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ZGNX > SEC Filings for ZGNX > Form 8-K on 21-Mar-2014All Recent SEC Filings

Show all filings for ZOGENIX, INC.

Form 8-K for ZOGENIX, INC.


21-Mar-2014

Regulation FD Disclosure, Financial Statements and Exhibits


Item 7.01. Regulation FD Disclosure.

On March 20, 2014, Zogenix, Inc. ("Zogenix" or the "Company") issued a letter from its Chief Executive Officer to the Company's stakeholders addressing certain statements that have been made about the Company and its product, Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, the first and only extended release hydrocodoneproduct without acetaminophen. The letter is attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.

The information in this report, including Exhibit 99.1, is being furnished pursuant to Item 7.01 and shall not be deemed "filed" for 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, and it shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or under the Exchange Act, whether made before or after the date hereof, except as expressly set forth by specific reference in such filing to this item of this report.

***

Zogenix cautions you that statements included in this Current Report on Form 8-K and the attached exhibit that are not a description of historical facts are forward-looking statements. Words such as "believes," "anticipates," "plans," "expects," "indicates," "will," "intends," "potential," "suggests," "assuming" and similar expressions are intended to identify forward-looking statements. These statements are based on the Company's current beliefs and expectations. These forward-looking statements include statements regarding the potential of Zohydro ER to provide a significant new management alternative within the chronic pain market and the ability to ensure that the risk of abuse, misuse and diversion of Zohydro ER is minimized. The inclusion of forward-looking statements should not be regarded as a representation by Zogenix that any of its plans will be achieved. Actual results may differ from those set forth in this report due to the risks and uncertainties inherent in Zogenix's business, including, without limitation: Zogenix's ability to adequately ensure that the risk of abuse, misuse and diversion of Zohydro ER is minimized; Zogenix's ability to successfully launch and drive market demand for Zohydro ER; unexpected adverse side effects or inadequate therapeutic efficacy of Zohydro ER that could limit commercialization, or that could result in recalls or product liability claims; competition from other pharmaceutical or biotechnology companies; and other risks detailed in Zogenix's public periodic filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Zogenix undertakes no obligation to revise or update this report to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.



Item 9.01 Financial Statements and Exhibits.

(d) Exhibits.

Exhibit No.       Description

99.1              Letter from Chief Executive Officer to Stakeholders, dated March
                  20, 2014


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