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Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

(Mark One)

QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended June 30, 2021

 

OR

 

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                            to                                 

 

Commission File Number: 001-33678

 

NOVABAY PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware

68-0454536

(State or other jurisdiction of incorporation or organization)

(I.R.S. Employer Identification No.)

 

2000 Powell Street, Suite 1150, Emeryville, CA 94608

(Address of principal executive offices) (Zip Code)

 

Registrants Telephone Number, Including Area Code: (510) 899-8800

 

Securities Registered Pursuant to Section 12(b) of the Act:

Title of Each Class

Trading Symbol(s)

Name of Each Exchange On Which Registered

Common Stock, par value $0.01 per share

NBY

NYSE American

 

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

 

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T during the preceding 12 months (or for such shorter period that the registrant was required to submit such files).

Yes ☒    No ☐

 

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

 

Large accelerated filer 

Accelerated filer 

Emerging growth company

Non-accelerated filer 

Smaller reporting company 

   

 

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

 

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

 

As of August 10, 2021, there were 44,943,364 shares of the registrant’s common stock outstanding.

 

 

 

 

NOVABAY PHARMACEUTICALS, INC.

 

TABLE OF CONTENTS

 

PART I

FINANCIAL INFORMATION

       

Item 1.

 

Financial Statements

3

       
 

1.

Condensed Consolidated Balance Sheets: June 30, 2021 (unaudited) and December 31, 2020

3

       
 

2.

Condensed Consolidated Statements of Operations and Comprehensive Loss: Three and six months ended June 30, 2021 and 2020 (unaudited)

4

       
 

3.

Condensed Consolidated Statements of Stockholders’ Equity (Deficit): Three and six months ended June 30, 2021 and 2020 (unaudited)

5

       
 

4.

Condensed Consolidated Statements of Cash Flows: Six months ended June 30, 2021 and 2020 (unaudited)

6

       
 

5.

Notes to Condensed Consolidated Financial Statements (unaudited)

8

       

Item 2.

 

Managements Discussion and Analysis of Financial Condition and Results of Operations

30

       

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

41

       

Item 4.

 

Controls and Procedures

41

       

PART II

OTHER INFORMATION

       

Item 1.

 

Legal Proceedings

41

       

Item 1A.

 

Risk Factors

41

       

Item 2.

 

Unregistered Sales of Equity Securities and Use of Proceeds

42

       

Item 3.

 

Defaults Upon Senior Securities

42

       

Item 4.

 

Mine Safety Disclosure

42

       

Item 5.

 

Other Information

42

       

Item 6.

 

Exhibits

43

       

SIGNATURES

44

   

EXHIBIT INDEX

43

 

Unless the context requires otherwise, all references in this report to “we,” “our,” “us,” the “Company” and “NovaBay” refer to NovaBay Pharmaceuticals, Inc.

 

NovaBay®, NovaBay Pharma®, Avenova®, NeutroPhase®, CelleRx®, Aganocide®, AgaDerm®, Neutrox® and Going Beyond Antibiotics® are trademarks of NovaBay Pharmaceuticals, Inc. All other trademarks and trade names are the property of their respective owners.

 

 

 

PART I

FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

 

 

NOVABAY PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

 

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 10,294     $ 11,952  

Accounts receivable, net of allowance for doubtful accounts ($0 at June 30, 2021 and December 31, 2020)

    1,232       1,106  

Inventory, net of allowance for excess and obsolete inventory ($185 and $236 at June 30, 2021 and December 31, 2020, respectively)

    682       608  

Prepaid expenses and other current assets

    564       576  

Total current assets

    12,772       14,242  

Operating lease right-of-use assets

    262       436  

Property and equipment, net

    94       84  

Other assets

    475       476  

TOTAL ASSETS

  $ 13,603     $ 15,238  
                 

LIABILITIES AND STOCKHOLDERS' EQUITY

               

Liabilities:

               

Current liabilities:

               

Accounts payable

  $ 208     $ 302  

Accrued liabilities

    1,883       2,115  

Operating lease liabilities

    298       416  

Total current liabilities

    2,389       2,833  

Operating lease liabilities-non-current

    5       87  

Total liabilities

    2,394       2,920  
Commitments & contingencies (please refer to Note 8)                  

Stockholders' equity:

               

Preferred stock: 5,000 shares authorized; none issued and outstanding at June 30, 2021 and December 31, 2020

           

Common stock, $0.01 par value; 100,000 and 75,000 shares authorized at June 30, 2021 and December 31, 2020, respectively; 44,615 and 41,782 shares issued and outstanding at June 30, 2021 and December 31, 2020, respectively

    447       418  

Additional paid-in capital

    150,202       147,963  

Accumulated deficit

    (139,440

)

    (136,063

)

Total stockholders' equity

    11,209       12,318  

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

  $ 13,603     $ 15,238  

 

The accompanying notes are an integral part of these condensed consolidated financial statements. 

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share data)

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2021

   

2020

   

2021

   

2020

 

Sales:

                               

Product revenue, net

  $ 2,126     $ 3,979     $ 3,927     $ 5,871  

Other revenue, net

    7       5       13       5  

Total sales, net

    2,133       3,984       3,940       5,876  
                                 

Product cost of goods sold

    614       2,040       1,069       2,621  

Gross profit

    1,519       1,944       2,871       3,255  

Operating expenses:

                               

Research and development

    21       115       26       124  

Sales and marketing

    1,788       1,423       3,468       2,983  

General and administrative

    1,569       1,477       2,756       2,754  

Total operating expenses

    3,378       3,015       6,250       5,861  

Operating loss

    (1,859 )     (1,071 )     (3,379 )     (2,606 )
                                 

Non-cash loss on changes in fair value of warrant liability

          (3,772 )           (3,635 )

Non-cash gain on changes in fair value of embedded derivative liability

                      2  

Other income, net

          362       2       176  
                                 

Loss before provision for income taxes

    (1,859 )     (4,481 )     (3,377 )     (6,063 )

Provision for income taxes

          (1 )     -       (1 )

Net loss and comprehensive loss

  $ (1,859 )   $ (4,482 )   $ (3,377 )   $ (6,064 )
                                 

Net loss per share (basic and diluted)

  $ (0.04 )   $ (0.15 )   $ (0.08 )     (0.21 )

Weighted-average shares of common stock used in computing net loss per share (basic and diluted)

    42,561       30,384       42,174     $ 29,012  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY (DEFICIT)

(Unaudited)

(in thousands)

 

   

Common Stock

   

Additional

Paid-In

   

Accumulated

   

Total

Stockholders'

Equity

 
   

Shares

   

Amount

   

Capital

   

Deficit

   

(Deficit)

 

Balance at December 31, 2020

    41,782     $ 418     $ 147,963     $ (136,063

)

  $ 12,318  

Net loss

                      (1,518

)

    (1,518

)

Stock-based compensation expense related to employee and director stock options

                130             130  

Stock-based compensation expense related to non-employee stock options

                53             53  

Balance at March 31, 2021

    41,782     $ 418     $ 148,146     $ (137,581

)

  $ 10,983  

Net loss

                      (1,859

)

    (1,859

)

Issuance of warrants

                13             13  

Issuance of common stock, net of offering costs

    2,673       27       1,749             1,776  

Vesting of employee restricted stock awards

    160       2       (2 )            

Stock-based compensation expense related to employee and director stock options

                242             242  

Stock-based compensation expense related to non-employee stock options

                54             54  

Balance at June 30, 2021

    44,615     $ 447     $ 150,202     $ (139,440

)

  $ 11,209  

 

 

   

Common Stock

   

Additional

Paid-In

   

Accumulated

   

Total

Stockholders'

Equity

 
   

Shares

   

Amount

   

Capital

   

Deficit

   

(Deficit)

 

Balance at December 31, 2019

    27,938     $ 279     $ 125,718     $ (125,024

)

  $ 973  

Net loss

                      (1,582

)

    (1,582

)

Issuance of common stock in connection with exercise of warrants

    299       3       198             201  

Vesting of employee restricted stock awards

    2             2             2  

Stock-based compensation expense related to employee and director stock options

                45             45  

Stock-based compensation expense related to non-employee stock options

                12             12  

Balance at March 31, 2020

    28,239     $ 282     $ 125,975     $ (126,606

)

  $ (349

)

Net loss

                      (4,482

)

    (4,482

)

Issuance of common stock, net of offering costs

    5,838       58       5,162             5,220  

Issuance of common stock in connection with exercise of warrants

    571       6       462             468  

Stock-based compensation expense related to employee and director stock options

                92             92  

Stock-based compensation expense related to non-employee stock options

                (2

)

          (2

)

Stock option modification

                36             36  

Balance at June 30, 2020

    34,648     $ 346     $ 131,725     $ (131,088

)

  $ 983  

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited) 

(In thousands)

 

   

Six Months Ended June 30,

 
   

2021

   

2020

 
                 

Operating activities:

               

Net loss

  $ (3,377

)

  $ (6,064

)

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

               

Depreciation and amortization

    20       28  

Stock-based compensation expense for options and stock issued to employees and directors

    372       137  

Stock-based compensation expense for options and stock issued to non-employees

    107       10  

Stock option modification expense

          36  

Vesting of employee restricted stock awards

    (2 )     2  

Issuance of warrants

    13        

Non-cash loss on changes in fair value of warrant liability

          3,635  

Non-cash (gain) on changes in fair value of embedded derivative liability

          (2

)

Interest expense related to amortization of debt issuance and debt discount

          143  

Interest expense related to amortization of debt issuance related to related party notes payable

          2  

Changes in operating assets and liabilities:

               

Accounts receivable

    (126 )     (498 )

Inventory

    (74

)

    (134

)

Prepaid expenses and other current assets

    12       (230

)

Operating lease right-of-use assets

    174       449  

Other assets

    (1 )      

Accounts payable and accrued liabilities

    (326

)

    473  

Operating lease liabilities

    (200

)

    (513

)

Deferred revenue

    2       115  

Related party notes payable

          73  

Long-term obligations

          432  

Net cash used in operating activities

    (3,406

)

    (1,906

)

                 

Investing activities:

               

Purchases of property and equipment

    (27

)

     

Net cash used in investing activities

    (27

)

     
                 

Financing activities:

               

Proceeds from common stock issuances, net

    1,775       5,220  

Proceeds from exercise of warrants

          669  

Payment on the Convertible Note (see Note 10)

          (1,145 )

Payment on the Promissory Note (see Note 9)

          (1,000 )

Net cash provided by financing activities

    1,775       3,744  

Net (decrease) increase in cash, cash equivalents, and restricted cash

    (1,658

)

    1,838  

Cash, cash equivalents and restricted cash, beginning of year

    12,427       7,412  

Cash, cash equivalents and restricted cash, end of period

  $ 10,769     $ 9,250  

 

 

   

Six Months Ended June 30,

 
   

2021

   

2020

 

Supplemental disclosure of cash flow information:

               

Interest paid

  $     $ 55  
                 

Supplemental disclosure of non-cash information:

               

Non-cash payment of related party loan accrued interest

  $     $ 173  

offset by related party accounts receivable

               

 

The accompanying notes are an integral part of these condensed consolidated financial statements.

 

 

 

NOTE 1. ORGANIZATION

 

NovaBay Pharmaceuticals, Inc. (the “Company”) is a medical device company predominantly focused on eye care. A majority of our revenue comes from Avenova®, an FDA cleared product sold in the United States that has proven in laboratory testing to have broad antimicrobial properties as it removes foreign material including microorganisms and debris from skin around the eye, including the eyelid. Avenova is formulated with our proprietary, stable and pure form of hypochlorous acid. Avenova is available directly to consumers through our online sales channel and is also often prescribed and dispensed by eyecare professionals for blepharitis and dry-eye disease.

 

We continue to promote Avenova through all four of our primary distribution channels: (1) our over-the-counter direct-to-consumer model, allowing customers to purchase either online or at select brick and mortar stores; (2) retail pharmacies, dispensing Avenova to patients through national pharmacy chains across all 50 states; (3) our Partner Pharmacy Program, providing a consistent patient experience at contracted pricing; and (4) our physician dispensed channel, allowing patients to buy Avenova during office visits to their preferred eye care specialist. We continue to achieve record overall Avenova unit sales quarter over quarter with more people using Avenova than ever before.

 

Avenova was launched as a prescription only product in 2016. To expand our addressable market, we launched Avenova as an over-the-counter product during the second quarter of 2019. By creating a consumer driven product that does not require a doctor’s prescription, we made Avenova available to many more potential customers. Over-the-counter Avenova also capitalizes on a trend to sell over-the-counter pharmaceutical products directly to consumers and adds convenience by allowing customers to forego a time-consuming doctor visit and trip to the pharmacy.

 

The launch of over-the-counter Avenova online proved to be especially fortuitous during the COVID-19 pandemic as it allowed consumers to order Avenova online without a prescription and without leaving their homes.

 

Over-the-counter Avenova is now our leading product by unit sales and net revenue despite having a lower average net selling price than prescription Avenova. This sales performance reflects our ongoing focus and increasing spend on digital marketing and public relations initiatives to promote Avenova directly to the end consumer. Avenova is available on Amazon.com, Walmart.com, and Avenova.com. Beginning in February 2021, Avenova became available at CVS store locations throughout the U.S. and on CVS.com, one of the nation’s largest retail chains.

 

Although we expect the online sales channel to continue to be our fastest-growing channel, support for Avenova from the medical community is important to maintaining its reputation as a preferred product. The “doctor recommended” halo effect around our brand remains strong due in part to our continued promotion of prescription Avenova.

 

Earlier this year, we launched a rebranded CelleRx® into the beauty industry as CelleRx® Clinical Reset™. Prior to this rebranding, our marketing of CelleRx focused on medical professionals only. Clinical Reset is formulated with NovaBay’s patented, pure, prescription-grade hypochlorous acid, a naturally occurring oxidant that is also produced by white blood cells within the human body. It keeps the skin’s natural barrier intact, which when out of balance can allow acne, rosacea and infection to set in.  Clinical Reset is complementary to a daily beauty regime for use on clean skin or over makeup. With the rebranding, we are leveraging new consumer focused messaging and the product’s pharmaceutical pedigree in robust social media and print advertising campaigns marketing CelleRx Clinical Reset in the beauty industry.

 

Beyond Avenova and CelleRx, we have developed additional products containing our proprietary, stable and pure form of hypochlorous acid, including NeutroPhase® and PhaseOne® for the wound care market. NeutroPhase is only sold in China through our exclusive distributor, Pioneer Pharma Co. Ltd. PhaseOne is only sold in the United States through our exclusive distributor, PhaseOne Health, LLC.

 

Last year, we responded to the national need for protective personal equipment (“PPE”) by tapping into our international supply network and launching the sale of third-party manufactured disposable KN95 facial coverings (“KN95 Masks”) and other PPE. Although sales from the KN95 Masks were significant in the second quarter of 2020, we experienced a significant decrease in PPE sales in the third and fourth quarters of 2020 as supply shortages narrowed, prices declined and distribution competition increased. We have returned our focus to our core business in eyecare and we do not anticipate dedicating significant future Company resources toward the sale of PPE and we do not expect significant future revenue from PPE sales.

 

During the second quarter of this year, we introduced two complementary products to support the use of Avenova. Our Warm Eye Compress not only provides effective heat therapy for many eye conditions, but it also improves Avenova’s ability to restore the eyes’ natural defenses against tear evaporation. Additionally, the i-Chek Illuminated Eye Examination Mirror (“i-chek”) allows Avenova customers to get a closer look at common eye conditions that are often of concern to Avenova customers. These eye conditions include blepharitis, chalazion and styes. The i-Chek also helps Avenova users who suffer from dry eye to identify dirt, oil or debris that need removed from the eyelids and eyelashes for optimum ocular health. The use of Avenova and both products is meant to provide Avenova customers with a holistic approach to lid and lash hygiene.

 

- 8-

 

Liquidity

 

Based primarily on our funds available on  June 30, 2021, management believes that the Company’s existing cash and cash equivalents and cash flows generated from product sales will be sufficient to enable the Company to meet its planned operating expenses at least through August 12, 2022. However, changing circumstances may cause the Company to expend cash significantly faster than currently anticipated, and the Company may need to spend more cash than currently expected because of circumstances beyond its control. Additionally, our future results, cash expenditures and ability to obtain additional external financing could be adversely affected by the COVID-19 pandemic and general adverse economic conditions. 

 

 

 

NOTE 2.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States (“U.S. GAAP”) and are expressed in U.S. dollars.

 

Use of Estimates

 

The preparation of financial statements in accordance with U.S. GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. These estimates include contract liabilities related to product sales, useful lives for property and equipment and related depreciation calculations, assumptions for valuing options and warrants, income taxes and other contingencies. Actual results could differ from those estimates.

 

- 9-

 

Unaudited Interim Financial Information

 

The accompanying unaudited interim condensed consolidated financial statements and related disclosures have been prepared on the same basis as the annual consolidated financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary for a fair statement of the results of operations for the periods presented.

 

The year-end condensed consolidated balance sheet data was derived from audited financial statements but does not include all disclosures required by U.S. GAAP. The condensed consolidated results of operations for any interim period are not necessarily indicative of the results to be expected for the full year or for any other future year or interim period. 

 

The financial statements and notes included herein should be read in conjunction with the annual financial statements and notes for the year ended December 31, 2020, included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 25, 2021.

 

Cash, Cash Equivalents, and Restricted Cash

 

The Company considers all highly-liquid instruments with a stated maturity of three months or less at the date of purchase to be cash equivalents. Cash and cash equivalents are stated at cost, which approximates fair value. As of June 30, 2021 and December 31, 2020, the Company’s cash and cash equivalents were held in a highly-rated, major financial institution in the United States.

 

The following table provides a reconciliation of the cash, cash equivalents, and restricted cash reported in the condensed consolidated balance sheets that sum to the total of the same reported in the condensed consolidated statements of cash flows (in thousands):

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 

Cash and cash equivalents

  $ 10,294     $ 11,952  

Restricted cash included in other assets

    475       475  

Total cash, cash equivalents, and restricted cash in the condensed consolidated statements of cash flows

  $ 10,769     $ 12,427  

 

The restricted cash amount included in other assets on the condensed consolidated balance sheets represents amounts held as certificates of deposit for Company credit cards and lease arrangements as contractually required by our financial institution and landlord.

 

Concentrations of Credit Risk and Major Partners

 

Financial instruments that potentially subject us to significant concentrations of credit risk consist primarily of cash, cash equivalents and restricted cash. The Company maintains deposits of cash, cash equivalents and restricted cash with a highly-rated, major financial institution in the United States. 

 

Deposits in this bank may exceed the amount of federal insurance provided on such deposits. The Company does not believe it is exposed to significant credit risk due to the financial position of the financial institution in which the deposits are held. 

 

During the three and six months ended June 30, 2021, Company revenues were derived primarily from sales of Avenova. During the three and six months ended June 30, 2020, revenues were derived primarily from sales of KN95 Masks and Avenova.

 

During the three and six months ended June 30, 2021 and 2020, revenues from each product were as follows (in thousands):

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2021

   

2020

   

2021

   

2020

 

Avenova

  $ 1,883     $ 1,140     $ 3,458     $ 2,686  

KN95 Masks

          2,839             3,012  

NeutroPhase

    175             175       173  

Other products

    68             294        

Total product revenue, net

    2,126       3,979       3,927       5,871  

Other revenue, net

    7       5       13       5  

Total sales, net

  $ 2,133     $ 3,984     $ 3,940     $ 5,876  

 

- 10-

 

During the three months ended June 30, 2021 and 2020, sales of Avenova via Amazon comprised 52% and 42% of total Avenova net revenue, respectively. During the six months ended June 30, 2021 and 2020, sales of Avenova via Amazon comprised 58% and 46% of total Avenova net revenue, respectively. No other individual distributor comprised greater than 10% of total Avenova net revenue during the three and six months ended June 30, 2021 and 2020.

 

As of June 30, 2021 and December 31, 2020, accounts receivable from our major distribution partners greater than 10% were as follows:

 

   

June 30,

   

December 31,

 

Major distribution partner

 

2021

   

2020

 
Distributor C     29 %     14 %

Distributor A

    19

%

    18

%

CVS     14 %     * %

Avenova Direct via Amazon

    13

%

    11

%

Congqing Pioneer Pharma Holdings Limited

    10

%

    16

%

Distributor B     *       14 %

* Less than 10% 

 

The Company relies on two contract manufacturers to produce its products. The Company does not own any manufacturing facilities and intends to continue to rely on third parties for the supply of finished goods. Contract manufacturers may or may not be able to meet the Company’s needs with respect to timing, quantity or quality. In particular, it is possible that we may suffer from unexpected supply chain delays in light of the ongoing COVID-19 pandemic.

 

Fair Value of Financial Assets and Liabilities

 

The Company’s financial instruments include cash and cash equivalents, restricted cash, accounts receivable, accounts payable, and accrued liabilities. The Company’s cash and cash equivalents, accounts receivable, accounts payable, and accrued liabilities are carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

 

The Company follows Accounting Standards Codification (“ASC”) 820, Fair Value Measurements and Disclosures, with respect to assets and liabilities that are measured at fair value on a recurring basis and nonrecurring basis. Under this standard, fair value is defined as the exit price, or the amount that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants as of the measurement date. The standard also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimizes the use of unobservable inputs by requiring that the most observable inputs be used when available. Observable inputs are inputs market participants would use in valuing the asset or liability developed based on market data obtained from sources independent of the Company. Unobservable inputs are inputs that reflect the Company’s assumptions about the factors market participants would use in valuing the asset or liability developed based upon the best information available in the circumstances. There are three levels of inputs that may be used to measure fair value:

 

Level 1 – quoted prices in active markets for identical assets or liabilities;

Level 2 – quoted prices for similar assets and liabilities in active markets or inputs that are observable; and

Level 3 – inputs that are unobservable (for example, cash flow modeling inputs based on assumptions).

 

Categorization within the valuation hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

 

Allowance for Doubtful Accounts

 

The Company charges bad debt expense and records an allowance for doubtful accounts when management believes it to be unlikely that specific invoices will be collected. Management identifies amounts due that are in dispute and it believes are unlikely to be collected. At June 30, 2021 and December 31, 2020, management recorded no reserve for accounts receivable.

 

Inventory

 

Inventory is comprised of (1) raw materials and supplies, such as bottles, packaging materials, labels, boxes and pumps; (2) goods in progress, which are normally filled but unlabeled bottles; and (3) finished goods. We utilize contract manufacturers to produce our products and the price paid to these manufacturers is included in inventory. Inventory is stated at the lower of cost or estimated net realizable value determined by the first-in, first-out method. At both June 30, 2021 and December 31, 2020, management had recorded an allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments of $0.2 million.  

 

- 11-

 

Property and Equipment

 

Property and equipment are stated at cost, less accumulated depreciation and amortization. Depreciation is calculated using the straight-line method over the estimated useful lives of the related assets of five to seven years for office equipment, three years for computer equipment and software, and seven years for furniture and fixtures. Leasehold improvements are amortized over the lease term.

 

The costs of normal maintenance, repairs, and minor replacements are expensed as incurred. 

 

Leases

 

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use assets may be required for items such as initial direct costs paid or incentives received.

 

The Company has elected to combine lease and non-lease components as a single component for all leases in which it is a lessee or a lessor. The lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, as of the effective date, the Company no longer recognizes deferred rent on the consolidated balance sheets.

 

Comprehensive Income (Loss)

 

ASC 220, Comprehensive Income, requires that an entity's change in equity or net assets during a period from transactions and other events from non-owner sources be reported.

 

Revenue Recognition

 

Revenue generated through the Company’s webstores, Avenova.com and CelleRx.com, for Avenova and CelleRx (as well as the KN95 Masks) is recognized upon fulfillment, which generally occurs upon delivery of the related products to multiple third-party carriers. Shipping and handling costs are expensed as incurred and included in cost of goods sold in the consolidated statements of operations and comprehensive loss. We present revenue net of sales taxes and refunds.

 

Revenue generated through Amazon.com and Walmart.com is recognized upon fulfillment, which generally occurs upon delivery of the related products to a third-party carrier. We present revenue net of commissions and any related fulfillment and shipping fees charged by these partners. Fees paid to partners for promoting our products are expensed as incurred and are included in sales and marketing expenses within the operating expenses in the consolidated statements of operations and comprehensive loss.

 

The Company also generates Avenova product revenue through product sales to its major distribution partners. Product supply of Avenova is the only performance obligation contained in these arrangements, and the Company recognizes product revenue upon transfer of control to its major distribution partners at the amount of consideration that the Company expects to be entitled to, generally upon receipt by the distributor on a “sell-in” basis. Upon recognition of product sales, contract liabilities are recorded for invoiced amounts that are subject to significant reversal, including product revenue allowances for cash consideration paid to customers for services, discounts, rebate programs, and product returns. The Company derives its rate of return from historical data and updates its return rate assumption quarterly. Payment for product supply is typically due 30 days after control transfers to the distributor.

 

Revenue gener

ated through the Company’s partner pharmacies is recognized when control of the product transfers to the end customer. Revenue for product sales to CVS is recognized upon transfer of control to CVS, which generally occurs upon delivery of the related products to a third-party carrier, net of estimated future product returns.

 

Cost of Goods Sold

 

Cost of goods sold includes third-party manufacturing costs, shipping and handling costs, and other costs associated with products sold. Cost of goods sold also includes any necessary allowance for excess and obsolete inventory along with lower of cost and estimated net realizable value.

 

Research and Development Costs

 

The Company charges research and development costs to expense as incurred. These costs include all costs associated with research, development and regulatory activities, including submissions to the Food and Drug Administration (“FDA”).

 

- 12-

 

Patent Costs

 

Patent costs, including legal expenses, are expensed in the period in which they are incurred. Patent expenses are included in general and administrative expenses in the condensed consolidated statements of operations and comprehensive loss.

 

Advertising Costs

 

Advertising costs are expensed in the period in which the costs are incurred. Advertising expenses were $0.7 million and $0.3 million for the three months ended June 30, 2021 and 2020, respectively. Advertising expenses were $1.5 million and $0.7 million for the six months ended June 30, 2021 and 2020, respectively.

 

Stock-Based Compensation

 

The Company’s stock-based compensation includes grants of stock options and restricted stock units (“RSUs”) to employees, consultants and non-employee directors. The expense associated with these grants is recognized in the Company’s condensed consolidated statements of stockholders’ equity (deficit) based on their fair values as they are earned under the applicable vesting terms. For stock options granted, the fair value of the stock options is estimated using a Black-Scholes option pricing model. See Note 13, “Equity-Based Compensation” for further information regarding stock-based compensation expense and the assumptions used in estimating that expense. The Company accounts for RSUs issued to employees and non-employees (board members and consultants) based on the fair market value of the Company’s common stock as of the date of issuance.

 

Income Taxes

 

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not that some portion or the entire deferred tax asset will not be recognized.

 

Common Stock Warrant Liability

 

The Company accounts for common stock purchase warrants issued in connection with its equity offerings in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging.

 

The Company accounts for common stock purchase warrants issued in connection with share-based compensation arrangements in accordance with the provisions of ASC 718, Stock Compensation, which encompasses the provisions of ASC 480, Distinguishing Liabilities from Equity.

 

The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). Additionally, for common stock purchase warrants accounted for in accordance with ASC 718, Stock Compensation, the Company classifies as liabilities any contracts where it believes the warrants are deemed to be probable of issuance.

 

For warrants that are classified as liabilities, the Company records the fair value of the warrants at each balance sheet date and records changes in the estimated fair value as a non-cash gain or loss in the consolidated statements of operations and comprehensive loss. The fair values of these warrants are determined using the Black-Scholes option pricing model, the Binomial Lattice (“Lattice”) valuation model, or the Monte Carlo simulation model where deemed appropriate. These values are subject to a significant degree of management’s judgment.

 

Net Loss Per Share

 

The Company computes net loss per share by presenting both basic and diluted earnings (loss) per share (“EPS”).

 

Basic EPS is computed by dividing net loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted EPS gives effect to all dilutive potential common shares outstanding during the period, including stock options and warrants, using the treasury stock method. In computing diluted EPS, the average stock price for the period is used to determine the number of shares assumed to be purchased from the exercise of stock options or warrants. Potentially dilutive common share equivalents are excluded from the diluted EPS computation in net loss periods because their effect would be anti-dilutive.

 

- 13-

 

During the three and six months ended June 30, 2021 and 2020, there was no difference between basic and diluted EPS in each period due to the Company’s net loss.

 

The following table sets forth the calculation of basic EPS and diluted EPS (in thousands, except per share amounts):

 

   

Three Months Ended

June 30,

   

Six Months Ended June 30,

 

Numerator

 

2021

   

2020

   

2021

   

2020

 

Net loss

  $ (1,859 )   $ (4,482 )   $ (3,377 )   $ (6,064 )
                                 

Denominator

                               

Weighted average shares of common stock outstanding, basic and diluted

    42,561       30,384       42,174       29,012  

Net loss per share, basic and diluted

  $ (0.04 )   $ (0.15 )   $ (0.08 )   $ (0.21 )

 

 

The following outstanding stock options and stock warrants were excluded from the diluted EPS computation as their effect would have been anti-dilutive (in thousands):

 

   

As of June 30,

 
   

2021

   

2020

 

Stock options

    3,873       2,692  

Stock warrants

    7,082       7,105  
      10,955       9,797  

 

Recent Accounting Pronouncements

 

For information regarding recent accounting pronouncements that could affect our business, results of operations, financial condition, and liquidity, see Note 2, “Summary of Significant Accounting Policies” included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 25, 2021.

 

- 14-

 

 

 

NOTE 3. FAIR VALUE MEASUREMENTS

 

The Company’s cash equivalents are classified within Level 1 of the fair value hierarchy because they are valued using quoted market prices in active markets, broker or dealer quotations, or alternative pricing sources with reasonable levels of price transparency. The types of investments that are generally classified within Level 1 of the fair value hierarchy include money market securities and certificates of deposit.

 

The following table presents the Company’s assets measured at fair value on a recurring basis as of June 30, 2021 (in thousands):

 

           

Fair Value Measurements Using

 
Assets  

Balance at

June 30,

2021

   

Quoted

Prices in

Active

Markets

for

Identical

Items

(Level 1)

   

Significant

Other

Observable

Inputs

(Level 2)

   

Significant

Unobservable

Inputs

(Level 3)

 

Restricted cash held as a certificate of deposit

  $ 324     $ 324     $     $  

Deposit held as a certificate of deposit

    151       151              

Total assets

  $ 475     $ 475     $     $  

 

The following table presents the Company's assets measured at fair value on a recurring basis as of December 31, 2020 (in thousands):

 

           

Fair Value Measurements Using

 
Assets  

Balance at

December 31,

2020

   

Quoted

Prices in

Active

Markets

for

Identical

Items

(Level 1)

   

Significant

Other

Observable

Inputs

(Level 2)

   

 

Significant

Unobservable

Inputs

(Level 3)

 

Restricted cash held as a certificate of deposit

  $ 324     $ 324     $     $  

Deposit held as a certificate of deposit

    151       151              

Total assets

  $ 475     $ 475     $     $  

 

There were no liabilities measured at fair value on a recurring basis as of June 30, 2021 or December 31, 2020. 

 

 

 

NOTE 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS

 

Prepaid expenses and other current assets consisted of the following (in thousands):

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 

Prepaid insurance

  $ 168     $ 165  

Prepaid inventory

    104        

Prepaid financing costs

    68        

Prepaid dues and subscriptions

    54       53  

Prepaid sales rebates (Avenova contract asset)

    42       144  

Prepaid patents

    31       47  

Prepaid security deposit for lease

          65  

Other

    97       102  

Total prepaid expenses and other current assets

  $ 564     $ 576  

 

- 15-

 

 

 

NOTE 5. INVENTORY   

 

Inventory consisted of the following (in thousands):

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 

Raw materials and supplies

  $ 294     $ 159  

Finished goods

    573       685  

Less: Reserve for excess and obsolete inventory

    (185

)

    (236

)

Total inventory, net

  $ 682     $ 608  

 

 

 

NOTE 6. PROPERTY AND EQUIPMENT

 

Property and equipment consisted of the following (in thousands):

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 

Computer equipment and software

  $ 395     $ 365  

Furniture and fixtures

    157       157  

Leasehold improvements

    79       79  

Production equipment

    65       65  

Office equipment

    20       20  

Total property and equipment, at cost

    716       686  

Less: accumulated depreciation and amortization

    (622

)

    (602

)

Total property and equipment, net

  $ 94     $ 84  

 

Depreciation and amortization expense was $11 thousand and $14 thousand for the three months ended June 30, 2021 and 2020, respectively, and $20 thousand and $28 thousand for the six months ended June 30, 2021 and 2020, respectively.

 

 

 

NOTE 7. ACCRUED LIABILITIES

 

Accrued liabilities consisted of the following (in thousands):

 

   

June 30,

   

December 31,

 
   

2021

   

2020

 

Avenova contract liabilities

  $ 943     $ 730  

Employee payroll and benefits

    421       632  

Consulting services

    208       98  

Inventory purchases

    121       181  

Sublease security deposit

          198  

Other

    190       276  

Total accrued liabilities

  $ 1,883     $ 2,115  

 

- 16-

 

 

 

NOTE 8. COMMITMENTS AND CONTINGENCIES 

 

Directors and Officers Indemnification

 

As permitted under Delaware law and in accordance with its bylaws, the Company indemnifies its officers and directors for certain events or occurrences while the officer or director is or was serving at the Company’s request in such capacity. The term of the indemnification period is for the officer’s or director’s lifetime. The maximum amount of potential future indemnification is unlimited; however, the Company has a director and officer insurance policy that limits its exposure and may enable it to recover a portion of any future payments. The Company believes the fair value of these indemnification agreements is minimal. Accordingly, it has not recorded any liabilities for these agreements as of June 30, 2021. 

 

In the normal course of business, the Company provides indemnification of varying scope under its agreements with other companies, typically its clinical research organizations, investigators, clinical sites, suppliers and others. Pursuant to these agreements, it generally indemnifies, holds harmless, and agrees to reimburse the indemnified parties for losses suffered or incurred by the indemnified parties in connection with the use or testing of its products or product candidates or with any U.S. patent or any copyright or other intellectual property infringement claims by any third party with respect to its products. The term of these indemnification agreements is generally perpetual. The potential future payments the Company could be required to make under these indemnification agreements is unlimited. Historically, costs related to these indemnification provisions have been immaterial. The Company also maintains various liability insurance policies that limit its exposure. As a result, it believes the fair value of these indemnification agreements is minimal. Accordingly, the Company has not recorded any liabilities for these agreements as of June 30, 2021. 

 

- 17-

 

Legal Matters

 

On July 29, 2019, Mr. John McGovern, the Company’s former Interim President & Chief Executive Officer and Chief Financial Officer, submitted a demand for arbitration in connection with his separation from service with the Company. The arbitration was settled in December 2020. Mr. McGovern released the Company from all outstanding obligations upon settlement.

 

The Company’s insurance carrier determined that the Company was entitled to a $0.3 million reimbursement for litigation costs incurred in conjunction with the McGovern matter. The Company received a $0.3 million reimbursement on April 23, 2021 which was offset against general and administrative expenses in the Company’s Consolidated Statement of Operation and Comprehensive Loss for the three months ended March 31, 2021.

 

As of June 30, 2021, there were no other matters that, in the opinion of management, would ultimately result in liability that would have a material adverse effect on the Company’s financial position, results of operations or cash flows.

 

Leases

 

The Company leases office space for its corporate headquarters located in Emeryville, California. The initial lease term is through February 28, 2022. The Company has the option to extend the term of the lease for one five (5)-year period upon written notice to the landlord. The Company intends to exercise the renewal option for this lease.

 

The Company also had a lease commitment for laboratory facilities and office space at EmeryStation North in Emeryville, California (“EmeryStation”) under an operating lease. In July 2016, the Company subleased the EmeryStation space (the “Sublease Agreement”). The Sublease Agreement commenced September 8, 2016. The EmeryStation lease and Sublease Agreement were terminated as of August 31, 2020 pursuant to a sublease termination agreement executed on July 31, 2020.

 

The components of lease expense for the three and six months ended June 30, 2021 and 2020 were as follows (in thousands):

 

Lease Costs

 

Three Months Ended

June 30,

   

Six Months Ended

June 30,

 
   

2021

   

2020

   

2021

   

2020

 

Operating lease cost

  $ 99     $ 250     $ 199     $ 514  

Sublease income

          (158

)

          (316

)

Net lease cost

  $ 99     $ 92     $ 199     $ 198  
                                 

Other information

                               

Operational cash flow used for operating leases

  $ 113     $ 284     $ 226     $ 580  

 

The Company has measured its operating lease liabilities at its incremental borrowing rate over the remaining term for each operating lease. The weighted average remaining lease term and the weighted average discount rate are summarized as follows:

 

 

   

June 30, 2021

   

June 30, 2020

 

Weighted-average remaining lease term (in years)

    0.7       1.4  

Weighted-average discount rate

    12

%

    12

%

 

- 18-

 

Future lease payments under non-cancelable leases as of June 30, 2021 were as follows (in thousands):

 

2021

  $ 228  

2022

    89  

Thereafter

     

Total future minimum lease payments

    317  

Less imputed interest

    (14

)

Total

  $ 303  
         

Reported as:

       

Operating lease liability

  $ 298  

Operating lease liability- non-current

    5  

Total

  $ 303  

 

Contracts

 

On May 13, 2020, the Company entered into an agreement with TLF Bio Innovation Lab LLC (“TLF Bio Innovation”) to manage the relaunch of the Company’s CelleRx product (the “TLF Agreement”) which was further amended on September 4, 2020 and subsequently terminated on February 4, 2021. TLF Bio Innovation was granted warrants exercisable for 15,000 shares of the Company’s common stock with an exercise price of $0.6718 on January 15, 2021.

 

On April 16, 2020, the Company entered into an international distribution agreement with Shenzhen Microprofit Biotech Co., Ltd. (“Microprofit”) (the “Microprofit Agreement”). In accordance with the Microprofit Agreement, the Company assisted Microprofit in applying for approval of Microprofit’s SARS-CoV-2 IgG and IgM Antibody Combined Test Kit (“Test Kits”) by the FDA. Under the terms of the Microprofit Agreement, if such approvals were granted, the Company would issue warrants to certain Microprofit officers exercisable for an aggregate number of shares of the Company’s common stock equivalent to 12% of the Company’s outstanding common stock on the date of approval. If FDA approval were received, the Microprofit Agreement would grant the Company exclusive rights to distribute the Test Kits in the United States through December 31, 2021. As of June 30, 2021, the Company determined that the issuance of warrants under the Microprofit Agreement is not probable. Accordingly, the parties mutually agreed to terminate the agreement subsequent to June 30, 2021 on August 10, 2021.

 

In connection with the Microprofit Agreement, on April 16, 2020, the Company entered into an intermediary distribution agreement with Chongqing Pioneer Pharma Holdings Limited (“Chongqing Pioneer”), a related party, which was subsequently amended on June 29, 2020 (the “Distribution Agreement”). The Distribution Agreement provided that the Company will purchase all Test Kits from Chongqing Pioneer as an intermediary. The Distribution Agreement was terminated subsequent to June 30, 2021 on August 10, 2021.

 

 

 

NOTE 9. RELATED PARTY NOTE PAYABLE

 

On February 27, 2019, the Company issued a $1.0 million promissory note payable to Pioneer Pharma (Hong Kong) Company Ltd. (“Pioneer Pharma”), which was amended on June 25, 2019 and May 14, 2020 (the “Promissory Note”). The Promissory Note provided for an interest payment of $0.2 million which was initially amended to a payment of $0.3 million and subsequently amended to replace the cash interest payment with the delivery of 65,178 units of NeutroPhase (40ml) to Pioneer Pharma. The second amendment to the Promissory Note also provided the Company with the right to repay the note at any time. On May 14, 2020, the Company repaid the $1.0 million principal balance of the Promissory Note using proceeds raised through the at-the-market offering and equity program (“ATM Program”) (see Note 12, “Stockholders’ Equity”). The Company settled the accrued interest through two separate shipments of NeutroPhase in 2020. Upon full repayment of principal and interest during the year ended December 31, 2020, the Company was released from the Promissory Note with Pioneer Pharma.

 

In connection with the Promissory Note, the Company paid China Kington a 2% fee for brokering the transaction and entered into a consulting agreement with China Kington for a term of one year, which expired on March 1, 2020 (the “Consulting Agreement”). Bob Wu, acting in a dual role as a member of the Company’s Board of Directors (the “Board”) and as principal of China Kington, was paid $0.1 million pursuant to the Consulting Agreement. Upon the expiration of the Consulting Agreement, the parties entered into a new consulting agreement, in which no cash compensation will be paid. Debt issuance costs associated with the issuance of the Promissory Note of $20 thousand was recognized and recorded as an offset to the related party note payable in the consolidated balance sheets.

 

The interest expense recognized, including amortization of the issuance costs, was $27 thousand and $75 thousand during the three and six months ended June 30, 2020, respectively. There was no comparable expense during the three and six months ended June 30, 2021.

 

- 19-

 

 

 

NOTE 10. CONVERTIBLE NOTE

 

On March 26, 2019, the Company entered into a Securities Purchase Agreement with Iliad Research and Trading, L.P. (the “Lender”), pursuant to which the Company issued a Secured Convertible Promissory Note (the “Convertible Note”) to the Lender dated as of March 26, 2019. The Convertible Note had an original principal amount of $2.2 million, bore interest at a rate of 10% per annum and matured on September 26, 2020, unless earlier paid, redeemed or converted in accordance with its terms. The Company received net proceeds of $2.0 million after deducting an original issue discount of $0.2 million and debt issuance cost of Lender’s transaction fees of $15 thousand. The Company recognized an additional $0.2 million of debt issuance costs associated with the issuance of the Convertible Note. The Convertible Note was repaid in full during the third quarter of 2020. Upon full repayment, the Company was released from the Iliad Securities Purchase Agreement with Lender.

 

During the three and six months ended June 30, 2020, the Company recorded a gain of $0 and $2 thousand, respectively, in the unaudited condensed consolidated statements of operations and comprehensive loss. There was no comparable gain or loss during the three and six months ended June 30, 2021.

 

During both the three and six months ended June 30, 2020, the effective interest rate on the Convertible Note was 37% and 43%, respectively. Interest expense recognized, including amortization of the issuance costs and debt discount, was $59 thousand and $199 thousand during the three and six months ended June 30, 2020, respectively. There was no comparable expense during the three and six months ended June 30, 2021.

 

 

 

NOTE 11. WARRANT LIABILITY  

 

July 2011 Warrants

 

The Company issued the July 2011 Warrants (as defined in Note 12, “Stockholders’ Equity”) in the third quarter of 2011. The terms of the July 2011 Warrants required registered shares to be delivered upon warrant exercise and potential cash-settlement in the event of a specified fundamental transaction. Under ASC 480, Distinguishing Liabilities from Equity, the warrants were classified as liabilities because the Company’s potential obligation to deliver registered shares and cash-settle the warrants were deemed to be beyond the Company’s control. The fair value of outstanding July 2011 Warrants was determined at each reporting date using a Lattice model with changes in fair value recorded in the consolidated statements of operations and comprehensive loss.

 

On March 6, 2020, the remaining 35,107 July 2011 Warrants expired unexercised. There were no July 2011 Warrants outstanding as of June 30, 2021.

 

October 2015 Warrants

 

The Company issued the October 2015 Warrants (as defined in Note 12, “Stockholders’ Equity”) in the third quarter of 2015. The terms of the October 2015 Warrants required potential cash-settlement in the event of a specified fundamental transaction. Under ASC 480, Distinguishing Liabilities from Equity, the warrants were classified as liabilities because the Company’s potential obligation to cash-settle the warrants was deemed to be beyond the Company’s control. The fair value of outstanding October 2015 Warrants was determined at each reporting date using a Lattice model with changes in fair value recorded in the consolidated statements of operations and comprehensive loss.

 

During the fourth quarter of 2020, a total of 22,680 October 2015 Warrants were exercised, resulting in gross proceeds of $5 thousand. The liability associated with these warrants was adjusted to fair value of $12 thousand as of the date of exercise, with the change in fair value recorded in the consolidated statements of operations and comprehensive loss. The fair value was then transferred to equity.

 

On October 27, 2020, 15,320 October 2015 expired unexercised. There were no October 2015 Warrants outstanding as of June 30, 2021.

 

2019 Domestic, Foreign & Ladenburg Warrants

 

As further described in Note 12, “Stockholders’ Equity”, the Company issued the 2019 Domestic Warrants, the 2019 Foreign Warrants and the 2019 Ladenburg Warrants in the third quarter of 2019. The terms of the 2019 Domestic Warrants, 2019 Foreign Warrants and 2019 Ladenburg Warrants all required potential cash-settlement in the event of a specified fundamental transaction. Under ASC 480, Distinguishing Liabilities from Equity, the warrants were classified as liabilities because the Company’s potential obligation to cash-settle the warrants was deemed to be beyond the Company’s control. The fair value of outstanding warrants was determined at each reporting date using a Black-Scholes option pricing model with the changes in fair value recorded in the consolidated statements of operations and comprehensive loss.

 

Upon issuance, the fair value of the 2019 Domestic Warrants, 2019 Foreign Warrants and 2019 Ladenburg Warrants was determined to be $3.1 million, $2.0 million and $0.1 million, respectively.

 

- 20-

 

In the third quarter of 2020, as further described in Note 12, “Stockholders’ Equity”, the 2019 Domestic Warrants and 2019 Foreign Warrants were exercised at reduced exercise prices. The warrant liabilities associated with these warrants was adjusted to their fair values as of the date of exercise, with the change in fair values recorded in the consolidated statements of operations and comprehensive loss. The fair values were then transferred to equity. As of the date of exercise, the fair value of the 2019 Domestic Warrants and 2019 Foreign Warrants was determined to be $4.9 million and $4.2 million, respectively, in accordance with the following key assumptions:

 

Assumptions

 

2019 Domestic

Warrants

   

2019 Foreign

Warrants

 

Expected price volatility

    178

%

    178

%

Expected term (in years)

    4.57       4.57  

Risk-free interest rate

    0.25

%

    0.27

%

Dividend yield

    0.00

%

    0.00

%

Weighted-average fair value of warrant

  $ 1.18     $ 1.54  

 

There were no 2019 Domestic Warrants or 2019 Foreign Warrants outstanding as of June 30, 2021.

 

In the third quarter of 2020, as further described in Note 12, “Stockholders’ Equity”, the Company amended the 2019 Ladenburg Warrants. The Company’s potential obligation to cash-settle the warrants if a specified fundamental transaction occurred was amended to apply only in situations within the Company’s control. Pursuant to this change, the 2019 Ladenburg Warrants were no longer classified as liabilities. The warrant liability associated with these warrants was adjusted to fair value as of the date of the amendment, with the change in fair value recorded in the consolidated statements of operations and comprehensive loss. The fair value was then transferred to equity. The fair value of the 2019 Ladenburg Warrants was determined to be $0.2 million on the date of amendment in accordance with the following key assumptions:

 

Expected price volatility

    186

%

Expected term (in years)

    4.05  

Risk-free interest rate

    0.22

%

Dividend yield

    0.00

%

Weighted-average fair value of warrants

  $ 1.17  

 

 

The 2019 Ladenburg Warrants will no longer be adjusted to fair value in reporting periods after the amendment. All 2019 Ladenburg Warrants remained outstanding as of June 30, 2021.

 

 

 

NOTE 12. STOCKHOLDERSEQUITY

 

Preferred Stock

 

The Company is authorized to issue up to 5,000,000 shares of preferred stock with rights and preferences as may be approved by its Board of Directors under its Amended and Restated Certificate of Incorporation. There were no shares of preferred stock outstanding as of June 30, 2021 and December 31, 2020.

 

Common Stock

 

April 2020 At the Market Offering

 

In the second quarter of 2020, the Company established the 2020 ATM Program with Ladenburg Thalmann & Co. Inc. (“Ladenburg”). For additional information regarding the offering and equity program, see the Company’s Current Reports on Form 8-K filed with the SEC on April 27, 2020 and June 15, 2020. During the second quarter of 2020, 5,836,792 shares of common stock were issued under the 2020 ATM Program for total net proceeds of $5.6 million, net of offering costs of $0.4 million.

 

May 2021 At the Market Offering

 

In the second quarter of 2021, the Company established the 2021 ATM Program with Ladenburg. For additional information regarding the offering and equity program, see the Company’s Current Report on Form 8-K filed with the SEC on May 14, 2021. During the second quarter of 2021, 2,672,000 shares of common stock were issued under the 2021 ATM Program for total net proceeds of $1.8 million, net of offering costs of $0.1 million.

 

TLF Bio Innovation Stock Purchase

 

On May 13, 2020, TLF Bio Innovation purchased 1,000 shares of the Company’s common stock for total proceeds of $1 thousand pursuant to the TLF Agreement described in Note 8, “Commitments and Contingencies”.

 

Common Stock Warrants

 

July 2011 Warrants

 

In the third quarter of 2011, the Company issued 139,520 common stock purchase warrants exercisable for 139,520 shares of common stock in connection with a registered direct financing (the “July 2011 Warrants”). The July 2011 Warrants were issued with an exercise price of $33.25 and an expiration date of July 5, 2016. In October 2015, in connection with a separate financing event, the exercise price of outstanding July 2011 Warrants was reduced to $5.00 per share and the expiration date extended to March 6, 2020. In February 2016 and May 2019, the exercise price of outstanding July 2011 Warrants was reduced to $1.81 and $0.2061 per share, respectively, pursuant to price protection provisions of the warrants.

 

- 21-

 

In March 2020, a total of 35,107 July 2011 Warrants expired unexercised. As of June 30, 2021, there were no July 2011 Warrants outstanding.

 

March 2015 Warrants

 

In the first quarter of 2015, the Company issued 649,133 common stock purchase warrants exercisable for 649,133 shares of common stock in connection with a private placement offering (the “March 2015 Warrants”). The exercise price of individual March 2015 Warrants varied between $15.00 and $16.25 per share at the time of issuance. The Company issued 278,200 of the March 2015 Warrants with an expiration date of March 6, 2020 and the remaining 370,933 March 2015 Warrants with an expiration date of June 6, 2015. In October 2015, in connection with a separate financing event, the exercise price of all outstanding March 2015 Warrants was reduced to $5.00 per share and the expiration date of all outstanding warrants expiring on June 6, 2015 was extended to March 6, 2020. In February 2016 and May 2019, the exercise price of all outstanding July 2011 Warrants was reduced to $1.81 and $0.2061 per share, respectively, pursuant to price protection provisions of the warrants.

 

During the first quarter of 2020, a total of 70,000 March 2015 Warrants were exercised, resulting in gross proceeds of $14 thousand. Also in the first quarter of 2020, all remaining 7,419 March 2015 Warrants expired unexercised. As of June 30, 2021, there were no March 2015 Warrants outstanding.

 

October 2015 Warrants

 

In the fourth quarter of 2015, the Company issued 442,802 common stock purchase warrants exercisable for 442,802 shares of common stock in connection with a public offering (the “October 2015 Warrants”). The warrants were issued with an exercise price of $5.00 and an expiration date of October 27, 2020. In February 2016 and May 2019, the exercise price of outstanding October 2015 Warrants was reduced to $1.81 and $0.2061 per share, respectively, pursuant to price protection provisions of the warrants. Also during the fourth quarter of 2020, a total of 22,680 October 2015 Warrants were exercised, resulting in gross proceeds of $5 thousand.

 

During the fourth quarter of 2020, all remaining 15,320 October 2015 Warrants expired unexercised. As of June 30, 2021, there were no October 2015 Warrants outstanding.

 

June 2019 Private Placement and June 2019 Warrants

 

During the second quarter of 2019, the Company entered into a private placement agreement to sell 1,371,427 shares of common stock and 1,371,427 common stock purchase warrants exercisable for 1,371,427 shares of common stock (the “June 2019 Warrants”) for an aggregate subscription price of $2.4 million. Three accredited investors, Messrs. Xiao Rui Liu, Hai Dong Pang and Ping Huang, subscribed to the private placement for $1.0 million, $0.4 million and $1.0 million, respectively. China Kington served as placement agent in exchange for a commission equal to six percent (6%) of the gross proceeds, totaling $0.1 million. The Company also paid other offering costs of $27 thousand.

 

The June 2019 Warrants were issued with an exercise price of $0.87 and an expiration date of June 17, 2020. The June 2019 Warrants were callable by the Company if the closing price of the Company’s common stock, as reported on the NYSE American, was $1.00 or greater.

 

During the first quarter of 2020, a total of 228,571 June 2019 Warrants were exercised, resulting in gross proceeds of $199 thousand. The Company paid China Kington a fee of $12 thousand, or six percent (6%) of the gross proceeds, for brokering the exercise transaction.

 

During the second quarter of 2020, a total of 571,428 June 2019 Warrants were exercised, resulting in gross proceeds of $497 thousand. The Company paid China Kington a fee of $29 thousand, or six percent (6%) of the gross proceeds, for brokering the exercise transaction. Also during the second quarter of 2020, all remaining 571,428 June 2019 Warrants expired unexercised. As of June 30, 2021, there were no June 2019 Warrants outstanding.

 

- 22-

 

August 2019 Common Stock Purchase Agreement, 2019 Domestic Warrants, 2019 Ladenburg Warrants and 2019 Foreign Warrants

 

In the third quarter of 2019, the Company entered into a purchase agreement (the “2019 Purchase Agreement”) for the sale of (i) 4,198,566 shares of common stock and (ii) 4,198,566 common stock purchase warrants exercisable for 4,198,566 shares of common stock (the “2019 Domestic Warrants”) for gross proceeds of $4.2 million. The 2019 Domestic Warrants were issued with an exercise price of $1.15 and an expiration date of February 13, 2025.

 

The Company allocated the proceeds between the common stock and 2019 Domestic Warrants by applying the relative fair value allocation methodology. The Company first allocated $3.1 million to the 2019 Domestic Warrants, with the residual amount allocated to the common stock. See Note 11, “Warrant Liability” for further discussion of the key assumptions used to value the 2019 Domestic Warrants.

 

Ladenburg served as the placement agent for the transaction in exchange for a commission representing six percent (6%) of the gross proceeds, totaling $0.3 million, and 167,942 common stock purchase warrants exercisable for 167,942 shares of common stock with an exercise price of $1.25 per share and an expiration date of August 8, 2024 (the “2019 Ladenburg Warrants”). In addition, the Company reimbursed the Placement Agent $60 thousand for certain expenses. The Company also incurred and paid other offering costs of $0.3 million.

 

The Company incurred total issuance costs of $0.5 million in conjunction with the 2019 Purchase Agreement. The Company allocated $0.2 million of the issuance costs to the warrant liability which was expensed in the Company’s consolidated statements of operations and comprehensive loss during the period. The remaining $0.3 million was recorded as a reduction of additional paid-in capital in the Company’s consolidated balance sheets. As the 2019 Ladenburg Warrants were accounted for as a stock issuance cost, $59 thousand was allocated to the warrant liability and expensed during the period and $65 thousand was recorded as a reduction to additional paid-in capital in the Company’s consolidated balance sheets. See Note 11, “Warrant Liability” for a discussion of the key assumptions used to value the 2019 Ladenburg Warrants.

 

During the third quarter of 2020, the Company and the holders of the 2019 Domestic Warrants and the 2019 Foreign Warrants entered into exercise agreements which resulted in the cash exercise of the warrants at a reduced exercise price of $0.99. The Company received aggregate gross proceeds of approximately $6.8 million from the exercises. The Company incurred and paid other offering costs of $0.2 million. The Company also incurred and paid a $0.2 million fee to China Kington for brokering the transaction, which equaled six percent (6%) of the gross proceeds from the 2019 Foreign Warrants.

 

During the third quarter of 2020, the Company and all holders of the 2019 Domestic Warrants and 2019 Foreign Warrants entered into warrant repricing letter agreements. Pursuant to the agreement, in consideration for the exercise in full of the 2019 Domestic Warrants and 2019 Foreign Warrants, the Company agreed to: (1) reduce the exercise price of the 2019 Domestic Warrants and the 2019 Foreign Warrants to $0.99 per share prior to exercise, and (2) in a private placement, issue new common stock purchase warrants (the “New Warrants”) to purchase up to a number of shares of common stock, equal to 100% of the number of 2019 Domestic Warrants and 2019 Foreign Warrants currently held by such holders upon the holders exercising their warrants.

 

The New Warrants became exercisable six months after their issuance, for an aggregate of 6,898,566 shares of common stock. The New Warrants have an exercise price of $1.65 per share and will expire five and a half years after their issuance. The Company determined that the common stock issued from the exercise of the 2019 Domestic and 2019 Foreign Warrants, and the New Warrants to be one unit of account, and therefore did not allocate the proceeds between the common stock and the New Warrants as, the proceeds, even if allocated, would be both recognized in additional paid-in capital.

 

During the third quarter of 2020, the Company also entered into a reprice agreement with Ladenburg which reduced the exercise price to $0.99 per share and amended certain terms of the 2019 Ladenburg Warrants. The Company’s potential obligation to cash-settle the warrants if a specified fundamental transaction occurred was amended to apply only in situations within the Company’s control. As further described in Note 11, “Warrant Liability”, the 2019 Ladenburg Warrants were no longer classified as a liability as a result of this amendment.

 

TLF Bio Innovation 2021 Warrants

 

On January 15, 2021, TLF Bio Innovation was granted warrants exercisable for 15,000 shares of the Company’s common stock with an exercise price of $0.6718 (the “TLF Warrants”) pursuant to the TLF Agreement described in Note 8, “Commitments and Contingencies”. The TLF Warrants will expire five years after their issuance. The TLF Warrants are classified as equity.

 

- 23-

 

The details of all outstanding warrants as of June 30, 2021 were as follows:

 

   

Warrants
(in thousands)

   

Weighted-

Average

Exercise

Price

 

Outstanding at December 31, 2020

    7,067     $ 1.63  

Warrants granted

    15     $ 0.67  

Warrants exercised

        $  

Warrants expired

        $  

Outstanding at June 30, 2021

    7,082     $ 1.63  

 

 

 

NOTE 13. EQUITY-BASED COMPENSATION

 

Equity Compensation Plans 

 

In October 2007, the Company adopted the 2007 Omnibus Incentive Plan (the “2007 Plan”) to provide for the granting of equity awards, such as stock options, unrestricted and restricted common stock, stock units, dividend equivalent rights, and stock appreciation rights to employees, directors and outside consultants, as determined by the Board. The 2007 Plan expired on March 15, 2017. Upon expiration, new awards cannot be issued pursuant to the 2007 Plan, but outstanding awards continue to be governed by its terms. Stock options granted under the 2007 Plan expire no later than ten years from the date of grant. All stock options outstanding under the 2007 Plan were fully vested as of December 31, 2020.

 

In March 2017, the Company adopted the 2017 Omnibus Incentive Plan (the “2017 Plan”), which was approved by stockholders on June 2, 2017, to provide for the granting of equity awards, such as nonqualified stock options (“NQSOs”), incentive stock options (“ISOs”), restricted stock, performance shares, stock appreciation rights (“SARs”), RSUs and other share-based awards to employees, directors, and consultants, as determined by the Board. The 2017 Plan does not affect awards previously granted under the 2007 Plan. Upon adoption, the 2017 Plan allowed for awards of up to 2,318,486 shares of the Company’s common stock, plus an automatic annual increase in the number of shares authorized for awards on the first day of each of the Company’s fiscal years beginning January 1, 2018 through January 1, 2027 equal to (i) 4% of the number of shares of common stock outstanding on the last day of the immediately preceding fiscal year or (ii) such lesser number of shares of common stock than provided for in Section 4(a)(i) of the 2017 Plan as determined by the Board. On January 15, 2021, the number of shares available for future awards under the 2017 Plan was increased by 1,671,303 shares. As of June 30, 2021, there were 2,751,227 shares available for future awards under the 2017 Plan.

 

Under the terms of the 2017 Plan, the exercise price of NQSOs, ISOs and SARs may not be less than 100% of the fair market value of the common stock on the date of grant and, if ISOs are granted to an owner of more than 10% of the Company’s stock, then not less than 110% of the fair market value of the common stock on the date of grant. The term of awards will not be longer than ten years, or in the case of ISOs, not longer than five years with respect to holders of more than 10% of the Company’s stock. Stock options granted to employees generally vest over four years, while options granted to directors and consultants typically vest over a shorter period, subject to continued service. The Company issues new shares to satisfy option exercises under the 2007 Plan and the 2017 Plan.

 

- 24-

 

Stock Option Summary 

 

The following table summarizes information about the Company’s stock options and restricted stock outstanding at June 30, 2021 and activity during the period ended June 30, 2021:

 

(in thousands, except years and per share data)

 

Options

   

Weighted-

Average

Exercise Price

   

Weighted-

Average

Remaining

Contractual

Life (years)

   

Aggregate

Intrinsic

Value

 

Outstanding at December 31, 2020

    3,165     $ 2.05       7.6     $ 189  

Options granted

    92     $ 0.94                  

Sales and marketing

    900     $                  

Options exercised

    -     $                  

Restricted stock units vested

    (160 )   $                  

Options forfeited/cancelled

    (124 )   $ 3.19                  

Restricted stock units cancelled

    -     $                  

Outstanding at June 30, 2021

    3,873     $ 1.59       7.7     $ 669  
                                 

Vested and expected to vest at June 30, 2021

    3,480     $ 1.69       7.6     $ 593  
                                 

Vested at June 30, 2021

    1,564     $ 3.06       5.3     $ 37  
                                 

Exercisable at June 30, 2021

    1,564     $ 3.06       5.3     $ 37  

 

The aggregate intrinsic value is calculated as the difference between the exercise price of the underlying stock option awards and the closing market price of the Company’s common stock as quoted on the NYSE American as of June 30, 2021 for options that have a quoted market price in excess of the exercise price. There were no stock option awards exercised during the three and six months ended June 30, 2021 and 2020. The Company received no cash payments for the exercise of stock options during the three and six months ended June 30, 2021 and 2020.

 

As of June 30, 2021, total unrecognized compensation cost related to unvested stock options and restricted stock units was approximately $1.3 million. This amount is expected to be recognized as stock-based compensation expense in the Company’s unaudited condensed consolidated statements of operations and comprehensive loss over the remaining weighted average vesting period of 2.47 years.

 

Stock Option Awards to Employees and Directors

 

The Company grants options to purchase common stock to its employees and directors at prices equal to or greater than the market value of the stock on the dates the options are granted. The Company has estimated the value of stock option awards as of the date of grant by applying the Black-Scholes option pricing model using the single-option valuation approach. The application of this valuation model involves assumptions that are judgmental and subjective in nature. See Note 2, “Summary of Significant Account Policies,” for a description of the accounting policies that the Company applied to value its stock-based awards. 

 

During the six months ended June 30, 2021 and 2020, the Company granted options to employees and directors to purchase an aggregate of 92,000 and 520,000 shares of common stock, respectively.

 

The weighted-average assumptions used in determining the value of options are as follows: 

 

   

Six Months Ended June 30,

 

Assumption

 

2021

   

2020

 

Expected price volatility

    164.31 %     159.81 %

Sales and marketing

    6.19       6.43  

Risk-free interest rate

    1.09 %     0.50 %

Dividend yield

    0.00 %     0.00 %

Weighted-average fair value of options granted during the period

  $ 0.90     $ 0.93  

 

Expected Price Volatility—This is a measure of the amount by which the stock price has fluctuated or is expected to fluctuate. The computation of expected volatility was based on the historical volatility of our own stock.

 

Expected Term—This is the period of time over which the options granted are expected to remain outstanding. The expected life assumption is based on the Company’s historical data.

 

Risk-Free Interest Rate—This is the U.S. Treasury rate for the week of the grant having a term approximating the expected life of the option.

 

- 25-

 

Dividend Yield—We have not made any dividend payments nor do we have plans to pay dividends in the foreseeable future.

 

Forfeitures are estimated at the time of grant and reduce compensation expense ratably over the vesting period. This estimate is adjusted periodically based on the extent to which actual forfeitures differ, or are expected to differ, from the previous estimate 

In addition, during the six months ended June 30, 2021, the Company granted 900,000 shares of restricted stock to employees and directors. During the six months ended June 30, 2020, the Company granted 160,000 shares of restricted stock to employees and directors.

 

For the three months ended June 30, 2021 and 2020, the Company recognized stock-based compensation expense of $242 thousand and $128 thousand, respectively, for stock-based awards to employees and directors.  For the six months ended June 30, 2021 and 2020, the Company recognized stock-based compensation expense of $372 thousand and $174 thousand, respectively, for stock-based awards to employees and directors.     

 

In April 2020, the Company modified stock options held by Ms. Gail Maderis, who resigned as a director of the Company, effective April 1, 2020. The option exercise period for Ms. Maderis was extended from three months to three years, calculated from her date of resignation. Also, her stock option awards became fully vested at the date of her resignation. In connection with the stock option modification, the Company recognized incremental stock-based compensation expense of $36 thousand, which is included in the figure above.

 

 

Stock-Based Awards to Non-Employees

 

During the six months ended June 30, 2021 and 2020, the Company did not grant options exercisable for shares of common stock to non-employees in exchange for advisory and consulting services.

 

When the Company grants stock options, the stock options are recorded at their fair value on the grant date and recognized over the respective service or vesting period. The fair value of the stock options that are granted is calculated using the Black-Scholes-Merton option pricing model as discussed above.

 

In addition, during the six months ended June 30, 2021 and 2020, the Company did not grant restricted stock to non-employees.

 

For the three months ended June 30, 2021 and 2020, the Company recognized stock-based compensation expense of $54 thousand and negative $2 thousand, respectively, related to non-employee consultant stock and option grants. For the six months ended June 30, 2021 and 2020, the Company recognized stock-based compensation expense of $107 thousand and $9 thousand, respectively, related to non-employee consultant stock and option grants.  

 

Summary of Stock-Based Compensation Expense

 

A summary of the stock-based compensation expense included in results of operations for the options and restricted stock awards discussed above is as follows (in thousands): 

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 

(in thousands)

 

2021

   

2020

   

2021

   

2020

 

Research and development

  $ 3     $ 7     $ 7     $ 14  

Sales and marketing

    34       11       65       20  

General and administrative

    259       108       407       149  

Total stock-based compensation expense

  $ 296     $ 126     $ 479     $ 183  

 

 

 

NOTE 14. LICENSE, COLLABORATION AND DISTRIBUTION AGREEMENTS

 

Transactions under the Company’s major distribution agreements are recognized upon transfer of control of product sold to its major distribution partners at the amount of consideration that the Company expects to be entitled to. The Company records contract liabilities for the amounts that are estimated to be subject to significant reversal, including allowances for services, discounts, rebate programs, and product returns.

 

The following table presents changes in the Company's contract assets and liabilities for the six months ended June 30, 2021 (in thousands): 

 

   

Balance at
December

31, 2020

   

Additions

   

Deductions

   

Balance at
June 30,

2021

 

Contract Liabilities: Deferred Revenue

  $ 2     $ 2     $ (2

)

  $ 2  

Contract Liabilities: Accrued Liabilities (includes contract assets)

    573       923       (594

)

    902  

Total

  $ 575     $ 925     $ (596

)

  $ 904  

 

- 26-

 

During the six months ended June 30, 2021 and 2020, the Company recognized the following revenue (in thousands):

 

   

Six Months Ended June 30,

 
   

2021

   

2020

 

Revenue recognized in the period from:

               

Amounts included in contract liabilities at the beginning of the period:

               

Performance obligations satisfied

  $ 573     $ 434  

New activities in the period:

               

Performance obligations satisfied

    3,367       5,442  
    $ 3,940     $ 5,876  

 

Avenova Distribution Agreements and Specialty Pharmacies

 

Prescription Avenova is made available in local pharmacies and major pharmacy retail chains under nationwide distribution agreements with McKesson Corporation, Cardinal Health and AmerisourceBergen. We have also entered into direct agreements with preferred pharmacy networks as part of our Partner Pharmacy Program. During the three months ended June 30, 2021 and 2020, the Company earned $0.3 million and $0.4 million, respectively, in sales revenue for its Avenova product from these distribution and partner pharmacy agreements. During the six months ended June 30, 2021 and 2020, the Company earned $0.4 million and $0.9 million, respectively, in sales revenue for its Avenova product from these distribution and partner pharmacy agreements.

 

Under the prescription Avenova product distribution arrangements, the Company had a contract liability balance of $0.9 million and $0.7 million at  June 30, 2021 and December 31, 2020, respectively. The contract liability is included in accrued liabilities in the consolidated balance sheets. The Company also recorded a prepayment of $42 thousand and $0.1 million for rebates related to these distribution agreements as of June 30, 2021 and December 31, 2020, respectively, that is recorded in the prepaid expenses and other current assets in the consolidated balance sheets. See Note 4, “Prepaid Expenses and Other Current Assets”. 

 

Over-the-counter Avenova

 

Non-prescription Avenova was launched online on June 1, 2019 direct to U.S. customers. Over-the-counter Avenova is offered primarily for sale on Amazon.com, the Company’s website (Avenova.com) and Walmart.com as well as in CVS stores. Over-the-counter Avenova is the same strength hypochlorous formulation as our prescription Avenova product, but comes in a smaller size. This channel provides the Company with more stable pricing and provides customers with easy access to our product. During the three and six months ended June 30, 2021, the revenue generated from over-the-counter Avenova was $1.3 million and $2.6 million, respectively. During the three and six months ended June 30, 2020, the revenue generated from over-the-counter Avenova was $0.6 million and $1.4 million, respectively.

 

 

 

NOTE 15. EMPLOYEE BENEFIT PLAN

 

The Company has a 401(k) plan covering all eligible employees. The Company is not required to contribute to the plan and made no contributions during either the three or six months ended June 30, 2021 or 2020. 

 

- 27-

 

 

 

NOTE 16. RELATED PARTY TRANSACTIONS      

 

Related Party Revenue 

 

The following table summarizes information about the Company’s related party revenue and cost of goods sold during the three and six months ended June 30, 2021 and 2020, respectively (in thousands):

 

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 

(in thousands)

 

2021

    2020    

2021

   

2020

 

Related party revenue:

                               

NeutroPhase

  $ 175     $     $ 175     $ 173  

Total related party revenue

  $ 175     $     $ 175     $ 173  
                                 

Cost of goods sold:

                               

NeutroPhase

  $ 131     $     $ 131     $ 90  

Total related party expenses

  $ 131     $     $ 131     $ 90  

 

 

 

Related party accounts receivable was $0.1 million and $0.2 million as of June 30, 2021 and December 31, 2020, respectively.

 

Other Related Party Expenses 

 

During the six months ended June 30, 2021 and the year ended December 31, 2020, the Company purchased KN95 Masks through an affiliate of China Pioneer. As of June 30, 2021 and December 31, 2020, related party accounts payable was $10 thousand and $8 thousand, respectively.

 

The following table summarizes information about the Company’s other related party expenses excluding stock-based compensation during the three and six months ended June 30, 2021 and 2020, respectively (in thousands):

 

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2021

   

2020

   

2021

   

2020

 

Commissions to China Kington related to:

                               

Exercise of June 2019 Warrants

  $     $ 29     $     $ 41  

Total commissions to China Kington

          29             41  

Board Director Bob Wu consulting fee

                      50  

Total related party expenses

  $     $ 29     $     $ 91  

 

In connection with the Company's re-launch of CelleRx Clinical Reset, on November 17, 2020, the Company entered into a consulting agreement with Eric Wu (the “Consulting Agreement”). Eric Wu is Partner and Senior Vice President of China Kington and the brother of Bob Wu, who serves on the Company’s Board of Directors. Pursuant to the Consulting Agreement, Eric Wu will act as a consultant to the Company in support of the CelleRx product re-launch as well as in potential financings and other transaction opportunities. The term of the Consulting Agreement is for twelve months. As consideration for his services, the Company granted Eric Wu options exercisable for 300,000 shares of the Company’s common stock under the Company’s 2017 Omnibus Incentive Plan with an exercise price equal to the Company’s closing stock price on the date of the grant and vesting on the one-year anniversary of the grant date. There was no stock-based compensation expense recorded for the three or six months ended June 30, 2020 related to Eric Wu’s options. For the three and six months ended June 30, 2021, a fee of $30 and $60 thousand was recorded.

 

- 28-

 

 

 

NOTE 17. PAYCHECK PROTECTION PROGRAM

 

On May 6, 2020, the Company received loan proceeds in the amount of $0.9 million from Wells Fargo Bank, N.A. (the “PPP Loan”) pursuant to the Paycheck Protection Program (“PPP”) under the Coronavirus Aid, Relief and Economic Security Act (the “CARES Act”), which was enacted on March 27, 2020.The terms of the PPP Loan were subsequently revised in accordance with the provisions of the Paycheck Protection Flexibility Act of 2020, or the PPP Flexibility Act, which was enacted on June 5, 2020. The PPP loan provides for an interest rate of 1.00% per year and matures two years after the date of initial disbursement, with initial principal and interest payments coming due late in fiscal 2021. The Note could be prepaid by the Company at any time prior to the maturity with no prepayment penalties. Funds from the PPP Loan may only be used for payroll costs, costs used to continue group health care benefits, rent and utilities incurred during the 24-week period after receiving the PPP Loan (collectively, “Qualifying Expenses”) in order for the PPP Loan to be forgiven in whole or in part. The Company used the entire PPP Loan amount for Qualifying Expenses.

 

Since the Company determined that there was reasonable assurance that it would meet the conditions for forgiveness of the full loan amount, the Company accounted for the forgivable PPP Loan as a government income grant that we earned through the Company’s compliance with the loan forgiveness criteria. A deferred income liability was recognized upon receipt of the forgivable loan proceeds. The deferred income liability was recognized as other income as Qualifying Expenses were incurred. For the three and six months ended June 30, 2020, $469 thousand was recognized as other income and recorded in the condensed consolidated statements of operations and comprehensive loss. No amount was recognized for the three and six six months ended June 30, 2021.

 

The Company received notice, dated May 24, 2021, from Wells Fargo Bank, N.A. confirming the full loan amount of $0.9 million was forgiven.

 

 

NOTE 18. SUBSEQUENT EVENTS

 

On August 10, 2021, the Company terminated the Microprofit Agreement, dated April 16, 2020, with Microprofit and the Distribution Agreement, dated April 16, 2020, with Chongqing Pioneer, as amended by the First Amendment, dated June 29, 2020, as further described in Note 8, “Commitments and Contingencies”.

 

Pursuant to the Microprofit Agreement and the Distribution Agreement, Microprofit granted the Company exclusive rights to distribute the Test Kits in the United States through December 31, 2021, subject to various assumptions including the approval by the FDA, with Chongqing Pioneer to act as an intermediary between Microprofit and the Company in the distribution of the Test Kits if approved by the FDA. As previously disclosed, on June 7, 2021, the Company was notified by the FDA that it declined to review the Company’s Emergency Use Authorization request for the Test Kits. As such, the Test Kits are not authorized to be distributed or used as proposed in the United States, and the Microprofit Agreement and Distribution Agreement were terminated by the parties mutual agreement for administrative and accounting purposes.

 

- 29-

 

 

 

ITEM 2.  MANAGEMENTS DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion of our financial condition and results of operations should be read together with our consolidated financial statements and related notes included in Part I, Item 1 of this report, and with our consolidated financial statements and related notes, and Managements Discussion and Analysis of Financial Condition and Results of Operations, included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the Securities and Exchange Commission (theSEC) on March 25, 2021. This discussion contains forward-looking statements that involve known and unknown risks, uncertainties and other factors that may cause the Companys actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by forward-looking statements. Words such asexpects,” “anticipates,” “intends,” “will,” “may,” “could,” “should,” “goals,” “potential,” “plans,” “believes,” “estimates,” “predicts,” “projects,variations of these words, and similar expressions are intended to identify these forward-looking statements. These statements reflect our current views with respect to future events, are based on assumptions, estimates and facts as of the date hereof and are subject to risks and uncertainties. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Factors that could cause actual results to differ from those discussed in the forward-looking statements include, but are not limited to:

 

 

the ongoing trajectory of COVID-19, including the new Delta variant of COVID-19 which appears to be the most transmissible variant to date, and the extent to which and speed at which the global economy recovers, the nature and extent of ongoing governmental measures to contain the pandemic, the speed and efficacy of the vaccine roll out, and our assumptions, estimates and beliefs regarding the possible effect of the COVID-19 pandemic on general economic conditions, public health and consumer demand, and the Companys results of operations, liquidity, capital resources and general performance in the future;

 

our history of losses and our ability to achieve or maintain sustained profitability;

 

whether demand develops for our proprietary products;

 

the impact of competitive or alternative products and pricing;

 

our ability to obtain adequate financing in the future, as and when we need it;

 

the adequacy of protections afforded to us by the patents that we own and the cost to us of maintaining, enforcing and defending those patents;

 

our exposure to and ability to defend third-party claims and challenges to our patent and other intellectual property rights;

 

our success at managing the risks involved in the foregoing items; and

 

other factors discussed in this report and our other filings with the SEC.

 

As a result of many factors, such as those listed above and set forth under the section entitledRisk Factorsin Part II, Item 1A elsewhere in this report or otherwise described in our filings with the SEC, you should not place undue reliance on these forward-looking statements. You should read this report and the documents that we reference and have filed as exhibits thoroughly and with the understanding that forward-looking statements represent our managements beliefs and assumptions only as of the date of this report and our actual future results may be materially different from what we expect. Except as required by law, we assume no obligation to update these forward-looking statements publicly, even if new information becomes available in the future.

 

Overview

 

We are a medical device company predominantly focused on eye care. A majority of our revenue comes from Avenova®, an FDA cleared product sold in the United States that has proven in laboratory testing to have broad antimicrobial properties as it removes foreign material including microorganisms and debris from skin around the eye, including the eyelid. Avenova is formulated with our proprietary, stable and pure form of hypochlorous acid. Avenova is available directly to consumers through our online sales channel and is also often prescribed and dispensed by eyecare professionals for blepharitis and dry-eye disease.

 

We continue to promote Avenova through all four of our primary distribution channels: (1) our over-the-counter direct-to-consumer model, allowing customers to purchase either online or at select brick and mortar stores; (2) retail pharmacies, dispensing Avenova to patients through national pharmacy chains across all 50 states; (3) our Partner Pharmacy Program, providing a consistent patient experience at contracted pricing; and (4) our physician dispensed channel, allowing patients to buy Avenova during office visits to their preferred eye care specialist We continue to achieve record overall Avenova unit sales quarter over quarter with more people using Avenova than ever before.

 

Avenova was launched as a prescription only product in 2016. To expand our addressable market, we launched Avenova as an over-the-counter product during the second quarter of 2019. By creating a consumer driven product that does not require a doctor’s prescription, we made Avenova available to many more potential customers. Over-the-counter Avenova also capitalizes on a trend to sell over-the-counter pharmaceutical products directly to consumers and adds convenience by allowing customers to forego a time-consuming doctor visit and trip to the pharmacy.

 

The launch of over-the-counter Avenova online proved to be especially fortuitous during the COVID-19 pandemic as it allowed consumers to order Avenova online without a prescription and without leaving their homes.

 

 

Over-the-counter Avenova is now our leading product by unit sales and net revenue despite having a lower average net selling price than prescription Avenova. This sales performance reflects our ongoing focus and increasing spend on digital marketing and public relations initiatives to promote Avenova directly to the end consumer. Avenova is available on Amazon.com, Walmart.com, and Avenova.com. Beginning in February 2021, Avenova became available at CVS store locations throughout the U.S. and on CVS.com, one of the nation’s largest retail chains.

 

Although we expect the online sales channel to continue to be our fastest-growing channel, support for Avenova from the medical community is important to maintaining its reputation as a preferred product. The “doctor recommended” halo effect around our brand remains strong due in part to our continued promotion of prescription Avenova.

 

Earlier this year, we launched a rebranded CelleRx® into the beauty industry as CelleRx® Clinical Reset™. Prior to this rebranding, our marketing of CelleRx focused on medical professionals only. Clinical Reset is formulated with NovaBay’s patented, pure, prescription-grade hypochlorous acid, a naturally occurring oxidant that is also produced by white blood cells within the human body.  It keeps the skin’s natural barrier intact, which when out of balance can allow acne, rosacea and infection to set in. Clinical Reset is complementary to a daily beauty regime for use on clean skin or over makeup. With the rebranding, we are leveraging new consumer focused messaging and the product’s pharmaceutical pedigree in robust social media and print advertising campaigns marketing CelleRx Clinical Reset in the beauty industry.

 

Beyond Avenova and CelleRx, we have developed additional products containing our proprietary, stable and pure form of hypochlorous acid, including NeutroPhase® and PhaseOne® for the wound care market. NeutroPhase is only sold in China through our exclusive distributor, Pioneer Pharma Co. Ltd. PhaseOne is only sold in the United States through our exclusive distributor, PhaseOne Health, LLC.

 

Last year, we responded to the national need for PPE by tapping into our international supply network and launching the sale of KN95 Masks and other PPE. Although sales from the KN95 Masks were significant in the second quarter of 2020, we experienced a significant decrease in PPE sales in the third and fourth quarters of 2020 as supply shortages narrowed, prices declined and distribution competition increased. We have returned our focus to our core business in eyecare and we do not anticipate dedicating future Company resources toward the sale of PPE and we do not expect future revenue from PPE sales.

 

During the second quarter of this year, we introduced two complementary products to support the use of Avenova. Our Warm Eye Compress not only provides effective heat therapy for many eye conditions, but it also improves Avenova’s ability to restore the eyes’ natural defenses against tear evaporation. Additionally, the i-Chek Illuminated Eye Examination Mirror allows Avenova customers to get a closer look at common eye conditions that are often of concern to Avenova customers. These eye conditions include blepharitis, chalazion and styes. The i-Chek also helps Avenova users who suffer from dry eye to identify dirt, oil or debris that need removed from the eyelids and eyelashes for optimum ocular health. The use of Avenova and both products is meant to provide Avenova customers with a holistic approach to lid and lash hygiene.  

 

Critical Accounting Policies and Estimates

 

Our condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these condensed consolidated financial statements requires us to make estimates, assumptions and judgments that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. In preparing these condensed consolidated financial statements, management has made its best estimates and judgments of certain amounts, giving due consideration to materiality. On an ongoing basis, we evaluate our estimates and judgments related to revenue recognition, research and development costs, patent costs, stock-based compensation, income taxes and other contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances. Actual results may differ from these estimates. 

 

 

While our significant accounting policies are more fully described in Note 2, “Summary of Significant Accounting Policies” to the Notes to Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this report, we believe that the following accounting policies are most critical to fully understanding and evaluating our reported financial results.

 

Allowance for Doubtful Accounts

 

The Company charges bad debt expense and records an allowance for doubtful accounts when management believes it to be unlikely that specific invoices will be collected. Management identifies amounts due that are in dispute and it believes are unlikely to be collected. Management recorded no reserve for accounts receivable at June 30, 2021 and December 31, 2020.

 

Inventory

 

Inventory is comprised of (1) raw materials and supplies, such as bottles, packaging materials, labels, boxes and pumps; (2) goods in progress, which are normally filled but unlabeled bottles; and (3) finished goods. We utilize contract manufacturers to produce our products and the price paid to these manufacturers is included in inventory. Inventory is stated at the lower of cost or estimated net realizable value determined by the first-in, first-out method. At both June 30, 2021 and December 31, 2020, management had recorded an allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments of $0.2 million.  

 

Leases

 

At the inception of an arrangement, the Company determines whether the arrangement is or contains a lease based on the unique facts and circumstances present. Operating lease liabilities and their corresponding right-of-use assets are recorded based on the present value of lease payments over the expected lease term. The interest rate implicit in lease contracts is typically not readily determinable. As such, the Company utilizes its incremental borrowing rate, which is the rate incurred to borrow, on a collateralized basis over a similar term, an amount equal to the lease payments in a similar economic environment. Certain adjustments to the right-of-use assets may be required for items such as initial direct costs paid or incentives received.

 

The Company has elected to combine lease and non-lease components as a single component for all leases in which it is a lessee or a lessor. The lease expense is recognized over the expected term on a straight-line basis. Operating leases are recognized on the balance sheet as right-of-use assets, operating lease liabilities current and operating lease liabilities non-current. As a result, as of the effective date, the Company no longer recognizes deferred rent on the consolidated balance sheets.

 

Revenue Recognition

 

Revenue generated through the Company’s webstores, Avenova.com and CelleRx.com, for Avenova and CelleRx (as well as the KN95 Masks previously offered and sold) is recognized upon receipt by the customer through multiple third-party carriers. Shipping and handling costs are expensed as fulfillment costs and are incurred and included in cost of goods sold in the consolidated statements of operations and comprehensive loss. We present revenue net of sales taxes and refunds.

 

Revenue generated through Amazon.com and Walmart.com for Avenova and other products is recognized upon fulfillment, which generally occurs upon delivery of the related products to a third-party carrier or, in the case of an Amazon or Walmart delivery, to the customer. We present revenue net of commissions and any related fulfillment and shipping fees charged by these partners. Fees paid to partners for promoting our product are expensed as incurred and are included in sales and marketing expenses within the operating expenses in the consolidated statements of operations and comprehensive loss.

 

The Company also generates Avenova product revenue through product sales to its major distribution partners. Product supply of Avenova is the only performance obligation contained in these arrangements, and the Company recognizes product revenue upon transfer of control to its major distribution partners at the amount of consideration that the Company expects to be entitled to, generally upon shipment to the distributor on a “sell-in” basis. Upon recognition of product sales, contract liabilities are recorded for invoiced amounts that are subject to significant reversal, including product revenue allowances for cash consideration paid to customers for services, discounts, rebate programs, and product returns. The Company derives its rate of return from historical data and updates its return rate assumption quarterly. Payment for product supply is typically due 30 days after control transfers to the distributor.

 

Revenue generated through the Company’s partner pharmacies is recognized when control of the product transfers to the end customer.

 

Revenue for product sales to CVS is recognized upon transfer of control to CVS, which generally occurs upon delivery of the related products to a third-party carrier, net of estimated future product returns.

 

 

The following table summarizes the activity in the accounts related to product revenue allowances during the six months ended June 30, 2021 (in thousands):

 

   

Wholesaler/

Pharmacy

fees

   

Cash
discounts

   

Rebates

   

Returns

   

Total

 
                                         

Balance at December 31, 2020

  $ (91

)

  $ (10

)

  $ 55     $ (527

)

  $ (573

)

Current provision related to sales made during current period

    (137

)

    (27

)

    (423

)

    (336

)

    (923

)

Payments

    63       19       320       192       594  

Balance at June 30, 2021

  $ (165

)

  $ (18

)

  $ (13

)

  $ (671

)

  $ (902

)

 

Cost of Goods Sold

 

Cost of goods sold includes third-party manufacturing costs, shipping and handling costs, and other costs associated with products sold. Cost of goods sold also includes any necessary allowance for excess and obsolete inventory along with lower of cost and estimated net realizable value.

 

Research and Development Costs

 

The Company charges research and development costs to expense as incurred. These costs include all costs associated with research, development and regulatory activities, including submissions to the Food and Drug Administration (“FDA”).

 

Stock-Based Compensation

 

The Company’s stock-based compensation includes grants of stock options and restricted stock units (“RSUs”) to employees, non-employee directors and consultants. The expense associated with these grants is recognized in the Company’s consolidated statements operations and comprehensive loss based on their fair values as they are earned under the applicable vesting terms. For stock options granted, the fair value of the stock options is estimated using a Black-Scholes option pricing model. See Note 13, “Equity-Based Compensation” for further information regarding stock-based compensation expense and the assumptions used in estimating that expense. The Company accounts for RSUs issued to employees and non-employees (board members and consultants) based on the fair market value of the Company’s common stock as of the date of issuance.

 

Income Taxes

 

The Company accounts for income taxes under the asset and liability method. Deferred tax assets and liabilities are recognized for the future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. The effect on deferred tax assets and liabilities of a change in tax rates is recognized in income in the period that includes the enactment date. A valuation allowance is recognized if it is more likely than not that some portion or the entire deferred tax asset will not be recognized.

 

Common Stock Warrant Liabilities

 

The Company accounts for common stock purchase warrants issued in connection with its equity offerings in accordance with the provisions of ASC 480, Distinguishing Liabilities from Equity, and ASC 815, Derivatives and Hedging.

 

The Company accounts for common stock purchase warrants issued in connection with share-based compensation arrangements in accordance with the provisions of ASC 718, Stock Compensation, which encompasses the provisions of ASC 480, Distinguishing Liabilities from Equity.

 

 

The Company classifies as equity any contracts that (i) require physical settlement or net-share settlement or (ii) give the Company a choice of net-cash settlement or settlement in its own shares (physical settlement or net-share settlement). The Company classifies as assets or liabilities any contracts that (i) require net-cash settlement (including a requirement to net-cash settle the contract if an event occurs and if that event is outside the control of the Company) or (ii) give the counterparty a choice of net-cash settlement or settlement in shares (physical settlement or net-share settlement). Additionally, for common stock purchase warrants accounted for in accordance with ASC 718, Stock Compensation, the Company classifies as liabilities any contracts where it believes the warrants are deemed to be probable of issuance.

 

For warrants that are classified as liabilities, the Company records the fair value of the warrants at each balance sheet date and records changes in the estimated fair value as a non-cash gain or loss in the consolidated statements of operations and comprehensive loss. The fair values of these warrants are determined using the Black-Scholes option pricing model, the Binomial Lattice (“Lattice”) valuation model, or the Monte Carlo simulation model where deemed appropriate. These values are subject to a significant degree of management’s judgment.

 

Recent Accounting Pronouncements

 

See Note 2, “Summary of Significant Accounting Policies” to the Notes to Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this report for information on recent accounting pronouncements.

 

Results of Operations

 

Comparison of the Three Months Ended June 30, 2021 and 2020

 

   

Three Months Ended

                 
   

June 30,

   

Dollar

   

Percent

 

(in thousands)

 

2021

   

2020

   

Change

   

Change

 

Statement of Operations

                               

Sales:

                               

Product revenue, net

  $ 2,126     $ 3,979     $ (1,853 )     (47 %)

Other revenue, net

    7       5       2       40 %

Total sales, net

    2,133       3,984       (1,851 )     (46 %)
                                 

Product cost of goods sold

    614       2,040       (1,426 )     (70 %)

Gross profit

    1,519       1,944       (425 )     (22 %)
                                 

Research and development

    21       115       (94 )     (82 %)

Sales and marketing

    1,788       1,423       365       26 %

General and administrative

    1,569       1,477       92       6 %

Total operating expenses

    3,378       3,015       363       12 %

Operating loss

    (1,859 )     (1,071 )     (788 )     74 %
                                 

Non-cash loss on changes in fair value of warrant liability

    -       (3,772 )     3,772       (100 %)

Other income, net

    -       362       (362 )     (100 %)
                                 

Loss before provision for income taxes

    (1,859 )     (4,481 )     2,622       (59 %)

Provision for income taxes

    -       (1 )     1       (100 %)

Net loss and comprehensive loss

  $ (1,859 )   $ (4,482 )   $ 2,623       (59 %)

 

Sales, Product Cost of Goods Sold and Gross Profit

 

Product revenue, net, decreased by $1.9 million, or 47%, to $2.1 million for the three months ended June 30, 2021, from $4.0 million for the three months ended June 30, 2020. The change in product revenue, net, is primarily the result of revenue generated from the sale of KN95 Masks resulting in $2.8 million in product revenue, net, during the three months ended June 30, 2020 with no comparable revenue in the 2021 period. We do not anticipate dedicating future Company resources toward the sale of KN95 Masks or other PPE and we do not expect any 2021 or future revenue from KN95 Masks or other PPE.

 

Avenova revenue increased by 65% to $1.9 million for the three months ended June 30, 2021, from $1.1 million for the three months ended June 30, 2020. The increase reflects a continued higher number of overall Avenova units sold, primarily a result of an increase in the number of over-the-counter units. The increase in over-the-counter units includes the impact of our ongoing focus and increasing spend on digital marketing initiatives to promote Avenova directly to end consumers. The increase was partially offset by a decrease in the number of units sold through our pharmacy channels. The overall increase in revenue due to unit sales was also partially offset by the lower average net selling price associated with over-the-counter units as compared to units sold through our pharmacy channels.

 

 

Cost of goods sold decreased by $1.4 million, or 70%, to $0.6 million for the three months ended June 30, 2021, from $2.0 million for the three months ended June 30, 2020. The decrease was primarily the result of cost of goods sold from the sale of KN95 Masks during the three months ended June 30, 2020, with no comparable result in the 2021 period. This decrease was partially offset by the overall increase in the number of Avenova units sold during the three months ended June 30, 2021, as compared to the 2020 period.

 

Gross profit decreased by $0.4 million, to $1.5 million for the three months ended June 30, 2021, from $1.9 million for the three months ended June 30, 2020. The decrease was primarily the result of the lack of sales of KN95 Masks in the 2021 period, partially offset by the increase in overall Avenova revenue.

 

Research and Development

 

Research and development expenses decreased by $94 thousand to $21 thousand for the three months ended June 30, 2021, from $115 thousand for the three months ended June 30, 2020. The decrease was primarily the result of regulatory expenses incurred in the 2020 period under the Microprofit Agreement as further described in Note 8, “Commitments and Contingencies”, of the Notes to Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this report, with no comparable expenditures in the 2021 period. The parties mutually agreed to terminate the agreement on August 10, 2021.

 

Sales and Marketing

 

Sales and marketing expenses increased by $0.4 million, or 26%, to $1.8 million for the three months ended June 30, 2021, from $1.4 million for the three months ended June 30, 2020. The increase was primarily due to an increase in Avenova and CelleRx digital advertising costs and was partly off-set by a decrease in sales representative headcount.

 

General and Administrative

 

General and administrative expenses increased by $0.1 million, to $1.6 million for the three months ended June 30, 2021, from $1.5 million for the three months ended June 30, 2020. The increase was primarily the result of an increase in the overall cost of general and administrative personnel which was partially offset by a decrease in the cost of consultants and legal expenses. The 2020 period includes legal expenses incurred in conjunction with a dispute with the Company’s former Interim President & Chief Executive Officer and Chief Financial Officer (see Note 8, “Commitments and Contingencies”) with no comparable costs incurred in the 2021 period.

 

Non-Cash Gain on Changes in Fair Value of Warrant Liability

 

The Company recorded a non-cash loss on a change in fair value of warrant liability of $3.8 million for the three months ended June 30, 2020. There was no comparable result for the three months ended June 30, 2021. For additional information regarding the warrants and their valuation, please see Note 11, “Warrant Liability”, to the Notes to Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this report.

 

Other Income, Net

 

The Company recorded other income, net of $362 thousand  for the three months ended June 30, 2020. There was no comparable result for the three months ended June 30, 2021. The 2020 result consisted primarily of income of $469 thousand representing qualifying expenses incurred under the PPP loan program. For additional information, see Note 17 “Paycheck Protection Program” The income was partially offset by the interest due on the Promissory Note issued in February 2019 and the amortization of discount and issuance cost related to the Convertible Note issued in March 2019.  For additional information regarding the Promissory Note and Convertible Note, please see Note 9, “Related Party Note Payable” and Note 10, “Convertible Note”, to the Notes to Unaudited Condensed Consolidated Financial Statements in Part 1, Item 1 of this report.”

 

 

Comparison of the Six Months Ended June 30, 2021 and 2020

 

   

Six Months Ended

                 
   

June 30,

   

Dollar

   

Percent

 

(in thousands)

 

2021

   

2020

   

Change

   

Change

 

Statement of Operations

                               

Sales:

                               

Product revenue, net

  $ 3,927     $ 5,871     $ (1,944 )     (33 %)

Other revenue, net

    13       5       8       160 %

Total sales, net

    3,940       5,876       (1,936 )     (33 %)
                                 

Product cost of goods sold

    1,069       2,621       (1,552 )     (59 %)

Gross profit

    2,871       3,255       (384 )     (12 %)
                                 

Research and development

    26       124       (98 )     (79 %)

Sales and marketing

    3,468       2,983       485       16 %

General and administrative

    2,756       2,754       2       0 %

Total operating expenses

    6,250       5,861       389       7 %

Operating loss

    (3,379 )     (2,606 )     (773 )     30 %
                                 

Non-cash loss on changes in fair value of warrant liability

    -       (3,635 )     3,635       (100 %)

Non-cash gain on changes in fair value of embedded derivative liability

    -       2       (2 )     (100 %)

Other income, net

    2       176       (174 )     (99 %)
                                 

Loss before provision for income taxes

    (3,377 )     (6,063 )     2,686       (44 %)

Provision for income taxes

    -       (1 )     1       (100 %)

Net loss and comprehensive loss

  $ (3,377 )   $ (6,064 )   $ 2,687       (44 %)

 

Sales, Product Cost of Goods Sold and Gross Profit

 

Product revenue, net, decreased by $1.9 million, or 33%, to $3.9 million for the six months ended June 30, 2021, from $5.9 million for the six months ended June 30, 2020. The change in product revenue, net, is primarily the result of revenue generated from the sale of KN95 Masks resulting in $3.0 million in product revenue, net, during the six months ended June 30, 2020 with no comparable revenue in the 2021 period. We do not anticipate dedicating future Company resources toward the sale of KN95 Masks or other PPE and we do not expect any 2021 or future revenue from KN95 Masks or other PPE.

 

Avenova revenue increased by 29% to $3.5 million for the six months ended June 30, 2021, from $2.7 million for the six months ended June 30, 2020. The increase reflects a continued higher number of overall Avenova units sold, primarily a result of an increase in the number of over-the-counter units. The increase in over-the-counter units includes the impact of our ongoing focus and increasing spend on digital marketing initiatives to promote Avenova directly to end consumers. The increase was partially offset by a decrease in the number of units sold through our pharmacy channels. The overall increase in revenue due to unit sales was also partially offset by the lower average net selling price associated with over-the-counter units as compared to units sold through our pharmacy channels.

 

 

Cost of goods sold decreased by $1.6 million, or 59%, to $1.1 million for the six months ended June 30, 2021, from $2.6 million for the six months ended June 30, 2020. The decrease was primarily the result of cost of goods sold from the sale of KN95 Masks during the six months ended June 30, 2020, with no comparable result in the 2021 period. This decrease was partially offset by the overall increase in the number of Avenova units sold during the six months ended June 30, 2021, as compared to the 2020 period.

 

Gross profit decreased by $0.4 million, to $2.9 million for the six months ended June 30, 2021, from $3.3 million for the six months ended June 30, 2020. The decrease was primarily the result of the Company no longer selling the KN95 Masks in the 2021 period, partially offset by the increase in overall Avenova revenue.

 

Research and Development

 

Research and development expenses decreased by $98 thousand to $26 thousand for the six months ended June 30, 2021, from $124 thousand for the six months ended June 30, 2020. The decrease was primarily the result of regulatory expenses incurred in the 2020 period under the Microprofit Agreement as further described in Note 8, “Commitments and Contingencies”, of the Notes to Unaudited Condensed Consolidated Financial Statements, included in Part I, Item 1 of this report, with no comparable expenditures in the 2021 period. The parties mutually agreed to terminate the agreement on August 10, 2021.

 

 

Sales and Marketing

 

Sales and marketing expenses increased by $0.5 million, or 16%, to $3.5 million for the six months ended June 30, 2021, from $3.0 million for the six months ended June 30, 2020. The increase was primarily due to an increase in Avenova and CelleRx digital advertising costs and was partly off-set by a decrease in sales representative headcount.

 

General and Administrative

 

General and administrative expenses remained consistent for the six months ended June 30, 2021 and 2020.

 

Non-Cash Loss on Changes in Fair Value of Warrant Liability

 

The adjustments to the fair value of warrant liability resulted in a loss of $3.6 million for the six months ended June 30, 2020. There was no comparable result for the six months ended June 30, 2021. For additional information regarding the warrants and their valuation, please see Note 11, “Warrant Liability”, in the Notes to Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this report.

 

Non-Cash Gain on Changes in Fair Value of Embedded Derivative Liability

 

The adjustments to the fair value of embedded derivative liability resulted in a gain of $2 thousand for the six months ended June 30, 2020. There was no comparable result for the six months ended June 30, 2021. For additional information, please see Note 10, “Convertible Note”, of the Notes to Unaudited Condensed Consolidated Financial Statements included in Part I, Item 1 of this report.

 

Other Income, Net

 

The other income, net, was $2 thousand and $176 thousand for the six months ended June 30, 2021 and 2020, respectively.  For the six months ended June 30, 2020, we recognized  income of $469 thousand which was a result of income recognized as a qualifying expense which were incurred under the PPP Loan. For additional information, see Note 17, “Paycheck Protection Program”. This income was partially offset by the interest due on the Promissory Note issued in February 2019 and the amortization of discount and issuance cost related to the Convertible Note issued in March 2019. For additional information regarding the Promissory Note and Convertible Note, please see Note 9, “Related Party Note Payable” and Note 10, “Convertible Note”, to the Notes to Unaudited Condensed Consolidated Financial Statements in Part 1, Item 1 of this report.”

 

Financial Condition, Liquidity and Capital Resources

 

As of June 30, 2021, our cash and cash equivalents were $10.3 million, compared to $12.0 million as of December 31, 2020. Based primarily on the funds available at June 30, 2021, management believes that the Company’s existing cash and cash equivalents and cash flows generated from product sales will be sufficient to enable the Company to meet its planned operating expenses at least through August 12, 2022. However, changing circumstances may cause the Company to expend cash significantly faster than currently anticipated, and the Company may need to spend more cash than currently expected because of circumstances beyond its control. The Company also may consider other plans to fund operations including raising additional capital through debt and equity financings or from other sources. The Company may issue securities, including common stock and warrants, through private placement transactions or registered public offerings (including the ATM Program), which may require the filing of a Form S-1 or Form S-3 registration statement with the Securities and Exchange Commission (the “SEC”).  Additionally, our future results, cash expenditures and ability to obtain additional external financing could be adversely affected by the COVID-19 pandemic and general adverse economic conditions.

 

Net Cash Used in Operating Activities

 

Net cash used in operating activities was $3.4 million for the six months ended June 30, 2021, which consisted primarily of a net loss of $3.4 million, adjusted by stock-based compensation expenses of $0.5 million, and a net change of $0.5 million in our net operating assets and liabilities.

 

 

Net cash used in operating activities was $1.9 million for the six months ended June 30, 2020, which consisted primarily of a net loss of $6.1 million due to increased product sales combined with reduction in insurance coverage of the product by national payors, loss on change of the warrant liability fair value by $3.6 million, decrease in stock compensation of $0.1 million, loss on change of the derivative liability fair value by $2 thousand and interest expense related to amortization of debt issuance cost and debt discount of $0.1 million.

 

Net Cash Used in Investing Activities

 

For the six months ended June 30, 2021, net cash used in investing activities for the purchase of property and equipment was $27 thousand, with no comparable result for the six months ended June 30, 2020.

 

Net Cash Provided By Financing Activities

 

Net cash provided by financing activities was $1.8 million for the six months ended June 30, 2021. The Company received net proceeds of $1.8 million raised from the ATM program pursuant to the ATM Agreement, dated May 14, 2021, with Ladenburg.

 

Net cash provided by financing activities was $3.7 million for the six months ended June 30, 2020. The Company received net proceeds of $5.2 million from the ATM Program, and an additional $0.7 million from exercise of warrants, which was offset by repayments of $1.1 million on the Convertible Note issued to Iliad Research and Trading L.P. and repayment of $1.0 million on the Promissory Note using proceeds raised through the ATM program pursuant to the ATM Agreement, dated April 27, 2020, with Ladenburg.

 

Inflation

 

We do not believe that inflation has had a material impact on our business and operating results during the periods presented, and we do not expect it to have a material impact in the near future, although there can be no assurances that our business will not be affected by inflation in the future.

 

Off-Balance Sheet Arrangements

 

We had no off-balance sheet arrangements as of June 30, 2021.

 

Seasonality

 

Consistent with our peers in the United States pharmaceutical industry, our prescription business experiences seasonality with the first quarter of each year typically being the lowest revenue quarter. This annual phenomenon is due to consumers facing the need to satisfy health insurance deductibles and changes to copays as each new insurance year begins.

 

Contractual Obligations

 

Our contractual cash commitments as of June 30, 2021 were as follows (in thousands):

 

Contractual Obligations

 

Less than 1

year

   

1-3 years

   

3-5 years

   

More than 5

years

   

Total

 

Facility leases

  $ 295     $     $     $     $ 295  

Equipment leases

    16       6                   22  

Total

  $ 311     $ 6     $     $     $ 317  

 

 

Our commitments as of June 30, 2021 consisted primarily of a facility operating lease and an operating lease for two copiers.

 

The total commitment for the facility lease as of June 30, 2021 was $0.3 million due over the lease term, compared to $0.5 million as of December 31, 2020. 

 

We had an operating lease for 2 copiers as of June 30, 2021. The total commitment for the lease as of June 30, 2021 was $22 thousand due over the lease terms, compared to $29 thousand as of December 31, 2020.

 

See Note 8, “Commitments and Contingencies” to the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report for further information regarding these leases.

 

Recent Events

 

The disclosure set forth in Part II, Item 5 of this report regarding the termination of the Microprofit Agreement and the Distribution Agreement is incorporated herein by reference.

 

 

ITEM 3.  QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK

 

Our market risk consists principally of interest rate risk on our cash and cash equivalents.  

 

With most of our focus on Avenova in the domestic U.S. market, we do not have any material exposure to foreign currency rate fluctuations.

 

ITEM 4.  CONTROLS AND PROCEDURES

 

As of the end of the period covered by this report, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of our disclosure controls and procedures pursuant to Rule 13a-15 and 15d-15 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).

 

A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are resource constraints, and the benefits of controls must be considered relative to their costs. Assessing the costs and benefits of such controls and procedures necessarily involves the exercise of judgment by management. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, have been detected.

 

Based upon that evaluation, our Chief Executive Officer and our Chief Financial Officer concluded that, as of the end of the period covered by this report, our disclosure controls and procedures were effective at the reasonable assurance level to ensure that information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms and were effective in ensuring that information required to be disclosed by us in the reports that we file or submit under the Exchange Act was accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure.

 

Changes in Internal Control Over Financial Reporting

 

There was no change in our internal control over financial reporting during the quarter ended June 30, 2021, that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

PART II. OTHER INFORMATION

 

ITEM 1. LEGAL PROCEEDINGS

 

The “Legal Matters” section of Note 8. “Commitments and Contingencies” to the Notes to Unaudited Condensed Consolidated Financial Statements in Part I, Item 1 of this report is incorporated herein by reference.

 

ITEM 1A. RISK FACTORS

 

For information regarding factors that could affect our business, results of operations, financial condition and liquidity, see the risk factors discussed under Part I, Item 1A included in our Annual Report on Form 10-K for the year ended December 31, 2020, which was filed with the SEC on March 25, 2021. We are a smaller reporting company as defined by Rule 12b-2 of the Securities Exchange Act of 1934 and, as such, are not required to provide updated quarterly information under this Item.

 

 

ITEM 2. UNREGISTERED SALES OF EQUITY SECURITIES AND USE OF PROCEEDS

 

None.

 

ITEM 3. DEFAULTS UPON SENIOR SECURITIES

 

None.

 

ITEM 4. MINE SAFETY DISCLOSURE

 

Not Applicable.

 

ITEM 5.  OTHER INFORMATION

 

On August 10, 2021, the Company terminated the Microprofit Agreement, dated April 16, 2020, with Microprofit and the Distribution Agreement, dated April 16, 2020, with Chongqing Pioneer, as amended by the First Amendment, dated June 29, 2020, the terms of which were previously disclosed in the Company’s Current Report on Form 8-K filed with the SEC on April 20, 2020 and the Company’s Quarter Report on Form 10-Q filed with the SEC on August 6, 2020.

 

Pursuant to the Microprofit Agreement and the Distribution Agreement, Microprofit granted the Company exclusive rights to distribute the Test Kits in the United States through December 31, 2021, subject to various assumptions including the approval by the FDA, with Chongqing Pioneer to act as an intermediary between Microprofit and the Company in the distribution of the Test Kits if approved by the FDA. As previously disclosed, on June 7, 2021, the Company was notified by the FDA that it declined to review the Company’s Emergency Use Authorization request for the Test Kits. As such, the Test Kits are not authorized to be distributed or used as proposed in the United States, and the Microprofit Agreement and Distribution Agreement were terminated by the parties mutual agreement for administrative and accounting purposes.

 

 

ITEM 6.  EXHIBITS

 

The following exhibits are filed with or incorporated by reference into this report.

 

EXHIBIT INDEX

 

   

Incorporation by Reference

Filed

Herewith

Exhibit

Number

Exhibit Description

Form

File

Number

Exhibit/

Form 8-K

Item

Reference

Filing

Date

 

3.1

Amended and Restated Certificate of Incorporation of NovaBay Pharmaceuticals, Inc.

10-K

001-33678

3.1

3/21/2018

 

3.2

Amendment to the Amended and Restated Certificate of Incorporation, dated June 4, 2018

8-K

001-33678

3.1

6/04/2018

 

3.3

Amendment to the Amended and Restated Certificate of Incorporation, as amended, dated May 27, 2020

8-K

001-33678

3.1

5/28/2020

 

3.4

Amendment to the Amended and Restated Certificate of Incorporation, as amended, dated May 24, 2021

8-K

001-33678

3.1

5/24/2021

 

3.5

Bylaws

8-K

001-33678

3.2

6/29/2010

 

4.1

Form of Warrant pursuant to the Services Agreement with TLF Bio Innovation Lab, LLC, dated May 13, 2020

8-K

001-33678

4.1

5/18/2020

 

4.2

Form of July 2020 Warrant

8-K

001-33678

4.1

7/21/2020

 

10.1

At the Market Offering Agreement, dated May 14, 2021, between NovaBay Pharmaceuticals, Inc. and Ladenburg Thalmann & Co. Inc.

8-K

001-33678

1.1

5/14/2021

 

31.1

Certification of the Principal Executive Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a)

       

X

31.2

Certification of the Principal Financial Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(a) or Rule 15d-14(a)

       

X

32.1

Certification by the Chief Executive Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)

       

X

32.2

Certification by the Chief Financial Officer of NovaBay Pharmaceuticals, Inc., as required by Rule 13a-14(b) or 15d-14(b) and Section 1350 of Chapter 63 of Title 18 of the United States Code (18 U.S.C. 1350)

       

X

101.INS

Inline XBRL Instance Document

       

X

101.SCH

Inline XBRL Taxonomy Extension Schema Document 

       

X

101.CAL