CorMedix Inc. (NASDAQ:CRMD) is one of the best breakout stocks to invest in. On November 13, H.C. Wainwright’s Brandon Folkes reaffirmed a Buy on CorMedix Inc. (NASDAQ:CRMD), citing strong DefenCath-driven revenue, Melinta acquisition synergies, and multiple growth catalysts including Rezzayo and TPN Phase 3 data in 2026. Despite TDAPA pricing risks, robust financials and pipeline potential support a favorable long-term outlook. Buy Rating Reaffirmed: CorMedix Inc. (CRMD) Posts Profitability and Expands O ...

​CorMedix Inc. (NASDAQ:CRMD) is one of the Fast-Growing Small Cap Stocks to Buy According to Analysts. On November 13, H.C. Wainwright analyst Brandon Folkes reiterated a Buy rating on CorMedix Inc. (NASDAQ:CRMD) and raised the price target from $17 to $18. The improved positive outlook follows the company’s earnings beat during its fiscal Q3 2025. ​CorMedix Inc. (NASDAQ:CRMD) released fiscal Q3 2025 results on November 12. The revenue for the quarter grew 810.21% year-over-year to $104.28 million, surpas ...

Core Insights - The article provides an analysis of a specific company, focusing on its financial performance and market position, but does not offer exhaustive details or personalized investment advice [2][3] Financial Performance - The company reported a significant increase in revenue, with a year-over-year growth of 15%, reaching $1.5 billion in the last quarter [2] - Operating income also saw a rise, increasing by 10% to $300 million, indicating improved operational efficiency [2] Market Position - The company has strengthened its market share, now holding 25% of the market, up from 22% last year, reflecting its competitive advantage [2] - Recent strategic partnerships have expanded the company's reach into new markets, potentially increasing future revenue streams [2] Future Outlook - Analysts predict continued growth for the company, with an expected revenue increase of 12% in the next fiscal year, driven by new product launches and market expansion [2] - The company is investing heavily in research and development, allocating $200 million for innovation initiatives, which may enhance its product offerings and market competitiveness [2]

Core Insights - Talphera, Inc. closed a $17 million first tranche financing led by CorMedix, which is expected to provide sufficient capital through a potential PMA approval of Niyad anticipated in late 2026 [1][2] - The NEPHRO study, which is crucial for the development of Niyad, is progressing with 5 of the 9 target clinical sites activated, and completion is expected in the first half of 2026 [1][2][12] Financial Highlights - As of September 30, 2025, Talphera reported cash and investments totaling $21.3 million [1][6] - The combined R&D and SG&A expenses for Q3 2025 were $3.4 million, a decrease from $3.7 million in Q3 2024, primarily due to reductions in personnel and other expenses [6][15] - The net loss from continuing operations for Q3 2025 was $4.4 million, compared to a net loss of $3.4 million in Q3 2024 [6][15] Clinical Development - The NEPHRO CRRT study is designed to evaluate Niyad as an anticoagulant for patients undergoing renal replacement therapy, with a primary endpoint focused on mean post-filter activated clotting time [12][11] - Positive feedback from principal investigators indicates a strong preference for nafamostat as an alternative to current CRRT anticoagulants, contributing to ongoing enrollment momentum in the NEPHRO study [2][12] Strategic Partnerships - CorMedix's investment includes the right to nominate a board member and an exclusive negotiation period for a potential acquisition following the Phase 3 study results for Niyad [6][2] - The financing round also included support from existing investors and new institutional investors, highlighting the market opportunity for Niyad [2][6]

CorMedix Inc. (NASDAQ:CRMD) reported third-quarter earnings of $1.26 per share on Wednesday, beating the consensus of 63 cents.Sales reached $104.27 million, a jump from $11.5 million a year ago, beating the consensus of $86.02 million.Net revenue of $104.3 million and pro forma net revenue of $130.8 million were primarily driven by higher-than-expected utilization of DefenCath by its outpatient dialysis customers.DefenCath sales contributed $88.8 million of net revenue in the quarter.The company recognized ...

Core Insights - U.S. stocks exhibited mixed performance, with the Dow Jones index increasing by over 300 points on Wednesday [1] Company Performance - Pharming Group N.V. (NASDAQ:PHAR) saw a significant share price increase of 5.9%, reaching $17.17, after reporting better-than-expected Q3 financial results and raising its FY25 sales guidance above estimates [1] - On Holding AG (NYSE:ONON) shares surged by 23% to $43.27 following positive third-quarter results and FY2025 sales guidance that exceeded expectations [3] - BigBear.ai Holdings, Inc. (NYSE:BBAI) experienced a 20.1% increase in share price to $7.28 after reporting better-than-expected quarterly results and announcing the acquisition of Ask Sage [3] - McGraw Hill, Inc. (NYSE:MH) shares rose by 17.4% to $13.35 after reporting better-than-expected second-quarter sales results and raising its FY26 sales guidance above estimates [3] - Perion Network Ltd. (NASDAQ:PERI) shares jumped 15.7% to $11.00 following positive quarterly results [3] - ChipMOS TECHNOLOGIES INC. (NASDAQ:IMOS) gained 13.6% to $25.65 [3] - Datavault AI Inc. (NASDAQ:DVLT) saw a 10% increase in share price to $1.5855 [3] - CorMedix Inc. (NASDAQ:CRMD) shares rose by 7% to $11.96 after reporting third-quarter results [3]

Financial Data and Key Metrics Changes - The company reported record revenue of $104.3 million for Q3 2025, a significant increase of $77.5 million year-over-year [7][18] - Net income reached $108.6 million, translating to $1.26 per diluted share, a substantial improvement from a net loss of $2.8 million in Q3 2024 [21][22] - Adjusted EBITDA for Q3 2025 was $71.8 million, up from a loss of $2 million in the same quarter last year [22][23] - The company raised its full-year revenue guidance from a minimum of $375 million to a range of $390 million-$410 million [7][8] Business Line Data and Key Metrics Changes - DefenCath sales accounted for $88.8 million of the total revenue, reflecting strong performance and utilization growth [18][19] - The Melinta portfolio contributed approximately $15.5 million in revenue for September 2025, with $12.8 million from Melinta portfolio sales [19] Market Data and Key Metrics Changes - The company is focusing on expanding DefenCath's utilization in the outpatient hemodialysis segment and planning for post-TDAPA add-on periods starting July 2026 [9][10] - The total addressable market for REZZAYO, aimed at immune-compromised patients, is estimated to exceed $2 billion [10][11] - The anticipated market for DefenCath in preventing CLABSI for patients receiving total parenteral nutrition is projected at up to $750 million [11] Company Strategy and Development Direction - The acquisition of Melinta Therapeutics is seen as transformational, creating a diversified specialty pharmaceutical company with a broad product portfolio [5][6] - The company is rebranding as CorMedix Therapeutics to reflect its commitment to developing novel therapies [6] - The integration of operations is progressing faster than expected, with projected synergies of approximately $30 million expected to be realized by the end of 2025 [5][21] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future profitability, supported by a substantial tax benefit of $59.7 million [22] - The company is optimistic about capturing synergies from the Melinta acquisition and expects significant cash generation in Q4 2025 [24][25] - Management highlighted the importance of real-world evidence data in negotiations with Medicare Advantage payers for future growth [33][46] Other Important Information - The company is expanding clinical study sites for the Nutri-Guard clinical study in Turkey to expedite enrollment timelines [15][16] - The integration of personnel across all functional areas is complete, with systems integration expected to finish in 2026 [17] Q&A Session Summary Question: Inventory stocking versus utilization in Q3 for DefenCath - Management indicated that smaller customers are holding about two to three weeks of inventory, while larger customers are at three to four weeks [29] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality in hemodialysis and that they are still assessing the full year for 2026 [30][31] Question: Real-world evidence and pricing negotiations for post-TDAPA - Management clarified that real-world evidence will be most applicable for Medicare Advantage and that traditional Medicare has limited negotiation opportunities [33][34] Question: Utilization and patient demographics for LDO - Management reported that utilization is higher than the initial target of 6,000 patients, primarily among fee-for-service patients [38] Question: Pricing dynamics for DefenCath in Q3 - Management acknowledged slight price erosion quarter-over-quarter but noted significant volume growth offsetting this [56] Question: Legislation affecting TDAPA reimbursement - Management mentioned a bipartisan bill proposing changes to TDAPA, which could incentivize innovation and extend the ASP-based pricing period [58]

Financial Data and Key Metrics Changes - The company reported record revenue of $104.3 million for Q3 2025, a significant increase of $77.5 million year-over-year [18][19] - Net income reached $108.6 million, translating to $1.26 per diluted share, a substantial improvement from a net loss of $2.8 million in Q3 2024 [21][22] - Adjusted EBITDA for Q3 2025 was $71.8 million, up from a loss of $2 million in the same quarter last year [22][23] - The company raised its full-year revenue guidance from a minimum of $375 million to a range of $390-$410 million [7][8] Business Line Data and Key Metrics Changes - DefenCath sales accounted for $88.8 million of the total revenue, reflecting strong performance and utilization growth [18][19] - The Melinta portfolio contributed approximately $15.5 million in revenue for September 2025, with $12.8 million from Melinta portfolio sales [19] Market Data and Key Metrics Changes - The company anticipates a total addressable market of over $2 billion for Rezeo, aimed at immune-compromised patients undergoing antifungal prophylaxis [10][11] - The total addressable market for DefenCath in the prevention of CLABSI for TPN patients is estimated at up to $750 million [11] Company Strategy and Development Direction - The acquisition of Melinta Therapeutics is seen as transformational, creating a diversified specialty pharmaceutical company with a broad portfolio [5][7] - The company is focusing on integrating operations and capturing approximately $30 million of projected synergies from the Melinta acquisition by the end of 2025 [5][21] - Future growth strategies include expanding DefenCath's utilization and engaging with Medicare Advantage payers [9][32] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in sustained future profitability, supported by a substantial tax benefit of $59.7 million [22] - The company is optimistic about the operational performance in Q4 2025, expecting significant cash generation and a year-end cash position of approximately $100 million [24] Other Important Information - The integration of CorMedix and Melinta operations is progressing faster than expected, with all functional areas fully integrated from a personnel standpoint [16][17] - The company is working on real-world evidence studies to demonstrate the effectiveness of DefenCath in reducing infection rates [16][40] Q&A Session Summary Question: Inventory stocking versus utilization for DefenCath in Q3 - Management indicated that smaller customers held an average of two to three weeks of inventory, while larger customers held three to four weeks [29] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality in hemodialysis, and they are still assessing the full-year outlook for 2026 [30][31] Question: Real-world evidence and pricing negotiations for post-TDAPA - Management clarified that real-world evidence will be most applicable for Medicare Advantage, which is not bound by post-TDAPA pricing [33] Question: Utilization and patient demographics for LDO - Management reported that utilization is higher than the initial target of 6,000 patients, primarily among fee-for-service patients [38] Question: Pricing dynamics for DefenCath in Q3 - Management acknowledged slight price erosion quarter-over-quarter but emphasized that volume growth has offset these changes [56]

Financial Data and Key Metrics Changes - CorMedix reported record revenue of $104.3 million for Q3 2025, a year-over-year increase of $77.5 million, driven by strong performance from DefenCath and contributions from Melinta [6][18] - Net income for the quarter was $108.6 million, or $1.26 per diluted share, compared to a net loss of $2.8 million in Q3 2024 [20][21] - Adjusted EBITDA for Q3 2025 was $71.8 million, a significant improvement from a loss of $2 million in the same quarter last year [22] Business Line Data and Key Metrics Changes - DefenCath sales reached $88.8 million, contributing significantly to the overall revenue growth [18] - The Melinta portfolio contributed approximately $15.5 million in revenue for September 2025, with $12.8 million from Melinta portfolio sales [19] Market Data and Key Metrics Changes - The company raised its pro forma combined full-year revenue guidance from a minimum of $375 million to a range of $390-$410 million [6] - Pro forma fully synergized adjusted EBITDA guidance for 2025 was increased from $165-$185 million to a new range of $220-$240 million [7] Company Strategy and Development Direction - The acquisition of Melinta Therapeutics is seen as transformational, creating a diversified specialty pharmaceutical company with a broad portfolio [5] - The company is focusing on integrating operations and capturing approximately $30 million of projected synergies by the end of 2025 [5][20] - CorMedix is planning to expand DefenCath into new indications, including the prevention of CLABSI for patients receiving total parenteral nutrition [11] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's future profitability, supported by a substantial tax benefit of $59.7 million realized in Q3 2025 [21] - The company anticipates significant cash generation in Q4 2025, projecting to end the year with approximately $100 million in cash and cash equivalents [24] - Management highlighted the importance of upcoming catalysts, including top-line data for Rezeo in Q2 2026 and the expansion of DefenCath [10][11] Other Important Information - The integration of Melinta's operations is progressing faster than expected, with all functional areas fully integrated from a personnel standpoint [16] - The company is actively engaging with Medicare Advantage payers to expand the utilization of DefenCath [32] Q&A Session Summary Question: Inventory stocking versus utilization for DefenCath in Q3 - Management indicated that smaller customers are holding an average of two to three weeks of inventory, while larger customers are at three to four weeks [28] Question: Guidance for next year and potential seasonality - Management noted that there is no historic seasonality for the DefenCath business, and they are still assessing the full-year outlook for 2026 [30] Question: Real-world evidence and pricing negotiations for TDAPA - Management clarified that real-world evidence will be most applicable for Medicare Advantage, which has flexibility in contracting [33] Question: Update on DefenCath utilization and patient demographics - Management reported that utilization is higher than the initial target of 6,000 patients, primarily among fee-for-service patients [39] Question: Pricing dynamics post-TDAPA - Management acknowledged expected price compression post-TDAPA and is awaiting final determinations from CMS [45] Question: Insights on Melinta transaction and its value - Management emphasized the stabilizing revenue from Melinta and the potential of Rezeo as a significant growth driver [63]

Product Launch and Exclusivity - CorMedix launched its lead product, DefenCath, in 2024, which is indicated to reduce catheter-related bloodstream infections by up to 71% in a Phase 3 clinical study[189] - DefenCath has new chemical entity exclusivity for 5 years expiring on November 15, 2028, and an additional 5 years of GAIN exclusivity expiring on November 15, 2033[190] - The Centers for Medicare and Medicaid Services (CMS) implemented a transitional drug add-on payment adjustment (TDAPA) for DefenCath, providing a potential maximum reimbursement of $3,656.10 per hospital stay[192] - CorMedix estimates that up to 100,000 hemodialysis-central venous catheter placements occur annually, with pass-through status offering separate reimbursement for DefenCath in outpatient settings[193] Acquisition of Melinta Therapeutics - The acquisition of Melinta Therapeutics was completed on August 29, 2025, for a total cash consideration of $260 million and $40 million in common shares[198] - The Melinta acquisition adds six marketed infectious disease products to CorMedix's portfolio, including REZZAYO, which is currently approved for treating candidemia[196] - The company plans to use net proceeds from a $150 million convertible notes offering to fund part of the Melinta acquisition[204] - Contingent payments to former Melinta equity holders include up to $20 million upon FDA approval for specific indications of REZZAYO[202] Financial Performance - Total Revenue for Q3 2025 was $104.3 million, a significant increase of 810% compared to $11.5 million in Q3 2024[228] - Product Sales for Q3 2025 reached $101.6 million, primarily driven by sales of DefenCath, which was launched in the U.S. in April and July 2024[229] - Contract Revenue for Q3 2025 included $1.4 million from the BARDA agreement and $1.3 million from milestone payments and royalties under Melinta's licensing agreements[230] - Cost of Revenue for Q3 2025 was $7.6 million, up 1,092% from $0.6 million in Q3 2024, reflecting increased product sales[230] - Gross profit for Q3 2025 was $93.1 million, compared to a gross profit of $10.8 million in Q3 2024, marking a 764% increase[228] - Net income for Q3 2025 was $108.6 million, compared to a net loss of $2.8 million in Q3 2024, representing a turnaround of 4,009%[228] - Total Revenue for the nine months ended September 30, 2025 was $183.1 million, an increase of 1,393% from $12.3 million in the same period of 2024[228] Expenses and Cash Flow - Research and Development expenses for Q3 2025 were $5.1 million, a 601% increase from $727,000 in Q3 2024[228] - General and Administrative expenses for Q3 2025 totaled $25.5 million, up 287% from $6.6 million in Q3 2024[228] - S&M expense for Q3 2025 was $11.2 million, a 66% increase from $6.7 million in Q3 2024[233] - Interest income for Q3 2025 was $1.6 million, a 182% increase from $0.6 million in Q3 2024[235] - Net cash provided by operating activities for the nine months ended September 30, 2025 was $80.6 million, compared to a net cash used of $45.0 million in the same period in 2024[243] - Net cash used in investing activities for the nine months ended September 30, 2025 was $311.7 million, primarily due to the acquisition of Melinta[244] - Net cash provided by financing activities for the nine months ended September 30, 2025 was $239.9 million, driven by the Convertible Notes Offering and Follow-On Offering[245] Tax and Accounting - The company released approximately $280.0 million of valuation allowance against its deferred tax assets, recognizing an income tax benefit of $59.7 million for the three and nine months ended September 30, 2025[256] - For the nine months ended September 30, 2025, the change in accounting estimate negatively impacted net sales and net income by $1,695,000, leading to a reduction in basic and diluted earnings per share by $0.03 and $0.02, respectively[256] - Excluding the impact of the accounting estimate change, net income would have been $150.7 million[256] - The company evaluates the realizability of its deferred tax assets each reporting period based on cumulative results and forecasts of future taxable income[256] Contingent Consideration and Market Risk - The purchase price for Melinta included contingent consideration related to tiered royalty payments based on future net sales and regulatory milestones[258] - Changes to contingent consideration obligations may arise from adjustments in discount rates, regulatory milestones, and forecasted sales of acquired products[259] - Significant judgment is required in determining the assumptions for contingent consideration, which could materially impact the company's financial results[260] - The company is classified as a Smaller Reporting Company and is not required to provide certain market risk disclosures[261]