Earnings Labs

CorMedix Inc. (CRMD)

Q1 2015 Earnings Call· Mon, May 11, 2015

$7.58

-3.13%

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Transcript

Operator

Operator

Greetings and welcome to the CorMedix First Quarter 2015 Results. 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. It is now my pleasure to introduce your host Mr. Randy Milby, the CEO of CorMedix. Thank you sir, Mr. Milby you may begin.

Randy Milby

Analyst

Good morning and welcome to the CorMedix's first quarter 2015 conference call. I will begin by providing you with an update of our commercial strategy and operational progress. Then Harry O'Grady our CFO, who is here with me today in New Jersey, will provide a more detailed summary of our financial results. 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 filing 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. This has been an important period for the company. I am excited and encouraged about where we are today and the progress we have made strategically and tactically this quarter. And I want to update you on several important areas. First, we are continuing our multi-pronged effort to assert our intellectual property in Germany. Second, we submitted our second pivotal Phase III protocol to the FDA. We have completed market research studies evaluating the health economics which articulate the value of Neutrolin and we plan…

Harry O'Grady

Analyst

Thank you again for joining us today. I would like to now review the financial summation you saw yesterday on Form 10-Q. As mentioned on our last call, we expected our cash burn to increase as we continued our commercialization efforts in Germany and the Middle East. Increased our business development activities, incurred and increased legal cost to defend our intellectual property and have additional R&D activities to support product registration and future commercialization initiatives. As a result, our cash spending in this quarter increased versus Q4, 2014 by approximately $1.1 million to $2.9 million. With the exercising warrants, demand from the IPO with the 343,75 strike price and options we raised and option in Q1. We raised approximately $6.8 million through March 31, 2015. We ended the quarter with a cash balance of approximately $8.9 million. On April 1 through April 30, our cash position net of market operational spend continue to improve to approximately $18 million driven mainly the excise of warrants and options, which resulted in an aggregate gross proceed with approximately $8 million. And in April, the company filed S3 [ph] sales registration statement for $100 million of securities which include an allocation of 40 million of common shares under an ATM program. On April 8, 2015 the company entered into at the market issuance sales agreement with MLB and company LLC. Under which the company made issuance fell up to $40 million this year to its common stock from time-to-time through MLB acting as agent. Subject to limitation imposed by the company such as the number or dollar amount of shares registered under the registration, statement to which the offering relates. And the company wishes to issues its common stock under the sales agreement. It will notify MLB as number of shares to be issued.…

Randy Milby

Analyst

Thank you, Harry. Operator, now we are available for questions.

Operator

Operator

[Operator Instructions] our first question comes from the line of Dan Trang with Stonegate Partners. Please proceed with your question.

Dan Trang

Analyst

I'm wondering what are some of the opportunities that Evercore has brought to you guys since you guys disengaged them.

Randy Milby

Analyst

Well, as I've stated, we're not going to provide additional details on the Evercore process, but I can tell you, that they've been out they had a target list of companies and as I mentioned on the last quarter call. They had a target list and they reached out to a number of these companies and it's an ongoing process.

Dan Trang

Analyst

Okay and so they're really helping you with your initiatives in the United States, right am I correct?

Randy Milby

Analyst

Well it's actually global because many of the companies that they contacted have an international footprint. Yes because just to remind everyone I have had business development people working on CorMedix for several years. But what Evercore brings is a global footprint they have access to the senior people within a number of companies, where Neutrolin would be a nice fit. So if they have the ability to ring up people at senior levels and initiated discussion right away and that's what they've been able to do for us.

Dan Trang

Analyst

Okay and talking about the injunction, you tried to get for regarding TauroPharm. And I know it's not only would that only pertain to Germany if I'm correct?

Randy Milby

Analyst

That is correct. So what this injunction and damages was for Germany and then the other countries would have to do something separate but the first injunction would have been in Germany only. But that injunction would have, if it would have been granted though they would have to cease operations and pay monetary damages.

Dan Trang

Analyst

Okay, all right. I'll get back in the queue. Thank you.

Operator

Operator

Thank You. Our next question comes from the line of Doug Smegel [ph], private investor please proceed with your question.

Unidentified Analyst

Analyst

Hi, Randy. Had a question with regards to the patent infringement and utility model attempted injunction. As I understand that I read from your queue last night. The expected or projected timeframe for any type of rulings with regards to the patent infringement and the termination from the EPO would be, is it mid-2016 or before mid-2016 and with regards to the utility model. Maybe later this year 2015.

Randy Milby

Analyst

What you've read yes, is correct that's what we've written previously. What we found out today was that, obviously these decisions don't come quickly and from a timeline point of view. The utility model now the patent infringement have been put together. So what I had mentioned in the call is that, now the Mannheim court will await the decision from the European patent office for the patent's validity. So this includes both Doug the patent infringement as well as the utility model before they make their ruling.

Unidentified Analyst

Analyst

So they're waiting to hear the rule - before they make a ruling, they're waiting to see if upholding the validity of the patent before the proposal patent from the EPO, when would be the timeframe that you would might project that we would know something. Are we talking in the 2016?

Randy Milby

Analyst

Well, as I mentioned these decisions don't come quickly, so we're talking about a 1 year or more.

Unidentified Analyst

Analyst

Okay, is it and we wouldn't have to hear it from both the European patent office and the patent and trademark office in Germany.

Randy Milby

Analyst

Right, so what we hear most likely first would be the European patent office and then that would play back into the German, the Mannheim court, but just recall as we have this other action in the clone court system that's the unfair competition which is based upon the misappropriation of the confidential and proprietary knowhow, that hearing is scheduled for July, 2. So we have other activities that are ongoing and now the strategy was one, two, three, punch.

Unidentified Analyst

Analyst

You've a little bit more color or granularity with regards to the unfair competition, action that you've filed. If CorMedix were to be successful in that, what could that potentially yield and damages, what could we see? I'm not quite as familiar with that.

Randy Milby

Analyst

Well that, whatever I would say be conjunction and speculation. So this has to do with, this has to do with as you recall the Biolink or the predecessor company and TauroPharm had privy to information knowhow when they were working for Biolink. So this has to do with the misappropriation of that confidential and proprietary knowhow and I don't want to be speculating as far as the actions. But you could anticipate an similar type infringement.

Unidentified Analyst

Analyst

And so by no means, we haven't lost anything off of this, it's just the court has said, listen we want more information with regards to the actions in Mannheim and we're going to sit back and await to hear the re-evaluation of the validity of the patent and the utility model. Also that, if we were to be successful in some type of injunction could we expect that there would be stoppage of the manufacturing sales and distribution of product, would we pursue have to pursue a different course on that. How does that work?

Randy Milby

Analyst

Well that would be a decision obviously that we would take internally and with the board discussions because you know all these actions are subject to appeal. But you're correct we could take injunctive and monetary damages. But you're also correct, this is what we were going after here, we were sick seeking an injunction against the company and the legal standard for issuing an injunction for another company and the patent case is quite high. But we took a shot at it, we felt that it was worth taking. But here again, the validity of the patent now just goes to the European patent office.

Unidentified Analyst

Analyst

Okay. And one final pursuit on in this line of questioning. TauroPharm is manufacturing other products, is there one site and that is in Germany is that correct?

Randy Milby

Analyst

That's correct, in Lahr.

Unidentified Analyst

Analyst

Okay, I kind of get an idea of what's going on there. All right, thank you very much.

Operator

Operator

[Operator Instructions] our next question comes from the line of Chet Steadman with PSB [ph] Capital. Please proceed with your question.

Unidentified Analyst

Analyst

Hi, Randy. It's a question in regards to how this decision is going to impact the overall sales as you've been guiding since day one, since like big make stress the opportunities at least in Europe and US or quite similar to one and other and just wondering, one if you had any insights into what the current sales for TauroLock in Germany and Europe in general right now and how this decision impacts those projections?

Randy Milby

Analyst

As you know that, TauroPharm is a privately held company, so we don't have access to their sales data. We do see them in the marketplace obviously and it has had an impact on our uptake, but as I mentioned on this call, is that we had minimal investment into Germany and what the value that we're painting out in Germany is the neutral and usage monitoring program and that type of data is something that our competition has not collected. We're approaching this from a scientific way and we have over greater than 90% reduction in infection thrombosis. So we'll see how it plays out on the patent side and for competition side. But we continue to make inroads in the Middle East, which is opportunistic for us as I mentioned on earlier.

Unidentified Analyst

Analyst

Okay, great. Thanks to that and one just quick follow-up there in regards to that and the 90% figure. Does that take into account, is that the level of reduction that's observed in most installed file is typically highly there depending on the clinical trial side and other numerous factors that being a benchmark of 3.5 per thousand catheter days, is it necessary always accurate?

Randy Milby

Analyst

That's a great question. So this is not a controlled clinical study as I mentioned. The reason we're encouraged its real world data. So even what you would expect the 3.5 out of thousand catheter days. Is from, we have in this case about four different literate sources for that as same on the thrombosis, which was 2.5. So here again, it is as you correctly assert, and is not a controlled clinical study. But what we're doing is, is comparing the real world data versus other data that's been collected from a multiple sources.

Unidentified Analyst

Analyst

Right okay, understand. All right, thank you.

Operator

Operator

Thank you. Our next question comes from the line of Mitch [indiscernible]. Please proceed with your question.

Unidentified Analyst

Analyst

Congratulations on your role first and foremost. My question is, with this tremendous results of reduction are we trying to get into Latin America or are we having problems in rest of Europe because of [indiscernible] whole competition?

Randy Milby

Analyst

We have discussions with some companies in Latin America. However, as I've mentioned earlier for an earlier previous question. Since, we have the Evercore process underway and many of the companies that they've, they're having discussions with having international footprint. Although, we're having these discussions at many of these companies we send to Evercore to incorporate into their process. So there is a lot of interest particularly and that's another reason frankly, why we're putting this data out and we're having abstract and well presentations globally, so that the information can get out there and it should help in the Evercore process.

Unidentified Analyst

Analyst

As a follow-up, I'm a little not confused, but I don't particularly understand or know, we are allowed to sell CorMedix's procedure of [indiscernible] in Europe now.

Randy Milby

Analyst

Yes, so we have it's in the European Union, it's a Class III medical drug device. So it's been, so you can sell in the European Union. However, you need to go country-by-country and get the appropriate registration within the each individual country. And we've done that in Italy, Malta, Australia, Netherlands and Germany.

Unidentified Analyst

Analyst

And do we have a sales team that's involved in calling on these hospitals and etc?

Randy Milby

Analyst

We have a minimal footprint in Germany of four contracts sales organization individuals. One other contractors that we've started beta testing oncology and then we use independent sales reps and one in Austria and one in the Netherlands.

Unidentified Analyst

Analyst

Yes, that would seem like for me that would seem like a virgin market there. Do the amount of cases that with benefit by this process. You know my sister has leukaemia, she has a fourth [ph] nervous system and of course, I don't know what procedure cleans out the [indiscernible] system and she to reset she has to get some [technical difficulty] and it seems like its [technical difficulty] market [technical difficulty].

Randy Milby

Analyst

Well in the European Union as you recall and you see it in the, we put it out in the K. there are competitive products. There is Citrolock [ph] which is high concentration citric solution. TauroPharm is in these markets and they use the distributor and saline and heparin are competitive products. I think your point is though and Neutrolin be the first in class in the United States. There are no competitive products, but with the calibre with both the anti-infective and anti-thrombotic effect as Neutrolin as. So the United States will be first in class.

Unidentified Analyst

Analyst

Sounds good. Thank you.

Operator

Operator

Our next question comes from the line of John Siegel with Private Investor. Please proceed with your question.

John Siegel

Analyst · Private Investor. Please proceed with your question.

Hi, Randy. Where we're at, I didn't hear you mention with regards to the South Korea.

Randy Milby

Analyst · Private Investor. Please proceed with your question.

South Korea, that's one export we'd signed the agreement with. Their FDA follows the US FDA. So what they're doing is. They will actually not be able to launch the product until after we've launched in the US. It's treated as drug there, not a device. So when we structure the agreement with them. They were unclear at the time, since we were Class III drug device, they were trying within Korea to be classified as a Class III medical device. But their FDA decided just like the US FDA that this should be viewed a drug and therefore, they can't launch until after we've finished the Phase III studies in the US.

John Siegel

Analyst · Private Investor. Please proceed with your question.

Okay, thank you.

Operator

Operator

There are no further questions at this. I'd like to turn the floor back over to management for closing remarks.

Randy Milby

Analyst

Thanks to everyone for dialling in today and I would just like to reiterate a couple of points. I'm truly excited and encouraged by what we've been able to accomplish this quarter and I would just like to highlight those key activities again, before we close. First, we continue or multi-pronged effort to assert our intellectual property in Germany. We've submitted that second Phase III protocol to the FDA. We've got very positive and interesting health economics data that we're going to publish in peer reviewed journals. But Neutrolin and usage monitoring programmed data shows over 90% reduction in infection and thrombosis versus a benchmark. We've initiated and planned and have underway to reduce our COGS which will improve our margins both in 2015 and even more greatly in 2016. We have the QIDP designation and have the Fast Track and it has Fast Track design and we're building the strong team to execute this. So thank you everyone for dialling in. I appreciate you support.