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 first quarter ended March 31, 2023.
“On May 1, we announced the final FDA approval and receipt of
Orphan Drug Exclusivity for LUMRYZ, the first and only
once-at-bedtime oxybate therapy for the treatment of cataplexy or
EDS in adults with narcolepsy. The receipt of Orphan Drug
Exclusivity recognizes the clinically superior benefit of a once at
bedtime treatment option over existing twice nightly oxybates,”
said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.
“With the approval of LUMRYZ, we are poised to positively impact
the treatment experience for all eligible patients, increase
oxybate utilization and secure a meaningful position in the $3
billion plus once-nightly oxybate market.”
First Quarter and Recent Company Highlights
- On May 1, 2023, Avadel announced final
approval and receipt of Orphan Drug Exclusivity for LUMRYZ from the
U.S. Food & Drug Administration (FDA), an extended-release
formulation of sodium oxybate indicated to be taken once at bedtime
for the treatment of cataplexy or excessive daytime sleepiness
(EDS) in adults with narcolepsy.
- With final approval, LUMRYZ becomes the
first and only FDA approved once-at-bedtime oxybate for people
living with narcolepsy.
- The FDA also found LUMRYZ to be
clinically superior to currently marketed twice-nightly oxybate
products and granted LUMRYZ seven years of Orphan Drug Exclusivity.
In particular, the FDA found that LUMRYZ makes a major contribution
to patient care over currently available, twice-nightly oxybate
products by providing a once-nightly dosing regimen that avoids
nocturnal arousal to take a second dose.
- U.S. commercial launch of LUMRYZ
expected in early June 2023.
- Advancing commercial preparations to
support launch, including the finalization of specialty pharmacy
network and patient services center, RYZUP.
- Avadel continues to engage with key
stakeholders including sleep specialists and payers while expanding
medical science liaisons, sales leadership team, territory business
managers and field reimbursement specialists.
- Successfully executed multiple
strategic financing activities and secured over $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
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.
- Completed an equity offering with gross
proceeds of $143.8 million, before deducting underwriting
discounts, commissions and estimated offering expenses.
- Exchanged $96.2 million of convertible
notes with a new maturity date of April 3, 2027.
Overview of Fourth Quarter Results
R&D expenses were $3.8 million in the quarter ended March
31, 2023, compared to $7.0 million for the same period in 2022. The
period-over-period decrease was primarily attributed to a decrease
in purchases of the active pharmaceutical ingredient used in the
manufacture of LUMRYZ.
SG&A expenses were $24.5 million in the quarter ended March
31, 2023, compared to $21.6 million for the same period in 2022.
The period-over-period increase is primarily the result of higher
legal costs and costs related to financing activities.
Net loss for the quarter ended March 31, 2023, was $30.8
million, or ($0.48) per diluted share, compared to net loss of
$26.4 million, or ($0.45) per diluted share, for the same period in
2022.
Cash, cash equivalents and marketable securities were $100.9
million as of March 31, 2023. 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.
About
LUMRYZ™ (sodium oxybate) for
extended-release oral suspension
LUMRYZ, is an extended-release sodium
oxybate medication approved by the FDA on May 1, 2023, as the first
and only once-at-bedtime treatment for cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy. The FDA
approval of LUMRYZ was supported by results from REST-ON, a
randomized, double-blind, placebo-controlled, pivotal Phase 3 trial
in adults with narcolepsy. LUMRYZ demonstrated statistically
significant and clinically meaningful improvements in the three
co-primary endpoints: EDS, clinicians’ overall assessment of
patients’ functioning (CGI-I) and cataplexy attacks, for all three
evaluated doses when compared to placebo. With its approval,
the FDA also granted seven years of Orphan Drug Exclusivity to
LUMRYZ for the treatment of cataplexy or EDS in adults with
narcolepsy due to a finding of clinical superiority of LUMRYZ
relative to currently available oxybate treatments. In particular,
the FDA found that LUMRYZ makes a major contribution to patient
care over currently available, twice-nightly oxybate products by
providing a once-nightly dosing regimen that avoids nocturnal
arousal to take a second dose.
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.
Avadel’s commercial product, LUMRYZ, was approved by the U.S. Food
& Drug Administration (FDA) as the first and only
once-at-bedtime oxybate for the treatment of cataplexy or excessive
daytime sleepiness (EDS) in adults with narcolepsy. For more
information, please visit www.avadel.com.
IMPORTANT SAFETY INFORMATION
WARNING: Taking LUMRYZ™ (sodium oxybate) with other central
nervous system (CNS) depressants, such as medicines used to make
you fall asleep, including opioid analgesics, benzodiazepines,
sedating antidepressants, antipsychotics, sedating anti-epileptic
medicines, general anesthetics, muscle relaxants, alcohol or street
drugs, may cause serious medical problems, including trouble
breathing (respiratory depression), low blood pressure
(hypotension), changes in alertness (drowsiness), fainting
(syncope) and death.The active ingredient of
LUMRYZ (sodium oxybate) is a form of gamma hydroxybutyrate (GHB), a
controlled substance. Abuse or misuse of illegal GHB alone or with
other CNS depressants (drugs that cause changes in alertness or
consciousness) have caused serious side effects. These effects
include seizures, trouble breathing (respiratory depression),
changes in alertness (drowsiness), coma and death. Call your doctor
right away if you have any of these serious side
effects.Because of these risks, LUMRYZ is
available only by prescription and filled through certified
pharmacies in the LUMRYZ REMS. You must be enrolled in the LUMRYZ
REMS to receive LUMRYZ. Further information is available
at www.LUMRYZREMS.com or by
calling 1-877-453-1029. |
INDICATIONSLUMRYZ (sodium oxybate) for
extended-release oral suspension is a prescription medicine used to
treat the following symptoms in adults with narcolepsy:
- sudden onset of weak or paralyzed muscles (cataplexy)
- excessive daytime sleepiness (EDS)
It is not known if LUMRYZ is safe and effective in people less
than 18 years of age.
Do not take LUMRYZ if you take other sleep
medicines or sedatives (medicines that cause sleepiness), drink
alcohol or have a rare problem called succinic semialdehyde
dehydrogenase deficiency.
Keep LUMRYZ in a safe place to prevent abuse and misuse. Selling
or giving away LUMRYZ may harm others and is against the law. Tell
your doctor if you have ever abused or been dependent on alcohol,
prescription medicines or street drugs.
Anyone who takes LUMRYZ should not do anything that requires
them to be fully awake or is dangerous, including driving a car,
using heavy machinery or flying an airplane, for at least six (6)
hours after taking LUMRYZ. Those activities should not be done
until you know how LUMRYZ affects you.
Falling asleep quickly, including while standing or while
getting up from the bed, has led to falls with injuries that have
required some people to be hospitalized.
LUMRYZ can cause serious side effects, including the
following:
- Breathing problems, including slower
breathing, trouble breathing and/or short periods of not breathing
while sleeping (e.g., sleep apnea). People who already have
breathing or lung problems have a higher chance of having breathing
problems when they take LUMRYZ.
- Mental health problems,
including confusion, seeing or hearing things that are not
real (hallucinations), unusual or disturbing thoughts (abnormal
thinking), feeling anxious or upset, depression, thoughts of
killing yourself or trying to kill yourself, increased tiredness,
feelings of guilt or worthlessness and difficulty concentrating.
Tell your doctor if you have or had depression or have tried to
harm yourself. Call your doctor right away if you have
symptoms of mental health problems or a change in weight or
appetite.
- Sleepwalking. Sleepwalking can cause
injuries. Call your doctor if you start sleepwalking.
Tell your doctor if you are on a salt-restricted diet or if you
have high blood pressure, heart failure or kidney problems. LUMRYZ
contains a lot of sodium (salt) and may not be right for you.
The most common side effects of LUMRYZ in adults include nausea,
dizziness, bedwetting, headache and vomiting. Your side effects may
increase when you take higher doses of LUMRYZ. LUMRYZ can cause
physical dependence and craving for the medicine when it is not
taken as directed. These are not all the possible side effects of
LUMRYZ.
For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side
effects.
You are encouraged to report negative side effects of
prescription drugs to the FDA. Visit www.fda.gov/medwatch, or
call 1-800-FDA-1088.
Please see full Prescribing
Information, including BOXED Warning.
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 potential therapeutic
benefit of LUMRYZ; the Orphan Drug Exclusivity for LUMRYZ and
potential benefits resulting from such designation; the preparation
and timing of commercial launch and the success of such
commercialization for LUMRYZ; expectations regarding the potential
market impact of LUMRYZ; the anticipated market availability of
LUMRYZ; the Company’s anticipated uses of capital, including the
proceeds from the recent financing; and the expected maturity of
the Company’s convertible notes. 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, 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 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 March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Operating expenses: |
|
|
|
Research and development expenses |
$ |
3,830 |
|
|
$ |
6,991 |
|
Selling, general and administrative expenses |
|
24,468 |
|
|
|
21,635 |
|
Total operating expense |
|
28,298 |
|
|
|
28,626 |
|
Operating loss |
|
(28,298 |
) |
|
|
(28,626 |
) |
Investment and other income (expense), net |
|
193 |
|
|
|
(104 |
) |
Interest expense |
|
(3,259 |
) |
|
|
(2,017 |
) |
Loss before income taxes |
|
(31,364 |
) |
|
|
(30,747 |
) |
Income tax benefit |
|
(580 |
) |
|
|
(4,323 |
) |
Net loss |
$ |
(30,784 |
) |
|
$ |
(26,424 |
) |
|
|
|
|
Net loss per share -
basic |
$ |
(0.48 |
) |
|
$ |
(0.45 |
) |
Net loss per share -
diluted |
|
(0.48 |
) |
|
|
(0.45 |
) |
|
|
|
|
Weighted average number of
shares outstanding - basic |
|
63,886 |
|
|
|
58,824 |
|
Weighted average number of
shares outstanding - diluted |
|
63,886 |
|
|
|
58,824 |
|
|
|
|
|
|
|
|
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per share data)
|
March 31, 2023 |
|
December 31, 2022 |
|
(Unaudited) |
|
|
ASSETS |
|
|
|
Current assets: |
|
|
|
Cash and cash equivalents |
$ |
83,391 |
|
|
$ |
73,981 |
|
Marketable securities |
|
17,532 |
|
|
|
22,518 |
|
Research and development tax credit receivable |
|
2,283 |
|
|
|
2,248 |
|
Prepaid expenses and other current assets |
|
6,264 |
|
|
|
2,096 |
|
Total current assets |
|
109,470 |
|
|
|
100,843 |
|
Property and equipment, net |
|
782 |
|
|
|
839 |
|
Operating lease right-of-use assets |
|
1,475 |
|
|
|
1,713 |
|
Goodwill |
|
16,836 |
|
|
|
16,836 |
|
Research and development tax credit receivable |
|
1,245 |
|
|
|
1,232 |
|
Other non-current assets |
|
10,931 |
|
|
|
11,322 |
|
Total assets |
$ |
140,739 |
|
|
$ |
132,785 |
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ (DEFICIT) EQUITY |
|
|
|
Current liabilities: |
|
|
|
Current portion of long-term debt |
$ |
20,515 |
|
|
$ |
37,668 |
|
Current portion of operating lease liability |
|
871 |
|
|
|
960 |
|
Accounts payable |
|
10,023 |
|
|
|
7,890 |
|
Accrued expenses |
|
7,683 |
|
|
|
7,334 |
|
Proceeds received in advance of Series B Preferred Shares
issuance |
|
40,000 |
|
|
|
— |
|
Other current liabilities |
|
269 |
|
|
|
1,941 |
|
Total current liabilities |
|
79,361 |
|
|
|
55,793 |
|
Long-term debt |
|
93,139 |
|
|
|
91,614 |
|
Long-term operating lease liability |
|
638 |
|
|
|
780 |
|
Other non-current liabilities |
|
5,767 |
|
|
|
5,743 |
|
Total liabilities |
|
178,905 |
|
|
|
153,930 |
|
|
|
|
|
Shareholders’ (deficit) equity: |
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; 488 issued and outstanding at March 31, 2023 and
488 issued and outstanding at December 31, 2022 |
|
5 |
|
|
|
5 |
|
Ordinary shares, nominal value of $0.01 per share; 500,000 shares
authorized; 64,478 issued and outstanding at March 31, 2023
and 62,878 issued and outstanding at December 31, 2022 |
|
644 |
|
|
|
628 |
|
Additional paid-in capital |
|
603,215 |
|
|
|
589,783 |
|
Accumulated deficit |
|
(616,004 |
) |
|
|
(585,220 |
) |
Accumulated other comprehensive loss |
|
(26,026 |
) |
|
|
(26,341 |
) |
Total shareholders’ (deficit) equity |
|
(38,166 |
) |
|
|
(21,145 |
) |
Total liabilities and
shareholders’ (deficit) equity |
$ |
140,739 |
|
|
$ |
132,785 |
|
|
|
|
|
|
|
|
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS(In thousands)(Unaudited)
|
Three Months Ended March 31, |
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
Cash flows from
operating activities: |
|
|
|
Net loss |
$ |
(30,784 |
) |
|
$ |
(26,424 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
Depreciation and amortization |
|
588 |
|
|
|
259 |
|
Amortization of debt discount and debt issuance costs |
|
1,873 |
|
|
|
312 |
|
Changes in deferred taxes |
|
— |
|
|
|
(4,323 |
) |
Share-based compensation expense |
|
1,522 |
|
|
|
2,505 |
|
Other adjustments |
|
(1 |
) |
|
|
669 |
|
Net changes in assets and liabilities |
|
|
|
Prepaid expenses and other current assets |
|
(4,131 |
) |
|
|
(2,058 |
) |
Research and development tax credit receivable |
|
— |
|
|
|
(19 |
) |
Accounts payable & other current liabilities |
|
468 |
|
|
|
(5,613 |
) |
Accrued expenses |
|
348 |
|
|
|
2,314 |
|
Other assets and liabilities |
|
(116 |
) |
|
|
(1,667 |
) |
Net cash used in operating
activities |
|
(30,233 |
) |
|
|
(34,045 |
) |
|
|
|
|
Cash flows from
investing activities: |
|
|
|
Proceeds from sales of marketable securities |
|
15,295 |
|
|
|
44,341 |
|
Purchases of marketable securities |
|
(10,229 |
) |
|
|
(2,090 |
) |
Net cash provided by investing
activities |
|
5,066 |
|
|
|
42,251 |
|
|
|
|
|
Cash flows from
financing activities: |
|
|
|
Proceeds received in advance of Series B Preferred Shares
Issuance |
|
40,000 |
|
|
|
— |
|
Payments for February 2023 Notes |
|
(17,500 |
) |
|
|
— |
|
Proceeds from issuance of shares off the at-the-market offering
program |
|
11,913 |
|
|
|
— |
|
Proceeds from stock option exercises and employee share purchase
plan |
|
29 |
|
|
|
2,009 |
|
Net cash provided by financing
activities |
|
34,442 |
|
|
|
2,009 |
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
135 |
|
|
|
(50 |
) |
|
|
|
|
Net change in cash and cash equivalents |
|
9,410 |
|
|
|
10,165 |
|
Cash and cash equivalents at January 1, |
|
73,981 |
|
|
|
50,708 |
|
Cash and cash equivalents at March 31, |
$ |
83,391 |
|
|
$ |
60,873 |
|
|
|
|
|
|
|
|
|
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 6월(6) 2024 으로 7월(7) 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
과거 데이터 주식 차트
부터 7월(7) 2023 으로 7월(7) 2024