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CorMedix(CRMD) - 2023 Q1 - Quarterly Report
2023-05-15 00:00
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 ☐ 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 ...
CorMedix(CRMD) - 2022 Q4 - Earnings Call Transcript
2023-03-31 00:51
CorMedix Inc. (NASDAQ:CRMD) Q4 2022 Earnings Conference Call March 30, 2023 8:30 AM ET Company Participants Dan Ferry – Managing Director-LifeSci Advisors Joe Todisco – Chief Executive Officer Matt David – Executive Vice President and Chief Financial Officer Phoebe Mounts – Executive Vice President and General Counsel Erin Mistry – Executive Vice President and Chief Commercial Officer Conference Call Participants Jason Butler – JMP Securities Joon Lee – Truist Securities Serge Belanger – Needham & Co. Opera ...
CorMedix(CRMD) - 2022 Q4 - Annual Report
2023-03-30 00:00
主力产品DefenCath - 公司主要关注开发主力产品DefenCath,旨在在美国和其他主要市场作为导管锁溶液进行潜在商业化[126] - DefenCath相对于肝素,成功减少了72%的导管相关血流感染,证明了其有效性[126] - FDA接受了DefenCath NDA的重新提交,并进行了优先审查,以缩短审查周期[127] - FDA发出第二份CRL,指出DefenCath NDA在解决CRO和API供应商的缺陷之前无法获得批准[127] - 公司计划在美国市场使用Alcami作为DefenCath的备用制造地点,并寻求额外适应症以扩大市场机会[128] - 公司计划在DefenCath获得成人透析患者批准后进行儿童研究,以获得额外的市场独家权[128] 其他产品和市场 - 公司正在评估将taurolidine用作罕见孤儿儿童肿瘤的潜在治疗方法,并寻求战略合作伙伴[128] - 公司在欧盟市场已获得Neutrolin的CE标志批准,并计划在美国市场提交PMA以获得市场授权[128] - 公司决定停止在沙特阿拉伯销售Neutrolin,并计划在2022年底停止在欧盟和中东销售Neutrolin[130] 财务状况 - 公司自成立以来主要通过债务和股权融资支持运营,累计亏损约2.754亿美元[130] - 2022年度营收为65,000美元,较2021年减少126,000美元;2022年度研发费用为10,680,000美元,较2021年减少2,453,000美元[139] - 2022年度利息收入为326,000美元,较2021年增加312,000美元[140] - 2022年度经营活动净现金流出为24,357,000美元,较2021年增加3,202,000美元[142] - 2022年度投资活动净现金流出为3,709,000美元,较2021年净现金流入9,135,000美元[144] - 我们将继续依赖外部资金来源,直到能够产生收入为止[141] - 我们将可能需要筹集额外资金以继续资助研发活动,并且我们无法保证融资或战略关系将以可接受的条件或根本不可用[146] - 预计公司将继续通过现金储备和资本筹集等方式资助运营,可能会通过产品许可收入或战略联盟进行,预计将继续利用ATM计划支持持续的资金需求[147] - 预计在未来可预见的时间内,公司在美国以外销售Neutrolin不会产生重要的产品收入,预计在美国获得FDA批准后,我们将增加DefenCath的产品销售[147] - 我们目前估计截至2022年12月31日,我们有足够的现金资金,可以从本年度10-K表格发布之日起至少资助12个月的运营[147] 其他 - 研发费用包括内部开发活动的成本、向第三方合同研究组织、合同制造商、调查站点和顾问支付的费用[132] - 我们正在寻求从taurolidine中获得价值的额外机会,包括用于手术网格、缝合材料和水凝胶的taurolidine-infused的初步临床前研究[134] - 我们根据FASB会计准则718号对股票期权进行会计处理,股票期权的成本是在授予日测量的,基于使用Black-Scholes期权定价模型估计的奖励的公允价值[150]
CorMedix(CRMD) - 2022 Q3 - Earnings Call Transcript
2022-11-11 00:11
CorMedix Inc. (NASDAQ:CRMD) Q3 2022 Earnings Conference Call November 10, 2022 8:30 AM ET Company Participants Joe Todisco - Chief Executive Officer Matt David - Executive Vice President, Chief Financial Officer Phoebe Mounts - Executive Vice President, General Counsel Erin Mistry - Senior Vice President, Commercial Daniel Ferry - LifeSci Advisors Conference Call Participants Assam - Truist Securities Jason Butler - JMP Securities Serge Belanger - Needham & Co. Operator Good morning and welcome to the CorMe ...
CorMedix(CRMD) - 2022 Q2 - Earnings Call Transcript
2022-08-12 02:36
CorMedix Inc. (NASDAQ:CRMD) Q2 2022 Earnings Conference Call August 11, 2022 8:30 AM ET Company Participants Daniel Ferry - LifeSci Advisors, LLC Erin Mistry - Senior Vice President and Head, Payer Strategy, Government Affairs and Trade Joseph Todisco - Chief Executive Officer Matt David - Executive Vice President & Chief Financial Officer Phoebe Mounts - Executive Vice President & General Counsel Conference Call Participants Rohit Bhasin - Needham & Co. Operator Greetings and welcome to the CorMedix Inc. S ...
CorMedix(CRMD) - 2022 Q1 - Earnings Call Transcript
2022-05-13 08:45
CorMedix Inc. (NASDAQ:CRMD) Q1 2022 Earnings Conference Call May 12, 2022 4:30 PM ET Company Participants Daniel Ferry - Investor Relations Joe Todisco - Chief Executive Officer Matt David - Executive Vice President and Chief Financial Officer Erin Mistry - Senior Vice President and Head, Payer Strategy, Government Affairs and Trade Conference Call Participants Jason Butler - JMP Securities Rohit Bhasin - Needham & Company Operator Hello and welcome to the CorMedix Inc. First Quarter 2022 Earnings Call and ...
CorMedix(CRMD) - 2021 Q4 - Earnings Call Transcript
2022-03-30 09:44
CorMedix Inc. (NASDAQ:CRMD) Q4 2021 Earnings Conference Call March 29, 2022 4:30 PM ET Company Participants Daniel Ferry - LifeSci Advisors, Investor Relations Matt David - Interim Chief Executive Officer, Executive Vice President and Chief Financial Officer Phoebe Mounts - Executive Vice President and General Counsel Conference Call Participants Jason Butler - JMP Securities LLC Joon Lee - Truist Securities, Inc. Rohit Bhasin - Needham & Company Operator Good afternoon, and welcome to the CorMedix's Fourth ...
CorMedix(CRMD) - 2021 Q3 - Earnings Call Transcript
2021-11-10 08:58
CorMedix Inc. (NASDAQ:CRMD) Q3 2021 Earnings Conference Call November 9, 2021 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors, IR Matt David - Interim CEO, EVP, and CFO Phoebe Mounts - EVP and General Counsel Conference Call Participants Jason Butler - JMP Securities Rohit Bhasin - Needham & Company Operator Good afternoon and welcome to the CorMedix's Third Quarter Earnings Conference Call. Today's conference call is being recorded. There will be a question-and-answer session At this time, all ...
CorMedix(CRMD) - 2021 Q2 - Earnings Call Transcript
2021-08-13 08:09
CorMedix Inc. (NASDAQ:CRMD) Q2 2021 Earnings Conference Call August 12, 2021 4:30 PM ET Company Participants Dan Ferry - LifeSci Advisors, IR Khoso Baluch - CEO Phoebe Mounts - EVP and General Counsel Matt David - EVP and CFO Conference Call Participants Jason Butler - JMP Securities Joon Lee - Truist Securities Chad Messer - Needham & Company Operator Greetings and welcome to the CorMedix Inc. Second Quarter 2021 Earnings Conference Call. At this time, all participants are on a listen-only mode. A question ...
CorMedix(CRMD) - 2021 Q1 - Earnings Call Transcript
2021-05-14 07:29
CorMedix Inc. (NASDAQ:CRMD) Q1 2021 Results Conference Call May 13, 2021 4:30 PM ET Company Participants Daniel Ferry - Investor Relations Khoso Baluch - Chief Executive Officer Thomas Nusbickel - Executive Vice President and Chief Commercial Officer Phoebe Mounts - Executive Vice President and General Counsel Elizabeth Masson-Hurlburt - Executive Vice President for Clinical Operations Matthew David - Executive Vice President and Chief Financial Officer Conference Call Participants Jason Butler - JMP Securi ...