Cyclo Therapeutics, Inc. - Quarter Report: 2019 March (Form 10-Q)
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: March 31, 2019
or
☐ Transition Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934
For the transition period from ____ to ____
Commission file number: 0-25466
CTD HOLDINGS, INC.
(Exact name of registrant as specified in its charter)
Florida |
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59-3029743 |
(State or other jurisdiction of |
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(IRS Employer |
6714 NW 16th Street, Suite B, Gainesville, Florida |
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32653 |
(Address of principal executive offices) |
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(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 every Interactive Data File required to be submitted 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 such files).
☒ Yes ☐ No
Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.
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Large accelerated filer |
☐ |
Accelerated filer |
☐ |
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Non-accelerated filer |
☐ |
Smaller reporting company |
☒ |
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Emerging growth company |
☐ |
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act)
☐ Yes ☒ No
Securities registered pursuant to Section 12(b) of the Act:
Title of each class |
Trading Symbol(s) |
Name of each exchange on which registered |
N/A | N/A | N/A |
As of May 13, 2019, the Company had outstanding 91,264,463 shares of its common stock.
TABLE OF CONTENTS
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Description |
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Page |
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PART I |
FINANCIAL INFORMATION |
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1 |
Item 1. |
Financial Statements. |
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1 |
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Consolidated Balance Sheets as of March 31, 2019 (Unaudited) and December 31, 2018. |
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1 |
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Consolidated Statements of Operations (Unaudited) for the Three Months Ended March 31, 2019 and 2018. |
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2 |
Consolidated Statement of Stockholders’ Equity (Unaudited) for the Three Months Ended March 31, 2018 |
3 |
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Consolidated Statement of Stockholders’ Equity (Deficit) (Unaudited) for the Three Months Ended March 31, 2019 |
4 |
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Consolidated Statements of Cash Flows (Unaudited) for the Three Months Ended March 31, 2019 and 2018. |
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5 |
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Notes to Consolidated Financial Statements. |
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6 |
Item 2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations. |
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12 |
Item 3. |
Quantitative and Qualitative Disclosures about Market Risk. |
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16 |
Item 4. |
Controls and Procedures. |
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16 |
PART II |
OTHER INFORMATION |
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17 |
Item 1A. |
Risk Factors. |
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17 |
Item 6. |
Exhibits. |
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17 |
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SIGNATURES |
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18 |
PART I. FINANCIAL INFORMATION
Item 1. Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED BALANCE SHEETS
March 31, 2019 |
December 31, 2018 |
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(Unaudited) |
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ASSETS |
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CURRENT ASSETS |
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Cash and cash equivalents |
$ | 1,115,133 | $ | 2,217,412 | ||||
Accounts receivable |
74,796 | 80,044 | ||||||
Inventory, net |
413,253 | 416,531 | ||||||
Current portion of mortgage note receivable |
37,439 | 37,439 | ||||||
Other |
46,901 | 18,185 | ||||||
Total current assets |
1,687,522 | 2,769,611 | ||||||
FURNITURE AND EQUIPMENT, NET |
18,411 | 18,571 | ||||||
RIGHT-TO-USE LEASE ASSET, NET |
63,771 | - | ||||||
MORTGAGE NOTE RECEIVABLE, LESS CURRENT PORTION |
120,458 | 129,674 | ||||||
OTHER |
15,000 | - | ||||||
TOTAL ASSETS |
$ | 1,905,162 | $ | 2,917,856 | ||||
LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT) |
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CURRENT LIABILITIES |
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Current portion of lease liability |
$ | 14,182 | $ | - | ||||
Accounts payable and accrued expenses |
2,622,511 | 1,925,332 | ||||||
Total current liabilities |
2,636,693 | 1,925,332 | ||||||
LONG-TERM LEASE LIABILITY |
50,049 | - | ||||||
STOCKHOLDERS' EQUITY (DEFICIT) |
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Common stock, par value $.0001 per share, 500,000,000 shares authorized, 90,759,324 shares issued and outstanding, at March 31, 2019 and December 31, 2018 |
9,075 | 9,075 | ||||||
Preferred stock, par value $.0001 per share, 5,000,000 shares authorized |
- | - | ||||||
Additional paid-in capital |
18,701,211 | 18,701,211 | ||||||
Stock subscription receivable |
- | (130,062 |
) |
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Accumulated deficit |
(19,491,866 |
) |
(17,587,700 |
) |
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Total stockholders' equity (deficit) |
(781,580 |
) |
992,524 | |||||
TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY (DEFICIT) |
$ | 1,905,162 | $ | 2,917,856 |
See accompanying Notes to Consolidated Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended |
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March 31, |
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2019 |
2018 |
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REVENUES |
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Product sales |
$ | 220,826 | $ | 198,069 | ||||
EXPENSES |
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Personnel |
409,999 | 277,567 | ||||||
Cost of products sold (exclusive of depreciation, shown separately below) |
20,550 | 23,672 | ||||||
Research and development |
1,342,763 | 409,198 | ||||||
Repairs and maintenance |
1,684 | - | ||||||
Professional fees |
214,975 | 233,976 | ||||||
Office and other |
102,642 | 47,867 | ||||||
Board of Director fees and costs |
33,085 | 15,783 | ||||||
Depreciation |
1,484 | 2,500 | ||||||
Freight and shipping |
1,434 | 1,882 | ||||||
Total operating expenses |
2,128,616 | 1,012,445 | ||||||
LOSS FROM OPERATIONS |
(1,907,790 |
) |
(814,376 |
) |
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OTHER INCOME |
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Investment and other |
3,624 | 1,432 | ||||||
LOSS BEFORE INCOME TAXES |
(1,904,166 |
) |
(812,944 |
) |
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PROVISION FOR INCOME TAXES |
- | - | ||||||
NET LOSS |
$ | (1,904,166 |
) |
$ | (812,944 |
) |
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BASIC AND FULLY DILUTED NET LOSS PER COMMON SHARE |
$ | (.02 |
) |
$ | (.01 |
) |
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WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING |
90,759,324 | 72,999,361 |
See Accompanying Notes to Consolidated Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY
FOR THE THREE MONTHS ENDED MARCH 31, 2018
(unaudited)
Common Stock |
Preferred Stock Series B |
Additional |
Total |
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Shares |
Par |
Units |
Par Value |
Paid-In |
Subscription |
Accumulated |
Stockholders’ Equity |
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Balance, December 31, 2017 |
72,999,361 | $ | 7,299 | 15,500 | $ | 2 | $ | 14,470,984 | $ | - | $ | (13,332,667 |
) |
$ | 1,145,618 | |||||||||||||||||
Net loss |
- | - | - | - | - | - | (812,944 | ) | (812,944 | ) | ||||||||||||||||||||||
Balance, March 31, 2018 |
$ | 72,999,361 | $ | 7,299 | $ | 15,500 | $ | 2 | $ | 14,470,984 | $ | - | $ | (14,145,611 |
) |
$ | 332,674 |
See Accompanying Notes to Consolidated Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR THE THREE MONTHS ENDED MARCH 31, 2019
(unaudited)
Common Stock |
Preferred Stock Series B |
Additional |
Total |
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Shares |
Par |
Units |
Par Value |
Paid-In |
Subscription |
Accumulated |
Stockholders’ Equity (Deficit) |
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Balance, December 31, 2018 |
90,759,324 | $ | 9,075 | - | $ | - | $ | 18,701,211 | $ | (130,062 |
) |
$ | (17,587,700 |
) |
$ | 992,524 | ||||||||||||||||
Collection of subscription receivable |
- | - | - | - | - | 130,062 | - | 130,062 | ||||||||||||||||||||||||
Net loss |
- | - | - | - | - | - | (1,904,166 |
) |
(1,904,166 |
) |
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Balance, March 31, 2019 |
90,759,324 | $ | 9,075 | - | $ | - | $ | 18,701,211 | $ | - | $ | (19,491,866 | ) | $ | (781,580 |
) |
See Accompanying Notes to Consolidated Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
CONSOLIDATED STATEMENTS OF CASH FLOWS
(Unaudited)
Three Months Ended |
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March 31, |
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2019 |
2018 |
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CASH FLOWS FROM OPERATING ACTIVITIES |
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Net loss |
$ | (1,904,166 |
) |
$ | (812,944 |
) |
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Adjustments to reconcile net loss to net cash used in operating activities: |
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Depreciation |
1,484 | 2,500 | ||||||
Accrued stock compensation to employees |
7,300 | 3,300 | ||||||
Accrued stock compensation to non-employees |
24,090 | 10,890 | ||||||
Increase or decrease in: |
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Accounts receivable |
5,248 | 9,178 | ||||||
Inventory |
3,278 | 17,778 | ||||||
Other current assets |
(28,716 |
) |
(4,258 |
) |
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Other |
460 | - | ||||||
Accounts payable and accrued expenses |
665,789 | 35,859 | ||||||
Total adjustments |
678,933 | 75,247 | ||||||
NET CASH USED IN OPERATING ACTIVITIES |
(1,225,233 |
) |
(737,697 |
) |
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CASH FLOWS FROM INVESTING ACTIVITIES |
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Purchase of equipment |
(1,324 |
) |
(1,634 |
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Proceeds from mortgage note receivable |
9,216 | 2,934 | ||||||
NET CASH PROVIDED BY INVESTING ACTIVITIES |
7,892 | 1,300 | ||||||
CASH FLOWS FROM FINANCING ACTIVITIES |
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Collection of subscription receivable |
130,062 | - | ||||||
Advance – private placement |
- | 74,983 | ||||||
Other |
(15,000 |
) |
- | |||||
NET CASH PROVIDED BY FINANCING ACTIVITIES |
115,062 | 74,983 | ||||||
NET DECREASE IN CASH AND CASH EQUIVALENTS |
(1,102,279 |
) |
(661,414 | ) | ||||
CASH AND CASH EQUIVALENTS, beginning of period |
2,217,412 | 1,270,973 | ||||||
CASH AND CASH EQUIVALENTS, end of period |
$ | 1,115,133 | $ | 609,559 | ||||
SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION |
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Cash paid for interest |
$ | - | $ | - | ||||
Cash paid for income taxes |
$ | - | $ | - | ||||
NON-CASH INVESTING AND FINANCING ACTIVITIES |
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Capitalization of right-to-use asset and lease liability |
$ | 64,231 | - |
See Accompanying Notes to Consolidated Financial Statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
The information presented herein as of March 31, 2019 and for the three months ended March 31, 2019 and 2018 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,” “we,” “our” or “us”) 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”), a rare and fatal cholesterol metabolism disease that impacts the brain, lungs, liver, spleen, and other organs. The FDA approved our Investigational New Drug application (IND) which describes our Phase I clinical plans in the U.S. for Trappsol® Cyclo™ and in January 2017 the FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC. Initial patient enrollment in the U.S. Phase I study commenced in September 2017. We have also filed Clinical Trial Applications with several European regulatory bodies, including those in the United Kingdom, Sweden and Italy, and in Israel, all of which have approved our applications. The first patient was dosed in our European study in July 2017.
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. However, 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 month period ended March 31, 2019 are not necessarily indicative of the results that may be expected for the year ending December 31, 2019. 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, 2018, as filed with the Securities and Exchange Commission on March 15, 2019.
(c) CASH AND CASH EQUIVALENTS––Cash and cash equivalents consist of cash and any highly liquid investments with an original purchased 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, an allowance for uncollectible accounts was not deemed necessary at March 31, 2019 and December 31, 2018.
(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 value. 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. The Company records a specific reserve for inventory items that are determined to be obsolete. The reserve for obsolete inventory was $39,700 at March 31, 2019 and December 31, 2018.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(f) EQUIPMENT––Equipment is recorded at cost, less accumulated depreciation. Depreciation is computed using primarily the straight-line method over the estimated useful lives of the assets (generally three to five years for computers, and seven to ten years for equipment and office furniture).
(g) REVENUE RECOGNITION––Effective January 1, 2018, the Company adopted the provisions of ASC 606 using the modified retrospective method. The adoption of the new revenue standards as of January 1, 2018, did not change our revenue recognition as the majority of our revenues continue to be recognized when the customer takes control of our product. As we did not identify any accounting changes that impacted the amount of reported revenues with respect to our product revenues and no adjustment to retained earnings was required upon adoption.
Under the new revenue standards, we recognize revenues when our customer obtains control of promised goods or services, in an amount that reflects the consideration which we expect to receive in exchange for those goods or services. We recognize revenues following the five step model prescribed under ASU No. 2014-09: (i) identify contract(s) with a customer; (ii) identify the performance obligations in the contract; (iii) determine the transaction price; (iv) allocate the transaction price to the performance obligations in the contract; and (v) recognize revenues when (or as) we satisfy the performance obligation.
Product revenues
In the U.S. we sell our products to the end user or wholesale distributors. In other countries, we sell our products primarily to wholesale distributors and other third-party distribution partners. These customers subsequently resell our products to health care providers and patients.
Revenues from product sales are recognized when the customer obtains control of our product, which occurs at a point in time, typically upon delivery to the customer. We expense incremental costs of obtaining a contract as and when incurred if the expected amortization period of the asset that we would have recognized is one year or less or the amount is immaterial. We treat shipping and handling costs performed after a customer obtains control of the product as a fulfillment cost. We have identified one performance obligation in our contracts with customers which is the delivery of product to our customers. The transaction price is recognized in full when we deliver the product to our customer, which is the point at which we have satisfied our performance obligation.
Reserves for Discounts and Allowances
Revenues from product sales are recorded net of reserves established for applicable discounts and allowances that are offered within contracts with our customers, health care providers or payors, including those associated with the implementation of pricing actions in certain of the international markets in which we operate. Our process for estimating reserves established for these variable consideration components do not differ materially from our historical practices.
Product revenue reserves, which are classified as a reduction in product revenues, are generally characterized in the following categories: discounts, contractual adjustments and returns.
These reserves are based on estimates of the amounts earned or to be claimed on the related sales and are classified as reductions of accounts receivable (if the amount is payable to our customer) or a liability (if the amount is payable to a party other than our customer). Our estimates of reserves established for variable consideration typically utilize the most likely method and reflect our historical experience, current contractual and statutory requirements, specific known market events and trends, industry data and forecasted customer buying and payment patterns. The transaction price, which includes variable consideration reflecting the impact of discounts and allowances, may be subject to constraint and is included in the net sales price only to the extent that it is probable that a significant reversal of the amount of the cumulative revenues recognized will not occur in a future period. Actual amounts may ultimately differ from our estimates. If actual results vary, we adjust these estimates, which could have an effect on earnings in the period of adjustment.
For additional information on our revenues, please read Note 6, Revenues, to these condensed consolidated financial statements.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(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. Outstanding warrants to purchase 32,192,294 common shares and 28,500,478 common shares, for the three months ended March 31, 2019 and 2018, respectively, and 1,768,147 common shares that may be issued under warrants to purchase units sold in the Company’s private placements, were antidilutive for the three months ended March 31, 2018 and March 31, 2019, 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) LIQUIDITY AND GOING CONCERN––For the three months ended March 31, 2019 and 2018, the Company incurred net losses of $1,904,166 and $812,944. At March 31, 2019, the Company had a cash balance of $1,115,133 and its current assets less current liabilities were $(949,171). The Company has an accumulated deficit of $19,491,866 at March 31, 2019. Our recent losses have predominantly resulted from research and development expenses for our Trappsol® Cyclo™ product and other general operating expenses, including board advisory fees. We believe our expenses will continue to increase as we conduct clinical trials and continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC.
For year ended December 31, 2018, our operations used approximately $3,188,000 in cash. This cash was provided primarily by cash on hand and net proceeds of $4,102,000 from equity issuances. At December 31, 2018, the Company had a cash balance of $2,217,000 and current assets less current liabilities of $844,000. We will need additional capital to maintain our operations, continue our research and development programs, conduct clinical trials, seek regulatory approvals and manufacture and market our products.
We will need to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund the development of 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 our overall business performance and market conditions. If we cannot raise the additional funds required for our anticipated operations, we may be required to reduce the scope of or eliminate our research and development programs, delay our clinical trials and the ability to seek regulatory approvals, downsize our general and administrative infrastructure, or seek alternative measures to avoid insolvency. If we raise additional funds through future offerings of shares of our Common Stock or other securities, such offerings would cause dilution of current stockholders’ percentage ownership in the Company, which could be substantial. Future offerings also could have a material and adverse effect on the price of our Common Stock.
We have incurred losses from operations in each of our last five fiscal years. Our ability to continue as a going concern is dependent upon the availability of equity financing as noted above. We will need to raise additional capital to support our ongoing operations and continue our clinical trials. There can be no assurance that the Company will be successful with these fundraising endeavors. These factors raise substantial doubt about our ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of these uncertainties.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(m) 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, including contingencies. 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.
(n) FAIR VALUE MEASUREMENTS AND DISCLOSURES––The Fair Value Measurements and Disclosures topic of the Accounting Standards Codification (“ASC”) requires companies to determine fair value based on the price that would be received to sell the asset or paid to transfer the liability to a market participant. The Fair Value Measurements and Disclosures topic emphasizes that fair value is a market-based measurement, not an entity-specific measurement.
The guidance requires that assets and liabilities carried at fair value be classified and disclosed in one of the following categories:
● |
Level 1: Quoted market prices in active markets for identical assets or liabilities. |
● |
Level 2: Observable market based inputs or unobservable inputs that are corroborated by market data. |
● |
Level 3: Unobservable inputs that are not corroborated by market data. |
We have no assets or liabilities that are required to have their fair value measured on a recurring basis at March 31, 2019 or December 31, 2018. Long-lived assets are measured at fair value on a non-recurring basis and are subject to fair value adjustments when there is evidence of impairment.
For short-term classes of our financial instruments which are not reported at fair value, the carrying amounts approximate fair value due to their short-term nature, which include cash, accounts receivable, and accounts payable. The fair value of the mortgage note receivable is estimated based on the present value of the underlying cash flows discounted at current rates. At March 31, 2019 and December 31, 2018, the carrying value of the mortgage note receivable approximates fair value.
(o) Accounting Standards Adopted––
● |
Leases - In February 2016, the FASB issued ASU 2016-02, “Leases (Topic 842),” (“ASU 2016-02”), which amends leasing guidance by requiring companies to recognize a right-of-use asset and a lease liability for all operating and financing leases with lease terms greater than twelve months. The lease liability is equal to the present value of lease payments. The lease asset is based on the lease liability, subject to adjustment for prepaid and deferred rent and tenant incentives. For income statement purposes, leases will continue to be classified as operating or financing with lease expense in both cases calculated substantially the same as under the prior leasing guidance. |
The Company adopted Topic 842 as of January 1, 2019 (the first day of fiscal 2019). See Note 7
(p) Accounting Standards to be Adopted in Future Periods––There are no outstanding accounting standards to be adopted that will have a material effect on the Company’s financial position and operations.
(2) MORTGAGE NOTE RECEIVABLE
On January 21, 2016, we sold our real property located in High Springs, Florida to an unrelated party. 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 us 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 that commenced March 1, 2016, with the unpaid balance due in February 2023.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(3) EQUITY TRANSACTIONS:
The Company expensed $31,390 and $14,190 in employee and board member stock compensation for the three months ended March 31, 2019 and 2018, respectively. These shares were valued using quoted market values. The Company accrues stock compensation expense over the period earned for employees and board members.
In April, 2018, the Company completed a private placement resulting in gross proceeds to the Company of $2,010,000. Prior to March 31, 2018, the Company received $74,983 in advance from these investors, which has been recorded as an advance -- private placement in the accompanying statement of cash flows.
As of March 31, 2019, the Company had warrants outstanding to purchase 32,192,294 shares of common stock at exercise prices of $0.25 - $1.00 per share that expire at various dates through 2025. An additional 1,768,147 shares of common stock may be issued under warrants outstanding to purchase 480,000 Units sold in the Company’s May 2016 private placement at an exercise price of $0.25 per Unit, 164,074 Units sold in the Company’s February 2017 private placement at an exercise price of $0.35 per Unit, and 600 Units sold in the Company’s October 2017 private placement at an exercise price of $100 per Unit.
(4) INCOME TAXES:
The Company reported a net loss for the three months ended March 31, 2019 and 2018, respectively. The Company increased its deferred tax asset valuation allowance rather than recognize an income tax benefit.
(5) SALES CONCENTRATIONS:
Sales to four major customers accounted for 76% of total sales for the three months ended March 31, 2019 and 2018, respectively. 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.
(6) REVENUES:
The Company operates in one business segment, which primarily focuses on the development and commercialization of innovative cyclodextrin-based products for the treatment of people with serious and life threatening rare diseases and medical conditions. The Company considers there to be revenue concentration risks for regions where net product revenues exceed 10% of consolidated net product revenues. The concentration of the Company’s net product revenues within the regions below may have a material adverse effect on the Company’s revenues and results of operations if sales in the respective regions experience difficulties. See Note 1(g) – Revenue Recognition for additional discussion.
Revenues by product are summarized as follows:
Three Months Ended |
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March 31, |
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2019 |
2018 |
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Trappsol Cyclo |
$ | 30,096 | $ | 30,096 | ||||
Trappsol HPB |
70,867 | 74,762 | ||||||
Trappsol research |
65,852 | 61,025 | ||||||
Aquaplex |
52,560 | 29,455 | ||||||
Other |
1,451 | 2,731 | ||||||
Total revenues |
$ | 220,826 | $ | 198,069 |
Substantially all of our sales of Trappsol® Cyclo™ for the three months ended March 31, 2019 and March 31, 2018 were to a particular customer who exports the drug to South America. Substantially all of our Aquaplex sales are to one customer.
CTD HOLDINGS, INC. AND SUBSIDIARIES
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
MARCH 31, 2019
(7) LEASES:
The Company adopted ASU 2016-02 “Leases (Topic 842)” along with related clarifications and improvements effective at the beginning of fiscal 2019, using the modified retrospective transition method. There was no cumulative-effect adjustment to the Company's Consolidated Balance Sheet as of December 31, 2018. Comparative information has not been restated and continues to be reported under the accounting standards in effect for those periods, as the Company has elected the package of practical expedients permitted under the transition guidance, which among other things, allows us to carryforward our prior lease classifications under ASC 840, “Leases.”
Under the new guidance, right-of-use assets and lease liabilities are recognized based on the present value of the future minimum lease payments over the lease terms at the commencement dates. The Company uses its incremental borrowing rates as the discount rate for its leases, which is equal to the rate of interest the Company would have to pay on a collateralized basis to borrow an amount equal to the lease payments under similar terms. The incremental borrowing rate for all existing leases as of the opening balance sheet date was based upon the remaining terms of the leases; the incremental borrowing rate for all new or amended leases is based upon the lease terms. The lease terms for all the Company’s leases include the contractually obligated period of the leases, plus any additional periods covered by a Company options to extend the leases that the Company is reasonably certain to exercise.
The Company has elected the package of practical expedients permitted under the transition guidance, which among other things, allows us to carryforward our prior lease classifications under ASC 840, “Leases.”
Adoption of Topic 842 did not have a material impact on our annual operating results or cash flows. Operating lease expense is recognized on a straight-line basis over the lease term and is included in operating costs or General and administrative expense. Variable lease payments are expensed as incurred.
The effects of the changes made to the Company’s Consolidated Balance Sheet as of December 31, 2018 for the adoption of Topic 842 is as follows:
The Company determines if an arrangement is or contains a lease at contract inception and recognizes a right-of-use asset and a lease liability at the lease commencement date. Leases with an initial term of 12 months or less but greater than one month are not recorded on the balance sheet for select asset classes. The lease liability is measured at the present value of future lease payments as of the lease commencement date, or the opening balance sheet date for leases existing at adoption of Topic 842. The right-of-use asset recognized is based on the lease liability adjusted for prepaid and deferred rent and unamortized lease incentives.
Certain leases provide that the lease payments may be increased annually based on the fixed rate terms or adjustable terms such as the Consumer Price Index. Future base rent escalations that are not contractually quantifiable as of the lease commencement date are not included in our lease liability.
The Company has one office lease, which is as an operating lease and included in the right-of-use asset, current portion of lease liability, and long-term lease liability captions on the Company’s consolidated balance sheet.
Operating lease assets are recorded net of accumulated amortization of $4,251 as of March 31, 2019.
Lease expense for lease payments are recognized on a straight-line basis over the lease term. Lease expense for the first quarter of 2019 was $3,331.
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, 2018. 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. All amounts presented herein are rounded to nearest $1,000.
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 filed a Type II Drug Master File with the U.S. Food and Drug Administration (“FDA”) in 2014 for our lead drug candidate, Trappsol® Cyclo™ (hydroxypropyl beta cyclodextrin) as a treatment for Niemann-Pick Type C disease (“NPC”). NPC is a rare and fatal cholesterol metabolism disease that impacts the brain, lungs, liver, spleen, and other organs. In 2015, we launched an International Clinical Program for Trappsol® Cyclo™ as a treatment for NPC. In 2016, we 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 U.S. The Phase I study will evaluate the safety of Trappsol® Cyclo™ along with markers of cholesterol metabolism and markers of NPC during a 14-week treatment period of intravenous administration of Trappsol® Cyclo™ every two weeks to participants 18 years of age and older. The IND was approved by the FDA in September 2016, and in January 2017 the FDA granted Fast Track designation to Trappsol® Cyclo™ for the treatment of NPC. Initial patient enrollment in the U.S. Phase I study commenced in September 2017.
We have also filed Clinical Trial Applications with several European regulatory bodies, including those in the United Kingdom, Sweden and Italy, and in Israel, all of which have approved our applications. The European Phase I/II study will evaluate the safety of Trappsol® Cyclo™ along with a range of clinical outcomes, including neurologic, hepatic, and respiratory, in addition to measurements of cholesterol metabolism and markers of NPC. The European study is similar to the U.S. study, providing for the administration of Trappsol® Cyclo™ intravenously to NPC patients every two weeks in a double-blind, randomized trial. The first patient was dosed in this study in July 2017.
Preliminary data from our clinical studies suggests that Trappsol® Cyclo™ crosses the blood-brain-barrier in individuals suffering from NPC. Following intravenous administration of Trappsol® Cyclo™ to study subjects, it was detected in subjects' cerebrospinal fluid. The clinical significance of these findings will be determined as part of the final analysis of both clinical trials.
We are also exploring the use of cyclodextrins in the treatment of Alzheimer's disease under a collaborative arrangement with Kerwin Research Center, which is funding this project. In January 2018, the FDA authorized a single patient IND expanded access program using Trappsol® Cyclo™ for the treatment of this disease, and in October 2018, we filed a patent application with respect to the use of hydroxypropyl beta cyclodextrins in the treatment of Alzheimer's disease.
We also continue to operate our legacy fine chemical business, consisting of the sale of 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. However, 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 that had been primarily reselling basic cyclodextrin products.
We have retained Torreya Capital, LLC, as our strategic advisor to support business development.
Trappsol® Cyclo™
At the end of 2009, we provided Trappsol® Cyclo™ (our first generation product) to a customer for compassionate use as an Investigational New Drug to treat a set of twins in the U.S. who were diagnosed 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. Trappsol® Cyclo™ (first and second generation product) has been administered to more than 20 NPC patients in compassionate use programs around the world, including in the U.S., Brazil and Spain. In 2012, we began to offer 100ml vials of Trappsol® Cyclo™ in a liquid form from a contract manufacturer (second generation product). In 2014, we completed validation of our proprietary 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. Our third generation product of Trappsol® Cyclo™ in liquid form is in clinical trials. We hold Orphan Drug Designation for Trappsol® Cyclo™ in both the U.S. and Europe.
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), and are gradually finding supply sources in the United States. While we enjoy lower supply prices from outside the United States, changes in shipping costs and currency exchange rates are making domestic sources more competitively priced. 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 approximately $1,115,000 as of March 31, 2019, compared to $2,217,000 as of December 31, 2018. Our current assets less current liabilities were $(949,000) as of March 31, 2019, compared to $844,000 at December 31, 2018. Cash used in operations was $1,225,000 for the three months ended March 31, 2019, compared to $738,000 for the same period in 2018.
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.
We expect to continue to raise additional capital through the sale of our securities from time to time for the foreseeable future to fund the development of 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 our overall business performance and market conditions.
We have no off-balance sheet arrangements at March 31, 2019.
Results of Operations - Three Months Ended March 31, 2019 Compared to Three Months Ended March 31, 2018
We reported a net loss of $(1,904,000) for the three months ended March 31, 2019, compared to net loss of $(813,000) for the three months ended March 31, 2018.
Total revenues for the three month period ended March 31, 2019 increased 11% to $221,000 compared to $198,000 for the same period in 2018. Our change in the mix of our product sales for the three months ended March 31, 2019 and 2018 is as follows:
Trappsol® Cyclo
Our sales of Trappsol® Cyclo™ remained consistent at $30,000 for the three month periods ended March 31, 2019, and 2018. Substantially all of our sales of Trappsol® Cyclo™ for the three months ended March 31, 2019 and 2018 were to a particular customer who exports the drug to South America. Our annual 2018 sales to this customer were $167,000 (100% of total 2018 sales of Trappsol® Cyclo™). This product is designated as an orphan drug; the population of patients who use the product on a compassionate basis is small.
Trappsol® HPB
Our sales of Trappsol® HPB decreased by 5% for the three month period ended March 31, 2019, to $71,000 from $75,000 for the three months ended March 31, 2018.
Trappsol® other products
Our sales of other Trappsol® products increased for the three month period ended March 31, 2019, to $66,000 from $61,000 for the three months ended March 31, 2018.
Aquaplex®
Our sales of Aquaplex® were $53,000 for the three months ended March 31, 2019 compared to $29,000 for the three months ended March 31, 2018.
The largest customers for our legacy fine chemical business continue to follow historical product ordering trends by placing periodic large orders that represent a significant share of our annual sales volume. During the three months ended March 31, 2019, our four largest customers accounted for 76% of our sales; the largest accounted for 22% of sales. During the three months ended March 31, 2018, our four largest customers accounted for 76% of our sales; the largest accounted for 28% 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 three month period ended March 31, 2019 decreased 13% to $21,000 from $24,000 for the same period in 2018. Our cost of products sold (excluding any allocation of direct and indirect overhead and handling costs) as a percentage of sales was 9% and 12% for the three months ended March 31, 2019 and 2018, respectively. 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 2018, or the first quarter of 2019.
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 expense. Our employees provide receiving, inspection, warehousing and shipping operations for us. The cost of our employees is included in personnel expense. Our other costs of warehousing and shipping functions are included in office and other expense.
As we buy inventory from foreign suppliers, the change in the value of the U.S. dollar in relation to the Euro, Yen and Yuan has 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. The cost of our bulk inventory often changes due to fluctuations in the U.S. dollar. The cost of shipping from outside the U.S. also has a significant effect on our inventory acquisition costs. When we experience short-term increases in currency fluctuation or supplier price increases, we are often not able to raise our prices sufficiently to maintain our historical margins. Therefore, our margins on these sales may decline.
Personnel expenses increased by 48%, to $410,000 for the three months ended March 31, 2019 from $278,000 for the three months ended March 31, 2018. The increase in personnel expense is due to bonuses paid in 2018. We expect to maintain our level of employees and related costs in the near term.
Research and development expenses increased 228% to $1,343,000 for the three months ended March 31, 2019, from $409,000 for the three months ended March 31, 2018. Research and development expenses as a percentage of our total operating expenses increased to 63% for the three months ended March 31, 2019 from 40% for the three months ended March 31, 2018. The increase in research and development expense is due to increased activity in our International Clinical Program and U.S. clinical trials. We expect future research and development costs to further increase as we continue to seek regulatory approval for the use of Trappsol® Cyclo™ in the treatment of NPC.
Professional fees decreased 8% to $215,000 for the three months ended March 31, 2019, compared to $234,000 for the three months ended March 31, 2018. Professional fees may increase in the future due to new initiatives in raising capital and the continuation of product development.
Office and other expenses increased 113% to $103,000 for the three months ended March 31, 2019, compared to $48,000 for the three months ended March 31, 2018. Office and other expenses include costs for travel to, and participation in, industry conferences and similar events, which vary from period to period.
Board of Directors fees and costs increased to $33,000 for the three months ended March 31, 2019, compared to $16,000 for the three months ended March 31, 2018. Board of Directors fees and costs include fees (generally in the form of stock compensation) paid to our non-employee directors and scientific advisory board members, reimbursement of expenses of our board members, and related expenses.
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 months ended March 31, 2019, and 2018, 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 report (the "Evaluation Date"). Based on such evaluation, our principal executive and principal financial officer has concluded that our disclosure controls and procedures were effective as of March 31, 2019.
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.
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, 2018. 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. |
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DESCRIPTION |
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31.1 |
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32.1 |
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101.INS |
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XBRL Instance Document |
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101.SCH |
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XBRL Taxonomy Extension Schema Document |
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101.CAL |
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XBRL Taxonomy Extension Calculation Linkbase Document |
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101.DEF |
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XBRL Taxonomy Extension Definition Linkbase Document |
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101.LAB |
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XBRL Taxonomy Extension Label Linkbase Document |
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101.PRE |
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XBRL Taxonomy Extension Presentation Linkbase Document |
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.
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CTD HOLDINGS, INC. |
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Date: May 15, 2019 |
By: |
/s/ N. Scott Fine |
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N. Scott Fine |
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Chief Executive Officer |
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(principal executive, financial and accounting officer) |
18