0001213900-16-018214.txt : 20161110 0001213900-16-018214.hdr.sgml : 20161110 20161110165248 ACCESSION NUMBER: 0001213900-16-018214 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 40 CONFORMED PERIOD OF REPORT: 20160930 FILED AS OF DATE: 20161110 DATE AS OF CHANGE: 20161110 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CTD HOLDINGS INC CENTRAL INDEX KEY: 0000922247 STANDARD INDUSTRIAL CLASSIFICATION: INDUSTRIAL ORGANIC CHEMICALS [2860] IRS NUMBER: 593029743 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: 1934 Act SEC FILE NUMBER: 000-25466 FILM NUMBER: 161988776 BUSINESS ADDRESS: STREET 1: 14120 NW 126TH TERRACE CITY: ALACHUA STATE: FL ZIP: 32615-4816 BUSINESS PHONE: 386-418-8060 MAIL ADDRESS: STREET 1: 14120 NW 126TH TERRACE CITY: ALACHUA STATE: FL ZIP: 32615-4816 FORMER COMPANY: FORMER CONFORMED NAME: CYCLODEXTRIN TECHNOLOGIES DEVELOPMENT INC DATE OF NAME CHANGE: 19941012 10-Q 1 f10q0916_ctdholdingsinc.htm QUARTERLY REPORT

 

  

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION

Washington, D. C. 20549

 

FORM 10-Q

 

☒   Quarterly Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

 

For the quarterly period ended: September 30, 2016

 

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: 0-25466

 

CTD HOLDINGS, INC.

(Exact name of registrant as specified in its charter)

 

Florida   59-3029743
(State or other jurisdiction of
incorporation or organization)		   (IRS Employer
Identification No.)

 

 14120 N.W. 126th Terrace, Alachua, Florida   32615
(Address of principal executive offices)   (Zip Code)

 

Registrant's telephone number, including area code: 386-418-8060

  

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the 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, or a smaller reporting company. See the definitions of 'large accelerated filer, 'accelerated filer,' and 'smaller reporting company' in Rule 12b-2 of the Exchange Act.

 

  Large accelerated filer ☐  Accelerated filer ☐ 
  Non-accelerated filer ☐  Smaller reporting company ☒
         

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)

☐ Yes ☒ No

 

As of November 10, 2016, the Company had outstanding 66,952,529 shares of its common stock.

 

 

 

 
 

  

TABLE OF CONTENTS

 

  Description   Page
       
PART I FINANCIAL INFORMATION   1
Item 1. Financial Statements.   1
  Consolidated Balance Sheets as of September 30, 2016 (Unaudited) and December 31, 2015.   1
  Consolidated Statements of Operations (Unaudited) for the Three and Nine Months Ended September 30, 2016 and 2015.   2
  Consolidated Statements of Cash Flows (Unaudited) for the Nine Months Ended September 30, 2016 and 2015.   3
  Notes to Consolidated Financial Statements.   4
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations.   9
Item 3. Quantitative and Qualitative Disclosures about Market Risk.   13
Item 4. Controls and Procedures.   13
PART II OTHER INFORMATION   14
Item 1A. Risk Factors.   14
Item 6. Exhibits.   14
       
SIGNATURES   15

  

 
 

 

PART I. FINANCIAL INFORMATION

 

Item 1. Financial Statements.

 

CTD HOLDINGS, INC.

CONSOLIDATED BALANCE SHEETS

 

   September 30, 2016   December 31, 2015 
   (Unaudited)     
ASSETS
CURRENT ASSETS        
Cash and cash equivalents  $1,270,046   $1,842,233 
Accounts receivable, net   124,234    55,636 
Inventory   595,366    610,166 
Current portion of mortgage note receivable   27,228    - 
Other current assets   1,678    14,851 
Total current assets   2,018,552    2,522,886 
           
PROPERTY AND EQUIPMENT, NET   33,691    1,892,943 
           
OTHER ASSETS          
Property held for sale   963,115    275,000 
Mortgage note receivable, less current portion   218,569    - 
Total other assets   1,181,684    275,000 
           
TOTAL ASSETS  $3,233,927   $4,690,829 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY          
           
CURRENT LIABILITIES          
Accounts payable and accrued expenses  $267,716   $257,537 
Notes payable   608,232    653,313 
Line of credit   -    34,296 
Total current liabilities   875,948    945,146 
           
STOCKHOLDERS' EQUITY          
Common stock, par value $.0001 per share, 100,000,000 shares authorized, 66,952,529 and 58,670,347 shares issued and outstanding, respectively   6,695    5,867 
Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, no shares issued or outstanding   -    - 
Additional paid-in capital   11,018,915    9,015,582 
Accumulated deficit   (8,667,631)   (5,275,766)
Total stockholders' equity   2,357,979    3,745,683 
           
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY  $3,233,927   $4,690,829 

 

 See accompanying Notes to Consolidated Financial Statements.

 

 1 

 

 

CTD HOLDINGS, INC.

CONSOLIDATED STATEMENTS OF OPERATIONS

(Unaudited)

 

   Three Months Ended   Nine Months Ended 
   September 30,   September 30, 
   2016   2015   2016   2015 
                 
REVENUES                
Product sales  $278,196   $234,660   $975,267   $788,198 
                     
EXPENSES                    
Personnel   327,858    222,922    1,010,296    551,194 
Cost of products sold (exclusive of amortization and depreciation, shown separately below)   30,893    25,219    123,896    105,091 
Research and development   311,351    221,362    1,254,900    399,427 
Repairs and maintenance   3,334    7,144    19,073    23,693 
Professional fees   175,616    101,097    454,646    324,005 
Office and other   171,425    85,005    478,740    212,792 
Board of Director fees and costs   53,195    140,068    99,576    391,857 
Amortization and depreciation   3,789    44,426    92,146    124,990 
Freight and shipping   1,465    2,599    5,257    5,929 
Loss (gain) on disposal of property and equipment   -    -    4,489    (700)
Impairment on assets held for sale   810,000    125,000    810,000    125,000 
    1,888,926    974,842    4,353,019    2,263,278 
                     
LOSS FROM OPERATIONS   (1,610,730)   (740,182)   (3,377,752)   (1,475,080)
                     
OTHER INCOME (EXPENSE)                    
Investment and other income   2,766    375    7,609    2,615 
Interest expense   (6,969)   (7,749)   (21,722)   (23,527)
    (4,203)   (7,374)   (14,113)   (20,912)
                     
LOSS BEFORE INCOME TAXES   (1,614,933)   (747,556)   (3,391,865)   (1,495,992)
                     
Provision for income taxes   -    -    -    - 
                     
NET LOSS  $(1,614,933)  $(747,556)  $(3,391,865)  $(1,495,992)
                     
BASIC AND FULLY DILUTED NET LOSS PER
 COMMON SHARE		  $(.02)  $(.01)  $(.05)  $(.03)
                     
WEIGHTED AVERAGE NUMBER OF COMMON
 SHARES OUTSTANDING		   66,889,822    57,262,835    62,121,283    55,390,366 

 

See Accompanying Notes to Consolidated Financial Statements.

  

 2 

 

 

CTD HOLDINGS, INC.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(Unaudited)

 

   Nine Months Ended 
   September 30, 
   2016   2015 
CASH FLOWS FROM OPERATING ACTIVITIES        
Net loss  $(3,391,865)  $(1,495,992)
           
Adjustments to reconcile net loss to net cash used in operating activities:          
Depreciation and amortization   92,146    124,990 
Loss (gain) on sale of property and equipment   4,489    (700)
Impairment on assets held for sale   810,000    125,000 
Stock compensation to employees   57,114    - 
Stock compensation to non-employees   44,106    - 
Increase or decrease in:          
Accounts receivable   (68,598)   (33,279)
Inventory   19,758    (63,941)
Other current assets   13,173    (8,183)
Accounts payable and accrued expenses   33,120    185,541 
Total adjustments   1,005,308    329,428 
           
NET CASH USED IN OPERATING ACTIVITIES   (2,386,557)   (1,166,564)
           
CASH FLOWS FROM INVESTING ACTIVITIES          
Purchase of equipment and building improvements   (9,343)   (337,884)
Proceeds from mortgage note receivable   19,203    - 
Proceeds from sale of property and equipment, net of closing costs   5,510    700 
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES   15,370    (337,184)
           
CASH FLOWS FROM FINANCING ACTIVITIES          
Principal payments on notes payable   (46,704)   (44,484)
Payments on line of credit   (34,296)   - 
Net proceeds from sale of common stock and warrants   1,880,000    1,910,595 
NET CASH PROVIDED BY FINANCING ACTIVITIES   1,799,000    1,866,111 
           
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS   (572,187)   362,363 
           
CASH AND CASH EQUIVALENTS, beginning of period   1,842,233    2,380,054 
           
CASH AND CASH EQUIVALENTS, end of period  $1,270,046   $2,742,417 
           
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION          
Cash paid for interest  $21,722   $23,527 
           
Cash paid for income taxes  $-   $- 
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING          
Exchange of property held for sale for a mortgage note receivable  $265,000   $- 

 

See Accompanying Notes to Consolidated Financial Statements.

 

 3 

 

 

CTD HOLDINGS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

 

The information presented herein as of September 30, 2016 and for the three and nine months ended September 30, 2016 and 2015 is unaudited.

 

(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

 

The following is a summary of the more significant accounting policies of CTD Holdings, Inc. and subsidiaries (the “Company”) that affect the accompanying consolidated financial statements.

 

(a) ORGANIZATION AND OPERATIONS––The Company was incorporated in August 1990, as a Florida corporation with operations beginning in July 1992. We are a biotechnology company that develops cyclodextrin-based products for the treatment of disease. We have filed a Type II Drug Master File with the U.S. Food and Drug Administration (“FDA”) for our lead drug candidate, Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”), and recently filed an Investigational New Drug application (IND) with the FDA which describes our Phase I clinical plans in the US. The Company has also filed a Clinical Trial Application with the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and launched an International Clinical Program for Trappsol® Cyclo™.

 

While we also sell cyclodextrins and related products to the pharmaceutical, nutritional, and other industries, primarily for use in diagnostics and specialty drugs with continuing growth in research and new product development, our core business has transitioned to a biotechnology company primarily focused on the development of cyclodextrin-based biopharmaceuticals for the treatment of disease from a business which had been primarily reselling basic cyclodextrin products. 

  

(b) BASIS OF PRESENTATION––The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.

 

Operating results for the three and nine-month periods ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 30, 2016.

 

(c) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original maturity of three months or less.

 

(d) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and non-interest bearing and stated at the amount we expect to collect from outstanding balances. Based on our assessment of the credit history with customers having outstanding balances and current relationships with them, we have concluded that losses on balances outstanding at September 30, 2016 and December 31, 2015 will be immaterial.

 

(e) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our pharmaceutical drug Trappsol® Cyclo™, cyclodextrin products and chemical complexes purchased for resale recorded at the lower of cost (first-in, first-out) or net realizable. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense.

 

 4 

 

 

CTD HOLDINGS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

 

(f) PROPERTY AND EQUIPMENT––Property and equipment are recorded at cost. Depreciation on property and equipment is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three to five years for computers and vehicles, seven to ten years for machinery and furniture, fifteen years for certain land improvements, and forty years for buildings and building improvements). We periodically review our long-lived assets to determine if the carrying value of assets may not be recoverable. If an impairment is identified, we recognize a loss for the difference between the carrying amount and the estimated fair value of the asset (see Note 2).

 

(g) REVENUE RECOGNITION––We recognize revenue from product sales, royalties, and drying services rendered when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable, and collectability is reasonably assured. Product sales and shipping revenues, net of any discounts or return allowances, are recorded when the products are shipped and title passes to customers. Sales to customers are made pursuant to a sales contract that provides for transfer of both title and risk of loss upon our delivery to the carrier. Return allowances, which reduce product revenue, have been historically infrequent, and are recorded when they become known. Amounts received in advance are deferred and recognized as revenue when all four revenue recognition criteria have been met. There is no deferred revenue at September 30, 2016 and December 31, 2015.

 

(h) RESEARCH AND DEVELOPMENT COSTS––Research and development costs are expensed as incurred.

 

(i) INCOME TAXES––Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. In addition, tax benefits related to positions considered uncertain are recognized only when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts.

 

(j) NET LOSS PER COMMON SHARE––Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented, as outstanding warrants to purchase 9,057,500 and 577,500 common shares were antidilutive for the three and nine months ended September 30, 2016 and 2015, respectively, and have been excluded from the calculation of loss per common share.

 

(k) STOCK BASED COMPENSATION––The Company periodically awards stock to employees, directors, and consultants. An expense is recognized equal to the fair value of the stock determined using the closing trading price of the stock on the award date.

 

(l) CONCENTRATIONS OF CREDIT RISK––Significant concentrations of credit risk for all financial instruments owned by the Company are as follows:

 

(i) DEMAND AND CERTIFICATE OF DEPOSITS––We maintain bank accounts in Federal credit unions and other financial institutions, which are insured up to the Federal Deposit Insurance Corporation limits. The bank accounts may exceed Federally insured levels; however, we have not experienced any losses in such accounts.

 

(ii) ACCOUNTS RECEIVABLE––Our accounts receivable consist of amounts due primarily from chemical supply and pharmaceutical companies located primarily in the United States. Three customers accounted for 94% of the accounts receivable balance at September 30, 2016. Five customers accounted for 89% of the accounts receivable balance at December 31, 2015. We have no policy requiring collateral or other security to support our accounts receivable.

 

 5 

 

 

CTD HOLDINGS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

 

(m) LIQUIDITY––For the year ended December 31, 2015, the Company incurred a net loss of approximately $2,551,000 and used net cash in operations in the amount of approximately $1,989,000. For the nine months ended September 30, 2016, the Company incurred a net loss of $3,391,865, used net cash in operations in the amount of $2,386,557, and received net proceeds of $1,880,000 from the sale of its securities. At September 30, 2016, the Company had a cash balance of $1,270,046, current assets of $2,018,552 and current liabilities of $875,948. The Company seeks to raise capital from time to time through the sale of its common stock and other securities. In the event that the Company cannot raise sufficient capital when required, management may have to reduce expenditures related to its operations.

 

(n) USE OF ESTIMATES––The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Although management bases its estimates on historical experience and assumptions that are believed to be reasonable under the circumstances, actual results could significantly differ from these estimates.

 

(o) NEW ACCOUNTING PRONOUNCEMENTS––The Financial Accounting Standards Board (FASB) has issued various Accounting Standards Updates (ASUs), including ASU 2014-09, Revenue from Contracts with Customers, as subsequently amended; ASU 2014-15, Presentation of Financial Statements-Going Concern; ASU 2015-17, Income Taxes; and ASU 2016-02, Leases, which are effective in future fiscal years. We do not expect the adoption of these standards to have a material effect on our financial position or results of operations. The Company adopted ASU 2015-03, Interest-Imputation of Interest (Simplifying the Presentation of Debt Issuance Costs), and reclassified net deferred financing costs of $64,801 from noncurrent assets as a reduction of the associated notes payable balance as of September 30, 2016. This change reduced noncurrent assets and liabilities by $64,801. There was no change in the net loss for the periods presented as a result of this reclassification. The Company also reclassified certain items on the December 31, 2015 balance sheet to be consistent with the current presentation.

 

(2) ASSETS HELD FOR SALE

 

The Company has offered for sale its office and manufacturing facility in Alachua, Florida, which includes its pulse dryer. Accordingly, these assets have been reclassified as assets held for sale in the accompanying balance sheet as of September 30, 2016. As a result, an impairment loss of $810,000 has been identified and recognized in the three and nine months ended September 30, 2016. The impairment loss is equal to the difference between the former carrying amount and the current estimated market value of $963,000 for these assets. For the three and nine months ended September 30, 2015, the Company determined the fair value of its High Springs property was less than its carrying value and therefore recorded an impairment loss of $125,000 to adjust the carrying value to $275,000. The High Springs property was sold in January 2016 (see Note 3 below).

 

(3) MORTGAGE NOTE RECEIVABLE

 

On January 21, 2016, the Company sold its real property located in High Springs, Florida to an unrelated party. This property was previously classified on our balance sheet as property held for sale, with a carrying value of $275,000. Pursuant to the terms of the sale, at the closing, the buyer paid $10,000 in cash, less selling costs and settlement charges, and delivered to the Company a promissory note in the principal amount of $265,000, and a mortgage in our favor securing the buyer’s obligations under the promissory note. The promissory note provides for monthly payments of $3,653, including principal and interest at 4.25%, over a seven-year period commencing March 1, 2016, with the unpaid balance due in February 2023. Scheduled debt principal collections on this mortgage for the next five years and thereafter are as follows:

 

Year Ending    
December 31,  Principal 
2016  $46,431 
2017   34,393 
2018   35,884 
2019   37,439 
2020   39,061 
Thereafter   71,792 
   $265,000 

 

 6 

 

 

CTD HOLDINGS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

 

(4) FAIR VALUES OF FINANCIAL INVESTMENTS

 

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short maturity of those instruments. The Company accounts for the fair value of financial investments in accordance with FASB ASC No. 820 “Fair Value Measurements” (ASC No. 820). ASC No. 820 defines fair value as the price that would be received upon the sale of an asset or paid to transfer a liability (i.e. exit price) in an orderly transaction between market participants at the measurement date. ASC No. 820 requires disclosures that categorize assets and liabilities measured at fair value into one of three different levels depending on the assumptions (i.e. inputs) used in the valuation. Financial assets and liabilities are classified in their entirety based on the lowest level of input significant to the fair value measurement. The ASC No. 820 fair value hierarchy is defined as follows:

 

● Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.
● Level 2—Valuations are based on quoted prices for similar assets or liabilities in active markets, or quoted prices in markets that are not active for which significant inputs are observable, either directly or indirectly.
● Level 3—Valuations are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. Inputs reflect management’s best estimate of what market participants would use in valuing the asset or liability at the measurement date.

 

The following table represents the Company’s financial assets and liabilities which are carried at fair value at September 30, 2016.

 

   Level 1   Level 2   Level 3 
Non-recurring fair value instrument  $-   $-   $245,797 

 

The level 3 non-recurring fair value investment represents a mortgage note receivable (see Note 2). The carrying amount of the mortgage note receivable approximates fair value because the stated interest rate approximates current market interest rates.

 

(5) DEBT

 

The Company owed $500,667 and $516,685, at September 30, 2016 and December 31, 2015, respectively, on a mortgage note payable, collateralized by land and a building acquired in September 2010. Monthly payments of $3,506, including principal and interest at 3.99%, are due, with a final balloon payment of approximately $350,000 due in July 2023. The note is secured by a mortgage on the Company’s Alachua property. The note has a voluntary prepayment penalty which was 2% of the principal repaid as of the date of this filing in the event of a refinancing, and which decreases 1% on July 17 of each year. The Company was not in compliance with a debt coverage ratio covenant for the year ended December 31, 2015. As a result, the principal due in 2016 and beyond one year has been reclassified as current in the accompanying balance sheet.

 

The Company also owed this lender $172,366 and $203,052 at September 30, 2016 and December 31, 2015, respectively, under an equipment loan related to the installation of a pulse dryer and related building renovations. Monthly payments of $4,051, including principal and interest at 3.99%, are due through and including July 2020. The note is collateralized by all of the Company’s equipment. There is a prepayment penalty of 2% of the outstanding balance if the Company voluntarily repays the loan prior to July 17, 2018. Principal due under this loan has also been reclassified as current in the accompanying balance sheet due to the Company’s non-compliance with the loan covenant referred to above.

 

Notes payable has been reduced by capitalized deferred financing costs of $64,801 and $66,424 at September 30, 2016 and December 31, 2015, respectively.

 

Scheduled debt obligations on both loans for the next five years and thereafter are as follows, assuming the bank does not call the loans due to the debt covenant non-compliance: 

 

Year Ending December 31,   
2016  $62,411 
2017   64,982 
2018   67,658 
2019   67,709 
2020   24,940 
Thereafter   385,333 
   $673,033 

 

 7 

 

 

CTD HOLDINGS, INC.

NOTES TO CONSOLIDATED FINANCIAL STATEMENTS

SEPTEMBER 30, 2016

 

(6) EQUITY TRANSACTIONS:

 

The Company expensed $30,460 and $101,220 in stock compensation for the three and nine months ended September 30, 2016. The Company did not have any stock compensation expense for the three and nine months ended September 30, 2015. The Company accrues stock compensation expense over the period earned for employees and board members. The Company issued 264,000 shares of common stock due to an employee and board member on July 22, 2016.

 

On January 21, 2015, the Company awarded 35,000 shares of common stock to a consultant for past services. The Company accrued and expensed $16,520 for this award in 2014.

 

On July 10, 2015, the Company entered into a Securities Purchase Agreement under which it issued 2.6 million shares of its common stock in a private placement, at a purchase price of $0.50 per share, for aggregate gross proceeds to the Company of $1.3 million. Scarsdale Equities LLC (“Scarsdale”) acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement and it and its designees were issued seven-year warrants to purchase 156,000 shares of common stock at an exercise price of $0.50 per share.

 

On July 28, 2015, the Company received $78,616 from the exercise of previously outstanding warrants for 314,465 shares of common stock at an exercise price of $0.25 per share.

 

On August 20, 2015, the Company issued 1.3 million shares of its common stock in a private placement, at a purchase price of $0.50 per share, for aggregate gross proceeds to the company of $650,000. Scarsdale acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement and it and its designees were issued seven-year warrants to purchase 78,000 shares of common stock at an exercise price of $0.50 per share.

 

On June 6, 2016, the Company issued 8 million units (“Units”) at a purchase price of $0.25 per Unit in a private placement, each Unit consisting of one share of its common stock, and a seven-year warrant to purchase an additional share of common stock at an exercise price of $0.25, for aggregate gross proceeds to the Company of $2 million. Scarsdale acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement, and it and its designees were issued seven-year warrants to purchase 480,000 Units at an exercise price of $0.25 per Unit.

 

As of September 30, 2016, the Company had warrants outstanding to purchase 8,577,500 shares of common stock at exercise prices of $0.25 - $1.00 per share that expire in years 2021 through 2023. The Company also had warrants outstanding to purchase 480,000 Units, which expire in 2023.  Each Unit consists of one share of its common stock, and a seven-year warrant to purchase an additional share of common stock at an exercise price of $0.25

 

(7) INCOME TAXES:

 

The Company reported a net loss for the three and nine months ended September 30, 2016 and 2015, respectively. The Company increased its deferred tax asset valuation allowance rather than recognize an income tax benefit.

 

(8) SALES CONCENTRATIONS:

 

Sales to two major customers accounted for 52% of total sales for the nine months ended September 30, 2016. Sales to one major customer accounted for 34% of total sales for the nine months ended September 30, 2015. A loss of one of these customers could have a significant adverse effect on the Company’s financial condition, results of operations and cash flows.

 

 8 

 

 

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

 

The following discussion and analysis provides information to explain our results of operations and financial condition.  You should also read our unaudited consolidated interim financial statements and their notes included in this Form 10-Q, and our audited consolidated financial statements and their notes and other information included in our Annual Report on Form 10-K for the year ended December 31, 2015.  This report may contain forward-looking statements. Forward-looking statements within this Form 10-Q are identified by words such as “believes,” “anticipates,” “expects,” “intends,” “may,” “will” “plans” and other similar expressions; however, these words are not the exclusive means of identifying such statements. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements.  These forward-looking statements are subject to significant risks, uncertainties and other factors, which may cause actual results to differ materially from those expressed in, or implied by, these forward-looking statements.  Except as expressly required by the federal securities laws, we undertake no obligation to publicly update or revise any forward-looking statements to reflect events, circumstances or developments occurring subsequent to the filing of this Form 10-Q with the U.S. Securities and Exchange Commission (the “SEC”) or for any other reason and you should not place undue reliance on these forward-looking statements.  You should carefully review and consider the various disclosures the Company makes in this report and our other reports filed with the SEC that attempt to advise interested parties of the risks, uncertainties and other factors that may affect our business.

 

Overview

 

CTD Holdings, Inc. (“we” “our” “us” or “the Company”) was organized as a Florida corporation on August 9, 1990, with operations beginning in July 1992. In conjunction with a restructuring in 2000, we changed our name from Cyclodextrin Technologies Development, Inc., or CTDI, to CTD Holdings, Inc.; CTDI was then incorporated as a Florida corporation and became a wholly owned subsidiary of CTD Holdings, Inc.

 

We are a biotechnology company that develops cyclodextrin-based products for the treatment of disease. We have filed a Type II Drug Master File with the U.S. Food and Drug Administration (“FDA”) for our lead drug candidate, Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”), and recently filed an Investigational New Drug application (“IND”) with the FDA which describes our Phase I clinical plans for a randomized, double blind, parallel group study at a single clinical site in the US. We have also filed a Clinical Trial Application with the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and launched an International Clinical Program for Trappsol® Cyclo™.

 

While we also sell cyclodextrins and related products to the pharmaceutical, nutritional, and other industries, primarily for use in diagnostics and specialty drugs with continuing growth in research and new product development, our core business has transitioned to a biotechnology company primarily focused on the development of cyclodextrin-based biopharmaceuticals for the treatment of disease from a business which had been primarily reselling basic cyclodextrin products.  On August 5, 2016, we listed for sale our real property (which includes our pulse dryer) located in Alachua, Florida. In the event we are able to complete the sale of this property, we expect to repay our secured loans. Although we expect to continue to operate our cyclodextrin distribution business following such sale, our strategy going forward is to focus on biopharmaceutical opportunities in healthcare where we believe cyclodextrin applications have maximum value.

 

Substantially all of our revenues are derived from the sale of cyclodextrins, including bio-pharmaceuticals containing cyclodextrins, cyclodextrin complexes, resale of cyclodextrins manufactured by others for our clients to their specifications, and our own licensed cyclodextrin products.  We have trademarked certain products under our Trappsol®, Aquaplex®, and AP™-Flavor product lines.  We currently sell our products directly to customers in the diagnostics, pharmaceutical, and industrial chemical industries, and to chemical supply distributors.  

 

 9 

 

 

Trappsol® Cyclo™

 

At the end of 2008, we provided Trappsol® Cyclo™ to a customer for compassionate use as an Investigational New Drug to treat a set of twins in the U.S. who were diagnosed with NPC, also known as Childhood Alzheimer’s. NPC is a fatal disease caused by a genetic defect that prevents proper handling of cholesterol in the body’s cells. The patient’s treatment with our Trappsol® Cyclo™ product proved to provide an ameliorative benefit. On May 17, 2010, the FDA granted orphan drug status to our customer for Trappsol® Cyclo™ for the treatment of NPC. To date, Trappsol® Cyclo™ has been administered to approximately 20 NPC patients in compassionate use programs around the world, including in the U.S., Brazil and Spain. Our annual sales of Trappsol® Cyclo™ decreased to $352,000 for 2015 from $901,000 for 2014. Sales of Trappsol® Cyclo™ were $21,000 and $401,000 for the three and nine months ended September 30, 2016, respectively. In 2012, we began to offer 100ml vials of Trappsol® Cyclo™ in a liquid form from a contract manufacturer. In 2014, we completed validation of the Trappsol® Cyclo™ manufacturing process and submitted a Type II Drug Master File to the FDA. In 2015 we established an International Clinical Program that includes a team of experienced drug development companies and individuals. We have also obtained Orphan Drug Designation for Trappsol® Cyclo™ in both the U.S. and Europe.

 

Most recently, we obtained regulatory approval of both the IND we filed with the FDA for Trappsol® Cyclo™ as a treatment for NPC, and the Clinical Trial Application we filed with the United Kingdom's Medicines and Healthcare Products Regulatory Agency. As a result, we expect to conduct multiple U.S. and international clinical studies in which we will provide Trappsol® Cyclo™ intravenously to NPC patients in order to track biochemical markers of cholesterol metabolism and to measure effects on neurologic, lung and liver symptoms.

 

Resale of Cyclodextrin and Cyclodextrin Complexes

 

Our sales of cyclodextrins and cyclodextrin complexes are primarily to chemical supply houses around the world, to pharmaceutical companies, to food companies for research and development and to diagnostics companies.

 

We acquire our products principally from outside the United States, including from Wacker Biosolutions, a division of Wacker Chemie AG (Germany), with a production facility located in Adrian, Michigan and Hangzhou Pharma and Chem Co. (China), Quian Hui (China), and Cyclodextrin Research & Development Laboratory (Hungary), but are gradually finding satisfactory supply sources in the United States. We make patent information about cyclodextrins available to our customers. We also offer our customers our knowledge of the properties and potential new uses of cyclodextrins and complexes.

 

As most of our customers use our cyclodextrin products in their research and development activities, the timing, product mix, and volume of their orders from us are unpredictable. We also have four large customers (each of whom has historically purchased from us annually and, depending upon the year, may account for greater than 10% of our annual revenues) who have a significant effect on our revenues when they increase or decrease their research and development activities that use cyclodextrins. We keep in constant contact with these customers as to their cyclodextrin needs so we can maintain the proper inventory composition and quantity in anticipation of their needs. The sales to large customers and the product mix and volume of products sold has a significant effect on our revenues and product margins. These factors contribute to our revenue volatility from quarter to quarter and year to year.

 

Liquidity and Capital Resources

 

Our cash decreased to $1,270,000 as of September 30, 2016, compared to $1,842,000 as of December 31, 2015. Our current assets and current liabilities were $2,018,552 and $875,948, respectively, as of September 30, 2016, compared to current assets of $2,522,886 and current liabilities of $945,146 at December 31, 2015. All of our term debt is classified as current at both September 30, 2016 and December 31, 2015 due to our non-compliance with a loan covenant as described below. We owed $500,667 at September 30, 2016 on a secured mortgage note and $172,366 under an equipment loan, with a bank that has a debt service covenant. We are not in compliance with this debt service coverage covenant. If we are unable to have the debt covenant modified, or we are unable to refinance the indebtedness, we may be required to use our cash on hand to repay the indebtedness, which will have a material adverse effect on our financial condition by diverting cash intended for use in our development of a clinical trial program or for other business development efforts.

 

 10 

 

 

On August 5, 2016, the Company listed for sale its real property located in Alachua, Florida. In the event we are able to complete the sale of this property on terms acceptable to us, we expect to repay our secured loans in full.

 

The Company presently believes that it will require additional cash to meet its anticipated operating costs and capital expenditure requirements for the next twelve months, including, without limitation, to commence and continue its approved U.S. and U.K. clinical trials. To date, the Company has been able to generate sufficient cash to fund its drug development activities from private offerings of its equity securities, together with cash generated from operations and asset sales. While we expect to continue to be successful in obtaining additional funds to meet our cash requirements, no assurance can be given that adequate additional funding will be available to us on acceptable terms, if at all. Additional capital will also be required in the future to develop our drug product candidates through clinical development, manufacturing and commercialization. Our ability to obtain such additional capital will likely be subject to various factors, including the results of our clinical trials, our progress in obtaining regulatory approval for our drug candidates and market conditions.

 

On January 21, 2016, we closed on the sale of our real property located in High Springs, Florida, which had been previously classified on our balance sheet as property held for sale, with a carrying value of $275,000. Pursuant to the terms of the sale, at the closing, the buyer paid us $10,000 in cash, less selling costs and settlement charges, and we received a promissory note in the principal amount of $265,000, and a mortgage in our favor securing the buyer’s obligations under the promissory note. The promissory note provides for monthly payments of $3,653, including principal and interest at 4.25%, over a seven-year period commencing March 1, 2016.

 

We plan to use our available cash primarily for the development of our Trappsol® Cyclo™ orphan drug product, including implementation of our U.S. and international clinical trials and designs, and other general corporate purposes.

 

We have no off-balance sheet arrangements at September 30, 2016.

 

Results of Operations - Three and Nine Months Ended September 30, 2016 Compared to Three and Nine Months Ended September 30, 2015

 

We reported a net loss of $(1,615,000) and $(3,392,000) for the three and nine months ended September 30, 2016, respectively, compared to a net loss of $(748,000) and $(1,496,000) for the three and nine months ended September 30, 2015, respectively.  

 

Total revenues for the three-month period ended September 30, 2016 increased 18% to $278,000 compared to $235,000 for the same period in 2015. Total revenues for the nine-month period ended September 30, 2016 increased 24% to $975,000 compared to $788,000 for the same period in 2015.

 

Our change in the mix of our product sales for the three and nine months ended September 30, 2016 and 2015 is as follows:

 

Trappsol® Cyclo

Our sales of Trappsol® Cyclo™ increased 11% for the three-month period ended September 30, 2016, to $21,000, from $19,000 for the three-month period ended September 30, 2015.  Our sales of Trappsol® Cyclo™ increased by 22% for the nine-month period ended September 30, 2016, to $401,000 from $329,000 for the nine-month period ended September 30, 2015. Our sales to a particular customer who exports Trappsol® Cyclo™ to South America were $21,000 (100% of total sales of Trappsol® Cyclo™) for the three months ended September 30, 2016, compared to no sales for the three months ended September 30, 2015; and our sales to that same customer who exports Trappsol® Cyclo™ to South America were $386,000 (96% of total sales of Trappsol® Cyclo™) for the nine-month period ended September 30, 2016, compared to $270,000 (82% of total sales of Trappsol® Cyclo™) for the nine-month period ended September 30, 2015. Our 2015 sales to this customer were $296,000 (84% of total 2015 sales of Trappsol® Cyclo™).  This product is designated as an orphan drug; the population of patients is small and while we expect our future sales to increase, the timing of sales will be unpredictable and our ability to market the drug for use other than research is severely constrained by regulatory restrictions in the applicable jurisdictions.  

 

Trappsol® HPB

Our sales of Trappsol® HPB increased by 31% for the three-month period ended September 30, 2016, to $163,000 from $124,000 for the three months ended September 30, 2015. Our sales of Trappsol® HPB increased by 43% for the nine-month period ended September 30, 2016, to $397,000 from $278,000 for the nine-month period ended September 30, 2015.

 

Trappsol® other products

Our sales of other Trappsol® products decreased by 36% for the three-month period ended September 30, 2016, to $35,000 from $55,000 for the three-month period ended September 30, 2015. Our sales of other Trappsol® products decreased by 32% for the nine-month period ended September 30, 2016, to $74,000 from $109,000 for the nine-month period ended September 30, 2015.

 

 11 

 

 

Aquaplex®

Our sales of Aquaplex® were $57,000 for the three-month period ended September 30, 2016 compared to $32,000 for the three-month period ended September 30, 2015. Our sales of Aquaplex® were $78,000 for the nine-month period ended September 30, 2016 compared to $63,000 for the nine-month period ended September 30, 2015.

 

Our largest customers continue to follow historical product ordering trends by placing periodic large orders that represent a significant share of our annual sales volume. During the nine months ended September 30, 2016, our two largest customers accounted for 52% of our sales; the largest accounted for 41% of sales. During the nine months ended September 30, 2015, our three largest customers accounted for 50% of our sales; the largest accounted for 34% of sales. Historically, our usual smaller sales of HPB occur more frequently throughout the year compared to our large sales that we receive periodically. The timing of when we receive and are able to complete these two kinds of sales has a significant effect on our quarterly revenues and operating results and makes period to period comparisons difficult.

 

Our cost of products sold (excluding any allocation of direct and indirect overhead and handling costs) for the nine-month period ended September 30, 2016 was 13% ($124,000) compared to 13% ($105,000) for the same period in 2015. Our cost of products sold (excluding any allocation of direct and indirect overhead and handling costs) as a percentage of sales was 11% ($31,000) for the three months ended September 30, 2016 compared to 11% ($25,000) for the same period in 2015.  Historically, the timing and product mix of sales to our large customers has had a significant effect on our sales, cost of products sold (excluding any allocation of direct and indirect overhead and handling costs) and the related margin. We did not experience any significant increases in material costs during 2015 or 2014, or the first nine months of 2016.

 

Our gross margins may not be comparable to those of other entities, since some entities include all the costs related to their distribution network in cost of goods sold. Our cost of goods sold includes only the cost of products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense. We have six employees who provide receiving, inspection, warehousing and shipping operations for us. The cost of these employees, and our other employees, are included in personnel expense. Our other costs of warehousing and shipping functions are included in office and other expense. As we buy most of our inventory from foreign suppliers, the change in the value of the U.S. dollar in relation to the Euro, Yen and Yuan has had and will continue to have an effect on our cost of inventory. Our main supplier of specialty cyclodextrins and complexes, Cyclodextrin Research & Development Laboratory, is located in Hungary and its prices are set in Euros.

 

Personnel expenses increased to $328,000 for the three months ended September 30, 2016 from $223,000 for the three months ended September 30, 2015. Personnel expenses increased to $1,010,000 for the nine months ended September 30, 2016 from $551,000 for the nine months ended September 30, 2015. The increase in personnel expense is due to an increase in the number of employees and employee benefits. We expect personnel costs to continue to increase in 2016 as the result of additional employees and our International Clinical Program product development activities.

 

Research and development expenses increased to $311,000 for the three months ended September 30, 2016, from $221,000 for the three months ended September 30, 2015. Research and development expenses increased to $1,255,000 for the nine months ended September 30, 2016, from $399,000 for the nine months ended September 30, 2015. The increase in research and development expense is due to the International Clinical Program. We expect research and development costs to increase in 2016 as we continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC.

 

Repairs and maintenance expenses decreased to $3,000 for the three months ended September 30, 2016 from $7,000 for the three months ended September 30, 2015. Repairs and maintenance expenses decreased to $19,000 for the nine months ended September 30, 2016 from $24,000 for the nine months ended September 30, 2015.

 

Professional fees increased to $176,000 for the three months ended September 30, 2016, compared to $101,000 for the three months ended September 30, 2015. Professional fees increased to $455,000 for the nine months ended September 30, 2016, compared to $324,000 for the nine months ended September 30, 2015. Professional fees may further increase due to new initiatives in raising capital or compliance for developing new products.

 

Office and other expenses increased to $171,000 for the three months ended September 30, 2016 compared to $85,000 for the three months ended September 30, 2015. Office and other expenses increased to $479,000 for the nine months ended September 30, 2016 compared to $213,000 for the nine months ended September 30, 2015.

 

 12 

 

 

Board of Directors fees and costs decreased to $53,000 for the three months ended September 30, 2016, compared to $140,000 for the three months ended September 30, 2015. Board of Directors fee and costs decreased to $100,000 for the nine months ended September 30, 2016, compared to $392,000 for the nine months ended September 30, 2015.

 

Amortization and depreciation was $4,000 for the three months ended September 30, 2016, compared to $44,000 for the three months ended September 30, 2015. Amortization and depreciation was $92,000 for the nine months ended September 30, 2016, compared to $125,000 for the nine months ended September 30, 2015.

 

Freight and shipping was $1,000 for the three months ended September 30, 2016, compared to $3,000 for the three months ended September 30, 2015. Freight and shipping was $5,000 for the nine months ended September 30, 2016, compared to $6,000 for the nine months ended September 30, 2015.

 

Interest expense was $7,000 for the three months ended September 30, 2016, compared to $8,000 for the three months ended September 30, 2015. Interest expense was $22,000 for the nine months ended September 30, 2016, compared to $24,000 for the nine months ended September 30, 2015.

 

We recorded a $810,000 impairment loss on our office and pulse dryer for the three and nine months ended September 30, 2016. We recorded a $125,000 impairment loss on our High Springs property (which was subsequently sold) for the three and nine months ended September 30, 2015.

 

We increased our valuation allowance to offset the increase in our deferred tax asset from our net operating loss and did not recognize an income benefit or provision for the three and nine months ended September 30, 2016, and 2015, respectively.

 

Item 3.  Quantitative and Qualitative Disclosures About Market Risk.

 

Not applicable.

 

Item 4. Controls and Procedures.

 

a.  Evaluation of Disclosure Controls and Procedures.

 

Our management, with the participation of our principal executive and principal financial officer, has evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) as of the end of the period covered by this quarterly report (the "Evaluation Date"). Based on such evaluation, our principal executive and principal financial officer has concluded that, as of the Evaluation Date, our disclosure controls and procedures are effective.

 

 

b. Changes in Internal Control.

  

We made no changes in our internal control over financial reporting (as defined in Rules 13a-15(f)) and 15d-15(f) under the Exchange Act) identified in connection with the evaluation of our internal controls that occurred during our last fiscal quarter that has materially affected, or which is reasonably likely to materially affect, our internal controls over financial reporting.

 

 13 

 

 

PART II. OTHER INFORMATION

 

Item 1A. Risk Factors.

 

We have identified no additional risk factors other than those included in Part I, Item 1A of our Form 10-K for the fiscal year ended December 31, 2015.  Readers are urged to carefully review our risk factors because they may cause our results to differ from the "forward-looking" statements made in this report. Additional risks not presently known to us or other factors not perceived by us to present significant risks to our business at this time also may impair our business, financial condition and results of operations.  We do not undertake to update any of the "forward-looking" statements or to announce the results of any revisions to these "forward-looking" statements except as required by law.

 

Item 6. Exhibits.

 

EXHIBIT NO.    DESCRIPTION
     
31.1   Rule 13a-14(a)/15d-14a(a) Certifications
     
32.1   Section 1350 Certifications

 

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

 

 14 

 

 

SIGNATURES

 

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

 

  CTD HOLDINGS, INC.
     
Date: November 10, 2016    By: /s/ N. Scott Fine 
    N. Scott Fine
    Chief Executive Officer
    (principal executive, financial and accounting officer)

 

 

15

 

 

 EX-31.1 2 f10q0916ex31i_ctdholdingsinc.htm CERTIFICATION

EXHIBIT 31.1

 

CERTIFICATION PURSUANT TO RULE 13a-14(a)/15d-14(a)

OF THE SECURITIES EXCHANGE ACT OF 1934

 

I, N. Scott Fine, certify that:

 

1. I have reviewed this Quarterly Report on Form 10-Q of CTD Holdings, Inc.;

 

2. Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;

 

3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;

 

4. The registrant's other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:

 

  a. Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;

 

  b. Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;

 

  c. Evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and

 

  d. Disclosed in this report any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the registrant's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant's internal control over financial reporting; and

 

5. The registrant's other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions):

 

  a. All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant's ability to record, process, summarize and report financial information; and

 

  b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant's internal control over financial reporting.

 

Date: November 10, 2016 By: /s/ N. Scott Fine
    N. Scott Fine
    Chief Executive Officer
    (principal executive, financial and accounting officer)

 

 EX-32.1 3 f10q0916ex32i_ctdholdingsinc.htm CERTIFICATION

EXHIBIT 32.1

 

CERTIFICATION PURSUANT TO

18 U.S.C. SECTION 1350,

AS ADOPTED PURSUANT TO

SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002

 

In connection with this Quarterly Report on Form 10-Q of CTD Holdings, Inc. (the “Company”) for the fiscal quarter ended September 30, 2016, as filed with the Securities and Exchange Commission on the date hereof (the “Report”), I, N. Scott Fine, certify, pursuant to 18 U.S.C. §1350, as adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002, that:

 

  (1) The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and

 

  (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.

 

Date:  November 10, 2016 /s/ N. Scott Fine
  N. Scott Fine
  Chief Executive Officer
  (principal executive, financial and accounting officer)

 

 

 

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Document and Entity Information - shares
 9 Months Ended
Sep. 30, 2016
Nov. 10, 2016
Document and Entity Information [Abstract]    
Entity Registrant Name CTD HOLDINGS INC  
Entity Central Index Key 0000922247  
Amendment Flag false  
Current Fiscal Year End Date --12-31  
Document Type 10-Q  
Document Period End Date Sep. 30, 2016  
Document Fiscal Year Focus 2016  
Document Fiscal Period Focus Q3  
Entity Filer Category Smaller Reporting Company  
Entity Common Stock, Shares Outstanding   66,952,529
XML 11 R2.htm IDEA: XBRL DOCUMENT v3.5.0.2
Consolidated Balance Sheets - USD ($)
Sep. 30, 2016
Dec. 31, 2015
CURRENT ASSETS    
Cash and cash equivalents $ 1,270,046 $ 1,842,233
Accounts receivable, net 124,234 55,636
Inventory 595,366 610,166
Current portion of mortgage note receivable 27,228
Other current assets 1,678 14,851
Total current assets 2,018,552 2,522,886
PROPERTY AND EQUIPMENT, NET 33,691 1,892,943
OTHER ASSETS    
Property held for sale 963,115 275,000
Mortgage note receivable, less current portion 218,569
Total other assets 1,181,684 275,000
TOTAL ASSETS 3,233,927 4,690,829
CURRENT LIABILITIES    
Accounts payable and accrued expenses 267,716 257,537
Notes payable 608,232 653,313
Line of credit 34,296
Total current liabilities 875,948 945,146
STOCKHOLDERS' EQUITY    
Common stock, par value $.0001 per share, 100,000,000 shares authorized, 66,952,529 and 58,670,347 shares issued and outstanding, respectively 6,695 5,867
Preferred stock, par value $.0001 per share, 5,000,000 shares authorized, no shares issued or outstanding
Additional paid-in capital 11,018,915 9,015,582
Accumulated deficit (8,667,631) (5,275,766)
Total stockholders' equity 2,357,979 3,745,683
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY $ 3,233,927 $ 4,690,829
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Consolidated Balance Sheets (Parenthetical) - $ / shares
Sep. 30, 2016
Dec. 31, 2015
Statement of Financial Position [Abstract]    
Common stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Common stock, shares authorized 100,000,000 100,000,000
Common stock, shares issued 66,952,529 58,670,347
Common stock, shares outstanding 66,952,529 58,670,347
Preferred stock, par value (in dollars per share) $ 0.0001 $ 0.0001
Preferred stock, shares authorized 5,000,000 5,000,000
Preferred stock, shares issued
Preferred stock, shares outstanding
XML 13 R4.htm IDEA: XBRL DOCUMENT v3.5.0.2
Consolidated Statements of Operations (Unaudited) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
REVENUES        
Product sales $ 278,196 $ 234,660 $ 975,267 $ 788,198
EXPENSES        
Personnel 327,858 222,922 1,010,296 551,194
Cost of products sold (exclusive of amortization and depreciation, shown separately below) 30,893 25,219 123,896 105,091
Research and development 311,351 221,362 1,254,900 399,427
Repairs and maintenance 3,334 7,144 19,073 23,693
Professional fees 175,616 101,097 454,646 324,005
Office and other 171,425 85,005 478,740 212,792
Board of Director fees and costs 53,195 140,068 99,576 391,857
Amortization and depreciation 3,789 44,426 92,146 124,990
Freight and shipping 1,465 2,599 5,257 5,929
Loss (gain) on disposal of property and equipment 4,489 (700)
Impairment on assets held for sale 810,000 125,000 810,000 125,000
Total expenses 1,888,926 974,842 4,353,019 2,263,278
LOSS FROM OPERATIONS (1,610,730) (740,182) (3,377,752) (1,475,080)
OTHER INCOME (EXPENSE)        
Investment and other income 2,766 375 7,609 2,615
Interest expense (6,969) (7,749) (21,722) (23,527)
Total other income (expense) (4,203) (7,374) (14,113) (20,912)
LOSS BEFORE INCOME TAXES (1,614,933) (747,556) (3,391,865) (1,495,992)
Provision for income taxes
Net loss $ (1,614,933) $ (747,556) $ (3,391,865) $ (1,495,992)
BASIC AND FULLY DILUTED NET LOSS PER COMMON SHARE $ (0.02) $ (0.01) $ (0.05) $ (0.03)
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING 66,889,822 57,262,835 62,121,283 55,390,366
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Consolidated Statements of Cash Flows (Unaudited) - USD ($)
 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
CASH FLOWS FROM OPERATING ACTIVITIES    
Net loss $ (3,391,865) $ (1,495,992)
Adjustments to reconcile net loss to net cash used in operating activities:    
Depreciation and amortization 92,146 124,990
Loss (gain) on disposal of property and equipment 4,489 (700)
Impairment on assets held for sale 810,000 125,000
Stock compensation to employees 57,114
Stock compensation to non-employees 44,106
Increase or decrease in:    
Accounts receivable (68,598) (33,279)
Inventory 19,758 (63,941)
Other current assets 13,173 (8,183)
Accounts payable and accrued expenses 33,120 185,541
Total adjustments 1,005,308 329,428
NET CASH USED IN OPERATING ACTIVITIES (2,386,557) (1,166,564)
CASH FLOWS FROM INVESTING ACTIVITIES    
Purchase of equipment and building improvements (9,343) (337,884)
Proceeds from mortgage note receivable 19,203
Proceeds from sale of property and equipment, net of closing costs 5,510 700
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES 15,370 (337,184)
CASH FLOWS FROM FINANCING ACTIVITIES    
Principal payments on notes payable (46,704) (44,484)
Payments on line of credit (34,296)
Net proceeds from sale of common stock and warrants 1,880,000 1,910,595
NET CASH PROVIDED BY FINANCING ACTIVITIES 1,799,000 1,866,111
NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (572,187) 362,363
CASH AND CASH EQUIVALENTS, beginning of period 1,842,233 2,380,054
CASH AND CASH EQUIVALENTS, end of period 1,270,046 2,742,417
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION    
Cash paid for interest 21,722 23,527
Cash paid for income taxes
SUPPLEMENTAL DISCLOSURE OF NONCASH INVESTING AND FINANCING    
Exchange of property held for sale for a mortgage note receivable $ 265,000
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Summary of Significant Accounting Policies
 9 Months Ended
Sep. 30, 2016
Summary of Significant Accounting Policies [Abstract]  
SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

(1) SUMMARY OF SIGNIFICANT ACCOUNTING POLICIES:

 

The following is a summary of the more significant accounting policies of CTD Holdings, Inc. and subsidiaries (the “Company”) that affect the accompanying consolidated financial statements.

 

(a) ORGANIZATION AND OPERATIONS––The Company was incorporated in August 1990, as a Florida corporation with operations beginning in July 1992. We are a biotechnology company that develops cyclodextrin-based products for the treatment of disease. We have filed a Type II Drug Master File with the U.S. Food and Drug Administration (“FDA”) for our lead drug candidate, Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”), and recently filed an Investigational New Drug application (IND) with the FDA which describes our Phase I clinical plans in the US. The Company has also filed a Clinical Trial Application with the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and launched an International Clinical Program for Trappsol® Cyclo™.

 

While we also sell cyclodextrins and related products to the pharmaceutical, nutritional, and other industries, primarily for use in diagnostics and specialty drugs with continuing growth in research and new product development, our core business has transitioned to a biotechnology company primarily focused on the development of cyclodextrin-based biopharmaceuticals for the treatment of disease from a business which had been primarily reselling basic cyclodextrin products. 

  

(b) BASIS OF PRESENTATION––The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.

 

Operating results for the three and nine-month periods ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 30, 2016.

 

(c) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original maturity of three months or less.

 

(d) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and non-interest bearing and stated at the amount we expect to collect from outstanding balances. Based on our assessment of the credit history with customers having outstanding balances and current relationships with them, we have concluded that losses on balances outstanding at September 30, 2016 and December 31, 2015 will be immaterial.

 

(e) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our pharmaceutical drug Trappsol® Cyclo™, cyclodextrin products and chemical complexes purchased for resale recorded at the lower of cost (first-in, first-out) or net realizable. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense.

  

(f) PROPERTY AND EQUIPMENT––Property and equipment are recorded at cost. Depreciation on property and equipment is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three to five years for computers and vehicles, seven to ten years for machinery and furniture, fifteen years for certain land improvements, and forty years for buildings and building improvements). We periodically review our long-lived assets to determine if the carrying value of assets may not be recoverable. If an impairment is identified, we recognize a loss for the difference between the carrying amount and the estimated fair value of the asset (see Note 2).

 

(g) REVENUE RECOGNITION––We recognize revenue from product sales, royalties, and drying services rendered when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable, and collectability is reasonably assured. Product sales and shipping revenues, net of any discounts or return allowances, are recorded when the products are shipped and title passes to customers. Sales to customers are made pursuant to a sales contract that provides for transfer of both title and risk of loss upon our delivery to the carrier. Return allowances, which reduce product revenue, have been historically infrequent, and are recorded when they become known. Amounts received in advance are deferred and recognized as revenue when all four revenue recognition criteria have been met. There is no deferred revenue at September 30, 2016 and December 31, 2015.

 

(h) RESEARCH AND DEVELOPMENT COSTS––Research and development costs are expensed as incurred.

 

(i) INCOME TAXES––Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. In addition, tax benefits related to positions considered uncertain are recognized only when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts.

 

(j) NET LOSS PER COMMON SHARE––Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented, as outstanding warrants to purchase 9,057,500 and 577,500 common shares were antidilutive for the three and nine months ended September 30, 2016 and 2015, respectively, and have been excluded from the calculation of loss per common share.

 

(k) STOCK BASED COMPENSATION––The Company periodically awards stock to employees, directors, and consultants. An expense is recognized equal to the fair value of the stock determined using the closing trading price of the stock on the award date.

 

(l) CONCENTRATIONS OF CREDIT RISK––Significant concentrations of credit risk for all financial instruments owned by the Company are as follows:

 

(i) DEMAND AND CERTIFICATE OF DEPOSITS––We maintain bank accounts in Federal credit unions and other financial institutions, which are insured up to the Federal Deposit Insurance Corporation limits. The bank accounts may exceed Federally insured levels; however, we have not experienced any losses in such accounts.

 

(ii) ACCOUNTS RECEIVABLE––Our accounts receivable consist of amounts due primarily from chemical supply and pharmaceutical companies located primarily in the United States. Three customers accounted for 94% of the accounts receivable balance at September 30, 2016. Five customers accounted for 89% of the accounts receivable balance at December 31, 2015. We have no policy requiring collateral or other security to support our accounts receivable.

  

(m) LIQUIDITY––For the year ended December 31, 2015, the Company incurred a net loss of approximately $2,551,000 and used net cash in operations in the amount of approximately $1,989,000. For the nine months ended September 30, 2016, the Company incurred a net loss of $3,391,865, used net cash in operations in the amount of $2,386,557, and received net proceeds of $1,880,000 from the sale of its securities. At September 30, 2016, the Company had a cash balance of $1,270,046, current assets of $2,018,552 and current liabilities of $875,948. The Company seeks to raise capital from time to time through the sale of its common stock and other securities. In the event that the Company cannot raise sufficient capital when required, management may have to reduce expenditures related to its operations.

 

(n) USE OF ESTIMATES––The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Although management bases its estimates on historical experience and assumptions that are believed to be reasonable under the circumstances, actual results could significantly differ from these estimates.

 

(o) NEW ACCOUNTING PRONOUNCEMENTS––The Financial Accounting Standards Board (FASB) has issued various Accounting Standards Updates (ASUs), including ASU 2014-09, Revenue from Contracts with Customers, as subsequently amended; ASU 2014-15, Presentation of Financial Statements-Going Concern; ASU 2015-17, Income Taxes; and ASU 2016-02, Leases, which are effective in future fiscal years. We do not expect the adoption of these standards to have a material effect on our financial position or results of operations. The Company adopted ASU 2015-03, Interest-Imputation of Interest (Simplifying the Presentation of Debt Issuance Costs), and reclassified net deferred financing costs of $64,801 from noncurrent assets as a reduction of the associated notes payable balance as of September 30, 2016. This change reduced noncurrent assets and liabilities by $64,801. There was no change in the net loss for the periods presented as a result of this reclassification. The Company also reclassified certain items on the December 31, 2015 balance sheet to be consistent with the current presentation.
XML 16 R7.htm IDEA: XBRL DOCUMENT v3.5.0.2
Assets Held for Sale
 9 Months Ended
Sep. 30, 2016
Assets Held for Sale [Abstract]  
ASSETS HELD FOR SALE

(2) ASSETS HELD FOR SALE

 

The Company has offered for sale its office and manufacturing facility in Alachua, Florida, which includes its pulse dryer. Accordingly, these assets have been reclassified as assets held for sale in the accompanying balance sheet as of September 30, 2016. As a result, an impairment loss of $810,000 has been identified and recognized in the three and nine months ended September 30, 2016. The impairment loss is equal to the difference between the former carrying amount and the current estimated market value of $963,000 for these assets. For the three and nine months ended September 30, 2015, the Company determined the fair value of its High Springs property was less than its carrying value and therefore recorded an impairment loss of $125,000 to adjust the carrying value to $275,000. The High Springs property was sold in January 2016 (see Note 3 below).
XML 17 R8.htm IDEA: XBRL DOCUMENT v3.5.0.2
Mortgage Note Receivable
 9 Months Ended
Sep. 30, 2016
Mortgage Note Receivable [Abstract]  
MORTGAGE NOTE RECEIVABLE

(3) MORTGAGE NOTE RECEIVABLE

 

On January 21, 2016, the Company sold its real property located in High Springs, Florida to an unrelated party. This property was previously classified on our balance sheet as property held for sale, with a carrying value of $275,000. Pursuant to the terms of the sale, at the closing, the buyer paid $10,000 in cash, less selling costs and settlement charges, and delivered to the Company a promissory note in the principal amount of $265,000, and a mortgage in our favor securing the buyer’s obligations under the promissory note. The promissory note provides for monthly payments of $3,653, including principal and interest at 4.25%, over a seven-year period commencing March 1, 2016, with the unpaid balance due in February 2023. Scheduled debt principal collections on this mortgage for the next five years and thereafter are as follows:

 

Year Ending      
December 31,   Principal  
2016   $ 46,431  
2017     34,393  
2018     35,884  
2019     37,439  
2020     39,061  
Thereafter     71,792  
    $ 265,000
XML 18 R9.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Values of Financial Investments
 9 Months Ended
Sep. 30, 2016
Fair Values of Financial Investments [Abstract]  
FAIR VALUES OF FINANCIAL INVESTMENTS

(4) FAIR VALUES OF FINANCIAL INVESTMENTS

 

The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair value because of the short maturity of those instruments. The Company accounts for the fair value of financial investments in accordance with FASB ASC No. 820 “Fair Value Measurements” (ASC No. 820). ASC No. 820 defines fair value as the price that would be received upon the sale of an asset or paid to transfer a liability (i.e. exit price) in an orderly transaction between market participants at the measurement date. ASC No. 820 requires disclosures that categorize assets and liabilities measured at fair value into one of three different levels depending on the assumptions (i.e. inputs) used in the valuation. Financial assets and liabilities are classified in their entirety based on the lowest level of input significant to the fair value measurement. The ASC No. 820 fair value hierarchy is defined as follows:

 

● Level 1—Valuations are based on unadjusted quoted prices in active markets for identical assets or liabilities.
● Level 2—Valuations are based on quoted prices for similar assets or liabilities in active markets, or quoted prices in markets that are not active for which significant inputs are observable, either directly or indirectly.
● Level 3—Valuations are based on prices or valuation techniques that require inputs that are both unobservable and significant to the overall fair value measurement. Inputs reflect management’s best estimate of what market participants would use in valuing the asset or liability at the measurement date.

 

The following table represents the Company’s financial assets and liabilities which are carried at fair value at September 30, 2016.

 

    Level 1     Level 2     Level 3  
Non-recurring fair value instrument   $ -     $ -     $ 245,797  

 

The level 3 non-recurring fair value investment represents a mortgage note receivable (see Note 2). The carrying amount of the mortgage note receivable approximates fair value because the stated interest rate approximates current market interest rates.
XML 19 R10.htm IDEA: XBRL DOCUMENT v3.5.0.2
Debt
 9 Months Ended
Sep. 30, 2016
Debt [Abstract]  
DEBT

(5) DEBT

 

The Company owed $500,667 and $516,685, at September 30, 2016 and December 31, 2015, respectively, on a mortgage note payable, collateralized by land and a building acquired in September 2010. Monthly payments of $3,506, including principal and interest at 3.99%, are due, with a final balloon payment of approximately $350,000 due in July 2023. The note is secured by a mortgage on the Company’s Alachua property. The note has a voluntary prepayment penalty which was 2% of the principal repaid as of the date of this filing in the event of a refinancing, and which decreases 1% on July 17 of each year. The Company was not in compliance with a debt coverage ratio covenant for the year ended December 31, 2015. As a result, the principal due in 2016 and beyond one year has been reclassified as current in the accompanying balance sheet.

 

The Company also owed this lender $172,366 and $203,052 at September 30, 2016 and December 31, 2015, respectively, under an equipment loan related to the installation of a pulse dryer and related building renovations. Monthly payments of $4,051, including principal and interest at 3.99%, are due through and including July 2020. The note is collateralized by all of the Company’s equipment. There is a prepayment penalty of 2% of the outstanding balance if the Company voluntarily repays the loan prior to July 17, 2018. Principal due under this loan has also been reclassified as current in the accompanying balance sheet due to the Company’s non-compliance with the loan covenant referred to above.

 

Notes payable has been reduced by capitalized deferred financing costs of $64,801 and $66,424 at September 30, 2016 and December 31, 2015, respectively.

 

Scheduled debt obligations on both loans for the next five years and thereafter are as follows, assuming the bank does not call the loans due to the debt covenant non-compliance: 

 

Year Ending December 31,    
2016   $ 62,411  
2017     64,982  
2018     67,658  
2019     67,709  
2020     24,940  
Thereafter     385,333  
    $ 673,033
XML 20 R11.htm IDEA: XBRL DOCUMENT v3.5.0.2
Equity Transactions
 9 Months Ended
Sep. 30, 2016
Equity Transactions [Abstract]  
EQUITY TRANSACTIONS:

(6) EQUITY TRANSACTIONS:

 

The Company expensed $30,460 and $101,220 in stock compensation for the three and nine months ended September 30, 2016. The Company did not have any stock compensation expense for the three and nine months ended September 30, 2015. The Company accrues stock compensation expense over the period earned for employees and board members. The Company issued 264,000 shares of common stock due to an employee and board member on July 22, 2016.

 

On January 21, 2015, the Company awarded 35,000 shares of common stock to a consultant for past services. The Company accrued and expensed $16,520 for this award in 2014.

 

On July 10, 2015, the Company entered into a Securities Purchase Agreement under which it issued 2.6 million shares of its common stock in a private placement, at a purchase price of $0.50 per share, for aggregate gross proceeds to the Company of $1.3 million. Scarsdale Equities LLC (“Scarsdale”) acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement and it and its designees were issued seven-year warrants to purchase 156,000 shares of common stock at an exercise price of $0.50 per share.

 

On July 28, 2015, the Company received $78,616 from the exercise of previously outstanding warrants for 314,465 shares of common stock at an exercise price of $0.25 per share.

 

On August 20, 2015, the Company issued 1.3 million shares of its common stock in a private placement, at a purchase price of $0.50 per share, for aggregate gross proceeds to the company of $650,000. Scarsdale acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement and it and its designees were issued seven-year warrants to purchase 78,000 shares of common stock at an exercise price of $0.50 per share.

 

On June 6, 2016, the Company issued 8 million units (“Units”) at a purchase price of $0.25 per Unit in a private placement, each Unit consisting of one share of its common stock, and a seven-year warrant to purchase an additional share of common stock at an exercise price of $0.25, for aggregate gross proceeds to the Company of $2 million. Scarsdale acted as financial advisor to the Company in connection with the private placement and was paid a cash fee in an amount equal to 6% of the gross proceeds of the private placement, and it and its designees were issued seven-year warrants to purchase 480,000 Units at an exercise price of $0.25 per Unit.

 

As of September 30, 2016, the Company had warrants outstanding to purchase 8,577,500 shares of common stock at exercise prices of $0.25 - $1.00 per share that expire in years 2021 through 2023. The Company also had warrants outstanding to purchase 480,000 Units, which expire in 2023.  Each Unit consists of one share of its common stock, and a seven-year warrant to purchase an additional share of common stock at an exercise price of $0.25
XML 21 R12.htm IDEA: XBRL DOCUMENT v3.5.0.2
Income Taxes
 9 Months Ended
Sep. 30, 2016
Income Taxes [Abstract]  
INCOME TAXES:

(7) INCOME TAXES:

 

The Company reported a net loss for the three and nine months ended September 30, 2016 and 2015, respectively. The Company increased its deferred tax asset valuation allowance rather than recognize an income tax benefit.
XML 22 R13.htm IDEA: XBRL DOCUMENT v3.5.0.2
Sales Concentrations
 9 Months Ended
Sep. 30, 2016
Sales Concentrations [Abstract]  
SALES CONCENTRATIONS:

(8) SALES CONCENTRATIONS:

 

Sales to two major customers accounted for 52% of total sales for the nine months ended September 30, 2016. Sales to one major customer accounted for 34% of total sales for the nine months ended September 30, 2015. A loss of one of these customers could have a significant adverse effect on the Company’s financial condition, results of operations and cash flows.
XML 23 R14.htm IDEA: XBRL DOCUMENT v3.5.0.2
Summary of Significant Accounting Policies (Policies)
 9 Months Ended
Sep. 30, 2016
Summary of Significant Accounting Policies [Abstract]  
ORGANIZATION AND OPERATIONS

(a) ORGANIZATION AND OPERATIONS––The Company was incorporated in August 1990, as a Florida corporation with operations beginning in July 1992. We are a biotechnology company that develops cyclodextrin-based products for the treatment of disease. We have filed a Type II Drug Master File with the U.S. Food and Drug Administration (“FDA”) for our lead drug candidate, Trappsol® Cyclo™ as a treatment for Niemann-Pick Type C disease (“NPC”), and recently filed an Investigational New Drug application (IND) with the FDA which describes our Phase I clinical plans in the US. The Company has also filed a Clinical Trial Application with the United Kingdom's Medicines and Healthcare Products Regulatory Agency, and launched an International Clinical Program for Trappsol® Cyclo™.

 

While we also sell cyclodextrins and related products to the pharmaceutical, nutritional, and other industries, primarily for use in diagnostics and specialty drugs with continuing growth in research and new product development, our core business has transitioned to a biotechnology company primarily focused on the development of cyclodextrin-based biopharmaceuticals for the treatment of disease from a business which had been primarily reselling basic cyclodextrin products.
BASIS OF PRESENTATION

(b) BASIS OF PRESENTATION––The accompanying consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation have been included.

 

Operating results for the three and nine-month periods ended September 30, 2016 are not necessarily indicative of the results that may be expected for the year ending December 31, 2016. For further information, refer to the consolidated financial statements and footnotes thereto included in the Company's Annual Report on Form 10-K for the year ended December 31, 2015, as filed with the Securities and Exchange Commission on March 30, 2016.
CASH AND CASH EQUIVALENTS
(c) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original maturity of three months or less.
ACCOUNTS RECEIVABLE
(d) ACCOUNTS RECEIVABLE––Accounts receivable are unsecured and non-interest bearing and stated at the amount we expect to collect from outstanding balances. Based on our assessment of the credit history with customers having outstanding balances and current relationships with them, we have concluded that losses on balances outstanding at September 30, 2016 and December 31, 2015 will be immaterial.
INVENTORY AND COST OF PRODUCTS SOLD
(e) INVENTORY AND COST OF PRODUCTS SOLD––Inventory consists of our pharmaceutical drug Trappsol® Cyclo™, cyclodextrin products and chemical complexes purchased for resale recorded at the lower of cost (first-in, first-out) or net realizable. Cost of products sold includes the acquisition cost of the products sold and does not include any allocation of inbound or outbound freight charges, indirect overhead expenses, warehouse and distribution expenses, or depreciation and amortization expense.
PROPERTY AND EQUIPMENT
(f) PROPERTY AND EQUIPMENT––Property and equipment are recorded at cost. Depreciation on property and equipment is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three to five years for computers and vehicles, seven to ten years for machinery and furniture, fifteen years for certain land improvements, and forty years for buildings and building improvements). We periodically review our long-lived assets to determine if the carrying value of assets may not be recoverable. If an impairment is identified, we recognize a loss for the difference between the carrying amount and the estimated fair value of the asset (see Note 2).
REVENUE RECOGNITION
(g) REVENUE RECOGNITION––We recognize revenue from product sales, royalties, and drying services rendered when the following four revenue recognition criteria are met: persuasive evidence of an arrangement exists, delivery has occurred or services have been rendered, the selling price is fixed or determinable, and collectability is reasonably assured. Product sales and shipping revenues, net of any discounts or return allowances, are recorded when the products are shipped and title passes to customers. Sales to customers are made pursuant to a sales contract that provides for transfer of both title and risk of loss upon our delivery to the carrier. Return allowances, which reduce product revenue, have been historically infrequent, and are recorded when they become known. Amounts received in advance are deferred and recognized as revenue when all four revenue recognition criteria have been met. There is no deferred revenue at September 30, 2016 and December 31, 2015.
RESEARCH AND DEVELOPMENT COSTS
(h) RESEARCH AND DEVELOPMENT COSTS––Research and development costs are expensed as incurred.
INCOME TAXES
(i) INCOME TAXES––Deferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective income tax bases. Deferred tax assets and liabilities are measured using enacted rates expected to apply to taxable income in the years in which those temporary differences are expected to be recovered or settled. In addition, tax benefits related to positions considered uncertain are recognized only when it is more likely than not the position will be sustained upon examination by the tax authorities. Such tax positions shall initially and subsequently be measured as the largest amount of tax benefit that has a greater than 50% likelihood of being realized upon ultimate settlement with the tax authority assuming full knowledge of the position and relevant facts.
NET LOSS PER COMMON SHARE
(j) NET LOSS PER COMMON SHARE––Basic and fully diluted net loss per common share is computed using a simple weighted average of common shares outstanding during the periods presented, as outstanding warrants to purchase 9,057,500 and 577,500 common shares were antidilutive for the three and nine months ended September 30, 2016 and 2015, respectively, and have been excluded from the calculation of loss per common share.
STOCK BASED COMPENSATION
(k) STOCK BASED COMPENSATION––The Company periodically awards stock to employees, directors, and consultants. An expense is recognized equal to the fair value of the stock determined using the closing trading price of the stock on the award date.
CONCENTRATIONS OF CREDIT RISK

(l) CONCENTRATIONS OF CREDIT RISK––Significant concentrations of credit risk for all financial instruments owned by the Company are as follows:

 

(i) DEMAND AND CERTIFICATE OF DEPOSITS––We maintain bank accounts in Federal credit unions and other financial institutions, which are insured up to the Federal Deposit Insurance Corporation limits. The bank accounts may exceed Federally insured levels; however, we have not experienced any losses in such accounts.

 

(ii) ACCOUNTS RECEIVABLE––Our accounts receivable consist of amounts due primarily from chemical supply and pharmaceutical companies located primarily in the United States. Three customers accounted for 94% of the accounts receivable balance at September 30, 2016. Five customers accounted for 89% of the accounts receivable balance at December 31, 2015. We have no policy requiring collateral or other security to support our accounts receivable.
LIQUIDITY
(m) LIQUIDITY––For the year ended December 31, 2015, the Company incurred a net loss of approximately $2,551,000 and used net cash in operations in the amount of approximately $1,989,000. For the nine months ended September 30, 2016, the Company incurred a net loss of $3,391,865, used net cash in operations in the amount of $2,386,557, and received net proceeds of $1,880,000 from the sale of its securities. At September 30, 2016, the Company had a cash balance of $1,270,046, current assets of $2,018,552 and current liabilities of $875,948. The Company seeks to raise capital from time to time through the sale of its common stock and other securities. In the event that the Company cannot raise sufficient capital when required, management may have to reduce expenditures related to its operations.
USE OF ESTIMATES
(n) USE OF ESTIMATES––The preparation of consolidated financial statements in conformity with accounting principles generally accepted in the United States of America requires management to make estimates and assumptions that affect the amounts reported in the consolidated financial statements and accompanying notes. Although management bases its estimates on historical experience and assumptions that are believed to be reasonable under the circumstances, actual results could significantly differ from these estimates.
NEW ACCOUNTING PRONOUNCEMENTS
(o) NEW ACCOUNTING PRONOUNCEMENTS––The Financial Accounting Standards Board (FASB) has issued various Accounting Standards Updates (ASUs), including ASU 2014-09, Revenue from Contracts with Customers, as subsequently amended; ASU 2014-15, Presentation of Financial Statements-Going Concern; ASU 2015-17, Income Taxes; and ASU 2016-02, Leases, which are effective in future fiscal years. We do not expect the adoption of these standards to have a material effect on our financial position or results of operations. The Company adopted ASU 2015-03, Interest-Imputation of Interest (Simplifying the Presentation of Debt Issuance Costs), and reclassified net deferred financing costs of $64,801 from noncurrent assets as a reduction of the associated notes payable balance as of September 30, 2016. This change reduced noncurrent assets and liabilities by $64,801. There was no change in the net loss for the periods presented as a result of this reclassification. The Company also reclassified certain items on the December 31, 2015 balance sheet to be consistent with the current presentation.
XML 24 R15.htm IDEA: XBRL DOCUMENT v3.5.0.2
Mortgage Note Receivable (Tables)
 9 Months Ended
Sep. 30, 2016
Mortgage Note Receivable [Abstract]  
Scheduled of debt principal collections on mortgage
Year Ending      
December 31,   Principal  
2016   $ 46,431  
2017     34,393  
2018     35,884  
2019     37,439  
2020     39,061  
Thereafter     71,792  
    $ 265,000
XML 25 R16.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Values of Financial Investments (Tables)
 9 Months Ended
Sep. 30, 2016
Fair Values of Financial Investments [Abstract]  
Schedule of fair value of financial assets and liabilities
    Level 1     Level 2     Level 3  
Non-recurring fair value instrument   $ -     $ -     $ 245,797
XML 26 R17.htm IDEA: XBRL DOCUMENT v3.5.0.2
Debt (Tables)
 9 Months Ended
Sep. 30, 2016
Debt [Abstract]  
Summary of long-term debt obligations
Year Ending December 31,    
2016   $ 62,411  
2017     64,982  
2018     67,658  
2019     67,709  
2020     24,940  
Thereafter     385,333  
    $ 673,033  
XML 27 R18.htm IDEA: XBRL DOCUMENT v3.5.0.2
Summary of Significant Accounting Policies (Details)
 3 Months Ended 9 Months Ended 12 Months Ended
Sep. 30, 2016
USD ($)
Sep. 30, 2015
USD ($)
Sep. 30, 2016
USD ($)
Customers
shares
Sep. 30, 2015
USD ($)
shares
Dec. 31, 2015
USD ($)
Customers
Dec. 31, 2014
USD ($)
Summary of Significant Accounting Policies (Textual)            
Antidilutive securities excluded from computation of earnings per share | shares     9,057,500 577,500    
Number of customers accounted | Customers     3   5  
Net loss $ (1,614,933) $ (747,556) $ (3,391,865) $ (1,495,992) $ 2,551,000  
Net cash used in operating activities     (2,386,557) (1,166,564) 1,989,000  
Cash and cash equivalents 1,270,046 $ 2,742,417 1,270,046 $ 2,742,417 1,842,233 $ 2,380,054
Proceeds from sale of securities     1,880,000      
Current assets 2,018,552   2,018,552   2,522,886  
Current liabilities 875,948   875,948   945,146  
Deferred financing costs $ 64,801   64,801   $ 66,424  
Noncurrent assets and liabilities     $ 64,801      
Accounts Receivable [Member]            
Summary of Significant Accounting Policies (Textual)            
Concentration risk, percentage of major customer     94.00%   89.00%  
Computers And Vehicles [Member] | Maximum [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     5 years      
Computers And Vehicles [Member] | Minimum [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     3 years      
Machinery and Equipment [Member] | Maximum [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     10 years      
Machinery and Equipment [Member] | Minimum [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     7 years      
Land Improvements [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     15 years      
Building and Building Improvements [Member]            
Summary of Significant Accounting Policies (Textual)            
Property, Plant and Equipment, Useful Life     40 years      
XML 28 R19.htm IDEA: XBRL DOCUMENT v3.5.0.2
Assets Held for Sale (Details) - USD ($)
 3 Months Ended 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Sep. 30, 2016
Sep. 30, 2015
Jan. 21, 2016
Dec. 31, 2015
Assets Held for Sale (Textual)            
Impairment on assets held for sale $ 810,000 $ 125,000 $ 810,000 $ 125,000    
Carrying value of property held for sale $ 963,115   $ 963,115   $ 275,000 $ 275,000
XML 29 R20.htm IDEA: XBRL DOCUMENT v3.5.0.2
Mortgage Note Receivable (Details)
Sep. 30, 2016
USD ($)
Mortgage Note Receivable [Abstract]  
2016 $ 46,431
2017 34,393
2018 35,884
2019 37,439
2020 39,061
Thereafter 71,792
Total $ 265,000
XML 30 R21.htm IDEA: XBRL DOCUMENT v3.5.0.2
Mortgage Note Receivable (Details Textual) - USD ($)
 1 Months Ended
Jan. 21, 2016
Sep. 30, 2016
Dec. 31, 2015
Mortgage Note Receivable [Abstract]      
Carrying value of property held for sale $ 275,000 $ 963,115 $ 275,000
Selling costs and settlement charges 10,000    
Promissory note, principal amount $ 265,000    
promissory not, interest rate 4.25%    
promissory note, maturity description Over a seven-year period commencing March 1, 2016, with the unpaid balance due in February 2023.    
Promissory note monthly payments $ 3,653    
XML 31 R22.htm IDEA: XBRL DOCUMENT v3.5.0.2
Fair Values of Financial Investments (Details)
Sep. 30, 2016
USD ($)
Level 1 [Member]  
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]  
Non-recurring fair value instrument
Level 2 [Member]  
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]  
Non-recurring fair value instrument
Level 3 [Member]  
Fair Value, Balance Sheet Grouping, Financial Statement Captions [Line Items]  
Non-recurring fair value instrument $ 245,797
XML 32 R23.htm IDEA: XBRL DOCUMENT v3.5.0.2
Debt (Details)
Sep. 30, 2016
USD ($)
Summary of Long -term debt obligations  
2016 $ 62,411
2017 64,982
2018 67,658
2019 67,709
2020 24,940
Thereafter 385,333
Total Long-term debt obligations $ 673,033
XML 33 R24.htm IDEA: XBRL DOCUMENT v3.5.0.2
Debt (Details Textual) - USD ($)
 1 Months Ended 9 Months Ended
Jan. 21, 2016
Sep. 30, 2016
Dec. 31, 2015
Debt (Textual)      
Promissory note monthly payments $ 3,653    
Deferred financing costs   $ 64,801 $ 66,424
Land and building acquired [Member]      
Debt (Textual)      
Note payable amount   $ 500,667 516,685
Debt instrument, Payment terms   Monthly payments of $3,506, including principal and interest at 3.99%, are due, with a final balloon payment of approximately $350,000 due in July 2023.  
Maturity date of notes   Jul. 31, 2023  
Accrued interest rate per year   3.99%  
Promissory note monthly payments   $ 3,506  
Payment of Final balloon (principal and accrued interest)   $ 350,000  
Description of prepayment penalty   The note has a voluntary prepayment penalty which was 3% of the principal repaid as of the date of this filing, and which decreases 1% on July 17 of each year.  
Building and improvements [Member]      
Debt (Textual)      
Note payable amount   $ 172,366 $ 203,052
Debt instrument, Payment terms   Monthly payments of $4,051, including principal and interest at 3.99%, are due through and including July 2020.  
Maturity date of notes   Jul. 31, 2020  
Accrued interest rate per year   3.99%  
Promissory note monthly payments   $ 4,051  
Description of prepayment penalty   Penalty of 2% of the outstanding balance if the Company voluntarily repays the loan prior to July 17, 2018.  
XML 34 R25.htm IDEA: XBRL DOCUMENT v3.5.0.2
Equity Transactions (Details) - USD ($)
 1 Months Ended 3 Months Ended 9 Months Ended
Jun. 06, 2016
Jul. 10, 2015
Jul. 22, 2016
Aug. 20, 2015
Jan. 21, 2015
Sep. 30, 2016
Sep. 30, 2016
Jul. 28, 2015
Stock Transactions (Textual)                
Shares issued under common stock transaction         35,000      
Accrued and expensed         $ 16,520      
Outstanding warrants of common stock           480,000 480,000  
Warrant expiration             Expire in 2023.  
Stock compensation           $ 30,460 $ 101,200  
Board of director [Member]                
Stock Transactions (Textual)                
Shares issued under common stock transaction     264,000          
Employees [Member]                
Stock Transactions (Textual)                
Shares issued under common stock transaction     264,000          
Warrant [Member]                
Stock Transactions (Textual)                
Term of warrant 7 years 7 years   7 years     7 years  
Warrants issued to purchase common stock 480,000 156,000   78,000     8,577,500  
Exercise price per share $ 0.25 $ 0.50   $ 0.50   $ 0.25 $ 0.25 $ 0.25
Outstanding warrants of common stock, Value               $ 78,616
Outstanding warrants of common stock           480,000 480,000 314,465
Warrant expiration             Expire in years 2021 through 2023.  
Warrant [Member] | Maximum [Member]                
Stock Transactions (Textual)                
Exercise price per share           $ 1.00 $ 1.00  
Warrant [Member] | Minimum [Member]                
Stock Transactions (Textual)                
Exercise price per share           $ 0.25 $ 0.25  
Private Placement [Member]                
Stock Transactions (Textual)                
Shares issued under common stock transaction 8,000,000 2,600,000   1,300,000        
Aggregate gross proceeds from common stock issued $ 2,000,000 $ 1,300,000   $ 650,000        
Purchase price $ 0.25 $ 0.50   $ 0.50        
Exercise price per share $ 0.25              
XML 35 R26.htm IDEA: XBRL DOCUMENT v3.5.0.2
Sales Concentrations (Details) - Sales [Member] - Customer Concentration Risk [Member] - Customers
 9 Months Ended
Sep. 30, 2016
Sep. 30, 2015
Concentrations (Textual)    
Number of major customers accounted for accounts receivable 2 1
Percentage of revenue accounted by major customer 52.00% 34.00%
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