Earnings Labs

CorMedix Inc. (CRMD)

Q2 2016 Earnings Call· Sat, Aug 6, 2016

$7.58

-3.13%

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Transcript

Operator

Operator

Greetings and welcome to the CorMedix Second Quarter 2016 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. I would now like to turn the conference over to Josh Drumm of Tiberend Strategic Advisors. Thank you. You may go ahead.

Josh Drumm

Analyst

Good morning. And welcome to the CorMedix second quarter 2016 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. The forward-looking statements are 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 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. At this time, it’s my pleasure to turn the call over to Mr. Randy Milby, Chief Executive Officer of CorMedix. Randy, please go ahead.

Randy Milby

Analyst

Good morning, everyone. And thanks for joining us for our second quarter 2016 business update. With me is Jim Altland, our interim CFO; Dr. Anthony Pfaffle, our Chief Scientific Officer; Dr. Steve Howard our Medical Director; and Jack Armstrong, our Executive VP of Technical Operations. They will be available during the Q&A portion of the conference call. Before I began, I want to remind everyone listening about the motivation behind our mission and share with you a startling picture. Catheter-related bloodstream infections cost the U.S. health care system approximately $6 billion every year, that’s every year. We’re talking about infections that occur in patients who have an implanted central venous catheter CVC also known as a central line. This is essentially a thin tube that runs from outside the body and into a major blood vessel, which goes into the heart. Patients have to live with these for days, weeks or months depending upon the medical use. But most importantly, each day the catheter is emplaced, these patients are at risk for serious bloodstream infections. These infections can be devastating if not deadly for patients who are already very sick, either acutely in the ICU or chronically in the case of hemodialysis and oncology patients. Eliminating catheter-related bloodstream infections is a top priority for hospitals and dialysis centers globally. These infections have significant impact on patient morbidity and more mortality as well as the tremendous health economic burden, I’ve just shared with you a moment ago. Hospital programs enforcing stringent sterile techniques have been effective, but unfortunately infection rates still persist. From a patient point of view, reducing the ergative [ph] infection at best could mean the difference between significantly longer hospital stay and potentially living with the permanent health complication, at worst it leads the difference between life and…

Operator

Operator

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

Scott Henry

Analyst

Thank you and good morning. Just a couple of quick questions. For starters, the blinded interim safety analysis in fourth quarter of this year, should we expect any information out of that or basically just proceed halt for safety or halt positively or negatively for efficacy?

Randy Milby

Analyst

The question is what to expect from the DSMB safety analysis review at the fourth quarter. I’ll turn that over to Dr. Pfaffle.

Dr. Anthony Pfaffle

Analyst

Yes, Dough; good morning. Our mission is just to complete the study, and we have relentless focus on that and getting to our interim analysis with the DSMB which meets monthly, will review the interim results primarily for safety. And they will have options to continue the study or stop the study for futility; that is the primary focus of the interim analysis. Under Fast Track, there is ability to request accelerated approval. If the DSMB were to find unusual efficacy signal and paralleling what we see in Europe, then they could come to the Company and request accelerated approval, but that’s not the primary focus of the DSMB’s interim analysis, primary is safety. But there is an accommodation available on the Fast Track to request accelerated review.

Randy Milby

Analyst

So, as a follow-on to that Scott, what you’d expect from us is the DSMB comes out just go forward, we’ll release that information as a press release.

Scott Henry

Analyst

Okay, great. Thank you that is helpful. Other, just a couple of quick modeling questions. First, the ex-U.S. revenues, clearly a the de minimis number at about 16,000, 17,000. Should I expect that to trickle along at those levels or should I expect to rebound, how should I think about that revenue line?

Randy Milby

Analyst

Right now, we’re expecting a rebound on mainly from the Middle East. As we’ve talked before, we’re starting to see some traction in Middle East, based upon the gender business that we’ve been submitted for.

Scott Henry

Analyst

Okay, all right, keep track of that. And then, the final question, with regards to spending levels, how should I think of Q2 as representative for the rest of the year; should I expect a slight uptick, or just trying to get a sense of that?

Randy Milby

Analyst

I’ll turn that over to Jim Altland, the CFO.

Jim Altland

Analyst

As we add new patients to the clinical trial, the expenses are going to continue to build. And you will see a major uptick in clinical expenses until we peak in the probably the first quarter of 2016, 2017 and then it will start to decline.

Randy Milby

Analyst

So, Scott, that’s consistent what I talked about as how that full patient enrollment fourth quarter 2016, first quarter 2017, now that’d be 632 patients. So, as Jim just highlighted, that’s when you’d see the biggest ramp, because we’d have all patients onboard.

Operator

Operator

Thank you. And our next question is coming from the line of Ed White with FBR. Please proceed with your questions.

Ed White

Analyst

The first question is just on, you had mentioned that you have cash through the third quarter of 2017, does that include the ATM or that’s the current cash on hand?

Jim Altland

Analyst

That would be the current cash on hand. We can use additional ATM financings and extend our runway farther.

Ed White

Analyst

Okay, great. Thanks. And then, just on the enrollment for the LOCK-IT trial, it seems like it slipped a little bit from the fourth quarter of 2016 to the fourth quarter of 2016 or early first quarter of 2017. Is there any reason for that slippage?

Dr. Anthony Pfaffle

Analyst

Ed, this is Tony Pfaffle. There is no slippage; enrollment is on track. We have a very dedicated multifaceted approach for getting the sites up and running and getting the patients identified, screened and enrolled in the trial. That’s going very well. And, we haven’t seen a slippage. At the beginning of the trial, with first patient in, you see a few patients entering but then we have geared up since then, and we’re on track.

Ed White

Analyst

And you’re still adding sites or are you…?

Dr. Anthony Pfaffle

Analyst

Yes.

Randy Milby

Analyst

One thing that we’re seeing is due to the hard work of Dr. Pfaffle and the team, because we do have see CRA oversized, [ph] we’re bidding more patients per site than we originally projected. So, originally, as you recall, I announced that we got 70 sites for 630 patients; we’re actually getting more patients for the sites enrolled. Some of the -- so, we’re seeing a lot more. That’s a good return on investment from a CRAs point of view.

Ed White

Analyst

Just the last question I have for you, we are still seeing the cost to sales outpacing net sales and this -- should we expect to see that going forward or is this due to inventory build up or how come we explain -- how do you explain that phenomenon in the second quarter?

Jim Altland

Analyst

At the end of the second quarter, we do an assessment looking forward and using our current run rate for units sales. We determined we needed to increase our result for obsolete material and inventory going forward, and we took charge of $166,000 in the quarter.

Operator

Operator

Thank you. And our next question comes from the line of Doug Schwegel [ph] who is a private investor? Please go ahead with your questions.

Unidentified Analyst

Analyst

First of all, I wanted to see if things are still proceeding with regards to an executive search; is that still ongoing; and if so, how that’s proceeding?

Randy Milby

Analyst

Dough, this is Randy. Yes, the executive search is still underway. In the interim, I am 100% committed to continuing to deliver on these deliverables. And as you know, I am one of the very large private shareholder as well, I put my own personal money at stake. So, I am driven to make sure that the team hits on these deliverables in the timeline until we find the new CEO.

Unidentified Analyst

Analyst

Where might we be in that process, Randy?

Randy Milby

Analyst

They are in the process of interviewing people now.

Unidentified Analyst

Analyst

Secondly, could you give us a brief update with regards to things in Germany with regards to patent protection and that type of stuff?

Randy Milby

Analyst

Absolutely, as you know,, we will patent positions in various aspects of Neutrolin, and our underlying technology in United States and Europe and other territories. You’re referring most likely to the utility patent. And as I put out in the release, in June we reported that the German Patent Trademark Office affirmed its preliminary finding that utility patent or Prosl patent was invalid based upon prior publication. However, this judgment has no depletory effects as the utility modeling question has expired in 2015. This ruling to your point has really no bearing on the ongoing consideration with the European Patent Office for the validity and possible infringement of the Prosl patent. Unfortunately, we still not have the date yet set for this patent discussion with the EPO. As far as the ongoing Unfair Competition, that suit -- the hearing will be in the fourth quarter of 2016.

Unidentified Analyst

Analyst

Great. Thanks so much.

Randy Milby

Analyst

Just as a highlight, Dough, what’s going on in European Patent Office has no effect on the U.S. patent situation.

Operator

Operator

Thank you. It seems we have no further questions at this time. I’d like to turn the floor back over to management for closing remarks.