Company Quick10K Filing
Quick10K
Uluru
10-Q 2018-09-30 Quarter: 2018-09-30
10-Q 2018-06-30 Quarter: 2018-06-30
10-Q 2018-03-31 Quarter: 2018-03-31
10-K 2018-03-29 Annual: 2018-03-29
10-Q 2017-09-30 Quarter: 2017-09-30
10-Q 2017-06-30 Quarter: 2017-06-30
10-Q 2017-03-31 Quarter: 2017-03-31
10-K 2016-12-31 Annual: 2016-12-31
10-Q 2016-09-30 Quarter: 2016-09-30
10-Q 2016-06-30 Quarter: 2016-06-30
10-Q 2016-03-31 Quarter: 2016-03-31
10-K 2015-12-31 Annual: 2015-12-31
10-Q 2015-09-30 Quarter: 2015-09-30
10-Q 2015-06-30 Quarter: 2015-06-30
10-Q 2015-03-31 Quarter: 2015-03-31
10-K 2014-12-31 Annual: 2014-12-31
10-Q 2014-09-30 Quarter: 2014-09-30
10-Q 2014-06-30 Quarter: 2014-06-30
10-Q 2014-03-31 Quarter: 2014-03-31
10-K 2013-12-31 Annual: 2013-12-31
8-K 2019-02-05 Other Events, Exhibits
8-K 2018-12-07 Officers
8-K 2018-06-12 Shareholder Vote
8-K 2018-04-26 Accountant, Exhibits
DBA Invesco DB Agriculture Fund 412
HGEN Humanigen 99
VINO Algodon 39
NMUS Nemus Bioscience 38
ROII ROI Land Investments 4
BOXS Boxscore Brands 2
CDTI CDTI Advanced Materials 2
MAGAA Magna Lab 0
SCY Scandium International Mining 0
NHMD Nate's Food 0
ULU 2018-09-30
Part I - Financial Information
Item 1. Financial Statements.
Note 1. Company Overview and Basis of Presentation
Note 2. The Effect of Recently Issued Accounting Standards
Note 3. Significant Accounting Policies
Note 4. Segment Information
Note 5. Inventory
Note 6. Property, Equipment and Leasehold Improvements
Note 7. Intangible Assets
Note 8. Accrued Liabilities
Note 9. Convertible Note Payable - Related Party
Note 10. Equity Transactions
Note 11. Stockholders' Equity
Note 12. Earnings per Share
Note 13. Share Based Compensation
Note 14. Fair Value Measurements
Note 15. Income Taxes
Note 16. Commitments and Contingencies
Note 17. Legal Proceedings
Note 18. Subsequent Events
Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
Item 4. Controls and Procedures.
Part II - Other Information
Item 1. Legal Proceedings.
Item 1A. Risk Factors.
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.
Item 3. Defaults Upon Senior Securities.
Item 4. Mine Safety Disclosures.
Item 5. Other Information.
Item 6. Exhibits.
EX-31.1 ex_31-1.htm
EX-31.2 ex_31-2.htm
EX-32.1 ex_32-1.htm
EX-32.2 ex_32-2.htm

Uluru Earnings 2018-09-30

ULU 10Q Quarterly Report

Balance SheetIncome StatementCash Flow

10-Q 1 10q_093018.htm ULURU INC. FORM 10-Q 09/30/2018


UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549

FORM 10-Q

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


For the quarterly period ended: September 30, 2018

OR

[_] Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934.


For the transition period from: ___ to ___.

Commission File Number: 001-336180

ULURU Inc.
(Exact Name of Registrant as Specified in its Charter)

Nevada
41-2118656
(State or Other Jurisdiction of
(I.R.S. Employer Identification No.)
Incorporation or Organization)
 

4410 Beltway Drive
Addison, Texas
75001
(Address of Principal Executive Offices)
(Zip Code) 

(214) 905-5145
Registrant's Telephone Number, including Area Code

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

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

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

Large accelerated filer
 
 
Accelerated filer
 
Non-accelerated filer
 
 
Smaller reporting company
 
 
       
Emerging growth company
 

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 7(a)(2)(B) of the Securities Act. 

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

As of November 14, 2018, there were 201,349,431 shares of the registrant's Common Stock, $0.001 par value per share ("Common Stock"), nil shares of Series A Preferred Stock, $0.001 par value per share, issued and outstanding, and nil shares of Series B Preferred Stock, $0.001 par value per share, issued and outstanding.



ULURU Inc.

INDEX TO FORM 10-Q

For the Three and Nine Months Ended SEPTEMBER 30, 2018

   
Page
 
     
     
 
 
 
 
     
     
     
     
 
     
     
     
     
     
     
     
     
 
     
     

 
PART I – FINANCIAL INFORMATION


ITEM 1.
Financial Statements.


ULURU Inc.
CONDENSED CONSOLIDATED BALANCE SHEETS

   
September 30, 2018
   
December 31, 2017
 
   
(Unaudited)
       
ASSETS
           
Current Assets
           
Cash and cash equivalents
 
$
2,813,043
   
$
3,710,882
 
Accounts receivable, net
   
172,593
     
256,123
 
Inventory
   
422,425
     
497,461
 
Prepaid expenses and deferred charges
   
133,712
     
170,686
 
Total Current Assets
   
3,541,773
     
4,635,152
 
                 
Property, Equipment and Leasehold Improvements, net
   
37,282
     
53,723
 
                 
Other Assets
               
Intangible asset - patents, net
   
152,030
     
179,737
 
Intangible asset - licensing rights, net
   
3,345,264
     
3,656,636
 
Deposits
   
4,666
     
18,069
 
Total Other Assets
   
3,501,960
     
3,854,442
 
                 
TOTAL ASSETS
 
$
7,081,015
   
$
8,543,317
 
                 
LIABILITIES AND STOCKHOLDERS' EQUITY
         
Current Liabilities
               
Accounts payable
 
$
1,167,976
   
$
1,213,246
 
Accrued liabilities
   
165,050
     
163,969
 
Accrued interest
   
193,151
     
99,658
 
Convertible notes payable, current portion, net of unamortized debt discount and debt issuance costs
   
837,209
     
---
 
Deferred revenue, current portion
   
49,027
     
35,761
 
Total Current Liabilities
   
2,412,413
     
1,512,634
 
                 
Long Term Liabilities
               
Convertible notes payable, net of unamortized debt discount and debt issuance costs
   
---
     
570,189
 
Deferred revenue, net of current portion
   
331,800
     
352,698
 
Total Long Term Liabilities
   
331,800
     
922,887
 
                 
TOTAL LIABILITIES
   
2,744,213
     
2,435,521
 
                 
COMMITMENTS AND CONTINGENCIES
   
---
     
---
 
                 
STOCKHOLDERS' EQUITY
               
                 
Preferred Stock - $0.001 par value; 20,000 shares authorized;
               
Preferred Stock Series A, 1,000 shares designated; no shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively
   
---
     
---
 
Preferred Stock Series B, 1,250 shares designated; no shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively
   
---
     
---
 
                 
Common Stock - $0.001 par value; 750,000,000 shares authorized;
               
201,349,431 and 201,349,431 shares issued and outstanding at September 30, 2018 and December 31, 2017, respectively
   
201,349
     
201,349
 
Additional paid-in capital
   
68,569,329
     
68,556,734
 
Accumulated (deficit)
   
(64,433,876
)
   
(62,650,287
)
TOTAL STOCKHOLDERS' EQUITY
   
4,336,802
     
6,107,796
 
                 
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY
 
$
7,081,015
   
$
8,543,317
 
                 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 

 
ULURU Inc.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)


   
Three Months Ended September 30,
   
Nine Months Ended September 30,
   
2018
   
2017
   
2018
    2017  
 
Revenues
                       
     
License fees
 
$
---
   
$
1,453
   
$
---
   
$
4,311
 
Product sales, net
   
84,612
     
199,486
     
273,957
     
418,059
 
Total Revenues
   
84,612
     
200,939
     
273,957
     
422,370
 
                                         
Costs and Expenses
                                     
Cost of product sold
   
31,399
     
73,569
     
101,510
     
178,985
 
Regulatory, research and development
   
76,889
     
90,294
     
161,454
     
198,615
 
Selling, general and administrative
   
378,955
     
315,490
     
1,109,108
     
1,016,883
 
Amortization of intangible assets
   
114,268
     
114,268
     
339,079
     
316,602
 
Depreciation
   
5,480
     
5,481
     
16,441
     
71,039
 
Gain on sale of equipment
   
---
     
---
     
(29,179
)
   
---
 
Total Costs and Expenses
   
606,991
     
599,102
     
1,698,413
     
1,782,124
 
Operating (Loss)
   
(522,379
)
   
(398,163
)
   
(1,424,456
)
   
(1,359,754
)
                                 
Other Income (Expense)
                               
Interest and miscellaneous income
   
4,452
     
41
     
4,452
     
45
 
Interest expense
   
(128,098
)
   
(133,972
)
   
(380,247
)
   
(289,113
)
Foreign currency transaction loss
   
(3,701
)
   
(6,151
)
   
(10,000
)
   
(9,222
)
Gain on settlement of liability
   
---
     
---
     
---
     
114,013
 
(Loss) Before Income Taxes
   
(649,726
)
   
(538,245
)
   
(1,810,251
)
   
(1,544,031
)
                                 
Income taxes
   
---
     
---
     
---
     
---
 
Net (Loss)
 
$
(649,726
)
 
$
(538,245
)
 
$
(1,810,251
)
 
$
(1,544,031
)
                                 
                                 
Basic and diluted net (loss) per common share
 
$
(0.00
)
 
$
(0.00
)
 
$
(0.01
)
 
$
(0.02
)
                                 
Weighted average number of common shares outstanding
   
201,349,431
     
159,229,866
     
201,349,431
     
99,919,486
 
                                 
The accompanying notes are an integral part of these consolidated financial statements.




ULURU Inc.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)

   
Nine Months Ended September 30,
 
   
2018
   
2017
 
OPERATING ACTIVITIES:
           
Net loss
 
$
(1,810,251
)
 
$
(1,544,031
)
                 
Adjustments to reconcile net loss to net cash used in operating activities:
               
                 
Amortization of intangible assets
   
339,079
     
316,602
 
Depreciation
   
16,441
     
71,039
 
Share-based compensation for stock and options issued to employees
   
---
     
7,923
 
Share-based compensation for options issued to non-employees
   
12,595
     
---
 
Amortization of debt discount on promissory notes
   
260,438
     
174,577
 
Amortization of debt issuance costs on promissory notes
   
6,582
     
3,976
 
Gain on sale of equipment
   
(29,179
)
   
---
 
Gain on settlement of liability
   
---
     
(114,013
)
                 
Change in operating assets and liabilities:
               
Accounts receivable
   
83,530
     
(101,748
)
Inventory
   
75,036
     
61,500
 
Prepaid expenses and deferred charges
   
36,974
     
(8,676
)
Deposits
   
13,403
     
---
 
Accounts payable
   
(45,270
)
   
(116,237
)
Accrued liabilities
   
1,081
     
(112,099
)
Accrued interest
   
93,493
     
68,098
 
Deferred revenue
   
19,030
     
(14,773
)
Total
   
883,233
     
236,169
 
Net Cash Used in Operating Activities
   
(927,018
)
   
(1,307,862
)
                 
INVESTING ACTIVITIES:
               
Purchase of equipment
   
---
     
(3,501
)
Proceeds from sale of equipment
   
29,179
     
---
 
Net Cash Provided / (Used) in Investing Activities
   
29,179
     
(3,501
)
                 
FINANCING ACTIVITIES:
               
Proceeds from issuance of convertible notes and warrant, net
   
---
     
983,092
 
Proceeds from sale of Series B preferred stock, net
   
---
     
4,915,661
 
Proceeds from issuance of promissory notes
   
---
     
120,000
 
Repayment of principle due on promissory notes
   
---
     
(140,000
)
Net Cash Provided by Financing Activities
   
---
     
5,878,753
 
                 
Net (Decrease) / Increase in Cash
   
(897,839
)
   
4,567,390
 
                 
Cash, beginning of period
   
3,710,882
     
36,615
 
Cash, end of period
 
$
2,813,043
   
$
4,604,005
 
                 
SUPPLEMENTAL CASH FLOW DISCLOSURE:
               
Cash paid for interest
 
$
---
   
$
2,697
 
Cash paid for income taxes
 
$
---
   
$
---
 
                 
Non-cash investing and financing activities:
               
Issuance of common stock for acquisition of licensing rights
 
$
---
   
$
869,375
 
                 
The accompanying notes are an integral part of these condensed consolidated financial statements.
 



ULURU Inc.

NOTES TO
CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
(Unaudited)


NOTE 1.
COMPANY OVERVIEW AND BASIS OF PRESENTATION

Company Overview

ULURU Inc. (hereinafter "we", "our", "us", "ULURU", or the "Company") is a Nevada corporation.  We are a specialty medical technology company committed to developing and commercializing innovative wound care and drug delivery systems based on our patented technologies.  Our mission is to improve the lives of patients the world over by delivering comprehensive solutions that optimize outcomes for the key stakeholders in our healthcare systems: patients, providers, and payers.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles in the United States of America ("U.S. GAAP") for interim financial information and with the instructions to Form 10-Q and include the accounts of ULURU Inc., a Nevada corporation, and its wholly-owned subsidiary, Uluru Delaware Inc., a Delaware corporation.  They do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. All adjustments (consisting of normal recurring accruals) considered necessary for a fair presentation of the Company's financial position as of September 30, 2018 and the results of its operations for the three and nine months ended September 30, 2018 and 2017 and cash flows for the nine months ended September 30, 2018 and 2017 have been made.

The preparation of financial statements in conformity with U.S. GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, as well as disclosure of contingent assets and liabilities at the date of the financial statements, and the reported amounts of revenues and expenses during the reporting periods.  Actual results may differ from those estimates and assumptions.  These differences are usually minor and are included in our consolidated financial statements as soon as they are known.  Our estimates, judgments, and assumptions are continually evaluated based on available information and experience. Because of the use of estimates inherent in the financial reporting process, actual results could differ from those estimates.

All intercompany transactions and balances have been eliminated in consolidation.  Certain prior period amounts have been reclassified to conform to current period presentations.

Operating results for the three and nine months ended September 30, 2018 are not necessarily indicative of the results that may be expected for the year ending December 31, 2018.

These condensed consolidated financial statements should be read in conjunction with the financial statements and notes thereto contained in the Company's Annual Report on Form 10-K for the year ended December 31, 2017, as filed with the Securities and Exchange Commission on March 30, 2018 (the "2017 Form 10-K"), including the risk factors set forth therein.


NOTE 2.
THE EFFECT OF RECENTLY ISSUED ACCOUNTING STANDARDS

In May 2014, the Financial Accounting Standards Board ("FASB") issued Accounting Standards Update ("ASU") No. 2014-09, Revenue from Contracts with Customers ("Topic 606"), which amends the guidance for accounting for revenue from contracts with customers and requires revenue recognition based on the transfer of promised goods or services to customers in an amount that reflects consideration the Company expects to be entitled to in exchange for goods or services.  Topic 606 supersedes prior revenue recognition requirements in ASC Topic 605 and most industry-specific accounting guidance. In 2015 and 2016, the FASB issued additional updated guidance, which clarified certain aspects of the Topic 606 and the related implementation guidance issued by the FASB-IASB Joint Transition Resource Group for Revenue Recognition.

Topic 606 became effective for the Company on January 1, 2018, and was adopted using the modified retrospective method under which previously presented financial statements are not restated and the cumulative effect of adopting the new revenue standard on contracts in process is recognized by an adjustment to retained earnings at the effective date. The cumulative effect of applying the new revenue standard was an increase of $26,662 to stockholder's equity as of January 1, 2018.  The adoption of ASC 606 does not materially impact the Company's revenue recognition as the Company's revenue primarily comes from the sale of products which do not required long term contracts, contracts with multiple deliverables or performance obligations.  Additionally, the Company already historically accounted for variable consideration on its product sales such as sale returns and discounts as part of revenue recognition.  Topic 606 requires more robust disclosures than required by previous guidance, including disclosures related to disaggregation of revenue into appropriate categories, performance obligations, the judgements made in revenue recognition determinations, adjustments to revenue which relate to activities from previous quarters or years, any significant reversals of revenue, and costs to obtain or fulfill contracts. See Note 3, "Revenue Recognition."

In February 2016, the FASB issued ASU 2016-02, Leases (Topic 842) ("ASU 2016-02"), which supersedes current lease accounting guidance. The primary difference between current GAAP and the new standard is the recognition of lease assets and lease liabilities by lessees for those leases classified as operating leases under current GAAP. The standard requires a modified retrospective approach upon adoption, with practical expedients that may be available to elect. The standard is effective for the Company in the first quarter of 2019 and early adoption is permitted. The Company is evaluating the impact of the ASU on its consolidated financial statements.

In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation (Topic 718): Improvements to Employee Share-Based Payment Accounting ("ASU 2016-09"). ASU 2016-09 simplifies several aspects of the accounting for share-based payment transactions, including the accounting for income taxes, classification of awards as either equity or liabilities, the estimation of forfeitures, statutory tax withholding requirements, and classification in the statement of cash flows. This guidance is effective for the Company on January 1, 2017 and early adoption was permitted. The Company adopted ASU 2016-09 during the first fiscal quarter ended on March 31, 2017. As part of the adoption of this guidance, the Company elected to continue estimating forfeitures in its calculation of stock-based compensation expense. The excess tax benefits and tax deficiencies from stock-based compensation awards accounted for under ASC 718 are recognized as income tax benefit or expense, respectively, in the statement of operations and comprehensive loss. The income tax related items had no effect on the current period presentation as the Company maintains a full valuation allowance against its deferred tax assets. In addition, excess tax benefits for share-based payments are presented as an operating activity in the statement of cash flows rather than financing activity. The changes have been applied retrospectively in accordance with the ASU and prior periods have not been adjusted. The adoption of ASU 2016-09 did not have a material impact on our consolidated financial statements.

In August 2016, the FASB issued ASU 2016-15, Statement of Cash Flows (Topic 230): Classification of Certain Cash Receipts and Cash Payments ("ASU 2016-15"), providing additional guidance on eight specific cash flow classification issues. The goal of ASU 2016-15 is to reduce diversity in practice of classifying certain items. The amendments in ASU 2016-15 are effective for the Company in the first quarter of 2018 using a retrospective transition method, and early adoption is permitted. The Company's adoption of ASU 2016-15 did not have a material impact on its consolidated financial statements.

In November 2016, the FASB issued ASU No. 2016-18, Restricted Cash, Statement of Cash Flows (Topic 230) ("ASU 2016-18").  ASU 2016-18 requires that a statement of cash flows explain the change during the period in the total of cash, cash equivalents, and amounts generally described as restricted cash or restricted cash equivalents. Therefore, amounts generally described as restricted cash and restricted cash equivalents should be included with cash and cash equivalents when reconciling the beginning-of-period and end-of-period total amounts shown on the statement of cash flows. ASU 2016-18 is effective for public business entities for fiscal years beginning after December 15, 2017, and interim periods within those fiscal years, with early adoption permitted. The amendments in ASU 2016-18 should be applied using a retrospective transition method to each period presented. The Company's adoption of ASU 2016-18 did not have a material impact on its consolidated financial statements.

In January 2017, the FASB issued ASU 2017-04, Intangibles-Goodwill and Other (Topic 350): Simplifying the Test for Goodwill Impairment ("ASU 2017-04").  The amended guidance eliminates a step from the goodwill impairment test. Under the amended guidance, an entity should perform its annual or interim goodwill impairment test by comparing the fair value of a reporting unit with its carrying amount. An entity would recognize an impairment charge for the amount by which the carrying amount exceeds the reporting unit's fair value; however, the loss recognized should not exceed the total amount of goodwill allocated to that reporting unit. The Company adopted this new guidance in the fourth quarter of 2017. The Company's adoption of ASU 2017-04 did not have a material impact on its consolidated financial statements.

In May 2017, the FASB issued ASU No. 2017-09, Compensation - Stock Compensation (Topic 718): Scope of Modification Accounting ("ASU 2017-09").  ASU 2017-09 provides clarity when a change to terms or conditions of a share-based payment award must be accounted for as a modification. The new guidance requires modification accounting if the vesting condition, fair value or the award classification is not the same both before and after a change to the terms and conditions of the award. The new guidance is effective on a retrospective basis beginning on January 1, 2018 with early adoption permitted.  The Company's adoption of ASU 2017-09 did not have a material impact on its consolidated financial statements.
 
In June 2018, the FASB issued ASU 2018-07 "Compensation – Stock Compensation (Topic 718): Improvements to Nonemployee Share-Based Payment Accounting" ("ASU 2018-07") which expands the scope of Topic 718, "Compensation – Stock Compensation", to include share-based payment transactions for acquiring goods and services from non-employees.  The objective of ASU 2018-07 is to maintain or improve the usefulness of the information provided to the users of financial statements while reducing cost and complexity by simplifying several aspects of existing guidance.  The amendments are effective for public business entities for fiscal years beginning after December 15, 2018, including interim periods within that fiscal year and early adoption is permitted. The Company elected the early adoption of ASU 2018-07, effective on January 1, 2018, which did not have a material impact on its consolidated financial statements.

In July 2018, the FASB issued ASU 2018-11 "Leases (Topic 842) Targeted Improvements"("ASU 2018-11") which provides entities with an alternative transition method for adopting the new lease standard described in ASU 2016-02, which is described above.  Entities can elect to initially apply the new leases standard at the adoption date and recognize a cumulative-effect adjustment to the opening balance of retained earnings.  Consequently, comparative periods will continue to be accounted for in accordance with the current lease standard (Topic 840) and the disclosures will be in accordance with ASC 840.  The Company is assessing this option in conjunction with its analysis of ASU 2016-02.


NOTE 3.
SIGNIFICANT ACCOUNTING POLICIES

Please refer to the notes in the Company's 2017 Form 10-K for additional details of the Company's financial condition and a description of the Company's accounting policies, which have been continued without change except for the Company's Revenue Recognition accounting policy, which has been updated as a result of the Company's adoption of ASU 2014-09 in the first quarter of 2018.

Revenue Recognition

The Company's product, Altrazeal®, is distributed to and through a limited number of specialty distributors internationally and a combination of wholesalers and direct to customer sales in the United States.

The Company recognizes revenue as the transfer of control of its products to the Company's customers in an amount reflecting the consideration the Company expects to be entitled. In order to achieve this core principle, the Company applies the following five-step approach:

§  
identification of the contract, or contracts, with a customer;
§  
recognition of revenue when, or as, we satisfy the performance obligations;
§  
determination of the transaction price;
§  
allocation of the transaction price to the performance obligations in the contract; and
§  
recognition of revenue when, or as, we satisfy the performance obligations.

The Company considers customer purchase orders, which in some cases are governed by master distribution agreements, to be the contracts with the 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 the Company expects to be entitled. In addition, the Company evaluates the customer's ability to pay as part of its consideration of the contract. As the Company's standard payment terms are less than one year, the Company elected the practical expedient under Accounting Standards Codification (ASC) 606-10-32-18, and determined that its contracts do not have a significant financing component. The Company allocates the transaction price to each distinct product based on the relative standalone selling price. Revenue is recognized when control of the product is transferred to the customer, the customer is obligated to pay the Company, and the Company has no remaining obligations, which is typically at shipment. In certain locations, primarily outside the United States, product shipping terms may vary. Thus, in such locations, the point at which control of the product transfers to the customer and revenue recognition occurs will vary accordingly.

Customer returns of non-conforming products are estimated at the time revenue is recognized. In certain customer relationships, rebates exist, which are recognized according to the terms and conditions of the contractual relationship. Customer returns, rebates, and discounts are not material to the Company's consolidated financial statements. The Company has elected to recognize the revenue and cost for freight and shipping when control over the products has transferred to the customer. When applicable, taxes collected from Customers relating to product sales and remitted to governmental authorities are excluded from revenues.  

The Company has elected to immediately expense contract costs from obtaining a contract as the amortization period of the asset the Company otherwise would have recognized would have been less than a year.

Reserves for Variable Consideration

Revenues from product sales are recorded at the transaction price, which includes estimates of variable consideration for which reserves are established and which result from discounts, returns, and other allowances that are offered within contracts between the Company and its customers.  These reserves are based on the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to the customer) or a current liability (if the amount is payable to a party other than a customer).  Where appropriate, these estimates take into consideration a range of possible outcomes and contemplates relevant factors such as the Company's historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns.  Overall, these reserves reflect the Company's best estimates of the amount of consideration to which it is entitled based on the terms of the contract.  The amount of variable consideration which is included in the transaction price may be constrained, and is included in the net sales price only to the extent that it is probable that a significant reversal in the amount of the cumulative revenue recognized will not occur in a future period.  Actual amounts of consideration ultimately received may differ from the Company's estimates. 
The Company believes that the reserves it has established are reasonable based upon current facts and circumstances. Applying different judgments or interpretations to the same facts and circumstances could result in the estimated amount for reserves to vary.  If actual results vary with respect to the Company's reserves, the Company may need to adjust its estimates, which could have a material effect on the Company's results of operations in the period of adjustment. To date, such adjustments have not been material.

Trade Discounts and Allowances 

The Company receives sales order management, marketing and promotions, data and distribution services from certain customers.  To the extent the services received are distinct from the Company's sale of products to the customer, these payments are classified in selling, general and administrative expenses in the consolidated statements of operations of the Company. The company revenue recognition is net of estimated trade discounts and allowances.

Other Revenues

The Company enters into licensing agreements, from time to time, which are within the scope of Topic 606, under which it may license certain rights to its products or product candidates to third parties.  The terms of these arrangements typically include payment to the Company of one or more of the following: non-refundable, up-front license fees; development, regulatory and commercial milestone payments; and royalties on net sales of licensed products.  Each of these payments results in revenues recognized and classified as other revenues.

Licenses of intellectual property:  If the license of the Company's intellectual property is determined to be distinct from the other performance obligations identified in the arrangement, the Company recognizes revenues from non-refundable, up-front fees allocated to the license when the license is transferred to the customer and the customer is able to use and benefit from the license.  For licenses that are bundled with other promises, the Company utilizes judgment to assess the nature of the combined performance obligation to determine whether the combined performance obligation is satisfied over time or at a point in time and, if over time, the appropriate method of measuring progress for purposes of recognizing revenue from non-refundable, up-front fees.  The Company evaluates the measure of progress each reporting period and, if necessary, adjusts the measure of performance and related revenue recognition.

Milestone Payments:  At the inception of each arrangement that includes development milestone payments, the Company evaluates whether the milestones are considered probable of being reached and estimates the amount to be included in the transaction price using the most likely amount method.  If it is probable that a significant revenue reversal would not occur, the associated milestone value is included in the transaction price.  Milestone payments that are not within the control of the Company or the licensee, such as regulatory approvals, are not considered probable of being achieved until those approvals are received. The transaction price is then allocated to each performance obligation on a relative stand-alone selling price basis, for which the Company recognizes revenue as or when the performance obligations under the contract are satisfied.  At the end of each subsequent reporting period, the Company re-evaluates the probability of achievement of such development milestones and any related constraint, and if necessary, adjusts its estimate of the overall transaction price.  Any such adjustments are recorded on a cumulative catch-up basis, which would affect license, collaboration and other revenues and earnings in the period of adjustment.
 
Royalties:  For arrangements that include sales-based royalties, including milestone payments based on the level of sales, and the license is deemed to be the predominant item to which the royalties relate, the Company recognizes revenue at the later of (i) when the related sales occur, or (ii) when the performance obligation to which some or all of the royalty has been allocated has been satisfied (or partially satisfied). 

Under the Company's various contracts, the Company may receive up-front payments and fees, which may require deferral of revenue recognition to a future period until the Company performs its obligations under these arrangements.  Amounts are recorded as accounts receivable when the Company's right to consideration is unconditional.  The Company does not assess whether a contract has a significant financing component if the expectation at contract inception is such that the period between payment by the customer and the transfer of the promised goods or services to the customer will be one year or less.

We received upfront cash payments for licenses of our technology in years 2007 to 2013. The revenue was recognized straight-line over the life of the patent. Our obligation was performed at the time the license was granted. Following the revenue recognition policies in accordance with ASC 606, we decreased the accumulated deficit by $26,662 as of January 1, 2018 and decreased deferred revenue by the same amount.

Effective January 1, 2018, we adopted Accounting Standards Update (ASU) 2014-09, Revenue from Contracts with Customers, as amended (commonly referred to as ASC 606) using the modified retrospective transition method. The cumulative effect of applying the standard was an increase of $26,662 to stockholder's equity as of January 1, 2018. Our statement of operations for the three and nine months ended September 30, 2018 and our balance sheet as of September 30, 2018 are presented under ASC 606, while our statement of operations for the three and nine months ended September 30, 2017 and our balance sheet as of December 31, 2017 are presented under ASC 605, Revenue Recognition. See below for disclosure of the impact of the adoption of ASC 606 on our statement of operations and balance sheet for the three and nine months ended September 30, 2018, and the effect of changes made to our consolidated balance sheet as of January 1, 2018.

The table below presents the cumulative effect of the changes made to the consolidated January 1, 2018 balance sheet due to the adoption of ASC 606.
 
 
 
December 31, 2017
         
January 1, 2018
 
BALANCE SHEET
 
As Reported
   
Adjustments Due
   
As Adjusted
 
   
Under ASC 605
   
to ASC 606
   
Under ASC 606
 
Liabilities
                 
  Current liabilities
                 
    Current portion of deferred revenue
 
$
35,761
   
$
(5,764
)
 
$
29,997
 
    Total current liabilities
   
1,512,634
     
(5,764
)
   
1,506,870
 
  Deferred revenue, net of current portion
   
352,698
     
(20,898
)
   
331,800
 
    Total liabilities
   
2,435,521
     
(26,662
)
   
2,408,859
 
Stockholders' Equity
                       
  Accumulated deficit
   
(62,650,287
)
   
26,662
     
(62,623,625
)
    Total equity
 
$
6,107,796
   
$
26,662
   
$
6,134,458
 



The table below presents the impact of the adoption of ASC 606 on our statement of operations.
 
 
 
Nine Months Ended September 30, 2018
 
STATEMENT OF OPERATIONS
 
Under
   
Effect of
   
As Reported
 
   
ASC 605
   
ASC 606
   
Under ASC 606
 
Revenues
                 
  License revenues
 
$
1,422
   
$
(1,422
)
 
$
---
 
    Total revenues
   
275,379
     
(1,422
)
   
273,957
 
 
                       
Loss from operations
 
$
(1,423,034
)
 
$
(1,422
)
 
$
(1,424,456
)
Net loss
 
$
(1,808,829
)
 
$
(1,422
)
 
$
(1,810,251
)
 
                       
Basic and diluted loss per common share
 
$
(0.01
)
 
$
(0.00
)
 
$
(0.01
)


The table below presents the impact of the adoption of ASC 606 on our balance sheet.
 
 
 
September 30, 2018
 
BALANCE SHEET
 
Under
   
Effect of
   
As Reported
 
   
ASC 605
   
ASC 606
   
Under ASC 606
 
Liabilities and Stockholders' Equity
                 
  Current liabilities
                 
    Current portion of deferred revenue
 
$
54,791
   
$
(5,764
)
 
$
49,027
 
    Total current liabilities
   
2,418,177
     
(5,764
)
   
2,412,413
 
  Deferred revenue, net of current portion
   
351,276
     
(19,476
)
   
331,800
 
    Total liabilities
   
2,769,453
     
(25,240
)
   
2,744,213
 
 
                       
Stockholders' Equity
                       
  Accumulated deficit
   
(64,459,116
)
   
25,240
     
(64,433,876
)
    Total stockholders' equity
 
$
4,311,562
   
$
25,240
   
$
4,336,802
 
 
Disaggregation of Revenue

Revenue is disaggregated by primary geographic markets, as we believe this best depicts how the nature, amount, timing, and uncertainty of our revenue and cash flows are affected by economic factors.  For more information on the Company's disaggregated revenue, see Note 4, Segment Information.


NOTE 4.
SEGMENT INFORMATION

Our entire business is managed by a single management team, which reports to the Chief Executive Officer.  Our corporate headquarters in the United States collects proceeds from product sales, licensing fees, royalties, and sponsored research revenues from our arrangements with external customers and licensees.  Our revenues are currently derived primarily from distribution partners for international activities and our domestic sales activities for our products.
 
Revenues per geographic area for the three and nine months ended September 30 are summarized as follows:

   
Three Months Ended September 30,
   
Nine months Ended September 30,
 
Revenues
 
2018
   
%
   
2017
   
%
   
2018
   
%
   
2017
   
%
 
Domestic
 
$
19,523
     
23
%
 
$
3,012
     
2
%
   
32,625
     
12
%
 
$
8,427
     
2
%
International
   
65,089
     
77
%
   
197,927
     
98
%
   
241,332
     
88
%
   
413,943
     
98
%
Total
 
$
84,612
     
100
%
 
$
200,939
     
100
%
 
$
273,957
     
100
%
 
$
422,370
     
100
%

A significant portion of our revenues are derived from a few major customers.  For the three months ended September 30, 2018 and 2017, four customers and one customer, respectively, had greater than 10% of total revenues and represented in aggregate 89% and 98%, respectively, of total revenues.  For the nine months ended September 30, 2018 and 2017, two customers and two customers, respectively, had greater than 10% of total revenues and represented in aggregate 81% and 97%, respectively, of total revenues.


NOTE 5.
INVENTORY

As of September 30, 2018, our inventory was comprised of Altrazeal® finished goods, manufacturing costs incurred in the production of Altrazeal®, and raw materials.  Inventories are stated at the lower of cost (first in, first out method) or net realizable value.  We regularly review inventories on hand and write down the carrying value of our inventories for excess and potentially obsolete inventories based on historical usage and estimated future usage.  In assessing the ultimate realization of our inventories, we are required to make judgments as to future demand requirements.  As actual future demand or market conditions may vary from those projected by us, adjustment to inventories may be required.

The components of inventory, at the different stages of production, consisted of the following at September 30, 2018 and December 31, 2017:

Inventory
 
September 30, 2018
   
December 31, 2017
 
  Packaging and raw materials
 
$
40,327
   
$
32,329
 
  Work-in-progress
   
318,297
     
311,632
 
  Finished goods
   
63,801
     
153,500
 
  Total
 
$
422,425
   
$
497,461
 



NOTE 6.
PROPERTY, EQUIPMENT and LEASEHOLD IMPROVEMENTS

Property, equipment and leasehold improvements, net, consisted of the following at September 30, 2018 and December 31, 2017:

Property, equipment and leasehold improvements
 
September 30, 2018
   
December 31, 2017
 
  Laboratory equipment
 
$
424,888
   
$
424,888
 
  Manufacturing equipment
   
1,589,286
     
1,604,894
 
  Computers, office equipment, and furniture
   
154,781
     
154,781
 
  Computer software
   
4,108
     
4,108
 
  Leasehold improvements
   
95,841
     
95,841
 
     
2,268,904
     
2,284,512
 
  Less: accumulated depreciation and amortization
   
(2,231,622
)
   
(2,230,789
)
  Property, equipment and leasehold improvements, net
 
$
37,282
   
$
53,723
 

Depreciation expense on property, equipment and leasehold improvements was $5,480 and $5,481 for the three months ended September 30, 2018 and 2017, respectively, and was $16,441 and $71,039 for the nine months ended September 30, 2018 and 2017, respectively.


NOTE 7.
INTANGIBLE ASSETS

Patents

Intangible patent assets are composed of patents acquired in October, 2005.  Intangible assets, net consisted of the following at September 30, 2018 and December 31, 2017:

Intangible assets – patents
 
September 30, 2018
   
December 31, 2017
 
  Patent - Amlexanox (Aphthasol®)
 
$
2,090,000
   
$
2,090,000
 
  Patent - Amlexanox (OraDisc™ A)
   
6,873,080
     
6,873,080
 
  Patent - OraDisc™
   
73,000
     
73,000
 
  Patent - Hydrogel nanoparticle aggregate
   
589,858
     
589,858
 
     
9,625,938
     
9,625,938
 
  Less: accumulated amortization
   
(7,446,598
)
   
(7,418,891
)
  Less: reserve for impairment
   
(2,027,310
)
   
(2,027,310
)
  Intangible assets - patents, net
 
$
152,030
   
$
179,737
 

Amortization expense for intangible patent assets was $9,337 and $9,337 for the three months ended September 30, 2018 and 2017, respectively, and was $27,707 and $27,707 for the nine months ended September 30, 2018 and 2017, respectively.


The future aggregate amortization expense for intangible patent assets, remaining as of September 30, 2018, is as follows:

Calendar Years
 
Future Amortization
Expense
 
  2018 (Three months)
 
$
9,337
 
  2019
   
37,044
 
  2020
   
37,145
 
  2021
   
37,044
 
  2022
   
31,460
 
  Total
 
$
152,030
 

Licensing rights

Acquisition of Licensing Rights – 2017

On February 27, 2017, we entered into a Note, Warrant and Preferred Stock Purchase Agreement (the "Purchase Agreement") with Velocitas Partners, LLC ("Velocitas") and Velocitas I LLC ("Velo LLC"), an entity controlled by Velocitas, with respect to an aggregate financing of up to $6,000,000.

Refer to a description in greater detail of the financing event with Velocitas and Velo LLC in Note 9. Convertible Debt.

At the second closing of the financing event with Velocitas and Velo LLC, which occurred on March 31, 2017, the Company acquired the Altrazeal® distributor agreements Velocitas had with its sub-distributors in exchange for the issuance of 13,375,000 shares of Common Stock.  The Company has valued the acquisition of the Altrazeal® distributor agreements from Velocitas at $869,375 based on the closing price of $0.065 per share of the Company's Common Stock on March 31, 2017.

Licensing rights, net consisted of the following at September 30, 2018 and December 31, 2017:

Intangible assets - licensing rights
 
September 30, 2018
   
December 31, 2017
 
  Intangible assets – licensing rights, gross
 
$
4,381,881
   
$
4,381,881
 
  Less: accumulated amortization
   
(1,036,617
)
   
(725,245
)
  Intangible assets - licensing rights, net
 
$
3,345,264
   
$
3,656,636
 

Amortization expense for intangible licensing rights assets was $104,931 and $104,931 for the three months ended September 30, 2018 and 2017, respectively, and was $311,372 and $288,895 for the nine months ended September 30, 2018 and 2017, respectively.
The future aggregate amortization expense for intangible licensing rights assets, remaining as of September 30, 2018, is as follows:

Calendar Years
 
Future Amortization
Expense
  
  2018 (Three months)
 
$
104,931
 
  2019
   
416,303
 
  2020
   
416,303
 
  2021
   
416,303
 
  2022
   
416,303
 
  2023 & Beyond
   
1,575,121
 
  Total
 
$
3,345,264
 


NOTE  8.
ACCRUED LIABILITIES

Accrued liabilities consisted of the following at September 30, 2018 and December 31, 2017:

Accrued Liabilities
 
September 30, 2018
   
December 31, 2017
 
  Accrued compensation/benefits
 
$
117,419
   
$
124,819
 
  Accrued property taxes
   
4,413
     
---
 
  Accrued royalties
   
43,218
     
39,144
 
  Product rebates/returns
    ---      
6
 
  Total accrued liabilities
 
$
165,050
   
$
163,969
 
 
 
NOTE 9.
CONVERTIBLE NOTE PAYABLE – RELATED PARTY

Debt Financing – February and March 2017

On February 27, 2017, the Company entered into the Purchase Agreement with Velocitas and Velo LLC under which the Company received gross proceeds of $6,000,000 in two closings, with the initial closing occurring on February 27, 2017 and the second closing occurring on March 31, 2017, which we refer to as the "March 2017 Offering".  Refer to a description in greater detail of the Company's related party affiliation with Velocitas and Velo LLC in Note 16. Related Party Transactions and Concentration.

The first closing, which occurred on February 27, 2017, included the purchase by Velocitas at face value of a Secured Convertible Note, dated February 27, 2017, in the principal amount of $500,000 (the "Initial Note"), with the Initial Note accruing interest at 12.5% per annum and having a term of two years (subject to acceleration under certain circumstances).

The second closing, which occurred on March 31, 2017, included the purchase by Velocitas at face value of an additional $500,000 Secured Convertible Note, dated March 31, 2017, (the "Second Note") with the Second Note accruing interest at 12.5% per annum and having a term of two years (subject to acceleration under certain circumstances), and Velo LLC purchasing 1,250 shares of Series B Convertible Preferred Stock of the Company for gross proceeds of $5,000,000, at an as-converted-to-Common Stock purchase price of $0.04 per share. The Company received of $983,092 of net proceeds from the issuance of the Initial Note and the Second Note due to $16,908 of debt issuance costs and received of $4,915,661 of net proceeds from the sale of the Series B Convertible Preferred Stock due to $84,339 of equity issuance costs.
 
The Initial Note and the Second Note are convertible into shares of Common Stock at a conversion price of $0.04 per share, subject to equitable adjustments, with mandatory conversion of all unpaid principal and interest required on the second anniversary of each such note, unless an event of default has occurred and is continuing.  The Initial Note and the Second Note are secured by all of the assets of the Company and its subsidiaries pursuant to a Security Agreement executed at the initial closing.

The Series B Convertible Preferred Stock that was issued in connection with the second closing provided, among other things, that it would automatically convert into Common Stock when the number of authorized shares of Common Stock is increased within 190 days of the second closing as necessary to permit all outstanding convertible or exercisable securities (including the Series B Convertible Preferred Stock) to convert to Common Stock. Following stockholder approval of an amendment to our articles of incorporation increasing the number of authorized shares of Common Stock from 200,000,000 shares to 750,000,000 shares, the Company filed on July 26, 2017 with the State of Nevada an amendment to its articles of incorporation implementing such increase.  This resulted in the conversion of all 1,250 outstanding shares of Series B Convertible Preferred Stock held by Velo LLC into 125,000,000 shares of Common Stock.

As a condition of the March 2017 Offering, the Company issued to Velocitas at the second closing a warrant to purchase up to 57,055,057 shares of Common Stock (the "Warrant").  The Warrant has an exercise price of $0.04 per share, a 10-year term and is subject to cashless exercise. In addition, at the second closing, the Company acquired the Altrazeal distributor agreements Velocitas had with its sub-distributors in exchange for the issuance of 13,375,000 shares of Common Stock.

The Company, Velocitas, Velo LLC, and certain affiliates also signed a Voting Agreement (the "Voting Agreement") pursuant to which the parties agreed to set the size of the Board of Directors at six directors, and agreed to vote for the election to the Board of Directors of four persons designated by Velocitas (initially to be Anish Shah, Oksana Tiedt, Vaidehi Shah and Arindam Bose), one director designated by Bradley Sacks and one additional director designated by a major investor or by the Board of Directors.  In addition, the parties to the Voting Agreement agreed to vote in favor of a proposal to amend the Company's articles of incorporation to increase the authorized shares as required to permit the conversion of the Series B Convertible Preferred Stock.

In addition, the Company, Velocitas, Velo LLC, and certain affiliates entered into an Investor Rights Agreement (the "Investor Rights Agreement") that provides the parties thereto with demand, Form S-3 and piggy back registration rights, Rule 144 information rights, and a right of first offer (or preemptive right) in connection with future sales of securities by the Company (subject to standard exceptions).  The Investor Rights Agreement includes indemnification obligations associated with the registration rights.  Michael Sacks and Bradley Sacks and affiliates are parties to the Investor Rights Agreement, in part in exchange for the termination by certain of such persons and The Punch Trust of a Registration Rights Agreement dated as of January 31, 2014.
 
Using specific guidelines in accordance with U.S. GAAP, we allocated the value of the proceeds received to the promissory note and to the Warrant on a relative fair value basis.  We calculated the fair value of the Warrant issued with the debt instrument using the Black-Scholes valuation method, using the same assumptions used for valuing employee stock options, except the contractual life of the Warrant was used. Using the effective interest method, the allocated fair value of the Warrant was recorded as a debt discount and is being amortized over the expected term of the promissory note to interest expense.

Information relating to the Initial Note and the Second Note is as follows:

                             
As of September 30, 2018
 
Transaction
 
Initial
Principal
Amount
   
Interest
Rate
 
Maturity
Date
 
Conversion Price
   
Principal
Balance
   
Unamortized
Debt
Discount
   
Unamortized Debt Issuance Costs
   
Carrying
Value
 
  Initial Note
 
$
500,000
     
12.5
%
02/27/2019
 
$
0.04
   
$
500,000
   
$
73,589
   
$
1,991
   
$
424,420
 
  Second Note
 
$
500,000
     
12.5
%
03/31/2019
 
$
0.04
   
$
500,000
   
$
84,929
   
$
2,282
   
$
412,789
 
  Total
 
$
1,000,000
                     
$
1,000,000
   
$
158,518
   
$
4,273
   
$
837,209
 

As part of the Initial Note and the Second Note, at the holder's option, all unpaid principle and interest due under each convertible promissory note may be converted into shares of Common Stock based on a conversion price of $0.04 per share.  The Initial Note and the Second Note mature on February 27, 2019 and March 31, 2019, respectively, and on each such maturity date each convertible promissory note, and accrued interest thereon, is subject to mandatory conversion based on a conversion price of $0.04 per share, unless an event of default has occurred and is continuing.

The amount of interest cost recognized from our promissory notes and our convertible debt was $31,507 and $31,507 for the three months ended September 30, 2018 and 2017, respectively, and $93,493 and $68,848 for the nine months ended September 30, 2018 and 2017, respectively.

The amount of debt discount amortized from our convertible debt was $87,767 and $87,571 for the three months ended September 30, 2018 and 2017, respectively, and $260,438 and $174,577 for the nine months ended September 30, 2018 and 2017, respectively.

The amount of debt issuance costs amortized from our convertible debt was $2,253 and $2,060 for the three months ended September 30, 2018 and 2017, respectively, and $6,582 and $3,976 for the nine months ended September 30, 2018 and 2017, respectively.


NOTE 10.
EQUITY TRANSACTIONS

Preferred Stock Transaction

March 2017 Offering

On February 27, 2017, the Company entered into the Purchase Agreement with Velocitas and Velo LLC under which the Company received gross proceeds of $6,000,000, in two closing with the initial closing occurring on February 27, 2017 and the second closing occurring on March 31, 2017.

The second closing included, among other transaction components, the purchase by Velo LLC of 1,250 shares of Series B Convertible Preferred Stock of the Company for $5,000,000.  The Company received of $4,915,661 of net proceeds from the sale of the Series B Convertible Preferred Stock due to $84,339 of equity issuance costs.

On July 26, 2017, all 1,250 outstanding shares of Series B Convertible Preferred Stock held by Velo LLC were converted into 125,000,000 shares of Common Stock.

Refer to a description in greater detail of the financing event with Velocitas and Velo LLC in Note 9. Convertible Debt.


NOTE 11.
STOCKHOLDERS' EQUITY

Common Stock

As of September 30, 2018, we had 201,349,431 shares of Common Stock issued and outstanding.  For the nine months ended September 30, 2018, we did not issue or redeem any shares of Common Stock.

Preferred Stock

As of September 30, 2018, we had no shares of Series A Preferred Stock (the "Series A Shares") issued and outstanding.  For the nine months ended September 30, 2018, we did not issue or redeem any Series A Shares.

As of September 30, 2018, we had no shares of Series B Preferred Stock (the "Series B Shares") issued and outstanding.  For the nine months ended September 30, 2018, we did not issue or redeem any Series B Shares.
 
Warrants

The following table summarizes the warrants outstanding and the number of shares of Common Stock subject to exercise as of September 30, 2018 and the changes therein during the nine months then ended:

   
Number of Shares of Common Stock Subject to Exercise
   
Weighted – Average
Exercise Price
 
Balance as of December 31, 2017
   
83,234,617
   
$
0.06
 
Warrants issued
   
---
     
---
 
Warrants exercised
   
---
     
---
 
Warrants cancelled
   
(660,000
)
 
$
0.60
 
Balance as of September 30, 2018
   
82,574,617
   
$
0.06
 

For the nine months ended September 30, 2018, we did not issue or redeem any warrants.

Of the warrant shares subject to exercise as of September 30, 2018, expiration of the right to exercise is as follows:

Date of Expiration
 
Number of Warrant Shares of Common Stock Subject to Expiration
 
  January 15, 2019
   
80,000
 
  April 30, 2020
   
194,118
 
  March 30, 2021
   
25,245,442
 
  March 31, 2027
   
57,055,057
 
  Total
   
82,574,617
 


NOTE 12.
EARNINGS PER SHARE

Basic and Diluted Net Loss Per Share

In accordance with FASB ASC Topic 260, Earnings per Share, basic earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding for the period.  Diluted earnings (loss) per common share is computed by dividing net income (loss) by the weighted average number of common shares outstanding during the period, increased to include potential dilutive common shares.  The effect of outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants, when dilutive, is reflected in diluted earnings (loss) per common share by application of the treasury stock method.  We have excluded all outstanding stock options, restricted vesting Common Stock, convertible debt, convertible preferred stock, and warrants from the calculation of diluted net loss per common share because all such securities are antidilutive for all periods presented.
 
Shares used in calculating basic and diluted net loss per common share exclude these potential common shares as of September 30, 2018 and December 31, 2017:

   
September 30, 2018
   
December 31, 2017
 
Warrants to purchase Common Stock
   
82,574,617
     
83,234,617
 
Stock options to purchase Common Stock
   
2,630,000
     
150,736
 
Common Stock issuable upon the assumed conversion of our convertible promissory notes (1)
   
31,250,000
     
31,250,000
 
  Total
   
116,454,617
     
114,635,353
 

(1)
As part of the Initial Note and the Second Note, at the holder's option, all unpaid principle and interest due under each convertible promissory note may be converted into shares of Common Stock based on a conversion price of $0.04 per share.  The Initial Note and the Second Note mature on February 27, 2019 and March 31, 2019, respectively, and on each maturity date each convertible promissory note, and accrued interest thereon, is subject to mandatory conversion based on a conversion price of $0.04 per share, unless an event of default has occurred and is continuing.  For the purposes of this Table, we have assumed that all outstanding principal and interest will be converted on each applicable maturity date.


NOTE 13.
SHARE BASED COMPENSATION

The Company maintains the 2006 Equity Incentive Plan and the 2018 Equity Incentive Plan.  Each of the Equity Incentive Plans are administered by the Board of Directors, acting in lieu of a compensation committee, which selects persons to receive awards and determines the number of shares subject to each award and the terms, conditions, performance measures, and other provisions of the award.

As of March 29, 2016, the 2006 Equity Incentive Plan expired by its terms, and no additional awards may be granted thereunder.  The expiration of the 2006 Equity Incentive Plan does not affect outstanding awards.

On March 28, 2018, the Board of Directors approved the 2018 Equity Incentive Plan, which was subsequently ratified at the Company's 2018 Annual Meeting of Stockholders held on June 11, 2018.  The 2018 Equity Incentive Plan allows for the Company to grant awards for up to 20,000,000 shares of Common Stock.  Awards under the 2018 Equity Incentive Plan may include the following award types: stock options, which may be either incentive stock options or nonqualified stock options; stock appreciation rights; restricted stock; RSUs; other stock-based awards, including unrestricted shares; or any combination of the foregoing. The exercise price of stock options granted under the 2018 Equity Incentive Plan is equal to or greater than the closing price of a share of the Company's Common Stock on the grant date.
 
Our Board has granted the following stock option awards for the three and nine months ended September 30:

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2018 (1)
   
2017 (2)
   
2018
   
2017 (2)
 
Quantity
   
1,000,000
     
---
     
2,500,000
     
---
 
Weighted average fair value per share
 
$
0.03
     
---
   
$
0.03
     
---
 
Fair value
 
$
34,960
     
---
   
$
79,960
     
---
 

 
(1) 
On July 20, 2018, the Company granted to certain consultants stock option awards to purchase up to 1,000,000 shares of common stock at an exercise price of $0.05 per share during a term expiring on July 19, 2028 as payment for consulting services provided by such consultants.  The stock option awards vest based upon the respective consultant achieving certain revenue and performance goals.  The Company has evaluated the probability of each consultant's achievement of each revenue and performance goal and will continue such evaluation over the term of the stock option award.
 
(2) 
The Company did not award any shared-based compensation for the three and nine months ended September 30, 2017

We account for share-based compensation under FASB ASC Topic 718, Stock Compensation, which requires the measurement and recognition of compensation expense for all share-based payment awards made to employees, consultants, and directors based on estimated fair values of the award on the grant date.  We use the Black-Scholes option-pricing model to estimate the fair value of share-based awards with the following weighted average assumptions for the three and nine months ended September 30:

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
Stock Option Awards
 
2018
   
2017 (1)
   
2018
   
2017 (1)
 
  Expected volatility  (1)
   
138.7
%
   
---
     
137.3
%
   
---
 
  Risk-free interest rate %  (2)
   
2.89
%
   
---
     
2.69
%
   
---
 
  Expected term (in years)
   
10.0
     
---
     
7.0
     
---
 
  Dividend yield  (3)
   
---
     
---
     
---
     
---
 

(1) 
Expected volatility assumption was based upon a combination of historical stock price volatility measured on a daily basis and an estimate of expected future stock price volatility
(2) 
Risk-free interest rate assumption is based upon U.S. Treasury bond interest rates appropriate for the term of the stock options.
(3) 
The Company does not currently intend to pay cash dividends, thus has assumed a 0% dividend yield.
(4) 
The Company did not award any shared-based compensation for the three and nine months ended September 30, 2017.

Stock Options (Incentive and Nonstatutory)

The following table summarizes share-based compensation related to stock options for the three and nine months ended September 30:

   
Three Months Ended
September 30,
   
Nine Months Ended
September 30,
 
   
2018
   
2017
   
2018
   
2017
 
Regulatory, research and development
 
$
5,670
   
$
(3,345
)
 
$
11,469
   
$
---
 
Selling, general and administrative
   
1,126
     
2,571
     
1,126
     
7,923
 
  Total share-based compensation expense
 
$
6,796
   
$
(774
)
 
$
12,595
   
$
7,923
 

As of September 30, 2018, the balance of unearned share-based compensation to be expensed in future periods related to unvested stock option awards, as adjusted for expected forfeitures, is approximately $50,000.  The period over which the unearned share-based compensation is expected to be recognized is approximately seventy two months.

The following table summarizes the stock options outstanding and the number of shares of Common Stock subject to exercise as of September 30, 2018 and the changes therein during the nine months then ended:
   
Stock Options
   
Weighted Average Exercise Price per Share
 
Outstanding as of December 31, 2017
   
150,736
   
$
4.26
 
Granted
   
2,500,000
   
$
0.05
 
Forfeited/cancelled
   
(20,736
)
 
$
27.33
 
Exercised
   
---
     
---
 
Outstanding as of September 30, 2018
   
2,630,000
   
$
0.08
 
                 
Exercisable as of September 30, 2018
   
130,000
   
$
0.58
 
 
Summary of Plans

2006 Equity Incentive Plan

In March 2006, our Board adopted and our stockholders approved our 2006 Equity Incentive Plan, which initially provided for the issuance of up to 133,333 shares of our Common Stock pursuant to stock option and other equity awards.  At subsequent annual meetings of the stockholders held in 2007, 2009, 2010, 2012, 2013, and 2014, our stockholders approved amendments to the 2006 Equity Incentive Plan that increased the number of shares of Common Stock issuable under the 2006 Equity Incentive Plan to a total of 2,800,000 shares.
 
In December 2006, we began issuing stock options to employees, consultants, and directors.  The stock options issued generally vest over a period of one to four years and have a maximum contractual term of ten years.  In January 2007, we began issuing restricted stock awards to our employees.  Restricted stock awards generally vest over a period of six months to five years after the date of grant.  Prior to vesting, restricted stock awards do not have dividend equivalent rights, do not have voting rights and the shares underlying the restricted stock awards are not considered issued and outstanding.  Shares of Common Stock are issued on the date the restricted stock awards vest.

As of September 30, 2018, we had granted options to purchase 2,061,167 shares of Common Stock since the inception of the 2006 Equity Incentive Plan, of which 130,000 were outstanding at a weighted average exercise price of $0.58 per share, and we had granted awards for 68,616 shares of restricted stock since the inception of the 2006 Equity Incentive Plan, of which none were outstanding. As of March 29, 2016, the 2006 Equity Incentive Plan expired by its terms, and no additional awards may be granted thereunder.  The expiration of the 2006 Equity Incentive Plan does not affect outstanding awards.

2018 Equity Incentive Plan

On March 28, 2018, our Board of Directors adopted and approved our 2018 Equity Incentive Plan which initially provides for the issuance of up to 20,000,000 shares of our Common Stock pursuant to stock options and other equity awards.

As of September 30, 2018, we had granted options to purchase 2,500,000 shares of Common Stock since the inception of the 2018 Equity Incentive Plan, of which 2,500,000 were outstanding at a weighted average exercise price of $0.05 per share.  As of September 30, 2018, there were 17,500,000 shares that remain available for future grants under the 2018 Equity Incentive Plan.


NOTE 14.
FAIR VALUE MEASUREMENTS

In accordance with FASB ASC Topic 820, Fair Value Measurements, ("ASC Topic 820") certain assets and liabilities of the Company are required to be recorded at fair value.  Fair value is determined based on the exchange price that would be received for an asset or paid to transfer a liability in an orderly transaction between market participants.  The guidance in ASC Topic 820 also establishes a hierarchy for inputs used in measuring fair value that maximizes the use of observable inputs and minimized the use of unobservable inputs by requiring that the most observable inputs be used when available.

Observable inputs are based on market data obtained from independent sources, while unobservable inputs are based on our market assumptions.  Unobservable inputs require significant management judgment or estimation.  In some cases, the inputs used to measure an asset or liability may fall into different levels of the fair value hierarchy.  In those instances, the fair value measurement is required to be classified using the lowest level of input that is significant to the fair value measurement.  Such determination requires significant management judgment.
The three-tier value hierarchy, which prioritizes the inputs used in the valuation methodologies, is as follows:

 
Level 1
Valuations based on quoted prices (unadjusted) for identical assets or liabilities in active markets.

 
Level 2
Valuations based on observable inputs other than quoted prices in Level 1, such as quoted prices for similar assets or liabilities in active markets, quoted prices for identical or similar assets and liabilities in markets that are not active, and other inputs that are observable or can be corroborated by observable market data.

 
Level 3
Valuations based on unobservable inputs reflecting the Company's own assumptions, consistent with reasonably available assumptions made by other market participants.

Assets and liabilities are classified in their entirety based on the lowest level of input that is significant to the fair value measurements.  We review the fair value hierarchy classification on a quarterly basis.  Changes in the observability of valuation inputs may result in a reclassification of levels for certain securities within the fair value hierarchy.

Our financial instruments, including cash, cash equivalents, accounts receivable, and accounts payable are carried at cost, which approximates their fair value because of the short-term maturity of these instruments.  We believe that the carrying value of our promissory note payable balances approximates fair value based on a valuation methodology using the income approach and a discounted cash flow model.

The following table summarizes the fair value of our financial instruments at September 30, 2018 and December 31, 2017.

Description
 
September 30, 2018
   
December 31, 2017
 
  Liabilities:
           
Convertible Note Payable – Related Party – March 2017
 
$
500,000
   
$
500,000
 
Convertible Note Payable – Related Party – February 2017
 
$
500,000
   
$
500,000
 
Total
 
$
1,000,000
   
$
1,000,000
 


NOTE 15.
INCOME TAXES

There was no current federal tax provision or benefit recorded for any period since inception, nor were there any recorded deferred income tax assets and the Company has provided a full valuation allowance. As a result, the effective tax rate is zero and the net deferred tax assets are zero.



NOTE 16.
COMMITMENTS AND CONTINGENCIES

Operating Leases

On January 31, 2006 we entered into a lease agreement for office and laboratory space in Addison, Texas.  The lease commenced on April 1, 2006 and originally continued until April 1, 2013.  The lease required a minimum monthly lease obligation of $9,330, which was inclusive of monthly operating expenses, until April 1, 2011 and at such time increased to $9,776, which was inclusive of monthly operating expenses.  On February 22, 2013, we executed an Amendment to Lease Agreement (the "Lease Amendment") that renewed and extended our lease until March 31, 2015.  The Lease Amendment required a minimum monthly lease obligation of $9,193, which was inclusive of monthly operating expenses, until March 31, 2014 and at such time, increased to $9,379, which was inclusive of monthly operating expenses.  On March 17, 2015, we executed a Second Amendment to Lease Agreement (the "Second Amendment") that renewed and extended our lease until March 31, 2018.  The Second Amendment required a minimum monthly lease obligation of $9,436, which was inclusive of monthly operating expenses.

On December 15, 2017, we entered into a Termination of Lease Agreement whereby we cancelled our existing lease for office and laboratory space and concurrently entered into a new lease agreement (the "Office Lease") that will continue until December 2019.  The Office Lease encompasses approximately 2,500 rentable square feet and currently requires a minimum monthly lease obligation of $2,729, which is inclusive of monthly operating expenses.

We are also subject to two lease agreements for storage, housing, and warehouse space with each lease commencing in 2018 and continuing until no later than December 2019.  The lease agreements currently require a minimum monthly lease obligation of $2,783, which is inclusive of monthly operating expenses.

The future minimum lease payments under the Office Lease and the Warehouse Lease are as follows as of September 30, 2018:

Calendar Years
 
Future Lease Expense
 
  2018 (Three months)
 
$
16,415
 
  2019
   
60,367
 
  2020
   
---
 
  2021
   
---
 
  Total
 
$
76,782
 

Rent expense for our operating leases amounted to $13,875 and $30,301 for the three months ended September 30, 2018 and 2017, respectively, and $42,654 and $96,245 for the nine months ended September 30, 2018 and 2017, respectively.

Indemnification

In accordance with our restated articles of incorporation and our amended and restated bylaws, we have indemnification obligations to our officers and directors for certain events or occurrences, subject to certain limits, while they are serving at our request in their respective capacities.  We have a director and officer insurance policy that enables us to recover a portion of any amounts paid for future potential claims.  We have also entered into contractual indemnification agreements with each of our officers and directors.
 
Related Party Transactions and Concentration

Note, Warrant and Preferred Stock Purchase Agreement

On February 27, 2017, we entered into the Purchase Agreement with Velocitas and Velo LLC, an entity controlled by Velocitas, with respect to an aggregate financing of up to $6,000,000.

Refer to a description in greater detail of the financing event with Velocitas and Velo LLC in Note 9. Convertible Debt.

On March 31, 2017, the second closing of the Purchase Agreement included, among other transaction components, the Company acquiring the Altrazeal distributor agreements Velocitas had with its sub-distributors in exchange for the issuance of 13,375,000 shares of Common Stock.  The Company has valued the acquisition of the Altrazeal distributor agreement from Velocitas at $869,375 based on the closing price of $0.065 per share of the Company's Common Stock on March 31, 2017.

For the nine months ended September 30, 2018 and 2017, the Company recorded revenues, in approximate numbers, of nil and $214,000, respectively, with Velocitas GmbH, an affiliated entity of Velocitas, which represented 0% and 51% of our total revenues, respectively.  As of September 30, 2018 and December 31, 2017, Velocitas GmbH did not have any outstanding net accounts receivable.

Consulting Agreement – Velocitas GmbH

On April 1, 2017, the Company entered into a Consulting Agreement with Velocitas GmbH to provide the Company with operational support services in the fields of regulatory administration, finance, international customer account management, manufacturing, supply chain logistics, and other services required by the Company. Velocitas GmbH receives a monthly payment of $25,833 for providing such services to the Company.

Related Party Obligations

Since 2011, our named executive officers and certain key executives have temporarily deferred portions of their compensation as part of a plan to conserve and manage the Company's cash and financial resources.  As of September 30, 2018 and December 31, 2017, the Company's obligation to these executives for temporarily deferred compensation was approximately $72,000 which was included in accrued liabilities.

Contingent Milestone Obligations

We are subject to paying Access Pharmaceuticals, Inc. ("Access") for certain milestones based on our achievement of certain annual net sales, cumulative net sales, and/or our having reached certain defined technology milestones including licensing agreements and advancing products to clinical development.  As of September 30, 2018, the future milestone obligations that we are subject to paying Access, if the milestones related thereto are achieved, total $4,750,000.  Such milestones are based on total annual sales of 20 and 40 million dollars of certain products, annual sales of 20 million dollars of any one certain product, and cumulative sales of such products of 50 and 100 million dollars.  As of September 30, 2018, the Company has accrued approximately $43,000 of expense relating to future milestone payments to Access.
On March 7, 2008, we terminated the license agreement with ProStrakan Ltd. for Amlexanox-related products in the United Kingdom and Ireland.  As part of the termination, we agreed to pay ProStrakan Ltd. a royalty of 30% on any future payments received by us from a new licensee in the United Kingdom and Ireland territories, up to a maximum of $1,400,000.  On November 17, 2008, we entered into a licensing agreement for Amlexanox-related product rights to the United Kingdom and Ireland territories with MEDA AB.

Prescription Drug User Fee Obligation

The Company was assessed prescription drug user fees ("PDUFA") of approximately $535,000 by the United States Department of Health and Human Services (the "DHHS") for the sale and manufacture of Aphthasol® from 2009 to 2012.  In November 2017, the Company negotiated a settlement payment of $400,000 with DHHS thereby cancelling certain unpaid invoices and accrued penalties and interest thereon.  There continues to be a PDUFA fee and accrued penalties and interest that remains unpaid as of this Report.  Since the Company has not yet reached a settlement with the DHHS on the unpaid PDUFA fee, it is possible that the Company may be subject to additional collection costs.


NOTE 17.
LEGAL PROCEEDINGS

From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management's opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto; however, one or more events may lead to a formal dispute or proceeding in the future.


NOTE 18.
SUBSEQUENT EVENTS

Effective as of November 1, 2018, we agreed to issue to certain consulting firms warrants to purchase up to 1,000,000 shares of common stock with exercise prices ranging from $0.05 per share to $0.06 per share, with the warrants having a term expiring on November 1, 2028, as payment for consulting services provided by such consulting firms.  The warrants vest based upon the respective consulting firm achieving certain revenue and performance goals. The Company has evaluated the probability of each consulting firms achievement of each revenue and performance goal and will continue such evaluation over the term of the warrants.
 

 




ITEM 2.
Management's Discussion and Analysis of Financial Condition and Results of Operations.

You should read the following discussion and analysis together with all financial and non-financial information appearing elsewhere in this report and with our consolidated financial statements and related notes included in our Annual Report on Form 10-K for the year ended December 31, 2017, referred to as our 2017 Form 10-K, which has been previously filed with the Securities and Exchange Commission on March 30, 2018, including the risk factors set forth therein.  In addition to historical information, the following discussion and other parts of this report contain forward-looking information that involves risks and uncertainties.  Our actual results could differ materially from those anticipated by such forward-looking information due to competitive factors and other risks discussed in our 2017 Form 10-K under "Risks Associated with our Business".

SPECIAL NOTE REGARDING FORWARD-LOOKING STATEMENTS

This quarterly report on Form 10-Q (including documents incorporated by reference) (this "Report") and other written and oral statements the Company makes from time to time contain certain "forward-looking" statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934.  You can identify these forward-looking statements by the fact that they do not relate strictly to historical or current facts.  Forward-looking statements may include words such as "should", "expect", "anticipate", "estimate", "target", "may", "project", "guidance", "will", "intend", "plan", "believe" and other words and terms of similar meaning and expression in connection with any discussion of future operating or financial performance. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes to differ materially from current expectations. These statements are likely to relate to, among other things, the Company's goals, plans and projections regarding its financial position, statements indicating that the Company has cash and cash equivalents sufficient to fund our operations in the future, statements regarding expected cash flows, market position, product development, product approvals, future revenue, expense levels, performance or results of current and anticipated products and the outcome of contingencies such as legal proceedings, acquisitions, financings, and financial results, which are based on current expectations that involve inherent risks and uncertainties, including internal or external factors that could delay, divert or change any of them in the next several years.  Actual results will likely vary from anticipated results and may vary materially.
No assurance can be given that any goal or plan set forth in forward-looking statements can be achieved, and readers are cautioned not to place undue reliance on such statements, which speak only as of the date made.  We undertake no obligation to release publicly any revisions to forward-looking statements as a result of new information, future events or otherwise.

Business Overview

Business

ULURU Inc. (together with our subsidiaries, "we", "our", "us", "ULURU" or the "Company") is a Nevada corporation.  We are a specialty medical technology company committed to developing and commercializing innovative wound care and drug delivery systems based on our patented technologies.  Our mission is to improve the lives of patients the world over by delivering comprehensive solutions that optimize outcomes for the key stakeholders in our healthcare systems: patients, providers, and payers.
 
Utilizing our platform technologies, a number of products were developed of which one is being actively marketed in the wound care market. This product, Altrazeal® Transforming Powder Dressing ("Altrazeal®"), based on our Nanoflex® technology, has the potential to change the way health care providers approach wound treatment.  Altrazeal® is indicated for exuding acute wounds, both surgical and traumatic, as well as for chronic wounds such as venous leg ulcers, diabetic foot ulcers, and pressure ulcers. Altrazeal® is registered for sale with the United States Food and Drug Administration (the "FDA"), the European Union (the "EU") and a number of other international markets.

Our current strategy is to primarily focus on the commercialization of Altrazeal® and to establish a strong leadership position in wound management by developing and commercializing a customer focused portfolio of innovative wound care products.  We are also evaluating the potential for commercialization of the other products as well as explore strategic collaborations to further develop our oral mucoadhesive film technology (OraDiscTM) for systemic drug delivery and for delivery of actives to the oral cavity.

During 2017, we were successful in improving the sales of Altrazeal® particularly in international markets.  We were also able to achieve significant savings in our operating expense structure, which was highlighted by the settlement of certain liabilities at a level below the original indebtedness. In addition to recruiting new talent to stimulate revenue growth during 2017 and beyond, we also engaged a new regulatory team that reviewed and enhanced our existing quality management systems.

In 2018, we are continuing to execute a series of operational plans originally launched in 2017 to enhance and streamline our business. These include undertaking efforts to stimulate sales, enhance marketing, and expedite regulatory approvals for new market entry of Altrazeal® as well as to improve operational efficiencies and reduce costs. While we continue to focus on growing our international revenue base in 2018, we have also decided to initiate sales and marketing efforts in the United States.  In preparation for this, we have been reaching out to a number of potential customers to identify and validate potential marketing strategies for Altrazeal® that will reposition its entry into certain market segments and certain medical indications that may enable faster adoption and market penetration. We have also established a scientific advisory board with pre-eminent domestic and international experts in the advanced wound care field as well as launched a new website and other marketing collaterals for Altrazeal® in preparation of a global product relaunch.


RESULTS OF OPERATIONS

Fluctuations in Operating Results

Our results of operations have fluctuated significantly from period to period in the past and are likely to continue to do so in the future. We anticipate that our quarterly and annual results of operations will be impacted for the foreseeable future by several factors, including the timing and amount of payments received pursuant to our current and future collaborations, and the progress and timing of expenditures related to our development and commercialization efforts. Due to these fluctuations, we believe that the period-to-period comparisons of our operating results may not be a good indication of our future performance.
 
Comparison of the three months ended September 30, 2018 and 2017

Total Revenues

Revenues were approximately $85,000 for the three months ended September 30, 2018, as compared to revenues of approximately $201,000 for the three months ended September 30, 2017, and were composed of entirely of Altrazeal® product sales.  The decrease of $116,000 in revenues is primarily attributable to the timing of Altrazeal® product orders received from our international distributors and due to some production delays driven by regulatory related process changes.
 
Costs and Expenses

Cost of Goods Sold

Cost of goods sold for the three months ended September 30, 2018 were approximately $31,000 and were composed of, in approximate numbers, $26,000 from the sale of Altrazeal® and $5,000 from the write-off of obsolete product components.  Cost of goods sold for the three months ended September 30, 2017 were approximately $74,000 and were composed of, in approximate numbers, $69,000 from the sale of Altrazeal® and $5,000 from the write-off of obsolete raw materials.

Regulatory, Research and Development

Regulatory, research and development expenses totaled approximately $77,000 for the three months ended September 30, 2018 as compared to approximately $90,000 for the three months ended September 30, 2017.  The decrease of approximately $13,000 in regulatory, research and development expenses was primarily due to, in approximate numbers, a decrease of $32,000 in regulatory consulting costs and a decrease of $9,000 in facility related costs.  These expense decreases were partially offset by an increase of $28,000 in direct research costs as the prior year costs included a non-recurring expense adjustment.

Selling, General and Administrative

Selling, general and administrative expenses totaled approximately $379,000 for the three months ended September 30, 2018 as compared to approximately $315,000 for the three months ended September 30, 2017.  The increase of approximately $64,000 in selling, general and administrative expenses was primarily due to, in approximate numbers, an increase of $51,000 in costs associated with the marketing and promotion of Altrazeal®, an increase of $34,000 in patent related costs due to timing of annual patent annuity fees, and an increase of $7,000 in costs for accounting services related to accruals for the current year audit.  These expense increases were partially offset by, in approximate numbers, a decrease of $17,000 in compensation costs, and a decrease of $11,000 in facility related costs.

Amortization of Intangible Assets

Amortization of intangible assets expense totaled approximately $114,000 for the three months ended September 30, 2018 as compared to approximately $114,000 for the three months ended September 30, 2017.  The expense for each period consists primarily of amortization associated with our acquired patents and licensing rights.
Depreciation

Depreciation expense totaled approximately $5,000 for the three months ended September 30, 2018 as compared to approximately $5,000 for the three months ended September 30, 2017.

Interest Expense

Interest expense totaled approximately $128,000 for the three months ended September 30, 2018 as compared to approximately $134,000 for the three months ended September 30, 2017.  Interest expense typically includes interest costs related to regulatory fees and interest costs and amortization of debt discount and debt issuance costs related to debt.  The decrease of approximately $6,000 in interest expense is primarily attributable to costs associated with regulatory fees that were settled in November 2017.

Foreign Currency Transaction Loss

Foreign currency transaction loss totaled approximately $4,000 for the three months ended September 30, 2018 as compared to a foreign currency transaction loss of approximately $6,000 for the three months ended September 30, 2017.  The decrease in foreign currency transaction loss of approximately $2,000 is related to fluctuations in the Euro exchange rate experienced during 2018 and the pricing of Altrazeal® to our international distributors being denominated in Euros.
 
 
Comparison of the nine months ended September 30, 2018 and 2017

Total Revenues

Revenues were approximately $274,000 for the nine months ended September 30, 2018, as compared to revenues of approximately $422,000 for the nine months ended September 30, 2017, and were composed entirely of Altrazeal® product sales.  The decrease of $148,000 in revenues is primarily attributable to the timing of Altrazeal® product orders received from our international distributors and due to some production delays driven by regulatory related process changes.

Costs and Expenses

Cost of Goods Sold

Cost of goods sold for the nine months ended September 30, 2018 were approximately $102,000 and were composed of, in approximate numbers, $91,000 from the sale of Altrazeal® and $11,000 from the write-off of obsolete product components.  Cost of goods sold for the nine months ended September 30, 2017 were approximately $179,000 and were composed of, in approximate numbers, $174,000 from the sale of Altrazeal® and $5,000 from the write-off of obsolete raw materials.
 
Regulatory, Research and Development

Regulatory, research and development expenses totaled approximately $161,000 for the nine months ended September 30, 2018 as compared to approximately $199,000 for the nine months ended September 30, 2017.  The decrease of approximately $38,000 in regulatory, research and development expenses was primarily due to, in approximate numbers, a decrease of $45,000 in scientific compensation related to lower head-count and lower share-based compensation, a decrease of $31,000 in facility related costs, and a decrease of $8,000 in regulatory consulting costs.  These expense decreases were partially offset by an increase of $18,000 in scientific advisory consulting costs and an increase of $28,000 in direct research costs as the prior year costs included a non-recurring expense adjustment.

Selling, General and Administrative

Selling, general and administrative expenses totaled approximately $1,109,000 for the nine months ended September 30, 2018 as compared to approximately $1,017,000 for the nine months ended September 30, 2017.  The increase of approximately $92,000 in selling, general and administrative expenses was primarily due to, in approximate numbers, an increase of $71,000 in costs associated with the marketing and promotion of Altrazeal®, an increase of $47,000 in patent related legal and annual annuity costs, an increase of $35,000 in legal costs, an increase of $31,000 in costs for accounting services related to transitional costs for appointing a new independent accounting firm and accruals for the current year audit, and an increase of $7,000 in other miscellaneous expenses.  These expense increases were partially offset by, in approximate numbers, a decrease of $33,000 in facility related costs, a decrease of $31,000 in royalty expenses associated with product sales as the prior year included a non-recurring expense adjustment, a decrease of $20,000 in insurance costs, and a decrease of $15,000 in compensation costs.

Amortization of Intangible Assets

Amortization of intangible assets expense totaled approximately $339,000 for the nine months ended September 30, 2018 as compared to approximately $317,000 for the nine months ended September 30, 2017.  The expense for each period consists primarily of amortization associated with our acquired patents and licensing rights.  The increase of approximately $22,000 in amortization expense is attributable to the purchase of additional licensing rights of approximately $869,000 from Velocitas that occurred in March 2017.

Depreciation

Depreciation expense totaled approximately $16,000 for the nine months ended September 30, 2018 as compared to approximately $71,000 for the nine months ended September 30, 2017.  The decrease of approximately $55,000 is attributable to certain equipment being fully depreciated.
Interest Expense

Interest expense totaled approximately $380,000 for the nine months ended September 30, 2018 as compared to approximately $289,000 for the nine months ended September 30, 2017.  Interest expense typically includes interest costs related to regulatory fees and interest costs and amortization of debt discount and debt issuance costs related to debt.  The increase of approximately $91,000 in interest expense is primarily attributable to costs associated with the two convertible promissory notes issued to Velocitas as part of the $6,000,000 offering of convertible notes and equity securities pursuant to the Purchase Agreement with Velocitas and Velo LLC.

Foreign Currency Transaction Loss

Foreign currency transaction loss totaled approximately $10,000 for the nine months ended September 30, 2018 as compared to a foreign currency transaction loss of approximately $9,000 for the nine months ended September 30, 2017.
 
LIQUIDITY AND CAPITAL RESOURCES

We have funded our operations primarily through the public and private sales of convertible notes and Common Stock.  Product sales, royalty payments, contract research, licensing fees and milestone payments from our corporate alliances have also provided, and are expected in the future to provide, funding for operations.

Our principal source of liquidity is cash and cash equivalents.  As of September 30, 2018, our cash and cash equivalents were approximately $2,813,000 which is a decrease of approximately $898,000 as compared to our cash and cash equivalents at December 31, 2017 of approximately $3,711,000.  Our working capital (current assets less current liabilities) was approximately $1,129,000 at September 30, 2018 as compared to our working capital at December 31, 2017 of approximately $3,123,000.

Consolidated Cash Flow Data
     
   
Nine Months Ended September 30,
 
Net Cash Provided by (Used in)
 
2018
   
2017
 
Operating activities
 
$
(927,000
)
 
$
(1,308,000
)
Investing activities
   
29,000
     
(4,000
)
Financing activities
   
---
     
5,879,000
 
  Net increase in cash and cash equivalents
 
$
(898,000
)
 
$
4,567,000
 
 
Operating Activities

For the nine months ended September 30, 2018, net cash used in operating activities was approximately $927,000.  The principal components of net cash used for the nine months ended September 30, 2018 were, in approximate numbers, our net loss of $1,810,000 and a decrease of $45,000 in accounts payable due to timing of payments to our vendors.  Our net loss for the nine months ended September 30, 2018 included substantial non-cash charges of approximately $606,000, in the form of share-based compensation, amortization of patents and licensing rights, depreciation, amortization of debt discount, amortization of debt issuance costs, and a gain on the sale of equipment.  The aforementioned net cash used for the nine months ended September 30, 2018 was partially offset by, in approximate numbers, an increase of $94,000 in accrued interest related to our convertible promissory notes, an increase of $19,000 in deferred revenue due to deposits received on product orders, a decrease of $84,000 in accounts receivable due to collection activities, a decrease of $75,000 in inventories, a decrease of $37,000 in prepaid expenses related to insurance and listing fees, and a decrease of $13,000 in deposits related to our office space lease.

For the nine months ended September 30, 2017, net cash used in operating activities was approximately $1,308,000.  The principal components of net cash used for the nine months ended September 30, 2017 were, in approximate numbers, our net loss of $1,544,000, a decrease of $116,000 in accounts payable due to timing of vendor payments, a decrease of $112,000 in accrued liabilities due to payment of temporary compensation deferrals, a decrease of $15,000 in deferred revenues due to amortization of revenues, an increase of $102,000 in accounts receivable due to timing of customer remittances, and an increase of $9,000 in prepaid expenses related to insurance policy renewals.  Our net loss for the nine months ended September 30, 2017 included substantial non-cash charges of approximately $460,000 in the form of share-based compensation, amortization of patents and licensing rights, depreciation, amortization of debt discount, and amortization of debt issuance costs.  The aforementioned net cash used for the nine months ended September 30, 2017 was partially offset by, in approximate numbers, an increase of $68,000 in accrued interest and a decrease of $62,000 in inventories.

Investing Activities

Net cash provided by investing activities for the nine months ended September 30, 2018 was approximately $29,000 and was composed of the proceeds from the sale of manufacturing equipment.

Net cash used in investing activities for the nine months ended September 30, 2017 was approximately $4,000 and relates to the purchase of computer equipment.

Financing Activities

There were no financing activities for the nine months ended September 30, 2018.

Net cash provided by financing activities for the nine months ended September 30, 2017 was approximately $5,879,000 and was composed of, in approximate numbers, the net proceeds of $5,899,000 from the March 2017 Offering and the net proceeds of $120,000 from certain short-term promissory notes issued to Velocitas and Kirkwood Investors, Inc. ("Kirkwood").  The aforementioned net cash provided for the nine months ended September 30, 2017 was partially offset by the repayment of $140,000 of short-term promissory notes issued to Velocitas and Kirkwood.
Liquidity

As of September 30, 2018, we had cash and cash equivalents of approximately $2,813,000.  We expect to use our cash, cash equivalents, and investments on working capital, for general corporate purposes, on property and equipment, and for the payment of contractual obligations.  Our long-term liquidity will depend to a great extent on our ability to fully commercialize our Altrazeal® wound care product; therefore, we are continuing to look both domestically and internationally for opportunities that will enable us to expand our business.  At this time, we cannot accurately predict the effect of certain developments on the rate of sales growth, if any, during 2018 and beyond, such as the speed and degree of market acceptance, the impact of competition, the effectiveness of the sales and marketing efforts of our distributors and sub-distributors, and the outcome of our current efforts to develop, receive approval for, and successfully launch our near-term product candidates.

As of September 30, 2018, our net working capital (current assets less current liabilities) was approximately $1,129,000 and we believe that our liquidity will be sufficient to fund operations beyond 2018.

In the event that we need to raise capital in the future, due to our limited revenue we may be unable to obtain the necessary financing on terms acceptable to us, or at all.  If we are unable to raise capital when needed, we would be unable to continue our operations.  Even if we are able to raise capital, we may raise capital by selling equity securities or convertible debt securities, which will be dilutive to existing stockholders.  If we incur additional indebtedness, costs of financing may be extremely high, and we will be subject to default risks associated with such indebtedness, which may harm our ability to continue our operations.  We have no commitments with respect to additional capital.

Our future capital requirements and adequacy of available funds will depend on many factors including:

§  
our ability to successfully commercialize our wound management product and the market acceptance of this product;
§  
our ability to establish and maintain collaborative arrangements with business partners for the development and commercialization of certain product opportunities;
§  
scientific progress in our development programs;
§  
the marketing and sales efforts of our distributors and sub-distributors;
§  
the costs involved in filing, prosecuting and enforcing patent claims and our maintenance of patent rights;
§  
our ability to obtain favorable reimbursement approvals in various jurisdictions;
§  
the cost of manufacturing and production scale-up;
§  
competing product developments;
§  
the trading volume and price of our capital stock;
§  
the actions of parties whose consents, waivers or prompt responses are required for approval of a financing (such as parties with rights of first refusal or consent rights); and
§  
our general financial situation, including our revenues, liquidity, capitalization, and other factors.

 
Contractual Obligations

The following table summarizes our outstanding contractual cash obligations as of September 30, 2018, which is composed of lease agreements for storage, housing, and warehouse space in the Dallas metroplex.  These obligations and commitments assume non-termination of agreements and represent expected payments based on current operating forecasts, which are subject to change:

   
Payments Due By Period
 
Contractual Cash Obligations
 
Total
   
Less Than
1 Year
   
1-2
Years
   
3-5
Years
   
After 5
Years
 
  Operating leases
 
$
76,782
   
$
63,710
   
$
13,072
   
$
---
   
$
---
 
    Total contractual cash obligations
 
$
76,782
   
$
63,710
   
$
13,072
   
$
---
   
$
---
 


Capital Expenditures

For the nine months ended September 30, 2018 and 2017, our expenditures for property, equipment, and leasehold improvements were nil and approximately $4,000, respectively, and consisted primarily of computer equipment.

Off-Balance Sheet Arrangements

As of September 30, 2018, we did not have any off-balance sheet arrangements.

Impact of Inflation

We have experienced only moderate price increases over the last three fiscal years under our agreements with third-party manufacturers as a result of raw material and labor price increases.  However, there can be no assurance that possible future inflation would not impact our operations.

Concentrations of Credit Risk

Concentration of credit risk with respect to financial instruments, consisting primarily of cash and cash equivalents, potentially expose us to concentrations of credit risk due to the use of a limited number of banking institutions and due to maintaining cash balances in banks, which, at times, may exceed the limits of amounts insured by the Federal Deposit Insurance Corporation.  Currently, we utilize JP Morgan/Chase Bank, Bank of America, N.A., and South State Bank as our banking institutions.  At September 30, 2018 and December 31, 2017 our cash and cash equivalents totaled approximately $2,813,000 and $3,711,000, respectively.  We also invest cash in excess of immediate requirements in money market accounts, certificates of deposit, corporate commercial paper with high quality ratings, and U.S. government securities.  These investments are not held for trading or other speculative purposes.  We are exposed to credit risk in the event of default by these institutions.
 
Concentration of credit risk with respect to trade accounts receivable are customers with balances that exceed 5% of total consolidated trade accounts receivable at September 30, 2018 and at December 31, 2017.  As of September 30, 2018, two customers exceeded the 5% threshold, jointly with 93%.  As of December 31, 2017, three customers exceeded the 5% threshold, jointly with 92%.  We routinely assess the financial strength of our most significant customers and monitoring the amounts owed to us, taking appropriate action when necessary.  As a result, we believe that our prospective accounts receivable credit risk exposure is limited.

Concentrations of Foreign Currency Risk

Currently, a portion of our revenues and all of our expenses are denominated in U.S. dollars. We are experiencing an increase in revenues in international territories denominated in a foreign currency.  Certain of our licensing and distribution agreements in international territories are denominated in Euros.  Currently, we do not employ forward contracts or other financial instruments to mitigate foreign currency risk.  As our international operations continue to grow, we may engage in hedging activities to hedge our exposure to foreign currency risk.


CRITICAL ACCOUNTING POLICIES AND ESTIMATES

Management's Discussion and Analysis of Financial Condition and Results of Operations addresses our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States ("GAAP") for interim financial information. The preparation of our financial statements requires that we make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. We evaluate these estimates and judgments on an on-going basis. We base our estimates and judgments on historical experience and on various other factors that are believed to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.  Our critical accounting policies are summarized in our 2017 Form 10-K as filed with the Securities and Exchange Commission on March 30, 2018.  We had no significant changes in our critical accounting policies since our last annual report except as described in "Note 3. Significant Accounting Policies" included in this Report.


ITEM 3.
Quantitative and Qualitative Disclosures About Market Risk.

This item is not applicable to smaller reporting companies.

ITEM 4.
Controls and Procedures.

Evaluation of Disclosure Controls and Procedures

As of the end of the period covered by this Quarterly Report on Form 10-Q, we carried out an evaluation, under the supervision and with the participation of our management, including our Chief Executive Officer and our Chief Financial Officer, of the effectiveness of our disclosure controls and procedures, (as defined in Rule 13a-15(e) under the Securities and Exchange Act of 1934, as amended, (the "Exchange Act")).  Disclosure controls and procedures are controls and other procedures designed to reasonably assure that information required to be disclosed in our reports filed or submitted under the Exchange Act, such as this Quarterly Report on Form 10-Q, is recorded, processed, summarized and reported within the time periods specified in the Securities and Exchange Commission's rules and forms. Disclosure controls and procedures are also designed to reasonably assure that this information is accumulated and communicated to our management, including the Chief Executive Officer and the Chief Financial Officer, to allow timely decisions regarding required disclosure.

Based on this evaluation, our principal executive officer and principal financial officer concluded that as of September 30, 2018, our disclosure controls and procedures were not effective, at a reasonable assurance level, to ensure that information we are required to disclose in the reports we file or submit under the Exchange Act is (a) recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms and is (b) accumulated and communicated to our management, including our principal executive officer and principal financial officer as appropriate to allow timely decisions regarding required disclosure, primarily as a result of the lack of segregation of duties due to a limited number of employees.
 
Changes in Internal Controls Over Financial Reporting

There were no changes in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act) that occurred during the period covered by this Quarterly Report on Form 10-Q that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.


PART II - OTHER INFORMATION


ITEM 1.
 Legal Proceedings.

From time to time, we may be involved in litigation relating to claims arising out of our operations in the normal course of business. We are not currently a party to any legal proceedings, the adverse outcome of which, in management's opinion, individually or in the aggregate, would have a material adverse effect on the results of our operations or financial position. There are no material proceedings to which any director, officer or any of our affiliates, any owner of record or beneficially of more than five percent of any class of our voting securities, or any associate of any such director, officer, our affiliates, or security holder, is a party adverse to us or our consolidated subsidiary or has a material interest adverse thereto; however, one or more events may lead to a formal dispute or proceeding in the future.


ITEM 1A.
 Risk Factors.

This item is not applicable to smaller reporting companies.  Information about certain risks associated with an investment in our Common Stock is found in Part I, Item 1A of our 2017 Form 10-K.


ITEM 2.
Unregistered Sales of Equity Securities and Use of Proceeds.
 
Set forth below is a description of unregistered sales of equity securities, to the extent not previously reported on a Current Report on Form 8-K.

Effective as of November 1, 2018, we agreed to issue to certain consulting firms warrants to purchase up to 1,000,000 shares of common stock with exercise prices ranging from $0.05 per share to $0.06 per share, with the warrants having a term expiring on November 1, 2028, as payment for consulting services provided by such consulting firms.  The warrants vest based upon the respective consulting firm achieving certain revenue and performance goals. The Company has evaluated the probability of each consulting firms achievement of each revenue and performance goal and will continue such evaluation over the term of the warrants.
 
The warrants above will be issued in reliance upon the exemptions for sales of securities not involving a public offering, as set forth in Section 4(a)(2) of the Securities Act of 1933, as amended (the "Securities Act") and/or Regulation D promulgated under the Securities Act, based upon the following: (a) each investor confirmed that it had such background education and experience in financial and business matters as to be able to evaluate the merits and risks of an investment in the securities; (b) each investor confirmed that it was an "accredited investor" as defined in Rule 501(a) under the Securities Act; (c) there was no public offering or general solicitation with respect to the offering; (d) each investor was provided with certain disclosure materials and all other information requested with respect to the Company; (e) each Investor acknowledged that the securities being purchased were "restricted securities" for purposes of the Securities Act and agreed to transfer the underlying securities only in a transaction registered under the Securities Act or exempt from registration under the Securities Act; and (f) restrictive legends will be placed on the shares of common stock issuable upon exercise of the warrants.
 
 
  
ITEM 3.
Defaults Upon Senior Securities.

None.


ITEM 4.
Mine Safety Disclosures.

Not applicable.


ITEM 5.
Other Information.

None.



ITEM 6.
Exhibits.

Exhibit Number
 
Description
 
 
101.INS
***
XBRL Instance Document
101.SCH
***
XBRL Taxonomy Extension Schema Document
101.CAL
***
XBRL Taxonomy Extension Calculation Linkbase Document
101.DEF
***
XBRL Taxonomy Extension Definition Linkbase Document
101.LAB
***
XBRL Taxonomy Extension Label Linkbase Document
101.PRE
***
XBRL Taxonomy Extension Presentation Linkbase Document
---------------------------------------------------
(1)
 
Incorporated by reference to the Company's Form 10-Q filed on August 14, 2017.
(2)
 
Incorporated by reference to the Company's Form 8-K filed on December 11, 2008.
 
*
Filed herewith.
 
**
Filed herewith.  This exhibit shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 or otherwise subject to the liabilities of that Section nor shall it be deemed incorporated by reference in any filings under the Securities Act of 1933 or the Securities and Exchange Act of 1934.
 
***
Pursuant to Rule 406T of Regulation S-T, the XBRL-related information in Exhibit 101 to this Quarterly Report on Form 10-Q is deemed not filed or part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, is deemed not filed for purposes of Section 18 of the Securities and Exchange Act of 1934, and otherwise is not subject to liability under these sections.



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.

 
ULURU Inc.
 
 
 Date:  November 14, 2018
 
By:
 /s/ Vaidehi Shah
 
 
 
Vaidehi Shah
   
Chief Executive Officer
 
 
(Principal Executive Officer)
 
 
 
 
 Date:  November 14, 2018
 
By:
 /s/ Terrance K. Wallberg
 
   
Terrance K. Wallberg
   
Chief Financial Officer and Vice President
 
 
(Principal Financial and Accounting Officer)

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