SEC Company Response from Scilex Holding (SCLX) — Aug 29, 2025
Scilex Holding Co
Date: Aug. 29, 2025 · CIK: 0001820190 · Accession: 0001193125-25-192744
AI Filing Summary & Sentiment
File numbers found in text: 001-39852
Referenced dates: August 20, 2025
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CORRESP 1 filename1.htm CORRESP FOIA CONFIDENTIAL TREATMENT REQUESTED BY SCILEX HOLDING COMPANY UNDER 17 C.F.R. § 200.83 Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 Submitted pursuant to a Request for Confidential Treatment Pursuant to 17 C.F.R. 200.83 August 29, 2025 CERTAIN PORTIONS OF THIS LETTER HAVE BEEN OMITTED FROM THE VERSION FILED VIA EDGAR. CONFIDENTIAL TREATMENT HAS BEEN REQUESTED WITH RESPECT TO THE OMITTED PORTIONS. INFORMATION THAT WAS OMITTED IN THE EDGAR VERSION HAS BEEN NOTED IN THIS LETTER WITH A PLACEHOLDER IDENTIFIED BY THE MARK “[***].” VIA EDGAR AND SECURE FILE TRANSFER U.S. Securities and Exchange Commission Division of Corporation Finance Office of Life Sciences 100 F Street, NE Washington, D.C. 20549 Attn: Franklin Wyman, Angela Connell Re: Scilex Holding Company Form 10-K for the Fiscal Year Ended December 31, 2024 Filed March 31, 2025 Form 10-Q for the Quarterly Period Ended June 30, 2025 Filed August 13, 2025 File No. 001-39852 Ladies and Gentlemen: Scilex Holding Company, a Delaware corporation (the “Company”), files this letter in response to the comments of the staff of the Division of Corporation Finance of the U.S. Securities and Exchange Commission (the “Staff”) with respect to the Staff’s letter dated August 20, 2025 in reference to the above-referenced Annual Report on Form 10-K filed on March 31, 2025 ( the “Form 10-K”) and Quarterly Report on Form 10-Q filed on August 13, 2025 (the “Form 10-Q”). For ease of reference, each of the Staff’s comments are reproduced below in bold and italics, followed in each case by the Company’s response. Form 10-K for the Fiscal Year Ended December 31, 2024 Notes to Consolidated Financial Statements 1. Nature of Operations and Basis of Presentation Revenue Recognition, page F-14 1. Please describe and quantify key factors underlying the significant increase in the accrued rebates and fees liability to $162.5 million as of December 31, 2024, as well as corresponding adjustments to gross revenue for each period presented. Revise your disclosure accordingly. Response: The Company respectfully acknowledges the Staff’s comment and will revise future disclosures accordingly to describe and quantify key factors underlying significant changes in accrued rebates and fees liability, as well as corresponding adjustments to gross revenues. Set forth below is an illustrative example of the updated disclosure, with the new disclosure added in blue and underlined text. FOIA CONFIDENTIAL TREATMENT REQUESTED BY SCILEX HOLDING COMPANY UNDER 17 C.F.R. § 200.83 Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 Revenue Recognition The Company’s revenue is generated from product sales within the United States. The Company does not incur significant direct costs to obtain contracts with its customers. Revenue from product sales is comprised of sales of ZTlido, ELYXYB and GLOPERBA. The Company’s performance obligation with respect to sales of ZTlido, ELYXYB and GLOPERBA is satisfied at a point-in-time, when control is transferred upon delivery of product to the customer. The Company considers control to have transferred upon delivery because the customer has legal title to the product, physical possession of the product has been transferred to the customer, the customer has significant risks and rewards of ownership of the product, and the Company has a present right to payment at that time. Invoicing typically occurs upon shipment and the length of time between invoicing and when payment is due is not significant. The aggregate dollar value of unfulfilled orders as of December 31, 2024 and 2023 were not material. Revenues from product sales are recorded net of reserves established for commercial and government rebates, fees and chargebacks, wholesaler and distributor fees, sales returns, special marketing programs and prompt payment discounts. Such variable consideration is estimated in the period of the sale and is estimated using a most likely amount approach based primarily upon provisions included in the Company’s customer contract, customary industry practices and current government regulations. Deductions from Revenues The Company’s gross product revenues are subject to a variety of deductions, which generally are estimated and recorded in the same period that the revenues are recognized. Such variable consideration represents chargebacks, rebates, sales allowances and sales returns. These deductions represent estimates of the related obligations and, as such, knowledge and judgment are required when estimating the impact of these product revenue deductions on net sales for a reporting period. Rebates and Chargebacks Rebates are discounts which the Company pays under either government or private health care programs. Government rebate programs include state Medicaid drug rebate programs, the Medicare coverage gap discount programs and the Tricare programs. Commercial rebate and fee programs relate to contractual agreements with commercial healthcare providers, under which the Company pays rebates and fees for access to and position on that provider’s patient drug formulary. Rebates and chargebacks paid under government programs are generally mandated under law, whereas private rebates and fees are generally contractually negotiated by the Company with commercial healthcare providers. Both types of rebates vary over time. The Company records a reduction to gross product sales at the time the customer takes title to the product based on estimates of expected rebate claims. The Company monitors the sales trends and adjusts for these rebates on a regular basis to reflect the most recent rebate experience and contractual obligations. Reserves for rebates and chargebacks are separately presented as accrued rebates and fees under current liabilities within the Company’s consolidated balance sheets. Prompt Payment Discounts The Company provides its customers with prompt payment discounts which may result in adjustments to the price that is invoiced for the product transferred, in the case that payments are made within a defined period. The prompt payment discount reserve is based on actual gross sales and contractual discount rates. Reserves for prompt payment discounts are included in accounts receivable, net on the consolidated balance sheets. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. 3 FOIA CONFIDENTIAL TREATMENT REQUESTED BY SCILEX HOLDING COMPANY UNDER 17 C.F.R. § 200.83 Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 Service Fees The Company compensates its customer and others in the distribution chain for wholesaler and distribution services. The Company has determined such services received to date are not distinct from the Company’s sale of products to the customer and, therefore, these payments have been recorded as a reduction of revenue. Service fees are presented as accrued rebates and fees under current liabilities within the Company’s consolidated balance sheets. Product Returns The Company is obligated to accept the return of products sold that are expiring within six months, damaged or do not meet certain specifications. The Company may authorize the return of products sold in accordance with the term of its sales contracts, and estimates allowances for such amounts at the time of sale. The Company estimates the amount of its product sales that may be returned by its customer and records this estimate as a reduction of revenue in the period the related product revenue is recognized. Product returns are presented as accrued rebates and fees under current liabilities within the Company’s consolidated balance sheets. The allowance for product returns is determined based on historical return rates, product shelf life, and inventory levels within the distribution channel. This estimated rate is applied to gross sales to accrue the sales allowance. Discounts, typically 2% of sales, are offered to wholesalers for prompt payment. Upon receipt of actual product returns, the Company updates its balances accordingly, while continuing to refine its estimates based on historical trends. Co-Payment Assistance Patients who have commercial insurance or pay cash and meet certain eligibility requirements may receive co- payment assistance. The Company accrues for co-payment assistance based on actual program participation and estimates of program redemption using data provided by third-party administrators. Co-payment assistance is presented as accrued rebates and fees under current liabilities within the Company’s consolidated balance sheets. Gross-to-Net Revenue Adjustments Gross revenue is directly impacted by the Company’s gross-to-net revenue adjustments for sales rebates, discounts, coupons, fees, returns, and chargebacks. For the year ended December 31, 2024, gross revenue was $167.4 million while net revenue was $56.6 million. The gross-to-net revenue adjustment of approximately $110.8 million was primarily attributable to the following: • $77.4 million for sales rebates. • $16.7 million for service fees. • $9.7 million of estimated sales returns, discounts, co-payment assistance, and coupons. • $7.0 million for chargebacks. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. 4 FOIA CONFIDENTIAL TREATMENT REQUESTED BY SCILEX HOLDING COMPANY UNDER 17 C.F.R. § 200.83 Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 The Company’s accruals for Medicare, Medicaid and related state program and contractual rebates, chargebacks, sales allowances and sales returns and cash discounts are as follows: As of December 31, in millions 2024 2023 Other current liabilities: Accrued rebates $ 152.9 $ 81.7 Other accruals and fees 9.6 8.0 Total accrued rebates, other related sales accruals and fees $ 162.5 $ 89.7 As of December 31, 2024, the Company’s accrued rebates and fees liability was $162.5 million, compared to $89.7 million as of December 31, 2023. The increase of approximately $72.8 million year-over-year was mainly due to the fact that the Company made only limited disbursements to counterparties during 2024 as its focus was to deploy its cash resources to repay Company debt. The rebates balance of $152.9 million primarily consists of government disbursements (Medicare and Medicaid) and commercial insurance disbursements. The other accrual balance of $9.6 million consists of service fees, returns, and coupons. Year-over-year the accrued rebates balance increased by approximately $71.2 million while the other accrual and fees balance increased by approximately $1.6 million. 2. Liquidity and Going Concern, page F-17 2. Please provide us with an analysis supporting your accounting for the FSF Commitment Side Letter and related Satisfaction Agreement. As part of this analysis, please provide us with illustrative journal entries depicting your accounting for the following: • Receipt of FSF Deposit from FSF Lender • Issuance of warrants to FSF Lender • Satisfaction of Deposit via delivery of product to Endeavor Response: In response to the Staff’s comment, the Company has set forth below the background for each of the FSF Commitment Side Letter and related Satisfaction Agreement and the Company’s analysis of its accounting for such agreements. FSF Commitment Side Letter As disclosed in the Form 10-K, on June 11, 2024, the Company entered into that certain Commitment Side Letter (the “FSF Commitment Side Letter”) with FSF 33433 LLC (“FSF Lender”), pursuant to which FSF Lender committed to provide the Company a loan (the “FSF Loan”) in the aggregate amount of $100.0 million (the “Commitment Amount”). Under the FSF Commitment Letter, the Company and FSF Lender would enter into definitive documents with respect to the FSF Loan on terms to be mutually agreed in good faith. Subject to the execution of such definitive documents, the Commitment Amount was payable as follows: (i) $85.0 million no later than the date that is 70 days following the date on which the Company received the FSF Deposit (the “Outside Date” and the funding of the initial $85 million, the “Initial Closing”) and (ii) the remaining $15.0 million within 60 days following the Initial Closing. Pursuant to the Commitment Letter, FSF Lender was required to provide the Company a non-refundable deposit in immediately available funds in the aggregate principal amount of $10.0 million with such deposit creditable towards the $85.0 million required to be funded by FSF Lender on the Initial Closing (the “FSF Deposit” and the date on which such funds are fully received, the “Deposit Date”). On the Deposit Date, the Company would be obligated to issue a warrant to purchase up to an aggregate of 3,250,000 shares of common stock (the “Deposit Warrant”), with an exercise price of $1.20 per share. On June 18, 2024, the Company received the FSF Deposit and issued the Deposit Warrant to FSF Lender. The Deposit Warrant was immediately exercisable upon issuance and expires five years from the date of issuance. [*] Certain confidential information in this letter, marked by brackets, has been omitted and filed separately with the SEC pursuant to 17 C.F.R. §200.83. 5 FOIA CONFIDENTIAL TREATMENT REQUESTED BY SCILEX HOLDING COMPANY UNDER 17 C.F.R. § 200.83 Scilex Holding Company 960 San Antonio Road Palo Alto, CA 94303 Since the Initial Closing did not occur on or prior to the Outside Date, the FSF Deposit automatically converted into an unsecured loan on the first day after the Outside Date in accordance with the terms of the FSF Commitment Side Letter. The unsecured loan had a maturity date of five years after the date of the Unsecured Promissory Note, and was prepayable without premium or penalty. Accounting Treatment for FSF Commitment Side Letter and Illustrative Journal Entries The Company determined that the FSF Deposit of $10.0 million substantively represented a loan arrangement, since as of the FSF Commitment Date, the Company was required to repay this amount on the Outside date, even if the definitive documents with the FSF Lender were not executed, in which case the FSF Deposit was convertible into an unsecured loan with a five-year maturity. The remaining commitment of up to $90.0 million was contingent upon the execution of definitive documents and was not deemed outstanding as of the date of the FSF Commitment Letter. On June 11, 2024, upon the initial receipt of the FSF Deposit, the Company recorded the following entries (in thousands): Dr. Cash and Cash Equivalents $ 10,000 Cr. FSF Deposit Liability $ 10,000 The terms of the FSF Commitment letter included complex features within the FSF Deposit that could require separate accounting if the Company were to account for this financial instrument under the amortized cost model. Under the fair value option, no separate accounting is required for these features, as they are measured as part of the combined financial instrument. Accordingly, the Company elected to account for the FSF Deposit using the fair value option, with changes in the fair value reflected in the consolidated statements of operations and comprehensive loss. The Deposit Warrant was determined to be embedded within the FSF Deposit since these instruments were not legally detachable. Specifically, as of the issuance date, the Deposit Warrant could not be transferred apart from the FSF Deposit without the Company’s prior written consent. As such, the Deposit Warrant and the FSF Deposit initially were determined to be a single unit of account for the fair value measurement within the FSF Deposit liability. The combined instrument, including the