earnings
confidence high
sentiment positive
materiality 0.70
CorMedix Q1 net loss $10.6M; DefenCath NDA resubmitted to FDA for 6-month review
CorMedix Inc.
2023-Q1 EPS reported
-$0.24
- Q1 net loss $10.6M ($0.24/share) vs $7.0M loss in Q1 2022; operating expenses $11.0M, up 57% YoY due to pre-launch activities.
- DefenCath NDA resubmitted to FDA; classified as Type 2 resubmission with 6-month review cycle, target action date November 2023.
- CMS proposed rule grants DefenCath NTAP up to $17,111 per hospital stay, contingent on FDA approval by July 1, 2024.
- US Patent Office issued notice of allowance for DefenCath composition, extending IP protection to 2042.
- Cash and short-term investments $55.6M; management believes sufficient to fund operations through first half of 2024.