PALO ALTO, Calif. - Scilex Holding Company (NASDAQ:SCLX) announced today that it has received FDA approval to commence commercial manufacturing of Gloperba®, an FDA-approved treatment for the prevention of painful gout flares in adults. Gloperba®, the first and only liquid oral formulation of colchicine, is set to be available in major U.S. wholesalers and pharmacies starting June 10, 2024.
The market for gout treatments in the U.S. is expected to reach $2.0 billion by 2028, with a growing patient population currently estimated at 9.2 million. Gloperba® is designed to meet the needs of over 70% of gout patients who have comorbid conditions such as chronic kidney disease and gastrointestinal sensitivity, which may require lower doses of colchicine. The liquid formulation allows healthcare providers to prescribe precise dosing, especially beneficial for patients who have experienced severe side effects from standard colchicine tablets or capsules.
Scilex, a company specializing in non-opioid pain management, is positioned to distribute Gloperba® through its established network, leveraging its experience with products such as ZTlido® and Elyxyb®. The launch price for Gloperba® is set at $595 per 150ml bottle, which can last more than 30 days for patients on doses below the standard 0.6 mg once or twice daily.
A market research study conducted by Scilex among rheumatologists indicated a strong interest in the liquid colchicine formulation for its precision dosing capabilities. The American College of Rheumatology guidelines also reflect the need for such a treatment option.
This news follows Scilex's successful commercialization of ZTlido® and the launch of Elyxyb® in April 2023. The company is also advancing its pipeline with product candidates SP-102, SP-103, and SP-104, targeting various pain management indications.
The information in this article is based on a press release statement from Scilex Holding Company.
In other recent news, Scilex Holding Company has been involved in several significant developments. The company reported suspected market manipulation activities affecting its stock to regulatory authorities, including the U.S. Securities and Exchange Commission (SEC) and the Financial Industry Regulatory Authority (FINRA). In a similar move, Scilex also addressed concerns of alleged illegal market manipulation to the U.S. House of Representatives.
In a separate event, Scilex reached a settlement in a patent lawsuit with Takeda Pharmaceuticals over its gout treatment, Gloperba. The settlement agreement was endorsed by the U.S. District Court for the District of Delaware. Following this, Scilex submitted the Consent Judgment to the FDA, seeking final approval for the proposed label expansion of Gloperba.
H.C. Wainwright adjusted its outlook on Scilex shares, reducing the price target to $8.00 from the prior $12.00, while reiterating a Buy rating on the stock. This revision was based on recent developments within the company and market conditions affecting its financial strategies.
In another development, Scilex secured a definitive agreement with certain institutional investors for a registered direct offering involving the sale of 15 million shares of common stock and warrants. The company anticipates gross proceeds of approximately $15 million from this offering, which it plans to allocate towards working capital and general corporate purposes.
InvestingPro Insights
As Scilex Holding Company (NASDAQ:SCLX) gears up to introduce Gloperba® into the U.S. market, the financial health of the company is a vital aspect for investors to consider. Scilex operates with a significant debt burden, which could impact its ability to manage the costs associated with the commercial manufacturing and distribution of its new gout treatment. With short-term obligations surpassing liquid assets, there is a concern that Scilex may face difficulties in meeting its immediate financial commitments.
Analyzing the company's financials, Scilex has a market capitalization of $129.6 million, indicating its size within the pharmaceutical sector. Despite a 12.54% revenue growth in the last twelve months as of Q1 2024, the company remains unprofitable with an operating income margin of -226.01% and a P/E ratio of -0.84. These figures suggest that Scilex is not generating profit from its operations, a trend that analysts do not expect to change within this fiscal year. Furthermore, the company has experienced a price decline of 85.04% over the past year, although it has seen a strong return of 24.78% over the last month.
For investors considering Scilex's potential, it's important to note that the company does not pay a dividend, which could be a factor for those seeking income in addition to capital gains. With these financial insights, prospective investors may want to explore additional InvestingPro Tips for a more comprehensive analysis of Scilex's financial situation and future outlook. There are currently 7 additional tips available on InvestingPro, which could help in making a more informed investment decision. Readers can use the coupon code PRONEWS24 to get an additional 10% off a yearly or biyearly Pro and Pro+ subscription, providing access to in-depth financial data and expert analysis.
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