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| Statement |
|---|
| CorMedix remains in a good position from a balance sheet perspective as we prepare the company for commercial launch of DefenCath in April |
| I am proud of what we’ve accomplished over these recent months and excited to bring DefenCath to patients |
| Yes, we’re excited, actually - we’re going to be presenting two abstracts this spring at the upcoming Society for Healthcare Epidemiology of America, or SHEA’s annual meeting, and both field teams, both medical and commercial are going to be present at over a dozen conferences this year and continuing to connect with key stakeholders - those include SHEA, MAD-ID, the NKIF spring conference, Renal Physicians Association, so I think we have a really good presence out there |
| Since that time, obviously the landscape has shifted - TDAPA is now five years, we’ve had a number of conversations with customers in both settings of care over the last two years, and on the outpatient side specifically have gotten much more comfortable and confident around the ability to, first of all, secure reimbursement with TDAPA, and second get sufficient uptake |
| We’ve actively engaged in customer discussions on both the in-patient and outpatient settings of care and are optimistic about our launch potential for 2024 and beyond |
| We have that opportunity to leverage a payment mechanism on the in-patient side, and we also have the opportunity to leverage the health economics, right, the long term complications of these patients |
| Since we last presented earnings in November, the company has achieved a number of key milestones, most notably the final NDA approval of DefenCath by the U.S |
| So I think to the question you asked about do you expect this price point to have a positive or a negative impact on utilization, the feedback we’re getting is that the lower acquisition cost of product should drive higher utilization on the in-patient side, so certainly we’re happy with that |
| I think the benefit here is that we have secured the NTAP prior to being approved |
| I am thankful for all of those involved in the latest expansion, our new team members, and all the work that has gone into preparing the company for our anticipated commercial launch |
| Based upon our current base case forecast for 2024, we continue to believe that the company can achieve breakeven profitability on a run rate basis by the end of December 2024, assuming we are able to achieve our internal base case assumptions for DefenCath demand, uptake, net pricing and reimbursement |
| Assuming a favorable FDA review of the supplement, additional production from that site would come online by the end of 2024 |
| One of the other key pieces of feedback we took over the last two years from in-patient institutions, as we messaged around the NTAP and the value of the NTAP, was from many institutions that they perceived lower acquisition cost of product to be preferred to a higher NTAP reimbursement, so to that extent, the feedback we’ve gotten in the in-patient side is that the lower WAC price is more favorable |
| We have staffed and trained our field sales and medical affairs organizations and held a successful internal team launch meeting during the last week of February |
| We believe our cash, cash equivalents, short term investments and projected future operating cash flow gives the company the ability to fund operations for at least 12 months and to fund the commercial launch of DefenCath through to anticipated profitability, which may occur on a run rate basis by the end of December 2024, assuming we are able to achieve our internal base case assumptions for DefenCath demand, uptake, net pricing and reimbursement |
| We may look to grow over time into the 45, 50 range, but right now we’re comfortable where we’re at, that we have the right team in place |
| Matt? Matt David Thanks Joe, and good morning everyone |
| We’ve seen a lot of interest in the product, both organically and inorganically, right, where we’ve done some reach outs and we’ve also had reach outs from hospitals to us |
| Good morning everyone and thank you for joining us on this call |
| As we have discussed previously, we expect our operating expenses, especially SG&A to increase in 2024 given the growth of the company and the costs driven by the commercial launch of DefenCath |
| The team we have built is deeply experienced and specialized with backgrounds in both infectious disease and nephrology spanning both the in-patient and outpatient settings of care |
| I appreciate everyone’s continued support in CorMedix, and I am happy to take questions |
| The increase is primarily driven by an increase in net loss primarily attributable to an increase in operating expenses as compared with the same period in 2022 |
| We think there’s a lot of launch value to DefenCath that is certainly not captured in the trading value of the stock, and we also think that there’s potentially long term value |
| That said, we have received significant interest over the last few months and are actively working through the P&T process with several large and midsized health systems |
| We thank you for participating and ask that you please disconnect your lines |
| Thanks |
| Anish Nikhanj Great, thank you |
| R&D expense increased 23% to $13.2 million, driven primarily by an increase in personnel expenses, an increase in costs related to medical affairs activities, and an increase in costs related to the technical and quality operations for the manufacturing of DefenCath prior to its marketing approval |
| Congrats on the progress this quarter, and thanks for taking my questions |
| Statement |
|---|
| With respect to our fourth quarter of 2023 financial results, our net loss was approximately $14.8 million or $0.26 per share compared with a loss of $8.2 million of $0.20 per share in the fourth quarter of 2022 |
| If demand is a little bit slower, it may take some more time |
| The last question that you asked, about when we cut over, it’s a difficult one because it depends on uptake and demand |
| Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development, regulatory approvals, and commercialization |
| You know, I still think we’re a story that’s not completely widely understood |
| R&D expense decreased by approximately 19% to $2.3 million driven primarily by decreases in manufacturing costs related to DefenCath |
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