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) |
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 |
☐ | 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, 2019 | By: | /s/ Michael P. Smith | ||||
Name: | Michael P. Smith | |||||
Title: | Executive Vice President, Chief Financial Officer, Treasurer and Secretary |
• | Agreement reached with U.S. FDA for resubmission of NDA for FINTEPLA® for the treatment of Dravet syndrome; resubmission expected in September |
• | Enrollment complete for FINTEPLA global Phase 3 trial in Lennox Gastaut syndrome; top-line data anticipated in Q1 2020 |
• | Strengthened intellectual property position through notice of allowance for one U.S. patent application and the issuance of two new U.S. patents |
• | FINTEPLA for the treatment of seizures associated with Dravet syndrome |
◦ | Following a Type A meeting with the FDA, Zogenix has a defined pathway for the resubmission of the FINTEPLA NDA for the treatment of seizures associated with Dravet syndrome |
◦ | NDA resubmission can proceed without Zogenix having to conduct the additional chronic toxicity studies noted in the Refusal to File letter received on April 5 |
◦ | NDA resubmission on track for September 2019 |
◦ | FINTEPLA MAA under review by EMA in Europe |
◦ | Commercial preparations ongoing in the U.S. and Europe |
• | FINTEPLA for the treatment of seizures associated with LGS |
◦ | Completed enrollment for, and randomized the last patient into the treatment period of, Study 1601, Zogenix’s Phase 3 trial of FINTEPLA in LGS |
◦ | Top-line safety and efficacy data anticipated in first quarter of 2020 |
• | FINTEPLA intellectual property position |
◦ | Strengthened intellectual property position through notice of allowance for one U.S. patent application and the issuance of two new U.S. patents |
▪ | Allowed patent application covers elements to assure the safe use of fenfluramine for epilepsy treatment |
▪ | Two issued patents cover the proprietary synthetic process used to manufacture fenfluramine |
• | The Company recorded $1.1 million in revenue for the second quarter ended June 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018. |
• | Research and development expenses for the second quarter ended June 30, 2019, totaled $27.1 million, up from $26.7 million in the second quarter ended June 30, 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 second quarter ended June 30, 2019, totaled $15.5 million, compared with $8.6 million in the second quarter ended June 30, 2018. |
• | Net loss for the second quarter ended June 30, 2019, was $37.8 million, or a net loss of $0.89 per share, compared with a net loss of $29.0 million, or a net loss of $0.83 per share, in the second quarter ended June 30, 2018. |
• | The Company recorded $1.1 million in revenue for the six months ended June 30, 2019, as a result of its March 2019 collaboration with Nippon Shinyaku Co., Ltd. for FINTEPLA in Dravet syndrome and LGS in Japan. Zogenix recorded no revenue for the corresponding period of 2018. |
• | Research and development expenses for the six months ended June 30, 2019, totaled $51.4 million, up from $49.7 million in the six months ended June 30, 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 six months ended June 30, 2019, totaled $26.4 million, up from $16.6 million in the six months ended June 30, 2018. |
• | Net loss for the six months ended June 30, 2019, was $73.0 million, or a net loss of $1.72 per share, compared with a net loss of $59.2 million, or a net loss of $1.69 per share, in the six months ended June 30, 2018. |
• | As of June 30, 2019, the Company had $463.0 million in cash, cash equivalents, and marketable securities, compared to $514.2 million at December 31, 2018. |
June 30, 2019 | December 31, 2018 | ||||||
Assets: | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 50,788 | $ | 68,454 | |||
Marketable securities | 412,180 | 445,733 | |||||
Prepaid expenses | 7,701 | 6,718 | |||||
Other current assets | 5,113 | 11,825 | |||||
Total current assets | 475,782 | 532,730 | |||||
Property and equipment, net | 10,141 | 2,870 | |||||
Operating lease right-of-use assets | 8,110 | — | |||||
Intangible assets | 102,500 | 102,500 | |||||
Goodwill | 6,234 | 6,234 | |||||
Other noncurrent assets | 1,850 | 3,997 | |||||
Total assets | $ | 604,617 | $ | 648,331 | |||
Liabilities and stockholders’ equity: | |||||||
Current liabilities: | |||||||
Accounts payable | 3,012 | 7,989 | |||||
Accrued and other current liabilities | 20,946 | 18,086 | |||||
Deferred revenue, current | 6,027 | — | |||||
Current portion of operating lease liabilities | 1,402 | — | |||||
Current portion of contingent consideration | 34,800 | 32,300 | |||||
Total current liabilities | 66,187 | 58,375 | |||||
Deferred revenue, noncurrent | 8,404 | — | |||||
Operating lease liabilities, net of current portion | 11,186 | — | |||||
Contingent consideration, net of current portion | 35,700 | 45,900 | |||||
Deferred income taxes | 17,425 | 17,425 | |||||
Other long-term liabilities | — | 3,830 | |||||
Total liabilities | 138,902 | 125,530 | |||||
Commitments and contingencies | |||||||
Stockholders’ equity: | |||||||
Common stock | 42 | 42 | |||||
Additional paid-in capital | 1,233,866 | 1,218,710 | |||||
Accumulated deficit | (768,919 | ) | (695,954 | ) | |||
Accumulated other comprehensive income | 726 | 3 | |||||
Total stockholders’ equity | 465,715 | 522,801 | |||||
Total liabilities and stockholders’ equity | $ | 604,617 | $ | 648,331 |
Three Months Ended June 30, | Six Months Ended June 30, | ||||||||||||||
2019 | 2018 | 2019 | 2018 | ||||||||||||
Collaboration revenue | $ | 1,069 | $ | — | $ | 1,069 | $ | — | |||||||
Operating expenses: | |||||||||||||||
Research and development | 27,096 | 26,741 | 51,448 | 49,721 | |||||||||||
Selling, general and administrative | 15,459 | 8,577 | 26,377 | 16,647 | |||||||||||
Change in fair value of contingent consideration | (700 | ) | (2,500 | ) | 2,300 | (2,500 | ) | ||||||||
Total operating expenses | 41,855 | 32,818 | 80,125 | 63,868 | |||||||||||
Loss from operations | (40,786 | ) | (32,818 | ) | (79,056 | ) | (63,868 | ) | |||||||
Other income (expense): | |||||||||||||||
Interest income | 2,983 | 1,029 | 6,139 | 1,862 | |||||||||||
Other income (expense) | 40 | 2,950 | (48 | ) | 2,987 | ||||||||||
Total other income | 3,023 | 3,979 | 6,091 | 4,849 | |||||||||||
Net loss from continuing operations | (37,763 | ) | (28,839 | ) | (72,965 | ) | (59,019 | ) | |||||||
Loss from discontinued operations, net of tax | — | (198 | ) | — | (198 | ) | |||||||||
Net loss | $ | (37,763 | ) | $ | (29,037 | ) | $ | (72,965 | ) | $ | (59,217 | ) | |||
Net loss per share, basic and diluted: | |||||||||||||||
Continuing operations | $ | (0.89 | ) | $ | (0.82 | ) | $ | (1.72 | ) | $ | (1.68 | ) | |||
Discontinued operations | — | (0.01 | ) | — | (0.01 | ) | |||||||||
Total | $ | (0.89 | ) | $ | (0.83 | ) | $ | (1.72 | ) | $ | (1.69 | ) | |||
Weighted average common shares used in the calculation of basic and diluted net loss per common share | 42,458 | 35,355 | 42,348 | 35,099 |