Core Viewpoint - Arcutis Biotherapeutics has initiated a Phase 2 open-label study for ZORYVE (roflumilast) cream 0.05% in infants with atopic dermatitis, marking a significant step in addressing unmet needs in pediatric dermatology [1][2][3] Company Overview - Arcutis Biotherapeutics, Inc. is a commercial-stage biopharmaceutical company focused on innovations in immuno-dermatology, with a commitment to addressing urgent needs in dermatological diseases [15] Study Details - The INTEGUMENT-INFANT study will enroll approximately 35 infants aged 3 months to less than 2 years with mild to moderate atopic dermatitis, evaluating the safety and tolerability of roflumilast cream applied once daily over four weeks [3][9] - This study builds on previous successful results from the ARQ-151-105 (MUSE) study, which also evaluated roflumilast cream in infants [3] Atopic Dermatitis (AD) Insights - Atopic dermatitis is a chronic condition affecting approximately 9.6 million children in the United States, with up to 60% of cases developing symptoms within the first year of life [5][9] - The condition significantly impacts families by disrupting sleep and increasing the risk of skin infections, highlighting the need for effective treatments [2] ZORYVE Product Information - ZORYVE is the first and only branded topical therapy for atopic dermatitis, seborrheic dermatitis, and plaque psoriasis, representing a next-generation topical PDE4 inhibitor [6][7] - ZORYVE cream 0.15% is currently under FDA review for the treatment of mild to moderate atopic dermatitis in children aged 2 to 5 years, with a target action date of October 13, 2025 [8]

Core Insights - Arcutis Biotherapeutics, Inc. is presenting five posters at the 2025 Revolutionizing Atopic Dermatitis (RAD) Conference, showcasing new data on the long-term safety and efficacy of ZORYVE cream in treating atopic dermatitis (AD) in children aged 2 to 5 [1][2] Group 1: Study Findings - The INTEGUMENT-OLE study demonstrated that ZORYVE cream 0.05% has long-term safety and durable efficacy in children aged 2 to 5 with AD, with a median duration of disease control of 238 days for those switching to a proactive twice-weekly application [2][5] - In the study, 32.7% of participants aged 6 years and older and 28.8% of participants aged 2 to 5 achieved a validated Investigator Global Assessment (vIGA-AD) score of clear or almost clear by Week 4, improving to 55.7% and 63.1% respectively by Week 52 [3][5] - Significant improvements in itch were observed, with 30.9% of participants aged 6 years and older and 41.2% of participants aged 2 to 5 achieving a clinically meaningful reduction in itch at the conclusion of the parent studies, improving to 55.3% and 60.7% respectively after up to 56 weeks of treatment [3][5] Group 2: Clinical Implications - The data highlight the critical need for effective, long-term, steroid-free treatment options for young children with AD, as chronic use of topical steroids can lead to significant adverse events [4][5] - ZORYVE cream formulations were well tolerated, with treatment-related adverse events reported in 4.7% of participants aged 6 years and older and 2.5% of participants aged 2 to 5 [4][5] - The investigational ZORYVE cream 0.05% is currently under FDA review, with a target action date of October 13, 2025, indicating potential for future market introduction [13]

Group 1 - The article emphasizes the importance of proof of concepts or product market fits in biotech investments to mitigate regulatory and approval risks while gauging market responses [1] - The author has over 20 years of experience in quantitative research, financial modeling, and risk management, focusing on equity valuation, market trends, and portfolio optimization [1] - The investment research is co-authored with a partner, combining strengths to deliver high-quality, data-driven insights, with a focus on macroeconomic trends, corporate earnings, and financial statement analysis [1]

Core Insights - Arcutis Biotherapeutics, Inc. is participating in the Goldman Sachs 46th Annual Global Healthcare Conference from June 9-11, 2025, with a fireside chat scheduled for June 10, 2025, at 4:00 pm EDT [1] - The company focuses on developing innovations in immuno-dermatology, addressing the needs of patients with immune-mediated dermatological diseases [2] Company Overview - Arcutis is a commercial-stage medical dermatology company with a commitment to addressing urgent patient needs in dermatology [2] - The company has a growing portfolio of advanced targeted topicals approved for treating three major inflammatory skin diseases [2] - Arcutis utilizes a unique dermatology development platform and expertise to create differentiated therapies against biologically validated targets, resulting in a robust pipeline for various inflammatory dermatological conditions, including atopic dermatitis and alopecia areata [2]

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].

Core Insights - Arcutis Biotherapeutics announced positive results from a pivotal Phase 3 study of ZORYVE (roflumilast) foam 0.3% for treating psoriasis of the scalp and body, published in JAMA Dermatology [1][9] Efficacy Results - ZORYVE foam demonstrated significant improvements in co-primary efficacy endpoints, with 66.4% achieving Scalp-Investigator Global Assessment (S-IGA) Success and 45.5% achieving Body-Investigator Global Assessment (B-IGA) Success at Week 8, compared to 27.8% and 20.1% for the vehicle, respectively (P<0.0001) [4][5] - Clinically meaningful improvements in scalp itch were observed, with 65.3% of ZORYVE-treated individuals achieving a significant reduction in itch compared to 30.3% for the vehicle at Week 8 (P<0.0001) [6][8] - At Week 8, 70.9% of ZORYVE-treated individuals achieved at least 75% improvement in Psoriasis Scalp Severity Index (PSSI-75) compared to 31.3% for the vehicle (P<0.001) [13] Study Design - The ARRECTOR study was a Phase 3, randomized, double-blinded, vehicle-controlled trial involving 432 participants aged 12 years and older across 49 sites in the U.S. and Canada [3][5] Safety and Tolerability - ZORYVE foam was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar to the vehicle group; common adverse events included headache, diarrhea, and nausea [8][9] - Investigator-rated application-site tolerability showed no evidence of irritation for at least 99.2% of patients at all time points [8] Regulatory Status - A Supplemental New Drug Application (sNDA) for ZORYVE foam 0.3% is under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) action date set for May 22, 2025 [5][11] Market Context - Psoriasis affects approximately nine million people in the U.S., with more than half experiencing scalp involvement, highlighting the need for effective treatment options [10][11]

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 - ...

Financial Data and Key Metrics Changes - The company reported revenues of $63.8 million for Q1 2025, representing a 196% increase year-over-year, excluding a nonrecurring reduction in reserves for product returns of $4.1 million from Q4 2024 [31][7][14] - Cost of sales for Q1 2025 was $8.8 million, compared to $3.3 million in Q1 2024, primarily due to amortization related to a sales milestone [32] - R&D expenses decreased by 24% year-over-year to $17.5 million, while SG&A expenses increased by 17% to $64 million due to investments in the commercial organization [33] Business Line Data and Key Metrics Changes - The Zurief portfolio achieved net product revenue of $68.3 million in Q1 2025, reflecting a 196% growth year-over-year [14] - Prescription demand for Zurief grew by 10% compared to Q4 2024, with a record high of 17,000 weekly prescriptions on a rolling four-week average [15][9] - The company anticipates further expansion of Zurief's approved indications in 2025, including a new foam formulation for scalp and body psoriasis [9][10] Market Data and Key Metrics Changes - The topical steroid market has declined by 200 basis points over the past year, with branded topicals, led by Zurief, capturing that share [20] - The company has achieved approximately 80% insurance reimbursement for Zurief prescriptions, indicating strong payer access [17] - The total addressable market includes 17 million patients currently treated with topical steroids, presenting a significant growth opportunity for Zurief [11][12] Company Strategy and Development Direction - The company is focused on converting the large topical steroid market to its nonsteroidal treatments, with a strong emphasis on the unique attributes of Zurief [5][6] - The management highlighted the importance of expanding coverage and partnerships to access the entire patient opportunity [12] - The company aims to achieve cash breakeven by 2026, supported by the growth of the Zurief portfolio and improved profitability [34][36] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustaining growth throughout 2025 and beyond, citing multiple upcoming catalysts and expanding markets [5][6] - There is a growing momentum among clinicians shifting away from topical steroids, which is expected to accelerate [27][38] - The company remains optimistic about achieving cash flow breakeven in 2026, supported by a strong balance sheet and revenue growth [39][36] Other Important Information - The company announced a joint stipulation to stay ongoing patent litigation, allowing for a delay in litigation costs and distractions [10] - The company has a total debt of $107.6 million and the option to withdraw $100 million, providing financial flexibility [37] Q&A Session Summary Question: What is the expected cadence of Zurief performance throughout the year? - Management expects some seasonal impact but remains positive about growth drivers, including the upcoming launch of foam for scalp and body psoriasis [43] Question: What are the expectations for the ARQ 255 readout? - The Phase 1b trial focuses on safety and tolerability, with results expected in mid-2025 [44] Question: How will the new scalp and body psoriasis indication impact Zurief foam utilization? - Management anticipates broader utilization of Zurief foam without significant cannibalization of the cream, as it offers unique benefits for scalp involvement [51][52] Question: What is the current split of psoriasis patients treated in dermatology versus primary care? - The split is approximately 50/50, with primary care expected to become a significant contributor to growth over time [71] Question: What are the next steps after the patent litigation stay? - The stay is indefinite, and the company will provide quarterly updates to the court regarding the status of the dispute [78]