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 ...

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 ...

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]

‒ Q3 2025 Net Revenue of $104.3 million; Pro Forma Net Revenue of $130.8 million ‒ ‒ Q3 2025 Net Income of $108.6 million; Adjusted EBITDA of $71.9 million ‒ ‒ FY 2025 Pro Forma Net Revenue Guidance Raised to a Range of $390 to $410 million ‒ ‒ Conference Call Scheduled for Today at 8:30 a.m. Eastern Time ‒ BERKELEY HEIGHTS, N.J., Nov. 12, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening dis ...

Core Insights - CorMedix (CRMD) and Theravance Biopharma (TBPH) are small-cap biotechnology companies with market caps under $1 billion, operating in niche therapeutic markets and characterized by limited product portfolios and high volatility potential for investors [1][5] CorMedix (CRMD) - CorMedix's lead product, DefenCath, received FDA approval in late 2023 as the first antimicrobial catheter lock solution in the U.S., aimed at reducing catheter-related bloodstream infections in adult patients undergoing hemodialysis [2] - DefenCath generated $78.8 million in net revenues in the first half of 2025, with expectations for strong year-over-year growth in the third quarter [7] - The company plans to expand DefenCath's label into total parenteral nutrition, enhancing its customer base [8] - CorMedix acquired Melinta Therapeutics for $300 million, adding seven approved therapies to its portfolio and diversifying its revenue streams [9] - Preliminary third-quarter 2025 results showed net revenues exceeding $125 million, prompting an increase in full-year revenue guidance to at least $375 million [12] - The Zacks Consensus Estimate for CorMedix's 2025 sales and EPS indicates year-over-year increases of approximately 488% and 717%, respectively [19] Theravance Biopharma (TBPH) - Theravance collaborates with Viatris to commercialize Yupelri, a nebulized treatment for COPD, sharing profits with Viatris receiving 65% and Theravance 35% [13] - Revenues from the Viatris collaboration rose 19% year-over-year to $34.1 million in the first half of 2025 [15] - Theravance is developing ampreloxetine for neurogenic orthostatic hypotension, with top-line data expected in Q1 2026 [16] - The company sold its remaining royalty interest in Trelegy Ellipta to GSK for $225 million, strengthening its balance sheet [17] - The Zacks Consensus Estimate for Theravance's 2025 sales implies an 88% year-over-year increase, with a projected 75% narrowing of loss per share [19] Comparative Analysis - CorMedix's strategy focuses on immediate revenue generation through DefenCath, while Theravance relies on a partnership for revenue and is dependent on the success of its late-stage drug program [4][31] - CorMedix's diversified portfolio and strong commercial execution position it favorably compared to Theravance, which faces higher risks due to its limited pipeline and reliance on a single collaboration [31] - Year-to-date, CRMD shares have gained 39.6%, while TBPH shares have increased by 50.5%, outperforming the industry average of 10.7% [24]

Key Takeaways CorMedix posted preliminary Q3 2025 net revenues topping $125M, with over $85M from DefenCath alone.The company raised its full-year 2025 revenue outlook to at least $375M and expects $70M in EBITDA.Melinta's integration and DefenCath's exclusivity through 2033 reinforce CRMD's growth and profitability.CorMedix (CRMD) is expected to report its third-quarter 2025 earnings results soon. The Zacks Consensus Estimate for sales and earnings is pegged at $70 million and 48 cents per share, respectiv ...

Core Insights - CorMedix Inc. announced that its product DefenCath has received an Innovative Technology designation from Vizient, indicating its potential impact on patient care and healthcare operations [1][4] - DefenCath is the first FDA-approved antimicrobial catheter lock solution in the U.S., specifically designed to reduce catheter-related bloodstream infections in adult patients undergoing chronic hemodialysis [3][5] - In clinical studies, DefenCath demonstrated a 71% reduction in the risk of developing catheter-related bloodstream infections compared to control [3] Company Overview - CorMedix is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening conditions, including DefenCath for preventing catheter-related bloodstream infections [5] - Following the acquisition of Melinta Therapeutics LLC in August 2025, CorMedix is also commercializing a portfolio of anti-infective products [5] - The company has ongoing clinical studies for DefenCath in various patient populations and intends to expand its applications [6] Industry Context - Vizient, the organization granting the Innovative Technology designation, represents a diverse client base with approximately $156 billion in annual purchasing volume, including academic medical centers and community hospitals [4] - The Innovative Technology designation is awarded based on evaluations by healthcare experts for products that enhance clinical care and improve business operations [2]