Full Press Release Details
Avadel Pharmaceuticals
Provides Corporate Update and Reports Fourth Quarter and Full Year 2022 Financial
LUMRYZ NDA amendment filed March 1 requesting FDA final approval
Received FDA authorization to import LUMRYZ in advance of final approval decision; shortens timeline between potential approval and product availability
Secured $200 million of capital to fund the launch of LUMRYZ and extended the maturity of $96.2 million of the convertible notes to 2027
Launch preparations on track to support U.S. commercial launch of LUMRYZ
Management to host a conference call today at 8:30 a.m. ET
DUBLIN, Ireland, March 30, 2023 - Avadel Pharmaceuticals plc (Nasdaq:
AVDL), a biopharmaceutical company focused on transforming medicines to transform lives, today provided a corporate update and announced
its financial results for the fourth quarter ended December 31, 2022.
"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 U.S. ahead of a final approval
decision. Collectively, these milestones move us closer to the potential commercialization of LUMRYZ," said Greg Divis, Chief Executive
Officer of Avadel Pharmaceuticals. "In parallel, the completion of multiple strategic financings in the current market environment
reinforces the potential of LUMRYZ and positions us for long-term success as we enter a pivotal stage of growth for the company. I want
to thank all stakeholders including patients, healthcare practitioners, and our investors for their strong support during this process.
We look forward to our continued progress as we execute on our strategic plan to bring LUMRYZ to the $3 billion plus once-at-bedtime oxybate
Fourth Quarter and Recent Company Highlights
Overview of Fourth Quarter Results
R&D expenses were $6.2 million in the
quarter ended December 31, 2022, compared to $2.1 million for the same period in 2021. The period-over-period increase was primarily attributed
to an increase in purchases of the active pharmaceutical ingredient used in the manufacture of LUMRYZ.
SG&A expenses were $17.0 million in the
quarter ended December 31, 2022, compared to $21.0 million for the same period in 2021. The period-over-period decrease is the result
of a number of factors including lower marketing and commercial spend. These decreases were partially offset by higher legal costs.
Net loss for the quarter ended December 31,
2022, was $27.5 million, or ($0.44) per diluted share, compared to net loss of $22.3 million, or ($0.38) per diluted share, for the same
Cash, cash equivalents and marketable securities
were $96.5 million as of December 31, 2022. The Company extended the maturity of $96.2 million of its convertible notes to April 2027
and $21.2 million will mature in October 2023.
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 8:30 a.m. ET. To access the live conference call, please register here. A live audio webcast of the
call and accompanying slide presentation will also be available in 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.
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 March 2020, Avadel completed the REST-ON study, a randomized, double-blind,
placebo-controlled, pivotal Phase 3 trial, to assess the efficacy and safety of LUMRYZ in patients with narcolepsy. Among the three co-primary
endpoints, LUMRYZ demonstrated statistically significant and clinically meaningful results in EDS, the clinician's overall assessment
of the patient's functioning, and reduction in cataplexy attacks, for all three evaluated does when compared to placebo.
In January 2018, the U.S. Food and Drug Administration
(FDA) granted LUMRYZ Orphan Drug Designation for the treatment of narcolepsy based on the plausible hypothesis that LUMRYZ may be safer
than the twice-nightly formulation of sodium oxybate already approved by the FDA due to the ramifications associated with dosing regimen
of that product. LUMRYZ is currently under review by the FDA.
On July 18, 2022, the FDA tentatively approved
the LUMRYZ NDA for the treatment of cataplexy or EDS in adults with narcolepsy. Avadel submitted a minor amendment to the FDA on March
1, 2023, requesting final approval of LUMRYZ. This minor amendment submission occurred shortly after the delisting of the REMS Patent
from FDA's Orange Book by Jazz Pharmaceuticals in response to the unanimous 3-0 panel decision by the United States Court of Appeals
for the Federal Circuit on February 24, affirming the previous ruling from the United States District Court for the Federal District of
Delaware, ordering Jazz to do so.
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 Avadel Pharmaceuticals plc
Avadel Pharmaceuticals plc (Nasdaq: AVDL)
is a biopharmaceutical company focused on transforming medicines to transform lives. Our approach includes applying innovative solutions
to the development of medications that address the challenges patients face with current treatment options. Our current lead drug candidate,
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 EDS in adults with narcolepsy. For more information, please visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking
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 December 31, 2022, which was filed with the Securities and Exchange Commission (SEC) on
March 29, 2023, and subsequent SEC filings.
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
Stern Investor Relations, Inc.
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except per share data)
| (Unaudited) | ||||||||||||||||
| Three Months Ended December 31, | Twelve Months Ended December 31, | |||||||||||||||
| 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 |
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
| December 31, 2022 | December 31, 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 | ||||||
| Goodwill | 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 $0.01 per share; 50,000 shares authorized; 488 issued and outstanding at December 31, 2022 and 2021, respectively | 5 | 5 | ||||||
| Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 62,878 and 58,620 issued and outstanding at December 31, 2022 and 2021, respectively | 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 |
AVADEL PHARMACEUTICALS PLC
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS