Intra-Cellular Therapies (ITCI) came out with a quarterly loss of $0.16 per share versus the Zacks Consensus Estimate of a loss of $0.18. This compares to loss of $0.45 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 11.11%. A quarter ago, it was expected that this biopharmaceutical company would post a loss of $0.31 per share when it actually produced a loss of $0.16, delivering a surprise of 48.39%. Over the last four quart ...

产品管线和临床试验进展 - 公司获得FDA批准CAPLYTA用于治疗成人精神分裂症和双相抑郁症[70] - 公司正在进行CAPLYTA用于治疗重度抑郁症的三期临床试验,结果显示CAPLYTA可显著改善抑郁症状[71,72] - 公司正在进行CAPLYTA用于治疗双相抑郁症合并焦虑症状的三期临床试验,结果显示CAPLYTA可显著改善症状[74] - 公司正在开发CAPLYTA的长效注射剂型,为患者提供更多治疗选择[76] - 公司正在开发新药ITI-1284-ODT-SL,用于治疗广泛性焦虑症、阿尔茨海默病相关精神病和激越症,目前正在进行II期临床试验[77] - 公司的磷酸二酯酶1(PDE1)抑制剂项目正在开发用于治疗帕金森病,并将评估用于免疫系统调节、神经退行性疾病、癌症等其他适应症[78] - 公司的ITI-333项目正在开发用于治疗药物成瘾、疼痛及相关的抑郁焦虑症状[79] 财务表现 - 公司主要收入来自于CAPLYTA在美国的商业销售[82] - CAPLYTA在治疗精神分裂症和双相抑郁症方面的销售额分别增长46%和49%[91] - 销售、一般及管理费用增加20%,主要由于营销和广告费用、薪酬福利和股份支付费用的增加[93,94] - 研发费用增加13%,主要用于临床试验和非临时性项目的开支[101,102] 资金状况 - 公司现金及现金等价物、投资证券和受限现金合计约10亿美元,预计可为未来运营提供资金支持[103] - 公司维持充足的现金、现金等价物和投资组合以满足预期需求[104] - 公司可能会寻求通过公开或私募发行股权证券、发行债务证券、从商业贷款机构获得债务融资、战略合作、许可部分或全部产品候选药和技术等方式获得额外融资[104] - 公司现金、现金等价物和投资主要存放在高评级金融机构的支票账户、货币市场账户、政府机构证券、定期存单、商业票据和公司债券中[105] - 公司2024年上半年经营活动现金流出3357.4万美元,较2023年同期减少6329.4万美元,主要由于产品销售收入增加[108] - 公司2024年上半年投资活动现金流入2394.5万美元,较2023年同期减少5434.1万美元,主要由于投资证券到期减少[109] - 公司2024年上半年筹资活动现金流入55516.8万美元,较2023年同期增加54294.3万美元,主要由于2024年4月完成公开发行股票募集约5431.1万美元[110]

分组1：CAPLYTA销售情况 - CAPLYTA在2024年第二季度的净产品销售额为1.613亿美元，同比增长46%[1] - CAPLYTA的总处方量在2024年第二季度同比增长36%[1] - 公司将2024年CAPLYTA的净产品销售指引上调至6.5亿至6.8亿美元[1] 分组2：财务概况 - 2024年第二季度总收入为1.614亿美元，同比增长45.7%[6] - 2024年第二季度净亏损为1620万美元，相比去年同期亏损4280万美元有所减少[6] - 公司产品销售净额为1.101亿美元（三个月结束于2023年6月30日）和3.061亿美元（六个月结束于2023年6月30日）[30] - 公司总收入净额为1.108亿美元（三个月结束于2023年6月30日）和3.063亿美元（六个月结束于2023年6月30日）[30] - 公司净亏损为4278.4万美元（三个月结束于2023年6月30日）和3146.7万美元（六个月结束于2023年6月30日）[30] 分组3：费用和支出 - 2024年第二季度销售、一般和管理费用为1.216亿美元，同比增长20.4%[7] - 2024年第二季度研发费用为5620万美元，同比增长12.8%[7] - 公司运营费用总计为1.580亿美元（三个月结束于2023年6月30日）和3.549亿美元（六个月结束于2023年6月30日）[30] - 公司预计2024年全年销售、一般和管理费用将增加至4.8亿至5.1亿美元，主要原因是销售、营销和其他与销售团队扩张相关的费用[10] 分组4：资产和负债 - 截至2024年6月30日，公司现金、现金等价物、投资证券和限制性现金总额为10.25亿美元[7] - 公司现金及现金等价物为6.933亿美元（2024年6月30日），相比2023年12月31日的1.478亿美元有所增加[31] - 公司总资产为13.205亿美元（2024年6月30日），相比2023年12月31日的7.283亿美元有所增加[31] - 公司总负债为1.759亿美元（2024年6月30日），相比2023年12月31日的1.369亿美元有所增加[31] - 公司股东权益总计为11.446亿美元（2024年6月30日），相比2023年12月31日的5.914亿美元有所增加[31] 分组5：战略和计划 - 公司计划在2024年第三季度增加约150名销售代表，以扩大在初级护理办公室的覆盖范围和频率[8] - 公司计划扩大销售团队，进行临床或非临床试验，并计划向FDA提交监管文件[27] 分组6：风险因素 - 公司面临的风险包括CAPLYTA的商业成功不确定性，供应链和制造活动的挑战，以及临床试验结果可能与实际结果不符[28]

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sanjeev Narula will join the Company on August 12, 2024 and will serve as Executive Vice President, Chief Financial Officer. Mr. Narula will report to Dr. Sharon Mates, ITCI's Chairman and Chief Executive Officer. Lawrence Hineline, who currently serves as Chief ...

NEW YORK, Aug. 07, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced that Sanjeev Narula will join the Company on August 12, 2024 and will serve as Executive Vice President, Chief Financial Officer. Mr. Narula will report to Dr. Sharon Mates, ITCI's Chairman and Chief Executive Officer. Lawrence Hineline, who currently serves as Chief ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

CAPLYTA Q2 2024 net product sales were $161.3 million, compared to $110.1 million for the same period in 2023, representing a 46% increase CAPLYTA's strong prescription uptake continues: Q2 2024 CAPLYTA total prescriptions increased 36%, versus the same period in 2023 CAPLYTA 2024 net product sales guidance raised to $650 to $680 million Announced positive Phase 3 results from Study 501 and Study 502 evaluating lumateperone as an adjunctive therapy to antidepressants in patients with major depressive disord ...

To attend the live conference call by phone please use this registration link. All participants must use the link to complete the online registration process in advance of the conference call. Intra-Cellular Therapies is a biopharmaceutical company founded on Nobel prize-winning research that allows us to understand how therapies affect the inner-workings of cells in the body. The company leverages this intracellular approach to develop innovative treatments for people living with complex psychiatric and ne ...

NEW YORK, July 24, 2024 (GLOBE NEWSWIRE) -- Intra-Cellular Therapies, Inc. (Nasdaq: ITCI), a biopharmaceutical company focused on the development and commercialization of therapeutics for central nervous system (CNS) disorders, today announced it will host a conference call and live webcast discussion at 8:30 a.m. Eastern Time on Wednesday, August 7, 2024, to provide a corporate update and discuss details of the Company's financial results for the quarter ended June 30, 2024. To attend the live conference c ...

While the consensus price target is highly sought after by investors, the ability and unbiasedness of analysts in setting price targets have long been questionable. And investors making investment decisions solely based on this tool would arguably do themselves a disservice. Here's What You Should Know About Analysts' Price Targets They usually do that to drum up interest in shares of companies that their firms either have existing business relationships with or are looking to be associated with. In other w ...