018 Notes Payable

    200       800  

September 2018 5% Notes Payable

    117       390  

October 2018 5% Notes Payable

    375       550  

November and December 2018 Notes Payable

    668       1,429  

March 2019 Note Payable

    375       -  
April 2019 Notes Payable     940       -  
May 2019 Note Payable     459       -  

Total notes payable

    3,134       4,081  

Less: Debt discount

    (813 )     (1,008 )

Carrying value

    2,321       3,073  

Less: Current portion

    (2,321 )     (3,073 )

Notes payable, net of current portion

  $ -     $ -  

 

The following table summarizes the future minimum payments as of June 30, 2019 for the notes payable:

 

Remainder of 2019

  $ 1,993  

2020

    1,141  
    $ 3,134  

 

March 2019 Note Payable

 

On March 27, 2019, we entered into a securities purchase agreement with an unrelated third-party investor in which the investor loaned us gross proceeds of $400,000 pursuant to a 0% promissory note ("March 2019 Note Payable"). The note has an Original Issue Discount ("OID") of $100,000 and requires payments of $47,000 in principal per month through March 2020.

 

In connection with the March 2019 Note Payable, we issued the investor restricted shares of common stock totaling 18,000 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the March 2019 Note Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $161,000 in March 2019. In connection with the financing, we issued 5,600 restricted shares of common stock in March 2019 to a third-party consultant. The fair value of the restricted shares of common stock issued of $28,000 was recorded as a debt discount to the carrying value of the notes payable. The discount is being amortized to interest expense using the effective interest method over the term of the March 2019 Note Payable.

 

 

April 2019 Notes Payable

 

On April 8, 2019, we entered into two securities purchase agreements with unrelated third-party investors in which the investors purchased 5% promissory notes, resulting in gross proceeds to us of $850,000 (“April 2019 Notes Payable”). The notes have an OID of $90,000 and require payment of principal and interest of $140,000 in October 2019, $704,000 in January 2020, and $132,000 in April 2020.

 

In connection with the April 2019 Notes Payable, we issued the investors restricted shares of common stock totaling 98,334 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the April 2019 Notes Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $318,000 in April 2019. The discount is being amortized to interest expense using the effective interest method over the term of the April 2019 Notes Payable.

 

October 2018 5% Notes Payable

 

In April 2019, the Company elected to settle a portion of the outstanding principal and interest balance of $175,000 due in connection with certain 5% promissory notes issued by the Company in October 2018 ("October 2018 5% Notes Payable") in exchange for 100,000 shares of common stock.  The fair value of the shares of common stock issued was based on the market price of the Company's common stock on the date of the securities exchange agreement and was determined to be $300,000.  Due to the settlement of the principal and interest balance of $175,000 into shares of common stock, the transaction was recorded as a debt extinguishment and the fair value of the shares of common stock issued in excess of the settled principal and interest balance totaling $125,000 was recorded as a loss on debt extinguishment in the accompanying condensed consolidated statement of operations.  

 

May 2019 Note Payable

 

On May 13, 2019, we entered into a securities purchase agreement with an unrelated third-party investor in which the investor loaned us gross proceeds of $400,000 pursuant to a 0% promissory note (“May 2019 Note Payable”). The note has an Original Issue Discount (“OID”) of $100,000 and requires payments of $42,000 in principal per month through May 2020.

 

In connection with the May 2019 Note Payable, we issued the investor restricted shares of common stock totaling 34,000 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the May 2019 Note Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $178,000 in May 2019. In connection with the financing, we issued 10,036 restricted shares of common stock in May 2019 to a third-party consultant. The fair value of the restricted shares of common stock issued of $28,000 was recorded as a debt discount to the carrying value of the notes payable. The discount is being amortized to interest expense using the effective interest method over the term of the May 2019 Note Payable.

 

Interest Expense

 

We recognized interest expense on notes payable of $18,000 and $21,000 and $35,000 and $34,000 for the three and six months ended June 30, 2019 and 2018, respectively. Amortization of the debt discount to interest expense during the three and six months ended June 30, 2019 and 2018 totaled $447,000 and $305,000 and $908,000 and $534,000, respectively.

 

 

NOTE 7 – STOCKHOLDERS’ EQUITY

 

Issuances of Common Stock

 

Private Placement

 

On January 3, 2019, we completed a sale of common stock and warrants under a Securities Purchase Agreement with an accredited investor (the "Investor"). The gross proceeds to us from the offering were $3.2 million before underwriting discounts and commissions and other offering expenses ($2.7 million of net proceeds after underwriting discounts, commissions and expenses of H.C. Wainwright & Co., LLC ("HCW"), the Company's sole placement agent).

 

Under the terms of the Securities Purchase Agreement, the Company completed the sale of common stock and warrants under a Securities Purchase Agreement with an accredited investor (the “Investor”), pursuant to which the Company sold an aggregate of 431,490 units (“Units”) for $7.35 per unit, with each Unit consisting of (i) one share of the Company’s common stock (“Shares”), (ii) one warrant to purchase one share of common stock at an exercise price of $7.35 per share (“Series A Warrant”), and (iii) one warrant to purchase one share of common stock at an exercise price of $8.40 per share (“Series B Warrant”) (the “Private Placement”); provided, however, that in order to ensure that the Investor’s beneficial ownership did not exceed 9.99% of the outstanding shares of Common Stock, the Investor elected to exercise its right to purchase 200,637 prefunded warrants (“Series C Warrants”) in lieu of the issuance of Shares to the Investor, which Series C Warrants have a nominal exercise price of $0.105 per share. In addition, the Company issued Series B Warrants to purchase 32,362 shares of common stock, an amount equal to 7.5% of the aggregate number of Shares, including Series C Warrants, sold in the Private Placement, at an exercise price of $9.19 per share to the designees of HCW, the Company’s sole placement agent, as compensation for its services in connection with the Private Placement. The fair value of the warrants issued to HCW totaled $221,000 and was determined using Black-Scholes. The fair value of the warrants was recorded as an offering cost but has no net impact to additional paid-in-capital in stockholders' equity in the accompanying consolidated balance sheet.

 

 

Other Stock Issuances and Related Stock-Based Compensation

 

In connection with the March 2019 Notes Payable, we issued 18,000 restricted shares of common stock in March 2019 and 5,600 restricted shares of common stock in March 2019 to a third-party consultant. The fair value of the restricted shares of common stock issued of $118,000 was recorded as a debt discount to the carrying value of the notes payable in March 2019 (see Note 6).

 

In April 2019, the Company entered into two securities purchase agreements relating to the April 2019 Notes Payable upon which the Company issued the investors 98,334 restricted shares of common stock.  The fair value of the restricted shares of common stock issued of $300,000 was recorded as a debt discount to the carrying value of the notes payable in April 2019 (see Note 6).

 

In May 2019, we entered into a securities purchase agreements relating to the May 2019 Note Payable upon which the Company issued the investors 34,000 restricted shares of common stock.  The fair value of the restricted shares of common stock issued of $93,000 was recorded as a debt discount to the carrying value of the notes payable in May 2019. In connection with the May 2019 Notes Payable, the Company also issued 10,036 restricted shares of common stock in May 2019 to a third-party consultant.  The fair value of the restricted share of common stock issued of $28,000 was recorded as a debt discount to the carrying value of the notes payable in May 2019 (see Note 6).

 

During the three and six months ended June 30, 2019, we issued 36,916 shares of restricted common stock for services and recorded an expense of $106,000 for the three and six months ended June 30, 2019, which is included in general and administrative expense in the accompanying condensed consolidated statement of operations. The 36,916 shares of common stock vested on the date of issuance and the fair value of the shares of common stock issued was based on the market price of our common stock on the date of vesting.

 

2013 Equity Incentive Plan

 

We have issued common stock, restricted stock units and stock option awards to employees, non-executive directors and outside consultants under the 2013 Equity Incentive Plan (“2013 Plan”), which was approved by our Board of Directors in February of 2013. The 2013 Plan allows for the issuance of up to 95,268 shares of our common stock to be issued in the form of stock options, stock awards, stock unit awards, stock appreciation rights, performance shares and other share-based awards. As of June 30, 2019, there were no shares available under the 2013 Plan.

 

2014 Equity Incentive Plan

 

We have issued common stock, restricted stock units and stock options to employees, non-executive directors and outside consultants under the 2014 Equity Incentive Plan (“2014 Plan”), which was approved by our Board of Directors in November 2014. The 2014 Plan allows for the issuance of up to 190,477 shares of our common stock to be issued in the form of stock options, stock awards, stock unit awards, stock appreciation rights, performance shares and other share-based awards. As of June 30, 2019, there were no shares available under the 2014 Plan.

 

2016 Equity Incentive Plan

 

On March 21, 2016, our Board of Directors approved the adoption of the 2016 Equity Incentive Plan and on October 20, 2016 adopted the Amended and Restated 2016 Equity Incentive Plan (“2016 Plan”). The 2016 Plan was then approved by our stockholders in November 2016. The 2016 Plan allows for the issuance of up to 190,477 shares of our common stock to be issued in the form of stock options, stock awards, stock unit awards, stock appreciation rights, performance shares and other share-based awards. The 2016 Plan includes an evergreen provision in which the number of shares of common stock authorized for issuance and available for future grants under the 2016 Plan will be increased each January 1 after the effective date of the 2016 Plan by a number of shares of common stock equal to the lesser of: (a) 4% of the number of shares of common stock issued and outstanding on a fully-diluted basis as of the close of business on the immediately preceding December 31, or (b) a number of shares of common stock set by our Board of Directors. In April 2019, our Board of Directors approved an increase of 84,051 shares of common stock to the shares authorized under the 2016 Plan in accordance with the evergreen provision in the 2016 Plan. As of June 30, 2019, 211,453  shares were available under the 2016 Plan.

 

2019 Equity Incentive Plan

 

On April 16, 2019, our Board of Directors approved the adoption of the 2019 Equity Incentive Plan (“2019 Plan”). The 2019 Plan was then approved by our stockholders in May 2019. The 2019 Plan allows for the issuance of up to 400,000 shares of our common stock to be issued in the form of stock options, stock awards, stock unit awards, stock appreciation rights, performance shares and other share-based awards. The 2019 Plan includes an evergreen provision in which the number of shares of common stock authorized for issuance and available for future grants under the 2019 Plan will be increased each January 1 after the effective date of the 2019 Plan by a number of shares of common stock equal to the lesser of: (a) 4% of the number of shares of common stock issued and outstanding on a fully-diluted basis as of the close of business on the immediately preceding December 31, or (b) a number of shares of common stock set by our Board of Directors. As of June 30, 2019, 400,000 shares were available under the 2019 Plan.

 

 

Stock Options

 

For the six months ended June 30, 2019 and 2018, the following weighted average assumptions were utilized for the calculation of the fair value of the stock options granted during the period using Black-Scholes:

 

   

2019

   

2018

 

Expected life (in years)

    3.7       6.25  

Expected volatility

    198.7 %     201.3 %

Average risk-free interest rate

    2.82 %     2.79 %

Dividend yield

    0 %     0 %

Grant date fair value

  $ 3.51     $ 0.06  

 

The dividend yield of zero is based on the fact that we have never paid cash dividends and have no present intention to pay cash dividends. Expected volatility is based on the historical volatility of our common stock over the period commensurate with the expected life of the stock options. Expected life in years is based on the “simplified” method as permitted by ASC Topic 718. We believe that all stock options issued under its stock option plans meet the criteria of “plain vanilla” stock options. We use a term equal to the term of the stock options for all non-employee stock options. The risk-free interest rate is based on average rates for treasury notes as published by the Federal Reserve in which the term of the rate corresponds to the expected term of the stock options.

 

The following table summarizes the number of stock options outstanding and the weighted average exercise price:

 

   

Options

   

Weighted average exercise price

   

Weighted remaining contractual life (years)

   

Aggregate intrinsic value

 

Outstanding at December 31, 2018

    4,498     $ 14.63       9.2     $ 190  

Granted

    174       3.71       -       -  

Exercised

    -       -       -       -  

Cancelled

    (1,099 )     (14.96 )     -       -  

Forfeited

    -       -       -       -  

Outstanding at June 30, 2019

    3,573     $ 14.00       8.8     $ -  
                                 

Vested and Expected to Vest at June 30, 2019

    3,573     $ 14.00       8.8     $ -  

 

The aggregate intrinsic value is calculated as the difference between the exercise price of all outstanding stock options and the quoted price of our common stock at June 30, 2019.  During the three and six months ended June 30, 2019 and 2018, we recognized stock-based compensation from stock options of $ 2,000  and $1,000 and $ 5,000  and $4,000 , respectively. As of June 30, 2019, compensation expense related to unvested options not yet recognized in the condensed consolidated statement of operations was approximately $ 50,000  and will be recognized over a remaining weighted-average term of 8.8  years.

 

Restricted Stock Units

 

The following table summarizes the restricted stock unit activity for the three months ended June 30, 2019:

 

   

Restricted Stock Units

 

Outstanding at December 31, 2018

    175,765  

Granted

    13,007  

Exchanged

    -  

Cancelled

    -  

Outstanding at June 30, 2019

    188,772  
         

Vested at June 30, 2019

    131,651  

 

The vested restricted stock units at June 30, 2019 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 us, or (iii) 10 years from date of issuance. Settlement of vested restricted stock units may be made in the form of (i) cash, (ii) shares, or (iii) any combination of both, as determined by the board of directors and is subject to certain criteria having been fulfilled by the recipient.

 

We calculate the fair value of the restricted stock units based upon the quoted market value of the common stock at the date of grant. The grant date fair value of restricted stock units issued during the three and six months ended June 30, 2019 was $24,000 and $84,000, respectively. For the three and six months ended June 30, 2019 and 2018, we recognized $135,000 and $105,000 and $270,000 and $197,000 , respectively, of stock-based compensation expense for the vested units. As of June 30, 2019, compensation expense related to unvested shares not yet recognized in the condensed consolidated statement of operations was approximately $ 636,000  and will be recognized over a remaining weighted-average term of 1.8  years.

 

 

Warrants

 

In January 2015, we issued 2,381 warrants with an exercise price of $31.50 per share to a former executive in connection with the January 2015 debenture. The warrants expire on January 21, 2020. The warrants contain anti-dilution protection, including protection upon dilutive issuances. In connection with the convertible debentures issued in 2015, the exercise price of these warrants was reduced to $9.45 per share and an additional 5,588 warrants were issued per the anti-dilution protection afforded in the warrant agreement during the year ended December 31, 2015. Warrants to purchase 7,969 shares of common stock remain outstanding as of June 30, 2019.

 

In connection with the convertible debentures in 2015, we issued warrants with an exercise price of $31.50 per share and expiration in 2020 to investors and placement agents. Warrants to purchase 7,379 shares of common stock remain outstanding as of June 30, 2019.

 

In connection with the convertible debentures in 2016, we issued warrants to the investors and placement agents with an exercise price of $42.00 per share and expire in 2021. Warrants to purchase 40,201 shares of common stock remain outstanding as of June 30, 2019.

 

In connection with the public equity offering in March 2017, we issued Series A Warrants to purchase 244,455 shares of common stock at $15.75 per share and Series B Warrants to purchase 244,455 shares of common stock at $15.75 per share. The Series A Warrants expire in 2022. During 2018, certain investors elected to exercise 180,247 Series B Warrants and 953 Series A Warrants and the remaining Series B Warrants expired in March 2018. We also issued warrants to purchase 12,223 shares of common stock to our placement agent with an exercise price of $19.69 per share and expire in 2022, as well as in March 2018 we issued our placement agent warrants to purchase 8,219 shares of common stock with an exercise price of $19.69 per share and expire in 2023 in connection with the Series B Warrants exercised. Warrants to purchase 263,944 shares of common stock remain outstanding as of June 30, 2019.

 

In connection with the public equity offering in January 2019, we issued Series A Warrants to purchase 431,490 shares of common stock at $7.35 per share, Series B Warrants to purchase 431,490 shares of common stock at $8.40 per share and Series C Warrants to purchase 200,637 shares of common stock at $7.35 per share. The Series A and B Warrants expire in 2020 and 2024 respectively. The Series C Warrants were prefunded and have a nominal exercise price of $0.105 per share. We also issued warrants to purchase 32,362 shares of common stock to our placement agent with an exercise price of $9.19 per share and expire in 2024. Warrants to purchase 1,095,979 shares of common stock remain outstanding as of June 30, 2019.

 

For the six months ended June 30, 2019, the following weighted average assumptions were utilized for the calculation of the fair value of the warrants issued during the period using Black-Scholes:

 

   

2019

 

Expected life (in years)

    3.9  

Expected volatility

    147.1 %

Average risk-free interest rate

    2.40 %

Dividend yield

    0 %

 

At June 30, 2019, there are 1,415,472 fully vested warrants outstanding. The weighted average exercise price of outstanding warrants at June 30, 2019 is $10.46 per share, the weighted average remaining contractual term is 3.25 years and the aggregate intrinsic value of the outstanding warrants is $284,000.

 

Net Loss per Share

 

Restricted stock units that are vested but which the issuance and delivery of the shares are deferred until the employee or director resigns are included in the basic and diluted net loss per share calculations.

 

The weighted average shares of common stock outstanding used in the basic and diluted net loss per share calculation for the three and six months ended June 30, 2019 and 2018 was 2,536,530 and 1,851,910 and 2,432,338 and 1,768,635, respectively.

 

The weighted average restricted stock units vested but which 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 which were used in the basic and diluted net loss per share calculation for the three and six months ended June 30, 2019 and 2018 was 123,905 and 101,490 and 120,874 and 98,703, respectively.

 

The following table shows the anti-dilutive shares excluded from the calculation of basic and diluted net loss per common share as of June 30, 2019 and 2018: 

 

   

As of June 30,

 
   

2019

   

2018

 

Gross number of shares excluded:

               

Restricted stock units – unvested

    57,121       65,366  

Stock options

    3,573       2,591  

Warrants

    1,415,472       313,496  

Total

    1,476,166       381,453  

 

 

 

NOTE 8 – COMMITMENTS AND CONTINGENCIES

 

In May 2017, we entered into a commercial agreement with WWPIL, a wholly-owned subsidiary of Hikma Pharmaceuticals PLC (“Hikma”) (LSE: HIK) (NASDAQ Dubai: HIK) (OTC: HKMPY). Pursuant to the commercial agreement, WWPIL provided us with the rights to launch our branded, fluticasone propionate nasal spray USP, 50 mcg per spray (FlutiCare®), under WWPIL’s FDA approved ANDA No. 207957 in the U.S. in mid-November 2017. The initial term of the commercial agreement is for two years, and upon expiration of the initial term, the agreement will automatically renew for subsequent one-year terms unless either party notifies the other party in writing of its desire not to renew at least 90 days prior to the end of the then current term. The agreement requires us to meet certain minimum product batch purchase requirements in order for the agreement to continue to be in effect. We have met the minimum product batch purchase requirements through August 2019.

 

Leases

 

We lease approximately 172,000 square feet of office and warehouse facilities under a non-cancellable operating lease. Our lease has a remaining term of 4 years, which represents the non-cancellable periods of the lease. We exclude extension options that are not reasonably certain to be exercised from our lease terms. Our lease payment consists of fixed rental payments for the right to use the underlying assets over the lease term as well as payments for common-area-maintenance and administrative services. We have also received customary incentives from our landlord for tenant improvements and rent abatement periods, which effectively reduce the total lease payments owed for the lease.

 

Operating lease right-of-use assets and liabilities on our condensed consolidated balance sheets represent the present value of our remaining lease payments over the remaining lease terms. We do not allocate lease payments to non-lease components; therefore, fixed payments for common-area-maintenance and administrative services are included in our operating lease right-of-use assets and liabilities. We use our incremental borrowing rate to calculate the present value of our lease payments, as the implicit rates in our lease is not readily determinable.

 

As of June 30, 2019, the maturities of our operating lease were as follows (in thousands):

 

 

Remaining Lease Payments

2019

$ 130

2020

267

2021

274

2022

282

2023 94

Total remaining lease payments

1,047

Less: imputed interest

(258)

Total operating lease liabilities

789

Less: current portion

(155)

Long-term operating lease liabilities

634

Weighted-average remaining lease term

4 years

Weighted-average discount rate

15%

 

 

The components of our lease costs included in our condensed consolidated statement of operations consist of operating lease costs of $ 115,000 . Operating lease costs consist of the fixed lease payments included in our operating lease liability and are recorded on a straight-line basis over the lease term.

 

Litigation

 

James L. Yeager, Ph.D., and Midwest Research Laboratories, LLC v. lnnovus Pharmaceuticals, Inc. On January 18, 2018, Dr. Yeager and Midwest Research Laboratories (the "Plaintiffs") filed a complaint in the Illinois Northern District Court in Chicago, Illinois, which Plaintiffs amended on February 26, 2018 ("Amended Complaint''). The Amended Complaint alleges that the Company violated Dr. Yeager's right of publicity and made unauthorized use of his name, likeness and identity in advertising materials for its product Sensum+®. Plaintiffs seek actual and punitive damages, costs and attorney's fees, an injunction and corrective advertising. In October 2018, we filed a motion to dismiss the action. In February 2019, the Judge in the Illinois action issued a ruling invalidating some of Plaintiff’s causes of action, while accepting others and the case continues in that jurisdiction. The parties are currently engaged in discovery.

 

We believe that the Plaintiffs’ allegations and claims are wholly without merit, and we intend to defend the case vigorously and assert counterclaims against the Plaintiffs.  More specifically, we believe that we secured and paid for all of the rights claimed by Dr. Yeager from his company Centric Research Institute (“CRI”) pursuant to agreements with CRI (the “CRI Agreements”) and that CRI has indemnification obligations under the CRI Agreements for all expenses and losses associated with the claims made by the Plaintiffs.

 

On January 23, 2019 we filed a complaint in the U.S. Federal District Court for the Southern District located in San Diego, California against Dr. Yeager, Servet Buyuktimken and Nadir Buyuktimkin (the “021 Patent Claimed Inventors”), who are all the inventors names on the US issued patent number 9,821,021 entitled Sensitization Composition and Methods of Action (the “021 Patent”), for copyright infringement relating to a clinical study table (the “Innovus Pharm Clinical Study Table”) included in the 021 Patent. We claim that the 021 Patent Claimed Inventors illegally stole and used the Innovus Pharm Clinical Study Table and the suit requests certain damages and injunctive relief described therein.

 

Marin County District Attorney s Letter . On August 24, 2018, the Company received a letter from the Marin County District Attorney's Office requesting substantiation for certain advertising claims made for certain of the Company's products, DiabaSens®, and Apeaz® that were marketed and sold to customers in that County. The Marin County District Attorney's Office is part of a larger ten county Northern California Task Force of district attorneys to handle customer protection matters. In November 2018, the Company responded through its regulatory attorneys to the Marin County’s District Attorney’s letter. In March 2019, the Company heard back from the Marin County District Attorney.  In April 2019, the Company responded to the letter and in June 2019 the Company met with the Northern California Task Force. The Company is currently responding to additional due diligence requests from the Marin County District Attorney's office.

 

In the ordinary course of business, we may face various claims brought by third parties and we may, from time to time, make claims or take legal actions to assert our rights, including intellectual property disputes, contractual disputes and other commercial disputes. Any of these claims could subject us to litigation. Management believes the outcomes of currently pending claims are not likely to have a material effect on our consolidated financial position and results of operations.

 

 

 

NOTE 9 – SUBSEQUENT EVENTS

 

In July 2019, the Company issued 26,000 shares of common stock to two vendors in exchange for services rendered.

 

In July 2019, the Company entered into an Amendment to the Promissory Note Agreement relating to the October 2018 5% Note Payable to extend the maturity date to October 1, 2019 in exchange for the future issuance of 60,000 restricted shares of common stock.

 

On August 8, 2019, the Company entered into a non-secured promissory note agreement with an unrelated investor in which the investor loaned the Company gross proceeds of $1 million in consideration for the issuance of a 10% promissory note.  The note requires repayment of principal by February 29, 2020.

 

The Company has evaluated subsequent events through the filing date of this Form 10-Q and determined that no additional subsequent events have occurred that would require recognition in the condensed consolidated financial statements or disclosures in the notes thereto other than as disclosed in the accompanying notes to the condensed consolidated financial statements.

 

 

ITEM 2.

MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

Innovus Pharmaceuticals, Inc., together with its subsidiaries, are collectively referred to as “Innovus,” the “Company,” “us,” “we,” or “our.” The following information should be read in conjunction with the condensed consolidated financial statements and notes thereto appearing elsewhere in this report. For additional context with which to understand our financial condition and results of operations, see the discussion and analysis included in Part II, Item 7 of our Annual Report on Form 10-K for the year ended December 31, 2018, filed with the Securities and Exchange Commission (“SEC”) on April 1, 2019, as well as the consolidated financial statements and related notes contained therein.

 

 

Forward Looking Statements

 

Certain statements in this report, including information incorporated by reference, are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements reflect current views about future events and financial performance based on certain assumptions. They include opinions, forecasts, intentions, plans, goals, projections, guidance, expectations, beliefs or other statements that are not statements of historical fact. Words such as “may,” “should,” “could,” “would,” “expects,” “plans,” “believes,” “anticipates,” “intends,” “estimates,” “approximates,” “predicts,” or “projects,” or the negative or other variation of such words, and similar expressions may identify a statement as a forward-looking statement. Any statements that refer to projections of our future financial performance, our anticipated growth and trends in our business, our goals, strategies, focus and plans, and other characterizations of future events or circumstances, including statements expressing general optimism about future operating results and the development of our products, are forward-looking statements.

 

Although forward-looking statements in this Quarterly Report on Form 10-Q reflect the good faith judgment of our management, such statements can only be based on facts and factors currently known by us. Consequently, forward-looking statements are inherently subject to risks and uncertainties and actual results and outcomes may differ materially from the results and outcomes discussed in or anticipated by the forward-looking statements. Factors that could cause or contribute to such differences in results and outcomes include, without limitation, those specifically addressed under the heading “Risks Factors” below, as well as those discussed elsewhere in this Quarterly Report on Form 10-Q. Readers are urged not to place undue reliance on these forward-looking statements, which speak only as of the date of this Quarterly Report on Form 10-Q. We file reports with the SEC. You can read and copy any materials we file with the SEC at the SEC’s Public Reference Room at 100 F Street, NE, Washington, DC 20549. You can obtain additional information about the operation of the Public Reference Room by calling the SEC at 1-800-SEC-0330. In addition, the SEC maintains an Internet site (www.sec.gov) that contains reports, proxy and information statements, and other information regarding issuers that file electronically with the SEC, including us.

 

Overview

 

We are an emerging over-the-counter (“OTC”) consumer goods and specialty pharmaceutical company engaged in the commercialization, licensing and development of safe and effective non-prescription medicine, consumer care products, supplements and certain related devices to improve men’s and women’s health and vitality, urology, brain health, pain and respiratory diseases. We deliver innovative and uniquely presented and packaged health solutions through our (a) OTC medicines, devices, consumer and health products, and clinical supplements, which we market directly, (b) commercial retail and wholesale partners to primary care physicians, urologists, gynecologists and therapists, and (c) directly to consumers through our proprietary Beyond Human™ Sales & Marketing Platform including print media, on-line channels, websites, retailers and wholesalers. We are dedicated to being a leader in developing and marketing new OTC and branded Abbreviated New Drug Application (“ANDA”) products, supplements and certain related devices. We are actively pursuing opportunities where existing prescription drugs have recently, or are expected to, change from prescription (or Rx) to OTC. These “Rx-to-OTC switches” require Food and Drug Administration (“FDA”) approval through a process initiated by the New Drug Application (“NDA”) holder.

 

Our business model leverages our ability to (a) develop and build our current pipeline of proprietary products, and (b) to also acquire outright or in-license commercial products that are supported by scientific and/or clinical evidence, place them through our existing supply chain, retail and on-line (including our Amazon®, eBay®, Wish.com®, Sears.com®, Walmart.com®, and Walgreens.com® on-line stores and other e-commerce business platforms) channels to tap new markets and drive demand for such products and to establish physician relationships. 

 

 

Our Strategy

 

Our corporate strategy focuses on the following primary objectives:

 

1.

Developing a diversified product portfolio of exclusive, unique and patented non-prescription OTC and branded ANDA drugs, devices, consumer health products, and clinical supplements through: (a) the introduction of line extensions and reformulations of either our or third-party currently marketed products; (b) the development of new proprietary OTC products, supplements and devices; and (c) the acquisition of products or obtaining exclusive licensing rights to market such products; 

 

2. Building an innovative, U.S. and global sales and marketing model through direct to consumer approaches such as our proprietary Beyond Human® sales and marketing platform, the addition of new online platforms such as Amazon®, eBay®, Wish.com, Sears.com, Walmart.com® and Walgreens.com and commercial partnerships with established international complementary partners that: (a) generates revenue, and (b) requires a lower cost structure compared to traditional pharmaceutical companies, thereby increasing our gross margins; and

 

3.

Developing and acquiring on-line marketplaces such as Supplementhunt.com and Primesavingsclub.com that focus on certain market segments such as lower priced, soon to expire supplement business with the Supplementhunt.com acquisition and with the select consumer product business through Primesavingsclub.com among others in which we sell third party, brand or non-branded products.

 

Our Products

 

Marketed Products

 

We currently market and sell over 35 products in the U.S. and more than 10 in multiple countries around the world through our 12 international commercial partners. The following represents the core products:

 

 

1.

Vesele® 

 

2.

UriVarx® 

 

3.

FlutiCare® 

 

4.

Apeaz® 

 

5.

Diabasens® 

 

6.

Prostagorx® 

 

7.

Sensum+® 

 

In addition, we currently expect to launch in the U.S. the following products in 2019 and/or 2020, subject to the applicable regulatory approvals, if required:

 

 

1.

Trexar  is a supplement that provides neuropathy support and enhanced sensation (third quarter of 2019); 

 

2.

Musclin® is a proprietary supplement made of two FDA Generally Recognized As Safe (GRAS) approved ingredients designed to increase muscle mass, endurance and activity (second half of 2019).  The main ingredient in Musclin® is a natural activator of the transient receptor potential cation channel, subfamily V, member 3 (TRPV3) channels on muscle fibers responsible to increase fibers width resulting in larger muscles;

 

3.

Regenerum™ is a proprietary product containing two natural molecules: the first is an activator of the TRPV3 channels resulting in the increase of muscle fiber width, and the second targets a different unknown receptor to build the muscle's capacity for energy production and increases physical endurance, allowing longer and more intense exercise.  Regenerum™ is being developed for patients suffering from muscle wasting.  We currently expect to launch this product in 2020 pending successful clinical trials in patients with muscle wasting or cachexia; 

 

4.

Octiq™ is an expected FDA ophthalmic OTC monograph compliant product for the treatment of eye redness and eye lubrication (late 2019/early 2020); and

  5. Regoxidine™ is an ANDA approved 5% Minoxidil foam for men and women for hair growth on the top of the scalp (second half 2019).

 

We currently expect potential supply interruption of Fluticare from its supplier for the coming 90-180 days based on inventory availability.

 

 

Sales and Marketing Channels

 

Print and Direct Mail Marketing

 

Through our Beyond Human ® sales and marketing platform, we have access to advertise in the vast majority of newspapers and magazines on a regular basis. We have developed our own proprietary algorithm which allows us to target customers looking for specific health products allowing us to increase the return on our investment and reduce the cost to acquire new customers. We have expanded our reach to Canada with the approval of twelve of our products by Health Canada and successfully expanded our Beyond Human ® sales and marketing platform.

 

E-Commerce

 

We have an extensive on-line media channel through our Amazon®, NewEgg®, Walmart.com®, eBay®, Wish.com®, and Walgreens.com® sites, in addition to our own InnovusPharma.com site along with sites for each of our products individually.  Our expertise allows us to successfully drive product sales through proper marketing campaigns through third-party sites as well as through email marketing campaigns to increase traffic to our own sites. Additionally, we have recognized that maintaining a proper e-commerce presence allows those customers who read our advertisements in the newspapers and magazine or receive our direct mail another avenue to purchase products.

 

Retail/Wholesale

 

We are continuously introducing our products to varieties of retail and wholesale partners to enhance the brand and product awareness for our customers. Since 2018, we significantly increased our advertising expenses specifically in the Print and Direct Mail Marketing channel which, in turn, has had a direct positive impact to the success of products in retail.  We intend to continue to demonstrate to our retail and wholesale partners the advantages of incorporating our products in their stores, especially due to our proprietary consumer targeted marketing approach that our print advertising allows us to achieve.

 

International Distribution

 

We continue to work with our exclusive commercial partners outside of the U.S. that would be responsible for sales and marketing in those territories. We evaluate the performance of each of these partners to ensure a steady flow of consumer activity for each of our products. Our strategy outside the U.S. is to partner with companies who can effectively market and sell our products in their countries through their direct marketing and sales teams. The strategy of using our partners to commercialize our products is designed to limit our expenses and fix our cost structure, enabling us to increase our reach while minimizing our incremental spending.

 

Results of Operations for the Three and Six Months Ended June 30, 2019 Compared with the Three and Six Months Ended June 30, 2018

 

   

Three Months Ended June 30, 2019

   

Three Months Ended June 30, 2018

   

$ Increase (Decrease)

   

% Increase (Decrease)

 

Net revenue:

                       

Product sales, net

 

$ 6,594

   

$ 6,970

   

$ (376)

   

(5.4)

%

Service revenue

 

56

   

156

   

(100)

   

64.1

%

Cooperative marketing revenue

 

91

   

183

   

(92)

   

50.3

%

License revenue

 

107

   

3

   

-

   

-

%

Net revenue

 

6,848

   

7,312

   

(464)

   

(6.3)

%

                         

Cost of product sales

 

2,356

   

1,339

   

1,017

   

76.0

%

Gross Profit

 

4,492

   

5,973

   

(1,481)

   

(24.8)

%

                         

Operating expense:

                       

Research and development

 

91

   

23

   

68

   

295.7

%

Sales and marketing

 

2,858

   

5,529

   

(2,671)

   

(48.3)

%

General and administrative

 

2,724

   

1,919

   

805

   

41.9

%

Total operating expense

 

5,673

   

7,471

   

(1,798)

   

(24.1)

%

                         

Loss from operations

 

(1,181)

   

(1,498)

   

317

   

21.2

%

                         

Other income (expense):

                       

Interest expense

 

(486)

   

(326)

   

(160)

   

(49.1)

%

Loss on extinguishment of debt

 

(125)

   

(38)

   

(87)

   

(228.9)

%

Other income (expense), net

 

29

   

-

   

29

   

(100.0)

%

Fair value adjustment for contingent consideration

 

4

   

22

   

(18)

   

81.8

%

Total other expense, net

 

(578)

   

(342)

   

(236)

   

(69.0)

%

                         

Net loss

 

$ (1,759)

   

$ (1,840)

   

$ 81

   

4.4

%

 

 

   

Six Months Ended June 30, 2019

   

Six Months Ended June 30, 2018

   

$ Increase (Decrease)

   

% Increase (Decrease)

 

Net revenue:

                       

Product sales, net

 

$ 11,783

   

$ 11,512

   

$ 271

   

2.4

%

Service revenue

 

156

   

$ 156

   

-

   

-

%

Cooperative marketing revenue

 

162

   

$ 184

   

(22)

   

12.0

%

License revenue

 

110

   

$ 5

   

-

   

-

%

Net revenue

 

12,211

   

11,857

   

354

   

3.0

%

                         

Cost of product sales

 

4,134

   

2,203

   

1,931

   

87.7

%

Gross Profit

 

8,077

   

9,654

   

(1,577)

   

(16.3)

%

                         

Operating expense:

                       

Research and development

 

148

   

34

   

114

   

335.3

%

Sales and marketing

 

5,453

   

8,831

   

(3,378)

   

(38.3)

%

General and administrative

 

5,158

   

3,615

   

1,543

   

42.7

%

Total operating expense

 

10,759

   

12,480

   

(1,721)

   

(13.8)

%

                         

Loss from operations

 

(2,682)

   

(2,826)

   

144

   

5.1

%

                         

Other income (expense):

                       

Interest expense

 

(976)

   

(568)

   

(408)

   

(71.8)

%

Loss on extinguishment of debt

 

(125)

   

(294)

   

169

   

57.5

%

Other income (expense), net

 

29

   

-

   

29

   

(100.0)

%

Fair value adjustment for contingent consideration

 

6

   

19

   

(13)

   

68.4

%

Total other expense, net

 

(1,066)

   

(843)

   

(223)

   

(26.5)

%

                         

Net loss

 

$ (3,748)

   

$ (3,669)

   

$ (79)

   

(2.2)

%

 


Net Revenue  

 

We recognized net revenue of approximately $6.8 million and $7.3 million and $12.2 million and $11.9 million for the three and six months ended June 30, 2019 and 2018, respectively. The decrease in net revenue for the three months ended June 30, 2019 compared with the three months ended June 30, 2018 is due to our focus on being more selective of the marketing media utilized which has reduced the overall net sales but has resulted in improved marketing efficiency for the period. The increase in net revenue for the six months ended June 30, 2019 compared with the six months ended June 30, 2018 was primarily the result of the addition of the Supplement Hunt and Prime Savings Club platforms, which were acquired in December 2018 and January 2019, respectively. During 2019, we focused on increasing revenues from e-commerce channels to continue to diversify our revenue channels.  During 2019, e-commerce sales represented approximately 30% of total net revenue.  During the three and six months ended June 30, 2019 and 2018, we shipped 201,164 and 165,116 units and 364,855 and 248,989 units of our core products, respectively.

 

Cost of Product Sales

 

We recognized cost of product sales of approximately $2.4 million and $1.3 million and $4.1 million and $2.2 million for the three and six months ended June 30, 2019 and 2018, respectively. The cost of product sales includes the cost of inventory, internal and third-party shipping and warehouse costs, royalties and salaries and benefits for our warehouse employees. The increase in cost of product sales is a result of higher shipping and fulfillment costs relating to our Supplement Hunt entity, for which we currently utilize the services of a third-party fulfillment company, and higher costs of products in the Prime Savings Club entity due to a more diverse product mix. The decrease in the gross margin to 66.1% in 2019 compared to 81.4% in 2018 is due to the increase in e-commerce revenues as a percentage of total revenues during the current period, which generate lower gross margins due to pricing competition, as well as an increase in the cost of shipping and fulfillment especially related to Supplement Hunt and Prime Savings Club, which have products that are costlier to ship due to their size and weight.

 

Research and Development

 

We recognized research and development expense of approximately $91,000 and $23,000 and $148,000 and $34,000 for the three and six months ended June 30, 2019 and 2018, respectively. Research and development expense includes costs for stability testing, clinical trials of certain products and other development related costs for our products.

 

Sales and Marketing

 

We recognized sales and marketing expense of approximately $2.9 million and $5.5 million and $5.5 million and $8.8 million for the three and six months ended June 30, 2019 and 2018, respectively. Sales and marketing expense consists primarily of print advertisements and sales and marketing support. The decrease in the sales and marketing expense is a direct result of the increased focus on e-commerce channels which do not require as large of upfront marketing costs as the traditional direct-to-consumer channel requires. Additionally, we have focused marketing efforts in the traditional direct-to-consumer channel to those that have experienced lower cost of customer acquisition. 

 

General and Administrative

 

We recognized general and administrative expense of approximately $2.7 million and $1.9 million and $5.2 million and $3.6 million for the three and six months ended June 30, 2019 and 2018, respectively. The increase in general and administrative expense is directly related to the increase in employee headcount, especially management level employees, from approximately ten employees as of June 30, 2018 to 21 employees as of June 30, 2019.  General and administrative expense consists primarily of investor relation expense, legal, accounting, public reporting costs and other infrastructure expense related to the launch of our products. Additionally, our general and administrative expense includes professional fees, insurance premiums and general corporate expense.

 

 

Other Income and Expense

 

We recognized interest expense of approximately $486,000 and $326,000 and $976,000 and $568,000 for the three and six months ended June 30, 2019 and 2018, respectively. Interest expense primarily includes interest related to our debt and amortization of debt discounts (see Note 6 to the accompanying condensed consolidated financial statements). Due to the shares and cash discounts provided to our lenders, the effective interest rate is significantly higher than the coupon rate. The increase in interest expense in 2019 is due to the larger amount of debt discount amortization in 2019 compared to 2018 as a result of the note payable financings completed in both 2018 and 2019.

 

We recognized a loss on extinguishment of debt of approximately $125,000 and $38,000 and $125,000 and $294,000 during the three and six months ended June 30, 2019 and 2018, respectively . The loss on debt extinguishment in 2019 was the result of securities exchange agreement entered in with a note holder in May 2019. In exchange for the issuance of 100,000 shares of common stock with a fair value of $300,000, we settled a principal and interest balance of $175,000 with the note holder. The loss on debt extinguishment in 2018 was the result of the securities exchange agreement entered into with certain note payable holders. In exchange for the issuance of 35,470 shares of common stock with a fair value of approximately $581,000, we settled the principal balance totaling $332,000 with the noteholders. The remaining loss on debt extinguishment was the write off of the remaining unamortized debt discount as of the date of settlement.

 

Net Loss

 

Net loss for the three and six months ended June 30, 2019 was approximately $1.8 million or $0.66 basic and diluted net loss per share and $3.7 million or $1.47 basic and diluted net loss per share, respectively, compared to a net loss of $1.8 million or $0.94 basic and diluted net loss per share and $3.7 million or $1.96 basic and diluted net loss per share for the three and six months ended June 30, 2018, respectively.

 

Liquidity and Capital Resources

 

Historically, we have funded losses from operations through the sale of equity and issuance of debt instruments. Combined with revenue, these funds have provided us with the capital to operate our business, to sell and support our products, attract and retain key personnel, and add new products to our portfolio. To date, we have experienced net losses each year since our inception. As of June 30, 2019, we had an accumulated deficit of $47.6 million and working capital deficit of $2.4 million.

 

As of June 30, 2019, we had approximately $1.6 m illion in cash and $0.7 million held by merchant processors reported in other current assets for a total of $2.3 million and as of August 9, 2019 we had approximately $1.6 million in cash and $0.5  million held by merchant processors for a total of $2.1  million. Although no assurances can be given, we currently plan to raise additional capital through the sale of equity or debt securities. We expect, however, that our existing capital resources, revenue from sales of our products and upcoming new product launches and sales milestone payments from the commercial partners signed for our products, and equity instruments available to pay certain vendors and consultants, will be sufficient to allow us to continue our operations, commence the product development process and launch selected products through at least the next 12 months. In addition, our CEO, who is also a significant shareholder, has deferred the remaining payment of his salary earned through June 30, 2016 totaling $1.0 million for at least the next 12 months if such receipt would jeopardize the ability of the Company to operate.

Our actual needs will depend on numerous factors, including timing of introducing our new products to the marketplace, our ability to attract additional Ex-U.S. distributors for our products and our ability to in-license in non-partnered territories and/or develop new product candidates. In addition, we continue to seek new licensing agreements from third-party vendors to commercialize our products in territories outside the U.S., which could result in upfront, milestone, royalty and/or other payments.

We currently intend to raise additional capital through the sale of debt or equity securities to provide additional working capital, for further expansion and development of our business, and to meet current obligations, although no assurances can be given. If we issue equity or convertible debt securities to raise additional funds, our existing stockholders may experience substantial dilution, and the newly issued equity or debt securities may have more favorable terms or rights, preferences and privileges senior to those of our existing stockholders. If we raise funds by incurring additional debt, we may be required to pay significant interest expense and our leverage relative to our earnings or to our equity capitalization may increase. Obtaining commercial loans, assuming they would be available, would increase our liabilities and future cash commitments and may impose restrictions on our activities, such as financial and operating covenants. Further, we may incur substantial costs in pursuing future capital and/or financing transactions, including investment banking fees, legal fees, accounting fees, printing and distribution expense and other costs. We may also be required to recognize non-cash expense in connection with certain securities we may issue, such as convertible notes and warrants, which would adversely impact our financial results. We may be unable to obtain financing when necessary as a result of, among other things, our performance, general economic conditions, conditions in the pharmaceuticals industries, or our operating history. In addition, the fact that we are not and have never been profitable could further impact the availability or cost to us of future financings. As a result, sufficient funds may not be available when needed from any source or, if available, such funds may not be available on terms that are acceptable to us. If we are unable to raise funds to satisfy our capital needs when needed, then we may need to forego pursuit of potentially valuable development or acquisition opportunities, we may not be able to continue to operate our business pursuant to our business plan, which would require us to modify our operations to reduce spending to a sustainable level by, among other things, delaying, scaling back or eliminating some or all of our ongoing or planned investments in corporate infrastructure, business development, sales and marketing and other activities, or we may be forced to discontinue our operations entirely.

 

The Company’s principle debt instruments include the following:

 

August 2018 Notes Payable

 

In August 2018, we entered into securities purchase agreements with two unrelated third-party investors, pursuant to which the investors loaned us gross proceeds of $1,000,000 pursuant to 0% promissory notes (“August 2018 Notes Payable”). The August 2018 Notes Payable have an OID of $200,000 and require twelve payments of $100,000 in principal per month through August 2019. The August 2018 Notes Payable bear no interest per annum. In connection with the August 2018 Notes Payable, we issued the investors restricted shares of common stock totaling 1,000,000 shares. The remaining principal balance under these notes was $200,000 at June 30, 2019.

 

 

September 2018 5% Notes Payable

 

In September 2018, we entered into a promissory note agreement and a securities purchase agreement with an unrelated third-party investor, pursuant to which the investor loaned us gross proceeds of $350,000 pursuant to 5% promissory notes (“September 2018 5% Notes Payable”). The September 2018 5% Notes Payable have an OID of $40,000 and require aggregate payments of $390,000 in principal. The September 2018 5% Notes Payable bear interest at the rate of 5% per annum and the principal amount and accrued interest are payable in three installments on March 12, 2019, June 12, 2019 and September 12, 2019. In connection with the September 2018 5% Notes Payable, we issued the investor restricted shares of common stock totaling 1,000,000. The remaining principal balance under these notes was $117,000 at June 30, 2019.

 

October 2018 5% Notes Payable

 

On October 22, 2018, the Company entered into a promissory note agreement and securities purchase agreement with an unrelated third-party investor in which the investor loaned the Company gross proceeds of $500,000 pursuant to 5% promissory notes (“October 2018 5% Notes Payable”). The notes have an OID of $50,000 and require payments of $550,000 in principal. The notes bear interest at the rate of 5% per annum and the principal amount and interest are payable at maturity on May 1, 2019. In connection with the October 2018 5% Notes Payable, the Company issued the investor restricted shares of common stock totaling 15,239 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the October 2018 5% Notes Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $176,000. In April, the Company elected to settle a portion of the October 2018 5% Note Payable outstanding principal and interest balance of $175,000 in exchange for 100,000 shares of common stock. The fair value of the shares of common stock issued was based on the market price of the Company's common stock on the date of the securities exchange agreement. The exchange agreement also extended the maturity date to October 1, 2019. The remaining principal balance under this note was $375,000 at June 30, 2019.

 

November and December 2018 Notes Payable

 

On November 6, 2018, November 8, 2018 and December 12, 2018, the Company entered into promissory note agreements and securities purchase agreements with three unrelated third-party investors, pursuant to which the investors loaned the Company gross proceeds of $1.25 million pursuant to 0% promissory notes (“November and December 2018 Notes Payable”). The notes have an OID of $270,000 and require aggregate payments of $1.52 million in principal. The notes bear interest at the rate of 0% per annum. In connection with the November and December 2018 Notes Payable, the Company issued the investors restricted shares of our common stock totaling 14,763 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the November and December 2018 Notes Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $374,000 in November 2018 and $125,000 in December 2018. The remaining principal balance under these notes was $668,000 at June 30, 2019.

March 2019 Note Payable

On March 27, 2019, we entered into a promissory note agreement and securities purchase agreement with an unrelated third-party investor in which the investor loaned us gross proceeds of $400,000 pursuant to a 0% promissory note (“March 2019 Note Payable”). The note has an OID of $100,000 and requires payments of $47,000 in principal per month through March 2020. In connection with the March 2019 Note Payable, we issued the investor restricted shares of common stock totaling 18,000 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the March 2019 Note Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $161,000 in March 2019. In connection with the financing, we issued 5,600 restricted shares of common stock in March 2019 to a third-party consultant. The fair value of the restricted shares of common stock issued of $28,000 was recorded as a debt discount to the carrying value of the notes payable. The remaining principal balance under this note was $375,000 at June 30, 2019.

 

April 2019 Notes Payable

 

On April 8, 2019, we entered into two securities purchase agreements with unrelated third-party investors in which the investors purchased 5% promissory notes, resulting in gross proceeds to us of $850,000 (“April 2019 Notes Payable”). The notes have an OID of $90,000 and require payment of principal and interest of $140,000 in October 2019, $704,000 in January 2020, and $132,000 in April 2020. In connection with the April 2019 Notes Payable, we issued the investors restricted shares of common stock totaling 98,334 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the April 2019 Notes Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $318,000 in April 2019. The discount is being amortized to interest expense using the effective interest method over the term of the April 2019 Notes Payable.

 

May 2019 Note Payable

 

On May 13, 2019, we entered into a securities purchase agreement with an unrelated third-party investor in which the investor loaned us gross proceeds of $400,000 pursuant to a 0% promissory note (“May 2019 Note Payable”). The note has an Original Issue Discount (“OID”) of $100,000 and requires payments of $42,000 in principal per month through May 2020. In connection with the May 2019 Note Payable, we issued the investor restricted shares of common stock totaling 34,000 shares. The fair value of the restricted shares of common stock issued was based on the market price of our common stock on the date of issuance of the May 2019 Note Payable. The allocation of the proceeds received to the restricted shares of common stock based on their relative fair value and the OID resulted in us recording a debt discount of $178,000 in May 2019. In connection with the financing, we issued 10,036 restricted shares of common stock in May 2019 to a third-party consultant. The fair value of the restricted shares of common stock issued of $28,000 was recorded as a debt discount to the carrying value of the notes payable. The discount is being amortized to interest expense using the effective interest method over the term of the May 2019 Note Payable.

 

Net Cash Flows

 

   

Six Months Ended June 30, 2019

   

Six Months Ended June 30, 2018

Net cash used in operating activities

 

$ (1,356)

   

$ (3,461)

Net cash used in investing activities

 

(359)

   

(135)

Net cash provided by financing activities

 

2,041

   

3,646

Net change in cash

 

326

   

50

Cash at beginning of period

 

1,248

   

1,565

Cash at end of period

 

$ 1,574

   

$ 1,615

 

 

Operating Activities

 

For the six months ended June 30, 2019, cash used in operating activities was approximately $1.4 million, consisting primarily of the net loss for the period of approximately $3.7 million, which was primarily offset by non-cash common stock, restricted stock units and stock options issued for services and compensation of approximately $275,000, amortization of debt discount of $908,000, and amortization of intangible assets of $363,000. Additionally, working capital changes consisted of cash increases of approximately $0.8 million related primarily to the reduction of inventory levels due to improved management of inventory purchasing and more experience to understand inventory turnover for each product as well as an increase in customer deposit for sales occurring toward the end of the first quarter.

 

Investing Activities

 

For the six months ended June 30, 2019, cash used in investing activities was approximately $359,000, which consisted of the purchase of assets from the Prime Consultants LLC entity on January 1, 2019 and the purchase of property and equipment of $16,000.

 

Financing Activities

 

For the six months ended June 30, 2019, cash provided by financing activities was approximately $2.0 million, consisting primarily of the net proceeds from the private placement completed on January 3, 2019, for a total net proceeds of $2.7 million and the issuance of a promissory note agreements and short-term loans of $2.7 million in 2019 offset by the repayment of outstanding notes payable and short-term loans of $3.4 million during the period. 

 

Critical Accounting Policies and Estimates

 

On January 1, 2019, we adopted Financial Accounting Standards Board (“FASB”) ASU 2016-02, Leases (Topic 842) . This ASU requires lessees to recognize most leases on the balance sheet as lease liabilities with corresponding right-of-use assets and to disclose key information about leasing arrangements. We elected the available package of practical expedients upon adoption, which allowed us to carry forward our historical assessment of whether existing agreements contained a lease and the classification of our existing operating leases. We continue to report our financial position as of December 31, 2018 under the former lease accounting standard (Topic 840) in our condensed consolidated balance sheet. The adoption impact resulted in the recognition of an operating lease liability with a corresponding right-of-use asset based on the present value of our remaining minimum lease payments which offset the previously reported deferred rent balance.

 

On January 1, 2019, we adopted FASB ASU 2018-07, Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . The update aligns the accounting for share-based payment awards issued to nonemployees with those issued to employees. Under the new guidance, the nonemployee awards will be measured on the grant date and compensation costs will be recognized when achievement of the performance condition is probable. This new standard is effective for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year. Early adoption is permitted. The adoption of the new guidance does not have a material impact on its consolidated financial statements.

 

For the six months ended June 30, 2019, 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, 2018.

 

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.

 

ITEM 4.

CONTROLS AND PROCEDURES

 

Evaluation of disclosure controls and procedures.

 

As of June 30, 2019, we evaluated, with the participation of our principal executive officer and principal financial officer, the effectiveness of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the “Exchange Act”)).

 

 

Based on that evaluation, our principal executive officer and principal financial officer concluded that, as of June 30, 2019, our disclosure controls and procedures are designed at a reasonable assurance level and are effective to provide reasonable assurance that information we are required to disclose in reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and that such information is accumulated and communicated to our management, including chief executive officer and vice president, finance, as appropriate to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, but not absolute, assurance that the objectives of the disclosure controls and procedures are met. The design of any disclosure control and procedure also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

Changes in internal control over financial reporting.

 

During the quarter ended June 30, 2019, there were no changes in our internal control over financial reporting that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting.

 

PART II—OTHER INFORMATION

 

ITEM 1.

LEGAL PROCEEDINGS

 

James L. Yeager, Ph.D., and Midwest Research Laboratories, LLC v. lnnovus Pharmaceuticals, Inc. On January 18, 2018, Dr. Yeager and Midwest Research Laboratories (the "Plaintiffs") filed a complaint in the Illinois Northern District Court in Chicago, Illinois, which Plaintiffs amended on February 26, 2018 ("Amended Complaint''). The Amended Complaint alleges that the Company violated Dr. Yeager's right of publicity and made unauthorized use of his name, likeness an identity in advertising materials for its product Sensum+®. Plaintiffs seek actual and punitive damages, costs and attorney's fees, an injunction and corrective advertising. In October 2018, we filed a motion to dismiss the action. In February 2019, the Judge in the Illinois action issued a ruling invalidating some of Plaintiff’s causes of action, while accepting others and the case continues in that jurisdiction. The parties are currently engaged in discovery.

We believe that the Plaintiffs’ allegations and claims are wholly without merit, and we intend to defend the case vigorously and assert counterclaims against the Plaintiffs.  More specifically, we believe that we secured and paid for all of the rights claimed by Dr. Yeager from his company Centric Research Institute (“CRI”) pursuant to agreements with CRI (the “CRI Agreements”) and that CRI has indemnification obligations under the CRI Agreements for all expenses and losses associated with the claims made by the Plaintiffs.

 

On January 23, 2019 we filed a complaint in the U.S. Federal District Court for the Southern District located in San Diego, California against Dr. Yeager, Servet Buyuktimken and Nadir Buyuktimkin (the “021 Patent Claimed Inventors”), who are all the inventors names on the US issued patent number 9,821,021 entitled Sensitization Composition and Methods of Action (the “021 Patent”), for copyright infringement relating to a clinical study table (the “Innovus Pharm Clinical Study Table”) included in the 021 Patent. We claim that the 021 Patent Claimed Inventors illegally stole and used the Innovus Pharm Clinical Study Table and the suit requests certain damages and injunctive relief described therein.

 

Marin County District Attorney s Letter. On August 24, 2018, the Company received a letter from the Marin County District Attorney’s Office requesting substantiation for certain advertising claims made for certain of the Company's products, DiabaSens® and Apeaz® that were marketed and sold to customers in that County. The Marin County District Attorney’s Office is part of a larger ten county Northern California Task Force of district attorneys to handle consumer protection matters. In November 2018, the Company responded through its regulatory attorneys, Olshan, to the Marin County’s District Attorney’s letter. In March 2019, the Company received a response from the Marin County District Attorney. In April 2019 we responded to the letter and in June 2019 the Company met with the Northern California Task Force. The Company is currently responding to additional due diligence requests from the Marin County District Attorney's office.

 

From time to time, in addition to the matters identified above, we may become involved in various lawsuits and legal proceedings which arise in the ordinary course of business. Litigation is subject to inherent uncertainties, and an adverse result in the matter identified above or other matters may harm our business.

 

ITEM 1A.

RISK FACTORS

 

The risks described in  Part I Item 1A Risk Factors , in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018, could materially and adversely affect our business, financial condition and results of operations. These risk factors do not identify all of the risks that we face. Our business, financial condition and results of operations could also be affected by factors that are not presently known to us or that we currently consider to be immaterial. There have been no material changes to the “Risk Factors” section included in our Annual Report on Form 10-K for the fiscal year ended December 31, 2018.

  

ITEM 2.

UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

Unregistered Sales of Equity Securities

 

In April 2019, we entered into a securities purchase agreement with unrelated third-party investors in which the investors loaned us gross proceeds of $850,000 and we issued such investors (i) promissory notes in the aggregate principal amount of $1 million, and (ii) 98,334 restricted shares of common stock.

 

In April 2019, we elected to settle a portion of the October 2018 5% Notes Payable outstanding principal and interest balance of $175,000 in exchange for 100,000 restricted shares of common stock.

 

In May 2019, we entered into a securities purchase agreement with an unrelated third-party investor in which the investor loaned us gross proceeds of $400,000 and we issued such investor (i) a promissory note in the aggregate principal amount of $500,000, and (ii) 34,000 restricted shares of common stock.

 

 

We believe that each of the offers, sales and issuances of securities described were exempt from registration under the Securities Act pursuant to Regulation D under the Securities Act or pursuant to Section 4(a)(2) of the Securities Act regarding transactions not involving a public offering. The recipients of securities in each of these transactions represented their intention to acquire the securities for investment only and not with a view to or for sale in connection with any distribution thereof and appropriate legends were affixed to the stock certificates and instruments issued in such transactions. All recipients had adequate access, through their relationships with us, to information about us.

 

Use of Proceeds from the Sale of Registered Securities

 

On February 12, 2019, our registration statement on Form S-1 (File No. 333-229223) was declared effective by the SEC for our public offering pursuant to which we sold an aggregate of 230,853 shares of our common stock at an offering price of $7.35 per share.  There has been no material change in our use of proceeds from our public offering as described in our final prospectus filed with the SEC on February 13, 2019, pursuant to Rule 424(b).

 

ITEM 3.

DEFAULTS UPON SENIOR SECURITIES

 

None.

   

ITEM 4.

MINE SAFETY DISCLOSURES

 

Not applicable.

 

ITEM 5.

OTHER INFORMATION

 

None.

 

ITEM 6.

EXHIBITS

 

Exhibit No.

 

Description

4.1   Form of Promissory Note, dated August 8, 2019

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 Ryan Selhorn, CPA, principal financial officer, pursuant to Rule 13-a-14(a) or 15d-14(a) of the Securities and Exchange Act of 1934, as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.

32.1**

 

Certification of Bassam Damaj, Ph.D., principal executive officer, and Ryan Selhorn, CPA, principal financial officer, pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. 

 

 

 

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

 

*

Filed herewith.

 

**

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.

 

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

 

Innovus Pharmaceuticals, Inc.

 

(Registrant)

 

 

Date: August 13, 2019

/s/ Bassam Damaj

 

 

Bassam Damaj, Ph.D.

President, Chief Executive Officer and Director

(Principal Executive Officer)

 

 

/s/ Ryan Selhorn

 

 

Ryan Selhorn, CPA

Vice President, Chief Financial Officer

(Principal Financial Officer)

 

26

Exhibit 4.1

 

 

PROMISSORY NOTE

 

$1,000,000

August 8, 2019 

(“ Effective Date ”)

 

For value received, Innovus Pharmaceuticals, Inc., a Nevada corporation (“ Borrower ”), with its principal place of business at 8845 Rehco Road, San Diego, CA 92121, hereby promises to pay to [                                   ] (“ Lender ”), with its principal place of business at [                                        ], in lawful money of the United States of America, the principal amount of ONE MILLION DOLLARS ($1,000,000), plus applicable interest thereon, pursuant to the below terms.

 

Article I.
DEFINITIONS AND ACCOUNTING TERMS

 

Section 1.1      Defined Terms . As used in this Note, the following terms shall have the following respective meanings (and such meanings shall be equally applicable to both the singular and plural form of the terms defined, as the context may require).

 

Borrower ”: As defined in the opening paragraph.

 

Charges ”: As defined in Section 2.1(c).

 

Equity Interests ”: All stock, shares, interests or other equivalents, however designated, of Borrower, whether or not voting, including but not limited to common stock, member interests, warrants, preferred stock, convertible debentures, and all agreements, instruments and documents convertible, in whole or in part, into any one or more or all of the foregoing.

 

Event of Default ”: Any event described in Section 4.1.

 

Indebtedness ”: Any of the following (a) obligations for borrowed money (including the obligations under this Note and the other Loan Documents), (b) obligations representing the deferred purchase price of property or services (other than accounts payable arising in the ordinary course of business payable on terms customary in the trade), (c) obligations, whether or not assumed, secured by Liens or payable out of the proceeds or production from property now or hereafter owned or acquired, (d) obligations which are evidenced by notes, acceptances, or other instruments, (e) obligations to purchase securities or other property arising out of or in connection with the sale of the same or substantially similar securities or property, (f) capitalized lease obligations, (g) obligations as an account party with respect to standby and commercial letters of credit, (h) contingent obligations, including under any guaranty or surety, and (i) any other obligation or other financial accommodation which in accordance with GAAP would be shown as a liability on the balance sheet of Borrower.

 

Lender ”: As defined in the opening paragraph.

 

 

 

 

Lien ” means any lien (statutory or other), mortgage, pledge, hypothecation, assignment, deposit arrangement, encumbrance or preference, priority or other security agreement or preferential arrangement of any kind or nature whatsoever (including the interest of a vendor or lessor under any conditional sale, capitalized lease or other title retention agreement).

 

Loan Documents ”: Collectively, this Note and any other document evidencing or securing this Note, if any, as any of the same may be amended or modified from time to time.

 

Maximum Rate ”: As defined in Section 2.1(c).

 

Article II.
TERMS OF THE
LOAN

 

Section 2.1      Interest .

 

(a)     Beginning on the Effective Date, interest shall accrue on the principal amount outstanding under this Note from time to time until (but excluding) the date that the principal amount is paid in full to Lender at a rate equal to ten percent (10.0%) per annum. Upon the occurrence of any Event of Default, interest shall, at the option of Lender (and without notice to Borrower), accrue from the time of the Event of Default on the principal amount outstanding under this Note from time to time until paid in full at a rate equal to fifteen percent (15.0%) per annum.

 

(b)     Interest on this Note shall be computed on the basis of actual days elapsed and a year of 360 days.

 

(c)     Notwithstanding anything herein to the contrary, if at any time the interest rate applicable to this Note, together with all fees, charges and other amounts that are treated as interest on this Note under applicable law (collectively, the “ Charges ”), shall exceed the maximum lawful rate (the “ Maximum Rate ”) that may be contracted for, charged, taken, received or reserved by Lender in accordance with applicable law, the rate of interest payable in respect hereof, together with all Charges payable in respect thereof, shall be limited to the Maximum Rate, and any amounts received by Lender above the Maximum Rate will be applied to principal payments under this Note.

 

Section 2.2      Repayment; Prepayment .

 

(a)     The unpaid principal amount of this Note, together with all accrued and unpaid interest thereon, shall be due and payable on or before the earlier of (i) February 29, 2020; and (ii) such other date the principal amount becomes due and payable by acceleration after an Event of Default or otherwise.

 

(b)     The Borrower may prepay this Note at any time and from time to time, in whole or in part, without premium or penalty.

 

2

 

 

Section 2.3      Payments Set Aside . If any payment by or on behalf of Borrower is made to Lender, and such payment or any part thereof is subsequently invalidated, declared to be fraudulent or preferential, set aside or required to be repaid to a trustee, receiver or any other person or entity, then to the extent of such recovery, the obligation originally intended to be satisfied, and all rights and remedies relating thereto, shall be revived and continued in full force and effect as if such payment had not occurred.

 

Article III.
REPRESENTATIONS AND WARRANTIES

 

Borrower represents and warrants to Lender as follows:

 

Section 3.1      Existence and Standing . Borrower is duly and properly incorporated, validly existing and in good standing under the laws of its jurisdiction of incorporation, and has all requisite authority to conduct its business in each jurisdiction in which its business is conducted.

 

Section 3.2      Authorization and Validity . Borrower has the power and authority and legal right to execute and deliver the Loan Documents and to perform its obligations thereunder. The execution, delivery, and performance by Borrower of the Loan Documents have been duly authorized by proper proceedings and are legal, valid and binding obligations enforceable against Borrower in accordance with their terms, except as enforceability may be limited by bankruptcy, insolvency or similar Laws affecting the enforcement of creditors’ rights generally.

 

Section 3.3      No Conflict; Government Consent . Neither the execution and delivery by Borrower of the Loan Documents, nor the consummation of the transactions therein contemplated, nor compliance with the provisions thereof will violate (a) any law, order, writ, judgment, injunction, decree or award binding on Borrower, (b) Borrower’s organizational documents, or (c) any agreement to which Borrower is a party or subject, or by which it or its property is bound, conflict with or be a default thereunder, or result in or require the creation or imposition of any Lien on any of Borrower’s property. No order, consent, adjudication, approval, license, authorization, or validation of, filing, recording or registration with, exemption by, or other action in respect of any governmental authority that has not been obtained is required in connection with the execution, delivery, and performance of the Loan Documents or the legality, validity, binding effect or enforceability of any of the Loan Documents.

 

Section 3.4      Accuracy of Information . No information, exhibit or report furnished by Borrower to Lender hereunder contained any material misstatement of fact or omitted to state a material fact or any fact necessary to make the statements therein not misleading.

 

Section 3.5      Taxes . Borrower has filed all required tax returns and has paid all taxes due. No tax Liens have been filed or exist on any property of Borrower, and no claims are being asserted with respect to any such taxes.

 

Section 3.6      Amounts Payable . As of June 30, 2019, the total amount of Borrower's payables and liabilities, calculated in accordance with GAAP, is $10,790,892.    

 

 

3

 

 

Article IV.

COVENANTS

 

Section 4.1      Use of Proceeds .

 

(a)     Borrower must use the proceeds of the loan evidenced by this Note to continue the commercial operations of Borrower or to pay the following vendors:  [                                        ]

 

(b)     Other than the vendors specifically listed in Section 4.1(a) above, Borrower may not make any payments to any vendor, person or entity in excess of $65,000 (whether in a single payment or a series of payments) without obtaining the prior, written consent of Lender (which consent may be withheld in Lender’s sole discretion).

 

Section 4.2      Taxes . Borrower must timely file complete and correct federal and applicable foreign, state and local tax returns required by law and pay when due all taxes upon it or its income, profits or property.

 

Section 4.3      Insurance . Borrower must maintain with financially sound and reputable insurance companies insurance on its property, in such amounts, subject to such deductibles and self-insurance retentions and covering such risks as is consistent with sound business practice, and Borrower must furnish to Lender upon request full information as to the insurance carried. Immediately after execution of this Note, Borrower must use best efforts to (a) name Lender as lender loss payee and additional insured, as applicable, with respect to such insurance, and (b) cause each provider of any such insurance to give Lender 30 days’ prior written notice before any such policy is cancelled.

 

Section 4.4      Maintenance of Properties . Borrower must do all things reasonably necessary to maintain, preserve, protect and keep its property in good repair, working order and condition, ordinary wear and tear excepted, and make all necessary and proper repairs, renewals and replacements to properly conduct its business at all times.

 

Section 4.5      Books and Records; Inspection . Borrower must keep proper books of record and account in which full, true and correct entries are made of all dealings and transactions related to its business and activities (including but not limited to its assets, liabilities and property). Borrower must permit Lender to inspect the property, books and financial records of Borrower (including but not limited as relates to liabilities and amounts payable by Borrower), and to examine and make copies of the books of accounts and other financial records of Borrower, at such reasonable times and intervals as Lender may designate. Borrower will promptly provide to Lender, upon request by Lender, such documents, back-up and other information requested by Lender relating to Borrower’s business and activities (including but not limited to its assets, liabilities and property).

 

Section 4.6      Indebtedness . Borrower must not incur or suffer to exist any other Indebtedness, except: (a) the obligations owing to Lender under this Note, the other Loan Documents, or otherwise, (b) Indebtedness existing as of the date hereof and disclosed to Lender in writing, and (c) other Indebtedness incurred in the ordinary course of Borrower’s business (but in no event Indebtedness for borrowed money).

 

Section 4.7      Sale of Property . Borrower must not lease, sell or otherwise dispose of any of its property, except: (a) sales of inventory, or used, worn-out or surplus equipment, all in the ordinary course of business; and (b) sales of equipment (i) in exchange for credit against the purchase price of similar replacement equipment, or (ii) the proceeds of which are applied with reasonable promptness to the purchase price of such replacement equipment.

 

Section 4.8      Liens . Borrower must not create, incur, or suffer to exist any Lien in, of, or on any of its property, except Liens existing on the date hereof and disclosed to Lender in writing.

 

Section 4.9      Further Assurances . Borrower must promptly correct any ambiguity, omission, defect, inconsistency or error in any Loan Document or in the execution, acknowledgment or recordation thereof. Borrower must execute and deliver, or cause to be executed and delivered, to Lender such documents, agreements and instruments, and must take or cause to be taken such further actions that may be required by law or requested by Lender to carry out the terms and conditions of the Loan Documents, all in form and substance reasonably satisfactory to Lender.

 

Section 4.10      Negative Pledges; Subsidiary Restrictions . Borrower must not enter into any agreement or other instrument with or for the benefit of any person or entity other than Lender that would require Borrower to grant a Lien to any other person or entity.

 

 

4

 

 

 

Article V.
EVENTS OF DEFAULT AND REMEDIES

 

Section 5.1      Events of Default . The occurrence of any one or more of the following events shall constitute an Event of Default:

 

(a)     Borrower fails to make when due, whether by acceleration or otherwise, any payment of principal of or interest on this Note.

 

(b)     Any representation or warranty made or deemed made by Borrower in connection with this Note or any Loan Document is materially false on the date made.

 

(c)     The breach of any of the covenants or other terms of this Note or any other Loan Document by Borrower.

 

(d)     Borrower shall become insolvent or shall generally not pay its respective debts as they mature or shall apply for, shall consent to, or shall acquiesce in the appointment of a custodian, trustee or receiver of Borrower or for a substantial part of its property or, in the absence of such application, consent or acquiescence, a custodian, trustee or receiver shall be appointed for Borrower or for a substantial part of its property and shall not be discharged within 45 days, or Borrower shall make an assignment for the benefit of creditors.

 

(e)     Any bankruptcy, reorganization, debt arrangement or other proceedings under any bankruptcy or insolvency law shall be instituted by or against Borrower, and, if instituted against Borrower, shall have been consented to or acquiesced in by Borrower, or shall remain undismissed for 45 days, or an order for relief shall have been entered against Borrower.

 

(f)     Any dissolution or liquidation proceeding shall be instituted by or against Borrower, and, if instituted against Borrower, shall be consented to or acquiesced in by Borrower or shall remain for 45 days undismissed .

 

(g)     Any execution or attachment shall be issued whereby any substantial part of the property of Borrower shall be taken or attempted to be taken and the same shall not have been vacated or stayed within 45 days after the issuance thereof.

 

Section 5.2      Remedies . If (a) any Event of Default described in Sections 5.1 (d), (e), (f) or (g) shall occur, this Note and all obligations hereunder shall automatically become immediately due and payable; or (b) any other Event of Default shall occur, then Lender shall take any of the following actions so requested: (i) declare the outstanding unpaid principal balance of this Note, the accrued and unpaid interest thereon and all other obligations hereunder to be forthwith due and payable, whereupon this Note, all accrued and unpaid interest thereon and all such obligations hereunder shall immediately become due and payable, in each case without presentment, demand, protest or other notice of any kind. Upon the occurrence of any of the events described in the preceding sentence, Lender may exercise all rights and remedies under any of the Loan Documents and enforce all rights and remedies under any applicable law.

 

8

 

 

Section 5.3      No Waiver; Remedies . No failure or delay on the part of Lender in exercising any power or right under this Note shall operate as a waiver thereof, nor shall any single or partial exercise of any such power or right preclude any other or further exercise thereof of the exercise of any other power or right. No notice to or demand on Borrower in any case shall entitle Lender to any notice or demand in similar or other circumstances. The remedies herein provided are cumulative and not exclusive of any remedies provided by law.

 

Article VI.
MISCELLANEOUS

 

Section 6.1      Governing Law and Consent to Jurisdiction . THIS NOTE IS TO BE GOVERNED BY AND INTERPRETED IN ACCORDANCE WITH THE LAWS OF THE STATE OF UTAH, WITHOUT REFERENCE TO PRINCIPLES OF CONFLICTS OF LAW. AT THE OPTION OF LENDER, THIS NOTE MAY BE ENFORCED IN ANY FEDERAL COURT OR UTAH STATE COURT SITTING IN SALT LAKE COUNTY, UTAH; AND BORROWER CONSENTS TO THE JURISDICTION AND VENUE OF ANY SUCH COURT AND WAIVES ANY ARGUMENT THAT THE VENUE IN SUCH FORUMS IS NOT CONVENIENT. IF BORROWER COMMENCES ANY ACTION IN ANOTHER JURISDICTION OR VENUE UNDER ANY TORT OR CONTRACT THEORY ARISING DIRECTLY OR INDIRECTLY FROM THE RELATIONSHIP CREATED BY THIS NOTE, LENDER AT ITS OPTION SHALL BE ENTITLED TO HAVE THE CASE TRANSFERRED TO ONE OF THE JURISDICTIONS AND VENUES ABOVE-DESCRIBED, OR, IF SUCH TRANSFER CANNOT BE ACCOMPLISHED UNDER APPLICABLE LAW, TO HAVE SUCH CASE DISMISSED WITHOUT PREJUDICE.

 

Section 6.2      Waiver of Jury Trial . BORROWER AND, BY ITS ACCEPTANCE OF THIS NOTE, LENDER IRREVOCABLY WAIVE ANY AND ALL RIGHT TO TRIAL BY JURY IN ANY LEGAL PROCEEDING ARISING OUT OF OR RELATING TO THIS NOTE OR THE TRANSACTIONS CONTEMPLATED HEREBY OR THEREBY.

 

Section 6.3      Notices . Any notice or other communication to any party in connection with this Note shall be in writing and shall be sent by e-mail, manual delivery, overnight courier or United States mail (postage prepaid) addressed to such party at the address specified in the preamble hereto, or at such other address as such party shall have specified to the other party hereto in writing. All periods of notice shall be measured from the date of delivery thereof if sent by e-mail or manually delivered or, from the first business day after the date of sending if sent by overnight courier, or from four days after the date of mailing if mailed.

 

9

 

 

Section 6.4      Successors and Assigns . This Note shall (a) be binding upon Borrower and its successors and assigns, and (b) inure, together with the rights and remedies of Lender hereunder, to the benefit of, and be enforceable by, Lender and its successors, heirs, transferees and assigns. Notwithstanding anything to the contrary, (a) Borrower may not assign its rights or delegate its obligations hereunder without the prior written consent of Lender and (b) Lender may at any time sell, assign, transfer, grant participations in, or otherwise dispose of any portion of its rights or obligations under this Note to any person or entity.

 

Section 6.5      Attorneys’ Fees . Borrower must indemnify and hold harmless Lender against all losses, claims, damages, penalties, judgments, liabilities and expenses (including reasonable attorneys’ fees, charges and disbursements and settlement costs (including all expenses of litigation or preparation therefor) whether or not Lender is a party thereto) arising out of or relating to the Borrower’s Default of the Loan Documents, the transactions contemplated hereby, any environmental liability related in any way to Borrower, or any actual or prospective claim, litigation, investigation or proceeding relating to any of the foregoing, whether based on contract, tort or any other theory, whether brought by a third party or by Borrower, or the direct or indirect application or proposed application of the proceeds of the loan evidenced by this Note except to the extent that they are determined in a final non-appealable judgment by a court of competent jurisdiction to have resulted from the gross negligence or willful misconduct of Lender. The obligations of Borrower under this Section 6.5 survive the termination of this Note. Without limiting the foregoing, if an Event of Default occurs hereunder, Borrower must pay all costs and expenses of collection and enforcement (including reasonable attorneys’ fees) incurred by Lender.

 

Section 6.6      Entire Agreement; Amendment; Waiver . This Note and the other Loan Documents embody the entire understanding between Lender and Borrower with respect to the subject matter hereof. This Note supersedes all prior agreements and understandings relating to the subject matter hereof. This Note may not be amended, modified or changed, nor shall any waiver of any provision hereof be effective, except by a written instrument signed by the party against whom enforcement of the waiver, amendment, change, or modification is sought, and then only to the extent set forth in that instrument. No specific waiver of any of the terms of this Note shall be considered as a general waiver.

 

 

[The remainder of this page is intentionally left blank.]

 

10

 

 

IN WITNESS WHEREOF, the undersigned has duly caused this Note to be dated and effective as of the date first above written.

 

 

 

INNOVUS PHARMACEUTICALS, INC., a

Nevada corporation

 

 

 

 

By:

Name: Bassam Damaj, PhD

Title: President and Chief Executive Officer

 

 

[Signature Page to Promissory Note]

Exhibit 31.1

 

CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Bassam Damaj, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of Innovus Pharmaceuticals, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 13, 2019

/s/ Bassam Damaj

Bassam Damaj, Ph.D.

President, Chief Executive Officer and Director

     

 

Exhibit 31.2

 

CERTIFICATION OF PRINCIPAL FINANCIAL OFFICER PURSUANT TO

SECTION 302 OF THE SARBANES-OXLEY ACT OF 2002

 

I, Ryan Selhorn, certify that:

 

1.

I have reviewed this quarterly report on Form 10-Q of Innovus Pharmaceuticals, Inc.;

 

2.

Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3.

Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4.

The registrant’s other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

 

a)

designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

 

b)

designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

 

c)

evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

 

d)

disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and

 

5.

The registrant’s other certifying officer and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):

 

 

a)

all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and

 

 

b)

any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.

 

Date: August 13, 2019  /s/ Ryan Selhorn
  Ryan Selhorn
  Vice President, Chief Financial Officer
  (Principal Financial Officer)
   

                                                           

 

Exhibit 32.1

 

CERTIFICATION REQUIRED BY

SECTION 1350 OF TITLE 18 OF THE UNITED STATES CODE

 

Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, each of the undersigned hereby certifies in his capacity as the specified officer of Innovus Pharmaceuticals, Inc. (the “Company”), that, to the best of his knowledge, the Quarterly Report of the Company on Form 10-Q for the fiscal quarter ended June 30, 2019 fully complies with the requirements of Section 13 (a) or 15(d), as applicable, of the Securities Exchange Act of 1934, and that the information contained in such report fairly presents, in all material respects, the financial condition and results of operations of the Company as of the dates and for the periods presented in the financial statements included in such report.

 

Date: August 13, 2019

 

/s/ Bassam Damaj

Bassam Damaj, Ph.D.

President, Chief Executive Officer and Director

(Principal Executive Officer)

 

Date: August 13, 2019

 

/s/ Ryan Selhorn

Ryan Selhorn

Vice President, Chief Financial Officer

 

(Principal Financial Officer)

 

This certification accompanies this Report on Form 10-Q pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, and shall not be deemed filed by the Company for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Such certification will not be deemed to be incorporated by reference into any filing under the Securities Act of 1933, as amended, or the Exchange Act, except to the extent that the Company specifically incorporates it by reference.