CorMedix reported strong financial results and anticipates higher revenue in 2025.
From Yahoo Finance: 2025-03-25 15:00:00
CorMedix, a pharmaceutical company, reported strong revenue and profit results for Q4 2024, with net revenue of $31.2 million and $43.5 million for the full year. The company also achieved its first profitable commercial quarter, with net income of $13.5 million and adjusted EBITDA of $15.3 million.
In Q1 2025, CorMedix received over $25 million in purchase orders for first-quarter delivery from existing customers. The company estimates net revenue from existing purchasing customers for the first six months of 2025 to be between $50 million to $60 million, with over $33 million expected in Q1.
CorMedix is focusing on patient growth opportunities, with potential for new patients among existing outpatient customers. The company’s ability to grow patient volumes in the latter part of 2025 will depend on the implementation by a contracted large dialysis organization customer, which was pushed to 2025 due to operational constraints.
The company is also seeing increased utilization in the inpatient segment and has reorganized its commercialization strategy to focus on inpatient customers. CorMedix has partnered with Syneos Health for a dedicated inpatient field team and with WSI for marketing resources for facilities operated by the Veterans Administration.
CorMedix is starting a Phase 3 clinical study for the reduction of central line-associated bloodstream infections in patients receiving total parenteral nutrition. The study aims to enroll less than 150 patients and targets completion by the end of 2026, with an estimated peak sales potential of $150 million to $200 million.
CorMedix is running a real-world evidence study in cooperation with U.S. Renal Care, focusing on the value of its products in clinical settings. The company aims to provide investors with updates on progress in this area of unmet need. CorMedix is conducting a study to assess the impact of DefenCath on patient care, infection rates, and hospitalizations, among other metrics, with data collection already underway. A pediatric hemodialysis study is also planned for 2025, meeting FDA requirements. Additionally, an expanded access program is in place for high-risk populations.
Financially, CorMedix saw a net revenue of $31.2 million in Q4 2024, achieving profitability with a net income of $13.5 million. Operating expenses increased by 9%, driven by higher selling and marketing costs. Full-year revenue for 2024 totaled $43.5 million, with operating expenses increasing by 28%.
CorMedix reported a net cash used in operations of $50.6 million in 2024. Cash and cash equivalents stood at $51.7 million as of December 31st, 2024, with an anticipated increase to at least $75 million by the end of Q1 2025. 2025 cash operating expenses are expected to be around $72-78 million, primarily due to increased R&D spending.
CEO Joe Todisco expressed gratitude for support and mentioned efforts to grow the customer base and expand the use of DefenCath. A question-and-answer session followed the financial update, with the first question coming from Roanna Ruiz from Leerink Partners. Syneos Health is partnering with an inpatient sales team for DefenCath. Inpatient sales are at 3% unit volume and 4-5% of dollars in the first quarter. The team is near completion and will focus on academic medical centers and VA centers for support and orders.
There is expected net price erosion starting in the second quarter, impacting revenue. Discounts and rebates off government ASP are stable but may decrease in the third quarter. Inventory levels in the channel by the end of the second quarter will impact revenue from existing business over the year.
The contracted LDO is going through a process that may lead to ordering in the next few months. Support is being provided for training and reimbursement to reinforce confidence in future orders. This support includes information requests and assistance with services for the LDO. CorMedix is hopeful to stick to the original timeline for implementation of their product by mid-year. They are making all resources available to customers to accelerate rollout. Communication with potential new customers, including smaller providers, is ongoing to increase ordering size and frequency for the product. Medicare Advantage market share is growing, presenting an opportunity for CorMedix. Real-world evidence studies are being conducted to prepare for future contract negotiations. The FDA’s acknowledgment of bloodline shortages in hemodialysis procedures may impact the uptake of DefenCath. The manufacturing challenge facing DefenCath won’t impact hemodialysis due to alternative manufacturers. The company has more than a year’s worth of finished dosage on hand. Updates on DefenCath manufacturing capacity are positive. The TPN program focuses on patients at higher risk for CLBSI, similar to dialysis patients. The policy change last November led to a lift in patient numbers. The new administration’s proposed changes present opportunities for DefenCath in the market. CorMedix discusses potential cost savings and impact on infections through replicating clinical results in real-world settings, aiming to reduce hospitalizations and antibiotic use. The company sees opportunities for growth and innovation under the new administration and legislative initiatives, including TDAPA reform and positive adjustments in reimbursement policies. CorMedix has set up a third-party hub to assist providers with claims processing for reimbursement, offering benefits verification, billing and coding expertise, and navigating payer policies and challenges. The company is well-positioned from a raw material standpoint to meet increased demand, with sufficient inventory and capacity to pivot to finished dosage contract manufacturers within a few months. CorMedix is optimistic about its ability to ramp up production to meet any potential increase in demand. In a surprising turn of events, the stock market experienced a sharp decline today, with the S&P 500 dropping by 3%. This sudden drop has investors on edge as concerns about inflation and rising interest rates continue to weigh on market sentiment.
Amidst the market volatility, tech giant Apple announced a new partnership with a leading electric vehicle manufacturer to develop autonomous driving technology. This move is seen as a strategic play by Apple to enter the rapidly growing EV market and diversify its revenue streams.
In other news, the Federal Reserve announced that it will be raising interest rates by 0.25% in an effort to combat inflation. This decision comes as no surprise to investors, as the Fed has been signaling for months that rate hikes were imminent in response to rising prices across the economy.
Meanwhile, the latest job report showed that the economy added 400,000 new jobs last month, surpassing analysts’ expectations. This positive data suggests that the labor market is continuing to recover from the impact of the pandemic, providing a glimmer of hope for economic growth in the coming months.