Financial Data and Key Metrics - Net revenue for Q2 2024 was $0.8 million, marking the first time the company reported revenue from the U.S. distribution of DefenCath [15] - Net loss for Q2 2024 was approximately $14.2 million, compared to a net loss of $11.3 million in Q2 2023, driven by increased SG&A expenses [15] - Operating expenses increased by 32% to $15.6 million in Q2 2024, compared to $11.8 million in Q2 2023 [16] - R&D expenses decreased by 86% to $0.7 million due to the approval of DefenCath [16] - SG&A expenses increased by 113% to $14.9 million in Q2 2024, driven by marketing efforts and personnel costs related to the commercial launch [17] - Cash and cash equivalents stood at $45.6 million as of June 30, 2024 [18] Business Line Data and Key Metrics - DefenCath's inpatient launch began on April 15, 2024, with outpatient launch starting in early July 2024 [4] - Q2 sales were modest, primarily due to trade stocking for inpatient facilities, with sales expected to ramp up in Q4 as more hospitals adopt DefenCath [5][6] - Unaudited quarter-to-date sales as of August 13 were $5.2 million, with 95% pull-through to the clinic level [6] - The company is in late-stage negotiations with a top dialysis provider and multiple smaller providers for DefenCath implementation [7] Market Data and Key Metrics - Outpatient reimbursement under TDAPA commenced on July 1, covering 45% of ESRD patients under Medicare fee-for-service [8] - UnitedHealthcare, covering 30% of Medicare Advantage enrollment, confirmed TDAPA reimbursement for DefenCath starting September 1 [9] - Humana, covering 20% of Medicare Advantage enrollment, also confirmed TDAPA reimbursement, though it may vary by provider contracts [9] Company Strategy and Industry Competition - The company aims to expand DefenCath's use to adult Total Parenteral Nutrition (TPN) patients, with FDA approval targeted for 2027-2028 and peak sales potential estimated at $150-$200 million annually [11] - Additional clinical initiatives include pediatric hemodialysis studies and expanded access programs for high-risk populations [12][13] - A real-world evidence study is planned to generate data on DefenCath's impact on patient care costs, infection rates, and hospitalizations, aiming to support future reimbursement negotiations [14] Management Commentary on Operating Environment and Future Outlook - Management is optimistic about the sales trajectory of DefenCath, particularly in the outpatient segment, and expects growth to continue throughout 2024 [4][7] - The company anticipates breakeven EBITDA on a run-rate basis by the end of 2024, assuming current sales growth and new account onboarding [19] - Long-term, the company expects ESRD Medicare patients to migrate from fee-for-service to Medicare Advantage plans, which will be a key focus for reimbursement strategies [10] Other Important Information - The company submitted a final protocol for adult TPN studies to the FDA, with patient enrollment expected to begin in Q1 2025 [10] - Clinical budget for the TPN study is estimated at $10-$12 million, with most expenses occurring in 2025 and 2026 [12] - Pediatric hemodialysis study costs are estimated at $4-$6 million over four to five years [12] Q&A Session Summary Question: CLABSI vs. CRBSI and DefenCath's marketing strategy - CLABSI is a broader term, while CRBSI is a subset requiring clinical correlation [21][22] - Pass-through status allows providers to bill for DefenCath on a buy-and-bill basis, similar to other Medicare B products [23] Question: Q3 sales run rate and clinic pull-through - The company has seen consistent orders over the first four weeks of Q3, with shipments to several hundred clinics [25][26] - Management expects breakeven EBITDA by the end of 2024, driven by current sales growth and new account onboarding [27][29] Question: Progress with large dialysis operators and market penetration - The company is in advanced discussions with a top dialysis provider, though the process has taken longer than expected [31] - The sales team has engaged with the top 20 accounts representing 99% of the dialysis market [32] Question: Weekly progression of $5.2 million sales and utilization rates - Sales have been consistent, with repeat orders indicating product utilization at the clinic level [34][36] Question: Funding for clinical studies and TPN enrollment timeline - The company does not anticipate needing large dilutive financing, with cash on hand and operating cash flow expected to cover clinical study costs [38][39] - TPN study enrollment is expected to begin in Q1 2025, with interim data expected before 2028 [40] Question: Inpatient vs. outpatient adoption process and TDAPA reimbursement - Inpatient adoption involves a longer process due to hospital bureaucracy, while outpatient adoption is faster but still requires significant operational effort [44][45] - TDAPA reimbursement is relatively new, and some operators require education on the process [42][43] Question: Contract with a top-tier midsized dialysis provider - The company is pleased with the relationship and product uptake but will not disclose customer-specific sales breakdowns [48][49] Question: Medicare Advantage vs. traditional Medicare and TDAPA reimbursement - Medicare Advantage plans assume risk for all costs associated with Medicare patients, and UnitedHealthcare has confirmed TDAPA reimbursement for DefenCath starting September 1 [51][52]

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 ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 Delaware 20-5894890 (State or Other Jurisdiction of Incorporation or Organization) (I.R.S. Employer Identification No.) Title of each class Trading Symbol(s) Name of each exchange on which registered Common stock, $0.001 par value CRMD Nasdaq Global Market 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 June 30, 2024 ☐ TRANSITION REPORT PURSUAN ...

Exhibit 99.1 CORMEDIX INC. REPORTS SECOND QUARTER AND SIX MONTH 2024 FINANCIAL RESULTS AND PROVIDES BUSINESS UPDATE Conference Call Scheduled for Today at 8:30 a.m. Eastern Time Berkeley Heights, NJ – August 14, 2024 – CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today announced financial results for the second quarter and six months ended June 30, 2024 and provided an update on its busi ...

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 ...

Core Insights - CorMedix Inc. is set to report its financial results for Q2 2024 on August 14, 2024, before market opening [1] - The company will host a corporate update conference call at 8:30 AM Eastern Time on the same day [1] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases [2] - The company's lead product, DefenCath®, received FDA approval on November 15, 2023, and was commercially launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] - CorMedix plans to develop DefenCath as a catheter lock solution for additional patient populations [2]

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) ...

Core Insights - CorMedix Inc. has entered into a multi-year commercial supply contract with a leading midsized dialysis provider for its product DefenCath® [1][2] - DefenCath® received NDA approval under the Limited Population Pathway for Antibacterial and Antifungal Drugs on November 15, 2023, and began commercialization in inpatient settings on April 15, 2024, with plans to expand to outpatient dialysis clinics in July 2024 [2][3] - The agreement will provide access to DefenCath® at over 500 dialysis facilities nationwide, aiming to reduce catheter-related bloodstream infections for potentially thousands of patients [2][3] Company Overview - CorMedix Inc. is focused on developing and commercializing therapeutic products for life-threatening conditions, with a primary focus on DefenCath® [3] - The company aims to establish long-term relationships with dialysis providers committed to innovation and infection reduction [2][3] - Future plans include developing DefenCath® as a catheter lock solution for other patient populations [3]