财务数据和关键指标变化 - 第二季度SKYTROFA销量同比翻倍,但收入下降27%至2620万欧元,主要是由于销售折扣和折扣调整所致 [22][23] - 上半年SKYTROFA收入同比增长35%至9120万欧元,但也受到7.6百万欧元的折扣调整影响 [23] - 预计2024年全年SKYTROFA收入将在2.2亿至2.4亿欧元之间 [23] - 第二季度YORVIPATH收入为520万欧元,反映了德国和奥地利首个完整季度的商业收入 [24] - 第二季度总收入为3600万欧元,包括4.6百万欧元的服务和许可收入 [24] 各条业务线数据和关键指标变化 - SKYTROFA在美国儿童生长激素缺乏治疗患者群体中的渗透率达到18%,占整个生长激素市场的10%左右,还有很大的增长空间 [23] - YORVIPATH在德国和奥地利的患者数已超过250人,处方医生超过125名,患者留存率高达98% [14][41][42] - 公司正在美国和欧洲多个国家推广YORVIPATH,并计划在2025年前在更多欧洲国家上市 [45] 各个市场数据和关键指标变化 - 美国生长激素市场规模约为14亿美元,SKYTROFA的净价值是其他产品的3倍 [30][31] - 公司正在努力扩大SKYTROFA在成人生长激素缺乏症、Turner综合征等适应症的覆盖范围,以实现在美国单一市场的销售突破 [31] - 欧洲YORVIPATH的销售势头良好,已在德国和奥地利实现首个完整季度的商业收入 [14][41][42][45] 公司战略和发展方向及行业竞争 - 公司致力于开发内分泌系统疾病领域的创新产品,已获得SKYTROFA和YORVIPATH在美国和欧洲的批准 [10][12] - 公司正在积极推进TransCon CNP用于治疗achondroplasia的III期临床试验,预计在未来几周内公布结果 [17][18][19] - 公司在肿瘤学领域也有3个II期临床试验正在进行,正在探索其他大市场机会,如肥胖、代谢疾病和心血管疾病 [20][21] - 公司产品在同类竞争产品中具有明显优势,在市场准入和定价方面也有优势 [30][31][34][35][36] 管理层对经营环境和未来前景的评论 - 公司有望在2025年底前获得3个内分泌系统疾病产品的批准,实现既定目标 [10] - 公司的创新算法和TransCon技术使产品开发的成功率高于传统药物开发 [11] - 公司将继续专注于内分泌系统疾病领域,同时也在探索其他大市场机会 [11][20][21] - 公司对TransCon CNP在治疗achondroplasia方面的潜力感到非常兴奋 [17] - 公司正在与FDA积极沟通,希望尽快推出YORVIPATH,满足患者的迫切需求 [74][75] 问答环节重要的提问和回答 问题1 **Jessica Fye 提问** 如何将SKYTROFA打造成美国单一市场的销售突破品种 [29] **Jan Moller Mikkelsen 回答** 公司将通过扩大适应症覆盖范围、提升市场准入和定价优势等措施,实现SKYTROFA在美国市场的销售突破 [30][31] 问题2 **Tazeen Ahmad 提问** SKYTROFA的定价策略如何应对竞争对手的动态 [33][34][35][36] **Jan Moller Mikkelsen 回答** 公司产品在同类竞争产品中具有明显优势,在市场准入和定价方面也有优势,预计能够保持定价水平并进一步扩大市场份额 问题3 **Derek Archila 提问** YORVIPATH在美国的定价反馈如何,在德国和奥地利的市场渗透情况如何 [38][40][41][42] **Jan Moller Mikkelsen 回答** 公司采取了负责任的定价策略,未收到不可接受的反馈;在德国和奥地利的市场渗透超出预期,患者留存率高达98%

COPENHAGEN, Denmark and NEW YORK, Sept. 03, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) and Royalty Pharma plc (Nasdaq: RPRX) today announced that Ascendis Pharma Bone Diseases A/S, a wholly-owned subsidiary of Ascendis Pharma A/S, has entered into a $150 million capped synthetic royalty funding agreement with Royalty Pharma based on U.S. net sales of YORVIPATH. “We are pleased to again partner with Royalty Pharma, a leading funder of innovation across the biopharma industry, as we launch YO ...

YORVIPATH approved by U.S. Food & Drug Administration (FDA) as the first and only treatment of hypoparathyroidism in adultsTransCon CNP (navepegritide) pivotal ApproaCH Trial topline results expected in the coming weeksSKYTROFA Q2 revenue of €26 million – 134% year-over-year volume growth offset by negative adjustment of €27 million, resetting market access for continued growthRevising full year 2024 SKYTROFA revenue outlook to €220 - €240 millionConference call today at 4:30 pm ET COPENHAGEN, Denmark, Sept ...

COPENHAGEN, Denmark, Aug. 28, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (Nasdaq: ASND) today announced it will report second quarter 2024 financial results and provide a business update on Tuesday, September 3, 2024, after the close of the U.S. financial markets. Ascendis Pharma will also host a conference call and live webcast on September 3, 2024, at 4:30 p.m. Eastern Time (ET) to discuss its second quarter 2024 financial results. Those who would like to participate may access the live webcast here, or ...

Shares of Ascendis Pharma A/S (ASND) were up 8.7% on Aug 13 after the company announced that the FDA had approved Yorvipath (palopegteriparatide) for the treatment of adults with hypoparathyroidism.Yorvipath (developed as TransCon PTH) is a hormone replacement therapy for treating adults with hypoparathyroidism, a rare condition in which the body produces abnormally low levels of parathyroid hormone (PTH). Low production of this hormone causes deficiencies of calcium and phosphorus compounds in the blood, r ...

Ascendis Pharma A/S (ASND) shares rallied 8.7% in the last trading session to close at $139.66. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 6.3% loss over the past four weeks.Earlier this week, the FDA approved the company’s hormone replacement therapy, Yorvipath (palopegteriparatide; developed as TransCon PTH) for the treatment of adults with hypoparathyroidism. This might have driven the share price ral ...

da-kuk Ascendis Pharma A/S (ASND), based in Copenhagen, Denmark, is a biopharmaceutical company that utilizes its proprietary TransCon technology platform to develop advanced therapeutics for endocrinology, rare diseases, and oncology. This TransCon system aims to deliver best-in-class therapies with controlled drug release, optimized effects, and less toxicity. The company’s FDA-approved product, Skytrofa, is indicated for pediatric growth hormone deficiency [GHD] and is proof of the efficacy of TransC ...

文章核心观点 - 公司的TransCon CNP(navepegritide)在1年治疗中显示了与安慰剂相比在健康状况和身体功能方面的显著改善[1][2] - 这些改善不仅仅可以解释为线性生长的变化,支持TransCon CNP可能具有超越线性生长的直接治疗效果[1][2] - TransCon CNP作为针对achondroplasia(侏儒症)健康和生活质量并发症的首个获得统计学显著改善的候选药物,有潜力满足这一需求[3] 公司概况 - 公司正在利用其创新的TransCon技术平台建立一家领先的、全面整合的生物制药公司,致力于为患者的生活带来积极影响[6] - 公司以"患者、科学和热情"为核心价值观,利用TransCon技术创造新的潜在最佳疗法[6] - 公司总部位于丹麦哥本哈根,在欧洲和美国也有其他设施[6] 临床试验情况 - ACcomplisH是一项2期、多中心、随机、双盲、安慰剂对照、剂量递增试验,评估了每周一次的TransCon CNP与安慰剂在2-10岁achondroplasia患儿中的疗效和安全性[3] - 在100μg/kg/周的剂量组,患者在日常生活功能和情感健康等方面显示出统计学显著改善,5岁及以上患者的身体功能综合评分也有显著提高[4] - 整个试验人群在100μg/kg/周剂量下52周的生长结果与随机期间该剂量组一致[4] - 未观察到新的安全信号,也未报告与研究药物相关的严重不良事件[4] - 大多数治疗期不良事件为1-2级,注射部位反应发生率较低[5]

COPENHAGEN, Denmark, June 04, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that company executives will participate in a fireside chat at the Goldman Sachs 45th Annual Global Healthcare Conference on Tuesday, June 11, 2024, at 8:00 a.m. ET in Miami, Florida. A live webcast of the fireside chat will be available via the Investors & News section of the Ascendis Pharma website at investors.ascendispharma.com. A webcast replay will also be available on this website shortly after co ...

COPENHAGEN, Denmark, May 30, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced that it will host informational booths, events, and presentations showcasing use of its innovative TransCon technology in the areas of growth hormone deficiency (GHD), hypoparathyroidism, achondroplasia, and Turner syndrome during ENDO 2024, the annual meeting of the Endocrine Society being held June 1-4, 2024, in Boston. "In addition to physician and caregiver presentations in pediatric GHD, we look forw ...