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 ...

This article is published by Terry Chrisomalis, who runs the Biotech Analysis Central pharmaceutical service on Seeking Alpha Marketplace. If you like what you read here and would like to subscribe to, I'm currently offering a two-week free trial period for subscribers to take advantage of. My service offers a deep-dive analysis of many pharmaceutical companies. The Biotech Analysis Central SA marketplace is $49 per month, but for those who sign up for the yearly plan will be able to take advantage of a 33. ...

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]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2024 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 ARCUTIS BIOTHERAPEUTICS, INC. (Exact name of registrant as specified in its charter) Delaware (State or Other Jurisdiction of Inco ...

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]

WESTLAKE VILLAGE, Calif., Feb. 25, 2025 (GLOBE NEWSWIRE) -- Q4 2024 net product revenue for ZORYVE® (roflumilast) was $69.4 million, a 413% increase compared to Q4 of 2023 and a 55% increase compared to Q3 of 2024; driven by strong portfolio demand growth and including a non-recurring adjustment of $4.1 million due to a reduction in reserves for product returnsFull Year 2024 net product revenue for ZORYVE was $166.5 million, an increase of 471% over the prior year, setting the stage for sustained growth and ...

ZORYVE® (roflumilast) cream 0.05% improved atopic dermatitis (AD) across all primary and secondary efficacy endpoints, with significant improvement as early as Week 1 on multiple efficacy endpoints.  39.4% of children treated with roflumilast cream 0.05% achieved a 75% improvement in Eczema Area and Severity Index (EASI-75), a key secondary endpoint.Children treated with ZORYVE cream experienced improvement in itch as early as 24 hours. Efficacy and safety results were consistent with previous trials of ZOR ...