One poster will share pooled INTEGUMENT data of ZORYVE® (roflumilast) cream 0.15% in atopic dermatitis (AD) in patients with prior inadequate response, intolerance, and/or contraindications to topical treatments including topical steroidsSecond poster will highlight improvements in patient-related outcomes with ZORYVE® (roflumilast) foam 0.3% in psoriasis of the scalp and body WESTLAKE VILLAGE, Calif., Feb. 28, 2025 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT), a commercial-stage biopharm ...

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Core Insights - The article highlights the background and achievements of Brendan, a key figure in the biotechnology sector, emphasizing his academic credentials and professional experience in both pharmaceutical and biotech industries [1] Group 1: Professional Background - Brendan completed a Ph.D. in organic synthesis at Stanford University in 2009 [1] - He worked for Merck, a major pharmaceutical company, from 2009 to 2013 [1] - His experience includes roles in biotech startups such as Theravance and Aspira before joining Caltech [1] Group 2: Entrepreneurial Ventures - Brendan was the first employee and co-founder of 1200 Pharma, which spun out of Caltech and secured significant investment in the eight-figure range [1] - He remains actively involved in investing, particularly focusing on market trends and biotechnology stocks [1]

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of October 13, 2025 Application supported by positive efficacy and safety data from pivotal Phase 3 trial, pivotal long-term extension study, and Phase 1 pharmacokinetic study If approved, ZORYVE cream 0.05% will be a new topical therapy option for approximately 1.8 million children aged 2 to 5 with atopic dermatitis (AD) in the United States WESTLAKE VILLAGE, Calif., Feb. 26, 2025 (GLOBE NEWSWIRE) -- ...

Financial Data and Key Metrics Changes - In Q4 2024, the company reported revenues of $71 million, with $69 million from the ZORYVE franchise, reflecting a strong sequential revenue growth [9][10] - For the full year 2024, total revenues reached $197 million, with ZORYVE product sales of $167 million, marking a 471% year-over-year growth [10][57] - The company expects gross-to-net percentages to remain in the 50s, despite some quarterly fluctuations [10][32] Business Line Data and Key Metrics Changes - The ZORYVE franchise saw significant growth, with product sales of $167 million for the year, driven by prescription growth across its portfolio [10][21] - Prescription volume for ZORYVE reached a record high of 16,000 weekly scripts in Q4, representing a 334% year-over-year increase [24][25] - The company launched ZORYVE foam for seborrheic dermatitis and ZORYVE foam 0.15% cream for atopic dermatitis, expanding its product offerings [8][10] Market Data and Key Metrics Changes - The company has secured broad access to approximately 4.5 million commercially insured patients treated by dermatologists and is making progress in gaining Medicare and Medicaid coverage [13][31] - The dermatology market treats over 8 million patients across approved indications, with a significant opportunity to convert patients from topical steroids to ZORYVE [12][42] Company Strategy and Development Direction - The company aims to drive a shift away from topical steroids, focusing on expanding the ZORYVE portfolio and increasing prescriber base beyond dermatology [6][8] - Upcoming PDUFA dates for new indications, including scalp and body psoriasis, are expected to enhance ZORYVE's market presence [8][45] - The company is committed to maintaining strong commercial coverage and expanding its reach into primary care and pediatrics [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the strong foundation established for ZORYVE and the potential for continued growth in 2025 and beyond [7][11] - The management highlighted the importance of educating physicians on the benefits of ZORYVE and the ongoing shift in clinical practice away from steroids [14][48] - The company anticipates reaching cash flow break-even in 2026, which will enhance operational flexibility [62][66] Other Important Information - The company announced a partnership with Odell Beckham Jr. to increase patient awareness of seborrheic dermatitis and promote ZORYVE foam [39][40] - The company has a strong cash position with $228.6 million in cash and marketable securities as of December 31, 2024 [61][62] Q&A Session Summary Question: Clarification on Q4 results delta - Management clarified that the delta between preannounced and actual Q4 results was primarily due to conservative estimates and adjustments for product return reserves [72][73] Question: Confidence in IP protection - Management expressed confidence in the strength of the IP portfolio and the ability to maintain exclusivity for ZORYVE, while also preparing to defend its rights [74] Question: Impact of sales force expansion - The sales force expansion in June significantly enhanced the company's share of voice among dermatologists, contributing to increased prescription growth [83] Question: Refills and tube consumption estimates - Management reported encouraging refill rates of around 40% for ZORYVE cream and foam, with expectations of similar rates for atopic dermatitis as the product matures [91] Question: Medicare and Medicaid coverage - Approximately 1 in 2 Medicaid beneficiaries now have access to ZORYVE, with ongoing negotiations to improve Medicare coverage [102][103] Question: Profitability priorities - While achieving cash break-even is important, the primary focus remains on investing in the growth of ZORYVE and driving revenue growth [105][109]

Group 1 - Arcutis Biotherapeutics reported a quarterly loss of $0.09 per share, significantly better than the Zacks Consensus Estimate of a loss of $0.27, and an improvement from a loss of $0.72 per share a year ago, resulting in an earnings surprise of 66.67% [1] - The company achieved revenues of $71.36 million for the quarter ended December 2024, exceeding the Zacks Consensus Estimate by 23.56%, and showing a substantial increase from $13.53 million in the same quarter last year [2] - Over the last four quarters, Arcutis has surpassed consensus EPS estimates four times and topped revenue estimates twice [2] Group 2 - The stock has underperformed the market, losing about 11.1% since the beginning of the year, while the S&P 500 has gained 1.7% [3] - The company's earnings outlook is crucial for investors, as it includes current consensus earnings expectations for upcoming quarters and any recent changes to these expectations [4] - The current consensus EPS estimate for the next quarter is -$0.26 on revenues of $61 million, and for the current fiscal year, it is -$0.90 on revenues of $277.07 million [7] Group 3 - The Zacks Industry Rank places the Medical - Biomedical and Genetics sector in the top 27% of over 250 Zacks industries, indicating a favorable outlook for stocks in this sector [8] - The estimate revisions trend for Arcutis Biotherapeutics is currently favorable, resulting in a Zacks Rank 2 (Buy) for the stock, suggesting it is expected to outperform the market in the near future [6]

Product Launches and Approvals - ZORYVE cream 0.3% was launched in August 2022 for plaque psoriasis treatment, with FDA approval expanded to children aged 6 years and older in October 2023[29]. - ZORYVE foam received FDA approval in December 2023 for seborrheic dermatitis treatment in individuals aged 9 years and older, becoming commercially available in late January 2024[29]. - ZORYVE cream 0.15% was launched in July 2024 for mild to moderate atopic dermatitis in patients aged 6 years and older, with a supplemental new drug application submitted for children aged 2 to 5 years in December 2024[29]. - ZORYVE cream was commercially launched in August 2022 for the treatment of plaque psoriasis in individuals aged 12 and older, with FDA approval for once-daily use[47]. - In October 2023, FDA approved the expanded indication of ZORYVE cream for children aged 6 to 11 years, with plans to further expand to patients as young as 2 years[47]. - The company plans to launch a lower-dose concentration of ZORYVE cream (0.05%) after completing Phase 2 and Phase 3 studies, with an sNDA submitted in December 2024[48]. - ZORYVE foam is the first drug approved for seborrheic dermatitis with a new mechanism of action in over two decades, becoming commercially available in late January 2024[94]. Clinical Study Results - In the pivotal Phase 3 ARRECTOR study, 66% of individuals treated with ZORYVE foam achieved the co-primary efficacy endpoint of Scalp IGA Success at Week 8[31]. - ZORYVE cream demonstrated a 42.4% success rate in achieving Investigator Global Assessment (IGA) success in the DERMIS-1 study, compared to 6.1% for the vehicle group, and 37.5% in DERMIS-2 compared to 6.9% for the vehicle group[69]. - 57.1% of ZORYVE cream-treated patients achieved an IGA score of clear or almost clear at any time during the study, with a median duration of 40.1 weeks[73]. - In the INTEGUMENT-1 study, 32.0% of individuals treated with ZORYVE cream 0.15% achieved IGA Success compared to 15.2% for the vehicle group (P<0.0001)[76]. - INTEGUMENT-PED trial showed that 25.4% of patients treated with ZORYVE cream 0.05% achieved IGA success at Week 4, compared to 10.7% for the vehicle group (p < 0.0001)[80]. - The STRATUM Phase 3 study showed 79.5% of individuals treated with ZORYVE foam achieved IGA Success at Week 8, significantly higher than the 58.0% for the vehicle group[106]. - The ARRECTOR Phase 3 study reported 67.3% of individuals treated with ZORYVE foam achieved scalp IGA Success at Week 8, compared to 28.1% for the vehicle group[110]. Market Opportunity and Strategy - The company estimates an actively prescription treated patient market of approximately 17.0 million patients in the U.S. for plaque psoriasis, seborrheic dermatitis, and atopic dermatitis[37]. - Less than 20% of moderate-to-severe psoriasis patients in the U.S. are on biologic therapy, indicating a significant market opportunity for new treatments like ZORYVE[58]. - Atopic dermatitis affects approximately 26 million people in the U.S., with a prevalence increase from 8% to 12% in the last two decades[60]. - The company aims to address significant unmet needs in immuno-dermatology by leveraging innovations in inflammation and immunology[37]. - The company is exploring strategic opportunities to in-license or acquire best-in-class dermatology assets to address unmet medical needs in immunology and dermatology[49]. Intellectual Property and Licensing - The company has a licensing agreement with AstraZeneca for exclusive worldwide rights to roflumilast as a topical product for dermatological indications, with exclusivity expected until at least 2037[50]. - The company aims to maintain proprietary rights through patent applications and monitoring third-party patents to protect its product candidates[142]. - As of February 25, 2025, the company holds 32 issued U.S. patents and 58 issued foreign patents, with 31 pending U.S. patent applications and 200 pending foreign patent applications[143]. - The company has 20 issued U.S. patents related to roflumilast cream and foam, with 12 patents listed in the FDA's Orange Book for roflumilast 0.15% and 0.3% cream products[143]. - The company entered a co-promotion agreement with Kowa Pharmaceuticals in July 2024 to market ZORYVE in the U.S. until at least July 2029, with Kowa receiving a commission from net sales[148]. - A License Agreement with Sato Pharmaceutical was established on February 27, 2024, providing an upfront payment of $25 million and potential additional payments of up to $40 million based on regulatory and sales milestones[152]. Development Pipeline - The company is developing ARQ-255, a topical formulation for alopecia areata, with Phase 1b study data expected in the first half of 2025[33]. - ARQ-234, acquired from Ducentis BioTherapeutics, is in preclinical development for atopic dermatitis and other inflammatory conditions, with an IND application planned for submission in 2025[34]. - The acquisition of Ducentis and its lead asset ARQ-234 is expected to enhance the company's portfolio in atopic dermatitis, with plans to submit an IND in 2025[115]. - ARQ-255 utilizes a unique "4D" drug delivery technology to potentially deliver sufficient concentrations of ivarmacitinib deep into hair follicles[117]. - The current treatment landscape for alopecia areata includes oral JAK inhibitor baricitinib, which was FDA approved in June 2022, but there remains a significant unmet medical need for mild to moderate cases[120][121]. Safety and Adverse Events - ZORYVE cream 0.3% demonstrated a favorable safety profile with only 3.6% of subjects experiencing treatment-related adverse events over 52 weeks[73]. - The incidence of adverse events was low, with most being mild to moderate in nature, and no treatment-related serious adverse events reported[73]. - ZORYVE cream 0.15% demonstrated rapid improvements in itch reduction, with 33.6% of individuals achieving a 4-point reduction in WI-NRS at Week 4 in INTEGUMENT-1[77]. Regulatory Considerations - The FDA has a goal of completing a standard review of an NDA for a new molecular entity within ten months from the filing date[184]. - The FDA may grant orphan drug designation for drugs intended to treat rare diseases affecting fewer than 200,000 individuals in the U.S.[199]. - Orphan drug exclusivity prevents the FDA from approving other applications for the same drug for seven years, with limited exceptions[200]. - The FDA may require post-marketing Phase 4 studies to monitor the safety and effectiveness of approved products[203]. - The FDA may require a risk evaluation and mitigation strategy (REMS) as a condition for NDA approval[189].

Financial Performance - Arcutis Biotherapeutics, Inc. announced preliminary unaudited revenue for Q4 2024 and full year 2024[4] - The press release detailing the financial results was issued on January 12, 2025[4] Company Information - The company is listed on the Nasdaq Global Select Market under the symbol ARQT[2]

Core Insights - Arcutis Biotherapeutics reported significant growth in its product ZORYVE, with a 413% increase in Q4 2024 net product revenue compared to Q4 2023, reaching $69.4 million, and a full-year revenue of $166.5 million, a 471% increase year-over-year [6][10] Business Performance - The company successfully launched ZORYVE for two new indications, enhancing its market presence and reimbursement strategies [3][4] - ZORYVE foam has filled over 246,000 prescriptions since its launch, indicating strong demand and high unmet needs in seborrheic dermatitis [5][7] - The company aims to expand Medicaid coverage for ZORYVE cream and foam in additional states during 2025 [7] Financial Results - Total revenues for Q4 2024 were $71.4 million, a substantial increase from $13.5 million in Q4 2023, driven by strong unit demand and improved gross-to-net sales deductions [10] - The net loss for Q4 2024 was $10.8 million, significantly reduced from $66.3 million in Q4 2023, reflecting improved operational efficiency [15][24] - Cash and cash equivalents as of December 31, 2024, were $228.6 million, down from $272.8 million a year earlier, with net cash used in operating activities totaling $112.2 million for the full year [16] Product Pipeline and Development - The company submitted supplemental new drug applications (sNDA) for ZORYVE cream for atopic dermatitis in children and for ZORYVE foam for scalp and body psoriasis, with anticipated FDA action dates in 2025 [6][8] - Arcutis is advancing its pipeline with ARQ-255 for alopecia areata and ARQ-234 for atopic dermatitis, with ongoing clinical trials and expected data releases in 2025 [8] Corporate Highlights - The company made a partial prepayment of $100 million on its outstanding debt, reflecting strong financial management [14] - ZORYVE cream received recognition as "Best Eczema Product" by Glamour in 2024, enhancing its brand visibility [14]

Core Insights - Arcutis Biotherapeutics announced positive results from the pivotal phase 3 trial of ZORYVE (roflumilast) cream 0.05% for treating mild to moderate atopic dermatitis in children aged 2 to 5 years [1][2][3] Efficacy Results - ZORYVE cream 0.05% demonstrated significant improvements in multiple efficacy endpoints, including a statistically significant primary efficacy endpoint of IGA Success and a 75% improvement in Eczema Area and Severity Index (EASI-75) at Week 4 [2][4] - 25.4% of children treated with ZORYVE achieved vIGA-AD Success compared to 10.7% for the vehicle group (P<0.0001) [4] - Rapid improvement in itch was observed within 24 hours of the first application, with 35.3% of children achieving a four-point reduction in Worst Itch Numeric Scale (WI-NRS) at Week 4 [5][6] Study Design - The INTEGUMENT-PED trial was a Phase 3, double-blind, vehicle-controlled study involving 652 children with a mean Body Surface Area (BSA) of 22% [3][4] - The treatment was applied once daily for four weeks, with significant improvements noted as early as Week 1 [4][5] Safety and Tolerability - ZORYVE cream was well-tolerated, with low incidence of Treatment Emergent Adverse Events (TEAEs) similar in both active and vehicle groups [6] - The most common adverse events included upper respiratory tract infection, diarrhea, and vomiting, all occurring in less than 4.1% of patients [6] Market Potential - Approximately 1.8 million children aged 2 to 5 in the U.S. are affected by atopic dermatitis, indicating a significant market opportunity for ZORYVE cream if approved [4][5] - A Supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% has been submitted to the FDA, with potential approval anticipated later this year [6][7]