BERKELEY HEIGHTS, N.J., Oct. 23, 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 third quarter ended September 30, 2024, before the market opens on Wednesday, October 30, 2024, and will host a corporate update conference call at 8:30am Eastern Time. | --- | --- | |----------------|--------------------- ...

BERKELEY HEIGHTS, N.J., Sept. 13, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases, today announced that management will be participating in a fireside chat and investor meetings at the 2024 Cantor Healthcare Conference, being held in New York, NY on September 17 – 19, 2024. | --- | --- | --- | --- | |----------|------------------------ ...

Shares of CorMedix (CRMD) have been struggling lately and have lost 7.7% over the past week. However, a hammer chart pattern was formed in its last trading session, which could mean that the stock found support with bulls being able to counteract the bears. So, it could witness a trend reversal down the road. The formation of a hammer pattern is considered a technical indication of nearing a bottom with likely subsiding of selling pressure. But this is not the only factor that makes a bullish case for the s ...

BERKELEY HEIGHTS, N.J., Sept. 09, 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 global healthcare company for the supply of DefenCath® (taurolidine and heparin) to its facilities in the US. The company, which provides healthcare services to more than 2,000 clinics in the United States, expects to ...

Momentum investing is all about the idea of following a stock's recent trend, which can be in either direction. In the 'long' context, investors will essentially be "buying high, but hoping to sell even higher." And for investors following this methodology, taking advantage of trends in a stock's price is key; once a stock establishes a course, it is more than likely to continue moving in that direction. The goal is that once a stock heads down a fixed path, it will lead to timely and profitable trades. Eve ...

CorMedix (CRMD) closed the last trading session at $5.74, gaining 45.7% 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 $12.50 indicates an 117.8% upside potential. The mean estimate comprises four short-term price targets with a standard deviation of $4.51. While the lowest estimate of $9 indicates a 56.8% increase from the current price level, the most optimistic analyst expects ...

CorMedix (CRMD) closed the last trading session at $5.16, gaining 8.9% 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 $12.50 indicates a 142.3% upside potential. The mean estimate comprises four short-term price targets with a standard deviation of $4.51. While the lowest estimate of $9 indicates a 74.4% increase from the current price level, the most optimistic analyst expects th ...

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 ...