BioLineRx Ltd. (NASDAQ:BLRX) Q4 2022 Earnings Conference Call March 22, 2023 10:00 AM ET Company Participants John Lacey - Investor Relations Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Ella Sorani - Chief Development Officer Conference Call Participants Mark Breidenbach - Oppenheimer Joe Pantginis - Wainwright John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx 2022 Financial Resul ...

公司概况 - 公司是一家生物制药公司，自2003年成立以来一直处于研发阶段，截至2022年底，累计亏损3.3亿美元[28] - 公司持有的现金和短期投资为5,110万美元，预计可以支撑资本需求至2024年上半年[28] 财务状况 - 公司与Kreos签订了一项担保贷款协议，如违约可能导致资产被没收[29] 新药申请 - 公司已向FDA提交了motixafortide的新药申请，FDA已接受并审查，预计审批日期为2023年9月9日[30] 市场批准 - 公司面临着严格的监管审批流程，可能需要进行额外的临床试验，增加成本和延迟市场批准[30] 商业化计划 - 公司正在独立执行motixafortide在多发性骨髓瘤患者中干细胞动员方面的商业化计划[32] 销售与营销 - 公司历史上没有销售、营销或分销产品的经验[32] - 公司必须开发内部销售、营销和分销能力，或与第三方签订外部许可协议来执行这些服务[33][34] 风险因素 - 公司的业务存在临床试验和产品责任索赔的重大风险，如果无法获得和维持适当水平的保险，索赔可能会对业务产生不利影响[64] 知识产权 - 公司目前拥有或独家许可了33个专利家族，包含129项已颁发专利、10项允许专利申请和80多项待定专利申请[70] 市场竞争 - 竞争激烈，许多公司拥有比我们更多的财务、技术和市场资源[168] 国际市场 - 公司总部、运营和供应商位于以色列中部，政治、经济和军事不稳定可能对业务产生不利影响[84]

研发支出 - BioLineRx Ltd. 2022年度财务报告显示，研发支出为1762万美元，较2021年的1950万美元有所下降[5] - BioLineRx公司的主要发展项目motixafortide在多发性骨髓瘤患者中的干细胞动员方面取得了积极进展[3] 销售和营销支出 - 销售和营销支出为650万美元，较2021年的100万美元大幅增加[5] 净亏损 - 总体而言，2022年度公司净亏损为2500万美元，较2021年的2710万美元有所减少[5] - 公司2022年度总体亏损为2495万美元，较2021年的27054万美元有所减少[12] 现金及等价物 - 公司截至2022年12月31日的现金、现金等价物和短期银行存款总额为5110万美元[5] 合作项目 - 公司已与哥伦比亚大学合作进行第二阶段研究，评估motixafortide与PD-1抑制剂和化疗药物在转移性胰腺癌治疗中的疗效[3] 抗肿瘤疫苗研究 - BioLineRx公司的AGI-134抗肿瘤疫苗在转移性实体瘤的第一阶段/第二阶段研究中达到了安全性和耐受性的主要终点[4] 股东权益 - BioLineRx公司的股东权益截至2022年底为5084.1万美元，较2021年的6808.7万美元有所下降[11] 现金流 - 2020年度经营活动现金流净额为-23,206千美元，2021年度为-23,573千美元，2022年度为-26,240千美元[14] - 2020年度投资活动现金流净额为16,668千美元，2021年度为-38,224千美元，2022年度为4,006千美元[14] - 2020年度融资活动现金流净额为17,866千美元，2021年度为57,749千美元，2022年度为20,438千美元[14]

BioLineRx Ltd. (NASDAQ:BLRX) Q3 2022 Earnings Conference Call November 15, 2022 10:00 AM ET Company Participants John Lacey - IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Third Quarter 2022 Results Confer ...

BioLineRx Ltd. (NASDAQ:BLRX) Q2 2022 Earnings Conference Call August 16, 2022 10:00 AM ET Company Participants Tim McCarthy - IR, LifeSci Advisors Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Holly May - Chief Commercial Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joe Pantginis - H.C. Wainwright Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx Second ...

Exhibit 2 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 BioLineRx Ltd. CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS (UNAUDITED) AS OF JUNE 30, 2022 TABLE OF CONTENTS Page Condensed consolidated interim statements of financial position F-1 F-2 F-3 - F-4 F-5 - F-6 F-7 - F-9 | --- | |------------------------------------------------------------------| | | | | | Condensed consolidated interim statements of comprehensive | | Condensed consolidated interi ...

BioLineRx Ltd. (NASDAQ:BLRX) Q1 2022 Earnings Conference Call May 11, 2022 10:00 AM ET Company Participants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - CEO Mali Zeevi - CFO Conference Call Participants Mark Breidenbach - Oppenheimer John Vandermosten - Zacks Operator Ladies and gentlemen, thank you for standing by. Welcome to the BioLineRx First Quarter 2022 Conference Call. All participants are presently in a listen-only mode. Following management's formal presentation instructions will be given fo ...

Call Start: 10:00 January 1, 0000 10:31 AM ET BioLineRx Ltd. (NASDAQ:BLRX) Q4 2021 Earnings Conference Call March 16, 2022 10:00 ET CompanyParticipants Tim McCarthy - LifeSci Advisors, IR Philip Serlin - Chief Executive Officer Mali Zeevi - Chief Financial Officer Ella Sorani - Chief Development Officer Abi Vainstein-Haras - Chief Medical Officer Conference Call Participants Joseph Pantginis - H.C. Wainwright & Co. John Vandermosten - Zacks Investment Research Operator Ladies and gentlemen, thank you for st ...

Exhibit 99.1 INEEX For Immediate Release BioLineRx Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update - Commercial assessment commissioned indicating US stem-cell mobilization opportunity of ~$360m - - Successful pre-NDA meeting with FDA; NDA submission anticipated in mid-2022 - - Announced highly positive results from additional pharmacoeconomic study indirectly comparing Motixafortide plus G-CSF versus plerixafor plus G-CSF - - Cash and cash equivalents at December 31, 2021 of $57 ...

Exhibit 99.1 INEEX For Immediate Release BioLineRx Reports Fourth Quarter 2021 Financial Results and Provides Corporate Update - Commercial assessment commissioned indicating US stem-cell mobilization opportunity of ~$360m - - Successful pre-NDA meeting with FDA; NDA submission anticipated in mid-2022 - - Announced highly positive results from additional pharmacoeconomic study indirectly comparing Motixafortide plus G-CSF versus plerixafor plus G-CSF - - Cash and cash equivalents at December 31, 2021 of $57 ...