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 issued a letter
from Jaisim Shah, its Chief Executive Officer and President, to its
stockholders highlighting the Company’s accomplishments in 2023 and
its forward outlook for 2024.
A MESSAGE FROM OUR CHIEF EXECUTIVE OFFICER AND
PRESIDENT
Dear Scilex Holding Company Stockholders,
I would like to express my deepest gratitude for your unwavering
support, patience, and invaluable feedback throughout the
transformative year in 2023. It is our hope that this communication
serves as both a reflection on Scilex’s significant strides in the
past year and an insightful preview into the challenges and
opportunities that lie ahead in 2024.
Our guiding principle has always been and remains a
patient-first approach, which drives our mission to meet the
increasing global demand for more effective and safer non-opioid
pain management solutions. Through rigorous research
and development, we believe we are on the cusp of establishing
Scilex as the preeminent name in commercial non-opioid pain
management, specifically targeting the unmet needs in both acute
and chronic pain sectors with our innovative and leading therapies.
We've not only responded to the global demand for safer, more
effective pain relief solutions but also made substantial progress
in demonstrating the rapid onset and enhanced safety of our
products.
The unmet need in pain management is not just a medical
challenge; it's a societal imperative. Every day, countless
individuals grapple with pain, yet are left with limited options
due to the risks associated with opioid treatments. At Scilex, we
recognize our vital role in addressing this unmet need. Our efforts
are concentrated on pioneering non-opioid alternatives that are not
just innovative but also aim to re-define the standards of safety
and accessibility in pain management.
As we continue to navigate the complexities of the
pharmaceutical landscape, your role as stockholders in this journey
is invaluable. Thank you for being an integral part of our mission
and for your unwavering belief in our vision. Together, we are not
just witnessing, but actively shaping, a pivotal chapter in
healthcare history.
2023 Accomplishments
We accomplished all of the goals that we set out at the
beginning of 2023, including:
- Built on our late 2022
transformation into an independent publicly traded company listed
in Nasdaq under the ticker symbol “SCLX” with three FDA approved
non-opioid agents to address acute and chronic pain.
- Continuous growth for ZTlido®.
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%.
- ZTlido® profile being viewed as a
leading prescription lidocaine patch by pain specialists. Based on
the independent market research conducted by Syneos Health
Consulting (“Syneos”), with the new campaign, health care providers
(HCPs) report increased awareness and substantial intent to utilize
for ZTlido® with peak sales potential projected to reach over $500
million in the next 6 years in the U.S.
- Expanded the market for ZTlido® by
entering into a territory distribution agreement for the
commercialization of ZTlido® in the Middle East and North Africa
(MENA) with $105 Million minimum multi-year purchase
commitment.
- Successfully completed a Good
Manufacturing Practices (GMP) inspection by the U.S. Food and Drug
Administration (“FDA”) of the enhanced 250kg manufacturing facility
in Japan, which assures increased capacity to meet the rapidly
growing demand for ZTlido®.
- Issued two new patents by the U.S.
Patent and Trademark Office: (a) Patent No. 11,786,455, titled
“Non-aqueous Patch”, which covers a non-aqueous lidocaine patch
with certain specifications, as well as a method of relieving pain
through the application of a non-aqueous lidocaine-containing
patch, and (b) Patent No. 11,793,766, titled “Non-aqueous Patch for
the Relief of Pain”, which covers a method of relieving pain
through the application of a lidocaine-containing patch. These two
new patents further strengthen the Company’s intellectual property
position and coverage for ZTlido®, and will not expire until 2031.
These two new issued patents will be listed in the FDA’s Orange
Book in connection with ZTlido®.
- Continued to add ZTlido® as a
preferred agent to the Medicaid Preferred Drug List (PDL) in a
number of U.S. States.
- ZTlido® was recognized as the most
prescribed non-opioid branded pain treatment by pain specialists,
according to Prescription Data from Symphony Health.
- Acquired rights to 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, and successfully
launched ELYXYB® in the U.S. in April 2023.
- Launched major pharmacy initiative
with two leading national pharmacy chains to stock ELYXYB® in most
of their stores throughout the U.S.
- Expanded access to ELYXYB® by the
execution of the first ELYXYB® insurance coverage agreement with
one of the top three national Pharmacy Benefit Manager’s for its
Medicare population.
- Filed a New Drug Submission (NDS)
with Health Canada’s Pharmaceutical Drugs Directorate, Bureau of
Cardiology, Allergy and Neurological Sciences for the approval of
ELYXYB® for acute treatment of migraine with or without aura in
Canada.
- Continued preparing for the
potential launch of Gloperba® in 2024. Scilex is well-positioned to
market and distribute Gloperba®. Scilex has a direct distribution
network to national and regional wholesalers and pharmacies
throughout the U.S., and an experienced commercial and managed care
team that has successfully launched and grown market access for
ZTlido® (lidocaine topical system) to more than 225 million covered
lives in the U.S. as well as successfully launching ELYXYB®
(celecoxib oral solution) in the U.S.
- Completed SP-103 (lidocaine topical
system) 5.4%, Triple Strength Formulation of ZTlido®, Phase 2 trial
which achieved its objectives to evaluate the safety and efficacy
of SP-103 in subjects with moderate to severe acute lower back pain
(LBP).
- Held positive Type C meeting with
the FDA and reached agreement on path forward to file a New Drug
Application (NDA) for SP-102 (SEMDEXATM) in lumbosacral radicular
pain (Sciatica). Scilex is planning to commence an open-label
multi-center safety and efficacy trial in the first half of 2024 in
which it will seek to enroll approximately 700 patients with
moderate-to-severe Lumbosacral Radicular Pain (LRP) requiring an
epidural steroid injection. SP-102 (SEMDEXATM) is expected to be
administered in up to 3 injections during a 6-month observation
period. Completion of enrollment in the trial is projected to occur
in 2025.
- Repurchased all of the shares of
Scilex common stock and preferred stock and warrants previously
owned by our former parent company, Sorrento Therapeutics,
Inc.
Outlook for 2024
The lessons learned from the challenges we faced as a company in
2023 have positioned us for incredible opportunities in 2024, as
the team has laid the foundation for the execution of a
commercially appealing strategy which will transform how Scilex is
viewed on the world stage. We are determined to
continue to expand our pain management products and product
candidates and mark a major milestone in our strategy to build a
robust offering of novel, non-opioid treatments to improve patient
care along the acute and chronic pain pathway. Importantly,
ZTlido®, ELYXYB®, and Gloperba® will enhance our topline, and we
believe will provide meaningful synergies that we expect to drive
substantial near- and long-term accretion to our cash flows and
earnings. Despite the challenges that remain ahead, we are setting
ambitious goals for the Company in 2024, including:
- Expected launch of Gloperba®. Gloperba® is the first line
therapy and first and only liquid oral version of the anti-gout
medicine colchicine indicated for the prophylaxis of painful gout
flares in adults. Gout is a painful arthritic disorder affecting an
estimated 9.2 million people in the United States.(1) As gout cases
increase every year, treatment requirements increase. The gout
treatment market is projected to reach $2.0 billion in the U.S. by
2028 with a well-defined area of unmet need.(2)
- Seek FDA approval for the modification of Gloperba® label to
address unmet medical needs and to provide specific dosing guidance
to patients with renal impairment.
- Continue to grow our gross sales with a goal of exceeding $200
million.
- Seek FDA approval of ELYXYB® in acute pain in the
U.S. ELYXYB®, a rapid onset and ready to use
formulation of Celecoxib, delivers a first line non-opioid
therapeutic alternative to habit-forming opioids and acetaminophen,
the leading cause of acute liver failure in the
U.S.(3) DelveInsight estimates there were approximately 100
million cases of acute pain in the United States and that the total
acute pain market in the U.S. was approximately $3 billion in
2021.(4)
- Continue to develop our novel clinical pipeline with the goal
of launching another product from one of our pipeline molecules
within 24 months. We will utilize existing data to advance our
clinical research program, and work with leading researchers to get
the best possible data for assessment by regulators.
- Initiation of ELYXYB® pediatric study for migraine.
- Finalize plan with FDA for Phase 2/3 study for SP-103 in acute
pain.
- Initiation of SP-102 chemistry, manufacturing and controls
(CMC) activities for commercial scale manufacturing for NDA filing
in the U.S.
- File ZTlido® applications in ex-US markets. We will work to
launch our product and develop a distribution network in Middle
East to serve the new ZTlido® market there, while continuing to
support our clinical trials and other potential customers around
the world.
- Prepare for the next major international change affecting the
demand for non-opioid therapeutics and be ready to capitalize on
that change.
- Continue to enhance our product portfolio by in-licensing and
out-licensing commercial products.
- Continue to enhance stockholder value and optimize our
capitalization structure.
As we look beyond our immediate goals, it's important to
recognize the foundational beliefs that have guided the creation
and growth of our company:
- True stability comes from revenue generating products that not
only meet significant medical needs but also have a strong
commercialization track record.
- The pace at which a company moves from development to
commercialization is a key determinant of success. By focusing on
projects with a higher likelihood of market entry, a firm can not
only innovate but also realize quicker returns and greater market
impact.
- n an era marked by the opioid crisis, there is a vital need for
timely and effective non-opioid solutions. Companies that respond
to such urgent needs, especially in pain management, are not just
making a business move; they are addressing a critical societal
imperative recognized by both regulators and healthcare
providers.
There are many challenges that we have to overcome before our
goals can become reality, but as a leading non-opioid therapeutics
company, we know that we have a valuable and important role to play
as a supplier for our patients. Our focus is on fostering robust
relationships with all stakeholders – including patients,
neurologists, pain specialists, rheumatologists, distributors, and
clinic health care professionals. This collaboration is key to
ensuring that prescribers have access to our comprehensive
portfolio of non-opioid drugs, with the ultimate aim of
significantly improving patient lives.
In closing, my heartfelt thanks go to the remarkable team at
Scilex. Your unwavering dedication, creativity, and resilience are
the driving forces behind our success. To our partners, our
stockholders, and our dedicated board members: thank you for your
confidence in us as we continue to forge ahead with our
mission.
Best Regards,
Jaisim ShahChief Executive Officer and PresidentScilex Holding
Company
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 SEMDEXATM, 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 (SEMDEXATM) 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. 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. SP-103 received
FDA Fast Track status in low back pain. 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 Company’s outlook, goals and expectations for 2024,
projected figures for ZTlido peak sales in the next six years, the
Company’s ongoing preparations for the expected launch of Gloperba
in 2024, the Company’s plans to commence an open label trial for
SP-102 and the anticipated enrollment timing and figures,
projections and goals for the Company’s gross sales figures, the
status of any ongoing discussions with the FDA and other
regulators, the Company’s plans for launching other pipeline
products and plans to file ZTlido applications in ex-U.S. markets,
the timing of the FDA’s review process and whether the FDA approves
the sNDA for ELYXYB, ELYXYB’s potential to further expand Scilex’s
non-opioid portfolio and its potential to address high unmet needs
in treating acute pain, the potential market size and the size of
the patient population for acute pain in the U.S., 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, and any projections or
estimates for sales figures 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
References
-
https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20population
- Evaluate Pharma data
- Bunchorntavakul C, Reddy K. Acetaminophen (APAP or
N-Acetyl-p-Aminophenol) and Acute Liver Failure. Clin Liver Dis.
2018 May;22(2):325-346. PMID: 29605069
- DelveInsight Acute Pain - Market Insight, Epidemiology And
Market Forecast – 2032; Dec 2022;
https://www.delveinsight.com/report-store/acute-pain-market#:~:text=The%20DelveInsight's%20acute%20pain%20market,be%20either%20acute%20or%20chronic
# # #
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.
© 2024 Scilex Holding Company All Rights
Reserved.
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