Table of Contents

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.DC 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, 2017

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

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

For the quarterly period ended December 31, 2023

OR

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

For the transition period from ____________ to ______________

 

Commission File Number file number: 001-33216

 

SONOMA PHARMACEUTICALS, INC.

(Exact nameName of registrant as specified in its charter)

 

Delaware68-0423298

(State or other jurisdiction of

incorporation Incorporation or organization)

Organization)

(I.R.SI.R.S. Employer

Identification identification No.)

5445 Conestoga Court, Suite 150, Boulder, CO80301
(Address of principal executive offices)(Zip Code)

 

1129 North McDowell Blvd.

Petaluma, CA 94954(800)759-9305

(Address of principal executive offices) (Zip Code)

(707) 283-0550

Registrant’s telephone number, including area codecode)

 

N/A

(Former name or former address and former fiscal year, if changed since last report)

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

Title of Each ClassTrading SymbolName of Each Exchange on Which Registered
Common Stock, $0.0001 par valueSNOAThe Nasdaq Stock Market LLC

Indicate by checkmarkcheck mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yesx     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). Yesx     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.Act:

 

Large accelerated filerFiler ☐Accelerated filerFiler
Non-accelerated Filer
Non-accelerated filer☐  (Do not check if a smaller reporting company)Smaller reporting company
Emerging growth companyGrowth 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☐    Nox

 

As of February 9, 2018, theThe number of shares outstanding of the registrant’s common stock, $0.0001 par value $0.0001 per share, as of February 7, 2024 was 4,732,20215,607,433.

 

 

   

 

SONOMA PHARMACEUTICALS, INC.

Index

 

 Page
PART I - FINANCIAL INFORMATION3
Item 1.Unaudited Financial Statements3
Condensed Consolidated Balance Sheets3
Condensed Consolidated Statements of Comprehensive Loss4
Condensed Consolidated Statements of Cash Flows5
Condensed Consolidated Statements of Changes in Stockholders’ Equity6
Notes to Condensed Consolidated Financial Statements67
Item 2.Management’s Discussion and Analysis of Financial Condition and Results of Operations17
Item 3.Quantitative and Qualitative Disclosures About Market Risk2527
Item 4.Controls and Procedures2527
  
PART II - OTHER INFORMATION2629
Item 1.Legal Proceedings2629
Item 1A.Risk Factors2629
Item 2.Unregistered Sales of Equity Securities and Use of Proceeds2629
Item 3.Defaults Upon Senior Securities2729
Item 4.Mine Safety Disclosures (Not applicable.)2729
Item 5.Other Information2729
Item 6.Exhibits2730
Signatures33

 

 

 

 

 

 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,      
 2017  2017  

December 31,

2023

 

March 31,

2023

 
 (Unaudited)      (Unaudited)   
ASSETS                
Current assets:                
Cash and cash equivalents $8,625  $17,461  $2,406  $3,820 
Accounts receivable, net  2,609   2,108   2,876   2,572 
Inventories, net  2,701   2,221   2,955   2,858 
Prepaid expenses and other current assets  1,508   616   4,009   4,308 
Current portion of deferred consideration, net of discount  229   237   256   240 
Total current assets  15,672   22,643   12,502   13,798 
Property and equipment, net  1,200   1,239   397   488 
Operating lease, right of use assets  341   418 
Deferred tax asset  922   949 
Deferred consideration, net of discount, less current portion  1,392   1,497   378   505 
Other assets  91   80   78   73 
Total assets $18,355  $25,459  $14,618  $16,231 
                
LIABILITIES AND STOCKHOLDERS’ EQUITY                
Current liabilities:                
Accounts payable $1,400  $1,255  $864  $841 
Accrued expenses and other current liabilities  1,515   1,302   1,847   2,029 
Deferred revenue  180   345   75   100 
Deferred revenue Invekra  140   176   63   60 
Current portion of long-term debt  12   123 
Current portion of capital leases  146   74 
Taxes payable     13 
Short-term debt  44   431 
Operating lease liabilities  181   256 
Total current liabilities  3,393   3,288   3,074   3,717 
Long-term deferred revenue Invekra  492   527   101   140 
Long-term debt, less current portion  35   45 
Long-term capital leases, less current portion  179   168 
Withholding tax payable  4,591   4,235 
Operating lease liabilities, less current portion  160   162 
Total liabilities  4,099   4,028   7,926   8,254 
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, 2023 and March 31, 2023, respectively, no shares issued and outstanding at December 31, 2023 and March 31, 2023, respectively      
Common stock, $0.0001 par value; 24,000,000 shares authorized at December 31, 2023 and March 31, 2023, respectively, 13,684,333 and 4,933,550 shares issued and outstanding at December 31, 2023 and March 31, 2023, respectively (Note 7)  2   5 
Additional paid-in capital  171,332   168,709   202,795   200,904 
Accumulated deficit  (152,677)  (143,101)  (193,282)  (189,514)
Accumulated other comprehensive loss  (4,400)  (4,178)  (2,823)  (3,418)
Total stockholders’ equity  14,256   21,431   6,692   7,977 
Total liabilities and stockholders’ equity $18,355  $25,459  $14,618  $16,231 

 

The accompanying footnotes are an integral part of these unaudited 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,
 
  2017  2016  2017  2016 
Revenues            
Product $4,647  $3,174  $12,394  $8,158 
Service  196   187   609   638 
Total revenues  4,843   3,361   13,003   8,796 
Cost of revenues                
Product  2,308   1,476   6,529   4,507 
Service  167   179   496   568 
Total cost of revenues  2,475   1,655   7,025   5,075 
Gross profit  2,368   1,706   5,978   3,721 
Operating expenses                
Research and development  349   487   1,099   1,226 
Selling, general and administrative  5,219   4,784   14,319   12,557 
Total operating expenses  5,568   5,271   15,418   13,783 
Loss from operations  (3,200)  (3,565)  (9,440)  (10,062)
Interest expense  (11)     (31)  (2)
Interest income  14   6   85   8 
Other income (expense), net  10   282   (179)  276 
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) 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 
Foreign currency translation adjustments  (377)  (416)  (222)  (817)
Comprehensive (loss) income $(3,564) $15,812  $(9,787) $10,893 
             
  

Three Months Ended

December 31,

  

Nine Months Ended

December 31,

 
  2023  2022  2023  2022 
Revenues $3,138  $2,944  $9,296  $10,258 
Cost of revenues  1,678   2,113   5,642   6,645 
Gross profit  1,460   831   3,654   3,613 
Operating expenses                
Research and development  601      1,462   6 
Selling, general and administrative  1,703   2,665   5,484   7,030 
Total operating expenses  2,304   2,665   6,946   7,036 
Loss from operations  (844)  (1,834)  (3,292)  (3,423)
Other expense, net  (79)  (71)  (380)  (322)
Loss before income taxes  (923)  (1,905)  (3,672)  (3,745)
Income tax benefit (expense)  57   (34)  (96)  (98)
Net loss $(866) $(1,939) $(3,768) $(3,843)
                 
Net loss per share: basic and diluted $(0.08) $(0.62) $(0.54) $(1.24)
Weighted-average number of shares: basic and diluted  10,909   3,107   7,011   3,104 
                 
Other comprehensive loss                
Net loss $(866) $(1,939) $(3,768) $(3,843)
Foreign currency translation adjustments  297   235   595   136 
Comprehensive loss $(569) $(1,704) $(3,173) $(3,707)

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

4

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash Flows

(In thousands)

(Unaudited)

       
  Nine Months Ended 
  December 31, 
  2023  2022 
Cash flows from operating activities        
Net loss $(3,768) $(3,843)
Adjustments to reconcile net loss to net cash used in operating activities:        
Depreciation and amortization  135   91 
Stock-based compensation  447   569 
Deferred income taxes  92   (244)
Changes in operating assets and liabilities:        
Accounts receivable, net  (221)  129 
Inventories, net  (93)  (162)
Prepaid expenses and other current assets  546   572 
Operating lease right-of-use assets  99   94 
Deferred consideration  161   129 
Accounts payable  (12)  (353)
Accrued expenses and other current liabilities  (226)  346 
Deferred revenue  33   (1,204)
Withholding tax payable  356   259 
Operating lease liabilities  (99)  (94)
Net cash used in operating activities  (2,550)  (3,711)
         
Cash flows from investing activities:        
Purchases of property and equipment  (20)  (79)
Deposits     (97)
Net cash used in investing activities  (20)  (176)
         
Cash flows from financing activities:        
Proceeds from issuance of common stock, net of issuance costs  1,446    
Payments of ATM agreement costs  (5)  (89)
Payments on PPP Loan     (120)
Principal payments on short-term debt  (387)  (674)
Net cash provided by (used in) financing activities  1,054   (883)
Effect of exchange rate on cash and cash equivalents  102   8 
Net decrease in cash and cash equivalents  (1,414)  (4,762)
Cash and cash equivalents, beginning of period  3,820   7,396 
Cash and cash equivalents, end of period $2,406  $2,634 
         
Supplemental disclosure of cash flow information:        
Cash paid for interest $15  $12 

 

 

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

 


 45 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Cash FlowsChanges in Stockholders’ Equity

For the Nine Months ended December 31, 2023 and 2022

(In thousands)thousands, except share amounts)

(Unaudited)

 

  Nine Months Ended December 31, 
  2017  2016 
  (In thousands) 
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:        
Depreciation and amortization  366   178 
Gain on sale of Latin American assets, net of tax     (14,906)
Income tax benefit     (4,040)
Stock-based compensation  1,530   1,732 
Service provider expenses settled with common stock  62   98 
Changes in operating assets and liabilities:        
Accounts receivable  (500)  (118)
Inventories  (521)  (644)
Prepaid expenses and other current assets  (951)  1,104 
Accounts payable  151   (205)
Accrued expenses and other current liabilities  174   86 
Deferred revenue  (137)  (467)
Net cash used in operating activities  (9,391)  (5,472)
Cash flows from investing activities:        
Purchases of property and equipment  (178)  (195)
Proceeds from sale of Latin American assets, net of costs     17,444 
Deposits  (15)  (17)
Net cash (used in) provided by investing activities  (193)  17,232 
Cash flows from financing activities:        
Proceeds from issuance of common stock, net of offering costs  968    
Proceeds from exercise of common stock purchase warrants  52    
Principal payments on capital leases  (97)    
Principal payments on long-term debt  (121)  (119)
Net cash provided by (used in) financing activities  802   (119)
Effect of exchange rate on cash and cash equivalents  (54)  (127)
Net (decrease) increase in cash and cash equivalents  (8,836)  11,514 
Cash and cash equivalents, beginning of period  17,461   7,469 
Cash and cash equivalents, end of period $8,625  $18,983 
         
Supplemental disclosure of cash flow information:        
Cash paid for interest $31  $2 
         
Non-cash operating and financing activities:        
Automobiles financed using capital leases $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 
                   
  Common Stock
($0.0001 par Value)
  Additional
Paid in
  Accumulated  Accumulated Other Comprehensive    
  Shares  Amount  Capital  Deficit  Loss  Total 
Balance, March 31, 2023  4,933,550  $5  $200,904  $(189,514) $(3,418) $7,977 
Cost in connection with ATM        (5)        (5)
Employee stock-based compensation expenses  208,046      177         177 
Foreign currency translation adjustment              511   511 
Net loss           (1,418)     (1,418)
Balance, June 30, 2023  5,141,596  $5  $201,076  $(190,932) $(2,907) $7,242 
Adjustment to correct par value     (4)  4          
Employee stock-based compensation expenses  37,737      130         130 
Foreign currency translation adjustment              (213)  (213)
Net loss           (1,484)     (1,484)
Balance, September 30, 2023  5,179,333  $1  $201,210  $(192,416) $(3,120) $5,675 
Proceeds from October 30, 2023 offering, net of offering expenses  8,500,000   1   1,445         1,446 
Employee stock-based compensation expenses  5,000      140         140 
Foreign currency translation adjustment              297   297 
Net loss           (866)     (866)
Balance, December 31, 2023  13,684,333  $2  $202,795  $(193,282) $(2,823) $6,692 

                   
  Common Stock
($0.0001 par Value)
  Additional
Paid in
  Accumulated  Accumulated Other Comprehensive    
  Shares  Amount  Capital  Deficit  Loss  Total 
Balance March 31, 2022  3,100,937  $2  $197,370  $(184,363) $(4,312) $8,697 
Employee stock-based compensation expenses        214         214 
Foreign currency translation adjustment              (65)  (65)
Net loss           (887)     (887)
Balance, June 30, 2022  3,100,937  $2  $197,584  $(185,250) $(4,377) $7,959 
Employee stock-based compensation expense        108         108 
Stock based compensation related to issuance of restricted common stock  2,035      5         5 
Foreign currency translation adjustment              (34)  (34)
Net loss           (1,017)     (1,017)
Balance, September 30, 2022  3,102,972  $2  $197,697  $(186,267) $(4,411) $7,021 
Employee stock-based compensation expense        233         233 
Stock based compensation related to issuance of restricted common stock  6,680      9         9 
Foreign currency translation adjustment              235   235 
Net loss           (1,939)     (1,939)
Balance, December 31, 2022  3,109,652  $2  $197,939  $(188,206) $(4,176) $5,559 

 

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

 


 56 

 

SONOMA PHARMACEUTICALS, INC. AND SUBSIDIARIES

Notes to Condensed Consolidated Financial Statements

(Rounded to nearest thousand unless specified)

(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’sCompany moved its principal office is locatedfrom Petaluma, California to Woodstock, Georgia in Petaluma, California.June 2020 and to Boulder, Colorado in October 2022. The Company is a specialty pharmaceutical company dedicated to identifying,global healthcare leader for developing and commercializing unique, differentiated therapies to millionsproducing stabilized hypochlorous acid (“HOCl”) products for a wide range of patients living with chronic skin conditions.applications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, animal health care, and as a non-toxic disinfectant. The Company believes itsCompany’s 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,reduce infections, scarring infections, itch, pain and harmful inflammatory responses.responses in a safe and effective manner. In-vitro and clinical studies of HOCl show it to have impressive antipruritic, antimicrobial, antiviral and anti-inflammatory properties. The Company’s stabilized HOCl immediately relieves itch and pain, kills pathogens and breaks down biofilm, does not sting or irritate skin and oxygenates the cells in the area treated assisting the body in its natural healing process. The Company sells its products either directly or via partners in 55 countries worldwide.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements as of December 31, 2017 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(“GAAP”) for interim financial informationstatements and pursuant toare in the form prescribed by the Securities and Exchange Commission (the “SEC”) in instructions to Form 10-Q and Article 8Rule 10-01 of Regulation S-X of the Securities and Exchange Commission (“SEC”) and on the same basis as the Company prepares its annual auditedS-X. The accompanying condensed consolidated financial statements. The condensed consolidated balance sheet as of December 31, 2017, the condensed consolidated statements of comprehensive (loss) income for the three and nine months ended December 31, 2017 and 2016 and the condensed consolidated statements of cash flows for the nine months ended December 31, 2017 and 2016 are unaudited, but includereflect all adjustments, consisting only of normal recurring adjustments, which the Company considersconsidered necessary for a fair presentationstatement of the consolidatedCompany’s financial position, operating results of operations and cash flows for the periods presented. The results for the threeindicated. All material intercompany accounts and nine months ended December 31, 2017 are not necessarily indicative of results to be expected for the year ending March 31, 2018 or for any future interim period. The condensed consolidated balance sheet at March 31, 2017 has been derived from audited consolidated financial statements. These unaudited condensed consolidated financial statements of the Companytransactions have been preparedeliminated 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.consolidation. The accompanying condensed consolidated financial statements should be read in conjunction with the consolidated financial statements for the year ended March 31, 2017,2023, and notes thereto included in the Company’s annual report on Form 10-K, which was filed with the SEC on June 28, 2017.21, 2023.

 

Note 2.Liquidity and Financial Condition

 

The Company reported a net loss of $9,565,000$866,000 and $1,939,000 for the three months ended December 31, 2023 and 2022, respectively, and $3,768,000 and $3,843,000 for the nine months ended December 31, 2017.2023 and 2022, respectively. At December 31, 20172023 and March 31, 2017,2023, the Company’s accumulated deficit amounted to $152,677,000$193,282,000 and $143,101,000,$189,514,000, respectively. The Company had working capital of $12,279,000$9,428,000 and $19,355,000$10,081,000 as of December 31, 20172023 and March 31, 2017,2023, respectively. The Company expects to continue incurring losses forcash balance at December 31, 2023 and March 31, 2023 was $2,406,000 and $3,820,000, respectively. During the foreseeable future and may need to raise additional capital to pursue its product development initiatives, penetrate markets for the sale of its products and continue as a going concern.

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 threenine months ended December 31, 2017, the Company sold 228,000 shares of common stock for gross proceeds of $1,034,0002023 and 2022, net proceeds of $968,000 after deducting commissionscash used in operating activities amounted to $2,550,000 and other offering expenses.$3,711,000, respectively.

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 assurance 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.

 

7

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, valuation of equity and derivative instruments, debt discounts, valuation of investments, 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 earningsThe following table provides the net loss for each period along with the computation of basic and diluted net loss per share:

Schedule of computation of earning per share            
  Three Months Ended December 31,  Nine Months Ended December 31, 
(In thousands, except per share data) 2023  2022  2023  2022 
Numerator:            
Net loss $(866) $(1,939) $(3,768) $(3,843)
                 
Denominator:                
Weighted-average number of common shares outstanding: basic and diluted  10,909   3,107   7,011   3,104 
                 
Net loss per share: basic and diluted $(0.08) $(0.62) $(0.54) $(1.24)

The computation of basic loss per share for both continuingthe three and discontinued operations are computed by dividing the net income or loss available to common stockholders by the weighted average number of common shares outstanding during the period. Diluted earnings per share is computed using the weighted average number of common sharesnine months ended December 31, 2023, and if dilutive, potential common shares outstanding during the period. Potential common shares consist of the incremental common shares issuable upon the exercise of stock options (using the treasury stock method) and warrants (using the if-converted method). Diluted loss per share2022 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 
Schedule of anti-dilutive shares            
  Three Months Ended December 31,  Nine Months Ended December 31, 
(In thousands) 2023  2022  2023  2022 
Stock options  1,011   576   1,011   576 
Warrants     108      108 
Common stock units     46      46 
   1,011   730   1,011   730 

 

 

 


 78 

 

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

  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 

 

Revenue Recognition

The Company recognizes revenue in accordance with Accounting Standards Codification (“ASC”), Topic 606 Revenue from Contracts with Customers (“Topic 606”). Revenue is recognized when the Company transfers promised goods or services to the customer, in an amount that reflects the consideration which the Company 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 directly to end users and to distributors. The Company also sells 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 Companyhas also has entered into agreements to license its technology and products.

 

The Company also provides regulatory compliance testing and quality assurance servicesconsiders customer purchase orders, which in some cases are governed by master sales agreements, to medical device and pharmaceutical companies.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.

 

The Company records revenue when (i) persuasive evidence of an arrangement exists, (ii) delivery has occurred, (iii) the fee is fixed or determinable, and (iv) collectabilityFor all of the sale is reasonably assured.

The Company requires all productCompany’s sales to be supported by evidencenon-consignment distribution channels, revenue is recognized when control of a sale transaction that clearly indicates the selling priceproduct is transferred 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 its 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 For product sales to its value-added resellers, non-stocking distributors and end-user customers, the Company grants 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 all goodsproduct that will be returned. Sales incentives and other programs that the Company may make available to these customers are fixed,considered to be a form of variable consideration, and agreedthe Company maintains estimated accruals and allowances using the expected value method. With the movement of these sales to witha full distributor model in fiscal year 2022, the customer,Company no longer provides these arrangements although the Company still receives some returns from the period 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 wholesale 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 certain 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 rebate programs which provide discounted prescriptions to qualified patients. The Company contracts with a third-party to administer the program. The Company estimates and accrues for future rebates based on historical data for rebate redemption rates and the historical value of redemptions. Rebates are recognized as a reduction of revenue in the same period the related revenue is recognized.year ended March 31, 2023.

 

The Company evaluateshas entered into consignment arrangements, in which goods are left in the creditworthinesspossession of new customersanother party to sell. As products are sold from the customer to third parties, the Company recognizes revenue based on a variable percentage of a fixed price.  Revenue recognized varies depending on whether a patient is covered by insurance or is not covered by insurance. In addition, the Company may incur a revenue deduction related to the use of the Company’s rebate program.

Sales to stocking distributors are made under terms with fixed pricing and monitorslimited rights of return (known as “stock rotation”) of the creditworthiness of its existing customers to determine whether an event or changesCompany’s products held in their financial circumstances would raise doubt asinventory. Revenue from sales to distributors is recognized upon the transfer of control to the collectability of a sale atdistributor.

The Company assessed the time in which a sale is made. Payment terms on sales madepromised goods and services in the United States are generally 30 to 60 daystechnical support contract with Invekra for a ten-year period as being a distinct service that Invekra can benefit from on its own and are extended up to 90 daysas separately identifiable from any other promises within the contract. Given that the distinct service is not substantially the same as other goods and services within the Invekra contract, the Company accounted for initial product launches, payment terms internationally generally range from prepaid prior to shipment to 90 days.the distinct service as a performance obligation.

 

 

 

 

 89 

 

In the event a saleAccounts 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 made to a customer under circumstancesreserve for uncollectible accounts based on its best estimate of probable credit losses in which collectability is not reasonably assured, the Company either requires the customer to remit payment prior to shipment or defers recognition of the revenue until payment is received.its existing accounts receivable. The Company maintains a reserve for amounts which may not be collectible due 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 arrangementsperiodically 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 elements canrealization of an account may be separated. Analysis is performed atin doubt. Other factors that the inceptionCompany considers include its existing contractual obligations, historical payment patterns of its customers and individual customer circumstances, an analysis of days sales outstanding by customer and geographic region, and a review of the arrangementlocal economic environment and as each productits 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 delivered. If a product or service is not separable, the combined deliverables are accountedconsidered remote. The Company did not deem it necessary to record an allowance for as a single unit of accountingdoubtful accounts for probable credit losses at December 31, 2023 and recognized over the performance obligation period.

When appropriate, the Company defers recognition of non-refundable upfront fees. IfMarch 31, 2023. Additionally, at December 31, 2023 and March 31, 2023 the Company has continuing performance obligations then such up-frontallowances of $29,000 and $16,000, respectively, related to potential discounts, returns, distributor fees and rebates. The allowances are deferred and recognized overincluded in accounts receivable, net in the period of continuing involvement.

The Company recognizes royalty revenues from licensed products upon the sale of the related products.

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.

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$292,000 and $61,000$236,000 at December 31, 20172023 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 impact2023, respectively, which is included in cost of 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, the adoption of ASU No. 2016-09 related to 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 current consolidated financial statements or on any prior period financial statements presented.

Recent Accounting Standards

Leases

In February 2016, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) No. 2016-02, Leases (Topic 842) which supersedes FASB ASC Topic 840, Leases (Topic 840) and provides principles for the recognition, measurement, presentation and disclosure of leases for both lessees and lessors. The FASB 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 based 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 its consolidated financial statements and related disclosures.

Revenue

In May 2014, the FASB issued ASU No. 2014-09,Revenue from Contracts with Customers (“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. The 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 intended to make 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. The Company will adopt the new standard 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, the Company’s analysis is preliminary and subject to change. The Company has not completed its assessment of multiple element arrangements and certain discount and trade promotion programs.

10

Business Combinations

In January 2017, the FASB issued an ASU 2017-01, Business Combinations (Topic 805) Clarifying the Definition of a Business. The amendments in this Update is to clarify 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 evaluating the impact of adopting this guidance.

Stock Compensation

In May 2017, the FASB issued ASU No. 2017-09,Compensation–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 is effective for the Company on a prospective basis beginning on April 1, 2018, with early adoption permitted. The Company is currently evaluating the impact that ASU 2017-09 will have on its consolidated financial statements and related disclosures.

 

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 OperationsCondensed Consolidated Balance Sheet

 

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 onInventories, 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.

 

Inventories, net consist of the following:

Schedule of inventories      
  December 31,  March 31, 
  2023  2023 
Raw materials $1,507,000  $1,764,000 
Finished goods  1,448,000   1,094,000 
Inventories, net $2,955,000  $2,858,000 

 

 

 1110 

 

Discontinued operationsLeases

The Company's operating leases are comprised primarily of facility leases. The Company did not have any finance leases as of December 31, 2023 and March 31, 2023. Balance sheet information related to our leases is presented below:

Schedule of lease information      
  December 31,  March 31, 
  2023  2023 
Operating leases:      
Operating lease right-of-use assets $341,000  $418,000 
Operating lease liabilities – current  181,000   256,000 
Operating lease liabilities – non- current  160,000   162,000 

Other information related to leases is presented below:

Nine Months Ended December 31, 2023   
Operating lease cost $328,000 
Other information:    
Operating cash flows from operating leases  (99,000)
Weighted-average remaining lease term – operating leases (in months)  21.5 
Weighted-average discount rate – operating leases  6.00% 

 

As of December 31, 2016,2023, the Company determined that the saleannual minimum lease payments of its Latin American operations to Invekra qualifiedour operating lease liabilities were 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.follows:

Schedule of minimum operating lease liabilities   
For Years Ending March 31,   
2024 (excluding the nine months ended December 31, 2023) $38,000 
2025  134,000 
2026  175,000 
2027  34,000 
Total future minimum lease payments, undiscounted  381,000 
Less: imputed interest  (40,000)
Present value of future minimum lease payments $341,000 

 

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.Inventories

Inventories, net

Inventories consist of the following:

  December 31,  March 31, 
  2017  2017 
Raw materials $1,526,000  $1,480,000 
Finished goods  1,175,000   741,000 
  $2,701,000  $2,221,000 

Note 6.5.Commitments and Contingencies

Legal Matters

The Company on occasion, 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.

11

 

Employment Agreements

 

As of December 31, 2017, theThe Company hadhas employment agreements in place with sixtwo of its key executives. TheThese executive employment agreements provide, among other things, for the payment of twelveup to eighteen months of severance compensation for terminations under certain circumstances. With

Amendments

On June 16, 2023, we entered into an amended and restated employment agreement with our Chief Executive Officer, Amy Trombly. The amended and restated agreement provides that, in the event of termination upon change of control either without cause or for good reason, Ms. Trombly is entitled to receive, in addition to the other benefits described therein, a lump sum severance equal to one and a half times her base salary and one and a half times her target annual bonus. All other material terms of the amended and restated agreement remain unchanged from her prior employment agreement.

On June 16, 2023, we amended and restated our employment agreement with Bruce Thornton, our Chief Operating Officer. Under the amended and restated agreement, Mr. Thornton will serve as Executive Vice President and Chief Operating Officer of the Company. Mr. Thornton will no longer receive a monthly car allowance; however, his base salary is adjusted to include such amount. The amended and restated agreement also provides that, in the event of termination upon change of control either without cause or for good reason, Mr. Thornton is entitled to receive, in addition to the other benefits described therein, to a lump sum severance equal to one and a half times his base salary and one and a half times his target annual bonus. The agreement further provides that upon termination for any reason, Mr. Thornton’s outstanding and vested equity awards shall remain exercisable for 18 months following termination. Either party may terminate the employment agreement for any reason upon at least 60 days prior written notice. All other material terms of his amended and restated agreement remain unchanged from his prior employment agreement.

Bonus Grants

On June 16, 2023, the Compensation Committee of the Board of Directors approved annual bonus awards of $162,500 for Ms. Trombly and $150,000 for Mr. Thornton.

Equity Awards

On June 16, 2023, the Compensation Committee of the Board of Directors approved an equity award of 100,000 shares of the Company’s common stock to each of Ms. Trombly and Mr. Thornton, to be issued to on June 30, 2023, at a valuation based on the five day weighted trailing average of the Company’s stock price on the day of grant. In addition, the Compensation Committee also approved a one-time cash payment by the Company as reimbursement for estimated taxes payable with respect to such equity awards. On September 22, 2023, the Company paid taxes related to the common stock issuance in the amount of $149,000.

As of December 31, 2023, with respect to these agreements, at December 31, 2017, aggregated annual salaries would be $1,167,000was $586,000 and potential severance payments to these key executives would be $1,417,000was $1,300,000, if triggered.

 

Note 6.Debt

Financing of Insurance Premiums

On February 1, 2022, the Company entered into a note agreement for $748,000 with an interest rate of 4.68% per annum with final payment on January 1, 2023. This instrument was issued in connection with financing insurance premiums. The note is payable in ten monthly installment payments of principal and interest of $76,000, with the first installment beginning March 1, 2022.

On February 1, 2023, the Company entered into a note agreement for $453,000 with an interest rate of 8.98% per annum with final payment on January 1, 2024. This instrument was issued in connection with financing insurance premiums. The note is payable in eleven monthly installment payments of principal and interest of $43,000, with the first installment beginning March 1, 2023.

 

 

 

 12 

 

Note 7.Stockholders’ Equity

 

Authorized Capital

The Company is authorized to issue up to 12,000,00024,000,000 shares of common stock with a par value of $0.0001$0.0001 per share and 714,286 shares of convertible preferred stock with a par value of $0.0001$0.0001 per share.

At Market IssuanceSale of Common Stock

 

On December 8, 2017,October 26, 2023, the Company entered into a placement agency agreement with Maxim Group LLC (“Maxim”), pursuant to which Maxim agreed to use its reasonable best efforts to solicit offers to purchase up to an At Market Issuance Sales Agreement, with B. Riley FBR, Inc. (“B. Riley”) under which the Company may issue and sellaggregate of 8,500,000 shares of itsthe Company’s 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.par value $0.0001 per share. The Company willagreed to pay B. RileyMaxim a commission ratecash fee equal to 3.0%8.0% of the gross proceeds from the offering, plus reimbursement of up to $75,000 of legal fees and other expenses. Additionally, on October 26, 2023, the Company entered into a securities purchase agreement with the purchasers party thereto for the sale and issuance of anyan aggregate of up to 8,500,000 shares of the Company’s common stock sold through B. Riley as agent. Forat a public offering price of $0.20 per share.

The closing of the three months ended December 31, 2017,offering occurred on October 30, 2023. In connection with the offering, the Company sold 228,0008,500,000 shares of the Company’s common stock for aggregate gross proceeds of $1,034,000$1,700,000 and net proceeds of $968,000$1,446,000, after deducting commissionsplacement agent fees and other estimated offering expenses.expenses paid by the Company.

 

Common Stock Issued to Services Provider

During the nine months ended December 31, 2017, the Company entered into an agreement with Actual, Inc., a firm that provides marketing and branding consulting services. 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. On December 1, 2017, the Company issued 5,479 shares of restricted common stock valued at $5.02 per share. The aggregate fair market value of the common stock issued was $27,000. 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. The expense was recorded as selling, general and administrative expense in the accompanying condensed consolidated statement of comprehensive (loss) income for the three and nine months ended December 31, 2017.

Note 8.Stock-Based Compensation

 

On April 1, 2017,Stock-based compensation expense is as follows:

For the three months ended December 31, 2023 and 2022, the Company adopted ASU 2016-09incurred $140,000 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$242,000 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 reducesstock-based compensation expense, based on the expected forfeitures. Beginning April 1, 2017, the Company will record forfeitures as they occurrespectively, and will reduce compensation cost at the time of forfeiture.

The weighted average grant date fair values of options granted duringfor the nine months ended December 31, 2017 was $6.01.

Share-based awards2023 and 2022, the Company incurred $447,000 and $569,000 of stock-based compensation expense, respectively. All stock-based compensation incurred is as follows:included in selling, general and administrative expense in the accompanying condensed consolidated statements of comprehensive loss.

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

At December 31, 2017,2023, there were unrecognized compensation costs of $2,636,000$312,000 related to stock options which isare expected to be recognized over a weighted-average amortization period of 2.201.44 years.

 

At December 31, 2017, there were unrecognized compensation costs of $178,000 related to restricted stock whichStock options award activity is expected to be recognized over a weighted-average amortization period of 1.66 years.as follows:

Schedule of options activity      
  Number of
Shares
  Weighted-
Average
Exercise Price
 
Outstanding at April 1, 2023  565,000  $8.84 
Options granted  500,000   0.19 
Options forfeited  (49,000)  32.26 
Options expired  (5,000)  47.39 
Outstanding at December 31, 2023  1,011,000  $3.24 
Exercisable at December 31, 2023  605,000  $4.37 

 

 

 

 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 

 

The aggregate intrinsic value of stock options of zero 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$0.18 per share at December 31, 2017.2023.

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.

Schedule of unvested restricted stock activity      
  

Number of

Shares

  

Weighted

Average Award

Date Fair Value

per Share

 
Unvested restricted stock awards outstanding at April 1, 2023    $ 
Restricted stock awards granted  251,000   1.04 
Restricted stock awards vested  (251,000)  1.04 
Unvested restricted stock awards outstanding at December 31, 2023    $ 

 

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 stockstock-based awards.

 

Note 9.Income Taxes

 

TheAt the end of each interim reporting period, the Company has completed a study to assess whether a change in control has occurred or whether there have been multiple changes of control sincedetermines the Company’s formation through March 31, 2017. The Company determined, based on the resultsincome tax provision by using an estimate of the study, no changeannual effective tax rate, adjusted for discrete items occurring in control occurredthe quarter.

The Company’s effective tax rate for purposesthe three and nine months ended December 31, 2023 was (2.49)% and 6.43%, respectively. The Company’s effective tax rate for the three and nine months ended December 31, 2023 differed from the federal statutory tax rate of Internal Revenue Code section 382. The Company, after considering all available evidence, fully reserved its21% primarily due to the valuation allowance recognized against deferred tax assets sincein the U.S., and permanent tax adjustment of intercompany interest expense in Mexico and Netherlands.

Judgment is required in determining whether deferred tax assets will be realized in full or in part. Management assesses the available positive and negative evidence on a jurisdictional basis to estimate if deferred tax assets will be recognized and when it is more likely than not such benefits,that all or some deferred tax assets will not be realized, and a valuation allowance must be established. As of December 31, 2023, the Company continues to maintain a valuation allowance in future periods. the U.S.

Note 10.Revenue Disaggregation

The Company incurred losses for both financial reportinggenerates revenues from products which are sold into the human and income tax purposes for the year ended March 31, 2017. Accordingly, the Company is continuinganimal healthcare markets and 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.multiple geographic regions.

 

As a result of certain realization requirements of Accounting Standards Codification Topic 718,The following table presents 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. Equity will be increaseddisaggregated revenues by approximately $533,000 if and when such deferred tax assets are ultimately realized.revenue source:

 Schedule of disaggregated revenue by revenue source            
(In thousands) Three Months Ended December 31,  Nine Months Ended December 31, 
  2023  2022  2023  2022 
Human Care $2,461  $2,435  $7,286  $7,050 
Animal Care  621   434   1,688   1,957 
Service and Royalty  56   75   322   1,251 
  $3,138  $2,944  $9,296  $10,258 

 

 

 

 

 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. The Tax Act reduces the federal corporate tax rate to 21 percent in the fiscal year ending March 31, 2018.  Section 15 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 the number of days in the year.  The reduction 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 response to the Tax Act, or any updates or changes to estimates 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.

Note 10.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 shows the Company’s product revenues by geographic region:

Schedule of revenues by geographic region             
  Three Months Ended December 31,  Nine Months Ended December 31, 
(In thousands) 2023  2022  2023  2022 
United States $868  $761  $2,214  $2,603 
Europe  1,217   1,104   3,488   3,117 
Asia  522   514   1,730   1,952 
Latin America  368   384   1,165   1,827 
Rest of the World  163   181   699   759 
Total $3,138  $2,944  $9,296  $10,258 

 

  

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 

The Company’s service revenues amounted to $196,000 and $187,000 for the three months ended December 31, 2017 and 2016, respectively. The Company’s service revenues amounted to $609,000 and $638,000 for the nine months ended December 31, 2017 and 2016, respectively.

15

Note 11.Significant Customer Concentrations

 

For the three months ended December 31, 2017, oneThe following table shows customer represented 21%revenues as a percentage of net revenue, onerevenue:

Schedule of customer concentrations            
  Three Months Ended December 31,  Nine Months Ended December 31, 
  2023  2022  2023  2022 
Customer A  11%   13%   12%   18% 
Customer B  17%   11%   15%   16% 
Customer C  13%   11%   15%   10% 
Customer D  *%   *%   *%   *% 
Customer E  *%   *%   *%   *% 

The following table shows customer represented 16%accounts receivable balances as a percentage of net revenue, one customer represented 14% of net revenue and one customer represented 12% of net revenue. For the three months ended December 31, 2016, one customer represented 22%, one customer represented 16%, one customer represented 13% and one customer representedaccounts receivables:

       
  December 31,  December 31, 
  2023  2022 
Customer A  13%   *% 
Customer B  15%   12% 
Customer C  *%   *% 
Customer D  13%   18% 
Customer E  *%   10% 

* Represents less than 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, one customer represented 36%, one customer represented 17%, and one customer represented 15% of the accounts receivable balance. At March 31, 2017, one customer represented 26%, one customer represented 12%, and one customer represented 10% of the accounts receivable balance.

 

15

Note 12.Subsequent Events

 

Sale of Common Stock Issued to Independent Directors and Chief Executive Officers

 

On January 2, 2018,December 15, 2023, the Company granted discretionaryentered into an Equity Distribution Agreement (the “Agreement”), with Maxim Group LLC (“Maxim”), pursuant to which the Company may offer and sell, from time to time, through Maxim, as sales agent or principal, shares of its common stock, bonuses$0.0001 par value per share.

Subject to all directorsthe terms and conditions of the Company, includingAgreement, Maxim will use commercially reasonable efforts consistent with its Chief Executive Officernormal trading and Director, Jim Schutz, for their services in connection withsales practices, applicable state and federal law, rules and regulations and the turn-around of our Company and in an effort to increase the stock ownershiprules of the BoardNasdaq Capital Market to sell shares from time to time based upon the Company’s instructions, including any price, time or size limits specified by the Company. Under the Agreement, Maxim may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the U.S. Securities Act of 1933, as amended, or any other method permitted by law, including in privately negotiated transactions. Maxim’s obligations to sell shares under the Agreement are subject to satisfaction of certain conditions, including customary closing conditions for transactions of this nature. The Company will pay Maxim a commission of 3% of the aggregate gross proceeds from each sale of shares and has agreed to provide Maxim with customary indemnification and contribution rights. The Company also agreed to reimburse Maxim for certain specified expenses of up to $20,000. On January 11, 2024, the Company sold 1,923,100 shares of its common stock for gross proceeds of approximately $392,000 and net proceeds of approximately $356,000.

Commercial Agreement

On January 5, 2024, the Company entered into a license and distribution agreement with NovaBay Pharmaceuticals, Inc. for the sale and marketing of Avenova®-branded products by the Company in the amountEuropean Union. The agreement is for an initial term 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,two years, subject to automatic renewal periods. These products combine the Company’s Board of Directors awarded an additional stock bonus of $50,000 or 8,606 shares of common stock subjectexisting eye product Ocudox®, which already has a Class IIB CE mark for sale in the European Union, with Avenova branding, and are expected to be marketed through 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.Company’s established European distribution network.

 

 

 

 

 

 

 

 16 

 

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, 20172023 and our audited consolidated financial statements for the year ended March 31, 20172023 included in our Annual Report on Form 10-K, filed with the Securities and Exchange Commission on June 28, 2017.21, 2023.

 

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,” “aim,” “seek,” “project,” “continue,” “ongoing,” “potential,” “expect,” “predict,” “believe,” “intend,” “may,” “will,” “should,” “could,” “would,” “likely,” “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 impactour dependence on third-party distributors; certain tax impacts of the Invekra transaction oninter-company loans between us and our business and results of operations; the vulnerability of our Petaluma facility to extreme weather events; the impact of seasonality on our sales;Mexican subsidiary; 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; our ability to protect our information technology and infrastructure; 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,global healthcare leader for developing and commercializing unique, differentiated therapies to millionsproducing stabilized hypochlorous acid, or HOCl, products for a wide range of patients living with chronic skin conditions. We believe ourapplications, including wound care, eye, oral and nasal care, dermatological conditions, podiatry, animal health care and non-toxic disinfectants. Our 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,reduce infections, scarring infections, itch, pain and harmful inflammatory responses.

responses in a safe and effective manner. In-vitro and clinical studies of HOCl show it to have impressive antipruritic, antimicrobial, antiviral and anti-inflammatory properties. Our stabilized HOCl immediately relieves itch and pain, kills pathogens and breaks down biofilm, does not sting or irritate skin and oxygenates the cells in the area treated, assisting the body in its natural healing process. We are focused on the development and commercialization of therapeutic solutionssell our products either directly or via partners 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.55 countries worldwide.

 

 

 

 17 

 

SomeBusiness Channels

Our core market differentiation is based on being the leading developer and producer of stabilized hypochlorous acid, or HOCl, solutions. We have been in business for over 20 years, and in that time, we have developed significant scientific knowledge of how best to develop and manufacture HOCl products, backed by decades of studies and data collection. HOCl is known to be among the safest and most-effective ways to relieve itch, inflammation and burns while stimulating natural healing through increased oxygenation and eliminating persistent microorganisms and biofilms.

We sell our products based on our HOCl technology into many markets both in the U.S. and internationally. Our core strategy is to work with partners to market and distribute our products. In some cases, we market and sell our own products.

Dermatology

We have developed unique, differentiated, prescription-strength and safe dermatologic products that support paths to healing among various key dermatologic conditions. Our products are primarily targeted at the treatment of redness and irritation, the management of scars, and symptoms of eczema/atopic dermatitis. 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 United States, we partner with EMC Pharma, LLC to sell our prescription dermatology products. Pursuant to our March 2021 agreement with EMC Pharma, we manufacture products for EMC Pharma and EMC Pharma has the right to market, sell and distribute them to patients and customers for an initial term of five years, subject to meeting minimum purchase and other requirements.

In September 2021, we launched a new over-the-counter product, Regenacyn® Advanced Scar Gel, which is clinically proven to improve the overall appearance of scars while reducing pain, itch, redness, and inflammation. On the same day, we launched Regenacyn® Plus, a prescription-strength scar gel which is available as an office dispense product through physician offices.

In October 2022, we launched two new over-the-counter dermatology products in the United States, are:Reliefacyn® Advanced Itch-Burn-Rash-Pain Relief Hydrogel for the alleviation of red bumps, rashes, shallow skin fissures, peeling, and symptoms of eczema/atopic dermatitis, and Rejuvacyn® Advanced Skin Repair Cooling Mist for management of minor skin irritations following cosmetic procedures as well as daily skin health and hydration.

 

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

In June 2022, the Natural Products Association certified Rejuvacyn Advanced as a Natural Personal Care Product. Reliefacyn Advanced received the National Eczema Association Seal of AcceptanceTM in 2023.

·Ceramax™ Skin Barrier Cream helps manage dry itchy skin, minor skin irritations, rashes, and inflammation caused by various skin conditions.

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

·Alevicyn™, a prescription hypochlorous acid based atopic dermatitis product line clinically proven to reduce pruritus (itch) and pain associated with various dermatoses.
·Sebuderm™, 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™, a prescription liquid containing Cetiol® CC and medical grade dimethicone, intended to manage and relieve erythema and itching for various types of dermatoses.

·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:In January 2023, we launched a line of office dispense products exclusively for skin care professionals, including two new prescription strength dermatology products, Reliefacyn® Plus Advanced Itch-Burn-Rash-Pain Relief Hydrogel and Rejuvacyn® Plus Skin Repair Cooling Mist. These products, along with Regenacyn® Plus Scar Gel, are marketed and sold directly to dermatology practices and medical spas.

 

·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.

In April 2023, we introduced a new pediatric dermatology and wound care product for over-the-counter use, Pediacyn™ All Natural Skin Care & First Aid For Children.

 

As of December 31, 2017,In January 2024, we have obtained 20 clearances from the U.S. Food and Drug Administration, or FDA, that permit us to sell our products as medical devices for Section 510(k) of the Federal Food, Drug and Cosmetic Actlaunched LumacynTM Clarifying Mist, a direct-to-consumer skin care product in the United States.

Outside the United States, we sell products for dermatological Lumacyn is an all-natural daily toner to soothe skin, reduce redness and advanced tissue care with a European Conformity marking (known as Conformité Européenne or CE) covering 25 of our products,irritation, and various approvals in China, Southeast Asia, South Korea, India, Australia, New Zealand, and the Middle East.manage blemishes by reducing infection.

 

Our Strategyconsumer products are available through Amazon.com, our online store, and third-party distributors.

 

Our strategy isWe sell dermatology products in Europe and Asia through distributors. In these international markets, we have a network of partners, ranging from country specific distributors to in-license, acquire,large pharmaceutical companies to full-service sales and marketing companies. We work with our international partners to create products they can market in their home country. Some products we develop and commercialize unique, affordable and differentiated therapies thatmanufacture are custom label while others use branding we believe advance the standardhave already developed. We have created or co-developed a wide range of careproducts for patients with dermatological diseases. The key components ofinternational markets using our strategy are to:

·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.

·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 repaircore HOCl 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.

 

 

 18 

 

First Aid and Wound Care

Our HOCl-based wound care products are intended for the treatment of acute and chronic wounds as well as first- and second-degree burns, and as an intraoperative irrigation treatment. They work by first removing foreign material and debris from the skin surface and moistening the skin, thereby improving wound healing. Secondly, our HOCl products assist in the wound healing process by removing microorganisms. HOCl is an important constituent of our innate immune system, formed and released by the macrophages during phagocytosis. Highly organized cell structures such as human tissue can tolerate the action of our wound care solution while single-celled microorganisms cannot, making our products advantageous to other wound-irrigation and antiseptic solutions. Due to its unique chemistry, our wound treatment solution is also much more stable than similar products on the market and therefore maintains much higher levels of hypochlorous acid over its shelf life.

In the United States, we sell our wound care products directly to hospitals, physicians, nurses, and other healthcare practitioners and indirectly through non-exclusive distribution arrangements. In Europe, the Middle East and Asia, we sell our wound care products through a diverse network of distributors.

To respond to market demand for our HOCl technology-based products, we launched our first direct to consumer over-the-counter product in the United States in February 2021. Microcyn® OTC Wound and Skin Cleanser is formulated for home use without prescription to help manage and cleanse wounds, minor cuts, and burns, including sunburns and other skin irritations. Microcyn OTC is available without prescription through Amazon.com, our online store, and third-party distributors.

In March 2021, we received approval to market and use our HOCl products as biocides under Article 95 of the European Biocidal Products Regulation in France, Germany and Portugal. The approval applies to our products MucoClyns™ for human hygiene to be marketed and commercialized by us, MicrocynAH® for animal heath marketed and commercialized through our partner, Petagon Limited, and MicroSafe for disinfectant use to be marketed and commercialized through our partner, MicroSafe Group DMCC.

In June 2022, the Natural Products Association certified Microcyn OTC as a Natural Personal Care Product in the United States.

In June 2023, we announced a new application of our HOCl technology for intraoperative pulse lavage irrigation treatment, which can replace commonly used IV bags in a variety of surgical procedures. The intraoperative pulse lavage container is designed to be used in combination with a pulse lavage irrigation device, or flush gun, for abdominal, laparoscopic, orthopedic, and periprosthetic procedures. It is in trial use by hospitals in Europe and launched in the U.S. in November 2023.

Eye Care

Our prescription product Acuicyn™ is an antimicrobial prescription solution for the treatment of blepharitis and the daily hygiene of eyelids and lashes and helps manage red, itchy, crusty and inflamed eyes. It is strong enough to kill the bacteria that causes discomfort, fast enough to provide near instant relief, and gentle enough to use as often as needed. In the United States, our partner EMC Pharma sells Acuicyn through its distribution network.

In September 2021, we launched Ocucyn® Eyelid & Eyelash Cleanser, which is sold directly to consumers on Amazon.com, through our online store, and through third party distributors. Ocucyn® Eyelid & Eyelash Cleanser, designed for everyday use, is a safe, gentle, and effective solution for good eyelid and eyelash hygiene.

In international markets we rely on distribution partners to sell our eye products. On May 19, 2020, we entered into an expanded license and distribution agreement with our existing partner, Brill International S.L., for our Microdacyn60® Eye Care HOCl-based product. Under the license and distribution agreement, Brill has the right to market and distribute our eye care product under the private label Ocudox™ in Italy, Germany, Spain, Portugal, France, and the United Kingdom for a period of 10 years, subject to meeting annual minimum sales quantities. In return, Brill paid us a one-time fee and the agreed upon supply prices. In parts of Asia, Dyamed Biotech markets our eye product under the private label Ocucyn.

In January 2024, we entered into a license agreement with NovaBay Pharmaceuticals, Inc. for the sale and marketing of Avenova®-branded Ocudox products in the European Union through our European distribution network.

 ·19Create 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.

 

Oral, Dental and Nasal Care

We sell a variety of oral, dental, and nasal products around the world.

In late 2020, we launched a HOCl-based product in the dental, head and neck markets called Endocyn®, a biocompatible root canal irrigant. In the U.S., we sell Endocyn through U.S.-based distributors.

In international markets, our product Microdacyn60® Oral Care treats mouth and throat infections and thrush. Microdacyn60 assists in reducing inflammation and pain, provides soothing cough relief and does not contain any harmful chemicals. It does not stain teeth, is non-irritating, non-sensitizing, has no contraindications and is ready for use with no mixing or dilution.

Our international nasal care product Sinudox™ based on our HOCl technology is an electrolyzed solution intended for nasal irrigation. Sinudox clears and cleans stuffy, runny noses and blocked or inflamed sinuses by ancillary ingredients that may have a local antimicrobial effect. Sinudox is currently sold through Amazon in Europe. In other parts of the world, we partner with distributors to sell Sinudox.

Podiatry

Our HOCl-based wound care products are also indicated for the treatment of diabetic foot ulcers. In the United States, we sell our wound care products directly to podiatrists, as well as hospitals, nurses, and other healthcare practitioners, and indirectly through non-exclusive distribution arrangements. In Europe, we sell our wound care products for podiatric use through a diverse network of distributors.

On April 11, 2023, we launched Podiacyn™ Advanced Everyday Foot Care direct to consumers for over-the-counter use in the United States, intended for management of foot odors, infections, and irritations, as well as daily foot health and hygiene. Podiacyn is available through Amazon.com, our online store, and third-party distributors.

Animal Health Care

MicrocynAH® is an HOCl-based topical product that cleans, debrides and treats a wide spectrum of animal wounds and infections. It is intended for the safe and rapid treatment of a variety of animal afflictions including cuts, burns, lacerations, rashes, hot spots, rain rot, post-surgical sites, pink eye symptoms and wounds to the outer ear.

For our animal health products sold in the U.S. and Canada, we partner with Manna Pro Products, LLC. Manna Pro distributes non-prescription products to national pet-store retail chains and farm animal specialty stores such as Chewy.com, PetSmart, Tractor Supply, Cabela’s, PetExpress, and Bass Pro Shops. In August 2022, we announced the launch of a MicrocynVS® line of products exclusively for veterinarians for the management of wound, skin, ear and eye afflictions in all animal species.

For the Asian and European markets, on May 20, 2019, we partnered with Petagon, Limited, an international importer and distributor of quality pet food and products for an initial term of five years. We supply Petagon with all MicrocynAH products sold by Petagon. On August 3, 2020, Petagon received a license from the People’s Republic of China for the import of veterinary drug products manufactured by us. This is the highest classification Petagon and Sonoma can receive for animal health products in China.

 ·20Develop 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.

Surface Disinfectants

 

Our planHOCl technology has been formulated as a disinfectant and sanitizer solution for our partner MicroSafe and is sold in numerous countries. It is designed to evolvebe used to spray in aerosol format in areas and environments likely to serve as a breeding ground for the spread of infectious disease, which could result in epidemics or pandemics. The medical-grade surface disinfectant solution is used in hospitals worldwide to protect doctors and patients. In May 2020, Nanocyn® Disinfectant & Sanitizer received approval to be entered into the Australian Register of Therapeutic Goods, or ARTG for use against the coronavirus SARS-CoV-2, or COVID-19, and was also authorized in Canada for use against COVID-19. Nanocyn has also met the stringent environmental health and social/ethical criteria of Good Environmental Choice Australia, or GECA, becoming one of the very few eco-certified, all-natural disinfectant solutions in Australia.

Through our partner MicroSafe, we sell hard surface disinfectant products into Europe, the Middle East and Australia.

On July 31, 2021, we granted MicroSafe the non-exclusive right to sell and distribute Nanocyn in the United States provided that MicroSafe secure U.S. EPA approval. In April of 2022, MicroSafe secured the EPA approval for Nanocyn® Disinfectant & Sanitizer, meaning that it can now be sold in the United States as a leading dermatology company, providing innovativesurface disinfectant. Nanocynwas subsequently added to the EPA’s list N for use against COVID-19. In June 2022, the EPA added Nanocyn to List Q as a disinfectant for Emerging Viral Pathogens, including Ebola virus, Mpox, and cost-effective solutionsSARS-CoV-2, and in March 2023 the EPA added Nanocyn to patients, while generating strong, consistent revenue growthLists G and maximizing long-term shareholder value.H, for use against Methicillin Resistant Staphylococcus Aureus (MRSA), Salmonella, Norovirus, Poliovirus, and as a fungicide. Nanocyn also received the Green Seal® Certification after surpassing a series of rigorous standards that measure environmental health, sustainability and product performance. Nanocyn is currently sold by MicroSafe in Europe, the Middle East and Australia.

 

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.

 

Comparison of the Three Months Ended December 31, 2017 and 2016

Revenues

Total revenues for the three months ended December 31, 2017 of $4,843,000 increased by $1,482,000, or 44%, as compared to $3,361,000 for the three months ended December 31, 2016. Product revenues for the three months ended December 31, 2017 of $4,647,000 increased by $1,473,000, or 46%, as compared to $3,174,000 for the three months ended December 31, 2016. This increase wasaresult of strong growth in the United States, Europe, and Latin America.

Product revenues in the United States for the three months ended December 31, 2017 of $2,883,000 increased by $1,212,000, or 73%, as compared to $1,671,000 for the three months ended December 31, 2016. This increase was mostly the result of higher 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. During the three months ended December 31, 2017, we reported $772,000 of Latin America product revenue related to Invekra.  

The following table shows our 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% 

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, 2017 of $196,000 increased by $9,000, or 5%, when compared to $187,000 in the prior period. The increase in service revenues was related to an increase in our lab services business.

 

 

 

19

Gross Profit

For the three months ended December 31, 2017, we reported total revenues of $4,843,000 and total cost of revenues of $2,475,000, resulting in total gross profit of $2,368,000 or 49% of total revenues, compared to a gross profit of $1,706,000 or 51% 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, we reported product revenues of $4,647,000 and cost of product revenues of $2,308,000, resulting in product gross profit of $2,339,000, or 50% of product revenues, compared to product gross profit of $1,698,000, or 53% of product revenues, for the same period in the prior year. The decrease in gross profit, as a percent of revenue, percentage 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.

For the three months ended December 31, 2017, we reported service revenues of $196,000 and cost of service revenues of $167,000, resulting in 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.

Research and Development Expense

Research and development expenses for the three months ended December 31, 2017 of $349,000 decreased by $138,000, or 28%, as compared to $487,000 for the three months ended December 31, 2016. The decrease is largely due to a decrease in spending on product development and clinical studies.

Selling, General and Administrative Expense

Selling, general and administrative expenses for the three months ended December 31, 2017 of $5,219,000 increased by $435,000, or 9%, when compared to $4,784,000 for the three months ended December 31, 2016. The increase for the three months ended December 31, 2017 was primarily due to higher sales and marketing expenses related to our growing dermatology sales force.

Interest Expense

Interest expense for the three months ended December 31, 2017 of $11,000, increased by $11,000, when compared to the three months ended December 31, 2016. The increase in interest expense relates primarily to capital leases.

Interest Income

Interest income for the three months ended December 31, 2017 of $14,000 increased by $8,000 when compared to $6,000 for the three months ended December 31, 2016. The increase is due to interest income earned on increased cash and cash equivalent balances.

Other Income

Other income for the three months ended December 31, 2017 of $10,000 decreased by $272,000 when compared to $282,000 for the three months ended December 31, 2016. The increase in other income relates primarily to fluctuation in foreign exchange in the prior period.

Loss Income from Continuing Operations

Loss from continuing operations for the three months ended December 31, 2017 of $3,187,000 increased $3,950,000, when compared to income from continuing operations of $763,000 for the three months ended December 31, 2016. The increase in net loss from continuing operations is primarily due to $4,040,000 of income tax benefit recorded in the prior period as a result of the transaction with Invekra.

 

 

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, 2017 and 2016

Total revenues for the nine months ended December 31, 2017 of $13,003,000 increased by $4,207,000, or 48%, as compared to $8,796,000 for the nine months ended December 31, 2016. Product revenues for the nine months ended December 31, 2017 of $12,394,000 increased by $4,236,000, or 52%, as compared to $8,158,000 for the nine months ended December 31, 2016. This increase was the result of strong growth in the United States, Europe, and the Rest of the World.

Product revenues in the United States for the nine months ended December 31, 2017 of $7,010,000 increased by $2,269,000, or 48%, as compared to $4,741,000 for the nine months ended December 31, 2016. This increase was mostly the result of higher 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.

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. During the nine months ended December 31, 2017, we reported $2,095,000 of Latin America product revenue related to Invekra.

The following table shows our product revenues by geographic region:

  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 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, 2017 of $609,000 decreased by $29,000, or 5%, when compared to $638,000 in the prior period. The decrease in service revenues was related to a decrease in our lab services business.

 

 

 

 21 

 

Gross ProfitResults of Continuing Operations

 

ForComparison of the Three and Nine Months Ended December 31, 2023 and 2022

Revenue

The following table shows our consolidated total revenue and revenue by geographic region for the three and nine months ended December 31, 2017, we reported total revenues of $13,003,0002023 and total cost of revenues of $7,025,000, resulting in total gross profit of $5,978,000 or 46% of total revenues, compared to a gross profit of $3,721,000 or 42% of total revenues, for the same period in the prior year. 2022:

  

Three Months Ended

December 31,

       
(In thousands) 2023  2022  $ Change  % Change 
United States $868  $761  $107   14% 
Europe  1,217   1,104   113   10% 
Asia  522   514   8   2% 
Latin America  368   384   (16)  (4%)
Rest of the World  163   181   (18)  (10%)
Total $3,138  $2,944  $194   7% 

  

Nine Months Ended

December 31,

       
(In thousands) 2023  2022  $ Change  % Change 
United States $2,214  $2,603  $(389)  (15%)
Europe  3,488   3,117   371   12% 
Asia  1,730   1,952   (222)  (11%)
Latin America  1,165   1,827   (662)  (36%)
Rest of the World  699   759   (60)  (8%)
Total $9,296  $10,258  $(962)  (9%)

The increase in gross profit was primarily due toUnited States revenue of $107,000 for 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 ninethree months ended December 31, 2017, we reported product revenues2023 and decrease in United States revenue of $12,394,000 and cost of product revenues of $6,529,000, resulting in 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, we reported service revenues of $609,000 and cost of service revenues of $496,000, resulting in 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$389,000 for the nine months ended December 31, 20172023, were primarily the result of $1,099,000 decreased by $127,000, or 10%, as compared to $1,226,000fluctuations in over-the-counter animal health care sales.

The increase in Europe revenue for the three and nine months ended December 31, 2023 of $113,000 and $371,000, respectively, was the result of increased demand for our products.

The increase in Asia revenue for the three months ended December 31, 2023 of $8,000 and decrease of revenue in Asia of $222,000 for the nine months ended December 31, 2016. The decrease is largely2023, was primarily due to a decrease in spending on product developmenttiming of orders. Revenues from our international distributors tend to fluctuate from period to period due to customer placement of larger but less frequent orders to benefit from quantity discounts and clinical studies.reduced shipping costs.

  

Selling, General and Administrative Expense

Selling, general and administrative expensesThe decrease in Latin America revenue for the three months ended December 31, 2023 of $16,000 was primarily the result of the timing of orders from our partner in Mexico. The decrease in Latin America revenue for the nine months ended December 31, 20172023 of $14,319,000 increased by $1,762,000, or 14%, when compared$662,000 was primarily due to $12,557,000service revenue recorded from selling machinery to a customer for $750,000 in the prior period. Management expects this to be a one-time event.

The decrease in Rest of World revenue for the three and nine months ended December 31, 2016. The increase for the nine months ended December 31, 20172023 of $18,000 and $60,000, respectively, was primarily due to higher sales expenses related to our growing dermatology sales force.timing of customer orders.

 

Interest Expense

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

Interest Income

Interest income for the nine months ended December 31, 2017 of $85,000 increased by $77,000 when compared to $8,000 for the nine months ended December 31, 2016. The increase is due to interest income earned on increased cash and cash equivalent balances.

Other Income Expense, net

Other expense for the nine months ended December 31, 2017 of $179,000 increased by $455,000 when compared to other income of $276,000 for the nine months ended December 31, 2016. The increase in other expense relates primarily to fluctuation in foreign exchange.

Loss from Continuing Operations

Loss from continuing operations for the nine months ended December 31, 2017 of $9,565,000 decreased $3,825,000, when compared to income from continuing operations of $5,740,000 for the nine months ended December 31, 2016. The increase in net loss from continuing operations is primarily due to $4,040,000 of income tax benefit recorded in the prior period as a result of the transaction with Invekra.

 

 

 

 22 

Cost of Revenue and Gross Profit

The cost of revenue and gross profit metrics for the three and nine months ended December 31, 2023 and 2022 are as follows:

  

Three Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Cost of Revenues $1,678  $2,113  $(435)  (21%)
Cost of Revenue as a % of Revenues  53%   72%         
Gross Profit $1,460  $831  $629   76% 
Gross Profit as a % of Revenues  47%   28%         

  

Nine Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Cost of Revenues $5,642  $6,645  $(1,003)  (15%)
Cost of Revenue as a % of Revenues  61%   65%         
Gross Profit $3,654  $3,613  $41   1% 
Gross Profit as a % of Revenues  39%   35%         

The increase in gross profit margin of $629,000 for the three months ended December 31, 2023, as compared to the prior period, was primarily due to overall product mix, redeployment of labor to research and development projects in the current year and higher costs of materials and transportation in the prior period.

The increase in gross profit margin of $41,000 for the nine months ended December 31, 2023, as compared to the prior period, was primarily due to an increase in revenue in the current period.

Research and Development Expense

The research and development expense metrics as of December 31, 2023 and 2022 are as follows:

  

Three Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Research and Development Expense $601  $   601   100% 
Research and Development Expense as a % of Revenues  19%   0%         

  

Nine Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Research and Development Expense $1,462  $6   1,456   N/A 
Research and Development Expense as a % of Revenues  16%   0%         

Increases in research and development expenses for the three and nine months ended December 31, 2023 of $601,000 and $1,456,000, respectively, were due to increased product development and expanded regulatory efforts in the U.S. and Europe to support new product releases.

23

Selling, General and Administrative Expense

The selling, general and administrative expense metrics are as of December 31, 2023 and 2022 are as follows:

  

Three Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Selling, General and Administrative Expense $1,703  $2,665  $(962)  (36%)
Selling, General and Administrative Expense as a % of Revenues  54%   91%         

  

Nine Months Ended

December 31,

       
(In thousands, except for percentages) 2023  2022  Change  % Change 
Selling, General and Administrative Expense $5,484  $7,030  $(1,546)  (22%) 
Selling, General and Administrative Expense as a % of Revenues  59%   69%         

The decline in selling, general and administrative expense for the three and nine months ended December 31, 2023 of $962,000 and $1,546,000, respectively, was the result of ongoing efforts to contain expenses across all parts of the company.

Other Expense, net

Other expense, net for the three and nine months ended December 31, 2023 was $79,000 and $380,000, respectively, compared to $71,000 and $322,000, respectively, for the three and nine months ended December 31, 2022. The changes in other expense, net primarily relate to exchange rate fluctuations.

 

Income from Discontinued Operations, net of Taxtax benefit (expense)

Income tax benefit (expense) for the three and nine months ended December 31, 2023 was $57,000 and ($96,000), respectively. Income tax expense for the three and nine months ended December 31, 2022 was ($34,000) and ($98,000), respectively.

Net Loss

 

The following summarizes operationstable provides the net loss for each period along with the computation of our Latin American business included in discontinued operations:basic and diluted net loss per share: 

 

  

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 
             
  Three Months Ended December 31,  Nine Months Ended December 31, 
(In thousands, except per share data) 2023  2022  2023  2022 
Numerator:            
Net loss $(866) $(1,939) $(3,768) $(3,843)
                 
Denominator:                
Weighted-average number of common shares outstanding: basic and diluted  10,909   3,107   7,011   3,104 
                 
Net loss per share: basic and diluted $(0.08) $(0.62) $(0.54) $(1.24)

24

 

Liquidity and Capital Resources

 

We reported a net loss of $9,565,000$866,000 and $1,939,000 for the three months ended December 31, 2023 and 2022, respectively, and $3,768,000 and $3,843,000 for the nine months ended December 31, 2017.2023 and 2022, respectively. At December 31, 20172023 and March 31, 2017,2023, our accumulated deficit amounted to $152,677,000$193,282,000 and $143,101,000,$189,514,000, respectively. We had working capital of $12,279,000 and $19,355,000 asAs of December 31, 20172023, we had cash and Marchcash equivalents of $2,406,000 compared to $2,634,000 on December 31, 2017, respectively.2022. 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, royalty payments from licensing our products, as well as various loans and the sale of certain assets to Invekra, Petagon, and Microsafe.

On October 26, 2023, we entered into a placement agency agreement with Maxim Group LLC (“Maxim”), pursuant to which Maxim agreed to use its reasonable best efforts to solicit offers to purchase up to an aggregate of 8,500,000 shares of our common stock, par value $0.0001 per share.  We agreed to pay Maxim a cash fee equal to 8.0% of the gross proceeds from the offering, plus reimbursement of up to $75,000 of legal fees and other expenses. Additionally, on October 26, 2023, we entered into a securities purchase agreement with the purchasers party thereto for the sale and issuance of an aggregate of up to 8,500,000 shares of our common stock at a public offering price of $0.20 per share.

The closing of the offering occurred on October 30, 2023.  In connection with the offering, we sold 8,500,000 shares of the our common stock for aggregate gross proceeds of $1,700,000 and net proceeds of $1,446,000, after deducting placement agent fees and other offering expenses.

On December 15, 2023, we entered into an Equity Distribution Agreement (the “Agreement”), with Maxim Group LLC (“Maxim”), pursuant to which we may offer and sell, from time to time, through Maxim, as sales agent or principal, shares of our common stock, $0.0001 par value per share.

Subject to the terms and conditions of the Agreement, Maxim will use commercially reasonable efforts consistent with its normal trading and sales practices, applicable state and federal law, rules and regulations and the rules of the Nasdaq Capital Market to sell shares from time to time based upon our instructions, including any price, time or size limits specified by us. Under the Agreement, Maxim may sell shares by any method deemed to be an “at the market” offering as defined in Rule 415 under the U.S. Securities Act of 1933, as amended, or any other method permitted by law, including in privately negotiated transactions. Maxim’s obligations to sell shares under the Agreement are subject to satisfaction of certain conditions, including customary closing conditions for transactions of this nature. We will pay Maxim a commission of 3% of the aggregate gross proceeds from each sale of shares and we have agreed to provide Maxim with customary indemnification and contribution rights. We also agreed to reimburse Maxim for certain specified expenses of up to $20,000. On January 11, 2024, we sold 1,923,100 shares of our common stock for gross proceeds of approximately $392,000 and net proceeds of approximately $356,000.

The following table presents a summary of our consolidated cash flows for operating, investing and financing activities for the nine months ended December 31, 2023 and 2022, as well as balances of cash and cash equivalents and working capital:

  Nine Months Ended December 31, 
(In thousands) 2023  2022 
Net cash used in:        
Operating activities $(2,550) $(3,711)
Investing activities  (20)  (176)
Financing activities  1,054   (883)
Effect of exchange rates on cash  102   8 
Net change in cash and cash equivalents  (1,414)  (4,762)
Cash and cash equivalents, beginning of the period  3,820   7,396 
Cash and cash equivalents, end of the period $2,406  $2,634 
Working capital (1), end of period $9,428  $7,298 

(1)Defined as current assets minus current liabilities

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Net cash used in operating activities during the nine months ended December 31, 2023 was $2,550,000, primarily due to a net loss of $3,768,000, an increase in accounts receivables of $221,000, and an increase in inventory of $93,000, offset by stock compensation of $447,000 and an increase in prepaid expenses of $546,000.

Net cash used in operating activities during the nine months ended December 31, 2022 was $3,711,000, primarily due to a net loss of $3,843,000, and a decrease in deferred revenue of $1,204,000, offset by $569,000 of stock based compensation. 

Net cash used in investing activities was $20,000 for the nine months ended December 31, 2023, primarily related to purchases of equipment.

Net cash used in investing activities was $176,000 for the nine months ended December 31, 2022, primarily related to long term deposits and purchases of equipment.

Net cash provided by financing activities was $1,054,000 for the nine months ended December 31, 2023, primarily due to the sale of common stock for net proceeds of $1,446,000 offset by principal payments on short-term debt of $387,000.

Net cash used in financing activities was $883,000 for the nine months ended December 31, 2022, primarily due to principal payments on short-term debt of $674,000 and payments of PPP loan of $120,000. 

We expect revenues to continue incurringfluctuate and may incur losses forin the foreseeable future and may need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our products and 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 assurance 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 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.

 

SourcesMaterial Trends and Uncertainties

We rely on certain key customers for a significant portion of Liquidityour revenues. A small number of customers may represent a significant portion of our total revenues in any given period. These customers may not consistently purchase our products at a particular rate over any subsequent period.

We are exposed to risk from decline in foreign currency for both the Euro and the Mexico Peso versus the U.S. dollar. Most recently there has been a sharp decline in the Euro versus the U.S. dollar which has impacted our financial results.

 

As we have previously discussed in our annual report on Form 10-K filed with the SEC on June 21, 2023, we face a substantial Mexico tax liability, intercompany debt, unpaid technical assistance charges and accrued interest. These amounts are not due until 2027. At this time, management believes there are sufficient assets on the balance sheet to more than cover any tax obligation without interrupting our operations or business. We have engaged tax professionals to review all options to limit our exposure to these amounts and to proceed in a manner that is most advantageous to us.

The effects of December 31, 2017,the recent pandemic continue to impact economies worldwide, and we had cashare closely watching inflation, increased volatility within financial markets, shipping costs, supply chain issues and cash equivalents of $8,625,000. Sincelabor costs. Any impact to our inception, substantially allbusiness operations, customer demand and supply chain due to increased shipping costs may ultimately impact sales. We continue to evaluate our end-to-end supply chain and assess opportunities to refine the impact on sales. Currently, most of our operationscustomers pay for shipping expenses, including increased shipping costs, if any. We have been financed through sales of equity securities. Other sources of financing thatnot yet faced labor shortages however it is possible we may have used to date includedifficulties retaining and finding qualified employees in a tight labor market in the future. Furthermore, overall inflation tendencies may put pressure on our revenues, as well as various loansproduct pricing and/or costs.

We also closely monitor overall economic conditions, consumer sentiment and the saleprospect of certain Latin American assets to Invekra.

Since January 1, 2016, substantially all ofa recession in the United States which may impact 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 received from the sale of common stock through our At the Market Issuance Sales Agreement dated April 2, 2014;
·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 received from the sale of common stock through our At the Market Issuance Sales Agreement dated December 8, 2017.

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.financial results.

 

 

 

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Cash Flows

As of December 31, 2017, we had cash and cash equivalents of $8,625,000, compared to $17,461,000 as of March 31, 2017.

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 operating activities during the nine months ended December 31, 2016 was $5,472,000, 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 sale of our Latin American assets to, net of tax, of $14,906,000 and the income tax benefit realized of $4,040,000.

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

Net provided by investing activities was $17,232,000 for the nine months ended December 31, 2016, consisting of primarily proceeds from the sale of our Latin American Assets, net of costs, of $17,444,000, offset by $195,000 related to equipment purchases and $17,000 related to changes in long-term assets.

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 Capital 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.

We expect to continue incurring losses for the foreseeable future and may need to raise additional capital to pursue our product development initiatives, to penetrate markets for the sale of our products and 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 assurance 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 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 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:

·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.

24

 

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, valuation of equity and derivative instruments, debt discounts, 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.our most recent fiscal quarter. Based upon this evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures were not effective as of December 31, 2017.2023 due to the fact that material weaknesses in our internal controls over financial reporting exist at period end.

Notwithstanding our ineffective disclosure controls and procedures, management believes the consolidated financial statements included in this Quarterly Report on Form 10-Q present fairly, in all material respects, our financial condition, results of operations and cash flows at and for the periods presented in accordance with U.S. generally accepted accounting principles.

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Management’s Remediation Measures

Our management is responsible for establishing and maintaining adequate internal control over financial reporting, as such term is defined in the Exchange Act Rule 13a-15(f) and 15d-15(f). Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an evaluation of the effectiveness of our internal control over financial reporting based on the framework in the 2013 Internal Control — Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission. Based on our evaluation, our management concluded that our internal control over financial reporting was not effective as of December 31, 2023. We have determined that there were inadequate spreadsheet controls, a lack of separation of duties with preparation and review of the reported numbers, and inadequate analysis of revenue reporting among other things. We believe we have taken steps to correct this, but the controls have not been tested and have not been working for a sufficient period of time to remove this weakness.

Management, with oversight from the Audit Committee of our Board of Directors, is actively engaged in remediation efforts to address the material weaknesses identified in the management’s evaluation of internal controls and procedures. Management has taken a number of actions to remediate the material weaknesses described above, including the following:

·Improved monitoring and risk assessment activities to address these control deficiencies.
·Hired an interim Chief Financial Officer in April 2023 and a Controller in July 2023.
·Separated the preparation of the financial reports from review of the financial reports.
·Implemented additional process-level controls over revenue recognition of new contracts.
·Developed and delivered further internal controls training to individuals associated with these control deficiencies and enhanced training provided to all personnel who have financial reporting or internal control responsibilities in these areas. The training includes a review of individual roles and responsibilities related to internal controls, proper oversight and reemphasizes the importance of completing the control procedures.
·Did a detailed review of income taxes and our intercompany agreements which uncovered the fact that we should be accruing withholding taxes that will be paid to Mexico when intercompany interest and technical assistance payments are made to Mexico from the United States and that we will not be eligible for a tax credit in the United States because of our net operating loss positions.

These improvements are targeted at strengthening our internal control over financial reporting and remediating the material weaknesses. We remain committed to an effective internal control environment, and management believes that these actions and the improvements management expects to achieve as a result will effectively remediate the material weaknesses. However, the material weaknesses in our internal control over financial reporting will not be considered remediated until the controls operate for a sufficient period of time and management has concluded, through testing that these controls operate effectively. As of the date of filing this Quarterly Report on Form 10-Q, management is in the process of testing and evaluating these additional controls to determine whether they are operating effectively. We have hired appropriate accounting staff to establish effective internal controls and processes.

 

Changes in Internal Control over Financial Reporting

 

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 quarterthree months ended December 31, 20172023 that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. We have not finished testing our controls and sufficient time has not elapsed to make the determination these controls are operating effectively.

 

 

 

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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

 

ThereOther than the risks set forth below, 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, 2017,2023, as filed with the SEC on June 28, 2017.21, 2023.

 

Our failure to maintain compliance with Nasdaq’s continued listing requirements could result in the delisting of our common stock.

On September 22, 2023, we received a letter from The newly enacted Tax Cuts and Jobs Act may affect our financial results, including our net deferred tax asset, andNasdaq Stock Market LLC (“Nasdaq”) indicating that we are not in compliance with Nasdaq Listing Rule 5550(a)(2), which requires companies listed on The Nasdaq Stock Market to maintain a minimum bid price of $1 per share for continued listing. Nasdaq’s letter has no immediate impact on the processlisting of evaluating its effects.our common stock, which will continue to be listed and traded on Nasdaq, subject to our compliance with the other continued listing requirements. Nasdaq has granted us a period of 180 calendar days, or until March 20, 2024, to regain compliance with the rule. We may regain compliance at any time during this compliance period if the minimum bid price for our common stock is at least $1 for a minimum of ten consecutive business days.

 

On December 22, 2017, the Tax Cuts 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 ofUntil Nasdaq has reached a territorial tax system, affecting the deductibility of capital expenditures, assessing a one-time transition tax on earnings of certain foreign subsidiariesfinal determination that were previously tax deferred, and the creation of 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 subject to potential amendments and technical corrections, any of which could lessen or increase certain adverse impactswe have regained compliance with all of the legislation. We are in the process of determining what, if any, effect those provisions will have on our financial results, andapplicable continued listing requirements, there can be no assurance of whether such additional effects will be positive or negative.

A significant portionassurances regarding the continued listing of our earnings are earned bycommon stock or warrants on Nasdaq. The delisting of our subsidiaries outside the U.S. Changes to the taxation of certain foreign earnings resultingcommon stock and warrants from the newly enacted Tax Cuts and Jobs Act, along with the state tax impact of these changes and potential future cash distributions, mayNasdaq would have ana material adverse effect on our effective tax rate. Furthermore, changesaccess to the taxation of undistributed foreign earnings could change our future intentions regarding reinvestment of such earnings. The foregoing items could have a material effectcapital markets, and any limitation on our business, cash flow, results of operationsmarket liquidity or financial conditions.

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 earningsreduction in the United States. Asprice of its common stock as a result of the reduction in the corporate income tax rate, we are requiredthat delisting would adversely affect our ability to revalue our net deferred tax assetraise capital on terms acceptable 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.us, if at all.

 

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

 

OnWe did not issue any unregistered 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, 2023 and through February 8, 2024.

 

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.

26

Item 3.Default Upon Senior Securities

 

We did not default upon any senior securities during the quarter ended December 31, 2017.2023.

 

Item 4.Mine Safety Disclosures

 

Not applicable.

 

Item 5.Other Information

 

On January 2, 2018, we granted discretionary stock bonuses to all directors of the Company, including our 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,Effective February 7, 2024, our Board of Directors awarded an additional stockappointed Jerome Dvonch as our Chief Financial Officer. Prior to this appointment, Mr. Dvonch has served as our interim Chief Financial Officer since April 7, 2023.

Mr. Dvonch will be employed at-will on a full-time basis. We agreed to compensate Mr. Dvonch $240,000 per year. Mr. Dvonch is eligible for a bonus up to 50% of $50,000 or 8,606 shareshis annual salary, prorated the first year based on a fiscal year end of common stock subjectMarch 31 and dependent upon meeting specified performance goals. He is also eligible for equity grants within the normal employee equity programs and for benefits, such as vacation, and our medical, dental, vision and retirement plans.

The foregoing description is not complete and is qualified in its entirety by reference to the same conditionsfull text of the offer letter to Mr. Dvonch, a copy of which is filed herewith as Exhibit 10.41 to this Quarterly Report on Form 10-Q and incorporated herein by reference.

Also on February 7, 2024, we entered into a new offer letter with our long-standing director Jay BirnbaumController, John Dal Poggetto, pursuant to which Mr. Dal Poggetto will be employed at-will on a full-time basis. We agreed to compensate Mr. Dal Poggetto $200,000 per year. Mr. Dal Poggetto is eligible for a bonus up to 20% of his 10 yearsannual salary, prorated the first year based on a fiscal year end of servicesMarch 31 and longevity ondependent upon meeting specified performance goals. He is also eligible for equity grants within the normal employee equity programs and for benefits, such as vacation, and our Board. medical, dental, vision and retirement plans.

The stock awards include a 40% tax gross up paidforegoing description is not complete and is qualified in cash or approximately $160,000its entirety by reference to the directorsfull text of the offer letter to Mr. Dal Poggetto, a copy of which is filed herewith as Exhibit 10.42 to this Quarterly Report on Form 10-Q and $40,000 to the Chief Executive Officer.incorporated herein by reference. 

 

29

Item 6.Exhibits

 

Exhibit Index

Exhibit No.Description
3.1Restated Certificate of Incorporation of Oculus Innovative Sciences, Inc., effective January 30, 2006(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 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 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 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 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 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 as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed December 7, 2016, and incorporated herein by reference).
3.83.9Amended and Restated Bylaws, as amended, of Sonoma Pharmaceuticals, Inc., effective December 6, 2016(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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3.93.10Certificate 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 as Exhibitexhibit 4.2 to the Company’s Current Report on Form 8-K, filed April 25, 2012, and incorporated herein by reference).
3.103.11Certificate of Designation of Series B Preferred Stock, effective October 18, 2016(included as Exhibitexhibit 3.1 to the Company’s Current Report on Form 8-K filed October 21, 2016, and incorporated herein by references).
4.13.12Certificate of Amendment of Restated Certificate of Incorporation of Sonoma Pharmaceuticals, Inc., as amended, effective June 19, 2019(included as exhibit 3.1 to the Company’s Current Report on Form 8-K filed June 19, 2019, and incorporated herein by reference).
4.1Specimen Common Stock Certificate(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 as Exhibit 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 as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.8Underwriters Warrant issued to Maxim Partners LLC on January 26, 2015(included as Exhibit 4.2 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.9Underwriters Warrant issued to Robert D. Keyser, Jr. on January 26, 2015(included as Exhibit 4.3 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.10Underwriters Warrant issued to R. Douglas Armstrong on January 26, 2015(included as Exhibit 4.4 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.11Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015(included as Exhibit 4.5 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.12Underwriters Warrant issued to Dawson James Securities, Inc. on January 26, 2015(included as Exhibit 4.6 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
4.13Warrant 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 as Exhibit 4.1 to the Company’s Current Report on Form 8-K filed March 18, 2016, and incorporated herein by reference).
4.14Form of Warrant issued to Dawson James Securities, Inc. on March 31, 2016(included as Exhibit 4.25 to the Company’s Annual Report on Form 10-K filed June 21, 2016, and incorporated herein by reference).
4.15Section 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 as Exhibitexhibit 4.1 to the Company’s Current Report on Form 8-K filed October 21, 2016, and incorporated herein by reference).
10.14.3Form 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).
4.4Form of Placement Agent Warrant granted to Dawson James Securities, Inc. in connection with the November 2019 public offering(included as exhibit 4.1 to the Company’s Current Report on Form 8-K filed on November 29, 2019, and incorporated herein by reference).
10.1Form of Indemnification Agreement between Oculus Innovative Sciences, Inc. and its officers and directors(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 as Exhibit 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 as Exhibit 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 as Exhibit 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 as Exhibit 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(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).
10.710.3Office Lease Agreement, dated July 2003, between Oculus Innovative Sciences, B.V. and Artikona Holding B.V. (translated from Dutch)(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).

10.830

10.4Form of Director Agreement(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).
10.910.5Amended and Restated Oculus Innovative Sciences, Inc. 2006 Stock Incentive Plan and related form stock option plan agreements(included as Exhibitexhibit 10.2 to the Company’s Current Report on Form 8-K filed May 2, 2007, and incorporated herein by reference).
10.1010.6Amendment No. 4 to Office Lease Agreement, dated September 13, 2007, by and between Oculus Innovative Sciences, Inc. and RNM Lakeville L.P.(included as Exhibit 10.43 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).
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 as Exhibitexhibit 10.44 to the Company’s Annual Report on Form 10-K filed June 13, 2008, and incorporated herein by reference).
10.1210.7Amendment No. 5 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and RNM Lakeville, LLC, dated May 18, 2009(included as Exhibit 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 as Exhibit 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 as Exhibitexhibit A in the Company’s Definitive Proxy Statement on Schedule 14A filed July 29, 2011, and incorporated herein by reference).
10.1510.8†Amendment No. 7 to Office Lease Agreement by and between Oculus Innovative Sciences, Inc. and 1125-1137 North McDowell, LLC, dated October 10, 2012(included as Exhibit 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 as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed April 2, 2014, and incorporated herein by reference).
10.18Lease Agreement by and between Oculus Innovative Sciences, Inc. and 2500 York, L.P., dated July 9, 2014(included as Exhibit 10.82 to the Company’s Quarterly Report on Form 10-Q filed August 12, 2014, and incorporated herein by reference).
10.19Underwriting 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 as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed January 26, 2015, and incorporated herein by reference).
10.20†Sales Representation Contract, dated February 1, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc.(included as Exhibit 10.1 to the Company’s Current Report on Form 8-K filed March 2, 2015, and incorporated herein by reference).
10.21†Amendment No. 1 to Sales Representation Contract, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and SLA Brands, Inc.(included as Exhibit 10.88 to the Company’s Quarterly Report on Form 10-Q filed February 16, 2016, and incorporated herein by reference).
10.22Underwriting 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 as Exhibit 1.1 to the Company’s Current Report on Form 8-K filed March 18, 2016, and incorporated herein by reference).
10.23†Exclusive Sales and Distribution Agreement, dated November 6, 2015, by and between Oculus Innovative Sciences, Inc. and Manna Pro Products, LLC(included as Exhibitexhibit 10.1 to the Company’s Current Report on Form 8-K filed March 23, 2016 and incorporated herein by reference).
10.2410.9†Employment Agreement by and between Oculus Innovative Sciences, Inc. and Jim Schutz, dated July 26, 2016(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†Asset Purchase Agreement dated October 27, 2016, between Oculus Innovative Sciences, Inc. and Invekra, S.A.P.I de C.V.(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†10.10†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 as Exhibit 10.2 to the Company’s Current Report on Form 8-K filed October 31, 2016, and incorporated herein by reference).
10.2710.11Employment2016 Equity Incentive Plan(included as exhibit A in the Company’s Definitive Proxy Statement on Schedule 14A filed July 29, 2016, and incorporated herein by reference).
10.12Securities Purchase Agreement entered into by and between Oculus Innovative Sciences,Sonoma Pharmaceuticals, Inc. and Robert Miller,Montreux Equity Partners V, L.P., dated November 30, 2016March 1, 2018(included as Exhibitexhibit 10.2 to the Company’s Current Report on Form 8-K filed on March 6, 2018, and incorporated herein by reference).
10.13†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 December 1, 2016,on June 5, 2018, and incorporated herein by reference).
10.2810.14EmploymentWarrant Agency Agreement entered into by and between Oculus Innovative Sciences,among Sonoma Pharmaceuticals, Inc., Computershare, Inc. and Bruce Thornton,Computershare Trust Company, N.A., dated November 30, 201621, 2018(included as Exhibitexhibit 10.2 to the Company’s Current Report on Form 8-K filed December 1, 2016,on November 21, 2018, and incorporated herein by reference).
10.2910.15⸸+EmploymentAsset Purchase Agreement by anddated May 14, 2019, between Oculus Innovative Sciences,Sonoma Pharmaceuticals, Inc. and Robert Northey, dated November 30, 2016Petagon, Ltd.(included as Exhibit 10.3exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 1, 2016,on May 22, 2019, and incorporated herein by reference).
10.3010.16⸸+EmploymentAsset Purchase Agreement by anddated February 21, 2020, between Oculus Innovative Sciences,Sonoma Pharmaceuticals, Inc. and Jeffrey Day, dated November 30, 2016MicroSafe Group, DMCC(included as Exhibit 10.4exhibit 10.1 to the Company’s Current Report on Form 8-K filed December 1, 2016,on February 27, 2020, and incorporated herein by reference).reference.)
10.3110.17⸸+EmploymentLicense, Distribution and Supply Agreement by and between Sonoma Pharmaceuticals, Inc. and Marc Umscheid,Brill International, S.L. dated December 31, 2016May 19, 2020(included as Exhibit 10.97exhibit 10.1 to the Company’s QuarterlyCurrent Report on Form 8-K filed on May 26, 2020, and incorporated herein by reference.)
10.18Consulting Agreement between the Company and Dr. Robert Northey, dated May 30, 2020.(included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on June 4, 2020, and incorporated herein by reference.)
10.19⸸+Asset Purchase Agreement between the Company and Infinity Labs SD, Inc., dated June 24, 2020(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on June 30, 2020, and incorporated herein by reference.)
10.20Boulder Lease Agreement between the Company and Westland Development Services, Inc., dated February 19, 2021. (included as exhibit 10.20 to the Company’s Current Report on Form 10-Q filed February 17, 2017,on November 13, 2023, and incorporated by herein by reference.)
10.21⸸Licensing Agreement between Sonoma Pharmaceuticals, Inc. and MicroSafe Group, effective July 27, 2020(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on August 6, 2020, and incorporated herein by reference).
10.3210.22⸸Master VendorLicensing and Distribution Agreement between Sonoma Pharmaceuticals, Inc. and Gabriel Science, LLC, effective December 14, 2020(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 17, 2020, and incorporated herein by reference).
10.23⸸Exclusive Supply and Distribution Agreement between the Company and EMC Pharma, LLC, dated March 26, 2021(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on March 31, 2021, and incorporated herein by reference).
10.24Amended and Restated Employment Agreement by and between the Company and Amy Trombly, dated June 16, 2023(included as exhibit 10.38 to the Company’s Current Report on Form 10-K filed on June 21, 2023, and incorporated herein by reference).
10.25Amended and Restated Employment Agreement by and between the Company and Bruce Thornton, dated June 16, 2023(included as exhibit 10.39 to the Company’s Current Report on Form 8-K filed on June 21, 2023, and incorporated herein by reference).
10.26At-The-Market Offering Agreement, by and between the Company and H.C. Wainwright & Co., LLC, dated July 30, 2021(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 30, 2021, and incorporated herein by reference).
10.272021 Equity Incentive Plan(included as appendix on the Company’s proxy statement filed on July 29, 2021 and incorporated herein by reference).

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10.28+⸸Exclusive License and Distribution Agreement between the Company and Dyamed Biotech Pte Ltd., dated November 4, 2021 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on November 9, 2021, and incorporated herein by reference).
10.29+⸸Non-Exclusive Distribution and Supply Agreement between the Company and Salus Medical, LLC dated January 19, 2022 (included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on January 20, 2022, and incorporated herein by reference).
10.30+⸸Exclusive License and Distribution Agreement between Sonoma Pharmaceuticals, Inc. and Anlicare International dated January 18, 2022 (included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on January 20, 2022, and incorporated herein by reference).
10.31At-The-Market Offering Agreement, by and between the Company and Ladenburg Thalmann & Co. Inc., dated December 23, 2022(included as exhibit 1.1 to the Company’s Current Report on Form 8-K filed on December 23, 2022, and incorporated herein by reference).
10.32Sonoma Pharmaceuticals, Inc. Non-Employee Director Compensation Program and Stock Ownership Guidelines, revised by the Board of Directors on December 29, 2022(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 30, 2022, and incorporated herein by reference).
10.33+⸸Exclusive Distribution and Supply Agreement, dated January 26, 2023, by and between Sonoma Pharmaceuticals, Inc. and PetSmart Home Office, Inc.Daewoong Pharmaceutical Co., dated November 21, 2016Ltd.(included as Exhibit 10.32exhibit 10.1 to the Company’s AnnualCurrent Report on Form 10-K8-K filed on June 28, 2017,January 31, 2023, and incorporated herein by reference).
10.3310.34Amendment to At-The-Market Offering Agreement, by and between the Company and Ladenburg Thalmann & Co. Inc., dated February 24, 2023(included as exhibit 1.1 to the Company’s Current Report on Form 8-K filed on February 24, 2023, and incorporated herein by reference).
10.35Consulting Agreement, by and between the Company and Jerome Dvonch, dated April 7, 2023(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on April 13, 2023, and incorporated herein by reference).
10.36Offer letter to John Dal Poggetto dated July 11, 2023(included as exhibit 10.1 to the Company’s Current Report on Form 8-K filed on July 14, 2023, and incorporated herein by reference).
10.37Consulting Agreement, by and between the Company and Jerome Dvonch Consulting, LLC, effective August 15, 2023(included as exhibit 10.2 to the Company’s Current Report on Form 8-K filed on July 14, 2023, and incorporated herein by reference).
10.38First Amendment to the Lease between the Company and Westland Development Services, Inc, dated June 21, 2023.
10.39Equity Distribution Agreement, by and between Sonoma Pharmaceuticals, Inc. and G. Pohl-Boskamp GmbH & Co. KG,Maxim Group LLC., dated April 13, 2016December 15, 2023(included (included as Exhibit 10.33exhibit 1.1 to the Company’s AnnualCurrent Report on Form 10-K8-K filed on June 28, 2017,December 15, 2023, and incorporated herein by reference).
10.3410.40⸸+Amendment No. 8 to Office Lease Agreement by the between Oculus Innovative Sciences, Inc.License and SSCOP Properties LLC, dated June 23, 2016(included as Exhibit 10.34 to the Company’s Annual Report on Form 10-K on June 28, 2017, and incorporated herein by reference).
10.35At Market Issuance SalesDistribution Agreement, dated December 8, 2017,January 5, 2024, by and between Sonoma Pharmaceuticals, Inc. and B. Riley FBR,NovaBay Pharmaceuticals, Inc. (included as Exhibitexhibit 10.1 to the Company’s Current Report on Form 8-K filed on December 8, 2017,January 9, 2024, and incorporated herein by reference).
14.110.41*Offer letter to Jerome Dvonch dated February 7, 2024.
10.42*Offer letter to John Dal Poggetto dated February 7, 2024.
14.1Code of Business Conduct(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*21.1List of Subsidiaries(included as Exhibit 21.1 to the Company’s Annual Report on Form 10-K on June 28, 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*101.INSInline XBRL Instance Document.Document (the instance document does not appear in the Interactive Data File because its XBRL tags are embedded within the Inline XBRL document)
101.SCH*101.SCHInline XBRL Taxonomy Extension Schema.Schema Document
101.CAL*101.CALInline XBRL Taxonomy Extension Calculation Linkbase.Linkbase Document
101.DEF*101.DEFInline XBRL Taxonomy Extension Definition Linkbase.Linkbase Document
101.LAB*101.LABInline XBRL Taxonomy Extension Label Linkbase.Linkbase Document
101.PRE*101.PREInline XBRL Taxonomy Extension Presentation Linkbase.Linkbase Document
104Cover Page Interactive Data File (formatted in inline XBRL, and included in exhibit 101).

 

*Filed herewith.
Confidential treatment has been granted with respect to certain portions of this agreement.
Certain portions of the exhibit have been omitted to preserve the confidentiality of such information. The Company will furnish copies of any such information to the SEC upon request.
+The schedules to the exhibit have been omitted from this filing pursuant to Item 601(a)(5) of Regulation S-K.  The Company will furnish copies of any such schedules to the SEC upon request.

 

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.

5445 Conestoga Court, Suite 150, Boulder, Colorado 80301.

 

 

 

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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.

 

Date: February 8, 2024SONOMA PHARMACEUTICALS, INC.By:/s/ Amy Trombly

Amy Trombly

President and Chief Executive Officer, (Principal Executive Officer)

   
Date: February 14, 20188, 2024By:/s/ Jim SchutzJerome Dvonch
  Jim SchutzJerome Dvonch
  Chief ExecutiveFinancial Officer
  

(Principal ExecutiveFinancial and

Principal Accounting Officer)

 
Date: February 14, 2018By:/s/ Robert Miller
Robert Miller
Chief Financial Officer
(Principal Financial Officer and Principal Accounting Officer)

 

 

 

 

 

 

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