Zogenix Provides Corporate Update and Reports First Quarter 2016 Financial Results
- Initiated the first Phase 3 clinical trial of ZX008 in
North Americafor the treatment of seizures in Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy.
- Received Fast Track designation from the
FDAfor ZX008 in Dravet syndrome.
- Presented updated data from the ongoing open-label clinical trial in
Belgiumdemonstrating sustained effectiveness and cardiovascular-related safety, as well as high levels of sleep quality and quality of life, in the cohort of Dravet syndrome patients who began add-on treatment with ZX008 as early as 2010.
- Completed the three months ended
March 31, 2016, with $132.2 millionin cash and cash equivalents. Zogenix’s expected cash runway extends through 2017.
“Zogenix remains focused on advancing our ZX008 Phase 3 program for Dravet syndrome, with the North American clinical trial having recently been initiated and our multi-national study expected to begin very shortly,” said
First Quarter 2016 Financial Results Compared to First Quarter 2015 Financial Results
As a result of the sale of the Zohydro ER business, all Zohydro ER revenue and expenses have been excluded from continuing operations for all periods herein and reported as discontinued operations. All prior period information has been recast to conform to this presentation.
- Total revenue for the first quarter of 2016 was
$9.2 million, consisting entirely of contract manufacturing revenue. This compared with total revenue of $4.6 millionin the same quarter last year, which included $4.2 millionof contract manufacturing revenue and $0.4 millionof service and other product revenue. The increase in contract manufacturing revenue in the first quarter of 2016 was due primarily to an increase in expenses billed to Endo International Plcunder the supply agreement between the two companies.
- First quarter 2016 research and development expenses totaled
$8.0 million, up from $5.2 millionin the first quarter a year ago, as the Company continued preparations for its two Phase 3 studies for ZX008 and initiated the North American study.
- First quarter 2016 selling, general and administrative expenses totaled
$6.1 million, compared with $6.3 millionin the first quarter a year ago.
- Net loss from continuing operations for the first quarter of 2016 was
$10.2 million, essentially unchanged from the same quarter a year ago.
- Net loss from discontinued operations was
$0.2 millionfor the first quarter of 2016, compared with a net loss of $12.7 millionin the first quarter a year ago.
- Total net loss for the first quarter of 2016 was
$10.4 million, or $0.42per share, compared with a net loss of $22.9 million, or $1.19per share, for the first quarter a year ago.
- Cash and cash equivalents at
March 31, 2016totaled $132.2 million, as compared to $155.3 millionat December 31, 2015.
2016 Financial Guidance
- Research and development expenses are expected to be
$54-59 million, reflecting initiation and ramp-up of ZX008 clinical studies;
- Selling, general and administrative expenses are expected to be
$25-27 million; and
- Contract manufacturing revenue from the supply of Sumavel DosePro to
Endois expected at a low single-digit markup over cost of contract manufacturing.
Conference Call Details
Investors interested in participating in today’s live call can dial 888-576-4398 from the U.S. and international callers can dial 719-457-2727 and use conference ID: 6099104. A telephone replay will be available approximately two hours after the call and will run through
For more information, visit www.zogenix.com.
Forward Looking Statements
DosePro® and Relday® are registered trademarks of
All other trademarks are of the associated companies.
|Condensed Consolidated Statements of Operations|
|(in thousands, except per share amounts)|
|Three Months Ended|
|Contract manufacturing revenue||$||9,206||$||4,181|
|Service and other product revenue||-||433|
|Cost of contract manufacturing||7,804||3,923|
|Research and development||7,987||5,150|
|Selling, general & administrative||6,124||6,268|
|Change in fair value of contingent consideration||1,300||(1,000||)|
|Total operating expense||23,286||14,413|
|Loss from operations||(14,080||)||(9,799||)|
|Other income (expense):|
|Interest expense, net||(598||)||(643||)|
|Change in fair value of warrant liabilities||4,527||410|
|Other income (expense)||(7||)||(120||)|
|Total other income (expense)||3,922||(353||)|
|Net loss from continuing operations before income taxes||(10,158||)||(10,152||)|
|Income tax expense||(62||)||(13||)|
|Net loss from continuing operations||(10,220||)||(10,165||)|
|Net loss from discontinued operations, net of applicable tax||(169||)||(12,696||)|
|Net loss per share, basic and diluted||$||(0.42||)||$||(1.19||)|
|Weighted average shares outstanding, basic and diluted||24,772||19,170|
|Condensed Consolidated Balance Sheets|
|March 31,||December 31,|
|Cash and cash equivalents||$||132,184||$||155,349|
|Trade accounts receivable, net||4,904||1,396|
|Prepaid expenses and other current assets||6,463||5,518|
|Current assets of discontinued operations||41||208|
|Total current assets||163,053||184,503|
|Property and equipment, net||8,959||9,254|
|LIABILITIES AND STOCKHOLDERS’ EQUITY|
|Common stock warrant liabilities||1,669||6,196|
|Long-term debt, current portion||6,357||6,321|
|Current liabilities of discontinued operations||2,370||2,906|
|Total current liabilities||20,722||29,986|
|Long-term debt, less current portion||14,400||15,899|
|Deferred revenue, less current portion||5,207||6,139|
|Contingent purchase consideration||52,300||51,000|
|Deferred income taxes||18,450||18,450|
|Other long-term liabilities||1,669||1,588|
|Total liabilities and stockholders’ equity||$||286,607||$||305,822|
Ann RhoadsChief Financial Officer Zogenix, Inc.858-436-9208 firstname.lastname@example.org Andrew McDonaldFounding Partner LifeSci Advisors, LLC646-597-6987 Andrew@LifeSciAdvisors.com