Scilex Holding Company Provides Certain Preliminary Unaudited Financial Results For Gross And Net Sales For The Fiscal Year Ended December 31, 2023, Based On Currently Available Information

Rhea-AI Summary

Scilex Holding Company (Nasdaq: SCLX) provided preliminary unaudited financial results for gross and net sales for the fiscal year ended December 31, 2023. ZTlido gross sales for 2023 were estimated to be in the range of $145.0 million to $150.0 million, representing a growth of approximately 51% to 56% compared to 2022. ZTlido net sales for 2023 were in the range of $46.0 million to $52.0 million, showing a growth of approximately 21% to 37% compared to 2022. Total product gross sales for 2023 were estimated to be in the range of $150.0 million to $155.0 million, representing a growth of approximately 56% to 61% compared to 2022. Total product net sales for 2023 were in the range of $46.5 million to $52.5 million, showing a growth of approximately 22% to 38% compared to 2022.

Insights

Financial Analyst

The reported preliminary financial results from Scilex Holding Company indicate a significant year-over-year growth in both gross and net sales, particularly for ZTlido, their non-opioid pain management product. The gross sales increase of approximately 51% to 56% and net sales increase of 21% to 37% for ZTlido suggest a robust market acceptance and increased demand for non-opioid pain management solutions. This performance is especially noteworthy considering the broader pharmaceutical industry's efforts to move away from opioid-based painkillers due to addiction concerns.

From a financial perspective, the increase in total product gross sales by 56% to 61% and net sales by 22% to 38% indicates effective scaling and potentially improved operational efficiencies. Investors should monitor the final audited results for any material adjustments, as preliminary data has not undergone independent review. Long-term implications may include increased market share and stronger competitive positioning for Scilex, provided they maintain product efficacy and compliance with regulatory standards.

Market Research Analyst

Scilex's substantial growth in sales of their non-opioid pain management product aligns with current market trends favoring alternative pain treatments. The societal push for non-opioid options due to the opioid crisis has likely fueled the adoption of products like ZTlido. The reported sales growth figures highlight the company's potential to capitalize on this shift in consumer and prescriber preferences.

Understanding the market dynamics, such as the regulatory environment, payer reimbursement policies and competitive landscape, is crucial in assessing the sustainability of Scilex's growth. The company's ability to navigate these factors while expanding its product portfolio will be critical for continuous growth. Stakeholders should also consider the potential for increased R&D investments to drive innovation and maintain a competitive edge in the non-opioid pain management market.

Medical Research Analyst

The increased sales figures for Scilex's ZTlido product indicate a successful uptake within the medical community, suggesting that the product's clinical profile is resonating with healthcare professionals and patients seeking non-opioid pain management. This is particularly relevant in the context of the ongoing opioid epidemic, which has heightened the demand for safer, effective alternatives for pain treatment.

Further research and development into the efficacy and safety profile of ZTlido and similar products will be essential to maintain this growth trajectory. Additionally, the potential expansion into new indications or improvements in the product's formulation could further solidify Scilex's position in the market. Healthcare providers and patients will benefit from a broader range of non-opioid options, which could lead to improved patient outcomes and reduced healthcare costs associated with opioid misuse.

PALO ALTO, Calif., Jan. 02, 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 provided certain preliminary unaudited financial results for gross and net sales for the fiscal year ended December 31, 2023, based on currently available information.

The Company estimates that:

• 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%.
• Total product gross sales for the fiscal year ended December 31, 2023 were in the range of $150.0 million to $155.0 million, compared to $96.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 56% to 61%.
• Total product net sales for the fiscal year ended December 31, 2023 were in the range of $46.5 million to $52.5 million, compared to $38.0 million for the fiscal year ended December 31, 2022, representing growth in the range of approximately 22% to 38%.

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 fiscal year ended December 31, 2023. 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.

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 SEMDEXA™, 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 (SEMDEXA™) 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, with FDA Fast Track status. 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. 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 potential impact of the successful FDA audit on Scilex’s commercialization plans for ZTlido®, 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 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 Media
Scilex Holding Company
960 San Antonio Road
Palo Alto, CA 94303
Office: (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 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.

© 2023 Scilex Holding Company All Rights Reserved.

FAQ

What were the ZTlido gross sales for Scilex in 2023?

The ZTlido gross sales for Scilex in 2023 were estimated to be in the range of $145.0 million to $150.0 million.

What was the growth percentage in ZTlido gross sales for Scilex from 2022 to 2023?

The growth in ZTlido gross sales for Scilex from 2022 to 2023 was approximately 51% to 56%.

What were the ZTlido net sales for Scilex in 2023?

The ZTlido net sales for Scilex in 2023 were in the range of $46.0 million to $52.0 million.

What was the growth percentage in ZTlido net sales for Scilex from 2022 to 2023?

The growth in ZTlido net sales for Scilex from 2022 to 2023 was approximately 21% to 37%.

What were the total product gross sales for Scilex in 2023?

The total product gross sales for Scilex in 2023 were estimated to be in the range of $150.0 million to $155.0 million.

What was the growth percentage in total product gross sales for Scilex from 2022 to 2023?

The growth in total product gross sales for Scilex from 2022 to 2023 was approximately 56% to 61%.

What were the total product net sales for Scilex in 2023?

The total product net sales for Scilex in 2023 were in the range of $46.5 million to $52.5 million.

What was the growth percentage in total product net sales for Scilex from 2022 to 2023?

The growth in total product net sales for Scilex from 2022 to 2023 was approximately 22% to 38%.