Overview of CorMedix’s Financial Performance

CorMedix is a pharmaceutical company focused on developing and commercializing treatments for life-threatening diseases. The company has not yet generated substantial revenue and has funded operations primarily through debt and equity financing.

In November 2023, CorMedix received FDA approval for its lead product DefenCath, an antimicrobial catheter lock solution used to reduce catheter-related bloodstream infections in kidney dialysis patients. This approval allows CorMedix to begin commercially launching DefenCath in the US.

Revenue

As of March 31, 2024, CorMedix has not yet generated product revenue as the commercial launch of DefenCath occurred in April 2024. The company expects to begin generating DefenCath sales revenue in the second quarter of 2024.

Expenses

• Research and Development Expenses: R&D expenses were $838,000 in Q1 2024, down 75% from $3.4 million in Q1 2023. The decrease reflects the FDA approval of DefenCath which has transitioned many R&D activities into commercialization efforts under SG&A.

• Selling, General and Administrative Expenses: SG&A expenses rose 98% to $15 million in Q1 2024 from $7.6 million in Q1 2023. The increase reflects investments in personnel, marketing, market research and other commercial launch activities for DefenCath.

Net Loss

• CorMedix reported a net loss of $14.5 million in Q1 2024 compared to a $10.6 million net loss in Q1 2023. The wider net loss reflects increased SG&A expenses for the DefenCath commercial launch.

Cash Position

• As of March 31, 2024, CorMedix held $58.6 million in cash, cash equivalents and short-term investments. The company estimates it has sufficient capital to fund continued operations for at least the next 12 months.

Key Events in Early 2024

• Received important CMS reimbursement coding decisions to enable DefenCath reimbursement in both the inpatient and outpatient settings
• First commercial supply contract signed with a Florida dialysis provider
  
• DefenCath launch in the inpatient hospital setting
• Submitted application to add an alternate manufacturing site to expand production capacity

Commercial Outlook

With the launch of DefenCath in April 2024, CorMedix expects to transition to a commercial-stage company generating sales revenue. However, the company is still expected to operate at a loss in 2024 as it invests in the DefenCath launch before sales volumes ramp up.

CorMedix is focused on executing a successful DefenCath launch, establishing reimbursement coverage, and demonstrating the clinical and economic value of DefenCath to drive adoption. If the launch goes well, the company targets generating positive cash flow in 2025.

Tables

Financial Results	Q1 2024	Q1 2023	% Change
Revenues	$0	$0	0%
R&D Expenses	$0.8 million	$3.4 million	-75%
SG&A Expenses	$15 million	$7.6 million	+98%
Net Loss	$14.5 million	$10.6 million	+37%

Cash Position	March 31, 2024	Dec 31, 2023
Cash, Cash Equivalents, Short-Term Investments	$58.6 million	$76 million

In summary, CorMedix is at an important inflection point as it transitions from an R&D focused company to a commercial organization. The FDA approval and launch of DefenCath gives CorMedix its first revenue generating product. Successful commercialization is critical for the company to establish a path to profitability after years of operating losses. The next 12-18 months will be crucial to demonstrate CorMedix can effectively launch DefenCath and gain sales traction.