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Avadel Pharmaceuticals Provides Corporate Update and Reports First Quarter 2021 Financial Results
- Announced FDA acceptance of NDA for once-nightly FT218 and an
October 15, 2021 target action PDUFA date - Presented positive secondary endpoint data at the AAN 2021 Annual Meeting, which further highlights the overall clinical value proposition of FT218
- FT218 launch preparation progressing
- Management to host a conference call today at
8:30 a.m. ET
“We entered 2021 with positive momentum which included the announcement of several significant milestones for the FT218 program that will help shape our company’s future, including FDA acceptance of the NDA filing for once-nightly FT218, which was assigned a PDUFA target action date of
“During the AAN annual meeting, we presented positive secondary endpoint data that further highlights the consistency with which once-nightly FT218 improved both subjective and objective symptoms of narcolepsy, as early as week three with the 6 g dose. Notably, the clinical data from the REST-ON phase 3 study presented at AAN shows that FT218 improved disturbed nocturnal sleep, with a single dose taken at bedtime. We believe the overwhelmingly positive data from this pivotal trial along with our Special Protocol Assessment agreement with FDA provides a strong foundation for our NDA,” said Dr.
“Educating the medical community on the clinical data from the REST-ON study is an important part of our broader strategy for FT218. We will be presenting the secondary data and additional clinical data from the REST-ON study at future medical congresses, including the Associated Professional Sleep Societies’ annual SLEEP meeting, as well as publishing in peer-reviewed journals throughout the remainder of 2021,” concluded
First quarter and recent Company highlights
- Announced that the New Drug Application (NDA) for FT218 was accepted for filing by the
U.S. Food and Drug Administration (FDA) during the first quarter of 2021, and was assigned a Prescription Drug User Fee Act (PDUFA) target action date ofOctober 15, 2021 - Presented positive secondary endpoint data from the REST-ON trial at the
American Academy of Neurology (AAN) annual meeting, which further bolster the previously announced positive data regarding the three co-primary endpoints, including:- FT218 demonstrated significant consolidation of sleep, significant increase in time in deep sleep and significant decrease in light sleep compared to placebo, for all doses evaluated (6 g, 7.5 g, and 9 g), beginning by week three
- FT218 demonstrated significant improvement in the Epworth Sleepiness Scale, a patient-reported outcome, as well as significantly improving patient perceptions of both the quality and refreshing nature of sleep, and a reduction of sleep paralysis, also for all doses evaluated (6 g, 7.5 g, and 9 g)
- Scheduled to present additional data from the REST-ON trial at the SLEEP congress in
June 2021 - Continued the expansion and enrollment of the RESTORE open-label extension/switch study of FT218 designed to generate long-term safety, tolerability, and efficacy data, as well as data on switching from twice-nightly sodium oxybate and patient preference
Overview of First Quarter Results
As a result of the sale of the sterile injectable products to
R&D expenses were $3.9 million in the quarter ended
SG&A expenses were
Income tax benefit was
Net loss for the quarter ended
Cash, cash equivalents and marketable securities were
Conference Call
A conference call to discuss these results has been scheduled for
About FT218
FT218 is an investigational, once-nightly formulation of sodium oxybate that includes Avadel’s MicroPump™ controlled-release technology. In March of 2020, the Company completed the REST-ON study, a pivotal, double-blind, randomized, placebo-controlled Phase 3 trial, to assess the efficacy and safety of FT218 in the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. In
About
Cautionary Disclosure Regarding Forward-Looking Statements
This press release includes “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. Such forward-looking statements include, but are not limited to, the FDA’s review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the presentation of additional clinical trial data for FT218, the commercial launch of FT218 (if approved), the market acceptance of FT218 (if approved), and the advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for FT218. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “next steps” and similar expressions, and the negatives thereof (if applicable).
The Company’s forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable. However, the Company’s business and operations are subject to significant risks, and, as a result, there can be no assurance that actual results and the results of the company’s business and operations will not differ materially from the results contemplated in such forward-looking statements. Factors that could cause actual results to differ from expectations in the Company’s forward-looking statements include the risk that: positive results from the REST-ON trial may not necessarily be predictive of the results of future or ongoing clinical studies; the NDA for FT218 is not approved by the FDA or such approval is delayed; the risk that commercial launch of FT218 (if approved) is delayed or never occurs; the risk that the potential market acceptance of FT218 (if approved) may differ materially from projections; the risk that the RESTORE study may be delayed or may not be completed at all; and the risk that the impact of the current COVID-19 pandemic on the Company’s financial results and results of operations could be greater than we anticipate and the risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of the Company’s Annual Report on Form 10-K for the year ended
Forward-looking statements speak only as of the date they are made and are not guarantees of future performance. Accordingly, you should not place undue reliance on forward-looking statements. The Company does not undertake any obligation to publicly update or revise our forward-looking statements, except as required by law.
Contacts:
Investor Contacts
Chief Financial Officer
Phone: (636) 449-1843
Email: tmchugh@avadel.com
Phone: (212) 915.2564
Email: tim@lifesciadvisors.com
Media Contact
Phone: (646) 970-4688
Email: pbursey@lifescicomms.com
CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except share and per share data)
(Unaudited)
Three Months Ended |
||||||||||
2021 | 2020 | |||||||||
Product sales | $ | — | $ | 12,243 | ||||||
Operating expenses: | ||||||||||
Cost of products | — | 2,457 | ||||||||
Research and development expenses | 3,852 | 5,530 | ||||||||
Selling, general and administrative expenses | 11,012 | 7,913 | ||||||||
Intangible asset amortization | — | 203 | ||||||||
Changes in fair value of contingent consideration | — | 2,478 | ||||||||
Restructuring (income) costs | (53 | ) | 159 | |||||||
Total operating expense | 14,811 | 18,740 | ||||||||
Operating loss | (14,811 | ) | (6,497 | ) | ||||||
Investment and other income (expense), net | 610 | (378 | ) | |||||||
Interest expense | (1,929 | ) | (3,190 | ) | ||||||
Gain from release of certain liabilities | 78 | — | ||||||||
Other expense - changes in fair value of contingent consideration payable | — | (310 | ) | |||||||
Loss before income taxes | (16,052 | ) | (10,375 | ) | ||||||
Income tax benefit | (2,607 | ) | (9,510 | ) | ||||||
Net loss | $ | (13,445 | ) | $ | (865 | ) | ||||
Net loss per share - basic | $ | (0.23 | ) | $ | (0.02 | ) | ||||
Net loss per share - diluted | (0.23 | ) | (0.02 | ) | ||||||
Weighted average number of shares outstanding - basic | 58,443 | 41,057 | ||||||||
Weighted average number of shares outstanding - diluted | 58,443 | 41,057 | ||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except share and per share data)
(unaudited) | ||||||||||||
ASSETS | ||||||||||||
Current assets: | ||||||||||||
Cash and cash equivalents | $ | 59,172 | $ | 71,722 | ||||||||
Marketable securities | 145,803 | 149,680 | ||||||||||
Research and development tax credit receivable | 3,108 | 3,326 | ||||||||||
Prepaid expenses and other current assets | 34,231 | 38,726 | ||||||||||
Total current assets | 242,314 | 263,454 | ||||||||||
Property and equipment, net | 344 | 359 | ||||||||||
Operating lease right-of-use assets | 2,427 | 2,604 | ||||||||||
16,836 | 16,836 | |||||||||||
Research and development tax credit receivable | 3,303 | 3,445 | ||||||||||
Other non-current assets | 27,717 | 24,939 | ||||||||||
Total assets | $ | 292,941 | $ | 311,637 | ||||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||||
Current liabilities: | ||||||||||||
Current portion of operating lease liability | $ | 484 | $ | 474 | ||||||||
Accounts payable | 2,824 | 2,934 | ||||||||||
Accrued expenses | 4,297 | 6,501 | ||||||||||
Other current liabilities | 1,515 | 5,200 | ||||||||||
Total current liabilities | 9,120 | 15,109 | ||||||||||
Long-term debt | 141,461 | 128,210 | ||||||||||
Long-term operating lease liability | 1,717 | 1,840 | ||||||||||
Other non-current liabilities | 4,139 | 4,212 | ||||||||||
Total liabilities | 156,437 | 149,371 | ||||||||||
Shareholders’ equity: | ||||||||||||
Preferred shares, nominal value of |
5 | 5 | ||||||||||
Ordinary shares, nominal value of |
584 | 583 | ||||||||||
Additional paid-in capital | 542,093 | 566,916 | ||||||||||
Accumulated deficit | (383,872 | ) | (384,187 | ) | ||||||||
Accumulated other comprehensive loss | (22,306 | ) | (21,051 | ) | ||||||||
Total shareholders’ equity | 136,504 | 162,266 | ||||||||||
Total liabilities and shareholders’ equity | $ | 292,941 | $ | 311,637 | ||||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Three Months Ended |
||||||||||
2021 | 2020 | |||||||||
Cash flows from operating activities: | ||||||||||
Net loss | $ | (13,445 | ) | $ | (865 | ) | ||||
Adjustments to reconcile net loss to net cash provided by operating activities: | ||||||||||
Depreciation and amortization | 218 | 456 | ||||||||
Remeasurement of acquisition-related contingent consideration | — | 2,478 | ||||||||
Remeasurement of financing-related contingent consideration | — | 310 | ||||||||
Amortization of debt discount and debt issuance costs | 312 | 1,573 | ||||||||
Change in deferred tax and income tax deferred charge | (2,534 | ) | (8,440 | ) | ||||||
Stock-based compensation expense | 1,728 | 742 | ||||||||
Gain from the release of certain liabilities | (78 | ) | — | |||||||
Other adjustments | 561 | 573 | ||||||||
Net changes in assets and liabilities | ||||||||||
Accounts receivable | — | (517 | ) | |||||||
Inventories | — | 47 | ||||||||
Prepaid expenses and other current assets | (3,736 | ) | 899 | |||||||
Research and development tax credit receivable | 80 | 160 | ||||||||
Accounts payable & other current liabilities | (3,789 | ) | (1,187 | ) | ||||||
Accrued expenses | (2,112 | ) | (4,905 | ) | ||||||
Accrued income taxes | — | 2,253 | ||||||||
Earn-out payments for contingent consideration in excess of acquisition-date fair value | — | (1,774 | ) | |||||||
Royalty payments for contingent consideration payable in excess of original fair value | — | (291 | ) | |||||||
Other assets and liabilities | (618 | ) | (3,148 | ) | ||||||
Net cash used in operating activities | (23,413 | ) | (11,636 | ) | ||||||
Cash flows from investing activities: | ||||||||||
Purchases of property and equipment | (26 | ) | — | |||||||
Proceeds from the disposition of the hospital products | 8,250 | — | ||||||||
Proceeds from sales of marketable securities | 40,736 | 14,788 | ||||||||
Purchases of marketable securities | (37,769 | ) | (1,562 | ) | ||||||
Net cash provided by investing activities | 11,191 | 13,226 | ||||||||
Cash flows from financing activities: | ||||||||||
Proceeds from the |
— | 60,733 | ||||||||
Proceeds from stock option exercises and employee stock purchase plan | 149 | 1,477 | ||||||||
Net cash provided by financing activities | 149 | 62,210 | ||||||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | (477 | ) | (68 | ) | ||||||
Net change in cash and cash equivalents | (12,550 | ) | 63,732 | |||||||
Cash and cash equivalents at |
71,722 | 9,774 | ||||||||
Cash and cash equivalents at |
$ | 59,172 | $ | 73,506 |
Source: Avadel Pharmaceuticals plc