8-K

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

May 29, 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

Securities registered pursuant to Section 12(b) of the Act:

Title of each class	Trading Symbol(s)	Name of each exchange on which registered
Common stock, par value $0.001 per value	VLRX	The Nasdaq Capital Market

EAST\166828732.2

Item 2.02. Results of Operations and Financial Condition.

On May 29, 2019, Valeritas Holdings, Inc. (the "Company") issued a press release (i) announcing that it will participate in this year’s American Diabetes Association’s (ADA) 79th Scientific Sessions at the Moscone Center in San Francisco, CA, on June 7-11, 2019; and (ii) reiterating its previously announced preliminary revenue guidance for the second quarter and full year of 2019 (described in further detail under Item 8.01 below). The Company is furnishing a copy of the press release, which is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

In accordance with General Instruction B.2 of Form 8-K, the information included in Item 2.02 of this Current Report on Form 8-K (including Exhibit 99.1 hereto), shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference into any filing made by the Company under the Exchange Act or Securities Act of 1933, as amended, except as shall be expressly set forth by specific reference in such a filing.

Item 8.01. Other Information.

On May 29, 2019, the Company reiterated the following preliminary guidance for the second quarter and full year of 2019: revenue for the second quarter of 2019 is projected to be between $7.4 million and $7.6 million, and annual revenue for 2019 is expected to be between $31.0 million and $34.0 million. The Company also announced that it now expects its cash, cash equivalents and investments to be approximately $27 million on June 30, 2019, as compared to the original estimate of $25 million that it announced previously. Aside from the projected change in cash, cash equivalents and investments, the Company does not expect any significant changes from its second quarter 2019 guidance that it released on May 9, 2019, as follows: (i) gross margin is expected to be between 49% and 50% for the second quarter; and (ii) operating expense for the second quarter is expected to be approximately $17 million, with total liabilities consistent with March 31, 2019.

Set forth above are certain preliminary revenue and gross profit estimates for the three and six months ended June 30, 2019 and the Company’s expected cash balance at June 30, 2019. These preliminary results represent the Company’s estimates only based on currently available information and do not present all necessary information for an understanding of the Company’s financial condition as of June 30, 2019 or the Company’s results of operations for the three and six months ended June 30, 2019. As the Company completes its quarter-end close process and finalizes its second quarter 2019 unaudited financial statements, the Company will be required to make significant judgments in a number of areas. This financial information has been prepared by and is the responsibility of the Company’s management. The Company’s independent registered public accounting firm has not audited, reviewed or performed any procedures with respect to this preliminary data or the accounting treatment thereof and does not express an opinion or any other form of assurance with respect thereto.

Item 9.01.Financial Statements and Exhibits.

(d) Exhibits

Exhibit Number	Description
99.1	Press Release dated May 29, 2019.

EAST\166828732.2

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: May 29, 2019	By: s/ John E. Timberlake
	Name: John E. Timberlake
	Title: Chief Executive Officer

EAST\166828732.2

EX-99.1

Valeritas to Participate in the American Diabetes Association’s 79th Scientific Sessions;

Company Reiterates Second Quarter and Full-Year 2019 Revenue Guidance

BRIDGEWATER, New Jersey, May 29, 2019 --- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of V-Go^®Wearable Insulin Delivery device, announced today it will participate in this year’s American Diabetes Association’s (ADA) 79th Scientific Sessions at the Moscone Center in San Francisco, CA, on June 7-11, 2019.

Additionally, Valeritas reiterated its second quarter 2019 revenue guidance of $7.4 million to $7.6 million and its 2019 annual revenue guidance of $31.0 million to $34.0 million. Also, the Company now expects to end the second quarter with $27 million in cash and cash equivalents vs. the original estimate of $25 million with the Company’s current cash position now allowing it to operate into February 2020, assuming no additional capital or non-dilutive financing.

“This year’s ADA Scientific Sessions will be an exciting one for Valeritas and V-Go,” said John Timberlake, President and Chief Executive Officer of Valeritas. “Over the five days, there will be multiple abstracts and posters presented on the efficacy, safety, and economics of V-Go, our simple to use, all-in-one basal-bolus insulin delivery device. Come visit us at booth #217 to learn more about V-Go and our V-Go SIM^TM (Simple Insulin Management) Bluetooth connected accessory.”

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.

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, Valeritas' expected cash burn rate and its ability to continue to increase new and total prescription growth, the effects of the reverse stock split on the trading price of Valeritas’ common stock, in both the short and long-term; the inherent uncertainties associated with developing new products or technologies, the ability to continue 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. 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

Media Contact:

Kevin Knight

Knight Marketing Communications, Ltd.

206-451-4823