CorMedix Inc.
Q3 2015 Earnings Call Transcript

Published: 13 Nov 2015

[Operator:]

Greetings and welcome to the CorMedix Third Quarter 2015 Results conference call. At this time, all participants are in a listen-only mode. A brief question and answer session will follow the formal presentation. If anyone should require operator assistance during the conference, please press star, zero on your telephone keypad. As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Mr. Randy Milby. Thank you, you may begin.

[Randy Milby:]

Good morning and welcome to the CorMedix third quarter 2015 investor conference call. In the room with me, who will be available during the Q&A portion of the conference call are Jim Altland, our interim CFO; Dr. Tony Pfaffle, our Chief Scientific Officer, and Jack Armstrong, our EVP of Technical Operations. 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 costs should be considered forward-looking. Forward-looking statements include statements about our clinical development plans and timing, regulatory actions, and cash needs. 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’s 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. We are encouraged about the ongoing progress that we have made and expect to continue to make at CorMedix, both from a standpoint of strategically positioning the company for long-term success as well as executing tactically this quarter. I want to update you on several important areas

[Operator:]

[Operator instructions] Our first question comes from the line of Scott Henry from Roth Capital Partners. Please go ahead with your question.

[Scott Henry:]

Thank you and good morning. I guess just to get started, revenues in the quarter took a dip down from the second quarter rate. How should we think about that number going forward? Should we expect it to bounce back considerably or just kind of start working its way back up? Just trying to get an idea of what to be thinking about for the revenue line.

[Randy Milby:]

Well as I mentioned in the call, Scott, that’s a good question. Part of it has to do with it’s a tender business, so it’s going to be a little bit choppy as we bring more countries on. As I’ve mentioned to some people before in some of my other presentations, we’ve registered the product in a number of countries. There are several of the countries that we’ve registered the product that I didn’t mention, because I only mentioned the countries where we’re actually selling, and these countries now, since it’s a tender process, it’s going to be a little choppy as the orders come through. So it’s going to be trending up, but you’re going to see a few down months, and part of that was just when we wanted to ship and when we get paid.

[Scott Henry:]

Okay, I’ll take a shot at that, then. Then I also just wanted to check on the expense side, going into 2016, I’m guessing SG&A should resemble the Q4 rate, but what about R&D? When should I expect that to spike up? Should I start to see a spike in the fourth quarter as you start the trial, continuing into 2016? Just trying to get an idea of where that number is going to go.

[Randy Milby:]

Yes, you should start seeing it go up in the fourth quarter because there’s going to be more expenditures with PPD as we enroll the patients, and then it will escalate into the 2016 time frame.

[Scott Henry:]

Okay. Final question - it sounds like the first trial is right on track. Would you still be looking for that interim analysis to happen sometime around the summer of 2016 and then data in first half of ’17? Is that still the target?

[Randy Milby:]

Yes, so as I mentioned on the call, it’s six months or--it’s actually event driven, so when we have 81 events, that’s when we’ll do it. But a good ballpark right now is six months, so I’m kind of envisioning that June-July time frame. That goes back to the importance of site selection, and Dr. Pfaffle is spending a lot of time on that, because what we’ve done is we’re looking at those sites which have a higher infection rate, and those are the ones we’ve targeted for the initial enrollment.

[Scott Henry:]

Okay, so is it six months from when the first patient comes in, or is there a critical mass of patients you need to have?

[Randy Milby:]

It’s 81 events, and so I would start the clock on the six months in that January time frame because we’re enrolling patients in November and December, but you’re going to see heavier enrollment in that January time frame, January-February. Tony can add a little color to that.

[Tony Pfaffle:]

Sure. Scott, we’re physically on the ground, visiting the dialysis centers and basically making sure that everything is up to speed for this. So to Randy’s point, we believe that once we start enrolling, we’re going to have the wind at our backs and that we’ll get to that point, and that’s the method of what he described as spending a lot of time hand-picking the centers, make sure they have the right percentage of catheter use, the right infection rate so that you’re essentially targeting those centers that are most likely to yield the events. So you know, we’re optimistic that we will get there in the time frame that Randy described.

[Scott Henry:]

Okay, great. Thank you for taking the questions.

[Randy Milby:]

You’re welcome.

[Operator:]

Thank you. Our next question comes from the line of Adam Cohen from Rodman & Renshaw. Please go ahead.

[Adam Cohen:]

Yes, could you please tell me about your search for the CEO, a new CEO, and how that’s going?

[Randy Milby:]

Absolutely. As you well know, the process is well underway. We’re working with Korn/Ferry International - it’s a leading search firm, and it may take some time to find the right person. I am committed to remain on the job until we do with the support of the board of directors. So the board interviews the candidates, we’ve interviewed several candidates, and it’s boiling down to just finding the right person.

[Adam Cohen:]

Okay, thank you very much. Does the termination of the license agreement with Polaschegg mean that CorMedix is no longer working on any gel formulations for taurolidine?

[Randy Milby:]

No, actually that’s why I put a little more emphasis on the call today about some of those provisions patents. On the wound management, that patent is the hydragel, so that is in the gel. What we did is we have a small team that’s working on--I’ve talked previously about having a taurolidine franchise, so we have a small team with a physician and another clinical development person looking over the Polaschegg patents and the estate that we had and what we could do with that, and maximize the value of taurolidine. What we did, we determined that the CRMD004 gel technology patent targeting the catheter lock was narrow in scope and it limited the market potential, so based upon our technical analysis of the other patents under the Polaschegg license agreement, we determined that extensive investment would be required to strengthen these patents. So upon termination of the Polaschegg license, all rights were returned to the Polascheggs.

[Adam Cohen:]

Okay, thank you very much. I appreciate you taking my questions.

[Randy Milby:]

Pleasure.

[Operator:]

Thank you. Our next question comes from the line of Doug Schwegel [ph], a private investor. Please go ahead with your question.

[Doug Schwegel:]

Good morning, Randy.

[Randy Milby:]

Hi Doug.

[Doug Schwegel:]

I got on the call late, so if some of my questions are redundant, I apologize in advance. Could you go over how you determine the valuations that you--you stated a market size, I think for dialysis, oncology and critical care settings - CCU, ICU as potentially over a billion dollar market. How would you value the potential market for the gel formulation?

[Randy Milby:]

Right, and this will surely be on the website, but just in a nutshell, for the Neutrolin we always talk about--I have it on there right now as the number of hemodialysis is around 700,000 patients on hemodialysis, and that’s 127 million catheter days. A patient would get one vial, and we’ve used the number 2.3 days, so in other words you get 0.44 vials per day, and then we’ve projected out the number of vials or cartridges. We did the same type of math in oncology. In oncology, we’re looking at Stage 3 and 4 tumor types on TPN. It’s 7,740,000 patients, and that’s 90,000 catheter days, and it’s one lock and two flushes, so that’s where I get the number three. Then on intensive care, 4 million patients, 20 million catheter days because it’s five catheter days per patient, and we used seven potential vials or cartridges per day because they’d use two locks and five flushes. One of the new things we’ve spent some market research on during this past quarter is drilling down into these spaces and talking with the physicians, and finding out they’d use a lock as well as you well know would use flushes, so we’ve incorporated locks and flushes into the calculation now. This is important in the U.S. market in particular because the product Neutrolin that has 1,000 units of heparin, that’s for hemodialysis. We’re going to bifurcate the market, though, on the oncology and the ICU markets, we’ll have a different SKU or a different product, that one will have zero heparin in it and the other will have 100 units of heparin. So that could be a cartridge market, whereas the hemodialysis would be a vial market.

[Doug Schwegel:]

I got you, so--

[Randy Milby:]

And Tony would like to interject.

[Tony Pfaffle:]

Doug, looking at it, we vetted this with Ivy League ICU directors, so people like the professorial level who run large ICUs and also NCI cancer centers. So these numbers were for market research, but we also vetted them with the people who actually control those units.

[Doug Schwegel:]

I got you. So the ICU-CCU market, to me, that’s really a potentially huge market. I know we really focus on dialysis, we talk dialysis, dialysis, but the cartridge application in the critical care setting is potentially an enormous market.

[Randy Milby:]

Right, and that’s why, as I mentioned in the call, we have in a peer-reviewed journal, in a critical care journal the health economics or pharmo-economics data that will be published. This is another reason, as I’ve mentioned too speaking at the CMS on hemodialysis, but under the Affordable Care Act this is a big market and it’s a big opportunity for us.

[Doug Schwegel:]

When would you expect the publication in the journal, by chance? Have you got any kind of working time frame?

[Randy Milby:]

We’re anticipating by year-end. Right now, it’s under final review, so they just sent back some questions and we’ve followed up on those, so most likely by year end.

[Doug Schwegel:]

Okay, in the near term. All right. Next question is what are you looking at as far as financing options for the gel formulation, and where are you at on the provisional patent status for the gel formulations and the applications that you announced at the beginning of the call?

[Randy Milby:]

So what we’ve done on those five, we filed the five provisionals and the next step is to file a PCT patent, and we’re doing some basic research in two of the areas. We’ve already advanced the suture market area as far as putting taurolidine, incorporating it into the sutures, particularly absorbable sutures. For some of the other areas, we’re going to just take it up to a certain level to file the PCT patent, and we’ll take it out to some larger players in the suture space for potential partnerships after we’ve obtained that data. So that data will have--we already know it can be embedded in the suture, and now we’re looking to see how much infection control it has and MIC that those sutures could have. The other--several of the other areas, we’ve started to initiate the product to solicit SPIR graphs [ph], and we’re looking at different sources of funding and having some initial discussions with DARPA and other organizations like that.

[Doug Schwegel:]

What time frame on the first thing would you be kind of looking at, six to 12 months or--?

[Randy Milby:]

For the sutures, we anticipate to have this data by year-end and be speaking with potential partners by the first quarter of next year.

[Doug Schwegel:]

Great, fantastic. Let’s see here - I think we addressed the CEO search. Could you give us a little update with regards to Germany and what’s upcoming, and all that please with regards to the suit that you’ve filed in Cologne and--I’m forgetting the other site.

[Randy Milby:]

Okay, as you know, we hold patent positions in various aspects of Neutrolin and our underlying technology in the United States, Europe and other territories. We are confident we have the freedom to operate and commercialize our product in the manner we are now doing, and we are in the midst of bringing a series of legal challenges to our rival in Europe and we expect that there will be rulings concerning our patent position and activities of the rival in due course. Beyond that, I really can’t say much more, but we are determined to press on these matters. The Unfair Competition Act is in the Cologne court system on November 19 - that’s in the Q we put out, and the European Patent Office hearing will be in Munich on November 25. So we should have--both of these are subject to appeal, as you know, but we should have at least a sense of where the wind is blowing, if you will.

[Doug Schwegel:]

If the courts--let’s say the European Patent Office should rule in our favor - I understand this is a hypothetical, but play along with me on this - certainly there is an appeal process for Terra Pharma. Would you all look at providing a bond and a mechanism to stop their manufacturing and sales of their product?

[Randy Milby:]

Well, we’d have to take that into consideration. As you know, there’s pluses and minuses, but yes, we would consider it.

[Doug Schwegel:]

Okay, that’s all the questions that I had at this time. Thanks.

[Randy Milby:]

Thanks Doug.

[Operator:]

Thank you. Ladies and gentlemen, we have no further questions in queue at this time. I would like to turn the floor back over to management for closing comments.

[Randy Milby:]

Thank you everyone for dialing in today. I would just like to reiterate and summarize the quarter because this quarter has been a very important period to advance the company. As I mentioned, CorMedix is on the verge of initiating our first Phase III study in hemodialysis, the LOCKIT clinical study. Patient enrollment will be this month, interim analysis will be six months or 81 events. We continue to collaborate with regional marketing partners to further expand the availability of Neutrolin in patients in additional countries, including the Middle East where we’re seeing increased acceptance. We’ve recently presented two health economics abstracts that articulate the potential value of Neutrolin, and we are executing a publication plan to publish a third article in the critical care journal. We will continue to assert our intellectual property rights on the context of patent infringement and unfair competition law claims brought in Germany, and we continue to execute on our plan to reduce cost of goods. Thank you everyone for joining and have a good day.

[Operator:]

Thank you. Ladies and gentlemen, this does conclude our teleconference for today. You may disconnect your lines at this time. Thank you for your participation and have a wonderful day.