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ZOGENIX, INC. Form 8-K: Current report, 2014

ZOGENIX, INC. Form 8-K: Current report

Filings on SEC EDGAR, newest first; amendments sit with their base form. Values are as filed.

  • 2014-12-31: Form 8-K; Period of report 2014-12-30; Description 1.01 Entry into a Material Definitive Agreement; 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant; 3.02 Unregistered Sales of Equity Securities; Details 1.01.
  • 2014-12-23: Form 8-K/A; Period of report 2014-10-24; Description 8.01 Other Events; Details 8.01.
  • 2014-11-18: Form 8-K; Period of report 2014-11-18; Description 7.01 Regulation FD Disclosure; Details 7.01.
  • 2014-11-06: Form 8-K; Period of report 2014-11-06; Description 2.02 Results of Operations and Financial Condition; Details 2.02.
FiledFormPeriod of reportDescriptionDetailsDocument
2014-12-318-K2014-12-301.01 Entry into a Material Definitive Agreement; 2.03 Creation of a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement of a Registrant; 3.02 Unregistered Sales of Equity Securities1.01 Entry into a Material Definitive Agreement.
2.03 Effective as of December 30, 2014 (the “effective date”), we entered into a loan and security agreement (the “credit facility”) with Oxford Finance LLC (“Oxford”), as collateral agent, and the lenders party thereto from time to time (the “Lenders”), including Oxford and Silicon Valley Bank (“SVB”), pursuant to which the Lenders agreed to make term loans and a revolving line available to us for working capital and general business purposes, in a principal amount of up to $20 million in term loan commitments and $4 million in revolving line commitments.
3.02 The warrants described in Item 2.03 above were offered and sold in reliance upon the exemption from registration provided by Section 4(2) under the Securities Act of 1933 (the “Securities Act”).
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2014-12-238-K/A2014-10-248.01 Other Events8.01 The Company has updated the estimated timing with respect to the initiation of Phase 3 studies for ZX0008 (previously referred to as Brabafen TM), low dose fenfluramine, for the treatment of Dravet syndrome.d841941d8ka.htm
2014-11-188-K2014-11-187.01 Regulation FD Disclosure7.01 On November 18, 2014, Zogenix, Inc. (“Zogenix”) management will be attending the Stifel Nicolaus 2014 Healthcare Conference in New York City, New York, and will present the slides attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.d823044d8k.htm
2014-11-068-K2014-11-062.02 Results of Operations and Financial Condition2.02 On November 6, 2014, Zogenix, Inc. issued a press release announcing its financial results for the third quarter ended September 30, 2014.d815888d8k.htm
2014-10-318-K2014-10-291.01 Entry into a Material Definitive Agreement1.01 Entry into a Material Definitive Agreement.a8kwaiveragrmtpurdue.htm
2014-10-278-K2014-10-241.01 Entry into a Material Definitive Agreement; 2.01 Completion of Acquisition or Disposition of Assets; 3.02 Unregistered Sales of Equity Securities1.01 Entry into a Material Definitive Agreement.
2.01 On October 24, 2014, Zogenix Europe completed its acquisition of Brabant as described in Item 1.01, which description is incorporated herein by reference.
3.02 As partial consideration for the acquisition of Brabant described above, on October 24, 2014, Zogenix issued an aggregate of 11,995,202 shares of Common Stock to the Sellers in connection with the closing of the Acquisition.
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2014-10-038-K2014-09-298.01 Other Events8.01 On September 29, 2014, Zogenix, Inc. (“Zogenix”) received a paragraph IV certification from Alvogen Pine Brook, Inc. (“Alvogen”) advising Zogenix of the filing of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (the “FDA”) for a generic version of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII.a8-krealvogenparagraphivce.htm
2014-10-018-K2014-09-308.01 Other Events8.01 On September 30, 2014, Zogenix, Inc. (the “Company”) submitted a supplemental New Drug Application (“sNDA”) to the U.S. Food and Drug Administration for a modified formulation of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII, which has been designed to have abuse deterrent properties.d798184d8k.htm
2014-09-198-K2014-09-155.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers5.02 On September 15, 2014, James C. Blair, Ph.D. resigned from the Board of Directors (the “Board”) of Zogenix, Inc. (the “Company”).form8-krejimblairresignati.htm
2014-09-188-K2014-09-121.01 Entry into a Material Definitive Agreement1.01 On September 12, 2014, Zogenix, Inc. (“Zogenix” or the “Company”) and Daravita Limited (“Daravita”) entered into a third amendment (the “Third Amendment”) to the License Agreement, dated November 27, 2007, by and between Zogenix and Daravita (the “License Agreement”).a8kthirdamendmenttoalkslic.htm
2014-09-088-K2014-09-087.01 Regulation FD Disclosure7.01 On September 10, 2014, Zogenix, Inc. (“Zogenix”) management will be presenting at the Morgan Stanley Global Healthcare Conference 2014 in New York, New York.a8kzgnxmsinvestorpresentat.htm
2014-09-048-K2014-09-038.01 Other Events8.01 On September 3, 2014, Daravita Limited (“Daravita”) filed suit in the United States District Court for the District of Delaware against Actavis Laboratories FL, Inc. and certain of its affiliates (“Actavis”).zgnx-form8xkrealksxactavis.htm
2014-08-148-K2014-08-138.01 Other Events8.01 On August 13, 2014, Zogenix, Inc. (“Zogenix”) received a paragraph IV certification from Actavis Laboratories FL, Inc. (“Actavis”) advising Zogenix of the filing of an Abbreviated New Drug Application (“ANDA”) with the U.S. Food and Drug Administration (the “FDA”) for a generic version of Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII.d776556d8k.htm
2014-08-058-K2014-08-052.02 Results of Operations and Financial Condition2.02 On August 5, 2014, Zogenix, Inc. issued a press release announcing its financial results for the second quarter ended June 30, 2014.d767507d8k.htm
2014-07-248-K2014-07-225.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers5.02 Target Bonuses for Executive Officers.d763267d8k.htm
2014-07-098-K2014-07-088.01 Other Events8.01 On July 8, 2014, the U.S. District Court in Massachusetts issued an order upholding an injunction to stop restrictions on prescribing Zogenix, Inc.’s Zohydro® ER (hydrocodone bitartrate) Extended-Release Capsules, CII in Massachusetts.d755345d8k.htm
2014-06-238-K2014-06-237.01 Regulation FD Disclosure7.01 On June 24, 2014, Ann Rhoads, Chief Financial Officer of Zogenix, Inc. (“Zogenix”), will be attending the JMP Securities Healthcare Conference in New York, New York, and will present the slides attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.d746038d8k.htm
2014-06-188-K2014-06-187.01 Regulation FD Disclosure7.01 On June 18, 2014, Ann Rhoads, Chief Financial Officer of Zogenix, Inc. (“Zogenix”), will be attending the Wells Fargo 2014 Healthcare Conference in Boston, Massachusetts, and will present the slides attached as Exhibit 99.1 to this Current Report on Form 8-K, which is incorporated herein by reference.d744986d8k.htm
2014-06-048-K2014-06-047.01 Regulation FD Disclosure7.01 On June 4, 2014, representatives of Zogenix, Inc. (“Zogenix”) will be attending meetings with investors, analysts and others in connection with the Jefferies 2014 Global Healthcare Conference in New York City, New York.d736633d8k.htm
2014-05-228-K2014-05-215.07 Submission of Matters to a Vote of Security Holders5.07 Zogenix, Inc. (the “Company”) held its annual meeting of stockholders on May 21, 2014.d732248d8k.htm
2014-05-198-K2014-05-161.01 Entry into a Material Definitive Agreement; 1.02 Termination of a Material Definitive Agreement; 2.04 Triggering Events That Accelerate or Increase a Direct Financial Obligation or an Obligation under an Off-Balance Sheet Arrangement1.01 On May 16, 2014, Zogenix, Inc. (the “Company”) closed (the “Closing”) the previously announced sale of its SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) product line to Endo Ventures Bermuda Limited (“Endo Ventures Bermuda”) and Endo Ventures Limited (“Endo Ventures” and, together with Endo Ventures Bermuda, the “Buyers”), pursuant to an Asset Purchase Agreement, dated as of April 23, 2014, between the Company and the Buyers.
1.02 On May 16, 2014, in connection with the sale of the SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) product line to the Buyers, Cowen Healthcare Royalty Partners II, L.P. (“HRP”) exercised its right to terminate the Financing Agreement, dated June 30, 2011, between the Company and HRP (the “Financing Agreement”).
2.04 The information provided in Items 1.01 and 1.02 of this Form 8-K is hereby incorporated by reference into this Item 2.04.
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2014-05-088-K2014-05-082.02 Results of Operations and Financial Condition2.02 On May 8, 2014, Zogenix, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2014.d725295d8k.htm
2014-04-248-K2014-04-231.01 Entry into a Material Definitive Agreement1.01 On April 23, 2014, Zogenix, Inc. (the “Company” or “Zogenix”) entered into an asset purchase agreement (“Asset Purchase Agreement”) with Endo Ventures Bermuda Limited (“Endo Ventures Bermuda”) and Endo Ventures Limited (“Endo Ventures” and, together with Endo Ventures Bermuda, the “Buyers”), pursuant to which, and on the terms and subject to the conditions thereof, among other things, the Company agreed to sell its SUMAVEL® DosePro® Needle-free Delivery System (sumatriptan injection) migraine therapy business to the Buyers, including the registered trademarks, certain contracts, the New Drug Application and other regulatory approvals, the books and records, marketing materials and product data relating to SUMAVEL DosePro.d718064d8k.htm
2014-04-168-K2014-04-158.01 Other Events8.01 On April 15, 2014, Zogenix, Inc. (“Zogenix” or the “Company”) announced that, in connection with the previously disclosed lawsuit that the Company filed in the U.S. District Court in Massachusetts requesting a temporary restraining order preventing the implementation of the Commonwealth’s ban of Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, the Court entered such order on Constitutional grounds.d712091d8k.htm
2014-04-078-K2014-04-078.01 Other Events8.01 On April 7, 2014, Zogenix, Inc. (“Zogenix” or the “Company”) filed a lawsuit in the U.S. District Court in Massachusetts requesting the court to grant a temporary restraining order against execution of the executive order recently announced by Governor Deval Patrick of the Commonwealth of Massachusetts, which prohibits the prescribing and dispensing of the Company’s prescription pain product, Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, that was approved by the U.S. Food and Drug Administration, or the FDA.d707635d8k.htm
2014-04-048-K2014-04-047.01 Regulation FD Disclosure7.01 On April 4, 2014, Zogenix, Inc. (the “Company”) issued a statement regarding the call by Health and Human Services and the U.S. Food and Drug Administration for a balanced approach to fighting drug abuse while meeting the needs of patients in severe chronic pain.d706059d8k.htm
2014-04-048-K2014-04-027.01 Regulation FD Disclosure7.01 On April 2, 2014, Zogenix, Inc. (the “Company”) issued a statement addressing comments made by the Administrator of the U.S. Drug Enforcement Administration regarding the Company’s product, Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, the first and only extended release hydrocodone product without acetaminophen.d706517d8k.htm
2014-03-288-K2014-03-277.01 Regulation FD Disclosure7.01 On March 27, 2014, Zogenix, Inc. (“Zogenix” or the “Company”) issued a statement addressing Massachusetts’ Governor Deval Patrick’s ban on the Company’s product, Zohydro™ ER (hydrocodone bitartrate) extended-release capsules, the first and only extended release hydrocodone product without acetaminophen, in the state of Massachusetts.d702350d8k.htm
2014-03-268-K2014-03-255.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers5.02 On March 25, 2014, James B. Breitmeyer, M.D., Ph.D. accepted an appointment to fill a newly-created seat on Zogenix, Inc.’s (the “Company”) Board of Directors (the “Board”), effective immediately.d699176d8k.htm
2014-03-218-K2014-03-207.01 Regulation FD Disclosure7.01 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 hydrocodone product without acetaminophen.d697511d8k.htm
2014-03-078-K2014-03-035.02 Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory Arrangements of Certain Officers5.02 Pursuant to the Company’s Annual Incentive Plan (the “Plan”), each named executive officer is eligible for a performance bonus based upon the achievement of certain corporate performance goals approved by the Board and, with respect to the named executive officers other than the Company’s Chief Executive Officer, individual performance objectives.d689712d8k.htm
2014-03-058-K2014-03-052.02 Results of Operations and Financial Condition2.02 On March 5, 2014, Zogenix, Inc. issued a press release announcing its financial results for the fourth quarter and full-year ended December 31, 2013.d688921d8k.htm
2014-01-138-K2014-01-132.02 Results of Operations and Financial Condition2.02 On January 13, 2014, Zogenix, Inc. (the “Company” or “Zogenix”) announced preliminary unaudited gross product sales and preliminary unaudited net product sales for the fourth quarter ended December 31, 2013.d658891d8k.htm
2014-01-098-K2014-01-081.01 Entry into a Material Definitive Agreement; 1.02 Termination of a Material Definitive Agreement1.01 Entry into a Material Definitive Agreement.
1.02 The Company and Mallinckrodt agreed to terminate the Agreement effective as of January 31, 2014 pursuant to the Amendment.
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