UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
________________________
FORM 8-K
________________________
CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
 
March 28, 2019
Date of report (Date of earliest event reported)
_______________________
Valeritas Holdings, Inc.
(Exact name of registrant as specified in its charter)
________________________
 
 
 
 
 
 
 
 
 
 
Delaware
001-38038
46-5648907
(State or other jurisdiction
of incorporation)
(Commission
File Number)
(IRS Employer
Identification No.)
 
750 Route 202, Suite 600
Bridgewater, NJ
(Address of principal executive offices)
 
08807
(Zip Code)
 
Registrant's telephone number, including area code  (908) 927-9920
 
 
(Former name or former address, if changed since last report)
________________________
Check the appropriate box below if the Form 8‑K is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:



Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
 
 
Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12).
 
Pre-commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b)).
 
 
Pre-commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))

Indicate by check mark whether the Registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company x
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. x
 

Item 8.01 Other Events
 
On March 28, 2019, Valeritas Holdings, Inc. (the “Company”) issued a press release announcing that it signed an exclusive distribution agreement with TRITECH BioMed for the commercialization of its V-Go® Wearable Insulin Delivery device in Israel. Under the terms of the agreement, TRITECH BioMed will have the rights to promote, market and sell the V-Go to diabetes clinics and patients in Austria and Germany.
 
The full text of the press release is filed as Exhibit 99.1 hereto and is incorporated herein by reference.
 
 
Item 9.01.   Financial Statements and Exhibits.
(d) Exhibits
 
 
 
 
 
 
 
Exhibit Number
 
Description
 
 
99.1
 
 
 
 




SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
  
Valeritas Holdings, Inc.
  
Dated: March 28, 2019                     By: s/ John E. Timberlake
Name: John E. Timberlake
Title: Chief Executive Officer
 
 
 

Valeritas Announces V-Go® Distribution Agreement in Israel BRIDGEWATER, New Jersey, March 28, 2019 --- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of V-Go® Wearable Insulin Delivery device, a simple, all-in-one, wearable insulin delivery option for patients with diabetes, today announced that it signed an exclusive distribution agreement with TRITECH BioMed for the commercialization of its V-Go® Wearable Insulin Delivery device in Israel. Under the terms of the agreement, TRITECH BioMed will have the rights to promote, market and sell the V-Go to diabetes clinics and patients in Israel. “We are excited to partner with TRITECH BioMed to bring V-Go® Wearable Insulin Delivery device to patients with diabetes who need insulin in Israel,” said John Timberlake, CEO and President of Valeritas. “There are over 600,000 adults with diabetes in Israel, and we believe V-Go can become an important tool to help patients on insulin manage their diabetes.” Valeritas will retain responsibility for product development, regulatory approval, quality management, and manufacturing while TRITECH BioMed will be responsible for sales, marketing, customer support, and distribution activities in Israel. About Valeritas Holdings, Inc. Valeritas is a commercial-stage medical technology company focused on improving health and simplifying life for people with diabetes by developing and commercializing innovative technologies. Valeritas’ flagship product, V-Go® Wearable Insulin Delivery device, is a simple, affordable, all-in-one basal-bolus insulin delivery option for patients with type 2 diabetes that is worn like a patch and can eliminate the need for taking multiple daily shots. V-Go administers a continuous preset basal rate of insulin over 24 hours, and it provides discreet on-demand bolus dosing at mealtimes. It is the only basal- bolus insulin delivery device on the market today specifically designed keeping in mind the needs of type 2 diabetes patients. Headquartered in Bridgewater, New Jersey, Valeritas operates its R&D functions in Marlborough, Massachusetts. More information is available at www.valeritas.com and our Twitter feed @Valeritas_US, www.twitter.com/Valeritas_US. About TRITECH Ltd. Tritech has highly experienced and professional Application Engineers, supporting demand creation / design-in activities from the early stage of the project’s definition until production. Our customers and suppliers benefit from our advanced CRM and ERP fulfillment systems, supporting the entire supply chain cycle, including VMI services and EDI communication. We offer and serve our customers and principles with a long term and close partnership.


 
Forward-Looking Statements This press release may contain forward-looking statements. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to Valeritas technologies, business and product development plans and market information. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the ability to raise the additional funding needed to continue to pursue Valeritas’ business and product development plans, the inherent uncertainties associated with developing new products or technologies, the ability to commercialize the V-Go® Wearable Insulin Delivery device with limited resources, competition in the industry in which Valeritas operates and overall market conditions. Statements or claims made by third parties regarding the efficacy or functionality of V-Go as compared to other products are statements made by such individual and should not be taken as evidence of clinical trial results supporting such statements or claims. Further, notwithstanding whether a distribution agreement has been entered into, Valeritas’ ability to launch its product in a specific country outside of the United States is dependent upon it or its distribution partner obtaining local government reimbursement pricing and possible regulatory clearance. Any forward- looking statements are made as of the date of this press release, and Valeritas assumes no obligation to update the forward-looking statements or to update the reasons why actual results could differ from those projected in the forward-looking statements, except as required by law. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents Valeritas files with the SEC available at www.sec.gov. Investor Contacts: Lynn Pieper Lewis or Greg Chodaczek Gilmartin Group 646-924-1769 ir@valeritas.com Media Contact: Kevin Knight Knight Marketing Communications, Ltd. 206-451-4823 pr@valeritas.com