Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on
developing FT218, an investigational, once-nightly formulation of
sodium oxybate for treating excessive daytime sleepiness (EDS) and
cataplexy in adults with narcolepsy, today provided a corporate
update and announced its financial results for the second quarter
ended June 30, 2021.
“This quarter, we made significant progress advancing FT218,
which we believe holds tremendous potential to transform the
treatment landscape for patients as a once-at-bedtime option for
managing EDS and cataplexy in adult patients with narcolepsy. The
data presented at SLEEP 2021 demonstrates the additional benefit of
consolidating sleep, which we believe holds great promise as many
people with narcolepsy also suffer from fragmented sleep,” said
Greg Divis, Chief Executive Officer of Avadel. “As we enter the
final stages of NDA review and approach our October PDUFA date, we
remain confident in the strength of our regulatory filing strategy.
In parallel, our commercial and launch preparations are on track,
including the addition of key hires to our leadership team, and we
look forward to providing more detail on our commercial strategy
following potential approval of FT218.”
Second Quarter and Recent Company
Highlights
- Progressed preparations and launch readiness activities for the
potential commercialization of FT218 as the first and only
once-at-bedtime option for managing EDS and cataplexy in narcolepsy
- New Drug Application (NDA) for FT218 was accepted for filing by
the U.S. Food and Drug Administration (FDA) in February 2021, and
was assigned a Prescription Drug User Fee Act (PDUFA) target action
date of October 15, 2021
- Conducting scientific and medical community engagement and
education, as well as payor clinical presentations
- Presented new clinical post-hoc analyses from the pivotal Phase
3 REST-ON clinical study at SLEEP 2021 further supporting clinical
benefit of all evaluated doses of FT218, beginning as early as week
three of treatment
- Data demonstrated improvement in EDS for both narcolepsy
subtypes with and without stimulant use as well as decreases in
weight and body mass index
- Expanded leadership team with addition of established biopharma
industry leaders to support anticipated regulatory approval and
commercialization of FT218
- Appointed Jeff Cruikshank as Vice President, Sales; Denise
Strauss as Vice President, Marketing and New Product Strategy; and
Angela Woods as Vice President, People and Culture
- Progressed the RESTORE open-label extension/switch study of
FT218 designed to generate long-term safety, tolerability, and
efficacy data, as well as data on switching from twice-nightly
oxybates and patient preference
Avadel plans to present data from RESTORE study on patient
preference to once-nightly or twice-nightly dosing regimens, as
well as nocturnal experiences when using twice-nightly sodium, at
future medical congresses.
Overview of Second Quarter ResultsAs a result
of the sale of the sterile injectable products to Exela
Sterile Medicines LLC on June 30, 2020, the Company did
not report any revenue for the quarter ended June 30, 2021,
compared to $10.1 million for the same period in 2020.
R&D expenses were $6.8 million in the quarter ended June 30,
2021, compared to $4.1 million for the same period in 2020. The
increase on a year-over-year basis was primarily attributed to
increased costs associated with pre-NDA approval activities,
primarily the purchase of raw materials, in preparation for product
launch, if FT218 is approved.
SG&A expenses were $15.2 million in the quarter ended June
30, 2021, compared to $7.1 million for the same period in 2020. The
year-over-year increase is the result of a number of factors
including commercial launch planning costs related to FT218 and
higher compensation costs associated with higher headcount,
primarily in the areas of commercial and medical affairs.
Income tax benefit was $3.8 million in the quarter ended June
30, 2021, compared to income tax expense of $5.3 million for the
same period in 2020. The income tax expense recorded in 2020 was
the result of taxes recorded on the gain from the sale of the
hospital products.
Net loss for the quarter ended June 30, 2021 was $19.6 million,
or ($0.33) per diluted share, compared to net income of $30.9
million, or $0.49 per diluted share, for the same period in 2020.
The Company reported net income and diluted income per share for
the quarter ending June 30, 2020, resulting from the $45.8 million
pre-tax gain from sale of the sterile injectable products.
Cash, cash equivalents and marketable securities were $202.8
million as of June 30, 2021. The Company has convertible debt of
$143.8 million due in February 2023.
Conference CallA conference call to discuss
these results is scheduled for Monday, August 9, 2021 at 8:30 a.m.
ET. To access the conference call, investors are invited to dial
(844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International).
The conference ID number is 4560878. A live audio webcast 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.
About FT218FT218 is an investigational,
once-nightly formulation of sodium oxybate. In March of 2020, the
Company completed the REST-ON study, a pivotal, double-blind,
randomized, placebo-controlled Phase 3 trial, to assess the
efficacy and safety of FT218 in the treatment of excessive daytime
sleepiness and cataplexy in patients suffering from narcolepsy. In
December 2020, the Company submitted a New Drug Application (NDA)
to the U.S. Food and Drug Administration (FDA) for FT218 to treat
excessive daytime sleepiness and cataplexy in adults with
narcolepsy. The NDA for FT218 was accepted by the FDA in February
2021 and assigned a Prescription Drug User Fee Act (PDUFA) target
action date of October 15, 2021. FT218 has been granted Orphan Drug
Designation from the U.S. Food and Drug Administration (FDA) for
the treatment of narcolepsy. The designation was granted on the
plausible hypothesis that FT218 may be clinically superior to the
twice-nightly formulation of sodium oxybate already approved by the
FDA for the same indication. In particular, FT218 may be safer due
to ramifications associated with the dosing regimen of the
previously approved product.
About Avadel Pharmaceuticals plcAvadel
Pharmaceuticals plc (Nasdaq: AVDL) is a biopharmaceutical company
primarily focused on the development and FDA approval of FT218, an
investigational, once-nightly, extended-release formulation of
sodium oxybate designed to treat excessive daytime sleepiness and
cataplexy in adults with narcolepsy. For more information, please
visit www.avadel.com.
Cautionary Disclosure Regarding Forward-Looking
StatementsThis 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, the
FDA’s review of the NDA for FT218, the sufficiency of data
supporting the NDA for FT218, the publication of additional
clinical trial data for FT218, the commercial launch of FT218 (if
approved), the market acceptance of FT218 (if approved), and the
advancement and expected timing of the RESTORE study to generate
long-term safety, tolerability, and efficacy data for FT218. 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 risk that: positive results
from the REST-ON trial may not necessarily be predictive of the
results of future or ongoing clinical studies; the NDA for FT218 is
not approved by the FDA or such approval is delayed; the risk that
commercial launch of FT218 (if approved) is delayed or never
occurs; the risk that the potential market acceptance of FT218 (if
approved) may differ materially from projections; the risk that
FT218 may be found to infringe one or more patents of third
parties; the risk that the RESTORE study may be delayed or may not
be completed at all; and the risk that the impact of the current
COVID-19 pandemic on the Company’s financial results and results of
operations could be greater than we anticipate and 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, 2020, which was filed with the Securities and
Exchange Commission (SEC) on March 9, 2021 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:Nicole Raisch GoelzReal
Chemistryngoelz@realchemistry.com (408) 568-4292
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF (LOSS)
INCOME (In thousands, except per share
data)(Unaudited)
|
|
Three Months Ended June 30, |
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
2021 |
|
2020 |
|
|
|
|
|
|
|
|
|
|
|
Product sales |
|
$ |
— |
|
|
$ |
10,091 |
|
|
$ |
— |
|
|
$ |
22,334 |
|
|
Operating expenses: |
|
|
|
|
|
|
|
|
|
Cost of products |
|
— |
|
|
3,285 |
|
|
— |
|
|
5,742 |
|
|
Research and development expenses |
|
6,762 |
|
|
4,057 |
|
|
10,614 |
|
|
9,587 |
|
|
Selling, general and administrative expenses |
|
15,174 |
|
|
7,095 |
|
|
26,186 |
|
|
15,008 |
|
|
Intangible asset amortization |
|
— |
|
|
203 |
|
|
— |
|
|
406 |
|
|
Changes in fair value of contingent consideration |
|
— |
|
|
918 |
|
|
— |
|
|
3,396 |
|
|
Gain on sale of Hospital Products |
|
— |
|
|
(45,760 |
) |
|
— |
|
|
(45,760 |
) |
|
Restructuring costs (income) |
|
— |
|
|
24 |
|
|
(53 |
) |
|
183 |
|
|
Total operating expense (income) |
|
21,936 |
|
|
(30,178 |
) |
|
36,747 |
|
|
(11,438 |
) |
|
Operating (loss) income |
|
(21,936 |
) |
|
40,269 |
|
|
(36,747 |
) |
|
33,772 |
|
|
Investment and other income (expense), net |
|
432 |
|
|
(741 |
) |
|
1,042 |
|
|
(1,119 |
) |
|
Interest expense |
|
(1,930 |
) |
|
(3,237 |
) |
|
(3,859 |
) |
|
(6,427 |
) |
|
Gain from release of certain liabilities |
|
88 |
|
|
— |
|
|
166 |
|
|
— |
|
|
Other expense - changes in fair value of contingent consideration
payable |
|
— |
|
|
(125 |
) |
|
— |
|
|
(435 |
) |
|
(Loss) income before income taxes |
|
(23,346 |
) |
|
36,166 |
|
|
(39,398 |
) |
|
25,791 |
|
|
Income tax (benefit) expense |
|
(3,765 |
) |
|
5,292 |
|
|
(6,372 |
) |
|
(4,218 |
) |
|
Net (loss) income |
|
$ |
(19,581 |
) |
|
$ |
30,874 |
|
|
$ |
(33,026 |
) |
|
$ |
30,009 |
|
|
|
|
|
|
|
|
|
|
|
|
Net (loss) income per share - basic |
|
$ |
(0.33 |
) |
|
$ |
0.57 |
|
|
$ |
(0.56 |
) |
|
$ |
0.63 |
|
|
Net (loss) income per share - diluted |
|
(0.33 |
) |
|
0.49 |
|
|
(0.56 |
) |
|
0.58 |
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding - basic |
|
58,488 |
|
|
54,272 |
|
|
58,465 |
|
|
47,665 |
|
|
Weighted average number of shares outstanding - diluted |
|
58,488 |
|
|
69,942 |
|
|
58,465 |
|
|
63,083 |
|
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED BALANCE
SHEETS(In thousands, except per share data)
|
|
June 30, 2021 |
|
December 31, 2020 |
|
|
(unaudited) |
|
|
ASSETS |
|
|
|
|
Current assets: |
|
|
|
|
Cash and cash equivalents |
|
$ |
67,142 |
|
|
$ |
71,722 |
|
Marketable securities |
|
135,701 |
|
|
149,680 |
|
Research and development tax credit receivable |
|
2,551 |
|
|
3,326 |
|
Prepaid expenses and other current assets |
|
25,308 |
|
|
38,726 |
|
Total current assets |
|
230,702 |
|
|
263,454 |
|
Property and equipment, net |
|
321 |
|
|
359 |
|
Operating lease right-of-use assets |
|
2,249 |
|
|
2,604 |
|
Goodwill |
|
16,836 |
|
|
16,836 |
|
Research and development tax credit receivable |
|
983 |
|
|
3,445 |
|
Other non-current assets |
|
31,500 |
|
|
24,939 |
|
Total assets |
|
$ |
282,591 |
|
|
$ |
311,637 |
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS’ EQUITY |
|
|
|
|
Current liabilities: |
|
|
|
|
Current portion of operating lease liability |
|
494 |
|
|
474 |
|
Accounts payable |
|
5,116 |
|
|
2,934 |
|
Accrued expenses |
|
7,524 |
|
|
6,501 |
|
Other current liabilities |
|
3,146 |
|
|
5,200 |
|
Total current liabilities |
|
16,280 |
|
|
15,109 |
|
Long-term debt |
|
141,774 |
|
|
128,210 |
|
Long-term operating lease liability |
|
1,589 |
|
|
1,840 |
|
Other non-current liabilities |
|
4,068 |
|
|
4,212 |
|
Total liabilities |
|
163,711 |
|
|
149,371 |
|
|
|
|
|
|
Shareholders’ equity: |
|
|
|
|
Preferred shares, nominal value of $0.01 per share; 50,000 shares
authorized; 488issued and outstanding at June 30, 2021 and 488
issued and outstanding atDecember 31, 2020, respectively |
|
5 |
|
|
5 |
|
Ordinary shares, nominal value of $0.01 per share; 500,000 shares
authorized;58,488 issued and outstanding at June 30, 2021 and
58,396 issued and outstandingat December 31, 2020 |
|
584 |
|
|
583 |
|
Additional paid-in capital |
|
544,094 |
|
|
566,916 |
|
Accumulated deficit |
|
(403,453 |
) |
|
(384,187 |
) |
Accumulated other comprehensive loss |
|
(22,350 |
) |
|
(21,051 |
) |
Total shareholders’ equity |
|
118,880 |
|
|
162,266 |
|
Total liabilities and shareholders’ equity |
|
$ |
282,591 |
|
|
$ |
311,637 |
|
|
|
|
|
|
AVADEL PHARMACEUTICALS
PLCCONDENSED CONSOLIDATED STATEMENTS OF CASH
FLOWS(In thousands)(Unaudited)
|
|
|
|
|
Six Months Ended June 30, |
|
|
2021 |
|
2020 |
|
|
|
|
|
Cash flows from operating activities: |
|
|
|
|
Net (loss) income |
|
$ |
(33,026 |
) |
|
$ |
30,009 |
|
Adjustments to reconcile net (loss) income to net cash provided by
operating activities: |
|
|
|
|
Depreciation and amortization |
|
417 |
|
|
975 |
|
Remeasurement of acquisition-related contingent consideration |
|
— |
|
|
3,396 |
|
Remeasurement of financing-related contingent consideration |
|
— |
|
|
435 |
|
Amortization of debt discount and debt issuance costs |
|
625 |
|
|
3,193 |
|
Change in deferred tax and income tax deferred charge |
|
(6,228 |
) |
|
161 |
|
Stock-based compensation expense |
|
3,729 |
|
|
1,511 |
|
Gain on the disposition of the hospital products |
|
— |
|
|
(45,760 |
) |
Gain from the release of certain liabilities |
|
(166 |
) |
|
— |
|
Other adjustments |
|
757 |
|
|
477 |
|
Net changes in assets and liabilities |
|
|
|
|
Accounts receivable |
|
— |
|
|
2,589 |
|
Inventories |
|
— |
|
|
(1,353 |
) |
Prepaid expenses and other current assets |
|
(3,106 |
) |
|
(1,149 |
) |
Research and development tax credit receivable |
|
3,078 |
|
|
2,036 |
|
Accounts payable & other current liabilities |
|
176 |
|
|
(1,550 |
) |
Accrued expenses |
|
1,199 |
|
|
(6,906 |
) |
Accrued income taxes |
|
— |
|
|
321 |
|
Earn-out payments for contingent consideration in excess of
acquisition-date fair value |
|
— |
|
|
(3,736 |
) |
Royalty payments for contingent consideration payable in excess of
original fair value |
|
— |
|
|
(608 |
) |
Other assets and liabilities |
|
(1,021 |
) |
|
(3,458 |
) |
Net cash used in operating activities |
|
(33,566 |
) |
|
(19,417 |
) |
|
|
|
|
|
Cash flows from investing activities: |
|
|
|
|
Purchases of property and equipment |
|
(26 |
) |
|
— |
|
Proceeds from the disposition of the hospital products |
|
16,500 |
|
|
14,500 |
|
Proceeds from sales of marketable securities |
|
66,213 |
|
|
15,716 |
|
Purchases of marketable securities |
|
(53,372 |
) |
|
(97,878 |
) |
Net cash provided by (used in) investing activities |
|
29,315 |
|
|
(67,662 |
) |
|
|
|
|
|
Cash flows from financing activities: |
|
|
|
|
Proceeds from the February 2020 private placement |
|
— |
|
|
60,639 |
|
Proceeds from the May 2020 public offering |
|
— |
|
|
116,974 |
|
Proceeds from stock option exercises and employee stock purchase
plan |
|
149 |
|
|
1,903 |
|
Net cash provided by financing activities |
|
149 |
|
|
179,516 |
|
|
|
|
|
|
Effect of foreign currency exchange rate changes on cash and cash
equivalents |
|
(478 |
) |
|
(37 |
) |
|
|
|
|
|
Net change in cash and cash equivalents |
|
(4,580 |
) |
|
92,400 |
|
Cash and cash equivalents at January 1, |
|
71,722 |
|
|
9,774 |
|
Cash and cash equivalents at June 30, |
|
$ |
67,142 |
|
|
$ |
102,174 |
|
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