EMERYVILLE, Calif., Aug. 06, 2018 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a pharmaceutical company developing therapies for the treatment of rare central nervous system (CNS) disorders, today provided a corporate update and announced financial results for the second quarter and six months ended June 30, 2018.

“We were thrilled to recently announce positive top-line data from our second global Phase 3 trial of ZX008, Study 1504, for the control of convulsive seizures in children and young adults with Dravet syndrome,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “Study 1504 met the primary efficacy endpoint, and all key secondary objectives, with high statistical significance.  This confirmatory study corroborated the positive data from Study 1, our first pivotal Phase 3 trial of ZX008 in Dravet syndrome.”

“Looking ahead, Study 1 and Study 1504 will provide the basis for regulatory submissions in both the U.S. and EU with data that reflect global clinical practice for the treatment of Dravet syndrome,” continued Dr. Farr.  “We are now focused on submitting applications for registration in the U.S. and EU before the end of the year.”

“We also continue to be pleased with the rate of enrollment in our ongoing global Phase 3 trial of ZX008 in Lennox-Gastaut syndrome (LGS), Study 1601, in the U.S.  We will continue to add sites in Europe and Australia to this global study as we advance through the rest of the year,” concluded Dr. Farr.    

Corporate Update

Second Quarter 2018 Financial Results

Six Months Ended June 30, 2018 Financial Results Compared to Six Months Ended June 30, 2017

Conference Call 
Monday, August 6th @ 4:30 PM Eastern Time/1:30 PM Pacific Time 
Toll Free:800-263-0877
International:323-794-2094
Conference ID:1390518
Webcast:
  
Replays, Available through August 20th: 
Domestic:844-512-2921
International:412-317-6671
Replay PIN:1390518


About Zogenix
Zogenix, Inc. (Nasdaq: ZGNX) is a pharmaceutical company dedicated to developing therapies for people living with severe central nervous system (CNS) disorders who have limited or no treatment options. Led by a team of experts in rare disease development and CNS conditions, Zogenix is rapidly advancing the clinical investigation and development of ZX008 (fenfluramine hydrochloride) for patients with severe, rare epilepsies, including Dravet and Lennox-Gastaut syndromes.

For more information, visit www.zogenix.com.

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 are based on the Zogenix's current beliefs and expectations. These forward-looking statements include statements regarding Study 1 and Study 1504 providing the basis for regulatory submissions in both the U.S. and EU for ZX008 in Dravet syndrome and the timing of such submissions; continued enrollment and the addition of clinical sites for Study 1601; and potential regulatory approval and launches of ZX008 in the U.S. and Europe. 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: the uncertainties associated with the clinical development and regulatory approval of product candidates such as ZX008, including potential delays in the timing of regulatory submissions; the top-line data Zogenix 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 clinical trial and such top-line data may not accurately reflect the complete results of the trial, and the FDA and other regulatory authorities may not agree with Zogenix’s interpretation of such results; potential delays in the commencement, enrollment and completion of clinical trials; Zogenix’s reliance on third parties to conduct its clinical trials, enroll patients, manufacture its preclinical and clinical drug supplies and manufacture commercial supplies of its drug products, if approved; unexpected adverse side effects or inadequate therapeutic efficacy of ZX008 may limit regulatory approval and/or commercialization, or may result in recalls or product liability claims; and other risks described in Zogenix's prior press releases as well as in 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 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:
Investors:  Andrew McDonald
Founding Partner, LifeSci Advisors LLC
646-597-6987 | Andrew@lifesciadvisors.com


Zogenix, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands, except par value)

 June 30,
 2018		 December 31,
 2017
Assets   
Current assets:   
Cash and cash equivalents$272,103  $293,503 
Prepaid expenses9,089  5,994 
Other current assets3,933  5,206 
Total current assets285,125  304,703 
Property and equipment, net279  245 
Intangible assets102,500  102,500 
Goodwill6,234  6,234 
Other assets1,040  3,931 
Total assets$395,178  $417,613 
Liabilities and stockholders’ equity   
Current liabilities:   
Accounts payable$4,434  $3,356 
Accrued clinical trial expenses12,160  8,657 
Accrued compensation3,267  6,616 
Other accrued liabilities2,501  1,842 
Contingent consideration, current portion18,500  — 
Common stock warrant liabilities543  512 
Total current liabilities41,405  20,983 
Contingent consideration55,900  76,900 
Deferred income taxes17,425  17,425 
Other long-term liabilities582  784 
Commitments and contingencies   
Stockholders’ equity:   
Preferred stock, $0.001 par value; 10,000 shares authorized; none issued and outstanding—  — 
Common stock, $0.001 par value; 50,000 shares authorized; 35,827 and 34,808 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively36  35 
Additional paid-in capital911,087  873,526 
Accumulated deficit(631,257) (572,040)
Total stockholders’ equity279,866  301,521 
Total liabilities and stockholders’ equity$395,178  $417,613 


Zogenix, Inc.
Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except per share amounts)

 Three Months Ended June 30, Six Months Ended June 30,
 2018 2017 2018 2017
Contract manufacturing revenue$—  $7,125  $—  $9,821 
Costs and expenses:       
Cost of contract manufacturing—  8,242  —  10,729 
Research and development26,741  14,850  49,721  28,191 
Selling, general and administrative8,577  5,502  16,647  12,056 
Asset impairment charges—  107  —  920 
Change in fair value of contingent consideration(2,500) 500  (2,500) 1,100 
Total costs and expenses32,818  29,201  63,868  52,996 
Loss from operations(32,818) (22,076) (63,868) (43,175)
Other income (expense):       
Interest income1,029  117  1,862  211 
Interest expense—  (692) (6) (1,363)
Change in fair value of common stock warrant liabilities(48) 153  (31) 740 
Other income, net2,998  29  3,024  9 
Total other income (expense)3,979  (393) 4,849  (403)
Loss from continuing operations before income taxes(28,839) (22,469) (59,019) (43,578)
Income tax benefit (expense)—  16  —  (1)
Net loss from continuing operations(28,839) (22,453) (59,019) (43,579)
Loss from discontinued operations, net of taxes(198) (555) (198) (736)
Net loss$(29,037) $(23,008) $(59,217) $(44,315)
Net loss per share, basic and diluted:       
Continuing operations$(0.82) $(0.90) $(1.68) $(1.76)
Discontinued operations$(0.01) $(0.03) $(0.01) $(0.03)
Total$(0.83) $(0.93) $(1.69) $(1.79)
        
Weighted average common shares used in the calculation of basic and diluted net loss per common share35,355  24,822  35,099  24,817