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CorMedix, Inc.

Q4 2012 Earnings Call

March 28, 2013 8:30 AM ET

Executives

Richard Cohen – CFO

Randy Milby – CEO

Anthony Pfaffle – Acting Chief Scientific Officer

Analysts

Bruce Walck

Operator

Good morning ladies and gentlemen, and thank you for waiting. Welcome to the CorMedix 2012 Yearend Results Call. Chairman and Chief Financial Officer, Richard Cohen, Chief Executive Officer, Randy Milby and Chief Scientific Officer Dr. Anthony Pfaffle. All lines have been placed on listen-only mode. And the floor will be open for your questions following the presentation.

Without further adieu, it’s my pleasure to turn the floor over to your host Mr. Richard Cohen. Mr. Cohen, the floor is yours.

Richard Cohen

Good morning everyone and welcome to our call. I’m going to now turn the floor over to Randy Milby, our Chief Executive Officer and Randy will take you through the results of our yearend 2012. Randy.

Randy Milby

Thanks Rich. Good morning everyone. What I’d like to do today is summarize the yearend results for December 2012. And then also highlight a couple of the things that are being going on in the fourth quarter and the first quarter of 2013.

So, let me first get started with the year-end results. We finished with a net loss in December of 2012, $3.4 million, this compares to a net loss of $6.7 million in 2011. The reason for this or the driver for this is the refocus on the CE Mark approval for the commercialization of Neutrolin and then Europe. And we’ve refocused all the efforts in that regard.

The general and administrative expense finished at $1.8 million, this is a decrease of $1.3 million from a $3.1 million from yearend of 2011. Here again as we said in our press release we’ve been managing the cash and it’s the change of personnel and we’re managing the cast very carefully to Advanced Neutrolin.

Last but not least, the amount of cash, we finished the year at $800,000 compared to $2 million in 2011. And we’ve done a couple of things as you see in the last quarter as well as 2013 in the cash regard. And that is, we have strived to minimize the dilution to our current shareholders and we will continue this approach as we raise money for the best terms available. And we’re trying to balance our cash needs for launch Neutrolin versus the impact on the existing shareholders.

So, in that regard you see that we raised $500,000 in a private placement in November of 2012, this was part of the second tranche of an aggregate of $1.3 million. In addition, we recently in February, we raised $533,000 on the sale to a current existing institutional investor with our Series A Non-Voting Convertible Preferred Stock.

The other aspect that you see in the press release is that we get – entered in a marketing agreement with MKM Co-Pharma in January. This is for us to take Neutrolin forward within the German market. I spent the last week with Joachim Petrak, who is our Marketing and Sales Director within Germany, visiting dialysis centers. So we intend to work as our own in the Germany market but we have ongoing discussions with other companies in other countries working – trying to determine what’s best for CorMedix as far the distributor relationship with an existing Pharma company versus going alone.

Richard Cohen

Thank you.

Randy Milby

Sure. If I would, I’d just like to provide an update really on the status of the CE Mark and then we can go into questions. So, as you saw in our 10-K we have received a positive response MEB, which is the Medicinal Evaluation Board, which is the clinical aspects of Neutrolin. At the current time we’re working on completing all the information to submit TÜV-SÜD which includes the final packaging and labeling for the designed RCA.

And we stated that we anticipate receiving a CE Mark approval in the second quarter of 2013, unfortunately I can’t control the regulators as far as the timing goes. And we can’t get any more specific guidance beyond this.

That’s it for the highlights. Rich, do you have any comments.

Richard Cohen

No, I think at this point in time Erin, we can open up the floor to questions and…

Randy Milby

Let’s do so please.

Question-and-Answer Session

Operator

Certainly, the floor is now open for questions. (Operator Instructions). We do have a question on the line from Bruce Walck. Bruce?

Bruce Walck

Hi guys, how are you doing?

Randy Milby

Good morning.

Richard Cohen

Hi Bruce.

Bruce Walck

I’ve been through the recent releases etcetera. Is it fair to assume that the technical aspects of the registration are complete and by that I mean, no more science story about – are we simply down to a boxing issue at this point or packaging issue?

Randy Milby

That’s a fair assessment. So as you say in the K, we talk about – and I mentioned earlier about the positive response from the MEB which is Medicinal Evaluation Board that is true. That is the clinical aspect of the – of our application. So anything related to the pharmaceutical has been answered and there are no more questions.

As we also announced in the K, it is a transportation test and packaging and labeling so it’s just fine-tuning several questions with the two before they grant the final approval.

Bruce Walck

Then, I guess the next question is centered around the marketing effort. Is it fair to guess that you’re marketing on in Europe is knocking on doors currently kind of gauging appetite here?

Randy Milby

Right. I just spent a week with Joachim Petrak and we are visiting dialysis centers. We can’t talk about the products because we don’t have the CE Mark but we’re gauging interest at Catheter Lock Solutions. And we’ve brought on and he’s identified other sales individuals that know this space. So, in the German market in particular, it’s fair to say that we are – we are out there least gauging the awareness with our talking about Neutrolin specifically.

Bruce Walck

Okay. And as far as competitive – your product has a couple of things, anticoagulant and antimicrobial. With the exception of CorePharma are there other competitors out there who have similar robustness in their product or most of them just we call it earlier generation products?

Randy Milby

That’s a great question. The standard of care is Hepburn so one thing that you will see is we talk to the dialysis centers, really the competition is Hepburn a Dr. Pfaffle can add a little more to this but the tri-sodium there are other citric products out there but in a center of care is Hepburn at this point.

Bruce Walck

Okay. And do you have any, so if we’re assuming that this product and CorePharma’s products are probably the closest equivalents that of course (inaudible) not there. Do you have any feeling if the marketplace even knows of or understands their products – I was talking about Virgin territories, additional costs things like that that’s actually stepping up into a different kind of product? Do you have an education that we need out there?

Anthony Pfaffle

Bruce, this is Tony Pfaffle.

Bruce Walck

Hi.

Anthony Pfaffle

Good morning, good morning. I think to echo Randy’s sense of belief, we believe that our products once approved will be the best product available to Catheter’s or Catheter Lock Solution use in dialysis. And our product contains the right combination of anti-infectives throughout –the right amount of Hepburn and the right amount of citrates to make it the leading product. And we are approaching it very diligently we’re collecting information. And it is our belief that we can and will dominate the market.

Bruce Walck

Is, without getting any particulars, will the price-point be theoretically dramatically different than existing products?

Randy Milby

We haven’t released any information on the pricing right now. And we are currently doing quite a bit of work that Mr. Petrak is working on as in the pricing area.

Bruce Walck

Okay. That’s all it is.

Randy Milby

The other thing I would say Bruce.

Richard Cohen

I would say, we’re building dedicated models for pricing Bruce and when it’s the appropriate within disclosure we can sit down and discuss those things.

Randy Milby

Yeah, my question was – it’s like most things because more people tend to be hesitant to adopt is always the issue but then of course the savings on the side with the anti-infectives.

Bruce Walck

And this is for Dr. Pfaffle, probably you’re the best qualified to answer this. Is the European model, do they look more at let’s call it cost of care – overall cost of treatment, the idea behind that being – is there a premium for keeping patients healthy?

Anthony Pfaffle

There is an advantage to keeping patients healthy and that’s they don’t miss dialysis injections. And the units, many of them get reimbursed based upon their dialysis injections. And if they are hospitalized of course the system – the whole healthcare system Germany and the rest of Europe more money. So by taking these patients, many of which are diabetic patients with Vasculopathy and inflammatory diseases and giving them the best solution to reduce the infection rate, we believe is overall we’ll say is the entire health system in German and Europe overall. And we’ve giving detailed pharmacoeconomic analysis of that cost savings.

Bruce Walck

And I guess, another – sorry for all the questions.

Randy Milby

Well, those are great questions.

Anthony Pfaffle

If possible, and as soon as we get more and more data we will share it with everyone.

Bruce Walck

And last question I promise. Can you give me a feel for how fragmented European market is, obviously in the States there are two large providers? Are there other organizations of hundred clinics in Europe or are these really single occasion venues?

Randy Milby

I’m not sure of the question Bruce, as far as are you saying they’re dominant players or how?

Bruce Walck

Yeah, for example, are there other owners of hundred clinics in Europe at the time or is it really just locally owned by local doctors or local hospitals?

Randy Milby

It varies. So there is the private, there is the private ownership hospitals and then there is – there are others that are part of the chain. But what we’re finding and this is how we’re working – it tend to be regionalized. So up here in the Frankfurt area for example there may be several clinics linked together.

Bruce Walck

Got it, okay.

Randy Milby

If you’re in Munich, it’s the same. There are some more government funded dialysis centers so there the approval process to get into those takes a little longer. But you can triage and that’s part of the thing that Petrak is working on.

Bruce Walck

Yeah, that was one of question, I was trying to figure out adoption if it’s going to be truly house by house either if it’s possible that if you get one, you might get five from getting the one at some point, okay. Good enough.

Randy Milby

There is – from the key opinion need point of view there is regional pockets of excellence and that’s how we set up our approach.

Bruce Walck

Perfect, okay. I’m done, thank you.

Anthony Pfaffle

Thank you.

Randy Milby

Thanks Bruce.

Operator

(Operator Instructions). It appears there are no further questions at this time.

Richard Cohen

Okay. Thank you very much everyone. And we look forward to your continued support as we move CorMedix forward. Thanks everyone for dialing in. And if you have any questions or things, you can always reach us through our website.

Randy Milby

Thank you very much.

Richard Cohen

Thank you.

Operator

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

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