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 September 30, 2024.
“Over a year ago, we set out on our mission to
transform the lives of those living with narcolepsy, including
expanding the oxybate market through the introduction of LUMRYZ.
This quarter, we are proud to see that expansion come to fruition
and continue to be encouraged by patient uptake and
quarter-over-quarter growth of LUMRYZ. In parallel to our launch in
adults with narcolepsy, we are expanding into additional patient
populations, starting with the recent FDA approval of LUMRYZ for
the treatment of cataplexy or EDS in patients 7 years and older
with narcolepsy, significantly alleviating the burden on patients
and their caregivers of waking up in the middle of the night to
administer treatment,” stated Greg Divis, Chief Executive Officer
of Avadel Pharmaceuticals. “We are also pleased with the recent
court ruling affirming FDA’s determination that LUMRYZ, dosed once
at bedtime, demonstrates clinical superiority to twice-nightly
oxybates, which mitigates an important legal and business risk for
the company. With our Phase 3 pivotal trial in IH ongoing, our
continued execution of the LUMRYZ launch including our expansion of
LUMRYZ into pediatric narcolepsy, we are closing in our business
objectives of being a leader in the sleep field and fulfilling the
promise of LUMRYZ for all stakeholders.”
Third Quarter and Recent Company
Highlights
LUMRYZ Commercial
Updates:
- Generated $50.0 million of net product
revenue from sales of LUMRYZ in the third quarter of 2024.
- As of September 30, there were 2,300
patients on LUMRYZ compared to 1,900 patients on LUMRYZ at June 30.
- In the third quarter, generated
consistent patient demand for LUMRYZ with 700 patients initiating
therapy.
- Observed continuing growth in demand
from patients who are new to oxybate – these patients represent the
fastest growing patient segment for LUMRYZ.
Corporate and Pipeline
Updates:
- On October 30, 2024, the U.S. District
Court for the District of Columbia ruled in favor of the U.S. Food
and Drug Administration (FDA) in a suit brought by Jazz
Pharmaceuticals Inc. under the Administrative Procedure Act
regarding the FDA’s approval of LUMRYZ.
- With this ruling, the approval of
LUMRYZ is upheld based on the FDA’s determination that LUMRYZ is
clinically superior to Jazz’s twice-nightly oxybate products.
- On October 16, 2024, the FDA approved
LUMRYZ for the treatment of cataplexy or excessive daytime
sleepiness (EDS) in patients 7 years or older with narcolepsy.
- LUMRYZ was granted Orphan Drug
Exclusivity (ODE) for this patient population through October 16,
2031.
- Patient enrollment is ongoing in the
REVITALYZ pivotal study, a Phase 3 double-blind,
placebo-controlled, randomized withdrawal, multicenter study
designed to evaluate the efficacy and safety of LUMRYZ in
idiopathic hypersomnia (IH).
- During the quarter ended September 30,
2024, announced publication of results of:
- A post-hoc analysis showing consistent
efficacy in participants currently taking alerting agents,
highlighting the benefit of LUMRYZ to augment response, as well as
the 37% who responded positively based upon LUMRYZ
monotherapy.
- Data from the RESTORE open-label
study, based upon the largest cohort of switch patients, in which
94% preferred the once-nightly dosing regimen and 93% who would
recommend LUMRYZ to a friend or family member with narcolepsy.
- A post-hoc analysis demonstrating
weight loss associated with LUMRYZ compared to placebo, and
shifting from obese category into overweight and overweight into
normal BMI categories.
Overview of Third Quarter Financial
Results
Recognized $50.0 million in net product revenue for
the third quarter 2024 compared to $7.0 million in the same period
in 2023. Net product revenue consists of LUMRYZ product sales,
which was launched in the U.S. on June 5, 2023.
Gross profit for the third quarter 2024 was $43.9
million compared to $6.9 million in the same period in 2023.
Total operating expenses were $44.2 million in the
quarter ended September 30, 2024 compared to $42.0 million in the
same period in 2023. The current quarter operating expenses incudes
$6.4 million of non-cash charges comprised of $5.4 million of stock
based compensation expense and $1.0 million of depreciation and
amortization.
Selling, general and administrative (SG&A)
expenses were $40.4 million in the quarter ended September 30,
2024, compared to $39.2 million for the same period in 2023.
Research and development (R&D) expenses were
$3.8 million in the quarter ended September 30, 2024, compared to
$2.8 million for the same period in 2023. R&D expenses in the
current period include clinical study costs related to the Phase 3
pivotal trial in IH.
Operating loss was $0.3 million for the quarter
ended September 30, 2024 compared to $35.1 million in the same
period in 2023.
Net loss for the quarter ended September 30, 2024,
was $2.6 million, or ($0.03) per diluted share, compared to a net
loss of $36.3 million, or ($0.41) per diluted share, for the same
period in 2023.
Cash, cash equivalents and marketable securities
were $65.8 million as of September 30, 2024. Cash used in the
quarter ended September 30, 2024 included the payment of a $2.0
million commitment fee due to the decision to not draw the second
financing tranche that was available under the royalty financing
agreement entered into in March 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. To access the
conference call, investors are invited to dial (800) 579-2543 (U.S.
and International) and reference the conference ID AVADEL.
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. On October 16,
2024, LUMRYZ was additionally approved as a once-at-bedtime
treatment for cataplexy or EDS in patients 7 years and older 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 (MWT),
clinicians’ overall assessment of patients’ functioning (CGI-I),
and cataplexy attacks, for all three evaluated doses when compared
to placebo.
With its approval in May 2023 and in October 2024,
the FDA also granted 7 years of Orphan Drug Exclusivity to LUMRYZ
for the treatment of cataplexy or EDS in adults with narcolepsy and
pediatric patients 7 years and older with narcolepsy (respectively)
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 EDS in patients 7 years
and older with narcolepsy. For more information, please visit
www.avadel.com
Avadel intends to use its Investor Relations
website as a means of disclosing material nonpublic information and
for complying with its disclosure obligations under Regulation FD.
Accordingly, investors should monitor the Company’s Investor
Relations website, in addition to following the Company’s press
releases, SEC filings, public conference calls, presentations, and
webcast.
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 patients 7 years and older
with narcolepsy:
- sudden onset of weak
or paralyzed muscles (cataplexy)
- excessive daytime
sleepiness (EDS)
Do not take LUMRYZ if you take or your
child takes 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 or your child 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 or your child have or had
depression or have tried to harm yourself. Call your doctor
right away if you or your child have symptoms of mental health
problems or a change in weight or appetite.
-
Sleepwalking. Sleepwalking can cause injuries.
Call your doctor if you or your child start sleepwalking.
Tell your doctor if you or your child are on a
salt-restricted diet or 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. The
most common side effects in children include nausea, bedwetting,
vomiting, headache, decreased weight, decreased appetite,
dizziness, and sleepwalking. 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
http://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 and expansion into
additional patient populations; the anticipated market demand and
sales opportunity of LUMRYZ; the potential for the Company to be a
leader in the market; the Company’s idiopathic hypersomnia clinical
study for LUMRYZ, including enrollment 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
MogerleyPrecision AQCourtney.Mogerley@precisionAQ.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 September 30, |
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
|
|
|
|
Net product revenue |
|
$ |
50,025 |
|
|
$ |
7,014 |
|
|
$ |
118,707 |
|
|
$ |
8,510 |
|
Cost of products sold |
|
|
6,155 |
|
|
|
117 |
|
|
|
10,465 |
|
|
|
153 |
|
Gross profit |
|
|
43,870 |
|
|
|
6,897 |
|
|
|
108,242 |
|
|
|
8,357 |
|
Operating expenses: |
|
|
|
|
|
|
|
|
Research and development expenses |
|
|
3,803 |
|
|
|
2,849 |
|
|
|
10,922 |
|
|
|
10,902 |
|
Selling, general and administrative expenses |
|
|
40,394 |
|
|
|
39,158 |
|
|
|
136,422 |
|
|
|
110,404 |
|
Total operating expense |
|
|
44,197 |
|
|
|
42,007 |
|
|
|
147,344 |
|
|
|
121,306 |
|
Operating loss |
|
|
(327 |
) |
|
|
(35,110 |
) |
|
|
(39,102 |
) |
|
|
(112,949 |
) |
Investment and other income, net |
|
|
610 |
|
|
|
903 |
|
|
|
3,114 |
|
|
|
1,719 |
|
Interest expense |
|
|
(2,820 |
) |
|
|
(1,978 |
) |
|
|
(8,128 |
) |
|
|
(7,532 |
) |
Loss on extinguishment of debt |
|
|
— |
|
|
|
— |
|
|
|
— |
|
|
|
(13,129 |
) |
Loss before income taxes |
|
|
(2,537 |
) |
|
|
(36,185 |
) |
|
|
(44,116 |
) |
|
|
(131,891 |
) |
Income tax provision (benefit) |
|
|
88 |
|
|
|
89 |
|
|
|
(327 |
) |
|
|
(401 |
) |
Net loss |
|
$ |
(2,625 |
) |
|
$ |
(36,274 |
) |
|
$ |
(43,789 |
) |
|
$ |
(131,490 |
) |
|
|
|
|
|
|
|
|
|
Net loss per share -
basic |
|
$ |
(0.03 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.46 |
) |
|
$ |
(1.71 |
) |
Net loss per share -
diluted |
|
$ |
(0.03 |
) |
|
$ |
(0.41 |
) |
|
$ |
(0.46 |
) |
|
$ |
(1.71 |
) |
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding - basic |
|
|
96,300 |
|
|
|
89,380 |
|
|
|
94,720 |
|
|
|
76,931 |
|
Weighted average number of
shares outstanding - diluted |
|
|
96,300 |
|
|
|
89,380 |
|
|
|
94,720 |
|
|
|
76,931 |
|
|
AVADEL PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED BALANCE SHEETS(In thousands, except per share
data) |
|
|
|
September 30, 2024 |
|
December 31, 2023 |
|
|
(Unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
28,582 |
|
|
$ |
31,167 |
|
Marketable securities |
|
|
37,225 |
|
|
|
73,944 |
|
Accounts receivable, net |
|
|
37,102 |
|
|
|
12,103 |
|
Inventories |
|
|
16,097 |
|
|
|
10,380 |
|
Prepaid expenses and other current assets |
|
|
8,252 |
|
|
|
6,608 |
|
Total current assets |
|
|
127,258 |
|
|
|
134,202 |
|
Property and equipment, net |
|
|
469 |
|
|
|
585 |
|
Operating lease right-of-use assets |
|
|
1,930 |
|
|
|
2,591 |
|
Goodwill |
|
|
16,836 |
|
|
|
16,836 |
|
Other non-current assets |
|
|
11,760 |
|
|
|
10,484 |
|
Total assets |
|
$ |
158,253 |
|
|
$ |
164,698 |
|
|
|
|
|
|
LIABILITIES AND
SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of operating lease liability |
|
$ |
725 |
|
|
$ |
934 |
|
Accounts payable |
|
|
7,917 |
|
|
|
11,433 |
|
Accrued expenses |
|
|
33,907 |
|
|
|
24,227 |
|
Other current liabilities |
|
|
234 |
|
|
|
261 |
|
Total current liabilities |
|
|
42,783 |
|
|
|
36,855 |
|
Long-term operating lease liability |
|
|
1,216 |
|
|
|
1,690 |
|
Royalty financing obligation |
|
|
34,437 |
|
|
|
32,760 |
|
Other non-current liabilities |
|
|
5,154 |
|
|
|
5,654 |
|
Total liabilities |
|
|
83,590 |
|
|
|
76,959 |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; zero issued and outstanding at September 30, 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; 96,338 issued and outstanding at September 30,
2024 and 89,825 issued and outstanding at December 31,
2023 |
|
|
963 |
|
|
|
898 |
|
Additional paid-in capital |
|
|
886,787 |
|
|
|
855,452 |
|
Accumulated deficit |
|
|
(789,285 |
) |
|
|
(745,496 |
) |
Accumulated other comprehensive loss |
|
|
(23,802 |
) |
|
|
(23,167 |
) |
Total shareholders’ equity |
|
|
74,663 |
|
|
|
87,739 |
|
Total liabilities and
shareholders’ equity |
|
$ |
158,253 |
|
|
$ |
164,698 |
|
|
AVADEL PHARMACEUTICALS PLCCONDENSED
CONSOLIDATED STATEMENTS OF CASH FLOWS(In
thousands)(Unaudited) |
|
|
|
Nine Months Ended September 30, |
|
|
|
2024 |
|
|
|
2023 |
|
|
|
|
|
|
Cash flows from
operating activities: |
|
|
|
|
Net loss |
|
$ |
(43,789 |
) |
|
$ |
(131,490 |
) |
Adjustments to reconcile net loss to net cash used in operating
activities: |
|
|
|
|
Depreciation and amortization |
|
|
2,013 |
|
|
|
1,784 |
|
Amortization of debt discount and debt issuance costs |
|
|
— |
|
|
|
2,796 |
|
Share-based compensation expense |
|
|
16,261 |
|
|
|
12,293 |
|
Loss on extinguishment of debt |
|
|
— |
|
|
|
13,129 |
|
Other adjustments |
|
|
(1,052 |
) |
|
|
(349 |
) |
Net changes in assets and liabilities |
|
|
|
|
Accounts receivable |
|
|
(24,999 |
) |
|
|
(6,239 |
) |
Inventories |
|
|
(5,255 |
) |
|
|
(5,286 |
) |
Prepaid expenses and other current assets |
|
|
(1,615 |
) |
|
|
(3,203 |
) |
Accounts payable & other current liabilities |
|
|
(3,516 |
) |
|
|
3,837 |
|
Accrued expenses |
|
|
9,680 |
|
|
|
10,621 |
|
Other assets and liabilities |
|
|
(2,508 |
) |
|
|
1,625 |
|
Net cash used in operating
activities |
|
|
(54,780 |
) |
|
|
(100,482 |
) |
|
|
|
|
|
Cash flows from
investing activities: |
|
|
|
|
Proceeds from sales of marketable securities |
|
|
298,829 |
|
|
|
125,498 |
|
Purchases of marketable securities |
|
|
(261,962 |
) |
|
|
(203,519 |
) |
Net cash provided by (used in)
investing activities |
|
|
36,867 |
|
|
|
(78,021 |
) |
|
|
|
|
|
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 |
) |
Proceeds from royalty purchase agreement |
|
|
— |
|
|
|
30,000 |
|
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 |
|
|
5,840 |
|
|
|
2,241 |
|
Net cash provided by financing
activities |
|
|
15,090 |
|
|
|
156,446 |
|
|
|
|
|
|
Effect of foreign currency
exchange rate changes on cash and cash equivalents |
|
|
238 |
|
|
|
(113 |
) |
|
|
|
|
|
Net change in cash and cash
equivalents |
|
|
(2,585 |
) |
|
|
(22,170 |
) |
Cash and cash equivalents at
January 1, |
|
|
31,167 |
|
|
|
73,981 |
|
Cash and cash equivalents at
September 30, |
|
$ |
28,582 |
|
|
$ |
51,811 |
|
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