Roflumilast

Q1 2026 net product revenue for ZORYVE® (roflumilast) was $105.4 million, a 65% increase compared to Q1 2025, and a 17% decrease compared to Q4 2025 Continued strong demand for ZORYVE despite typical Q1 seasonality, with continued growth in share of branded non-steroidal topical treatments Submitted supplemental New Drug Application (sNDA) for ZORYVE cream 0.05% to the U.S. Food and Drug Administration (FDA) to expand the indication for the treatment of atopic dermatitis in infants ages 3 to 24 months Completed enrollment in ZORYVE foam 0.3% Maximum Usage Systemic Exposure (MUSE) trial in children with plaque psoriasis of the scalp and body ages 2 to 11 years Initiated Phase 1a/1b, first-in-human study to evaluate safety and tolerability for investigational ARQ-234 in healthy volunteers and adults with moderate to severe atopic dermatitis Completed expansion of dermatology sales force at the beginning of May, and initiated the build-out of a primary care and pediatrics-focused organization including the hiring of the head of Primary Care Franchise Maintained positive operating cash flow for the quarter WESTLAKE VILLAGE, Calif., May 06, 2026 (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, 2026, and provided a business update. “Strong product revenue in the first quarter was driven by continued robust demand for ZORYVE, which remains the leading prescribed branded topical across its three approved indications. During the quarter, we also advanced our pipeline with the initiation of a Phase 1 trial for ARQ‑234, our biologic candidate for atopic dermatitis, submission of an sNDA to the FDA to expand the ZORYVE cream indication in atopic dermatitis to patients as young as 3 months, and progress on our Phase 2 proof-of-concept studies of ZORYVE in potential new indications,” said Frank Watanabe, president and chief executive officer. “We also continued to generate positive cash flow, underscoring our focus on financial and operational discipline as we continue to advance our corporate strategy.” First Quarter 2026 Financial Results and Business HighlightsCommercial HighlightsZORYVE — a highly potent and selective phosphodiesterase-4 (PDE4) inhibitor in once-daily cream and foam formulations, approved in the United States and Canada for the treatment of plaque psoriasis, atopic dermatitis, and seborrheic dermatitis. ZORYVE net product sales for the first quarter of 2026 were $105.4 million, reflecting a 17% sequential decline versus the fourth quarter of 2025 and 65% year-over-year growth. The sequential decline was primarily due to typical first-quarter patient deductible resets and insurance changes. The dermatology sales force expansion has been completed, with representatives in the field at the beginning of May, to optimize prescriber targeting and call frequency in order to deepen adoption of ZORYVE. Began the build-out of an internal, targeted sales team dedicated to primary care and pediatric healthcare providers with the hiring of Katie Swolfs as the head of Primary Care Franchise. Katie brings an incredible breadth and depth of commercial experience to the role, having held a series of strategic and operational senior leadership positions for dermatology-focused companies. Clinical and Regulatory Developments Submitted an sNDA for ZORYVE cream 0.05% to the FDA to expand the indication for the treatment of mild to moderate atopic dermatitis in infants ages 3 to 24 months. Presented new results from the INTEGUMENT-INFANT Phase 2 trial in infants with atopic dermatitis in a late-breaking session at the 2026 American Academy of Dermatology (AAD) Annual Meeting, highlighting that investigational ZORYVE cream 0.05% was well tolerated, improved signs and symptoms of mild to moderate atopic dermatitis, and demonstrated a rapid improvement in itch in as little as 10 minutes in nearly half of infants, as reported by caregivers. Prescription Drug User Fee Act target action date for ZORYVE cream 0.3% for the treatment of plaque psoriasis down to 2 years of age is assigned for June 29, 2026. Completed enrollment in the 0.3% ZORYVE foam MUSE trial in children with plaque psoriasis of the scalp and body ages 2 to 11 years intended to serve as the basis for an sNDA submission to expand the indication for this age group. The Company continues to enroll patients in Phase 2 proof-of-concept studies with ZORYVE foam 0.3% for the treatment of vitiligo and hidradenitis suppurativa, and expects to report results, as well as decisions on program advancement in these indications, in the fourth quarter of 2026 and the first quarter of 2027, respectively. Initiated Phase 1a/1b, first-in-human study to evaluate safety and tolerability for investigational ARQ-234, a fusion protein that is a potent and highly selective checkpoint agonist of the CD200 receptor, in healthy volunteers and adults with moderate to severe atopic dermatitis. Corporate Updates ZORYVE cream 0.05% received a strong recommendation in the AAD Clinical Practice Guidelines for the management of pediatric atopic dermatitis. Sustained positive cash flow, generating $2.2 million of positive cash flow from operating activities in Q1 2026. First Quarter 2026 Summary Financial ResultsNet Product revenues for the quarter ended March 31, 2026 were $105.4 million compared to $63.8 million for the corresponding period in 2025. Revenues for the quarter were $32.7 million for ZORYVE (roflumilast) cream 0.3%, $49.6 million for ZORYVE (roflumilast) topical foam 0.3%, $21.7 million for ZORYVE (roflumilast) cream 0.15%, and $1.4 million for ZORYVE (roflumilast) cream 0.05%. Year-over-year increases were due to strong unit demand as well as improvements in gross-to-net sales deductions. In addition, the first quarter of 2025 included Other revenues of $2.0 million related to license revenues received in connection with the Huadong Pharmaceutical collaboration and licensing agreement covering China and Greater Asia. Cost of sales for the quarter ended March 31, 2026 were $9.8 million compared to $8.8 million for the corresponding period in 2025, due to increased ZORYVE sales. Research and development (R&D) expenses for the quarter ended March 31, 2026 were $30.6 million compared to $17.5 million for the corresponding period in 2025. The year-over-year increase was primarily due to the $10.0 million milestone obligation to former stockholders of Ducentis triggered by the dosing of the first patient in the ARQ-234 Phase 1a/1b trial. Selling, general, and administrative (SG&A) expenses for the quarter ended March 31, 2026 were $74.1 million compared to $64.0 million for the corresponding period in 2025. The year-over-year increase was primarily due to compensation and personnel-related expenses and to higher sales and marketing expenses related to the Company’s continued commercialization efforts for ZORYVE. Net loss was $11.3 million, or $0.09 per basic and diluted share, for the quarter ended March 31, 2026 compared to $25.1 million, or $0.20 per basic and diluted share, for the corresponding period in 2025. Cash, cash equivalents, restricted cash, and marketable securities were $224.3 million as of March 31, 2026, compared to $221.3 million as of December 31, 2025. Net cash provided by operating activities was $2.2 million during the first quarter. Financial GuidanceThe Company continues to anticipate net product revenue of between $480 million and $495 million for the full year 2026. Conference Call and WebcastArcutis management will host a conference call and webcast today at 4:30 PM ET to discuss the financial results for the quarter and provide a business update. The webcast for this conference call may be accessed in the “Events” section of the Company’s website. A replay of the webcast will be available on the Arcutis website following the call. About ArcutisArcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company that champions meaningful innovation to address the urgent needs of individuals living with immune-mediated dermatological diseases and conditions. With a commitment to solving the most persistent patient challenges in dermatology, Arcutis has a growing portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases. Arcutis’ unique dermatology development platform coupled with our dermatology expertise allows us to develop differentiated therapies against biologically validated targets, and has produced a robust pipeline for a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram and X. Forward Looking StatementsThis press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company's current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential to address large markets with significant unmet need; the development, submission, and potential approval, and potential commercialization of product candidates and expanded indications; the potential commercial success and growth of ZORYVE in plaque psoriasis, seborrheic dermatitis, and atopic dermatitis; anticipated net product sales for 2026; the expansion of the Company's dermatology sales force and the success of the Company's efforts in primary care and pediatric health care providers; the Company's ability to maintain positive operating cash flow on a quarterly basis; the building and advancement of the Company's pipeline; and the timing of regulatory filings. These statements involve substantial known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements and you should not place undue reliance on our forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in the clinical development process and regulatory approval process, the timing of regulatory filings, the timing, expenses, and success of our commercialization efforts, including uncertainty of future commercial sales and related items that can impact net sales, and our ability to defend our intellectual property. For a further description of the risks and uncertainties applicable to our business, see the “Risk Factors” section of our Form 10-K filed with U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Contacts: MediaAmanda Sheldon, head of Corporate Communicationsmedia@arcutis.com InvestorsBrian Schoelkopf, head of Investor Relationsir@arcutis.com

伊顿健康导读： 长期抹激素药膏，你是否总在担心皮肤变薄、停药反弹？其实，特应性皮炎（AD）治疗早已跨入“非激素精准时代”。 2025年《特应性皮炎外用治疗与管理专家共识》明确提出：治疗策略从“阶梯式升级激素”转向“分层式精准匹配”，根据年龄、病情、部位靶向用药。同期2026年美国AAD指南也强烈推荐多类非激素外用制剂用于儿童及成人长期管理。掌握以下四类非激素药物，就能告别激素依赖。 1. 钙调神经磷酸酶抑制剂（TCI）——薄嫩部位首选 他克莫司软膏（0.03%用于2-12岁，0.1%用于成人）抗炎效果与中效激素相当，但无皮肤萎缩风险。皮损消退后每周主动用2次，可降低约60%复发率。 吡美莫司乳膏（1%）适用于3月龄以上婴幼儿，安全性更高。注意： 初期可能短暂灼热，冷藏后涂抹可缓解。 2. PDE-4抑制剂——轻中度初始治疗优选 克立硼罗软膏获批用于3月龄以上轻中度患者，约1周起效，常见轻微灼热或刺痛感。 新一代罗氟司特乳膏（0.15%）获批用于6岁及以上，耐受性更优，无灼热刺痛。 3. 外用JAK抑制剂——止痒快、效力强 芦可替尼乳膏：中国III期临床显示，治疗8周后63.0%患者实现皮损清除或基本清除，78.0%达到EASI-75，安全性和耐受性良好。2026年1月已在国内获批白癜风适应症，AD适应症申请已于2026年2月获优先审评。 迪高替尼乳膏在日本已用于中重度手部湿疹，国内尚未上市，可关注。 4. 芳香烃受体（AhR）调节剂——抗炎+修复屏障 本维莫德乳膏（泽立美） 是全球首个AhR靶点AD治疗药物，同步抗炎和修复皮肤屏障。临床研究显示，用药第2天瘙痒显著缓解，治疗8周约54.4%患者达到EASI-75，儿童2-17岁应答率更高达69.2%，停药10个月后约70%未复发。适用于2岁以上儿童及成人，面部、颈部等薄嫩部位均可安心使用，2025年AAD指南给予其强烈推荐。 主动维持期是防复发关键。 皮损消退后，每周用2-3次他克莫司、克立硼罗或本维莫德等非激素药物，持续3-6个月，可显著延长缓解期。 针对不同部位精准用药： 面部、颈部、腋窝等薄嫩部位首选TCI、PDE-4抑制剂或本维莫德；手足部位可短期中强效激素快速控炎，维持期转为非激素药物。孕期及哺乳期优先选择润肤剂、弱中效激素或TCI，哺乳后用药并清洁。 你在用什么非激素药膏？效果如何？欢迎留言分享！ 相关临床试药招募 JAK口服 1.阿布昔替尼口服混悬剂III期，国内外已上市（950元），研究周期16周。治疗后有机会参加2年扩展研究。 2.长森药业LW402片（阿布昔替尼/乌帕替尼同靶点） III期临床，用药一年。 生物制剂 赛诺菲信达OX40L 单抗，司普奇拜单抗，达必妥头对头，IL-4Rα和TSLP双靶点等多种生物制剂正在开展临床。 临床是由国家药监局审批通过，三甲医院专家随访，符合条件用药、体检均不收费，有一定补贴！ 参加临床项目 直接报名 了解更多资讯 可添加工作人员 参考文献： 1.特应性皮炎外用治疗与管理专家共识（2025版） 2.中国特应性皮炎诊疗指南（2020版） 3.澳大利亚《用于药师的特应性皮炎(湿疹)管理指南》解读 4.Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis Topical treatments for atopic dermatitis (eczema): Systematic review and network meta-analysis of randomized trialsof randomized trials 5.Molecular mechanisms of atopic dermatitis pathogenesis 本文仅做参考，不构成对任何药物或诊疗方案的推荐、推广或宣传，也不可替代专业医疗建议。如有问题，请咨询医疗卫生专业人士。材料图片等源自网络，侵删。 点击下方关注我们的皮肤病专属平台