WESTLAKE VILLAGE, Calif. - Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a biopharmaceutical company, announced the commercial availability of ZORYVE cream 0.15% for treating mild to moderate atopic dermatitis in adults and children aged six and older in the United States. The product, which is steroid-free and designed for once-daily application, is said to offer rapid relief of disease symptoms and itch reduction.
Atopic dermatitis, a common form of eczema, impacts an estimated 9.6 million children and 16.5 million adults across the U.S. ZORYVE cream aims to provide long-term disease control and can be applied on any part of the body. According to Todd Edwards, Arcutis' chief commercial officer, the cream has been developed with patient tolerance in mind for continuous, long-term use.
The commercial launch of ZORYVE cream is the third for Arcutis in two years, expanding its portfolio of dermatological products. The cream is available in pharmacies this week and is covered under two commercial PBM contracts, potentially offering immediate insurance coverage for many patients.
Arcutis emphasizes responsible pricing and the ZORYVE Direct Program, which supports patients in accessing their prescribed medication. This includes assistance in navigating the payer process, adherence support, and a savings card program for eligible commercially insured patients. Moreover, the Arcutis Cares patient assistance program offers ZORYVE at no cost to financially eligible patients who are uninsured or underinsured.
The U.S. Food and Drug Administration (FDA) approved ZORYVE cream 0.15% for the topical treatment of atopic dermatitis on July 9, 2024. The cream is prescription-only. For further information, the company directs individuals to zoryve.com.
Arcutis will host an investor event today featuring a dermatology expert to discuss the treatment landscape for atopic dermatitis. The event will be accessible via the company's investor website, with an archived webcast available afterward.
This article is based on a press release statement.
In other recent news, Arcutis Biotherapeutics has been in the spotlight due to positive developments. The company reported robust financial results for the first quarter of 2024, with net revenues reaching $21.6 million, a 59% increase from the previous quarter. This growth was primarily driven by the success of the company's ZORYVE product lineup, which generated over 255,000 prescriptions from more than 12,500 unique prescribers.
Mizuho Securities has maintained its Outperform rating on Arcutis Biotherapeutics and raised the price target from $18.00 to $19.00. The adjustment reflects Mizuho's positive outlook on the company's Zoryve product sales, which are anticipated to exceed market expectations for the second quarter of 2024. The company's management expects a modest quarter-over-quarter improvement in gross-to-net figures, which is likely to be a focal point during the company's earnings call.
In terms of product development, Arcutis is awaiting the FDA's final decision on its supplemental New Drug Application for roflumilast cream 0.15% for the treatment of atopic dermatitis. Mizuho Securities has reiterated its Outperform rating on the company's stock, expressing optimism about the FDA approval. Arcutis has also received positive feedback for its ZORYVE foam for seborrheic dermatitis and plans to expand indications for scalp and body psoriasis.
Finally, Arcutis Biotherapeutics raised $172 million in a secondary offering and entered into a licensing agreement with Sato Pharmaceutical. These recent developments underscore Arcutis Biotherapeutics' strong position in the dermatology treatments market.
InvestingPro Insights
As Arcutis Biotherapeutics (NASDAQ:ARQT) launches ZORYVE cream into the competitive dermatological market, the company's financial health and market performance provide valuable context for investors.
With a market capitalization of $1.17 billion, Arcutis showcases a robust presence in the biopharmaceutical industry. The impressive revenue growth rate of 1545.18% over the last twelve months as of Q1 2024 signals a strong market reception to its product offerings, which may be bolstered by the commercial availability of ZORYVE cream.
InvestingPro Tips for Arcutis indicate that the company holds more cash than debt on its balance sheet and has liquid assets that exceed short-term obligations, suggesting a stable financial footing that could support its operational needs and investment in growth opportunities.
Furthermore, analysts anticipate sales growth in the current year, which could be fueled by the recent FDA approval and commercial launch of ZORYVE cream. With gross profit margins standing at an impressive 92.99% over the last twelve months, Arcutis demonstrates the ability to maintain profitability in its core operations.
However, it is worth noting that analysts do not anticipate the company will be profitable this year, and Arcutis has been quickly burning through cash. These factors, combined with a negative P/E ratio of -3.82, highlight some of the challenges the company faces. Yet, the large price uptick of 66.17% over the last six months signals investor optimism, which could be linked to the company's strategic product launches and market expansion efforts.
For those interested in deeper analysis, there are additional InvestingPro Tips available, which can provide further insights into Arcutis' performance and prospects. To access these tips and more detailed metrics, visit https://www.investing.com/pro/ARQT. Remember to use the coupon code PRONEWS24 to get up to 10% off a yearly Pro and a yearly or biyearly Pro+ subscription.
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