CorMedix(CRMD) - 2025 Q1 - Quarterly Report

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$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$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$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$0.6 million for the three months ended March 31, 2025, compared to $0.8 million for the same period last year[130]