公司业绩公布 - BioCryst Pharmaceuticals将于2024年5月6日公布第一季度财务业绩[1] - 公司管理层将在当天上午8:30举行电话会议和网络直播，讨论财务业绩并提供公司更新[2] 公司背景介绍 - BioCryst Pharmaceuticals是一家全球生物技术公司，致力于改善患有补体介导和其他罕见疾病的患者生活，公司利用结构引导药物设计的专业知识开发首创或最佳口服小分子和蛋白质治疗药物，已经推出ORLADEYO®（berotralstat）并正在推进一系列小分子和蛋白质疗法的研发[4]

ORLADEYO获得批准 - BioCryst Pharmaceuticals宣布ORLADEYO（berotralstat）获得巴西卫生监管机构批准，用于预防成人和12岁及以上儿童的遗传性血管性水肿（HAE）发作[1] 合作与推广 - 与Pint Pharma GmbH独家合作，在整个拉丁美洲地区注册和推广ORLADEYO[3] 专门设计口服疗法 - ORLADEYO（berotralstat）是首个也是唯一一个专门设计用于预防成人和12岁及以上儿童遗传性血管性水肿（HAE）发作的口服疗法[4]

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财务数据和关键指标变化 - 2023年第四季度总收入为9340万美元,其中ORLADEYO销售收入为9090万美元 [33] - 2023年全年ORLADEYO全球销售收入为3.26亿美元,同比增长30% [33] - 2023年第四季度美国ORLADEYO销售收入为7940万美元,占全球收入的87.3% [34] - 2023年全年美国ORLADEYO销售收入为2.884亿美元,占全球收入的88.5% [34] 各条业务线数据和关键指标变化 - 无相关内容 各个市场数据和关键指标变化 - 2023年第四季度美国ORLADEYO销售收入为7940万美元,占全球收入的87.3% [34] - 2023年全年美国ORLADEYO销售收入为2.884亿美元,占全球收入的88.5% [34] - 公司预计在未来几年内,ORLADEYO在美国的峰值销售额将达到8亿美元 [8][9] - 公司预计ORLADEYO在全球范围内的峰值销售额将达到10亿美元 [8] 公司战略和发展方向及行业竞争 - 公司正在持续推进ORLADEYO的全球市场拓展,并计划进一步扩大其适应症范围,如儿童适应症 [39] - 公司正在积极投资早期管线,以持续创新和保持竞争优势 [137][138] - 公司预计在2024年实现收入超过营业支出,进入盈利状态,并在2025年下半年和2026年全年实现净收益和现金流正数 [37][38][39] 管理层对经营环境和未来前景的评论 - 公司对ORLADEYO在未来几年内实现8亿美元峰值销售的目标充满信心,这得益于2023年在患者增长、付费率提升和价格调整等方面的出色执行 [8][9] - 公司认为ORLADEYO在疗效和便利性方面的优势将帮助其持续增长,并吸引更多患者使用 [23][24][29] - 公司预计随着医疗保险改革的推进,ORLADEYO的可负担性将进一步提高,有助于提升付费率 [92][93] 问答环节重要的提问和回答 问题1 **Tazeen Ahmad 提问** 公司在2023年新增的患者中,是否有某些特定类型的患者超出预期?患者在转换到ORLADEYO时的基线发作率通常如何? [42][43] **公司回答** 公司没有发现某些特定类型患者的增加超出预期,因为从一开始ORLADEYO就吸引了各种不同背景的患者 [44][45][46][47] 无论基线发作率高低,患者在ORLADEYO上都能获得很好的控制 [47][48] 问题2 **Brian Abrahams 提问** 公司2024年的销售和营销策略与2023年相比有何变化?预计未来会更多关注从其他预防疗法转换到ORLADEYO的患者群体 [54][55] **公司回答** 2023年对销售团队的调整将在2024年继续发挥作用,有助于保持良好的业绩 [56][57] 公司将更多关注向医生和患者传达ORLADEYO相对于注射预防疗法的优势,包括疗效和便利性 [57]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 Form 10-K x ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2023 o TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _____ to _____ Commission File Number 000-23186 BIOCRYST PHARMACEUTICALS, INC. (Exact name of registrant as specified in its charter) Delaware 62-1413174 (State or other jurisdi ...

BioCryst Pharmaceuticals (BCRX) came out with a quarterly loss of $0.28 per share versus the Zacks Consensus Estimate of a loss of $0.24. This compares to loss of $0.38 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of -16.67%. A quarter ago, it was expected that this drugmaker would post a loss of $0.25 per share when it actually produced a loss of $0.19, delivering a surprise of 24%. Over the last four quarters, the company h ...

—ORLADEYO net revenue of $90.9 million for Q4 2023 and $326.0 million for FY 2023 (+30 percent y- o-y) — —2024 ORLADEYO net revenue expected to be between $380-$400 million— —Company expects operating profit in 2024, approaching positive EPS and positive cash flow in 2H 2025 — RESEARCH TRIANGLE PARK, N.C., Feb. 26, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (NASDAQ:BCRX) today reported financial results for the fourth quarter and full year ended December 31, 2023, and provided a corporate updat ...

RESEARCH TRIANGLE PARK, N.C., Feb. 23, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced new analyses of real-world use of oral, once-daily ORLADEYO® (berotralstat) that showed patients who initiated ORLADEYO experienced rapid, substantial and sustained reductions in attack rates through 18 months of treatment regardless of the severity of their disease, their history of prior prophylaxis or their C1-inhibitor (C1-INH) level and function. The data are being presented in ...

RESEARCH TRIANGLE PARK, N.C., Feb. 21, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the company will present at the TD Cowen 44th Annual Health Care Conference in Boston on Wednesday, March 6, 2024, at 10:30 a.m. ET and the Barclays 26th Annual Global Healthcare Conference in Miami on Tuesday, March 12, 2024, at 7:30 a.m. ET. Links to the live audio webcasts and replays of the presentations may be accessed in the Investors & Media section of BioCryst's website ...

RESEARCH TRIANGLE PARK, N.C., Feb. 19, 2024 (GLOBE NEWSWIRE) -- BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX) today announced that the Italian Medicines Agency, Agenzia Italiana del Farmaco (AIFA), has finalized reimbursement and recommended ORLADEYO® (berotralstat) for the routine prevention of recurrent attacks of hereditary angioedema (HAE) in eligible patients 12 years and older. With this recommendation, HAE patients in Italy now have access to the first oral, once-daily therapy for the routine prevent ...