Q1 2022 CorMedix Inc Earnings Call

Operator: Hello, and welcome to the CorMedix, Inc. first quarter 2022 earnings call-in webcast. At this time, all participants are in a listen-only mode.

Hello, and welcome to the core Medical Inc. First quarter 2022 earnings call and webcast. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. Please press star zero on your telephone keypad as a reminder, this conference is being recorded.

Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance, please press star zero on your telephone keypad. As a reminder, this conference is being recorded. It's now my pleasure to turn the call over to Daniel Ferry with Lifescyte Advisors. Please go ahead.

It's now my pleasure to turn the call over to Daniel Perry with lifestyle Advisors. Please go ahead.

Daniel Ferry: Good afternoon, and welcome to the CorMedix First Quarter 2022 Earnings Conference Call. Leading the call today is Joe Todisco, the newly appointed Chief Executive Officer of CorMedix, and Dr. Matt David, Executive Vice President and CFO. They are joined by... Dr. Phoebe Mounts, EVP.

Good afternoon, and welcome to the Carmax first quarter 2022 earnings conference call.

Leading the call today is Joe to disco newly appointed Chief Executive Officer of <unk> and Dr. Matt, David Executive Vice President and CFO .

They are joined by.

Doctor Phoebe mounts EVP.

Daniel Ferry: General Counsel and Head of Technical Operations, and Erin Mistry, SVP and Head of Payor Strategy, Government Affairs, and Trade. Before we begin, I would like to remind everyone that during the call, management may make what are known as forward-looking statements within the meeting set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following, any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its Clinical Development Program, Manufacturing Activities, and marketing approval for DefenCath in the U.S. and other product candidates, future financial position, future revenues and projected costs, potential market acceptance of Defencaf, Nutrilin, and other product candidates.

General Counsel and head of technical operations and Aaron Mystery F.

C P and head of payer strategy government affairs and trade.

Daniel Ferry: More specifically, forward-looking statements include any statements about our clinical development plans and the submission and timing, cost, progress, results, estimates, and interpretations thereof; projections as to the company's future capital raising and spending and cash position; expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development, or other transactions. Any commercial plans and expectations? market projections for our product candidates, and expectations as to manufacturing and product component costs.

Before we begin I would like to remind everyone that during the call management may make what are known as forward looking statements within the meaning set forth in the private Securities Litigation Reform Act of 1995.

Daniel Ferry: 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. These lists are described in greater detail in CorMedix filings with the SEC, copies of which are available free of charge at the SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements. An investor should not place undue reliance on these statements.

These statements are subject to certain risks uncertainties and include but are not limited to.

Any of the following any statements other than statements of historical fact regarding management's expectations beliefs goals and plans about the company's prospects, including its clinical development program manufacturing activities.

And marketing approval.

For defend cats in the U S and other product candidates future financial position.

Future revenues and projected costs.

Potential market acceptance of defend Caf neutrolin and other product candidates.

More specifically forward looking statements include any statements about our clinical development plans and the submission timing cost progress results estimates and interpretations thereof.

Projections as to the company's future capital, raising and spending and cash position.

Expectations as to the timing and nature of anticipated regulatory actions possible product licensing business development or other transactions any commercial plans and expectations market projections for our product candidates and expectations as to manufacturing and product component costs.

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.

These risks are described in greater detail and chromatics filings with the SEC copies of which are available free of charge at the SEC's website at Www SEC Gov.

Or upon request from <unk>.

<unk> may not actually achieve the goals or plans described in these forward looking statements and investors should not place undue reliance on these statements. Please note that <unk> does not intend to update these forward looking statements.

As required by law.

Daniel Ferry: Please note that CorMedix does not intend to update these forward-looking statements, except as required by law. At this time, it is now my pleasure to turn the call over to Joe Todisco, Chief Executive Officer of CorMedix. Joe, please go ahead.

At this time it is now my pleasure to turn the call over to Joe to Disco Chief Executive Officer of Carmax. Joe. Please go ahead.

Thanks, Dan.

Joseph Todisco: Thanks, Dan. Good afternoon, everyone, and thank you for joining us on this call. I'm excited to begin my tenure this week as the Chief Executive Officer of CorMedix. I'd like to start by thanking Dr. Matt David for his continued leadership while I fulfilled my contractual obligations to my previous employer. I look forward to working with Matt more closely as our growth and commercial strategy must be aligned with our financial strategy. In addition, I would like to thank the broader CorMedix team who have worked tirelessly over the last year to complete the DefendCath NDA resubmission.

Good afternoon, everyone and thank you for joining us on this call.

I'm excited to begin my tenure this week as the Chief Executive Officer cosmetics I'd like to start by thanking Dr. Matt David for his continued leadership Wi fulfilling our contractual obligations to my previous employer.

Look forward to working with Matt more closely as our growth in commercial strategy must be aligned with our financial strategy.

In addition, I would like to thank the broader <unk> team, who have worked tirelessly over the last year to complete the defend cath NDA resubmission.

Joseph Todisco: These past two months during my transition, I've had the opportunity to meet with each CorMedix employee individually, and I've been incredibly impressed with the knowledge, skill, and commitment of the current team. I've also developed a deeper understanding of the operational, commercial, financial, and regulatory hurdles the company and our lead product defend cast face in the near to medium term. While my first 100 days will include continued evaluation and understanding, the company must make several key operating and commercial decisions over the next several months in order to be ready to commercialize FENCAF as soon as possible after securing anticipated FDA approval of the NDA. To that extent, I will not have the luxury of delaying many key decisions related to supply chain planning, distribution, commercial strategy, or personnel.

These past two months during my transition I've had the opportunity to meet with each <unk> employee individually.

<unk> been incredibly impressed with the knowledge and skill and commitment of the current team.

I've also developed a deeper understanding of the operational commercial financial and regulatory hurdles the company and our lead product defend cat face in the near to medium term.

While my first 100 days will include continued evaluation in understanding the company must make several key operating and commercial decisions over the next several months in order to be ready to commercialize defend caf as soon as possible after securing anticipated FDA approval of the NDA.

To that extent I will not have the luxury of delaying many key decisions related to supply chain planning distribution commercial strategy or personnel.

Joseph Todisco: As such, this morning, we announced certain key management and reporting changes within the leadership team of CorMedix and operational changes with our international business. Liz Hurlburt, EVP of Clinical Operations, will take on an expanded role as EVP of Clinical and Medical Affairs, assuming oversight of medical affairs, drug safety, and pharmacovigilance, in addition to her existing clinical operations responsibilities. Donna Ucci has been appointed to the role of SVP and head of global quality, reporting directly to me.

As such this morning, we announced certain key management and reporting changes within the leadership team of <unk> and operational changes with our international business Lids.

Lids Hurlbert EVP of clinical operations will take on an expanded role as EVP of clinical and medical affairs, assuming oversight of medical affairs drug safety and Pharmacovigilance and addition to our existing clinical operations responsibilities.

Donna Ucci has been appointed to the role of SVP and head of global quality reporting directly to me Donna joins us. After most recently, serving as VP global quality management at immune pharmaceuticals, and with more than 20 years quality leadership experience in previous roles at impacts Allergan and Pfizer.

Joseph Todisco: Donna joins us after most recently serving as VP of Global Quality Management at Amnio Pharmaceuticals and with more than 20 years of quality leadership experience in previous roles at Impact, Allergan, and Pfizer. Frank Raphael has been appointed to the role of VP of Supply Chain, joining the company with more than 30 years of supply chain experience, including previous roles at Teva and Quotient Sciences.

Frank Raphael has been appointed to the role of VP of supply chain, joining the company with more than 30 years of supply chain experience, including previous roles at Teva and <unk> Sciences.

Joseph Todisco: I'm excited to have Don and Frank join the organization as they together add meaningful quality, manufacturing, and supply chain expertise. And I look forward to bolstering the organization with other key additions as we aim to transition from a development stage company to a commercial organization. Lastly, the company and Tom Nussbickel, EVP and Chief Commercial Officer, have mutually agreed to part ways.

I am excited to have Don and Frank joined the organization as they together add meaningful quality manufacturing supply chain expertise and I look forward to bolstering the organization with other key additions as we aim to transition from a development stage company to a commercial organization.

Lastly, the company and Tom <unk>, EVP, and Chief commercial officer have mutually agreed to part ways.

Joseph Todisco: I want to thank Tom for his commitment and dedication to CorMedix and wish him success in his future endeavors. Until such time as a permanent chief commercial officer is appointed, I will be taking a more active role in the day-to-day activities of the commercial team as we build out our commercial strategy. We've also made the decision to wind down our operations in Europe.

I want to thank Tom for his commitment and dedication to <unk> and wish him success in his future endeavors.

Until such time as permanent Chief commercial officer was appointed.

We'll be taking a more active role in the day to day activities of the commercial team as we build out our commercial strategy.

We've also made the decision to wind down our operations in Europe .

Joseph Todisco: The company had previously made Nutrilin available for sale in France, Germany, and some Middle Eastern countries as a medical device. Going forward, the company will focus on its U.S. commercialization and launch strategy, and after securing FDA approval, may pursue an international expansion via larger regional partnerships. During our year-end earnings call in March, Matt and Phoebe communicated that FDA has accepted for review our DefendCath NDA resubmission and informed CorMedix that the resubmission is complete and considered a class 2 response to the action letter with a six-month review cycle from the date of submission and an action date in the third quarter.

The company had previously made neutral and available for sale in France, Germany, and some middle eastern countries as a medical device.

Going forward the company will focus on our U S commercialization and launch strategy and after securing FDA approval may pursue with international expansion via larger regional partnership.

During our year end earnings call in March Madness, CV communicated that FDA has accepted for review our defend cast NDA Resubmission and informed cosmetics that the Resubmission is complete and considered a class two response to the action letter with a six month review cycle from the date of submission.

An action date in the third quarter it.

Joseph Todisco: It is important to keep in mind that the PDUFA goal of six months is merely an internal FDA target for the review of 90% of this type of resubmission, and FDA is not compelled or obligated to act on the application within the six-month timeframe.

It is important to keep in mind that the producer goal date of that.

<unk> of six months is merely an internal FDA target for the review of 90% of this type of Resubmission.

And FDA is not compelled or obligated to act on the application within the six month time frame.

Joseph Todisco: As Phoebe mentioned on the prior earnings call, we expect FDA to conduct a pre-approval inspection of the company's CMO as part of the review cycle. We have been notified by our CMO that FDA has provided a date for that inspection, and that inspection date is prior to our goal. It is important to note that any FDA inspection of our CMO will assess the commercial readiness of the facility and manufacturing operations beyond those specific to the vent cap, and CorMedix will only have visibility into FDA observations related to our product.

As Phebe mentioned on the prior earnings call, we expect FDA to conduct a pre approval inspection of the Companys CMO as part of the review cycle.

We have been notified by our CMO that FDA has provided a date for that inspection and Thats scheduled date is prior to our goal date it.

It is important to note that any FDA inspection of our CMO will assess the commercial readiness of the facility and manufacturing operations beyond those specific to <unk> and <unk> will only have visibility to FDA observations related to our product.

Joseph Todisco: It is also worth noting that any planned inspection from FDA could always be delayed or rescheduled as a result of the ongoing COVID-19 pandemic. We also disclosed in our March earnings call an ongoing workstream to identify U.S.-based CMOs that could be utilized for expanded manufacturing capacity to support commercial launch and for development of a prefilled syringe format. That workstream is progressing on schedule, and we will provide updates later in the year.

It is also worth noting that any planned inspection from FDA could always be delayed rescheduled as a result of the ongoing COVID-19 pandemic.

We also disclosed in our March earnings call and ongoing work stream to identify U S. Based CMO that could be utilized for expanded manufacturing capacity to support commercial launch and for development of a pre filled syringe formats that work streams progressing on schedule and we will provide updates later in the year.

Joseph Todisco: Lastly, from a supply chain standpoint, we're also continuing initiatives to dual source key components and active ingredients in order to de-risk potential global supply chain disruptions, as well as potential governmental regulatory actions at any key supplier. Over the next few months, I'll be working closely with the commercial team as we build out our launch strategy for DefendCast, including critical decisions around pricing, reimbursement, messaging, staffing, and sales deployment. Certain roles will need to be filled and decisions made prior to securing FDA approval of the DefendCast NDA. However, it is not my intention to hire or train field-based sales personnel until we have our FDA approval firmly in hand.

Lastly from a supply chain standpoint, we're also continuing initiatives to dual source key components and active ingredients in order to derisk potential global supply chain disruptions as well as potential governmental regulatory actions at any key supplier.

Over the next few months I'll be working closely with the commercial team as we build out our launch strategy for <unk>, including critical decisions around pricing reimbursement messaging staffing and sales deployment.

Certain roles will need to be filled and decisions made prior to securing FDA approval of the defend cast NDA.

It is not my intention to higher trained field based sales personnel until we have our FDA approval firmly in hand.

Joseph Todisco: As a core part of our market access strategy, we'll be working to secure favorable reimbursement for DefendCash in both the inpatient and outpatient dialysis settings. Based on our expanded understanding of the market opportunity for DefendCast, gleaned from our discussions with key stakeholders, such as dialysis providers, hospitals, CMS, and patient advocacy groups, we see market potential for DefendCast beyond outpatient dialysis clinics with a meaningful market opportunity for utilization in the hospital and patient setting this past Tuesday, May 10.

A core part of our market access strategy will be working to secure favorable reimbursement for <unk> in both the inpatient and outpatient dialysis settings.

<unk> on our expanded understanding of the market opportunity for defend cash gleaned from our discussions with key stakeholders, such as dialysis providers hospitals, CMS and patient advocacy groups.

We see market potential for <unk> beyond the outpatient dialysis clinics with a meaningful market opportunity for utilization in the hospital in patient setting.

This past Tuesday may 10th.

Joseph Todisco: The Center for Medicare and Medicaid Services, CMS, published in the Federal Register the Fiscal Year 2023 Hospital Inpatient Prospective Payment System, or IPPS for short, a proposed rule to update IPPS hospital policies, which includes the agency's thoughts on new technology add-on payment, or NTAP, applications, which provide the hospital with additional reimbursement for novel therapeutics beyond the bundled payment associated with a DRG for inpatient care in a particular diagnosis code. CorMedix has submitted its application for DefendCast to receive NTAP designation.

The center for Medicare and Medicaid services CMS published in the Federal Register the fiscal year 2023 hospital inpatient prospective payment system or <unk> for short.

A proposed rule to update Ips hospital policies, which includes the agency's thoughts on new technology add on payment or <unk> applications.

And then tap provide the hospital with additional reimbursement for novel Therapeutics beyond the bundled payment associated with the DRG for inpatient care in a particular diagnosis code.

<unk> has submitted its application for defend cath to receive and tap designation. It has been reviewed favorably by CMS against eligibility criteria and a final rule will be published by CMS in the Federal Register No later than August one.

Joseph Todisco: It has been reviewed favorably by CMS against eligibility criteria, and a final rule will be published by CMS in the Federal Register no later than August. Typically, in order for an NTAP to be effective on October 1st of a current year, the product NDA must be approved by July 1st of that year.

Typically an order for an end cap to be effective October 1st of a current year the product NDA must be approved by July 1st of that year. However.

Joseph Todisco: However, because DefendCath has received Qualified Infectious Disease Product Designation, or QIDP, from FDA, we are eligible for a more flexible start date. Specifically, we expect our NTAP to take effect the first quarter following the anticipated FDA approval of the NDA, provided such approval occurs before July 1st, 2023. In the NTAP application, which was submitted in October of 2021 to ensure a start date as early as possible, we stated that the DefendCath NDA had received a complete response letter and was pending resubmission without being able to provide CMS with information on the anticipated approval timeline or a Federal Registered Notice published this week. CMS has incorrectly stated that CorMedix expects the FDA to approve the DefendCath NDA prior to July 1st of this year.

However, because defend cath has received qualified infectious disease product designation.

Q IDP from FDA.

We are eligible for a more flexible start date.

Specifically, we expect our untapped to take effect the first quarter. Following the anticipated FDA approval of the NDA provided such approval occurs before July one of 2023.

In the <unk> application, which was submitted in October of 2021 to ensure a start date as early as possible. We stated that <unk> NDA had received a complete response letter and was pending resubmission without being able to provide CMS with information.

The anticipated approval timeline.

In the Federal Register notice published this week.

CMS is incorrectly incorrectly stated the core medics expects the FDA to approve the defend cast NDA prior to July one of this year we've.

Joseph Todisco: We've advised CMS of this error and requested the agency publish a correction on the outpatient side. We remain committed to exploring all avenues for product reimbursement, including our efforts to secure a transitional drug and on-payment adjustment, or TADAPA, as soon as practicable after securing our anticipated FDA approval. That said, we are also employing a dual strategy with CMS to simultaneously petition the agency to exclude Defend CAS from the ESRD payment bundle entirely.

We've advised CMS of this error requested the agency published a correction.

On the outpatient side, we remain committed to exploring all avenues for product reimbursement, including our efforts to secure transitional drug add on payment adjustment or to dapper.

As soon as practicable after securing our anticipated FDA approval.

That said, we're also employing a dual strategy with CMS to simultaneously petition the agency to exclude defend cast from the ESR D payment bundle entirely.

Joseph Todisco: We believe there are compelling arguments that FENCAPS does not fall within the scope of products and services calculated as part of the dialysis bundle under the current statute and therefore should be reimbursed separately by CMS as an outpatient drug product with a unique J-code. To be clear, any decision to separately reimburse for FENCAS, or order FENCAS to DAPA is ultimately at the sole discretion of CMS. But we will be working diligently over these next few months, along with other key stakeholders, such as hospital systems, dialysis clinics, and patient advocacy groups, to make these arguments to CMS.

We believe there are compelling arguments that defend caf does not fall within the scope of products and services calculated as part of the dialysis Thunder bundle under the current statute.

And therefore, it should be reimbursed separately by CMS as an outpatient drug product with a unique J code.

To be clear any decision to separately reimbursed defend cast.

Order grant defend cast the dapper is ultimately at the sole discretion of CMS, but we will be working diligently over these next few months along with other key stakeholders, such as hospital systems dialysis clinics and patient advocacy groups to make these arguments to CMS.

Joseph Todisco: We will disclose more about our market access reimbursement and pricing strategy once we receive anticipated FDA approval and we get closer to our potential commercial launch date. Meanwhile, the company has been focused on obtaining FDA approval for and commercializing DefendCast. I believe it will be equally important to establish a medium-to-long-term strategic growth plan that involves not only pursuing new indications for defense capability, of potentially new uses of tyrolidine, as well as potential products in licensing and acquisitions of products, both commercial and pre-commercial, that will be synergistic with our expected sales deployment in hospitals or dialysis.

We will disclose more about our market access reimbursement and pricing strategy. Once we receive anticipated FDA approval and we get closer to our potential commercial launch date.

While the company has been focused on obtaining FDA approval of and commercializing defend caf.

I believe it will be equally important to establish a medium to long term strategic growth plan that involves not only pursuing new indications for <unk>.

A potentially new uses of <unk> as well as potential product in licensing and acquisitions of products.

Commercial and pre commercial that will be synergistic with our expected sales deployment and hospitals or dialysis centers.

Joseph Todisco: To bolster these efforts, the company recently announced the formation of a new Scientific Advisory Board, or SAB, comprised of experts in nephrology, infectious disease, Medical Nutrition, and Oncology. ESAB's mission is to provide strategic and scientific advice to CorMedix as it advances toward a potential commercial launch, as well as evaluate life cycle expansion and business development opportunities for the company. I'll now turn the call over to Matt to cover financial results and cash guidance.

To bolster these efforts the company recently announced the formation of our new scientific Advisory Board or SAB.

Comprised of experts in nephrology infectious disease.

Medical nutrition and oncology.

<unk> mission is to provide strategic and scientific advice to <unk> as we advance toward a potential commercial launch as well as evaluate lifecycle expansion and business development opportunities for the company.

I'll now turn the call over to Matt to cover our financial results and cash guidance Matt.

Joseph Todisco: Thanks, Joe. I'm pleased to be here today to provide an overview of our first quarter 2022 financial results, as well as an update on our cash position. The company has filed its report on Form 10-Q for the first quarter ended March 31st, 2022. I urge you to read the information contained in the report for a more complete discussion of our financial results, with respect to our first quarter of 2022 financial results. Our net loss was approximately $7,000,000, or $0.18 per share, compared with a loss of $7.2,000,000, or $0.20 per share, in the first quarter of 2021.

Thanks, Joe I am pleased to be here today to provide an overview of our first quarter 2022 financial results as well as an update on our cash position.

The company has filed its report on Form 10-Q for the first quarter ended March 31, 2022, I urge you to read the information contained in the report for a more complete discussion of our financial results.

With respect to our first quarter of 2022 financial results.

Our net loss was approximately $7 million or <unk> 18 per share compared with a loss of $7 2 million or <unk> 20 per share in the first quarter of 2021.

Matthew David: The marginally lower net loss recognized in 2022 compared with 2021 included a decrease in R&D expenses versus the first quarter of 2021, offset by slight increases in SG&A expenses. Operating expenses in the first quarter of 2022 decreased approximately 3% to $7 million, compared with $7.2 million in the first quarter of 2021. R&D expense decreased by approximately 13% to $2.3 million, driven primarily by net decreases in personnel expenses and non-cash charges for stock-based compensation, offset by an increase in costs related to the manufacturing of DefendCath prior to its potential marketing approval. SG&A expense increased by approximately 3% to $4.8 million compared with $4.6 million in the first quarter of 2021.

The marginally lower net loss recognized in 2022 compared with 2021 included a decrease in R&D expenses versus the first quarter of 2021 offset by slight increases in SG&A expenses.

Operating expenses in the first quarter of 2022 decreased approximately 3% to $7 million compared with $7 2 million in the first quarter of 2021.

R&D expense decreased by approximately 13% to $2 3 million driven primarily by net decreases in personnel expenses and noncash charges for stock based compensation.

We offset by an increase in costs related to the manufacturing defend cap prior to its potential marketing approval.

SG&A expense increased approximately 3% to $4 8 million compared with $4 6 million in the first quarter of 2021. This.

Matthew David: This increase was primarily attributable to an increase in legal fees, mainly due to the securities litigation, and an increase in personnel expenses, partially offset by a decrease in non-cash charges for stock compensation, reduced costs related to market research in preparation for the potential approval of FENCAS, and a decrease in consulting fees. We recorded net cash used in operations during the first quarter of 2022 of $6.7 million, compared with net cash used in operations of $6.7 million in the first quarter of 2021.

This increase was primarily attributable to an increase in legal fees, mainly due to the securities litigation and an increase in personnel expenses, partially offset by a decrease in noncash charges for stock compensation reduced costs related to market research in preparation for the potential approval of defense cost and a decrease in consulting fees.

We recorded net cash used in operations during the first quarter of 2022 of $6 7 million compared with net cash used in operations of $6 7 million in the first quarter of 2021.

Matthew David: As we discussed on our year-end earnings call, CorMedix remains in a good position from a balance sheet perspective. The company has cash-in-exchange and short-term investments of $61.7 million as of March 31, 2022. Inclusive of approximately $2.2 million raised since the quarter closed from our ATM program and approximately $0.6 million from the sale of unused New Jersey NOLs, CorMedix has pro forma cash-in equivalents of approximately $64.5 million.

As we have discussed on our year end earnings call <unk> remains in a good position from a balance sheet perspective, the company has cash and equivalents and short term and short term investments of $61 7 million as of March 31 2022.

Inclusive of approximately $2 2 million raised since the quarter close from our ATM program and approximately zero point $6 million from the sale of unused New Jersey, Nols cosmetics is pro forma cash and equivalents of approximately $64 5 million.

Joseph Todisco: We believe our pro forma cash and equivalents give the company flexibility to fund its operations at least through the first half of 2023 after taking into consideration costs related to commercial supply and costs related to the initial stages of the potential commercial launch for DefendCash. We remain optimistic about our progress toward an anticipated FDA approval for Defend-Cath in 2022. As highlighted previously, we believe that our current cash and equivalents, as well as the potential mechanisms available to us for capital raising, allow us to be prepared for the future, given we are facing what we hope and believe will be a pivotal time ahead for CorMedix as we seek to bring Defend-Cath to patients in the hemodialysis setting. I will now turn the call back over to Joe for his closing remarks. Joe?

We believe our pro forma cash and equivalents gives the company flexibility to fund its operations at least through the first half of 'twenty 'twenty three after taking into consideration costs related to commercial supply and costs related to the initial stages of the potential commercial launch for defend cap.

We remain optimistic about our progress toward an anticipated FDA approval for defend cap in 2022 as highlighted previously we believe that our current cash and equivalents as well as the potential mechanisms available to us for capital raising allow us to be prepared for the future. Given we are facing what we hope and believe.

We will be a pivotal time ahead for <unk> as we seek to bring defend caf two patients in the hemodialysis setting.

I will now turn the call back over to Joe for closing remarks, Joe.

Joseph Todisco: Thanks Matt. As I look toward our next few months, I'm excited about the opportunities and optimistic about the challenges that lay ahead. If approved by the FDA, Defend-CAHPS has the potential to significantly improve patient outcomes while also having an impact on the health equity disparity that is pervasive in our healthcare system. Catheter-related bloodstream infections, or CRBSIs, place a heavy financial burden on the US health care system, estimated at roughly $2.6 billion per year of incremental cost.

Thanks, Matt.

As I look toward our next few months I'm excited about the opportunities and optimistic about the challenges that lay ahead.

If approved by the FDA defend cap has the potential to significantly improve patient outcomes. While also having an impact on the health equity disparity that is pervasive in our health care system.

Joseph Todisco: Hemodialysis patients with a CRBSI have double the rate of hospitalization as non-infected HD patients, with an average duration of stay that is four times longer and a three times higher fatality rate. In addition, African-Americans represent under 14% of the US population but account for more than 35% of the patients undergoing hemodialysis. To that extent, African-Americans are disproportionately at risk for a catheter-related bloodstream infection compared to other demographic groups.

Catheter related bloodstream infections or <unk>.

Please a heavy financial burden on the U S health care system estimated at roughly $2 $6 billion per year of incremental cost.

Hemodialysis patients with a <unk> Si.

Double the rate of hospitalization has not infected HD patients with an average duration of stay that is four times longer.

And a three times higher fatality rate.

In addition.

African Americans represent under 14% of the U S population.

But account for more than 35% of the patients undergoing hemodialysis.

To that extent.

And Americans are disproportionately at risk for a catheter related bloodstream infection compared to other demographic groups.

Operator: Defend-CAS in clinical trials reduced CRBSI occurrence by 71% in hemodialysis patients compared to the existing standard of care. Taken together, the strong clinical profile of FENCAS and its potential to significantly improve patient outcomes and health equity, while also potentially decreasing the overall cost burden on the healthcare system. I see DefendCast as a strong platform asset for growth from which CorMedix can build. So, thank you for your continued support of and interest in CorMedix, and this concludes management's presentation.

Defend cash and clinical trials reduced <unk> by 71% and hemodialysis patients compared to the existing standard of care.

Taken in totality, the strong clinical profile of defend cath and potential to significantly improve patient outcomes and health equity, while also potentially decreasing the overall cost burden on the healthcare system.

Defend cast as a strong platform asset for growth from which <unk> can build.

Thank you for your continued support of and interest in cosmetics and this concludes management's presentation. Operator, you can open the call for questions.

Operator: Operator, you can open the call for questions. Sure, we'll now be conducting a question and answer session. If you'd like to be placed in the question queue, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue.

Certainly, we'll now be conducting a question and answer session if you'd like to be placed in the question queue. Please press star one on your telephone keypad.

A confirmation tone will indicate your line is in the question queue.

If you'd like to remove your question from the queue. Please press star two one moment. Please while we poll for questions. Our first question today is coming from Jason Butler from JMP Securities. Your line is now live.

Operator: If you'd like to remove your question from the queue, please press star two. One moment, please, while we poll for questions. Our first question today is coming from Jason Butler from J&P Security. Your line is now live. Hi, thanks for taking the questions and congratulations on all the progress and the new hires. Joe, congratulations on, you know, your start here.

Hi, Thanks for taking the questions and congrats on all the progress.

New hires.

Joe Congrats on the start here.

Maybe just to start from a high level can you just maybe you started to touch on this in the prepared comments, but.

Two it's about what attracted you to <unk> and how you think your prior successes can set the company up for a successful launch to defend Caf and then I have a follow up thanks.

Jason Butler: Maybe just as a start from a high level, can you maybe, you started touching this in the prepared comments, but, you know, talk to us about what attracted you to CorMedix and how you think your prior successes can set the company up for a successful launch into FENCAS. And then I have a follow-up. Thanks. Sure. Thanks, Jason, and I appreciate the question. So, look, when I think about what I bring to CorMedix, right?

Sure. Thanks, Jason.

I appreciate the question so look when I think about.

What I bring to core medics right I think I bring a long track record of building and managing commercial organizations across different therapeutic categories in different geographies as well as deep expertise in business development and strategy.

Joseph Todisco: I think I bring a long track record of building and managing commercial organizations across different therapeutic categories and different geographies, as well as deep expertise in business development and strategy. And, you know, in terms of kind of why I'm excited about CorMedix, I saw in CorMedix a unique opportunity to lead a company whose primary product has the potential to make a meaningful impact on patient outcomes. And when I think about patient outcomes, I'm talking about saving lives, right? So... DefendCat has, in my opinion, exceptional phase 3 data.

Joseph Todisco: And I see strong potential to expand into additional indications while also adding new products to CorMedix beyond the torolidine platform. So, you know, especially given recent markets, their impact on our valuation and market cap, I see a lot of potential for growth in CorMedix from where we are today. So, you know, in my view, I really saw this as a perfect opportunity and an ideal fit between what CorMedix needed as a company and the skills I bring as a leader.

And.

In terms of kind of why I'm excited about <unk> I saw <unk>.

Joseph Todisco: Great, that's helpful. And then just on reimbursement, you talked about both the TDAPA program as well as petitioning to have the products excluded from the bundle. Are these mutually exclusive processes, or is there any, you know, crosstalk between the two?

Our unique opportunity to lead a company, whose primary product has the potential to make a meaningful impact on patient outcomes and when I think about patient outcomes I'm talking about saving lives right. So.

I think Hess has in my opinion exceptional phase III data.

And I see strong potential to expand into additional indications while also.

Adding new products to <unk> beyond petroleum platform, so, especially given.

Recent markets their impact on our evaluation of market cap I see a lot of potential for growth.

<unk> from where we are today. So my view I really thought this is a perfect opportunity and an ideal fit between what <unk> needed as a company and the skills I bring as a leader.

Great. That's helpful. And then just on reimbursement you talked up relative to that.

<unk> program as well as <unk>.

Petitioning to have the products are excluded from the bundle are these mutually.

Exclusive.

Processes or is there any cross talk between the two and then just following on from that.

Can you speak to how you think defend cap aligns with the dialysis providers from a from a health economic perspective.

Joseph Todisco: And then, just following on from that, can you speak to how you think DefendCap aligns with dialysis providers from a health economic perspective? Okay, thanks. So, I mean, let me say unequivocally first that this is going to be a dual strategy that, you know, we pursue simultaneously, right? So, you know, DAPA is absolutely an adequate pathway to drive reimbursement and build value for DefendCast. But in pursuing separate reimbursement and pursuing a J-code, we saw the potential to create, let's say, a more sustainable long-term approach.

Okay. Thanks, So let me say unequivocally first.

This is going to be a dual strategy that we pursue simultaneously right. So.

That is absolutely absolutely inadequate pathway.

To drive reimbursement and build value for defend cast but.

In pursuing separate reimbursement and pursuing a J code, we saw the potential to create let's say a more sustainable long term.

Joseph Todisco: And ultimately, it is CMS that makes that distinction, right? CMS and its sole authority. And it is the same decision-maker at CMS, essentially, that's going to work on this parallel pathway. So, you know, those are not mutually exclusive. I'm actually going to defer the question on ATOR to Erin Mistry, who is here with me. And Erin?

Broach and ultimately to CMS that makes that distinction CMS and its sole authority.

And it is the same decision maker at CMS, essentially that's going to that's going to work.

This parallel pathway so.

Those are not mutually exclusive.

I'm actually going to defer a question on AQR to air industry, who is here with me.

Alright.

Erin Mistry: Sure, the health economics component of this certainly plays a big role in how we're going to pay for it and how we go about it. First of all, it's a population issue, and we have identified the health disparities and health equity components of this that make up a large portion of that health economic impact. So we feel that we've got the right combination of data to support that, and we're doing health economics work across settings of care, both inpatient and outpatient, to identify where we can put defense caps in, where we can get the most value out of the product. Thanks for taking the question and congrats again on the program. Thank you, Jason.

Sure.

The health economics component of that certainly plays a big role in how were going for reimbursement and how we go about it.

First of all it's a health population issue and we have identified the health disparities in health equity components that make up a large portion of that health economic play.

We feel that we've got the right combination of.

Data to support that.

And we're doing health economics work on across settings of care.

Both inpatient and the outpatient to identify where we can.

But to put defend Kathryn we can happen with that you get out of the products.

Great. Thanks for taking the question and congrats again on the progress.

Thank you Jason.

Operator: Thank you. The next question today is coming from Julene from Truist Securities. Your line is now live. Yes, good evening. This is Les for June.

Thank you next question today is coming from Joon Lee from <unk> Securities. Your line is now live.

Yes.

Yes. Good evening this is less than one for joon. Thanks for taking my questions.

Leszek Sulewski: Thanks for taking my questions. I'll start off with the EU wind-down. Can you just talk about the costs associated with that, how long it might take, and then the impact on the CMO that has currently been producing the product there in the EU?

I'll start off with on the EU wind down can you just talk about the cost associated with that how long it might take.

And then the impact flipped to the CMO.

That has currently been producing the product there in EU is that going to be a closure of the CMO as you look for a new CMO in the U S and what will happen to that relationship.

Joseph Todisco: Is that going to be a closure of that CMO? Do you look for a new CMO in the U.S.? And what will happen to that relationship?

Joseph Todisco: Okay, yes. Thanks for the question, Les. Let me clarify that the CMO that was being utilized for production of the product as a medical device is completely different from the CMO we would utilize to commercialize it in the United States. So there's absolutely no overlap between the manufacturing of Neutrolin and that for Defendcast.

Okay. Yes. Thanks for the question last let me clarify that the CMO that was being utilized.

For production of the product as a medical device is completely different from the CMO, we would utilize to.

Commercialized for the United States So.

There's absolutely no overlap between the manufacturing.

For Neutrolin and defend gas.

In terms of the EUR wind down and cost I'll defer to Matt and a moat.

Joseph Todisco: You know, in terms of the EU wind-down and cost, I'll defer to Matt in a moment if he has any estimates. But look, this is just a decision that's been made. We're starting that process, but we're not setting a timeline. I can tell you that we are in the process of discontinuing distribution of the product because the sales, as they were, were not overly meaningful in the near term. So we'll have a better sense of that over the next quarter, I believe.

<unk>.

If he has any estimates but look this is just a decision that we made we're starting that process, we're not setting a comp.

Timeline I can tell you that we are in the process of discontinuing distribution of the product sales as they were not overly overly meaningful in the near term.

So it will have a better sense for that over the over the next quarter I believe Matt any any clarity on one time cost.

Joseph Todisco: Matt, any clarity on winding down costs? Yeah, I'll just add that the costs related to Europe will be de minimis. As you can see, sales have been relatively insignificant in recent quarters, and therefore, the costs that we have been spending have also been de minimis.

Yes, I'll just I'll just add only that the costs related to Europe will be de Minimis as you can see that the sales have been relatively insignificant.

In recent quarters and therefore, the costs that we had been spending have also been de Minimis. So this is more of a strategic decision as Joe walked through.

Matthew David: So this is more of a strategic decision, as Joe offered. Thank you. And then just to follow up on that on the CMO selection side, it appears that you have identified a number of manufacturers in the U.S. Can you just talk about the progress there in your due diligence process and when we can, I guess, perhaps hear some announcement on that front? Yeah, I think we're going to probably be in a position to update on the next call.

Great makes sense. Thank you and then just a follow up to that on the CMO selection side.

It appears that you have identified and a number of manufacturers in the U S. Can you just talk about the progress there on your due diligence process and when can we I guess, perhaps hear some announcements on that front.

Yes, I think we're going to we're going to probably be in a position to update on the next call. We've got a couple of work streams that are that are still ongoing and we're working through those but the project is moving forward really well and.

Matthew David: We've got a couple work streams that are still ongoing, and we're working through those, but the project is moving forward really well, and we'll be able to provide an update in a couple months. Great, and I guess I'll squeeze one more in.

It will be able to provide an update in a couple of months.

Joseph Todisco: With your current guidance of cash through the first half of 2023, with the new hires and bringing in the Scientific Advisory Board, has that impacted any of your cash guidance? Thank you. I'm going to defer that to Matt. Go ahead, Matt.

Great and I'll guess I'll squeeze one more in on.

With your current guidance of cash through first half of 'twenty three.

The new hires and bringing in a scientific advisory board has that impacted any of your cash guidance. Thank you.

Yeah.

I'm going to defer that to Matt go ahead, Matt Thanks, Jeff Yeah.

Matthew David: Thanks, Joe. Yeah, no problem, June. So, yeah, it is included.

So yes. It is included.

Matthew David: Look, our cash guidance assumes the assumption of increasing spend related to preparing for the potential commercial launch of the Venkat, as we've said before. And so we've anticipated things to increase. We've anticipated being able to spend on launch supply and the initial stages of a commercial launch. And so we have not changed our guidance that we put out a few weeks ago, as well. Okay.

Cash guidance assumes the assumption of increasing spend related to preparing for the potential commercial launch of <unk> as we've said before.

So we've anticipated for things to increase our debt.

Anticipating to be able to spend on launch supply and the initial stages of a commercial launch.

So we have not changed our guidance that we put out a few weeks back as well.

Got it thank you.

Operator: Thank you. Thank you. The next question today is coming from Rohit Bhasin from Evening Company. Your line is now live. Hi, this is Rohit on for Surge.

Thank you. Your next question today is coming from Rohit Boston from Needham <unk> Company. Your line is now live.

Rohit Bhasin: Thanks for taking my question. Can you talk to us a little bit about how you see the market opportunity for DefendCats? And what do you think is the main competition based on what hospitals are currently using?

Hi, This is robin on for Serge Thanks for taking my question.

Can you talk a little bit about how you see the market opportunity for defense costs and what do you think it would be our main competition based on what hospitals are currently using.

And then what kind of preparations are you guys.

Making sure in terms of launch in terms of commercial prep and manufacturing supply ahead of time.

Joseph Todisco: And then what kind of preparations are you guys making for in terms of launch, in terms of commercial prep, and manufacturing supply ahead of time? Thanks for the question. So obviously, we see a market opportunity in two segments, right, both on the outpatient and inpatient side. And I think the outpatient side is clearly well known, largely, you know, controlled by the large dialysis operators.

Okay. Thanks for the questions on it so.

Obviously, we see we see a market opportunity in two segments right. Both on the outpatient and inpatient side I think the outpatient side is clearly well known.

Largely.

Controlled by the large dialysis dialysis operators on the inpatient side.

Joseph Todisco: On the inpatient side, you know, it's a little bit different of a market opportunity. And we're, you know, somewhat dependent on the final label from the FDA as to what that total market opportunity will be. But we do know it's a smaller market than the outpatient in terms of, let's say, total lumen locks, right?

It's a little bit different of a market opportunity and were.

Somewhat dependent on the final label from the FDA as to what that total market opportunity will be.

We do know, it's a smaller market than the outpatient in terms of let's say total lumen locks right, but we.

We do think there is the potential for possibly higher net pricing.

And a more favorable reimbursement landscape again, depending on the outcome of our discussions.

With CMS.

Joseph Todisco: But we do think there's the potential for, you know, possibly higher net pricing and a more favorable reimbursement landscape, again, depending on the outcome of our discussions with CMS. On the launch prep side, in terms of activities that we're currently undertaking, we're doing right now all the typical pre-launch planning. We're building out our commercial plan, building out our core messaging, doing our pricing studies, building our staffing plans, but most importantly, we're engaging those reimbursement activities and engaging key stakeholders to work with CMS, and we see that as one of the most critical components of our launch strategy.

On the launch prep side.

In terms of activities that we're currently undertaking and we're doing right now all the typical prelaunch planning we are building out our commercial plan.

Building out our core messaging doing our pricing studies building our staffing plans.

But most importantly, we're engaging those reimbursement activities and engaging.

Key stakeholders to work with CMS, and we see that as one of the most critical components.

Of our launch strategy.

Great. Thanks.

Joseph Todisco: Thank you. I'd like to turn the floor back over to Dan for further Q&A. Thank you, operator. I do have a few written questions from the audience. So, let me pull those up here. I appreciate it.

Thank you I would like to turn the floor back over to Dan for further Q&A.

Okay.

Thank you operator, I do have a few written questions from the audience.

So let me pull those up here I appreciate it.

Operator: First, can you provide any updates on plans for additional indications, like Pediatrics, TPN, and Oncology?

Our first.

Can you provide any updates on plans for additional indications like.

Tricks TPN.

Apology.

Joseph Todisco: Okay, thanks Dan. I guess first we need to separate, I'd say, pediatrics from what we'll call new indications, right? So we have an obligation to FDA to pursue a pediatric study with the initial indication that we will commence once we have final FDA approval of the NDA. So that is a separate clinical trial that will commence, expected shortly after we get final approval. On the other hand, on TPN, oncology, and potentially some other areas that we're taking a look at, I think the team has done some really good initial analysis, you know, of those kind of market segments.

Okay. Thanks, Dan I guess first we need to separate I'd say pediatrics from what we'll call new and new indications right. So we have an obligation to FDA to pursue a pediatric study.

With the initial indication.

We commence once we have final FDA approval of the NDA. So that is a separate clinic.

Clinical trial that will commence.

Expected shortly after we get final approval.

On the on the other side.

TPN oncology and potentially some other areas that we're taking a look at I think the team has done some really good initial analysis.

Of those market segments and we're in the process of kicking off over the next few weeks, what I'll call a deeper evaluation process, that's really going to build out our market landscape.

Joseph Todisco: And we're in the process of kicking off over the next few weeks what I'll call a deeper evaluation process that's really going to build out a market landscape for both TPN and oncology, as well as a couple other potential options. We're going to look at the reimbursement landscape. We're going to look at the clinical trial or expected clinical trial pathway cost and timing, as well as evaluate whether we would need to make any modifications to the formulation for those respective indications. I'd like to be in a position by the end of the year to make a decision on a pathway forward from a return on investment standpoint.

For both TPN oncology as well as a couple other potential options, we're going to look at reimbursement landscape, we're going to look at the clinical trial are expected clinical trial pathway cost and timing.

As well as evaluate whether we would need to make any modifications to the formulation for those respective indications.

I would like to be in a position by the back part of the year to make a decision on a pathway forward from a from a return on investment standpoint.

Joseph Todisco: Okay, thanks Joe. And the final question is... What do you see as launch timing relative to your potential approval? Yeah, thanks, that's a good question, Dan.

Okay. Thanks, Joe.

And the final question is.

What do you see <unk> launch timing.

Relative to your potential approval.

Joseph Todisco: So, you know, there are a couple of rate-limiting factors when we're thinking about watch timing relative to approval. First, on the reimbursement side, from an outpatient standpoint, whether, you know, we end up ultimately going the Tadapa route or getting separate reimbursement, both of those processes really kick off when you get your final approval. You submit your application to CMS, and, you know, on average, I think it's about six months for, you know, depending on the pathway, that we'll get a final decision.

Yes, Thanks, Thats a good question Dan.

Yes, there is a couple of rate limiting factors when we're when we're thinking about launch timing relative to approval.

First on the on the reimbursement side.

From an outpatient standpoint, whether we end up ultimately going to tap out or getting separate reimbursement.

Both of those processes really kick off when you get your final approval you submit your application to CMS.

Yes.

On average I think it's about six months.

Joseph Todisco: You know, that said, we would look to kick off our inpatient launch strategy or launch initiative a bit earlier. And, you know, depending on the time it would take to, let's say, hire, train, you know, a field-based team, as well as, you know, get our core messages, you know, those pre-approved by FDA, we have to submit our marketing materials. I would be thinking somewhere between, you know, three months, you know, four months post-approval for a full-scale launch.

Depending on the pathway that we will get a final decision.

That said, we would look to kick off our inpatient launch strategy or launch.

An initiative a bit earlier and depending on the time it would take to let's say higher train.

Our field based team as well as get our core messages.

Those pre approved by FDA with some of our marketing materials I would be thinking somewhere between.

Three months four months post approval for really a full scale launch.

Joseph Todisco: Excellent. Thank you, Joe. Operator, this concludes our question and answer session. You may now close the call. Thank you. That does conclude today's teleconference and webcast. You may disconnect your lines at this time and have a wonderful day. We thank you for your participation.

Excellent.

Thank you Joe Operator. This concludes our question and answer session. You may now close the call.

Thank you that does conclude today's teleconference and webcast you may disconnect. Your lines at this time and have a wonderful day, we thank you for your participation today.