Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 the month ended June
30, 2024 and quarter ended June 30, 2024.
“For the month of June 2024, sales were highlighted by
year-over-year growth trends improving in the second half of the
second quarter and ZTlido® is surpassing in the month of June with
the gross sales in the range of $22.0 million to $26.0 million mark
for the first time,” said Jaisim Shah, Chief Executive Officer and
President of Scilex. “In addition to ZTlido® expansion across all
target market segments, we continue to expect improving sales
trends throughout this year for ELYXYB® and our launch of Gloperba®
as we broaden education and awareness around these complementary
and standalone non-opioid solutions for managing acute pain.”
The Company estimates that:
- ZTlido net sales for the month ended June 30, 2024 were in the
range of $7.5 million to $9.0 million, compared to $4.4 million for
the same period last year, representing growth in the range of
approximately 70% to 104%.
- ZTlido net sales for the quarter ended June 30, 2024 were in
the range of $15.8 million to $17.5 million, compared to $12.3
million for the same period last year, representing growth in the
range of approximately 28% to 42%.
- Total product net sales for the month ended June 30, 2024 were
in the range of $7.8 million to $9.5 million, compared to $4.4
million for the same period last year, representing growth in the
range of approximately 77% to 116%.
- Total product net sales for the quarter ended June 30, 2024
were in the range of $16.4 million to $18.2 million, compared to
$12.6 million for the same period last year, representing growth in
the range of approximately 30% to 44%.
- Cash and cash equivalents as of June 30, 2024 were in the range
of $7.0 million to $10.0 million, compared to $34.1 million as of
June 30, 2023.
- Accounts receivable as of June 30, 2024 were in the range of
$38.0 million to $40.0 million, compared to $27.6 million as of
June 30, 2023.
- Operating expenses for the quarter ended June 30, 2024 were in
the range of $23.0 million to $26.0 million, compared to $31.2
million for the same period last year.
- Net loss for the quarter ended June
30, 2024 was in the range of $15.0 million to $20.0 million,
compared to $26.6 million for the same period last year.
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 month and quarter
ended June 30, 2024. 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.
For more information on Scilex Holding Company, refer to
www.scilexholding.com
For more information on ZTlido®, including Full Prescribing
Information, refer to www.ztlido.com.
For more information on ELYXYB®, including Full Prescribing
Information, refer to www.elyxyb.com.
For more information on Gloperba®, including Full Prescribing
Information, refer to www.gloperba.com.
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info@scilexholding.com
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 targets indications with high unmet needs and
large market opportunities with non-opioid therapies for the
treatment of patients with acute and chronic pain and are dedicated
to advancing and improving patient outcomes. Scilex’s commercial
products include: (i) ZTlido® (lidocaine topical system) 1.8%, a
prescription lidocaine topical product approved by the U.S. Food
and Drug Administration (the “FDA”) for the relief of neuropathic
pain associated with postherpetic neuralgia, which is a form of
post-shingles nerve pain; (ii) ELYXYB®, a potential first-line
treatment and the only FDA-approved, ready-to-use oral solution for
the acute treatment of migraine, with or without aura, in adults;
and (iii) Gloperba®, the first and only liquid oral version of the
anti-gout medicine colchicine indicated for the prophylaxis of
painful gout flares in adults.
In addition, Scilex has three product candidates: (i) SP-102 (10
mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or
“SP-102”), a novel, viscous gel formulation of a widely used
corticosteroid for epidural injections to treat lumbosacral
radicular pain, or sciatica, for which Scilex has completed a Phase
3 study and was granted Fast Track status from the FDA in 2017;
(ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a
next-generation, triple-strength formulation of ZTlido, for the
treatment of chronic neck pain and for which Scilex has recently
completed a Phase 2 trial in low back pain. SP-103 has been granted
Fast Track status from the FDA in low back pain; and (iii) SP-104
(4.5 mg, low-dose naltrexone hydrochloride delayed-release
capsules) (“SP-104”), a novel low-dose delayed-release naltrexone
hydrochloride being developed for the treatment of fibromyalgia,
for which Phase 1 trials were completed in the second quarter of
2022.
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 month and quarter ended June
30, 2024, the Company’s outlook, goals and expectations for 2024,
and the Company’s development and commercialization plans.
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: 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
and studies for SP-102, SP-103 or SP-104 may not be successful or
reflect positive outcomes; risks that the prior results of the
clinical and investigator-initiated 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 described in Scilex’s most recent
periodic reports filed with the Securities and Exchange Commission,
including Scilex’s Annual Report on Form 10-K for the year ended
December 31, 2023 and subsequent Quarterly Reports on Form 10-Q
that the Company has filed or may file, including the risk factors
set forth in those filings. 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 Scilex Holding Company to use the
registered trademark.
ELYXYB® is a registered trademark owned by
Scilex Holding Company.
All other trademarks are the property of their
respective owners.
© 2024 Scilex Holding Company All Rights
Reserved.
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