Scilex Holding Company

Company identity and strategy

• Focused on developing and commercializing non-opioid, non-addictive pain management therapies for acute and chronic pain with unmet needs.
• Pursues a mix of marketed products and product candidates, using a specialized delivery/adhesion platform and existing commercialization infrastructure.
• Classified as an “emerging growth company” under the JOBS Act.

Commercial product portfolio

• ZTlido® (lidocaine topical system) 1.8%

  • FDA-approved for relief of neuropathic pain associated with postherpetic neuralgia (PHN) in adults.
  • Launched October 2018; differentiated by improved adhesion, a thinner patch, and efficient drug delivery.
  • Exclusive worldwide rights to Oishi’s formulation outside Japan.
  • Commercial footprint includes a dedicated sales force, multi-channel marketing, and formulary engagement with major payers. Distribution through national and regional wholesalers and pharmacies.
  • As of 12/31/2025, approximately 5.6% share of the lidocaine patch prescription market in covered territories. Stored/dispensed via Cardinal Health 105 and other distributors (McKesson, Cardinal Health 110, AmerisourceBergen).
  • Formulary coverage on many large payors; over 200 million covered lives or in negotiation for ZTlido.
  • Sales organization of over 30 representatives, direct-to-patient marketing, and multiple adhesion and dermal safety studies.

• ELYXYB® (celecoxib oral solution)

  • FDA-approved ready-to-use oral solution for acute migraine (with or without aura) in adults. Rights acquired in February 2023.
  • Launched April 2023; approved in Canada in 2025 for acute migraine.
  • Commercial plan uses Scilex’s commercial infrastructure for migraine and overlaps with the PHN sales force.

• GLOPERBA® (liquid colchicine)

  • FDA-approved liquid colchicine for prophylaxis of gout flares in adults; launched June 2024.
  • Rights licensed from Romeg (amended January 2025); Romeg remains a license partner with royalties and milestones.

Product candidates (pipeline)

• SP-102 (SEMDEXA)

  • Injectable viscous gel dexamethasone sodium phosphate for epidural injections to treat lumbosacral radicular pain (sciatica).
  • Phase 3 program completed with positive primary and secondary endpoints in the pivotal CLEAR trial (2022).
  • Multiple patents and trade secrets protect the formulation.

• SP-103 (lidocaine topical system) 5.4%

  • Next-generation lidocaine patch, triple-strength (108 mg vs 36 mg for ZTlido) using the same adhesive technology.
  • Phase 2 results reported in acute low back pain. Fast Track designation by the FDA for low back pain.

• SP-104 (4.5 mg low-dose naltrexone HCl delayed-release)

  • Targeting fibromyalgia; Phase 1 completed. Delayed-release formulation designed to minimize gastric exposure and side effects.
  • Plans for a Phase 3 registration trial pending favorable data.

• SP-102, SP-103, and SP-104 are planned to use existing commercial infrastructure if approved.

Treasury and cryptocurrency strategy

• Adopted a cryptocurrency treasury strategy intended to hold Ethereum, Bitcoin, BNB, Dogecoin and other crypto assets as long-term treasury.
• Strategy includes professional asset management, custody via offline (cold) storage, and potential use of crypto-based financing or asset-backed transactions.
• Accounting moved to fair value measurement under ASU 2023-08. Hedging is not currently adopted but remains possible.
• Strategy anticipates additional holdings and potential strategic investments or acquisitions aligned with the treasury.

Commercial operations and go-to-market

• Commercialization backbone includes a dedicated sales force (over 30 reps) and marketing and managed care capabilities.
• In May 2025, sales force activities were outsourced to Syneos Health Commercial Services, LLC.
• Target physician audiences include over 3,500 primary care physicians, pain specialists, neurologists, and palliative care physicians.
• Market access programs include extensive formulary engagement and payer contracting. ZTlido coverage exceeds 200 million lives.
• Distribution network encompasses national and regional wholesalers and pharmacies; primary distributors include McKesson, Cardinal Health, and AmerisourceBergen. Major retailers include CVS, Walgreens, Rite Aid, and Walmart.
• ZTlido advantages emphasized in adhesion, dermal safety, and reduced residual drug exposure versus competing patches.

Intellectual property

• IP portfolio covers ZTlido and SP-103 adhesion/delivery technology, GLOPERBA, ELYXYB, SEMDEXA, SP-104, and related compositions and methods.
• U.S. patents and applications span multiple families. ZTlido and SP-103 are licensed from Oishi/Itochu under a Product Development Agreement.
• GLOPERBA is licensed under the Romeg License Agreement.
• Patents cited expire in the 2030s through 2041, with several active U.S. patents listed for each product.

Manufacturing and supply

• ZTlido: manufactured by Oishi in Japan; exclusive rights to the formulation outside Japan. Supply and contract manufacturing managed through Itochu/Oishi under development and commercial supply agreements.
• SP-102: manufactured by Lifecore under a Master Services Agreement; supply planning tied to a projected 2027 commercial launch.
• SP-103: manufactured by Oishi using processes consistent with ZTlido.
• SP-104: manufactured by Tulex Pharmaceuticals in New Jersey under a master services agreement for development and clinical production.
• Sodium hyaluronate component for SP-102 sourced via Genzyme/Sanofi-related supply; arrangements are transitioning to additional suppliers. Lifecore and other CMOs support development and manufacturing.

Financial and liquidity snapshot

• Employees: approximately 34 full-time as of 12/31/2025 (including 3 MD/PhD staff; 7 in R&D; 8 in sales/marketing; 19 in management/administration).
• Net loss: $374.1 million for 2025; $72.8 million for 2024.
• Accumulated deficit: approximately $921.8 million as of 12/31/2025; $563.1 million as of 12/31/2024.
• Inventory purchases under Commercial Supply Agreement: $3.4 million in 2025; $5.0 million in 2024.
• Debt and financings:
  • Oramed senior secured promissory note: initial principal $101.875 million; outstanding principal and accrued amounts about $28.19 million as of 12/31/2025. Maturity extended to 3/31/2026 via amendments; includes exit/make-whole features and covenants.
  • Tranche B convertible notes: aggregate principal $50 million issued 10/8/2024; outstanding as of 12/31/2025 includes principal and accrued interest; notes include covenants and redemption rights on default or fundamental transactions.
• Customer and payer reach: ZTlido-covered lives exceed 200 million; product access through a broad distributor network and direct marketing to clinicians and patients.

Business development and partnerships

• Itochu and Oishi: Product Development Agreement and Commercial Supply Agreement for ZTlido and SP-103 (outside Japan), granting exclusive worldwide rights outside Japan and supporting development, manufacturing scale-up, and regulatory filings.
• Romeg: Romeg License Agreement for GLOPERBA, amended January 2025.
• Lifecore: Master Services Agreement for SP-102 development and clinical material manufacturing, with potential for commercial production.
• Semnur/Sorrento lineage: SP-102 and SP-104 assets originated from Semnur and Aardvark-related transactions, with historical merger and contingent payment obligations.

Business position

• Three marketed products (ZTlido, ELYXYB, GLOPERBA) with active commercialization and payer engagement.
• Three product candidates in development (SP-102 SEMDEXA; SP-103; SP-104) aimed at expanding the non-opioid pain management portfolio.
• Material net losses and a growing accumulated deficit, supported by debt facilities (Oramed and Tranche B notes).
• A cryptocurrency treasury strategy with governance, custody, and fair-value accounting in place.
• A growth-oriented, high-risk profile typical of a late-stage development and commercialization-focused biopharma company.