Q: What is CorMedix (CRMD) Q3 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. FDA completed a pre-approval inspection for CorMedix's finished CDMO site in September.
2. Company is not aware of any outstanding review items or deficiencies that would lead to a negative outcome.
3. Intensified preparations for commercial launch with key new hires in various departments.
4. Targeting a commercial launch before the end of the first quarter of 2024.
5. CorMedix is in a strong position from a balance sheet perspective as we prepare the company for a potential commercial launch in the first quarter of 2024.
6. The company has cash and cash equivalents of 86.6 million as of September 30th, 2023.
7. We believe our cash, cash equivalents, short-term investments, and other available resources give the company the capability to fund the commercial launch of DefenCath through to anticipated profitability.
8. No surprises in the FDA label feedback, which is consistent with expectations.
9. Phase 3 clinical results demonstrated a 71% reduction with risk associated with CRBSI for hemodialysis patients.
10. DefenCath is the first-in-class therapy for prevention of CRBSI.
Bearish Points:
1. Assumptions around commercial launch and sales ramp may be impacted by external factors, such as the timing of reimbursement guidance from CMS.
2. Prolonged government shutdown could adversely impact the timing of any guidance from CMS around reimbursement.
3. Inpatient formulary lag and the expected timing to implement any outpatient reimbursement may result in no meaningful revenue contributions until the second half of 2024.
4. Net loss in Q3 2023 was approximately 9.7 million, or $0.17 per share, compared with the loss of 6.9 million, or $0.17 per share, in the third quarter of 2022.
5. Operating expenses in the third quarter of 2023 increased approximately 50% to 10.5 million, compared with 7 million in the third quarter of 2022.
6. Total operating expenses during the nine months year to date of 2023 amounted to 33.3 million, compared with 22.3 million in the first nine months of 2022, an increase of 49%.
7. Net cash used in operations during the nine months year to date of 2023 was 27.7 million, compared with net cash used in operations of 18.2 million in the same period in 2022.
8. Potential government shutdown could impact the timing of commercial launch and reimbursement guidance.
9. Still waiting on EIR from pre-approval inspection for primary CDMO.
10. Reimbursement determination from CMS needed for revenue guidance.
For more information about CorMedix Inc.'s earnings call, you can read the relevant news: CorMedix (CRMD) Q3 2023 Earnings Call Transcript.
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