Core Insights - CorMedix Inc. has engaged WSI PBG to promote its product DefenCath to healthcare providers in facilities operated by the Department of Veterans Affairs and other federal facilities, aiming to enhance access for approximately 40,000 veterans with end-stage renal disease [1][2] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases, with its lead product DefenCath (taurolidine and heparin) approved by the FDA on November 15, 2023 [3] - The company launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024, and plans to commence clinical studies in adult Total Parenteral Nutrition patients and pediatric hemodialysis patient populations in 2025 [3] Collaboration Details - The collaboration with WSI PBG leverages their expertise in navigating the VA and federal facilities, focusing on access, procurement processes, and regulations to meet the unique needs of federal healthcare systems [2] - Joe Todisco, CEO of CorMedix, expressed excitement about the collaboration, highlighting WSI PBG's understanding of the federal healthcare landscape to improve access to DefenCath for veterans and other beneficiaries [3]

Core Insights - CorMedix's shares increased nearly 30% following the announcement of preliminary sales figures for Q4 and full-year 2024 [1] - Preliminary net revenues for Q4 2024 reached approximately $31 million, surpassing the Zacks Consensus Estimate of $21.5 million, with adjusted EBITDA expected to exceed $12 million [2] - For the full year 2024, preliminary net revenues were about $43 million, exceeding the Zacks Consensus Estimate of $33.8 million, with cash and short-term investments totaling around $52 million at year-end [3] Company Performance - The sales figures are likely attributed to the sales of DefenCath, CorMedix's sole marketed product, which received FDA approval in November 2023 [4] - CorMedix has exceeded its previous guidance of achieving break-even by the end of 2024, although no specific bottom-line numbers were provided [5] - Over the past year, CorMedix's shares have surged 185.3%, contrasting with a 15.7% decline in the industry [5] Business Strategy - CorMedix plans to expand its efforts in the inpatient hospital segment in 2025, collaborating with Syneos Health to create a dedicated field sales team for DefenCath [7] - The company anticipates that the expanded deployment and internal realignment will have a neutral impact on overall sales and marketing expenses, projecting operating expenses between $72 million and $78 million [8] - CorMedix is working with its Large Dialysis Operator customer to implement DefenCath, targeting a patient utilization of 4,000 by the second half of 2025, with existing purchase orders exceeding $25 million for Q1 2025 [9]

Financial Performance - CorMedix Inc. reported preliminary unaudited net revenue of approximately $31 million for Q4 2024 and approximately $43 million for FY 2024 [1][3] - The company expects Q4 2024 adjusted EBITDA to exceed $12 million [1][3] - Preliminary unaudited cash and short-term investments as of December 31, 2024, are approximately $52 million [3] Business Developments - The company is actively shipping DefenCath to all three midsized dialysis operator customers, with continuous ordering of increasing size throughout the quarter [3] - CorMedix has over $25 million of existing open purchase orders scheduled for delivery during Q1 2025 [3] - An expanded deployment effort in the inpatient hospital segment is set to begin in Q1 2025, with Syneos Health engaged to build a dedicated inpatient field sales team [3] Clinical Initiatives - A final clinical study protocol for DefenCath in Total Parenteral Nutrition (TPN) was submitted to the FDA in Q4, with study enrollment expected to begin in H1 2025 [3] - Patient enrollment in the pediatric study for DefenCath in pediatric hemodialysis is expected to begin in H2 2025 [3] Operational Guidance - The company estimates that the expanded inpatient deployment and internal commercial realignment will be cost neutral on overall sales and marketing expenses in 2025 [3] - Preliminary operating expense guidance for FY 2025 is set at $72 million to $78 million, excluding non-cash and one-time items, with the increase primarily driven by R&D spending [3]

Group 1: Company Performance - CorMedix (CRMD) has achieved a year-to-date performance increase of approximately 126.1%, significantly outperforming the average loss of 3.5% in the Medical sector [6] - ResMed (RMD) has also shown strong performance with a year-to-date return of 36% [6] - The Zacks Consensus Estimate for CRMD's full-year earnings has increased by 20.7% over the past three months, indicating a positive trend in analyst sentiment [5] Group 2: Industry Rankings - CorMedix is part of the Medical - Biomedical and Genetics industry, which consists of 501 individual stocks and currently ranks 61 in the Zacks Industry Rank [1] - The Medical - Products industry, which includes ResMed, has 87 stocks and is ranked 127 [1] - The Medical sector overall includes 1020 individual stocks and holds a Zacks Sector Rank of 2 [4]

BERKELEY HEIGHTS, N.J., Dec. 19, 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 it will be added to the Nasdaq Biotechnology Index (NASDAQ:NBI) (the "NBI"). CorMedix's addition to the NBI will become effective prior to the market open on Monday, December 23, 2024. The NBI is designed to track the performance of a set of securities listed on The NASDA ...

BERKELEY HEIGHTS, N.J., Nov. 26, 2024 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions, today highlights key policy changes from CMS that benefit hemodialysis patients. Yesterday, the Centers for Medicare & Medicaid Services (CMS) and the Center for Medicare and Medicaid Innovation (CMMI) released important policy updates that will broaden the access of Medicare patients m ...

CorMedix (CRMD) appears an attractive pick, as it has been recently upgraded to a Zacks Rank #1 (Strong Buy). This upgrade is essentially a reflection of an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices.The sole determinant of the Zacks rating is a company's changing earnings picture. The Zacks Consensus Estimate -- the consensus of EPS estimates from the sell-side analysts covering the stock -- for the current and following years is tracked by the system.Since ...

Here are three stocks with buy rank and strong momentum characteristics for investors to consider today, November 8:CorMedix Inc. (CRMD) : This biopharmaceutical company has a Zacks Rank #1 and witnessed the Zacks Consensus Estimate for its current year earnings increasing 20.7% over the last 60 days.CorMedix's shares gained 165.8% over the last three months compared with the S&P 500’s advanced of 12.2%. The company possesses a Momentum Score of A.Flushing Financial Corporation (FFIC) : This bank holding co ...

CorMedix (CRMD) closed the last trading session at $9.99, gaining 12.3% 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 $15.20 indicates a 52.2% upside potential. The average comprises five short-term price targets ranging from a low of $9 to a high of $19, with a standard deviation of $4.15. While the lowest estimate indicates a decline of 9.9% from the current price level, the mo ...

Financial Data and Key Metrics Changes - The company's net revenue for Q3 2024 was $11.5 million, exceeding Street consensus, driven largely by the initial anchor customer, U.S. Renal [8][19] - The net loss for Q3 2024 was approximately $2.8 million or $0.05 per share, compared to a loss of $9.7 million or $0.17 per share in Q3 2023, indicating improved financial performance [19] - Operating expenses increased by approximately 33% to $14.1 million in Q3 2024 compared to $10.5 million in Q3 2023, primarily due to higher selling and marketing and G&A expenses [19][20] Business Line Data and Key Metrics Changes - DefenCath's commercial launch has seen significant progress, with the first full quarter of product shipments and outpatient utilization [7][8] - Selling and marketing expenses increased 66% to $6.7 million in Q3 2024, while G&A expenses rose 76% to $6.6 million, reflecting increased marketing efforts and personnel costs [20][22] - R&D expenses decreased by approximately 73% to $0.7 million due to the approval of DefenCath, with costs related to medical affairs now recognized in selling and marketing or G&A expenses [21] Market Data and Key Metrics Changes - The company has secured agreements with two midsized dialysis operators and one large-scale operator, which will provide access to DefenCath in roughly 60% of U.S. dialysis clinics [8][12] - The company expects to operationalize agreements with new partners and commence purchases before the end of Q4 2024 [9][10] Company Strategy and Development Direction - The company is focused on expanding the utilization of DefenCath among existing customers and onboarding new ones, while also exploring opportunities to expand the product label beyond hemodialysis [24] - The company plans to submit a refined clinical protocol for adult total parenteral nutrition (TPN) to the FDA by mid-November, aiming for FDA approval by late 2027 to 2028 [13][14] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about achieving EBITDA positivity in Q4 2024, despite variability in revenue guidance due to the timing of purchases by new customers [10][24] - The management noted that the initial rollout of DefenCath has been protocolized, indicating a top-down approach in outpatient settings, which is expected to lead to a quick patient conversion ramp once implemented [11][27] Other Important Information - The company recorded net cash used in operations of $45 million for the first nine months of 2024, compared to $27.7 million in the same period in 2023, with cash and cash equivalents of $46 million as of September 30, 2024 [23] - The company anticipates the clinical study for TPN to cost between $10 million and $12 million, with the majority of expenses occurring in 2025 and 2026 [14] Q&A Session Summary Question: Can you speak to the use you are seeing today to what extent it is being driven by individual doctors or centers' decision to use the product versus the overall institution already implementing SOPs? - Management indicated that the rollout has been largely protocolized, driven by a top-down approach in outpatient settings, with centers establishing criteria for DefenCath use [27] Question: How do the reimbursement dynamics compare to what you are actually seeing during the launch? - Management noted that claims data lags, with initial utilization primarily among fee-for-service patients, expanding to Medicare Advantage and commercial payers [28] Question: How should we think about expenses in Q4? - Management expects operating expenses to be in the range of $15 to $17 million for Q4 [29] Question: Can you remind us of the stocking of DefenCath facilities, the holding time, and the order frequency? - Management stated that initial customers are not seeing much stocking, with estimates of holding inventory for about 10 days, while larger customers may hold 15 to 30 days [33] Question: What is the strategy to capture the other 40% operators? - Management is re-engaging with the remaining operators and generating additional data to encourage adoption, with a focus on the top five dialysis providers in the U.S. [43] Question: What percentage of Q3 sales did U.S. Renal account for? - U.S. Renal accounted for more than 90% of Q3 sales, and management is working to replicate their successful implementation with other customers [48] Question: What is the expected impact of the transition from WAC to ASP on ordering patterns? - Management does not expect the transition to impact ordering patterns significantly, as agreements have been structured around this change [50]