Q3 2020 CorMedix Inc Earnings Call

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Your conference will begin momentarily. Thank you for your patience, and I ask that you please remain on. Greetings and welcome to the CorMedix Incorporated 3rd Quarter 2020 Earnings Call. During the presentation, all participants will be in a listen-only mode.

Afterward, we will conduct a question and answer session. At that time, if you have a question, please press the 1 followed by the 4 on your telephone. If at any time during the conference you need to reach an operator, please press star zero.

Daniel Ferry: As a reminder, this conference is being recorded for Thursday, November 5th, 2020. I would now like to turn the conference over to Dan Ferry from Lifesci Advisors. Please go ahead.

Unknown Executive: Good afternoon, and welcome to the CorMedix third quarter 2020 earnings conference call. Leading the call today is Kosa Baloch, Chief Executive Officer of CorMedix. He is joined by Dr. Phoebe Mounts, Executive Vice President and General Counsel, and Dr. Matt David, Executive Vice President and Chief Financial Officer. 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 as set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and may include, but are not limited to, any of the following:

Any statements other than statements of historical fact regarding management's expectations, beliefs, goals, and plans about the company's prospects, including its clinical development program and marketing approval for DefendCath in the U.S. and other product candidates; Future Financial Position, Future Revenues and Projected Costs, and Potential Market Acceptance of Defendcast, Neutralink, 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, and projections as to the company's future capital raising and spending and cash position, as well as expectations as to the timing and nature of anticipated regulatory actions, possible product licensing, business development, or other transactions. Any commercial plans and expectations, market projections for our product candidates, and expectations as to manufacturing and product component costs.

Greetings and welcome to the core medics incorporated third quarter of 2020 earnings call. During the presentation. All participants will be in a listen only mode. Afterwards, we will conduct a question and answer session at that time. If you have a question. Please first of one.

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 SEC's website at www.sec.gov or upon request from CorMedix. CorMedix may not actually achieve the goals or plans described in these forward-looking statements, and investors should not place undue reliance on these statements.

Followed by the four on your telephone.

If at any time during the carpets you need to reach an operator, Please press star zero.

As a reminder, this conference is being recorded.

Thursday November 5th 2020, I would now like to turn the conference over to Dan Ferry Some life Sigh advisors. Please go ahead.

Good afternoon, and welcome to the car medics third quarter Twenty-twenty earnings conference call when you.

Didn't call today is kosta below <unk>, Chief Executive Officer of car medics. He is joined by Doctor Phoebe mounts Executive Vice President.

In General Counsel and Doctor, Matt, David Executive Vice President and Chief Financial Officer.

Before we begin I would like to remind everyone that during the call management may make what are known as forward looking statements within the meaning set forth 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.

Unknown Executive: 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.

Any statements other than statements of historical fact regarding management's expectations beliefs goals and plans about the company's prospects, including it's clinical development program and marketing approval for defend cats in the U S and other product candidates.

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

Future financial position future revenues and projected costs and potential market acceptance defend calf H O N 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.

The four topics I will cover are regulatory, our Board of Directors update, commercial planning, and our Annual Meeting Logistics. So let me begin with the first point, which is regulatory.

And projections as to the Denise finally at future capital, raising and spending and cash position.

[noise] expectations as to the timing and nature of anticipated regulatory actions.

Unknown Executive: As we disclosed on August 31st, 2020, the submission to the FDA of the new drug application or NDA for different care, which was completed in June, has been accepted for filing, the FDA-granted priority review, and set a Prescription Drug Use Act, PDUFA, date of February 28, 2021. We are delighted to have a review period that is shorter than the 10-month standard review and appreciate the hard work of the CorMedix team to achieve this accomplishment.

Possible product licensing is this development or other transactions any commercial plans and expectations market projections for our product candidates.

And expectations as to manufacturing and product component costs.

Actual results may differ materially from these projections or estimates due to a variety of important factors, including but not limited to uncertainties related to clinical development regulatory approvals and commercialization.

These risks are described in greater detail and chromatics filings with the SEC copies of which are available free of charge at the S. E. C. S website at Www Dot S. U C dot gov or upon request from Chromatics Chromatics may not actually achieve the goals or plans described in these forward looking statements and.

Unknown Executive: As mentioned in our August 31, 2020 press release, the FDA also noted that it was planning to hold an advisory committee meeting to discuss the application, and that it had not identified any potential review issues at that time. During this call, Phoebe will provide you an update on the advisory committee. The second item that I'd like to update you on is the changes at the board level. As you saw in our press release of September 17, Paolo Costa has joined the CorMedix board. Paolo is a tremendous addition to our board, given his decades of leadership experience in the pharmaceutical sector and significant strategic experience gained, in part, during his time spent as chairman of Amelin Pharmaceuticals through a successful sale to BMS and AstraZeneca.

Vester should not place undue reliance on these statements. Please.

Please note that chromatics 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 Mister Xhosa below <unk>, Chief Executive officer of corn medics co. So please go ahead.

Thank you that.

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

On today's buildings call, we will discuss several topics with you on the overall progress.

Medical cause making in bringing defend cats to the U S market boy spoke indication for use as a Katherine rock solution for hemodialysis patients to prevent calculated bloodstream infections with subsequent expansion into other indications.

Joining me on this call R P D and Matt.

The four topics I will cover a regulatory.

Our board of directors update commercial planning and our annual meeting logistics. So let me begin with the first point, which is regulatory.

Unknown Executive: Paolo's leadership experience includes his time as president and CEO of Novartis, a U.S. corporation, from 2005 to 2008, and President and CEO of Novartis Pharmaceuticals, Inc. from 1999 to 2005. Prior to joining Novartis, Paulo spent 30 years at Johnson & Johnson, including as president of its pharmaceutical business. We also announced on November 2nd that Mahmoud Khan, who has been a board member for the last three years, has stepped down due to policies related to his new role and responsibilities within an investment organization. Well, I'm disappointed that Mahmoud had to step down.

As we disclose on August 31st 2020, the submission to the F. D. A off the new drug application or N D. H will defend cat, which was completed in June has been accepted for filing.

In addition, yep, yeah granted prior to review.

And set a prescription drug use <unk> <unk>.

Date of February 28, 2021.

We are delighted with a review period that is shorter than the 10 months standard review and appreciate the hard work of the car.

Medical <unk> to achieve this accomplishment.

As mentioned in our August 31st 2020 press release.

The F. B I also noted that it is planning to hold an advisory committee meeting to discuss the application and that it had not identified any potential review issues at that time.

Unknown Executive: I very much appreciated the insight and advice Mehmood had provided over the years. I wish Mehmood continued success and thank him both personally and on behalf of CorMed. Replacing Mehmood is another pharmaceutical industry veteran, Greg Gump, who brings decades of senior executive commercial experience across a range of medicines, as well as strategic leadership experience. Greg has spent the majority of his career in senior leadership roles in commercial-stage pharmaceutical companies, including serving as president of UCB's North American Biz. In addition to acting on the executive committee and guiding the strategic direction for the company's specialty biopharma business, Greg was responsible for managing a multi-billion dollar global business and overseeing the launch of multiple new products. Prior to his roles with UCB, Greg spent approximately 18 years at Pfizer, where he gained significant experience across sales and marketing functions, including serving as Senior Vice President of U.S. Marketing and later as President of Pfizer's Latin American business.

During this call Phoebe will provide you an update on the Advisory Committee.

The second item that I'd like to update you on is the changes at the bold level.

As you saw in a press release off September 17th follow costs that drawing the core medics Bowl.

Barlow is a tremendous addition to a bold given his decades of leadership experience and the pharmaceutical sector and significant strategic experience gained in pot. During this time spent as chairman of Amylin pharmaceuticals fluids.

Blue was successful failed to be M S and astrazeneca.

Paulos leadership experienced include this time as president and C off Novartis <unk> Corporation for 2005 to 2008, and President and see off Novartis pharmaceutical U S from 1999 to 2005.

Prior to joining Novartis Palo spent 30th at Johnson, and Johnson, including as President office pharmaceutical business.

Okay.

We also announced on November 2nd set my mood <unk>, who has been a board member for the last three years has stepped down due to policies related in his new role and responsibilities within an investment organization.

While I'm disappointed that my mood had to stabbed uhm I'd very much appreciated the insight and advice Mehmood had provided over the years.

I wish men with continued success and thank them, both personally and on behalf of core medics.

Replacing memo is another pharmaceutical industry veteran Greg Duncan, who bring decades of senior executive commercial experience across a range of medicine as well as strategic leadership experience.

Unknown Executive: The addition of Paolo and Greg to our CorMedix board further augments the expertise in commercial and corporate strategy at the board level and will be invaluable to CorMedix as we plan our progression into a commercial stage company over the year ahead. On the third item, during the last quarter, the CorMedix team continued to prepare for DefendCat's anticipated commercial launch and continued to have discussions with many key players in the dialysis space, including dialysis organizations and CMS. The interactions have been positive and clearly positioned CorMedix to ensure that once DefendCap is approved by the FDA, it will be in the best possible position to successfully launch in the U.S. market. And finally, on the fourth topic, I'd like to highlight that our upcoming annual meeting is scheduled for December 16. Due to the ongoing pandemic, we're planning to hold it virtually.

Greg has spent the majority of as Korea, and senior leadership roles and commercial state pharmaceutical companies, including having served as president of Ucb's North American business.

In addition to acting on the Executive Committee.

And guiding the strategic direction for the company specialty Biopharma business, Greg was responsible for managing a multibillion dollar global business and oversee the launch of multiple new products.

Unknown Executive: The agenda will include the director's re-election and re-confirmation of our audit. With that, now, let's move on to the first topic, the Regulatory Update. Phoebe.

Phoebe Mounts: Thank you, Koso. I'm happy to report that FDA's review of the DEFENDCAP new drug application is continuing expeditiously due to the engagement of FDA's review team and the tremendous effort of the CorMedix team. As noted by COSO, we are very grateful for the dedication and ongoing efforts of the CorMedix team to bring Defend-Caf to the U.S. market and address the unmet medical need for reducing catheter-related bloodstream infections. As I have stated on the previous earnings call, it is important to remember that the goal for completing the priority review by the PDUFA date is truly a goal and can be shorter or longer than the February 28, 2021 PDUFA date for the priority review.

Course, it F D. As review of the defend cast new drug application is continuing expeditiously due to the engagement of F. D. As review team and a tremendous effort of the core medics Jean.

Phoebe Mounts: As noted by COSO, FDA intends to consult an advisory committee during the review of the DEFENDCAP NDA. FDA has now tentatively scheduled the meeting of the Antimicrobial Drugs Advisory Committee for January 14, 2021, to discuss the Defend-CAF NDA. When FDA accepted the submitted NDEFENCAS NDA for filing, it informed CorMedix that it intended to consult an advisory committee and that it had not identified any review issues at that time. During review of initial product approvals, supplemental indications, or safety actions, FDA can rely on a panel of independent external experts to respond to specific FDA questions. The decision to involve an advisory committee is usually at the discretion of the division director and is intended to help FDA make appropriate scientific decisions. FDA reviewers complete the review of a new drug application and identify questions for the advisory committee. However, as the name suggests, it is an advisory committee, and FDA may or may not follow its recommendations.

As noted by coast. So we are very grateful for the dedication is ongoing out for till the core medics team to bring to fend calf to the U S market and address the unmet medical need a producing catheter related bloodstream infections.

As I have stated on the previous earnings call. It is important to remember that the goal for completing the priority review by the to do for date is truly a gold and can be shorter.

Anger send the February 28, 2021 could do for date for the priority review.

As noted by come so.

F D. A intends to consult an advisory committee during the review of the defend Cats N D. A.

F D. A has now tentatively scheduled the meeting of the anti microbial drugs Advisory Committee for January 14th 2021.

To discuss the defend cast India.

Would that be a accepted the submitted and defend cast N b a for filing it informed cormac <unk> that is intended to consult an advisory committee and that had not identified any review issues at that time.

During review of initial product approvals supplemental indications or safety actions F. B I can rely on a panel of independent external expert to respond to specific F. D a questions.

The decision to involve an advisory committee is usually at the discretion of the division director as it is intended to help F D a make appropriate scientific decisions.

F D. A reviewers complaint to review of a new drug application and identify questions for the Advisory Committee how.

Phoebe Mounts: Because of the ongoing coronavirus pandemic, the meeting will not be face-to-face but rather will be conducted using FDA's online teleconferencing platform, which is currently in use for advisory committee meetings. Because of the COVID-19 pandemic, FDA has been employing video conferencing for advisory committees, and we have been discussing the parameters of the meeting with the staff at FDA, who are responsible for conducting advisory committee meetings. Information for this meeting has not yet been made publicly available by FDA. An announcement by FDA will be made in a Federal Register Notice and will be available on FDA's website. No information on questions to be posed to the advisory committee is available now, but it will be publicly available within a few days before the meeting.

However, as the name implies it is an advisory committee and F. D. A may or May not followed the advisory committee's recommendations.

Because of my ongoing coronavirus pandemic.

Meeting will not be face to face, but rather will be conducted using F. T. A online teleconferencing platform, which is currently in use for advisory Committee meetings.

Because of the COVID-19 pandemic F. D. A has been employing video conferencing for Advisory Committee and we have been discussing the parameters and the meeting with the staff that F. D. A who are responsible for conducting this advisory committee meetings.

Information for this meeting has not yet been made publicly available by F. D. A.

And announcements by S. P. A will be made in a federal register notice and will be available on F. D A's website.

No information on questions to be posed to the advisory Committee is available now.

And will be publicly available within a few days before the meeting.

These meetings are open to the public and information on connecting to the meeting will also be posted by F. D. A on its website, which is W. W. W. Dot F D a dot gov.

Phoebe Mounts: These meetings are open to the public, and information on connecting to the meeting will also be posted by FDA on its website, which is www.fda.gov. We, of course, have begun preparing briefing materials that will be provided in advance to the advisory committee. FDA will similarly prepare a briefing package for the advisory committee. Briefing materials from both CorMedix and FDA will be posted on FDA's website before the meeting. We have also begun preparing individuals who will be presenters at the meeting and will be responders to questions. The advisory committee meeting is a critical part of the FDA approval process for new drugs and will be an important focus of the CorMedix regulatory team going forward. With that update, let me pass the floor to cover financial results and our recent financing activities. Thanks, Phoebe.

We of course have begun preparing briefing materials that will be provided in advance to the advisory Committee.

F D. A will similarly prepare her breathing package for the Advisory Committee.

Briefing materials from both core medics and F. D. A will be posted on F. D. A's website before the meeting.

We have also begun preparing individuals who will be presenters at the meeting and will be responders questions.

The Advisory Committee meeting is a critical part of the F. D. A approval process for new drugs and will be an important focus of the core medics regulatory team going forward.

What was that update that'd be password, Florida mapped to cover financial results in a recent financing activities Matt.

Thanks Baby I'm pleased to be here today to provide an overview of our third quarter financial results as well as an update on recent financing activity. The company is just file. This report on foreign Thank you for the third quarter and nine months and it's September 30th 2020.

Matthew T. David: I am pleased to be here today to provide an overview of our third quarter financial results, as well as an update on recent financing activity. The company has just filed its report on Form 10-Q for the third quarter and nine months ended September 30, 2020. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our third quarter 2020 financial results, Our net loss was approximately $6.6 million, or $0.22 per share, compared with a loss of $5.3 million, or $0.22 per share, in the third quarter of 2019, excluding the impact of one-time items in 3Q19. The higher net loss recognized in 2020 compared with 2019 was due to increased expenses related to our preparations for DefendCat's commercial launch; we recorded increases in both SG&A as well as R&D.

I urge you to read the information contained in a report for a more complete discussion of our financial results.

With respect to our third quarter of 2020 financial results.

Our net loss was approximately 6.6 million or 22 cents per share compared with a loss of 5.3 million or 22 cents per share in the third quarter of 2019, excluding the impact of one time items and three Q 19th.

The higher net loss recognized in 2020, compared with 2019 was due to increased expenses related to our preparations for defend cats commercial launch we recorded increases in both SG&A as well as R&D expenses.

Matthew T. David: Operating expenses in the third quarter of 2020 increased approximately 28 percent to $6.6 million compared with $5.2 million in the third quarter of 2019. R&D expense increased by approximately 16% to $2.9 million, driven primarily by additional staffing costs and an increase in costs related to the purchase of raw materials and manufacturing of Defendcast for commercial launch. SG&A expense increased approximately 40% to $3.7 million compared with $2.6 million in the third quarter of 2019.

Operating expenses in the third quarter of 2020 increased approximately 28% to 6.6 million compared with 5.2 million in the third quarter of 19.

R&D expense increased by approximately 16% to 2.9 million driven primarily by additional staffing costs and an increase in costs related to the purchase of raw materials and manufacturing of defend cats for commercial lunch.

SG&A expense increased approximately 40% to 3.7 million compared with 2.6 million in the third quarter of 2019. This increase was driven by increased cost related to market research and preparation for the potential approval defend cast and higher staffing costs due to.

Matthew T. David: This increase was driven by increased costs related to market research in preparation for the potential approval of FENCAS and higher staffing costs due to additional hires. We recorded net cash used in operations during the third quarter of 2020 of $7.3 million, primarily driven by increases in operating expenses due to R&D expenses related to the cost of manufacturing DefendCap prior to its potential approval and SG&A expenses related to market research in preparation for the potential approval. This compares with net cash used in operations of $4 million that we recorded in the third quarter of 2019. We reported $37 million in cash and short-term investments on September 30th.

Additional hires.

We recorded net cash used in operations during the third quarter of 2020 of 7.3 million, primarily driven by increases in operating expenses due to R&D expenses related to the cost of manufacturing defend cap prior to its potential approval and SG&A expenses related to market research and preparation.

And for the potential approval.

This compares with net cash using operations Ah 4 million, we recorded in the third quarter of 2019.

We reported 37 million in cash and short term investments at September 30th. In addition, we have generated net proceeds of approximately 4.6 million through selling shares via our a T. M program following the quarter clothes.

Matthew T. David: In addition, we have generated net proceeds of approximately $4.6 million through selling shares via our ATM program following the quarter close. Pro Forma cash, including cash on the balance sheet at September 30, 2020, and net proceeds from the recent ATM issuance, is approximately $41.8 million, and roughly $2.1 million less than the Pro Forma cash described during our 2Q earnings call. We believe we have the funds necessary to continue our operations beyond the coming 12 months. On our second quarter earnings call, we highlighted that a key goal of the company was to continue to broaden our recognition and awareness among the financial community. We are pleased to be able to share that two banks, Truist, previously called SunTrust, and J&P Securities, initiated research coverage of CorMedix during this quarter.

Matthew T. David: Given their fundamental analysis of the company and their dialogue with the institutional investor community, we note that these activities should continue to help attract investors to follow the DefendCat story. Today, CorMedix has also followed a refreshed universal shelf, which, once declared effective, will give the company significant flexibility in the types of capital raising that it can explore over the coming years. As you may be aware, CorMedix used most of the remaining 2018 shelves in completing our July 2020 equity offering.

Matthew T. David: So we believe, as with many of our peers, that having a shelf life is good corporate health. While we have described that the company has sufficient resources to extend into the fourth quarter of 2021, we also must ensure that the company is appropriately capitalized to allow us to ensure a robust commercial launch of FANCAF upon regulatory approval. With that, I would like to pass the floor back to Cody.

Unknown Executive: Thank you, Matt. As I've stated, our goal is to maximize shareholders' value because hemodialysis is a very concentrated pair provider market.

Unknown Executive: We continue our preparation to commercialize defense care from the U.S., whether on our own or with a commercial partner or other party if a favorable transaction is available. All options are on the table and will be evaluated with maximizing shareholder value in mind. We are now focusing a great deal of our energy on engaging specifically with the various stakeholders within the dialysis market and continuing our discussions with dialysis 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 venous catheters.

All with a commercial partner.

The other party, it's a favorable transaction is available.

All options on the table and will be evaluated with maximizing shareholders value in mind.

We are now focusing a great deal of energy on engaging specifically with the various stakeholders within the dialysis market and continuing our discussions with the dialysis providers and with payers, including CMS.

This will provide core metrics 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.

Unknown Executive: I believe that should DefendCat be approved by the FDA, it could rapidly become the standard of care in the U.S. So, let me summarize the key takeaways from this call. What Phoebe and Matt covered with you hopefully provides you with insight into the effort on which we are focused and that has been accomplished over the last couple of months. I'm pleased about the progress we're making despite challenges imposed by the coronavirus pandemic. I'd like to re-emphasize.

Unknown Executive: I'm delighted that the NDA has been accepted for filing an ongoing priority review. We eagerly look forward to the FDA's Advisory Committee meeting on January 14. We're also pleased with the addition to the CorMedix board.

Unknown Executive: The new members bring experience and insight as CorMedix evolves into a commercial-stage company in the U.S. And finally, our outreach efforts continue, and our focus is on the payer contracting side for CorMedix. And these efforts clearly prepare us to launch DefendCast into the hemodialysis market in the U.S. upon FDA approval. A reminder that while we are initially focused on the hemodialysis market, we are determined to seek additional indications for different uses in catheters for oncology and TPN patients. We've had previous discussions with the FDA on clinical trial designs 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-related bloodstream infections in these additional patient groups and executing on these plans on a post-approval basis.

Discussions with the F D. A on clinical crowd designs for use as a catalog solution in oncology and T. P M patients.

And are working to develop the protocols with a goal of finalising the regulatory pathway for reducing calculated bloodstream infections, India's additional patient groups and executing on these plans on a post approval basis.

In confusion updates going forward will be around the following key events. The F D Advisory Committee.

Unknown Executive: In conclusion, updates going forward will be around the following key events, the FDA Advisory Committee, the anticipated and approval by the FDA, DEFENDCAT launch, and successful PDAPA approval. I look forward to providing you with material development updates via the CorMedix website, press release, and conference call. I'd also like to note that as of November 16th, The physical address for CorMedix will be Inc. 300 Colony Avenue, Colony Drive, Suite 4200, Berkeley Heights, New Jersey, zip code 07922.

The anticipated N D approval by the F D a diff.

Defend cats raunch and successful TDAP approval.

I look forward to providing you with material development updates via <unk> website press release in conference call.

I'd also like to note that as of November 16th the physical address for cosmetics will be.

Cosmetics ink 300 currently Avenue a call any dry sweet four 200, Bertie Heights, New Jersey ZIP code 07922.

Thank you for your continued support of cord medics.

Unknown Executive: Thank you for your continued support of CorMedix. Now, let me pass the floor over to the operator, Grant. Thank you. And if you would like to register a question, press the 1 followed by the 4 on your telephone keypad right now. You will hear a three-tone prompt to acknowledge your request.

With this let me pass the floor over to the operator grumped.

Thank you.

And if you would like to register a question.

Rest of one followed by the four on your telephone keypad right now you'll hear a three tone prompt to acknowledge a request.

Two question has been answered and you would like to withdraw your registration. Please press. The one followed by the three and one moment. Please for the first question.

Jason Nicholas Butler: If your question has been answered and you would like to withdraw your registration, please press the 1 followed by the 3. One moment, please, for the first question. The first question comes from the line of Jason Butler with JMP Securities. Please proceed with your question. Hi, thanks for taking the questions. The first one, just on the regulatory review, you said, so obviously, Defencaf would be the first CLS product to be approved with anti-infectious efficacy.

First question comes from the line of Jason Butler was JMP Securities. Please proceed with your questions.

Hi, Thanks for taking my questions. The first one to some the the regulatory review you said, so obviously to think that would be the the first CLS broke be approved with and two factors efficacy could you maybe just common and in that context.

What you might expect an AD calm the upcoming you had come to to focus on and then secondly closer you you mentioned willingness to explore potential <unk> commercial partnerships or strategic alliances can you maybe give us some more color on what you would be looking for in that kind of relationship. Thanks.

Unknown Executive: Could you maybe just comment in that context on what you might expect the upcoming adcom to focus on? And then, secondly, you mentioned a willingness to explore potential commercial partnerships or strategic alliances. Can you maybe give us some more color on what you would be looking for in that kind of relationship?

Thank you Jason for the first question I lost C V. If you can respond.

Certainly thank you for the question, Jason as I said in my comments and we don't have any inside at this time on the specific questions that F. B I will be posing that comes much later in the process.

Unknown Executive: Thank you, Jason. For the first question, I'll ask Phoebe if she can respond. Certainly. Thank you for the question, Jason. As I said in my comments, we don't have any insight at this time on the specific questions that FDA will be posing. That comes much later in the process as the review team works through the NDA. The process is very much ongoing at this time. Most of the questions, as you know from looking at previous advisory committee meetings, focus on the clinical data and determining whether or not that provides substantial evidence of safety and effectiveness for product approval. I would note that this is a first in class product. This is the first time Tirolidine will have been approved by FDA as a new drug.

As the review team works through the N B a.

Process is very much ongoing at this time.

Most of the questions as you know from looking at previous Advisory Committee meetings focus on the clinical data and determining whether or not that provide substantial evidence of safety and effectiveness for private approval I would note that this is the first in class product. This is the first time trawling.

We'll have been approved by T. A.

A new drug uhm, so it's not uncommon for first thing class products to go before an advisory Committee.

Thanks Phoebe.

And to your second part of your question, Jason We've articulated in the past that we look to prioritize the creation of long term value for our shareholders.

To this effect, we will continue to explore all options in order to maximize the commercial value of defend cats once a pool.

Remember that you know hemodialysis, a pretty concentrated market and therefore can suddenly be covered by modest sized commercial footprint for a successful launch and hence we have stated that all options out on the table and we will consider or whatever.

Phoebe Mounts: So it's not uncommon for first-in-class products to go before an advisory committee. Thanks, Phoebe. And to the second part of your question, Jason, we've articulated in the past that we look to prioritize the creation of long-term value for our shareholders. To this effect, we will continue to explore all options in order to maximize the commercial value of DefendCast once approved.

Ideas partners bring forward to us they will carefully be considered an shed with the bold.

Okay, great Congrats on all the progress and thanks again for taking the questions.

Thank you Jason.

And the next question is from the line of Julian was true Securities. Please proceed with your question.

Yes, Hi, all this is actually less uhm for June congrats on the quarter and the acceptance of the N D. A so first you had two additions to the board, but can you comment on expectations for additional hires ahead of the launch and also can you provide some more details on the steps you have taken thus far.

Unknown Executive: Remember that, you know, hemodialysis is a pretty concentrated market and therefore can certainly be covered by a moderate sized commercial footprint for a successful launch. Hence, we have stated that all options are on the table, and we will consider whatever ideas partners bring forward to us. They will be carefully considered and shared with the board. Okay, great. Congratulations on all the progress and thanks again for taking the time to answer the question. Thank you, Jason.

Preparing for commercial launch assuming approval and I have a follow up.

Okay Uhm, so I don't need to go over the addition to board members that we've added clearly that brings bold commercial and and strategic leadership experiencing the capabilities to the board in the pharmaceutical space.

Tons of highest we have added a couple of individuals over the last quarter, specifically in medical affairs and supply chain that were critically needed. The preparations we have focused so so far today has been in the pale space and medical.

Joon So Lee: And the next question is from the line of Joon Lee with Truist Securities. Please proceed with your question. Yes, hi everyone. This is actually Les for June.

Unknown Executive: Congratulations on the quarter and the acceptance of the NDA. So first, you had two additions to the board. Can you comment on expectations for additional hires ahead of the launch? And also, can you provide some more details on the steps you have taken thus far in preparing for commercial launch, assuming approval? And I have a follow-up. Okay, so I don't need to go over the addition of board members that we've added. Clearly, that brings both commercial and strategic leadership experience and capabilities to the board in the pharmaceutical space. In terms of hires, we have added a couple of individuals over the last quarter, specifically in medical affairs and supply chain, that were critically needed. The preparations we have focused so far today have been in the payer space and medical affairs, and we have the leadership in place for both those parts of the organization.

Unknown Executive: And we have done quite a bit of work in the payer space, specifically to ensure that we are able to take the necessary steps that are required when we get approval for different caps in the US market. Thank you. That's helpful.

Yeah.

The second part of your question was about the pommel.

Pharmacodynamics data.

June.

Yes.

Phoebe could you take that question did they give me the form of economic data.

Unknown Executive: And then lastly, how are you thinking about pricing for FEMCAF, and when can we expect to learn more about the pharmacokinetic data? Thank you.

Oh <unk> economic data like I said, we're working on putting that together right now the formal quake genomic data.

Okay. That's very helpful. Thank you.

Unknown Executive: So, let me cover the pricing. You know, our team has been pretty much focused on doing the work required on the payer side of the market. So, we have spent time understanding, doing work, and research, understanding the clinical and economic value of DefendCast for most patients and the healthcare system, health economics publication data, and evaluating the optimal reimbursement scenarios across the portfolio. We have not yet finalized on a price, and we will do that closer to approval and launch. The second part of your question was about far more important pharmacodynamic data. Julie?

Thank you.

Unknown Executive: Yes. Phoebe, could you take that question? about pharmacoeconomic data?

Phoebe Mounts: Like I said, we are working on putting that together right now, the pharmacoeconomic data. Okay, that's very helpful. Thank you. Thank you. And the next question comes from the line of Andrew DeSilva with B. Reilly. Please proceed with your question. Hi, good afternoon. This is Noreen Kibriyan on behalf of Andy.

Yeah, both of them are clinical and economic perspective, and all view is that we have a legible for TDAP of coverage and clearly we bring and fill a huge unmet medical need and the farmer Quake economics data, we have will clearly show that to see M. S.

Andrew DeSilva: Thanks for taking the question. So, as it relates to obtaining Tdapa designation, it looks like only very limited success has taken place to date, primarily with Amgen. Can you run us through the gives and takes on obtaining the designation? Does Defencap being a catheter lock solution matter as we think about Tdapa's text that notes new injectable or intravenous drugs are what will be considered for the designation? Yeah, so number one, and thanks for your question. Number one is that the QDAPA program is relatively new. Amgen applied and got two of their products onto the TDAPA reimbursement program. Unknown Speaker

Unknown Executive: ........

Unknown Executive: We've had meetings with CMS, we've introduced the company, and we've introduced DefendCap and our perspectives regarding TDAPA eligibility. CMS has been very clear, the TDAPA eligibility criteria are well posted on their website, and we are working very diligently to make DefendCap meet these listed criteria. The determination from CMS will help drive utilization within the dialysis organization and capture the data both from a clinical and economic perspective. And our view is that we are eligible for Tdapa coverage and that we bring and fill a huge unmet medical need, and the pharmacoeconomic data we have will clearly show that to some. Got it, that's helpful. And I realize that, you know, you don't want to talk about pricing until everything's finalized.

I did not.

This is Muslim Forum I was wondering how that.

I was wondering how the preclinical testing for C.M.D. exteriors, everyone go and instead.

Unknown Executive: But is it possible to comment on how you might think about, you know, in terms of the high and low for a potential price in terms of, you know, bundling with TDAPA or low without the designation? Yeah, so we are not giving any guidance on that at the moment. Suffice to say that we are focused on a value-based pricing strategy, so clearly looking at the benefits to the patient and to the health care system. Clearly, T-DAPA designation will help us significantly, and it's gonna be very important for us. So the focus on getting the health economics model and being able to share that with CMS is gonna be a key part of our strategy as we go forward. And clearly, the pricing then will come pretty close to approval and launch.

Unknown Executive: Great. That's helpful. Thank you. That's all for me. And the next question comes from the line of Raja Haram. Salvaraju with H.C. Wainwright. Please proceed with your question. This is Maz on the floor.

Hello.

How is this asset progressing and I was wondering if youve, perhaps explored other funding sources such as from the department of defense.

Raja Haram. Salvaraju: I had a few questions about your other... I was wondering how the pre-clinical testing for CMDX001 is going for your rare PGM? Cancer indication. Hello, Ron. I did not hear the question. This is Mazan Faram.

Okay, and then just probably now based on your questions. We have patent applications around those.

Unknown Executive: I was wondering how the preclinical testing for CMDX001 is going in terms of rare patriotic cancers. Okay, thanks for your question. Phoebe, would you like to cover that? Certainly. We continue our laboratory studies. We're working on various animal models where human tumor cells are propagated in generally immunodeficient mice, and then the activity of the compound can be tested.

Phoebe Mounts: So we are making progress on the animal models, but it's all preclinical activity at this time. Okay, thanks for the update. And perhaps, Phoebe, you could answer this one too.

Unknown Executive: Have you had initial dialogue with the FDA regarding the accelerated 510K device pathway for your medical device opportunity? We have had conversations with the Center for Devices and Rheumatological Health on applications of Tirolidine in Medical Devices, but our focus for the past several years has been on facilitating approval for hemodialysis as a catheter-locked solution. Okay, and one final question about your nanoparticle formulations for the torolidine hydrogels. How is this asset progressing? And I was wondering if you've perhaps explored other funding sources, such as from the Department of Defense? As you probably know, based on your questions, we have patent applications around those potential product development areas. But as I said a few minutes ago, our effort has been really securing approval as a new drug to address the end of medical need for hemodialysis patients. Thanks very much for your color.

So it is properly considered an anti microbial.

Or you could refer to it as an anti bacterial and anti fungal.

But given the commonly used meaning of antibiotic antibiotic would not be appropriate.

Okay. Thank you phebe.

We have an additional question for for met David.

Matt I see that you had initiation of coverage from both Suntrust truest.

Unknown Executive: That's all from me, and I would now like to turn the conference over to Dan Ferry for some written questions. Thank you, operator. I have one for Phoebe here.

And JMP.

Daniel Ferry: Phoebe, why don't you refer to Defencas as an antibiotic? Thank you, Dan. That's a good question, and I think it's not an uncommon question for us.

Phoebe Mounts: Tyrolidine, which is the novel antimicrobial component of Dufencaf, has been shown in laboratory studies to kill both bacteria and fungi. As you probably know, the term antibiotic has come to mean a drug that treats bacterial infections. Defend-CAF is not a treatment but rather a catheter lock solution that's being developed to prevent catheter-related bloodstream infections by killing bacteria as well as fungi that could grow in the catheter and cause the bloodstream infection. So it is properly considered an antimicrobial, or you could refer to it as an antibacterial and antifungal. But given the commonly used meaning of antibiotic, it would not be appropriate.

Daniel Ferry: Okay, thank you, Phoebe. I have an additional question for Matt David. Matt, I see that you have initiated coverage from both SunTrust and Truist and JMT. What is the value of this coverage?

Infections and keeping patients out of hospital is even more of a patterns during the ongoing corona virus pandemic.

Matthew T. David: Sure. Thanks, Dan, for the question from the audience. Yeah, we were pleased to see the initiation, as I mentioned, of coverage by both Truist and JMP Securities in September. And, of course, we thank them for joining us on this call as well. These analysts have done fundamental analysis on the DefendCath opportunity and market potential and have also conveyed their thoughts on the commercial round. In addition, these firms, plus our other covering analysts, have extensive dialogue with healthcare-focused institutional investors, and we expect that their support will help to continue to broaden interest and awareness of CorMedix across the investor community.

With that I'd like to thank you all for your attention and have a good evening.

And that does conclude today's conference. We thank you for your participation and ask that you. Please disconnect your line.

[music].

Matthew T. David: Thank you, Matt. I have no further questions, and I'd like to pass the call back over to Koso Belos for closing remarks. Koso?

Unknown Executive: Thank you again. So, just I wanted to close by saying, you know, CorMedix has an experienced team of executives who have taken pharmaceuticals through the various phases of clinical study, registration, and successfully launched products in the U.S. market. CorMedix remains committed to bringing DefendCat to the U.S. market, whether on our own or with a strategic or commercial partner, to help patients in need of protection from life-threatening infections. The importance of preventing infections and keeping patients out of hospitals is even more apparent during the ongoing coronavirus pandemic.

Unknown Executive: With that, I'd like to thank you all for your attention and have a good evening. And that does conclude today's conference. We thank you for your participation and ask that you please disconnect your line. Erin Mistry, Jason Butler, Gregory Renza, Joseph Todisco, Phoebe Mounts, Elizabeth Masson, Joon Lee, Daniel Ferry, Leszek Sulewski, Joseph Todisco, Phoebe Mounts, Elizabeth Masson, Joseph Todisco, Phoebe Mounts, Joseph Todisco, Phoebe Mounts, Joseph Todisco, Phoebe Mounts, [inaudible] JosephTodisco, Elizabeth Mounts, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts, JosephTodisco, Elizabeth Mounts,