Q2 2020 CorMedix Inc Earnings Call

News in projected costs.

Unknown Executive: project the cost and potential market acceptance of Defencaf, 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 positions, expectations as to the timing and nature of anticipated regulatory action, possible product licensing, business development, or other transactions. Any commercial plans and expectations? market projections for our audit 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 in CorMedix's filings with the SEC. Copies of which are available free of charge on the FCC's website at www.fcc.gov or upon request from CorMedix.

And 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 timing.

Cost results and interpretations thereof.

Rejections has to the company's future capital raising and spending cash position.

Expectations as to the timing in 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 were estimates due to a variety of important factors, including but not limited to uncertain uncertainties related to do clinical development.

Regulatory approvals and commercialization.

These risks are described in greater detail in Cormedix filings with the SEC.

These which are available free of charge at the Fccs website, Www Dot FCC dot Gov.

Or upon request from Cormedix.

Unknown Executive: 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 Koso Baloch, Chief Executive Officer of CorMedix. Koso, please go ahead.

Cormedix may not actually achieved the goals are plants described in these forward looking statements.

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 is now my pleasure to turn the call over to Coso below.

Chief Executive Officer of core Medix COSA. Please go ahead.

Thank you Dan.

Koso Baloch: Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's call, we will discuss several topics, including the overall progress CorMedix is making in bringing Dufencaf to the U.S. market for its first indication for use as a catheter-locked solution for hemodialysis patients to prevent catheter-related bloodstream infections with subsequent expansion into other indications. Joining me on this call are Phoebe and Matt.

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

On today's earnings call. We've got several topics with you on the overall progress Paul maybe making in bringing depend cast the U.S. market for its first indication for use as the capital walk solution for hemodialysis patients.

Prevent catheter related bloodstream infections.

I didn't expansion into other indications.

Joining me on this call our CVN Matt.

The three topics I will cover Paul in the regulatory financing and promotional area.

Koso Baloch: The three topics I will cover fall in the regulatory, financing, and commercial areas. First, as we disclosed several weeks ago, I am very pleased that the submission to the FDA of the new drug application, or NDA, for DefendCat was completed in June. This submission was completed using the rolling submission format approved by the FDA, which we started in March.

As we disclosed several weeks ago I'm very pleased at the submission to the FDA or the new drug application or NDN will defend cap was completed in June.

This submission was completed using the rolling submission format.

Granted by the FDA.

Which we started in March.

Competing this filing with the major undertaking as a team had to work through the chemistry manufacturing and control information CMC.

Koso Baloch: Completing this filing was a major undertaking as the team had to work through the Chemistry, Manufacturing, and Control Information, CMC, and a large volume of data generated due to the size of the LOCKIT 100 trials and the underlying health issues of the hemodialysis patient group. This was the first NDA submitted by CorMedix, and our goals are obviously to secure acceptance for filing of the NDA submission and then to obtain NDA approval from the FDA. I'm proud of the team at CorMedix for bringing their collective experience to bear and completing a high-quality submission. Phoebe will provide more color during this call.

And a large volume of data generated due to the size of block at 100 trial and the underlying health issues of the hemodialysis patients who.

This was the first endeared committed by commenting.

And our goal obviously after securing acceptance for filing of the engineered submission and then two octane and de approval from the FDA.

I'm proud to team at coal meeting for bringing the collective experience to bear and completing a high quality submission.

PB will provide more color during this call.

We're also pleased to have recently completed an equity financing consisting of 23 million in gross proceeds.

Koso Baloch: We're also pleased to have recently completed an equity financing consisting of $23 million in gross proceeds, including a full execution of the Green Shield. The proceeds from this financing provide CorMedix with the cash needed to continue the preparation required to launch PENCAS into the U.S. hemodialysis market following approval from the FDA. CorMedix is appreciative of the effort from the team handling the financing and the opportunity to continue broadening our banking relationship. We were also... New Life Science focused investors became shareholders as part of this transaction. We believe that completing institutional financing, bringing in life science-focused investors, and expanding our relationship with investment banking firms will serve to further strengthen CorMedix's appeal to a broader audience of institutional investors.

Including a full execution of the green shoe.

The proceeds from this financing provide cormedix the cash needed to continue the preparation required to launch the pent up into the UN hemodialysis market following approval from the FDA yet.

Core mitigated appreciative of the effort from the team handling the financing and the opportunity to continue broadening our banking relationships.

We were also pleased to see new life science focus investors become shareholders as part of this transaction.

We believe that completing an institutional finance, bringing in life science focused investor and expanding our relationship with investment banking firms, let's turn to further strengthen cosmetics appeal for broader audience of institutional finance investors.

During this call Matt will share more details about the goals set out to achieve with this financing and additional details of what we have accomplished.

Koso Baloch: During this call, Matt will share more details about the goals we set out to achieve with this financing and additional details of what we have accomplished. I'd also like to provide an update on several work efforts that are moving forward with the goal of being prepared when we receive NDA approval so that Defend cats can be launched into the U.S. hemodialysis market as soon as possible. In terms of market preparation, the team has been working on understanding the defend cap product, characteristics that best draw the attention of FAERS, large dialysis organizations, LDOs, and healthcare professionals. Extensive primary market research, and qualitative testing have been completed, and the value proposition for Defend-CAT is now being finalized for quantitative tests. The team has also defined the effort to properly size the Salesforce Market Access Organization that will be required to best address the targeted LDOs, healthcare professionals, and payer markets. This effort continues and will identify the national and regional accounts that CorMedix will target for the greatest return. The Market Access team has been working with external payers to build a budgeting model that best addresses our respective needs. This outreach is ongoing with many dialogues.

I'd also like provide an update on several work efforts that are moving forward with the goal of be prepared when will we see MD approval. So that the finca can be launch into the U.S. hemo dialysis market as soon as possible.

In terms of market preparation the team has been working on understanding depend cap product.

Characteristics that best probably intentional failed largely dialysis organization LDL and healthcare professionals.

Extensive primary market research and qualitative testing has been completed and the value proposition for defend cat now being finalized the quantitative testing.

The team has also defined the efforts to properly sized the salesforce market access organization that we'd be required to best compressed targeted LDL healthcare professional and payer market.

This effort continues and we'll identify the national and regional accounts that cosmetics, one target for the greatest returns.

The market access team has been working with external payers to build the budgeting modeled at best address August active needs.

This.

Outreach ongoing with many guide service provider, both healthcare providers and payers.

Koso Baloch: providers, both healthcare providers and patients. That is why we're so excited about the opportunity to bring our data to the Center of Medicare and Medicaid Services, CMS, which pays for the health care costs for the majority of patients who are receiving hemodialysis. CMS pays for a significant amount of the cost of hemodialysis under its Basic Reimbursement Program for End-Stage Renal Disease Patients, referred to as the BUNDRA. A fixed dollar reimbursement arrangement which has historically acted as an unfortunate impediment to the adoption of new technologies and better case strategies for patients undergoing hemodialysis. However, in recognition of this issue, CMS,

That is why we're so excited about the opportunity to bring our data center of Medicare and Medicaid services, CMS, which faced a healthcare costs for the majority of patients was it's we think hemodialysis.

CMS paper significant amount of the cost of hemodialysis under its basically reimbursement program for end stage renal disease patients referred to as bundle.

A fixed dollar reimbursement arrangement, which has historically acting as an unfortunate impediments to the adoption of new technology and better care strategy for patients undergoing hemodialysis.

However in recognition of with issue CMS now has the relatively new program to accelerate the adoption of new treatments that can both improve patient care and or reduce the cost of treating end stage renal disease patients. This program is called two data.

Koso Baloch: The Center now has a relatively new program to accelerate the adoption of new treatments that can both improve patient care and reduce the cost of treating end-stage renal disease patients. This program is called TDAP, which stands for Transitional Drug Add-On Payment Adjustment, which allows for reimbursement of a new technology outside the bundle while the necessary utilization data are collected to determine how best to permanently incorporate the cost of these products into the CMS reimbursement regime. Now that the NDA is submitted, CorMedix will continue interacting with CMS to further our discussions about defense cast inclusion in the TDAPA program. The official application requesting to be added to DDAPA can only occur after FDA approval of the application. CorMedix is also focused on its goal of becoming a contributing member of several key patient healthcare provider advocacy organizations focused on kidney care. The first one of them.

Which stands for transition drug add on payment adjustment.

Which allows for reimbursement of a new technology outside the bundle wasnt necessarily utilization data collected to determine how best to permanently incorporate the cost of these products in the CMBS CMS reimbursement Blue gene.

Now that NDS submitted core Medix will continue interacting with CMS to further discussions about the same cache inclusion into the teed up a program.

The official application requesting to be added to do gap up can only occur after the FDA approval of the India.

Core medical also focused on his goal of becoming a contribution member of several key patient health care providers advocacy organization focused on kidney care.

The first one of.

The group that we are.

Koso Baloch: The group that we are working with is called KCP, which stands for Kidney Care Partners, which is a National Nonprofit Alliance of Patient Advocates. Healthcare professionals, and providers, and managers seeking to develop community-wide policy positions in an effort to ensure strong and unified advocacy on capital health and with federal agencies, including kidney-related issues. The second one is GPC, which stands for Dialysis Patients to Distance, which is a non-profit, patient-led membership organization founded in April 2004 by end-stage renal disease patients who saw the need for an organization focused on advocacy and education for dialysis patients and their families. The effort will focus on sponsoring patient ambassadors who are dialysis patients who advocate for the needs of dialysis patients with their legislators, both at the federal level in Congress and at the state legislative level, for including new drugs, devices, and services. The third organization is ANNA, which stands for American Nephrology Nurses Association, which is a non-profit organization established in 1969 that has a membership of about 8,500 nephrology nurses

Focus with this call case compete which stands for kidney care partner.

Which is a national nonprofit alignment of patient advocate health care professionals.

And provide unmanned seeking to develop community by policy position in an effort to ensure a strong and unified advocacy on Capitol Hill, and with federal agencies, including kidney related issues.

The second one GPC, which stands for adult patients citizens, which is a nonprofit patient led membership organization founded April 2004 by end stage renal disease patients who saw the need for an organization focused on efficacy and education for doubt patients and their families.

Yes, it will focus on sponsoring patient ambassadors, who are dollar order patients who advocate for the need of dialysis patients with alleges latest both at the federal level in Congress and has eight legislative level, four including new products devices and services.

And the third organization with Hana with staff, Merck Prologis Nurses Association, which you can nonprofit organization establishing 1969.

That has a membership about equal have thousands nephrology nurses.

Members include registered nurses and other healthcare professionals.

Koso Baloch: Members include registered nurses and other healthcare professionals with their experiences and expertise in hemodialysis, home therapy, chronic kidney disease, continual renal replacement therapy, acute care, and transplantation. CorMedix will continue to push ahead in preparation for the commercialization of DefendCAF by reaching out to all the important stakeholders in the hemodialysis market to ensure that once DefendCAF is approved by the FDA, it will be in the best possible position to successfully launch in the U.S. market. With that in mind, now, let me move to the second topic, which is the regulatory update.

Specials with very expensive Nx 30 in hemodialysis home therapy chronic kidney disease.

Tuniu renal replacement therapy acute care and transportation.

Core metrics will continue to push ahead in preparation for the commercialization of the 10 cap by reaching out all the important stake holders in the heat models market to ensure that wants to defend cap is approved by the FDA. It would be in the best possible position to successfully launched in the us markets.

With that let me move the tailored to the second topic, which is the regulatory update feeding.

Phoebe: Phoebe?

Thank you cut though.

Phoebe: Thank you, Kuzco. It is a pleasure to be here again to report on our continuing efforts to bring DefendCaf to the U.S. market and address the continuing need to reduce catheter-related bloodstream infections. As we previously announced, we have requested and been granted by FDA a rolling submission and review of the modules for the new drug application, which is intended to expedite the review process for new products intended to address an unmet medical need. The rolling submission was started in March and completed in June. Consistent with the rolling submission and review process, FDA began an ongoing dialogue with us on the submission as it was in progress. As noted by Toto, we are very grateful for the effort of the CorMedix team in preparing the high-quality submission.

It is probably going to be here again report on our continuing effort to bring defend cap to the us market and address the continuing need to reduce catheter related bloodstream infections.

As we previously announced we had requested in granted by asking a rolling submission and review the modules to the new drug application, which is intended to expedite review process for new product intended to address an unmet medical need.

The Rolling submission was started in March in completed in June.

Consistent with the rolling submission and review process.

Yeah on an ongoing dialogue with upon the submission as it was in progress.

As noted like that so we're very grateful for the effort with the Cormedix team in preparing for high quality submission.

Now that the submission of modules is completed.

Phoebe: Now that the submission of modules is complete, the FDA has 60 days from the date of submission of the final module to review the submission and decide if it is sufficiently complete and in the correct electronic format for substantive review. If the FDA finds the submission complete, it will be accepted for filing. If it is not complete, we will need to provide the missing information and resubmit the NDA. In the submission, we also requested priority review of the NDA. As we previously reported,

FDA has 60 days from the data submission of the fine module to review the submission and decide for this sufficiently complete and in the correct electronic format for Substantives review.

The FDA fine missing complete.

It will be accepted for filing.

Instead is not simply we will need to provide missing information and resubmit San Diego.

In this image.

We also requested priority review of the India.

As we previously reported.

The pentathlon da is eligible for priority review as a result, the SAP trend and qualified these product designation.

Phoebe: The Defend-Cath NDA is eligible for priority review as a result of FASTRAP and Qualified Infectious Disease Product Designation. At the pre-MDA meeting with FDA, we confirmed the eligibility for priority review; if FDA accepts the NDA submission for filing and awards priority review, then the goal for the review period, consistent with the Prescription Drug User Fee Amendment, or PDUFA, will be six months from the filing date instead of the standard review period of ten months. It is important to note that the goal for completing the review is truly a goal and can be shorter or longer than six or ten months. We intend to announce the FDA's decisions on filing the NDA and priority review when the information is received from FDA. We expect to hear by the end of August, but it could come at any time before then.

At the pre NDA meeting with that yes, we confirmed the eligibility for priority review.

Is that FDA, except the NDA submission for finally and awards priority review.

Then the goal for the review period consistent with the prescription drug user fee amendments or PDUFA will be six months from the five eight.

Instead of the standard review period of 10.

It is important to note.

That's the goal for completing the review it truly at home and can be shorter or longer than six or 10.

We intend to announce the FDA decisions on filing the NDA.

And priority review when the information is received from Ftn.

We expect to here by the end of August, but it can come in anytime before then.

We have previously discussed our intention to request India approval.

Matt: We have previously discussed our intention to request NDA approval pursuant to the limited population pathway for antibacterial and antifungal drugs, or LPAD, if needed to provide FDA with additional flexibility for NDA approval based on the data from the single study of block of 100. We continue to believe that LOCK100 provides substantial evidence of the safety and effectiveness of DefendCast for reducing catheter-related bloodstream infections in hemodialysis patients using Recent guidance from FDA states that a product approved pursuant to LPAT may follow a streamlined clinical development program that may involve fewer clinical trials. In the same guidance document, FDA stated that, quote, if an applicant submits a request for approval of an application under the LPAD pathway, but the drug instead can be approved under the traditional approval pathway alone.

So in to the limited populations have today.

Anti bacterial and antifungal drugs or L. pad.

If needed to provide you with additional flexibility for India approval based on the data from the single study of block and 100.

We continue to believe that block 100 provide substantial what sense of the safety and effectiveness of the 10-Q.

Well reach and catheter related bloodstream infections in hemo dialysis patients using central venous catheter.

Recent guidance from FC a state set of products approved pursuant to El Paso May follow a streamlined clinical development program that may involve fewer clinical trial.

In the same guidance document FDIC stated that well.

It's an applicant submitted a request for approval of an application under the El Paso pathway.

The Dragon and instead can be approved under the traditional approval pathway alone FDIC will approve the application.

Matt: FDA will approve the application, but not under the LPAD pathway. Accordingly, we have requested that, if needed, FDA consider approving CENTCAS under LPAT for reducing catheter-related bloodstream infections in the limited population of adult hemodialysis patients using central penis catheters. On a final note, we are continuing to focus on our goals of developing the protocols for use in pediatric hemodialysis patients and for expanding the indications for use of the 10-Cas in oncology patients and for patients requiring total parenteral nutrition, or TPS, who are using central venous catheters and are at risk for life-threatening catheter-related bloodstream infections. With that update, let me pass the floor to Matt to cover financial results Matt.

Not under the El Paso pathway.

Accordingly, we have requested that if needed sta consider proving to send cap on your El Paso for reach and catheter related bloodstream infections in the limited population panel hemo dialysis patients using central venous catheter.

On a final work, we're continuing to focus on our goal of developing the protocols for you.

Pediatric hemo dialysis patients and for expanding the indications for use of the 10 cap.

Ecology patients in for patients requiring total parenteral nutrition or TTM, who are using central venous catheters and darkness for life threatening catheter related bloodstream infections.

With that update let me pass before it Matt to cover financial results and our recent financing Matt.

Thanks, Steve I'm pleased to beat your day to provide my first financial report for Cormedix because it just filed this report on form 10-Q for the second quarter and six months ended June 32020, I urge you to read the information contained in this report for a more complete discussion of our financial results.

Matt: Thanks, Phoebe. I'm pleased to be here today to provide my first financial report for CorMedix. The conference has just filed its report on Form 10-Q for the second quarter and six months ended June 30, 2020. I urge you to read the information contained in this report for a more complete discussion of our financial results, with respect to our second quarter 2020 financial results. Our net loss was approximately $3.8 million, or $0.14 per share, compared with a loss of $0.7 million, or $0.03 per share, in the second quarter of 2019. The higher net loss recognized in 2020, compared with 2019, was due to increased expenses related to our preparations for DefendCast's commercial launch. We recorded significant increases in both R&D and SG&A expenses.

With respect to our second quarter 2020 financial results.

Our net loss was approximately 3.8 million or 14 cents per share compared with the loss of point sevenmillion or three cents per share in the second quarter of 29 team the higher net loss recognized in 2020 compared with 2019 was due to increased expenses related to our preparations for defense catamaran.

We will launch.

We recorded significant increases in both R&D and SGN expenses.

Recognize the tax benefit of 5.2 million in 2020 on the television Jersey net operating losses, compared with a 5.1 million benefit recorded 2019.

Matt: We recognize a tax benefit of $5.2 million in 2020 from the tail of our New Jersey net operating losses, compared with the $5.1 million benefit recorded in 2019. Operating expenses in the second quarter of 2020 increased approximately 61% to $8.9 million, compared with $5.6 million in the second quarter of 2019. R&D expense increased by approximately 91% to 5.7 million, including a 3.4 million purchase of raw materials that will be used in the production of FENCAS for sale in the U.S. upon receipt of FDA marketing approval, partially offset by a 12% decrease in other R&D expenses. SG&A expense increased approximately 26% to $3.2 million, compared with $2.6 million in the second quarter of 2019. Higher staffing, marketing, and insurance were primarily responsible for the increase, partially offset by reductions in several areas, particularly legal and accounting.

Operating expenses in the second quarter of 2020 increased approximately 61% to 8.9 million compared with 5.6 million in the second quarter of 29 team.

R&D expense increased by approximately 91% is 5.7 billion, including a 3.4 million purchase of raw material that will be used in the production of the 10 cap for sale in the U.S. upon receipt of that FDA marketing approval, partially offset by 4% decrease in other R&D expenses.

SGN expense increased approximately 26% to 3.2 million compared with 2.6 million in the second quarter of 2019.

Your staffing marketing insurance expenses were primarily responsible for the increase partially offset by reductions in several areas, particularly legal and accounting fees.

We recorded net cash used in operations during the second quarter 2020 of 23 million, primarily result of the cash received from the celebrating Jersey it allowed and the refund of the NDA filing fees offset by raw material purchase and higher restaurant expenses.

Matt: We recorded net cash used in operations during the second quarter of 2020 of $0.3 million, primarily as a result of the cash received from the sale of New Jersey NOLs and the refund of the NDA filing fee, offset by the raw material purchase and higher SG&A expense. This compares with net cash from operations of $0.2 million we recorded in the second quarter of 2019. We reported $22.4 million in cash and short-term investments at June 30, approximately $1 million below the amount we reported on our balance sheet at March 31, 2020. Pro forma cash, including the cash on our balance sheet at June 30, 2020 and net proceeds from the recent financing, is $43.9 million. We believe we have the funds necessary to continue our operations beyond the coming 12 months. We were very pleased to have completed our recent equity financing, raising approximately $21.5 million after expenses. When we set out to execute on this transaction, we had several goals in mind. Complete the financing of at least $20 million.

This compares with net cash from operations of point 2 million, we recorded in the second quarter of 2019th.

We reported 22.4 million in cash and short term investments at June Thirtyth, approximately 1 million below the amount we reported on our balance sheet at March 30, Onest 2020.

Pro forma cash, including the cash on our balance sheet at June 32020, and net proceeds from the recent financing is 43.9 million.

We believe we have the funds that to sorry to continue our operations beyond 12 months.

We were very pleased to have completed our recent equity financings raising approximately 21.5 million after expenses.

When we set out to execute on this transaction we had several goals in mind, one completed financing of at least 20 million to include primarily institutional investors, including life Sciences specialists and three expand our investment banking relationships are working with some highly respected team with capabilities that allow for medic mistake.

Joseph: include primarily institutional investors, including life sciences specialists, and three, expand our investment banking relationships by working with some highly respected teams with capabilities that align informatics with stage and needs. We believe the recent financing accomplishes each of these goals. We believe it is important to have this additional cash on our balance sheet now because it is essential for us to continue to advance our preparation for the commercial launch of the FENCAP once it is approved by the FDA. We plan to continue to refine and finalize our marketing strategy to have sufficient quantities of defense caps ready to fill the sales channels at launch and to lay the groundwork for what will become a modified sales force around the time of regulatory approval. With that, I would like to pass the floor back to Joseph.

Okay and needs we believe the recent financings accomplish each of these goals.

We believe it is important to have this additional cash on our balance sheet now because it is essential for us to continue to advance our preparation for the commercial launch of the Fancast. Once it is approved by the FDA.

We plan to continue to refine and finalize our marketing strategy self sufficient quantities of defend cap ready to focus sales channels at launch and to lay the groundwork for what will become a modest sized sales force around the time of regulatory approval.

With that I would like to past four bucks or so.

Thank you.

Joseph: Thank you. As I've stated, this is to maximize shareholders' value. Because hemodialysis is a very concentrated care provider market, we continue our preparations to commercialize the pen cap in the U.S., whether on our own or with a commercial partner or other parties if a favorable transaction is available; all options are on the table and will be evaluated with the maximum shareholder value in mind.

As I've stated system acts my shareholders value because hemo dialysis is a very concentrated ill provide a market. We continue our preparations to commercialize depend cap the U.S., whether on our own all with a commercial partner or other parts, it's a favorable transactions.

Saleable.

All options on the table and will be evaluated with a maximum maximizing shareholder value in mind.

We've now stepped up in our focusing a great youre for energy on engaging specifically with the various take hold us within for dialysis market through direct contact both with a large dialysis providers and with sales including CMS.

Joseph: Markets through direct contact both with the large analysis providers and with payers, including CMS. This will provide CorMedix with a strong foundation required for an efficient and successful launch. Once again, let me remind you that this significant market represents a very large unmet medical need. As of today, there is no pharmacological agent approved in the U.S. for the prevention of CRBSI in central U.S. catheters.

This will provide core medic strong foundation required for an efficient and successful launch.

Once again, let me remind you that this significant market represents a very large unmet medical need as today. There is more pharmacological agent approved us for the prevention of CRB aside in central venous catheters.

I think that should defend cap the approved by the update we can rapidly become the standard of care in the U.S.

Joseph: I believe that should FENCAP be approved by the FDA, it could rapidly become the standard of care in the U.S. So in summary and the key takeaway, what Phoebe and Matt covered with you, hopefully provide you with insight into the effort on which we are focused and that has been accomplished over the last two and a half years. I am pleased about the progress we are making despite the challenges imposed by the coronavirus pandemic. I'd like to...

So in summary, and the key take away what CDN, Matt covered here hopefully provide you with the insight into the effort on which we are focused and that have been accomplished over the last 12.

I am pleased about progress, making despite challenges imposed by the corner buyers and Doug.

I'd like to reemphasize I'm delighted to be India was submitted.

Joseph: I am delighted that the NDA has been submitted. We eagerly look forward to the FDA decision on acceptance for filing and priority review. We are pleased that we successfully completed a financing bringing several healthcare-focused institutional investors and building new investment banking relationships. We are continuing to ramp up our outreach efforts and are establishing the foundation required for CorMedix to launch defense caps into the hemodialysis market in the U.S. upon FDA approval. Finally, a reminder that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for defend-cat use in catheters, oncology, and TPN patients. We've had discussions with the FDA on clinical trial design for use as a catheter lock solution in oncology and TPN patients and are working to develop the protocols with the goal of finalizing the regulatory pathway for reducing catheter-linked bloodstream infections in these additional patient groups and executing on these plans on a post-approval basis.

Equally over to the FDA decision one of the acceptance for filing and product to review.

We are pleased that successfully completed a financing, bringing several healthcare focus institutional investors and building new investment bank.

Yes.

We are continuing to ramp up our outreach efforts and our established foundations required for Coleman.

To launch defense tap into that hemo dialysis market grew less upon as the approval.

Foreign or a marker, but while we initially focused on the hemo dialysis market. We are determined to seek additional indications for defend cash used in catheters bone colleague and TPN patients.

That concludes discussions with the FDA on clinical trial designed for use as a catalog solution in college and typically patient and are working to develop protocols with the goal of finalizing the regulatory pathway for reducing catheter related bloodstream infections in this additional patient groups and executing on these plants when of course.

Approved basis.

In conclusion.

Joseph: In conclusion, updates going forward will be around the key of that. FDA Decision on Acceptance of Filing the NDA, including Priority Review and Produce-a-Day, and approval by the FDA. T-DAPA, Submission, Defend-CAST, Launch. I look forward to being able to provide you with material, development, and updates via the CorMedix website, press release, and conference call. Thank you for your continued support of CorMed

Dates going forward could be around the key of them.

Yeah deficient on acceptance for filing the India, including power to the on for dual today.

And the approval of the by the FDA.

Pete Dapa submission defense.

Launch.

I look forward to being able to provide you with material development updates we aren't the Corematrix website press release and conference call. Thank you for your continued support of core metrics.

Thank you will now be conducting a question and answer session. If he would like to ask a question. Please press star one on your telephone keypad a confirmation total indicate your line is in the question give you May press star to if youd like to remove your question from the Q for participate.

Operator: Thank you. We will now 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 key.

If you think speaker equipment, and maybe not quite pick up your handset before pressing the star.

One moment, please what we poll for questions.

Operator: One moment, please, while we poll for questions. Our first question comes from the line of Andrew DeSilva with C. Reilly FDR. Please proceed with your question. Good afternoon. Thank you very much for taking my questions. Just a few quick ones for me.

Our first question comes from the line of answer to filled up with B. Riley FBR. Please proceed with your question.

Hey, good afternoon. Thank you very much for taking my questions. Just it's just two quick ones for me I'm sorry, If you mentioned if there was bouncing between calls did you recognize the the anda filing fee during the second quarter or what exactly just led to the substantial.

Andrew DeSilva: And sorry, if you mentioned this; I was bouncing between calls. Did you recognize the NDA filing fee during the second quarter? Or what exactly led to the substantial quarter-over-quarter uptick in R&D? And what should we expect your normalized R&D run rate to be going forward?

For the quarter uptick in R&D and what should we expect your normalized R&D run rate to be going forward.

Thank you Wendy So the question, Matt would you up take question.

Matt: Thank you, Andy, for the question. Matt, would you take the question?

Matt: Thank you. I'm sorry, it didn't come across as clearly. Could you please repeat the question?

Thank you and probably doesn't come across as clearly could you. Please repeat the question.

Yeah, just look at what was the reason for the sequential uptick and R&D.

Andrew DeSilva: Yeah, just what was the reason for the sequential uptick in R&D? Oh yeah.

Oh, Yeah, no no problem I think as we mentioned briefly and you'll see in some of the filing that we posted by now we.

Andrew DeSilva: Oh, yeah, no problem. I think, as we mentioned briefly, and you'll see in some of the filings that should be posted by now.

We had an additional three point fourmillion expense that fell under R&D as part of raw materials that are going into specifically for heparin that are going into the production of defend cap that we intend to be able to use for commercial supply following an FDA approval.

Matt: We had an additional $3.4 million expense that fell under R&D.

Matt: as part of the raw materials that are going into, specifically for heparin, that are going into the production of FENCAS, which we intend to be able to use for commercial supply following FDA approval.

Okay. So the.

Matt: Okay, so the typical run rate for R&D going forward, we should assume is about 3.4 million lower. And then should your gross margin be assumed to be stronger after you get approval for a little bit because of the stockpile that you just mentioned? I think that's fair.

Typical run rates for R&D going forward should we should she was up 3.4 million lower and then should your gross margin you seem to be stronger after you get approval for a little bit because of the other stocking that you say you just mentioned.

I think Thats fair, we'll be able to provide more detail wants to get closer, but I think thats a reasonable way to look at it.

Andrew DeSilva: We'll be able to provide more detail once we get closer, but I think that's a reasonable way to look at it.

Okay great.

Matt: Okay, great. And then can you just discuss maybe what you're hearing as of late or what needs to take place after you obtain approval for CorMedix to obtain reimbursement from CMS? I'm looking for timing and what can be done in the interim while there is no CMS reimbursement, assuming you have approval.

And then can you just discuss.

Maybe what you're hearing as of late or what needs to take place. After you obtain approval for cormedix obtain reimbursement for from CMS and looking for timing and and on what can be done.

In the interim watt, while there is no CMS reimbursement, assuming you have approval.

Koso Baloch: Yeah, so let me answer that, Andy, thanks for the question. As I indicated in my prepared remarks, you know, CMS takes on the majority of the patients, and so it's critically important for us to work with CMS to get reimbursement under the Transitional Drug Add-On Payment Adjustment, called T-DAPA. That process starts once you have the NDA approved, and so our plan is, as soon as we get the NDA approval, we would obviously submit for T-DAPA reimbursement. At the same time that we submit our filing to get the Healthcare Common Procedure Codes, that takes place. And usually, the process takes about a quarter; they do a quarterly review, so depending exactly on the approval timing, it takes a quarter for CMS to approve it, and then basically, you're able to move forward with that reimbursement.

Yeah. So let me on so that the thanks for the question.

As I'd indicated in the prepared remarks, you know CMS takes on the majority of the patients and so it's critically important for us to to work with CMS.

To get reimbursement under the transitional drug at on payments adjustment called Teed up Oh, that's what's to stop once you have the N. da approved.

And so our plan is as soon as we get the India approval, we would obviously summit for T. Docker reimbursement at the same time that we submit.

Our.

Our filings to get the healthcare common procedure codes that that take place and usually the process takes about a quarter made from a quarterly reviews have been duffield approval timing. It takes a quarter uncle CMS to prove itself and then basically you're you're able.

Sure to move forward does that give us much.

[laughter] radically next year, you could have a a mid year a reimbursement established.

Koso Baloch: So theoretically, next year, you could have a mid-year reimbursement established with CMS if everything kind of goes according to your expectations.

With CMS everything kind of.

Goes to your your expectations.

Andrew DeSilva: A lot depends on exactly what the FDA is going to give us. Are they going to give us a priority review, a standard review, and what is the PDUFA date? And as soon as we get clarity on that, that would help provide us the opportunity to guide further in terms of the exact timing when we expect to get the PDAPA approval. But we need to first get that feedback from the FDA in terms of whether we are getting a priority review or a standard review and what to do for that. Okay.

A lot depends on exactly when what are the fts going to give us through the other clinical support to reveal the standard review what is due for a date and as soon as we get clarity on that that would help guide.

Provide us the opportunity to guide global in terms of exact timing when we expect.

To get them, the teed up approval, but we need to present get that feedback from the FDA in terms of well I'll be getting a priority review or standard review and what could do for Delta anything else.

Fair enough that makes sense for all thank you very much.

Koso Baloch: Fair enough. That makes sense.

Andrew DeSilva: Well, thank you very much. Congratulations on getting the NDA filed, and good luck going forward.

Congrats on getting the NDA filed and good luck on for.

Thanks, Andy.

Thank you. Our next question comes from the line of from Soetoro with HC Wainwright. Please proceed with your question.

Operator: Thank you. My next question comes from the line of Ram Siljuraru with H.C. Wainwright. Please proceed with your question. Thanks very much for taking my questions.

Thanks, very much for taking my question. So firstly with respect to the regulatory process. I was wondering if you could comment on if the defend cap years accorded priority review.

Ram Siljuraru: So, firstly, with respect to the regulatory process, I was wondering if you could comment on whether the DefendCast TA is accorded priority review, does that, by definition, accord a six-month review time frame?

By definition Acorda six month review timeframe through the FDA or could it potentially be approved in a faster timeframe than that I mean, we have seen examples of this kind of thing happening before but just wanted to clarify whether getting priority review, hi, Newport month clock or if it could actually be.

Ram Siljuraru: The NPA, or could it potentially be approved in a faster timeframe than that? I mean, we have seen examples of this kind of thing happening before, but I just wanted to clarify whether getting priority review ties into a six-month clock, or if it could potentially be approved faster.

Approved faster.

Thanks, Ron.

Phoebe: Thanks, Ron.

You take that.

Phoebe: Sure, absolutely. Thank you, Robin. That's a good question.

Sure absolutely. Thanks, Ron that's a good question.

Yes, let me put do day, which will reflect a six month review goal. If we got a priority review.

Phoebe: The PDUCA date, which will reflect a six-month review goal if we get a priority review, is only a goal. As you know, the review may occur, and the approval may occur faster than that, or it can take longer than that. It really depends on how long it takes FDA to work through the information in the NDA. And that's why we put a premium on making sure that we understand FDA's expectations and what they want to see in the NDA.

Is the goal.

And.

As you know.

The review May occur only provable may occur fast enough or it can take longer than that.

It really depends on how long it take testing to work through the information the India.

And that's why report.

Premium on making sure that we understood that FDA expectation.

And what they want to see in India doing those analyses and making sure that San Diego.

Phoebe: doing those analyses and making sure that the NDA had the information that we wanted to get in there. And so we're hoping that we've helped FDA have an efficient review period and speed up the review process. You're absolutely right if you go in and look at the review time. You can find priority review for products that take longer than six months, and you can find standard review times that take a lot shorter than 10 months. So it's purely a reflection of how long it takes the FDA to work through the material.

I had the information that we wanted to get in there and so we're hoping that.

We help our FDA other inefficient purview curious and yet they review process faster you're absolutely right. You go in and look at the review time, you can find is probably pretty with you probably for product takes longer than six month and you can find Andrew review time that takes a lot shorter than 10 or so.

It's purely a reflection on how long it takes yesterday to work through the material.

Okay, just to clarify you have fast track designation, but not breakthrough therapy designation is that correct.

Ram Siljuraru: Okay, is that just for clarification?

Phoebe: Just to clarify, you have fast track therapy but not breakthrough therapy. Is that correct?

We have sat stock does it take there as well as qualified infectious disease product information both designation confer eligibility for priority review of fast track because we're developing an invitation for you that addresses our life threatening.

Phoebe: We have FASFAS designations as well as Qualified Infectious Disease Product designations. Both of those designations confer eligibility for priority review. FASTRAC, because we're developing an indication for use that addresses a life-threatening unmet medical need. And the CIDP, because we're addressing antibiotic use and reduction of a pathogen that causes serious infections. So, we talked to FDA at our preemptive...

That makes me.

And the public line.

Product, because we're addressing antibiotic use and production out of a pathogen that causes serious infections. So we talked camp yea or pre India, meaning about our intention to request.

Phoebe: Yay, or.

Priority review enough Yeah, I agree we were eligible to make that request.

Phoebe: a meeting about our intention to request Priority Review, and FDA agreed we were eligible to

Okay. That's just not commercial side, if I may.

One item.

Back to what you think the commercial environment is going to look like at the time that you introduced a fun cap and if any of the restrictions that Mike hypothetically be in place regarding specific lines of promotional activity due to colder 19 would have any impact on your ability to commercialize defend cap effectively.

Phoebe: make that request.

Phoebe: That's just on the commercial side.

Ram Siljuraru: If I may, one item is with respect to what you think the commercial environment is going to look like at the time that you introduce FENCAS.

Ram Siljuraru: any of the restrictions that might I put.

And if you have identified and potential strategies to potentially overcome these considerations and also if you could perhaps comment on the sales preparations are specifically a you know what do you expect the salesforce composition to look like what kinds of people you anticipate hiring and their background that would be very helpful.

Koso Baloch: and the last one is the question is, what would hypothetically be in place regarding specific promotional activities due to COVID-19 would have any impact on commercializing anticipate hiring and their backgrounds? That would be very helpful. Thank you.

Thank you.

Okay. Thank you.

Koso Baloch: Okay, thank you. So, on the commercial side, and taking into account COVID-19, clearly, the situation is evolving, and we will need to look as we get closer to the timing of approval and launch as to what the environment will be as it relates to COVID-19. Clearly, there are restrictions right now in clinics and in centers about individuals entering those places. So clearly, we'll have its challenges if it remains into next year.

So in terms of commercial on the commercial side and taking Entercom overnight you clearly.

Well situations is evolving and when we will need to look as we get closer to the timing of approval and launch asked to walk the environment will be as it relates to cope with 19 clearly they are restrictions of right now in in clinics and centers about.

Individuals.

Pringles places so clearly.

Oh.

Will have its challenges if it remains a into next year.

Koso Baloch: So we're going to closely monitor that, but that would be the only item that I would see that could have an impact. And that's all, you know; our focus is on a lot of the advocacy groups that I outlined in my prepared remarks, that we are finding different ways to begin to communicate both with the health care providers and perhaps those channels to communicate with the health care providers in order to ensure that the message of Defend CAP gets out. In terms of salesforce composition, assuming that we get back to a more traditional model, we have indicated that an organization no greater than about 50 people is what would be required to cover both the salesforce, market access, and also medical affairs would be required to provide the coverage that we need because of the concentration of the providers for hemodialysis but also the concentration of the payers.

So we're going to quote closely monitor that but that would be the holy.

Only items that I would see that could or could have an impact and medical.

Our focus is being with a lot to be advocacy groups that I outlined in the prepared remarks that we are finding different ways to begin to communicate both will be healthcare providers, who have those channels to communicate with the healthcare provider in order to show that the message or any kind of gets out.

In terms of sales force composition, assuming that we get back to more traditional model. We have indicated that you know and organization.

Great and then about 50 people is what would be required that would cover both the sales force the market access and also medical affairs.

Would be required to.

To provide.

The coverage that we need because of the concentration of the providers for hemodialysis, but also pay the concentration we'll see.

Payers and and so which is again, a very concentrated small organization and most of those individuals would come on.

Koso Baloch: And so it is, again, a very concentrated, small organization, and most of those individuals would come on board closer to the time of approval and launch. So we would clearly be watching the situation raised by your first point, how COVID-19 will take place. Clearly, we're going to look to get individuals that have experienced the hemodialysis space. That would add a lot of benefits in terms of the learning curve that one would require. So hopefully, that answers your question. Yep.

So to the time.

Oh approval and launch so we will clearly be watching the situation raise for your first point, how kopec 19 will take place Gary We're gonna look.

Forget individuals that are has experienced the hemodialysis space.

Got it that would add a lot of.

Benefits in terms of the learning.

Learning curve, that's wonderful required so hopefully that answers your question.

And then just right two very quick financial housekeeping items can you confirm that the overallotment exercising fall in your most recent financing and then also do you have perspective regarding the timeframe within which the series G preferred stock might be converted to common stock bye. Thank you.

Ram Siljuraru: And then just two very quick financial housekeeping items. Can you confirm that the overall allotment was exercised in full in your most recent financing? And then also, do you have any thoughts regarding the timeframe within which the Spirit G preferred stock might be converted to common stock fivefold?

Matt: Thanks, Ron. Yeah, so I think that for

Thanks, Matt.

Yes, I think that for the first part of your question, we can confirm that the overlap with the Greenshoe I was executed in fall.

Matt: For the first part of your question, we can confirm that the over-allotment of green shoes was executed in full. So we're pleased to be able to share that with you. On the second point, I don't have any information that we can share at this point about the series G for First.

So we're pleased to be able to share that with you.

On on that on the second point I don't have any information that we can tell at this point about the series D preferred.

Thank you.

Operator: Thank you. Thank you. We have no further audio questions at this time. I'd like to turn the floor over to Mr. Ferry for written questions.

Thank you we have no further audio questions at this time, let's turn the floor over to Mr. Barry for written questions.

Thank you operator.

Operator: Thank you, Operator. So my first one is for Matt. Matt, given your previous cash runaway guide, NT2Q21. Can you comment on the timing of the most recent race?

So my first one is for Matt.

Matt given your previous cash runway guidance.

In Q2 Q 21.

Can you comment on the timing of the most recent risks.

Sure No no problem. Thank you for the question.

Matt: Sure, no problem. Thank you for the question. As we have said in the past, it is our responsibility to make sure that the company is appropriately capitalized to execute on our plans to commercialize FENCAP in the U.S. We don't believe it's good corporate finance practice to wait until there's just a few months of cash on the balance sheet in order to account for unexpected market turbulence, setbacks, and other unexpected circumstances such as COVID-19. Ultimately, our decision is driven by our goals of one, having sufficient capital to execute on our plans, two, broadening our institutional shareholder base, and three, expanding our investment banking relationship.

As we have set in the past it is our responsibility to make sure that the company is appropriately capitalized to execute on our plan to commercialize defend cap in the U.S.

We don't believe it's good corporate finance practice to wait so there's just a few months of cash on the balance sheet in order to account for unexpected market turbulence step back and other unexpected circumstances, such a topic 19th.

Ultimately our decision is driven by our goals of one having sufficient capital to execute on our plan to broadening our institutional shareholder base and three expanding our investment banking relationship.

Thanks, Matt.

Phoebe: Thanks, Matt. I now have one for Phoebe. Phoebe, is there still a risk that the FDA would reject the NDA for filing because there is only a single study?

I now have ones for phebe.

CV is there still arrest that the FDA would reject the NDA filing.

Because there's only a single study.

Thanks, Dan that's a good question, we think we de risk the process as much as possible.

Phoebe: Thanks, Dan. That's a good question.

Phoebe: We think we've de-risked the process as much as possible at this point. It should properly now be an NDA review issue, not a filing decision. The acceptance profile is based on the completeness of the submission to enable a review. The review itself will determine whether there is substantial evidence of safety and effectiveness of DefendCast.

Point.

It should properly now be in India, where if you wish no final decision.

On the acceptance for filing based on the completeness of the submission to enable a review.

There were you sell well determine whether there is substantial evidence of safety and effectiveness of defend cap in reducing CRP aside hemo dialysis patients based on the data in lock it 100.

Phoebe: based on the data in LOCKIT-100. There are examples of FDA requiring additional clinical data for NDA approval, even when there are two physical trials based on a review of the information in the NDA. So it's not a completeness issue, letter review issue. So we don't think it should be an obstacle for FDA accepting the NDA profiling.

There are examples the FDA requiring additional clinical data for India approval, even when there are two pivotal trials they've done a review of the information in India.

So it's not a complete analysis.

But a review issue. So we don't think it should be an obstacle for FDA accepting the N.B. profiling.

Phoebe: Thanks, Phoebe. And as a follow-up, if you believe that LockIt 100 is sufficient... Why request approval under LPAD?

Thanks, Amy and and as a follow up if you believe that lock it 100 insufficient.

Why request approval under L. pad.

Oh, Yeah question, I think most folks who would agree.

Phoebe: I think most folks would agree that it's prudent to have alternatives or a plan B. I like to think of LPAT as our plan. Our goal has always been to bring defend counts to the market as fast as possible to help address unmet medical needs. If FDA needs additional flexibility to approve the NDA, which is based on a single study, then by relying on LPAD, then it will be fulfilling the purpose of LPAD as enacted by Congress in the 21st Century Cures Act.

That is prudent to have alternative or plan b.

I like to think about pad is our plan b.

Our goal has always been to bring it on counts to the market as fast as possible to help address unmet medical needs.

Yes, sta needs additional flexibility to approve the N. Yang switches, we just talked about is based on a single study.

Relying on else had.

And then it will be fulfilling the purpose of El Penon hasn't assets like Congress and the 21st century Cures Act.

Koso Baloch: Thanks, Phoebe. And Koso, if I might ask you, Koso, is a partnership still on the table? Are you in active discussion? Did you raise more cash because you don't have an interested partner?

Thanks Amy.

And co so if I might.

Close its is a partnership still on the table.

Are you in active discussions.

Did you raise more cash because.

Don't have an interested partner.

Thanks, Dan for your question in terms of partnership on the table, we have never never.

Koso Baloch: Thanks, Dan, for your question. In terms of a partnership on the table, we have never publicly said that there's any discussion going on, but all options will be evaluated with maximizing shareholder value in mind. And to that effect, you know, we will actively pursue all options, whether on our own or with a commercial partner or other party, if a favorable transaction is available. And clearly, those discussions remain confidential until the moment that we would require to disclose them, and it would be appropriate to disclose them.

50 cents that there's any discussion going on.

But all options will be evaluated with maximizing shareholder value in mind, and so that affect you know, we will that didnt pursue all options, whether or not old or with a commercial partner or other party for favorable transaction is available and clearly those discussions remain confidential so the moment.

That we would require to disclose it and it would be appropriate to disclose.

Operator: Operator, that concludes the written questions that I have from the audience.

Great. Thank you co. So operator that concludes the written questions that I have from the audience.

Koso Baloch: Thank you. I'd now like to turn the floor back over to COSO for closing comments.

Thank you I'd now like to turn the floor back over to closer for closing comments.

Thank you operator.

Koso Baloch: Thank you. CorMedix has an experienced team of executives that have taken pharmaceuticals through the various phases of clinical studies, registration, and successfully launched products into the U.S. market. And we remain very committed to bringing DefendCats to the U.S. market, as I've said, 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 preventing infections and keeping patients out of hospitals is even more apparent during the ongoing coronavirus pandemic. So please stay tuned as we should have updates from the FDA in the next few weeks. Thank you for your time and attention, and have a good evening. Thank you.

Cormatrix has an experienced Cmos executives that have taking pharmaceutical through the various phases of clinical study registration and successfully launch product bus market.

And we remain very committed to bringing you defend cash to the U.S. market that.

Whether or not.

Or with the strategical commercial partner 12 patients in need of protection from life threatening infections.

The importance of preventing infections, and keeping patients out of possibly even more apparent given the ongoing or one of our spend damage.

So please go to as we should have update from the FDA in the next few weeks. Thank you for your time attention.

And have a good evening. Thank you.

Operator: This does conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.

This does conclude today's teleconference. You may disconnect. Your lines at this time. Thank you for your participation and have a wonderful day.