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Mar 31, 2023
CorMedix Q1 2023 Earnings Report
Reported a net loss due to increased operating expenses, but is preparing for potential commercial launch of DefenCath in early 2024.
Key Takeaways
CorMedix reported a net loss of $10.6 million for the first quarter of 2023, driven by increased operating expenses related to pre-launch activities for DefenCath. The company is preparing for a potential commercial launch in early 2024, pending FDA approval. They have sufficient resources to fund operations at least through the first half of 2024.
DefenCath NDA is ready to be resubmitted to the FDA.
Focus is increasing on preparations for a potential commercial launch in early 2024.
Net loss for Q1 2023 was $10.6 million, or $0.24 per share.
Cash and short-term investments were $55.6 million as of March 31, 2023.
CorMedix
CorMedix
Forward Guidance
CorMedix anticipates potential FDA approval of DefenCath in 2023 and is preparing for a commercial launch in early 2024. The company believes it has sufficient resources to fund operations at least through the first half of 2024.
Positive Outlook
- DefenCath NDA resubmission to FDA.
- Potential commercial launch in early 2024.
- Sufficient resources to fund operations at least through the first half of 2024.
- Focus on reducing the risk of infections in patients receiving hemodialysis.
- Ongoing development of taurolidine-based therapies for rare pediatric cancers.
Challenges Ahead
- Net loss of $10.6 million in Q1 2023.
- Increased operating expenses.
- Reliance on FDA approval of DefenCath.
- Risks associated with relationships with CMO and heparin supplier.
- Uncertainty regarding securing final FDA approval prior to July 1, 2024.