Quarterly Report (10-q)

Date : 08/07/2019 @ 10:54AM
Source : Edgar (US Regulatory)
Stock : NovaBay Pharmaceuticals Inc New (NBY)
Quote : 0.54  0.0119 (2.25%) @ 11:00PM

Quarterly Report (10-q)

 

 

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, 2019

  

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)

 

Registrant’s Telephone Number, Including Area Code: (510) 899-8800

 

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 and posted 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 6, 2019, there were 21,003,284 shares of the registrant’s common stock outstanding. 

 

-1-

 
 

 

 

NOVABAY PHARMACEUTICALS, INC.

 

TABLE OF CONTENTS

 

  

PART I

FINANCIAL INFORMATION

 

 

 

 

Item 1.

 

Financial Statements

3

 

 

 

 

 

1.

Consolidated Balance Sheets: June 30, 2019 (unaudited) and December 31, 2018

3

       

 

2.

Consolidated Statements of Operations and Comprehensive Loss (unaudited): Three and six months ended June 30, 2019 and 2018

4

 

 

 

 

 

3.

Consolidated Statements of Cash Flows (unaudited): Six months ended June 30, 2019 and 2018

5

       
 

4.

Consolidated Statements of Stockholders’ Equity (unaudited): Three and six months ended June 30, 2019 and 2018

6
       

 

5.

Notes to Consolidated Financial Statements (unaudited)

7

 

 

 

 

Item 2.

 

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

35

 

 

 

 

Item 3.

 

Quantitative and Qualitative Disclosures About Market Risk

45

 

 

 

 

Item 4.

 

Controls and Procedures

45

 

 

 

 

PART II

OTHER INFORMATION

 

 

 

 

Item 1A.

 

Risk Factors

46

  

  

  

 

Item 6.

 

Exhibits

59

 

 

 

 

SIGNATURES   

62

 

 

  

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 ® , intelli-Case™, AgaNase ® , 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.

 

-2-

 

 

 

PART I

FINANCIAL INFORMATION

 

ITEM 1.

FINANCIAL STATEMENTS

NOVABAY PHARMACEUTICALS, INC.

CONSOLIDATED BALANCE SHEETS

(In thousands, except par value amounts)

 

   

June 30,

   

December 31,

 
   

2019

   

2018

 
   

(Unaudited)

         

ASSETS

               

Current assets:

               

Cash and cash equivalents

  $ 3,668     $ 3,183  

Accounts receivable, net of allowance for doubtful accounts ($24 and $10 at June 30, 2019 and December 31, 2018, respectively)

    1,536       3,385  

Inventory, net of allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments ($109 and $104 at June 30, 2019 and December 31, 2018, respectively)

    664       280  

Prepaid expenses and other current assets

    1,628       1,760  

Total current assets

    7,496       8,608  

Operating lease right-of-use assets

    1,655       -  

Property and equipment, net

    177       201  

Other assets

    542       552  

TOTAL ASSETS

  $ 9,870     $ 9,361  
                 

LIABILITIES AND STOCKHOLDERS' EQUITY

               

Liabilities:

               

Current liabilities:

               

Accounts payable

  $ 356     $ 551  

Accrued liabilities

    1,931       3,255  

Deferred revenue

          41  

Operating lease liabilities

    1,065        

Total current liabilities

    3,352       3,847  

Operating lease liabilities-non-current

    889       -  

Deferred rent

          184  

Notes payable, related party

    1,110        

Warrant liability

    266       178  

Convertible note

    1,654        

Embedded derivative liability

    673        

Other liabilities

    257       198  

Total liabilities

    8,201       4,407  
                 

Stockholders' equity :

               

Preferred stock: 5,000 shares authorized; none outstanding at June 30, 2019 and December 31, 2018

           

Common stock, $0.01 par value; 50,000 shares authorized; 20,733 and 17,089 shares issued and outstanding at June 30, 2019 and December 31, 2018, respectively

    207       171  

Additional paid-in capital

    123,518       119,764  

Accumulated deficit

    (122,056 )     (114,981 )

Total stockholders' equity

    1,669       4,954  

TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY

  $ 9,870     $ 9,361  

 

As the Company adopted the requirements of Accounting Standards Update (“ASU”) 2016-02, Leases (Topic 842) , as of January 1, 2019, using the modified retrospective method, there is a lack of comparability to the prior periods presented. See Note 2.

 

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

 

 

-3-

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(Unaudited)

(In thousands, except per share data)

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 
   

2019

   

2018

   

2019

   

2018

 

Sales:

                               

Product revenue, net

  $ 1,789     $ 2,794     $ 3,239     $ 5,728  

Other revenue

                41       13  

Total sales, net

    1,789       2,794       3,280       5,741  
                                 

Product cost of goods sold

    403       479       744       730  

Gross profit

    1,386       2,315       2,536       5,011  
                                 

Research and development

    32       61       117       107  

Sales and marketing

    1,535       2,977       5,066       6,373  

General and administrative

    1,198       1,360       2,803       2,982  

Total operating expenses

    2,765       4,398       7,986       9,462  

Operating loss

    (1,379 )     (2,083 )     (5,450 )     (4,451 )
                                 

Non cash (loss) gain on changes in fair value of warrant liability

    (487 )     490       (544 )     704  

Non cash loss on changes in fair value of embedded derivative liability

    (246 )           (246 )      

Other (expense) income, net

    (387 )     5       (447 )     9  
                                 

Loss before provision for income taxes

    (2,499 )     (1,588 )     (6,687 )     (3,738 )

Provision for income tax

    (2 )     (1 )     (3 )     (1 )

Net loss and comprehensive loss

  $ (2,501 )   $ (1,589 )   $ (6,690 )   $ (3,739 )
                                 

Net loss per share attributable to common stockholders (basic)

  $ (0.14 )   $ (0.09 )   $ (0.38 )   $ (0.22 )

Net loss per share attributable to common stockholders (diluted)

  $ (0.14 )   $ (0.12 )   $ (0.38 )   $ (0.26 )

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

    18,613       17,089       17,857       16,750  

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

    18,613       17,292       17,857       16,985  

 

As the Company adopted the requirements of ASU 2016-02, Leases (Topic 842) , as of January 1, 2019, using the modified retrospective method, there is a lack of comparability to the prior periods presented. See Note 2.

 

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

 

-4-

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)  

(In thousands)

 

   

Six Months Ended
June 30,

 
   

2019

   

2018

 
                 

Operating activities:

               

Net loss

  $ (6,690 )   $ (3,739 )

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

               

Depreciation and amortization

    33       127  

Impairment of operating lease right-of-use assets

    125        

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

    202       250  

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

    14       13  

Stock option modification expense

    21       77  

Issuance of RSUs to employees

    10        

Non-cash loss (gain) on change in fair value of warrant liability

    544       (704 )

Non-cash loss on derivative liability

    246        

Interest expense related to amortization of debt issuance and debt discount

    263        

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

    15        

Changes in operating assets and liabilities:

               

Accounts receivable

    1,849       2,134  

Inventory

    (383 )     160  

Prepaid expenses and other assets

    80       64  

Operating lease right-of-use assets

    458        

Other assets long-term

    9       33  

Accounts payable and accrued liabilities

    (1,411 )     (327 )

Operating lease liabilities

    (519 )      

Deferred rent

          (32 )

Deferred revenue

    (41 )     (13 )

Related party notes payable

    115        

Long-term obligations

    60        

Net cash (used) in operating activities

    (5,000 )     (1,957 )
                 

Investing activities:

               

Purchases of property and equipment

    (19 )     (5 )

Net cash (used) by investing activities

    (19 )     (5 )
                 

Financing activities:

               

Proceeds from common stock issuances, net

    2,467       5,585  

Proceeds from issuance of notes payable, related party

    1,000        

Proceeds from exercise of options, net

    189       11  

Proceeds from stock options & RSUs sold to cover taxes

    4       1  

Proceeds from exercise of warrants

    46        

Proceeds from convertible notes, net of discount

    2,000        

Debt issuance cost

    (202 )      

Net cash provided by investing activities

    5,504       5,597  

Net increase in cash, cash equivalents, and restricted cash

    485       3,635  

Cash, cash equivalents and restricted cash, beginning of period

    3,658       3,673  

Cash, cash equivalents and restricted cash, end of period

  $ 4,143     $ 7,308  

 

 

   

Six Months Ended June 30,

 
   

2019

   

2018

 

Supplemental disclosure of non cash information:

               

Cumulative effect of adoption of ASU 606

  $       2,638  

Cumulative effect of adoption of ASU 2017-11

  $ 56        

Addition of operating lease, right-of-use asset

  $ 2,473        

Fixed asset purchases, included in accounts payable and accrued liabilities

  $ 10     $ 1  

Proceeds from stock options and restricted stock for taxes, in accounts payable and accrued liabilities

  $     $ 1  

Warrant liability transferred to equity

  $ 400     $  

 

As the Company adopted the requirements of ASU 2016-02, Leases (Topic 842) , as of January 1, 2019, using the modified retrospective method, there is a lack of comparability to the prior periods presented. See Note 2.

 

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

 

-5-

 

 

 

NOVABAY PHARMACEUTICALS, INC.

CONSOLIDATED STATEMENTS OF STOCKHOLDERS' EQUITY

(Unaudited)

(in thousands)

 

                   

Additional 

            Total    
   

Common Stock

    Paid-In      Accumulated     Stockholders'    

2019

 

Shares

   

Amount

    Capital     Deficit      Equity   

Balance at December 31, 2018

    17,089     $ 171     $ 119,764     $ (114,981 )   $ 4,954  

Net loss

    -       -       -       (4,189 )     (4,189 )

Reclassification of Warrant Liability to Equity – see note 2

    -       -       412       (356 )     56  

Vesting of employee restricted stock awards

    6       -       10       -       10  

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

    -       -       107       -       107  

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

    -       -       7       -       7  

Debt discount associated with convertible note – beneficial conversion feature

    -       -       184       -       184  

Balance at March 31, 2019

    17,095       171       120,484       (119,526 )     1,129  

Net loss

    -       -       -       (2,501 )     (2,501 )

Down round feature adjustment related to warrants

    -       -       29       (29 )     -  

Issuance of common stock in connection with offering, net of offering costs

    3,269       33       2,434       -       2,467  

Issuance of common stock in connection with exercise of warrants

    286       3       443       -       446  

Issuance of common stock for option exercises

    83       -       189               189  

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

    -       -       95       -       95  

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

    -       -       7       -       7  

Stock option modification

    -       -       21       -       21  

Debt discount associated with convertible note – beneficial conversion feature

    -       -       (184 )     -       (184 )

Balance at June 30, 2019

    20,733     $ 207     $ 123,518     $ (122,056 )   $ 1,669  

 

  

                   

Additional 

            Total    
   

Common Stock

    Paid-In      Accumulated     Stockholders'    

2018

 

Shares

   

Amount

    Capital     Deficit      Equity   

Balance at December 31, 2017

    15,385     $ 154     $ 113,514     $ (111,074 )   $ 2,594  

Net loss

    -       -       -       (2,150 )     (2,150 )

Issuance of common stock in connection with offering

    1,700       17       5,967       -       5,984  

Offering costs

    -       -       (393 )     -       (393 )

Issuance of stock for option exercises

    4       -       11       -       11  

Adoption of ASC 606

    -       -       -       2,638       2,638  

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

    -       -       102       -       102  

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

    -       -       7       -       7  

Stock option modification

    -       -       77       -       77  

Balance at March 31, 2018

    17,089       171       119,285       (110,586 )     8,870  

Net loss

    -       -       -       (1,589 )     (1,589 )

Offering costs

    -       -       (6 )     -       (6 )

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

    -       -       148       -       148  

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

    -       -       6       -       6  

Balance at June 30, 2018

    17,089     $ 171     $ 119,433     $ (112,175 )   $ 7,429  

 

As the Company adopted the requirements of ASU 2016-02, Leases (Topic 842) , as of January 1, 2019, using the modified retrospective method, there is a lack of comparability to the prior periods presented. See Note 2.

 

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

 

-6-

 

 

 

NOTE 1. ORGANIZATION

  

NovaBay Pharmaceuticals, Inc. is a biopharmaceutical company focusing on commercializing and developing its non-antibiotic anti-infective products to address the unmet therapeutic needs of the global, topical anti-infective market with its two distinct product categories: the NEUTROX ® family of products and the AGANOCIDE ® compounds. The Neutrox family of products includes AVENOVA ® for the eye care market, NEUTROPHASE ® for the wound care market, and CELLERX ® for the aesthetic dermatology market. The Aganocide compounds, still under development, have target applications in the dermatology and urology markets.

 

The Company was incorporated under the laws of the State of California on January 19, 2000, as NovaCal Pharmaceuticals, Inc. It had no operations until July 1, 2002, on which date it acquired all of the operating assets of NovaCal Pharmaceuticals, LLC, a California limited liability company. In February 2007, it changed its name from NovaCal Pharmaceuticals, Inc. to NovaBay Pharmaceuticals, Inc. In June 2010, the Company changed the state in which it was incorporated (the “Reincorporation”) and is now incorporated under the laws of the State of Delaware. All references to “the Company” herein refer to the California corporation prior to the date of the Reincorporation and to the Delaware corporation on and after the date of the Reincorporation. Historically, the Company operated as four business segments. In April 2016, the Company dissolved DermaBay, a wholly-owned U.S. subsidiary that was formed to explore dermatological opportunities. At the direction of its Board of Directors, the Company is now focused primarily on commercializing Avenova for managing hygiene of the eyelids and lashes in the United States and is managed as a single segment.

 

Effective December 18, 2015, the Company effected a 1-for-25 reverse split of its outstanding common stock (the “Reverse Stock Split”). The accompanying financial statements and related notes give retroactive effect to the Reverse Stock Split.

  

Liquidity

 

Based primarily on the funds available at June 30, 2019, the Company believes these resources will be sufficient to fund its operations through the third quarter of 2019. The Company has sustained operating losses for the majority of its corporate history and expects that its 2019 expenses will exceed its 2019 revenues, as the Company continues to re-invest in its Avenova commercialization efforts. The Company expects to continue incurring operating losses and negative cash flows until revenues reach a level sufficient to support ongoing growth and operations. Accordingly, the Company's planned operations raise substantial doubt about its ability to continue as a going concern. The Company's liquidity needs will be largely determined by the success of operations in regard to the commercialization of Avenova. The Company also may consider other plans to fund operations including: (1) out-licensing rights to certain of its products or product candidates, pursuant to which the Company would receive cash milestones or an upfront fee; and (2) 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, which would require the filing of a Form S-1 or Form S-3 registration statement with the Securities and Exchange Commission (the “SEC”). In the absence of the Company's completion of one or more of such transactions, there will be substantial doubt about the Company's ability to continue as a going concern within one year after the date these financial statements are issued, and the Company will be required to scale back or terminate operations and/or seek protection under applicable bankruptcy laws. The accompanying financial statements have been prepared assuming the Company will continue to operate as a going concern, which contemplates the realization of assets and the settlement of liabilities in the normal course of business. The consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts of liabilities that may result from uncertainty related to its ability to continue as a going concern.

 

 

 

 

NOTE 2.  SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES

 

Basis of Presentation

 

The accompanying 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 useful lives for property and equipment and related depreciation calculations, estimated amortization periods for payments received from product development and license agreements as they relate to revenue recognition, assumptions for valuing options and warrants, and income taxes. Actual results could differ from those estimates.

 

-7-

 

 

Unaudited Interim Financial Information

 

The accompanying interim condensed consolidated financial statements and related disclosures are unaudited, 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. 

 

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, 2019, the Company’s cash and cash equivalents were held in a highly-rated, major financial institution in the United States. As of December 31, 2018, the Company’s cash and cash equivalents were held in two highly-rated, major financial institutions in the United States.

 

Beginning fiscal 2018, the Company adopted ASU 2016-18, Statement of Cash Flows (Topic 230): Restricted Cash , which requires the statement of cash flows to explain the change during the period relating to total cash, cash equivalents, and restricted cash. Net cash flows for the three and six months ended June 30, 2019 and 2018 did not change as a result of including restricted cash with cash and cash equivalents when reconciling the beginning-of-period and end-of-period amounts presented on the statements of cash flows.

 

The following table provides a reconciliation of the cash, cash equivalents, and restricted cash reported in the consolidated balance sheet that sum to the total of the same reported in the consolidated statement of cash flows:

 

   

June 30,

   

December 31,

 
   

2019

   

2018

 

Cash and cash equivalents

  $ 3,668     $ 3,183  

Restricted cash included in Other assets

    475       475  

Total cash, cash equivalents, and restricted cash in the statement of cash flows

  $ 4,143     $ 3,658  

 

The restricted cash amount included in other assets on the consolidated balance sheet represents amounts held as certificate of deposit for long-term financing 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 and cash equivalents. The Company maintains deposits of cash and cash equivalents 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 six months ended June 30, 2019 and 2018, revenues were derived primarily from sales of Avenova directly to doctors through the Company’s webstore, directly to consumers through Amazon.com, and to pharmacies via three major distribution partners.

 

-8-

 

 

During the six months ended June 30, 2019 and 2018, revenues from our major distribution partners and specialty pharmacies greater than 10% were as follows:

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 

Major distribution or collaboration partner

 

2019

   

2018

   

2019

   

2018

 

Distributor A

    13

%

    21

%

    18

%

    21

%

Distributor B

    12

%

    23

%

    15

%

    24

%

Distributor C

    23

%

    24

%

    19

%

    25

%

 

As of June 30, 2019 and December 31, 2018, accounts receivable from our major distribution or collaboration partners greater than 10% were as follows:

 

   

June 30,

   

December 31,

 

Major distribution or collaboration partner

 

2019

   

2018

 

Distributor A

    34 %     32 %

Distributor B

    21 %     31 %

Distributor C

    12 %     23 %

 

The Company relies on two contract sole source manufacturers to produce its finished goods. The Company does not have any manufacturing facilities and intends to continue to rely on third parties for the supply of finished goods. Third party manufacturers may not be able to meet the Company’s needs with respect to timing, quantity or quality.

  

Fair Value of Financial Assets and Liabilities

 

The Company’s financial instruments include cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, related party notes payable, convertible note, and warrants. The fair value of cash and cash equivalents, accounts receivable, accounts payable and accrued liabilities, and related party notes payable is carried at cost, which management believes approximates fair value due to the short-term nature of these instruments.

 

The convertible note issued in March 2019 (the “Convertible Note”) is carried at cost, which management believes approximates fair value. The warrant liability is carried at fair value. Additionally, the derivative liability related to certain embedded features contained within the Convertible Note is carried at fair value.

 

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. As of June 30, 2019 and December 31, 2018, management reserved $24 thousand and $10 thousand, respectively, primarily based on specific amounts that were in dispute or were over 120 days past due.

 

-9-

 

 

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 unlabeled bottles; and (3) finished goods. We utilize contract manufacturers to produce our products and the cost associated with manufacturing is included in inventory. At June 30, 2019 and December 31, 2018, management had recorded an allowance for excess and obsolete inventory and lower of cost or estimated net realizable value adjustments of $109 thousand and $104 thousand, respectively.

 

Inventory is stated at the lower of cost or estimated net realizable value determined by the first-in, first-out method.

 

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 and laboratory equipment, three years for computer equipment and software and seven years for furniture and fixtures. Leasehold improvements are amortized over the shorter of seven years or the lease term.

 

The costs of normal maintenance, repairs, and minor replacements are charged to operations when incurred. 

 

Impairment of Long-Lived Assets

 

The Company accounts for long-lived assets and operating lease right-of-use assets in accordance with ASC 360, Property, Plant and Equipment , which requires that companies consider whether events or changes in facts and circumstances, both internally and externally, may indicate that an impairment of long-lived assets held for use or right-of-use assets are present. Management periodically evaluates the carrying value of long-lived assets and right-of-use assets. Determination of recoverability is based on an estimate of undiscounted future cash flows resulting from the use of the asset and its eventual disposition. In the event that such cash flows are not expected to be sufficient to recover the carrying amount of the asset, the assets are written down to their estimated fair values and the loss is recognized in the statements of operations. During the first quarter of 2019, in connection with the restructuring of its U.S. sales force, the Company reviewed its fleet leases for impairment and recorded an impairment charge of $125 thousand. See Note 8, “Commitments and Contingencies” for further information regarding the impairment. There was no impairment charge during the three months ended June 30, 2019, and the three and six months ended June 30, 2018.

 

Leases

 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) , to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted the standard effective January 1, 2019. Using the optional transition method, prior period financial statements have not been recast to reflect the new lease standard.

 

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, at 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 balance sheet.

 

Comprehensive Income (Loss)

 

Accounting Standards Codification (“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. The Company reports unrealized gains and losses on its available-for-sale securities as other comprehensive income (loss).

 

Revenue Recognition

 

The Company generates product revenue through product sales to its major distribution partners, a limited number of distributors and via its webstore and Amazon.com. Product supply 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.

 

-10-

 

 

Other revenue is primarily generated through commercial partner agreements with strategic partners for the development and commercialization of the Company’s product candidates. The terms of the agreements typically include more than one performance obligation and generally contain non-refundable upfront fees, payments based upon achievement of certain milestones and royalties on net product sales.

 

In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under its agreements, it performs the following steps: (i) identification of the promised goods or services in the contract; (ii) determination of whether the promised goods or services are performance obligations including whether they are distinct in the context of the contract; (iii) measurement of the transaction price, including the constraint on variable consideration; (iv) allocation of the transaction price to the performance obligations based on estimated selling prices; and (v) recognition of revenue when (or as) the Company satisfies each performance obligation.

 

Performance Obligations

 

A performance obligation is a promise in a contract to transfer a distinct good or service to the customer and is the unit of account in ASC Topic 606. The Company’s performance obligations include:

 

 

Product supply

 

Exclusive distribution rights in the product territory

 

Regulatory submission and approval services

 

Development services

 

Sample supply, free of charge

 

Incremental discounts and product supply prepayments considered material rights to the customer

 

The Company has optional additional items in contracts, which are considered marketing offers and are accounted for as separate contracts when the customer elects such options. Arrangements that include a promise for future commercial product supply and optional research and development services at the customer’s or the Company’s discretion are generally considered as options. The Company assesses if these options provide a material right to the licensee and if so, such material rights are accounted for as separate performance obligations.

 

Transaction Price

 

The Company has both fixed and variable consideration. Under the Company’s license arrangements, non-refundable upfront fees and product supply selling prices are considered fixed, while milestone payments are identified as variable consideration when determining the transaction price. Funding of research and development activities is considered variable until such costs are reimbursed at which point they are considered fixed. The Company allocates the total transaction price to each performance obligation based on the relative estimated standalone selling prices of the promised goods or services for each performance obligation.

 

For product supply under the Company’s distribution arrangements, 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, chargebacks, and product returns. Because the Company does not have sufficient historical data to compute its own return rate, the return rate used to estimate the constraint on variable consideration for product returns is based on an average of peer and competitor company historical return rates. The Company updates the return rate assumption quarterly and applies it to the inventory balance that is held at the distributor and has not yet been sold through to the end customer. Payment for product supply is typically due 30 days after control transfers to the customer. At any point in time there is generally one month of inventory in the sales channel, therefore uncertainty surrounding constraints on variable consideration is generally resolved one month from when control is transferred.

 

At the inception of each arrangement that includes milestone payments, the Company evaluates whether the milestones are considered probable of being achieved and estimates the amount to be included in the transaction price using the most likely amount method. If it is probable that a significant revenue reversal would not occur, the value of the associated milestone (such as a regulatory submission by the Company) is included in the transaction price. Milestone payments that are not within the control of the Company, such as approvals from regulators, are not considered probable of being achieved until those approvals are received.

 

For arrangements that include sales-based royalties and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (a) when the related sales occur, or (b) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied).

  

-11-

 

 

Allocation of Consideration

 

As part of the accounting for arrangements that contain multiple performance obligations, the Company must develop assumptions that require judgment to determine the stand-alone selling price of each performance obligation identified in the contract. When a contract contains more than one performance obligation, the Company uses key assumptions to determine the stand-alone selling price of each performance obligation. The estimated stand-alone selling prices for distribution rights and material rights for incremental discounts on product supply are calculated using an income approach discounted cash flow model and can include the following key assumptions: forecasted commercial partner sales, product life cycle estimates, costs of product sales, commercialization expenses, annual growth rates and margins, discount rates and probabilities of technical and regulatory success. For all other performance obligations, the Company uses a cost-plus margin approach. The Company allocates the total transaction price to each performance obligation based on the estimated relative stand-alone selling prices of the promised goods or services underlying each performance obligation.

 

Timing of Recognition

 

Significant management judgment is required to determine the level of effort required under an arrangement and the period over which the Company expects to complete its performance obligations under the arrangement. If the Company cannot reasonably estimate when its performance obligations either are completed or become inconsequential, then revenue recognition is deferred until the Company can reasonably make such estimates. Revenue is then recognized over the remaining estimated period of performance using the cumulative catch-up method. Revenue is recognized for products at a point in time and for licenses of functional intellectual property at the point in time the customer can use and benefit from the license. For performance obligations that are services, revenue is recognized over time proportionate to the costs that the Company has incurred to perform the services using the cost-to-cost input method.

 

The Company’s intellectual property in the form of distribution rights are determined to be distinct from the other performance obligations identified in the arrangements and considered “right to use” licenses which the customer can benefit from at a point in time. The Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer, and the customer can use and benefit from the license. 

 

Cost of Goods Sold

 

Cost of goods sold includes third party manufacturing costs, shipping costs, and other costs of goods 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 salaries and benefits for research and development personnel, costs associated with clinical trials managed by contract research organizations, and other costs associated with research, development and regulatory activities. Research and development costs may vary depending on the type of item or service incurred, location of performance or production, level of availability of the item or service, and specificity required in production for certain compounds. The Company uses external service providers to conduct clinical trials, to manufacture supplies of product candidates and to provide various other research and development-related products and services. The Company’s research, clinical and development activities are often performed under agreements it enters into with external service providers. The Company estimates and accrues the costs incurred under these agreements based on factors such as milestones achieved, patient enrollment, estimates of work performed, and historical data for similar arrangements. As actual costs are incurred, the Company adjusts its accruals. Historically, the Company’s accruals have been consistent with management’s estimates and no material adjustments to research and development expenses have been recognized. Subsequent changes in estimates may result in a material change in the Company’s expenses, which could also materially affect its results of operations. 

 

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 consolidated statements of operations and comprehensive loss.

 

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 programs is recognized in the Company’s consolidated statements of stockholders’ equity based on their fair values as they are earned under the applicable vesting terms or the length of an offering period. For stock options granted, the fair value of the stock options is estimated using a Black-Scholes-Merton 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 restricted stock unit awards issued to employees and non-employees (consultants and advisory board members) based on the fair market value of the Company’s common stock as of the date of issuance.

 

-12-

 

 

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

 

For warrants that are newly issued or modified and there is a deemed possibility that the Company may have to settle them in cash, the Company records the fair value of the issued or modified warrants as a liability 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 have been determined using the Binomial Lattice (“Lattice”) valuation model. The Lattice valuation model provides for assumptions regarding volatility, call and put features and risk-free interest rates within the total period to maturity. These values are subject to a significant degree of our judgment.

 

On January 1, 2019, the Company adopted ASU 2017-11, “ Earnings Per Share (Topic 260), Distinguishing Liabilities from Equity (Topic 480) and Derivatives and Hedging (Topic 815): I. Accounting for Certain Financial Instruments with Down Round Features; II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception ” on a modified retrospective basis. ASU 2017-11 changes the classification analysis of certain equity-linked financial instruments with down round features. When determining whether certain financial instruments should be classified as liabilities or equity instruments, securities with anti-dilution features no longer preclude equity classification when assessing whether the instrument is indexed to an entity’s own stock. As a result, freestanding equity-linked financial instruments (or embedded conversion features) would no longer be accounted for as liabilities at fair value because of the existence of an anti-dilution feature. Upon adoption of ASU 2017-11, the Company changed its method of accounting for warrants by reclassifying warrant liabilities related to outstanding warrants that have a down round feature to additional paid in capital on its March 31, 2019 consolidated balance sheet, which increased additional paid-in capital by $56 thousand and decreased warrant liability by $56 thousand. In addition, because of the modified retrospective adoption, the Company recorded a cumulative-effect adjustment of $356 thousand to the Company’s beginning accumulated deficit as of January 1, 2019, with an offset that increased additional paid-in capital by $356 thousand (see Note 11, “Warrant Liability”).

 

Net (Loss) per Share

 

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

 

Basic EPS is computed by dividing net (loss) available to common shareholders 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, using the if-converted method. In computing diluted EPS, the average stock price for the period is used in determining 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 since their effect would be anti-dilutive.

 

During the three and six months ended June 30, 2019, there was no difference between basic and diluted EPS due to the Company’s net loss for the three and six months ended June 30, 2019, respectively. The basic and diluted EPS was a net loss of $0.14 for the three months ended June 30, 2019 and a net loss of $0.38 for the six months ended June 30, 2019. During the three and six months ended June 30, 2018, the basic EPS was a net loss of $0.09 and $0.22, respectively, per share and the diluted EPS was a net loss of $0.12 and $0.26, respectively, per share due to the gain on changes in fair value of warrant liability. 

 

-13-

 

 

The following table sets forth the calculation of basic EPS and diluted EPS:   

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 

Numerator

 

2019

   

2018

   

2019

   

2018

 

Net loss

  $ (2,501 )   $ (1,589 )   $ (6,690 )   $ (3,739 )

Less retained earning reduction related to round down feature triggered

    (29 )     -       (29 )     -  

Net loss, basic

    (2,530 )     (1,589 )     (6,719 )     (3,739 )

Less gain on changes in fair value of warrant liability

    -       (490 )     -       (704 )

Net loss, diluted

  $ (2,530 )   $ (2,079 )   $ (6,719 )   $ (4,443 )
                                 

Denominator

                               

Weighted average shares outstanding, basic

    18,613       17,089       17,857       16,750  

Net loss per share, basic

  $ (0.14 )   $ (0.09 )   $ (0.38 )   $ (0.22 )
                                 

Weighted average shares outstanding, basic

    18,613       17,089       17,857       16,750  

Effect of dilutive warrants

    -       203       -       235  

Weighted average shares outstanding, diluted

    18,613       17,292       17,857       16,985  

Net loss per share, diluted

  $ (0.14 )   $ (0.12 )   $ (0.38 )   $ (0.26 )

 

The following outstanding stock options and stock warrants were excluded from the diluted net loss per share computation, as their effect would have been anti-dilutive:   

 

   

As of June 30,

 

(in thousands)

 

2019

   

2018

 

Period end stock options to purchase common stock

    2,274       3,189  

Period end common stock warrants

    1,624       -  
      3,898       3,189  

 

 

Recent Accounting Pronouncements  

 

SEC Disclosure Regulation Simplifications

During the fourth quarter of 2018, the SEC published Final Rule Release No. 33-10532, “Disclosure Update and Simplification.” This standard, effective for quarterly and annual reports submitted after November 5, 2018, streamlines disclosure requirements by removing certain redundant topics. For the Company, the most notable standard implemented in 2019 is the inclusion of the shareholders’ equity reconciliation to display quarter-to-quarter details.

 

Leases

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) , which replaces the existing guidance for leases. The new standard establishes a right-of-use (ROU) model that requires a lessee to record a ROU asset and a lease liability on the balance sheet for all leases with terms longer than 12 months. Disclosure requirements have been enhanced with the objective of enabling financial statement users to assess the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 became effective for the Company beginning in the first quarter of 2019. The Company has implemented the standard using an optional transition method that allows the Company to initially apply the new leases standard as of the adoption date and recognize a cumulative-effect adjustment to the opening balance of accumulated deficit, if applicable, in the period of adoption. In connection with the adoption, the Company has elected to utilize the package of practical expedients, including not reassessing: (1) the lease classification for any expired or existing leases, (2) the treatment of initial direct costs as they relate to existing leases, and (3) whether expired or existing contracts are or contain leases. The Company also elected the practical expedient not to separate lease and non-lease components of its operating leases in which it is the lessee.

 

The adoption of the new leases standard resulted in the following adjustments to the consolidated balance sheet as of January 1, 2019 (in thousands):

 

Prepaid expenses and other current assets (a)

  $ (49

)

Operating lease right-of-use assets

    2,239  

Other assets (b)

    (2

)

Other accrued liabilities (c)

    (101

)

Operating lease liability

    1,063  

Deferred rent

    (184

)

Operating lease liability - non-current

    1,410  

 

 

(a)

Represents current portion of prepaid fleet leasing costs reclassified to o perating lease right-of-use assets.

 

(b)

Represents noncurrent portion of prepaid fleet leasing costs reclassified to o perating lease right-of-use assets.

 

(c)

Represents current portion of deferred rent and lease incen tive liability reclassified to o perating lease liability.

 

-14-

 

 

The adoption of the new leases standard did not impact previously reported financial results because the Company applied the optional transition method and therefore all adjustments were reflected as of January 1, 2019, the date of adoption.

 

In June 2016, the FASB issued ASU 2016-13, Financial Instruments—Credit Losses (Topic 326): Measurement of Credit Losses on Financial Instruments . The amendments in ASU 2016-13 require a financial asset (or a group of financial assets) measured at amortized cost basis to be presented at the net amount expected to be collected. ASU 2016-13 is effective for the Company for annual and interim reporting periods beginning January 1, 2020. The Company is currently evaluating the impact ASU 2016-13 will have on its consolidated financial statements.

 

In July 2017, the FASB issued ASU 2017-11, Earnings Per Share (Topic 260 ), Distinguishing Liabilities from Equity (Topic 480 ), Derivatives and Hedging (Topic 815 ): I. Accounting for Certain Financial Instruments with Down Round Features and II. Replacement of the Indefinite Deferral for Mandatorily Redeemable Financial Instruments of Certain Nonpublic Entities and Certain Mandatorily Redeemable Noncontrolling Interests with a Scope Exception. Part I applies to entities that issue financial instruments such as warrants, convertible debt or convertible preferred stock that contain down round features. Part II simply replaces the indefinite deferral for certain mandatorily redeemable noncontrolling interests and mandatorily redeemable financial instruments of nonpublic entities contained within ASC Topic 480 with a scope exception and does not impact the accounting for these mandatorily redeemable instruments. This ASU is effective for public companies for the annual reporting periods beginning after December 15, 2018, and interim periods within those annual periods. The Company adopted ASU 2017-11 on a modified retrospective basis effective January 1, 2019. Upon adoption of ASU 2017-11, the Company changed its method of accounting for warrants by reclassifying warrant liabilities related to outstanding warrants that have a down round feature to additional paid in capital on its March 31, 2019 consolidated balance sheets, and recorded a cumulative-effect adjustment to the Company’s beginning accumulated deficit as of January 1, 2019 (see Note 11, “Warrant Liability”).

 

In June 2018, the FASB issued ASU 2018-07,  Compensation—Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting . The ASU aligns the measurement and classification guidance for share-based payments to nonemployees with the guidance for share-based payments to employees, with certain exceptions. Under the new standard, equity-classified share-based payment awards issued to nonemployees will be measured on the grant date, instead of the current requirement to remeasure the awards through the performance completion date. The Company adopted ASU 2018-07 effective January 1, 2019, and this guidance had an approximately $2 thousand impact on the Company’s financial statements.

 

In August 2018, the FASB issued ASU 2018-13,  Fair Value Measurement (Topic 820): Disclosure Framework - Changes to the Disclosure Requirements for Fair Value Measurement . This amendment modifies the disclosure requirements on fair value measurements. The guidance is effective for fiscal years ending after December 15, 2019, and interim periods within those fiscal years. Early adoption is permitted. The Company does not expect the adoption to have a material impact on the Company's financial position, results of operations or cash flows.

 

 

 

 

NOTE 3. FAIR VALUE MEASUREMENTS

 

The Company follows 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 Company's cash equivalents and investments are classified within Level 1 or Level 2 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 types of investments that are generally classified within Level 2 of the fair value hierarchy include corporate securities and U.S. government securities.

 

The Company's warrant liability is classified within Level 3 of the fair value hierarchy because the value is calculated using significant judgment based on the Company’s own assumptions in the valuation of this liability. The Company determined the fair value of the warrant liability using the Lattice valuation model. See Note 11, “Warrant Liability” for further discussion of the calculation of the fair value of the warrant liability.

 

-15-

 

 

As a result of the call option and the put feature within the Convertible Note entered into in March 2019, the Company recorded a derivative liability on its consolidated balance sheet with a corresponding debt discount which is netted against the face value of the Convertible Note. The fair value of embedded derivative liability is classified within Level 3 of the fair value hierarchy because the value is calculated using significant judgment based on the Company’s own assumptions in the valuation of this liability. The Company determined the fair value of the embedded derivative liability using the Monte Carlo simulation model. See Note 10, “Convertible Note” for further discussion of the calculation of the fair value of the embedded derivative liability.

 

The following table presents the Company’s assets and liabilities measured at fair value on a recurring basis as of June 30, 2019:

 

           

Fair Value Measurements Using

 

 

 

 

   

Quoted Prices in

   

Significant

   

 

 
   

 

   

Active Markets

   

Other

    Significant  
   

Balance at

   

for Identical

   

Observable

    Unobservable  
    June 30,      

Items

   

Inputs

    Inputs  
(in thousands)     2019      

(Level 1)

   

(Level 2)

    (Level 3)    

Assets

                               

Cash equivalents

  $     $     $     $  

Restricted cash held as a certificate of deposit

    324       324              

Deposit held as a certificate of deposit

    151       151              

Total assets

  $ 475     $ 475     $     $  
                                 

Liabilities

                               

Warrant liability

  $ 266     $     $     $ 266  

Derivative liability

    673                   673  

Total liabilities

  $ 939     $     $     $ 939  

 

The following table presents the Company’s assets and liabilities measured at fair value on a recurring basis as of December 31, 2018:

 

           

Fair Value Measurements Using

 

(in thousands)

 

Balance at December 31,

2018

   

Quoted

Prices in

Active

Markets

for Identical

Items

(Level 1)

   

Significant

Other

Observable

Inputs

(Level 2)

   

Significant Unobservable Inputs

(Level 3)

 

Assets

                               

Cash equivalents

  $ 103     $ 103     $     $  

Restricted cash held as a certificate of deposit

    324       324              

Deposit held as a certificate of deposit

    151       151              

Total assets

  $ 578     $ 578     $     $  
                                 

Liabilities

                               

Warrant liability

  $ 178     $     $     $ 178  

Total liabilities

  $ 178     $     $     $ 178  

 

-16-

 

  

Upon adoption of ASU 2017-11 effective January 1, 2019, the Company reclassified 210,586 warrants from warrant liabilities to equity and is no longer required to record the change in fair values for these instruments. 334,109 warrants continued to be classified as a liability, out of which 158,400 warrants were exercised in the second quarter of 2019. The Company recorded a non-cash loss of $487 and $544 thousand for the three and six months ended June 30, 2019, an increase in the fair value of the warrants which are classified as a liability. See Note 11, “Warranty Liability” for further discussion of the calculation of the fair value of the warrant liability.

 

The following is a reconciliation of the beginning and ending balances for the liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3) during the three and six months ended June 30, 2019:

 

 

 

Level 3

 
(in thousands)    

liabilities

 

Balance at December 31, 2018

  $ 178  

Fair value of warrant liability reclass to equity-Adoption of ASU 2017-11

    (56 )

Increase in fair value of warrant liability at March 31, 2019

    57  

Derivative liability embedded in Convertible Note issued in March 31, 2019

    427  

Fair value of warrant liability and embedded derivative liability at March 31, 2019

  $ 606  

Fair value of warrants transferred to equity upon exercise

    (400 )

Increase in fair value of warrant liability at June 30, 2019

    487  

Increase in fair value of embedded derivative liability at June 30, 2019

    246  

Fair value of warrant liability and embedded derivative liability at June 30, 2019

  $ 939  

 

 

 

 

NOTE 4. PREPAID EXPENSES AND OTHER CURRENT ASSETS

 

Prepaid expenses and other current assets consisted of the following:

 

 

 

June 30,

   

December 31,

 
(in thousands)    

2019

   

2018

 

Prepaid sales rebates

  $ 902     $ 925  

Rent receivable

    113       108  

Prepaid rent

          130  

Prepaid employees’ benefits

    8       113  

Prepaid dues and subscription

    102       130  

Prepaid Insurance

    251       57  

Other

    252       297  

Total prepaid expenses and other current assets

  $ 1,628     $ 1,760  

 

-17-

 

 

 

NOTE 5. INVENTORY    

 

Inventory consisted of the following:

 

 

 

June 30,

   

December 31,

 
(in thousands)    

2019

   

2018

 

Raw materials and supplies

  $ 175     $ 217  

Finished goods

    598       167  

Less: Reserve for excess and obsolete inventory

    (109 )     (104 )

Total inventory, net

  $ 664     $ 280  

 

 

 

 

NOTE 6. PROPERTY AND EQUIPMENT

 

Property and equipment consisted of the following:

 

 

 

June 30,

   

December 31,

 
(in thousands)    

2019

   

2018

 

Office and laboratory equipment

  $ 24     $ 24  

Furniture and fixtures

    157       157  

Computer equipment and software

    394       385  

Production equipment

    65       65  

Leasehold improvements

    79       79  

Total property and equipment, at cost

    719       710  

Less: accumulated depreciation and amortization

    (542 )     (509 )

Total property and equipment, net

  $ 177     $ 201  

 

Depreciation and amortization expense was $16 thousand and $86 thousand for the three months ended June 30, 2019 and 2018, respectively, and $33 thousand and $127 thousand for the six months ended June 30, 2019 and 2018, respectively.

 

 

 

 

NOTE 7. ACCRUED LIABILITIES

 

Accrued liabilities consisted of the following:

 

 

 

June 30,

   

December 31,

 
(in thousands)    

2019

   

2018

 

Employee payroll and benefits

  $ 582     $ 708  

Avenova contract liabilities

    1,190       2,282  

Deferred rent

          101  

Other

    159       164  

Total accrued liabilities

  $ 1,931     $ 3,255  

 

-18-

 

 

 

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, 2019. 

 

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 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, 2019.

 

Legal Matters

 

From time to time, the Company may be involved in various legal proceedings arising in the ordinary course of business. There are no matters as of June 30, 2019, 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 (“Office Lease”). 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 has a lease commitment for laboratory facilities and office space at EmeryStation North in Emeryville, California (“EmeryStation”) under an operating lease that will expire on October 31, 2020. There are no stated renewal terms. Per the terms of the agreements, the Company does not have any residual value guarantees.

 

In July 2016, the Company subleased all rentable square feet of real property at EmeryStation (“Sublease Agreement”). The Sublease Agreement commenced September 8, 2016. The Sublease Agreement will terminate on October 21, 2020 and there are no stated renewal terms. Per the terms of the agreement, the sublessee does not have any residual value guarantees.

 

In addition to the facility leases, the Company has leased 54 vehicles under a master fleet lease agreement. Each lease is for a period of 36 months, which commenced upon the delivery of the vehicle during the first quarter of 2017. During the first quarter of 2019, in connection with the restructuring of its U.S. sales force, the Company reviewed its fleet leases for impairment. The Company estimated fair value based on the lowest level of identifiable estimated future cash flows and recorded an impairment charge of $125 thousand, which is included in the Sales and Marketing expenses line item within the Operating Expenses in the Consolidated Statements of Operations and Comprehensive Loss.

 

Additionally, the Company has an operating lease for 2 copiers which will expire in August 2019. The monthly lease payment for the copiers is not material.

 

In calculating the present value of the lease payments, the Company has elected to utilize its incremental borrowing rate based on the original lease term and not the remaining lease term. The Company has elected to account for each lease component and its associated non-lease components as a single lease component, and has allocated all of the contract consideration across lease components only. This will potentially result in the initial and subsequent measurement of the balances of the right-of-use assets and lease liability for leases being greater than if the policy election was not applied. The leases include variable components (i.e. common area maintenance, excess mileage charges, etc.) that are paid separately from the monthly base payment based on actual costs incurred and therefore were not included in the right-of-use assets and lease liability, but are reflected as an expense in the period incurred.

 

-19-

 

 

The components of lease expense for the three and six months ended June 30, 2019 were as follows (in thousands except lease term and discount rate):

  

   

Three months

ended June 30,

2019

   

Six months

ended June 30,

2019

 

Operating lease cost

  $ 276     $ 588  

Sublease income

    (158 )     (316 )

Net lease cost

  $ 118     $ 272  
                 

Other information

               

Operational cash flow used for operating leases

  $ 324     $ 648  

 

   

June 30, 2019

 

Weighted-average remaining lease term (in years)

    2.0  

Weighted-average discount rate

    12 %

 

Future lease payments under non-cancelable leases as of June 30, 2019 were as follows (in thousands):

 

Remaining in 2019

  $ 646  

2020

    1,046  

2021

    438  

2022

    75  

Thereafter

     

Total future minimum lease payments

    2,205  

Less imputed interest

    (251 )

Total

  $ 1,954  
         

Reported as:

       

Operating lease liability

  $ 1,065  

Operating lease liability- non-current

    889  

Total

  $ 1,954  

 

Future lease payments to be received under non-cancelable leases as of June 30, 2019 were as follows (in thousands):

 

Remaining in 2019

  $ 380  

2020

    577  

2021

     

2022

     

Thereafter

     

Total future minimum lease payments

  $ 957  

 

-20-

 

 

 

NOTE 9. RELATED PARTY NOTES PAYABLE

 

On February 27, 2019, the Company issued a $1.0 million promissory note (the “Promissory Note”) payable to Pioneer Pharma (Hong Kong) Company Ltd. (“Pioneer Hong Kong”). The Promissory Note bears an interest payment of $150 thousand and is payable in full upon the Company's next financing with Pioneer Hong Kong and in no event after July 27, 2019. The transaction was facilitated by China Kington Asset Management Co. Ltd. (“China Kington”) which has a perfected security interest in all tangible and intangible assets of the Company. In connection with the Promissory Note, the Company must pay China Kington a 2% fee for brokering the transaction and enter into a consulting agreement with China Kington for the term of one year. Bob Wu, acting in a dual role as a member of the Company’s Board of Directors and as principal of China Kington, will be paid $100 thousand pursuant to this consulting agreement. Debt issuance costs associated with the issuance of the Promissory Note of $20 thousand is recognized and recorded as an offset to the related party notes payable in the consolidated balance sheet. The debt issuance cost is being amortized to interest expense using the effective interest rate method over the term of the Promissory Note, assuming that the Promissory Note will be fully paid on July 27, 2019.

 

On June 25, 2019, the Company entered into a first amendment to the Promissory Note. Pursuant to the Amendment, the maturity date of the Promissory Note was extended from July 27, 2019 to July 1, 2020, and the interest payment was increased from $150 thousand to $300 thousand. All other provisions of the Promissory Note remain in full force and effect. The Company determined that the changes in the terms of Promissory Note are accounted for as troubled debt restructurings in accordance with ASC 470. However, as future undiscounted cash flow is greater than the net carrying value of the original Promissory Note, no gain is recognized. The Company established a new effective interest rate based on the carrying value of the original debt and the revised cash flows.

 

The interest expense recognized, including amortization of the issuance costs, was $98 thousand and $130 thousand during the three and six months ended June 30, 2019, respectively.

 

The Promissory Note is presented as follows as of June 30, 2019:

 

(in thousands)

       

Principal amount

  $ 1,000  

Unamortized debt issuance costs

    (5 )

Accrued interest

    115  

Total debt

    1,110  

Less: short-term

     

Long-term

  $ 1,110  

 

 

 

 

NOTE 10. CONVERTIBLE NOTE

 

On March 26, 2019 (the “Closing Date”), the Company entered into a Securities Purchase Agreement (the “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 the Closing Date. The Convertible Note has an original principal amount of $2,215,000, bears interest at a rate of 10% per annum and will mature 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 $200 thousand and debt issuance cost of Lender’s transaction fees of $15 thousand. The Company recognized additional $182 thousand of debt issuance costs associated with the issuance of the Convertible Note, which had been paid as of June 30, 2019.

 

The Convertible Note provides the Lender with the right to convert, at any time, all or any part of the outstanding principal and accrued but unpaid interest into unregistered shares of the Company’s common stock at a conversion price of $1.65 per share. Beginning on September 26, 2019, the Convertible Note also provides the Lender with the right to redeem all or any portion of the Convertible Note (“Redemption Amount”) up to $200 thousand per calendar month. The payments of each Redemption Amount may be made, at the option of the Company, in cash, by converting such Redemption Amount into unregistered shares of Common Stock (“Redemption Conversion Shares”), or a combination thereof. The number of Redemption Conversion Shares equals the portion of the applicable Redemption Amount being converted divided by the lesser of $1.65 or the Market Price. The Market Price is defined as 85% of the lowest closing bid price during the 20 trading days immediately preceding the applicable measurement date. In addition, the Company may redeem the Convertible Note at its option at any time at a redemption price equal to 115% of the aggregate outstanding balance of principal and interest.

 

The Company has reserved 3,200,000 shares of its authorized and unissued common stock to provide for all issuances of common stock under the Convertible Note.

 

-21-

 

 

Pursuant to a Security Agreement between the Company and the Lender, repayment of the Convertible Note is secured by all of the assets of the Company. The assets covered by the Security Agreement are currently first encumbered by that certain lien of up to $1.0 million, plus accrued and unpaid interest and fees, in favor of Pioneer Hong Kong described above.

 

The Convertible Note contains events of default upon the occurrence and during the continuance of which all obligations may be declared immediately due and payable. Under certain events of default, the outstanding balance of principal and interest shall be automatically due and payable in cash. Upon other events of default, the Lender, at its option, can elect to increase the outstanding balance by up to 15%, depending on the magnitude of the default, without accelerating the outstanding balance.

 

The Company’s prepayment terms represent an embedded call option, the Lender’s share redemption terms represent an embedded put option and certain events of default also represent embedded derivatives, each of which require bifurcation. A single derivative comprising all bifurcatable features was measured at fair value using a Monte Carlo simulation model. The key assumptions used to value the combined embedded derivative upon issuance at March 26, 2019 were as follows:

 

   

As of

 

Assumption

 

March 26, 2019

 

Stock price (latest bid price)

  $ 1.28  

Equity volatility

    93.8

%

Risk-free interest rate

    2.34

%

Remaining term

    1.5  

 

The key assumptions used to value the combined embedded derivative as of June 30, 2019 were as follows:

 

Assumption

 

As of

June 30, 2019

 

Stock price

  $ 1.70  

Equity volatility

    129.0

%

Risk-free interest rate

    1.88

%

Remaining term

    1.2

 

 

 

The fair value of the combined embedded derivative was $673 thousand as of June 30, 2019. The fair value of the combined embedded derivative was $427 thousand as of March 26, 2019. The Company believed that the fair value at March 31, 2019 approximates the fair value at March 26, 2019 due to the short duration between the issuance date and the quarter ended March 31, 2019. The change of $246 thousand in fair value was recorded in the consolidated statements of operations and comprehensive loss.

 

-22-

 

 

The aggregate $627 thousand discount, including the original issue discount, and the aggregate $197 thousand of debt issuance costs, including the Company’s issuance costs and payment for the Lender’s transaction fees, were recorded at issuance, and were classified as an offset to the Convertible Note on the consolidated balance sheet. The Convertible Note is presented as follows as of June 30, 2019:

 

(in thousands)

       

Principal amount

  $ 2,215  

Unamortized discount

    (427 )

Unamortized debt issuance costs

    (134 )

Total debt

    1,654  

Less: short-term

     

Long-term

  $ 1,654  

 

The Convertible Note is classified as long-term based on the Company’s intent and ability to issue shares of its common stock upon early redemption by the Lender.

 

The discount and debt issuance costs are being amortized to interest expense using the effective interest rate method over the term of the Convertible Note, assuming that the Convertible Note will be redeemed at the maximum $200 thousand per month beginning in September 2019. During both the three and six months ended June 30, 2019, the effective interest rate on the Convertible Note was 54%. Interest expense recognized, including amortization of the issuance costs and debt discount, was $302 thousand and $322 thousand during the three and six months ended June 30, 2019, respectively.

 

As of June 30, 2019, the Company's contractual maturity of the principal balance of the Convertible Note was as follows:

 

(in thousands)

       

Remainder of 2019

  $  

2020

    2,215  

2021 and thereafter

     

Total

  $ 2,215  

 

 

 

 

NOTE 1 1 . WARRANT LIABILITY  

 

In July 2011, the Company sold common stock and warrants in a registered direct financing. As part of this transaction, 139,520 warrants were issued with an exercise price of $33.25 and were exercisable from January 1, 2012 to July 5, 2016. The terms of the warrants require registered shares to be delivered upon each warrant’s exercise and also require possible cash payments to the warrant holders (in lieu of the warrant’s exercise) upon specified fundamental transactions involving the Company’s common stock, such as an acquisition of the Company. Under ASC 480, Distinguishing Liabilities from Equity , the Company’s ability to deliver registered shares upon an exercise of the warrants and the Company’s potential obligation to cash-settle the warrants if specified fundamental transactions occur are deemed to be beyond the Company’s control. The warrants contain a provision according to which the warrant holder would have the option to receive cash, equal to the Black Scholes fair value of the remaining unexercised portion of the warrant, as cash settlement in the event that there is a fundamental transaction (contractually defined to include various merger, acquisition or stock transfer activities). Due to this provision, ASC 480 requires that these warrants be classified as liabilities. The fair values of these warrants have been determined using the Lattice valuation model, and the changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss. The Lattice valuation model provides for assumptions regarding volatility and risk-free interest rates within the total period to maturity. In addition, after January 5, 2012, and if the closing bid price per share of the common stock in the principal market equals or exceeds $66.50 for any ten trading days (which do not have to be consecutive) in a period of fifteen consecutive trading days, the Company has the right to require the exercise of one-third of the warrants then held by the warrant holders.

 

In October 2015, the holders of all warrants issued pursuant to the Company’s securities purchase agreement dated March 3, 2015 (the “2015 Securities Purchase Agreement”) agreed to reduce the length of notice required to such investors prior to the Company’s issuance of new securities from twenty business days to two business days, for the remainder of such investors’ pre-emptive right period (which expired March 3, 2016). The Company entered into these agreements to enable it to expeditiously raise capital in the October 2015 Offering (as described below) and future offerings. As consideration for these agreements, the Company amended certain provisions of both the warrants with a 15-month term (the “Short-Term Warrants”) and warrants with a five-year term (the “Long-Term Warrants”) issued pursuant to the 2015 Securities Purchase Agreement (together, the “March 2015 Warrants”) and the warrants issued pursuant to the placement agent agreement dated June 29, 2011 (the “July 2011 Warrants”). Specifically, the amendments decreased the exercise price for both the March 2015 Warrants and the July 2011 Warrants to $5.00 per share. In addition, the amendments extended the exercise expiration date for the Short-Term Warrants and the July 2011 Warrants to March 6, 2020. A price protection provision also was added to both the July 2011 Warrants and March 2015 Warrants, such that if the Company subsequently sells or otherwise disposes of Company common stock at a lower price per share than $5.00 or any securities exchangeable for common stock with a lower exercise price than $5.00, the exercise price of such warrants will be reduced to that lower price.

 

-23-

 

 

In October 2015, the Company also entered into an underwriting agreement with Roth Capital Partners, LLC, relating to the public offering and sale of up to (i) 492,000 shares of the Company’s common stock; and (ii) warrants to purchase up to 442,802 shares of the Company’s common stock (the “October 2015 Warrants”) with an exercise price of $5.00 per share (the “October 2015 Offering”). The shares of common stock and warrants were issued separately. Each warrant was exercisable immediately upon issuance and will expire 60 months from the date of issuance. The price to the public in the October 2015 Offering was $5.00 per share of common stock and related warrant. The net proceeds to the Company were approximately $2.1 million after deducting underwriting discounts and commissions and offering expenses.

 

In February 2016, the strike price of the July 2011, March 2015 and October 2015 warrants was reduced to $1.81 per share, pursuant to the price protection provisions in such warrants, because the Company sold common stock to Mr. Jian Ping Fu at that price. 

 

In May 2019, the strike price of the July 2011, March 2015 and October 2015 warrants was reduced to $0.2061 per share, pursuant to the price protection provisions in such warrants, because the Company sold common stock to Triton Funds LP at that price.

 

The key assumptions used to value the July 2011 Warrants as of June 30, 2019 and December 31, 2018 were as follows:

 

    As of  
   

June 30,

   

December 31,

 

Assumption

 

2019

   

2018

 

Expected price volatility

    141

%

    77

%

Expected term (in years)

    0.68       1.18  

Risk-free interest rate

    2.03

%

    2.60

%

Dividend yield

    0.00

%

    0.00

%

Weighted-average fair value of warrants

  $ 1.50     $ 0.29  

 

In March 2015, the Company issued both the Short-Term Warrants ($15.00 per share exercise price) and the Long-Term Warrants ($16.25 per share exercise price). At that time, the Company determined that these warrants qualified for equity accounting and did not contain embedded derivatives that required bifurcation. After the Company’s agreement to modify the terms of the March 2015 Warrants and July 2011 Warrants in October 2015, the Company evaluated the change in terms of the March 2015 Warrants and noted that the change in terms resulted in liability classification of both the Short-Term and Long-Term Warrants. The March 2015 Warrants were re-issued and valued as of October 27, 2015 at a total of $1.8 million with the new terms, and a modification expense was recorded as the difference between the fair value of the warrants on their new terms after modification as of October 27, 2015 and the fair value of the warrants on their original terms prior to modification as of October 27, 2015. The fair values of these warrants have been determined using the Lattice valuation model, and the changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss.

 

As described in Note 2, “Summary of Significant Account Policies,” upon adoption of ASU 2017-11, the Company determined that excluding the consideration of the down round provision, the Long-Term and the Short-Term Warrants are considered to be indexed to the Company’s stock and should be classified in equity. The Company reclassed warrant liabilities related to the Long-Term and Short-Term warrants to additional paid in capital on its March 31, 2019 consolidated balance sheets, which increased additional paid-in capital by $56 thousand and decreased warrant liability by $56 thousand. In addition, because of the modified retrospective adoption, the Company recorded a cumulative-effect adjustment of $356 thousand to the Company's beginning accumulated deficit as of January 1, 2019, with an offset that increased additional paid-in capital by $356 thousand.

 

-24-

 

 

The key assumptions used to value the Short-Term Warrants as of December 31, 2018 were as follows:

 

    As of  
   

December 31,

 

Assumption

 

2018

 

Expected price volatility

    77

%

Expected term (in years)

    1.18  

Risk-free interest rate

    2.60

%

Dividend yield

    0.00

%

Weighted-average fair value of warrants

  $ 0.24  

 

The key assumptions used to value the Long-Term Warrants as of December 31, 2018 were as follows:

 

    As of  
   

December 31,

 

Assumption

 

2018

 

Expected price volatility

    77

%

Expected term (in years)

    1.18  

Risk-free interest rate

    2.60

%

Dividend yield

    0.00

%

Weighted-average fair value of warrants

  $ 0.29  

 

As noted above, the Company issued warrants in connection with the October 2015 Offering. The Company evaluated the terms of the October 2015 Warrants and noted that under ASC 480, the Company’s potential obligation to cash-settle the warrants if specified fundamental transactions occur are deemed to be beyond the Company’s control. Due to this provision, ASC 480 requires that these warrants be classified as liabilities. The fair values of these warrants have been determined using the Lattice valuation model, and the changes in the fair value are recorded in the consolidated statement of operations and comprehensive loss. The fair value of the warrants at issuance on October 27, 2015 was $1.3 million. 

 

The key assumptions used to value the October 2015 warrants as of June 30, 2019 and December 31, 2018 were as follows:

 

    As of  
   

June 30,

   

December 31,

 

Assumption

 

2019

   

2018

 

Expected price volatility

    127

%

    73 %

Expected term (in years)

    1.33       1.83  

Risk-free interest rate

    1.86

%

    2.51 %

Dividend yield

    0.00

%

    0.00 %

Weighted-average fair value of warrants

  $ 1.52     $ 0.38  

 

During the third quarter of 2016, a total of 3,613,284 warrants to purchase 3,613,284 shares of common stock were exercised related to warrants issued during July 2011, March 2015 and October 2015, resulting in gross proceeds of $6.9 million. Upon exercise, the warrant liability associated with these warrants was adjusted to its fair value as of the date of exercise of $1.6 million, with any change in fair value recorded in the consolidated statement of operations and comprehensive loss. The $1.6 million fair value was subsequently transferred to equity as of the date of exercise.

  

During the fourth quarter of 2016, a total of 363,523 warrants to purchase 363,523 shares of common stock were exercised related to the October 2015, November 2015 and December 2015 warrants resulting in gross proceeds of $0.9 million. Upon exercise, the warrant liability associated with these warrants was adjusted to its fair value as of the date of exercise of $0.5 million, with any change in fair value recorded in the consolidated income statement and comprehensive loss. The $0.5 million fair value was subsequently transferred to equity as of the date of exercise.

 

-25-

 

 

During the second quarter of 2017, a total of 21,000 warrants to purchase 21,000 shares of common stock were exercised related to the March 2015 Short-Term and Long-Term warrants resulting in gross proceeds of $38 thousand. Upon exercise, the warrant liability associated with these warrants was adjusted to its fair value as of the date of exercise of $58 thousand, with any change in fair value recorded in the consolidated income statement and comprehensive loss. The $58 thousand fair value was subsequently transferred to equity as of the date of exercise.

 

During the second quarter of 2019, a total of 158,400 warrants to purchase 158,400 shares of common stock were exercised related to the July 2011 and October 2015 warrants resulting in gross proceeds of $33 thousand. Upon exercise, the warrant liability associated with these warrants was adjusted to its fair value as of the date of exercise of $0.4 million, with any change in fair value recorded in the consolidated statement of operations and comprehensive loss. The $0.4 million fair value was subsequently transferred to equity as of the date of their exercise.

 

The details of the outstanding warrant liability as of June 30, 2019, were as follows:

 

 

 

 

   

Warrant

 
Shares and dollars in thousands      Shares     

Liability

 

July 2011 Warrants

    35     $ 53  

October 2015 Warrants

    141       213  
      176     $ 266  

 

 

 

 

NOTE 1 2 . STOCKHOLDERS’ EQUITY

 

Preferred Stock

 

Under the Company’s amended articles of incorporation, the Company is authorized to issue up to 5,000,000 shares of preferred stock in such series and with such rights and preferences as may be approved by the Board of Directors. As of June 30, 2019 and December 31, 2018, there were no shares of Company preferred stock outstanding. 

 

Common Stock

 

During the first quarter of 2018, the Company entered into a share purchase agreement with OP Financial Investments Limited for the sale of an aggregate of 1,700,000 shares of the Company’s common stock, par value $0.01 per share, for an aggregate purchase price of $5,984,000 (the “OP Private Placement”). The OP Private Placement closed on February 8, 2018. China Kington served as placement agent in exchange for a commission equal to six percent (6%) of the gross proceeds, totaling $359,040 . The Company also paid $34 thousand to NYSE American for the listing of the additional shares.

 

On March 29, 2019, the Company entered into a Common Stock Purchase Agreement with Triton Funds LP, a Delaware limited partnership (the “Investor”), pursuant to which the Company has the right to sell up to $3,000,000 of shares of common stock of the Company at a purchase price equal to 90% of the lowest trading price of the common stock of the Company for the five business days prior to the applicable closing date. The Company also entered into a Registration Rights Agreement on March 29, 2019 with the Investor, pursuant to which the Company registered such shares for resale by the Investor on a registration statement on Form S-3 filed with the SEC on April 1, 2019 and declared effective on April 12, 2019. In connection with the transaction with Triton Funds LP, the Company entered into a Letter Agreement with Triton Funds LLC, an affiliate of the Investor, pursuant to which the Company issued 150,000 shares of common stock to Triton Funds LLC. During the second quarter of 2019, the Company issued to Triton Funds LP an aggregate of 1,747,312 shares of the Company’s common stock, par value $0.01 per share, for an aggregate purchase price of $360,121. The Company also incurred and paid other offering costs of $122 thousand.

 

On June 26, 2019, the Company entered into a private placement to sell 1,371,427 shares of Company common stock and warrants to purchase an additional 1,371,427 shares of Company common stock for an aggregate subscription price of $2.4 million to three accredited investors including Messrs. Xiao Rui Liu, Hai Dong Pang and Ping Huang, each of whom subscribed 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 $144,000. The Company also incurred and paid other offering costs of $27 thousand.

 

-26-

 

 

Stock Warrants

 

In February 2016, the strike prices of the July 2011, March 2015 Short-Term and Long-Term, and October 2015 warrants were reduced to $1.81 per share, pursuant to the price protection provisions in such warrants, because the Company sold common stock to Mr. Jian Ping Fu at that price. 

 

In May 2019, the strike price of the July 2011, March 2015 and October 2015 warrants were reduced to $0.2061 per share, pursuant to the price protection provisions in such warrants, because the Company sold common stock to Triton Funds LP at that price.

 

As more fully described in Note 3, “Fair Value Measurements,” the Company reclassified 210,586 warrants from warrant liabilities to equity upon adoption of ASU 2017-11, resulting in an increase to paid-in capital by $56 thousand and a decrease to warrant liability by $56 thousand. In addition, because of the modified retrospective adoption, the Company recorded a cumulative-effect adjustment of $356 thousand to the Company’s beginning accumulated deficit as of January 1, 2019.

 

In May 2019, a down round feature was triggered as the strike price of the March 2015 Long-Term and Short-term Warrants was reduced to $0.2061 per share resulting from the closing of the Common Stock Purchase Agreement with Triton Funds LP, pursuant to which the Company sold common stock to Triton Funds LP at $0.2061 per share. The Company measured the value of the effect of the down round feature as the difference between (1) the March 2015 warrants’ fair value (without the down round feature) using the pre-trigger exercise price and (2) the March 2015 warrants’ fair value (without the down round feature) using the reduced exercise price in accordance with ASC 820, and as a result, recorded a $29 thousand dividend, which is treated as a reduction to income available to common shareholders in the basic EPS calculation.

 

During the second quarter of 2019, a total of 158,400 warrants to purchase 158,400 shares of common stock were exercised related to the July 2011 and October 2015 warrants resulting in gross proceeds of $33 thousand. Please see Note 11, “Warrant Liability”, for further details. 

 

During the second quarter of 2019, a total of 133,167 warrants to purchase 133,167 shares of common stock were exercised related to the March 2015 Short-Term and Long-Term Warrants. Out of the 133,167 warrants exercised, 70,000 warrants were exercised in a cashless transaction, resulting in 64,979 shares issued. The remaining warrants were exercised for gross proceeds of $13 thousand. 

 

In June 2019, the Company issued 1,371,427 warrants to purchase 1,371,427 shares of Company common stock in a private placement. Please see the preceding subsection, “Common Stock,” for further details regarding such private placement. Such warrants have a one (1)-year term and an exercise price of $0.87, callable by the Company if the closing price of the Company’s common stock, as reported on the NYSE American, is $1.00 or greater.

 

The details of all outstanding warrants as of June 30, 2019, were as follows:

 

 

 

 

   

Weighted-

 
           

Average

 
           

Exercise

 
(in thousands)     Warrants    

Price

 

Outstanding at December 31, 2018

    544     $ 1.81  

Warrants granted

    1,371     $ 0.87  

Warrants exercised

    (291 )   $ 0.21  

Warrants expired

    -     $ -  

Outstanding at June 30, 2019

    1,624     $ 0.77  

 

  

 

 

NOTE 1 3 . 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 of Directors (the “Board”). At the inception of the 2007 Plan, 80,000 shares were reserved for awards under the 2007 Plan.

 

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For the years from 2009 to 2012, the number of shares of common stock authorized for awards under the 2007 Plan increased annually in an amount equal to the lesser of (a) 40,000 shares; (b) 4% of the number of shares of the Company’s common stock outstanding on the last day of the preceding year; or (c) such lesser number as determined by the Board. Accordingly, an additional 40,000, 37,427, and 37,207 shares of common stock were authorized for awards under the 2007 Plan in January 2012, 2011 and 2010, respectively. Beginning in 2013, the shareholders voted to remove the 40,000-share cap and the 2007 Plan’s shares authorized for awards increased annually by 4% of the number of shares of the Company’s common stock outstanding on the last day of the preceding year. Accordingly, an additional 32,646 and 59,157 shares of common stock were authorized for awards under the 2007 Plan in January 2014 and 2013, respectively. On March 30, 2015, the Company filed a registration statement to add an additional 82,461 shares to the 2007 Plan’s shares authorized for awards. In January 2016, the Company added 139,449 shares to the 2007 Plan’s shares authorized for awards, per the 2007 Plan’s evergreen provision. On May 26, 2016, the stockholders of the Company approved an amendment to the 2007 Plan to increase the number of shares of Company common stock authorized for awards thereunder by 1,124,826 shares. In January 2017, the Company added 610,774 shares to the 2007 Plan’s shares authorized for awards, per the 2007 Plan’s evergreen provision. As a result of the foregoing, the aggregate number of shares authorized for awards under the 2007 Plan was 2,318,486 shares, prior to its expiration on March 15, 2017 (after taking into account prior awards under the 2007 Plan).

 

Upon expiration of the 2007 Plan, new awards cannot be issued pursuant to the 2007 Plan, but awards outstanding as of its March 15, 2017 plan expiration date will continue to be governed by its terms. Under the terms of the 2007 Plan, the exercise price of incentive stock options may not be less than 100% of the fair market value of the common stock on the date of grant and, if 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. Stock options granted under the 2007 Plan expire no later than ten years from the date of grant. 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.

 

In March 2017, the Company adopted the 2017 Omnibus Incentive Plan (the “2017 Plan”), which was approved by shareholders 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”), restricted stock units (“RSUs”) and other share-based awards to employees, directors, and consultants, as determined by the Board. The 2017 Plan will not affect awards previously granted under the 2007 Plan. The 2017 Plan allows 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) four percent 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. As of June 30, 2019, there were 1,939,496 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 ten percent 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 and 2017 plans.

 

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Stock Option Summary  

 

The following table summarizes information about the Company’s stock options outstanding at June 30, 2019, and activity during the six-month period then ended:

 

(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, 2018

    3,374     $ 4.13       8.2     $ 8  

Options granted

    125     $ 0.33                  

Restricted stock units granted

    -     $                  

Options exercised

    (83 )   $ 2.30                  

Restricted stock units vested

    (6 )   $                  

Options forfeited/cancelled

    (1,135 )   $ 3.25                  

Restricted stock units cancelled

    (1 )   $                  

Outstanding at June 30, 2019

    2,274     $ 4.44       7.6     $ 183  
                                 

Vested and expected to vest at June 30, 2019

    2,250     $ 4.47       7.6     $ 182  
                                 

Vested at June 30, 2019

    1,719     $ 5.27       7.2     $  
                                 

Exercisable at June 30, 2019

    1,719     $ 5.27       7.2     $  

 

For options that have a quoted market price in excess of the exercise price (“in-the-money options”), 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 reported on the NYSE American as of June 30, 2019. There were 83 thousand stock option awards exercised for the three and six months ended June 30, 2019 for which the Company received cash payments of $189 thousand. There was no intrinsic value for stock option awards exercised for the six months ended June 30, 2019. There were 4 thousand stock option awards exercised during the six months ended June 30, 2018 for which the Company received cash payments of $11 thousand. The aggregate intrinsic value of stock option awards exercised was $1 thousand for the six months ended June 30, 2018.

 

As of June 30, 2019, total unrecognized compensation cost related to unvested stock options and restricted stock units was approximately $708 thousand. This amount is expected to be recognized as stock-based compensation expense in the Company’s consolidated statements of operations and comprehensive loss over the remaining weighted average vesting period of 2.58 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-Merton 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 Accounting Policies” for a description of the accounting policies that the Company applies to value its stock-based awards.

 

During the six months ended June 30, 2019 and 2018, the Company granted options to purchase an aggregate of 125 thousand and 809 thousand shares of common stock, respectively, to employees and directors. 

 

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

 

   

Six Months Ended June 30,

 

Assumption

 

2019

   

2018

 

Expected price volatility

    106.86 %     88.86 %

Expected term (in years)

    6.16       5.97  

Risk-free interest rate

    2.08 %     2.71 %

Dividend yield

    0.00 %     0.00 %

Weighted-average fair value of options granted during the period

  $ 0.27     $ 1.64  

 

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.

 

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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.

 

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.

  

Additionally, during the six months ended June 30, 2019, the Company did not grant restricted stock to employees. During the six months ended June 30, 2018, the Company issued 12 thousand shares of restricted stock to employees.

 

For the three months ended June 30, 2019 and 2018, the Company recognized stock-based compensation expense of $116 thousand and $148 thousand, respectively, for stock-based awards to employees and directors.  For the six months ended June 30, 2019 and 2018, the Company recognized stock-based compensation expense of $223 thousand and $327 thousand, respectively, for stock-based awards to employees and directors.      

 

In March 2018, the Company modified stock options held by Mr. Xiaoyan (Henry) Liu, who resigned as a director of the Company, effective March 21, 2018. The option exercise period for Mr. Henry Liu was extended from three months to three years, calculated from his date of resignation. Also, his stock option awards became fully vested at the date of his resignation. In connection with the stock option modification, the Company recognized stock-based compensation expense of $26 thousand, which is included in the figure above.

 

In April 2019, the Company modified stock options held by Mr. Yonghao (Carl) Ma, who resigned as a director of the Company, effective April 29, 2019. The option exercise period for Mr. Liu was extended from three months to three years, calculated from his date of resignation. Also, his stock option awards became fully vested at the date of his resignation. In connection with the stock option modification, the Company recognized stock-based compensation expense of $14 thousand, which is included in the figure above.

 

In May 2019, the Company modified stock options held by Mr. Yanbin (Lawrence) Liu, who resigned as a director of the Company, effective May 1, 2019. The option exercise period for Mr. Yanbin Liu was extended from three months to three years, calculated from his date of resignation. Also, his stock option awards became fully vested at the date of his resignation. In connection with the stock option modification, the Company recognized stock-based compensation expense of $7 thousand, which is included in the figure above.

 

  

Stock-Based Awards to Non-Employees  

 

During the six months ended June 30, 2019, the Company did not grant options to purchase shares of common stock to non-employees. During the six months ended June 30, 2018, the Company granted options to purchase an aggregate of 5 thousand shares of common stock to non-employees.  

 

The stock options are recorded at their fair value on the measurement date and recognized over the respective service or vesting period. The fair value of the stock options granted was calculated using the Black-Scholes-Merton option pricing model based upon the following assumptions:

 

   

Six Months Ended

June 30,

 

Assumption

 

2018

 

Expected price volatility

    84.83 %

Expected term (in years)

    10.0  

Risk-free interest rate

    2.81 %

Dividend yield

    0.00 %

Weighted-average fair value of options granted during the period

  $ 1.86  

 

In addition, during the six months ended June 30, 2019 and 2018, the Company did not grant restricted stock to non-employees.

  

For the three months ended June 30, 2019 and 2018, the Company recognized stock-based compensation expense of $7 thousand and $6 thousand, respectively, related to non-employee consultant stock and option grants. For the six months ended June 30, 2019 and 2018, the Company recognized stock-based compensation expense of $14 thousand and $13 thousand, respectively, related to non-employee consultant stock and option grants.  

 

-30-

 

 

Summary of Stock-Based Compensation Expense  

 

A summary of the stock-based compensation expense included in results of operations for the option and stock awards discussed above is as follows: 

 

   

Three Months Ended June 30,

   

Six Months Ended June 30,

 

(in thousands)

 

2019

   

2018

   

2019

   

2018

 

Research and development

  $ 13     $ 12     $ 24     $ 19  

Sales and Marketing

    27       45       46       79  

General and administrative

    83       97       167       242  

Total stock-based compensation expense

  $ 123     $ 154     $ 237     $ 340  

 

Since the Company has operating losses and net operating loss carryforwards, there are no tax benefits associated with stock-based compensation expense.

 

 

 

 

NOTE 14. LICENSE, COLLABORATION AND DISTRIBUTION AGREEMENTS

 

Transactions under the Company's major distribution agreements are recognized upon transfer of control 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 invoiced amounts that are estimated to be subject to significant reversal, including product revenue allowances for cash consideration paid to customers for services, discounts, rebate programs, chargebacks, and product returns.

 

Milestone payments are included in the estimated transaction price when they are considered probable of being achieved. For license and collaboration revenue, the transaction price under license and collaboration arrangements, including upfront fees and milestone payments, are allocated differently to each performance obligation and may be recognized at earlier points in time or with a different pattern of performance over time. 

 

The following table presents changes in the Company's contract assets and liabilities for the six months ended June 30, 2019:  

 

   

Balance at Beginning of the Period

   

Additions

   

Deductions

   

Balance at the end of the

Period

 
   

(in thousands)

 

Contract Liabilities: Deferred Revenue

  $ 41     $ -     $ (41 )   $ -  

Contract Liabilities: Accrued Liabilities

    1,432       4,001       (5,119 )     314  

Total

  $ 1,473     $ 4,001     $ (5,160 )   $ 314  

 

-31-

 

 

 During the six months ended June 30, 2019 and 2018, the Company recognized the following revenue (in thousands):

 

   

Six Months Ended June 30,

 
   

2019

   

2018

 

Revenue recognized in the period from:

               

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

               

Performance obligations satisfied

  $ 1,473     $ 1,426  

New activities in the period:

               

Performance obligations satisfied

    1,807       4,315  
                 
    $ 3,280     $ 5,741  

 

License, Collaboration and Distribution Agreements

 

In January 2012, the Company entered into a distribution agreement with China Pioneer, a Shanghai-based company that markets high-end pharmaceutical products into China and an affiliate of Pioneer Singapore, for the commercialization of NeutroPhase in this territory. Under the terms of the agreement, NovaBay received an upfront payment of $312,500. NovaBay also received $312,500 in January 2013, related to the submission of the first marketing approval for the product to the Chinese Food and Drug Administration (the “CFDA”). The deferred revenue was recognized as the purchase discounts were earned, with the remaining deferred revenue recognized ratably over the product distribution period. During the year ended December 31, 2014, NovaBay received $625,000 upon receipt of a marketing approval of the product from the CFDA.

 

In September 2012, the Company entered into two agreements with China Pioneer: (1) an international distribution agreement (“Distribution Agreement”) and (2) a unit purchase agreement (“Purchase Agreement”). These agreements were combined and accounted for as one arrangement with one unit of accounting for revenue recognition purposes.

 

Pursuant to the terms of the Distribution Agreement, China Pioneer has the right to distribute NeutroPhase, upon a marketing approval from a Regulatory Authority, in certain territories in Asia (other than China). Upon execution of the Distribution Agreement, the Company received an upfront payment, which was recorded as deferred revenue. China Pioneer is also obligated to make certain additional payments to the Company upon receipt of the marketing approval. The Distribution Agreement further provides that China Pioneer is entitled to a cumulative purchase discount not to exceed $500,000 upon the purchase of NeutroPhase product, payable in NovaBay unregistered restricted common stock.

 

Pursuant to the Purchase Agreement, the Company also received $2.5 million from China Pioneer for the purchase of restricted units (comprising one share of common stock and a warrant for the purchase of one share of common stock). The unit purchase was completed in two tranches: (1) 800,000 units in September 2012; and (2) 1,200,000 units in October 2012, with both tranches at a purchase price of $1.25 per unit. The fair value of the total units sold was $3.5 million, based upon the trading price of the Company’s common stock on the dates the units were purchased and the fair value of the warrants based on the Black-Scholes Merton option pricing model. Because the aggregate fair value of the units on the dates of purchase exceeded the $2.5 million in proceeds received from the unit purchase by approximately $1.0 million, the Company reallocated $600,000 from deferred revenue to stockholders’ equity as consideration for the purchase of the units.

 

In December 2013, the Company announced it had expanded its NeutroPhase commercial partnership agreement with China Pioneer. The expanded agreement includes licensing rights to Avenova and CelleRx, which were developed internally by NovaBay. The expanded partnership agreement covers the commercialization and distribution of these products in China and 11 countries in Southeast Asia.

 

On February 7, 2012, the Company entered into a distribution agreement with Integrated Healing Technologies, LLC, (“IHT”) to distribute NeutroPhase. NovaBay received an upfront payment of $750,000.

 

In April 2013, the Company entered into a collaboration and license agreement with Virbac. Under this agreement, Virbac acquired exclusive worldwide rights to develop the Company’s proprietary compound, auriclosene (NVC-422), for global veterinary markets for companion animals. The Company received an upfront payment of $250,000.

 

On June 1, 2013, the Company entered into a distribution agreement with Principal Business Enterprise Inc., (“PBE”) to distribute NeutroPhase. NovaBay received an upfront payment of $200,000.

 

During the three and six months ended June 30, 2019, the Company earned $0 and $41 thousand in revenue, respectively, due to the Company being relieved of contract liability as a result of changes in contract terms associated with the distribution agreement with PBE. During the three and six months ended June 30, 2018, the Company earned $0 and $13 thousand in revenue as a result of satisfied performance obligations of sample supply due to Pioneer China and PBE. The Company had $0 and $41 thousand deferred revenue at June 30, 2019 and December 31, 2018, respectively.

 

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Avenova Distribution Agreements and Specialty Ph armacies

 

In November 2014, the Company signed a nationwide distribution agreement for its Avenova product with McKesson Corporation (“McKesson”) as part of the Company’s commercialization strategy. McKesson makes Avenova widely available in local pharmacies and major retail chains across the U.S., such as Wal-Mart, Costco, CVS and Target. In January 2015, the Company signed a nationwide distribution agreement with Cardinal Health. In April 2015, the Company also signed a distribution agreement with AmerisourceBergen to distribute Avenova nationwide. 

 

During the three months ended June 30, 2019 and 2018, the Company earned $1.3 million and $2.3 million,   respectively, and $2.5 million and $4.9 million, respectively, for the six months ended June 30, 2019 and 2018, in product revenue under the Avenova distribution agreements.

 

Under the Avenova product distribution arrangements, the Company had a contract liability balance of $0.3 million and $1.4 million at June 30, 2019 and December 31, 2018, respectively. The contract liability is included in accrued liabilities in the consolidated balance sheet. The contract liability as of June 30, 2019 and December 31, 2018 both included a prepayment of $0.9 million rebate, that is recorded in the prepaid expenses and other current assets in the consolidated balance sheet (see Note 4, “Prepaid Expenses and Other Current Assets”).  

 

Since the start of the year we have doubled the number of pharmacies in our Partner Pharmacy Program to 16, putting us on track to increase Avenova sales through retail pharmacies from one-quarter to one-half of all sales. Our partner pharmacies provide patients with a quality experience that includes a relatively short time between receiving the initial prescription and filling it, fast refills and home delivery. The combination of a pre-negotiated price along with a reduction in coupon and rebate usage improves our gross-to-net and per-script profitability. During both the three and six months ended June 30, 2019, the revenue generated from these pharmacies comprised 25% of the total product revenue. During the three and six months ended June 30, 2018, the revenue generated from these pharmacies comprised 15% and 14% of the total product revenue, respectively.

 

Avenova Direct  

 

In an effort to improve patient access, Avenova Direct was launched on June 1, 2019 to U.S. customers exclusively on Amazon.com. Avenova Direct is the same strength hypochlorous formulation as Avenova Rx, but comes in a 20mL size. This channel offers the Company with stable gross-to-net pricing and provides customers with easy access to our product. This model capitalizes on a trend to sell pharmaceutical products directly to consumers in response to high-deductible health plans, allowing customers to forego a time-consuming doctor visit and trip to the pharmacy. We are promoting this program through complementary social media marketing to target consumers in specific demographics, as well as to ophthalmologists, optometrists, and current and former Avenova patients.

 

 

 

 

NOTE 1 5 . 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 the six months ended June 30, 2019 or June 30, 2018. 

 

 

 

 

NOTE 1 6 . RELATED PARTY TRANSACTIONS       

 

Related Party Financing

 

See Note 9, “Related Party Notes Payable” for a description of the Promissory Note issued on February 27, 2019, as amended on June 25, 2019.

 

Related Party Revenue  

 

The Company recognized related party revenues from product sales of $209 thousand for both the three and six months ended June 30, 2019. The Company did not recognize any related party revenues from products for the three months ended June 30, 2018. The Company recorded cost of goods sold of $176 thousand for both the three and six months ended June 30, 2019. The Company recognized related party revenues from license and collaboration fees of zero for both the three months ended June 30, 2019 and 2018, respectively, and $41 thousand and $13 thousand for the six months ended June 30, 2019 and 2018, respectively. The license and collaboration fees related to the Company's distribution agreements with China Pioneer, the Company's second largest stockholder. In fulfillment of the performance obligations under this contract, the Company supplied product samples with a cost of $219 thousand for the six months ended June 30, 2018. Related party accounts receivable was $145 thousand and $39 thousand as of June 30, 2019 and December 31, 2018, respectively. See Note 14, “License, Collaboration and Distribution Agreements” for additional information regarding the Company's distribution agreements with China Pioneer, the Company's second largest stockholder.

 

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Related Party Expenses  

 

The Company paid related party fees of $144 thousand and $0 for the three months ended June 30, 2019 and 2018, respectively. The fee of $144 thousand paid to China Kington during the three months ended June 30, 2019 represented the commission for the private placement with three accredited investors which closed on June 26, 2019. The $144 thousand was recorded as an offset to the additional paid-in capital in the consolidated balance sheet. The Company paid related party fees of $214 thousand and $359 thousand for the six months ended June 30, 2019 and 2018, respectively. A fee of $20 thousand was paid to China Kington in the first quarter of 2019 and represented the broker fee for the issuance of the Promissory Note to Pioneer Pharma (Hong Kong) Company Ltd., and it was recorded as an offset to the related party notes payable in the consolidated balance sheet. For the three and six months ended June 30, 2019, $11 thousand and $15 thousand were recorded to interest expense using the effective interest rate method over the term of the Promissory Note, respectively. The fee of $50 thousand paid to Director Bob Wu in the first quarter of 2019 represented the consulting fees pursuant to that certain Consulting Agreement, between the Company and China Kington, dated March 11, 2019. It was included in the prepaid expenses and other current assets in the consolidated balance sheet and will be amortized over the service period pursuant to the Consulting Agreement. The Company recorded a $24 thousand expense and $32 thousand expense for the three and six months ended June 30, 2019, respectively. See Note 9, “Related Party Notes Payable” for additional information regarding such fees. The fees paid to China Kington during the six months ended June 30, 2018 represented the commission on its sale of the Company’s common stock. See Note 12, “Stockholders’ Equity” – “Common Stock” for additional information regarding such commissions.

 

 

 

 

NOTE 17. SUBSEQUENT EVENTS

 

On July 29, 2019, former Chief Financial Officer and Interim Chief Executive Officer and President, John McGovern, made a demand for arbitration on the Company for certain relief totaling $370,000 including unpaid wages and expenses, waiting time penalties, concealment, negligence, promise without intent to perform, unfair business practices and punitive damages under California law. Mr. McGovern alleges that he was constructively terminated from his position on or about March 7, 2019. There can be no assurances as to the ultimate outcome of a legal proceeding; however, we intend to vigorously defend the Company against such demand.

 

As reported in the Company’s Current Report on Form 8-K filed with the SEC on July 25, 2019 (the “Form 8-K”), on July 20, 2019, Mark M. Sieczkarek resigned as a member of the Board. In connection with his resignation and his prior employment with the Company, on the same date, the Company and Mr. Sieczkarek entered into a Severance Agreement and General Release (the “Severance Agreement”). Pursuant to the Severance Agreement, the Company agrees to grant Mr. Sieczkarek restricted stock units from the Company's 2017 Omnibus Incentive Plan with a fair market value of $220,000 at the date of grant. Additionally, the Company entered into a two-year consulting agreement with Mr. Sieczkarek, pursuant to which Mr. Sieczkarek will provide consulting service to the Company in exchange for restricted stock units from the Company’s 2017 Omnibus Incentive Plan with an aggregate fair market value equal to $440,000 as of the date of grant. The restricted stock units will be issued in two equal tranches on July 1, 2020 and July 1, 2021, respectively, with the share amount calculated using the closing price on each respective grant date. The shares will be fully vested as of the date of grant.

 

Upon the resignation of Mr. Sieczkarek, the Board appointed Mr. Xiaopei (Ray) Wang to fill the vacancy on the Board resulting from the resignation of Mr. Sieczkarek. The Board further determined that such Class I vacancy resulting from Mr. Sieczkarek’s registration would become a Class II vacancy to evenly divide the directors between the Board’s three classes. Therefore, Mr. Wang is a Class II director who will serve until the Company’s Annual Meeting of Stockholders in 2021, subject to his prior death, resignation or removal from office as provided by law. Mr. Wang was nominated by Mr. Jian Ping Fu, the Company’s largest stockholder. Mr. Wang is a non-independent member and will not serve on any committees of the Board.

  

Separately, on July 1, 2019, the Company was notified by the NYSE American LLC that the Company’s plan to regain compliance with NYSE American’s continued listing standards had been accepted. As previously reported in Item 3.01 of the Company’s Current Report on Form 8-K filed with the SEC on April 15, 2019, the Company was previously notified by NYSE American on April 12, 2019 that it was not in compliance with the continued listing stockholders’ equity standards set forth in Section 1003(a)(iii) of the NYSE American Company Guide (requiring stockholders’ equity of $6.0 million or more if a company has reported net losses in its five most recent fiscal years) and was further notified on May 16, 2019 that it was not in compliance with Sections 1003(a)(i) and 1003(a)(ii) of the guide (requiring stockholders’ equity of $2.0 million or more and $4.0 million or more, respectively, if a company has reported net losses in three of the four most recent fiscal years), as reported in Item 3.01 of the Company’s Current Report on Form 8-K filed on May 21, 2019.

 

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ITEM 2.  MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

 

The following discussion of our financial condition and results of operations should be read 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 Management’s 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, 2018 , as amended, which was initially filed with the Securities and Exchange Co mmission (the “SEC”) on March 29, 2019 . This discussion contains forward-looking statements that involve risks and uncertainties. Words such as “expects,” “anticipated,” “will,” “may,” “goals,” “plans,” “believes,” “estimates,” variations of these words, and similar expressions are intended to identify these forward-looking statements.   As a result of many factors, such as those set forth under the section entitled “Risk Factors” in Part II, Item 1A and elsewhere in this report, our actual results may differ materially from those anticipated in these forward-looking statements. Readers are cautioned that these forward-looking statements are only predictions based upon assumptions made that we believed to be reasonable at the time, and are subject to risks and uncertainties. Therefore, actual results may differ materially and adversely from those expressed in any forward-looking statements. Except as required by law, we undertake no obligation to revise or update publicly any forward-looking statements.   

 

Overview 

 

We are a medical device company predominantly focused on eye care. We are currently focused primarily on commercializing Avenova ® , an FDA cleared product sold in the United States for cleansing and removing 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 has proven in laboratory testing to have broad antimicrobial properties as a preservative in solution as it removes foreign material including microorganisms and debris from the skin around the eye without burning or stinging. Avenova is free from the bleach impurities found in nearly all other hypochlorous products and is soothing when applied.

 

In the first quarter of 2019, many national insurance payors stopped reimbursing Avenova. Despite consistent demand for Avenova, we were challenged by the costs of maintaining an expanded commercial organization with our new lower net selling price. In the second quarter, we made a strategic shift by significantly reducing the number of field sales representatives by about three-quarters and redeploying our remaining representatives in territories that account for about 95% of retail pharmacy sales. This shift allowed us to effectively utilize our streamlined commercial resources to reach higher-prescribing physicians while significantly reducing our operating expenses

 

Going forward, our core business strategy will center around increasing sales of Avenova in all distribution channels: (1) Avenova Direct, our direct-to-consumer model, allowing customers to forego time-consuming doctor visits and trips to the pharmacy; (2) Retail Pharmacies, selling to consumers through local pharmacies across 50 states; (3) our Partner Pharmacy Program; providing a consistent patient experience at contracted pricing; and (4), our Buy-and-Sell channel, allowing patients to buy Avenova during their office visits to their preferred eye care specialist.

 

Beyond Avenova, we have developed additional products containing our proprietary, stable and pure form of hypochlorous acid, including NeutroPhase ®  for the wound care market and CelleRx ®  for the dermatology market. For NeutroPhase we have established a U.S. distribution partner and an international distribution partner in China. For CelleRx, we plan to begin selling directly to the consumer before the end of the year in a low-cost online distribution channel. Avenova, NeutroPhase, and CelleRx are medical devices cleared by the FDA under the Food and Drug Administration Act Section 510(k). 

 

Critical Accounting Policies and Estimates

 

Our consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States. The preparation of these 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 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.  

 

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While our significant accounting policies are more fully described in Note 2 of the Notes to Consolidated Financial Statements (Summary of Significant Accounting Policies), 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

 

We charge “Bad Debt” expense and set up an “Allowance for Doubtful Accounts” when management identifies amounts due that are in dispute and believes it unlikely a specific invoice will be collected. At June 30, 2019 and December 31, 2018, management had reserved $24 thousand and $10 thousand, respectively, primarily based on specific amounts that were in dispute or were over 120 days past due as of those dates.

 

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 unlabeled bottles; and (3) finished goods. We utilize contract manufacturers to produce our products and the cost associated with manufacturing is included in inventory. At June 30, 2019 and December 31, 2018, management had recorded an allowance for excess and obsolete inventory and the lower of cost or estimated net realizable value adjustments of $109 thousand and $104 thousand, respectively.

 

Inventory is stated at the lower of cost or estimated net realizable value determined by the first-in, first-out method.

 

Leases

 

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) , to enhance the transparency and comparability of financial reporting related to leasing arrangements. The Company adopted the standard effective January 1, 2019. Using the optional transition method, prior period financial statements have not been recast to reflect the new lease standard.

 

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