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 quarter ended March 31, 2024.
“We are pleased to report another strong quarter of
launch performance from LUMRYZ as we continue to serve the
narcolepsy patient community. The continued positive feedback we
hear daily from patients, prescribers and caregivers builds on the
strong commercial foundation we established early into the launch,”
said Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals.
“Over the course of 2024, we will be laser focused on the continued
market growth of LUMRYZ for the treatment of narcolepsy as well as
potentially expanding to the pediatric population and initiating
our Phase 3 pivotal trial in idiopathic hypersomnia in the second
half of the year.”
First Quarter and Recent Company
Highlights
LUMRYZ Commercial
Updates:
- Greater than 1,700 patients initiated
therapy as of March 31, representing an increase of greater than
70% from December 31.
- More than 2,800 patients enrolled in
Avadel’s RYZUP patient support services, an increase of
approximately 50% since December 31.
- The majority of RYZUP enrollments and
patients currently being treated with LUMRYZ are patients who
switched from first generation oxybates, with the balance made up
of patients who previously tried and discontinued a first
generation oxybate and patients who are new to oxybate
treatment.
Pipeline Updates:
- U.S. Food and Drug Administration
(FDA) accepted the Supplemental New Drug Application (sNDA) for
LUMRYZ for treatment of cataplexy or EDS in the pediatric
narcolepsy population. The FDA has assigned a target action date of
September 7, 2024.
- With potential approval in the
pediatric population, LUMRYZ could alleviate the burden placed on
families and caregivers of children with narcolepsy who are
responsible for waking up in the middle of the night to administer
a second dose.
- Pediatric patients currently represent
approximately 5% of all oxybate treated narcolepsy patients.
- On track to enroll the first patient
in a Phase 3 pivotal trial for the use of LUMRYZ to treat
idiopathic hypersomnia in the second half of 2024.
Overview of First Quarter Financial
Results
Recognized $27.2 million in net product revenue and
gross profit of $25.7 million for the quarter ended March 31, 2024.
Net product revenue consists of LUMRYZ product sales, which was
launched in the U.S. on June 5, 2023.
R&D expenses were $3.1 million in the quarter
ended March 31, 2024, compared to $3.8 million for the same period
in 2023. The decrease was driven primarily by lower pre-commercial
LUMRYZ related costs that were capitalized into inventory beginning
in May 2023 upon FDA approval of LUMRYZ.
SG&A expenses were $48.6 million in the quarter
ended March 31, 2024, compared to $24.5 million for the same period
in 2023. This increase was driven primarily by higher costs
associated with the commercial launch of LUMRYZ, higher
compensation costs due to increased headcount, higher selling and
marketing activities, and higher legal fees.
Net loss for the quarter ended March 31, 2024 was
$27.3 million, or ($0.30) per diluted share, compared to net loss
of $30.8 million, or ($0.48) per diluted share, for the same period
in 2023.
Cash, cash equivalents and marketable securities
were $88.8 million as of March 31, 2024.
Conference Call Details:
To access the conference call, investors are
invited to dial +1 (800) 715-9871 (U.S. and Canada) or +1 (646)
307-1963 (International) and use the conference ID 2270373. 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™
(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 success of the commercialization of LUMRYZ; the anticipated
market availability, demand and sales opportunity of LUMRYZ; the
potential expansion of LUMRYZ into the pediatric narcolepsy
population including FDA’s review of the sNDA for such population
and timing related thereto; the Company’s plans to initiate a Phase
3 pivotal trial for LUMRYZ in idiopathic hypersomnia and timing
related thereto; the Company’s anticipated financial condition,
expenses, uses of capital and other future financial results. In
some cases, forward-looking statements can be identified by 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 most recent Annual Report on Form 10-K and subsequent
filings with the Securities and Exchange Commission.
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
MogerleyStern Investor Relations, Inc.Courtney.Mogerley@sternir.com
(212) 698-8687
Media Contact:Lesley StanleyReal
Chemistrylestanley@realchemistry.com (609) 273-3162
|
AVADEL PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED STATEMENTS OF LOSS(In thousands, except per
share data)(Unaudited) |
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Net product revenue |
|
$ |
27,178 |
|
|
$ |
— |
|
Cost of products sold |
|
|
1,522 |
|
|
|
— |
|
Gross profit |
|
|
25,656 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
Research and development expenses |
|
|
3,068 |
|
|
|
3,830 |
|
Selling, general and administrative expenses |
|
|
48,623 |
|
|
|
24,468 |
|
Total operating expense |
|
|
51,691 |
|
|
|
28,298 |
|
Operating loss |
|
|
(26,035 |
) |
|
|
(28,298 |
) |
Investment and other income, net |
|
|
1,378 |
|
|
|
193 |
|
Interest expense |
|
|
(2,592 |
) |
|
|
(3,259 |
) |
Loss before income taxes |
|
|
(27,249 |
) |
|
|
(31,364 |
) |
Income tax provision (benefit) |
|
|
93 |
|
|
|
(580 |
) |
Net loss |
|
$ |
(27,342 |
) |
|
$ |
(30,784 |
) |
|
|
|
|
|
Net loss per share - basic |
|
$ |
(0.30 |
) |
|
$ |
(0.48 |
) |
Net loss per share - diluted |
|
|
(0.30 |
) |
|
|
(0.48 |
) |
|
|
|
|
|
Weighted average number of shares outstanding - basic |
|
|
91,693 |
|
|
|
63,886 |
|
Weighted average number of shares outstanding - diluted |
|
|
91,693 |
|
|
|
63,886 |
|
|
AVADEL PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands, except per share
data) |
|
|
|
March 31, 2024 |
|
December 31, 2023 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
35,794 |
|
|
$ |
31,167 |
|
Marketable securities |
|
|
52,995 |
|
|
|
73,944 |
|
Accounts receivable, net |
|
|
22,692 |
|
|
|
12,103 |
|
Inventories |
|
|
11,928 |
|
|
|
10,380 |
|
Research and development tax credit receivable |
|
|
1,293 |
|
|
|
1,322 |
|
Prepaid expenses and other current assets |
|
|
11,333 |
|
|
|
5,286 |
|
Total current assets |
|
|
136,035 |
|
|
|
134,202 |
|
Property and equipment, net |
|
|
526 |
|
|
|
585 |
|
Operating lease right-of-use assets |
|
|
2,374 |
|
|
|
2,591 |
|
Goodwill |
|
|
16,836 |
|
|
|
16,836 |
|
Research and development tax credit receivable |
|
|
360 |
|
|
|
332 |
|
Other non-current assets |
|
|
11,768 |
|
|
|
10,152 |
|
Total assets |
|
$ |
167,899 |
|
|
$ |
164,698 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of operating lease liability |
|
$ |
953 |
|
|
$ |
934 |
|
Accounts payable |
|
|
18,961 |
|
|
|
11,433 |
|
Accrued expenses |
|
|
27,642 |
|
|
|
24,227 |
|
Other current liabilities |
|
|
252 |
|
|
|
261 |
|
Total current liabilities |
|
|
47,808 |
|
|
|
36,855 |
|
Long-term operating lease liability |
|
|
1,449 |
|
|
|
1,690 |
|
Royalty financing obligation |
|
|
34,333 |
|
|
|
32,760 |
|
Other non-current liabilities |
|
|
5,925 |
|
|
|
5,654 |
|
Total liabilities |
|
|
89,515 |
|
|
|
76,959 |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; zero issued and outstanding at March 31, 2024 and
5,194 issued and outstanding at December 31, 2023 |
|
|
— |
|
|
|
52 |
|
Ordinary shares, nominal value of $0.01 per share; 500,000 shares
authorized; 96,097 issued and outstanding at March 31, 2024
and 89,825 issued and outstanding at December 31, 2023 |
|
|
960 |
|
|
|
898 |
|
Additional paid-in capital |
|
|
874,018 |
|
|
|
855,452 |
|
Accumulated deficit |
|
|
(772,838 |
) |
|
|
(745,496 |
) |
Accumulated other comprehensive loss |
|
|
(23,756 |
) |
|
|
(23,167 |
) |
Total shareholders’ equity |
|
|
78,384 |
|
|
|
87,739 |
|
Total liabilities and shareholders’ equity |
|
$ |
167,899 |
|
|
$ |
164,698 |
|
|
AVADEL PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS(In
thousands)(Unaudited) |
|
|
|
Three Months Ended March 31, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(27,342 |
) |
|
$ |
(30,784 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
541 |
|
|
|
588 |
|
Amortization of debt discount and debt issuance costs |
|
|
— |
|
|
|
1,873 |
|
Share-based compensation expense |
|
|
5,389 |
|
|
|
1,522 |
|
Other adjustments |
|
|
(719 |
) |
|
|
(1 |
) |
Net changes in assets and liabilities |
|
|
|
|
Accounts receivable |
|
|
(10,589 |
) |
|
|
— |
|
Inventories |
|
|
(1,260 |
) |
|
|
— |
|
Prepaid expenses and other current assets |
|
|
(6,093 |
) |
|
|
(4,131 |
) |
Research and development tax credit receivable |
|
|
(17 |
) |
|
|
— |
|
Accounts payable & other current liabilities |
|
|
7,528 |
|
|
|
468 |
|
Accrued expenses |
|
|
3,415 |
|
|
|
348 |
|
Other assets and liabilities |
|
|
(557 |
) |
|
|
(116 |
) |
Net cash used in operating activities |
|
|
(29,704 |
) |
|
|
(30,233 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Proceeds from sales of marketable securities |
|
|
119,066 |
|
|
|
15,295 |
|
Purchases of marketable securities |
|
|
(97,679 |
) |
|
|
(10,229 |
) |
Net cash provided by investing activities |
|
|
21,387 |
|
|
|
5,066 |
|
|
|
|
|
|
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 |
|
|
9,250 |
|
|
|
11,913 |
|
Proceeds from stock option exercises and employee share purchase
plan |
|
|
3,940 |
|
|
|
29 |
|
Net cash provided by financing activities |
|
|
13,190 |
|
|
|
34,442 |
|
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
|
(246 |
) |
|
|
135 |
|
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
4,627 |
|
|
|
9,410 |
|
Cash and cash equivalents at January 1, |
|
|
31,167 |
|
|
|
73,981 |
|
Cash and cash equivalents at March 31, |
|
$ |
35,794 |
|
|
$ |
83,391 |
|
Avadel Pharmaceuticals (NASDAQ:AVDL)
過去 株価チャート
から 4 2024 まで 5 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
過去 株価チャート
から 5 2023 まで 5 2024