Q4 2020 CorMedix Inc Earnings Call

Greetings and welcome to the core med ex fourth quarter and fiscal year 'twenty 'twenty earnings Conference call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation presentation instructions will be given at that time, if anyone should require operator assistance during the.

Operator: Welcome to the CorMedix 4th Quarter and Fiscal Year 2020 Earnings Conference Call. At this time, all participants are in a listen-only mode.

Operator: A question-and-answer session will follow the formal presentation. Instructions will be given at that time. If anyone should require operator assistance during the conference, please press star zero on your telephone keypad. Please note this conference is being recorded. I will now turn the call over to your host, Dan Ferry.

Conference. Please press Star zero on your telephone keypad. Please note. This conference is being recorded I will now turn the call over to your host day I'm sorry. Please go ahead.

Good afternoon, and welcome to the <unk> fourth quarter and fiscal year 2020 earnings Conference call.

Daniel Ferry: Good afternoon, and welcome to the CorMedix fourth quarter and fiscal year 2020 earnings conference call. Leading the call today is Kosa Blosch, Chief Executive Officer of CorMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel, and Dr. Matt David, Executive Vice President and Chief Financial Officer.

Leading the call today is coastal bluish chief Executive officer of Carmax.

He is joined by Dr. Phoebe mounts executive Vice President and General Counsel.

And Doctor, Matt, David Executive Vice President and Chief Financial Officer.

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 from the private Securities Litigation Reform Act of 1995.

Daniel Ferry: 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 limitations of 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 and Marketing Approval for DefendCath in the U.S. and other product candidates

These statements are subject to certain risks and uncertainties 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 Companys prospects.

Including its clinical development program.

Marketing approval.

For deferred cash in the U S and other product candidates.

Financial position future revenues and projected costs.

Daniel Ferry: Future Financial Position, Future Revenues and Projected Costs, potential market acceptance of Desencast, Neutralin, and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, cost, results, and interpretations thereof, projections as to the company's future capital raising, Spending, and Cash Position.

And potential market acceptance of defend cash neutrolin and other product candidates.

More specifically forward looking statements include any statements about our clinical development plans and the timing.

Cost results and interpretations thereof.

Projections as to the company's future capital raising and <unk>.

Spending and cash position.

Expectations as to the timing and nature of anticipated regulatory actions.

Daniel Ferry: 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 Cost. However, 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 in CorMedix filings with the SEC, copies of which are available free of charge on the SEC's website at www.sec.gov or upon request from CorMedix.

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.

[noise] approvals and commercialization these.

These risks are described in greater detail on core med ex filings with the SEC copies of which are available free of charge at the SEC's website at Www Dot FCC Dot Gov.

Or upon request from cosmetics.

<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.

Daniel Ferry: CorMedix 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 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 Mr. Koso Baloch, Chief Executive Officer of CorMedix. Koso, please go ahead.

Please note that <unk> 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 Mr. Coastal below <unk>, Chief Executive Officer of Chromatics Caso. Please go ahead.

Thank you Dan.

Koso Baloch: Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss fourth quarter and fiscal year 2020 financial information and the overall progress CorMedix is making in bringing DefendCaps to the U.S. market for its first indication for use as a catheter lock solution for hemodialysis patients, to reduce Cancer-Related Bloodstream Infections. Also joining me on this call are Fadi and

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

On today's earnings call, we will discuss fourth quarter and fiscal year 2020 financial information.

And the overall progress cosmetics is making in bringing defend cats to the U S market for its first indication for use as a catheter lock solution for hemodialysis patients.

To reduce catheter related bloodstream infections.

Joining me on this call Arkady en masse.

2020 was a yoga cosmetics continued to make significant strides.

Koso Baloch: 2020 was a year where CorMedix continued to make significant strides. We added to the team, including our appointment of Matt David, MD, as the company's Executive Vice President and Chief Financial Officer, and other senior-level hires on the market access and medical affairs side to help prepare the company for our anticipated commercial launch of DefendCat. In July, CorMedix announced a $23 million equity financing that brought in capital, new institutional holders, and broadened our Wall Street relationship with banks and research analysts.

Cosmetics added to the team, including our appointment of Matt David M D. As the company Executive Vice President and Chief Financial Officer.

And other senior level hires on the market access and medical affairs side to help prepare the company for anticipated commercial launch of defend cap.

In July <unk> announced a 23 million equity financing that brought in capital you institutional holders and broaden our wall Street relationship with banks and research analysts.

Later in the summer cosmetics announced the acceptance by the FDA of a new drug application the NDA for <unk>.

Koso Baloch: Late in the summer, CorMedix announced the acceptance by the FDA of a new drug application, the NDA, for different caps. Our product candidate is to be used as a catheter lock solution in hemodialysis patients for the prevention of catheter-related bloodstream infections, CRBSI. The FDA also granted priority review and set a Prescription Drug User Fee Act, which is called PDUFA, date of February 28th, 2021, for the completion of its review for approval of the NDA. In the fall, CorMedix added two new boat members. Paolo Costa and Greg Duncan.

Our product candidates to be use as a catheter lock solution in hemodialysis patients for the prevention of catheter related bloodstream infections <unk> Si.

The FDA also granted priority review and set a prescription drug user fee Act, which is called Purdue Pharma day to February 28 2021.

For the completion of its review for approval of the NDA.

In the fall cosmetics added two new board members.

Kosta and Greg Duncan.

Paulo brings decades of leadership experience in the pharmaceutical sector as president and CEO of Novartis U S Corporation.

Koso Baloch: Paolo brings decades of leadership experience in the pharmaceutical sector to his role as President and CEO of Novartis U.S. Corporation. He has also demonstrated his strategic insight as chairman of Amlin Pharmaceutical through its successful sale to BMS and AstraZeneca. Greg also brings decades of commercial leadership experience across a range of therapeutic areas, as well as experience in strategic transactions during his time at both Pfizer and UCB. As we rolled into 2021, CorMedix announced in January that it plans to transition to the Nasdaq platform, which we have said is a better fit with more of our biopharma peers, as well as more high-growth companies.

He has also demonstrated his strategic insight as chairman of family pharmaceutical through its successful sales to BMS and Astrazeneca.

Greg also brings decades of commercial leadership experience across a range of therapeutic areas as well as experienced in strategic transactions. During this time at both Pfizer and UCB.

As we rolled into 2021 cosmetics announced in January that we plan to transition to the NASDAQ platform, which we have said is a benefit with more of our biopharma peers as well as more high growth companies.

Just a few weeks ago, we announced that the U S food and drug administration, the FDA cannot approve the new drug application for defense Catharine its present fall.

Koso Baloch: Just a few weeks ago, we announced that the U.S. Food and Drug Administration, the FDA, cannot approve the new drug application for Defencap in its present form. FDA noted concerns at the third-party manufacturing facilities after a review of records requested by the FDA and provided by the manufacturing facility. All of the above took place during the pandemic, and while we were not pleased with the recent news, we were pleased that the FDA did not have any further questions about the efficacy and safety of defense caps.

FDA noted concerns at the third party manufacturing facilities. After a review of records requested by the FDA and provided by the manufacturing facility.

All of the above took place during the pandemic and while we were not pleased with the recent news. We were pleased that the FDA did not have any further questions about the efficacy and safety of different GAAP.

We outlined during our March nine call with investors that we will work with both the FDA and the contract manufacturing organization or CMO to resolve the deficiencies identified by the FDA.

Koso Baloch: We outlined during our March 9th call with investors that we will work with both the FDA and the Contract Manufacturing Organization, or CMO, to resolve the deficiencies identified by the FDA. Our plan, as we outlined, is to have a meeting in mid-April with the FDA to discuss the resolution plans with the FDA. Once we have the meeting with the FDA, we will provide further updates. In the meantime, we continue to use our time to focus our efforts on three fronts.

Our plan as we outline as to have a meeting mid April with the FDA and discuss the resolution plans with the FDA.

Once we have the meeting with the FDA, we will provide further updates.

Okay.

Now in the meantime, we continue to use our time to focus our efforts on three fronts.

First working with the CMO to result from third party manufacturing deficiencies and meeting with the FDA.

Koso Baloch: First, working with the CMO to resolve the third-party manufacturing deficiencies and meeting with the FDA. Second, continue to connect with the hemodialysis community and prepare CorMedix to successfully launch DefendCare when approved by the FDA. And thirdly, preparing the clinical study protocols for different cat label expansions so that in a post-approval setting, we will be able to start those studies in a timely manner. We are proceeding with these plans while conserving cash so that, financially, we have the resources required to successfully bring Defend Cash to patients in the U.S. market. Now, let's move to the first topic, a follow-up to the March 9th regulatory update we provided.

Second continue to connect with the hemodialysis community and prepare cosmetics to successfully launch different GAAP when approved by the FDA.

And thirdly preparing the clinical study protocols for different cash label expansions. So that in the post approval setting we would be able to start studies in a timely manner.

We are proceeding with these plants, while preserving cash so that financially we have the resources required to successfully bring defend catheter patients in the U S market.

Now, let's move to the first topic.

Follow up to the March 9th regulatory update we provided Phoebe.

Seabee.

Thank you so good afternoon everyone.

Phoebe Mounts: Thank you, Coso. Good afternoon, everyone.

Start with the all important timeline the timeline, we outlined on March 1st and reiterated on March 9th floor plans meeting with the FDA in mid April remains on track based on the progress we have made.

Phoebe Mounts: I will start with the all-important timeline. The timeline we outlined on March 1st and reiterated on March 9th for a planned meeting with the FDA in mid-April remains on track based on the progress we have made. We have been working intensely with our third-party manufacturing facility to develop proposed solutions to the deficiency. There has been a strong collaborative effort to develop responses for each of the six deficiencies identified by FDA for the manufacturing facility. In addition, we have developed a protocol for the manual extraction study being required by FDA to demonstrate that the labeled volume of the drug product can be consistently withdrawn from vials.

We have been working intensely with our third party manufacturing facility to develop the proposed resolutions to the deficiencies.

There has been a strong collaborative efforts develop responses for each of the six deficiencies identified by FDA for the manufacturing facility.

In addition, we have developed a protocol for manual extraction study being required by FDA to demonstrate that the labeled volume on the drug product can be consistently withdrawn from volume.

I am pleased to announce that FDA has granted our request to meet with them to begin resolving the outstanding deficiencies.

Phoebe Mounts: I am pleased to announce that FDA has granted our request to meet with them to begin resolving the outstanding deficiencies. As we have previously stated, the purpose of the meeting with FDA is to obtain agreement with the agency on the adequacy of our proposed plans for resolution of the deficiencies. Our contract manufacturing organization will join us in the meeting with FDA. As we planned, the meeting will occur in mid-April, and we will provide an update on our progress and timeline for resolution of the deficiencies after the meeting with FDA.

As we have previously stated the purpose of the meeting with the FDA is to obtain agreement with the agency on the adequacy of our proposed plans for resolution of the deficiencies.

Our contract manufacturing organizations will join us in the meeting with FDA.

As we planned the meeting will occur in mid April and we will provide an update on our progress and timeline for resolution of the deficiency after the meeting with FDA.

Our goal is to ensure that FDA can conclude that the manufacturing facility is ready to support commercial operation for defend cash without the need for non site inspections.

Phoebe Mounts: Our goal is to ensure that FDA can conclude that the manufacturing facility is ready to support commercial operations for DefendCaf without the need for an on-site inspection, as I have explained on previous calls. FDA identified the deficiencies based on a review of records that it had requested from the CMO. However, there was no on-site inspection due to travel restrictions in place because of the ongoing COVID-19 pandemic. The travel restrictions have resulted in an ever-increasing backlog of inspections at the agency.

As I have explained on previous calls F. D. A identified deficiencies based on a review of records that did had requested from the CMO.

There was no onsite inspection due to travel restrictions in place because of the ongoing COVID-19 pandemic.

The travel restrictions have resulted in an ever increasing backlog of inspections at the agency.

We are hopeful that FDA will continue to recognize the potential for venkat.

Phoebe Mounts: We are hopeful that FDA will continue to recognize the potential for defense care, to address an unmet medical need by reducing life-threatening catheter-related bloodstream infection, and complete the review of the manufacturing facility using the records review approach to approve the NDA as quickly as possible. Thank you, and I will now turn the call back to Matt to cover financial results and cash guidance.

To address an unmet medical need of reducing life threatening catheter related bloodstream infections and complete the review of the manufacturing facility using the records for value approach to approve the NDA as quickly as possible.

Thank you and I will now turn the call back to Matt to cover financial results and cash guidance net.

Matthew T. David: Thanks, Phoebe. I'm pleased to be here today to provide an overview of our fourth quarter and full year 2020 financial results, as well as an update on recent financing activities. The company has just filed its report on Form 10-K for the fourth quarter and year ended December 31, 2020. I urge you to read the information contained in the report for a more complete discussion of our financial results, with respect to our fourth quarter 2020 financial results.

Thanks, Phebe I am pleased to be here today to provide an overview of our fourth quarter and full year 2020 financial results as well as an update on our recent financing activity. The company has just filed its report on form 10-K for the fourth quarter and year ended December 31, 2020, I urge you.

To read the information contained in the report for a more complete discussion of our financial results.

With respect to our fourth quarter of 2020 financial results.

Our net loss was approximately $6 1 million or <unk> 19 per share compared with a loss of $5 3 million or <unk> 21 per share in the fourth quarter of 2019, the higher net loss recognized in 2020 compared with 2019 was due to increased expenses related to our preparations for.

Matthew T. David: Our net loss was approximately $6.1 million, or $0.19 per share, compared with a loss of $5.3 million, or $0.21 per share, in the fourth quarter of 2019. The higher net loss recognized in 2020, compared with 2019, was due to increased expenses related to our preparations for the FedCats commercial launch. We recorded increases in both SG&A as well as R&D expenses. Operating expenses in the fourth quarter of 2020 increased approximately 13% to $6.1 million compared with $5.4 million in the fourth quarter of 2019. R&D expense decreased by approximately 14% to 2.3 million, driven primarily by decreased spend on clinical trial costs and to a lesser extent by fewer manufacturing-related costs for the quarter.

Defend cats commercial launch we recorded increases in both SG&A as well as R&D expenses.

Operating expenses in the fourth quarter of 2020 increased approximately 13% to $6 1 million compared with $5 4 million in the fourth quarter of 2019.

R&D expense decreased by approximately 14% to $2 3 million driven primarily by decreased spend on clinical trial costs and to a lesser extent by fewer manufacturing related costs for the quarter.

SG&A expense increased approximately 41% to $3 8 million compared with $2 7 million in the fourth quarter of 2019. This increase was driven by increased costs related to market research and preparation for the potential approval defend caf and higher staffing costs due to additional hires.

Matthew T. David: SG&A expense increased approximately 41% to $3.8 million, compared with $2.7 million in the fourth quarter of 2019. This increase was driven by increased costs related to market research in preparation for the potential approval of FENCAS and higher staffing costs due to additional hires. We recorded net cash used in operations during the fourth quarter of 2020 of $5.9 million, primarily driven by increases in operating expenses due to higher SG&A expenses related to market research in preparation for the potential approval.

<unk>.

We reported net cash used in operations during the fourth quarter of 2020, a $5 9 million, primarily driven by increases in operating expenses due to higher SG&A expenses related to market research in preparation for the potential approval. This compares with net cash used in operations of $3 9 million we were.

Matthew T. David: This compares with net cash used in operations of $3.9 million we recorded in the fourth quarter of 2019, with respect to our full year 2020 financial results. Our net loss for 2020 was approximately $22 million, or $0.77 per share, compared with a net loss of $16.4 million before recognition of deemed dividends, or $0.68 per share, in 2019. The Higher Net Loss recognized in 2020 compared with 2019 was due to higher GNA costs as well as R&D costs.

Accordingly in the fourth quarter of 2019.

With respect to our full year 2020 financial results.

Our net loss for 2020 was approximately 22 million or <unk> 77 per share compared with a net loss of $16 4 million before recognition of deemed dividends or <unk> 68 per share in 2019.

The higher net loss.

Recognize.

In 2020, compared with 2019 was due to higher G&A costs as well as R&D costs.

Operating expenses in 2020 increased approximately 30% to $27 3 million compared with $20 9 million in 2019.

Matthew T. David: Operating expenses in 2020 increased approximately 30% to $27.3 million compared with $20.9 million in 2019. R&D expenses increased by approximately 21% to $13.4 million, driven primarily by increased costs related to raw material purchases that had to be expensed. However, increased personnel costs were offset by a reduction in clinical trial expenses related to the closing of the Lockett 100 clinical trial. SG&A expense increased approximately 41 percent to $13.9 million compared with $9.9 million in 2019.

R&D expense increased by approximately 21% to $13 4 million driven primarily by increased costs related to raw material purchases that has to be expense increased personnel costs offset by a reduction in clinical trial expenses related to the closing of the lock it 100 clinical trial.

SG&A expense increased approximately 41% to $13 9 million compared with $9 9 million in 2019. This increase was driven by higher staffing costs due to additional hires as well as increased costs related to market research in preparation for the potential approval of defend count.

Matthew T. David: This increase was driven by higher staffing costs due to additional hires as well as increased costs related to market research in preparation for the potential approval of defense. As we discussed on our March 9th investor call, CorMedix is in a strong position from a balance sheet perspective. Inclusive of our year-end cash and equivalents of $46.3 million and proceeds of $41.5 million from ATM issuance following the end of 2020, the company has pro forma cash and equivalents of $87.8 million as of December 31, 2020. We believe this gives the company flexibility to work through the manufacturing issues that have been described, continue to prepare for bringing DefendCat to market, and take CorMedix at least into the second half of 2020.

As we have discussed on our March 9th Investor call cosmetics is in a strong position from a balance sheet perspective.

Inclusive of our year end cash and equivalents of $46 3 million and proceeds of $41 5 million from ATM issuance. Following the end of 2020. The company has December 31, 2020 pro forma cash and equivalents of $87 8 million.

We believe this gives the company flexibility to work through the manufacturing issues that had been described continue to prepare for bringing defend cap the market and take chromatics at least into the second half of 2022.

While we are continuing to work through the identified manufacturing issues. We also intend to be active participants in several upcoming investor conferences as we continue to look to diversify the shareholder base and raise awareness among the investor community regarding <unk> and defend cash potential value proposition with that I would.

Koso Baloch: While we are continuing to work through the identified manufacturing issues, we also intend to be active participants in several upcoming investor conferences as we continue to look to diversify the shareholder base and raise awareness among the investor community regarding CorMedix and DefendCat's potential value proposition. With that, I would like to pass the floor back to Matt. Thank you, Matt.

I'd like to pass the floor back to coastal.

Thank you Matt.

Let me remind you that hemodialysis segment represents a significant market with a very large unmet medical need.

Koso Baloch: Let me remind you that the hemodialysis segment represents a significant market with a very large unmet medical need. Today, there is no pharmacological agent approved in the U.S. where patients urgently need an antimicrobial catheter lock solution for preventing CRBSI in central venous catheters. Defencap would be the first antimicrobial catalog solution approved by the FDA in the U.S., where deaths occur in as many as 35% of hemodialysis patients experiencing a CRBSI.

Today, there is no pharmacological agent approved in the U S. What patients urgently need an antimicrobial catheter lock solution from preventing a CRB assai in central venous catheters.

Defend cash would be the first antimicrobial catheter lock solution approved by the FDA in the U S where deaths occur in as many as 35% of hemodialysis patients experiencing a <unk>.

I believe that should defend cash be approved by the FDA, we can rapidly become the standard of care in the U S.

Koso Baloch: I believe that should DEFEND-CAS be approved by the FDA, it can rapidly become the standard of care in the U.S. To summarize, we continue to use this time to focus our efforts on three fronts: working with the CMO to resolve the third-party manufacturing deficiencies and meeting with the FDA. Second, continuing to connect with the hemodialysis community and prepare CorMedix to successfully launch DefendCast when it is approved by the FDA And thirdly, preparing the clinical study protocol for DefendCAT label expansion so that in the post-approval setting, we will be able to start those studies in a timely manner.

To summarize we continue to use the time to focus our efforts on three fronts.

Working with the CMO to resolve the third party manufacturing deficiencies and meeting with the FDA.

Second continuing to connect with the hemodialysis community and prepare core medics to successfully launch deferred cash when approved by the FDA.

And totally preparing the clinical study protocol to defend cash label expansion. So that in post approval setting we would be able to start the study in a timely manner.

Yeah.

A reminder, debt while we are initially focused on the hemodialysis market. We are determined to seek additional indications for defense cash use in central venous catheter oncology and total parental nutrition patients.

Koso Baloch: A reminder that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for different uses in central venous catheters, oncology, and total parental nutrition patients. We have had previous discussions with the FDA on the clinical trial design for use of Defend-Cal as a catalog solution in oncology and total parental nutrition patients. And I'm working to develop the protocols with the goal of finalizing the regulatory pathway for reducing cast-related bloodstream infections in these additional patient groups and executing on these plans on a post-approval basis.

We have had previous discussions with the FDA on the clinical trial design for use of deferred cash.

As a catheter lock solution in oncology and total parental nutrition patients.

And working to develop the protocols with the goal of finalizing the regulatory pathway for reducing catheter related bloodstream infections in these additional patient groups and executing on these plans on a post approval basis.

In conclusion, we remain confident that we have the right team and appropriate resources in place to resolve the third party manufacturing deficiencies that had been identified and bring defend cats to the hemodialysis patients from the U S.

Koso Baloch: In conclusion, we remain confident that we have the right team and appropriate resources in place to resolve the third-party manufacturing deficiencies that have been identified and bring defense cats to hemodialysis patients in the U.S. We expect to provide an update following the FDA meeting over the coming week. Thank you for your continued support of CorMedix. And with that, I will pass the floor back to the operator to open it up for questions. Stacey?

We expect to provide an update post the FDA meeting over the coming weeks.

Thank you for your continued support of core metrics.

And with this I will pass the floor back to the operator to open it up for questions Stacy.

At this time, we will be conducting a question and answer session. If you would like to ask a question. Please press star one on your telephone keypad a confirmation total indicate your line is in the question queue. You May Press Star two if you would like to remove your question from the queue.

Operator: At this time, we will be conducting a question and answer session. If you would like to ask a question, please press star 1 on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star 2 if you would like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys.

Our first question comes from Jason Butler with JMP Securities. Please go ahead.

Jason Nicholas Butler: Our first question comes from Jason Butler with JMP Securities. Please go ahead. Hi, thanks for taking the questions. First one on the FDA meeting, obviously, you said the goal of the meeting is to gain alignment with FDA on the resolution plans, but just wondering if you will actually have any of the work requested by FDA completed by the meeting, either in terms of documentation protocols or the volume study or airflow visualization studies that they asked for, will you've actually completed any or have any new data to take to the meeting? Thank you, Jason.

Hi, Thanks for taking the questions.

First one on the FDA meeting obviously, you said the goal of the meeting is to gain alignment with FDA on the resolution plans, but just wondering if you will actually have any of the work requested by FDA completed by the meeting either in terms of documentation protocols or the the vial fill volume.

Saudi or air flow visualization studies, but they they asked for will you've actually completed any or have any new data to take to the meeting.

Hum.

No.

Sure. Thank you, Jason let me pass the floor to Phoebe.

Koso Baloch: Thank you, Jason. Now, let me pass the floor to Phoebe.

[laughter]. Thank you for the question, Jason as you know when you request a meeting with FDA you have to put a background package together and justified to the agency that it's appropriate for them to grant our request based on time and information available. They don't want to meet with you it's premature.

Phoebe Mounts: Thank you for the question, Jason. As you know, when you request a meeting with FDA, you have to put a background package together and justify to the agency that it's appropriate for them to grant the request based on time and information available. They don't want to meet with you if it's premature.

Sure. So yes, we obviously were involved in developing the proposed responses some of those proposed responses involved.

Phoebe Mounts: So yes, we obviously were involved in developing the proposed responses. Some of those proposed responses involved existing documentation, and we made sure that where we could, we provided information that was responsive to the deficiency. So there is new information there for them to review for some of the responses. Great.

Listing documentation and we make sure that we where we could we provided information that was responsive to the deficiency. So.

There is new information there for them to review from some of the responses.

Great and then just one more clarification question on that on the complete response letter. There you mentioned that there was a couple of questions related to equipment that was not relevant to defend cash is it still your view that those parts of the C. Our LR are for equipment not relevant to defend cash.

Jason Nicholas Butler: And then just one more clarification question on that, in the complete response letter there. You mentioned that there were a couple of questions related to equipment that was not relevant to DEFENDCAT. Is it still your view that those parts of the CRL are for equipment not relevant to DEFENDCAT? Yes, Jason, the issue was planned expansion at the manufacturing facility which involved installation of new equipment.

Maybe yes.

Yes, Jason the issue was planned expansion at the manufacturing facility, which involved the installation of new equipment.

That is new equipment not intended for manufacture of defend caps. So the information that has been used and is in places is the appropriate equipment per defend counts manufacturer.

Phoebe Mounts: That is new equipment not intended for the manufacture of DEFEND-CALS. So the information that has been used and is in place is the appropriate equipment for DEFEND-CALS manufacture. Okay, great. And then, just last one for me in terms of the development plans for additional indications or use settings. Any color you can provide at this point on the scope of those development programs specifically, you know, do you think you need, you know, phase three efficacy and safety studies or could there be other potentially more rapid strategies to get those additional indications added to the label? Phoebe.

Okay, Great and then just last one from me in terms of the development plans for additional indications or are you settings.

Any color you can provide at this point on the scope of those development programs. Specifically you know do you think you need you know phase III efficacy and safety studies or could there be other potentially more rapid strat.

Strategies to get these additional indications added to the label.

Phoebe.

E. As you can imagine there's our issues that need to be discussed with FDA before anyone starts to trial you want to make sure that the agencies on board with the.

Jason Nicholas Butler: As you can imagine, those are issues that need to be discussed with FDA before anyone starts a trial. You want to make sure that the agency is on board with the way you intend to conduct the study and gather the data. So we will obviously meet with FDA at the appropriate time and talk to them. But our plan is to do it in a post-approval setting after the NDA has been approved for use in hemodialysis patients.

The way you intend to conduct the study and gather the data. So we will obviously meet with FDA at the appropriate time and talk to them and them. Our plan is to do it in the post approval setting after the NDA has been approved for use in hemodialysis patients.

So the expectation would be that we're doing it in a post approval setting.

Jason Nicholas Butler: So the expectation would be that we're doing it in a post-approval setting, and we would not be doing a phase three trial, but that the effectiveness of Defend-Cast for reducing catheter-related bloodstream infections in a catheter in a hemodialysis patient should be relatable to the use of a central venous catheter in other patient populations.

And we would not be doing a phase III trial, but that's the effectiveness of defend counts for reducing catheter related bloodstream infections in accounts that are in hemodialysis patients should be related to use of a central venous catheter in other patient populations and we would.

Koso Baloch: And we would argue that the proper focus should be on safety. Okay, great. Very helpful. Thanks for taking the time to answer the question. You're welcome. Thank you. Next question, Joon Lee with Truist Securities, please go ahead. Hi, thanks for taking our questions. I have a few. Has anyone reached out to discuss, you know, a potential acquisition of the company? I mean, if Defendcast is as good as it looks on paper, and if the CMC issues are as remediable as you say they are, wouldn't some obvious players make an offer to the company? Just curious if you can make any comments there, and I'll follow up.

Arguing that the proper focus should be on safety.

Okay, great very helpful. Thanks for taking the questions.

Youre welcome. Thank you.

Next question Joon Lee with Truest Securities. Please go ahead.

Hi, Thanks for taking our questions.

That's a few has anyone reached out to discuss.

The acquisition of the company I mean, if they think cash is as good as it looks on paper and if the CMC issues are as <unk> as you see they are winning some obvious players make an offer from a company. Just curious if you can make any comments there and I have follow ups.

Thanks Joan.

This is at the moment not the right forum or time to discuss that topic should there be any information that is material, we would clearly update the market.

Joon So Lee: Thanks Joon. You know, this is not the right forum or time to discuss that topic now. Should there be any information that is material, we would clearly update the market when and where appropriate.

When and where appropriate.

Okay fair enough.

Joon So Lee: And then, as you know, you mentioned that you are working closely with the CMO to address the deficiency of the third-party manufacturer. You know, so the impression is that it was their fault. So what are you, why do you need to be involved in addressing their issues? You know, what is it that you can contribute to the CMO's deficiency?

And then as you you know you mentioned that you were working closely with the CMO to adjusted deficiency of the third party manufacturer.

So the impression is that it was their deficiencies. So what are what are you why do you need to be involved in addressing their issues.

What is it that you can contribute to the cmo's deficiencies.

Thanks, Joan Phebe.

Joon So Lee: Thanks, Jude. Phoebe? Thanks, Joon.

Thanksgiving that that's a good question I think folks don't understand that there's a parallel process here.

Phoebe Mounts: Thanks, Joon. That's a good question. I think folks don't understand that there's a parallel process here. As you noted, we have direct control over documentation and information on manufacturing that's submitted directly to the new drug application. As part of that process, FDA inspects the manufacturing facility and reviews documentation and the facility for its ability to manufacture that product in a commercial setting. So the inspection by FDA, whether it's by a records assessment or an on-site inspection, involves reviewing manufacturing records for the product in the NDA, but it also goes further than that. It goes to the actual facility, the equipment, the maintenance, the training, and the personnel.

As you noted we have direct control over.

Argumentation and information on manufacturing not submitted directly to the new drug application.

As part of that process.

FDA inspected the manufacturing facility and reviews documentation and the facility for its ability to manufacture that product in a commercial setting.

So the inspection by FDA, whether it's by our records assessment tool or an onsite inspection.

Involves reviewing manufacturing records for the product in the NDA, but it also goes broader than that it goes to the actual facility and the equipment and the maintenance and the training and personnel.

So it's a parallel process, but obviously they are.

Phoebe Mounts: So it's a parallel process, but obviously they are intertwined and can't be separated because FDA is there to look at the potential for that facility to manufacture the product that's the subject of the NDA. And the last question is, at the meeting with the FDA in mid-April, will there be a determination as to whether a site visit will be needed or not, and is it still the case that the site visits are unlikely to occur within the next 12 months due to various restrictions? And if that determination is made during the meeting, how quickly would you be able to share that with the street? Thank you.

Intertwined and can't be separated them because FDA there to look at the potential for that facility to manufacture the product that's the subject of the NDA got.

Got it thanks for the clarification and the last question is at the at the meeting with the FDA in mid April Bill there would be a determination as to whether a site visit will be needed or not.

And is it is this still the case that the site visits are unlikely to occur within the next 12 months due to various restrictions and if that determination is made during the meeting them how quickly would you be able to share.

Share that with the street.

Yes.

Okay.

Phoebe.

So obviously, that's one of the topics for discussion with FDA.

Phoebe Mounts: So, obviously, that's one of the topics for discussion with FDA. And we obviously, as I said in my comments, would like the FDA to continue its records assessment and determine that it doesn't need to do an on-site inspection. We'll know after the meeting; I doubt that FDA will give us a definitive answer, but we'll certainly know if that remains a possibility. And, as you noted and as I said, there is a backlog of companies waiting for on-site inspections because of the travel restrictions, and it's not clear without a discussion with FDA and having more information available as to the timing of when that inspection would take place. But, again, that line of communication is between FDA and the manufacturing facility. And I think implicit in this discussion is that this is not a unique issue for CorMedix, that this is an industry-wide problem.

We obviously as I said in my comments.

I would like the F D. A to continue its records assessments and determined that it doesn't need to do an onsite inspection.

We'll know after the meeting I couch that FDA will give us a definitive answer, but we'll certainly knows that remains a possibility.

And as you noted are there and as I said, there is a backlog of companies waiting for onsite inspections because of the travel restrictions.

And it's not clear without discussion with FDA and having more information available. That's just the timing of when that inspection would take place, but again that line of communication is between F. D. A manufacturing facility and I think implicit in this discussion.

Is that this is not a unique.

Issue for kinetics that this is an industry wide problem and I think there. It's clear that is then the G. A L who stepped in and asked F. D. A per our plan for resolving the backlog.

Phoebe Mounts: And I think it's clear that the GAO has stepped in and asked FDA for a plan for resolving the backlog. And so I think it's incumbent upon industry and FDA to figure out how to get through this backlog as fast as possible so that patients aren't denied products that can save their lives.

And so I think it's incumbent upon industry and F D. A to figure out how to get through this backlog as fast as possible. So that patients aren't denied products that can save their lives.

Got it so just to clarify if I understood this correctly.

Joon So Lee: So just to clarify, you know, if I understand this correctly, is it the case that you will be able to share the update with the street right after the meeting or will you be waiting for the minutes, which should take several weeks? Or will you not be able to disclose the contents of the meeting because that is actually a communication between the FDA and the CMS? Which one is it?

Is it the case that you will be able to able to you'll be able to share the update with the street.

After the meeting or will you be waiting for the minutes, which could take several weeks.

Or is it the case that you won't be able to disclose the contents of the meeting debt because that is actually a communication between the FDA and the CMO.

Which one is I wasn't clear what the.

Phoebe Mounts: I wasn't clear. It's a simple answer, Jan. We'll be providing an update after we meet with FDA. Okay, thank you. Looking forward to the update. Next question, Chad Messer with Needham and Company. Please go ahead. Great.

It's a simple answer again, we'll be providing an update after we meet with FDA.

Okay. Thank you looking for something.

Next question, Chad Messer with Needham and company. Please go ahead.

Great. Thanks for taking my question.

Chad Messer: Thanks for taking my question. We've covered a lot of ground on this in previous calls, but just wondering what additional details you may be able to share with us for timing, assuming we do have a positive outcome. And we are looking at the potential label expansion into oncology and parental nutrition indications. What might that look like in an ideal situation? in terms of getting information back to us.

We've covered we've covered a lot of ground on this in previous calls, but just just wondering what additional.

Details you may be able to share with us in terms of expectations for timing.

Assuming we do have a positive outcome.

Here and.

And we are looking at potential label expansion.

Into the oncology and parental nutrition.

Indications.

What might that look like.

In an ideal situation.

In terms of getting information back to us.

So Chad I think you've got two parts to your question on the first part is what other color will we be able to provide in terms of timing or.

Koso Baloch: So, Chad, I think you've got two parts to your question. The first part is, what other color will we be able to provide in terms of the timing of our current situation? And then about label expansion. So let me start, and Phoebe, then you can add into what, add any other components to it.

Current situation and then about label expansion. So let me start and Phoebe then you can add into what at any other components to it but like we said after we've met with the FDA in mid April we will provide an update to the strength of the best.

Koso Baloch: But like we said, after we meet with the FDA in mid-April, we will provide an update to the street, the best update we can provide based on the meeting that we have with the FDA and the clarity we've got as to the plan we've got for our resolution. And as Phoebe outlined, once we have the NDA approved for hemodialysis, we will be sitting down with the FDA to finalize the protocol that we are working on right now.

Update we can provide based on the meeting that we have would be a day on the clarity we've got as to the plan We've got board resolution.

And as Phebe outlined you know once we have the NDA approved for hemodialysis, we will be sitting down with the FDA to finalize the protocol that we are working on right now and assuming we have got alignment with the FDA on debt protocol. We will then provide another update to the market in terms of what.

Koso Baloch: And assuming we've got alignment with the FDA on that protocol, we will then provide another update to the market in terms of what the timing and what the study will look like. But it's too early right now to speculate, because there can be a variety of different outcomes. So I wouldn't want, at the moment, to speculate. Phoebe? I think you covered it. Thank you.

The timing and what the study will look like but it's too early right now to speculate because it can be a variety of different outcomes. So I wouldn't want to at the moment to speculate phebe.

I think you've covered it thank you.

Great. Thank you.

Andrew DaSilva: Great, thank you. Next question, Andrew DaSilva, from B. Reilly & Company, please go ahead. Yeah, good afternoon. Thanks for taking my questions. I've got a few quick ones.

Next question Andrew to silver at B Riley and company. Please go ahead.

Hey, Yeah. Good afternoon. Thanks for taking my questions I've got a few quick ones.

Phebe, just you noticed or you noted actually back.

Phoebe Mounts: Phoebe, just, you noticed, or you noted actually that a lot of the CRLs or CRL-related activity in the market is maybe more of a factor related to macro pandemic-related issues with the FDA and their ability to travel. I was curious, did that also relate to the manual extraction study and the airflow visualization study, or those items that don't really fall under the aspect of them needing to travel to actually look at stuff? Well, you've mixed up two issues there, Andy.

That a lot of the <unk> or share all delayed activity in the market has made more of a factor related.

Related to two macro pandemic related issues.

D and their ability to travel.

I'm curious does that also relate to the manual extraction study and the airflow visualization study are those.

Items that.

Don't really fall under the the aspect of them needing to travel to actually look at stuff.

Yeah.

Well you mixed two issues there Andy the first one the cash flow dynamics.

Phoebe Mounts: The first one, the airflow dynamic, comes from information provided from the manufacturing facility to FDA as part of the records assessment. And so that is information they would ordinarily include in an on-site inspection. The manual extraction study came in the CRL to us, so remember very early on March 1st. We said that we were not aware of what the deficiencies were in the records assessment for the manufacturing facility were because that was information that went directly to the manufacturing facility. But the manual extraction study came to us in the CRL letter, in the complete response letter, sorry. So that is something that was not involved in the main assessment of the manufacturing facility.

Comes from information provided from the manufacturing facility to F. D. A as part of the records assessment.

And so.

Yeah. It is information they would ordinarily.

Got it.

Include in an onsite inspection.

Manual extraction study came in to the C. R L to us so remember.

Very early on March 1st.

We said that we were not aware of what the deficiencies were in our records assessment for the manufacturing facility because that was information that went directly to the manufacturing facility.

But the man, who extraction study came to us and let's see her held later and the complete response letter sorry. So that is something that was not involved in the assessment of the damage that factoring facility.

So it would theoretically even if the pandemic wasn't going on that that deficiency still would've wanted a C. O L. It was my understanding that correctly.

Phoebe Mounts: So it would be theoretically even.

Andrew DaSilva: And, basically, even if the pandemic wasn't going on, that deficiency still would have warranted a CRL. Am I understanding that correctly?

That's something you'd have to ask LTA I can't answer that question for you.

Phoebe Mounts: That's something you'd have to ask FDA. I can't answer that question for you. Okay. Um, and then.

Okay.

And then okay.

I remember last time.

Andrew DaSilva: I remember last time, when you had your call, we were talking about Class I or Class II submissions, and I was curious since the majority of this is actually non-efficacy related. I remember reading something about, at least with supplements, that if it's non-efficacy related, it doesn't even fall into class 1 or class 2. Do you know if that's applicable in this situation, or is this definitely, because it's an NDA, going to be a class 1 or class 2 resubmission system?

When you had your call we were talking about class, one or class two submissions.

And I was curious if the majority of this is actually a non efficacy related.

I remember reading something about.

At least with supplements that if it's not enough accumulated isn't even following the class one or class. Two do you do you know if that's applicable in this situation.

Or is this definitely because it's an NDA can be a class one or class two.

Submission.

Extinction.

Andrew DaSilva: Timing is clearly a critical issue in this process, and that's a topic for discussion with FDA. So hopefully, we'll have more insight after the meeting in mid-April. Okay, so procedurally, you don't know if this could actually even fall outside of class 1 or class 2 and just have kind of its own category for non-ethical. It's worthy of discussion with FDA.

But timing is clearly a critical issue and in this process and that's a topic for discussion with FDA. So hopefully we'll have more insights after the meeting in mid April.

Okay.

Procedurally you don't know if if this could actually even fall outside of our and and and.

And not outside of class one class two and just help us kind of.

One category for non efficacy.

It is worthy of discussion with FDA.

Okay and just last question from me a couple of quick bookkeeping can you, let us know since you're not really working on any commercialization activity.

Phoebe Mounts: Okay. And just last questions for me, a couple of quick bookkeeping questions. Can you let us know, since, you know, you're not really working on any commercialization activity, how we should think about OPEX in the first quarter, in the fourth quarter, a good representation of what the first quarter would look like. And then with the tax credit, I think over the last couple of years, it's been split between the first and second quarter. Should we model that in for the first quarter or the second quarter? Thanks.

Do you think about Opex in the first.

First quarter.

In the fourth quarter, a good representation of what the first quarter. It looked like and then with the tax credit.

Over the last couple of years, it's been split between the first and second quarter should we model that in for the first quarter or the second one thank you.

Hi, Andy Matt would you take those two questions.

Andrew DaSilva: Thanks, Andy. Matt, would you take those two questions?

Sure I'm happy to thanks, Andy for the question I think for your first question.

Matthew T. David: Sure, I'm happy to. Thanks, Andy, for the question. I think for your first question about some guidance, we're not giving you guidance, but I think that you can look to the fourth quarter as you indicated as reasonable for going forward, at least for the near term. You know, like, likely come in below that as a target, but I think it's a reasonable assumption.

About some guidance, we're not giving guidance, but I think that you can look to the fourth quarter as you indicated as reasonable forgoing.

If we're going forward at least for the near term.

You know like likely come in below that as a target, but I think it's a reasonable assumption.

Okay in terms of operating expenses.

Matthew T. David: Okay, in terms of operating expenses, I think moving on to your second question about the tax credit, I think we stated in the press release that we expect that to close in the second quarter. Okay, perfect. Thank you for the color. Best of luck going forward and good luck in your meeting as well. Thank you. Thank you.

I think moving onto your second question about the tax credit I think we stated in our press release that we expect that to close in the second quarter.

Okay perfect. Thank you for the color best of luck going forward and good luck in your meeting as well.

Thank you Kenny.

Thank you I will now turn the call over to Dan Ferry for additional questions received from the audience.

Daniel Ferry: I will now turn the call over to Dan Ferry for additional questions received from the audience. Thanks, Coso. Thanks, Operator. Coso, we have some... At least we have one additional question from the audience here. It is directed to you, Koso. Are you expecting any changes to the management team? Any additional hires needed to fix the current situation?

Thanks, Joe So thanks, operator coast. So we have some.

Or at least we have one additional question from the audience here. It is directed to you co. So how are you.

Expecting any changes to the management team.

The additional hires needed to fix the current situation.

Koso Baloch: Thanks, Dan. I do not see any need for additions or changes to the management team to address the current situation. The management team is very experienced, and as I've said during the prepared remarks, CorMedix, in conjunction with our CMO, is working to develop the information needed to be submitted to the FDA. So we're very confident with the team and the experience that they have, so no additions are planned or expected.

Thanks, Dan.

I do not see any need for additions or changes to the management team to address the current situation. The management team is very experienced and as I've said during the prepared remarks our.

Core metrics in conjunction with our CMO is working to develop the information needed to be submitted to the FDA. So we're very confident.

With the team and the.

The experience that they have got so no additions are planned or expected.

Okay. Thank you so I'll turn it back over to you for closing remarks.

Daniel Ferry: Okay, thank you, Koso. I'll turn it back over to you for closing remarks.

Koso Baloch: That question, which we just had, sort of touches on some of my closing remarks, and that is, you know, CorMedix has an experienced team of executives who have taken pharmaceuticals through the various phases of clinical studies, registration, and successfully launched products in the U.S. market. As we've stated previously, CorMedix remains committed to bringing DefendCat to the U.S. market, whether on our own or with a strategic or commercial partner to help patients in need of protection from life-threatening infections. The importance of reducing the incidence of infections and keeping patients out of hospitals is even more apparent during this ongoing coronavirus pandemic. So, thank you once again for your time and attention, and have a good evening.

Thank you Dan.

Yeah.

That question, we just had sort of touches on some of my closing remarks and that is format ex has an experienced team of executives what they can pharmaceutical through the various phases of clinical studies registration and successfully launch products in the U S market.

As we've stated previously cosmetics remains committed to bringing defend capture the U S market, whether on it on our own or with a strategic or commercial partner 12 patients in need of protecting from life threatening infections and the importance of reducing the incidence of infections and keeping patients out of hospitals, even more apparent.

During this ongoing coronavirus pandemic.

So thank you once again from the time and attention and have a good evening.

This concludes today's conference you may disconnect your lines at this time and thank you for your participation.

Operator: This concludes today's conference. You may disconnect your lines at this time, and thank you for your participation.

Okay.

Yeah.

Okay.

Yeah.

Yeah.

Yeah.