- Established global development plan and regulatory pathway for ZX008 (low-dose fenfluramine) in Dravet syndrome to expedite Phase 3 data readouts for U.S. and European regulatory submissions— Three ongoing Phase 3 double-blind, randomized clinical trials evaluating ZX008 as an adjunctive treatment for seizures in children and young adults with Dravet syndrome, having enrolled more than 180 patients to date— Identically designed Study 1501 (U.S. and Canada) and Study 1502 (Europe and Australia) will be combined into one adequately powered study (Study 1)—— Full enrollment of Study 1 expected by end of 1Q 2017—— Top-line data readout targeted for 3Q 2017— Efficacy and safety portion of Study 1504 (Cohort 2) currently enrolling patients in Europe and has been expanded to include sites in U.S. and Canada—— Study 1504 designed to meet requirements of a Phase 3 pivotal trial in U.S.—— Enrollment proceeding with a target data readout by end of 2017
- Received conditional approval from U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) for FINTEPLA™ as proprietary name for ZX008
- Method of use patent issued in U.S. for ZX008 in Dravet syndrome that is expected to provide protection of associated claims through 2033
- Granted "orphan drug" designation by European Commission for ZX008 to treat patients with LGS
- Presented new data at 70 th American Epilepsy Society Annual Meeting demonstrating effectiveness and safety, including cardiovascular-related safety, for patients treated with ZX008 as an adjunctive therapy for seizures associated with LGS, and continued effectiveness and safety for ongoing open-label patients with Dravet syndrome
- Initiation of Phase 3 clinical trial for ZX008 in LGS planned for second half 2017
- Appointed Michael Smith, a senior executive with more than 18 years of experience in biotechnology industry, as Company's new Chief Financial Officer
- Completed year ended December 31, 2016, with $91.6 million in cash and cash equivalents
- Total revenue for the fourth quarter ended December 31, 2016, was $11.0 million, consisting entirely of contract manufacturing revenue. This compared with total revenue of $6.1 million in the fourth quarter ended December 31, 2015, which included $5.3 million of contract manufacturing revenue.
- Research and development expenses for the fourth quarter ended December 31, 2016, totaled $13.4 million, up from $8.6 million in the fourth quarter ended December 31, 2015, as the Company progressed enrollment in its Phase 3 clinical trials for ZX008 in Dravet syndrome.
- Selling, general and administrative expenses for the fourth quarter ended December 31, 2016, totaled $7.5 million, compared with $6.8 million in the fourth quarter ended December 31, 2015.
- Net loss from continuing operations for the fourth quarter ended December 31, 2016, was $23.6 million, compared with $11.9 million in the fourth quarter ended December 31, 2015.
- Net income from discontinued operations for the fourth quarter ended December 31, 2016, was $0.1 million, compared with net income of $3.0 million in the fourth quarter ended December 31, 2015.
- Total net loss for the fourth quarter ended December 31, 2016, was $23.5 million, or $0.95 per share, compared with a net loss of $8.8 million, or $0.36 per share, in the fourth quarter ended December 31, 2015.
Zogenix and Endo International recently entered into a letter agreement acknowledging Endo's decision to have Zogenix discontinue the manufacturing and supply of the Sumavel DosePro product while the parties finalize the termination of the agreement. Zogenix expects to fulfill orders during the first half of 2017 and to cease to supply Endo with additional Sumavel DosePro following such time. Based on these actions, Zogenix recorded a non-cash $8.4 million impairment charge under its 2016 operating expenses, which was partially offset by the acceleration of approximately $4.9 million of previously deferred revenues.
- Total revenue for the year ended December 31, 2016, was $28.9 million, consisting almost entirely of contract manufacturing revenue. This compared with total revenue of $27.2 million in the year ended December 31, 2015, which included $24.4 million in contract revenue and $2.8 million in service and other product revenue. The increase in contract manufacturing revenue in 2016 as compared to 2015 was primarily due to the impending termination of Zogenix's contract manufacturing supply agreement with Endo and corresponding acceleration of deferred revenue.
- Research and development expenses for the year ended December 31, 2016, totaled $41.8 million, up from $27.9 million in the year ended December 31, 2015, as the Company increased development activities related to the Company's Phase 3 clinical trials in Dravet syndrome and funding of the open-label dose-ranging investigator initiated study in LGS.
- Selling, general and administrative expenses for the year ended December 31, 2016, totaled $27.0 million, compared with $26.3 million in the year ended December 31, 2015.
- Net loss from continuing operations for the year ended December 31, 2016 was $68.7 million, compared with $41.7 million in the year ended December 31, 2015.
- Net loss from discontinued operations for the year ended December 31, 2016, was $1.0 million, compared with net income of $67.8 million in the year ended December 31, 2015, which included the net gain on the sale of the Zohydro ER business.
- Total net loss for the year ended December 31, 2016, was $69.7 million, or $2.81 per share, compared with net income of $26.1 million, or $1.22 per share, in the year ended December 31, 2015, which included the net gain on the sale of the Zohydro ER business.
- As of December 31, 2016, the Company had cash and cash equivalents totaling $91.6 million, as compared to $155.3 million as of December 31, 2015. Zogenix believes it has sufficient funds to support operations into the first half of 2018.
|Condensed Consolidated Statements of Operations|
|(In Thousands, except Per Share Amounts)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Contract manufacturing revenue||$||10,988||$||5,325||$||28,525||$||24,369|
|Service and other product revenue||(2||)||756||325||2,813|
|Operating expenses (income):|
|Cost of contract manufacturing||5,917||4,850||22,173||22,356|
|Research and development||13,393||8,550||41,840||27,860|
|Selling, general and administrative||7,490||6,801||26,996||26,347|
|Change in fair value of contingent consideration||(1,000||)||(100||)||1,800||(2,000||)|
|Total operating expenses||34,302||20,197||101,535||74,908|
|Loss from operations||(23,316||)||(14,116||)||(72,685||)||(47,726||)|
|Other income (expense):|
|Interest expense, net||(594||)||(700||)||(2,382||)||(2,959||)|
|Loss on sale of short-term investments||—||(261||)||—||(5,746||)|
|Change in fair value of warrant liabilities||239||(242||)||5,387||(1,103||)|
|Other income (expense)||44||(15||)||46||(71||)|
|Total other (expense) income||(311||)||(1,218||)||3,051||(9,879||)|
|Net loss from continuing operations before income taxes||(23,627||)||(15,334||)||(69,634||)||(57,605||)|
|Income tax benefit||26||3,472||948||15,901|
|Net loss from continuing operations||(23,601||)||(11,862||)||(68,686||)||(41,704||)|
|Income (loss) from discontinued operations, net of taxes||109||3,019||(1,021||)||67,848|
|Net (loss) income||$||(23,492||)||$||(8,843||)||$||(69,707||)||$||26,144|
|Net (loss) income per share, basic||$||(0.95||)||$||(0.36||)||$||(2.81||)||$||1.22|
|Net (loss) income per share, diluted||$||(0.95||)||$||(0.36||)||$||(2.81||)||$||1.22|
|Weighted average shares outstanding, basic||24,799||24,764||24,785||21,449|
|Weighted average shares outstanding, diluted||24,799||24,764||24,785||21,449|
|Consolidated Balance Sheets|
|(In Thousands, except Per Share Amounts)(Unaudited)|
|Cash and cash equivalents||$||91,551||$||155,349|
|Trade accounts receivable||12,577||1,396|
|Other current assets||1,335||3,811|
|Current assets of discontinued operations||—||208|
|Total current assets||119,914||184,503|
|Property and equipment, net||1,710||9,254|
|Liabilities and stockholders' equity|
|Common stock warrant liabilities||809||6,196|
|Working capital advance note payable, net of discount of $3,733||3,267||—|
|Current portion of long-term debt||—||6,321|
|Current liabilities of discontinued operations||414||2,906|
|Total current liabilities||20,310||29,986|
|Deferred revenue, noncurrent||—||6,139|
|Contingent purchase consideration||52,800||51,000|
|Deferred tax liability||17,425||18,450|
|Other long-term liabilities||1,390||1,588|
|Commitments and contingencies|
|Common stock, $0.001 par value; 50,000 shares authorized; 24,813 and 24,772 shares issued and outstanding at December 31, 2016 and 2015, respectively||25||25|
|Additional paid-in capital||565,954||558,251|
|Total stockholders' equity||120,756||182,760|
|Total liabilities and stockholders' equity||$||231,505||$||305,822|
CONTACT:Investors:Andrew McDonaldFounding Partner, LifeSci Advisors LLC646-597-6987 | Andrew@lifesciadvisors.com