CorMedix (CRMD) Q2 2023 Earnings Call Transcript Summary
In the recent earnings call for CorMedix Inc.(CRMD), both bullish and bearish points were discussed. Here are the specific viewpoints from the earnings call:
Bullish Points:
1. NDA for DefenCath resubmitted to the FDA and accepted for review with a target action date of November 15, 2023.
2. CMS issued final rule for NTAP of up to $17,111 per hospital stay for DefenCath reimbursement, conditioned upon FDA approval prior to July 1st, 2024.
3. Newly allowed U.S. patent application extends intellectual property protection for DefenCath to an anticipated expiration date in 2042.
4. Successful completion of financing with gross proceeds of approximately $40 million, plus additional $6 million from overallotment option exercise.
5. Strong cash position with pro forma cash and equivalents of approximately $95 million as of June 30, 2023.
6. Secured inpatient reimbursement via the conditional NTAP published by CMS.
7. Preparing for an expected discussion with CMS in late 2023 around outpatient reimbursement.
8. CMS proposed expanding TDAPA from two years to five years.
9. CorMedix is focused on operational execution.
10. Successful preapproval inspections for some vendors.
Bearish Points:
1. Net loss of $11.3 million in Q2 2023, compared to a loss of $7.6 million in Q2 2022.
2. Operating expenses increased 43% to $11.8 million in Q2 2023 compared to $8.3 million in Q2 2022.
3. DefenCath's FDA approval and commercial launch are still uncertain and dependent on various factors.
4. No update on the compliance status of the primary API vendor.
5. Outpatient reimbursement decision needed before a more robust outpatient launch.
6. Lack of clear consistent guideline on how to best reduce infections in the patient population.
7. Struggle to find a pure-play comparable for similar drug launches.
For more information about CorMedix Inc.'s earnings call, you can read the relevant news: [CorMedix (CRMD) Q2 2023 Earnings Call Transcript](https://www.fool.com/earnings/call-transcripts/2023/08/08/cormedix-crmd-q2-2023-earnings-call-transcript/)
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