Core Insights - Arcutis Biotherapeutics has received FDA approval for ZORYVE (roflumilast) topical foam 0.3% for treating plaque psoriasis in patients aged 12 and older, marking a significant advancement in immuno-dermatology [1][5] - ZORYVE foam is a once-daily, steroid-free treatment that is now widely available, addressing the needs of nearly 9 million people in the U.S. living with plaque psoriasis, particularly those with scalp involvement [2][5] Product Details - ZORYVE foam demonstrated significant improvements in clinical trials, achieving Scalp-Investigator Global Assessment (S-IGA) Success in 66.4% of patients compared to 27.8% for the vehicle foam at Week 8 [8] - The foam also provided rapid itch relief, with 65.3% of patients experiencing a clinically significant reduction in scalp itch compared to 30.3% for the vehicle [10] - ZORYVE is indicated for both plaque psoriasis and seborrheic dermatitis, with a focus on hard-to-treat areas such as the scalp and body [14][15] Clinical Trial Results - The approval was supported by positive results from Phase 2 and pivotal Phase 3 trials, enrolling 736 adults and adolescents with mild to severe plaque psoriasis [7] - In the ARRECTOR study, 45.5% of individuals treated with ZORYVE foam achieved Body-IGA Success compared to 20.1% for the vehicle foam at Week 8 [8] - The treatment was well tolerated, with low incidence of adverse events, primarily mild to moderate in severity [12] Market Context - The approval of ZORYVE foam is the fifth for the product in less than three years, highlighting Arcutis' commitment to addressing urgent needs in dermatology [3][5] - The company aims to provide predictable access to ZORYVE through programs that assist patients with adherence and reduce out-of-pocket costs [4][21] Future Engagement - Arcutis will host a virtual Key Opinion Leader Event on June 2, 2025, to discuss the treatment landscape for plaque psoriasis, featuring insights from a leading expert [4][5]

Core Viewpoint - Arcutis Biotherapeutics has announced the publication of 14 consensus statements from the Genital Psoriasis Wellness Consortium, aimed at improving the understanding and management of genital psoriasis, which significantly impacts patients' quality of life and interpersonal relationships [1][2][3]. Group 1: Consensus Statements and Guidelines - The consensus statements focus on three key areas: physical diagnosis and patient conversations, impact on quality of life and interpersonal relationships, and treatment decisions [1][2]. - Genital psoriasis affects approximately six million Americans and is often underreported and undertreated due to its sensitive nature [2][4]. - The Consortium's guidelines aim to normalize conversations about genital psoriasis and improve shared decision-making between clinicians and patients [3][5]. Group 2: Research and Methodology - A comprehensive literature review was conducted, analyzing 78 unique publications to formulate the consensus statements [2]. - The consensus was developed using a modified Delphi process, which included virtual meetings and anonymous surveys to gather feedback [2][3]. Group 3: Clinical Implications - Genital psoriasis should be recognized as a distinct diagnosis with a unique ICD-10-CM code to facilitate better diagnosis and treatment [5]. - Early diagnosis is critical, as the psychological burden and symptoms may worsen over time if not addressed promptly [5][10]. - The implementation of standardized assessment tools and comprehensive skin examinations is recommended to improve patient care [5][10]. Group 4: Company Overview - Arcutis Biotherapeutics is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a portfolio aimed at addressing immune-mediated dermatological diseases [6]. - The company is committed to developing differentiated therapies and has a robust pipeline for various inflammatory dermatological conditions [6].

Once-daily, investigational ZORYVE foam 0.3%, rapidly improved psoriasis of the scalp and body, including itch, when used as a monotherapy66.4% of individuals treated with ZORYVE foam achieved Scalp-Investigator Global Assessment (S-IGA) Success at Week 845.5% of individuals treated with ZORYVE foam achieved Body-Investigator Global Assessment (B-IGA) Success at Week 8Efficacy and safety results were consistent with Phase 2 results of ZORYVE foam 0.3% in adults and adolescents 12 years of age and olderSuppl ...

Group 1 - Arcutis Biotherapeutics reported a quarterly loss of $0.20 per share, which was better than the Zacks Consensus Estimate of a loss of $0.21, and an improvement from a loss of $0.32 per share a year ago, resulting in an earnings surprise of 4.76% [1] - The company achieved revenues of $65.85 million for the quarter ended March 2025, exceeding the Zacks Consensus Estimate by 3.26%, and showing a year-over-year increase from $49.57 million [2] - Over the last four quarters, Arcutis Biotherapeutics has surpassed consensus EPS estimates four times and topped consensus revenue estimates three times [2] Group 2 - The stock has increased approximately 10.6% since the beginning of the year, contrasting with a decline of 3.9% in the S&P 500 [3] - The current consensus EPS estimate for the upcoming quarter is -$0.19 on revenues of $72.93 million, and for the current fiscal year, it is -$0.55 on revenues of $307.74 million [7] - The Medical - Biomedical and Genetics industry, to which Arcutis Biotherapeutics belongs, is currently ranked in the top 31% of over 250 Zacks industries, indicating a favorable outlook compared to the bottom 50% [8]

Arcutis Biotherapeutics (ARQT) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Company Participants Amanda Sheldon - Head of Corporate CommunicationsFrank Watanabe - President & CEOTodd Edwards - CCOPatrick Burnett - Senior VP & Chief Medical OfficerLatha Vairavan - CFOSeamus Fernandez - Senior Managing DirectorUy Ear - Vice PresidentKambiz Yazdi - Vice President - Equity ResearchDouglas Tsao - Managing Director Conference Call Participants Vikram Purohit - Executive Director, Equity AnalystTyler Van Buren - ...

Arcutis Biotherapeutics (ARQT) Q1 2025 Earnings Call May 06, 2025 04:30 PM ET Speaker0 Good day, and welcome to Arqudis Biotherapeutics twenty twenty five First Quarter Financial Results Conference Call. At this time, all participants are in a listen only mode. After the speakers' presentation, there will be a question and answer session. Please be advised that today's conference is being recorded. I would now like to hand the call over to Amanda Sheldon. Please go ahead. Speaker1 Thank you, Heidi. Good aft ...

1 st Quarter 2025 Financial Results & Business Update May 6, 2025 Legal Disclaimers This presentation and the accompanying oral presentation contain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended. Forward-looking statements include all statements other than statements of historical fact contained in this presentation, including information concerning our current and future financia ...

(Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For transition period from to Commission File Number: 001-39186 UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form10-Q ARCUTIS BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or Other Jurisdiction of ...

Arcutis Announces First Quarter 2025 Financial Results and Provides Business Update Westlake Village, CA, May 6, 2025 – Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial- stage biopharmaceutical company focused on developing meaningful innovations in immuno- dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. "In the first quarter we again delivered excellent performance driven by strong demand growth for our ZORYVE portfolio, which of ...

WESTLAKE VILLAGE, Calif., May 06, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today reported financial results for the quarter ended March 31, 2025, and provided a business update. "In the first quarter we again delivered excellent performance driven by strong demand growth for our ZORYVE portfolio, which offers a distinct and compelling value proposition and provides h ...