Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2021 Earnings Conference Call November 9, 2021 8:30 AM ET Company Participants Juan Sanchez - Vice President of Corporate Communications and Investor Relations Sharon Mates - Founder, Chairman and Chief Executive Officer Mark Neumann - Executive Vice President and Chief Commercial Officer Larry Hineline - Senior Vice President of Finance and Chief Financial Officer Suresh Durgam - Senior Vice President and Chief Medical Officer Conference Call Participants Br ...

Corporate Presentation September 2021 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are ...

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q2 2021 Earnings Conference Call August 9, 2021 8:30 AM ET Company Participants Sharon Mates - Founder, Chairman and CEO Mark Neumann - EVP and Chief Commercial Officer Suresh Durgam - SVP and Chief Medical Officer Larry Hineline - SVP of Finance and CFO Juan Sanchez - VP, Corporate Communications and IR Conference Call Participants Brian Abrahams - RBC Capital Markets Charles Duncan - Cantor Fitzgerald Andrew Tsai - Jefferies Jessica Fye - JPMorgan Rudy Li - SVB ...

Corporate Presentation May 2021 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based ...

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q1 2021 Earnings Conference Call May 10, 2021 8:30 AM ET Company Participants Juan Sanchez - Vice President, Corporate Communications and Investor Relations Sharon Mates - Chairman and Chief Executive Officer Mark Neumann - Executive Vice President and Chief Commercial Officer Suresh Durgam - Senior Vice President and Chief Medical Officer Larry Hineline - Senior Vice President and Chief Financial Officer Conference Call Participants Brian Abrahams - RBC Capital ...

财务数据和关键指标变化 - 第四季度CAPLYTA净产品收入为1240万美元，较第三季度的740万美元增长67.6% [36] - 全年CAPLYTA净产品收入为2250万美元 [36] - 第四季度研发费用为1430万美元，较去年同期的1910万美元下降25.1% [36] - 第四季度销售、一般和管理费用为5830万美元，较去年同期的2280万美元增长155.7% [36] - 第四季度净亏损为6070万美元，较去年同期的4060万美元扩大49.5% [36] - 全年总收入为2280万美元，其中CAPLYTA净收入为2250万美元 [36] - 全年研发费用为6580万美元，较去年的8910万美元下降26.1% [36] - 全年销售、一般和管理费用为1.864亿美元，较去年的6490万美元增长187.5% [36] - 全年净亏损为2.27亿美元，较去年的1.477亿美元扩大53.7% [36] - 截至2020年12月31日，现金、现金等价物和投资证券总额为6.588亿美元 [36] 各条业务线数据和关键指标变化 - CAPLYTA第四季度处方量环比增长77% [16] - CAPLYTA市场覆盖率保持在95%以上，覆盖了Medicare Part D和州医疗补助的主要支付渠道 [28] - CAPLYTA的LytaLink患者支持计划继续表现出色，帮助医生和患者获得药物 [28] - CAPLYTA的处方量在2020年持续增长，第四季度表现尤为强劲 [28] - CAPLYTA的医生和患者反馈积极，医生对其疗效和安全性评价高于其他品牌抗精神病药物 [31] - CAPLYTA的续方率表现良好，显示出患者对药物的持续接受度 [31] 公司战略和发展方向和行业竞争 - 2020年是Intra-Cellular Therapies的转型之年，成功推出了首个FDA批准产品CAPLYTA [10] - 公司计划在2021年推进三大领域：扩大CAPLYTA标签、继续开发抑郁症治疗药物、推进长效注射剂型 [11] - 公司致力于开发治疗神经精神疾病的创新药物，特别是针对精神分裂症、双相情感障碍和重度抑郁症 [13] - CAPLYTA在精神分裂症治疗中显示出疗效和良好的安全性，有望成为这些疾病的重要治疗选择 [15] - 公司计划在2021年提交CAPLYTA用于双相抑郁的补充新药申请，预计FDA将在下半年做出决定 [11] - 公司正在推进CAPLYTA在抑郁症治疗中的后期开发，包括双相抑郁和重度抑郁的研究 [11] - 公司正在开发长效注射剂型的CAPLYTA，预计将在2021年下半年获得初步结果 [11] - 公司正在推进其他管线项目，包括ITI-1284、PDE1抑制剂和ITI-333 [11] - 公司计划在2021年第三季度举办研发日，详细介绍管线项目 [11] 管理层对经营环境和未来前景的评论 - 管理层对CAPLYTA的季度处方量增长和市场表现感到满意 [16] - 管理层认为CAPLYTA在2020年的商业化努力是成功的，尽管面临COVID-19的挑战 [17] - 管理层对CAPLYTA在2021年的持续增长持乐观态度，特别是在COVID-19影响减弱的情况下 [30] - 管理层对CAPLYTA在双相抑郁市场的潜在扩展感到兴奋，并正在进行相应的商业计划 [33] - 管理层对公司在2020年的整体表现感到自豪，并对未来的增长和扩展充满期待 [26] 其他重要信息 - 公司计划在2021年启动两项针对重度抑郁的III期研究，评估CAPLYTA作为附加治疗的效果 [11] - 公司正在推进CAPLYTA的长效注射剂型开发，预计将在2021年下半年获得初步结果 [11] - 公司最近完成了ITI-1284的I期研究，发现其具有快速吸收和高系统暴露的特点，计划在2021年底和2022年启动相关研究 [11] - 公司的PDE1抑制剂项目正在推进，计划在2021年启动针对帕金森病的II期研究 [11] - 公司的ITI-333项目正在推进，计划在2021年下半年获得I期研究结果 [11] 问答环节所有提问和回答 问题: CAPLYTA在双相抑郁中的数据包和药物相互作用研究 - 公司已提交CAPLYTA用于双相抑郁的补充新药申请，并更新了UGT抑制剂相互作用研究，未发现相互作用 [43] 问题: CAPLYTA的商业化策略和治疗持续时间 - 公司将继续扩展CAPLYTA的处方医生范围，并增加现有医生的处方深度 [48] - CAPLYTA的续方率表现良好，显示出患者对药物的持续接受度 [45] 问题: CAPLYTA在双相抑郁市场的商业准备和医生反馈 - 公司计划在双相抑郁批准前增加销售团队，并准备在批准后立即抓住市场机会 [50] - 医生对CAPLYTA在双相抑郁中的安全性和耐受性持积极态度 [50] 问题: ITI-333和长效注射剂型的开发进展 - ITI-333是一种新型阿片类部分激动剂，具有低内在活性，与现有药物机制不同 [52] - 长效注射剂型开发面临挑战，但公司认为已找到最佳配方，计划从一个月剂量开始测试 [52] 问题: 2021年收入预期和ITI-1284的药代动力学特征 - 公司对2021年收入预期持乐观态度，预计全年收入将达到1.1亿美元 [51] - ITI-1284具有快速吸收和高系统暴露的特点，适用于老年患者 [51] 问题: ITI-1284的剂量和监管路径 - ITI-1284在I期研究中测试了两个剂量，计划在II期研究中进一步确定剂量 [55] - 公司将根据监管机构的讨论确定ITI-1284的监管路径 [55] 问题: ITI-1284的代谢特征和专利保护 - ITI-1284没有新的代谢物，具有强大的专利保护，专利期延长至2040年代 [61] 问题: 重度抑郁研究的计划和时间表 - 公司计划在2021年启动两项针对重度抑郁的III期研究，预计需要两年时间完成 [67] - 公司正在进行的Study '403研究将评估CAPLYTA在混合特征患者中的疗效，预计将在2022年下半年获得结果 [67] 问题: ITI-1284的机制和潜在适应症 - ITI-1284不会形成苯胺代谢物，适用于治疗老年患者的行为障碍、痴呆相关精神病和某些抑郁障碍 [77]

Corporate Presentation January 2021 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are ba ...

Corporate Presentation 1 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements are based on the ...

Intra-Cellular Therapies, Inc. (NASDAQ:ITCI) Q3 2020 Earnings Conference Call November 9, 2020 8:30 AM ET Company Participants Juan Sanchez - Vice President, Corporate Communications and Investor Relations Sharon Mates - Chairman and Chief Executive Officer Mark Neumann - Chief Commercial Officer Suresh Durgam - Chief Medical Officer Larry Hineline - Chief Financial Officer Conference Call Participants Jessica Fye - JP Morgan Charles Duncan - Cantor Fitzgerald Sumant Kulkarni - Canaccord Bo Chen - Evercore ...

Corporate Presentation September 2020 1 Safe Harbor Statement 2 This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. These statements involve known and unknown risks, uncertainties and assumptions and other factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These statements ar ...