Press Releases

Avadel Pharmaceuticals Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial Results
• LUMRYZ™ NDA amendment filed
• Received FDA authorization to import LUMRYZ in advance of final approval decision; shortens timeline between potential approval and product availability
• Secured
• Launch preparations on track to support
• Management to host a conference call today at
“2023 is shaping up to be a significant year for Avadel. I am proud of all that our team has recently accomplished, including submitting an amendment to the FDA requesting final approval for LUMRYZ and securing the FDA’s approval of our PLAIR request, which has allowed us to import product into the
Fourth Quarter and Recent Company Highlights
- Recently, Avadel made significant progress advancing LUMRYZ toward a final approval decision and preparing for
U.S. commercial launch.- On
March 1 st, the company submitted a minor amendment to theU.S. Food and Drug Administration (“FDA”) requesting final approval of LUMRYZ for the treatment of cataplexy or excessive daytime sleepiness (EDS) in adults with narcolepsy.- The Company filed the amendment shortly after Jazz Pharmaceuticals filed a submission with the FDA requesting the delisting of the REMS Patent from FDA’s Orange Book in response to the unanimous 3-0 panel decision of the
United States Court of Appeals for the Federal Circuit onFebruary 24 , affirming the previous ruling from theU.S. District Court for the Federal District of Delaware .
- The Company filed the amendment shortly after Jazz Pharmaceuticals filed a submission with the FDA requesting the delisting of the REMS Patent from FDA’s Orange Book in response to the unanimous 3-0 panel decision of the
- The FDA approved Avadel’s Pre-Launch Activities Important Requests (PLAIR) for LUMRYZ. Through PLAIR, Avadel is able to import tentatively approved LUMRYZ to the
U.S. ahead of a final approval decision.- Importation of LUMRYZ, prior to a potential final approval, enables Avadel to shorten the duration of time between a final FDA approval and commercial availability for people with narcolepsy.
- Advancements in commercial preparations ahead of potential
U.S. launch of LUMRYZ, including finalization of specialty pharmacy network, patient services center and the LUMRYZ REMS program. - Continued engagement with key stakeholders including sleep specialists and payers while expanding our customer facing teams including medical science liaisons, sales leadership, territory business managers, and field reimbursement specialists.
- On
- Successfully executed multiple strategic financing activities and secured
$200 million of capital to fund the launch of LUMRYZ.- Entered into a royalty agreement with RTW Investments (RTW) for up to
$75 million to support the potential commercialization of LUMRYZ.- Under the terms of the royalty agreement, RTW will provide up to
$75 million non-dilutive synthetic royalty financing commitment to Avadel in return for tiered rate, cash royalty payments based on net sales of LUMRYZ in theU.S.
- Under the terms of the royalty agreement, RTW will provide up to
- Completed an equity offering with gross proceeds of
$125 million , before deducting underwriting discounts, commissions and estimated offering expenses. - Exchanged
$96.2 million of convertible notes with a new maturity date ofApril 3, 2027 .
- Entered into a royalty agreement with RTW Investments (RTW) for up to
- Announced multiple data sets supporting the LUMRYZ product profile, including:
- The publication of real-world data describing the risk of accidental dosing errors with immediate-release twice-nightly oxybate, including an analysis on post-marketing safety surveillance data from the FDA Adverse Event Reporting System (FAERS).
- Multiple presentations at the
American Neurological Association (ANA) annual meeting in October describing demographic characteristics and comorbidities of patients with narcolepsy and reinforcing positive data from completed Phase 3 REST-ON trial and patient and clinician preference for once-nightly over twice-nightly dosing. - Posters at the
American College of Chest Physicians (CHEST) meeting in October featuring updated results from patient preference and nocturnal adverse event questionnaires from the RESTORE study with 94% of patients who switched from twice-nightly oxybates stating prefer for the once-at-bedtime dosing regime, as well as confirming challenges related to the middle-of-the-night dose.
- Expanded patent exclusivity for LUMRYZ with 5 additional
U.S. patents for a current total of 13 patents, providing Orange Book-listable patent protection into early 2042.
Overview of Fourth Quarter Results
R&D expenses were
SG&A expenses were
Net loss for the quarter ended
Cash, cash equivalents and marketable securities were
Conference Call
Avadel will host a conference all and live audio webcast to discuss its fourth quarter and full year quarter 2022 financial results and provide a corporate update today at
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 FDA’s potential final approval of LUMRYZ, including the timing of thereof, the Company’s preparation for launch of LUMRYZ, the potential time savings between a potential final FDA approval and commercial launch of LUMRYZ attributable to the FDA’s approval of the PLAIR; the market acceptance of LUMRYZ (if approved), the total addressable market size for sodium oxybate, the Company’s anticipated uses of capital, including the proceeds from the recent financing; the expected maturity of the Company’s convertible notes; and the anticipated duration and scope of patent exclusivity for LUMRYZ. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “could,” “believe,” “potential,” “can,” “would,” “seek,” “expect,” “look forward,” “on track,” “guidance,” “anticipate,” “estimate,” “project,” “investigational,” “pipeline,” “launch,” “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 | Twelve Months Ended | |||||||||||||||
2022 | 2021 | 2022 | 2021 | |||||||||||||
Operating expenses: | ||||||||||||||||
Research and development expenses | $ | 6,235 | $ | 2,110 | $ | 20,700 | $ | 17,104 | ||||||||
Selling, general and administrative expenses | 16,981 | 21,026 | 74,516 | 68,495 | ||||||||||||
Restructuring (income) expense | (178 | ) | — | 3,345 | (53 | ) | ||||||||||
Total operating expenses | 23,038 | 23,136 | 98,561 | 85,546 | ||||||||||||
Operating loss | (23,038 | ) | (23,136 | ) | (98,561 | ) | (85,546 | ) | ||||||||
Investment and other (expense) income, net | (1,072 | ) | 646 | (536 | ) | 2,343 | ||||||||||
Interest expense | (3,255 | ) | (4,154 | ) | (12,342 | ) | (9,942 | ) | ||||||||
Loss before income taxes | (27,365 | ) | (26,644 | ) | (111,439 | ) | (93,145 | ) | ||||||||
Income tax provision (benefit) | 85 | (4,343 | ) | 26,025 | (15,816 | ) | ||||||||||
Net loss | $ | (27,450 | ) | $ | (22,301 | ) | $ | (137,464 | ) | $ | (77,329 | ) | ||||
Net loss per share - basic | $ | (0.44 | ) | $ | (0.38 | ) | $ | (2.29 | ) | $ | (1.32 | ) | ||||
Net loss per share - diluted | (0.44 | ) | (0.38 | ) | (2.29 | ) | (1.32 | ) | ||||||||
Weighted average number of shares outstanding - basic | 62,276 | 58,620 | 60,094 | 58,535 | ||||||||||||
Weighted average number of shares outstanding - diluted | 62,276 | 58,620 | 60,094 | 58,535 | ||||||||||||
CONDENSED CONSOLIDATED BALANCE SHEETS | ||||||||
(In thousands, except per share data) | ||||||||
2022 | 2021 | |||||||
ASSETS | ||||||||
Current assets: | ||||||||
Cash and cash equivalents | $ | 73,981 | $ | 50,708 | ||||
Marketable securities | 22,518 | 106,513 | ||||||
Research and development tax credit receivable | 2,248 | 2,443 | ||||||
Prepaid expenses and other current assets | 2,096 | 32,826 | ||||||
Total current assets | 100,843 | 192,490 | ||||||
Property and equipment, net | 839 | 285 | ||||||
Operating lease right-of-use assets | 1,713 | 2,652 | ||||||
16,836 | 16,836 | |||||||
Research and development tax credit receivable | 1,232 | 1,225 | ||||||
Other non-current assets | 11,322 | 33,777 | ||||||
Total assets | $ | 132,785 | $ | 247,265 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
Current liabilities: | ||||||||
Current portion of long-term debt | $ | 37,668 | $ | — | ||||
Current portion of operating lease liability | 960 | 900 | ||||||
Accounts payable | 7,890 | 7,679 | ||||||
Accrued expenses | 7,334 | 7,151 | ||||||
Other current liabilities | 1,941 | 5,270 | ||||||
Total current liabilities | 55,793 | 21,000 | ||||||
Long-term debt | 91,614 | 142,397 | ||||||
Long-term operating lease liability | 780 | 1,707 | ||||||
Other non-current liabilities | 5,743 | 3,917 | ||||||
Total liabilities | 153,930 | 169,021 | ||||||
Shareholders’ (deficit) equity: | ||||||||
Preferred shares, nominal value of |
5 | 5 | ||||||
Ordinary shares, nominal value of |
628 | 586 | ||||||
Additional paid-in capital | 589,783 | 549,349 | ||||||
Accumulated deficit | (585,220 | ) | (447,756 | ) | ||||
Accumulated other comprehensive loss | (26,341 | ) | (23,940 | ) | ||||
Total shareholders’ (deficit) equity | (21,145 | ) | 78,244 | |||||
Total liabilities and shareholders’ (deficit) equity | $ | 132,785 | $ | 247,265 |
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
(In thousands) | ||||||||
Twelve Months Ended | ||||||||
2022 | 2021 | |||||||
Cash flows from operating activities: | ||||||||
Net loss | $ | (137,464 | ) | $ | (77,329 | ) | ||
Adjustments to reconcile net loss to net cash used in operating activities: | ||||||||
Depreciation and amortization | 1,493 | 815 | ||||||
Amortization of debt discount and debt issuance costs | 6,052 | 1,248 | ||||||
Changes in deferred tax | 26,025 | (15,666 | ) | |||||
Share-based compensation expense | 7,013 | 8,872 | ||||||
Other adjustments | 2,042 | 1,055 | ||||||
Net changes in assets and liabilities | ||||||||
Prepaid expenses and other current assets | 30,815 | (439 | ) | |||||
Research and development tax credit receivable | 30 | 2,796 | ||||||
Accounts payable & other current liabilities | (3,108 | ) | 4,232 | |||||
Accrued expenses | 227 | 895 | ||||||
Other assets and liabilities | (3,429 | ) | (3,789 | ) | ||||
Net cash used in operating activities | (70,304 | ) | (77,310 | ) | ||||
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 | 83,828 | 102,224 | ||||||
Purchases of marketable securities | (3,414 | ) | (61,769 | ) | ||||
Net cash provided by investing activities | 79,698 | 56,929 | ||||||
Cash flows from financing activities: | ||||||||
Payments for debt issuance costs | (4,804 | ) | — | |||||
Payments for extinguishment of |
(8,653 | ) | — | |||||
Proceeds from stock option exercises and employee share purchase plan | 2,682 | 263 | ||||||
Proceeds from issuance of shares off the at-the-market offering program | 25,318 | — | ||||||
Net cash provided by financing activities | 14,543 | 263 | ||||||
Effect of foreign currency exchange rate changes on cash and cash equivalents | (664 | ) | (896 | ) | ||||
Net change in cash and cash equivalents | 23,273 | (21,014 | ) | |||||
Cash and cash equivalents at |
50,708 | 71,722 | ||||||
Cash and cash equivalents at |
$ | 73,981 | $ | 50,708 |

Source: Avadel Pharmaceuticals plc