Scilex Holding Company Generates Monthly Revenue In November 2023 And Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The One Month Ended November 2023, And Year-To-Date Through November 30, 2023, Based On Currently Ava
01 Dezembro 2023 - 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 announced
monthly revenue in November 2023 and provided certain preliminary
unaudited financial results for gross and net sales for the one
month ended November 2023 and year-to-date through November 30,
2023.
The Company estimates that:
- ZTlido gross sales
for November 2023 were in the range of $14.0 million to $15.0
million with year-to-date gross sales through November 2023 in the
range of $125.0 million to $135.0 million, compared to $84.6
million for year-to-date through November 2022, representing growth
in the range of approximately 48% to 60%.
- Projected full year gross sales for
ZTlido in 2023 are estimated to be in the range of $140.0 million
to $150.0 million, compared to $96.0 million in 2022, representing
estimated growth in the range of approximately 46% to 56%.
- ZTlido net sales for November 2023
were in the range of $3.9 million to $4.5 million with year-to-date
net sales through November 2023 in the range of $40.0 million to
$43.0 million, compared to $33.9 million for year-to-date through
November 2022, representing growth in the range of approximately
18% to 27%.
- Projected full year net sales for
ZTlido in 2023 are estimated to be in the range of $44.0 million to
$50.0 million, compared to $38.0 million in 2022, representing
estimated growth in the range of approximately 16% to 32%.
- Total product gross sales for
November 2023 were in the range of $14.0 million to $16.0 million
with year-to-date total product gross sales through November 2023
in the range of $130.0 million to $140.0 million, compared to $84.6
million for year-to-date through November 2022, representing growth
in the range of approximately 54% to 65%.
- Total product net sales for
November 2023 were in the range of $4.0 million to $4.6 million
with year-to-date total product net sales through November 2023 in
the range of $41.0 million to $44.0 million, compared to $33.9
million for year-to-date through November 2022, representing growth
in the range of approximately 21% to 30%.
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 one month ended November 30,
2023, and year-to-date through November 30, 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 one
month ended November 30, 2023, and year-to-date through November
30, 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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