Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The Fiscal Year Ended December 31, 2023, Based On Currently Available Information
02 Janeiro 2024 - 11:00AM
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, today provided certain
preliminary unaudited financial results for gross and net sales for
the fiscal year ended December 31, 2023, based on currently
available information.
The Company estimates that:
- ZTlido gross sales for the fiscal
year ended December 31, 2023 were in the range of $145.0
million to $150.0 million, compared to $96.0 million for the fiscal
year ended December 31, 2022, representing growth in the range of
approximately 51% to 56%.
- ZTlido net sales for the fiscal
year ended December 31, 2023 were in the range of $46.0
million to $52.0 million, compared to $38.0 million for the fiscal
year ended December 31, 2022, representing growth in the range of
approximately 21% to 37%.
- Total product gross sales for the
fiscal year ended December 31, 2023 were in the range of
$150.0 million to $155.0 million, compared to $96.0 million for the
fiscal year ended December 31, 2022, representing growth in the
range of approximately 56% to 61%.
- Total product net sales for the
fiscal year ended December 31, 2023 were in the range of $46.5
million to $52.5 million, compared to $38.0 million for the fiscal
year ended December 31, 2022, representing growth in the range of
approximately 22% to 38%.
This preliminary financial data has been prepared by and is the
responsibility of Scilex. Scilex has not fully completed its review
of these preliminary financial results for the fiscal year ended
December 31, 2023. Scilex’s independent auditor has not reviewed or
audited these preliminary estimated financial results. Scilex’s
actual results may differ materially from these preliminary
financial results, and may be outside the estimated ranges.
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 a 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 fiscal year ended December 31,
2023, the potential impact of the successful FDA audit on Scilex’s
commercialization plans for ZTlido®, 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
fiscal year ended December 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 COVID-19 (and other similar
disruptions); 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
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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