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].

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]