Joshua Drumm - Investor Relations Khoso Baluch - Chief Executive Officer Bob Cook - Chief Financial Officer

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

Thanks, Kat. Good afternoon and welcome to the CorMedix third 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 U.S. and other product candidates, future financial position, future revenues and projected costs and potential market acceptance of Neutrolin and other product candidates. More specifically, forward-looking statements include any statements about our clinical development plans and the timing, 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 those 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. Please e-mail any questions you have during and at the conclusion of the call to cormedix@tiberend.com and we will try to answer as many of these 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.

Thank you, Josh. Good afternoon, everyone and thank you for joining us on our call today. Similar to our previous calls, today, we will provide updates on the key areas that are most critical to drive value for CorMedix. Number one, our ongoing Phase 3 clinical trial for Neutrolin, specifically the planned interim analysis; number two, our robust pipeline for taurolidine-based medical devices; number three, an update on our plan for financing the company; and number four, lastly, Bob Cook, our CFO, will provide a full financial update. So, let me begin with the first point. First and foremost, our Phase 3 clinical trial for Neutrolin, this remains our top priority and we have continued our efforts to complete this study as efficiently and quickly as possible. As a reminder, Neutrolin is commercially available in the EU based on EU data supporting the safety and efficacy and we are working tirelessly to meet the regulatory benchmark that were agreed upon with the FDA. As we described on our last quarterly call, 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 catheter-related bloodstream infections or CRBSI events in the study. The first change was the agency had agreed to the use of an independent Clinical Adjudication Committee or CAC to critically assess all suspected CRBSIs and determine, on a blinded, case by case basis if the particular event will be included in the primary analysis of the primary efficacy endpoint of the study. The CAC determination will be based on a set of defined decision rules, upon which the FDA also agreed. Number two, another important change was CAC will also evaluate cases based on the single positive blood culture…

Thank you very much, Khoso. The company will file its 10-Q for the third quarter ended September 30, 2017 momentarily. 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 third quarter 2017 financial results, our net loss was approximately $10 million or $0.17 per share compared with a net loss of $9.1 million or $0.23 per share in the third quarter of 2016. In the second quarter of 2017, we reported a net loss of $5.1 million or $0.10 per share. Our third quarter 2017 net loss was negatively impacted by a $2 million change in the fair value of derivative liability representing the difference between the fair value of the warrants issued in connection with the May financing as of June 30 and their estimated fair value as of August 10, the date on which these warrants were revalued and re-classed into stockholders’ equity, following the receipt of shareholder approval for increasing the company’s authorized shares. Disregarding the impact of the warrant liability on the company’s income statement during the year, the company’s net loss would have been approximately $8 million in the third quarter and $7 million in the second quarter of 2017. Operating expenses in the third quarter 2017 were $8 million compared with $7.1 million in the second quarter 2017, an increase of approximately 13%. This increase was due primarily to $0.9 million or 18% increase in R&D expense, while SG&A expense was essentially flat. Within R&D, the cost of the LOCK-IT-100 clinical trial increased by $1 million while other R&D decreased by $0.1 million. As we discussed on our last conference call, the expense of the…

Well, thank you, Bob. In conclusion, securing FDA approval of Neutrolin in the U.S. remains our primary focus and we expect to benefit from the changes that have been made to the prior protocol, which are designed to enhance our ability to capture potential CRBSI events and facilitate completion of the ongoing Phase 3 study. As Neutrolin gets closer to potential FDA approval, let me remind you that we will benefit from both the FDA Fast Track providing the potential for priority review of our marketing application and QIDP Designate, which secures up to 10 years of market exclusivity post potential approval. In parallel, we believe there is significant value to be unlocked based on our medical device pipeline and we will continue to advance these programs in the most capital efficient manner possible. We will also look opportunistically at additional development initiatives that leverage the unique properties of taurolidine to improve outcomes for patients. We believe all of these efforts add incremental value for our shareholders. As we continue to work diligently and begin to deliver solid data across our pipeline, we expect that value to be reflected in the market. We look forward to providing the next update. I will now hand it back to Joshua.

Thanks, Khoso. So I am reviewing the questions from the e-mail. So, the first question is asking about the medical devices, can you describe the status and future timeline for the device programs and which program is the most advanced?

Thank you, Josh. So, on the medical devices, we have all three programs pretty much within weeks are part of each other. All of them are as you know going through the animal models right now and the completion date for them we have at the tail end of this year. So, they are all pretty much at the same timeframe. I think the key emphasis right now is we are preparing ourselves to have a discussion with the FDA on the selected predicates that we have fixed for each of the medical devices and setting up that meeting with the FDA. And once we get that feedback having met the FDA, we will then be able to give a new estimate as to what the future timing will look for the medical devices. At present, our view is that based on the predicates we have selected and based on the work we are doing right now for our medical devices, we believe – these predicates will suffice and if that holds true for our meeting with the FDA, we would expect to do filing the 510(k) filing in the second half of 2018.

Okay. The next question is more about the Phase 3 study asking is your CRO or anyone else helping to review the patient records for packaging for the CAC and is there a way that this process can be expedited?

It’s a good question. So, our CRO in addition to members of our team at CorMedix are all actively collecting the information from the variety of different sites where the information is present. The reviews are taking place. We are continuing to add resources that are required to expedite the review of these documentations and to bring them in front of CAC. So, all of that effort is ongoing and I think over the last few months, we have continued to improve the process and make it efficient and a lot of it is driven by having the CRBSI events, confirmed CRBSI events and we have to get to 28 and so that is the driving factor for us to be able to be ready for the interim analysis.

Okay. And that’s a good segue. I have another question about how long the interim analysis may take once you – how long will it take to complete once 28 events are confirmed?

At present, based on our planning, we are expecting it would take around 2 weeks to prepare the interim analysis and for the DSMB to review the data about a week. So roughly estimate about 3 weeks from the time we have the 28 events to the time that we would be getting a feedback from the DSMB.

Okay. I have another question about the European litigation if you can just give a status update on that and specifically do you in your council see a pathway towards resolution?

Okay. So, there is not a lot of new news on the legal case in Europe, other than that, there is a hearing in two weeks from now on November 22 and 23 at the European patent office in Munich and that pretty much would be the first time we have got any new update for a long time. So at the moment, it’s going to be critical for us to attend that hearing and see what path that may take. Other than that, I don’t really have any other new news.

Okay. I am refreshing. And at this time, I am not seeing any additional questions. So, I can turn it back to the operator.

Alright. Thank you very much.