WEB NEWS Deal Flow
ALACHUA, FL--(Marketwired - July 22, 2014) - CTD Holdings, Inc. (OTCQB: CTDH), a manufacturer and distributor of cyclodextrins for the pharmaceutical, medical device, cosmetics, and other markets, announced today that it has closed on a Private Placement with a group of qualified private investors led by Novit L.P., an investment arm of U.S. Pharmacia.
The transaction involved the signing of a Securities Purchase Agreement under which CTD Holdings issued 1,725,000 shares of Common Stock at a price per share of $1.00 , resulting in a $1,725,000 capital infusion to the Company . There were no other conditions connected to the issuance of the shares.
Scarsdale Equities, LLC acted as financial advisor and exclusive placement agent of the Company in connection with the Securities Purchase Agreement.
A complete description of the transaction can be found in the Current Report on Form 8-K filed with the Securities and Exchange Commission in connection with this transaction.
"This vote of confidence from our existing shareholders is especially gratifying," said Dr. Jeffrey Tate, President and CEO. "They share our vision for saving the lives of children with Niemann-Pick Type C by developing this treatment we believe will prove effective against this devastating fatal disease. It continues to build the strength needed for the challenge of clinical trials ahead."
In 2010 the U.S. Food & Drug Administration designated Trappsol® Cyclo™ as an orphan drug for the treatment of Niemann-Pick Type C disease, a rare and fatal genetic condition that typically develops in children under 10 years of age. In the U.S. treatment with Trappsol® Cyclo™ is supervised by a physician holding an approved Investigational New Drug Protocol.
The proceeds of the transaction will be used primarily for the development of the Trappsol® Cyclo™ orphan drug, including filing the Drug Master File with U.S. FDA, planning for clinical trials in Europe and the U.S., and development of the third-generation product.
Comments & Business Outlook
First Quarter 2014 Results
CONSOLIDATED STATEMENTS OF OPERATIONS
(Unaudited)
Three Months Ended
March 31,
2014
2013
REVENUES
Product sales
$
$
EXPENSES
Personnel
114,821
80,428
Cost of products sold (exclusive of amortization and depreciation, shown separately below)
120,407
215,825
Repairs and maintenance
17,486
3,191
Professional fees
43,131
Office and other
26,150
Amortization and depreciation
37,819
35,391
Freight and shipping
2,093
2,866
406,982
OPERATING INCOME
158,238
176,509
OTHER INCOME (EXPENSES)
Investment and other income
2,173
715
Interest expense
(8,486
)
(17,146
)
(6,313
)
(16,431
)
INCOME BEFORE INCOME TAXES
151,925
160,078
Income taxes
55,000
40,000
NET INCOME
$
96,925
$
120,078
NET INCOME PER COMMON SHARE
$
.00
$
.00
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING
42,466,993
36,889,535
See Accompanying Notes to Consolidated Financial Statements.
Trappsol® Cyclo™
Future Initiatives for Business and Product Development
We believe we have identified an unmet need for commercial quantities of ultra pure cyclodextrins that can be filled using the proprietary manufacturing capabilities of our NanoSonic Products division. Work on qualifying a trade secret purification system is completed. Suppliers of suitable raw materials for these operations are being evaluated and will be qualified for contract supply.
The second generation formulation of Trappsol® Cyclo™, the orphan drug developed by our Sphingo Biotechnology division, is currently being sold. We have identified significant potential for growth in the South American market and are pursuing those opportunities. We are also conducting the validation of manufacturing batches that will be used in on-going stability studies and for the filing of a Drug Master File with U.S. FDA. Progress on these efforts is steady and the pace is driven by the rate of sales.
We continue to pursue projects in environmental remediation through our Ferrazo Environmental Technology division. We have identified two potential projects and are in negotiations to apply our cyclodextrin-based Ferrazo products to soil clean-up projects. If these negotiations result in a sales contract, we expect that this environmental remediation work will require metric ton quantities of low cost technical grade cyclodextrin raw materials. Our representatives will be traveling to Asia in 2014 to meet with and qualify suppliers of large quantities of the required raw materials. We are also investigating the establishment of a Foreign Trade Zone at our Alachua site that would be sponsored by the Port of Jacksonville, FL. A Foreign Trade Zone may have the benefit of reducing tariff costs when importing and converting large quantities of cyclodextrin raw materials from Asia.
Joint Venture
ALACHUA, FL--(Marketwired - April 16, 2014) - CTD Holdings, Inc. (OTCQB : CTDH), a manufacturer and distributor of cyclodextrins for the pharmaceutical, medical device, cosmetics and other markets, announced today that it has closed on a Securities Purchase and Collaboration Agreement with Novit LP an affiliated entity of the USP Group, a major manufacturer and distributor of over-the-counter pharmaceutical products in Poland.
The transaction involved the signing of a Securities Purchase and Collaboration Agreement under which CTD Holdings issued 4 million shares of Common Stock to Novit LP at $0.25 per share, resulting in a $1,000,000 capital infusion to the Company.
Pursuant to the terms of the Agreement, the Company also agreed to give USP Zdrowie Sp. z o.o. ("USPZ"), an affiliate of Novit LP, a "first look" for 60 days from the date of notice to USPZ by the Company, at any new products involving cyclodextrin technology developed or formulated by the Company for potential use by USPZ in its own product portfolio in certain Middle & Eastern European markets, prior to the Company marketing or selling such for use in the over-the-counter pharmaceutical markets products in the same region. Furthermore, the Company has agreed to explore opportunities for its cyclodextrin products to offer improvements to USPZ's product portfolio and to collaborate on new product development.
In connection with the Agreement, the Company's Board of Directors voted to increase its size from five (5) members to six (6) members, and voted to fill the resulting vacancy, effective as of April 9, 2014, with F. Patrick Ostronic, an officer and director of several affiliated entities within the USP Group.
Scarsdale Equities, LLC acted as financial advisor and exclusive placement agent of the Company in connection with the Securities Purchase and Collaboration Agreement.
A complete description of the transaction can be found in the Current Report on Form 8-K filed with the Securities Exchange Commission in connection with the transaction.
"This transaction opens the door to collaboration with a leading company in a growing market," said Dr. Jeffrey Tate, President of CTD Holdings and Chief Executive of two of its operating divisions. "Access to the impressive manufacturing and distribution capabilities of the USP Group will accelerate our product development and enhance our ability to move finished products to customers. It opens virgin sales territory for the Company."
"I look forward to exploring new product opportunities in Eastern Europe," said Mr. Strattan, Company Chairman & CEO. "I welcome our new Board member and look forward to his contributions to the team."
The proceeds of the transaction will be used for business development purposes, including the Company's priorities for 2014: expansion of e-commerce sales; production of ultra-pure cyclodextrin derivatives for the research, cosmetic, and medical industries; and completion of the Drug Master File for the Trappsol® Cyclo™ orphan drug. In 2010 the U.S. Food & Drug Administration designated Trappsol® Cyclo™ as an orphan drug for the treatment of Niemann-Pick disease, Type C, a rare and fatal genetic condition that typically develops in children under 10 years of age. In the U.S. treatment with Trappsol® Cyclo™ is supervised by a physician holding an approved Investigational New Drug Protocol.
