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EX-99.1 - EX-99.1 - GI DYNAMICS, INC.d801640dex991.htm

 

 

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

Date of Report (Date of earliest event reported): October 6, 2014

 

 

GI DYNAMICS, INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   000-55195   84-1621425

(State or other jurisdiction

of incorporation)

  (Commission File Number)  

(IRS Employer

Identification No.)

25 Hartwell Avenue

Lexington, MA 02421

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (781) 357-3300

 

 

(Former name or former address, if changed since last report.)

 

 

Check the appropriate box below if the Form 8-K filing 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))

 

 

 


Item 2.02    Results of Operations and Financial Condition.

Although GI Dynamics, Inc. (the “Company”) has not finalized its full financial results for the third quarter of 2014, on October 6, 2014 the Company issued a press release advising that preliminary revenues for the third quarter are estimated to be between $550,000 and $575,000, which represents a decrease from the second quarter revenues of $840,000. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K.

The information contained in this Item 2.02 of Form 8-K is unaudited and preliminary, and does not present all information necessary for an understanding of the Company’s financial condition for the third quarter of fiscal year 2014 and its results of operations for the three months ended September 30, 2014. The Company anticipates making a public announcement of its results of operations for the third quarter on or about October 31, 2014.

The information in this Item 2.02 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, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 8.01    Other Events.

On October 6, 2014, the Company issued a press release advising that its Notified Body in the European Union has ordered the Company to temporarily suspend commercial shipments of products labeled with a CE mark, affecting all countries where the Company is currently selling EndoBarrier®, pending a review of the Company’s vigilance and reporting systems. The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K.

Item 9.01    Financial Statements and Exhibits.

 

(d) Exhibits

See Exhibit Index attached hereto, which is incorporated by reference herein.


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

 

     GI DYNAMICS, INC.

Dated: October 8, 2014

    

/s/ Robert Crane                                             

    

Robert Crane

Chief Financial Officer


EXHIBIT INDEX

 

Exhibit
No.

  

Description                                                                                                                                                                        

99.1    Press release issued by the Company on October 6, 2014.