UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form10-Q 91361 (Zip Code) (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended September 30, 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 O ...

Arcutis Announces Third Quarter 2024 Financial Results and Provides Business Update • Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24 • Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarter • Sustained growth in pr ...

Third quarter net product revenues for ZORYVE® (roflumilast) franchise of $44.8M, with $22.0M for ZORYVE cream 0.3%, $20.3M for ZORYVE topical foam 0.3%, and $2.5M for ZORYVE cream 0.15%; sales growth of 452% vs. Q3 '23 and 45% vs. Q2 '24Continued gross-to-net (GTN) improvement with blended GTN across products now in the low 50 percent range, improving from the high 50 percent range last quarterSustained growth in prescriptions for both cream and foam, with total U.S. franchise unit demand increase of 25% q ...

The market expects Arcutis Biotherapeutics, Inc. (ARQT) to deliver a year-over-year increase in earnings on lower revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates. The stock might move higher if these key numbers top expectations in the upcoming earnings report. On the othe ...

Quarterly investor conference call and webcast is scheduled for Wednesday, November 6 at 4:30 p.m. ETArcutis management will also participate in the Guggenheim Securities Healthcare Innovation Conference in November WESTLAKE VILLAGE, Calif., Oct. 23, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that it will report third quarter 2024 financial results and ...

文章核心观点 - ZORYVE泡沫是加拿大批准的首个用于治疗seborrheic dermatitis的新机制外用疗法,在20多年内获得批准[1] - ZORYVE泡沫是ZORYVE产品组合在加拿大的第二个批准,使ZORYVE可供超过200万患有seborrheic dermatitis的加拿大人使用[2] 根据相关目录分别进行总结 ZORYVE泡沫概况 - ZORYVE泡沫是一种高效且选择性的磷酸二酯酶-4(PDE4)抑制剂roflumilast的外用泡沫制剂,作为一种每日一次的非类固醇外用治疗多种皮肤病的药物正在研究[3] - PDE4是皮肤科中的一个已确立的靶点,是一种细胞内酶,可增加促炎性介质的产生并降低抗炎性介质的产生[3] 公司概况 - Arcutis Biotherapeutics是一家商业阶段的医疗皮肤科公司,致力于解决免疫介导性皮肤病患者的迫切需求[4] - 公司拥有一个不断增长的产品组合,包括3个获FDA批准的产品,利用其独特的皮肤科开发平台和专业知识开发差异化疗法[4] - 公司的皮肤科开发平台包括一个针对多种炎性皮肤病(包括头皮和躯干银屑病、特应性皮炎和斑秃)的强大管线[4]

ZORYVE demonstrated consistent efficacy in disease clearance and reduction in itch for individuals with atopic dermatitis (AD) regardless of race, ethnicity, and Fitzpatrick skin typeZORYVE was safe and well tolerated across all subgroupsData presented at the 2024 European Academy of Dermatology & Venereology Congress WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovat ...

U.S. Food and Drug Administration (FDA) has set a Prescription Drug User Fee Act (PDUFA) target action date of May 22, 2025Almost half of the 9 million individuals in the United States with plaque psoriasis experience involvement of the scalpSupplemental New Drug Application (sNDA) supported by positive efficacy and safety data from Phase 2b and pivotal Phase 3 trials, and long-term ZORYVE cream plaque psoriasis program WESTLAKE VILLAGE, Calif., Sept. 24, 2024 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, In ...

FocalFinder/iStock via Getty Images Investment Overview At the end of January this year, I shared a note on Seeking Alpha covering Arcutis Biotherapeutics, Inc. (NASDAQ:ARQT). This is a Westlake Village, California-based biotech that markets and sells two dermatological products — ZORYVE® (roflumilast) cream 0.3%, and ZORYVE® (roflumilast) topical foam 0.3%. Roflumilast is — according to Arcutis' Q2 2024 quarterly report / 10Q submission: a highly potent and selective phosphodiesterase-4 ("PDE4") inhibi ...

财务数据和关键指标变化 - 公司第二季度净产品收入为3.09亿美元,较上年同期增长547%,较上一季度增长43% [43] - 研发费用为1.93亿美元,较上年同期有所下降,主要是由于持续减少了topical roflumilast项目的开发成本以及较上一季度较低的早期项目支出 [44] - 销售及一般管理费用为5.82亿美元,较上年同期增加,主要是由于投资于当前和未来的产品发布,包括扩大销售团队 [45] 各条业务线数据和关键指标变化 - ZORYVE系列产品(包括乳膏和泡沫剂)的处方量增长42%,达到接近每周10,000个处方的新高 [17] - ZORYVE乳膏在银屑病治疗中的处方量增长8%,ZORYVE泡沫剂在seborrheic dermatitis治疗中的处方量增长102% [18][19] 各个市场数据和关键指标变化 - ZORYVE乳膏和泡沫剂在三大PBM中都获得了覆盖,约80%的乳膏处方和75%的泡沫剂处方获得保险报销 [19] - 公司预计未来收入增长主要来自于银屑病、seborrheic dermatitis和新的特应性皮炎需求的处方量增长,以及处方医生群的扩大 [20] 公司战略和发展方向及行业竞争 - 公司正在积极拓展ZORYVE在特应性皮炎、头皮和全身银屑病等适应症的开发,并计划在2025年提交2岁至5岁儿童特应性皮炎的新适应症申请 [32][35] - 公司与Kowa Pharmaceuticals达成合作,将ZORYVE推广至初级护理和儿科医生,预计2025年将对收入产生重大贡献 [29][30] 管理层对经营环境和未来前景的评论 - 公司对2024年下半年及以后的持续收入增长保持乐观,主要来自于银屑病和seborrheic dermatitis产品的持续势头以及特应性皮炎新适应症的贡献 [13] - 公司与SLR重新谈判了债务协议的条款,获得了更好的财务灵活性,包括延长还款期限、降低利率、增加提前还款灵活性等 [47][48] 其他重要信息 - 公司现金及可流动资产为3.63亿美元,可为业务运营提供充足资金支持 [46] - 公司目前无需再次进入股权市场融资,可依靠产品收入和现有资金满足业务需求 [46] 问答环节重要的提问和回答 问题1 **Vikram Purohit 提问** - 询问ZORYVE在银屑病和seborrheic dermatitis治疗中的复购率和患者年使用量估计 [51][52] - 询问ZORYVE泡沫剂产品的稳定状态毛利率水平 [51] **Todd Edwards 回答** - ZORYVE在银屑病和seborrheic dermatitis治疗中的复购率分别约为38%和更高 [53][54] - 预计银屑病患者年使用量为2-3支管,seborrheic dermatitis患者年使用量约2罐 [54] - 预计ZORYVE泡沫剂的稳定状态毛利率将达到高50%区间 [55] 问题2 **Tyler Van Buren 提问** - 询问ZORYVE乳膏最近两周处方量大幅增加是否与特应性皮炎新适应症上市有关 [58] - 询问长期来看ZORYVE乳膏和泡沫剂的销售占比预期 [58] **Todd Edwards 回答** - ZORYVE乳膏最近处方量增加与产品组合效应和销售团队扩张有关,未来预计ZORYVE泡沫剂的处方量将超过乳膏 [61][62][63] 问题3 **Seamus Fernandez 提问** - 询问Kowa合作对公司特应性皮炎业务的影响和时间点 [66] - 询问公司对2岁至5岁儿童特应性皮炎适应症的看重程度 [66] **Todd Edwards 和 Patrick Burnett 回答** - Kowa合作预计在本季度末开始在初级护理和儿科医生中推广,但对2024年收入贡献有限,主要在2025年体现 [73][79] - 2岁至5岁儿童特应性皮炎适应症是公司的一个重要目标,与6岁以上儿童和青少年适应症相一致,有望进一步扩大ZORYVE在儿科市场的覆盖 [70][71]