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: August 6, 2018 | By: | /s/ Michael P. Smith | ||||
Name: | Michael P. Smith | |||||
Title: | Executive Vice President, Chief Financial Officer, Treasurer and Secretary |
• | Reported positive top-line results from second pivotal Phase 3 trial of ZX008 in patients with Dravet syndrome, Study 1504 |
• | Submission of U.S. and EU regulatory filings for ZX008 in Dravet syndrome anticipated by year-end 2018 |
• | Actively enrolling global Phase 3 trial of ZX008 for treatment of Lennox-Gastaut syndrome, Study 1601 |
• | Appointed Global Chief Commercial Officer |
• | Reported positive top-line results from Study 1504, the second pivotal Phase 3 clinical trial of ZX008 in Dravet syndrome in July. |
– | Patients taking ZX008 achieved a 54.7% greater reduction in mean monthly convulsive seizures compared to placebo (p<0.001). The study also met all key secondary efficacy endpoints. |
– | ZX008 was generally well-tolerated with the adverse events consistent with those observed in Study 1 and the known safety profile of fenfluramine. The incidence of overall rates of treatment-emergent adverse events was similar in the ZX008 and placebo groups. No clinical or echocardiographic evidence of the development of valvulopathy or pulmonary hypertension was observed in any subject. |
• | New Drug Application and Marketing Authorization Application preparations ongoing for ZX008 in Dravet syndrome, targeting submissions by year-end 2018. |
• | Continued enrollment in global Phase 3 trial of ZX008 for treatment of LGS, Study 1601. |
• | Appointed Ashish Sagrolikar, an industry veteran with over 25 years of global pharmaceutical sales, marketing and operations experience in rare disease and specialty pharmaceutical products, as Executive Vice President and Chief Commercial Officer, as the Company continues to build its commercial operations in preparation for anticipated launches in the U.S. and Europe. |
• | Due to the wind-down of Sumavel DosePro manufacturing operations in September 2017, the Company recorded no revenue for the three months ended June 30, 2018. This compares with total revenue of $7.1 million in the second quarter ended June 30, 2017, consisting entirely of contract manufacturing revenue for Sumavel DosePro. |
• | Research and development expenses for the second quarter ended June 30, 2018, totaled $26.7 million, up from $14.9 million in the second quarter ended June 30, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of ZX008 in Dravet syndrome and LGS. |
• | Selling, general and administrative expenses for the second quarter ended June 30, 2018, totaled $8.6 million, compared with $5.5 million in the second quarter ended June 30, 2017. |
• | Net loss from continuing operations for the second quarter ended June 30, 2018, was $28.8 million, compared with a net loss from continuing operations of $22.5 million in the second quarter ended June 30, 2017. |
• | Total net loss for the second quarter ended June 30, 2018, was $29.0 million, or a net loss of $0.83 per share, compared with a total net loss of $23.0 million, or a net loss of $0.93 per share, in the second quarter ended June 30, 2017. |
• | Due to the wind-down of Sumavel DosePro manufacturing operations in September 2017, the Company recorded no revenue for the six months ended June 30, 2018. This compares with total revenue of $9.8 million in the six month period ended June 30, 2017, consisting entirely of contract manufacturing revenue for Sumavel DosePro. |
• | Research and development expenses for the six months ended June 30, 2018, totaled $49.7 million, up from $28.2 million in the six months ended June 30, 2017, as the Company expanded clinical trial activities related to its ongoing Phase 3 development programs of ZX008 in Dravet syndrome and LGS. |
• | Selling, general and administrative expenses for the six months ended June 30, 2018, totaled $16.6 million, compared with $12.1 million in the six months ended June 30, 2017. |
• | Net loss from continuing operations for the six months ended June 30, 2018, was $59.0 million, compared with a net loss from continuing operations of $43.6 million in the six months ended June 30, 2017. |
• | Total net loss for the six months ended June 30, 2018, was $59.2 million, or a net loss of $1.69 per share, compared with a total net loss of $44.3 million, or a net loss of $1.79 per share, in the six months ended June 30, 2017. |
• | As of June 30, 2018, the Company had cash and cash equivalents of $272.1 million, compared to $293.5 million at December 31, 2017. |
Toll Free: | 800-263-0877 |
International: | 323-794-2094 |
Conference ID: | 1390518 |
Webcast: | http://public.viavid.com/index.php?id=130329 |
Replays, Available through August 20th: | |
Domestic: | 844-512-2921 |
International: | 412-317-6671 |
Replay PIN: | 1390518 |
June 30, 2018 | December 31, 2017 | ||||||
Assets | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 272,103 | $ | 293,503 | |||
Prepaid expenses | 9,089 | 5,994 | |||||
Other current assets | 3,933 | 5,206 | |||||
Total current assets | 285,125 | 304,703 | |||||
Property and equipment, net | 279 | 245 | |||||
Intangible assets | 102,500 | 102,500 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other assets | 1,040 | 3,931 | |||||
Total assets | $ | 395,178 | $ | 417,613 | |||
Liabilities and stockholders’ equity | |||||||
Current liabilities: | |||||||
Accounts payable | $ | 4,434 | $ | 3,356 | |||
Accrued clinical trial expenses | 12,160 | 8,657 | |||||
Accrued compensation | 3,267 | 6,616 | |||||
Other accrued liabilities | 2,501 | 1,842 | |||||
Contingent consideration, current portion | 18,500 | — | |||||
Common stock warrant liabilities | 543 | 512 | |||||
Total current liabilities | 41,405 | 20,983 | |||||
Contingent consideration | 55,900 | 76,900 | |||||
Deferred income taxes | 17,425 | 17,425 | |||||
Other long-term liabilities | 582 | 784 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Preferred stock, $0.001 par value; 10,000 shares authorized; none issued and outstanding | — | — | |||||
Common stock, $0.001 par value; 50,000 shares authorized; 35,827 and 34,808 shares issued and outstanding at June 30, 2018 and December 31, 2017, respectively | 36 | 35 | |||||
Additional paid-in capital | 911,087 | 873,526 | |||||
Accumulated deficit | (631,257 | ) | (572,040 | ) | |||
Total stockholders’ equity | 279,866 | 301,521 | |||||
Total liabilities and stockholders’ equity | $ | 395,178 | $ | 417,613 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2018 | 2017 | 2018 | 2017 | ||||||||||||
Contract manufacturing revenue | $ | — | $ | 7,125 | $ | — | $ | 9,821 | |||||||
Costs and expenses: | |||||||||||||||
Cost of contract manufacturing | — | 8,242 | — | 10,729 | |||||||||||
Research and development | 26,741 | 14,850 | 49,721 | 28,191 | |||||||||||
Selling, general and administrative | 8,577 | 5,502 | 16,647 | 12,056 | |||||||||||
Asset impairment charges | — | 107 | — | 920 | |||||||||||
Change in fair value of contingent consideration | (2,500 | ) | 500 | (2,500 | ) | 1,100 | |||||||||
Total costs and expenses | 32,818 | 29,201 | 63,868 | 52,996 | |||||||||||
Loss from operations | (32,818 | ) | (22,076 | ) | (63,868 | ) | (43,175 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 1,029 | 117 | 1,862 | 211 | |||||||||||
Interest expense | — | (692 | ) | (6 | ) | (1,363 | ) | ||||||||
Change in fair value of common stock warrant liabilities | (48 | ) | 153 | (31 | ) | 740 | |||||||||
Other income, net | 2,998 | 29 | 3,024 | 9 | |||||||||||
Total other income (expense) | 3,979 | (393 | ) | 4,849 | (403 | ) | |||||||||
Loss from continuing operations before income taxes | (28,839 | ) | (22,469 | ) | (59,019 | ) | (43,578 | ) | |||||||
Income tax benefit (expense) | — | 16 | — | (1 | ) | ||||||||||
Net loss from continuing operations | (28,839 | ) | (22,453 | ) | (59,019 | ) | (43,579 | ) | |||||||
Loss from discontinued operations, net of taxes | (198 | ) | (555 | ) | (198 | ) | (736 | ) | |||||||
Net loss | $ | (29,037 | ) | $ | (23,008 | ) | $ | (59,217 | ) | $ | (44,315 | ) | |||
Net loss per share, basic and diluted: | |||||||||||||||
Continuing operations | $ | (0.82 | ) | $ | (0.90 | ) | $ | (1.68 | ) | $ | (1.76 | ) | |||
Discontinued operations | $ | (0.01 | ) | $ | (0.03 | ) | $ | (0.01 | ) | $ | (0.03 | ) | |||
Total | $ | (0.83 | ) | $ | (0.93 | ) | $ | (1.69 | ) | $ | (1.79 | ) | |||
Weighted average common shares used in the calculation of basic and diluted net loss per common share | 35,355 | 24,822 | 35,099 | 24,817 |