SCLX

November 4, 2024

Scilex Holding Company sets November 7, 2024 as the Record Date for a Dividend of Preferred Stock Exchangeable for up to 10% of Scilex’s Ownership Interest in Semnur Pharmaceuticals, Inc., its Wholly Owned Subsidiary

ZTlido net sales for the quarter ended September 30, 2024 were in the range of $11.0 million to $13.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 9% to 29%

Total product net sales for the quarter ended September 30, 2024 were in the range of $12.0 million to $14.0 million, compared to $10.1 million for the same period last year, representing growth in the range of approximately 19% to 39%.

READ THE INVESTOR PRESENTATION HERE

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Hello Everyone,

Today’s profile definitely did not disappoint. It traded as high as 4.75 and was up over 6 bucks in the premarket!

Not too bad right?

We have another brand new profile to drop on your desk for Wednesdays session.

This is a company that we have never profiled this newsletter before and I have never seen it anywhere else.

Pull up SCLX on your screen right now and keep reading this email.

SCILEX HOLDING COMPANY (Nasdaq: SCLX), is dedicated to the development and commercialization of non-opioid pain management products. We are uncompromising in our 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.

The company’s lead pro duct ZTlido® (lidocaine topical system) 1.8%, is a marketed prescription lidocaine topical product approved by the U.S. Food and Drug Administration for the relief of pain associated with Post-Herpetic Neuralgia (PHN), which is a form of post-shingles nerve pain. ZTlido® possesses novel delivery and adhesion technology designed to address many of the limitations of current prescription lidocaine patches by providing significantly improved adhesion and continuous pain relief.

They have acquired two FDA approved non-opioid pain products, GLOPERBA® and ELYXYB®. GLOPERBA® is indicated for the prophylaxis of gout flares in adults. Elyxyb is indicated for the acute treatment of migraine with or without aura in adults. They aunched ELYXYB® in the U.S. in April 2023 , GLOPERBA® was launched on June 10th, 2024.

MAIN CATALYSTS

The company’s lead product ZTlido® (lidocaine topical system) 1.8%, 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 (PHN), which is a form of post-shingles nerve pain and a valuable option for topical pain relief.
The latest addition to our non-opioid pain management portfolio is Elyxyb® (celecoxib oral solution) indicated for the acute treatment of migraine with or without aura in adults. Scilex is planning to continue the commercialization of Elyxyb® in 2024, further enhancing our offerings in Chronic pain management and ensuring access to the best non opioid pain medications.
GLOPERBA®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, launched on June 10th 2024. Scilex in-licensed the exclusive rights to commercialize Gloperba® (colchicine USP) oral solution, an FDA-approved prophylactic treatment for painful gout flares in adults, in the U.S. Scilex launched GLOPERBA® on June 10th, 2024 and is well-positioned to market and distribute the product.

Scilex’s three product candidates are:

SP-102 (injectable dexamethasone sodium phosphate viscous gel product containing 10 mg dexamethasone), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, with FDA Fast Track status. If approved by the FDA, the company expects SP-102 to be the first FDA-approved non-opioid epidural injection to treat lumbosacral radicular pain, or sciatica, with the potential to replace 12 million off-label epidural steroid injections administered each year in the US, significantly enhancing options for non addictive pain management.

SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. We have recently completed a Phase 2 trial in acute low back with SP-103 and an investigator-initiated Phase 2 study in chronic neck pain with ZTlido that was published in Anesthesiology journal. SP-103 also received Fast Track status in low back pain from FDA.

SP-104, 4.5 mg Delayed Burst Release Low Dose Naltrexone Hydrochloride (DBR-LDN) Capsule, for the treatment of chronic pain, fibromyalgia.
Scilex Holding Company 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.

Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed Path Forward to NDA Upon Completion of Phase III Trials for Blockbuster Product Candidate, SP-1…

Scilex Pharmaceuticals Inc, a Wholly Owned Subsidiary of Scilex Holding Company, Announces Successful End of Phase II Meeting with FDA Leading to an Agreed Path Forward to NDA Upon Completion of Phase III Trials for Blockbuster Product Candidate, SP-103 (Lidocaine Topical System) 5.4%, a Next-Generation, Triple-Strength Formulation of ZTlido, for the Treatment of Chronic Neck Pain Associated with Muscle Spasms

Successful end of Phase II meeting with FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103, for the treatment of chronic neck pain associated with muscle spasms.
SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain. It is estimated that the U.S. low back and neck pain market will reach $134.5 billion.6 Based on the independent market research conducted by Syneos Health Consulting (“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach $1.2 billion annually in the 6th year post launch.
As previously announced that Scilex Holding Company’s Board of Directors has authorized management to explore ways to maximize the value of Scilex Holding Company and its wholly owned subsidiary, Scilex Pharmaceuticals Inc., including by way of conducting a spinoff or public listing of securities of Scilex Pharmaceuticals Inc.

PALO ALTO, Calif., Oct. 30, 2024 (GLOBE NEWSWIRE) — 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 it had a successful end of Phase II meeting with the FDA leading to an agreed path forward to NDA upon completion of Phase III trials for blockbuster product candidate, SP-103 (lidocaine topical system) 5.4%, a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain associated with muscle spasms.

Based on the independent market research conducted by Syneos Health Consulting(“Syneos”), with the substantial intent in utilization for SP-103 with peak sales potential projected to reach $1.2 billion annually in the 6th year post launch.

“We are very pleased with the end of Phase II meeting and received a clear path forward to NDA for our blockbuster product candidate, SP-103. SP-103 has the potential to meet our core goal of developing leading pain management therapies to significantly improve the lives of patients for the treatment of chronic neck pain associated with muscle spasms who are seeking new effective treatments. We are looking forward to conducting Phase 3 trials and believe that Scilex is the only company with technology allowing much higher lidocaine concentration than any other topical lidocaine system treatments. Higher concentration of a drug per covered area of skin is important for achieving therapeutic response”, said Dmitri Lissin, M.D., Chief Medical Officer of Scilex.

Scilex Pharmaceuticals, Inc. has three FDA-approved commercial products on the market and 3X version follow-on product, SP-103, is the next generation of ZTlido®:
- ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain with an average of 50% growth in gross sales for the past two years. ZTlido® is expected to be distributed outside of the U.S. in 2025 with exclusive territory distributors in the Middle East and North/South Africa countries with a $105 million minimum 5 year purchase commitment.
- ELYXYB® is a 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.1 The U.S. oral migraine drug market size was estimated to be $1.8 billion in 2022.2
- ELYXYB® filed a New Drug Submission (NDS) to Health Canada’s Pharmaceutical Drugs Directorate, Bureau of Cardiology, Allergy and Neurological Sciences for the approval of for acute treatment of migraine with or without aura in Canada. It is estimated to have impacted more than 2.7 million Canadians with the Canadian migraine therapeutics market estimated to reach approximately $400 million by 2025.3
- Gloperba®, the 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 States4. 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.5

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Scilex Holding Company sets November 7, 2024 as the Record Date for a Dividend of Preferred Stock Exchangeable for up to 10% of Scilex’s Ownership Interest in Semnur Pharmaceuticals, Inc., its Wholly Owned Subsidiary

PUBLISHED

OCT 28, 2024 6:00AM EDT

Scilex notified NASDAQ on October 28, 2024 that it has set a record date of November 7, 2024 (the “Record Date”) for the dividend of Scilex preferred stock to Scilex’s stockholders and certain other securityholders of Scilex.
Based on independent market research conducted by Syneos Health Consulting(“Syneos”), with the substantial intent in utilization for SP-102 (SEMDEXA™), the product candidate held by Semnur Pharmaceuticals, Inc. (“Semnur”) is estimated to have peak sales potential projected to be $3.6 billion annually in the 5th year post launch of SP-102.
Scilex previously announced that it anticipates the filing of a Registration Statement on Form S-4 (the “Registration Statement”) with the Securities and Exchange Commission (the “SEC”) by the end of October 2024 for the previously announced proposed business combination (the “Business Combination”) between Semnur and Denali Capital Acquisition Corp. (Nasdaq: DECA, the “SPAC”), which provides for a pre-transaction equity value of Semnur of $2.5 billion.
The closing of the Business Combination is expected to occur by the first quarter of 2025.
The Board of Directors of Scilex (the “Board”) declared a stock dividend consisting of an aggregate of 5,000,000 shares of Series 1 Mandatory Exchangeable Preferred Stock to its stockholders and certain other securityholders of Scilex as of the Record Date. Such preferred stock will be exchangeable for up to 10% of Scilex’s ownership interest in Semnur following the closing of the Business Combination. The Semnur common stock to be so exchanged is expected to be freely tradable upon such exchange.

PALO ALTO, Calif., Oct. 28, 2024 (GLOBE NEWSWIRE) — 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 that it has set a record date of November 7, 2024 (the “Record Date”) for the dividend of Scilex preferred stock (the “Dividend”) to its stockholders and certain other securityholders of Scilex. Subject to the Board’s right to change the Record Date and conditioned upon the effectiveness of the filing of the Certificate of Designation with the Secretary of State of the State of Delaware, the payment date (the “Payment Date”) will be determined by subsequent resolutions of the Board, which will be within 60 days following the Record Date.The Dividend consists of an aggregate of 5,000,000 shares (the “Dividend Stock”) of Series 1 Mandatory Exchangeable Preferred Stock, par value $0.0001 per share, of Scilex(the “Series 1 Preferred Stock”), which will be automatically exchanged for a pro-rata portion of the lesser of (i) 10% of Scilex’s ownership in Semnur immediately prior to the effective time of the Business Combination and (ii) $200,000,000 divided by the closing price of Semnur common stock on any national securities exchange on which such stock is listed on the date that is 10 trading days prior to the determination date (i.e., the earlier of (a) the effective time of the Business Combination and (b) the time at which the applicable registration statement is declared effective by the SEC), in each case as set forth in the Certificate of Designation governing the Series 1 Preferred Stock.The Dividend Stock will be subject to certain transfer restrictions set forth in the Certificate of Designation of Preferences, Rights and Limitations of Series 1 Mandatory Exchangeable Preferred Stock. The Record Date may be changed by the Board for any reason at any time prior to the actual payment of the Dividend, and payment of the Dividend is conditioned upon the Board not having revoked the dividend prior to the Payment Date, including for a material change to the solvency or surplus analysis presented to the Board. Scilex expects that the Dividend Stock will be freely tradable upon exchange for shares of post-closing public company Semnur common stock following the closing of the Business Combination.

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