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Avadel Pharmaceuticals Provides Corporate Update and Reports Third Quarter 2022 Financial Results
- LUMRYZ™ granted tentative approval on
July 18 , confirming its safety profile and clinical efficacy - Final approval decision of LUMRYZ expected by
June 2023 ; advancing strategy to potentially accelerate final approval - Commercial launch planned for no later than Q3 2023; launch preparations underway
- Updated RESTORE data demonstrates 94% of switch patients prefer once-at-bedtime LUMRYZ dosing regimen; presented new real-world data describing demographic characteristics and comorbidities of patients with narcolepsy
- Management to host a conference call today at
8:00 a.m. ET
“With tentative approval in hand and approximately seven months or less from a final approval decision, we are in launch preparation mode to make LUMRYZ available to people living with narcolepsy as soon as possible following a final approval decision. In this regard, we continue to execute our strategy to potentially accelerate the timeline to a final approval decision and shorten the timeline to a subsequent launch of LUMRYZ,” said
Third Quarter and Recent Company Highlights
- LUMRYZ (previously known as FT218), Avadel’s once-at-bedtime investigational formulation of extended-release sodium oxybate for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy, received tentative approval from the
U.S. Food and Drug Administration (FDA) in July of 2022.- Tentative approval validates the safety profile and clinical efficacy of LUMRYZ and allows the company to continue launch preparations to reduce the time between a potential final approval and commercial availability.
- Confirms that the latest date of a potential final approval decision is expected after expiry or other disposition of
U.S. Patent No. 8,731,963 (the “REMS Patent”), which expires onJune 17, 2023 .
- Continuing launch preparation activities for LUMRYZ to expedite the time between a final approval decision and product availability.
- Full commercial launch planned for no later than Q3 2023
- Building commercial inventory in preparation for potential launch
- Completing the build out of the LUMRYZ REMS, continuing the patient services center build, finalizing the specialty pharmacy network contracts and advancing payer GPO and PBM discussions
- Advancing the following action to potentially accelerate FDA’s final approval decision for LUMRYZ:
- Renewed Avadel’s request for expedited consideration of our motion to delist the REMS Patent from FDA’s Orange Book. Oral arguments on the motion are scheduled to occur in the
U.S. District Court for the District of Delaware onNovember 15, 2022 .
- Renewed Avadel’s request for expedited consideration of our motion to delist the REMS Patent from FDA’s Orange Book. Oral arguments on the motion are scheduled to occur in the
- Presented posters at the
American College of Chest Physicians (CHEST) meeting in October featuring updated interim analyses from the ongoing RESTORE open-label extension/switch study of LUMRYZ, including:- Patient preference questionnaires showed that 93.6% of patients who switched from twice-nightly oxybates preferred the once-at-bedtime dosing regimen of LUMRYZ
- Safety data affirming that LUMRYZ has been generally well tolerated with low discontinuation rates and no new safety signals
- Data related to dosing and titration demonstrating that most RESTORE participants, whether switching from twice-nightly, immediate-release oxybate or not currently taking oxybate, have successfully had their LUMRYZ dose titrated to a tolerable therapeutic dose.
- Nocturnal adverse event questionnaires, continuing to reaffirm challenges related to the middle-of-the-night dosing required by twice-nightly oxybates, including missing the middle-of-the-night dose, or taking it too late, both of which cause next day negative effects for patients
- Presented data at the
American Neurological Association (ANA) annual meeting in October, including:- Encore posters reinforcing positive data from completed Phase 3 REST-ON trial, demonstrating improvements for disrupted nighttime sleep in both NT1 and NT2; and patient and clinician preference for once-nightly over twice-nightly dosing as demonstrated in a discrete choice experiment.
- New real-world data describing demographic characteristics and comorbidities of patients with narcolepsy treated at the
Mayo Clinic , confirming increased psychiatric and sleep co-morbidities, as well as pain-related disorders. Cardiovascular disease was not among the top 20 comorbidities of the matched cohort of more than 2,000 patients.
- Publication of two new peer-reviewed papers: a Plain Language Summary in Future Neurology, describing the results of the pivotal REST-ON trial data, to make accessible for patients and the relative bioavailability comparison of LUMRYZ to twice-nightly sodium oxybate in Sleep Medicine
Overview of Third Quarter Results
R&D expenses were
SG&A expenses were
Income tax expense was
Net loss for the quarter ended
Cash, cash equivalents and marketable securities were
Conference Call
To access the live conference call, investors are invited to dial (800) 715-9871 or (646) 307-1963 (International). When joining the call, please ask to join the Avadel Pharmaceuticals call or state the conference ID 6188743. A live audio webcast of the call be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event.
About LUMRYZ
LUMRYZ 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 cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.
In
In
On
Avadel is currently evaluating the long-term safety and tolerability of LUMRYZ in the open-label RESTORE clinical study. For more information, visit: www.restore-narcolepsy-study.com.
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 timing of FDA’s final approval decision for LUMRYZ, ongoing efforts of the Company to accelerate the FDA’s final approval decision; the Company’s preparations to accelerate the timing between a potential final approval of LUMRYZ and commercial launch as well as the expected results thereof; the estimated once-at-bedtime oxybate market and anticipated market acceptance of LUMRYZ (if approved); the continued advancement of the RESTORE study to generate long-term safety, tolerability, and efficacy data for LUMRYZ; the Company’s cash runway and anticipated uses of capital; and the expected maturity of the Company’s convertible debt. 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
ggreig@realchemistry.com
(203) 249-2688
CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except per share data)
(Unaudited)
Three Months Ended |
Nine Months Ended |
||||||||||||||
2022 | 2021 | 2022 | 2021 | ||||||||||||
Operating expenses: | |||||||||||||||
Research and development expenses | $ | 2,933 | $ | 4,380 | $ | 14,465 | $ | 14,994 | |||||||
Selling, general and administrative expenses | 14,096 | 21,283 | 57,535 | 47,469 | |||||||||||
Restructuring (income) expense | (69 | ) | — | 3,523 | (53 | ) | |||||||||
Total operating expense | 16,960 | 25,663 | 75,523 | 62,410 | |||||||||||
Operating loss | (16,960 | ) | (25,663 | ) | (75,523 | ) | (62,410 | ) | |||||||
Investment and other income, net | 448 | 489 | 503 | 1,531 | |||||||||||
Interest expense | (3,564 | ) | (1,929 | ) | (9,087 | ) | (5,788 | ) | |||||||
Gain from release of certain liabilities | — | — | 33 | 166 | |||||||||||
Loss before income taxes | (20,076 | ) | (27,103 | ) | (84,074 | ) | (66,501 | ) | |||||||
Income tax provision (benefit) | 70 | (5,101 | ) | 25,940 | (11,473 | ) | |||||||||
Net loss | $ | (20,146 | ) | $ | (22,002 | ) | $ | (110,014 | ) | $ | (55,028 | ) | |||
Net loss per share – basic | $ | (0.33 | ) | $ | (0.38 | ) | $ | (1.85 | ) | $ | (0.94 | ) | |||
Net loss per share – diluted | (0.33 | ) | (0.38 | ) | (1.85 | ) | (0.94 | ) | |||||||
Weighted average number of shares outstanding - basic | 60,201 | 58,585 | 59,359 | 58,506 | |||||||||||
Weighted average number of shares outstanding - diluted | 60,201 | 58,585 | 59,359 | 58,506 | |||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
(Unaudited) | |||||||
ASSETS | |||||||
Current assets: | |||||||
Cash and cash equivalents | $ | 60,715 | $ | 50,708 | |||
Marketable securities | 45,760 | 106,513 | |||||
Research and development tax credit receivable | 2,077 | 2,443 | |||||
Prepaid expenses and other current assets | 4,670 | 32,826 | |||||
Total current assets | 113,222 | 192,490 | |||||
Property and equipment, net | 896 | 285 | |||||
Operating lease right-of-use assets | 1,947 | 2,652 | |||||
16,836 | 16,836 | ||||||
Research and development tax credit receivable | 1,137 | 1,225 | |||||
Other non-current assets | 11,720 | 33,777 | |||||
Total assets | $ | 145,758 | $ | 247,265 | |||
LIABILITIES AND SHAREHOLDERS’ (DEFICIT) EQUITY | |||||||
Current liabilities: | |||||||
Current portion of long-term debt | $ | 26,299 | $ | — | |||
Current portion of operating lease liability | 1,011 | 900 | |||||
Accounts payable | 2,479 | 7,679 | |||||
Accrued expenses | 7,965 | 7,151 | |||||
Other current liabilities | 3,757 | 5,270 | |||||
Total current liabilities | 41,511 | 21,000 | |||||
Long-term debt | 109,934 | 142,397 | |||||
Long-term operating lease liability | 1,026 | 1,707 | |||||
Other non-current liabilities | 5,727 | 3,917 | |||||
Total liabilities | 158,198 | 169,021 | |||||
Shareholders’ (deficit) equity: | |||||||
Preferred shares, nominal value of |
5 | 5 | |||||
Ordinary shares, nominal value of |
608 | 586 | |||||
Additional paid-in capital | 572,626 | 549,349 | |||||
Accumulated deficit | (557,770 | ) | (447,756 | ) | |||
Accumulated other comprehensive loss | (27,909 | ) | (23,940 | ) | |||
Total shareholders’ (deficit) equity | (12,440 | ) | 78,244 | ||||
Total liabilities and shareholders’ (deficit) equity | $ | 145,758 | $ | 247,265 | |||
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
(Unaudited)
Nine Months Ended |
|||||||
2022 | 2021 | ||||||
Cash flows from operating activities: | |||||||
Net loss | $ | (110,014 | ) | $ | (55,028 | ) | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||
Depreciation and amortization | 907 | 614 | |||||
Amortization of debt discount and debt issuance costs | 4,147 | 937 | |||||
Change in deferred taxes | 25,916 | (11,322 | ) | ||||
Share-based compensation expense | 5,086 | 6,088 | |||||
Gain from release of certain liabilities | (33 | ) | (166 | ) | |||
Other adjustments | 1,539 | 1,056 | |||||
Net changes in assets and liabilities | |||||||
Prepaid expenses and other current assets | 27,948 | (54 | ) | ||||
Research and development tax credit receivable | 27 | 3,079 | |||||
Accounts payable & other current liabilities | (11,629 | ) | (201 | ) | |||
Accrued expenses | 4,277 | 2,421 | |||||
Other assets and liabilities | (3,109 | ) | (2,228 | ) | |||
Net cash used in operating activities | (54,938 | ) | (54,804 | ) | |||
Cash flows from investing activities: | |||||||
Purchases of property and equipment | (716 | ) | (26 | ) | |||
Proceeds from the disposition of the hospital products | — | 16,500 | |||||
Proceeds from sales of marketable securities | 59,873 | 83,726 | |||||
Purchases of marketable securities | (2,334 | ) | (58,591 | ) | |||
Net cash provided by investing activities | 56,823 | 41,609 | |||||
Cash flows from financing activities: | |||||||
Payments for debt issuance costs | (4,803 | ) | — | ||||
Proceeds from issuance of shares off the at-the-market offering program | 10,532 | — | |||||
Proceeds from stock option exercises and employee share purchase plan | 2,192 | 263 | |||||
Net cash provided by financing activities | 7,921 | 263 | |||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | 201 | (621 | ) | ||||
Net change in cash and cash equivalents | 10,007 | (13,553 | ) | ||||
Cash and cash equivalents at |
50,708 | 71,722 | |||||
Cash and cash equivalents at |
$ | 60,715 | $ | 58,169 |
Source: Avadel Pharmaceuticals plc