Delaware | ||||
(State or other jurisdiction of incorporation) | ||||
001-37590 | 45-0705648 | |||
(Commission File Number) | (IRS Employer Identification No.) |
540 Gaither Road, Suite 400, Rockville, Maryland 20850 (Address of principal executive offices) (Zip Code) | ||
Registrant’s Telephone Number, Including Area Code: (410) 522-8707 |
¨ | 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(s) | Name of each exchange on which registered |
Common Stock, $0.001 Par Value | CERC | Nasdaq Capital Market |
99.1 |
CERECOR INC. | |||
Date: November 14, 2019 | /s/ Joseph M. Miller | ||
Joseph M. Miller | |||
Chief Financial Officer |
• | On October 10, 2019, the Company entered into, and subsequently closed on, an asset purchase agreement with Aytu BioScience, Inc. (Aytu) to sell its Pediatric Portfolio with the overall deal valued in excess of $43 million |
◦ | The Pediatric Portfolio includes the following five product lines: Aciphex® Sprinkle™, Cefaclor for Oral Suspension, Karbinal® ER, Flexichamber™, Poly-Vi-Flor® and Tri-Vi-Flor™ |
◦ | Composite of $17 million in cash and preferred stock ($4.5 in cash & 12.5 million of Aytu stock) |
◦ | Assumption of Cerecor’s outstanding payment obligations payable to Deerfield CSF, LLC (“Deerfield Note”) and other liabilities in excess of $15 million |
◦ | Elimination of existing royalty obligations & various commercial accruals of $11 million |
◦ | Estimated annual expense reduction of $7 to $9 million associated with Commercial Sales organization transfer to Aytu |
◦ | The Company retained all rights to Millipred®, which is the Company’s most profitable product. Millipred® profits will assist the Company in funding its pipeline assets and may provide future optionality towards monetization and further pipeline funding |
• | James Harrell, EVP of Marketing and Investor Relations, was promoted to Chief Commercial Officer |
• | Private Placement of ~$3.7 million from Armistice Capital in September 2019 |
• | The CDG FIRST trial enrolled its first patient in July 2019. The purpose of the trial is to investigate the natural course of disease and current treatment approaches for Congenital Disorders of Glycosylation (CDGs). The data acquired through the CDG FIRST study is expected to be used to support regulatory filings for the CERC-800s series (CERC-801, CERC-802 and CERC-803), and may help to expedite the first approved treatment(s) for CDGs |
• | The U.S. Food and Drug Administration (“FDA”) communicated that the Company may proceed under the IND for CERC-802 in MPI-CDG (Mannose-Phosphate Isomerase) |
• | CERC-802 obtained fast-track designation (FTD) from the FDA. Both CERC-801 and CERC-802 now have fast-track designation from the FDA |
• | CERC-802 completed its Phase I Safety Study in healthy volunteers. The single-center, US-based safety, tolerability and pharmacokinetic study was an open-label, randomized, single-dose, 4-way crossover study in 16 healthy adult volunteers. Pharmacokinetic (PK) data is expected in early 2020 |
• | CERC-301 completed and reported its final results from its Phase I trial in nOH |
◦ | The 20mg dose group (the highest dose tested) demonstrated rapid, robust and sustained increases in blood pressure over baseline and placebo with a maximum improvement of 29.1 mmHg throughout the study |
◦ | Additionally, there was strong dose-related consistency of plasma concentrations across all doses studied. We believe this data may support a single daily dose and has the potential to be used in a broader Orthostatic Hypotension patient population |
• | Initiated a Phase I Proof-of-Concept trial in diabetic orthostatic hypotension (DOH) |
◦ | The purpose of this study is to assess the single dose effects of CERC-301 in patients with symptomatic DOH |
◦ | This study is a randomized, double-blind, placebo-controlled, two-way cross-over trial over two 24-hour in-clinic visits. At each visit, subjects will receive a single 20 mg dose of CERC-301 or placebo then undergo a series of orthostatic challenge tests over the 24 hour in-clinic period |
◦ | Patients will also complete an OH symptomatic assessment following each orthostatic challenge. Safety, tolerability, PK data will also be collected. As part of the routine laboratory tests, particular interest will be paid to the patient’s plasma glucose levels over the course of the study |
Three Months Ended | Nine Months Ended | |||||||||||||||
September 30, | September 30, | |||||||||||||||
2019 (a), (b) | 2018 (a) | 2019 (a), (b) | 2018 (a) | |||||||||||||
(in thousands, except per share data) | (in thousands, except per share data) | |||||||||||||||
Revenues: | ||||||||||||||||
Product revenue, net | $ | 5,513 | $ | 4,075 | $ | 15,374 | $ | 13,046 | ||||||||
License and other revenue | 100 | — | 100 | — | ||||||||||||
Sales force revenue | — | — | — | 297 | ||||||||||||
Total revenues, net | 5,613 | 4,075 | 15,474 | 13,343 | ||||||||||||
Operating expenses: | ||||||||||||||||
Cost of product sales | 1,435 | 3,111 | 3,241 | 5,398 | ||||||||||||
Research and development | 1,743 | 1,048 | 8,857 | 3,780 | ||||||||||||
Acquired in-process research and development | — | 18,724 | — | 18,724 | ||||||||||||
General and administrative | 2,679 | 1,884 | 7,779 | 7,834 | ||||||||||||
Sales and marketing | 2,631 | 2,311 | 8,676 | 5,889 | ||||||||||||
Amortization expense | 1,037 | 1,065 | 3,195 | 3,316 | ||||||||||||
Impairment of intangible assets | — | 160 | 1,449 | 1,861 | ||||||||||||
Change in fair value of contingent consideration | (197 | ) | 85 | (1,009 | ) | 361 | ||||||||||
Total operating expenses | 9,328 | 28,388 | 32,188 | 47,163 | ||||||||||||
Loss from operations | (3,715 | ) | (24,313 | ) | (16,714 | ) | (33,820 | ) | ||||||||
Other (expense) income: | ||||||||||||||||
Change in fair value of warrant liability and unit purchase option liability | 35 | (3 | ) | 7 | (23 | ) | ||||||||||
Other (expense) income, net | (15 | ) | — | (24 | ) | 19 | ||||||||||
Interest expense, net | (206 | ) | (235 | ) | (614 | ) | (578 | ) | ||||||||
Total other expense, net | (186 | ) | (238 | ) | (631 | ) | (582 | ) | ||||||||
Net loss before taxes | (3,901 | ) | (24,551 | ) | (17,345 | ) | (34,402 | ) | ||||||||
Income tax expense | 115 | 52 | 349 | 92 | ||||||||||||
Net loss | $ | (4,016 | ) | $ | (24,603 | ) | $ | (17,694 | ) | $ | (34,494 | ) | ||||
Net loss per share of common stock, basic and diluted | $ | (0.07 | ) | $ | (0.71 | ) | $ | (0.31 | ) | $ | (1.05 | ) | ||||
Net loss per share of preferred stock, basic and diluted | $ | (0.35 | ) | $ | — | $ | (1.56 | ) | $ | — | ||||||
(a) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2019 and 2018 have been derived from the reviewed financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. | ||||||||||||||||
(b) The unaudited condensed consolidated statements of operations for the three and nine months ended September 30, 2019 do not include the impact of the Aytu transaction because the transaction was entered into and subsequently closed in the fourth quarter of 2019. |
September 30, 2019 (a), (b) | December 31, 2018 (a) | |||||||
(unaudited) | ||||||||
Assets | (in thousands) | |||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 5,251 | $ | 10,646 | ||||
Accounts receivable, net | 4,956 | 3,158 | ||||||
Other receivables | 208 | 5,469 | ||||||
Inventory, net | 402 | 1,111 | ||||||
Prepaid expenses and other current assets | 1,670 | 1,529 | ||||||
Restricted cash, current portion | 102 | 19 | ||||||
Total current assets | 12,589 | 21,932 | ||||||
Property and equipment, net | 1,497 | 587 | ||||||
Intangible assets, net | 26,595 | 31,239 | ||||||
Goodwill | 16,411 | 16,411 | ||||||
Restricted cash, net of current portion | 102 | 82 | ||||||
Total assets | $ | 57,194 | $ | 70,251 | ||||
Liabilities and stockholders’ equity | ||||||||
Current liabilities: | ||||||||
Accounts payable | $ | 826 | $ | 1,446 | ||||
Accrued expenses and other current liabilities | 13,134 | 19,731 | ||||||
Income taxes payable | 1,015 | 2,032 | ||||||
Long-term debt, current portion | 1,050 | 1,050 | ||||||
Contingent consideration, current portion | 1,237 | 1,957 | ||||||
Total current liabilities | 17,262 | 26,216 | ||||||
Long-term debt, net of current portion | 14,255 | 14,328 | ||||||
Contingent consideration, net of current portion | 6,236 | 7,094 | ||||||
Deferred tax liability, net | 98 | 69 | ||||||
License obligations | — | 1,250 | ||||||
Other long-term liabilities | 1,122 | 386 | ||||||
Total liabilities | 38,973 | 49,343 | ||||||
Stockholders’ equity: | ||||||||
Common stock—$0.001 par value; 200,000,000 shares authorized at September 30, 2019 and December 31, 2018; 44,106,794 and 40,804,189 shares issued and outstanding at September 30, 2019 and December 31, 2018, respectively | 44 | 41 | ||||||
Preferred stock—$0.001 par value; 5,000,000 shares authorized at September 30, 2019 and December 31, 2018; 2,857,143 shares issued and outstanding at September 30, 2019 and December 31, 2018 | 3 | 3 | ||||||
Additional paid-in capital | 134,086 | 119,082 | ||||||
Accumulated deficit | (115,912 | ) | (98,218 | ) | ||||
Total stockholders’ equity | 18,221 | 20,908 | ||||||
Total liabilities and stockholders’ equity | $ | 57,194 | $ | 70,251 | ||||
(a) The condensed consolidated balance sheets as of September 30, 2019 and December 31, 2018 have been derived from the reviewed and audited financial statements but do not include all of the information and footnotes required by accounting principles generally accepted in the United States for complete financial statements. | ||||||||
(b) The condensed consolidated balance sheet as of September 30, 2019 do not include the impact of the Aytu transaction because the transaction was entered into and subsequently closed in the fourth quarter of 2019. |
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