Core Insights - CorMedix Inc. reported third-quarter earnings of $1.26 per share, significantly exceeding the consensus estimate of 63 cents [1] - Sales reached $104.27 million, a substantial increase from $11.5 million a year ago, surpassing the consensus of $86.02 million [1] - The 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 outpatient dialysis customers [1] Financial Performance - The company recognized a net income of $108.6 million and adjusted EBITDA of $71.9 million [2] - Cash, cash equivalents, and short-term investments totaled $55.7 million [2] Guidance and Projections - CorMedix raised its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, compared to the consensus of $283.69 million [2] - Fourth quarter net revenue guidance was increased to $115 to $135 million, compared to the Wall Street estimate of $118.85 million [2] - The guidance for fully synergized pro forma adjusted EBITDA for 2025 was increased to a range of $220 to $240 million [3] Strategic Developments - The acquisition of Melinta Therapeutics was completed in August, with integration efforts proceeding more quickly than projected [3] - CorMedix estimates a synergy capture of approximately $30 million of the total estimated $35 to $45 million on an annual run-rate basis before the end of 2025 [3] Market Reaction - CRMD stock increased by 12.06% to $12.54 following the earnings report [4]

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]

[Filing Information](index=1&type=section&id=Filing%20Information) This section provides essential identification and contact details for CorMedix Inc. as the registrant, along with the report's filing date [Registrant Details](index=1&type=section&id=Registrant%20Details) This section provides the core identification details for CorMedix Inc. as the registrant, including its incorporation state, commission file number, IRS employer ID, principal executive offices, and contact information, along with the report date - Registrant: **CORMEDIX INC.**, incorporated in Delaware[1](index=1&type=chunk) - Report Date: **October 20, 2025**[1](index=1&type=chunk) - Principal Executive Offices: **300 Connell Drive, Suite 4200, Berkeley Heights, New Jersey 07922**[1](index=1&type=chunk) [Securities Information](index=1&type=section&id=Securities%20Information) This section details the registrant's securities registered under Section 12(b) of the Exchange Act and clarifies its status regarding emerging growth company provisions Securities Registered Under Section 12(b) | Title of each class | Trading Symbol | Name of exchange on which registered | | :------------------ | :------------- | :----------------------------------- | | Common Stock, $0.001 Par Value | CRMD | Nasdaq Global Market | - CorMedix Inc. is **not an emerging growth company**[3](index=3&type=chunk) [Item 2.02 Results of Operations and Financial Condition](index=2&type=section&id=Item%202.02%20Results%20of%20Operations%20and%20Financial%20Condition) This item reports the preliminary financial results for the recent quarter, emphasizing their provisional nature and attachment as an exhibit [Preliminary Financial Results Announcement](index=2&type=section&id=Preliminary%20Financial%20Results%20Announcement) CorMedix Inc. announced its preliminary financial results for the quarter ended September 30, 2025, via a press release issued on October 20, 2025. These results are explicitly stated as preliminary and subject to adjustment upon completion of standard accounting procedures - CorMedix Inc. issued a press release on **October 20, 2025**, announcing preliminary financial results for the quarter ended **September 30, 2025**[4](index=4&type=chunk) - The preliminary results are **subject to adjustment** upon completion of accounting procedures[4](index=4&type=chunk) - The press release is attached as **Exhibit 99.1** and incorporated by reference, furnished under Item 2.02 and Item 9.01[4](index=4&type=chunk)[5](index=5&type=chunk) [Item 9.01 Financial Statements and Exhibits](index=2&type=section&id=Item%209.01%20Financial%20Statements%20and%20Exhibits) This item provides a comprehensive list of all financial statements and supplementary exhibits included in the filing [List of Exhibits](index=2&type=section&id=List%20of%20Exhibits) This section lists the exhibits accompanying the Form 8-K filing, which include the press release detailing preliminary financial results and the interactive data file Exhibits Filed | Exhibit No. | Description | | :------------ | :----------------------------------------------------------------------- | | 99.1 | Press Release issued by CorMedix Inc., dated October 20, 2025. | | 104 | Cover Page Interactive Data File, formatted in Inline Extensible Business Reporting Language (iXBRL). | [SIGNATURES](index=3&type=section&id=SIGNATURES) This section formally confirms the report's authorization and signing by an official representative of the registrant [Authorization and Signing](index=3&type=section&id=Authorization%20and%20Signing) This section confirms the official signing of the report by an authorized representative of CorMedix Inc., fulfilling the requirements of the Securities Exchange Act of 1934 - The report was duly signed on behalf of CorMedix Inc. pursuant to the requirements of the **Securities Exchange Act of 1934**[9](index=9&type=chunk) - Signed by **Joseph Todisco**, Chief Executive Officer, on **October 20, 2025**[10](index=10&type=chunk)[11](index=11&type=chunk)

Core Insights - CorMedix Inc. reported Q3 2025 net revenue of $104.3 million and pro forma net revenue of $130.8 million, primarily driven by increased utilization of DefenCath by outpatient dialysis customers [4] - The company raised its full-year 2025 pro forma net revenue guidance to a range of $390 to $410 million, with fourth quarter guidance set between $115 to $135 million [4] - CorMedix achieved a net income of $108.6 million for Q3 2025, significantly improving from a net loss of $2.8 million in Q3 2024, aided by a one-time tax benefit of $59.7 million [3][4] Financial Performance - Q3 2025 net revenue was $104.3 million, with DefenCath sales contributing $88.8 million [4] - Adjusted EBITDA for Q3 2025 was reported at $71.9 million, with basic and diluted EPS at $1.42 and $1.26, respectively [4][3] - Total operating expenses for Q3 2025 were $41.7 million, a 197% increase from $14.1 million in Q3 2024, driven by non-recurring costs related to the Melinta acquisition [5] Business Developments - CorMedix completed the acquisition of Melinta Therapeutics on August 29, 2025, with integration efforts proceeding faster than expected, estimating a synergy capture of approximately $30 million [4] - The company announced a rebranding to CorMedix Therapeutics, with all employees operating under the new name [4] - CorMedix completed enrollment in the Phase III ReSPECT study for Rezzayo in October 2025, expecting top-line data in Q2 2026 [4] Cash Position - As of September 30, 2025, CorMedix reported cash and short-term investments of $55.7 million, projecting year-end cash of approximately $100 million [6][4]

Earnings Reports Overview - The earnings season is slowing down, but several retail-favorite companies are set to report this week [1] - Key companies reporting include Barrick Mining Corp., Plug Power Inc., Oklo Inc., Cisco Systems Inc., Walt Disney Co., and Applied Materials Inc. [2][3][5][10][11] Company-Specific Insights - Barrick Mining Corp. reported its third-quarter results before the market opened on November 10 [2] - Plug Power Inc. is expected to report losses of 12 cents per share and revenue of $179.54 million, having missed earnings expectations for the last 18 quarters [3] - Oklo Inc. is anticipated to report losses of 13 cents per share and revenue of $17.01 billion, with stock volatility noted ahead of the report [5] - Cisco Systems Inc. is expected to be a focal point for investors, particularly regarding management's guidance and updates on AI and cybersecurity business momentum [10] - Walt Disney Co. and JD.com Inc. will release earnings reports before the market opens on November 13 [11] - Applied Materials Inc. is set to release its Q4 results after the market closes on November 13 [11] Additional Companies Reporting - Other companies reporting this week include Workhorse Group Inc., Beyond Meat Inc., Microvision Inc., and Virgin Galactic Holdings Inc. [4][6][12]

Core Insights - CorMedix (CRMD) has been upgraded to a Zacks Rank 1 (Strong Buy), indicating a positive outlook based on rising earnings estimates [1][3] - The Zacks rating system is driven by changes in earnings estimates, which significantly influence stock prices [2][4] Earnings Estimates and Stock Performance - The Zacks Consensus Estimate for CorMedix has increased by 91.7% over the past three months, with expected earnings of $1.85 per share for the fiscal year ending December 2025, showing no year-over-year change [8] - Rising earnings estimates suggest an improvement in CorMedix's underlying business, which is likely to drive the stock price higher [5][10] Zacks Rating System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with Zacks Rank 1 stocks historically generating an average annual return of +25% since 1988 [7] - Only the top 5% of Zacks-covered stocks receive a "Strong Buy" rating, indicating superior earnings estimate revisions and potential for market-beating returns [9][10]