Core Insights - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases and conditions [2] - The company will participate in the RBC Capital Markets Global Healthcare Conference on May 20-21, 2025 [1] - CorMedix's lead product, DefenCath, was approved by the FDA on November 15, 2023, and was commercially launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] Company Overview - CorMedix Inc. specializes in therapeutic products aimed at preventing and treating life-threatening conditions [2] - The company is initiating clinical studies in adult Total Parenteral Nutrition (TPN) patients and pediatric hemodialysis (HD) patient populations in 2025 [2] - CorMedix plans to develop DefenCath as a catheter lock solution for use in additional therapeutic areas [2] Investor Relations - Investor contact for CorMedix is Dan Ferry, Managing Director at LifeSci Advisors [3]

Core Insights - CorMedix (CRMD) is experiencing solid improvement in earnings estimates, which may lead to continued short-term price momentum [1][2] - The rising trend in estimate revisions reflects growing analyst optimism regarding the company's earnings prospects, which is expected to positively impact its stock price [2][3] Current-Quarter Estimate Revisions - The earnings estimate for the current quarter is $0.15 per share, representing a +160% change from the previous year [5] - The Zacks Consensus Estimate for CorMedix has increased by 114.29% over the last 30 days, with two estimates moving higher and no negative revisions [5] Current-Year Estimate Revisions - For the full year, CorMedix is expected to earn $0.93 per share, indicating a +410% change from the prior year [6] - The consensus estimate has increased by 40.91% over the past month, with one estimate moving higher and one negative revision [6][7] Favorable Zacks Rank - CorMedix currently holds a Zacks Rank 1 (Strong Buy), indicating strong agreement among analysts in raising earnings estimates [8] - Stocks with Zacks Rank 1 and 2 significantly outperform the S&P 500, suggesting a favorable investment opportunity [8] Bottom Line - CorMedix's stock has risen by 75.9% over the past four weeks due to strong estimate revisions, indicating potential for further upside [9]

CorMedix (CRMD) Conference Call Summary Company Overview - CorMedix is a commercial stage biotech company focused on the launch of DefendCath, a catheter lock solution primarily for dialysis but with broader potential applications [1][4] - The product combines a proprietary new chemical entity, tyrolidine, with heparin to reduce catheter-related bloodstream infections (CRBSI) in patients undergoing hemodialysis [4][5] Financial Performance - First quarter sales for 2025 were over $39 million, with adjusted EBITDA exceeding $23 million [6][7] - Achieved profitability within twelve months of product launch, maintaining a clean balance sheet with no debt [7] Market Opportunity - The initial indication targets end-stage renal disease (ESRD) patients with high infection rates exceeding 25%, leading to significant mortality [8][11] - DefendCath is the only FDA-approved catheter lock solution with antimicrobial activity, addressing a critical unmet medical need [9] Clinical Data - Phase three clinical study (LACA100) showed a 71% reduction in CRBSI risk compared to standard care (heparin) [9] - A second phase three study is underway for an expanded label in patients receiving total parenteral nutrition (TPN) [10] Customer Adoption - US Renal Care is the largest customer, with over 3,000 patients currently using DefendCath [12][13] - The company is working to onboard additional mid-sized providers, with potential for significant patient conversion [14] Reimbursement Dynamics - The net selling price is expected to slightly decline due to government ASP erosion, with the first quarter at $2.45 and projected to decrease to $2.41 in the second quarter [18][19] - The TDAPA program incentivizes innovation in the ESRD setting, with reimbursement structured over five years [21][22] Medicare Advantage Insights - Approximately 90% of patients are Medicare, with a growing share in Medicare Advantage, which is expected to reach 70% in a few years [25] - Medicare Advantage payers are seen as more incentivized to invest in infection prevention due to their financial responsibility for treatment costs [25] Inpatient Market Strategy - The inpatient market represents about 10% of the total addressable market, with a focus on building a dedicated inpatient sales team [28][29] - Initial traction has been observed, with an increase in inpatient unit shipments from 3% to 6% in April [30] Future Growth and Strategy - The total addressable market for TPN is estimated between $500 million and $750 million, with peak sales potential of $150 to $200 million [38] - The company is exploring business development opportunities to complement DefendCath, focusing on adjacent markets [43][44] Metrics for Success - Revenue and profitability are primary metrics for gauging success, along with tracking inpatient progress and new account additions in outpatient hemodialysis [46][47] Additional Considerations - The company is generating data to support the pharmacoeconomic value of DefendCath, tracking metrics such as hospitalization rates and antibiotic use [26] - A partnership with WSI for dedicated sales reps targeting VA facilities has begun yielding orders [36]

Financial Performance - CorMedix reported quarterly earnings of $0.30 per share, exceeding the Zacks Consensus Estimate of $0.25 per share, compared to a loss of $0.25 per share a year ago, representing an earnings surprise of 20% [1] - The company posted revenues of $39.08 million for the quarter ended March 2025, surpassing the Zacks Consensus Estimate by 8.76%, compared to zero revenues a year ago [2] Stock Performance - CorMedix shares have increased approximately 11.5% since the beginning of the year, while the S&P 500 has declined by 3.9% [3] Earnings Outlook - The current consensus EPS estimate for the upcoming quarter is $0.10 on revenues of $26.31 million, and for the current fiscal year, it is $0.72 on revenues of $132.38 million [7] - The estimate revisions trend for CorMedix is mixed, resulting in a Zacks Rank 3 (Hold) for the stock, indicating expected performance in line with the market in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which CorMedix belongs, is currently in the top 31% of over 250 Zacks industries, suggesting that stocks in the top 50% outperform those in the bottom 50% by more than 2 to 1 [8]

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, aligning with preannounced results, and achieved adjusted EBITDA of $23.6 million, slightly above earlier expectations [7][15] - The company recognized net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [15] - Operating expenses increased approximately 9% to $17.4 million from $15.9 million year-over-year, with R&D expenses rising 281% to $3.2 million [16] Business Line Data and Key Metrics Changes - The majority of first quarter shipments (over 80%) came from U.S. Renal Care, with growth also noted in smaller outpatient dialysis operators and inpatient hospitals [31][32] - Inpatient hospital orders accounted for more than 6% of shipments in April, more than doubling from the first quarter [8] Market Data and Key Metrics Changes - The company anticipates net revenue guidance for DEFENCATH sales to existing customers in the first half of the year to be approximately $70 million, with a projected second quarter revenue of $23 million to $31 million [8] - The inpatient market is expected to grow as the dedicated sales team is now fully operational, and initial orders to VA facilities have been shipped [11] Company Strategy and Development Direction - CorMedix aims to expand DEFENCATH to new therapeutic indications and increase its customer base [18] - The company is optimistic about the implementation timeline with a large dialysis operator customer, targeting mid-year 2025 for the start [10] Management's Comments on Operating Environment and Future Outlook - Management expressed cautious optimism regarding the operational engagement with the large dialysis operator and noted that macro-level issues are not currently impacting inventory [25][26] - The company is focused on increasing utilization growth in the latter half of 2025 as new patients initiate therapy [10] Other Important Information - CorMedix has cash and cash equivalents of $77.5 million as of March 31, 2025, and expects cash operating expenses for 2025 to be between $72 million and $78 million [17] - The company is conducting a Phase 3 clinical study targeting the reduction of central line-associated bloodstream infections, with completion expected by late 2026 or early 2027 [12] Q&A Session Summary Question: Updates on the LDO partnership and operational engagement - Management noted increased preparatory activities with the large dialysis operator and remains cautiously optimistic about the timeline for implementation [22][23] Question: Drivers behind the first quarter revenue number - The majority of revenue was driven by U.S. Renal Care, with good growth also seen in smaller customers and hospitals [30][31] Question: Insights on U.S. Renal Care's patient pool and utilization tracking - Approximately 78% of first quarter revenue came from U.S. Renal Care, with good visibility into utilization versus inventory [42][43] Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with Medicare Advantage plans while TDAPA is still in force, with about 40% of claims currently from MA plans [44][46] Question: Inpatient segment opportunity and reimbursement process - The inpatient segment is expected to grow, but its overall percentage of business will depend on new customer onboarding and market dynamics [54][55]

Revenue and Profitability - Revenue for the three months ended March 31, 2025, was $39.1 million, compared to $0 for the same period in 2024, reflecting the launch of DefenCath[125] - Gross profit for the three months ended March 31, 2025, was $37.5 million, compared to a gross loss of $0.8 million for the same period in 2024, representing a 4,680% increase[125] - Income from operations for the three months ended March 31, 2025, was $20.1 million, compared to a loss of $16.7 million for the same period in 2024, reflecting a 220% increase[125] - Net income for the three months ended March 31, 2025, was $20.6 million, compared to a net loss of $14.5 million for the same period in 2024, representing a 243% increase[125] - The company achieved profitability in the fourth quarter of 2024 and the first quarter of 2025, driven by product sales of DefenCath[134] Expenses - Cost of revenue for the three months ended March 31, 2025, was $1.6 million, an increase from $0.8 million for the same period in 2024, due to manufacturing and distribution costs associated with DefenCath[126] - Research and development expense for the three months ended March 31, 2025, was $3.2 million, an increase of 281% from $0.8 million for the same period in 2024, primarily due to increased personnel and clinical trial services[127] - Selling and marketing expense for the three months ended March 31, 2025, was $4.5 million, a decrease of 29% from $6.3 million for the same period in 2024, attributed to the severance of the internal sales force[128] - General and administrative expense for the three months ended March 31, 2025, was $9.7 million, an increase of 11% from $8.7 million for the same period in 2024, driven by non-cash stock-based compensation charges[129] Cash Flow and Investments - Net cash provided by operating activities was $19.7 million for the three months ended March 31, 2025, compared to a net cash used of $17.3 million for the same period in 2024, driven by a net income of $20.6 million[136] - Total cash, cash equivalents, and short-term investments as of March 31, 2025, was $77.5 million, up from $51.7 million as of December 31, 2024[139] - Net cash provided by financing activities was $6.1 million for the three months ended March 31, 2025, primarily from the sale of common stock under the ATM program[138] - Net cash used in investing activities was $0.2 million for the three months ended March 31, 2025, compared to $8.9 million of net cash provided in the same period in 2024[137] - The company expects to fund operations for at least twelve months from the issuance of these financial statements based on current cash resources[142] Product Information - DefenCath is the first and only FDA-approved antimicrobial catheter lock solution in the U.S., shown to reduce the risk of catheter-related bloodstream infections by up to 71% in clinical studies[109] - DefenCath has new chemical entity exclusivity for 5 years expiring on November 15, 2028, with an additional 5-year exclusivity extension under the GAIN Act expiring on November 15, 2033[110] Agreements and Future Plans - The company entered into a three-year agreement with Syneos Health for a dedicated inpatient field sales force to promote DefenCath, with a minimum commitment of $9.1 million[145] - As of March 31, 2025, the company maintained a full valuation allowance against deferred tax assets due to uncertainty regarding future profitability[151] - The company has $23.2 million of common stock available for potential sale under the ATM program as of March 31, 2025[139] Interest Income - Interest income decreased by $0.2 million, or 25%, to $0.6 million for the three months ended March 31, 2025, compared to $0.8 million for the same period last year[130]

Financial Data and Key Metrics Changes - CorMedix reported first quarter net sales of $39.1 million, achieving profitability with a net income of $20.6 million or $0.32 per share, compared to a net loss of $14.5 million or $0.25 per share in the same quarter of the previous year [14][15]. - Adjusted EBITDA for the first quarter was $23.6 million, slightly above earlier preannounced results [6]. Business Line Data and Key Metrics Changes - The company experienced steady utilization growth with existing anchor customer U.S. Renal Care and new utilization from smaller outpatient dialysis operators and inpatient hospitals [6]. - Inpatient hospital ordering accounted for more than 6% of shipments in April, more than double from the first quarter [7]. Market Data and Key Metrics Changes - U.S. Renal Care accounted for over 80% of shipments in the first quarter, indicating its significance as the largest customer [30][31]. - The company anticipates utilization growth in the latter half of 2025 as new patients initiate therapy and new customers are added [9]. Company Strategy and Development Direction - CorMedix is focused on expanding its customer base and therapeutic indications for DEFENCATH, with a dedicated inpatient sales team now fully operational [10][13]. - The company has initiated a Phase 3 clinical study targeting central line-associated bloodstream infections, aiming for FDA submission by late 2026 or early 2027 [10][11]. Management's Comments on Operating Environment and Future Outlook - Management expressed optimism regarding the implementation timeline with a large dialysis operator customer, expecting to start mid-2025 [9]. - The company is monitoring macroeconomic factors but does not foresee them impacting inventory or earnings significantly [25]. Other Important Information - Operating expenses increased by approximately 9% to $17.4 million, with R&D expenses rising by 281% due to increased personnel and clinical trial services [15][16]. - The company has cash and cash equivalents of $77.5 million as of March 31, 2025 [16]. Q&A Session Summary Question: Updates on LDO partnership and operational expectations - Management noted heightened preparatory activities with the LDO but did not provide specific patient numbers or timelines [20][22]. Question: Inventory control and macroeconomic impacts - Management clarified that current macroeconomic issues are not affecting inventory, which is well-stocked to meet demand [25][26]. Question: Drivers behind Q1 revenue and customer contributions - U.S. Renal Care was the primary driver of revenue, accounting for over 80% of shipments, with growth also seen in smaller customers and hospitals [30][31]. Question: Reimbursement negotiations with Medicare Advantage - Management expects to enter negotiations with MA plans during TDAPA coverage, with 40% of claims currently from MA plans [46][47]. Question: Inpatient segment growth potential - Management indicated that the inpatient segment has potential for growth but is difficult to quantify at this stage [52][53].

Core Insights - CorMedix Inc. will report its financial results for Q1 2025 on May 6, 2025, before market opens [1] - The company will host a corporate update conference call at 8:30 AM ET on the same day [2] Company Overview - CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for life-threatening diseases [2] - The company's lead product, DefenCath® (taurolidine and heparin), received FDA approval on November 15, 2023 [2] - DefenCath was commercially launched in inpatient settings in April 2024 and in outpatient settings in July 2024 [2] - CorMedix plans to commence clinical studies in Total Parenteral Nutrition and Pediatric patient populations in 2025 [2] - The company also intends to develop DefenCath as a catheter lock solution for other patient populations [2]

Financial Results - CorMedix Inc. announced preliminary financial results for Q1 2025 on April 8, 2025[6] - The company provided a business update alongside the financial results[6] - The press release detailing these results is included as Exhibit 99.1[6]

Core Insights - CorMedix Inc. reported preliminary unaudited net revenue of $39.0 million for Q1 2025 and expects adjusted EBITDA to exceed $22.5 million [1][5] - The company has increased its H1 2025 net sales guidance to a range of $62 million to $70 million due to larger than expected orders and improved visibility into inventory levels [5] - Cash and cash equivalents as of March 31, 2025, amounted to approximately $77.5 million [1][5] Financial Performance - Q1 2025 unaudited net revenue: $39.0 million [1][5] - Expected Q1 2025 adjusted EBITDA: above $22.5 million [1][5] - Cash and cash equivalents: approximately $77.5 million as of March 31, 2025 [1][5] Business Updates - CorMedix is focused on commercializing its lead product DefenCath®, which was FDA approved on November 15, 2023, and launched in inpatient settings in April 2024 and outpatient settings in July 2024 [3] - The company plans to commence clinical studies in Total Parenteral Nutrition and pediatric patient populations in 2025 [3] - Expected peak annual sales for DefenCath in the Total Parenteral Nutrition patient population could reach between $150 million to $200 million, with a total addressable market of $500 million to $750 million [5]