CorMedix (CRMD) 2025 Conference May 21, 2025 03:05 PM ET Speaker0 Welcome back everyone to the twenty twenty five RBC Global Healthcare Conference. Speaker1 My name Speaker0 is Greg Brenza, one of the biotech equity research analysts, and we're pleased now to be joined by CorMedix. Joining us from the company, CEO Joe Tobisco. Joe, it's great to have you. Good to see you, and thanks for joining us. Speaker1 Thanks, Greg. Good to see you as well. Speaker0 Great. Look look forward to the discussion. And for t ...

CorMedix Inc. is a biopharmaceutical company focused on developing and commercializing therapeutic products for the prevention and treatment of life-threatening conditions and diseases. The Company is focused on commercializing its lead product DefenCath (taurolidine and heparin) which was approved by the FDA on November 15, 2023. CorMedix commercially launched DefenCath in inpatient settings in April 2024 and in outpatient settings in July 2024. CorMedix is commencing clinical studies in adult Total Parent ...

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]

CorMedix (CRMD) Q1 2025 Earnings Call May 06, 2025 08:30 AM ET Company Participants Dan Ferry - Managing DirectorJoe Todisco - Chief Executive OfficerMatt David - Executive VP & CFOLes Sulewski - VP - Biotech Equity ResearchLiz Hurlburt - EVP, Chief Clinical Strategy and Operations Officer Conference Call Participants Gregory Renza - Senior Biotechnology AnalystRoanna Ruiz - Senior Managing Director, Biotechnology AnalystSerge Belanger - Senior Analyst Operator Good day, and welcome to the CorMedix Inc. Fir ...

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].

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]

Domestic: 1-844-676-2922 International: 1-412-634-6840 Conference ID: 10198548 Webcast: Webcast Link About CorMedix BERKELEY HEIGHTS, N.J., April 29, 2025 (GLOBE NEWSWIRE) -- CorMedix Inc. (Nasdaq: CRMD), a biopharmaceutical company focused on developing and commercializing therapeutic products for life- threatening diseases and conditions, today announced that it will report its financial results for the first quarter ended March 31, 2025, before the market opens on Tuesday, May 6, 2025, and will host a co ...