BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q1 2023 Earnings Conference Call May 8, 2023 8:00 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Rob Risinger - Chief Medical Officer, Neuroscience Matt Wiley - Chief Commercial Officer Richard Steinhart - Chief Financial Officer Conference Call Participants Robyn Karnauskas - Truist Securities Mary Kate - Bank of America Colin Bristow - UBS Yatin Suneja - Guggenheim Partners Sumant Kulkarni - Canaccord Genuity Ram Selvaraju - H.C. Wainwri ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2023 OR ☐ 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: 001-38410 BioXcel Therapeutics, Inc. (Exact name of registrant as specified in its charter) Delaware 82-1386754 (State or other jur ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-K (Mark one) ☒ Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 For the year ended December 31, 2022 or ☐ 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 001-38410 BioXcel Therapeutics, Inc. (Exact name of Registrant as specified in its charter) Delaware 82-1386754 (State or other juri sdiction ...

财务数据和关键指标变化 - 2022年第四季度净收入约为23.8万美元,全年为37.5万美元,反映了有限的市场准入 [52] - 2022年第四季度研发费用为3250万美元,全年为9120万美元,主要由于BXCL501临床试验成本增加 [53][54] - 2022年第四季度销售、一般及管理费用为2070万美元,全年为6880万美元,主要由于人员和IGALMI上市相关成本增加 [55] - 2022年第四季度净亏损5480万美元,全年为16580万美元,包括1730万美元的非现金股票激励费用 [56] - 2022年现金支出总计1.353亿美元,2022年12月31日现金及等价物为1.937亿美元 [57] 各条业务线数据和关键指标变化 - IGALMI已获得FDA批准,是公司首个上市产品,用于治疗成人精神分裂症和双相障碍急性激动症 [10][11] - 公司正加速推进BXCL501在阿尔茨海默病相关激动症(TRANQUILITY)和双相障碍/精神分裂症激动症(SERENITY)适应症的III期临床试验,预计2023年第二季度公布关键数据 [14][15][16][17] - 正在进行BXCL501用于治疗重度抑郁症的I期多剂量试验,预计2023年第二季度公布结果 [19] - 正在开发新产品BXCL502,作为治疗老年痴呆及其他神经精神疾病慢性激动症的潜在疗法 [20] - OnkosXcel子公司的BXCL701在前列腺癌等适应症取得积极临床结果,计划2023年下半年启动潜在注册性II期临床试验 [22][45][46][47][48] 各个市场数据和关键指标变化 - IGALMI已在65家医院获得列入处方药目录,其中39家为一级医院,27家为二级医院 [32] - 公司正与主要采购组织(GPO)洽谈,已与3家GPO达成合同,覆盖约一半目标医院床位 [36][37] - 公司正与综合医疗网络(IDN)进行系统级合同谈判,已有7000张床位获得批准,另有25%的床位预计在未来两个季度内获批 [38] - 公司正在大幅提升营销力度,包括推出针对医疗服务提供者的广告宣传活动,预计在2023年第二季度产生1050万次曝光 [39][40][41][42][43] 公司战略和发展方向及行业竞争 - 公司利用人工智能平台在4年内从IND到商业化推出IGALMI,这是首个针对急性神经精神疾病的人工智能发现药物 [11] - 公司正积极推进BXCL501在激动症领域的临床开发,覆盖双相障碍、精神分裂症和阿尔茨海默病,预计这些适应症每年总计有1.39亿次激动发作 [14][15][16][17] - 公司正在开发新产品BXCL502,针对老年痴呆等慢性激动症,并在神经系统疾病领域发现了10多个新产品概念 [20][21] - OnkosXcel子公司的BXCL701在前列腺癌等恶性肿瘤中展现出积极疗效,公司正与FDA讨论启动潜在注册性临床试验 [22][23] - 公司正积极寻求为OnkosXcel子公司寻求独立投资或合作,以充分释放其价值 [24] 管理层对经营环境和未来前景的评论 - 公司认为IGALMI的作用机制和治疗激动症的能力为其在医疗机构设置中创造了独特的商业机会 [12] - 管理层对IGALMI的市场反馈和使用反馈非常积极,体现了该药物为患者、家属和医疗服务提供者带来的积极影响 [13] - 公司对BXCL501在激动症领域的市场扩展机会充满信心,认为这一领域存在巨大的未满足需求 [14] - 管理层对公司的人工智能平台及其在神经系统疾病和肿瘤免疫治疗领域的发现和开发能力充满信心 [25][26] 问答环节重要的提问和回答 问题1 **Colin Bristow 提问** 询问IGALMI的处方药目录获批情况,以及从获批到实际使用的时间线 [61][62][63] **Matt Wiley 回答** 公司已获得65家医院的处方药目录批准,占预期目标的约三分之二。从获批到实际使用通常需要6-12个月的时间。公司正在采取措施加快这一进程 [62][63] 问题2 **Robyn Karnauskas 提问** 询问IGALMI的销售数据,包括医院库存和实际使用情况 [73][74][75] **Vimal Mehta 和 Matt Wiley 回答** 公司尚未披露具体的销售数据,但强调正在密切关注医院的重订单模式,以了解实际使用情况。公司正在实施试用计划,帮助医院评估IGALMI的价值 [74][75][76] 问题3 **Graig Suvannavejh 提问** 询问公司与两家主要GPO谈判的进展情况 [142] **Matt Wiley 回答** 公司已与3家GPO达成合同,覆盖约一半目标医院床位。另外两家GPO谈判进展较慢,一家即将完成,另一家由于内部流程较慢而进展缓慢 [143]

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Matt Wiley - Chief Commercial Officer Richard Steinhart - Chief Financial Officer Rob Risinger - Chief Medical Officer, Neuroscience Vincent O’Neill - Chief Medical Officer, Oncology Conference Call Participants Greg Harrison - Bank of America Colin Bristow - UBS Yatin Suneja - Guggenheim Partners Graig Suvannavejh - Mizuho Securities Ra ...

| --- | --- | --- | |------------------------------------------------------------------------------------------------------------------------|-------|--------------| | | | | | | | | | | | | | | | | | ® AI-Driven Transformative Medicines in Neuroscience and Immuno-oncology | | | | | | | | September 2022 | | | | BioXcel Therapeutics \| 555 Long Wharf Drive, 12th Floor \| New Haven, CT 06511 \| www.bioxceltherapeutics.com | | NASDAQ: BTAI | Forward-Looking Statements This presentation includes "forward-looking ...

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q2 2022 Earnings Conference Call August 9, 2022 8:30 AM ET Company Participants Vimal Mehta - Chief Executive Officer & Founder Richard Steinhart - Senior Vice President and Chief Financial Officer Matt Wiley - Chief Commercial Officer Robert Risinger - Chief Medical Officer, Neuroscience Frank Yocca - Chief Scientific Officer Vincent O’Neill - Senior Vice President & Chief Medical Officer, Oncology Conference Call Participants Greg Harrison - Bank of America Robyn K ...

BioXcel Therapeutics Inc. (NASDAQ:BTAI) Q1 2022 Earnings Conference Call May 9, 2022 8:30 AM ET Company Participants Vimal Mehta - Chief Executive Officer Matt Wiley - Chief Commercial Officer Richard Steinhart - Vice President, Chief Financial Officer Rob Risinger - Chief Medical Officer, Neuroscience Conference Call Participants Greg Harrison - Bank of America Robyn Karnauskas - Truist Securities Sumant Kulkarni - Canaccord Yatin Suneja - Guggenheim Partners Colin Bristow - UBS Corinne Jenkins - Goldman ...

BioXcel Therapeutics, Inc. (NASDAQ:BTAI) Q4 2021 Earnings Conference Call March 10, 2022 8:30 AM ET Company Participants Vimal Mehta - Founder, President & Chief Executive Officer Richard Steinhart - Senior Vice President & Chief Financial Officer Robert Risinger - Vice President of Clinical Development Matthew Wiley - Senior Vice President & Chief Commercial Officer Vincent O'Neill - Senior Vice President & Chief Medical Officer Frank Yocca - Senior Vice President & Chief Scientific Officer Conference Call ...

NASDAQ: BTAI | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | --- | |-------|-------|-------|-------|-------|---------------------------|--------------------------------------------------------------|-------|-----------------------------|-------|--------------------------------|-------| | | | | | | | | | | | | | | | | | | | | | | | | | | | | | | ® | | | | | | | | | | | | | | | | | | | | | | | | | | | | | Healthcare Conference | | | | SVB Leerink 11th Annual Global | | | | | | | | | Februa ...