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Scilex Holding Company Announces Stocking of GLOPERBA® is Underway in all of the Wholesalers with which Scilex has Stocking Arrangements Throughout the U.S.

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Scilex Holding Company (Nasdaq: SCLX) announced that the stocking of GLOPERBA®, its third commercial product, is underway in all wholesalers with which it has stocking arrangements throughout the U.S. The process is expected to complete by June 12, 2024. GLOPERBA® is the first and only liquid oral formulation of colchicine for the prophylaxis of gout flares in adults. Scilex has increased the production of GLOPERBA® and supports patients with a co-pay savings card. For more details, visit www.gloperba.com.

Positive
  • Stocking of GLOPERBA® across all U.S. wholesalers is scheduled to complete by June 12, 2024.
  • GLOPERBA® is the first and only liquid oral colchicine formulation for gout flare prophylaxis in adults.
  • Scilex increased production and availability of GLOPERBA®.
  • Patients receive support through a co-pay savings card.
Negative
  • The PR does not provide specific sales projections or revenue expectations from GLOPERBA®.
  • The success of GLOPERBA® relies heavily on effective distribution and patient uptake, which remains to be seen.

Insights

Scilex's announcement regarding the nationwide stocking of GLOPERBA®, an FDA-approved treatment for gout flares, is a significant development. By adding this product to their portfolio, Scilex is strategically expanding its market presence in the non-opioid pain management sector. The availability of a liquid oral colchicine formulation presents a unique niche in a market predominantly filled with tablet-based treatments.

Market penetration is important here. Stocking arrangements with numerous wholesalers suggest that Scilex has robust distribution channels already in place. This bodes well for product accessibility, potentially leading to a quicker market uptake. Investors should note the competitive advantage provided by the co-pay savings card, which can drive patient adoption by reducing out-of-pocket expenses.

In assessing market dynamics, the gout medication market is projected to grow significantly due to rising prevalence. Therefore, a timely and effective launch could capture substantial market share. However, the success heavily relies on marketing execution and continued patient education to highlight the benefits of a liquid formulation.

From a financial perspective, the introduction of GLOPERBA® could be a revenue catalyst for Scilex. The company's strategic expansion into a new product line suggests a proactive approach to diversifying revenue streams. This move can stabilize earnings and reduce dependence on any single product.

Looking at costs and margins, investors should consider the impact of increased production on the company’s financials. While initial costs might rise, economies of scale could improve margins over time. The co-pay savings card is a double-edged sword; it can drive volume but may initially impact profitability.

In the short term, investors should monitor quarterly earnings for signs of revenue growth attributed to GLOPERBA®. Long-term success will depend on maintaining a sustainable cost structure and achieving substantial market penetration. Watch for updates on sales performance and any reported shifts in market dynamics.

As the first and only liquid oral formulation of colchicine, GLOPERBA® addresses a specific patient need, particularly for those who have difficulty swallowing pills. This can potentially improve patient compliance, an important factor in chronic disease management.

From a medical standpoint, it is important to highlight that colchicine is a well-established treatment for gout, but adherence to medication regimens can often be problematic. GLOPERBA's unique formulation could lead to better patient outcomes and fewer painful gout flares, which aligns with the growing emphasis on patient-centered care in the medical community.

Additionally, the introduction of co-pay savings cards can be seen as a strategic move to reduce financial barriers for patients, potentially leading to higher adherence rates and improved overall health outcomes. Long-term studies and real-world data will be critical to validate the clinical benefits and cost-effectiveness of this new formulation.

  • Stocking of GLOPERBA® is underway in all of the wholesalers with which Scilex has stocking arrangements throughout the U.S and Scilex expects completion of stocking by Wednesday June 12, 2024.
  • Today, Scilex is launching its third commercial product, GLOPERBA®.
  • Patients will have support of the co-pay savings card for GLOPERBA®.
  • GLOPERBA® is the first and only liquid oral formulation of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults.
  • Scilex increased production of GLOPERBA® and product availability under the brand marketed and distributed by Scilex Pharmaceuticals, Inc. for GLOPERBA®.

PALO ALTO, Calif., June 10, 2024 (GLOBE NEWSWIRE) -- Scilex Holding Company (Nasdaq: SCLX, “Scilex” or the “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 stocking of GLOPERBA® is underway in all of the wholesalers with which Scilex has stocking arrangements throughout the U.S. GLOPERBA®, an FDA-approved prophylactic treatment for painful gout flares in adults in the U.S., is launching today.

For more information on Gloperba®, including Full Prescribing Information, refer to www.gloperba.com.

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 targets indications with high unmet needs and large market opportunities with non-opioid therapies for the treatment of patients with acute and chronic pain and are dedicated to advancing and improving patient outcomes.    Scilex’s commercial products include: (i) ZTlido® (lidocaine topical system) 1.8%, a prescription lidocaine topical product approved by the U.S. Food and Drug Administration (the “FDA”) for the relief of neuropathic pain associated with postherpetic neuralgia, which is a form of post-shingles nerve pain; (ii) ELYXYB®, a potential 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; and (iii) Gloperba®, the first and only liquid oral version of the anti-gout medicine colchicine indicated for the prophylaxis of painful gout flares in adults, which is launching today.

In addition, Scilex has three product candidates: (i) SP-102 (10 mg, dexamethasone sodium phosphate viscous gel) (“SEMDEXA™” or “SP-102”), a novel, viscous gel formulation of a widely used corticosteroid for epidural injections to treat lumbosacral radicular pain, or sciatica, for which Scilex has completed a Phase 3 study and was granted Fast Track status from the FDA in 2017; (ii) SP-103 (lidocaine topical system) 5.4%, (“SP-103”), a next-generation, triple-strength formulation of ZTlido, for the treatment of chronic neck pain and for which Scilex has recently completed a Phase 2 trial in low back pain. SP-103 has been granted Fast Track status from the FDA in low back pain; and (iii) SP-104 (4.5 mg, low-dose naltrexone hydrochloride delayed-release capsules) (“SP-104”), a novel low-dose delayed-release naltrexone hydrochloride being developed for the treatment of fibromyalgia, for which Phase 1 trials were completed in the second quarter of 2022.

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 expectation that stocking of Gloperba® in all of the wholesalers with which Scilex has stocking arrangements will be completed by June 11, 2024 and estimates for potential demand of Gloperba®.  

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: 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 and studies for SP-102, SP-103 or SP-104 may not be successful or reflect positive outcomes; risks that the prior results of the clinical and investigator-initiated 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 described in Scilex’s most recent periodic reports filed with the Securities and Exchange Commission, including Scilex’s Annual Report on Form 10-K for the year ended December 31, 2023 and subsequent Quarterly Reports on Form 10-Q that the Company has filed or may file, including the risk factors set forth in those filings. 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 Scilex Holding Company to use the registered trademark.

ELYXYB® is a registered trademark owned by Scilex Holding Company.

All other trademarks are the property of their respective owners.

© 2024 Scilex Holding Company All Rights Reserved.


FAQ

What is GLOPERBA®?

GLOPERBA® is the first and only liquid oral formulation of colchicine, used for the prophylaxis of painful gout flares in adults.

When will GLOPERBA® be fully stocked in the U.S.?

The stocking of GLOPERBA® is expected to be completed by June 12, 2024.

What support is available for GLOPERBA® patients?

Patients will have access to a co-pay savings card for GLOPERBA®.

What is the stock symbol for Scilex Holding Company?

The stock symbol for Scilex Holding Company is SCLX.

Where can I find more information about GLOPERBA®?

More information can be found at www.gloperba.com.

Scilex Holding Company

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