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 second quarter ended June 30, 2022.
“The receipt of tentative approval from the FDA marks an
important milestone in our pursuit to bring LUMRYZ to all oxybate
eligible people living with narcolepsy. In addition to validating
LUMRYZ’s strong clinical and safety profile, we now know the timing
to a potential final approval is June 2023 or sooner,” said Greg
Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We will
continue to aggressively pursue all options for this clear unmet
need in the $3 billion plus once nightly oxybate market to
accelerate a final approval decision prior to June 2023 and launch
as quickly as possible thereafter.”
Second Quarter and Recent Company
Highlights
- Received tentative approval for LUMRYZ,
or 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 from
U.S. Food and Drug Administration (FDA) on July 18.
- Receipt of tentative approval validates
LUMRYZ’s safety profile and clinical efficacy, and allows the
company to accelerate potential launch preparations.
- Confirms that the latest date of a
potential final approval is after expiry of the remaining REMS
patent on June 17, 2023.
- Advancing the following actions to
potentially accelerate FDA’s final approval decision for LUMRYZ
prior to June 2023:
- Filed a lawsuit against the FDA in the U.S. District Court for
the District of Columbia alleging that the FDA’s decision requiring
Avadel to file a patent certification regarding U.S. Patent No.
8,731,963 (the “REMS patent”) was arbitrary, capricious and
contrary to law, and asks the Court to vacate the FDA’s decision
and order FDA to take final action on the LUMRYZ NDA.
- Pursuing delisting action in the U.S.
District Court for the District of Delaware to remove the REMS
patent, which expires on June 17, 2023, from the FDA's Orange
Book.
- Preparing for a claim construction
hearing (“Markman hearing”) in the existing patent litigation in
the U.S. District Court for the District of Delaware which is
scheduled for August 31, 2022. The Court has previously stated that
claim construction was needed prior to ruling on the motion to
delist the REMS patent from the Orange Book.
- Continuing activities to prepare for a
launch of LUMRYZ, including shortening the time of product
availability post approval by:
- Building commercial inventory in
preparation for potential launch
- Completing the build out of our LUMRYZ
REMS
- Continued engagement with sleep
specialists and patients through disease education, leveraging
Narcolepsy Disrupts campaign which is actively enrolling
patients
- Presented clinical data at SLEEP 2022, including a total of 9
posters:
- Interim data from the ongoing RESTORE open-label
extension/switch study of our LUMRYZ drug candidate:
- 92.5% of switched patients stated they preferred the
once-nightly dosing regimen over twice-nightly
- Additional validation that switch patients had difficulty in
preparing their second dose of twice-nightly oxybate products,
including 64% of patients accidentally missing their second dose in
the last 3 months, and 82% of these patients feeling worse the next
day
- 72% of switch patients reported taking the second dose of a
twice-nightly oxybate was somewhat, quite a bit or extremely
inconvenient
- Most participants (62%) switching from twice-nightly oxybate
formulations to LUMRYZ had a stable dose of LUMRYZ equal to their
starting daily dosage of twice-nightly oxybate
- Participants not currently taking twice-nightly oxybate
formulations (including oxybate naive participants) reached a
stable dose of LUMRYZ with 2–4 dose titrations within 4 weeks.
- Continued affirmation of the safety and tolerability profile,
with known side effects of oxybates and low rate of discontinuation
from side effects
- 5 post hoc analyses from the completed pivotal Phase 3 REST-ON
clinical trial of LUMRYZ, which reinforce the strong clinical
efficacy data, including in sub-groups of NT1/NT2 and those with or
without concomitant stimulants on disturbed nocturnal sleep
- Confirmed once-at-bedtime dosing most important oxybate
treatment attribute in a second discrete choice experiment (DCE)
with patients and clinicians
- In June, the Company announced an optimized cost structure to
reduce cash operating expenses and extend its cash runway to the
middle of 2023. Quarterly cash operating expenses, excluding
inventory purchases, are expected to be reduced to $12 - $14
million.
Overview of Second Quarter Results
R&D expenses were $4.5 million in the quarter ended June 30,
2022, compared to $6.8 million for the same period in 2021. The
period-over-period decrease was primarily attributed to lower
purchases of active pharmaceutical ingredients used in the
manufacture of LUMRYZ.
SG&A expenses were $21.8 million in the quarter ended June
30, 2022, compared to $15.2 million for the same period in 2021.
The period-over-period increase is primarily the result of fees
associated with the exchange and an eight-month maturity extension
on $117.4 million of the $143.8 million of
senior unsecured convertible notes due 2023. Higher legal and
compensation costs were offset by the reversal of expenses
previously recorded for stock based compensation and bonuses for
employees impacted by the restructuring.
A restructuring charge of $3.6 million was recorded in the
quarter ended June 30, 2022, primarily for severance benefits
associated with a nearly 50% reduction in the Company’s workforce.
The workforce reduction will be completed during the third quarter
of 2022 and the Company expects to reduce quarterly cash operating
expenses, excluding inventory purchases, to $12 - $14 million.
Income tax expense was $30.2 million in the quarter ended June
30, 2022, compared to income tax benefit of $3.8 million for the
same period in 2021. Income tax expense in the current quarter is
due primarily to a valuation allowance recorded against deferred
tax assets.
Net loss for the quarter ended June 30, 2022 was $63.4 million,
or ($1.07) per diluted share, compared to net loss of $19.6
million, or ($0.33) per diluted share, for the same period in
2021.
Cash, cash equivalents and marketable securities were $104.1
million as of June 30, 2022. Subsequent to June, Avadel received
$9.9 million of tax refunds and expects to receive an additional
$7.3 million of tax refunds. The Company has $26.4 million of
convertible debt that matures in February 2023 and $117.4 million
that matures in October 2023.
Conference Call
To access the conference call, investors are invited to dial
(833)-630-0586 or (412)-317-6701 (International). When joining the
call, please ask to join the Avadel Pharmaceuticals call. A live
audio webcast can 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 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.
Final approval of LUMRYZ cannot be granted until the expiration or
other disposition of U.S. Patent No. 8,731,963, which expires on
June 17, 2023.
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
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 the FDA’s final approval of
LUMRYZ, planned efforts of the Company to accelerate the FDA’s
final approval and to accelerate the timing between final approval
and launch as well as the expected results thereof; the estimated
charges and costs expected to be incurred in connection with launch
(if approved) and projected cost savings in connection with cost
structure optimization efforts; the 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 December
31, 2021, which was filed with the Securities and Exchange
Commission (SEC) on March 16, 2022, 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 by
law.
Investor Contact:Courtney TurianoStern Investor
Relations, Inc.Courtney.Turiano@sternir.com (212) 698-8687
Media Contact:Gabriella GreigReal
Chemistryggreig@realchemistry.com (203) 249-2688
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF
LOSS(In thousands, except per share data)(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
|
|
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development expenses |
|
$ |
4,541 |
|
|
$ |
6,762 |
|
|
$ |
11,532 |
|
|
$ |
10,614 |
|
Selling, general and administrative expenses |
|
|
21,804 |
|
|
|
15,174 |
|
|
|
43,439 |
|
|
|
26,186 |
|
Restructuring expense (income) |
|
|
3,592 |
|
|
|
— |
|
|
|
3,592 |
|
|
|
(53 |
) |
Total operating expense |
|
|
29,937 |
|
|
|
21,936 |
|
|
|
58,563 |
|
|
|
36,747 |
|
Operating loss |
|
|
(29,937 |
) |
|
|
(21,936 |
) |
|
|
(58,563 |
) |
|
|
(36,747 |
) |
Investment and other income, net |
|
|
192 |
|
|
|
432 |
|
|
|
55 |
|
|
|
1,042 |
|
Interest expense |
|
|
(3,506 |
) |
|
|
(1,930 |
) |
|
|
(5,523 |
) |
|
|
(3,859 |
) |
Gain from release of certain liabilities |
|
|
— |
|
|
|
88 |
|
|
|
33 |
|
|
|
166 |
|
Loss before income taxes |
|
|
(33,251 |
) |
|
|
(23,346 |
) |
|
|
(63,998 |
) |
|
|
(39,398 |
) |
Income tax provision (benefit) |
|
|
30,193 |
|
|
|
(3,765 |
) |
|
|
25,870 |
|
|
|
(6,372 |
) |
Net loss |
|
$ |
(63,444 |
) |
|
$ |
(19,581 |
) |
|
$ |
(89,868 |
) |
|
$ |
(33,026 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share –
basic |
|
$ |
(1.07 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.52 |
) |
|
$ |
(0.56 |
) |
Net loss per share –
diluted |
|
|
(1.07 |
) |
|
|
(0.33 |
) |
|
|
(1.52 |
) |
|
|
(0.56 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding - basic |
|
|
59,037 |
|
|
|
58,488 |
|
|
|
58,931 |
|
|
|
58,465 |
|
Weighted average number of
shares outstanding - diluted |
|
|
59,037 |
|
|
|
58,488 |
|
|
|
58,931 |
|
|
|
58,465 |
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per share data)
|
|
June 30, 2022 |
|
December 31, 2021 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
54,128 |
|
|
$ |
50,708 |
|
Marketable securities |
|
|
49,993 |
|
|
|
106,513 |
|
Research and development tax credit receivable |
|
|
2,205 |
|
|
|
2,443 |
|
Prepaid expenses and other current assets |
|
|
19,387 |
|
|
|
32,826 |
|
Total current assets |
|
|
125,713 |
|
|
|
192,490 |
|
Property and equipment, net |
|
|
252 |
|
|
|
285 |
|
Operating lease right-of-use assets |
|
|
2,180 |
|
|
|
2,652 |
|
Goodwill |
|
|
16,836 |
|
|
|
16,836 |
|
Research and development tax credit receivable |
|
|
1,187 |
|
|
|
1,225 |
|
Other non-current assets |
|
|
11,770 |
|
|
|
33,777 |
|
Total assets |
|
$ |
157,938 |
|
|
$ |
247,265 |
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ (DEFICIT) EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of long-term debt |
|
$ |
26,241 |
|
|
$ |
— |
|
Current portion of operating lease liability |
|
|
932 |
|
|
|
900 |
|
Accounts payable |
|
|
7,318 |
|
|
|
7,679 |
|
Accrued expenses |
|
|
9,675 |
|
|
|
7,151 |
|
Other current liabilities |
|
|
2,051 |
|
|
|
5,270 |
|
Total current liabilities |
|
|
46,217 |
|
|
|
21,000 |
|
Long-term debt |
|
|
108,074 |
|
|
|
142,397 |
|
Long-term operating lease liability |
|
|
1,263 |
|
|
|
1,707 |
|
Other non-current liabilities |
|
|
5,716 |
|
|
|
3,917 |
|
Total liabilities |
|
|
161,270 |
|
|
|
169,021 |
|
|
|
|
|
|
Shareholders’ (deficit) equity: |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; 488 issued and outstanding at June 30, 2022 and
488 issued and outstanding at December 31, 2021 |
|
|
5 |
|
|
|
5 |
|
Ordinary shares, nominal value of $0.01 per share; 500,000 shares
authorized; 59,038 issued and outstanding at June 30, 2022 and
58,620 issued and outstanding at December 31, 2021 |
|
|
590 |
|
|
|
586 |
|
Additional paid-in capital |
|
|
560,025 |
|
|
|
549,349 |
|
Accumulated deficit |
|
|
(537,624 |
) |
|
|
(447,756 |
) |
Accumulated other comprehensive loss |
|
|
(26,328 |
) |
|
|
(23,940 |
) |
Total shareholders’ (deficit) equity |
|
|
(3,332 |
) |
|
|
78,244 |
|
Total liabilities and
shareholders’ (deficit) equity |
|
$ |
157,938 |
|
|
$ |
247,265 |
|
|
|
|
|
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS(In thousands)(Unaudited)
|
|
Six Months Ended June 30, |
|
|
|
2022 |
|
|
|
2021 |
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(89,868 |
) |
|
$ |
(33,026 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
506 |
|
|
|
417 |
|
Amortization of debt discount and debt issuance costs |
|
|
2,229 |
|
|
|
625 |
|
Change in deferred taxes |
|
|
25,870 |
|
|
|
(6,228 |
) |
Stock-based compensation expense |
|
|
3,163 |
|
|
|
3,729 |
|
Gain from release of certain liabilities |
|
|
(33 |
) |
|
|
(166 |
) |
Other adjustments |
|
|
1,239 |
|
|
|
757 |
|
Net changes in assets and liabilities |
|
|
|
|
Prepaid expenses and other current assets |
|
|
13,305 |
|
|
|
(3,106 |
) |
Research and development tax credit receivable |
|
|
30 |
|
|
|
3,078 |
|
Accounts payable & other current liabilities |
|
|
(4,457 |
) |
|
|
176 |
|
Accrued expenses |
|
|
2,559 |
|
|
|
1,199 |
|
Other assets and liabilities |
|
|
(2,678 |
) |
|
|
(1,021 |
) |
Net cash used in operating activities |
|
|
(48,135 |
) |
|
|
(33,566 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
|
(26 |
) |
Proceeds from the disposition of the hospital products |
|
|
— |
|
|
|
16,500 |
|
Proceeds from sales of marketable securities |
|
|
56,501 |
|
|
|
66,213 |
|
Purchases of marketable securities |
|
|
(2,202 |
) |
|
|
(53,372 |
) |
Net cash provided by investing activities |
|
|
54,299 |
|
|
|
29,315 |
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
Payments for debt issuance costs |
|
|
(4,803 |
) |
|
|
— |
|
Proceeds from stock option exercises and employee share purchase
plan |
|
|
2,009 |
|
|
|
149 |
|
Net cash (used in) provided by financing activities |
|
|
(2,794 |
) |
|
|
149 |
|
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
|
50 |
|
|
|
(478 |
) |
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
3,420 |
|
|
|
(4,580 |
) |
Cash and cash equivalents at January 1, |
|
|
50,708 |
|
|
|
71,722 |
|
Cash and cash equivalents at June 30, |
|
$ |
54,128 |
|
|
$ |
67,142 |
|
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
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Avadel Pharmaceuticals (NASDAQ:AVDL)
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