CorMedix Inc. (NYSEMKT:CRMD)
Q1 2014 Results Earnings Conference Call
May 16, 2014 09:00 AM ET
Randy Milby - Chief Executive Officer
Steve Lefkowitz - Interim Chief Financial Officer
Dr. Tony Pfaffle - chairman
Hello ladies and gentlemen and thank you for waiting. Welcome to the CorMedix First Quarter 2014 Results Conference Call. All lines have been placed on listen only mode. And the floor will be opened for your questions and comments following the presentation. Without further ado, it’s my pleasure to turn the floor over to your host, Randy Milby. Mr. Milby, the floor is yours.
Thank you. Good morning and welcome to the CorMedix first quarter 2014 conference call.
I will start by providing you with an update of our ongoing operational progress before our Interim CFO, Steve Lefkowitz addresses our financial affairs.
Before we get started, I would like to remind all the listeners that this conference call contains 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 CorMedix prospects, future financial position, future revenues and projected costs should be considered forward-looking. Readers are cautioned that actual results may differ materially from projections or estimates due to the variety of important factors including obtaining regulatory approvals to conduct clinical trials and to commercialize CorMedix product candidates improving marketing of Neutrolin in countries other than Germany, the risk associated with the launch of Neutrolin in Europe and other markets, the risks and uncertainties associate with CorMedix ability to manage the limited cash resources, obtaining additional financing to support CorMedix R&D and clinical activities and operations, the outcome of clinical trials for CorMedix product candidates whether they demonstrate these candidates’ safety, effectiveness and CorMedix’ ability to enter into and maintain collaborations with third parties for the development and marketing programs. These and other 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 a request from CorMedix.
CorMedix may not actually achieve the goals and plans described in these forward-looking statements and investors should not place undue reliance on these statements. CorMedix assumes no obligation and does not intend to update these forward-looking statements except as required by law.
And with that let me get into the presentation.
As a background for the new listeners, CorMedix is the specialty pharmaceutical company focused on developing and commercializing therapeutic products for the treatment of infectious diseases in both acute and chronic care settings. There is a large market need for Neutrolin because central line-associated bloodstream infections happen when a central line which is in essence a tube that a doctor usually places in a large vein of a patient’s neck or chest to give an important medical treatment is not put in correctly or not kept clean. A line can become a freeway for germs to enter the body and cause serious bloodstream infections. Neutrolin contains taurolidine which is a potent broad spectrum anti infective agent active against gram-positive and gram negative bacteria including MRSA and fungi including [Canada] and heparin as antithrombotic anticoagulant
Today, I would like to update you on four areas of near and longer term catalysts for CorMedix growth. The first, the launch of Neutrolin in the EU; second, plans for label expansion in the EU beyond the initial dialysis market; third, geographic expansion activities; and fourth, plans for the U.S. marketing approval.
First, launch of Neutrolin in Germany and the EU. As you recall, we began to recognize sales in December of 2013. In January and February, we began a targeted stocking in sampling program to get Neutrolin in the hands of selected physicians. We are not giving sales guidance, but the current sales are not representative of the number of patients on Neutrolin. We've had more success than you are seeing in the numbers, because the first quarter had a relatively large amount of sampling as part of the promotion. The response, which is seen in the number of patients being placed on Neutrolin is encouraging. I will say we are continuing to gain traction in the hemodialysis market place.
Our key account managers and the independent sales team continue meeting with nephrologists and nephrology nurses. The independent sales reps have begun selling Neutrolin the 1st of February are located in major metropolitan areas throughout Germany. We have continued to enhance our launch efforts based on evolving market conditions and incorporation of new ideas.
Second, expand the product into additional applications. We submitted the package for label expansion into oncology, intensive care units, total parental nutrition, and peritoneal dialysis in late January. This package is being evaluated by TÜV SÜD, we have an ongoing dialog and much like the CE mark process are providing them additional information as requested. This process usually takes six months, but that is totally dependent upon the reviewer.
Third, expand sales into other countries. We continue to focus on selected prioritized countries and regions and have rated them as high, medium and low-price quarter countries. One use of fund from the last financing was to bring on additional resources in business development. We are negotiations with the third-party for the regional sales agreement which we believe will be completed before the end of the second quarter.
We have previously announced letters of intent with two distributors in the Middle East. The documentation required for selling these, selling within this country has been submitted for the country approval, we are waiting for approval to sell. We anticipate these approvals in quarter three, but here again we must await regulatory response. We continue to have discussions with global pharmaceutical and medical device companies as well as with companies for regional sales and distribution in additional markets. We continue to expect to complete one or more of these collaborations in the second quarter.
Fourth, apply for and receive marketing approval and launch the product in United States. Neutrolin is a Class 3 medical device in Europe Union but it is a drug in United States. The protocol for the Phase III has been submitted to Cedars Anti-Infective Division for review. We are in dialogue with the FDA. As we have mentioned previously, we believe there will be two Phase III studies. The study in hemodialysis maybe around 600 patients moderate for catheter-related bloodstream infections. The comparison of the Neutrolin versus heparin as the control. We are proposing a smaller Phase III for an expanding indication. We can share more about this after our next discussion with the FDA.
As you recall we were encouraged at the pre-IND meeting to file for a fast-track review and QIDP which stands for the qualified infectious disease product status under the GAIN, which means Generating Antibiotic Incentives Now Act, which extends patent exclusivity by five years above the standard five years for an NCE, new chemical entity. Along with possible pediatric extension, this could bring our period of exclusivity for Neutrolin in the United States to 10.5 years. I want to emphasize the objective remains to partner Neutrolin in the United States as we are doing in other countries.
In summary, we continue to focus on execution. We are in the early phase of commercialization of Neutrolin in Germany and expect to expand to other countries as soon as possible. We have submitted the documents for legal expansion in the EU and the protocol has been submitted for the Phase III trial in United States.
With that I would like to turn the call over to Steve Lefkowitz to provide some detail on our financial update. Steve?
Thanks everyone for joining us today. I’d like to now review our accomplishments for the quarter and then review the financial information filed yesterday on Form 10-Q.
During the quarter, we raised $9.4 million, $2 million in convertible preferred stock of warrants in January and $7.4 million in March of registered direct offering with common stock with warrants. As a result, we ended the quarter with approximately $9.4 million of cash. We began our launch of Neutrolin in Germany and the rest of the world as we mentioned in our last call we expected our cash burn to increase as we began our commercialization of Neutrolin.
I’d like to now review our operating results and financial statements. For the quarter ended 03/31/2014, we recorded a loss of $16.7 million. Of this amount, $15.2 million were non-cash charges including $1.4 million for stock-based compensation and $13.8 million for revaluation of derivative liabilities. It should be noted that the derivative liability charge is directly tied to the price of our stock which increased from $1.24 per share on December 31 of 2013 to $2.51 on March 31, 2014. The accounting treatment of these derivative liabilities cause for them to be mark-to-market with the change in value being charged to income. So as our stock rises the increase in their value shows up as a loss on our income statement. Should the opposite happen we would show a large gain on our incomes statement please keep in mind that while that this might result in gains or losses on our income statement each quarter they are not cash expenses and do not impact our ability to fund operations.
As Randy noted we’ve just started our commercial operations sales in the first quarter were $12,203 and cost of goods was $81,026, a majority of the cost of goods are not ongoing expenses and so as our sales increase we anticipate that our gross margins will turn positive.
Our operating costs were $2.9 million comprised of $353,000 for R&D and $2.5 million for SG&A generating the loss from operations of $2.9 million. In these amounts were $1.4 million of non-cash stock based compensation resulted in operating cash loss of $1.5 million versus $750,000 for the same period 2013 with the SG&A being the vast majority of the increase. The increase in SG&A was to fund our European operations and expenses related to a variety of other items including our FDA filing in the United States, legal and accounting fees from our financing activities and intellectual property portfolio and manufacturing costs. Of the amount spent in the first quarter, approximately $400,000 were for items that we don’t expect to the ongoing expenses, assuming no material sales and no material phase for our expected cash front, we believe that we have sufficient capital in Q3 of 2015, this also assumes that we will partner the U.S. clinical trials not be successful in any other partnership agreements and not materially alter our current operating expense levels.
Our net loss of $16.7 million with the change in fair value of derivative liabilities of $13.7 million making up the rest of the loss. As noted in our last call, these charges will fluctuate quarter-to-quarter but eventually they should accrue to our equity accounts. Pro forma for the $12.4 of derivative liabilities on our balance sheet, our total stockholders’ equity is approximately $8.7 million.
I believe we can now open it up for Q&A.
Certainly. The floor is now open for questions. (Operator Instructions). We have a question on the line from [Doug Schewegel]. Doug, please state your question.
Yes, good morning. This is directed I guess to Steve. Steve, how much do you see that we need to generate in sales to be cash flow positive for operations in future?
Doug, that depends completely upon where the sales come from, if they are direct sales our gross margin is at one level. If the sales is to partnerships as Randy mentioned in the Middle East it's a completely different level. So, at this point in time, given how early we are in the process and how little experience we have as an operating the company, it's probably inappropriate to put a specific number out there, because it completely depends on the product mix and the timing of when these transactions occur.
So, we could provide information more information in the future when we have more information about the specific agreements and how the launch is going in Germany.
(Operator Instructions). We do have another question from [Adam Brotman]. Adam, please state your question.
I think your last conference call you stated that you are renegotiating around patent rights with regard to [Tara Pharma], I was just wondering if there is any update on that and whether or not it would be a lawsuit against [Tara Pharma] for patent equipment infringement.
This is Randy. We have always said that it will depend our intellectual property and our preferences to negotiate versus litigate, so that is an ongoing process. Nothing new to add beyond that, I mean we've discussions obviously, but I can't say any more than that.
(Operator Instructions). The next question comes from [Scott Landrum]. Scott, please state your question.
Good morning gentlemen. Could you give us a little color on the FDA talks and where they are and what the back end forth is I know that submission is in, but what would -- have the final -- just give us an idea of what the timeline is going forward and what the timeline is for -- assume everything goes well, what the time line is for the start up for Phase III?
Dr. Pfaffle has been leading that effort. And Tony why don’t you address Scottie’s question.
Dr. Tony Pfaffle
Sure Randy. Scottie, thanks very good question. The FDA processes are going extraordinarily well and they are extraordinarily receptive to our mutual and protocol. They have provided us with very helpful and meaningful questions of which we're going through and they are all supportive of the development to mutual in us designing and executing a Phase III clinical trial program, which for a company of CorMedix size is an extraordinarily event having that approved product in most of the rest of the world in the Phase III opportunity in the U.S.
We plan, this is the timeline to have final protocol. We see from the FDA within the next 30 to 60 days. In that period, once we get the protocol in place the processes that the pre-IND will be converted to the IND, once we get that IND whether we will press release it. Then we would -- we are currently in negotiations with CROs and we would in a partnership ideally with a partner want a Phase III program before the end of the year.
So approximately in late Q3 or early Q4, we would start a Phase III trial. That trial will take approximately one year to complete and just completed the FDA has encouraged us proactively, we didn’t asked, they said why don't you apply for fast-track, why don't you apply for QIDP under the GAIN act. And why don't you apply for breakthrough drug status because of the importance of this product for treating infections and preventing infections and open label reading to a reduction and resistance switch, if you read any of the major newspapers, you’ll see as a major concern of both the FDA, the CDC and the Health and Human Services Department, Medicare. So we believe we have - that will be the timeline of gear study presumably starting in early Q4 to be conservative, 2014 that takes us into Q4 2015 to complete. As you know if we were to get fast track status, it’s a six months review that would be some time in 2016 that we would hear back that for NDA list filed and accepted and we’d be ready to launch in the U.S. either later 2016 or early 2017. So that’s a general guideline.
(Operator Instructions). We do have another question from [Doug Schewegel]. Doug, please state your question.
Maybe directed to Dr. Pfaffle. Where do you see us in the process with regards to label expansion where we might hear something final back on that? I think Randy addressed that on the last update. I want to see if there was any potential change on the timeline on that?
Dr. Tony Pfaffle
That’s a good question, Doug. I think I am equally optimistic about the label expansion. I’d say remember of the call from the initial approval for the hemodialysis label indication. There were periods where we received request for additional information that could have been a certificate of purity for heparin; it could have been some additional data on use of citrate as (inaudible). And we provided this data back and forth in an iterative process.
As Randy mentioned, we have already filed for the label expansion into TPN, oncology, ICU and peritoneal dialysis. We are about three months into a process which we estimate to be approximately six months. So we hope it will be any month now that we’ll get a response from TÜV-SÜD and MEB in which case again we’ll announce it. So lots of work has been done, lots of sections of documents that they have been requested for example a state of the art and catheter care et cetera has been submitted. And we are cautiously optimistic. And I don’t say that right away because we work on this everyday and at least many times per week. And we are making progress. Again everyone likes to throw out the disclaimer, all regulators are unpredictable and that’s true but we are humbly and of course optimistic that three months into a general time frame of six months, we are making progress with the label expansion.
Okay, thank you.
Dr. Tony Pfaffle
We do have another question on the line from [Mark Reid]. Mark, please state your question.
Hi. Yes, I find the net sales numbers were a little disappointing and I was just curious, Randy seem to imply that we’re in a period of sampling and introduction in Germany, and that’s the cause for the low numbers and they are not reflective of what’s going on. Is that period essentially over and are things ramping up or can we expect that to continue through another quarter or so?
This is Randy. As we stated, we are in the early stages of the launch in Germany. And I am very encouraged by the initial progress but as you go, you kind of segment the physicians by early adopters and then there is some later adopters. So, it takes a certain amount of time for our reps to get around to the different doctors. But it’s always choppy during the first couple of quarters and that’s why I didn’t want to give sales guidance. But as I said earlier in my discussion, we are very encouraged by the number of patients that are being added.
Okay, all right.
And the other point I’d just like to through in is one thing I check is the reorders. So as you know, when we first gave samples, are some of these -- are these physicians reordering? And that’s we’re seeing more reorders now, particularly in the month of May because as you can imagine, they started burn through the samples and now they are reordering. So these patients that they put on, if they reorder, that’s what we are tracking.
Good. If I could ask a follow up just, can you say again what the anticipated size of the German market is and are there efforts to expand in other countries in European Union?
Well, the size of the German market, as we always look at this way, the size of the hemodialysis market and then that percentage of patients that are on catheter. There are 80,000 hemodialysis patients in Germany and 20% -- around 20% are on catheter. So we have done our modeling based upon that. And there is other countries, if you look in -- done quite a bit of work in other EU countries; and generally the percentage is around 15% to 20% catheter use rate based upon hemodialysis.
So as I mentioned in my earlier discussion, we targeted the high price quarter countries which tend to be the Nordic countries, some of the other EU countries and the Middle East.
Okay, thank you very much.
You are welcome.
(Operator Instructions) We do have another question from [Doug Schewegel]. Doug? Please state your question.
Yes. Hi, Randy. What would you envision as far as earn out? Is the company primarily interested in potentially partnering at an appropriate time when you can show significant valuation with let's say being signed -- getting approval through the FDA for the trial process in U.S. or would you prefer to see the company go standalone and run the trial [expense] the trial themselves?
Our strategy has always been to partner. And the reason we used Germany as the beachhead just to establish pricing and establish the positioning. But the strategy is to always partner. I do want to highlight that we talk a lot about hemodialysis, but the questions that came on earlier in Dr. Pfaffle’s discussion about the label expansion the hemodialysis is less than 50% of the total market. So, the label expansion opens us a larger opportunity for CorMedix. And that's why partnering is you have to think a little beyond the hemodialysis market alone.
Sure. Thank you.
(Operator Instructions). It appears we have no further questions at this time.
I want to thank everybody for calling in. And we look forward to updating you as a lot of these activities that are underway, will put out press releases as appropriate. Thank you for the call.
Thank you. This does conclude today's teleconference. You may disconnect your line at this time.
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