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OMB APPROVAL
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UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
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OMB Number: 3235-0058
Expires: October 31, 2018
Estimated average burden hours per response
2.50
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FORM 12b-25
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SEC FILE NUMBER
000-28508
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NOTIFICATION OF LATE FILING
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CUSIP NUMBER
338488109
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(Check One):
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☐
Form 10-K
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☐
Form 20-F
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☐
Form 11-K
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☒
Form 10-Q
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☐
Form 10-D
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☐
Form N-SAR
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☐
Form N-CSR
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For Period Ended:
September 30, 2016
☐Transition Report on Form 10-K
☐Transition Report on Form 20-F
☐Transition Report on Form 11-K
☐Transition Report on Form 10-Q
☐Transition Report on Form N-SAR
For the Transition Period Ended: ____________________________________________________
Read Instruction (on back page) Before Preparing Form. Please Print or Type.
Nothing in this form shall be construed to imply that the Commission has verified any information contained herein.
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If the notification relates to a portion of the filing checked above, identify the Item(s) to which the notification relates:
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PART I — REGISTRANT INFORMATION
Flamel Technologies S.A.
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Full Name of Registrant
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Former Name if Applicable
Parc Club du Moulin à Vent, 33, avenue du Docteur Georges Levy
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Address of Principal Executive Office
(Street and Number)
69200 Venissieux, France
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City, State and Zip Code
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PART II — RULES 12b-25(b) AND (c)
If the subject report could not be filed without unreasonable effort or expense and the registrant seeks relief pursuant to Rule 12b-25(b), the following should be completed. (Check box if appropriate)
☒
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(a)
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The reasons described in reasonable detail in Part III of this form could not be eliminated without unreasonable effort or expense;
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☒
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(b)
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The subject annual report, semi-annual report, transition report on Form 10-K, Form 20-F, 11-K, Form N-SAR or Form N-CSR, or portion thereof, will be filed on or before the fifteenth calendar day following the prescribed due date; or the subject quarterly report of transition report on Form 10-Q or subject distribution report on Form 10-D, or portion thereof, will be filed on or before the fifth calendar day following the prescribed due date; and
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(c)
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The accountant's statement or other exhibit required by Rule 12b-25(c) has been attached if applicable.
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PART III — NARRATIVE
State below in reasonable detail the reasons why Forms 10-K, 20-F, 11-K, 10-Q, N-SAR, or the transition report or portion thereof, could not be filed within the prescribed time period.
The Registrant is unable to file its Quarterly Report on Form 10-Q for the period ended September 30, 2016 within the prescribed time because the Registrant requires additional time for compilation and review to ensure adequate disclosure of certain information to be included in such Report. The Registrant's Quarterly Report on Form 10-Q for the quarterly period ended September 30, 2016 will be filed on or before the 5th calendar day following the prescribed due date.
PART IV — OTHER INFORMATION
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(1)
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Name and telephone number of person to contact in regard to this notification:
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Michael F. Kanan
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(636)
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449-1844
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(Name)
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(Area Code)
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(Telephone Number)
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(2)
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Have all other periodic reports required under Section 13 or 15(d) of the Securities Exchange Act of 1934 or Section 30 of the Investment Company Act of 1940 during the preceding 12 months or for such shorter period that the registrant was required to file such report(s) been filed? If answer is no, identify report(s). YES
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No
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(3)
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Is it anticipated that any significant change in results of operations from the corresponding period for the last fiscal year will be reflected by the earnings statements to be included in the subject report or portion thereof? YES
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No
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If so, attach an explanation of the anticipated change, both narratively and quantitatively, and, if appropriate, state the reasons why a reasonable estimate of results cannot be made.
The Registrant anticipates that its results of operations for the three and nine months ended September 30, 2016 to be included in the Form 10-Q will reflect one or more significant changes from the corresponding periods for 2015. Set forth at the end of this Notification are the Company's unaudited condensed consolidated statements of loss for the three- and nine-month periods ended September 30, 2016 and 2015.
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Flamel Technologies S.A.
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(Name of Registrant as Specified in Charter)
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has caused this notification to be signed on its behalf by the undersigned hereunto duly authorized.
Date
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November 9, 2016
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By:
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/s/ Michael F. Kanan
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Michael F. Kanan, Chief Financial Officer
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INSTRUCTION: The form may be signed by an executive officer of the registrant or by any other duly authorized representative. The name and title of the person signing the form shall be typed or printed beneath the signature. If the statement is signed on behalf of the registrant by an authorized representative (other than an executive officer), evidence of the representative's authority to sign on behalf of the registrant shall be filed with the form.
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ATTENTION
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Intentional misstatements or omissions of fact constitute Federal Criminal Violations (See 18 U.S.C. 1001).
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Flamel Technologies S.A.
Unaudited Condensed Consolidated Statements of Loss
(In thousands, except per share data)
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Three Months Ended
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Nine Months Ended
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September 30,
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September 30,
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2016
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2015
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2016
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2015
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Revenues:
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Product sales and services
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$
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31,340
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$
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47,313
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$
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104,858
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$
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128,441
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License and research revenue
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747
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-
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2,303
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-
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Total
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32,087
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47,313
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107,161
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128,441
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Operating expenses:
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Cost of products and services sold
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2,844
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2,087
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10,657
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8,473
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Research and development expenses
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8,143
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7,221
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21,135
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20,447
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Selling, general and administrative expenses
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12,740
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4,568
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33,491
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14,904
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Intangible asset amortization
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3,702
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3,141
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10,918
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9,423
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Changes in fair value of related party contingent consideration
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20,848
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44,782
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52,989
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82,036
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Total
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48,277
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61,799
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129,190
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135,283
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Operating income (loss)
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(16,190
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)
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(14,486
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(22,029
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)
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(6,842
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Investment Income
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490
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197
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1,080
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1,171
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Interest Expense
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(264
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-
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(702
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-
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Other Expense - changes in fair value of related party payable
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(1,828
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(6,644
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(6,135
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(9,629
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Foreign exchange gain (loss)
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(1,054
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(160
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(2,315
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8,096
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Income (loss) before income taxes
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(18,846
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(20,773
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(30,101
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(7,204
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Income tax provision
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3,451
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7,302
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18,212
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24,516
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Net loss
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$
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(22,297
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$
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(28,075
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$
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(48,313
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$
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(31,720
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Net loss per share - Basic
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$
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(0.54
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$
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(0.69
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$
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(1.17
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$
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(0.79
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Net loss per share - Diluted
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$
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(0.54
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$
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(0.69
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$
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(1.17
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$
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(0.79
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Weighted average number of shares outstanding - Basic
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41,241
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40,625
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41,241
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40,397
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Weighted average number of shares outstanding - Diluted
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41,241
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40,625
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41,241
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40,397
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