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Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2021 Financial Results
- FDA review of NDA for FT218 ongoing; commercial and launch preparations progressing
- Presentation of new data from pivotal REST-ON clinical trial at CHEST 2021 demonstrating that treatment with FT218 causes meaningful improvement in cataplexy attacks and measurements of EDS with a dosing regimen preferred by patients
- Management to host a conference call today at
8:30 a.m. ET
“The need for patients living with the chronic, debilitating condition of narcolepsy to have a single bedtime dose of sodium oxybate is clear. We are confident in the strength of our data and our regulatory filing strategy for FT218, as the FDA continues their review of our NDA. Importantly, there are no outstanding requests from the FDA at this time, and questions previously received have been addressed. We remain committed to patients and sleep specialists, demonstrated by the significant advances we made during 2021 to support a successful launch of FT218, if approved,” said
Third Quarter and Recent Company Highlights
- In
October 2021 , theU.S. Food and Drug Administration (FDA) informed the company that the review of its New Drug Application (NDA) for FT218 was ongoing beyond its previously assigned target action date. - Continued preparations and launch readiness activities for the potential commercialization of FT218 as the first and only once-at-bedtime option for managing excessive daytime sleepiness (EDS) and cataplexy in narcolepsy
- Multiple presentations and publications in peer-reviewed forums of data from the pivotal Phase 3 REST-ON study of FT218 throughout the quarter, including:
- Published the previously announced primary results in SLEEP, the journal of the
Sleep Research Society - Presented new data at the
American College of Chest Physicians (CHEST) annual meeting supporting the clinical benefit of once-at-bedtime FT218 and patient preference for once-nightly dosing:- New post-hoc responder analyses demonstrated FT218 treatment was associated with statistically significant improvements compared to placebo on the number of weekly cataplexy episodes and statistically significant improvements compared to placebo on mean sleep latency
- Discrete choice experiment demonstrated that the strongest driver of patient preference for sodium oxybate was dosing frequency with once-nightly dosing preferred
- Presented encore posters featuring post hoc analyses from the REST-ON study at the meeting of the
American Neurological Association
- Published the previously announced primary results in SLEEP, the journal of the
- Progressed 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 oxybates and patient preference
- Avadel plans to present data from RESTORE study on patient preference to once-nightly or twice-nightly dosing regimens, as well as nocturnal experiences when using twice-nightly sodium, at future medical congresses
Overview of Third Quarter Results
R&D expenses were
SG&A expenses were
Income tax benefit was
Net loss for the quarter ended
Cash, cash equivalents and marketable securities were
Conference Call
To access the conference call, investors are invited to dial (844) 388-0559 (
About FT218
FT218 is an investigational formulation of sodium oxybate leveraging our proprietary drug delivery technology and designed to be taken once at bedtime for the treatment of excessive daytime sleepiness (EDS) or cataplexy in adults with narcolepsy.
In
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, expectations regarding the FDA’s review of the NDA for FT218, the sufficiency of data supporting the NDA for FT218, the commercial launch of FT218 (if approved), the market acceptance of FT218 (if approved), and the advancement and expected timing of the RESTORE study to generate long-term safety, tolerability, and efficacy data for FT218, and the publication of data from the RESTORE study. 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 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.
Investor Contact:
Stern Investor Relations, Inc.
Courtney.Turiano@sternir.com
(212) 698-8687
Media Contact:
Real Chemistry
ngoelz@realchemistry.com
(408) 568-4292
CONDENSED CONSOLIDATED STATEMENTS OF (LOSS) INCOME
(In thousands, except per share data)
(Unaudited)
Three Months Ended |
Nine Months Ended |
|||||||||||||||||||
2021 | 2020 | 2021 | 2020 | |||||||||||||||||
Product sales | $ | — | $ | — | $ | — | $ | 22,334 | ||||||||||||
Operating expenses: | ||||||||||||||||||||
Cost of products | — | — | — | 5,742 | ||||||||||||||||
Research and development expenses | 4,380 | 5,569 | 14,994 | 15,156 | ||||||||||||||||
Selling, general and administrative expenses | 21,283 | 8,423 | 47,469 | 23,431 | ||||||||||||||||
Intangible asset amortization | — | — | — | 406 | ||||||||||||||||
Changes in fair value of contingent consideration | — | (69 | ) | — | 3,327 | |||||||||||||||
Gain on sale of Hospital Products | — | — | — | (45,760 | ) | |||||||||||||||
Restructuring income | — | (226 | ) | (53 | ) | (43 | ) | |||||||||||||
Total operating expense | 25,663 | 13,697 | 62,410 | 2,259 | ||||||||||||||||
Operating (loss) income | (25,663 | ) | (13,697 | ) | (62,410 | ) | 20,075 | |||||||||||||
Investment and other income (expense), net | 489 | 213 | 1,531 | (906 | ) | |||||||||||||||
Interest expense | (1,929 | ) | (3,259 | ) | (5,788 | ) | (9,686 | ) | ||||||||||||
Gain from release of certain liabilities | — | — | 166 | — | ||||||||||||||||
Other expense - changes in fair value of contingent consideration payable | — | — | — | (435 | ) | |||||||||||||||
(Loss) income before income taxes | (27,103 | ) | (16,743 | ) | (66,501 | ) | 9,048 | |||||||||||||
Income tax benefit | (5,101 | ) | (5,040 | ) | (11,473 | ) | (9,258 | ) | ||||||||||||
Net (loss) income | $ | (22,002 | ) | $ | (11,703 | ) | $ | (55,028 | ) | $ | 18,306 | |||||||||
Net (loss) income per share - basic | $ | (0.38 | ) | $ | (0.20 | ) | $ | (0.94 | ) | $ | 0.36 | |||||||||
Net (loss) income per share - diluted | (0.38 | ) | (0.20 | ) | (0.94 | ) | 0.35 | |||||||||||||
Weighted average number of shares outstanding - basic | 58,585 | 58,213 | 58,506 | 51,206 | ||||||||||||||||
Weighted average number of shares outstanding - diluted | 58,585 | 58,213 | 58,506 | 52,849 |
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
(unaudited) | ||||||||||
ASSETS | ||||||||||
Current assets: | ||||||||||
Cash and cash equivalents | $ | 58,169 | $ | 71,722 | ||||||
Marketable securities | 122,924 | 149,680 | ||||||||
Research and development tax credit receivable | 2,493 | 3,326 | ||||||||
Prepaid expenses and other current assets | 22,234 | 38,726 | ||||||||
Total current assets | 205,820 | 263,454 | ||||||||
Property and equipment, net | 304 | 359 | ||||||||
Operating lease right-of-use assets | 2,070 | 2,604 | ||||||||
16,836 | 16,836 | |||||||||
Research and development tax credit receivable | 961 | 3,445 | ||||||||
Other non-current assets | 38,098 | 24,939 | ||||||||
Total assets | $ | 264,089 | $ | 311,637 | ||||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||||
Current liabilities: | ||||||||||
Current portion of operating lease liability | $ | 504 | $ | 474 | ||||||
Accounts payable | 6,874 | 2,934 | ||||||||
Accrued expenses | 8,738 | 6,501 | ||||||||
Other current liabilities | 1,471 | 5,200 | ||||||||
Total current liabilities | 17,587 | 15,109 | ||||||||
Long-term debt | 142,086 | 128,210 | ||||||||
Long-term operating lease liability | 1,460 | 1,840 | ||||||||
Other non-current liabilities | 3,999 | 4,212 | ||||||||
Total liabilities | 165,132 | 149,371 | ||||||||
Shareholders’ equity: | ||||||||||
Preferred shares, nominal value of |
5 | 5 | ||||||||
Ordinary shares, nominal value of |
586 | 583 | ||||||||
Additional paid-in capital | 546,565 | 566,916 | ||||||||
Accumulated deficit | (425,455 | ) | (384,187 | ) | ||||||
Accumulated other comprehensive loss | (22,744 | ) | (21,051 | ) | ||||||
Total shareholders’ equity | 98,957 | 162,266 | ||||||||
Total liabilities and shareholders’ equity | $ | 264,089 | $ | 311,637 | ||||||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Nine Months Ended |
||||||||||
2021 | 2020 | |||||||||
Cash flows from operating activities: | ||||||||||
Net (loss) income | $ | (55,028 | ) | $ | 18,306 | |||||
Adjustments to reconcile net (loss) income to net cash used in operating activities: | ||||||||||
Depreciation and amortization | 614 | 1,297 | ||||||||
Remeasurement of acquisition-related contingent consideration | — | 3,327 | ||||||||
Remeasurement of financing-related contingent consideration | — | 435 | ||||||||
Amortization of debt discount and debt issuance costs | 937 | 4,835 | ||||||||
Change in deferred taxes | (11,322 | ) | (4,582 | ) | ||||||
Stock-based compensation expense | 6,088 | 1,705 | ||||||||
Gain on the disposition of the hospital products | — | (45,760 | ) | |||||||
Gain from the release of certain liabilities | (166 | ) | — | |||||||
Other adjustments | 1,056 | 306 | ||||||||
Net changes in assets and liabilities | ||||||||||
Accounts receivable | — | 8,281 | ||||||||
Inventories | — | (1,352 | ) | |||||||
Prepaid expenses and other current assets | (54 | ) | 1,759 | |||||||
Research and development tax credit receivable | 3,079 | 2,036 | ||||||||
Accounts payable & other current liabilities | (201 | ) | (4,051 | ) | ||||||
Accrued expenses | 2,421 | (6,625 | ) | |||||||
Earn-out payments for contingent consideration in excess of acquisition-date fair value | — | (5,323 | ) | |||||||
Royalty payments for contingent consideration payable in excess of original fair value | — | (866 | ) | |||||||
Other assets and liabilities | (2,228 | ) | (3,337 | ) | ||||||
Net cash used in operating activities | (54,804 | ) | (29,609 | ) | ||||||
Cash flows from investing activities: | ||||||||||
Purchases of property and equipment | (26 | ) | (33 | ) | ||||||
Proceeds from the disposition of the hospital products | 16,500 | 17,250 | ||||||||
Proceeds from sales of marketable securities | 83,726 | 30,075 | ||||||||
Purchases of marketable securities | (58,591 | ) | (124,254 | ) | ||||||
Net cash provided by (used in) investing activities | 41,609 | (76,962 | ) | |||||||
Cash flows from financing activities: | ||||||||||
Proceeds from the |
— | 60,570 | ||||||||
Proceeds from the |
— | 116,924 | ||||||||
Proceeds from stock option exercises and employee stock purchase plan | 263 | 2,006 | ||||||||
Net cash provided by financing activities | 263 | 179,500 | ||||||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | (621 | ) | 406 | |||||||
Net change in cash and cash equivalents | (13,553 | ) | 73,335 | |||||||
Cash and cash equivalents at |
71,722 | 9,774 | ||||||||
Cash and cash equivalents at |
$ | 58,169 | $ | 83,109 | ||||||
Source: Avadel Pharmaceuticals plc