CorMedix (CRMD) came out with a quarterly loss of $0.25 per share versus the Zacks Consensus Estimate of a loss of $0.26. This compares to loss of $0.25 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of 3.85%. A quarter ago, it was expected that this pharmaceutical and medical device company would post a loss of $0.27 per share when it actually produced a loss of $0.25, delivering a surprise of 7.41%. Over the last four quarter ...

DefenCath产品获批及商业化 - 公司获得FDA批准上市首个美国获批的抗菌导管封锁液DefenCath[163] - DefenCath获得5年新药化合物专利保护期和5年GAIN专利延长期[164] - DefenCath在住院和门诊透析设置中获得CMS的新技术附加付款(NTAP)和过渡性药物附加付款调整(TDAPA)[165,166] - DefenCath在门诊手术中心和门诊透析中获得CMS的独立付款通道[167] - 公司与两家大型透析服务商签订了长期供应合同[168,169] - 公司于2024年4月在美国推出获批的DefenCath产品，实现了806万美元的收入[188] 财务表现 - 销售成本包括制造和分销DefenCath的直接和间接成本，间接成本主要为人工成本[189] - 研发费用下降86%至70万美元，主要由于DefenCath获批导致相关医疗事务和人员费用转入销售和管理费用[190] - 销售和营销费用增加127%至738.7万美元，主要用于营销推广和销售团队建设[191][192] - 管理费用增加101%至755.9万美元，主要用于支持商业化运营的人员和法律合规费用[193] - 利息收入增加19%和52%，分别为70万美元和150万美元[194] - 外汇交易损失对所有期间均不重大[195] - 其他收入为与之前使用的供应商的和解[196] - 利息费用对所有期间均不重大[197] - 其他综合收益(损失)对所有期间均不重大[198] 资金运营 - 公司通过ATM计划筹集了100万美元资金[199] - 公司出售了150万美元的新泽西州税收亏损获得了140万美元净收益[200] - 经营活动使用的现金净额增加1240万美元，主要由于运营费用增加[201] - 投资活动提供的现金净额为1520万美元，主要由于短期投资到期[202] - 筹资活动提供的现金净额减少1160万美元，主要由于ATM计划所得减少[203]

财务表现 - 公司2024年第二季度的净亏损为1,415.15万美元，每股亏损0.25美元[8] - 公司2024年上半年的净亏损为2,861.76万美元，每股亏损0.50美元[10] - 公司2024年第二季度的营业费用为1,559.71万美元，较2023年同期增加32%[9] - 公司2024年上半年的营业费用为3,148.28万美元，较2023年同期增加38%[10] - 公司2024年第二季度的销售及市场费用和管理费用分别增加127%和101%[9] 现金流及财务状况 - 公司于2024年6月30日的现金及短期投资余额为4,560万美元，预计可维持至少12个月的运营[11] 产品销售 - 公司在2024年第二季度实现净销售额806,119美元，主要来自于医院内部的库存补充[3] - 公司在2024年7月在门诊市场推出DefenCath产品，截至8月13日已实现5.2百万美元的未经审计的季度销售额[4] - 公司正在与各类肾透析服务商就DefenCath的商业供应协议进行洽谈，对未来的商业拓展持乐观态度[5] 临床试验 - 公司已向FDA提交了成人全肠外营养(TPN)适应症的临床试验方案，预计将于2025年第一季度开始患者入组[6]

BERKELEY HEIGHTS, N.J., Aug. 14, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for lifethreatening diseases and conditions, today announced financial results for the second quarter and six months ended June 30, 2024 and provided an update on its business. Recent Corporate Highlights: CorMedix today reports our initial partial quarter of sales since DefenCath's inpatient launch on April 15th. The Company repor ...

BERKELEY HEIGHTS, N.J., Aug. 07, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for lifethreatening diseases and conditions, today announced that it will report its financial results for the second quarter ended June 30, 2024, before the market opens on Wednesday, August 14, 2024, and will host a corporate update conference call at 8:30am Eastern Time. Wednesday, August 14th @ 8:30am ET About CorMedix CorMedix ...

BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (NASDAQ:CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utiliz ...

BERKELEY HEIGHTS, N.J., June 06, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced that the Center for Medicare & Medicaid Services (CMS) has determined that DefenCath® qualifies for pass-through status under the hospital Out-Patient Prospective Payment System (OPPS). Pass-through status provides for separate payment under Medicare Part B for the utili ...

BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin). CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) ...

BERKELEY HEIGHTS, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing therapeutic products for life-threatening diseases and conditions, today announced that it has entered into a multi-year commercial supply contract with a top tier midsized dialysis provider for the supply of DefenCath® (taurolidine and heparin). CorMedix received NDA approval of DefenCath® under the Limited Population Pathway for Antibacterial and Antifungal Drugs (LPAD) ...

财务数据和关键指标变化 - 公司第一季度净亏损约1450万美元,每股亏损0.25美元,而2023年同期为1060万美元,每股亏损0.24美元 [8] - 运营费用同比增加44%至1590万美元,主要由于销售、市场营销和医疗事务人员的增加 [8][9] - 研发费用下降约75%至80万美元,因为DefenCath获批后,之前计入研发的一些医疗事务和人员费用现已转入销售费用 [8] - 公司现金及现金等价物为5860万美元 [9] 各条业务线数据和关键指标变化 - 公司已开始在住院市场推广DefenCath,已有约50家主要医院推荐DefenCath进行处方审核 [3][4] - 公司计划于7月1日开始在门诊市场推广DefenCath,已与ARC Dialysis达成首个门诊采购合同,并正在与其他8家前10大透析服务商进行商业谈判 [4][5] 各个市场数据和关键指标变化 - 公司将重点瞄准约900家医院,占美国住院透析量的65% [3] - 公司预计第二季度住院市场销售不会有重大贡献,随着推广进程将逐步增加 [4] - 公司正在与医疗保险优势计划就额外报销事宜进行沟通,希望看到住院市场的需求增长 [14] 公司战略和发展方向及行业竞争 - 公司正在寻求扩大DefenCath适应症,已向FDA提交会议申请,讨论拓展至全肠外营养和肿瘤等适应症的可能性 [6][7] - 公司正在采取措施降低对单一生产商的依赖,已向FDA提交补充申请,增加Siegfried Hameln作为备用生产商 [7] - 公司正在关注潜在的并购和业务发展机会,以利用现有的商业基础拓展产品线 [18] 管理层对经营环境和未来前景的评论 - 公司预计2024年每季度运营费用将在1500万至1800万美元之间,以支持商业化基础设施建设和DefenCath的持续推广 [9] - 公司相信现有现金储备和未来经营现金流可为公司提供至少12个月的运营资金,并有望在2024年底前实现按季度盈亏平衡 [9] - 公司正在采取谨慎的现金管理措施,包括与大型贷款机构签订25亿美元的循环信贷额度,为未来潜在的资本需求提供灵活性 [5][16]