Earnings Labs

CorMedix Inc. (CRMD)

Q2 2017 Earnings Call· Wed, Aug 9, 2017

$7.58

-3.13%

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Transcript

Operator

Operator

Good day ladies and gentlemen and welcome to the CorMedix Second Quarter 2017 Results Conference Call. All lines have been place on listen-only mode. [Operator Instructions] At this time, it is my pleasure to turn the floor over to your host, Joshua Drumm, Investor Relations for CorMedix. Sir the floor is yours.

Joshua Drumm

Analyst

Thanks you. Good morning and welcome to the CorMedix second quarter 2017 investor conference call. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, we may make what are known as forward-looking statements within the meaning set forth in the Private Securities Litigation Reform Act of 1995. These statements are subject to certain risks and uncertainties and include, but are not limited to, any of the following. Any statements other than statements of historical fact regarding management’s expectations, beliefs, goals and plans about the Company’s prospects, including its clinical development program for Neutrolin in the United States and other product candidates, its future financial position, future revenues and projected costs, and potential market acceptance of Neutrolin and other product candidates. More specifically, any forward-looking statements include statements about our clinical development plans and the timing, the costs and results thereof, projections as to the company’s future capital raising, and spending and cash position, expectations as to the timing and nature of anticipated regulatory actions, possible product licensing or other business development transactions, any commercial plans and expectations, market projections for our current product candidates, and expectations as to manufacturing and product component costs. Our actual results may differ materially from these projections or estimates due to a variety of important factors including, but not limited to, 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. Also please note that there will not be a live Q&A at the conclusion of the call. Please email any questions you may have to cormedix@tiberend.com and we will try to answer as many of the submitted questions as possible at the end of the call. At this time, it is now my pleasure to turn the call over to Mr. Khoso Baluch, Chief Executive Officer of CorMedix. Khoso, please go ahead.

Khoso Baluch

Analyst

Thanks, Josh. Good afternoon, everyone, and thank you for joining us on our call today. During this call, I will provide updates on four key topics. Number one, our ongoing Phase 3, clinical trial of Neutrolin and our recent FDA communication. Number two, our robust pipeline of taurolidine-infused medical devices. Number three, our commercial strategy outside of the U.S. And number four the recent shareholders vote. Let me begin with the first topic, the ongoing Phase 3, clinical trials of Neutrolin. As you know our priority remains to bring Neutrolin, a broad spectrum a non-antibiotic, anti-infective solution to the U.S. markets. Neutrolin has already been shown safe and effective in the EU and we are working tirelessly to satisfy the regulatory obligations laid out by the FDA. As announced in April 2017, we saw a guidance from the FDA to address in part the apparent overall lower rate of catheter-related bloodstream infection events in the blinded study. Accurate and efficient capture of catheter-related bloodstream infections CRBSI events is absolutely critical. As the number of events in each study are, is the outcome measure for the primary efficacy end point. So we appreciate the FDA working with us to agree on a solution designed to help bring this study to a meaningful conclusion. Recently we concluded favorable correspondence with the FDA. Based on the information provided for the ongoing LOCK-IT-100 study and a revised plan that we submitted the FDA agreed to key changes to the study. Importantly we believe that these changes facilitate our ability to complete the ongoing Phase 3 study. Briefly the FDA, agreed to the following changes, which have already been implemented by CorMedix and which we expect to have a positive impact on our ability to more comprehensively include CRBSI events in the study. First the…

Bob Cook

Analyst

Thank you very much Khoso. The Company has just filed its 10-Q for the second quarter ended June 30, 2017. My financial report today largely compares our results for the second quarter of this year versus the first quarter of 2017 and for the first half of 2017 compared with the second half of 2016. So that you will better understand the trends affecting our operations. I urge you to read the information contained in the 10-Q report for a more complete explanation of our financial results and for an analysis of results compared with the comparable periods in 2016. With respect to our second quarter 2017 financial results our net loss was approximately $5.1 million or $0.10 per share compared with a net loss of $7.6 million or $0.19 per share in the first quarter of 2017. Our net loss in the second quarter was positively impacted by a $1.9 million change in the fair value of derivative liability, which is the difference between the fair value of warrants issued in connection with the May financing as of the closing date and there estimated value as of June 30. These warrants were considered derivatives because at the time we did not have sufficient authorized shares to reserve for their possible issuance. Given that we have now received shareholder approval to increase our authorized shares these warrants are equity instruments, and will be mark-to-market and reclassified to stockholders equity. Operating expenses in the second quarter 2017, were $7.1 million compared with $7.6 million in the first quarter of 2017. The decrease in operating expenses compared with the previous quarter was due primarily to a $0.6 million or 22% decrease in G&A expense partially offset by a $0.2 million or 3% increase in R&D expense. The quarter-over-quarter G&A expense decline, resulted…

Khoso Baluch

Analyst

Thank you Bob. In conclusion securing FDA approval of Neutrolin in the U.S. remains our primary focus. We are delighted to bringing Neutrolin to the market to help prevent potential deadly catheter-related bloodstream infections in already vulnerable patient population. We are pleased that the FDA has approved our changes, enhancing our ability to capture CRBSI events and facilitating completion of the ongoing Phase 3 study. As we push Neutrolin closer to seeking FDA approval, let me remind you that we would benefit from both FDA Fast-Track providing the potential for priority review of our marketing application and QIDP designation would secure up to 10 years of marketing exclusivity post potential approval. In parallel we’re developing our medical device pipeline in the most capital efficient manner possible. These devices have the potential to unlock multiple additional markets taking advantage of the unique properties of taurolidine to potentially prevent surgical site inflammation and infection. To propel both of these initiatives forward, we recently restructured our board of directors. Dr. Gary Gelbfish a practicing vascular surgeon and previous Board member rejoined our Board at this critical time with invaluable insight on advancing Neutrolin. We also recently appointed Dr. Mehmood Khan and Steven Lefkowitz to our Board. Dr Khan brings extensive clinical trial management and R&D expertise to CorMedix. And Mr. Lefkowitz is also returning to our Board with many years of corporate finance experience with micro-cap company. Janet Dillione continues to serve on the Board and brings leadership experience as a sitting CEO of a health technology company. Additionally we have appointed Myron Kaplan as Chairman of the Board. This Board composition and collective experience should help CorMedix accomplish the task ahead and get Neutrolin across the finish line. We look forward to providing the next update. With that we can now move on to the Q&A potion of the call. And some of you realized we have changed the format of this section of the call to have a writing questions in order to cover more questions. Therefore please submit any questions you have to cormedix@tiberend.com. Thank you. Josh over to you.

Q - Unidentified Analyst

Analyst

Yes of course. Thank you. So I have a couple of questions here. The first is what is the impact of the FDA changes on the cost of the LOCK-IT-100 study and how many patients do you expect to enroll?

Bob Cook

Analyst

We have it – initially or the latest estimate of costs related to LOCK-IT-100 were approximately $30 million. And at this moment, we have not changed that estimate and that is simply because at this point we just don't know how many events and we may have already in our database given as we said in the presentation that there is an ongoing work occurring with respect to the patients that have already been enrolled in this study and in which we can retrospectively go back and assess the data. So at this point, we really don't know exactly how many more patients may be required and therefore if the cost of the trial are very much dependent on the enrollment figure, the more or fewer patients that we need to enroll will have a definite impact in costs. So I think we're likely to have more insight on where the costs are going with respect to this trial at the next call. But at this point, I think we're not able to really make much more of an estimate with respect to the cost rather than we currently have. Then with respect to patients, I think I may have answered that but just in case. Because we are dependent on events and because we don't know retrospectively how many events we may have already in our database, we're not sure at this point exactly how many more patients we're going to need. So again that is a number that we’ll unfold as we get further into the analysis.

Unidentified Analyst

Analyst

I have a sort of related question what are your plans for starting the LOCK-IT-200?

Khoso Baluch

Analyst

Okay, I'll take that one on. In light of the experience we've had with the LOCK-IT-100 and our discussions with the FDA. We are really looking at LOCK-IT-200 to see how we are able to do a second study efficiently and with minimum cost. And so it's a complete re-look again at LOCK-IT-200 and we will have more for that later in future quarters as we get that buttoned down.

Unidentified Analyst

Analyst

Okay. Shifting gears do you expect to announce additional European commercial partnerships for Neutrolin this year and when do you expect sales in Europe to become meaningful.

Khoso Baluch

Analyst

I will take that question. So we expect, we are having ongoing discussions with a variety of different partners in Europe and so we expect to announce more partnerships this year again put it in context Europe sales will always remain a very small portion of the business. It is the U.S. market that has the greatest inflection point and as we go for couple of more quarters we would begin to see growth in European sales but again it will be small. So we have to keep that in context.

Unidentified Analyst

Analyst

Okay. When do you expect to find a commercial partner for the medical device candidates.

Khoso Baluch

Analyst

As we are right now working through the animal model, we are going to start discussions with potential partners. So that effort is underway in parallel, clearly we will need to complete the animal model before we would be able to conclude any partnerships. So right now, it's going to be a busy time for us in the second half of 2017 working for partnerships and bringing our animal models to completion.

Unidentified Analyst

Analyst

Okay. Do you have any update on the ongoing European litigation?

Khoso Baluch

Analyst

Not much has moved on the European litigation side from last quarter, the next hearing that we have with the European Patent Office is in November of 2017. And so that could take a variety of different facts, it could basically be a hearing and they would reset a new date for hearing it could be, they ask to get some witnesses. So nothing more I have to share than what we've had from the last quarter, it's still very much wait and see as we get to November off 2017.

Unidentified Analyst

Analyst

Okay, someone is asking how many votes were in favor of the proposal to increase the authorized share count?

Bob Cook

Analyst

In the 8-K that should have been filed by now we reported that we had – in total we had 48,667,000 votes cast out of a potential 59 million. There were 30.3 million votes cast in favor of the proposal, which is I think 62% of the amount of the number of the shares are actually voted and over 50% of the outstanding shares the Company, which was important in order to get it approved.

Unidentified Analyst

Analyst

Okay. Looks like I have two more here. Do you expect to have any further changes to the Board of Directors.

Khoso Baluch

Analyst

I would take that question. I mean our Board of Directors will continue to evolve as we go forward. Clearly as we move closer to getting Neutrolin approved in the United States we would be looking to strengthen our Board clearly with a couple of skillsets that would be important at that time. So yes, there would be a continuous evolution of the Board.

Unidentified Analyst

Analyst

Okay, so beyond Neutrolin and what do you see as the next largest opportunity in the pipeline and has the market potential been identified for this product?

Khoso Baluch

Analyst

Well as I covered in the presentation, that the medical devices sutures in particular at the moment based on what we've got seems to be the next biggest opportunity. The reason being is that, there's only one competitor anti-microbial competitor in the market, it's clearly an area where the WHO and CDC says more of these surgeries need to use sutures with anti-microbial and the current one that exists on the market, clearly has some challenges. So assuming our animal model, the work comes out positive, then I think we will be in a strong position to play in a sizable market. As I mentioned in the United States $1.7 billion. So it's a sizable market for us to participate in.

Unidentified Analyst

Analyst

And I missed the part of this question, they were also asking about the length of time to commercialization?

Khoso Baluch

Analyst

Just, just related to the medical devices you were referring to..

Unidentified Analyst

Analyst

It referred to that specific, part the suture set.

Khoso Baluch

Analyst

Okay, so just to explain right now we are doing the feasibility work on animal models and the work we're doing in order to keep costs under contained is non-GLP animal models. Assuming we get positive results with his we will then move because we already have the models into GLP model for the animals, which is pretty short. And we would then be moving forward, in assuming our predicates are accepted by the FDA, we would see us then being able to file in the second half of next year. So I would imagine the products available to be on the market in 2019.

Joshua Drumm

Analyst

And I am just refreshing, but I am not showing any more questions.

Khoso Baluch

Analyst

I don't know if anyone else wants to send more questions, here the purpose was to be able to use this mechanism to be able to launch as many questions as possible, but if there are no more questions, then I want to thank everyone for attending this quarterly call And forward to providing updates on our exciting Neutrolin lead products here in the U.S. and then the pipeline as we continue to go forward. So thank you very much.

Operator

Operator

Thank you this does conclude today’s conference call. We thank you for your participation. You may disconnect your lines at this time and have a great day.