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Zogenix, Inc. (ZGNX) SEC Filing 10-Q Quarterly report for the period ending Tuesday, March 31, 2020

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ZGNX Quarterly Reports

Zogenix, Inc.

CIK: 1375151 Ticker: ZGNX



Exhibit 99.1

zgnxlogo1.jpg
Zogenix Provides Corporate Update and Reports First Quarter 2020 Financial Results
FDA PDUFA target action date of June 25, 2020, for FINTEPLA® NDA in Dravet syndrome
Plan to meet with FDA in second half of 2020 to discuss planned FINTEPLA Lennox-Gastaut syndrome sNDA
Closed public offering of common stock for net proceeds of $221.7 million; approximately $420 million in cash and marketable securities at March 31, 2020
EMERYVILLE, Calif. – May 5, 2020 – Zogenix, Inc. (Nasdaq: ZGNX), a global pharmaceutical company developing rare disease therapies, today announced financial results for the three months ended March 31, 2020, and provided a corporate update. The Company will host a conference call today, Tuesday, May 5, at 4:30 PM Eastern Time/1:30 PM Pacific Time.
“We continue to make progress on several key initiatives to support Zogenix’s growth and transition to a commercial-stage company,” said Stephen J. Farr, Ph.D., President and CEO of Zogenix. “During the pandemic, our priority has been to ensure that the approximately 530 Dravet syndrome patients currently taking FINTEPLA® in our clinical studies and expanded access program continue to receive this investigational product. As we approach the June 25th PDUFA date for FINTEPLA in Dravet syndrome, we continue to support the FDA’s review of our application and advance our commercial preparations in parallel. Our plans now also address potential ongoing pandemic-related circumstances that could impact how we launch FINTEPLA, if approved, in the third quarter.
“Recently, we were very pleased to share additional compelling clinical efficacy and safety data from an interim analysis of our ongoing open-label extension (OLE) study in Dravet syndrome,” continued Dr. Farr. “These data demonstrated significant, lasting and clinically meaningful reductions in convulsive seizure frequency in patients after up to two years of treatment with FINTEPLA.”
“Following positive top-line results from our global pivotal Phase 3 trial (Study 1601) of FINTEPLA in Lennox-Gastaut syndrome (LGS), a notoriously difficult to treat rare epilepsy, we are now focused on finalizing the studies and data required to support a supplemental NDA (sNDA) and intend to meet with the FDA later this year to discuss our planned submission,” concluded Dr. Farr.
Corporate Update
FINTEPLA for the treatment of seizures associated with Dravet syndrome:
FDA has established a PDUFA target action date of June 25, 2020
FINTEPLA Marketing Authorization Application (MAA) under active review by the European Medicines Agency (EMA)
Commercial readiness activities ongoing in the U.S. and Europe
An interim analysis of the OLE study with a cutoff date of February 15, 2019, which includes results for a total of 330 patients and a median treatment duration of 445 days (range 7-899 days), was presented and showed continued clinically meaningful reductions in convulsive seizure frequency after up to two years of treatment. The most common adverse events (AEs) were pyrexia, nasopharyngitis, decreased appetite, and diarrhea. There were no cases of valvular heart disease or pulmonary arterial hypertension.


The following information was filed by Zogenix, Inc. (ZGNX) on Tuesday, May 5, 2020 as an 8K 2.02 statement, which is an earnings press release pertaining to results of operations and financial condition. It may be helpful to assess the quality of management by comparing the information in the press release to the information in the accompanying 10-Q Quarterly Report statement of earnings and operation as management may choose to highlight particular information in the press release.

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Inside Zogenix, Inc.'s 10-Q Quarterly Report:

Financial Statements, Disclosures and Schedules

Inside this 10-Q Quarterly Report

Cover Page
Condensed Consolidated Balance Sheets (Unaudited)
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical)
Condensed Consolidated Statements Of Cash Flows (Unaudited)
Condensed Consolidated Statements Of Comprehensive Loss (Unaudited)
Condensed Consolidated Statements Of Operations (Unaudited)
Condensed Consolidated Statements Of Stockholders' Equity (Unaudited)
Accrued And Other Current Liabilities
Accrued And Other Current Liabilities (Tables)
Accrued And Other Current Liabilities - Details Of Accrued And Other Current Liabilities (Details)
Cash, Cash Equivalents And Marketable Securities
Cash, Cash Equivalents And Marketable Securities (Details)
Cash, Cash Equivalents And Marketable Securities (Tables)
Collaborative Arrangement
Collaborative Arrangement (Details)
Fair Value Measurements
Fair Value Measurements (Tables)
Fair Value Measurements - Assets And Liabilities Measured At Fair Value On Recurring Basis (Details)
Fair Value Measurements - Reconciliation Of Liabilities Measured At Fair Value Using Significant Unobservable Inputs (Details)
Fair Value Measurements - Significant Inputs Used In Fair Value Measurement (Details)
Leases
Leases (Tables)
Leases - Information Related To Operating Leases (Details)
Leases - Maturities Of Lease Liabilities (Details)
Leases - Narrative (Details)
Net Loss Per Share
Net Loss Per Share (Tables)
Net Loss Per Share - Antidilutive Securities (Details)
Net Loss Per Share - Reconciliation Of Numerator And Denominators In Computing Net Loss Per Share (Details)
Organization, Basis Of Presentation And Liquidity
Organization, Basis Of Presentation And Liquidity - Narrative (Details)
Stockholders' Equity And Stock-Based Compensation
Stockholders' Equity And Stock-Based Compensation (Tables)
Stockholders' Equity And Stock-Based Compensation - Additional Information (Details)
Stockholders' Equity And Stock-Based Compensation - Options Activity (Details)
Stockholders' Equity And Stock-Based Compensation - Restricted Stock Unit Activity (Details)
Stockholders' Equity And Stock-Based Compensation - Stock-Based Compensation Expense (Detail)
Summary Of Significant Accounting Policies
Summary Of Significant Accounting Policies (Policies)
United Kingdom (U.K.) Research And Development Incentives
United Kingdom (U.K.) Research And Development Incentives (Details)

Material Contracts, Statements, Certifications & more

Zogenix, Inc. provided additional information to their SEC Filing as exhibits

Ticker: ZGNX
CIK: 1375151
Form Type: 10-Q Quarterly Report
Accession Number: 0001375151-20-000074
Submitted to the SEC: Tue May 05 2020 6:01:09 PM EST
Accepted by the SEC: Wed May 06 2020
Period: Tuesday, March 31, 2020
Industry: Pharmaceutical Preparations

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