Delaware | 001-34962 | 20-5300780 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
5858 Horton Street, Ste. 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)) |
Exhibit Number | Exhibit Description | |
ZOGENIX, INC. | ||||||
Date: February 28, 2019 | By: | /s/ Michael P. Smith | ||||
Name: | Michael P. Smith | |||||
Title: | Executive Vice President, Chief Financial Officer, Treasurer and Secretary |
• | Completed rolling submission of an NDA to the U.S. FDA and an MAA to the EMA for FINTEPLA® for the treatment of seizures associated with Dravet syndrome in February 2019 |
◦ | EMA has accepted MAA for review; outcome of the MAA review by the EMA expected in Q1 2020 |
◦ | Notice regarding FDA acceptance of NDA filing and notification of PDUFA target date expected in next several weeks |
• | Continued to advance enrollment of global Phase 3 trial of FINTEPLA for the treatment of Lennox-Gastaut syndrome (Study 1601) |
• | Presented data from nine abstracts, including four “late-breakers,” at the 2018 AES Annual Meeting |
• | Concluded full-year 2018 with $514.2 million in cash, cash equivalents, and marketable securities |
• | Completed the rolling submission of an NDA to the U.S. FDA and submitted an MAA to the EMA for FINTEPLA in February 2019, both for the treatment of seizures associated with Dravet syndrome. |
◦ | EMA has accepted the MAA for review; outcome of regulatory review anticipated in the first quarter of 2020. |
◦ | Zogenix expects to receive notice from the FDA regarding NDA acceptance for filing and a PDUFA target date in the next several weeks. |
• | Continued U.S. and European commercial preparations for FINTEPLA. The Company is preparing for a U.S. commercial launch shortly following potential NDA approval. |
• | Continued enrollment in global Phase 3 trial of FINTEPLA for treatment of seizures associated with LGS (Study 1601). |
• | Presented data from nine abstracts, including four “late-breakers,” at the 2018 American Epilepsy Society Annual Meeting. |
◦ | Data from second pivotal Phase 3 trial (Study 1504) consistent with results of first pivotal Phase 3 trial (Study 1) in showing highly significant convulsive seizure reduction for FINTEPLA versus placebo. |
◦ | Clinically meaningful reduction in convulsive seizure frequency for FINTEPLA maintained over Phase 3 open-label extension trial (Study 1503). |
◦ | Positive findings on the impact of treatment with FINTEPLA on everyday executive function in patients with Dravet syndrome. |
• | Concluded year ended December 31, 2018, with $514.2 million in cash, cash equivalents and marketable securities. |
• | Research and development expenses for the fourth quarter ended December 31, 2018, totaled $23.6 million, up from $18.1 million in the fourth quarter ended December 31, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of FINTEPLA in Dravet syndrome and LGS. |
• | Selling, general and administrative expenses for the fourth quarter ended December 31, 2018, totaled $11.3 million, compared with $7.8 million in the fourth quarter ended December 31, 2017. |
• | Net loss for the fourth quarter ended December 31, 2018, was $22.4 million, or a net loss of $0.53 per share, compared with a net loss of $39.7 million, or a net loss of $1.17 per share in the fourth quarter ended December 31, 2017. |
• | Due to the wind-down of Sumavel DosePro manufacturing operations in September 2017, the Company recorded no revenue for the year-ended December 31, 2018. This compares with total revenue of $9.8 million in the year ended December 31, 2017, consisting entirely of contract manufacturing revenue for Sumavel DosePro. |
• | Research and development expenses for the 12 months ended December 31, 2018, totaled $101 million, up from $67.4 million in the 12 months ended December 31, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of FINTEPLA in Dravet syndrome and LGS. |
• | Selling, general and administrative expenses for the 12 months ended December 31, 2018, were $39.0 million, compared with $25.9 million in the 12 months ended December 31, 2017. |
• | Net loss for the 12 months ended December 31, 2018, was $123.9 million, or a net loss of $3.27 per share, compared with a net loss of $126.8 million, or a net loss of $4.65 per share in the 12-months December 31, 2017. |
• | As of December 31, 2018, the Company had $514.2 million in cash, cash equivalents, and marketable securities, compared to $293.5 million at December 31, 2017. |
Toll Free: | 877-407-9716 |
International: | 201-493-6779 |
Conference ID: | 13687457 |
Webcast: | http://public.viavid.com/index.php?id=133233 |
Replays available through March 14: | ||
Domestic: | 844-512-2921 | |
International: | 412-317-6671 | |
Replay PIN: | 13687457 |
December 31, | |||||||
2018 | 2017 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 68,454 | $ | 293,503 | |||
Marketable securities | 445,733 | — | |||||
Prepaid expenses | 6,718 | 5,994 | |||||
Other current assets | 11,825 | 5,206 | |||||
Total current assets | 532,730 | 304,703 | |||||
Property and equipment, net | 2,870 | 245 | |||||
Intangible assets | 102,500 | 102,500 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other assets | 3,997 | 3,931 | |||||
Total assets | $ | 648,331 | $ | 417,613 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 7,989 | $ | 3,356 | |||
Accrued clinical trial expenses | 10,621 | 8,657 | |||||
Accrued compensation | 5,277 | 6,616 | |||||
Other accrued liabilities | 1,845 | 1,842 | |||||
Current portion of contingent consideration | 32,300 | — | |||||
Common stock warrant liabilities | 343 | 512 | |||||
Total current liabilities | 58,375 | 20,983 | |||||
Contingent consideration | 45,900 | 76,900 | |||||
Deferred income taxes | 17,425 | 17,425 | |||||
Other long-term liabilities | 3,830 | 784 | |||||
Total liabilities | 125,530 | 116,092 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock | — | — | |||||
Common stock | 42 | 35 | |||||
Additional paid-in capital | 1,218,710 | 873,526 | |||||
Accumulated deficit | (695,954 | ) | (572,040 | ) | |||
Accumulated other comprehensive loss | 3 | — | |||||
Total stockholders’ equity | 522,801 | 301,521 | |||||
Total liabilities and stockholders’ equity | $ | 648,331 | $ | 417,613 |
Three Months Ended December 31, | Twelve Months Ended December 31, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Contract manufacturing revenue | $ | — | $ | — | $ | — | $ | 9,821 | |||||||
Costs and expenses: | |||||||||||||||
Cost of contract manufacturing | — | — | — | 10,729 | |||||||||||
Research and development | 23,596 | 18,080 | 100,925 | 67,449 | |||||||||||
Selling, general and administrative | 11,287 | 7,756 | 38,950 | 25,885 | |||||||||||
Loss on contract termination | — | — | — | 478 | |||||||||||
Change in fair value of contingent consideration | (1,900 | ) | 12,500 | 1,300 | 24,100 | ||||||||||
Asset impairment charges | — | — | — | 1,116 | |||||||||||
Total costs and expenses | 32,983 | 38,336 | 141,175 | 129,757 | |||||||||||
Loss from operations | (32,983 | ) | (38,336 | ) | (141,175 | ) | (119,936 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 3,175 | 758 | 7,170 | 1,090 | |||||||||||
Interest expense | — | (579 | ) | (6 | ) | (2,644 | ) | ||||||||
Loss on extinguishment of debt | — | (1,498 | ) | — | (4,876 | ) | |||||||||
Change in fair value of common stock warrant liabilities | 264 | (63 | ) | 169 | 297 | ||||||||||
Other (expense) income, net | 7,111 | (24 | ) | 10,126 | 47 | ||||||||||
Total other income (expense) | 10,550 | (1,406 | ) | 17,459 | (6,086 | ) | |||||||||
Loss from continuing operations before income taxes | (22,433 | ) | (39,742 | ) | (123,716 | ) | (126,022 | ) | |||||||
Income tax benefit | — | (41 | ) | — | — | ||||||||||
Net loss from continuing operations | (22,433 | ) | (39,783 | ) | (123,716 | ) | (126,022 | ) | |||||||
Net loss (income) from discontinued operations, net of taxes | — | 75 | (198 | ) | (795 | ) | |||||||||
Net Loss | $ | (22,433 | ) | $ | (39,708 | ) | $ | (123,914 | ) | $ | (126,817 | ) | |||
Net loss per share, basic and diluted | $ | (0.53 | ) | $ | (1.17 | ) | $ | (3.27 | ) | $ | (4.65 | ) |