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CorMedix Inc. (NYSEMKT:CRMD)

Q2 2014 Results Earnings Conference Call

August 15, 2014; 09:00 a.m. ET

Executives

Randy Milby - Chief Executive Officer

Harry O'Grady - Chief Financial Officer

Analysts

Scott Henry - Roth Capital Partners

Operator

Good morning ladies and gentlemen and thank you for waiting. Welcome to the CorMedix, Second Quarter Conference Call.

All lines have been placed on listen-only mode and the floor will be open for your questions following the presentation.

Without further ado, it is my pleasure to turn the floor over to your host, Mr. Randy Milby. Mr. Milby, the floor is yours.

Randy Milby

Good morning and welcome to the CorMedix, second quarter 2014 conference call. I will begin by providing you with an update on our commercial strategy and operational progress. Then our new CFO, Harry O'Grady, who is here with me today in New Jersey, will provide a more detailed summary of our financial results.

Harry has just joined CorMedix and he brings with him a strong track record of financial management in operations and business development, he has experience at Mylan in Specialty Pharma business, Catalent Pharma Sterile business, as well as Bayer Healthcare. I look forward to working with him as the company evolves.

I want to thank our Interim CFO and Board Member, Steven Lefkowitz, who has gone above and beyond the call of duty in stepping in to fill this role as we searched for a full time replacement. Steve played a pivotal role not only in managing our financial matters on a day-to-day basis, but also for his significant contributions in structuring financings, reducing the level of our payables and strengthening our balance sheet.

First, I want to remind you that this conference call may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements, other than statements of historical facts regarding the management’s expectations, beliefs, goals, plans or the company’s prospects, future financial position and future revenues and projected cost should be considered forward-looking.

Our actual results may differ materially from these projections or estimates due to a variety of important factors, including uncertainties related to clinical development, regulatory approvals, commercialization and financial condition. These risks are described in greater detail in CorMedix’s filings with the SEC, copies which are available free of charge at the SEC’s website at www.sec.gov or upon request form 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. Please note that CorMedix does not intend to update these forward-looking statements, except as required by law.

Now, to the presentation.

CorMedix is a specialty pharmaceutical and biomedical device company, focused on developing and commercializing therapeutic products for the treatment of infectious diseases in both acute and chronic care settings. Our first commercial product is Neutrolin, which is used to prevent central venous catheter or central line-associated bloodstream infections and thrombosis or clotting.

There are over 15 million central venous catheter patient days in the U.S. alone. Neutrolin contains taurolidine, a potent broad spectrum, anti-effective agent. Its active against Gram-positive, Gram-negative bacteria, including MRSA and fungi, including Candida and heparin, an antithrombotic and anticoagulant. These two agents together are critical to preventing infections and clotting in central venous catheter patients.

Today, I will update you on four key areas of near and longer-term catalysts for CorMedix growth. The launch of Neutrolin in the EU, expanding of product label to include new indications in the EU, expansion beyond the EU and plans for U.S. marketing approval.

As you know we launched Neutrolin in the European Union beginning in Germany in the first quarter of this year. We began our efforts with targeted sampling program to selected key position thought leaders and other practitioners who treat substantial numbers of patients who may benefit from our product. We are continuing with this sampling effort and have worked to enhance the launch in terms of expanding the aggregate number of physician contacts during the quarter.

Since this introduction, while we are not yet satisfied with the rate of product adoptions, we have been encouraged by anecdotal reports from the physicians, both in terms of their discourse with our sales representatives and their market need. We have been working to better understand physician perspectives and to turn these fairly positive anecdotal reports into sales orders by expanding communications with nephrologists and selected oncologists with patients on a central venous catheter.

Outside Germany, as I have said to you on earlier calls, we have evaluated the various markets in the European Union and have paid particular attention to physician attitudes and reimbursement prospects. As such, we are in active discussions with potential partners who had worked with us to obtain country or regional marketing approval to sell Neutrolin in a number of other EU territories.

In January we submitted a package for label expansion to address those patients with a central venous catheter, who had been treated for cancer in a hospital intensive care unit or are receiving total parental nutrition.

This package is under active review by the Netherlands Medicinal Evaluation Board, which is in this case has the regulatory authority to pass judgment on the label expansion for the EU. This review process can take as little as six months, but the precise timing necessary depends upon the reviewer. Having said that, we continue to believe that we will have a decision on this important label expansion before year-end.

Outside the EU we seek to market Neutrolin on a global basis in those territories where there is evident in medical need and adequate reimbursement. And while we expect to partner in most countries, we may decide to establish our own commercial organization in the United States. We are very active in identifying and pursuing commercial partnerships in Asia, Latin America and the Middle East.

In general, we are seeking partners with regulatory and marketing strength that have historically focused upon hemodialysis and in the hospital market, including oncology, intensive care units and total parental nutrition.

We expect to be negotiating a reasonable number of collaborative marketing and distribution agreements in the coming months. Although I do not intend to provide the details of these on a country-by-country basis, I can tell you that I’m very pleased to have just signed a definitive agreement with an established commercial partner, with Wonik Group in South Korea, one of the key markets in East Asia.

As you know, it will take some time to gain regulatory approval to market the product and I will update you on this process. I can tell you that we are working actively to complete similar marketing and distribution agreements, including several territories in the Middle East.

In summary, we continue to have good discussions with a number of global and regional pharmaceutical and medical device companies; however, we will not do a collaboration just to do a collaboration. It has to be with favorable terms. I strongly believe that this is the best commercial strategy for CorMedix and in that it will allow us to introduce Neutrolin to a greater number of hemodialysis and other patients who rely on a central venous catheter as rapidly as possible, while minimizing the cash burn and fixed capital commitments, that would otherwise be required by substantial in-country operations.

As you know, Neutrolin is a Class 3 medical device in the European Union, but the FDA regards it as a drug for purposes of regulatory approval in the United States. To that end, we submitted earlier this year the protocol for a Phase III clinical trial to the Anti-Infective Division of FDAs Cedars drug approval unit.

As announced last night, we are very pleased that the FDA has agreed with the design of our Phase III protocol for Neutrolin in hemodialysis patients and the company plans to submit an IND for Neutrolin within the next 30 days. We hope to commence this study in late 2014 or early 2015.

We expect that the forthcoming study of hemodialysis will include about 600 patients monitored for catheter related blood stream infection and the relevant comparison will be Neutrolin versus Heparin as the control lock.

We are also proposing a smaller Phase III for a new indication in oncology patients undergoing total parental nutrition treatment. We are evaluating clinical research organizations and continuing our discussions with potential strategic partners. These are very important projects and that is in part why we brought Dr. Antony Pfaffle on fulltime.

One encouraging thing to note is that we hope to obtain the qualified infectious disease product status for our product under the GAIN Act. This would extend patent exclusivity by five years above the standard five years for our new chemical entity, along with a pediatric extension. This means that Neutrolin would have a period of exclusivity in the U.S. of as much as ten and a half years from launch.

In summary, we continue to focus on execution. We are in the early phase of commercialization of Neutrolin and are working to expand to other countries. We have submitted the documents for the label expansion in the EU and the new protocol has been accepted for the Phase III trial in the United States, with the IND expected to be submitted in the next 30 days.

We have accomplished much to this quarter. While there is more to do, we are encouraged by the progress evident in these recent successes and I look forward to your questions.

With that, I would like to turn the call over to Harry O'Grady to provide detail on our financial update.

Harry O'Grady

Thank you, Randy. Thank you all again for joining us today. I would like to now review the financial information filed yesterday on our Form 10-Q.

As Randy mentioned during the quarter, we continued our roll out of Neutrolin in Germany and recently signed our first strategic partnership agreement. As mentioned on our last call, we expected our cash burn to increase as we began our commercialization of Neutrolin and as a result we ended the second quarter with a cash balance of approximately $7.7 million. I would like to now review our operating results and financial statements.

For the quarter ended June 30, 2014, we recorded a gain of $3.5 million. Of this amount $5.1 million were non-cash items; a $5.4 million gain for revaluation of derivative liabilities, offset by $400,000 for stock based compensation. It should be noted that the derivative liability gain is directly tied to the price of our stock, which deceased from $2.51 on March 31 to $1.81 on June 30.

The accounting treatment of these derivatives calls for them to be marked-to-market, the change in value flowing through the income statement. So as our stock price rises, the increase in net value shows up as a loss on our income statement. This quarter with the decline in our stock price, the opposite happened resulting in a large gain on our income statement.

Please keep in mind that while this accounting treatment are resultant gains and losses on our income statement this quarter, they are not cash expenses and do not impact our ability to fund operations.

As Randy noted, we just started our commercial operation. Sales in the second quarter were approximately $40,000, while cost of goods was approximately $54,000. The charges of the cost of goods are not ongoing expenses and as far as our sales increase, we anticipate that our gross margins will turn positive.

Property and costs were $1.9 million, comprised of $172,000 for R&D and $1.703 million for SG&A, generating a loss from operations of $1.9 million. Included in these amounts were $400,000 non-cash stock based compensation, resulting in an operating cash loss of $1.5 million, which is approximately equal to as the first quarter.

The SG&A expense funded our European operations and expense related to a variety of other items, including our FDA filing in the U.S., legal and accounting fees, expenses related to our intellectual portfolio and manufacturing cost focus on efficiency improvement.

Based on operations continuing at current levels, we are pleased that we have sufficient capital entering Q3, 2015. This also assumes that we will partner the U.S. clinical trials, not be success on signing any other partnership agreements and not materially alter our current operating expense levels. Our net income was $3.5 million, driven by the chain of fair value derivative liabilities of 5.4.

As noted in our last call these charges will fluctuate quarter-to-quarter, but eventually they would accrue to our equity accounts. On a pro forma basis the $8.7 million of derivative liabilities on the balance sheet were not accounted for as such, our total stockholders equity would have been $7.1 million at June 30, 2014.

Randy Milby

With that we’ll turn it over to questions. Operator.

Question-and-Answer Session

Operator

The floor is now open for questions. (Operator Instructions). We do have a question on the line from Scott Henry, Scott go ahead.

Scott Henry - Roth Capital Partners

Thank you and good morning. I guess starting with EU royalties, roughly 40,000 in the quarter, which was a pretty good jump from Q1, but still pretty low. How should we think about that trajectory in the second half of ’14?

Randy Milby

Thanks Scott. As you heard from Harry, our numbers for the second quarter were not what we expected or hoped; I have to be candid about that. We need to do better, we are still in the early stages of the launch in Germany. Progress has been slower than we anticipated in hemodialysis patients on catheter. One factor is because of the competitive response. We continue to gain patients and the acceptance of Neutrolin and the early adopters have been placing reorders.

So as with any launch, we continue to refine our messages and market under those competitive conditions. There are of course both economic and competitive pressures. But we believe we are addressing these with the product characteristics and target messaging.

We are going to be – Tony and the German team will be very active in German and at the EU conference and meetings. So I think you can still continue to do ramp. Its still as you know, in phases of a launch. It’s really difficult to project.

Scott Henry - Roth Capital Partners

Okay, but you are starting to see reorders already. Correct.

Randy Milby

Yes, we’ve been seeing reorders. So what you’ve seen is on early adopters there have been a number of reorders and part of it depends on the number of patients they have on catheter and so there’s been reorders from a lot of the bigger centers.

Scott Henry - Roth Capital Partners

Okay, that’s certainly a positive sign. Shifting gears to the U.S. market, I mean what is you’re through in terms of – ideally would you like to partner before the trial starts or perhaps get the trail started and partner at that point. When are you looking towards timing of that U.S. partnership relative to visit to the trial?

Randy Milby

So the question is relative to the partnership in the U.S., whether we do it pre or during. Our strategy is to partner before. We have discussions as you know. We’ve mentioned on our earlier calls. We have ongoing discussions with a number of companies.

Now that we have the protocol approved from our earlier discussions, we think that the negotiations with some of these companies will accelerate. That being said, we are also putting external business development people on the task to accelerate the discussions with some of these companies.

Scott Henry - Roth Capital Partners

Okay, great. And then the final question, the deal in Korea, what would be the timeline for getting product on the market there?

Randy Milby

See, they have to go through. The question is there is timeline for the Korean market. They view this product as a medical device and therefore the timeline is a lot shorter. It would take most likely about a year or so to get the regulatory approval, according to their estimates.

Scott Henry - Roth Capital Partners

Okay and how big is that market relative to say Europe or the U.S.

Randy Milby

The hemodialysis in Korea is about the same size, a little smaller than Germany. It’s about 75,000 to 77,000 patients, and the oncology market is 1.2 million patients, about 55% to 60% are solid tumor, so they would be on a catheter.

Scott Henry - Roth Capital Partners

Okay, great. Thank you for taking the questions.

Randy Milby

You’re welcome.

Operator

The next question comes from Mark Kroenke (ph). (Operator Instructions). Mark.

Unidentified Participant

Hey. Hi, good morning guys.

Randy Milby

Hey Mark.

Unidentified Participant

I was wondering if you could comment on the QIPD status. The potential for that and when would that be granted?

Randy Milby

Question is about the QIPD. Tony do you want to take that?

Antony Pfaffle

Sure. Mark, good morning and thanks for getting up early and at the end of the day it is something that we have been working on and once the IND is accepted, then the application goes in right after that, so within the next 60 days.

Unidentified Participant

Okay and then you guys stated that you have cash until Q3, 2015 and so it sounds like based on how sales are going so far that there will be a gap between that point in time and breakeven, and so are you guys anticipating more dilutive financing next year or do you think you can bridge that gap with some of these deals and partnerships.

Randy Milby

The question is based upon our projections in the third quarter of 2015, if there is a gap. We intent to – one of the things we are trying to. You answered your own question and that is some of these partnerships, we accelerate in the partnerships. We do get up front with some of these partnerships. That’s part of the standard of our package. So that’s one of the reasons we are accelerating some of these partnerships and we feel very confident with the discussions we have in the Middle East and that’s why it always takes a little longer that we anticipate.

Unidentified Participant

Okay, and then one last quick question. know I think an issue on a lot of investors minds is the intellectual property issue in Europe and I know you can’t give strategy or details of what you guys are doing, but could you at least give us a timeframe maybe of when we can expect action to be taken on that.

Randy Milby

The question is relative to our IP in the EU. As I said on these calls, before we do hold that positions in the U.S., Europe and other territories. All I can say is we are confident. We have freedom to operate and commercialize our product in the manner we are now doing and that we are evaluating this path position relative to the activities of the third parties and will defend our intellectual property as appropriate.

We have always stated we will defend our intellectual property and our preferences to negotiate versus litigate. So based upon that you can kind of infer that we were under discussions.

Unidentified Participant

Okay. Thanks guys.

Randy Milby

You’re welcome.

Operator

The next question comes from Doug Schewegel (ph). (Operator Instructions). Doug.

Unidentified Participant

Yes, good morning. I had a question or several questions. First with regards to the South Korean regulatory market, when did you file for approval there and where are we at in that process? You stated the timeline, it takes about a year. Where are we at in the process?

Randy Milby

The question from Doug is the timeline in the Korean market. What we’ve done is for them to file, they need selected documents from us. We’ve submitted all those documents to them. We’ve had discussions about this during the negotiations. So once the deal was signed, we sent them all the documents and they will submit. They will keep us informed about when all that is done. All the package has not been submitted as of yet.

Unidentified Participant

Can you give me some granularity on the IND process? How much more challenging or how challenging is that relative to what we’ve got with regards to the recent approval on the clinical trial.

Randy Milby

So the question has to do with a little more color on the IND process. One of the reasons we brought Dr. Pfaffle onboard full time is because he’s jumped in, spending quite a bit on his time on this now. I’ll turn that over to Tony.

Antony Pfaffle

Thank you, Randy. Doug, good speaking with you and thank you for joining the call. Yes, so the IND process is a process, which in the line of progress has been made and we are on the verger of submitting the IND in a matter of weeks. And once we submit it, there will be a 30 day clock and the FDA will get back to us and they will tell us if its been excepted.

And then what happens is our PIND or PIND number or pre IND number gets converted to an IND upon the FDA acceptance of the IND and then we are ready to begin starting the trail. So we have been in close contact with the FDA. We really do appreciate their help and assistance in getting back to us on things like the protocol, which is essential to us filing the IND and we’ve gotten their acceptance to go ahead and file it, and we have been working on it, checking all the boxes on the list. There are numerous boxes, but we well into the process and again, within the next weeks we should be ready to file it, and when we do we’ll announce it.

Unidentified Participant

So again, relative to the process to get the clinical trial design approval, how challenging is the IND process relative to that?

Antony Pfaffle

We think – well, of course we’ll be optimistic, because the FDA has been very positive and we’ve gone back and forth on many conference calls with them from everything from end points to statistics to designs. So we are reasonably comfortable that they know what we are doing and that when the IND is submitted it’s a long list of items. There maybe a request for one of two additional items, I’m not saying that there will be or it may just be accepted out of the box.

Again, I can’t predict, other than that its not like okay, we got approval the other day for the protocol and now we’re going to start on the IND. The IND has been a work in progress now for a number of months. So we are getting ready. We don’t want to submit a half page (ph) application. We want to submit a very detailed one and hopefully that will serve us well and we’ll get a good response.

Randy Milby

So Doug, just for me to interject. As Tony mentioned, the IND has been work in progress and what we did was, we took the IDE as you recall. The interim was originally summated in the medical device and they were moved over to the drug division.

We too the IDE which has a lot of that background information and then we were able to just update it and modify it according to the requirements for IMD. And as Tony said, even during the discussion, when we are talking with then about the protocol design, we had people working on getting the IND prepared and stretching the boxes and filling in the right information.

So we feel pretty comfortable within the next 30 days as Tony said. In all these cases there’s a little back and forth discussions, which is good, because we educate them and they educate us. So we feel as Tony said we are very confident, and that’s why I stated this is within 30 days.

Unidentified Participant

And you still feel they want a timeline to possibly initiate the Phase III trail, assuming reasonably with the IND and being converted from PIND to an IND. Starting the trial in or before the first quarter 2015.

Antony Pfaffle

Yes. We are in the process, Randy and I and a variety of our staff members have been meeting with CROs and EDC or Electronic Data Capture groups that manage the date and we are in the process of eventually selecting one in the short term. So when the IND is accepted, we’ll be ready to hit the beaches running with the CROs. So yes, that timeline is very possible by the end of this year or the first quarter or next year.

Unidentified Participant

Great. And I know you all are very focused with regards to Neutrolin. Could you give us a little more insight with the gel formulation of Neutrolin and its thixotropic properties like with CRMD004?

Randy Milby

So the question has to do with the thixotropic gel. I can hardly say it, but that actually is a great question, because another reason that Tony came on full time is that he is leading a working group on the gel. We feel that the gel has a lot of market opportunities. We’ve met with some dermatologists and some leading physicians and evaluating the different applications of this gel, because we are trying to capitalize upon taurolidine. Taurolidine is the central core for CorMedix and the build out on the taurolidine franchise either through the gel, which we think has a lot of interesting properties for different applications.

Unidentified Participant

Right. Thank you.

Randy Milby

You’re welcome.

Operator

The next question comes from Scott Landrum (ph). Scott, go ahead.

Unidentified Participant

Hey guys, good morning. Nice call and congratulations. Lot of my questions have already been answered. One quick comment, may be Randy if you could. I see that you’ve been buying stock every month. Could you kind of – I know that it was part of your plan and so maybe some of the investors could see that? And kind of talk about what do you think the total market opportunity is here in the U.S., now that we are on the verge of a Phase III trial is. Thank you.

Randy Milby

Thanks Scotty. So the question, besides the comment about my buying stock, you’ll see that on a regular basis. Because I believe in where the company is today and where its going to be and as you look forward, both what we are doing in the EU, what we are doing in Latin America and in Asia and I am also very positive of the opportunities that that we are going to have in the United States.

I’ve been traveling around. I was down visiting with Michael Allon, our Principal Investigator in the University of Alabama, Birmingham. I visited with some physicians yesterday and I think there’s a great opportunity for Neutrolin in this market place, both in hemodialysis, as well as oncology.

Unidentified Participant

All right. Thank you.

Operator

The next question comes from Bruce Walck (ph). (Operator Instructions). Bruce.

Unidentified Participant

Hey, good morning Randy.

Randy Milby

Hi Bruce.

Unidentified Participant

Quick question. Are we still thinking Q3 for the Middle East or are you going to push that a bit.

Randy Milby

The question has to do with when will the Middle East sign some of their agreements. I wish I knew that answer, but right now I have it my model as third quarter, yes.

Unidentified Participant

Okay, good.

Randy Milby

As you now these last months they were in (inaudible) and then pretty much everything shuts down. But people are back and in September they start working, going though their documents. So we do have things well underway with the number of countries.

Unidentified Participant

And do you have any guess for me as far as market size there.

Randy Milby

I mean, it varies country-by-country. There is a pretty large hemodialysis population and also substantial oncology population. So if you look at the GCC, the Gulf Countries, you can kind of compile those. We’ve always believed in our projections and it’s not quite as large as the EU. The EU and the U.S. are about the same size, but it’s a significant market for us.

Unidentified Participant

I’ve been over there. I know it is probably a concentrated market as well. Some of those countries have probably two or three cities where you might have dialysis centers, that’s about it.

Randy Milby

Yes, that’s especially true in the United Arab Emirates and also in Saudi Arabia.

Unidentified Participant

Thank you.

Randy Milby

You’re welcome.

Operator

The next question comes from Doug Schewegel (ph). (Operator Instructions). Doug.

Unidentified Participant

Yes hi. This is directed to Randy or Tony. I noticed with the Phase III trial that we are doing it with hemodialysis and then looking at doing it in a smaller sub-segment with the total parental nutrition or TPN. Is there a reason that we chose TPN rather than the (Technical Difficulty).

Randy Milby

The question is related to the second Phase III trial. So I’ll turn this one over to Tony.

Antony Pfaffle

Okay, Doug, that’s a really good question. The reason is because we’ve done an analysis and we are working with – we can’t identify who they are, but three top tier NCI cancer centers in which we have been in a long term discussion with and they have selected that populating, because the type of central line used to pick one percutaneously lends itself best to following the patents, the type of patents you get that line versus (inaudible) and plant the disk or generally have a better performance scores and we can follow them out for a longer period of time.

So that’s the rational for it as selecting that type of catheter. In TPN patients generally, those are the ones that need to get extra nutrition, whether its post operative, they have a surgical repair for colon cancers or some other procedures and getting TPN to improve their nutrition and wound healing is very important. So those patients tend to be, of course with acceptance in it for the longer period in terms of fighting their neoplasm and their cancer.

Unidentified Participant

Okay, great. Thanks.

Antony Pfaffle

You’re welcome.

Operator

There are no other questions in the queue at this time.

Randy Milby

Okay. Thank you everyone for joining the call and I just want to reiterate once again that we will continue to focus on execution. We are in the early sage of commercialization of Neutrolin and expanding into other countries and we’ll expect to see more news and things coming from us in the near term. Thank you very much.

Operator

This does conclude today's teleconference. You may now disconnect.

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