UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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FORM 8-K
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CURRENT REPORT
Pursuant to Section 13 or 15(D)
of the Securities Exchange Act of 1934
May 2, 2019
Date of report (Date of earliest event reported)
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Valeritas Holdings, Inc.
(Exact name of registrant as specified in its charter)
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Delaware
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001-38038
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46-5648907
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(State or other jurisdiction
of incorporation)
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(Commission
File Number)
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(IRS Employer
Identification No.)
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750 Route 202, Suite 600
Bridgewater, NJ
(Address of principal executive offices)
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08807
(Zip Code)
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Registrant's telephone number, including area code
(908) 927-9920
(Former name or former address, if changed since last report)
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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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425).
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Soliciting material pursuant to Rule 14a‑12 under the Exchange Act (17 CFR 240.14a‑12).
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Pre-commencement communications pursuant to Rule 14d‑2(b) under the Exchange Act (17 CFR 240.14d‑2(b)).
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Pre-commencement communications pursuant to Rule 13e‑4(c) under the Exchange Act (17 CFR 240.13e‑4(c))
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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.
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Item 2.02. Results of Operations and Financial Condition.
On May 2, 2019, Valeritas Holdings, Inc. (the "Company") issued a press release announcing preliminary revenue guidance for the first quarter 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 March 5, 2019, the Company announced the following preliminary guidance for the first quarter of 2019: revenue for the first quarter ended March 31, 2019 is projected to be approximately $6.4 million. In addition, the Company does not expect any significant changes from its first quarter 2019 guidance that it released on March 5, 2019, as follows: (i) gross margin is expected to be between 47% and 48% for the first quarter; (ii) operating expense for the first quarter is expected to increase to between $16 and $17 million compared to $14 million in the fourth quarter of 2018 due to costs related to the expansion of Valeritas’ sales force by approximately 50% in January of this year; and (iii) cash, cash equivalents and investments is expected to be between $32.5 million and $33.5 million on March 31, 2019, with a projected increase in total liabilities of approximately $3 million in the first quarter of 2019 as compared to the fourth quarter of 2018.
Set forth above are certain preliminary revenue and gross profit estimates for the three months ended March 31, 2019 and the Company’s expected cash balance at March 31, 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 March 31, 2019 or the Company’s results of operations for the three months ended March 31, 2019. As the Company completes its quarter-end close process and finalizes its first 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
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Exhibit Number
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Description
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99.1
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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.
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Valeritas Holdings, Inc.
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Dated: May 2, 2019
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By:
s/ John E. Timberlake
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Name: John E. Timberlake
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Title: Chief Executive Officer
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Valeritas Expects First Quarter Revenue of $6.4 million
BRIDGEWATER, New Jersey, May 2, 2019 --- Valeritas Holdings, Inc. (NASDAQ: VLRX), a medical technology company and maker of
V-Go
®
Wearable Insulin Delivery device
, announced today it expects to report revenue of approximately $6.4 million for the first quarter ended March 31, 2019. In addition, Valeritas does not expect any significant changes from its first quarter 2019 guidance that it released on March 5, 2019, as the Company will achieve all metrics it provided guidance on for the quarter. Valeritas intends to report its full first quarter 2019 financial results on May 9, 2019.
Commenting on the announcement, John Timberlake, President and CEO of Valeritas stated, “I am very pleased with the first quarter results and all signs currently indicate this momentum should continue throughout 2019.”
The Company is announcing its first quarter revenue estimate due to investor meetings taking place today, May 2, 2019.
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, 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. 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
