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 third quarter ended September 30, 2023.
“We are very pleased with the significant progress we made
during the first full quarter of the launch of LUMRYZ, underscored
by the early patient demand and the overwhelmingly positive
feedback received from across the narcolepsy community. Our team
continues to execute on our launch plan, actively engaging with all
stakeholders, driving patient enrollments, converting RYZUP
enrollments to patients on therapy, and securing key coverage
policy decisions with payers, such as the recent CVS decision to
move LUMRYZ to preferred status effective January 1, 2024,” said
Greg Divis, Chief Executive Officer of Avadel Pharmaceuticals. “We
are building on the momentum we saw during the quarter, as we
continue our mission to transform the lives of those living with
narcolepsy. This includes the recently completed submission of our
supplemental NDA for LUMRYZ in the pediatric population, which, if
approved, will allow us to bring LUMRYZ to eligible children living
with narcolepsy and expand the reach of LUMRYZ.”
Third Quarter and Recent Company Highlights
LUMRYZ Commercial Updates:
- Launch progress through September 30, 2023:
- Generated $7 million of LUMRYZ net revenue in the first full
quarter of launch.
- Greater than 1,000 patients enrolled in Avadel’s RYZUP patient
support services:
- More than 400 patients initiated therapy with LUMRYZ during
Q3.
- Approximately 600 patients remained in the RYZUP process, going
through the benefits investigation or pending their first
shipment.
- RYZUP enrollments and patients currently being treated with
LUMRYZ includes majority switch patients from first generation
oxybates, followed by patients who previously tried and
discontinued a first generation oxybate, and patients who are new
to oxybates.
- Secured LUMRYZ coverage policies for over 100 million
commercial lives representing approximately 60% of the total
commercially insured lives across the country.
- Announced that LUMRYZ is moving to preferred status within the
CVS commercial formularies effective January 1, 2024.
- Nearly 1,400 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:
- Submitted Supplemental New Drug Application (sNDA) to the U.S.
Food and Drug Administration (FDA) for LUMRYZ for treatment of
cataplexy or EDS in the pediatric narcolepsy population on November
7, 2023. An approval decision is expected in the second half of
2024.
- LUMRYZ has the potential to significantly 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.
Clinical Updates:
- In October, announced new and encore data supporting the
clinical profile for LUMRYZ and patient preference for a
once-nightly oxybate in 15 poster presentations and two oral
presentations, at World Sleep 2023.
- New post-hoc analyses demonstrated the robust clinical efficacy
of LUMRYZ and provided further insight into the improvements on
measures of excessive daytime sleepiness (EDS) and cataplexy
compared with placebo in different demographic and clinical
subgroups.
- Post-hoc analyses reinforced data from
the completed pivotal Phase 3 REST-ON trial, demonstrating that
treatment with LUMRYZ resulted in statistically significant and
clinically meaningful improvement in EDS.
- RESTORE study poster demonstrated
long-term tolerability and clinically significant improvement in
symptoms.
Overview of Third Quarter Results
Recognized $7.0 million in net product revenue for the quarter
ended September 30, 2023. Net product revenue consists of LUMRYZ
product sales, which was launched in the U.S. on June 5, 2023.
R&D expenses were $2.8 million in the quarter ended
September 30, 2023, compared to $2.9 million for the same period in
2022.
SG&A expenses were $39.2 million in the quarter ended
September 30, 2023, compared to $14.1 million for the same period
in 2022. This increase was driven by higher compensation costs due
to increased headcount, higher selling and marketing and
launch-related activities and higher legal fees.
Net loss for the quarter ended September 30, 2023, was $36.3
million, or ($0.41) per diluted share, compared to net loss of
$20.1 million, or ($0.33) per diluted share, for the same period in
2022.
Cash, cash equivalents and marketable securities were $153.2
million as of September 30, 2023. The Company drew the first $30.0
million tranche from a $75.0 million royalty financing arrangement
on August 1, 2023. Subsequent to September 30, 2023, the Company
paid off the remaining $21.2 million of convertible notes.
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 acceptability for filing and FDA’s
review of the sNDA for such population; the potential benefits of
payor coverage, including CVS preferred status; 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 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: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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
7,014 |
|
|
$ |
— |
|
|
$ |
8,510 |
|
|
$ |
— |
|
Cost of products sold |
|
|
117 |
|
|
|
— |
|
|
|
153 |
|
|
|
— |
|
Gross profit |
|
|
6,897 |
|
|
|
— |
|
|
|
8,357 |
|
|
|
— |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
2,849 |
|
|
|
2,933 |
|
|
|
10,902 |
|
|
|
14,465 |
|
Selling, general and administrative expenses |
|
|
39,158 |
|
|
|
14,096 |
|
|
|
110,404 |
|
|
|
57,535 |
|
Restructuring (income) expense |
|
|
— |
|
|
|
(69 |
) |
|
|
— |
|
|
|
3,523 |
|
Total operating expense |
|
|
42,007 |
|
|
|
16,960 |
|
|
|
121,306 |
|
|
|
75,523 |
|
Operating loss |
|
|
(35,110 |
) |
|
|
(16,960 |
) |
|
|
(112,949 |
) |
|
|
(75,523 |
) |
Investment and other income, net |
|
|
903 |
|
|
|
448 |
|
|
|
1,719 |
|
|
|
536 |
|
Interest expense |
|
|
(1,978 |
) |
|
|
(3,564 |
) |
|
|
(7,532 |
) |
|
|
(9,087 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
(13,129 |
) |
|
|
— |
|
Loss before income taxes |
|
|
(36,185 |
) |
|
|
(20,076 |
) |
|
|
(131,891 |
) |
|
|
(84,074 |
) |
Income tax provision (benefit) |
|
|
89 |
|
|
|
70 |
|
|
|
(401 |
) |
|
|
25,940 |
|
Net
loss |
|
$ |
(36,274 |
) |
|
$ |
(20,146 |
) |
|
$ |
(131,490 |
) |
|
$ |
(110,014 |
) |
|
|
|
|
|
|
|
|
|
Net
loss per share – basic |
|
$ |
(0.41 |
) |
|
$ |
(0.33 |
) |
|
$ |
(1.71 |
) |
|
$ |
(1.85 |
) |
Net
loss per share – diluted |
|
|
(0.41 |
) |
|
|
(0.33 |
) |
|
|
(1.71 |
) |
|
|
(1.85 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding - basic |
|
|
89,380 |
|
|
|
60,201 |
|
|
|
76,931 |
|
|
|
59,359 |
|
Weighted average number of shares outstanding - diluted |
|
|
89,380 |
|
|
|
60,201 |
|
|
|
76,931 |
|
|
|
59,359 |
|
AVADEL PHARMACEUTICALS PLC |
CONDENSED CONSOLIDATED BALANCE SHEETS |
(In thousands, except per share data) |
|
|
|
September 30, 2023 |
|
December 31, 2022 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
51,811 |
|
|
$ |
73,981 |
|
Marketable securities |
|
|
101,368 |
|
|
|
22,518 |
|
Accounts receivable, net |
|
|
6,239 |
|
|
|
— |
|
Inventories |
|
|
5,286 |
|
|
|
— |
|
Research and development tax credit receivable |
|
|
1,199 |
|
|
|
2,248 |
|
Prepaid expenses and other current assets |
|
|
6,352 |
|
|
|
2,096 |
|
Total current assets |
|
|
172,255 |
|
|
|
100,843 |
|
Property and equipment, net |
|
|
648 |
|
|
|
839 |
|
Operating lease right-of-use assets |
|
|
2,804 |
|
|
|
1,713 |
|
Goodwill |
|
|
16,836 |
|
|
|
16,836 |
|
Research and development tax credit receivable |
|
|
409 |
|
|
|
1,232 |
|
Other non-current assets |
|
|
10,148 |
|
|
|
11,322 |
|
Total assets |
|
$ |
203,100 |
|
|
$ |
132,785 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY
(DEFICIT) |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of long-term debt |
|
$ |
21,187 |
|
|
$ |
37,668 |
|
Current portion of operating lease liability |
|
|
916 |
|
|
|
960 |
|
Accounts payable |
|
|
13,263 |
|
|
|
7,890 |
|
Accrued expenses |
|
|
17,957 |
|
|
|
7,334 |
|
Other current liabilities |
|
|
731 |
|
|
|
1,941 |
|
Total current liabilities |
|
|
54,054 |
|
|
|
55,793 |
|
Long-term debt |
|
|
— |
|
|
|
91,614 |
|
Long-term operating lease liability |
|
|
1,928 |
|
|
|
780 |
|
Royalty financing obligation |
|
|
31,151 |
|
|
|
— |
|
Other non-current liabilities |
|
|
5,818 |
|
|
|
5,743 |
|
Total liabilities |
|
|
92,951 |
|
|
|
153,930 |
|
|
|
|
|
|
Shareholders’ equity (deficit): |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; 5,194 issued and outstanding at September 30, 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; 89,398 issued and outstanding at September 30,
2023 and 62,878 issued and outstanding at December 31,
2022 |
|
|
893 |
|
|
|
628 |
|
Additional paid-in capital |
|
|
851,865 |
|
|
|
589,783 |
|
Accumulated deficit |
|
|
(716,710 |
) |
|
|
(585,220 |
) |
Accumulated other comprehensive loss |
|
|
(25,951 |
) |
|
|
(26,341 |
) |
Total shareholders’ equity (deficit) |
|
|
110,149 |
|
|
|
(21,145 |
) |
Total liabilities and shareholders’ equity (deficit) |
|
$ |
203,100 |
|
|
$ |
132,785 |
|
AVADEL PHARMACEUTICALS PLC |
CONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS |
(In thousands) |
(Unaudited) |
|
|
|
Nine Months Ended September 30, |
|
|
|
2023 |
|
|
|
2022 |
|
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net loss |
|
$ |
(131,490 |
) |
|
$ |
(110,014 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
1,784 |
|
|
|
907 |
|
Amortization of debt discount and debt issuance costs |
|
|
2,796 |
|
|
|
4,147 |
|
Changes in deferred taxes |
|
|
— |
|
|
|
25,916 |
|
Share-based compensation expense |
|
|
12,293 |
|
|
|
5,086 |
|
Loss on extinguishment of debt |
|
|
13,129 |
|
|
|
— |
|
Other adjustments |
|
|
(349 |
) |
|
|
1,506 |
|
Net changes in assets and liabilities |
|
|
|
|
Accounts receivable |
|
|
(6,239 |
) |
|
|
— |
|
Inventories |
|
|
(5,286 |
) |
|
|
— |
|
Prepaid expenses and other current assets |
|
|
(4,277 |
) |
|
|
27,948 |
|
Research and development tax credit receivable |
|
|
1,918 |
|
|
|
27 |
|
Accounts payable & other current liabilities |
|
|
3,837 |
|
|
|
(11,629 |
) |
Accrued expenses |
|
|
10,621 |
|
|
|
4,277 |
|
Other assets and liabilities |
|
|
781 |
|
|
|
(3,109 |
) |
Net
cash used in operating activities |
|
|
(100,482 |
) |
|
|
(54,938 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
|
— |
|
|
|
(716 |
) |
Proceeds from sales of marketable securities |
|
|
125,498 |
|
|
|
59,873 |
|
Purchases of marketable securities |
|
|
(203,519 |
) |
|
|
(2,334 |
) |
Net
cash (used in) provided by investing activities |
|
|
(78,021 |
) |
|
|
56,823 |
|
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
Proceeds from April 2023 public offering, net of issuance
costs |
|
|
134,149 |
|
|
|
— |
|
Payments for February 2023 Notes |
|
|
(17,500 |
) |
|
|
— |
|
Payments for debt issuance costs |
|
|
(4,357 |
) |
|
|
(4,803 |
) |
Proceeds from royalty purchase agreement |
|
|
30,000 |
|
|
|
— |
|
Proceeds from issuance of shares off the at-the-market offering
program |
|
|
11,913 |
|
|
|
10,532 |
|
Proceeds from stock option exercises and employee share purchase
plan |
|
|
2,241 |
|
|
|
2,192 |
|
Net
cash provided by financing activities |
|
|
156,446 |
|
|
|
7,921 |
|
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
|
(113 |
) |
|
|
201 |
|
|
|
|
|
|
Net
change in cash and cash equivalents |
|
|
(22,170 |
) |
|
|
10,007 |
|
Cash and cash equivalents at January 1, |
|
|
73,981 |
|
|
|
50,708 |
|
Cash and cash equivalents at September 30, |
|
$ |
51,811 |
|
|
$ |
60,715 |
|
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