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, 2023.
“We are carrying significant momentum into 2024 following the
successful launch of LUMRYZ and are pleased with the strong early
launch results we have seen. We have established a strong
foundation with patients, prescribers and payers to build on and
advance our mission of transforming the lives of people living with
narcolepsy,” said Greg Divis, Chief Executive Officer of Avadel
Pharmaceuticals. “While the launch is still in the early stages, we
believe the meaningful increase in patients initiating therapy with
LUMRYZ underscores the significant unmet need for a once-at-bedtime
therapy. We look forward to expanding the LUMRYZ indication for the
pediatric narcolepsy population with the anticipated approval
decision in September, initiating our Phase 3 pivotal trial program
in idiopathic hypersomnia and continuing our robust commercial
execution throughout 2024.”
Fourth Quarter and Recent Company
Highlights
LUMRYZ Commercial Updates Through the End of January
2024:
- Greater than 2,200 patients enrolled in Avadel’s RYZUP patient
support services:
- More than 1,200 patients initiated therapy.
- 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.
- Secured payor coverage policies for greater than 80% of
commercially covered lives with the inclusion of Anthem and the
United Healthcare national formulary.
- Contracts now established with all 3 PBM-owned GPOs
(Ascent/ESI, Zinc/CVS and Emisar/Optum).
- Approximately 1,900 health care providers have completed the
LUMRYZ REMS certification process, including both experienced
oxybate prescribers as well as providers who have never previously
prescribed an oxybate.
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, for its
approval decision.
- 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 3-5% of
all oxybate treated narcolepsy patients.
- Planning to enroll the first patient in a clinical study for
the use of LUMRYZ to treat idiopathic hypersomnia in the second
half of 2024.
Overview of Fourth Quarter and Full Year
Results
Recognized $19.5 million and $28.0 million in net product
revenue for the quarter and year ended December 31, 2023,
respectively. Net product revenue consists of LUMRYZ product sales,
which was launched in the U.S. on June 5, 2023.
R&D expenses for the quarter and year ended December 31,
2023, were $2.4 million and $13.3 million, respectively, compared
to $6.2 million and $20.7 for the same periods in 2022. The
decreases were 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 for the quarter and year ended December 31,
2023, were $41.3 million and $151.7 million, compared to $17.0
million and $74.5 million for the same periods in 2022. These
increases were driven primarily by higher costs associated with the
commercial launch of LUMRYZ, higher compensation costs due to
increased headcount, higher marketing and market research
activities, and higher legal fees.
Net losses for the quarter and year ended December 31, 2023,
were $28.8 million, or ($0.32) per diluted share and $160.3
million, or ($2.00) per diluted share, respectively, compared to
net losses of $27.5 million, or ($0.44) per diluted share, and
$137.5 million, or ($2.29) per diluted share, for the same periods
in 2022.
Cash, cash equivalents and marketable securities were $105.1
million as of December 31, 2023.
Conference call
details
A live audio webcast of the call 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. Participants may
register for the conference call here and are advised to do so at
least 10 minutes prior to joining the call.
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 and
timing to initiate the idiopathic hypersomnia clinical study; 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 Annual Report on Form 10-K for the year
ended December 31, 2023, which was filed with the Securities and
Exchange Commission (SEC) on February 29, 2024, 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 MogerleyStern
Investor Relations, Inc.Courtney.Mogerley@sternir.com (212)
698-8687
Media Contact:Lesley StanleyReal
Chemistrylestanley@realchemistry.com(609) 273-3162
|
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, |
|
|
2023 |
|
2022 |
|
2023 |
|
2022 |
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
19,453 |
|
|
$ |
— |
|
|
$ |
27,963 |
|
|
$ |
— |
|
Cost of products sold |
|
|
693 |
|
|
|
— |
|
|
|
846 |
|
|
|
— |
|
Gross profit |
|
|
18,760 |
|
|
|
— |
|
|
|
27,117 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
2,359 |
|
|
|
6,235 |
|
|
|
13,261 |
|
|
|
20,700 |
|
Selling, general and administrative expenses |
|
|
41,301 |
|
|
|
16,981 |
|
|
|
151,705 |
|
|
|
74,516 |
|
Restructuring (income) expense |
|
|
— |
|
|
|
(178 |
) |
|
|
— |
|
|
|
3,345 |
|
Total operating expenses |
|
|
43,660 |
|
|
|
23,038 |
|
|
|
164,966 |
|
|
|
98,561 |
|
Operating loss |
|
|
(24,900 |
) |
|
|
(23,038 |
) |
|
|
(137,849 |
) |
|
|
(98,561 |
) |
Investment and other (expense) income, net |
|
|
(1,632 |
) |
|
|
(1,072 |
) |
|
|
87 |
|
|
|
(536 |
) |
Interest expense |
|
|
(2,354 |
) |
|
|
(3,255 |
) |
|
|
(9,886 |
) |
|
|
(12,342 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(13,129 |
) |
|
|
— |
|
Loss before income taxes |
|
|
(28,886 |
) |
|
|
(27,365 |
) |
|
|
(160,777 |
) |
|
|
(111,439 |
) |
Income tax (benefit) provision |
|
|
(100 |
) |
|
|
85 |
|
|
|
(501 |
) |
|
|
26,025 |
|
Net loss |
|
$ |
(28,786 |
) |
|
$ |
(27,450 |
) |
|
$ |
(160,276 |
) |
|
$ |
(137,464 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share - basic |
|
$ |
(0.32 |
) |
|
$ |
(0.44 |
) |
|
$ |
(2.00 |
) |
|
$ |
(2.29 |
) |
Net loss per share - diluted |
|
|
(0.32 |
) |
|
|
(0.44 |
) |
|
|
(2.00 |
) |
|
|
(2.29 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding - basic |
|
|
89,798 |
|
|
|
62,276 |
|
|
|
80,174 |
|
|
|
60,094 |
|
Weighted average number of shares outstanding - diluted |
|
|
89,798 |
|
|
|
62,276 |
|
|
|
80,174 |
|
|
|
60,094 |
|
AVADEL PHARMACEUTICALS PLC |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands, except per share data) |
|
|
|
December 31, 2023 |
|
December 31, 2022 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
31,167 |
|
|
$ |
73,981 |
|
Marketable securities |
|
|
73,944 |
|
|
|
22,518 |
|
Accounts receivable, net |
|
|
12,103 |
|
|
|
— |
|
Inventories |
|
|
10,380 |
|
|
|
— |
|
Research and development tax credit receivable |
|
|
1,322 |
|
|
|
2,248 |
|
Prepaid expenses and other current assets |
|
|
5,286 |
|
|
|
2,096 |
|
Total current assets |
|
|
134,202 |
|
|
|
100,843 |
|
Property and equipment, net |
|
|
585 |
|
|
|
839 |
|
Operating lease right-of-use assets |
|
|
2,591 |
|
|
|
1,713 |
|
Goodwill |
|
|
16,836 |
|
|
|
16,836 |
|
Research and development tax credit receivable |
|
|
332 |
|
|
|
1,232 |
|
Other non-current assets |
|
|
10,152 |
|
|
|
11,322 |
|
Total assets |
|
$ |
164,698 |
|
|
$ |
132,785 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of long-term debt |
|
$ |
— |
|
|
$ |
37,668 |
|
Current portion of operating lease liability |
|
|
934 |
|
|
|
960 |
|
Accounts payable |
|
|
11,433 |
|
|
|
7,890 |
|
Accrued expenses |
|
|
24,227 |
|
|
|
7,334 |
|
Other current liabilities |
|
|
261 |
|
|
|
1,941 |
|
Total current liabilities |
|
|
36,855 |
|
|
|
55,793 |
|
Long-term debt |
|
|
— |
|
|
|
91,614 |
|
Long-term operating lease liability |
|
|
1,690 |
|
|
|
780 |
|
Royalty financing obligation |
|
|
32,760 |
|
|
|
— |
|
Other non-current liabilities |
|
|
5,654 |
|
|
|
5,743 |
|
Total liabilities |
|
|
76,959 |
|
|
|
153,930 |
|
|
|
|
|
|
Shareholders’ equity (deficit): |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; 5,194 issued and outstanding at December 31, 2023
and 488 issued and outstanding at December 31, 2022 |
|
|
52 |
|
|
|
5 |
|
Ordinary shares, nominal value of $0.01 per share; 500,000 shares
authorized; 89,825 issued and outstanding at December 31,
2023 and 62,878 issued and outstanding at December 31, 2022 |
|
|
898 |
|
|
|
628 |
|
Additional paid-in capital |
|
|
855,452 |
|
|
|
589,783 |
|
Accumulated deficit |
|
|
(745,496 |
) |
|
|
(585,220 |
) |
Accumulated other comprehensive loss |
|
|
(23,167 |
) |
|
|
(26,341 |
) |
Total shareholders’ equity (deficit) |
|
|
87,739 |
|
|
|
(21,145 |
) |
Total liabilities and shareholders’ equity (deficit) |
|
$ |
164,698 |
|
|
$ |
132,785 |
|
AVADEL PHARMACEUTICALS PLC |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
(In thousands) |
(Unaudited) |
|
|
|
Twelve Months Ended December 31, |
|
|
2023 |
|
2022 |
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(160,276 |
) |
|
$ |
(137,464 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
1,766 |
|
|
|
1,493 |
|
Amortization of debt discount and debt issuance costs |
|
|
2,796 |
|
|
|
6,052 |
|
Changes in deferred taxes |
|
|
— |
|
|
|
26,025 |
|
Share-based compensation expense |
|
|
15,811 |
|
|
|
7,013 |
|
Loss on extinguishment of debt |
|
|
13,129 |
|
|
|
— |
|
Other adjustments |
|
|
1,262 |
|
|
|
2,042 |
|
Net changes in assets and liabilities |
|
|
|
|
Accounts receivable |
|
|
(12,103 |
) |
|
|
— |
|
Inventories |
|
|
(9,532 |
) |
|
|
— |
|
Prepaid expenses and other current assets |
|
|
(3,127 |
) |
|
|
30,815 |
|
Research and development tax credit receivable |
|
|
1,884 |
|
|
|
30 |
|
Accounts payable & other current liabilities |
|
|
1,545 |
|
|
|
(3,108 |
) |
Accrued expenses |
|
|
16,892 |
|
|
|
227 |
|
Other assets and liabilities |
|
|
1,442 |
|
|
|
(3,429 |
) |
Net cash used in operating activities |
|
|
(128,511 |
) |
|
|
(70,304 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
|
(716 |
) |
Proceeds from sales of marketable securities |
|
|
187,136 |
|
|
|
83,828 |
|
Purchases of marketable securities |
|
|
(237,229 |
) |
|
|
(3,414 |
) |
Net cash (used in) provided by investing activities |
|
|
(50,093 |
) |
|
|
79,698 |
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
Proceeds from April 2023 public offering, net of issuance
costs |
|
|
134,151 |
|
|
|
— |
|
Payments for February 2023 Notes |
|
|
(17,500 |
) |
|
|
(8,653 |
) |
Payments for October 2023 Notes |
|
|
(21,165 |
) |
|
|
— |
|
Payments for debt issuance costs |
|
|
(4,357 |
) |
|
|
(4,804 |
) |
Proceeds from royalty purchase agreement |
|
|
30,000 |
|
|
|
— |
|
Proceeds from issuance of shares off the at-the-market offering
program |
|
|
11,913 |
|
|
|
25,318 |
|
Proceeds from stock option exercises and employee share purchase
plan |
|
|
2,293 |
|
|
|
2,682 |
|
Net cash provided by financing activities |
|
|
135,335 |
|
|
|
14,543 |
|
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
|
455 |
|
|
|
(664 |
) |
|
|
|
|
|
Net change in cash and cash equivalents |
|
|
(42,814 |
) |
|
|
23,273 |
|
Cash and cash equivalents at January 1 |
|
|
73,981 |
|
|
|
50,708 |
|
Cash and cash equivalents at December 31 |
|
$ |
31,167 |
|
|
$ |
73,981 |
|
Avadel Pharmaceuticals (NASDAQ:AVDL)
Graphique Historique de l'Action
De Mar 2024 à Avr 2024
Avadel Pharmaceuticals (NASDAQ:AVDL)
Graphique Historique de l'Action
De Avr 2023 à Avr 2024