Greetings and welcome to the CorMedix Second Quarter 2015 Results Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the conference over to your host, Mr. Randy Milby, the CEO of CorMedix. Thank you Mr. Milby, you may now begin.

Good morning and welcome to the CorMedix's second quarter 2015 conference call. I will begin by providing you with an update of our clinical and commercial strategy and operational progress. Then Harry O'Grady, our CFO, who is with me here today in New Jersey, will provide a more detailed summary of our financial results. Dr. Pfaffle, our CSO is also available during the question-and-answer portion of the conference call. 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 management's expectations, beliefs, goals, plans or the Company's prospects, future financial position, 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 and commercialization. These risks are described in greater detail in CorMedix filings with the SEC, copies of which are available free-of-charge at 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. Please note that CorMedix does not intend to update these forward-looking statements except as required by law. Thank you for joining us. I'm encouraged about where we are today and the progress we have made at CorMedix strategically and tactically this quarter and I want to update you on several important areas, clinical, scientific, financial and operational. I believe we are well positioned. First in terms of clinical progress, we have begun working with a PPD a leading clinical research organization to initiate the first…

Thank you, Randy and thank you all for joining us today. I would like to now review the financial information filed yesterday on Form 10-Q. As mentioned on our last call we expect our cash burn to remain really at high levels as we incurred additional research and development activities to support product registration to conduct product future commercialization initiatives and to initiate our program to reduce the future cost of goods sold for Neutrolin. We also incurred legal costs to defend our IP, increased business development activities, and increased our commercial assets in Germany and the Middle East. As a result, our cash spending in this quarter increased slightly versus Q1, 2015 by approximately $100,000 to $3 million. As Randy has mentioned, as of June 30, 2015 our cash and short term investment position improved significantly to approximately $37.5 million driven mainly by the exercise of warrants mainly from the IPO and our options we got in gross proceeds in the quarter of $8.4 million and also with the issuance of 3.6 million shares of common stock under the ATM program we realized net proceeds of approximately $24 million. As of June 30, the company has raised approximately $15 million additionally under the MLB agreement. For Q2 the quarter ended June 30, 2015 we recorded a net loss of 4.1 million. Of this amount $1.1 million were non-cash items mainly consisting of $1 million for stock based compensation and $100,000 charge in connection with modification of certain warrants. Q2 sales were approximately $120,000 which is an increase of approximately $80, 000 from the same period last year and an increase of approximately $89,000 from Q1 2015. This increase was driven mainly by sales in the Middle East most notably Saudi Arabia. In Q2 our cost of goods was approximately…

Thank you, Harry. Operator we will now open for questions.

Thank you. [Operator Instructions] Our first question is coming from the line of Scott Henry with Roth Capital. Please go ahead with your questions.

Thank you and good morning. A couple of questions. For starters you were talking about the LOCK-IT trial. My question is I know you referenced it, but I mean I've gotten all of it, when is it you expect to do an interim analysis?

Hi Scott, this is Randy. The interim analysis will be six months into the study or when half the patients, so it’s a 630-patient study once we get to the half way point we'll do the interim analysis.

Okay and when do you expect that to be?

We're going to start in the fourth quarter, so you can just run the dates from there.

Okay so it is six months from the first patient enrolled or…?

Yes, six months from the first patient enrolled or only half the patients in the study that are enrolled.

Okay.

So that's why I mentioned on the call is that Dr. Pfaffle and PPD are spending a lot of time right now on site selection. Because getting the patients enrolled early is what we're focused on.

Okay. And when you say or do you take the latter of those two dates, are they earlier or…?

The earlier.

Okay.

The earlier and most will be six months from the start.

Okay, perfect. And then second question, when did you, when were you planning on starting this, the Phase 4 trial?

Okay, for registration we're doing two Phase 3 trials and the label expansion trial would follow those two trials. So…

Okay, two will follow approval of the product. It wouldn’t be run prior to approval?

That's correct.

Okay, that is helpful. Shifting over to the income statement, first the cash, the $37.5 million cash as of June 30, any warrants or ATM activity since the end of the quarter or should we think about that as kind of a firm number?

That's a firm number.

Okay, and then looking at the model, R&D certainly continued to go up in 2Q, how should I think about R&D for the rest of the year, should it go up further from these levels or where should I be thinking about that?

I think R&D for the next quarter probably will be around same level and it is supposed to increase and as we start the trial obviously of course will go up.

Okay, and I guess finally, with regards to the ex-U.S. Neutrolin sale, any thoughts on how I should expect that to track over the remaining part of the year, certainly a big jump from Q1 to Q2?

Yes, we're gaining traction in the Middle East mainly, that's really where we're having some success and it is still early with the ramp up there, but as randy has indicated or what we indicated in the Q is we've added some countries [indiscernible] Qatar and we've had some success with Italy [ph] but as I said it is very early in the process, so we're going to keep a close eye on that and hopefully we can continue doing what we've done through the – in the second quarter.

So Scott we'll be in the Middle East we have countries in the queue as far as getting a registration. So as Harry just mentioned, [indiscernible] Qatar and Morocco are countries that we've added and there will be additional in this next quarter we should have more countries coming on line.

Okay great, thank you for taking the question.

Thank you. [Operator Instructions] Our next question is from the line of [indiscernible] a Private Investor. Please go ahead with your questions.

Yes, good morning, gentlemen. I got on the call a little bit late, so I'm thinking my questions are a little redundant, I apologize in advance. Several questions, number one, this may be directed to Harry. How much we have in carry-forward losses for the company?

Doug, I'll have to get you that information. I don’t have it at the top of my head, but I can get that for you.

Okay.

Carry forward from that tax carry forward loss, I have to get that for you.

Okay. I know this also in release, now board member, Janet Dillione or there about I think was the last name. She has been placed there with Manchester security is that correct?

Manchester is an affiliate, that’s hell yet.

Okay that's what I wanted to find out okay. Where are we at in regards to the dermal application COMD 0004?

We've actually made quite a progress. Recently, we've got a number of provisional patents actually that we're working in this space and it once again Doug, we're looking at this from a Taurolidine franchise point of view. So we can't talk a lot of deal about it but we will be filing some provisional caveats frankly in the next couple of weeks. So there has been an effort in this area and the whole point of this is that the Taurolidine franchise capitalized upon this antimicrobial, antibacterial power to Taurolidine and put it in different applications.

Fantastic. You may have discussed this whole bit, but where are we at on the executive search, and this is a particularly time line that you all can given us as far as any clarity or color on it, what type of reception that were received and just general information please?

Well the process is well underway, you can imagine. And frankly, so sooner the better and we're looking for the right person for the job and the board has actually begun interviewing some of the candidates. So it's moving along quickly – I was on the phone with the executives search person just the other day and he has had a number of viable candidates. But I can’t give you, I cannot give you a definite timeline, but I can tell you that’s moving quickly.

Okay, great, where we at with regards to development of JCOS?

Well, one of things we’re doing as far as and then we’re spending a lot more time on reimbursement. As I mentioned in my earlier texts, as far as bringing in people anti-infective experience the from the on the policy level reimbursement we'll work on the holding levels at Washington, but on the ground from the JCOS, which you’re referring to is we've bought in some consultants have done this before in other companies and that process is getting started now.

Great, I appreciate it. Good job guys.

Thank you.

Our next question is from the line of Paul Schneider, Private Investor. Please go ahead with your question.

Good morning Randy and others and thank you for taking my call. I’m curious if you could give us any information about what sort of feedback you got from companies that Evercore approached about actually buying out CorMedix?

Well, I can talk a little bit about the process. I’m not going to go into discuss the details of the process but I would like to just reiterate that in working with top tier investment bank like Evercore, we haven’t have the opportunity to present the company to wide range of firms that might logically consider strategic transaction or collaborative deal of some form. In the end though they were no proposed business combinations or acquisitions and we consider to be the best interest of our shareholders. Other kinds of collaborative structures are still possible and we continued to work with Evercore and consider them. But in summary, we are very confident. We export all opportunities with Evercore. We simply did not get to appoint where viable transaction was in the best interest of the shareholders.

All right and what you currently believe the U.S. market is worth for all – in terms of sales.

So you can see on the web page is positing our presentation on the website the slide that talks about the number of – days and then greater than a $1 billion market opportunity, obviously that’s based upon assumptions of penetration and pricing.

Okay and how long do you think it will take to fully enrolled your Phase 3 trial?

Hi, Paul its Tony Pfaffle, so we are, as Randy had mentioned site selection is a time goal and we brought a lot of very experienced people. The goal is to obviously choose sites where there is high catheter use rate, and high catheter infection rates so that the product can do its work and we believe that the trial and the discipline – on track will begin as Randy say in the fourth have the site selection process carefully worked out which will enhance enrollment and we believe we’ll stay on that schedule which is a 12 months enrollment, six months follow up. It’s possible because it’s in a – driven trial that things precede well, we could complete the trial well before the period, but that’s a possibility. So we are seeing on the current timeline that we’ve mentioned, 12 months enrollment, 6 months followup, but there is again a possibility again I like possibility that it could be done quicker because of the incidence of infections and et cetera.

Okay, one last question, so it sounds like you’re going to be going for sort of rolling approval first with hemodialysis and then for other indications as time passes.

Not really, so we’re staging the oncology TPM second quarter 2016 because it’s a shorter duration study we wanted to get the hemodialysis is a larger, 637 patients were as the oncology smaller fewer sites, smaller enrollment population and shorter duration. It’s a one year study whereas Tony just mentioned, hemodialysis is 18. So we’re staging the start but the finish should have that this it's being situated so that they can finish at the same time, but it is one submission.

Okay so you will one NDA submission at the completion of both Phase 3s.

Yes, right. And if you recall earlier discussion we had there the FDA encouraged us when we present, when we first met with them to pursue another indication in addition to hemodialysis and the reason we believe that they did that was because of the unmet need in this space.

Absolutely as Randy said, it was at the meeting with the FDA where they suggested to us to do a trial another indication because that their belief that it will be valuable to have not just one indication but multiple indications and we believe one of the prime factors is that is currently no known resistance in humans to neutral [indiscernible] and as a result of that, that is why the agency has given us the support into that.

Okay, thank you very much for your time Randy and Tony, I appreciate it.

Thanks Paul. Thank you.

Thank you. [Operator Instructions] Our next question is from the line of Robert Davidson [ph], a Private Investor. Please go ahead with your questions.

Hi gentlemen, can you hear me?

Yes.

Okay. I have actually have two questions, one is I’m just concerned about the amount of sales of Neutrolin currently the product has been approved non-U.S. for over a year now and then that the follow up to that is do we have any idea of what the TauroLock sales are currently in Germany and in the rest of the world? Thank you.

Bob the world addressed Germany as you heard from Harry we are getting traction in the Middle East and the German sales, the launch has been slow as you I acknowledge that, we have change our country sales leadership, the progress was slower than we anticipated due to a couple of reasons, the economic conditions, the competitive conditions and market access pressures. We also didn’t have the resources to conduct the necessary study to reimburse them and we continue to pay the price for this. However, we have been capitalizing upon the data, the Neutrolin usage monitoring programmed data and recently expanded Neutrolin usage monitoring programmed to obtain additional information to support our reimbursement submission. So again we didn’t have reimbursement and also just the competitive conditions. The other aspect of this is that during the Evercore process, we pretty much stopped our BB activity as far as signing up partners, you will see increased activity in that regard now that and this is a result of some of the Evercore work, but I acknowledge the sales are slow in Germany but I would point you to the Middle East, higher capital use rate, higher infection rates and we are getting good traction there.

Okay. And the second part of the question was do we have any idea what the TauroLock sales are right now through TauroPharm rather?

I really got to a private company and so it is just to be an estimate, that is speculation on the sales but I really don’t have solid numbers.

Okay. Thank you.

Thank you. There are no additional questions at this time. I'd like to turn the floor back to management for further comments.

Just wait, just give a few more minutes to see other questions, just give another minute, I guess somebody is dialing.

[Operator Instructions] And we have a question coming from the line of James Weathers [ph] a Private Investor. Please go ahead with your question.

Yes, thank you. Why is it that we only discuss Germany, what about other countries in Europe?

Other countries, yes. Other countries in Europe that we have, we have independent sales reps in Austria and the Netherlands and we discussed Germany is because we have a contract sales organization people on the ground. The personnel we have in Austria is an independent sales rep, they get paid for success. So they are not on our payrolls. They get compensated for sales, and what we find in these other countries is a tender business. So they have to they submit tenders. So that is why you sometimes you will see jump or not and it is because of the cycle of the tender cycle within a country.

As far as patent protection, you have patent protection in which countries in Europe?

Well, we have the CE Mark which enables us to sell in the European Union. We have had discussions with a number of countries, so that is what I said earlier about we put all those type of discussions on hold during the Evercore process. But I do not intend to have a CorMedix office country-by-country. So we are being very selective.

Okay, thank you.

Thank you. Our next question is from the line of Scott [indiscernible] with Aegis. Please go ahead with your question.

Good afternoon – good morning gentlemen. I have quick a question. We got added to the Russell 3000 and so we have got a lot more institutional awareness and holdings in the company, have you started to reach out to those new institutions that are involved in CorMedix and had any dialogs with those institutions?

We haven’t initiated that yet Scottie, it is something that is hard to do with, we are also signing up for more investor conferences that we will be attending to get the visibility of CorMedix particularly now that we are getting started with the Phase 3 clinical study.

All right, excellent, thank you guys.

Thank you. The next question comes from the line of Mark Read a Private Investor. Please go ahead with your question.

Hi, good morning, I just had a question about the, the last several weeks the news has been relating to CorMedix has been full of the notices of class action lawsuits based on the articles that appeared a month or so ago. Do you expect those to be easy to dismiss given the information and the record that you have or is that something that is going to be a significant dream [ph] on the bottom line as time goes on?

Well, I’m not going to comment on the pending legal matter. We have made our disclosure about the lawsuit and it is clear and complete, we have hired experience counsel and we do not believe that the suite has merit.

All right. Thank you very much.

Our next question is from line of Jonathan Long, a Private Investor. Please go ahead with your question.

Yes, I was wondering why CorMedix shows not to respond to that [indiscernible] obviously full of – article is there particular reason?

I noticed some of you believe that we should not respond to these anonymous postings of one persons opinion, but what we wanted to do is focus the company could advance to the product, so it's just advance the Neutrolin to the market and then in the end I believe the stock price will reflect the medical and clinical value of what we're doing advancing the product into Phase 3.

Okay a second part question may be – it's some shareholders I think would wonder if this may have affected our ability to raise funds through the ATM, if it did and anyway negatively impact us with and may be other so – such a person would CorMedix ever consider being part of that?

Restate tenderness question. I’m sorry.

I’m just wondering if this, if the article kind of had a negative financial impact on CorMedix would it ever pursue I think there is active interest in indentifying its individual and maybe other companies are actually pursuing legal action, what the CorMedix consider to being part of that action?

We would have to take that under advisement of counsel.

Okay, thank you.

You’re welcome.

Our next question is from the line of [indiscernible] a Private Investor. Please go ahead with your question.

Hi, good morning. Can you give us an update on the cost of goods and whether we are seeing reductions going forward as the new cost of good initiatives have being implemented? Thank you.

Yes, so this is Harry. We’re in process of working with RC2 on the cost reduction initiative. We should see the impact in 2016. The program is ongoing and should be completed in first quarter of 16 that’s the target right now and we’re hoping that that will bear fruit for us and get it from where we currently are which is more of an OTC type product margin to a pharma margin, so that’s the game plan. Anything else?

There are no questions at this time.

Okay, well thank you every one for dialing in. In summary I just want to re-summarize. This has been a very important period for advancing the company. As you will know Neutrolin is a QIDP product, ran a Fast Track status by the FDA. We expect to initiate the LOCK-IT clinical study in the fourth quarter of this year. We continue to discuss partnership arrangements with various partners and we will execute the clinical development study with a laser like focus. We have completed important product market research studies, and health economic studies. That is going to well position Neutrolin in the future and we will continue to assert our intellectual property rights in the context of the patent infringement not the competition law claims brought in Germany. And Harry just mentioned we have initiated our plan to reduce the cost and then the end, I just want to reiterate, it all comes down to execution and we have added the right staff members to our team that will enable us to do just that, execute, initiate the Phase 3 study. We've brought in people who have done this before. They have anti infective experience. They know how to work through the reimbursement and gain access and the know how to launch anti infective products. So thank you very much for dialing in and we appreciate your support.

Thank you. This will conclude today's teleconference. You may disconnect your lines at this time. Thank you for your participation.