0001193125-19-240524.txt : 20190909 0001193125-19-240524.hdr.sgml : 20190909 20190909080115 ACCESSION NUMBER: 0001193125-19-240524 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 14 CONFORMED PERIOD OF REPORT: 20190906 ITEM INFORMATION: Completion of Acquisition or Disposition of Assets ITEM INFORMATION: Unregistered Sales of Equity Securities ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20190909 DATE AS OF CHANGE: 20190909 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ZOGENIX, INC. CENTRAL INDEX KEY: 0001375151 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 205300780 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34962 FILM NUMBER: 191081006 BUSINESS ADDRESS: STREET 1: 5959 HORTON STREET, SUITE 500 CITY: EMERYVILLE STATE: CA ZIP: 94608 BUSINESS PHONE: (510) 550-8300 MAIL ADDRESS: STREET 1: 5959 HORTON STREET, SUITE 500 CITY: EMERYVILLE STATE: CA ZIP: 94608 FORMER COMPANY: FORMER CONFORMED NAME: ZOGENIX INC DATE OF NAME CHANGE: 20060911 8-K 1 d757427d8k.htm FORM 8-K Form 8-K
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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, DC 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): September 6, 2019

 

ZOGENIX, INC.

(Exact Name of Registrant as Specified in its Charter)

 

Delaware

  

001-34962

 

20-5300780

(State or Other Jurisdiction

of Incorporation)

  

(Commission

File Number)

  

(IRS Employer

Identification No.)

     

5959 Horton Street, Suite 500, Emeryville, CA

  

94608

(Address of Principal Executive Offices)

  

(Zip Code)

Registrant’s telephone number, including area code: (510) 550-8300

(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 (see General Instruction A.2. below):

☐ 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))

Securities registered pursuant to Section 12(b) of the Act:

Title of each class

  

Trading

Symbol(s)

  

Name of each exchange

on which registered

Common Stock, par value $0.001 per share

  

ZGNX

  

The Nasdaq Global Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (17 CFR §230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (17 CFR §240.12b-2 of this chapter).

Emerging growth company  ☐

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.  ☐

 

 

Item 2.01 Completion of Acquisition or Disposition of Assets.

On September 6, 2019, Zogenix, Inc. (the “Company” or “Zogenix”) closed (the “Closing”) the previously announced acquisition of Modis Therapeutics, Inc. (“Modis”), pursuant to the Agreement and Plan of Merger, dated August 23, 2019 (the “Merger Agreement”), by and among Zogenix, Modis, Xena Merger Sub, Inc., a Delaware corporation and wholly-owned subsidiary of Zogenix (“Merger Sub”), and Shareholders Representative Services LLC, a Colorado limited liability company, as the shareholders’ representative. At the Closing, Merger Sub merged with and into Modis (the “Merger”), with Modis being renamed Zogenix TK2d Corp. and surviving as a wholly-owned subsidiary of Zogenix. Modis’ lead product candidate, MT1621, an investigational deoxynucleoside substrate enhancement therapy, is in late-stage development for the treatment of thymidine kinase 2 deficiency.

At the Closing, Zogenix paid approximately $175 million in cash and issued 1,595,025 shares of Zogenix common stock (the “Shares”). The cash portion of the merger consideration was subject to certain adjustments, including Modis’ net working capital and cash amounts at Closing. The number of Shares issued was based on the 25-day volume weighted average price of $46.68 per share of Zogenix’s common stock. Zogenix will also be obligated to pay (a) up to an aggregate amount of $150.0 million upon the achievement of specified regulatory milestones and (b) a 5% royalty on net sales of Modis products. The royalty term expires on a country-by-country basis upon the later of 15 years after the first commercial sale a Modis product, expiration of regulatory exclusivity, and the expiration of the last to expire valid patent claim covering a Modis product. Zogenix is obligated to use its commercially reasonable efforts (as defined in the Merger Agreement) to develop and seek marketing approval of (so as to achieve the regulatory milestones) and to commercialize MT1621 in the United States, United Kingdom, Germany, France, Spain and Italy after marketing approval, if any, has been obtained in the applicable country.

Both Zogenix and Modis agreed to customary warranties and covenants in the Merger Agreement. Modis stockholders and equity award holders (the “Modis Holders”) agreed to indemnify Zogenix, severally and not jointly, for certain matters, including breaches of representations and warranties and covenants included in the Merger Agreement, up to the escrow amount (defined below), subject to specified exceptions. Of the closing cash consideration, $25.0 million (the “escrow amount”) was deposited into an escrow account to fund post-closing merger consideration adjustments and potential indemnification claims. The escrow amount will be released 12 months from the Closing, less the aggregate amount of any pending indemnification claims as of such date. Zogenix also has the right to offset damages for certain specified indemnification claims (including specified intellectual property representations) against future milestones and a specified percentage of royalty payments.

Pursuant to the Merger Agreement, Zogenix has agreed to prepare and file a prospectus supplement to its effective registration statement on Form S-3 (File No. 333-220759) covering the resale of the Shares issued to the Modis Holders within two business days of the closing and to use commercially reasonable efforts to maintain the availability of such registration statement for the resale of the Shares.

The foregoing description of the terms of the Merger Agreement is qualified in its entirety by reference to the provisions of the Merger Agreement, a copy of which was filed as Exhibit 2.1 to the Current Report on Form 8-K filed by Zogenix with the Securities and Exchange Commission on August 26, 2019, and is incorporated herein by reference.

Item 3.02. Unregistered Sales of Equity Securities

The information set forth in Item 1.01 above with respect to the issuance of the Shares as part of the merger consideration is incorporated into this Item 3.02 by reference. The Shares have not been registered under the Securities Act of 1933, as amended (the “Securities Act”), or any state securities laws. The Shares were issued pursuant to a private placement under Rule 506 of Regulation D promulgated under the Securities Act, and only to those Modis stockholders or equity award holders who are “accredited investors” as defined under Rule 501(a) thereof.

As described above, Zogenix has agreed to file a prospectus supplement to the Company’s Form S-3 providing for the resale of the Shares. The Shares may not be offered or sold in the United States absent registration or exemption from registration under the Securities Act and any applicable state securities laws. Neither this Current Report on Form 8-K nor any of the exhibits attached hereto is an offer to sell or the solicitation of an offer to buy the Shares or other securities of Zogenix.

Item 7.01. Regulation FD Disclosure.

On September 9, 2019, Zogenix issued a press release announcing the Closing of the Merger, a copy of which is filed as Exhibit 99.1 hereto and incorporated herein by reference.

The information in Item 7.01 of this Current Report on Form 8-K, including the press release incorporated herein by reference, is being furnished 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 7.01 of this Current Report on Form 8-K.

Item 9.01. Financial Statements and Exhibits.

(a) Financial Statements of Businesses Acquired

The financial statements required by Item 9.01(a) of Form 8-K, if any, will be filed by amendment no later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.

(b) Pro Forma Financial Information

The pro forma financial information required by Item 9.01(b) of Form 8-K, if any, will be filed by amendment no later than 71 calendar days after the date this Current Report on Form 8-K is required to be filed.

(d) Exhibits

Exhibit
No.

   

Description

         
 

  2.1

   

Agreement and Plan of Merger, dated August 23, 2019, by and among Zogenix, Inc., Xena Merger Sub, Inc., Modis Therapeutics, Inc. and Shareholder Representative Services, LLC, as the shareholders’ representative (incorporated by reference to Zogenix, Inc.’s Form 8-K filed with the Securities and Exchange Commission on August 26, 2019)

         
 

99.1

   

Press Release of Zogenix, Inc., dated September 9, 2019

         
 

104

   

Cover Page Interactive Data File (embedded within the Inline XBRL document)

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.

 

 

ZOGENIX, INC.

             

Date: September 9, 2019

 

 

By:

 

/s/ Michael P. Smith

 

 

Name:

 

Michael P. Smith

 

 

Title:

 

Executive Vice President, Chief Financial Officer, Treasurer and Secretary

EX-99.1 2 d757427dex991.htm EX-99.1 EX-99.1

Exhibit 99.1

Zogenix Completes Acquisition of Modis Therapeutics, Inc.

Acquisition strengthens Zogenix’s late-stage, rare disease pipeline with the addition of MT1621, a proprietary investigational therapy for Thymidine Kinase 2 deficiency (TK2d)

Emeryville, Calif., September 8, 2019 (GLOBE NEWSWIRE) – Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced that it has successfully completed its acquisition of Modis Therapeutics, Inc., a privately-held biopharmaceutical company, and added MT1621 to its late-stage development pipeline. MT1621 is a novel investigational deoxynucleoside substrate enhancement therapy for the treatment of Thymidine Kinase 2 deficiency (TK2d), an inherited mitochondrial DNA depletion disorder that predominantly affects children and is often fatal.

“We welcome Modis to our growing Zogenix team,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “With our strengthened portfolio, we are very excited to now be advancing two very promising potential new therapies to patients and families in need - FINTEPLA for Dravet and Lennox-Gastaut syndromes and MT1621 for TK2 deficiency.”

At closing, Zogenix paid Modis approximately $175 million in cash, funded in full via the Company’s existing balance sheet, and approximately $75 million in Zogenix common stock based on a 25-day volume weighted average price of $46.68 per share. Modis is also eligible to receive milestone payments consisting of $100 million upon U.S. Food and Drug Administration approval of MT1621 and $50 million upon European Medicines Agency approval of MT1621. Zogenix will also pay a 5% royalty on any future net sales of MT1621.

SVB Leerink acted as financial advisor to Zogenix. Latham & Watkins acted as legal advisor to Zogenix, and Fenwick & West acted as legal advisor to Modis.

About MT1621 and TK2 Deficiency

MT1621 is an investigational deoxynucleoside substrate enhancement therapy in late-stage development for the treatment of TK2 deficiency (TK2d), a genetic disorder that results in mitochondrial dysfunction, leading in turn to inadequate energy production in cells. The disease presents as progressive and severe muscle weakness that profoundly impairs movement, breathing, eating, and other normal functions, and is often fatal. Believed to be significantly underdiagnosed, TK2d affects up to 2,500 patients in the U.S., primarily infants and young children. There are currently no approved therapies for this disease.

MT1621 is designed to restore mitochondrial function by targeting the underlying pathophysiology of TK2d. Deoxynucleoside substrate enhancement therapy has been shown to improve cell function and prolong life in preclinical models of TK2d. Data from a Phase 2 retrospective treatment clinical study called RETRO demonstrated increased survival probability and improved functional abilities for patients treated with MT1621 compared with untreated natural history control patients, and suggest that MT1621 may meaningfully alter the course of the disease. With Breakthrough Therapy and PRIME designations already received, MT1621 may be eligible for an accelerated regulatory path in both the U.S. and Europe. Zogenix

will continue to work with regulatory authorities in the U.S. and Europe to discuss next steps for the MT1621 program.

About Zogenix

Zogenix is a global pharmaceutical company whose mission is to develop and commercialize therapies that transform the lives of patients and their families living with rare diseases. The company’s lead compound is FINTEPLA® (ZX008, fenfluramine) for the treatment of seizures associated with Dravet and Lennox-Gastaut syndromes, two rare and often-catastrophic childhood-onset epilepsies often marked by frequent and prolonged seizures and significant intellectual, behavioral, and motor disabilities. Zogenix is preparing to resubmit its New Drug Application for FINTEPLA® for Dravet syndrome to the U.S. Food & Drug Administration; FINTEPLA® for Dravet syndrome is under review by the European Medicines Agency and is also in development in Japan. The Company expects top-line data from its ongoing Phase 3 trial for FINTEPLA® in Lennox-Gastaut syndrome in the first quarter of 2020. With the recent acquisition of Modis Therapeutics, Zogenix added MT1621, a novel investigational deoxynucleoside substrate enhancement therapy for the treatment of TK2 deficiency (TK2d), to its late-stage development pipeline.

Forward-Looking Statement

Zogenix cautions you that statements included in this press release 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,” “designed,” and similar expressions are intended to identify forward-looking statements. These statements include: the size of the patient population of TK2d; the potential for MT1621 to significantly improve outcomes in patients with TK2d; the potential of MT1621 to receive for accelerated regulatory review in the U.S. or Europe; and Zogenix’s expectations that it discuss next steps with regulatory authorities for MT1621 program and that it will re-submit the NDA for FINTEPLA in patients with Dravet syndrome and the potential acceptance by the FDA thereof. These statements are based on Zogenix’s current beliefs and expectations. 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 release due to the risks and uncertainties inherent in Zogenix’s business, including, without limitation: risks associated with the acquisition of Modis and integration of Modis’ operations into Zogenix’s business, including an increase in near and long-term expenditures, exposure to unknown liabilities and diversion of Zogenix’s management’s time and attention; the inherent risks of clinical development of MT1621; the data Modis has reported is based on preliminary analysis of key efficacy and safety data, and such data may change following a more comprehensive review of the data related to the trial and such data may not accurately reflect the complete results of the trial; risks associated with relying on a retrospective analysis for pivotal efficacy and safety data for MT1621; Breakthrough Therapy and PRIME designations do not guarantee that the FDA or EMA will approve MT1621 or expedite its review of MT1621; the FDA may refuse to accept the re-submitted NDA for FINTEPLA the FDA may not agree with Zogenix’s interpretation of the results of the clinical trials of MT1621 or FINTEPLA; and other risks described in Zogenix’s prior press releases as well as in public periodic filings with the U.S. Securities & 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 press release 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.

CONTACTS:

Zogenix

Melinda Baker

Senior Director, Corporate Communications

+1 (510) 788-8732 | corpcomms@zogenix.com

Investors

Andrew McDonald

Founding Partner, LifeSci Advisors LLC

+1 (646) 597-6987 | Andrew@lifesciadvisors.com

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