Q4 2019 Earnings Call
Operator: Greetings. Welcome to the CorMedix Incorporated 4th Quarter and Fiscal Year 2019 earnings call. At this time, all participants are in a listen-only mode.
Greetings welcome to the core Medix incorporated fourth quarter in fiscal year 2019 earnings call. At this time all participants are in a listen only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance. During the conference. Please press star zero on your telephone keypad. Please note. This conference is being recorded.
Operator: A question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star zero on your telephone. Please note this conference is being recorded. I will now turn the conference over to your host, Dan Ferry. You may begin. Leading the call today is Kosa Baloch, Chief Executive Officer of CorMedix. He is joined by Phoebe Mounts, Executive Vice President and General Counsel.
I'll now turn the conference over to your host Dan Ferry you may begin.
We didn't call today, it's COSA below <unk>, Chief Executive Officer of core Medix, He's joined by female Executive Vice President and General Counsel.
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 meeting time limits 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 for Nutrilin in the U.S. and other product candidates; Future Financial Position, Future Revenues and Projected Costs, and Potential Market Acceptance of Neutralin and Other Product Candidates More specifically, forward-looking statements include any statements about our clinical development plans and the timing, costs, results, and interpretations thereof, as well as projections as to the company's future capital raising. Spending and Cash Position
Before we begin I would like to remind everyone that during the call management may make what are known as forward looking statements within the meaning set forth in the private Securities Litigation Reform Act of 1995.
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 for Neutrolin in the U.S. and other product candidates.
<unk> financial position future revenues in projected costs and potential market acceptance of neutrolin in other product candidates.
More specifically forward looking statements include any statements about our clinical development plans and the timing.
Cost results and interpretations that routes.
Projections as to the company's future capital raising.
And spending and cash position.
Daniel Ferry: Expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, or other business development transactions. Any commercial plans and expectations? market projections for our product candidates and Expectations as to Manufacturing and Product Component Costs. 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 SCC's website at www.scc.gov or upon request from CorMedix. 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.
[noise] expectations as to the timing in nature of anticipated regulatory actions.
Possible product licensing or other business development transactions.
Any commercial plans and expectations.
Market projections for our product candidates.
And expectations as to manufacturing and product component costs.
Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development regulatory approvals and commercialization.
These risks are described in greater detail in Chromadex filings with the FCC.
Copies of which are available free of charge at the Fccs website at Www Dot FCC does or upon request from Cormedix.
Cormedix may not actually achieved the goals are plants described in these forward looking statements and <unk> and investors should not place undue reliance on these statements.
Daniel Ferry: Please note that CorMedix does not intend to update these forward-looking statements, except as required by law. At this time, it is now my pleasure to turn the call over to Mr. Koso Baloch, Chief Executive Officer of CorMedix. Koso, please go ahead.
Please note that core metrics 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 Mr. co CIO below <unk>, Chief Executive Officer of core Medix Coso. Please go ahead.
Kosa Baloch: Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. On today's earnings call, we will discuss with you our continued effort to bring Nuclein to the U.S. market for the first indication for use as a catalog solution for hemodialysis patients, with subsequent expansion into other indications. Phoebe will participate in this call and provide details on our regulatory program. I plan to cover three topics.
Thank you Dan Good afternoon, everyone and thank you for joining us on this call.
On today's earnings call, we will cover with you our continued effort to bring new going into the U.S. market.
For the first indication for use as a catheter lock solution for hemodialysis patients with subsequent expansion into other indications.
BB will participate in this call and provide the details on our regulatory programs.
I plan to cover three topics first an update on the significant progress we've made on the NDA filing for Neutrolin.
Kosa Baloch: First, an update on the significant progress we've made on the NDA filing for new. I am very pleased to report that we have begun to submit modules of the NDA, following the FDA's agreement to grant our request for a rolling submission of modules as we announced in February 2020. As we've stated previously, we remain on schedule for a possible NDA approval in the second half of 2020. Phoebe will get into further details on our continuing regulatory progress with the FDA. Second, I want to update you on our plans to commercialize Nutrilent for the human diet. During our last earnings call, Jack Armstrong covered the progress we've made to establish the supply chain CorMedix will use to manufacture and distribute Neutral in the U.S. market. On this call, I will focus on the commercial plan. And finally, we'll update you on the progress we've made in our financial position. The detailed information is available for you to review in the 10-K that we plan to file today. So let's begin with Phoebe.
I'm very pleased to report that we have begun to submit modulates all D N D I.
Following from the FDIC agreement, our request for a rolling submission of modules as we announced in February Twentytwenty.
As we've stated previously we remain on schedule for a possible Andy approval in the second half of 2020.
People get into further details on a continuing regulation progress with the FDA.
Second I want to update you on our plans to commercialize new Glenn for human dialysis.
During our last earnings call Jack Armstrong covered the progress we've made to establish the supply chain core metrics were used to manufacture and distribute neutral in the U.S. market.
On this call I will focus on the commercial plans.
And finally, we'll update you on the progress we've made in our financial position.
The detail information is available for you to review in the 10-K, So we plan to file today.
So let's begin with baby. Thank you very much go so.
Phoebe Mounts: Thank you very much. It is a pleasure to be here again and report on the significant progress we have made on the regulatory activities required to secure marketing authorization for Nutrilin in the U.S. As you know from previous updates, our primary focus has been on preparing information required for filing the new drug application for new treatments. Secure Marketing Authorization in the U.S. for the Hemodialysis Indicator. I am extremely pleased to report that through the hard work and focus of the CorMedix team, we have continued to complete regulatory requirements and have begun submitting the NDA with efforts. First, as we have reported previously, in our pre-NDA meeting with FDA last, the agency agreed that we could request a rolling review for the neutral NDA based on the fast-track designation received in 2011.
It is a pleasure to be here again and report on the significant progress we have made on the regulatory activities required to secure marketing authorization for neutrolin in the U.S.
As you know from previous update our primary focus has been on preparing information required for filing the new drug application for Neutrolin.
Secure marketing authorization in the U.S. for the hemo dialysis syndication.
I'm extremely pleased to report that through the hard work and focus of the core Medix team. We have continued to complete regulatory requirements and have begun submitting the NDA.
With that FDA.
First as we have pre reported previously.
And our pre NDA meeting with FDA last year. The agency agreed that we could request to Rewalk a rolling review for the Neutrolin NDC based on the fast track designation received in 2015.
Phoebe Mounts: After the pre-NDA meeting, we submitted a formal request to FDA for a rolling submission and review of the NDA modules, with a proposed. In January of 2020, FDA granted the request for a rolling submission and agreed to the submission plan. Consistent with the submission plan, we have begun submission of the NDA module, and continue to focus on preparing all of the required information in the modules to ensure complete filing and facilitate an efficient review by FDA. We remain optimistic for a potential approval of the NDA in the second half of 2020. However, you may be aware that, like many government agencies and organizations, restrictions on travel overseas have been imposed by FDA for its employees because of the coronavirus pandemic.
After the pre NDA meeting, we submitted a formal request to FDIC for a rolling submission and review of N D. A module with their proposed submission plant.
In January of 2020, FDIC granted the request for Rolling review and agreed the submission plan was reasonable.
Consistent with the submission plan, we have begun submission of the N. da module.
We continue to focus on preparing all of the required information in the module to ensure a complete filing and facilitate an efficient review by the FDA, we remain optimistic for potential approval of the M.D.A. in the second half of 2020.
However, you may be aware that like many government agencies and organizations restrictions on travel overseas have been imposed by F.D.A. for its employees because of the Corona virus pandemic.
Phoebe Mounts: FDA announced on March 10th that it is postponing most foreign inspections through a process, and inspections outside of the U.S. deemed mission critical will still be considered on a case-by-case basis. We cannot predict if this will delay approval of the NDA because pre-approval inspections of the manufacturing facilities relied upon for the manufacturing of Neutralin are required. We will provide updates on any delays that would prevent approval of the NDA in the second half of 2020 as we become aware of them. Secondly, as you may know, the Pediatric Research Equity Act, or PREA, requires sponsors to conduct pediatric studies for new drug applications for a new active ingredient. Tyrolidine and Neutrogena.
Yeah, Yeah, you announced on March 10 that it is postponing most foreign inspections through April and inspections outside of the U.S. being mission critical will still be considered on a case by case safe.
We cannot predict if this will delay approval of the M.D.A. because preapproval inspections of the manufacturing facilities relied upon for manufacturing of Neutrolin are required.
We will provide updates on any delays that would prevent approval of the N.D.A. in the second half of 2020, as we become aware of them.
Secondly, as you May know the pediatric research equity act for Preah require sponsors to conduct pediatric studies for new drug application for a new active ingredients such as taurolidine in neutrolin unless the waiver or deferral is obtained from FCTA.
Phoebe Mounts: Unless a waiver or deferral is obtained from FDA, studies required and conducted under PREA may qualify for pediatric exclusivity, which would provide an additional six months of marketing exclusivity for an approved product. CorMedix filed a formal request for a waiver or deferral from conducting a pediatric study because hemodialysis for end-stage renal disease in children in the U.S. is uncommon. For example, our Lock It 100 trial was open to enrollment for individuals as young as 18. But there were no study subjects younger than 20 years of age among the 800 study subjects who were enrolled.
Studies required and conducted under Preah may qualify for pediatric exclusivity, which would provide an additional six months of marketing exclusivity for unapproved products.
Or medix filed a formal request for a waiver for deferral from conducting a pediatric study because hemo dialysis for end stage renal disease in children in the U.S. is on common.
For example, our lock is 100 trial was open to enrollment for individuals as young as 18.
But there were no study subjects younger than 20 years of age among the 800 study subjects were enrolled in this study.
Phoebe Mounts: This is consistent with 2018 data from the U.S. Renal Data System on the number of children and adolescents developing end-stage renal disease, the incidents or number of new cases in 2016, and those aged 0 to 17 in the U.S. 840 individuals. Furthermore, of the 9,619 children and adolescents under 22 years of age with prevalent kidney disease, kidney transplant was the most common end-stage renal disease therapeutic modality, followed by hemodialysis and then In 2016, the median waiting time for the first transplant for pediatric patients was 12.94 months.
This is consistent with 2018 data from the U.S. renal data system on the number of children and adolescence developing end stage renal disease worthy incidents or number of new cases in 2016, and those age zero to 17 in the U.S.
840 individual.
Furthermore of the 9619 children and adolescents under 22 years of age with prevalent.
End stage renal disease.
Kidney transplant was the most common end stage renal disease therapeutic modality, followed by hemo dialysis and then pair to Neal dialysis.
And 2016, the median waiting time for first transplant for pediatric patients was 12.94 month.
Phoebe Mounts: This is in stark contrast to the adult population, where the median waiting time for a kidney transplant in 2011 was four years, during which time hemodialysis is required, and the risk of developing a catheter-related bloodstream infection increases. Moreover, unlike the decline in pediatric patients developing end-stage renal disease, disease rates continue to climb in adults. According to the 2018 U.S. Renal Data System Annual Report, In 2016, there were 124,675 newly reported cases of End-Stage Renal Disease and Adolescence. With this increase in hemodialysis patients comes an increase in the potential cases of the life-threatening catheter-related bloodstream infection for which there is currently no preventative product on the market. We believe Nutrilin can address this unmet medical need, as demonstrated by the data from LockIt 100, which demonstrated a 71% reduction in catheter-related bloodstream infections with the use of neutrolin in adult hemodialysis.
This is in Stark contrast of the adult population, where the median waiting time to kidney transplant. In 2011 was four years during which time hemo dialysis is required and the risk of developing a catheter related bloodstream infection exists.
Moreover, unlike the decline in pediatric patients developing end stage renal disease, the disease rates continue to climb in adult patients.
According to the 2018 U.S. renal data system annual report in 2016, there were 124675 newly reported cases of end stage renal disease and the panel.
With this increase in hemo dialysis patients comes an increase in the potential cases of the life threatening catheter related bloodstream infections for which there is currently no preventative product on the market.
We believe Neutrolin can address this unmet medical needs in the adult Pinochet hemo dialysis population as demonstrated by the data from lock at 100, which demonstrated the 71% reduction in catheter related bloodstream infections with the use of Neutrolin in adult hemodynamic.
To stations.
Phoebe Mounts: The FDA responded to our request for a waiver or deferral for a pediatric study by granting a deferral. A deferral acknowledges that a pediatric assessment is required but permits the applicant to submit the pediatric assessment after the submission of an NDA. CorMedix has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemodialysis. We have submitted a plan for the proposed pediatric study to FDA for review and approval. We believe that conducting a study in children will be challenging given the very small number of pediatric patients.
The FDA responded to our request for a waiver or deferral for a pediatric study by granting a deferral a deferral acknowledges that a pediatric assessment is required.
But permits the applicants to submit the pediatric assessment after the submission of in India.
Core Medix has made a commitment to conduct the pediatric study after approval of the NDA for use in adult hemo dialysis patients.
We have submitted a plan for the proposed pediatric study to FCTA for review and approval.
We believe that conducting a study in children will be challenging given the very small number of pediatric patients.
Phoebe Mounts: But we are determined to fulfill the deferral requirement. We are also grateful that CorMedix can go forward with an indication for you, adult hemodialysis patients where there is an urgent unmet medical need. It is FDA's policy to offer applicants the opportunity to qualify for pediatric exclusivity for studies required and conducted under PREA. Receiving Pediatric Exclusivity provides an additional six months of marketing exclusivity. As we have discussed previously, Neutralin would have the potential to receive 10 years of marketing exclusivity upon approval of the NDA. Five years of marketing exclusivity are awarded for approval as a new chemical entity, and approval as a qualified infectious disease product would add an additional five years of marketing exclusivity. Therefore, pediatric exclusivity would provide the benefit of extending the marketing exclusivity for an additional six months from 10 years to 10.5 years.
But we are determined to fulfill the deferral requirement.
We are also grateful that Cormedix can go forward with an indication for use in adult hemo dialysis patients, where there is an urgent unmet medical need.
It is FDIC policy to offer applicants the opportunity to qualify for pediatric exclusivity for studies required and conducted under pressure.
Receiving pediatric exclusivity provides an additional six months of marketing exclusivity.
As we have discussed previously Neutrolin would have the potential to receive 10 years of marketing exclusivity upon approval of the India.
Five years of marketing exclusivity is awarded for approval as a new chemical entity and approval as a call side infectious disease product would add an additional five years of marketing exclusivity.
Therefore, pediatric exclusivity would provide the benefit of extending the marketing exclusivity for an additional six months from 10 years to 10.5 years.
Phoebe Mounts: CorMedix intends to meet the required elements to be eligible for pediatric exclusivity to extend marketing exclusivity to 10.5%. I continue to be excited about our progress in developing the information needed to secure marketing authorization for Nutrilin in the U.S. and remain confident that internally we have the team and capabilities to be successful. As I covered in the last earnings call, in addition to continuing with the submission of the NDA for the hemodialysis indication for use, we are working on developing the regulatory pathways for additional indications for use in oncology patients, for Patients Requiring Total Parenteral Nutrition, or TPRNN. However, we are focusing on securing the indication for use in hemodialysis patients first. Data from Lockheed-100 because we believe it will provide more flexibility leading to approval for the expansion. With that summary, please let me pass the floor back to Koso to cover the other topics. Thank you, Phoebe.
Cormedix intends to meet the required elements to be eligible for pediatric exclusivity to extend marketing exclusivity to 10.5 years.
I continue to be excited about our progress in developing the information needed to secure marketing authorization for neutrolin in the U.S.
And remain confident that internally, we have the team and capabilities to be successful.
As I covered in the last earnings call. In addition to continuing with the submission of the NDA for the hemo dialysis indication for you.
We are working on developing the regulatory pathways for additional indications for use in oncology patients.
Patients requiring total parenteral nutrition for TPN.
We are focusing on securing the indication for use in hemo dialysis patients first with the data from lock at 100, because we believe it will provide more flexibility leading to approval for the expanded indications.
With that summary, please let me pass the floor back to Coso to cover the other topics.
Kosa Baloch: As I've stated, our goal is to maximize shareholders' value because hemodialysis is a very concentrated payer-provider market. We are continuing to prepare to launch Neutralin in the hemodialysis segment, while at the same time being open to potential partnerships. All options are on the table and will be evaluated with one goal in mind. At the same time, we will refine our commercial organization optimization plan by matching our resources needs and locations where we can target most of the CVC catheter patients receiving hemodialysis. The hemodialysis market is a very concentrated market, with two or three players providing two-thirds of all dialysis in the U.S. and one large payer, CMS, reimburses about 90% of all dialysis patients.
Thank you phebe.
As I've stated our goal is to maximize shareholder value because hemo dialysis is a very concentrated payer provider market. We are continuing to prepare to launch neutrolin in the hemodialysis segment.
What are the same time being open to potential partnerships.
All options on the table and will be evaluated with one goal in mind.
At the same time, we will refine our commercial organization optimization plan by matching our resources needs and locations, where we can target most of the CVC Catherine patients receiving hemodialysis.
The hemo dialysis market is very concentrated market with two or three blair's, providing two thirds of all dot dollars is in the U.S and one large payoffs CMS reimbursing above 90% of $4 as patients.
Kosa Baloch: This level of concentration is not very common in the U.S. healthcare market and therefore provides CorMedix with a unique opportunity to tailor a strategy that will be leveraged to maximize the return on investment. We have begun building internal functions for medical affairs and payer markets. Additionally, we have begun hiring individuals to fill senior roles in these new units.
This level of concentration is not very common in the U.S healthcare market and therefore provides core medix a unique opportunity to tailor rose strategy that will be leveraged to maximize the return on investment.
We have begun building in total functions for medical Affairs NPL markets.
We have begun individuals to fill senior roles in these new units.
Kosa Baloch: This gradual buildup will help us move forward in preparing and refining our launch plans as we move closer to a potential nutrient approval. We intend to continue building out these functions over the course of the year, followed at the end by the hiring of the field sales force if we are in a go-it-alone scenario. In previous earnings calls, we covered the potential size of the different segments of the market. By 2025, the hemodialysis market alone will require an estimated 80 million catheter locks per year.
This gradual build up will help us move forward and preparing and refining our launch plans as we move closer for potential Neutrolin approval.
We intend to continue building all these functions over the course of the year followed at the end by the hiring of the field sales force. If we are going to launch scenario.
In previous earnings call, we've covered the potential size of the different segments of the market.
By 2025, the hemo dialysis market alone, we required estimated 80 million capital loss per year.
Kosa Baloch: If you add those receiving chemotherapy and total parental nutrition, then you would add another 150 million catheter-locked solutions for a total need of 230 million catheter-locked solutions estimated in 2025. We are now in a position to step up and focus a great deal of our energy on understanding the various stakeholders within the dialysis market through market research involving both providers and payers. We are now actively developing our plan of approach and pre-launch message strategy, which will need to be unique to each stakeholder yet consistent in strategy. We will be prepared to test our messages shortly and begin to actively re-engage with CMS and commercial payers. In addition, other priorities for the payer market include precisely mapping neutral and likely flow through the distribution channels, assessing opportunities to strengthen our product value through retrospective claims analysis, devising a coding TDAPR timeline to guide our forecasting effort for launch and through 2021, and segmenting our commercial markets target. These activities will be required in either case, whether we go it alone or we have a strategic partnership. Once again, let me remind you that this huge 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 venous catheters.
If you add those receiving chemotherapy and total parental nutrition, then you would add another 150 million catalog solution for a total need of 230 million catheter lock solutions estimated in 2025.
We are now in a position to step up and focus a great deal of energy on understanding the various stakeholders within the Dallas This market.
Market research involving both providers and payers.
We now are actively developing our plan of approach and pre launch message strategy, which will need to be unique to each day quarter, yet consistent and strategies.
We will be prepared to test our messages shortly and begin to actively reengage with CMS and commercial payers.
In addition, other priorities for the beer market include precisely mapping neutrolin likely flow through the distribution channels assessing opportunities to strengthen our product value through retrospective claims analysis.
Advising the coding teed up a timeline to guide our forecasting effort for launch and through 2021.
And segmenting, our commercial markets targets.
These activities will be required in either case, whether we go it alone or we have a strategic partnership.
Once again, let me remind you that this huge market represents a very large unmet medical need.
As today, there is no pharmacological agent approved in the us for the prevention of CRB thoughts in central venous catheters.
Kosa Baloch: I therefore believe should Nutrim be approved by the FDA, it would become the standard of care in the U.S. Now, let me provide you with a top-line review of our quarter 4 and full year 2019 financials. The company will file its annual report on Form 10-K for the year ending December 31st, 2019. I urge you to read the information contained in the report for a more complete discussion of our financial results. Total cash on hand and short-term investments as of December 31, 2019 amounted to $28.3 million, excluding restricted cash of $200,000.
By therefore believe should new couldn't be approved by the FDA.
It would become the standard of care in the us.
Now let me provide you with a top line review of our quarter full and full year 2019 financials.
The company will follow shortly its annual report on form 10-K for the year ending December 31st 2019.
And you to read the information contained in the report for a more complete discussion of our financial results.
Total cash on hand, and short term investments as of December 31st 2019 amounted to 28.3 million, excluding restricted cash of 200000.
Kosa Baloch: Beginning in January 2020, the company made selective use of its ATM program, raising approximately $2.5 million net of commission. We also announced in February that we expect to close shortly on the sale of a New Jersey net operating losses to the state tax certificate program and raise approximately $5.2 million net of commission. The company believes that based on the company's cash resources at December 31st, 2019, plus the ATM and NOL funding I've outlined. It has sufficient resources to fund operations to the end of quarter two.
Beginning in January Twentytwenty, the company made selective use profits ATM program, raising approximately 2.5 million net of commissions.
We also announced in February that we expect growth shortly on the sale of New Jersey net operating losses through the state tax certificate program and raise approximately 5.2 million net of commissions.
Because we believe that based on the company's cash resources at December 31st 2019, plus the ATM and oil funding.
I've outlined it has sufficient resources to fund operations to the end of quarter too.
Kosa Baloch: 2021, including the submission of the NDA for Neutralin and the initial preparation for commercial law. Additional financing will be necessary for a complete inventory build and other pre-launch commercial needs if the company launches Neutralin after approval without a commercial partner. As I covered earlier, our cash spent, defined as our cash used in operations, was $3.9 million during Q4 2019, about the same as during the third quarter.
Twentytwenty, while including the submission of the NDA or new Poland and the initial preparation for commercial launch.
Additional financing will be necessary for a complete inventory build and other prelaunch commercial needs. If the company launches new blood after approval with all the commercial partnership.
As I covered earlier, our cash spend defined as our cash used in operations were 3.9 million during quarter four 2019 about the same as during the third quarter.
Kosa Baloch: Our burn rate will increase, starting in early 2020, as we hire key personnel to prepare for commercialization and commence manufacturing an initial order of Neutralin for sale upon approval. So, let me summarize the key takeaways from this call. What Phoebe and I covered with you hopefully provides you with an insight into the work effort on which we are focused and that we have undertaken over the last three months. I'm pleased with the progress we are making. I'd like to reemphasize, number one... We are pleased to report to our shareholders that the effort to move the regulatory process forward with the FDA is on track. We have begun to submit the modules of the NDA for Neutralin and continue to plan for potential approval of the Neutralin NDA during the second half of 2020. The progress to build a Neutrolin supply line for the U.S. market is moving along as planned. CorMedix has started the hiring of personnel to launch Neutrolin in the U.S. in anticipation of CorMedix receiving marketing approval for Neutrolin from the FDA.
Burn rate will increase starting in early 2020, as we hired key personnel to prepare for commercialization and commenced manufacturing and initial order of Neutrolin for sale upon approval.
So let me summarize the key takeaways from this call.
Or freebie and I covered with you hopefully provide you with an insight into the work effort on which we are focused and then we have occurred over the last three months.
I am pleased on the progress we're making.
I'd like to reemphasize number one.
We're pleased to report to our shareholders that the effort to move the regulatory process forward with the FDA is on track we have begun to submit the modules of the NDA for Neutrolin and continue to plan for potential approval of Neutrolin endear during the second half of 2020.
The progress to build a new drum neutrolin supply line for the US market is moving along as planned core Medix has started the hiring of personnel to launch new plan in the U.S in anticipation of core Medix, receiving marketing approval for Neutrolin from the FDA.
We're also continuing our financial strategy, which is to raise the minimum amount of funds necessary to ensure that we meet the company's next inflection point.
Kosa Baloch: We're also continuing our financial strategy, which is to raise the minimum amount of funds necessary to ensure that we meet the company's next inflection point. Our current cash is sufficient to fund a portion of the inventory required for launch and to initiate the building of our marketing infrastructure. If we commit ourselves to marketing Nutrien on our own, additional financing will be required to complete the purchase of the inventory for the launch and for safety stocks and to fully stop our sales and marketing.
Our current cash is sufficient to fund a portion of the inventory required for launch and to initiate the building off our marketing infrastructure.
If we commit ourselves to marketing new for no no additional financing will be required to complete the purchase of the inventory for launch emphases safety stock.
And to 40 stop our sales and marketing.
Kosa Baloch: Should we conclude a commercial partnership prior to launch, our financing needs may be significantly lessened. Finally, please remember that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for neutraline use in oncology and TPM. We've had discussions with the FDA on the clinical trial design for neutralin used as a catheter lock solution in oncology and TPN, and we are working to develop the protocols with a goal of finalizing the regulatory pathway for these patient groups. Our goal is to maximize shareholders' value.
Should we conclude a commercial partnership prior to launch our financing financing needs may be significantly lessons.
Finally, please remember that while we are initially focused on the hemodialysis market. We're determined to seek additional indications for new blend used in oncology TPN.
We've had discussions with the FDA on the clinical trial designed for Neutrolin use as a catalog solution in oncology MTB, Ed and we're working to develop the protocols with a goal of finalizing the regulatory pathway for these patient groups.
Our goal is to maximize shareholder value.
Kosa Baloch: I also continue to believe that if Neutralin is approved, it will become the standard of care for preventing cancer-related bloodstream infections in hemodialysis patients. As Phoebe has discussed, the last year has been very productive in moving Neutralin through the regulatory process. I'm very pleased with the strength of our management team.
I also continue to believe that if new products approved it will become the standard of care for preventing catheter related bloodstream infections in hemodialysis patients.
As previously discussed the last year has been very productive in moving neutral into the regulatory process.
I'm very pleased with the strength of our management team the significant experience phebe brings in regulatory Drydock in manufacturing and supply chain, Paul in medical Affairs and lives in clinical operations, coupled with Mike Crs and by the launch experienced in the U.S just to name a few recent launches make.
Kosa Baloch: The significant experience Phoebe brings in regulatory, Jack in manufacturing and supply chain, Paul in medical affairs, and Liz in clinical operations, coupled with my Cialis and Paita launch experience in the U.S., just to name a few recent launches, makes for a winning team. Together, we have a combined experience of over 170 years in the pharmaceutical business. The team will continue to evolve over the coming quarters in areas of strategic need. As I've stated previously, we have been working hard to identify a new CFO. We expect to have one on board in the near future.
For a winning team.
Together, we have a combined experience of over 170 years of the pharmaceutical business.
The team will continue to evolve over the coming quarters in areas of strategic need.
As I've stated previously we have been working hard to identify a new CFO.
We expect to have one on board in the near future.
Kosa Baloch: The strategy we embarked on in early 2017 will continue to move forward at an ever-increasing pace. We are aware of the restrictions imposed by the coronavirus epidemic and have implemented precautions to ensure the safety and well-being of the CorMedix personnel. I look forward to providing you with material development updates via the CorMedix website, press releases, and conference calls. Thank you for your continued support of CorMedix.
The strategy, we embarked on in early 2017 will continue to move forward, but an ever increasing pace.
We are aware of the restrictions imposed by the Corona virus epidemic and have implemented precautions to ensure the safety in wellbeing of the core Medix personnel.
I look forward to providing you with material development updates we are the core Medix website press release and conference calls.
Thank you for your continued support of core Medix.
Operator: This concludes the management presentation, so let me hand the floor back to the 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. A confirmation tone will indicate your line is busy. You may press start, too, if you would like to remove your question. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the start button.
This concludes managements presentation.
So let me hand, the flow back to the operator.
Thank you.
At this time, we will be conducting a question and answer session. If he would like to ask your question. Please press star one on your telephone keypad, a confirmation tone will indicate your line is in the question Q you made for a stark too if you like to remove your question from the Q for participants using speaker equipment and may be necessary to pick up your handset before freshness dark.
One moment, please while we pull for questions.
Operator: One moment, please, while we poll for questions. And our first question is from Andrew De Silva from D. Reilly & Company. Please proceed with your questions. Good afternoon. Thanks for taking my questions. Just a couple quick ones. And also, just let me know if you gave any color on this during your prepared remarks. I was jumping between a couple calls.
And our first question is from Andrew the soon from B. Riley and company. Please proceed with your question.
Good afternoon. Thanks for taking my questions couple quick ones and also just let me know if you you gave color on this during your prepared remark I was jumping between a couple of calls so.
Andrew De Silva: So just to start, if you could, just give a little bit of color on the strategy you have as it relates to sales and marketing and building a sales force. And what I'm really looking for is maybe some context. If you do go from a direct standpoint, context on the side of the sales team, and maybe the timing before you determine if you'll be hiring a direct team or not.
Just to start if you could just give a little bit of color on the strategy you have as it relates to sales and marketing.
And building a sales force and we're really looking for is maybe some context. If you do go up from a direct standpoint.
Trying to size the sales team.
And maybe the timing before you determine if you will be hiring a direct team or not and then I know you touched on this briefly during prepared remarks, but just how to CMS coverage and presenting at the end to beat as much market share really.
Kosa Baloch: And then, I know you touched on this briefly during your prepared remarks, but just how does CMS coverage and Presenius and DaVita's market share really play a role in your decisions there? Okay, thank you, Andy. In terms of our sales and marketing organization, you know, we have been looking at a very top line in terms of the concentration of where the hemodialysis patients with catheters are located. Clearly, the payer environment is something that we will pay a lot of attention to. And that is the reason why the payer side, including medical affairs, are the first individuals that leadership that we are bringing into place and have already put in place. The sales force, the actual boots on the ground, will come very much at the tail end, when pretty much we are knowing that we are going it alone. And also, at that time, we have just about enough time to get them on board and be able to launch the product. In terms of your second question about CMS and the importance of CMS, that's a good question. And actually, it's one of the questions that I have also received from several people via email.
A play play a role engineered Segun Sir.
Okay. Thank you Andy in terms of our sales and marketing organization.
We have been looking at a very top line.
In terms of the concentration of where the hemodialysis patients with catheters are are located.
And we have seen that the requirements of having a direct sales force on the ground is not a very large organization. If you take a specialty organization.
Pretty much if you got to specialty organization in all you may not even need that many people clearly the payer environment is something that we will pay a lot of attention too and that is the reason why the payer side, including medical affairs are the first.
Individuals that leadership that we are bringing into place and abroad and to place. The salesforce. The actual boots on the ground will come very much of the tail end, where pretty much. We are re knowing that we are going it alone and also at that time, we have just about enough time to get them onboard and be able to launch.
Product.
In terms of your second question about.
CMS and the importance of CMS.
That's a good question and actually it's one of the questions that I have also received from.
From several people react E mail, so let me try to cover in its broader sense.
Kosa Baloch: So let me try to cover it in its broadest sense. The questions that we have received are about the role of CMS, what happens while you wait for CMS coverage, what potentially could be the delays in terms of reporting sales, and how does the T-DAPA program, which is the Transitional Add-On Program, play into this whole equation? So in order to answer this question completely, let me start the following way. It's very true that Medicare covers about 90% of all the hemodialysis patients under the Medicare program, so they are a very important stakeholder.
The questions that we have received as the role of CMS what out while you wait for CMS coverage, what potentially could be the delays.
In terms of reporting sales and out of the T. DARPA program, which is the transitional add on program play into this whole look equation. So.
In order to answer this question completely.
Let me let me start the following week. So it's very true that Medicare covers about 90% of all the hemodialysis patients under under.
The Medicare program.
So there are very important stakeholder what is even more important is not just the coverage.
Kosa Baloch: What is even more important is not just the coverage that one gets; what I mean by that is, is it going to be in the bundle, or is it going to fall under the transitional drug add-on payment adjustment system called T-DAPA? In January 2020, CMS finalized revisions to that T-DAPA program, and that took effect. Some of these changes include, you know, new molecule entities, new chemical entities that are eligible for CMS reimbursement outside of the bundle under the T-DAPA program. And that is very good news. So, if approved under T-DAPA, reimbursement for Nutrilin would be calculated based on its average selling price, ASP. If ASP is not available, that would be based on WAC, which is the wholesaler average cost.
That one gets what I mean by that is going to be in the bundle or is it going to fall under the transitional drug add on payment adjustments system called teed up.
In January 2020, CMS finalized revisions to that teed up a program that took effect. Some of these changes include new molecule entities, new chemical entities that are eligible for CMS reimbursement outside of the bundle under the teed up a program.
That is that is what is very good news.
So if approved under teed up our reimbursement of Neutrolin would be calculated based on its average selling price SP. If ASP is not available that would be based on whack, which is the wholesaler average cost and it was not available that will be based on drug manufacturers invoice.
Kosa Baloch: And if WAC is not available, then it will be based on the drug manufacturer's invoice. And generally, CMS will pay for the new renal drug or biological product using Tdapr for at least the first two years. And if the new drug or biological product is used to treat or manage a condition for which there's not an existing ESRD functional category, then they would look at it; it would be illegible. And today, there are 11 basic functional categories. We do not see Neutralin fitting in any one of these categories because of its preventive claim that it will have.
And generally CMS will pay for the new renal Drago biological product using teed up for at least the first two years and if the new drug of biological product is used to treat or manage our condition for which there is not an existing SRB functional category.
Then they would look at it would be eligible and today. They are 11 basic functional categories. We do not see neutrolin fitting in any one of these categories because of its preventive claim that neutral and we'll have currently the anti infectives that has a category Mds R&D PPS functional category is focused.
Kosa Baloch: Currently, the anti-infectives that have a category in the ESRD PPS functional category are focused on treatment, not prevention. Also, our initial analysis of the process is as follows, because this is a question that's come up quite a bit, is how long will it take? The FDA approval is the main gatekeeper. Once approval is obtained, applications are sent to the Division of Chronic Care Management, DCCM, in CMS, stating our interest in eligibility for Tdapr, and at the same time, we will need to apply for the Healthcare Common Procedure Coding System. Both these processes run in parallel and take about three to four months.
For treatment not prevention.
Also our an initial analysis of the process is as follows because this is the question that's come up quite a bit as how long will it take.
The FDA approval is the main gate people. Once you know the approval is obtained applications are sent to the division of the chronic care management DCM.
In CMS staging our interest in eligibility for T. DARPA and at the same time, we'll we'll need to apply for the healthcare common procedure coating systems.
Both these process one impella take about three to four months.
Kosa Baloch: CMS has moved their reviews to quarterly reviews, and their aim is to have an effective date for payment one quarter of the coding effective date. So, you know, as I've stated, this is the initial analysis. We will be working with experts in this area, they're called coders, to ensure that the nutrient, you know, value proposition gives us the best shot to ensure a successful outcome and that we get under the T-DAPA program at least for the first two years. And, you know, nothing is guaranteed.
CMS has moved their reviews to quarterly reviews and the regime is for having an effective date for payment one quarter off the coding effective date.
So as I've stated this is the initial analysis.
We will be working with experts in this area the coal quarters to ensure that new trend value proposition gives us the best shot to ensure successful outcome and that we get under the teed up a program at least for the first two years.
Nothing is guaranteed Amgen has two products up there and it's in its third year, but the robust clinical data results coupled with the huge unmet medical need gives us reason to be optimistic.
Kosa Baloch: Amgen has two products up there, and it's in its third year. But the robust clinical data results, coupled with the huge unmet medical need, give us reason to be optimistic. Okay, great. Thanks for the color on that.
Okay, great. Thanks for the color on that and then just my last question.
Andrew De Silva: And then just my last question, you know, just relates to some of the comments you've made previously as it relates to potentially having to run another Phase 3. That really doesn't apply anymore, correct, since the FDA granted your request for a rolling review, and it's not really whether the NDA, once you submit the various modules, has been filed adequately and with the appropriate amount of data or information. Is that a fair assessment, or are you still unsure as it relates to second Phase 3? It remains a review decision, Andy, so as you said, when FDA reviews, the NDA will provide the information in the NDA and review the data for LOCKIT-100. It will determine whether or not, in its opinion, the information in the NDA provides substantial evidence of safety and effectiveness.
Just relates to some of the comments you've made previously as it relates to potentially having to run another phase three.
Does that really doesnt apply any more corrections the FDA granted your request for Rolling review and it's now really if the NDA. Once you submit the various modules has been filed adequately and with appropriate lot of data or information that is that a fair assessment or are you still.
Onshore as it relates to the second phase three.
TV it remains.
Review decision Andy So as you said when Ft a review.
The submission and reviews the data for lock at 100, it will determine whether or not and its opinion. The information then the Andy a provides the substantial evidence of safety and effectiveness to me statutory requirements for drug approval. So if at that time.
Andrew De Silva: Statutory Requirements for Drug Approval. So, if at that time, it decides that the data are not sufficient, then it could request a second. But this isn't really any different than most other companies that run one pivotal trial and then file an NDA and, you know, look for an approval based on that one trial. It's just the way you're articulating it is from more of a conservative
It's decides that data are not sufficient then it could request the second phase III trial.
But this isn't really any different than most other companies that run one capital and then file in India.
And.
Look for an approval based on that one trial.
It's just the way you're articulating it in.
For more of a conservative stance that is that a fair assessment or from your previous experience is it.
Phoebe Mounts: Is that a fair assessment? Or, from your previous experience, is it, from your discussions with the FDA, a little bit different relative to running a single phase three versus having to do two?
Your discussions with the FDA.
A little bit.
The difference relative to running a single phase three versus having a due to.
Andrew De Silva: Well, we believe that the extremely robust data from Lockheed-100 does provide substantial evidence of safety and effectiveness. As we have summarized previously, it was a milestone study in hemodialysis patients. It was a very large study with over 800 subjects enrolled. It was conducted at 70 clinical sites across the U.S. That provides evidence to FDA that the product will perform as intended in different patient populations and demographics across the United States. We believe that the data will be sufficient. But you never can say never with the FDA until they actually get in and review it. Got it.
Well, we believed that the extremely robust data from lock at 100.
Does provide substantial evidence of safety and effectiveness as we have summarize previously.
As a milestone study in hemo dialysis subjects that was a very large stuff with over 800 subjects enrolled.
It was conducted at 70 clinical sites across the U.S.
That provides evidence to sta.
The product will perform as intended in different patient populations with different demographics across the United States. So we believe that the data will be sufficient but you never can say never who must now be a until they actually get in.
And review the Dino.
Phoebe Mounts: Great. Hey, thank you very much and best of luck in 2020. Thank you so much.
Got a great. Thank you very much and best of luck in 2020.
Thank you so thank you.
Thank you. Our next question is from Ram Selvaraju from H.C. Wainwright. Please proceed with your question.
Andrew De Silva: Thank you. Our next question is from Ram Selvaraju from HC Wainwright. Please proceed with your question. Thank you very much for taking my questions. Can you hear me?
Thanks, very much for taking my questions can you hear me.
Ram Selvaraju: Yes, Ron, we hear you. Okay, firstly, I just wanted to ask about the Pediatric Study Plan and where that fits into the processing of the NDA. Is that going to be a date item, meaning the review and approval of the Pediatric Study Plan for the actual approval of the Neutralin NDA, or is that something that is going to occur before the final NDA submission is completed, or is it something that will likely be done before the actual expected approval decision? Just give us an idea of where the Pediatric Study Plan falls in the overall continuum of the approval process. We requested and received deferral for conducting the pediatric study prior to NDA submission. So, it's part of that deferral process. The pediatric study plan was submitted, and FDA will then. We expect them to fulfill our commitment to conduct. Pediatric Study Post-approval of the NDA
Yes, Ron we hear you.
Okay. Firstly I just wanted to ask about the pediatric study plan and where that fits into the processing of the FDA is that going to be at gating item meeting. The review approval at the pediatric study plan for the actual approval of the two telenet da or is that something.
That is going to occur before the final FDA submission. This completed or is it something that will likely be done before the actual expected.
Eight approval this just give us an ideal.
Patrick States landfall overall continue above the approval process.
Oh, we requested and received the deferral for conducting the pediatric study prior to an NDA submission.
So it's hard to that deferral process.
A.
Pediatric study plan was better.
And.
Sta will then expect us to fulfill our commitment to conduct the pediatric study post approval of the India and as you know there are lots that we've done together clinical trial up and running so while the India is under review we can go forward with us discussion.
Phoebe Mounts: And as you know, there is a lot that needs to be done to get a clinical trial up and running. So while the NDA is under review, we can go forward with those discussions. Okay, but does the study plan... get approved by the FDA before the Neutralin NDA is approved, and has the study plan actually been approved by the FDA yet? My understanding was that that is still, The Pediatric Study Plan has been submitted to the FDA and agreed. Okay, great. Thank you.
With that FDA.
Okay, but does the study glad to be approved by the FDA before the Neutrolin da is approved and has the study plan actually in approved by the FDA. My understanding was that that is still.
The pediatric study plan has been submitted to FDA and agreed upon.
Okay, great. Thank you secondly, I was wondering if you could just give us some additional clarity closer you mentioned that some.
Ram Selvaraju: Secondly, I was wondering if you could just give us some additional clarity. Koso, you mentioned that some initial hiring has begun with respect to the sales and marketing infrastructure. Can you just give us a sense of what personnel, what staffing, if any, has actually been spun up, as it were, as you prepare for the potential commercialization of Nook Philly so far? Yeah, yeah.
Initial hiring has begun with respect to the sales and marketing infrastructure can you just give us a sense of so what personnel staff, we get ready has actually.
Ill bet spine up as it were as you prepare for the potential commercialization of the film so far.
Kosa Baloch: So, since the process has started, we have so far appointed two people, one in the payer world and one in medical affairs, to be focused here in the U.S., and we have others lined up behind these to bring on board. As I said, the focus will be initially on the payer and medical affairs components, and then the rest of the buildup will come through the remaining months and quarters. Okay, and then I just wanted some additional clarity regarding the differentiation between the new technology add-on, Kodapa, and what specific frameworks would apply to. So I'm maybe not prepared at the moment to talk about the differences between the two programs. What I can focus on is the Tdapr program, where if you've got a new chemical entry, a new molecule, then you would be eligible to apply for Tdapr And clearly, that has been the position we have taken, that they do not fit into those categories. And we will be a new chemical entity. But I cannot separate them out because the other one covers other supplies, so I don't have the separation of the two.
Yeah. So so with a process. The started we have so far appointed two people one in the payer Walden won in medical affairs to refocus tier in the U.S.
And we have others lined up behind these to bring on board as I said the focus will be initially on the payer and medical affairs components.
And then the rest of the build up will come through the remaining a month in quarters.
Okay, and then I just wanted some additional clarity regarding the differentiation between the new technology add on payment and to dapper and what specific frameworks would apply to neutral and specifically.
So I guess I'm maybe not.
Prepared at the moment to talk about the differences of the two program. What I can focus is on the T. DARPA program, where if you got to new chemical entity on new molecule.
Then you would be eligible to apply for T. dapa, particularly if you've got a drug oral biologic.
That does not fit in any of the categories and clearly that is being the position we have taken that they do not fit in those categories.
And we will be a new.
Chemical entity.
But I cannot.
Separate out because the other one covers other supplies would show I don't have the separation of the two I can get it and provide that or do you wrong.
Kosa Baloch: I can get it and provide that for you, Ron. With respect to distribution, can you comment at this time on what the distribution channel would look like for Neutralin and if you expect there to be any kind of learning curve as Neutralin is deployed in the field with respect to how it is used in conjunction with capital lock solutions, or if you expect it to be very seamless because everybody uses capital lock solutions and Neutralin is basically just going to be incorporated into that? Yeah, I think there are several questions in your one question. One is your distribution chain.
Okay, Great and then with respect to the distribution can you comment at this time on what the distribution channel what looks like for Neutrolin and if you expect there to be any kind of learning curve as it were as solid as deployed into the CEO.
To Howard.
Johnson with catheter lock solutions or is your cannot be very seamless because.
For the use of catheter lock solutions.
Basically just going to be.
Operated into that.
No I think there are.
Several questions in your one question what is your distribution train and I think when we had Jack on the call previously we talk that we will be using a threepl.
Kosa Baloch: And I think when we had Jack on the call previously, we talked about using a 3PL for coordinating our distribution in the U.S. But we expect, and I'm covered on this call, that we are now nailing down how that flow will look. But we expect to have sales going through specialty GPOs. We expect sales going through wholesalers.
For for coordinating our distribution in the U.S., but we expect to not.
Covered in our on in this and this call that we're now nailing down how that floor will look, but we expect to have sales going through especially GGB deals. We expect sales going to wholesalers and we also expect some direct sales that would be going.
Kosa Baloch: And we also expect some direct sales that will be going to the larger dialysis providers. The mix of how that flows is what we will be nailing down over the coming period with the team we now have in place. So that's the first part of your question. The second part of your question: could you repeat that last part of your question? I missed that last part.
To the larger dialysis providers.
The mix of how that that flows is what we will be nailing down over the coming period with the team now we've got in place.
So thats the first part of your question the second part of your question.
Could you repeat the last part of your question I missed that last month.
Ram Selvaraju: Yeah, it was just to be able to determine if there is going to be any learning curve with regard to the adoption of Nutrilin, or if you anticipate that to be very seamless because everyone knows what capital lock solutions are; this is just going to be a component of it. Yeah, so the answer would be, and our expectation would be that it would be seamless, because today they use a catheter lock solution, and the way they would use our catheter lock solution will be exactly the same. So it will be seamless from that perspective.
Yes, there was just to be able to determine if there is going to be any learning curve with regard to the adoption of neutral it or if you anticipate that to be very seamless because everyone knows what catheter lock solution, but this is just going to be a component of that.
So the answer would be is our expectation it would be that it would be seamless.
Because today they use a catalog solution in the way they would use our catalog solution will be exactly the same way. So it will be seamless from that perspective, clearly the benefit they get a with a 71% reduction in infection rate will make a huge difference and you know in today's environment, where we are with whats going.
Kosa Baloch: Clearly, the benefit they get with a 71% reduction in infection rates will make a huge difference. And you know, in today's environment, where we are with what's going on around us, infections and the implications of infections on loved ones mean a lot. Great, thank you very much.
And on a route clearly oh infections and the implications on infections on loved one means a lot.
Great. Thank you very much.
Okay.
And we have reached the end of the question and answer session and I will now turn the call back over to co CIO for closing remarks.
Operator: And we have reached the end of the question and answer session. And I will now turn the call back over to Coase. Okay, so before I do a closing, there were other questions that I had received and that I'd like to try to cover on this call. So, let me just get that question. So, let me begin with one question that is pretty prominent in the minds of people.
Okay. So.
Before I do have closed there were other questions that that I had received and that.
That I'd like to try to to cover in this call. So let me just get that questions.
So let me begin with with though one question that of that is pretty much a prominent in the mines of people.
Kosa Baloch: You know, with the recent report that a large quantity of U.S. antibiotics are being manufactured in China, there's likely going to be pressure, that's what the question indicated to us, to require some amount of critical drugs to be manufactured in the U.S. going forward. And so, the question was, will this affect our CMC plan, and if so, what is being done to address it? So, let's start with that question. Phoebe? Thank you, Koso.
The recent report that so a big quantity of US antibiotics are being manufactured in China, there is likely going to be potentially pressure. That's what the person indicated to us to require some amount of critical drugs to be manufactured in the us going forward and so the question was will this affect our CFO.
See plan and if so what is being done to address it so let's start with that question Phebe.
Thank you so.
I think Oh, that's are aware of Covidien 18, and the Corona virus pandemic, that's ongoing and that has certainly made us take precautions related to how we work and business related travel plans. However, cormedix was well aware of potential issues previously.
Phoebe Mounts: I think all of us are aware of COVID-19 and the coronavirus pandemic that's ongoing, and that has certainly made us take precautions related to how we work and business-related travel plans. Previously, we have taken precautions to ensure that our supply chain does not involve China. Nonetheless, we'll continue to closely monitor the situation and make any adjustments that are needed in the future. Thanks, Phoebe. Another question that we got was about the two large hemodialysis chains that participated in the Lockheed 100 trial, that is, basically, Fresenius and DeVita. Can you give some insight into discussions with these or other companies? So yes, both of these hemodialysis chains were part of our landmark study. Yes, they both know Neutralin.
We have taken precautions to ensure that our supply chain does not involve China.
The last will continue to closely monitor the situation then make any adjustments that are needed in the future.
Thanks Avi.
Now the question that we got was you know two large hemo dialysis change that participated in the lock at 100 trial, that's basically Fresenius and Davita can you give some insight into discussions with these or other companies.
So yes, both of these hemodialysis change what part of our landmark study, yes. They both know Neutrolin, there's always been an open dialogue with both of these centers.
Kosa Baloch: There's always been an open dialogue with both of these centers and providers, but it would really be inappropriate for me to share any further information on any discussions with them at the moment. There was another discussion, a question about the status of the NDA submission and how many sections have been submitted. So, Phoebe?
Providers.
But it would really be inappropriate for me to share any further information of any discussions with them at the moment.
There was another discussion question about what is the status of the NDA submission and how many sections have been submitted so phebe.
Yes.
Phoebe Mounts: Yes, as I said during the call, we have informed you that the NDA. FDA will not make a decision on the acceptability of the modules until after all of the modules have been submitted. Our next update will occur once we have accepted the NDA, or, as we mentioned during prepared remarks, if we hear from the FDA that there is some delay imposed by the COVID-19 pandemic due to travel. However, we are still optimistic that we're planning for a potential approval of the Neutral Lens NDA in the second half of 2020. Another question that we got is, could you comment on CMS TDAPA decisions and how they could affect DeVita and Fresenius negotiations in a positive or negative way? Clearly, the payoff strategy will be different if we obtain TDAPA zero.
He said during the call.
We have informed you that the NDA submission has started.
Sta will not make a decision on the acceptability of the modules until after all of the module has been submitted.
Our next update will occur once the FDA has accepted the idea.
Or as we mentioned during prepared remarks, if we hear from the FDA that there is some delay imposed by the cobot 19 pandemic due to travel restrictions symbols certainly provide an update however, we're still optimistic that we're planning for potential approval of Neutrolins, Andy I in the second half.
22 and.
Thanks Amy.
Another question that we got to is could you comment could you comment on CMS de dollar decisions and how it could affect davita and Fresenius.
Negotiations in a positive or negative way.
Clearly clearly the payers strategy will be different if we obtain teed up or not.
Kosa Baloch: We do believe the robust data from the Lockheed 100 study clearly demonstrates to all healthcare providers that implementation of Nutrilin in their catheter dialysis patients should be very carefully considered, as Nutrilin's ability to prevent life-threatening infections fulfills a huge unmet medical need. That will be part of the value proposition that is being developed. Another question that we got was, can you please update the status of the NDA? Is CorMedix on schedule to have the FDA review and give their guidance in the second half of 2020? Phoebe?
We do believe the robust data from the lock at 100 study clearly demonstrates two okay healthcare providers that implementation of new Poland.
In there.
Catheter dialysis patients should be very carefully consider as neutrals ability to prevent life threatening infections fulfills a huge unmet medical need.
That will be part of the value proposition that is being developed.
Another question that we got.
Can you please.
Update the status of the India is core metrics on schedule and to have.
The FDA review and give their guidance in the second half of 2020 Phebe.
Phoebe Mounts: Yes, as I noted during the call and just a few minutes ago, we remain optimistic for a potential approval of the NDA in the second half of 2012-20. However, it's clear that the impact of the COVID-19 pandemic is continuing to evolve and could significantly change FDA's ability to function effectively, which could delay approval. And then just the last question, again, to Phoebe, was that, you know, in light of the current coronavirus pandemic, the huge unmet need out there, has CorMedix had any discussions with government agencies to see how we could contribute to flattening the curve? So, Phoebe? Yeah, we agree that the coronavirus pandemic is imposing disruptions throughout the world, and the government is reacting on a daily basis to minimize the spread of the infection and provide medical resources over the next several weeks. We have not had any discussions with government agencies on redirecting limited resources given the unprecedented situation in which government agencies are operating.
Yes, as I noted during the call in just a few minutes ago, we remain optimistic for potential approval of the India in second half of 20 to 20. However, it's clear that the impact of the coded 19 pandemic is continuing to evolve and could significantly change ft A's ability.
To function effectively which could delay approval.
Thanks, Phoebe and.
And then just the last question again to Phebe was that you know in light of the current Corona Lvarez pandemic.
The huge unmet need out there.
Have core Medix had any discussions with Hyundai agencies to.
To see how we could contribute in flattening the curve so feeling.
Yeah, we agree that the current of ours pandemic as imposing disruption throughout the world and the government is reacting on a daily basis to minimize the spread of the infection and provide medical resources over the next several weeks, we have not had any discussions with government agencies.
On redirecting limited resources, given the unprecedented situation in which the government agencies are operating.
Thanks, Phebe. So those were the questions that we got to in writing our pride two or two.
Phoebe Mounts: So those were the questions that we got in writing. I tried to categorize them into these different groups so that we could answer as many questions as we could. So, for my closing remarks, I'd just like to thank you all for your time and attention. You know, CorMedix remains committed to bringing Neutrolin to the U.S. market to help patients in need of protection from life-threatening infections. The importance of preventing infections is even more apparent now during this coronavirus pandemic.
Categorize them into these different groupings, so that we could answer as many questions as we can so for my closing remarks I'd just like to thank you all for your time and attention in our core Medix remains committed to bringing neutral to the us market 12 patients in need of protection from life threatening infections.
The importance of preventing infections is even more apparent now during this.
Corona virus pandemic. So thank you very much for spending time with us this evening be safe and look forward to seeing your future call Bye bye.
Kosa Baloch: So thank you very much for spending time with us this evening. Be safe, and I look forward to seeing you on future calls. Bye bye. Thank you, ladies and gentlemen. This now concludes today's conference. You may now disconnect your lines. Thank you for your participation, and have a good day.
Thank you ladies and gentlemen. This now concludes today's conference you May now disconnect. Your lines. Thank you for your participation have a good day.
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