Delaware | 001-34962 | 20-5300780 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
5858 Horton Street, #455, Emeryville, CA | 94608 | |
(Address of Principal Executive Offices) | (Zip Code) |
¨ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
¨ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
¨ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
¨ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
Item 2.02 | Results of Operations and Financial Condition. |
Item 9.01 | Financial Statements and Exhibits. |
Exhibit No. | Description | |
99.1 | Press Release, dated May 10, 2016 |
ZOGENIX, INC. | ||||||
Date: May 10, 2016 | By: | /s/ Ann D. Rhoads | ||||
Name: | Ann D. Rhoads | |||||
Title: | Executive Vice President, Chief Financial Officer, Treasurer and Secretary |
Exhibit No. | Description | |
99.1 | Press Release, dated May 10, 2016 |
• | Initiated the first Phase 3 clinical trial of ZX008 in North America for the treatment of seizures in Dravet syndrome, a rare and debilitating form of epilepsy that begins in infancy. |
• | Received Fast Track designation from the FDA for ZX008 in Dravet syndrome. |
• | Presented updated data from the ongoing open-label clinical trial in Belgium demonstrating 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 million in cash and cash equivalents. Zogenix’s expected cash runway extends through 2017. |
• | 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 million in the same quarter last year, which included $4.2 million of contract manufacturing revenue and $0.4 million of service and other product revenue. The increase in contract manufacturing revenue in the first quarter of 2016 was due primarily to an increase in |
• | First quarter 2016 research and development expenses totaled $8.0 million, up from $5.2 million in 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 million in 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 million for the first quarter of 2016, compared with a net loss of $12.7 million in the first quarter a year ago. |
• | Total net loss for the first quarter of 2016 was $10.4 million, or $0.42 per share, compared with a net loss of $22.9 million, or $1.19 per share, for the first quarter a year ago. |
• | Cash and cash equivalents at March 31, 2016 totaled $132.2 million, as compared to $155.3 million at December 31, 2015. |
• | 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 Endo is expected at a low single-digit markup over cost of contract manufacturing. |
Ann Rhoads Chief Financial Officer Zogenix, Inc. 858-436-9208 arhoads@zogenix.com | Andrew McDonald Founding Partner LifeSci Advisors, LLC 646-597-6987 Andrew@LifeSciAdvisors.com |
Three Months Ended | |||||||
March 31, | |||||||
2016 | 2015 | ||||||
Revenues: | |||||||
Contract manufacturing revenue | $ | 9,206 | $ | 4,181 | |||
Service and other product revenue | — | 433 | |||||
Total revenue | 9,206 | 4,614 | |||||
Operating expense: | |||||||
Cost of contract manufacturing | 7,804 | 3,923 | |||||
Royalty expense | 71 | 72 | |||||
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 | $ | (10,389 | ) | $ | (22,861 | ) | |
Net loss per share, basic and diluted | $ | (0.42 | ) | $ | (1.19 | ) | |
Weighted average shares outstanding, basic and diluted | 24,772 | 19,170 |
March 31, | December 31, | ||||||
2016 | 2015 | ||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 132,184 | $ | 155,349 | |||
Restricted cash | 10,002 | 10,002 | |||||
Trade accounts receivable, net | 4,904 | 1,396 | |||||
Inventory | 9,459 | 12,030 | |||||
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 | |||||
Intangible assets | 102,500 | 102,500 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other assets | 5,861 | 3,331 | |||||
Total assets | $ | 286,607 | $ | 305,822 | |||
LIABILITIES AND STOCKHOLDERS’ EQUITY | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 3,482 | $ | 5,290 | |||
Accrued expenses | 6,183 | 8,328 | |||||
Common stock warrant liabilities | 1,669 | 6,196 | |||||
Long-term debt, current portion | 6,357 | 6,321 | |||||
Deferred revenue | 661 | 945 | |||||
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 | |||||
Stockholders’ equity | 173,859 | 182,760 | |||||
Total liabilities and stockholders’ equity | $ | 286,607 | $ | 305,822 | |||