Scilex Holding Company Announces That Many National Pharmacy Chains and Independent Pharmacies Have Begun Stocking GLOPERBA®

Rhea-AI Summary

Scilex Holding Company, trading on Nasdaq under SCLX, announced the launch of its third commercial product, GLOPERBA®, on June 10, 2024. GLOPERBA® is the first oral liquid medicine for the prophylaxis of gout flares. The product is now available in many national and independent pharmacy chains at a price of $595 per bottle.

Scilex is currently negotiating with additional pharmacy chains to expand distribution. The company emphasizes its commitment to making GLOPERBA® widely accessible across the U.S. Gout, which affects approximately 9.2 million Americans, presents a significant market opportunity, with the U.S. gout treatment market expected to reach $2.0 billion by 2028.

For more details, visit www.gloperba.com.

Positive

• GLOPERBA® is the first oral liquid medicine for gout flare prophylaxis, addressing an unmet medical need.
• Successful launch of the product on June 10, 2024.
• Available in many national and independent pharmacy chains, enhancing accessibility.
• Projected market growth for gout treatment in the U.S. to $2.0 billion by 2028.
• Commitment to broad distribution and strong supply, indicating robust infrastructure.

Negative

• High WAC price of $595 per bottle may limit accessibility for some patients.
• Ongoing negotiations imply potential delays in further distribution.
• Saturation of the market might lead to intense competition in the near future.

Insights

Medical Research Analyst

Gout is a significant health issue, affecting over 9 million Americans. The introduction of GLOPERBA® as the first oral liquid medicine for gout prophylaxis marks a notable advancement. This is particularly relevant for patients who have difficulties swallowing pills, offering an alternative that could improve adherence to treatment. Improved adherence typically results in better health outcomes, potentially reducing long-term healthcare costs associated with untreated or poorly managed gout.

Given the $2 billion market projection for gout treatments by 2028, Scilex is strategically positioned to capture a significant share. The WAC price of $595 per bottle seems competitive, but its success will depend on insurance coverage and patient out-of-pocket costs. If widely adopted, GLOPERBA® could become a standard in gout management, enhancing Scilex's revenue stream.

Financial Analyst

Scilex's announcement is essential from a financial perspective. Launching a new product like GLOPERBA® into many national pharmacy chains and independents indicates strong demand and distribution capability. This can lead to a considerable increase in revenue. Investors should watch quarterly earnings closely for signs of uptake and market penetration. Given the U.S. gout treatment market projection of $2 billion by 2028, even a modest market share could result in substantial revenue growth.

However, potential investors should also consider the risks: the ability of Scilex to maintain and expand its distribution network and manage production costs. The initial pricing and reception by insurance companies will be crucial. If insurers set high reimbursement hurdles, this could limit GLOPERBA®’s market penetration.

• Scilex launched its third commercial product, GLOPERBA^® on June 10, 2024.
• Scilex has officially shipped its recently approved, GLOPERBA^® to many national drug/pharmacy chains, as well as independent pharmacies.
• GLOPERBA^® will be the first oral liquid medicine for prophylaxis of gout flares available beginning this week with a WAC Price of $595/bottle.
• Scilex is also in the process of negotiating similar potential stocking arrangements with additional pharmacy chains in the U.S.
• Scilex remains committed to ensuring broad access, awareness and strong supply for broad distribution efforts across the U.S.
• Gout is a painful arthritic disorder affecting an estimated 9.2 million people in the United States¹. As gout cases increase every year, treatment requirements increase. The gout treatment market is projected to be $2.0 billion in the U.S. by 2028 with a well-defined area of unmet need.²

PALO ALTO, Calif., June 11, 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 that many national pharmacy chains and independent pharmacy stores have begun stocking GLOPERBA^®. Scilex launched GLOPERBA^®, an FDA-approved prophylactic treatment for painful gout flares in adults in the U.S., on June 10, 2024.

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 was launched on June 10, 2024.

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 potential for Scilex to enter into similar stocking arrangements with other pharmacy chains in the U.S.

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

Reference

1) https://jamanetwork.com/journals/jama/fullarticle/2787544#:~:text=How%20Common%20Is%20Gout%3F,%25%20of%20the%20adult%20populati1)

2) Evaluate Pharma data

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 oral liquid medicine for the prophylaxis of gout flares.

When was GLOPERBA® launched?

GLOPERBA® was launched on June 10, 2024.

What is the price of GLOPERBA®?

The WAC price of GLOPERBA® is $595 per bottle.

Where is GLOPERBA® available?

GLOPERBA® is available in many national and independent pharmacy chains.

What is the market projection for gout treatment?

The U.S. gout treatment market is projected to reach $2.0 billion by 2028.