Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

FORM 10-Q

 

xQUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 For the quarterly period ended December 31, 20172018

or

oTRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
  
 For the transition period from                               to                              

 

Commission File Number 001-33216

 

SONOMA PHARMACEUTICALS, INC.

(Exact name of registrant as specified in its charter)

 

Delaware68-0423298

(State or other jurisdiction of

incorporation or organization)

(I.R.S Employer

Identification No.)

 

1129 North McDowell Blvd.

Petaluma, CA 94954

(Address of principal executive offices) (Zip Code)

 

(707) 283-0550

Registrant’s telephone number, including area code

 

Indicate by checkmark 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  x   No  o

 

Indicate by check mark whether the registrant has submitted electronically and posted on its corporate Web site, if any, every Interactive Data File required to be submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes  x   No  o

 

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.

 

Large accelerated filer  Accelerated filer 
     
Non-accelerated filer ☐  (Do not check if a smaller reporting company) Smaller reporting company 
     
Emerging growth 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  o   No  x

 

As of February 9, 2018,11, 2019, the number of shares outstanding of the registrant’s common stock, $0.0001 par value, was 4,732,20211,972,328.

 

 

 

   
 

 

SONOMA PHARMACEUTICALS, INC.

Index

 

 Page
PART I - FINANCIAL INFORMATION3
Item 1. Financial Statements3
Condensed Consolidated Balance Sheets3
Condensed Consolidated Statements of Comprehensive Loss4
Condensed Consolidated Statements of Cash Flows5
Notes to Condensed Consolidated Financial Statements6
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations1718
Item 3. Quantitative and Qualitative Disclosures About Market Risk2526
Item 4. Controls and Procedures2526
  
PART II - OTHER INFORMATION2627
Item 1. Legal Proceedings2627
Item 1A. Risk Factors2627
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds2627
Item 3. Defaults Upon Senior Securities2728
Item 4. Mine Safety Disclosures (Not applicable.)2728
Item 5. Other Information2728
Item 6. Exhibits2728

 

 

 

 

 

 2 
 

 

PART I - FINANCIAL INFORMATION

 

Item 1.Financial Statements

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands, except share and per share amounts)

 

 December 31, March 31, 
 December 31, March 31,  2018  2018 
 2017  2017  (Unaudited)   
 (Unaudited)          
ASSETS                
Current assets:                
Cash and cash equivalents $8,625  $17,461  $6,496  $10,066 
Accounts receivable, net  2,609   2,108   3,121   1,537 
Inventories, net  2,701   2,221 
Inventories  3,215   2,865 
Prepaid expenses and other current assets  1,508   616   1,526   1,547 
Current portion of deferred consideration, net of discount  229   237   221   239 
Total current assets  15,672   22,643   14,579   16,254 
Property and equipment, net  1,200   1,239   817   1,136 
Deferred consideration, net of discount, less current portion  1,392   1,497   1,123   1,322 
Other assets  91   80   526   494 
Total assets $18,355  $25,459  $17,045  $19,206 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable $1,400  $1,255  $1,101  $1,272 
Accrued expenses and other current liabilities  1,515   1,302   1,535   1,406 
Deferred revenue  180   345   174   147 
Deferred revenue Invekra  140   176   55   59 
Current portion of long-term debt  12   123   8   230 
Current portion of capital leases  146   74   182   147 
Taxes payable     13 
Common stock liability  270    
Total current liabilities  3,393   3,288   3,325   3,261 
Long-term deferred revenue Invekra  492   527 
Long-term deferred revenue  366   443 
Long-term debt, less current portion  35   45   14   32 
Long-term capital leases, less current portion  179   168      144 
Total liabilities  4,099   4,028   3,705   3,880 
Commitments and Contingencies (Note 6)        
Commitments and Contingencies (Note 5)        
Stockholders’ Equity                
Convertible preferred stock, $0.0001 par value; 714,286 shares authorized, none issued and outstanding at December 31, 2017 and March 31, 2017, respectively      
Common stock, $0.0001 par value; 12,000,000 shares authorized at December 31, 2017 and March 31, 2017, 4,637,541 and 4,289,322 shares issued and outstanding at December 31, 2017 and March 31, 2017, respectively  1   1 
Convertible preferred stock, $0.0001 par value; 714,286 shares authorized at December 31, 2018 and March 31, 2018, respectively, 1.55 shares issued and outstanding at December 31, 2018 and no shares issued and outstanding at March 31, 2018      
Common stock, $0.0001 par value; 24,000,000 and 12,000,000 shares authorized at December 31, 2018 and March 31, 2018, respectively, 11,972,328 and 6,171,736 shares issued and outstanding at December 31, 2018 and March 31, 2018, respectively  2   1 
Additional paid-in capital  171,332   168,709   183,772   176,740 
Accumulated deficit  (152,677)  (143,101)  (166,016)  (157,440)
Accumulated other comprehensive loss  (4,400)  (4,178)  (4,418)  (3,975)
Total stockholders’ equity  14,256   21,431   13,340   15,326 
Total liabilities and stockholders’ equity $18,355  $25,459  $17,045  $19,206 

 

 

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

 

 3 
 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Comprehensive (Loss) IncomeLoss

(In thousands, except per share amounts)

(Unaudited)

 

 Three Months Ended
December 31,
  Nine Months Ended
December 31,
  

Three Months Ended

December 31,

 

Nine Months Ended

December 31,

 
 2017  2016  2017  2016  2018  2017  2018  2017 
Revenues                         
Product $4,647  $3,174  $12,394  $8,158  $5,045  $4,647  $13,775  $12,394 
Service  196   187   609   638   235   196   813   609 
Total revenues  4,843   3,361   13,003   8,796   5,280   4,843   14,588   13,003 
Cost of revenues                                
Product  2,308   1,476   6,529   4,507   2,269   2,308   7,006   6,529 
Service  167   179   496   568   164   167   577   496 
Total cost of revenues  2,475   1,655   7,025   5,075   2,433   2,475   7,583   7,025 
Gross profit  2,368   1,706   5,978   3,721   2,847   2,368   7,005   5,978 
Operating expenses                                
Research and development  349   487   1,099   1,226   451   349   1,191   1,099 
Selling, general and administrative  5,219   4,784   14,319   12,557   4,746   5,219   14,368   14,319 
Total operating expenses  5,568   5,271   15,418   13,783   5,197   5,568   15,559   15,418 
Loss from operations  (3,200)  (3,565)  (9,440)  (10,062)  (2,350)  (3,200)  (8,554)  (9,440)
Interest expense  (11)     (31)  (2)  (7)  (11)  (26)  (31)
Interest income  14   6   85   8   37   14   139   85 
Other income (expense), net  10   282   (179)  276   22   10   (135)  (179)
Net loss from continuing operations before income taxes  (3,187)  (3,277)  (9,565)  (9,780)
Tax benefit     4,040      4,040 
Net (loss) income from continuing operations  (3,187)  763   (9,565)  (5,740)
Net income from discontinued operations (net of tax)     15,465      17,450 
Net (loss) income $(3,187) $16,228  $(9,565) $11,710 
Net loss  (2,298)  (3,187)  (8,576)  (9,565)
Net loss per share: basic and diluted $(0.26) $(0.73) $(1.20) $(2.21)
Weighted-average number of shares used in per common share calculations: basic and diluted  8,739   4,392   7,152   4,333 
                                
Net (loss) income per share: basic                
Continuing operations $(0.73) $0.18  $(2.21) $(1.36)
Discontinued operations     3.66      4.15 
 $(0.73) $3.84  $(2.21) $2.79 
                
Weighted-average number of shares used in per share calculations: basic  4,392   4,225   4,333   4,209 
                
Net (loss) income per share: diluted                
Continuing operations $(0.73) $0.18  $(2.21) $(1.36)
Discontinued operations     3.66      4.15 
 $(0.73) $3.84  $(2.21) $2.79 
                
Weighted-average number of shares used in per share calculations: diluted  4,392   4,228   4,333   4,209 
                
Other comprehensive (loss) income                
Net (loss) income $(3,187) $16,228  $(9,565) $11,710 
Other comprehensive loss                
Net loss $(2,298) $(3,187) $(8,576) $(9,565)
Foreign currency translation adjustments  (377)  (416)  (222)  (817)  (291)  (377)  (443)  (222)
Comprehensive (loss) income $(3,564) $15,812  $(9,787) $10,893 
Comprehensive loss $(2,589) $(3,564) $(9,019) $(9,787)

 

 

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

 


 4 
 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

 

 Nine Months Ended December 31, 
 2017  2016  

Nine Months Ended

December 31,

 
 (In thousands)  2018  2017 
Cash flows from operating activities                
Net loss from continuing operations $(9,565) $(5,740)
Net income from discontinued operations, net of tax     17,450 
Net (loss) income  (9,565)  11,710 
Adjustments to reconcile net (loss) income to net cash used in operating activities:        
Net loss $(8,576) $(9,565)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  366   178   347   366 
Gain on sale of Latin American assets, net of tax     (14,906)
Income tax benefit     (4,040)
Stock-based compensation  1,530   1,732   1,275   1,530 
Service provider expenses settled with common stock  62   98 
Service provider fees settled with common stock  59   62 
Changes in operating assets and liabilities:                
Accounts receivable  (500)  (118)  (1,628)  (500)
Inventories  (521)  (644)  (514)  (521)
Prepaid expenses and other current assets  (951)  1,104   75   (951)
Accounts payable  151   (205)  (150)  151 
Accrued expenses and other current liabilities  174   86   150   174 
Deferred revenue  (137)  (467)  (9)  (137)
Net cash used in operating activities  (9,391)  (5,472)  (8,971)  (9,391)
Cash flows from investing activities:                
Purchases of property and equipment  (178)  (195)  (86)  (178)
Proceeds from sale of Latin American assets, net of costs     17,444 
Deposits  (15)  (17)  (37)  (15)
Net cash (used in) provided by investing activities  (193)  17,232 
Net cash used in investing activities  (123)  (193)
Cash flows from financing activities:                
Proceeds from issuance of common stock, net of offering costs  968    
Net proceeds from sale of common stock in connection with at market issuances  957   968 
Net proceeds from sale of common and preferred stock units  4,742    
Proceeds from exercise of common stock purchase warrants  52         52 
Proceeds from common stock liability  270    
Principal payments on capital leases  (97)      (109)  (97)
Principal payments on long-term debt  (121)  (119)  (288)  (121)
Net cash provided by (used in) financing activities  802   (119)
Net provided by financing activities  5,572   802 
Effect of exchange rate on cash and cash equivalents  (54)  (127)  (48)  (54)
Net (decrease) increase in cash and cash equivalents  (8,836)  11,514 
Net decrease in cash and cash equivalents  (3,570)  (8,836)
Cash and cash equivalents, beginning of period  17,461   7,469   10,066   17,461 
Cash and cash equivalents, end of period $8,625  $18,983  $6,496  $8,625 
                
Supplemental disclosure of cash flow information:                
Cash paid for interest $31  $2  $26  $31 
                
Non-cash operating and financing activities:                
Automobiles financed using capital leases $180  $  $  $180 
        
Sale to Invekra:        
Assets acquired and liabilities assumed:        
Restricted cash $  $1,500 
Deferred consideration – current, net     239 
Deferred consideration – long-term, net     1,509 
Taxes payable     (229)
Deferred tax liability     (312)
Deferred revenue – current     (674)
Deferred revenue – long-term     (531)
Total non-cash items $  $1,502 

 

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

 


 5 
 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Unaudited)

 

Note 1.Organization and Recent Developments

 

Organization

 

Sonoma Pharmaceuticals, Inc., (the “Company”), was incorporated under the laws of the State of California in April 1999 and was reincorporated under the laws of the State of Delaware in December 2006. The Company’s principal office is located in Petaluma, California. The Company is a specialty pharmaceutical company dedicated to identifying, developing and commercializing unique, differentiated therapies to millions of patients living with chronic skin conditions. The Company believes its products, which are sold throughout the United States and internationally, have improved patient outcomes for more than five million patients globally by treating and reducing certain topical skin diseases including acne, atopic dermatitis, scarring, infections, itch, pain and harmful inflammatory responses.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements as of December 31, 20172018 and for the three and nine months then ended have been prepared in accordance with the accounting principles generally accepted in the United States of America for interim financial information and pursuant to the instructions to Form 10-Q and Article 8 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual audited consolidated financial statements. The condensed consolidated balance sheet as of December 31, 2017,2018, the condensed consolidated statements of comprehensive (loss) incomeloss for the three and nine months ended December 31, 2018 and 2017 and 2016 and the condensed consolidated statements of cash flows for the nine months ended December 31, 20172018 and 20162017 are unaudited, but include all adjustments, consisting only of normal recurring adjustments, which the Company considers necessary for a fair presentation of the consolidated financial position, operating results and cash flows for the periods presented. The results for the three and nine months ended December 31, 20172018 are not necessarily indicative of results to be expected for the year ending March 31, 20182019 or for any future interim period. The condensed consolidated balance sheet at March 31, 20172018 has been derived from audited consolidated financial statements. These unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. Generally Accepted Accounting Principles (“GAAP”) for interim financial information. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended March 31, 2017,2018, and notes thereto included in the Company’s annual report on Form 10-K, which was filed with the SEC on June 28, 2017.26, 2018.

 

Note 2.Liquidity and Financial Condition

 

The Company reported a net loss of $9,565,000$8,576,000 for the nine months ended December 31, 2017.2018. At December 31, 20172018 and March 31, 2017,2018, the Company’s accumulated deficit amounted to $152,677,000$166,016,000 and $143,101,000,$157,440,000, respectively. The Company had working capital of $12,279,000$11,254,000 and $19,355,000$12,993,000 as of December 31, 20172018 and March 31, 2017,2018, respectively. The

On November 16, 2018, the Company expectsentered into a placement agency agreement with Dawson James Securities, Inc. with respect to continue incurring losses for the foreseeable futureissuance and may need to raise additional capital to pursue its product development initiatives, penetrate markets for the sale of an aggregate of up to 7,300,000 units with each unit consisting of one share of common stock, par value $0.0001 per share or, in lieu of common stock, if purchasing common stock would result in the purchaser, together with its productsaffiliates and continue ascertain related parties, beneficially owning more than 4.99% of the outstanding common stock, shares of Series C convertible preferred stock (“Series C”) convertible into shares of common stock, together with one half of one warrant to purchase one share of common stock at an exercise price equal to $1.00 per whole share, in a going concern.public offering. The public offering price for each unit was $1.00. On November 21, 2018, at closing of the offering, the Company sold 4,564,400 shares of common stock, 9.65 shares of Series C (convertible into 965,000 shares of common stock) and 2,764,700 warrants for gross proceeds of $5,530,000 and net proceeds of $4,742,000 after deducting placement agent commissions and other estimated offering expenses.

6

 

On December 8, 2017, the Company entered into an At Market Issuance Sales Agreement with B. Riley FBR, Inc. (“B. Riley”) under which the Company may issue and sell shares of its common stock having an aggregate offering price of up to $5,000,000 from time to time through B. Riley acting as its sales agent. The Company will pay B. Riley a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock sold through B. Riley as agent. For the three months ended December 31, 2017,period of April 1, 2018 through October 3, 2018, the Company sold 228,000267,394 shares of common stock for gross proceeds of $1,034,000$999,000 and net proceeds of $968,000$957,000 after deducting commissions and other offering expenses.

 

In addition, on October 4, 2018, the Company sold 113,000 shares of common stock, at a price of $2.39 per share, through its At Market Issuance Sales Agreement with B. Riley FBR, Inc. for gross proceeds of $270,000 and net proceeds of $262,000 after deducting commissions and other offering expenses. This sale exceeded the aggregate market value of the Company’s securities sold during the period of twelve calendar months prior to the sale of one-third of the aggregate market value of its common stock held by non-affiliates, and thus, the 113,000 shares of common stock were unregistered. The Company could be liable in the event claims or suits for rescission are brought and successfully concluded for failure to register these securities or for acts or omissions constituting offenses under the Securities Act, the Securities Exchange Act of 1934, or applicable state securities laws. The Company could be liable for damages and penalties assessed by the SEC and state securities regulators.

 

The Company expects to continue incurring losses for the foreseeable future and will need to raise additional capital to pursue its product development initiatives, to penetrate markets for the sale of its products and to continue as a going concern. The Company cannot provide any assurances that it will be able to raise additional capital.

6

 

Management believes that the Company has access to additional capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, the Company cannot provide any assuranceassurances that other new financings will be available on commercially acceptable terms, if needed. If the economic climate in the U.S. deteriorates, the Company’s ability to raise additional capital could be negatively impacted. If the Company is unable to secure additional capital, it may be required to curtail its research and development initiatives and take additional measures to reduce costs in order to conserve its cash in amounts sufficient to sustain operations and meet its obligations. These measures could cause significant delays in the Company’s continued efforts to commercialize its products, which is critical to the realization of its business plan and the future operations of the Company. These matters raise substantial doubt about the Company’s ability to continue as a going concern. The accompanying condensed consolidated financial statements do not include any adjustments that may be necessary should the Company be unable to continue as a going concern.

 

Note 3.Summary of Significant Accounting Policies

 

Use of Estimates

 

The preparation of condensed consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the condensed consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include reserves and write-downs related to receivables and inventories, the recoverability of long-lived assets, the valuation allowance relating to the Company’s deferred tax assets, the valuation of equity and derivative instruments, debt discounts, the valuation of investments, the determination of the relative selling prices of the components sold to Invekra, and the estimated amortization periods of upfront product licensing fees received from customers. Periodically, the Company evaluates and adjusts estimates accordingly. The allowance for doubtful accounts represents probable credit losses of $13,000 and $14,000 at December 31, 2017 and March 31, 2017, respectively. Additionally, at December 31, 2017 and March 31, 2017 the Company has allowances of $1,423,000 and $672,000, respectively, related to potential discounts, returns, distributor fees and rebates. The allowances are included in Accounts Receivable, net in the accompanying condensed consolidated balance sheets.

 

Basic and Diluted Net Income (Loss)Loss per common shareShare

 

Basic earnings andThe Company computes basic net loss per share for both continuing and discontinued operations are computed by dividing the net income or loss per share available to common stockholders by the weighted average number of common shares outstanding duringfor the period.period and excludes the effects of any potentially dilutive securities. Diluted earnings per share, is computed usingif presented, would include the weighted average number of common shares and, if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuabledilution that would occur upon the exercise or conversion of all potentially dilutive securities into common stock options (usingusing the treasury stock method) and warrants (using the if-converted method). Diluted“treasury stock” and/or “if converted” methods as applicable. The computation of basic loss per share for the three and nine months ended December 31, 2018 and 2017 excludes the shares issuable uponpotentially dilutive securities summarized in the exercise of stock options and warrants from the calculation of net loss per share astable below because their effectinclusion would be anti-dilutive.

  Three Months Ended  Nine Months Ended 
  December 31,  December 31, 
  2017  2016  2017  2016 
Numerator:            
Net (loss) income from continuing operations $(3,187,000) $763,000  $(9,565,000) $(5,740,000)
Net income from discontinued operations (net of tax)     15,465,000      17,450,000 
Net (loss) income $(3,187,000) $16,228,000  $(9,565,000) $11,710,000 
                 
Denominator:                
Weighted-average number of common shares outstanding - basic  4,392,000   4,225,000   4,333,000   4,209,000 
Options to purchase common stock     3,000       
Weighted-average number of common shares outstanding - diluted  4,392,000   4,228,000   4,333,000   4,209,000 
                 
Basic – net (loss) income from continuing operations $(0.73) $0.18  $(2.21) $(1.36)
Basic – net income from discontinued operations (net of tax)     3.66      4.15 
  $(0.73) $3.84  $(2.21) $2.79 
                 
Diluted – net loss income from continuing operations $(0.73) $0.18  $(2.21) $(1.36)
Diluted – net income from discontinued operations (net of tax)     3.66      4.15 
  $(0.73) $3.84  $(2.21) $2.79 

 

 

 


 7 
 

 

The following securities were excluded from the weighted average dilutive common shares outstanding because their inclusion would have been antidilutive.

  December 31, 
  2018  2017 
Restricted stock units  34,000   33,000 
Options to purchase common stock  1,441,000   1,385,000 
Warrants to purchase common stock  4,209,000   1,333,000 
Series C  155,000    
Common Stock Units (1)  415,000    
   6,254,000   2,751,000 

 

  Three Months Ended  Nine Months Ended 
  December 31,  December 31, 
  2017  2016  2017  2016 
Restricted stock units  33,000      33,000    
Options to purchase common stock  1,385,000   848,000   1,385,000   851,000 
Warrants to purchase common stock  1,333,000   1,365,000   1,333,000   1,365,000 
   2,751,000   2,213,000   2,751,000   2,216,000 

(1)Each unit consists of one share of common stock, par value $0.0001 per share, and one half of one warrant to purchase one share of common stock.

 

Revenue Recognition

On April 1, 2018, the Company adopted Accounting Standards Update ("ASU") No. 2014-09, "Revenue from Contracts with Customers Topic 606” (“Topic 606”) using the modified retrospective method. There was no impact to the Company upon the adoption of Topic 606. Revenue is recognized when the entity transfers promised goods or services to the customer, in an amount that reflects the consideration which the entity expects to receive in exchange for those goods or services. In determining the appropriate amount of revenue to be recognized as the Company fulfills its obligations under the agreement, the Company 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; and Accounts Receivable(v) recognition of revenue when (or as) the Company satisfies each performance obligation. The Company only applies the five-step model to contracts when it is probable that it will collect the consideration it is entitled to in exchange for the goods or services it transfers to the customer.

 

The Company generatesderives the majority of its revenue fromthrough sales of its products to a customer base, including hospitals, medical centers, doctors, pharmacies, distributors and wholesalers. The Company sells products directly to end users and to distributors. The Company also has entered into agreements to license its technology and products.

The Company also provides regulatory compliance testing and quality assurance services to medical device and pharmaceutical companies.

 

The Company recordsconsiders customer purchase orders, which in some cases are governed by master sales agreements, to be the contracts with a customer. For each contract, the Company considers the promise to transfer products, each of which are distinct, to be the identified performance obligations. In determining the transaction price the Company evaluates whether the price is subject to refund or adjustment to determine the net consideration to which it expects to be entitled.

For all of its sales to non-consignment distribution channels, revenue is recognized when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred, (iii) the fee is fixed or determinable, and (iv) collectabilitycontrol of the saleproduct is reasonably assured.

The Company requires all product sales to be supported by evidence of a sale transaction that clearly indicates the selling pricetransferred to the customer shipping terms and payment terms. Evidence of an arrangement generally consists of a contract or purchase order approved by the customer. The Company has ongoing relationships with certain customers from(i.e. when our performance obligation is satisfied), which it customarily accepts orders by telephone in lieu of purchase orders.

The Company recognizes revenue at the time it receives confirmation that the goods were either tendered at their destination,typically occurs when shipped “FOB destination,” or transferred to a shipping agent, when shipped “FOB shipping point.” Delivery to the customer is deemed to have occurred when the customer takes title to the product. Generally, title passes to the customer upon shipment but could occur when the customer receives the product based on the terms of the agreement with the customer.

The selling prices of all goods are fixed, and agreed  For product sales to with the customer, prior to shipment. Selling prices are generally based on established list prices. The right to return product is customarily based on the terms of the agreement with the customer. The Company estimates and accrues for potential returns and records this as a reduction of revenue in the same period the related revenue is recognized. Additionally, distribution fees are paid to certain wholesale distributors based on contractually determined rates. The Company estimates and accrues the fee on shipment to the respective wholesaleits value-added resellers, non-stocking distributors and recognizes the fee as a reduction of revenue in the same period the related revenue is recognized. The Company also offers cash discounts to certainend-user customers, generally 2% of the sales price, as an incentive for prompt payment. The Company accounts for cash discounts by reducing accounts receivable by the prompt pay discount amount and recognizes the discount as a reduction of revenue in the same period the related revenue is recognized. Additionally, the Company participates in certain rebategrants return privileges to its customers, and because the Company has a long history with its customers, the Company is able to estimate the amount of product that will be returned.  Sales incentives and other programs which provide discounted prescriptionsthat the Company may make available to qualified patients. The Company contracts withthese customers are considered to be a third-party to administer the program. The Company estimates and accrues for future rebates based on historical data for rebate redemption ratesform of variable consideration, and the historicalCompany maintains estimated accruals and allowances using the expected value of redemptions. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized.method.

 

The Company evaluateshas entered into consignment arrangements,in which goods are left in the creditworthinesspossession of new customers and monitorsanother party to sell. As products are sold from the creditworthinesscustomer to third parties, the Companyrecognizes revenue based on a variable percentage of its existing customers to determinea fixed price.  Revenue recognized varies depending on whether an eventa patient is covered by insurance or changes in their financial circumstances would raise doubt asis not covered by insurance. In addition, the Company may incur a revenue deduction related to the collectabilityuse of a sale at the time in which a sale is made. Payment terms on sales made in the United States are generally 30 to 60 days and are extended up to 90 days for initial product launches, payment terms internationally generally range from prepaid prior to shipment to 90 days.Company’s rebate program.

 

 

 

 

 8 
 

 

In the event a sale isSales to stocking distributors are made to a customer under circumstances in which collectability is not reasonably assured, the Company either requires the customer to remit payment prior to shipment or defers recognitionterms with fixed pricing and limited rights of return (known as “stock rotation”) of the revenue until paymentCompany’s products held in their inventory. Revenue from sales to distributors is received. The Company maintains a reserve for amounts which may not be collectible duerecognized upon the transfer of control to risk of credit losses.

In the event a sale is made to a customer under circumstances in which returns cannot be estimated, the Company defers recognition of the revenue until sell-through is confirmed.

Product license revenue is generated through agreements with strategic partners for the commercialization of Microcyn® products. The terms of the agreements sometimes include non-refundable upfront fees. The Company analyzes multiple element arrangements to determine whether the elements can be separated. Analysis is performed at the inception of the arrangement and as each product is delivered. If a product or service is not separable, the combined deliverables are accounted for as a single unit of accounting and recognized over the performance obligation period.

When appropriate, the Company defers recognition of non-refundable upfront fees. If the Company has continuing performance obligations then such up-front fees are deferred and recognized over the period of continuing involvement.distributor.

 

The Company recognizes royalty revenuesassessed the promised goods and services in the technical support to Invekra for a ten-year period as being a distinct service that Invekra can benefit from licensed products uponon its own and is separately identifiable from any other promises within the sale ofcontract. Given that the related products.distinct service is not substantially the same as other goods and services within the Invekra contract, the Company accounted for the distinct service as a performance obligation.

 

Revenue from consulting contracts is recognized as services are provided. Revenue from testing contracts is recognized as tests are completed and a final report is sent to the customer.

Disaggregation of Revenue

The following table presents the Company’s disaggregated revenues by revenue source:

  

Three Months Ended

December 31,

  

Nine Months Ended

December 31,

 
  2018  2017  2018  2017 
Product                
Human Skin Care $4,497,000  $4,358,000  $12,125,000  $11,297,000 
Animal Skin Care  548,000   289,000   1,650,000   1,097,000 
   5,045,000   4,647,000   13,775,000   12,394,000 
Service  235,000   196,000   813,000   609,000 
Total $5,280,000  $4,843,000  $14,588,000  $13,003,000 

Accounts Receivable

Trade accounts receivable are recorded net of allowances for cash discounts for prompt payment, doubtful accounts, and sales returns. Estimates for cash discounts and sales returns are based on analysis of contractual terms and historical trends.

The Company’s policy is to reserve for uncollectible accounts based on its best estimate of the amount of probable credit losses in its existing accounts receivable. The Company periodically reviews its accounts receivable to determine whether an allowance for doubtful accounts is necessary based on an analysis of past due accounts and other factors that may indicate that the realization of an account may be in doubt. Other factors that the Company considers include its existing contractual obligations, historical payment patterns of its customers and individual customer circumstances, an analysis of the number of days sales are outstanding by customer and geographic region, and a review of the local economic environment and its potential impact on government funding and reimbursement practices. Account balances deemed to be uncollectible are charged to the allowance after all means of collection have been exhausted and the potential for recovery is considered remote. The allowance for doubtful accounts represents probable credit losses of $16,000 and $17,000 at December 31, 2018 and March 31, 2018, respectively. Additionally, at December 31, 2018 and March 31, 2018 the Company had allowances of $1,834,000 and $1,275,000, respectively, related to potential discounts, returns, distributor fees and rebates. The allowances are included in Accounts Receivable, net in the accompanying condensed consolidated balance sheets.

 

Inventories

 

Inventories are stated at the lower of cost, cost being determined on a standard cost basis (which approximates actual cost on a first-in, first-out basis), or net realizable value.

 

Due to changing market conditions, estimated future requirements, age of the inventories on hand and production of new products, the Company regularly reviews inventory quantities on hand and records a provision to write down excess and obsolete inventory to its estimated net realizable value. The Company recorded reservesa provision to reduce the carrying amounts of inventories to their net realizable value in the amountsamount of $201,000$124,000 and $61,000$111,000 at December 31, 20172018 and March 31, 2017, respectively.

Reclassifications

Certain prior period amounts have been reclassified for comparative purposes to conform to the fiscal 2018, presentation. These reclassifications have no impactrespectively, which is included in cost of product revenues on the Company’s previously reportedaccompanying condensed consolidated netstatements of comprehensive loss.

Subsequent Events

The Company evaluates events that have occurred after the balance sheet date but before the financial statements are issued. Based upon the evaluation, the Company did not identify any recognized or non-recognized subsequent events that would have required adjustment or disclosure in the condensed consolidated financial statements (Note 11).

Adoption of Recent Accounting Standards

In March 2016 the FASB issued ASU No. 2016-09,Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting. This update simplifies the accounting for employee share-based payment transactions, including the accounting for income taxes, forfeitures, and statutory tax withholding requirements, as well as classification in the statement of cash flows.

On April 1, 2017, the Company adopted ASU No. 2016-09. As a result of adopting ASU No. 2016-09, the Company has made an accounting policy election to account for forfeitures as they occur. This change has been applied on a modified retrospective basis, with no material impacts on the Company’s financial statements. The adoption of ASU No. 2016-09 also requires excess tax benefits and tax deficiencies be recorded in the income statement as opposed to additional paid-in capital when the awards vest or are settled and recognize all previously unrecognized excess tax benefits and tax deficiencies upon adoption as a cumulative-effect adjustment to retained earnings. As of April 1, 2017, the Company recognized excess tax benefit of approximately $533,000 as an increase to deferred tax assets. However, the entire amount was offset by a full valuation allowance.  Accordingly, no cumulative-effect adjustment to retained earnings was recorded as of December 31, 2017.

 

 

 

 9 
 

 

Additionally,Subsequent Events

Management has evaluated subsequent events or transactions occurring through the adoption of ASU No. 2016-09 related todate the accounting for minimum statutory withholding tax requirements and cash paid by an employer when directly withholding shares for tax-withholding purposes had no impact on the Company's currentcondensed consolidated financial statements or on any prior period financial statements presented.were issued.

 

Adoption of Recent Accounting Standards

 

LeasesFinancial Instruments

 

In February 2016,On April 1, 2018, the Company adopted ASU No. 2016-01, Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842)Instruments-Overall, which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for theaddresses certain aspects of recognition, measurement, presentation, and disclosure of leases for both lessees and lessors.financial instruments. The FASBCompany has continued to clarify this guidance and most recently issued ASU 2017-13Amendments to SEC Paragraphs Pursuant to the Staff Announcement at the July 20, 2017 EITF Meeting and Rescission of Prior SEC Staff Announcements and Observer Comments. The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases baseddetermined there was no material impact on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease, respectively. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than twelve months regardless of classification. Leases with a term of twelve months or less will be accounted for similar to existing guidance for operating leases. The standard will be effective for annual and interim periods beginning after December 15, 2018, with early adoption permitted upon issuance. The Company is currently evaluating the impact that ASU 2016-02 will have on itsCompany’s consolidated financial statementsposition and related disclosures.results of operations upon adoption of this topic.

  

RevenueStatement of Cash Flows

In May 2014,On April 1, 2018, the FASB issuedCompany adopted ASU No. 2014-09,2016-15,Revenue from Contracts with CustomersStatement of Cash Flows (Topic 230) (“ASU 2014-09”). ASU 2014-09 amends the guidance for revenue recognition to replace numerous, industry-specific requirements and converges areas under this topic with those of the International Financial Reporting Standards. The ASU implements a five-step process for customer contract revenue recognition that focuses on transfer of control, as opposed to transfer of risk and rewards. TheThis amendment also requires enhanced disclosures regarding the nature, amount, timing and uncertainty of revenues and cash flows from contracts with customers. Other major provisions include the capitalization and amortization of certain contract costs, ensuring the time value of money is considered in the transaction price, and allowing estimates of variable consideration to be recognized before contingencies are resolved in certain circumstances. The amendments of ASU 2014-09 were effective for reporting periods beginning after December 15, 2016, with early adoption prohibited. Entities can transition to the standard either retrospectively or as a cumulative-effect adjustment as of the date of adoption. In August 2015, the FASB issued ASU 2015-14 Revenue from Contracts with Customers (Topic 606), Deferral of the Effective Date, which defers by one year the effective date of ASU 2014-09. Accordingly, this guidance is effective for interim and annual periods beginning after December 15, 2017 with early adoption permitted for interim and annual periods beginning after December 15, 2016. In March 2016, the FASB issued ASU 2016-08Principal versus Agent Considerations (Reporting Revenue Gross versus Net) which finalizes its amendments to the guidance in the new revenue standard on assessing whether an entity is a principal or an agent in a revenue transaction. This conclusion impacts whether an entity reports revenue on a gross or net basis. In April 2016, the FASB issued ASU 2016-10Identifying Performance Obligations and Licensing, which finalizes its amendments to the guidance in the new revenue standard regarding the identification of performance obligations and accounting for the license of intellectual property. In May 2016, the FASB issued ASU 2016-12Narrow-Scope Improvements and Practical Expedients, which finalizes its amendments to the guidance in the new revenue standard on collectability, noncash consideration, presentation of sales tax, and transition. In December 2016, the FASB issued ASU 2016-20,Technical Corrections and Improvements to Topic 606, Revenue from Contracts with Customers, which continues the FASB’s ongoing project to issue technical corrections and improvements to clarify the codification or correct unintended applications of guidance. In September 2017, the FASB issued ASU 2017-13,Revenue Recognition (Topic 605), Revenue from Contracts with Customers (Topic 606), Leases (Topic 840), and Leases (Topic 842),which provides additional implementation guidance on the previously issued ASU 2014-09. The amendments are intendedpresentation and classification of specific cash flow items to makeimprove consistency within the guidance more operable and lead to more consistent application. The amendments have the same effective date and transition requirements as the new revenue recognition standard.statement of cash flows. The Company will adopthas determined there was no material impact on the new standard onCompany’s consolidated financial position and results of operations upon adoption of this topic.

On April 1, 2018, and currently plans to use the modified retrospective method. The majority of the Company’s business is ship and bill and, on that primary revenue stream, the Company does not expect significant differences. However,adopted ASU No. 2016-18,Statement of Cash Flows (Topic 230): Restricted Cash, which changes the Company’s analysis is preliminarypresentation of restricted cash and subject to change.cash equivalents on the statement of cash flows. Restricted cash and restricted cash equivalents will be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. The Company has not completed its assessmentdetermined there was no material impact on the Company’s consolidated financial position and results of multiple element arrangements and certain discount and trade promotion programs.operations upon adoption of this topic.

10

Business Combinations

In January 2017,On April 1, 2018, the FASB issued anCompany adopted ASU No. 2017-01,Business Combinations (Topic 805): Clarifying the Definition of a Business. The amendments in this Update is to clarify, which clarifies the definition of a business with the objective of adding guidance to assist entities with evaluating whether transactions should be accounted for as acquisitions (or disposals) of assets or businesses. The definition of a business affects many areas of accounting, including acquisitions, disposals, goodwill, and consolidation. The guidance is effective for annual periods beginning after December 15, 2017, including interim periods within those periods. The Company is currently evaluatinghas determined there was no material impact on the impactCompany’s consolidated financial position and results of adoptingoperations upon adoption of this guidance.topic.

 

Stock Compensation

In May 2017,On April 1, 2018, the FASB issuedCompany adopted ASU No. 2017-09,Compensation–StockCompensation-Stock Compensation (Topic 718):Scope of Modification Accounting, clarifying when a change to the terms or conditions of a share-based payment award must be accounted for as a modification. The new guidance requires modification accounting if the fair value, vesting condition or the classification of the award is not the same immediately before and after a change to the terms and conditions of the award. The new guidance isCompany has determined there was no material impact on the Company’s consolidated financial position and results of operations upon adoption of this topic.

Recent Accounting Standards

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued ASU No. 2016-02,Leases (Topic 842), which will require lessees to recognize a right of use asset and lease liability on the balance sheet for leases with terms longer than 12 months. Leases will be classified as either finance or operating, with classification affecting the pattern of expense recognition in the income statement. The amendment will be effective for annual and interim periods beginning after December 15, 2018, including interim periods within those fiscal years. In July 2018, the Company on a prospective basis beginning on April 1, 2018, with earlyFASB issued ASU No. 2018-10,Codification Improvements to Topic 842, Leases and ASU No. 2018-11,Leases - Targeted Improvements.ASU No. 2018-10 provides certain amendments that affect narrow aspects of the guidance issued in ASU No. 2016-02. ASU No. 2018-11 allows entities the option to prospectively apply the new lease standard at the adoption permitted.date instead of recording the cumulative impact of all comparative reporting periods presented within retained earnings. The Company is currently evaluating the impact that ASU 2017-09No. 2016-02, ASU No. 2018-10 and ASU No. 2018-11 will have on its consolidated financial position, results of operations or financial statement disclosure. 

10

Reporting Comprehensive Income

In February 2018, the FASB issued ASU No. 2018-02,Income Statement - Reporting Comprehensive Income (Topic 220): Reclassification of Certain Tax Effects from Accumulated Other Comprehensive Income ("ASU 2018-02"). ASU 2018-02 provides financial statement preparers with an option to reclassify stranded tax effects within accumulated other comprehensive income to retained earnings in each period in which the effect of the change in the U.S. federal corporate income tax rate in the Tax Cuts and Jobs Act of 2017 (the “Tax Act”) (or portion thereof) is recorded. ASU 2018-02 is effective for fiscal years beginning after December 15, 2018. Early adoption is permitted for any interim period for which financial statements have not been issued. The Company does not believe that the adoption of this guidance will have a material impact on the Company's consolidated financial statements due to the presence of a full valuation allowance. However, the Company is in the process of evaluating the impact of this new guidance on the Company's consolidated financial statements and disclosures.

Stock Compensation

In June 2018, the FASB issued ASU No. 2018-07,Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting, which expands the scope of ASC Topic 718 to include all share-based payment arrangements related disclosures.to the acquisition of goods and services from both nonemployees and employees. This amendment will be effective for annual and interim periods beginning after December 31, 2018. The Company is currently evaluating the impact ASU No. 2018-07 will have on its consolidated financial position, results of operations or financial statement disclosure.

 

Accounting standards that have been issued or proposed by the FASB, the SEC or other standard setting bodies that do not require adoption until a future date are not expected to have a material impact on the consolidated financial statements upon adoption.

 

Note 4.Disposition of Latin American Operations

Description of Sale to Invekra

On October 27, 2016, the Company, along with its Mexican subsidiary and manufacturer Oculus Technologies of Mexico, S.A. de C.V. (“OTM”), closed on an asset purchase agreement with Invekra, S.A.P.I. de C.V. (“Invekra”), an affiliate of Laboratorios Sanfer S.A. de C.V., for the sale of certain of its Latin America assets. Specifically, the Company agreed to sell certain patents, patent applications, trademarks and territory rights for Mexico, the Caribbean and South America, excluding the sale of dermatology products in Brazil, as well as to build and deliver equipment that Invekra will use to produce its own product.

The aggregate purchase price that Invekra will pay for the assets is $22,000,000, of which $18,000,000 was paid upon closing, $1,500,000 was paid on March 16, 2017 upon the delivery of certain equipment, and $2,500,000 is to be paid in Mexican currency in quarterly installments over a period of ten years from closing as consideration for the provision of certain services and providing technical assistance, calculated as three percent on net sales of certain products in Latin America, excluding Mexico. Because the $2,500,000 is to be paid in foreign currency, the Company may receive more or less than $2,500,000 due to currency fluctuations. During the nine months ended December 31, 2017, the Company recorded $39,000 of service revenue and $33,000 of interest income related to technical assistance which is reflected in the accompanying condensed consolidated statement of comprehensive (loss) income for the nine months ended December 31, 2017.

In connection with the asset purchase agreement, the Company agreed to provide the technology, know-how and assistance to Invekra to enable Invekra to manufacture on its own the products as currently produced by the Company (“Technical Services Arrangement”), and continue to supply product to Invekra for a two-year transition period from the Sale Date, subject to mutual extension (“Supply Agreement”). During the three and nine months ended December 31, 2016, the Company reported $465,000 of Latin America product revenue related to the Supply Agreement with Invekra. During the three and nine months ended December 31, 2017, the Company reported $772,000 and $2,095,000, respectively, of Latin America product revenue related to the Supply Agreement with Invekra.

The Company will provide product under the Supply Agreement at a reduced price from its current price list, while Invekra builds its own manufacturing line. At the conclusion of the transition period, the Company will cease to be a supplier of product to Invekra. The Company is uncertain as to the duration of the transition period or when Invekra will complete the build out of its manufacturing line. Pursuant to the Supply Agreement, the Company is subject to a potential penalty for failure to supply the products for a consecutive period of nine months. The penalty, if triggered, will require the Company to make a one-time payment of $2,000,000 to Invekra. The penalty decreases by 12.5% each quarter of the term of the supply period.

11

Discontinued operations

As of December 31, 2016, the Company determined that the sale of its Latin American operations to Invekra qualified as a sale of a component of its business and, as such, all such activity prior to consummation of the sale is required to be included in discontinued operations on the Company’s statement of operations. This includes the direct labor and materials for the product delivered to Invekra, the revenue on the sales to Invekra and the gain on the sale to Invekra, net of tax.

The operations of its Latin American business included in discontinued operations is summarized as follows:

  

Three Months Ended

December 31,

  

Nine Months Ended

December 31,

 
  2017  2016  2017  2016 
Revenues $  $621,000  $  $3,105,000 
Cost of Revenues     62,000      561,000 
Income from discontinued operations before tax      559,000       2,544,000 
Gain on disposal of discontinued operations before income taxes     19,487,000      19,487,000 
Total income from discontinued operations, before tax     20,046,000      22,031,000 
Income Tax benefit (expense)     (4,581,000)     (4,581,000)
Income from discontinued operations, net of tax $  $15,465,000  $  $17,450,000 

Note 5.InventoriesCondensed Consolidated Balance Sheets

 

Inventories net

 

Inventories consist of the following:

  

 December 31, March 31,  December 31, March 31, 
 2017  2017  2018  2018 
Raw materials $1,526,000  $1,480,000  $1,819,000  $1,619,000 
Finished goods  1,175,000   741,000   1,396,000   1,246,000 
 $2,701,000  $2,221,000  $3,215,000  $2,865,000 

 

Note 6.5.Commitments and Contingencies

 

Legal Matters

 

TheOn March 17, 2017, the Company filed a lawsuit against Collidion, Inc. and several of its former employees, officers and directors, alleging the misappropriation of its confidential, proprietary and trade secret information as well as breach of fiduciary duties in the United States District Court for the Northern District of California, San Francisco Division. On September 26, 2018, the Company settled the lawsuit to the satisfaction of all parties. There has been no finding of wrongdoing against any party.

11

Aside from the lawsuit described above, on occasion, the Company may be involved in legal matters arising in the ordinary course of business including matters involving proprietary technology. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which the Company is or could become involved in litigation may have a material adverse effect on its business and financial condition of comprehensive (loss) income.loss.

 

Employment AgreementsMatters

Potential Severance Payments

 

As of December 31, 2017,2018, the Company had employment agreements in place with sixfour of its key executives. The agreements provide, among other things, for the payment of twelveup to eighteentwelve months of severance compensation for terminations under certain circumstances. With respect to theseThree of the employment agreements athave a provision for severance compensation. At December 31, 2017, aggregated annual salaries would be $1,167,000 and2018, potential severance payments to these key executives would be $1,417,000$704,000, if triggered.

Appointment of Chief Executive Office and Interim Financial Officer

On December 11, 2018, the Company’s Board appointed Mr. Frederick (Bubba) Sandford as its Chief Executive Officer and Interim Chief Financial Officer for an initial term of nine months, subject to a mutual extension of an additional three months. Mr. Sandford was appointed as a Class III director of the Board on December 14, 2018.

In connection with Mr. Sandford’s appointment as the Company’s Chief Executive Officer and Interim Chief Financial Officer, the Company entered into an employment agreement with him, in which the Company agreed to pay him a base annual salary of $350,000 per year. The Company also agreed to pay him a performance bonus of a maximum of 60% of his base annual salary for achieving certain agreed upon targets.

In addition, pursuant to the agreement, Mr. Sandford was granted 450,000 stock options to purchase the Company’s common stock, of which 400,000 stock options were treated as an inducement grant and 50,000 stock options were from the Company’s equity incentive plan. The Company granted the options on January 10, 2019 with an exercise price of $0.717 per share, and will become 100% exercisable nine months after date of grant and have a maximum term of ten years. Upon termination, the options are exercisable for up to twelve months from the termination date and in no event later than ten years from the grant date.

Resignation of Chief Executive Officer, President and Director and Chief Financial Officer and Secretary

On December 12, 2018, Jim Schutz and Robert Miller resigned from their positions as the Company’s Chief Executive Officer and President and Chief Financial Officer and Secretary, respectively. On the same date, Mr. Schutz also resigned from the Board.

In connection with Mr. Schutz’s resignation, the Company entered into a separation and mutual release agreement with Mr. Schutz on December 13, 2018, in which the Company agreed to pay him severance, consisting of $250,000, to be paid in two equal installments with the first half paid on December 14, 2018 and the second half to be paid with the next payroll after three months, $38,461 to compensate him for his unused paid time off, and continuation of dental, vision and health insurance until December 31, 2018. Mr. Schutz’s outstanding equity awards were accelerated to December 12, 2018 and remained exercisable until January 14, 2019. Mr. Schutz also agreed to aid with the transition for 30 calendar days. The options expired unexercised on January 14, 2019.

In connection with Mr. Miller’s resignation, the Company entered into a separation and mutual release agreement with Mr. Miller on December 13, 2018, in which the Company agreed to pay him severance, consisting of $225,000, to be paid in two equal installments with thefirst half paid on December 14, 2018and the second half to be paid with the next payroll after three months, $38,461 to compensate him for his unused paid time off, and continuation of dental, vision and health insurance until December 31, 2018. Mr. Miller’s outstanding equity awards were accelerated to December 12, 2018 and remained exercisable until January 14, 2019.The options expired unexercised on January 14, 2019.

 

 

 

 

 12 
 

 

Other Matters

Sale of Unregistered Shares

On October 4, 2018, the Company sold 113,000 shares of common stock, at a price of $2.39 per share, through its At Market Issuance Sales Agreement with B. Riley FBR, Inc. for gross proceeds of $270,000 and net proceeds of $262,000 after deducting commissions and other offering expenses. This sale exceeded the aggregate market value of the Company’s securities sold during the period of twelve calendar months prior to the sale of one-third of the aggregate market value of its common stock held by non-affiliates, and thus, the 113,000 shares of common stock were unregistered. The Company could be liable in the event claims or suits for rescission are brought and successfully concluded for failure to register these securities or for acts or omissions constituting offenses under the Securities Act, the Securities Exchange Act of 1934, or applicable state securities laws. The Company could be liable for damages and penalties assessed by the SEC and state securities regulators. Accordingly, at December 31, 2018, the Company recorded a $270,000 liability in the accompanying condensed consolidated balance sheet.

Nasdaq Listing

On January 4, 2019, the Company received a letter from the Listing Qualifications staff of The Nasdaq Stock Market LLC, notifying the Company that, for the previous 30 consecutive business days, the Company failed to comply with Nasdaq Listing Rule 5550(a)(2), which requires the Company to maintain a minimum bid price of $1.00 per share for its common stock.

In accordance with Listing Rule 5810(c)(3)(C), Nasdaq has granted the Company a period of 180 calendar days, or until July 3, 2019, to regain compliance with the Rule. The Company may regain compliance with the Rule at any time during this compliance period if the minimum bid price for its common stock is at least $1.00 for a minimum of ten consecutive business days.

The letter has no effect on the listing or trading of the Company’s common stock at this time. However, there can be no assurances that the Company will be able to regain compliance with Listing Rule 5550(a)(2). In the event the Company does not regain compliance with the Listing Rule prior to the expiration of the compliance period, the Company may be eligible for additional time. To qualify, the Company will be required to meet the continued listing requirement for market value of publicly held shares and all other initial listing standards for The Nasdaq Capital Market, with the exception of the bid price requirement, and will need to provide written notice of its intention to cure the deficiency during the second compliance period, by effecting a reverse split, if necessary. If the Company meets these requirements, Nasdaq will inform the Company that it has been granted an additional 180 calendar days. However, if it appears to the Staff of Nasdaq that the Company will not be able to cure the deficiency, or if the Company is otherwise not eligible, Nasdaq will provide notice that our securities will be subject to delisting.

Note 7.6.Stockholders’ Equity

 

Authorized Capital

 

TheAt the annual meeting, the Company’s stockholders approved an amendment to its Restated Certificate of Incorporation, as amended, to increase the number of authorized common stock, $0.0001 par value per share, from 12,000,000 to a total of 24,000,000 shares. Effective September 13, 2018, the Company filed a certificate of amendment with the Secretary of State of the State of Delaware in order to effect an increase of the total number of shares of common stock authorized for issuance to 24,000,000. Additionally, the Company is authorized to issue up to 12,000,000 shares of common stock with a par value of $0.0001 per share and 714,286 shares of convertible preferred stock with a par value of $0.0001 per share.

 

13

At Market IssuanceSale of Common and Preferred Stock Units

 

On December 8, 2017,November 16, 2018, the Company entered into an At Market Issuance Sales Agreement,a placement agency agreement with B. Riley FBR,Dawson James Securities, Inc. (“B. Riley”) under whichwith respect to the Company may issueissuance and sell sharessale of its common stock having an aggregate offering price of up to $5,000,000 from time7,300,000 units, each unit consisting of one share of common stock, par value $0.0001 per share or, in lieu of common stock, if purchasing common stock would result in the purchaser, together with its affiliates and certain related parties, beneficially owning more than 4.99% of the outstanding common stock, shares of Series C convertible into shares of common stock, together with one half of one warrant to time through B. Riley acting as its sales agent. The Company will pay B. Riley a commission ratepurchase one share of common stock at an exercise price equal to 3.0%$1.00 per whole share, in a public offering. The public offering price for each unit was $1.00. The warrants offered in the public offering are Series C warrants and will terminate on the fifth anniversary of the date of issuance. Each full warrant will entitle the holder to purchase one share of common stock at an initial exercise price of $1.00 per share.

The closing of the offering occurred on November 21, 2018 and at such closing the Company sold 4,564,400 shares of common stock, 9.65 shares of Series C (convertible into 965,000 shares of common stock) and 2,764,700 warrants for gross proceeds of $5,530,000. The net proceeds to the Company from the sale of anythe shares of common stock, or preferred stock, and the warrants was $4,742,000, after deducting placement agent commissions and other estimated offering expenses payable by the Company.

Pursuant to the placement agency agreement, the Company agreed to pay Dawson James Securities, Inc. a cash fee equal to 8% of the aggregate gross proceeds raised in this offering. The Company also agreed to pay fees and expenses of the placement agent, not to exceed $167,500, and to issue to Dawson James Securities, Inc., on the closing date, a unit purchase option for the purchase of up to 276,470 units, equal to 5% of the aggregate number of units sold through B. Riley as agent. Forin the public offering, with an exercise price of $1.25, or 125% of the price per unit. The Benchmark Company, LLC provided certain financial advisory services. As compensation for services provided, the Company made a cash payment of $74,000 and on November 16, 2018 issued 68,750 common stock purchase warrants. The common stock purchase warrants have an exercise price of $1.00 per share, become exercisable on the 180th day after the date of issuance and expire on November 16, 2023.

During the three months ended December 31, 2017,2018, investors who participated in the Company sold 228,000transaction converted 8.10 shares of Series C into 810,000 shares of common stock for gross proceeds of $1,034,000 and net proceeds of $968,000 after deducting commissions and other offering expenses.stock.

 

Common Stock Issued to Services ProviderProviders

 

During the nine months ended December 31, 2017, theThe Company entered into an agreement with Actual, Inc., a firm that providesfor certain marketing and branding consulting services. In connection with the agreement, the Company pays a portion of the service fees in common stock. On July 27, 2017, the Company issued 2,570 shares of restricted common stock valued at $6.74 per share, and on August 22, 2017, the Company issued 3,133 shares of restricted common stock valued at $5.53 per share. The aggregate fair market value of the common stock issued in July and August was $35,000. The Company has determined that the fair value of the common stock was more readily determinable than the fair value of the services rendered. On December 1, 2017,July 12, 2018, the Company issued 5,47917,741 shares of restricted common stock valued at $5.02$2.48 per share. The aggregate fair market value of the common stock issued was $27,000.$44,000. The Company has determined that the fair value of the common stock was more readily determinable than the fair value of the services rendered. Accordingly, during the three and nine months ended December 31, 2017, the Company recorded $28,000 and $62,000, respectively, of expense related to common stock issued. During the nine months ended December 31, 2018, the Company recorded $44,000 of expense related to common stock issued. The expense was recorded as selling, general and administrative expense in the accompanying condensed consolidated statement of comprehensive (loss) incomeloss.

The Company entered into an agreement with The Benchmark Company, LLC for certain finance related consulting services. In connection with the three andagreement, the Company pays a portion of the service fees in common stock. On July 31, 2018, the Company issued 6,881 shares of restricted common stock valued at $2.18 per share. The aggregate fair market value of the common stock issued was $15,000. The Company has determined that the fair value of the common stock was more readily determinable than the fair value of the services rendered. Accordingly, during the nine months ended December 31, 2017.2018, the Company recorded $15,000 of expense related to common stock issued. The expense was recorded as selling, general and administrative expense in the accompanying condensed consolidated statement of comprehensive loss.

 

14

Note 8.7.Stock-Based Compensation

On April 1, 2017, the Company adopted ASU 2016-09 and, as a result, made a Company-wide accounting policy change with respect to accounting for forfeitures. The Company applied a modified retrospective approach for adoption of the new policy and accordingly recorded an $11,000 increase to opening accumulated deficit at April 1, 2017. In accordance with the adoption of the accounting policy, the Company no longer estimates forfeitures based on historical experience and no longer reduces compensation expense based on the expected forfeitures. Beginning April 1, 2017, the Company will record forfeitures as they occur and will reduce compensation cost at the time of forfeiture.

 

The weighted average grant date fair values of options granted during the nine months ended December 31, 2018 and 2017 was $6.01.$2.20 and $6.01, respectively. During the three months ended December 31, 2018, the Company did not grant any stock options.

 

Share-based awards compensation expense is as follows:

 

 Three Months Nine Months  Three Months Nine Months 
 Ended Ended  Ended Ended 
 December 31,  December 31,  December 31,  December 31, 
 2017  2016  2017  2016  2018  2017  2018  2017 
Cost of service revenue $43,000  $63,000  $136,000  $197,000  $24,000  $43,000  $89,000  $136,000 
Research and development  38,000   77,000   128,000   201,000   26,000   38,000   87,000   128,000 
Selling, general and administrative  584,000   774,000   1,266,000   1,334,000   352,000   584,000   1,099,000   1,266,000 
Total stock-based compensation $665,000  $914,000  $1,530,000  $1,732,000  $402,000  $665,000  $1,275,000  $1,530,000 

 

At December 31, 2018, there were unrecognized compensation costs of $976,000 related to stock options, which is expected to be recognized over a weighted-average amortization period of 1.31 years. At December 31, 2017, there were unrecognized compensation costs of $2,636,000 related to stock options, which is expected to be recognized over a weighted-average amortization period of 2.20 years.

 

At December 31, 2018, there were unrecognized compensation costs of $78,000 related to restricted stock, which is expected to be recognized over a weighted-average amortization period of 1.49 years. At December 31, 2017, there were unrecognized compensation costs of $178,000 related to restricted stock, which is expected to be recognized over a weighted-average amortization period of 1.66 years.

 

No income tax benefit has been recognized relating to stock-based compensation expense and no tax benefits have been realized from exercised stock options.

13

 

Stock-Based Award Activity

On April 1, 2017, pursuant to “evergreen” provisions in the 2011 Stock Incentive Plan and the 2016 Stock Incentive Plan, the number of shares authorized for issuance in the 2011 Plan increased by 643,383 shares and the number of shares authorized for issuance in the 2016 Plan increased by 343,137 shares.

 

Stock options award activity is as follows:

 

  Number of
Shares
  Weighted-
Average
Exercise Price
  Weighted-
Average
Contractual Term
  Aggregate
Intrinsic
Value
 
Outstanding at April 1, 2017  899,000  $17.87         
Options granted  536,000   6.83         
Options exercised  (1,000)  5.27         
Options forfeited  (42,000)  6.77         
Options expired  (7,000)  228.22         
Outstanding at December 31, 2017  1,385,000  $12.76   7.68  $128,000 
Exercisable at December 31, 2017  757,000  $17.92   6.50  $90,000 
  

Number of

Shares

  

Weighted-

Average

Exercise Price

  

Weighted-

Average

Contractual Term

  

Aggregate

Intrinsic

Value

 
Outstanding at April 1, 2018  1,393,000  $12.70         
Options granted  159,000   2.64         
Options forfeited  (48,000)  6.69         
Options expired  (63,000)  11.91         
Outstanding at December 31, 2018  1,441,000  $11.83   4.79  $ 
Exercisable at December 31, 2018  1,103,000  $13.53   3.73  $ 

15

 

The aggregate intrinsic value of stock options is calculated as the difference between the exercise price of the underlying stock options and the fair value of the Company’s common stock, or $5.45$0.71 per share at December 31, 2017.2018.

 

Restricted stock award activity is as follows:

 

  

Number of

Shares

  

Weighted

Average Award

Date Fair Value

per Share

 
Unvested restricted stock awards outstanding at April 1, 2017  34,000  $7.27 
Restricted stock awards granted  98,000   5.49 
Restricted stock awards vested  (99,000)  5.78 
Unvested restricted stock awards outstanding at December 31, 2017  33,000  $6.46 

No income tax benefit has been recognized relating to stock-based compensation expense and no tax benefits have been realized from exercised stock options.

  

Number of

Shares

  

Weighted

Average Award

Date Fair Value

per Share

 
Unvested restricted stock awards outstanding at April 1, 2018  32,000  $6.46 
Restricted stock awards granted  27,000   1.90 
Restricted stock awards forfeited  (4,000)  6.97 
Restricted stock awards vested  (21,000)  5.91 
Unvested restricted stock awards outstanding at December 31, 2018  34,000  $3.18 

 

The Company did not capitalize any cost associated with stock-based compensation.

 

The Company issues new shares of common stock upon exercise of stock options or release of restricted stock awards.

 

The Company issues new shares of common stock upon exercise of stock based awards.

Note 9.8.Income Taxes

 

The Company has completed a study to assess whether a change in control has occurred or whether there have been multiple changes of control since the Company’s formation through March 31, 2017.2018. The Company determined, based on the results of the study, no change in control occurred for purposes of Internal Revenue Code sectionSection 382. The Company, after considering all available evidence, fully reserved for these and its other deferred tax assets since it is more likely than not such benefits will not be realized in future periods. The Company has incurred losses for both financial reporting and income tax purposes for the year ended March 31, 2017.2018. Accordingly, the Company is continuing to fully reserve for its deferred tax assets. The Company will continue to evaluate its deferred tax assets to determine whether any changes in circumstances could affect the realization of their future benefit. If it is determined in future periods that portions of the Company’s deferred income tax assets satisfy the realization standards, the valuation allowance will be reduced accordingly.

 

As a result of certain realization requirements of Accounting Standards Codification Topic 718,The Company only recognizes tax benefits from an uncertain tax position if it is more likely than not that the Company’s deferred tax assets and liabilities do not include certain deferred tax assets at December 31, 2017 that arose directly from tax deductions related to equity compensation in excess of compensation recognized for financial reporting purposes. Equityposition will be increasedsustained on examination by approximately $533,000 if and whenthe taxing authorities, based on the technical merits of the position. The tax benefits recognized in the financial statements from such deferreda position are measured based on the largest benefit that has a greater than fifty percent likelihood of being realized upon ultimate resolution. To date, the Company has not recognized such tax assets are ultimately realized.benefits in its consolidated financial statements.

14

 

On December 22, 2017, the U.S. government enacted comprehensive tax legislation commonly referred to as the Tax Cuts and Jobs Act (the “Tax Act”). The Tax Act makes broad and complex changes to the U.S. tax code that will affect the Company’s fiscal year ending March 31, 2018, including, but not limited to, reducing the U.S. federal corporate tax rate.Act. The Tax Act reduces the federal corporate income tax rate from 35% to 21 percent21%, effective January 1, 2018, which the Company expects will positively impact its future effective tax rate and after-tax earnings in the United States. The Company recognized a decrease related to its federal deferred tax assets and deferred tax liabilities, before the valuation allowance. Because a change in the valuation allowance completely offsets the change in deferred taxes, there was no impact on the consolidated financial statements related to the rate change.

The Company may also be affected by certain other aspects of the Tax Act, including, without limitation, provisions regarding repatriation of accumulated foreign earnings and deductibility of capital expenditures. However, these assessments are based on preliminary review and analysis of the Tax Act and are subject to change as the Company continues to evaluate these highly complex rules as additional interpretive guidance is issued. The Company is also in the process of determining the impacts of the new Global Intangibles Low-Taxed Income (“GILTI”) tax law and has not yet included any potential GILTI tax or elected any related accounting policy.

16

Also on December 22, 2017, the SEC staff issued Staff Accounting Bulletin 118, Income Tax Accounting Implications of the Tax Cuts and Jobs Act (“SAB 118”), which provides guidance on accounting for the impact of the Tax Act. As permitted by SAB 118, both of the tax benefits recorded by the Company for the fiscal year ended March 31, 2018 represent provisional amounts based on its current best estimates. Any adjustments made to those provisional amounts will be included in income from operations and recorded as an adjustment to tax expense through the fiscal year ending March 31, 2018.  Section 152019. The recorded, provisional amounts reflect assumptions made based upon our current interpretation of the Internal Revenue Code stipulates that our fiscal year ending March 31, 2018, will have a blended corporate tax rate of approximately 30 percent, which is based on the applicable tax rates before and after the Tax Act, and may change as the number of daysCompany receives additional clarification and guidance in the year.  The reductionform of the corporate tax rate to 21% will cause the Company to reduce its deferred tax asset, consisting primarily of net operating loss carry forwards, research and development tax credit carry-forwards and stock based compensation and adjust the valuation allowance against the deferred tax asset from approximately $42 million as of March 31, 2017 to approximately $28 million.  The effect of this discrete event has no effect on the basic condensed consolidated financial statements for the three and nine month period ended December 31, 2017.

The changes included in the Tax Act are broad and complex. The final impacts of the Tax Act may differ from the above estimate, possibly materially, due to, among other things, changes in interpretations of the Tax Act, any legislative action to address questions that arise because of the Tax Act, any changes in accounting standards for income taxes or related interpretations in responsetechnical corrections to the Tax Act or any updates or changes to estimatesregulations issued by the company has utilized to calculate the transition impact. The Securities Exchange Commission has issued rules that would allow for a measurement period of up to one year after the enactment date of the Tax Act to finalize the recording of the related tax impacts. We currently anticipate finalizing and recording any resulting adjustments within one year after the enactment date of the Tax Act.U.S. Treasury.

 

The Company does not have any tax positions for which it is reasonably possible the total amount of gross unrecognized tax benefits will increase or decrease within twelve months of March 31, 2018. The unrecognized tax benefits may increase or change during the next year for items that arise in the ordinary course of business.

Note 10.9.Segment and Geographic Information

 

The Company generates product revenues from products which are sold into the human and animal healthcare markets, and the Company generates service revenues from laboratory testing services which are provided to medical device manufacturers. Additionally, the Company provides technical services to Invekra.

 

The following table showspresents the Company’s disaggregated product revenues by geographic region:

 

  

Three months ended

December 31,

       
  2017  2016  $ Change  % Change 
United States $2,883,000  $1,671,000  $1,212,000   73% 
Latin America  772,000   465,000   307,000   66% 
Europe and Rest of the World  992,000   1,038,000   (46,000)  (4%)
Total $4,647,000  $3,174,000  $1,473,000   46% 

  Nine months ended
December 31,
       
  2017  2016  $ Change  % Change 
United States $7,010,000  $4,741,000  $2,269,000   48% 
Latin America  2,095,000   465,000   1,630,000   351% 
Europe and Rest of the World  3,289,000   2,952,000   337,000   11% 
Total $12,394,000  $8,158,000  $4,236,000   52% 

In connection with the Company’s sale of its Latin America business to Invekra, product related revenues were reclassified from continuing operations to discontinued operations. The amounts were classified in the prior periods as Latin America sales. The amounts reclassified are as follows:

  Three Months Ended December 31, 
  2017  2016 
Product revenues $  $359,000 
Product license fees and royalties     262,000 
Total product related revenues $  $621,000 

  Nine Months Ended December 31, 
  2017  2016 
Product revenues $  $2,693,000 
Product license fees and royalties     412,000 
Total product related revenues $  $3,105,000 
  

Three Months Ended

December 31,

  

Nine Months Ended

December 31,

 
  2018  2017  2018  2017 
United States $2,977,000  $2,883,000  $7,374,000  $7,010,000 
Latin America  929,000   772,000   3,005,000   2,095,000 
Europe and Rest of the World  1,139,000   992,000   3,396,000   3,289,000 
Total $5,045,000  $4,647,000  $13,775,000  $12,394,000 

 

The Company’s service revenues amounted to $196,000$235,000 and $187,000$196,000 for the three months ended December 31, 2018 and 2017, respectively. During the three months ended December 31, 2018 and 2016, respectively. 2017, the Company recorded service revenue related to technical services provided to Invekra in the amount of $14,000 in each period.

The Company’s service revenues amounted to $609,000$813,000 and $638,000$609,000 for the nine months ended December 31, 2018 and 2017, respectively. During the nine months ended December 31, 2018 and 2016,2017, the Company recorded service revenue related to technical services provided to Invekra in the amount of $42,000 and $39,000, respectively.

 

15

Note 11.10.Significant Customer Concentrations

 

For the three months ended December 31, 2018 one customer represented 14% of net revenue. For the three months ended December 31, 2017, one customer represented 21% of net revenue, one customer represented 16% of net revenue, one customer represented 14% of net revenue and one customer represented 12% of net revenue.

For the threenine months ended December 31, 2016,2018, one customer represented 22%, one customer represented 16%, one customer represented 13%17% of net revenue and one customer represented 10% of net revenue.

For the nine months ended December 31, 2017, one customer represented 21% of net revenue, one customer represented 16% of net revenue, one customer represented 13% of net revenue and one customer represented 12% of net revenue. For the nine months ended December 31, 2016, one customer represented 27% of net revenue. 

 

At December 31, 2017,2018, one customer represented 36%, one customer represented 17%, and one customer represented 15%12% of the net accounts receivable balance. At March 31, 2017,2018, one customer represented 26%, one customer represented 12%36%, and one customer represented 10%18% of the net accounts receivable balance.

 

Note 12.11.Subsequent Events

 

Stock Issued to Independent Directors and Chief Executive Officers

On January 2, 2018, the Company granted discretionary stock bonuses to all directors of the Company, including its Chief Executive Officer and Director, Jim Schutz, for their services in connection with the turn-around of our Company and in an effort to increase the stock ownership of the Board in the amount of $100,000 or 17,211 shares of common stock at $5.81 per share, each, which shares are immediately vested upon grant. In addition, on January 2, 2018, the Company’s Board of Directors awarded an additional stock bonus of $50,000 or 8,606 shares of common stock subject to the same conditions to its long-standing director Jay Birnbaum for his 10 years of services and longevity on our Board. The stock awards include a 40% tax gross up paid in cash or approximately $180,000 to the directors and $40,000 to the Chief Executive Officer.

None.

 

 

 

 

 1617 
 

 

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 in conjunction with the condensed consolidated financial statements and notes to those statements included elsewhere in this Quarterly Report on Form 10-Q as of December 31, 20172018 and our audited consolidated financial statements for the year ended March 31, 20172018 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on June 28, 2017.26, 2018.

 

This report contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. When used in this report, the words “anticipate,” “suggest,” “estimate,” “plan,” “project,” “continue,” “ongoing,” “potential,” “expect,” “predict,” “believe,” “intend,” “may,” “will,” “should,” “could,” “would,” “proposal,” and similar expressions are intended to identify forward-looking statements.

 

Forward-looking statements are subject to risks and uncertainties that could cause our actual results to differ materially from those projected. These risks and uncertainties include, but are not limited to the risks described in our Annual Report on Form 10-K, including: our ability to become profitable; the impact of changes to reimbursement levels from third-party payors or increased pricing pressure due to rebates; the impact of the Invekra transaction on our business and results of operations; the vulnerability of our Petaluma facility to extremesevere weather events; the impact of seasonality on our sales; the progress and timing of our development programs and regulatory approvals for our products; the benefits and effectiveness of our products; the ability of our products to meet existing or future regulatory standards; the progress and timing of clinical trials and physician studies; our expectations related to the use of our cash reserves; our expectations and capabilities relating to the sales and marketing of our current products and our product candidates; our ability to gain sufficient reimbursement from third-party payors; our ability to compete with other companies that are developing or selling products that are competitive with our products; the establishment of strategic partnerships for the development or sale of products; the risk our research and development efforts do not lead to new products; the timing of commercializing our products; our ability to penetrate markets through our sales force, distribution network, and strategic business partners to gain a foothold in the market and generate attractive margins; the expansion of our sales force and distribution network; the ability to attain specified revenue goals within a specified time frame, if at all, or to reduce costs; the outcome of discussions with the U.S. Food and Drug Administration, or FDA, and other regulatory agencies; the content and timing of submissions to, and decisions made by, the FDA and other regulatory agencies, including demonstrating to the satisfaction of the FDA the safety and efficacy of our products; our ability to manufacture sufficient amounts of our product candidates for clinical trials and products for commercialization activities; our ability to protect our intellectual property and operate our business without infringing on the intellectual property of others; our ability to continue to expand our intellectual property portfolio; our expectations about the outcome of litigation and controversies with third parties; the risk we may need to indemnify our distributors or other third parties; risks attendant with conducting a significant portion of our business outside the United States; our ability to comply with complex federal and state fraud and abuse laws, including state and federal anti-kickback laws; risks associated with changes to health care laws; our ability to attract and retain qualified directors, officers and employees; our expectations relating to the concentration of our revenue from international sales; our ability to expand to and commercialize products in markets outside the wound care market; and the impact of the Sarbanes-Oxley Act of 2002 and any future changes in accounting regulations or practices in general with respect to public companies. These forward-looking statements speak only as of the date hereof. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based, except as required by law.

Our Business

 

We are a specialty pharmaceutical company dedicated to identifying, developing and commercializing unique, differentiated therapies to millions of patients living with chronic skin conditions. We offer early-intervention relief with virtually no side-effects or contraindications. We believe our products, which are sold throughout the United States and internationally, have improved patient outcomes for more than fivenine million patients globally by treating and reducing certain topical skin diseases including acne, atopic dermatitis, scarring, infections, itch, pain and harmful inflammatory responses.

We are focused on the development Our vision is to be a catalyst for improved care and commercialization of therapeutic solutions in medical dermatology to treat skin conditions, such as acne, atopic dermatitis and scarring. These diseases impact millions of patients worldwide and can have significant, multi-dimensional effects on patients’ quality of life, including their physical, functional and emotional well-being.increased access for all patients.

 

 

 

 1718 
 

 

Some of our key products in the United States are:

 

 ·Celacyn®, a prescription hypochlorous acidHOCl based scar management gel clinically proven to soften and flatten raised scars while reducing redness and discoloration.

 

 ·Ceramax™Ceramax Skin Barrier CreamTM, a prescription cream / lotion that helps manage dry itchy skin, minor skin irritations, rashes, and inflammation caused by various skin conditions.

 

 ·Mondoxyne™MondoxyneTM, a prescription oral tetracycline antibiotic used for the treatment of certain bacterial infections, including acne.

 

 ·Alevicyn™LevicynTM, a prescription hypochlorous acidHOCl based atopic dermatitis product line clinically proven to reduce pruritus (itch) and pain associated with various dermatoses.
  
·Sebuderm™SebudermTM, a prescription topical gel used as an alternative to corticosteroids for the management of the burning, itching and scaling experienced with seborrhea and seborrheic dermatitis.

 

·

Loyon™Loyon®, a prescription liquid containing Cetiol® CC and medical grade dimethicone, intended to manage and relieve erythema and itching for various types of dermatoses.

 
·EpicynTM, a prescription topical cleanser helps achieve clear skin and provide relief from irritation when used as part of a daily skin care regimen for patients with acute and chronic dermal lesions.
·Microcyn® (sold under a variety of brand names), a line of products based on electrically charged oxychlorine small molecules designed to target a wide range of pathogens including viruses, fungi, spores and bacteria, including antibiotic-resistant strains.

 

Our key product outside the United States is:

 

 ·Microcyn® orMicrodacyn60® (sold under a variety of brand names), a line of products based on electrically charged oxychlorine small molecules designed to target a wide range of pathogens including viruses, fungi, spores and bacteria, including antibiotic-resistant strains.

  

As of December 31, 2017,To date, we have obtained 20 clearances from the21 U.S. Food and Drug Administration, or FDA, that permit us to sell ourclearances permitting the sale of products as medical devices for Section 510(k) of the Federal Food, Drug and Cosmetic Act in the United States.

 

Outside the United States, we sell products for dermatological and advanced tissue care with a European Conformity marking, (known as Conformité Européenne, or CE) coveringCE. These CEs cover 25 of our products andin 48 countries with various approvals in Brazil, China, Southeast Asia, South Korea, India, Australia, New Zealand, and the Middle East.

 

Our StrategyBusiness Channels

 

Our strategycore market differentiation is based on being the leading developer and producer of stabilized hypochlorous acid, or HOCl, solutions. HOCl is known to in-license, acquire, developbe among the safest and commercialize unique, affordablemost-effective ways to relieve itch, inflammation and differentiated therapies that we believe advance the standard of care for patients with dermatological diseases. The key components of our strategy are to:burns while stimulating natural healing through increased oxygenation and eliminating persistent microorganisms and biofilms.

 

·Expand our Internal U.S. Sales Force: We continue to hire additional experienced sales people who have established relationships with dermatologists in their territories and we currently have a sales force of 35 sales professionals.

Our core market includes patients who suffer from various skin diseases, including dermatoses, acne, scarring, skin-barrier and scaly skin conditions. Our secondary market includes eye-hygiene and acute care markets. These conditions impact patients worldwide who have had to live with less than optimal solutions or ones that come with significant side effects. Skin conditions can have significant, multi-dimensional effects on quality of life, including on patient’s physical, functional and emotional well-being.

 

·Develop and Launch New Dermatology Products: We currently sell nine prescription dermatology products in the United States, and have a strong product pipeline of new products, including an oral antibiotic for severe acne and Ceramax™, which utilizes a “state of the art” skin repair technology.
·In-License and Acquire New Product Candidates: Since beginning our turn-around strategy in 2014, we have executed multiple transactions resulting in adding new products and product candidates to our growing portfolio. In 2015, we acquired the U.S. marketing rights to Mondoxyne™, an oral antibiotic indicated for severe acne. In 2016, we in-licensed Ceramax™ indicated for various dermatoses, and Loyon® indicated as a descaler of various dermatoses and psoriasis.

 

 

 

 1819 
 

 

·Create a Competitive Pricing Strategy: We have and will continue to develop a unique product pricing strategy, which we believe solves many of the challenges associated with the prescription dermatology market’s current pricing and rebate programs.

We have also built on our HOCl technology foundation by adding two complementary technology platforms: Lipogrid® Skin Barrier solutions and Exuvimax Skin de-scaling solutions. Lipogrid is a lipid structural matrix of solid lipid particles and vesicles containing phospholipids, ceramides, fatty acids and cholesterol-type stabilizers that deliver building blocks to the dermis and protect the skin. Exuvimax contains a combination of dicaprylyl carbonate (Cetiol® Oil) and dimethicones that provide a patented formulation designed for a very effective but safe keratolytic effect which is the shedding of the top layer of skin. Our product Loyon® is based on the Exuvimax technology and its key benefit is to remove scale and therefore allow the topical treatments to work more effectively and faster on the underlying condition.

 

·Develop a Pharmaceutical Line: We plan to acquire or develop pharmaceutical products with affordable clinical trials to increase our market presence and create innovator patent protection.

Dermatology

In the United States, we sell into dermatology markets with a sales team that visits or calls dermatologists. Our dermatology products are primarily purchased by distributors, wholesalers, and pharmacies.

Although specific customer requirements can vary depending on applications, customers generally demand quality, innovation, affordability and clinically-supported efficacy. We have responded to these customer demands by introducing new products that treat persistent and common dermatological afflictions, as well as promote healing and improve results for patients opting for cosmetic dermatology procedures. We are strategically focused on introducing innovative new products that are supported by human clinical data with applications that address specific dermatological procedures currently in demand. In addition, we look for markets where we can provide effective product line extensions and pricing to new product families. In the future, to increase market penetration beyond marketing to core dermatologists, we are also evaluating how our products fit into the aesthetic dermatologists and plastic surgeons practice.

We seek to extend and expand our strong ongoing relationships with customers through new products, sales of existing products, ongoing training and support, and distribution of skincare products. We primarily target practitioners through office visits, workshops, trade shows, webinars and trade journals. We also market to potential patients through brochures, workshops and websites. In addition, we offer clinical forums with recognized expert panelists to promote advanced treatment.

Eye Care and Advanced Tissue Care

 

Our plan iseye care and advanced tissue care products provide patients similar benefits to evolvethose in dermatology. We support the eye care and advanced tissue care markets with a dedicated in-house sales force and through an inside call center. We have also entered into a leading dermatology company, providing innovativestrategic partnerships with respected and cost-effectiveinfluential physicians and surgeons to promote our products. Our eye care products include prescription and dispensing solutions prescribed mainly by ophthalmologists and optometrists supported by pharmacies and, in some cases, sold through wholesale networks. Our tissue care products are primarily purchased by hospitals, physicians, nurses, and other healthcare practitioners.

Animal Health Care

Our animal health care products provide similar benefits to patients, while generating strong, consistent revenue growththose in human dermatology. For our animal health products, we partnered with Manna Pro Products, LLC to bring relief to pets and maximizing long-term shareholder value.peace of mind to their owners. Manna Pro distributes non-prescription products to national pet store retail chains, farm animal specialty stores, farm animal veterinarians, grocery stores and mass retailers in the United States and Canada. Through Manna Pro, we primarily target marketing efforts to veterinarians through trade shows and to customers through social media.

  

Additional Information

 

Investors and others should note that we announce material financial information using our company website (www.sonomapharma.com), our investor relations website (ir.sonomapharma.com), SEC filings, press releases, public conference calls and webcasts. The information on, or accessible through, our websites is not incorporated by reference in this Quarterly Report on Form 10-Q.

 

20

Results of Operations

Comparison of the Three Months Ended December 31, 20172018 and 20162017

 

Revenues

Total revenues for the three months ended December 31, 20172018 of $4,843,000$5,280,000 increased by $1,482,000,$437,000, or 44%9%, as compared to $3,361,000$4,843,000 for the three months ended December 31, 2016.2017. Product revenues for the three months ended December 31, 20172018 of $4,647,000$5,045,000 increased by $1,473,000,$398,000, or 46%9%, as compared to $3,174,000$4,647,000 for the three months ended December 31, 2016.2017. This increase wasa primarily the result of strong growth in product revenue of $94,000, or 3%, in the United States, growth of product revenue of $157,000, or 20%, in Latin America, and growth of product revenue of $147,000, or 15%, in Europe and Latin America.the Rest of World.

  

Product revenues in the United States for the three months ended December 31, 20172018 of $2,883,000$2,977,000 increased by $1,212,000,$94,000, or 73%3%, as compared to $1,671,000$2,883,000 for the three months ended December 31, 2016.2017. This increase was mostly the result of highera $205,000, or 95%, increase in sales of our animal health care products, an increase of $120,000, or 26%, in sales of our acute care products, and a decrease of $231,000, or 10%, in sales of our dermatology acute care and animal health care products.

Product revenue in Europe and the Rest of the World for the three months ended December 31, 2017 of $992,000 decreased by $46,000, or 4%, as compared to $1,038,000 for the three months ended December 31, 2016. This decrease was the result of lower sales in the Middle East, mostly offset by increases in Europe, China, Singapore, and India.

 

As a result of the asset purchase agreement and arrangement we entered into on October 27, 2016 with Invekra, we expect our revenues in Latin America will decrease significantly. We will continue to supply Invekra with product at a reduced price until they set up their manufacturing facility. We expect our revenues in Latin America will decrease significantly once Invekra has set up their manufacturing facility. During the three months ended December 31, 2017,2018, we reported $772,000$715,000 of Latin America product revenue related to Invekra.  Invekra as compared to $772,000 during the three months ended December 31, 2017. Additionally, we reported $214,000 of Latin America product revenue related to dermatology products sold in Brazil.

Product revenue in Europe and the Rest of the World for the three months ended December 31, 2018 of $1,139,000 increased by $147,000, or 15%, as compared to $992,000 for the three months ended December 31, 2017. This increase was mostly the result of increases in Europe and India, partly offset by decreases in the Middle East, the Far East and New Zealand.

  

The following table shows our product revenues by geographic region:

 

 

Three months ended

December 31,

      Three Months Ended December 31,      
 2017  2016  $ Change  % Change  2018  2017  $ Change  % Change 
United States $2,883,000  $1,671,000  $1,212,000   73%  $2,977,000  $2,883,000  $94,000   3% 
Latin America  772,000   465,000   307,000   66%   929,000   772,000   157,000   20% 
Europe and Rest of the World  992,000   1,038,000   (46,000)  (4%)  1,139,000   992,000   147,000   15% 
Total $4,647,000  $3,174,000  $1,473,000   46%  $5,045,000  $4,647,000  $398,000   9% 

  

In connection with our sale of our Latin American business to Invekra, product revenues and cost of revenues reported in the prior period were reclassified from continuing operations to discontinued operations as follows:

  Three Months Ended December 31, 
  2017  2016 
Product revenues $  $359,000 
Product license fees and royalties     262,000 
Total product related revenues $  $621,000 

 

Service revenues for the three months ended December 31, 20172018 of $196,000$235,000 increased by $9,000,$39,000, or 5%20%, when compared to $187,000$196,000 in the prior period. The increase was primarily the result of higher volume of laboratory tests and services in the United States. Additionally, during the three months ended December 31, 2018, we recorded service revenues wasrevenue related to an increasetechnical services provided to Invekra in our lab services business.the amount of $14,000.

19

 

Gross Profit

 

For the three months ended December 31, 2017,2018, we reported total revenues of $4,843,000$5,280,000 and total cost of revenues of $2,475,000,$2,433,000, resulting in total gross profit of $2,368,000$2,847,000 or 49%54% of total revenues, compared to a gross profit of $1,706,000$2,368,000 or 51%49% of total revenues, for the same period in the prior year. The decrease in gross profit, as a percentage of revenue, was primarily due to the lower profitability in Latin America related to the higher sales to Invekra at a very low profit, partly offset by higher margins in the United States caused by the strong growth of the more profitable dermatology product lines. As dermatology product revenues increase as an overall percentage of our product revenues, we expect our margins will improve due to higher gross margins associated with our dermatology products.

 

For the three months ended December 31, 2017,2018, we reported product revenues of $4,647,000$5,045,000 and cost of product revenues of $2,308,000,$2,269,000, resulting in product gross profit of $2,339,000,$2,776,000, or 50%55% of product revenues, compared to product gross profit of $1,698,000,$2,339,000, or 53%50% of product revenues, for the same period in the prior year. The decreaseincrease in gross profit as a percentpercentage of revenue, percentageproduct revenues was primarily due to the lower profitabilitya decrease in Latin America related to the higher sales to Invekra at a very low profit, partly offset by higher marginsrebate costs in the United States caused by the strong growth of the more profitable dermatology product lines.current period.

 

For the three months ended December 31, 2017,2018, we reported service revenues of $196,000$235,000 and cost of service revenues of $167,000,$164,000, resulting in service gross profit of $71,000, or 30% of service revenues, compared to service gross profit of $29,000, or 15% of service revenues, compared to service gross profit of $8,000, or 4% of service revenues, for the same period in the prior year. The increase in service gross profit was primarily related to higher service revenue in the current period and the mix of tests and services performed.

21

 

Research and Development Expense

 

Research and development expenses for the three months ended December 31, 20172018 of $349,000 decreased$451,000 increased by $138,000,$102,000, or 28%29%, as compared to $487,000$349,000 for the three months ended December 31, 2016.2017. The decreaseincrease is largely due to a decreaseprimarily the result of higher salaries and benefits in spending onthe current period and product development and clinical studies.related studies performed in the current period.

 

Selling, General and Administrative Expense

 

Selling, general and administrative expenses for the three months ended December 31, 20172018 of $5,219,000 increased$4,746,000 decreased by $435,000,$473,000, or 9%, when compared to $4,784,000$5,219,000 for the three months ended December 31, 2016.2017. The increase fordecrease is primarily the three months ended December 31, 2017 was primarily due to higher salesresult of lower stock compensation costs of $649,000, and marketing expenseslower legal costs of $99,000, offset by $475,000 of severance costs incurred related to our growing dermatology sales force.the resignation of the Company’s former Chief Executive Officer and Chief Financial Officer.

 

Interest Expense

 

Interest expense for the three months ended December 31, 20172018 of $11,000, increased$7,000 decreased by $11,000,$4,000 when compared to $11,000 for the three months ended December 31, 2016.2017. The increasedecrease in interest expense relates primarily to capital leases.leases and insurance premiums financed.

 

Interest Income

 

Interest income for the three months ended December 31, 20172018 of $14,000$37,000 increased by $8,000$23,000 when compared to $6,000$14,000 for the three months ended December 31, 2016.2017. The increase is primarily due to interest income earnedreported related to a discount on increased cash and cash equivalent balances.deferred revenue from our agreement with Invekra.

Other Income

 

Other incomeexpense for the three months ended December 31, 20172018 of $10,000 decreased$22,000 increased by $272,000$12,000 when compared to $282,000other expense of $10,000 for the three months ended December 31, 2016.2017. The increase in other incomeexpense relates primarily to fluctuationfluctuations in foreign exchange in the prior period.and state franchise taxes.

 

Net Loss Income from Continuing Operations

 

Net Loss from continuing operations for the three months ended December 31, 20172018 of $3,187,000 increased $3,950,000,$2,298,000 decreased $889,000, when compared to income from continuing operationsnet loss of $763,000$3,187,000 for the three months ended December 31, 2016.2017. The increasedecrease in net loss from continuing operations is primarily due to $4,040,000a decrease of income tax benefit recorded inoperating losses, caused by lower stock compensation expenses of $692,000, higher sales and gross profitability, offset by severance costs incurred related to the prior period as a resultresignation of the transaction with Invekra.Company’s former Chief Executive Officer and Chief Financial Officer.

20

Income from Discontinued Operations, net of Tax

The following summarizes operations of our Latin American business included in discontinued operations:

  

Three Months Ended

December 31,

 
  2017  2016 
Revenues $  $621,000 
Cost of Revenues     62,000 
Income from discontinued operations before tax     559,000 
Gain on disposal of discontinued operations before income taxes     19,487,000 
Total income from discontinued operations, before tax     20,046,000 
Income Tax benefit (expense)     (4,581,000)
Income from discontinued operations, net of tax $  $15,465,000 

 

Comparison of the Nine Months Ended December 31, 20172018 and 20162017

 

Total revenues for the nine months ended December 31, 20172018 of $13,003,000$14,588,000 increased by $4,207,000,$1,585,000, or 48%12%, as compared to $8,796,000$13,003,000 for the nine months ended December 31, 2016.2017. Product revenues for the nine months ended December 31, 20172018 of $12,394,000$13,775,000 increased by $4,236,000,$1,381,000, or 52%11%, as compared to $8,158,000$12,394,000 for the nine months ended December 31, 2016.2017. This increase was primarily the result of strong growth in product revenue of $364,000, or 5%, in the United States, growth of product revenue of $910,000, or 43%, in Latin America, and growth of product revenue of $107,000, or 3%, in Europe and the Rest of the World.

 

Product revenues in the United States for the nine months ended December 31, 20172018 of $7,010,000$7,374,000 increased by $2,269,000,$364,000, or 48%5%, as compared to $4,741,000$7,010,000 for the nine months ended December 31, 2016.2017. This increase was mostly the result of highera $636,000, or 97%, increase in sales of our animal health care products, an increase of $85,000, or 6%, in sales of our acute care products, and a decrease of $357,000, or 7%, in sales of our dermatology and acute care products, partly offset by a decline in sales of $149,000 related to our animal health care products.

 

Product revenue in Europe and the Rest of the World for the nine months ended December 31, 2017 of $3,289,000 increased by $337,000, or 11%, as compared to $2,952,000 for the nine months ended December 31, 2016. This increase was mostly the result of increases in Europe, Hong Kong, Singapore, New Zealand and India partly offset by a decrease in the Middle East and China.

22

 

As a result of the asset purchase agreement and arrangement we entered into on October 27, 2016 with Invekra, we expect our revenues in Latin America will decrease significantly. We will continue to supply Invekra with product at a reduced price until they set up their manufacturing facility. We expect our revenues in Latin America will decrease significantly once Invekra has set up their manufacturing facility. During the nine months ended December 31, 2017,2018, we reported $2,095,000$2,543,000 of Latin America product revenue related to Invekra.Invekra as compared to $2,095,000 during the nine months ended December 31, 2017. Additionally, we reported $462,000 of Latin America product revenue related to dermatology products sold in Brazil.

Product revenue in Europe and the Rest of the World for the nine months ended December 31, 2018 of $3,396,000 increased by $107,000, or 3%, as compared to $3,289,000 for the nine months ended December 31, 2017. This increase was mostly the result of decreases in the Middle East, partly offset by increases in Europe.

  

The following table shows our product revenues by geographic region:

 

 Nine months ended
December 31,
       Nine Months Ended December 31,      
 2017  2016  $ Change  % Change  2018  2017  $ Change  % Change 
United States $7,010,000  $4,741,000  $2,269,000   48%  $7,374,000  $7,010,000  $364,000   5% 
Latin America  2,095,000   465,000   1,630,000   351%   3,005,000   2,095,000   910,000   43% 
Europe and Rest of the World  3,289,000   2,952,000   337,000   11%   3,396,000   3,289,000   107,000   3% 
Total $12,394,000  $8,158,000  $4,236,000   52%  $13,775,000  $12,394,000  $1,381,000   11% 

  

In connection with our sale of our Latin American business to Invekra, product revenues and cost of revenues reported in the prior period were reclassified from continuing operations to discontinued operations as follows:

  Nine Months Ended December 31, 
  2017  2016 
Product revenues $  $2,693,000 
Product license fees and royalties     412,000 
Total product related revenues $  $3,105,000 

 

Service revenues for the nine months ended December 31, 20172018 of $609,000 decreased$813,000 increased by $29,000,$204,000, or 5%33%, when compared to $638,000$609,000 in the prior period. The decreaseincrease was primarily the result of higher volume of laboratory tests and services in the United States. Additionally, during the nine months ended December 31, 2018 and 2017, the Company recorded service revenues wasrevenue related to a decreasetechnical services provided to Invekra in our lab services business.the amount of $42,000 and $39,000, respectively.

21

 

Gross Profit

 

For the nine months ended December 31, 2017,2018, we reported total revenues of $13,003,000$14,588,000 and total cost of revenues of $7,025,000,$7,583,000, resulting in total gross profit of $5,978,000$7,005,000 or 46%48% of total revenues, compared to a gross profit of $3,721,000$5,978,000 or 42%46% of total revenues, for the same period in the prior year. The increase in gross profit was primarily due to the reclassification, in the prior period, of Latin America product and license revenue and related variable cost of goods sold from continuing operations to discontinued operations and the higher margins in the United States. Additionally, as dermatology product revenues increase as an overall percentage of our product revenues, we expect our margins will improve due to higher gross margins associated with our dermatology products.

 

For the nine months ended December 31, 2017,2018, we reported product revenues of $12,394,000$13,775,000 and cost of product revenues of $6,529,000,$7,006,000, resulting in product gross profit of $6,769,000, or 49% of product revenues, compared to product gross profit of $5,865,000, or 47% of product revenues, compared to product gross profit of $3,651,000, or 45% of product revenues, for the same period in the prior year. The increase in gross profit was primarily due to the reclassification, in the prior period, of Latin America product and related variable cost of goods sold from continuing operations to discontinued operations and higher margins in the United States.

 

For the nine months ended December 31, 2017,2018, we reported service revenues of $609,000$813,000 and cost of service revenues of $496,000,$577,000, resulting in service gross profit of $236,000, or 29% of service revenues, compared to service gross profit of $113,000, or 19% of service revenues, compared to service gross profit of $70,000, or 11% of service revenues, for the same period in the prior year. The increase in service gross profit was primarily related to the mix of tests and services performed. 

 

Research and Development Expense

 

Research and development expenses for the nine months ended December 31, 20172018 of $1,099,000 decreased by $127,000,$1,191,000 increased $92,000, or 10%,8% as compared to $1,226,000$1,099,000 for the nine months ended December 31, 2016.2017. The decreaseincrease is largely due to a decreaseprimarily the result of higher salaries and benefits in spending onthe current period and product development and clinical studies.related studies performed in the current period.

 

Selling, General and Administrative Expense

 

Selling, general and administrative expenses for the nine months ended December 31, 20172018 of $14,319,000$14,368,000 increased by $1,762,000, or 14%,$49,000 when compared to $12,557,000$14,319,000 for the nine months ended December 31, 2016. The increase for the nine months ended December 31, 2017 was primarily due to higher sales expenses related to our growing dermatology sales force.2017.

 

Interest Expense

 

Interest expense for the nine months ended December 31, 20172018 of $31,000 increased by $29,000$26,000 decreased $5,000 when compared to $2,000$31,000 for the nine months ended December 31, 2016. The increase in interest expense relates primarily to capital leases.2017.

23

 

Interest Income

 

Interest income for the nine months ended December 31, 20172018 of $85,000$139,000 increased by $77,000$54,000 when compared to $8,000$85,000 for the nine months ended December 31, 2016.2017. The increase is primarily due to interest income earnedreported related to a discount on increased cash and cash equivalent balances.

deferred revenue from our agreement with Invekra. 

Other Income Expense net

 

Other expense for the nine months ended December 31, 20172018 of $179,000 increased$135,000 decreased by $455,000$44,000 when compared to other incomeexpense of $276,000$179,000 for the nine months ended December 31, 2016.2017. The increasedecrease in other expense relates primarily to fluctuationfluctuations in foreign exchange.

 

Net Loss from Continuing Operations

 

Net Loss from continuing operations for the nine months ended December 31, 20172018 of $9,565,000$8,576,000 decreased $3,825,000,$989,000, when compared to income from continuing operationsnet loss of $5,740,000$9,565,000 for the nine months ended December 31, 2016.2017. The increasedecrease in net loss from continuing operations is primarily due to $4,040,000a decrease of income tax benefit recorded inoperating losses, caused by lower stock compensation expenses of $258,000, higher sales and gross profitability, offset by severance costs incurred related to the prior period as a resultresignation of the transaction with Invekra.Company’s former Chief Executive Officer and Chief Financial Officer.

22

Income from Discontinued Operations, net of Tax

The following summarizes operations of our Latin American business included in discontinued operations:

  

Nine Months Ended

December 31,

 
  2017  2016 
Revenues $  $3,105,000 
Cost of Revenues     561,000 
Income from discontinued operations before tax     2,544,000 
Gain on disposal of discontinued operations before income taxes     19,487,000 
Total income from discontinued operations, before tax     22,031,000 
Income Tax benefit (expense)     (4,581,000)
Income from discontinued operations, net of tax $  $17,450,000 

 

Liquidity and Capital Resources

 

We reported a net loss of $9,565,000$8,576,000 for the nine months ended December 31, 2017.2018. At December 31, 20172018 and March 31, 2017,2018, our accumulated deficit amounted to $152,677,000$166,016,000 and $143,101,000,$157,440,000, respectively. We had working capital of $12,279,000$11,254,000 and $19,355,000$12,993,000 as of December 31, 20172018 and March 31, 2017,2018, respectively.

 

We expect to continue incurring losses for the foreseeable future and maywill need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our products and to continue as a going concern. We cannot provide any assurances that we will be able to raise additional capital.

 

Management believes that we have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, we cannot provide any assuranceassurances that new financingfinancings will be available on commercially acceptable terms, if at all. If the economic climate in the U.S. deteriorates, our ability to raise additional capital could be negatively impacted. If we are unable to secure additional capital, we may be required to curtail our research and development initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our continued efforts to commercialize our products, which is critical to the realization of our business plan and our future operations. These matters raise substantial doubt about our ability to continue as a going concern.

 

Sources of Liquidity

 

As of December 31, 2017,2018, we had cash and cash equivalents of $8,625,000.$6,496,000. Since our inception, substantially all of our operations have been financed through sales of equity securities. Other sources of financing that we have used to date include our revenues, as well as various loans and the sale of certain Latin American assets to Invekra.

 

Since January 1, 2016,2017, substantially all of our operations have been financed through the following transactions:

 

·proceeds of $150,000 received from the exercise of common stock purchase warrants and options;
·net proceeds of $2,994,000 received from an underwritten public offering on March 18, 2016;
·net proceeds of $202,000$1,925,000 received from the sale of common stock through our At the Market Issuance Sales Agreement dated April 2, 2014;December 8, 2017;
·net proceeds of $18,639,000 received from the sale of certain Latin America assets to Invekra on October 27, 2016;
·net proceeds of $968,000$4,500,000 received from the sale of common stock through our Ata registered direct offering which closed on March 6, 2018; and
·net proceeds of $4,742,000 received from the Market Issuance Sales Agreement dated December 8, 2017.sale of common stock and preferred stock units through a public offering which closed on November 21, 2018.

Pursuant to an At Market Issuance Sales Agreement with B. Riley FBR, Inc. dated December 8, 2017, we may issue and sell shares of common stock having an aggregate offering price of up to $5,000,000 from time to time through B. Riley FBR acting as our sales agent. During the three months ended December 31, 2017, we sold 228,000 shares of common stock for gross proceeds of $1,034,000 and net proceeds of $968,000 after deducting commissions and other offering expenses. We pay B. Riley FBR a commission rate equal to 3.0% of the gross proceeds from the sale of any shares of common stock sold through B. Riley FBR as agent.

 

 

 

 2324 
 

 

Cash Flows

 

As of December 31, 2017,2018, we had cash and cash equivalents of $8,625,000,$6,496,000, compared to $17,461,000$10,066,000 as of March 31, 2017.2018.

Net cash used in operating activities during the nine months ended December 31, 2018 was $8,971,000, primarily due to our net loss of $8,576,000 offset by non-cash stock compensation of $1,334,000 in the period. Additionally, we had an increase in accounts receivable of $1,628,000 and an increase of $514,000 in inventories both related to an increase in sales.

 

Net cash used in operating activities during the nine months ended December 31, 2017 was $9,391,000, primarily due to our net loss of $9,565,000 offset by stock related compensation of $1,592,000 in the period. Additionally, we had increases in prepaid expenses of $951,000 mostly related to taxes in Mexico.

 

Net cash used in operatinginvesting activities during thewas $123,000 for nine months ended December 31, 2016 was $5,472,000,2018, primarily due to our net income in the period of $11,710,000 which was offset by adjustments to net income related to our gain on salethe purchase of our Latin American assets to, net of tax, of $14,906,000 and the income tax benefit realized of $4,040,000.equipment.

 

Net cash used in investing activities was $193,000 for nine months ended December 31, 2017, primarily related to the purchase of equipment.

 

Net cash provided by investingfinancing activities was $17,232,000$5,572,000 for the nine months ended December 31, 2016, consisting of2018, primarily related to net proceeds from the sale of our Latin American Assets,common stock of $957,000 from the Company’s At Market Issuance Sales Agreement, with B. Riley FBR, Inc., and net proceeds of costs, of $17,444,000,$4,742,000 from a public offering placed by Dawson James Securities, Inc., offset by $195,000 related to equipment purchasesprincipal payments on debt and $17,000 related to changes in long-term assets.capital leases of $397,000.

 

Net cash provided by financing activities was $802,000 for the nine months ended December 31, 2017, primarily related to net proceeds from the sale of common stock of $968,000, proceeds of $52,000 from the exercise of common stock purchase warrants and options, offset by principal payments on debt and capital leases of $218,000.

 

Net cash used in financing activities was $119,000 for the nine months ended December 31, 2016, primarily related to principal payments on debt.

Operating CapitalMaterial Trends and Capital Expenditure Requirements

We reported a net loss of $9,565,000 for the nine months ended December 31, 2017. At December 31, 2017 and March 31, 2017, our accumulated deficit amounted to $152,677,000 and $143,101,000, respectively. We had working capital of $12,279,000 and $19,355,000 as of December 31, 2017 and March 31, 2017, respectively.Uncertainties

 

We expect to continue incurring losses for the foreseeable future and maywill need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our products and to continue as a going concern. We cannot provide any assurances that we will be able to raise additional capital.capital as we need it.

 

Management believes that we have access to capital resources through possible public or private equity offerings, debt financings, corporate collaborations or other means; however, we cannot provide any assuranceassurances that new financing will be available on commercially acceptable terms, if at all. If the economic climate in the U.S. deteriorates, our ability to raise additional capital could be negatively impacted. If we are unable to secure additional capital, we may be required to curtail our research and development and other business initiatives and take additional measures to reduce costs in order to conserve our cash in amounts sufficient to sustain operations and meet our obligations. These measures could cause significant delays in our continued efforts to commercialize our products, which is critical to the realization of our business plan and our future operations. These matters raise substantial doubt about our ability to continue as a going concern.

 

Our future funding requirements will depend on many factors, including:Consistent with other pharmaceutical companies in the United States, we experience seasonal fluctuations in the first quarter of each year, or our fourth fiscal quarter. This decrease in sales of pharmaceutical products is due to patients facing the need to satisfy health insurance deductibles, which are reset at the beginning of each year and adjusting to changing copays.

 

·our current and future revenues;
·the scope, rate of progress and cost of our research and development activities;
·future clinical trial results;
·the terms and timing of any collaborative, licensing and other arrangements that we may establish;
·the cost and timing of regulatory approvals;
·the cost and delays in product development as a result of any changes in regulatory oversight applicable to our products;
·the cost and timing of establishing sales, marketing and distribution capabilities;
·the effect of competing technological and market developments;
·the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; and
·the extent to which we acquire or invest in businesses, products and technologies.

Healthcare providers and insurers heavily influence the price patients pay for our products. Generally, insurers cover a lower percentage of our products compared to other medical products making our products seem relatively more expensive than other medical care. As a result, to remain competitive, we offer rebates on our products directly to patients. Most patients use these rebates to make our products more affordable. While we believe these rebates are necessary for many patients to buy our products and without them our revenues would likely decline, the impact of rebates on our bottom line has been significant. For example, in the three months ended December 31, 2018, dermatology rebates amounted to $1,249,000 and for the nine months ended December 31, 2018, dermatology rebates amounted to $4,567,000.

We continue to work with healthcare providers, insurers, third-party payors, pharmacies and others to manage pricing of our products to the consumer and to reduce the impact of rebates on our overall revenue. However, there is no guarantee we will be successful in reducing patient rebate use. Additionally, the legal landscape in healthcare is constantly changing. Adoption of new legislation at the federal or state level could further affect demand for, or pricing of, our products. For example, we face uncertainties due to federal legislative and administrative efforts to repeal, substantially modify or invalidate some or all of the provisions of the Affordable Care Act, or ACA, which could leave more patients without insurance coverage, which, in turn, could reduce the price patients are willing to pay for our products if they must bear the entire cost.

 

 

 

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During the three and nine months ended December 31, 2018, revenue from sales to our Latin America partner Invekra amounted to approximately 14% and 17% of our total revenue, respectively. We will continue to supply products to Invekra at a reduced price from list prices, pursuant to our contractual obligations for a transition period until, at the latest, October 27, 2020, while Invekra builds its own manufacturing lines. However, we expect that our future revenues from Latin American sales will be substantially reduced.

 

Use of Estimates

 

The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosures of contingent liabilities at the dates of the consolidated financial statements and the reported amounts of revenues and expenses during the reporting periods. Actual results could differ from these estimates. Significant estimates and assumptions include reserves and write-downs related to receivables and inventories, the recoverability of long-lived assets, the valuation allowance related to our deferred tax assets, the valuation of equity and derivative instruments, debt discounts, the valuation of investments and the estimated amortization periods of upfront product licensing fees received from customers.

 

Off-Balance Sheet Transactions

 

We currently have no off-balance sheet arrangements that have or are reasonably likely to have a current or future material effect on our financial condition, changes in financial condition, revenues or expenses, results of operations, liquidity, capital expenditures or capital resources.

 

Item 3.Quantitative and Qualitative Disclosures About Market Risk

 

As a smaller reporting company, we are electing scaled disclosure reporting obligations and therefore are not required to provide the information required by this Item.

 

Item 4.Controls and Procedures

 

Evaluation of Disclosure Controls and Procedures

 

We maintain disclosure controls and procedures that are designed to ensure that information required to be disclosed in the reports that we file or submit under the Exchange Act is recorded, processed, summarized, and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate, to allow timely decisions regarding required disclosure. In designing and evaluating our disclosure controls and procedures, our management recognized that disclosure controls and procedures, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the disclosure controls and procedures are met. Accordingly, our disclosure controls and procedures have been designed to meet reasonable assurance standards. Additionally, in designing disclosure controls and procedures, our management was necessarily required to apply its judgment in evaluating the cost-benefit relationship of possible disclosure controls and procedures. The design of any disclosure controls and procedures is also based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.

 

We carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of the end of the period covered by this report. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were effective as of December 31, 2017.2018.

 

Changes in Internal Control over Financial Reporting

 

ThereOn December 11, 2018, the Company’s Board appointed Mr. Frederick (Bubba) Sandford as its Chief Executive Officer and Interim Chief Financial Officer. On December 12, 2018, Jim Schutz and Robert Miller resigned from their positions as our Chief Executive Officer and President and Chief Financial Officer and Secretary, respectively. On the same date, Mr. Schutz also resigned from the Board.

Other than the change in management, there were no changes in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) during the quarter ended December 31, 20172018 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. The change in our management and our Board did not have an impact on our internal control over financial reporting during the quarter ended December 31, 2018 that materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

 

 

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PART II - OTHER INFORMATION

 

Item 1.Legal Proceedings

 

On occasion, we may be involved in legal matters arising in the ordinary course of our business, including matters involving proprietary technology. While management believes that such matters are currently insignificant, matters arising in the ordinary course of business for which we are or could become involved in litigation may have a material adverse effect on our business, financial condition or results of comprehensive loss.

 

Item 1A.Risk Factors

 

ThereExcept as follows, there have been no material changes from risk factors previously disclosed in our annual report on Form 10-K for the fiscal year ended March 31, 2017,2018, as filed with the SEC on June 28, 2017.26, 2018 and our quarterly report on Form 10-Q for the quarter ended September 30, 2018, as filed with the SEC on November 8, 2018.

 

The newly enacted Tax Cuts and Jobs ActAs of December 31, 2018, we may affect our financial results, including our net deferred tax asset, and we are innot have sufficient cash to continue operations for the process of evaluating its effects.next six to twelve months.

 

OnAs of December 22, 2017,31, 2018, we had $6,496,000 in cash and cash equivalents. We had working capital of $11,254,000 and $12,993,000 as of December 31, 2018 and March 31, 2018, respectively. We incurred net losses of $2,298,000, $8,576,000 and $14,328,000 during the Tax Cutsthree and Jobs Act was signed into law. The Tax Cuts and Jobs Act will significantly change the taxation of U.S.-based multinational corporations, by, among other things, reducing the U.S. corporate income tax rate, adopting elements of a territorial tax system, affecting the deductibility of capital expenditures, assessing a one-time transition tax on earnings of certain foreign subsidiaries that were previously tax deferred,nine months ended December 31, 2018 and the creationfiscal year ended March 31, 2018, respectively. We used net cash of $8,971,000 in operating activities during the nine months ended December 31, 2018. If our sales revenues do not increase or if we do not manage our expenses and cash flow in the near future, we may be required to obtain additional cash for operations from non-working capital sources, which may not be available, in which case we would have to significantly decrease or cease operations. The sale of additional equity or convertible debt securities would result in additional dilution to our stockholders, and debt financing, if available, may involve restrictive covenants that could restrict our operations or finances. Financing, if necessary, may not be available in amounts or on terms acceptable to us, if at all. If we cannot raise funds on acceptable terms or achieve positive cash flow, we may not be able to continue to conduct operations, develop new taxes on certain foreign-sourced earnings. The legislation is unclear in some respects and will require interpretations and implementing regulations by the Internal Revenue Service, as well as state tax authorities, and the legislation could be subjectproducts, grow market share, to potential amendments and technical corrections,take advantage of future opportunities or respond to competitive pressures or unanticipated requirements, any of which could lessenwould negatively impact our business, operating results and financial condition.

Our ability to use shares of our common stock to carry out our business plan, to offer stock as a form of compensation or increase certain adverse impactsto use stock to meet our financial obligations may be diminished.

We currently have 24,000,000 shares of authorized common stock. As of December 31, 2018, we had 11,972,328 shares of common stock outstanding and have committed to issue 155,000 shares of common stock upon conversion of 1.55 shares of Series C and approximately 5,700,000 shares of common stock upon the exercise of outstanding stock options and warrants. It is possible that some or all of the legislation. We arecurrently outstanding options and warrants will not be exercised and the shares of common stock we have reserved to satisfy our obligations under the terms of those securities may never be issued. If options or warrants expire prior to exercise, then the shares we have reserved in the processevent they are exercised may be used for other purposes. Having a limited number of determining what,authorized shares of common stock may diminish our ability to execute our business plan, to offer stock or stock options as part of a competitive compensation package for attracting and retaining the highly skilled officers, directors and employees on which our success relies, or to issue equity securities in the future to allow the Company flexibility in meeting our routine financial obligations, raising capital if any, effect those provisions will have on our financial results, and there canneeded and/or issuing equity securities to acquire assets or businesses or to engage in strategic collaborations where the transaction might be no assurance of whether such additional effects will be positive or negative.

A significant portion of our earnings are earnedimproved for us by our subsidiaries outside the U.S. Changes to the taxation of certain foreign earnings resulting from the newly enacted Tax Cuts and Jobs Act, along with the state tax impact of these changes and potential future cash distributions,issuing equity securities. This may have ana material adverse effect on our effective tax rate. Furthermore, changes to the taxation of undistributed foreign earnings could change our future intentions regarding reinvestment of such earnings. The foregoing items could have a material effect on our business,revenues, financial position, cash flow,flows and results of operations or financial conditions.operations.

 

The Tax Cuts and Jobs Act also reduces the federal corporate income tax rate from 35% to 21% effective January 1, 2018, which we expect will positively impact our future effective tax rate and after-tax earnings in the United States. As a result of the reduction in the corporate income tax rate, we are required to revalue our net deferred tax asset to account for the future impact of lower corporate tax rates on this deferred amount and record any change in the value of such asset as a one-time non-cash charge on our income statement.

Item 2.Unregistered Sales of Equity Securities and Use of Proceeds

 

OnOther than as previously disclosed, we did not issue unregistered equity securities during the quarter ended December 1, 2017, we issued 5,479 unregistered shares of common stock to a service provider valued at $5.02 per share.31, 2018.

 

We relied on the Section 4(a)(2) exemption from securities registration under the federal securities laws for transactions not involving any public offering. No advertising or general solicitation was employed in offering the securities. The securities were issued to an accredited investor. The securities were offered for investment purposes only and not for the purpose of resale or distribution. The transfer thereof was appropriately restricted by us.

 

 

 

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Item 3.Default Upon Senior Securities

 

We did not default upon any senior securities during the quarter ended December 31, 2017.2018.

 

Item 4.Mine Safety Disclosures

 

Not applicable.

 

Item 5.Other Information

 

On January 2,Effective December 11, 2018, we granted discretionary stock bonuses to all directors of the Company, includingour Board appointed Bubba Sandford as our Chief Executive Officer and Director,Interim Chief Financial Officer. On December 12, 2018, Jim Schutz forand Robert Miller resigned from their services in connection withpositions as our Chief Executive Officer and President and Chief Financial Officer and Secretary, respectively. On the turn-around of our Company and in an effort to increasesame date, Mr. Schutz also resigned from the stock ownershipBoard. Mr. Sandford was appointed as a Class III director of the Board on December 14, 2018.

Mr. Sandford, 57, served as a Navy SEAL and has over 30 years of experience leading companies in several industries and at various stages, including turnarounds. Most recently, Mr. Sandford transformed the amount of $100,000 or 17,211 shares of common stockunderperforming, public staffing company, Command Center, Inc., into a profitable enterprise, with nearly $100 million in revenue, 67 on-demand labor stores in 22 states and approximately 34,000 workers. During his tenure at $5.81 per share, each, which shares are immediately vested upon grant. In addition,Command Center, he successfully led the Company to uplist on January 2, 2018, our Board of Directors awarded an additional stock bonus of $50,000 or 8,606 shares of common stock subjectNasdaq, and he increased shareholder value by 150% while improving gross margins to the same conditionsindustry-leading standards.

We look forward to working with Mr. Sandford as he brings operational and leadership experience to our long-standing director Jay Birnbaum for his 10 years of services and longevity on our Board. The stock awards include a 40% tax gross up paid in cash or approximately $160,000 to the directors and $40,000 to the Chief Executive Officer.

 

Item 6.Exhibits

 

Exhibit No.Description
3.1Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., effective January 30, 2006(included (included as Exhibitexhibit 3.1 of the Company’s Annual Report on Form 10-K filed June 20, 2007, and incorporated herein by reference).
3.2Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., effective October 22, 2008(included (included as Exhibitexhibit A in the Company’s Definitive Proxy Statement on Schedule 14A filed July 21, 2008, and incorporated herein by reference).
3.33.4Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, effective March 29, 2013(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed March 22, 2013, and incorporated herein by reference).
3.43.5Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, effective December 4, 2014(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed December 8, 2014, and incorporated herein by reference).
3.53.6Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, effective October 22, 2015(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed October 27, 2015, and incorporated herein by reference).
3.63.7Certificate of Amendment of Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., as amended, effective June 24, 2016(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed June 28, 2016, and incorporated herein by reference).
3.73.8Certificate of Amendment of Restated Certificate of Incorporation of Sonoma Pharmaceuticals, Inc., as amended, effective December 6, 2016(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed December 7, 2016, and incorporated herein by reference).
3.83.9Certificate of Amendment of Restated Certificate of Incorporation of Sonoma Pharmaceuticals, Inc., as amended, effective September 13, 2018 (included as exhibit 3.1 to the Company’s Current Report on Form 8-K filed September 19, 2018, and incorporated herein by reference).
3.10Amended and Restated Bylaws, as amended, of Sonoma Pharmaceuticals, Inc., effective December 6, 2016(included (included as Exhibitexhibit 3.2 to the Company’s Current Report on Form 8-K filed December 7, 2016, and incorporated herein by reference).

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3.93.11Certificate of Designation of Preferences, Rights and Limitations of Series A 0% Convertible Preferred Stock, filed with the Delaware Secretary of State on April 24, 2012(included (included as Exhibitexhibit 4.2 to the Company’s Current Report on Form 8-K, filed April 25, 2012, and incorporated herein by reference).
3.103.12Certificate of Designation of Series B Preferred Stock, effective October 18, 2016(included (included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed October 21, 2016, and incorporated herein by references).
4.1Specimen Common Stock Certificate(included (included as Exhibitexhibit 4.1 to the Company’s Annual Report on Form 10-K filed June 28, 2017, and incorporated herein by reference).
4.2Form of Underwriters Warrant to be issued to the Underwriters in connection with the March 2013 Offering(included as Exhibit 4.1 to the Company’s Current Report on Form 8-K, filed March 7, 2013, and incorporated herein by reference).
4.3Warrant issued to Dawson James Securities, Inc., dated December 9, 2013(included as Exhibit 4.14 to the Company’s Quarterly Report on Form 10-Q filed February 14, 2014, and incorporated herein by reference).
4.4Form of Series A Common Stock Purchase Warrant for February 2014 offering(included (included as Exhibitexhibit 4.1 to the Company’s Current Report on Form 8-K filed February 26, 2014 and incorporated herein by reference).
4.5Form of Series B Common Stock Purchase Warrant for February 2014 offering(included as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed February 26, 2014, and incorporated herein by reference).
4.6Warrant issued to Dawson James Securities, Inc., dated February 26, 2014(included as Exhibit 4.3 to the Company’s Current Report on Form 8-K filed February 26, 2014, and incorporated herein by reference).
4.7Warrant Agreement, including Form of Warrant entered into by and between Oculus Innovative Sciences, Inc. and Computershare, Inc. and Computershare Trust Company, N.A., dated January 20, 2015(included (included as Exhibitexhibit 4.1 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).

4.828

4.4Underwriters Warrant issued to Maxim Partners LLC on January 26, 2015(included (included as Exhibitexhibit 4.2 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
4.94.5Underwriters Warrant issued to Robert D. Keyser, Jr. on January 26, 2015(included (included as Exhibitexhibit 4.3 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
4.104.6Underwriters Warrant issued to R. Douglas Armstrong on January 26, 2015(included (included as Exhibitexhibit 4.4 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
4.114.7Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015(included (included as Exhibitexhibit 4.5 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
4.124.8Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015(included (included as Exhibitexhibit 4.6 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
4.134.9Warrant Agreement, including Form of Warrant entered into by and between Oculus Innovative Sciences, Inc. and Computershare, Inc. and Computershare Trust Company, N.A., dated March 18, 2016(included (included as Exhibitexhibit 4.1 to the Company’s Current Report on Form 8-K filed March 18, 2016 and incorporated herein by reference).
4.144.10Form of Warrant issued to Dawson James Securities, Inc. on March 31, 2016(included (included as Exhibitexhibit 4.25 to the Company’s Annual Report on Form 10-K filed June 21, 2016, and incorporated herein by reference).
4.154.11Section 382 Rights Agreement, dated as of October 18, 2016, between Oculus Innovative Sciences, Inc. and Computershare Inc., which includes the Form of Certificate of Designation of Series B Preferred Stock as Exhibit A, the Form of Right Certificate as Exhibit B and the Summary of Rights to Purchase Preferred Stock as Exhibit C(included (included as Exhibitexhibit 4.1 to the Company’s Current Report on Form 8-K filed October 21, 2016, and incorporated herein by reference).
4.12Form of Placement Agent Warrant granted to Dawson James Securities, Inc. and The Benchmark Company, LLC in connection with the March 2, 2018 public offering, dated March 6, 2018 (included as exhibit 4.1 to the Company’s Current Report on Form 8-K filed March 6, 2018, and incorporated herein by reference).
4.13Form of Series C Warrant(included as exhibit 4.13 to the Company’s registration statement on Form S-1/A filed November 7, 2018, and incorporated herein by reference).
4.14

Form of Series C Warrant Certificate(included as exhibit 4.1 to the Company’s Current Report on Form 8-K filed on November 21, 2018, and incorporated herein by reference).

10.1Form of Indemnification Agreement between Oculus Innovative Sciences, Inc. and its officers and directors(included (included as Exhibitexhibit 10.1 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.2Office Lease Agreement, dated October 26, 1999, between Oculus Innovative Sciences, Inc. and RNM Lakeville, L.P.(included (included as Exhibitexhibit 10.7 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.3Amendment No. 1 to Office Lease Agreement, dated September 15, 2000, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P.(included (included as Exhibitexhibit 10.8 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.4Amendment No. 2 to Office Lease Agreement, dated July 29, 2005, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P.(included (included as Exhibitexhibit 10.9 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.5Amendment No. 3 to Office Lease Agreement, dated August 23, 2006, between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P.(included (included as Exhibitexhibit 10.23 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).

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10.6Office Lease Agreement, dated May 18, 2006, between Oculus Technologies of Mexico, S.A. de C.V. and Antonio Sergio Arturo Fernandez Valenzuela (translated from Spanish)(included (included as Exhibitexhibit 10.10 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.7Office Lease Agreement, dated July 2003, between Oculus Innovative Sciences, B.V. and Artikona Holding B.V. (translated from Dutch)(included (included as Exhibitexhibit 10.11 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.8Form of Director Agreement(included (included as Exhibitexhibit 10.20 to the Company’s Registration Statement on Form S-1 (File No. 333-135584), as amended, declared effective on January 24, 2007, and incorporated herein by reference).
10.9Amended and Restated Oculus Innovative Sciences, Inc. 2006 Stock Incentive Plan and related form stock option plan agreements(included (included as Exhibitexhibit 10.2 to the Company’s Current Report on Form 8-K filed May 2, 2007, and incorporated herein by reference).
10.10Amendment No. 4 to Office Lease Agreement, dated September 13, 2007, by and between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P.(included (included as Exhibitexhibit 10.43 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).

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10.11Amendment to Office Lease Agreement, effective February 15, 2008, by and between Oculus Innovative Sciences Netherlands B.V. and Artikona Holding B.V. (translated from Dutch)(included (included as Exhibitexhibit 10.44 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).
10.12Amendment No. 5 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and RNM Lakeville, LLC, dated May 18, 2009(included (included as Exhibitexhibit 10.54 to the Company’s Annual Report on Form 10-K filed June 11, 2009, and incorporated herein by reference).
10.13Amendment No. 6 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and RNM Lakeville, L.P., dated April 26, 2011(included (included as Exhibitexhibit 10.52 to the Company’s Annual Report on Form 10-K filed June 3, 2011, and incorporated herein by reference).
10.14Oculus Innovative Sciences, Inc. 2011 Stock Incentive Plan(included (included as Exhibitexhibit A in the Company’s Definitive Proxy Statement on Schedule 14A filed July 29, 2011, and incorporated herein by reference).
10.15Amendment No. 7 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and 1125-1137 North McDowell, LLC, dated October 10, 2012(included (included as Exhibitexhibit 10.58 to the Company’s Quarterly Report on Form 10-Q filed November 8, 2012, and incorporated herein by reference).
10.16Form of Securities Purchase Agreement by and between Oculus Innovative Sciences, Inc. and the Purchasers, dated February 21, 2014(included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed February 26, 2014, and incorporated herein by reference).
10.17At-the-Market Issuance Sales Agreement, dated April 2, 2014, by and between Oculus Innovative Sciences, Inc. and MLV & Co. LLC(included (included as Exhibitexhibit 10.1 to the Company’s Current Report on Form 8-K filed April 2, 2014 and incorporated herein by reference).
10.1810.17Lease Agreement by and between Oculus Innovative Sciences, Inc. and 2500 York, L.P., dated July 9, 2014(included (included as Exhibitexhibit 10.82 to the Company’s QuarterlyCurrent Report on Form 10-Q filed August 12, 2014, and incorporated herein by reference).
10.1910.18Underwriting Agreement entered into by and between Oculus Innovative Sciences, Inc. and Maxim Group LLC as representative of the underwriters named on Schedule A thereto, dated January 20, 2015(included (included as Exhibitexhibit 1.1 to the Company’s Current Report on Form 8-K filed January 26, 2015 and incorporated herein by reference).
10.20†10.19†Sales Representation Contract, dated February 1, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc.(included (included as Exhibitexhibit 10.1 to the Company’s Current Report on Form 8-K filed March 2, 2015 and incorporated herein by reference).
10.21†10.20†Amendment No. 1 to Sales Representation Contract, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc.(included (included as Exhibitexhibit 10.88 to the Company’s Quarterly Report on Form 10-Q filed February 16, 2016 and incorporated herein by reference).
10.2210.21Underwriting Agreement entered into by and between Oculus Innovative Sciences, Inc. and Dawson James Securities, Inc. as representative of the underwriters named on Schedule 1 thereto, dated March 18, 2016(included (included as Exhibitexhibit 1.1 to the Company’s Current Report on Form 8-K filed March 18, 2016 and incorporated herein by reference).
10.23†10.22†Exclusive Sales and Distribution Agreement, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and Manna Pro Products, LLC(included (included as Exhibitexhibit 10.1 to the Company’s Current Report on Form 8-K filed March 23, 2016 and incorporated herein by reference).
10.2410.23Employment Agreement by and between Oculus Innovative Sciences, Inc. and Jim Schutz, dated July 26, 2016(included (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed July 29, 2016, and incorporated herein by reference).
10.25†10.24†Asset Purchase Agreement dated October 27, 2016, between Oculus Innovative Sciences, Inc. and Invekra, S.A.P.I de C.V.(included (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed October 31, 2016, and incorporated herein by reference).

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10.26†10.25†Amendment Agreement to Acquisition Option dated October 27, 2016, by and between More Pharma Corporation S. de R.L. de C.V. and Oculus Technologies of Mexico, S.A. de C.V.(included (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed October 31, 2016, and incorporated herein by reference).
10.2710.26Employment Agreement by and between Oculus Innovative Sciences, Inc. and Robert Miller, dated November 30, 2016(included (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference).
10.2810.27Employment Agreement by and between Oculus Innovative Sciences, Inc. and Bruce Thornton, dated November 30, 2016(included (included as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference).
10.2910.28Employment Agreement by and between Oculus Innovative Sciences, Inc. and Robert Northey, dated November 30, 2016(included (included as Exhibit 10.3 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference).
10.3010.29Employment Agreement by and between Oculus Innovative Sciences, Inc. and Jeffrey Day, dated November 30, 2016(included (included as Exhibit 10.4 to the Company’s Current Report on Form 8-K filed December 1, 2016, and incorporated herein by reference).
10.3110.30Employment Agreement by and between Sonoma Pharmaceuticals, Inc. and Marc Umscheid, dated December 31, 2016(included (included as Exhibit 10.97 to the Company’s Quarterly Reportquarterly report on Form 10-Q filed February 17, 2017, and incorporated herein by reference).
10.3210.31Master Vendor Agreement by and between Sonoma Pharmaceuticals, Inc. and PetSmart Home Office, Inc., dated November 21, 2016(included (included as Exhibit 10.32 to the Company’s Annual Report on Form 10-K filed on June 28, 2017, and incorporated herein by reference).

10.3330

10.32†Distribution Agreement by and between Sonoma Pharmaceuticals, Inc. and G. Pohl-Boskamp GmbH & Co. KG, dated April 13, 2016(included (included as Exhibit 10.33 to the Company’s Annual Report on Form 10-K filed on June 28, 2017, and incorporated herein by reference).
10.3410.33Amendment No. 8 to Office Lease Agreement by the between Oculus Innovative Sciences, Inc. and SSCOP Properties LLC, dated June 23, 2016(included (included as Exhibit 10.34 to the Company’s Annual Report on Form 10-K filed on June 28, 2017, and incorporated herein by reference).
10.35At Market Issuance Sales Agreement, dated December 8, 2017, by and between Sonoma Pharmaceuticals, Inc. and B. Riley FBR, Inc. (included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 8, 2017, and incorporated herein by reference).
10.36Placement Agency Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and Dawson James Securities, Inc. as representative of the placement agents, dated March 2, 2018 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 6, 2018, and incorporated herein by reference).
10.37Securities Purchase Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and Montreux Equity Partners V, L.P., dated March 1, 2018 (included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on March 6, 2018, and incorporated herein by reference).
10.38†Exclusive License and Distribution Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and EMS.S.A., dated June 4, 2018 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 5, 2018, and incorporated herein by reference).
10.39Commercial Lease (Georgia office) by and between Sonoma Pharmaceuticals, Inc. and PMR Holdings, LLC, dated May 1, 2018.(included as exhibit 10.39 to the Company’s Form 10-K filed on June 26, 2018, and incorporated herein by reference).
10.40Placement Agency Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and Dawson James Securities, Inc., dated November 16, 2018 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 21, 2018, and incorporated herein by reference).
10.41Warrant Agency Agreement entered into by and among Sonoma Pharmaceuticals, Inc., Computershare, Inc. and Computershare Trust Company, N.A., dated November 21, 2018 (included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on November 21, 2018, and incorporated herein by reference).
10.42Separation and Mutual Release entered into by and between Sonoma Pharmaceuticals, Inc. and Jim Schutz, dated December 13, 2018 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 14, 2018, and incorporated herein by reference).
10.43Separation and Mutual Release entered into by and between Sonoma Pharmaceuticals, Inc. and Robert E. Miller, dated December 13, 2018 (included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on December 14, 2018, and incorporated herein by reference).
10.44Employment Agreement entered into by and between Sonoma Pharmaceuticals, Inc. and Frederick Sandford, dated December 11, 2018 (included as exhibit 10.3 to the Company’s Current report on Form 8-K filed on December 14, 2018, and incorporated herein by reference).
14.1Code of Business Conduct(included (included as Exhibit 14.1 to the Company’s Current Report on Form 8-K filed on January 23, 2017, and incorporated herein by reference).
31.1*Certification of Chief Executive Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
31.2*Certification of Chief Financial Officer pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.
32.1*Certification of Officers pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.
101.INS*XBRL Instance Document.
101.SCH*XBRL Taxonomy Extension Schema.
101.CAL*XBRL Taxonomy Extension Calculation Linkbase.
101.DEF*XBRL Taxonomy Extension Definition Linkbase.
101.LAB*XBRL Taxonomy Extension Label Linkbase.
101.PRE*XBRL Taxonomy Extension Presentation Linkbase.

 

*Filed herewith.
Confidential treatment has been granted with respect to certain portions of this agreement.

 

Copies of above exhibits not contained herein are available to any stockholder, upon payment of a reasonable per page fee, upon written request to: Chief Financial Officer, Sonoma Pharmaceuticals, Inc., 1129 N. McDowell Blvd., Petaluma, California 94954.

 

 

 

 

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SIGNATURES

 

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

 

 SONOMA PHARMACEUTICALS, INC.
   
Date: February 14, 20182019By:/s/ Jim SchutzFrederick Sandford
  Jim SchutzFrederick Sandford
  Chief Executive Officer
(Principal Executive Officer)
Date: February 14, 2018By:/s/ Robert Miller
Robert Miller
and Chief Financial Officer
  (Principal FinancialExecutive Officer and Principal Financial and Accounting Officer)

 

 

 

 

 

 

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