Earnings Labs

CorMedix Inc. (CRMD)

Q4 2017 Earnings Call· Mon, Mar 19, 2018

$7.58

-3.13%

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Transcript

Operator

Operator

Greetings and welcome to the CorMedix Fourth Quarter 2016 Results Conference Call. [Operator Instructions]. I would now like to turn the conference over to your host [indiscernible], Investor Relations Manager for CorMedix.

Unidentified Company Representative

Analyst

Thank you, Operator and thank you all for participating in today's fourth quarter and year-end 2017 investor conference call. On the call today Khoso Baluch, Chief Executive Officer of CorMedix will provide an update on the company's clinical programs and review upcoming milestones. We will then turn the call over to Bob Cook, Chief Financial Officer. After the prepared remarks we will have the operator coordinate a Q&A session. Before turning the call over to management, I would like to make the following remarks concerning forward-looking statements. During the call, management 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, results and interpretation 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 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. 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

Thank you. Good afternoon and thank you for joining us on our call today where we would like to review our fourth quarter and full year 2017 financial performance and provide you with an update of our corporate activities. As in our previous calls we will provide updates of key areas that are most critical to driving value for CorMedix including our ongoing Phase 3 clinical trials for Neutrolin and the planned interim analysis. Our pipeline development specifically the neuroblastoma and the taurolidine based medical devices and update on our financial plans and finally a financial update from Bob Cook, our CFO. So let me begin with the ongoing Phase 3 clinical trial and the interim analysis for Neutrolin. Since I joined CorMedix in October of 2016 the program in trial LOCK IT 100 has been our top priority. We remain focused on completing the interim analysis and the trial as efficiently and as quickly as possible. For those of you who may not be familiar with the LOCK IT 100 trial allow me to highlight the recent history. During the second half of 2016 subject enrolment into the study proceeded very slowly and the CorMedix team began to build capabilities internally to address the enrolment issues. That decision and effort resulted in a notable and rapid increase in enrolment rates. As of Friday, March 16, 2018 we have 757 subjects enrolled in this study. The original plan was to have a total of 632 subjects enrolled in this study, the increase in enrolment was discussed with the FDA to address lower than expected rate of CRBSI [ph]. The CorMedix team simultaneously started to investigate why at that time there were so few reported CRBSI's at the study sites. After a careful review including a thorough investigation at the haemodialysis…

Robert Cook

Analyst

Thank you very much, Khoso. The company will file its annual report on Form-10k for the year ended December 31, 2017 t momentarily. I urge you to read the information contained in the report for a more complete explanation of our financial results and analysis of results compared with comparable periods in 2016. With respect to our fourth quarter 2017 financial results are net loss was approximately $10.3 million or $0.15 per share compared with a net loss of a 6.4 million or $0.16 per share in the fourth quarter of 2016. In the third quarter of 2017 we recorded a net loss of $10 million or $0.17 per share. Our fourth quarter 2017 net loss was negatively impacted primarily by the costs related to the ongoing LOCK IT 100 clinical study and by increases in CMC in clinical supply expenses. Operating expenses in the fourth quarter 2017 were $10.4 million compared with 8 million in the third quarter of 2017, an increase of approximately 30%. This increase was due primarily to a $2.4 million or 40.6% increase in R&D expense while SG&A expense remained flat .Within R&D the cost of the LOCK IT 100 hundred clinical trial increased by 1.7 million and CMC clinical supply expenses increased 0.7 million, other R&D remained unchanged. As we discussed in our last conference call the expense of the LOCK IT 100 clinical trial increased during the fourth quarter of 2017 as we continue to enroll more patients and ramped up our efforts to prepare and submit potential CRBSI cases to the clinical adjudication committee. Expense also increased as a result of patients staying in the study longer than we had originally planned. Cash used in operations in the fourth quarter of 2017 was approximately $7.3 million compared with 6.8 million in the…

Khoso Baluch

Analyst

Thank you, Bob. In conclusion the LOCK IT 100 study remains our top priority and we remain focused on completing the interim analysis and the trial as efficiently and as quickly as possible. As Neutrolin gets closer to potential FDA approval let me remind you that we will benefit from both the FDA's fast tracked providing the potential for priority review and our current marketing application and the QIGP [ph] designation which secure owns up to 10 years of marketing exclusivities post approval. We are also pleased with the progress of our pipeline and the reason FDA grants of orphan drug designation to taurolidine for the treatment of neuroblastoma. We will provide a top line update on the proof of concept results in the next few weeks and with that we conclude our formal remarks and now we'll open up the line for questions. Monik [ph]

Operator

Operator

[Operator Instructions]. Our first question is from Ram Selvaraju, H.C. Wainwright. Please proceed with your question.

Ram Selvaraju

Analyst

Just point of clarity with respect to the LOCK IT 100 study interim analysis, can you give us a sense of what specific information you would be able to disclose once the interim analysis is complete and secondly if there would potentially be a scenario under which you would not necessarily need additional information in order to be able to say definitively whether Neutrolin is working in the study, in other words if there is a results coming from the interim analysis that would definitively show Neutrolin is an effective treatment in the context of CRBSI. Thank you.

Khoso Baluch

Analyst

As I outlined in the call we just had that we required 28 CRBSIs and we achieved that in December and so that last cases were reviewed and confirmed by CAG in early part of January 2018. We then started to review the final data which is normal that you do with when you have had the last patient inclusion included into the 28 CAG cases. So for us as I indicated there are there different scenarios that could occur and they are obviously the scenario occurs where we are statistically different in the Neutrolin arm versus the heparin arm then clearly that would lead us down a path which we would need to submit to the FDA, that would be the only time in my understanding is where we would have the information and the statistics behind it that we would be able to provide it to the FDA in any of the other scenarios. We will then end up having to continue in the second scenario to enrol upto 56 events for if in the unlikely event it's futile then obviously then we would have to stop the study. I think is that your question that you were asking?

Ram Selvaraju

Analyst

So that answers the second part of my question but the first part relates to what specific information you will be able to disclose once the interim analysis is completed? Would it be just a key value or would it be a key value plus some numeric details or would it be more contextual information than that?

Khoso Baluch

Analyst

Okay. So to the first part of your question the only time we will be able to provide any more details would be if we hate the first scenario potential scenario which is we show a statistical significance at the interim analysis and we submit it to the FDA and only once we hear back from the FDA would we be able to provide more clarity in terms of the top-line results that we have seen in the interim analysis. If we end up in the other two scenarios we will not be able to provide any more details at present to the marketplace till either we get to the 56 events or if the study obviously comes to a stop then that would be the end of it.

Ram Selvaraju

Analyst

And then just a follow up if I may on the medical device related application of these mesh's and so on that you are working on. Given the work you are expecting to release in the course of the near future, could you perhaps lay out for us what you would attempted to do on that front. You know I believe we had previously talked about the possibility of conducting some strategic partnering, or some other initiatives that would enable you to move those programs forward without necessarily having to deploy additional capital into them at this juncture, but could you perhaps give us a bit more color on that please.

Khoso Baluch

Analyst

Yes, so soon as we've got the results from our three animal study proof of concept we will obviously be looking at that very carefully we are also assessing you know the feedback from the FDA, the PMA pathway versus the 510(k) it's very interesting that in discussions that we have had with several prospective partners they actually express a preference for the PMA pathway over the 510(k) pathway just for the reason that they would be able to articulate the benefits and make claims on the product versus what is today standard of care in the marketplace. So we will be taking all of that information and obviously sharing the results of our study with the potential partners and then be able to lay out a pathway going forward.

Operator

Operator

Our next question comes from Alexis Woods with LifeSci Capital. Please proceed with your question.

Alexis Woods

Analyst · LifeSci Capital. Please proceed with your question.

Just for the LOCK IT 100 trial assuming that you wind up in a scenario where you have to continue until 56 events occur, what kind of timeline are you anticipating for the remaining 28 events that occur and then for that final data read out?

Khoso Baluch

Analyst · LifeSci Capital. Please proceed with your question.

Yes. We have not changed our guidance to what we have shared before and that is we expect enrolment to be completed in quarter two and then our top line readout at the tail end of 2018 so that guidance has not changed. We have not seen anything yet in the marketplace that would require us making any change in our assessment of timelines.

Alexis Woods

Analyst · LifeSci Capital. Please proceed with your question.

And then also with the Neutrolin for obviously you would have to do a second registration trial, are you -- have you made any decisions regarding which indication you'd be pursuing for that. I know there was a discussion of oncology and then also TPN have you come to any conclusions about what you'd be pursuing?

Khoso Baluch

Analyst · LifeSci Capital. Please proceed with your question.

At present no we have not come to any conclusion which of those two indications we would be pursuing for the second study. Our focus has been on the interim analysis and getting to that point before we begin to assess the next study in more detail than what we had originally done.

Alexis Woods

Analyst · LifeSci Capital. Please proceed with your question.

Okay. And then finally just one more question related to the paediatric neuroblastoma, I know you're planning to providing some results to us soon for the pre-clinical data. Do you have any timeline tentative timelines for moving it into the clinic based on -- assuming that there's positive results from that preclinical stuff?

Khoso Baluch

Analyst · LifeSci Capital. Please proceed with your question.

Yes. So on neuroblastoma all along I have been articulating that our goal very much is to find a partnership with a company that is focusing in the oncology space for us to move this forward into clinic and our goal very much is as this information has come in. We will begin to initiate discussions with potential interested parties and that will dictate timelines from which we will be able to then give further updates on future calls.

Operator

Operator

Ladies and gentlemen we have reached the end of the question and answer session and I would like to turn the call back to Khoso Baluch for closing remarks.

Khoso Baluch

Analyst

Thank you very much. I guess at the end of this call just want to thank everyone for following us very closely and having an interest in CorMedix. I think we continue to move forward with speed and clearly we are bringing a change to the marketplace and should Neutrolin get approved by the FDA it will be a change to the standard of care in the U.S. market and so I'm excited to continue this journey and get us across the finish line. So thank you very much following us. Take care. Bye, Bye.

Operator

Operator

This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.