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Zogenix, Inc.$42.95$.36.85%

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 Zogenix Provides Corporate Update and Reports Second Quarter 2019 Financial Results
   Tuesday, August 06, 2019 4:01:00 PM ET
  • Agreement reached with U.S. FDA for resubmission of NDA for FINTEPLA® for the treatment of Dravet syndrome; resubmission expected in September
  • Enrollment complete for FINTEPLA global Phase 3 trial in Lennox Gastaut syndrome; top-line data anticipated in Q1 2020
  • Strengthened intellectual property position through notice of allowance for one U.S. patent application and the issuance of two new U.S. patents

EMERYVILLE, Calif., Aug. 06, 2019 (GLOBE NEWSWIRE) -- Zogenix, Inc. (NASDAQ: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three and six months ended June 30, 2019, and provided a corporate update. The Company will host a conference call today, Tuesday, August 6, at 4:30 PM Eastern Time/1:30 PM Pacific Time.

“Following discussions with the U.S. Food and Drug Administration (FDA), we are very pleased to have a defined path for the resubmission of our New Drug Application (NDA) for FINTEPLA® for the treatment of seizures associated with Dravet syndrome,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “We are on track to resubmit our NDA in September and remain focused on preparing for potential approval and U.S. commercial launch next year. In Europe, our Marketing Authorization Application (MAA) remains under review by the European Medicines Agency (EMA).”

“We were excited in the second quarter to complete enrollment for Study 1601, our global Phase 3 trial of FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS),” continued Dr. Farr.  “We continue to anticipate top-line data for LGS in the first quarter of 2020.”

Corporate Update

  • FINTEPLA for the treatment of seizures associated with Dravet syndrome
       •   Following a Type A meeting with the FDA, Zogenix has a defined pathway for the resubmission of the  FINTEPLA NDA for the treatment of seizures associated with Dravet syndrome
       •   NDA resubmission can proceed without Zogenix having to conduct the additional chronic toxicity studies noted in the Refusal to File letter received on April 5
       •   NDA resubmission on track for September 2019
       •   FINTEPLA MAA under review by EMA in Europe
       •   Commercial preparations ongoing in the U.S. and Europe

  • FINTEPLA for the treatment of seizures associated with LGS
       •   Completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, Zogenix’s Phase 3 trial of FINTEPLA in LGS
       •   Top-line safety and efficacy data anticipated in first quarter of 2020

  • FINTEPLA intellectual property position
       •   Strengthened intellectual property position through notice of allowance for one U.S. patent application and the issuance of two new U.S. patents
             --   Allowed patent application covers elements to assure the safe use of fenfluramine for epilepsy treatment
             --   Two issued patents cover the proprietary synthetic process used to manufacture fenfluramine

Second Quarter 2019 Financial Results

  • The Company recorded $1.1 million in revenue for the second quarter ended June 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
     
  • Research and development expenses for the second quarter ended June 30, 2019, totaled $27.1 million, up from $26.7 million in the second quarter ended June 30, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
     
  • Selling, general and administrative expenses for the second quarter ended June 30, 2019, totaled $15.5 million, compared with $8.6 million in the second quarter ended June 30, 2018.
     
  • Net loss for the second quarter ended June 30, 2019, was $37.8 million, or a net loss of $0.89 per share, compared with a net loss of $29.0 million, or a net loss of $0.83 per share, in the second quarter ended June 30, 2018.

Six Months Ended June 30, 2019 Financial Results Compared to Six Months Ended June 30, 2018

  • The Company recorded $1.1 million in revenue for the six months ended June 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018.
     
  • Research and development expenses for the six months ended June 30, 2019, totaled $51.4 million, up from $49.7 million in the six months ended June 30, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS.
     
  • Selling, general and administrative expenses for the six months ended June 30, 2019, totaled $26.4 million, up from $16.6 million in the six months ended June 30, 2018.
     
  • Net loss for the six months ended June 30, 2019, was $73.0 million, or a net loss of $1.72 per share, compared with a net loss of $59.2 million, or a net loss of $1.69 per share, in the six months ended June 30, 2018.
     
  • As of June 30, 2019, the Company had $463.0 million in cash, cash equivalents, and marketable securities, compared to $514.2 million at December 31, 2018.

Conference Call

Tuesday, August 6th @ 4:30pm Eastern Time/1:30pm Pacific Time
Toll Free:     877-407-9716
International:      201-493-6779
Conference ID:     13692262
Webcast:      http://public.viavid.com/index.php?id=135166

About Zogenix
Zogenix is a global pharmaceutical company committed to developing and commercializing transformative therapies to improve the lives of patients and their families living with rare diseases. The Company is preparing to resubmit its New Drug Application for its lead product candidate, FINTEPLA® (ZX008, fenfluramine) to the U.S. Food & Drug Administration for the treatment of seizures associated with Dravet syndrome, a rare and often-catastrophic infant-onset epilepsy that can include frequent and prolonged seizures and significant intellectual, behavioral, and motor disabilities. FINTEPLA® is under review by the European Medicines Agency and is in development in Japan, also for the treatment of Dravet syndrome, and is also in development globally for the treatment of Lennox-Gastaut syndrome.

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 Zogenix’s expectations that it will re-submit the NDA for FINTEPLA in patients with Dravet syndrome in September 2019 and the potential acceptance by the FDA thereof; the timing and results of any decision regarding the NDA from the FDA or the MAA from the EMA; the potential timing of top-line data for Study 1601; the expected strengthening in Zogenix’s intellectual property position based on newly issued U.S. patents and the notice of allowance for a U.S. patent application; and FINTEPLA’s potential as a promising drug candidate and important new treatment option for the control of seizures in patients suffering from LGS. 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: the timing of the resubmission of the NDA for FINTEPLA for the treatment of Dravet syndrome may be delayed; the FDA may refuse to accept the re-submitted NDA; the FDA may disagree that the existing safety and efficacy data is sufficient to approve the NDA; the FDA may require Zogenix to conduct the additional chronic toxicity studies noted in the Refusal to File letter, dated April 3, 2019, or other studies or information in connection with its review of the NDA; the timing of the data from Study 1601 of FINTEPLA in patients suffering from LGS could be delayed; the results of Study 1601 may differ from the results of prior clinical studies in LGS or may demonstrate adverse safety data compared to the prior Phase 3 clinical trials of FINTEPLA; the FDA may not agree with Zogenix’s interpretation of the results of the clinical trials of FINTEPLA; later developments with the FDA that may be inconsistent with feedback received at prior meetings with the FDA; additional data from Zogenix’s ongoing studies may contradict or undermine the data submitted in the NDA for FINTEPLA; the uncertainties associated with the clinical development and regulatory approval of product candidates such as FINTEPLA; unexpected adverse side effects or inadequate therapeutic efficacy of FINTEPLA that could limit approval and/or commercialization, or that could 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 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

    
Zogenix, Inc.
Condensed Consolidated Balance Sheets (Unaudited)
(in thousands)
    
 June 30, 2019 December 31, 2018
Assets:   
Current assets:   
Cash and cash equivalents$50,788  $68,454 
Marketable securities412,180  445,733 
Prepaid expenses7,701  6,718 
Other current assets5,113  11,825 
Total current assets475,782  532,730 
Property and equipment, net10,141  2,870 
Operating lease right-of-use assets8,110   
Intangible assets102,500  102,500 
Goodwill6,234  6,234 
Other noncurrent assets1,850  3,997 
Total assets$604,617  $648,331 
Liabilities and stockholders’ equity:   
Current liabilities:   
Accounts payable$3,012  $7,989 
Accrued and other current liabilities20,946  18,086 
Deferred revenue, current6,027   
Current portion of operating lease liabilities1,402   
Current portion of contingent consideration34,800  32,300 
Total current liabilities66,187  58,375 
Deferred revenue, noncurrent8,404   
Operating lease liabilities, net of current portion11,186   
Contingent consideration, net of current portion35,700  45,900 
Deferred income taxes17,425  17,425 
Other long-term liabilities  3,830 
Total liabilities138,902  125,530 
Commitments and contingencies   
Stockholders’ equity:   
Common stock42  42 
Additional paid-in capital1,233,866  1,218,710 
Accumulated deficit(768,919) (695,954)
Accumulated other comprehensive income726  3 
Total stockholders’ equity465,715  522,801 
Total liabilities and stockholders’ equity$604,617  $648,331 


    
Zogenix, Inc.

Condensed Consolidated Statements of Operations (Unaudited)
(in thousands, except per share amounts)
    
 Three Months Ended June 30, Six Months Ended June 30,
 2019
 2018
 2019 2018
Collaboration revenue$1,069  $  $1,069  $ 
Operating expenses:       
Research and development$27,096  $26,741  51,448  49,721 
Selling, general and administrative15,459  8,577  26,377  16,647 
Change in fair value of contingent consideration(700) (2,500) 2,300  (2,500)
Total operating expenses41,855  32,818  80,125  63,868 
Loss from operations(40,786) (32,818) (79,056) (63,868)
Other income (expense):       
Interest income2,983  1,029  6,139  1,862 
Other income (expense)40  2,950  (48) 2,987 
Total other income (expense)3,023  3,979  6,091  4,849 
Net loss from continuing operations(37,763) (28,839) (72,965) (59,019)
Loss from discontinued operations, net of tax  (198)   (198)
Net loss$(37,763) $(29,037) $(72,965) $(59,217)
Net loss per share, basic and diluted:       
Continuing operations$(0.89) $(0.82) $(1.72) $(1.68)
Discontinued operations  (0.01)   (0.01)
Total$(0.89) $(0.83) $(1.72) $(1.69)
        
Weighted average common shares used in the calculation of basic and diluted net loss per common share42,458  35,355  42,348  35,099 


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Source: Zogenix, Inc


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