Scilex Holding Company Generates Record Monthly Revenue In October 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended October 2023, And Year-To-Date Through October 31, 2023, Based On Currently
01 Novembro 2023 - 10:00AM
Scilex Holding Company (Nasdaq: SCLX, “Scilex” or “Company”), an
innovative revenue-generating company focused on acquiring,
developing and commercializing non-opioid pain management products
for the treatment of acute and chronic pain, announced record
monthly revenue in October 2023 for ZTlido and provided certain
preliminary unaudited financial results for gross and net sales for
the one month ended October 2023 and year-to-date through October
31, 2023.
The Company estimates that:
- Record ZTlido gross sales for October 2023 were in the range of
$14.5 million to $15.5 million with record year-to-date gross sales
through October 2023 in the range of $110.0 million to $120.0
million, compared to $74.8 million for year-to-date through October
2022, representing growth in the range of 47% to 60%. Full year
gross sales for ZTlido in 2022 were $96.0 million.
- ZTlido net sales for October 2023 were in the range of $4.0
million to $5.0 million with year-to-date net sales through October
2023 in the range of $35.0 million to $40.0 million, compared to
$30.4 million for year-to-date through October 2022, representing
growth in the range of 15% to 32%. Full year net sales for ZTlido
in 2022 were $38.0 million.
- Total product gross sales for October 2023 were in the range of
$15.5 million to $16.5 million with year-to-date total product
gross sales through October 2023 in the range of $115.0 million to
$125.0 million, compared to $74.8 million for year-to-date through
October 2022, representing growth in the range of 54% to 67%.
- Total product net sales for October 2023 were in the range of
$4.0 million to $5.0 million with year-to-date total product net
sales through October 2023 in the range of $35.0 million to $40.0
million, compared to $30.4 million for year-to-date October 2022,
representing growth in the range of 15% to 32%.
About Scilex Holding Company
Scilex Holding Company is an innovative revenue-generating
company focused on acquiring, developing and commercializing
non-opioid pain management products for the treatment of acute and
chronic pain. Scilex is uncompromising in its focus to become the
global pain management leader committed to social, environmental,
economic, and ethical principles to responsibly develop
pharmaceutical products to maximize quality of life. Results from
the Phase III Pivotal Trial C.L.E.A.R. Program for SEMDEXA™, its
novel, non-opioid product for the treatment of lumbosacral
radicular pain (sciatica), were announced in March 2022. Scilex
participated in the type C meeting for purposes of pre-NDA
discussion with the FDA and reached agreement on the path forward
to file an NDA for SP-102 (SEMDEXA™) in Lumbosacral Radicular Pain
(Sciatica) with the FDA. Scilex targets indications with high unmet
needs and large market opportunities with non-opioid therapies for
the treatment of patients with moderate to severe pain.
Scilex launched its first commercial product ZTlido® in October
2018, in-licensed a commercial product Gloperba® in June 2022, and
launched its third FDA-approved product Elyxyb™ in April 2023.
It is also developing its late-stage pipeline, which includes a
pivotal Phase 3 candidate, and one Phase 2 and one Phase 1
candidate. Its commercial product, ZTlido® (lidocaine topical
system) 1.8%, or ZTlido®, is a prescription lidocaine topical
product approved by the U.S. Food and Drug Administration for the
relief of pain associated with post-herpetic neuralgia, which is a
form of post-shingles nerve pain. Scilex in-licensed the
exclusive right to commercialize Gloperba® (colchicine USP) oral
solution, an FDA-approved prophylactic treatment for painful gout
flares in adults, in the U.S. Scilex in-licensed the exclusive
rights to commercialize Elyxyb™ (celecoxib oral solution) in
the U.S. and Canada, the only FDA-approved ready-to-use oral
solution for the acute treatment of migraine, with or without aura,
in adults. Scilex launched Elyxyb™ in April 2023, and is
planning to commercialize Gloperba® by 2024, and is well-positioned
to market and distribute those products. Scilex’s three product
candidates are SP-102 (injectable dexamethasone sodium phosphate
viscous gel product containing 10 mg dexamethasone), or SEMDEXA™, a
Phase 3, novel, viscous gel formulation of a widely used
corticosteroid for epidural injections to treat lumbosacral
radicular pain, or sciatica, with FDA Fast Track status; SP-103
(lidocaine topical system) 5.4%, a Phase 2 study, triple-strength
formulation of ZTlido®, for the treatment of chronic neck pain,
with FDA Fast Track status. We received our SP-103 Phase 2 top-line
results in August 2023 and the trial achieved its objectives
characterizing safety, tolerability and preliminary efficacy of
SP-103 in acute low back pain associated with muscle spasms. SP-103
was safe and well-tolerated. Increase of lidocaine load in topical
system by three times, compared with approved ZTlido, 5.4% vs.
1.8%, did not result in signs of systemic toxicity or increased
application site reactions with daily applications over one month
treatment. We will continue to analyze the SP-103 Phase 2 trial
data along with a recently completed investigator study of ZTlido
in patients with chronic neck pain which also has showed promising
top-line efficacy and safety results. Scilex is planning to
initiate Phase 2/3 trial in chronic neck pain in 2024; and SP-104,
4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride
(DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia
that has completed multiple Phase 1 trial programs and is expected
to initiate Phase 2 trials in 2024.
Scilex Holding Company is headquartered in Palo Alto,
California.
Forward-Looking Statements
This press release and any statements made for and during any
presentation or meeting concerning the matters discussed in this
press release contain forward-looking statements related to Scilex
and its subsidiaries under the safe harbor provisions of Section
21E of the Private Securities Litigation Reform Act of 1995 and are
subject to risks and uncertainties that could cause actual results
to differ materially from those projected. Forward-looking
statements include statements regarding the Company’s preliminary
unaudited financial results for the one month ended October 31,
2023, and year-to-date through October 31, 2023, Scilex’s plans to
initiate a Phase 2/3 trial in chronic neck pain in 2024 and plans
to initiate Phase 2 trials in 2024 for SP-104, Scilex’s belief that
it is well positioned to continue its growth over the next several
years, Scilex’s long-term objectives and commercialization plans,
Scilex’s potential to attract new capital, future opportunities for
Scilex, Scilex’s future business strategies, the expected cash
resources of Scilex and the expected uses thereof; Scilex’s current
and prospective product candidates, planned clinical trials and
preclinical activities and potential product approvals, as well as
the potential for market acceptance of any approved products and
the related market opportunity; statements regarding ZTlido®,
Gloperba®, ELYXYB®, SP-102 (SEMDEXA™), SP-103 or
SP-104, if approved by the FDA; Scilex’s development and
commercialization plans; and Scilex’s products, technologies and
prospects.
Risks and uncertainties that could cause Scilex’s actual results
to differ materially and adversely from those expressed in our
forward-looking statements, include, but are not limited to: the
risk that Scilex’s actual unaudited financial results for the one
month ended October 31, 2023, and year-to-date through October 31,
2023 may differ from those set forth in this press release; risks
associated with the unpredictability of trading markets and whether
a market will be established for Scilex’s common stock; general
economic, political and business conditions; risks related to the
ongoing COVID-19 pandemic; the risk that the potential product
candidates that Scilex develops may not progress through clinical
development or receive required regulatory approvals within
expected timelines or at all; risks relating to uncertainty
regarding the regulatory pathway for Scilex’s product candidates;
the risk that Scilex will be unable to successfully market or gain
market acceptance of its product candidates; the risk that Scilex’s
product candidates may not be beneficial to patients or
successfully commercialized; the risk that Scilex has overestimated
the size of the target patient population, their willingness to try
new therapies and the willingness of physicians to prescribe these
therapies; risks that the outcome of the trials for SP-102, SP-103
or SP-104 may not be successful; risks that the prior results of
the clinical trials of SP-102 (SEMDEXA™), SP-103 or SP-104 may not
be replicated; regulatory and intellectual property risks; and
other risks and uncertainties indicated from time to time and other
risks set forth in Scilex’s filings with the Securities and
Exchange Commission. Investors are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date of this release, and Scilex undertakes no obligation to
update any forward-looking statement in this press release except
as may be required by law.
Contacts:
Investors and MediaScilex Holding Company 960 San Antonio
RoadPalo Alto, CA 94303Office: (650) 516-4310
Email: investorrelations@scilexholding.com
Website: www.scilexholding.com
Reference
- Source: Celecoxib Oral Solution Approved for Acute Migraine
March
2020.https://www.neurologylive.com/view/celecoxib-oral-solution-gets-goahead-for-acute-migraine
- Source: Evaluate Pharma data February 16, 2023
SEMDEXA™ (SP-102) is a trademark owned by Semnur
Pharmaceuticals, Inc., a wholly-owned subsidiary of Scilex Holding
Company. A proprietary name review by the FDA is planned.
ZTlido® is a registered trademark owned by
Scilex Pharmaceuticals Inc., a wholly-owned subsidiary of Scilex
Holding Company.
Gloperba® is the subject of an exclusive,
transferable license to use the registered trademark by Scilex
Holding Company.
ELYXYB® is the subject of an exclusive,
transferable license to use the registered trademark by Scilex
Holding Company.
All other trademarks are the property of their
respective owners.
© 2023 Scilex Holding Company All Rights
Reserved.
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