Delaware | 001-34962 | 20-5300780 | ||
(State or Other Jurisdiction of Incorporation) | (Commission File Number) | (IRS Employer Identification No.) |
5959 Horton Street, Suite 500, 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)) |
Title of each class | Trading Symbol | Name of each exchange on which registered | ||
Common Stock, par value $0.001 per share | ZGNX | The Nasdaq Global Market |
Exhibit Number | Exhibit Description | |
ZOGENIX, INC. | ||||||
Date: May 8, 2019 | By: | /s/ Michael P. Smith | ||||
Name: | Michael P. Smith | |||||
Title: | Executive Vice President, Chief Financial Officer, Treasurer and Secretary |
• | Type A meeting with U.S. FDA to discuss FINTEPLA® Dravet syndrome NDA expected by early June |
• | FINTEPLA Dravet syndrome MAA accepted for review by EMA |
• | Exclusive distribution agreement for FINTEPLA in Japan signed with Nippon Shinyaku |
• | FINTEPLA for the treatment of seizures associated with Dravet syndrome |
◦ | MAA accepted for review by the EMA. |
◦ | RTF letter received from the U.S. FDA regarding the submitted NDA for FINTEPLA for the treatment of seizures associated with Dravet syndrome. |
◦ | FDA Type A meeting expected to take place by early June to gain clarity on NDA resubmission. |
◦ | The FDA has not requested or recommended additional clinical efficacy or safety studies of FINTEPLA. |
• | FINTEPLA for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS) |
◦ | Advanced enrollment in ongoing global Phase 3 clinical trial (Study 1601) of FINTEPLA for the treatment of seizures associated with LGS; full enrollment expected in second half of 2019. |
◦ | Top-line LGS study results anticipated in Q1 2020. |
• | FINTEPLA in Japan |
◦ | Entered into an exclusive distribution agreement with Nippon Shinyaku, Co., Ltd. for the commercialization of FINTEPLA in Japan. |
◦ | Zogenix retains responsibility for completing its global clinical development programs for FINTEPLA, including those already underway to support the Company’s planned submissions of new drug applications in Japan for Dravet syndrome and LGS. |
◦ | Zogenix to receive $20 million upon signing and over the next two years, and will also be eligible to receive future regulatory and sales-based milestone payments worth up to $108.5 million. |
◦ | Zogenix to supply product to Nippon Shinyaku and receive a tiered transfer price of up to a high-double digit percentage of the annual net sales of FINTEPLA in Japan. |
• | Research and development expenses for the first quarter ended March 31, 2019, totaled $24.4 million, up from $23.0 million in the first quarter ended March 31, 2018, as the Company concluded Phase 3 clinical trials in Dravet syndrome and expanded clinical trial activities related to its ongoing Phase 3 development program of FINTEPLA in LGS. |
• | Selling, general and administrative expenses for the first quarter ended March 31, 2019, totaled $10.9 million, compared with $8.1 million in the first quarter ended March 31, 2018. |
• | Net loss for the first quarter ended March 31, 2019, was $35.2 million, or a net loss of $0.83 per share, compared with a net loss of $30.2 million, or a net loss of $0.87 per share, in the first quarter ended March 31, 2018. |
• | As of March 31, 2019, the Company had $480.7 million in cash, cash equivalents, and marketable securities, compared to $514.2 million at December 31, 2018. |
March 31, 2019 | December 31, 2018 | ||||||
Assets: | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 58,288 | $ | 68,454 | |||
Marketable securities | 422,407 | 445,733 | |||||
Accounts receivable | 15,500 | — | |||||
Prepaid expenses | 8,071 | 6,718 | |||||
Other current assets | 6,323 | 11,825 | |||||
Total current assets | 510,589 | 532,730 | |||||
Property and equipment, net | 10,632 | 2,870 | |||||
Operating lease right-of-use assets | 8,423 | — | |||||
Intangible assets | 102,500 | 102,500 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other noncurrent assets | 2,154 | 3,997 | |||||
Total assets | $ | 640,532 | $ | 648,331 | |||
Liabilities and stockholders’ equity: | |||||||
Current liabilities: | |||||||
Accounts payable | 8,167 | 7,989 | |||||
Accrued and other current liabilities | 18,594 | 18,086 | |||||
Deferred revenue, current | 5,000 | — | |||||
Current portion of operating lease liabilities | 1,412 | — | |||||
Current portion of contingent consideration | 22,800 | 32,300 | |||||
Total current liabilities | 55,973 | 58,375 | |||||
Deferred revenue, noncurrent | 10,500 | — | |||||
Operating lease liabilities, net of current portion | 11,355 | — | |||||
Contingent consideration, net of current portion | 48,400 | 45,900 | |||||
Deferred income taxes | 17,425 | 17,425 | |||||
Other long-term liabilities | — | 3,830 | |||||
Total liabilities | 143,653 | 125,530 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock | 42 | 42 | |||||
Additional paid-in capital | 1,227,620 | 1,218,710 | |||||
Accumulated deficit | (731,156 | ) | (695,954 | ) | |||
Accumulated other comprehensive income | 373 | 3 | |||||
Total stockholders’ equity | 496,879 | 522,801 | |||||
Total liabilities and stockholders’ equity | $ | 640,532 | $ | 648,331 |
Three Months Ended March 31, | |||||||||
2019 | 2018 | ||||||||
Operating expenses: | |||||||||
Research and development | $ | 24,352 | $ | 22,980 | |||||
Selling, general and administrative | 10,918 | 8,070 | |||||||
Change in fair value of contingent consideration | 3,000 | — | |||||||
Total operating expenses | 38,270 | 31,050 | |||||||
Loss from operations | (38,270 | ) | (31,050 | ) | |||||
Other income (expense): | |||||||||
Interest income | 3,156 | 833 | |||||||
Other (expense) income, net | (88 | ) | 37 | ||||||
Total other income | 3,068 | 870 | |||||||
Net loss | (35,202 | ) | (30,180 | ) | |||||
Net loss per share, basic and diluted | $ | (0.83 | ) | $ | (0.87 | ) | |||
Weighted average common shares used in the calculation of basic and diluted net loss per common share | 42,236 | 34,841 |