BERKELEY HEIGHTS, N.J., June 06, 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 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 lifethreatening 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., 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]

BERKELEY HEIGHTS, N.J., May 10, 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 management will be participating in fireside chats and investor meetings at both the JMP Securities Life Sciences Conference being held in New York on May 13 – 14, 2024 and the 2024 RBC Capital Markets Global Healthcare Conference being held in New York on May 14 – 1 ...

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, 2024 ☐ 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 001-34673 CORMEDIX INC. (Exact Name of Registrant as Specified in Its Charter) Delaware 20-5894890 (State or Other Ju ...

Exhibit 99.1 ● On April 2, 2024, CMS published its HCPCS coding decision for DefenCath, establishing a new HCPCS Level II code for the product. CMS subsequently notified the Company on April 18 of its determination that DefenCath meets the criteria for a Transitional Drug Add-On Payment (TDAPA) and will be effective July 1, 2024. The TDAPA program currently provides for five years of additional payment reimbursement beyond the ESRD bundled rate to outpatient providers. ● Cash and short-term investments, exc ...

BERKELEY HEIGHTS, N.J., May 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 it will report its financial results for the first quarter ended March 31, 2024, before the market opens on Thursday, May 9, 2024, and will host a corporate update conference call at 8:30am Eastern Time. Thursday, May 9th @ 8:30am ETDomestic:1-888-886-7786Internationa ...

CorMedix (CRMD) closed the last trading session at $5.52, gaining 33.7% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $13 indicates a 135.5% upside potential.The mean estimate comprises four short-term price targets with a standard deviation of $4.55. While the lowest estimate of $9 indicates a 63% increase from the current price level, the most optimistic analyst expects the sto ...