CorMedix Inc. (CRMD) Q4 2018 Earnings Report, Transcript and Summary

Greetings, and welcome to CorMedix Fourth Quarter 2018 Conference Call. At this time, all participants are in a listen-only mode. A question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now pleasure to introduce your host, Daniel Ferry, LifeSci Advisors. Please go ahead, sir.

Good afternoon. And welcome to the CorMedix fourth quarter 2018 investor conference call. Leading the call today is, Khoso Baluch, Chief Executive Officer of CorMedix. He is joined by Bob Cook, Chief Financial Officer of CorMedix; Liz Masson, Executive Vice President and Head of Clinical Operations; and Paul Chew, Chief Medical Officer. After the prepared remarks, we will open up the call for Q&A. Before we begin, I would like to remind everyone that 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 interpretations 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. 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 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.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on this call. Today's call will focus on the three areas most critical to driving value for CorMedix. Number one, the Phase 3 LOCK-IT-100 clinical trials for Neutrolin, in particular the progress we can report from our last meeting with the FDA and the work we are currently undertaking in order to provide FDA with the analysis requested for the complete. Number two, an update on the Company's financial position and strategy including balance sheet, capital raises and planned reverse stock split. And number three, an update on the recent Board appointment. Before we get into details, let me cover a couple of key highlights. First, during the month of January, we made two announcements related to LOCK-IT-100 study. First, we shared the top-line results of the interim analysis on January 17 followed by a second announcement on January 30 on the primary endpoints of the study based on the full dataset. Please note that the CorMedix team became unblinded only after the database lock just prior to the full dataset top-line release. Subsequently, on February 14th, we announced that we had begun discussions with the FDA regarding the use of the recently unblended Phase 3 LOCK-IT-100 study as a single study to support regulatory approval for Neutrolin. The Company's investigational product in development as a catheter lock solution for patients suffering from end stage renal disease undergoing hemodialysis. To be clear, this meeting with the FDA was not a pre-NDA meeting, rather it was a meeting to discuss specifically the regulatory pathway for bringing Neutrolin to the market. We were delighted that the FDA agreed to this discussionary meeting and that the meeting went forward despite an intervening government shutdown. At the meeting, the FDA agreed that the Company could request consideration of Neutrolin for approval under LPAD pathway. This stands for Limited Population Pathway for Antibacterial and Antifungal Drugs. We were very pleased about this outcome. What this mean for Neutrolin is that if the FDA agrees to approve pursuant to LPAD, it provides FDA with approaches for streamlined development and regulatory flexibility regarding the evidence required to support drug approval for patient populations with serious disease and limited or no treatment options, while meeting appropriate standards for safety and effectiveness including fewer or shorter clinical trials. The data that we originally submitted to the FDA at the time of our request for this meeting included preliminary analysis from the 653 subjects at the time of the interim analysis including the first 28 cases of the catheter-related blood stream infection, CRBSI. Because the study continued enrolling and treating patients until the study terminated in August 2018, the full data set is based on a total of 795 subjects and 41 CRBSI events, as determined by the Clinical Adjudication Committee. During the meeting, we also shared with the FDA the top-line results from the full dataset since the unblinding data had just become available to us. The FDA requested us to provide it detailed analysis of the primary endpoints for the newly available full dataset as well as the secondary endpoints which are loss of patency and catheter removal. These additional analyses could facilitate FDA's assessment of the evidence supporting safety and effectiveness, once it has had time to fully review the LOCK-IT-100 study results. The work to conduct the analyses is ongoing, and we are diligently focusing on getting the information to the FDA. The primary goal is to provide the FDA with robust analysis because it's important for the FDA's decision-making regarding the regulatory pathway for Neutrolin, which will impact the timing for submission of the new drug application. These analyses will be required anyway for the NDA filing. So, while it is time-consuming work, it may not significantly impact our timeline for an NDA filing. And it's important that we do it at the highest quality level. We expect to submit the analyses to the FDA in the next several weeks. Later on in this call, both Paul and Liz will provide more details on this ongoing effort. Now, let me move to the Company finances. I'm pleased to say that the Company is today in a much stronger financial position than it has been for some time. With the steps that we have been taking over the last few quarters to raise the cash required to keep operations going coupled with the successful completion of the LOCK-IT-100 study, the CRO settlement and the tight expense management, CorMedix currently has over $26 million in cash, which we anticipate will finance us into quarter two 2020. Consequently, our auditors are issuing their opinion on our 2018 financial statements without a going concern paragraph. Bob will cover further details with you. The third major highlight I would like to address is the recent appointment that CorMedix has made. I'm delighted Alan Dunton is joining the CorMedix Board. In Alan, we have a seasoned pharmaceutical executive with depth and breadth as both an operating executive and a Board member, and it is critical to CorMedix at this point in its evolution including drug development, regulatory reimbursement, commercialization and corporate governance experience. Alan has participated significantly in developing and achieving approval of over 20 prescription and OTC drugs. He has led major pharma R&D and regulatory divisions and has been a director of approximately 20 public and private companies, many of similar size and positions as CorMedix. Dr. Dunton has devoted his 35 years career to discovery and development of new drugs. Most recently, he was Senior Vice President of Research and Development at Purdue Pharmaceuticals based in Stamford. At Purdue, he was brought into build a research and development department. During his two years at Purdue, Alan developed two assets, one to treat a sleep disorder and another for inflammation. He then left Purdue as he felt his mission had been completed. Prior to Purdue, Alan was Chief Executive Officer of two biotech companies and for many years as President and Managing Director of Janssen Research Foundation, the R&D regulatory arm of the pharmaceutical giant of J&J. Dr. Dunton currently serves on the Board of two public companies, Palatin Technologies and Oragenics Incorporation. He chairs the compensation committee and is a member of the audit company of each of these companies. He's also a member of the board of Cytogel Pharma, a private biopharmaceutical development company focused on developing products for pain. Now, let's here Paul and Liz who will share more with you as to where we are in the ongoing discussions with the FDA. So, let me start first with Paul.

Thank you, Khoso. First, we're pleased with the outcome of our meeting with FDA. It was a good start of the dialogue we expect to have with them. I want to tell you more about the meeting as I receive questions about it. The specific the meeting we had with FDA was a meeting to discuss the regulatory pathway for Neutrolin in line with the extraordinarily positive results that we received during our interim analysis. This meeting was requested by CorMedix to revisit the previous guidance that the FDA had provided to the Company as the Neutrolin’s regulatory pathway and the timing of the filing of an NDA. We clearly wanted to have this discussion with FDA as soon as possible while we continue to work on the database lock and begin analyzing the full dataset. As it happens, the timing of the FDA meeting coincided with the database locking and the top-line readout of the full dataset as well as the receipt of the DSMB’s guidance after they had reviewed the top-line data. During our meeting with FDA, we’re able to share this new information that we believe further strengthened our request that the data from LOCK-IT-100 provides substantial evidence of safety and effectiveness. The FDA's information request to us from the meeting was expected in light of the fact that the full dataset has just recently become available for us to start our internal review. Liz will provide you a flavor of the effort underway. Once this phase and the discussion is completed and should the FDA agree that CorMedix can file an NDA based on our single clinical trial, we'll then enter into the next phase of our discussions, which is an end of Phase 3 meeting. This end of Phase 3 meeting usually occurs once the clinical study report is completed. After this phase, we'll have a pre-NDA meeting in which we will cover such topics as how to plan to file the NDA, for example by rolling submission, the element of the submission, requesting a priority review LPAD request et cetera. In addition, there are several other meetings that usually take place with FDA on an ongoing basis, so that we can obtain guidance from the agency relating to the individual sections of the NDA. I hope this clarifies and helps to clarify where we are in our ongoing discussions with the agency. Now, let me hand the floor to Liz who'll provide you further colors as to the current efforts in preparing the information for the FDA. Liz?

Thank you, Paul. As Khoso and Paul mentioned, a cross-functional team is working on preparing a material that will be sent to the FDA, based on their further information requests during the recent face to face meetings. The information the FDA requested is a subset of the clinical section one would normally expect while you file an NDA. Since our request of the FDA, it’s to reconsider their previous two study requirement guidance on the regulatory pathway. FDA is interested in seeing additional information before making a decision. This additional information requires the team to plan and perform more extensive analyses to ensure that all aspects of the clinical data are reviewed and available. While we looked previously at these data focused on CRBSI as the primary endpoint, we are now broadening the analyses to look at the data cumulatively and collectively. The effort is in two basis, first, we have to compile a significant amount of data to perform many analyses for a variety of different data points. For example, the specific pathogens identified by subject, agent location of catheters and adverse events just to name a few. As we discussed before, due to the medical complexities of these subjects, the volume of data from the many hospitals and clinics requiring review and analysis is significant. There is a very large number of adverse events to review, one subject alone could have 30 such adverse events. Further, we are carefully reviewing the events leading up to a CRBSI along with any and all contributing factors. This requires the preparation of numerous tables using strict quality controls coupled with sensitivity analyses to see if there is any statistically significant trend. Once this phase is completed and we have the tables, we will then have to tie thread to all of this information to support Neutrolin's clinical performance. As I previously mentioned, all of this information and more would normally be prepared as part of an NDA filing. Therefore, as we spend time analyzing the data on the front end, it may not significantly affect the overall timeline for NDA filings. Please remember that until we have the pre-NDA meeting, it would be premature to speculate on firm timelines as to when we would file the NDA. I hope this helps clarify where we are in the process. I will now turn the call back over to Khoso.

Thanks, Liz and Paul. Clearly important work for CorMedix as we prepare the required information to submit to the FDA. Now, let me ask Bob to cover quarter four financial results and CorMedix's overall finances. Bob?

Thank you, Khoso, the company has filed its annual report on Form 10-K for the year-ended December 31, 2018. I urge you to read the information contained in the report for a more complete discussion of our financial results. With respect to our financial results for the 12 months ended December 31, 2018, our net loss was approximately $26.8 million or $0.30 per share compared with a net loss of $33 million or $0.60 per share for the year-ended December 31, 2017. Lower operating expenses during the fourth quarter of the year accounted for the much reduced net loss in 2018. Operating expenses during 2018 amounted to $26.9 million compared with $33.1 previous year, a decrease of $6.2 million or 18.7%. The decrease in operating expense was due primarily to the benefit derived from the financial settlement with our CRO in November 2018. I will discuss this in more detail in a few moments. R&D expense decreased by $5.6 million compared with 2017, while SG&A expense declined by approximately $0.6 million. Cash used in operations during 2018 was approximately $23.7 million compared with cash used of $28.6 million in 2017. The reduction in cash used in operations occurred primarily as a result of the CRO settlement reflected in the lower net loss for the year coupled with modest year-over-year increases in accounts payable and accrued expenses plus reductions in inventory, receivables and prepaid expenses. With respect to our financial results for the fourth quarter of last year, we recorded a net income from operations of $2.1 million compared with the loss of $10.3 million in the fourth quarter of 2017 and an operating loss of $10.2 million in the third quarter of 2018 just for comparison. The CRO settlement was the primary reason we recognized income in the quarter. As a result of the CRO settlement, we recorded a benefit of $4.3 million from research and development compared with an expense of approximately $8.5 million in the fourth quarter of 2017, a $12.8 million swing. We booked a gain in clinical trial expense of $5.3 million during the fourth quarter of 2018 while clinical trial expense during the quarter was $7.6 million. SG&A expense of $2.2 million in the fourth quarter increased approximately 10% from the third quarter of 2018. The increase in expense occurred primarily due to work we have commenced with respect to marketing preparation for Neutrolin's anticipated commercialization in the U.S. Cash used in operations in the fourth quarter of 2018 was approximately $7.2 million compared with a use of $5.1 million in the third quarter of 2018. The quarter-over-quarter increase in cash used in operations was primarily due to a $9.8 million reduction in accounts payable and accrued expenses, which offset the net income for the period. Primarily as a result of the CRO settlement and our resumption of payments to the CRO for services not covered by the settlement, our total of accounts payable and accrued expenses decreased from $17.5 million at September 30, 2018 to $7.8 million at December 31, that year. As I reported during our call in November 2018, while the terms of our settlement with the CRO are confidential, we received cash, credits and other significant consideration in return for agreeing to make cumulative payments of approximately $6.2 million through the end of January 2019, plus investigator fees and third-party costs that were not invoiced through September 30th, last year. Due to some delays in receiving final invoices from sites in connection with the winding up of the LOCK-IT-100 study, the final payment due to our CRO for investigator fees and third-party costs is anticipated to be made sometime during the second quarter of 2019. The settlement agreement, once fully implemented, will result in the full satisfaction of the $14.5 million outstanding accounts payable and accrued expenses recorded as of September 30th last year in connection with the CRO Master Services Agreement. We recorded $0.6 million in expense in the fourth quarter of last year related to the new work order we signed with our CRO, which was related to study closure and data transfer activities. During the fourth quarter of 2018, we continued to judiciously utilize our at-the-market facility, raising approximately $11 million net after commissions at an average price of $1.31 share. We were able to take further advantage of our ATM facility given the significant increase in our stock price during the first quarter of this year, raising an additional $15 million at an average price of $1.78 per share. This was an important action for us to take, because by raising this amount of money prior to the filing of our annual report on Form 10-K, our auditors had determined that they would not include the going concern paragraph in their opinion on our financial statements for the year, which by comparison they had done in their opinion on the company's 2016 and 2017 financial statements. We were also pleased to have completed and closed on a $7.5 million three-year convertible debt financing with our largest shareholder on December 31st. The debt bears interest at the rate of 10% per annum and is convertible at the investor's option into the Company's common stock at a price equal to $1.50 per share. It is callable by the company beginning in June of 2020. In connection with the financing, we issued new five-year warrants to purchase 450,000 shares of our common stock with an exercise price of $1.50 per share and reduce the exercise price to one-tenth of $0.01 on two existing warrants held by Elliott from prior financing, one to purchase 500,000 shares at $0.65 per share expiring in May and the other for 750,000 warrants at $0.90 per share expiring in October 2019. This transaction was particularly attractive to us as we were able to raise a substantial amount of money at what was then a significant premium to the then current market price of our stock, which significantly extended our cash runway. In December of last year, we announced that the New Jersey Economic Development Authority had approved the Company's application to participate in the New Jersey Technology Business Tax Certificate Transfer program for the state's fiscal year 2018. The approval allows CorMedix to transfer approximately $5.4 million of the total $6.1 million in available tax benefits to an unrelated, profitable New Jersey corporation. We had anticipated that the sale would be completed around the end of the year. At this time, we are in the process of finalizing the sale to two parties. The delay in closing the transaction occurred because earlier buyers unexpectedly reversed their decision to purchase NOLs. These decisions were specific to those buyers and unrelated at all to CorMedix. Fortunately, we have been able to replace them with other buyers and we expect to conclude the sale over the coming weeks. Based on our existing cash at December 31, 2018 of $17.6 million, the $15 million additional cash we have subsequently realized to date through our ATM program, and the anticipated $5 million in proceeds from the sale of our NOLs, we believe we have the resources to fund the Company's operating needs into the second quarter of next year. As we discussed during our last quarter's conference call, the extent of our ongoing financing needs will become clearer once we have guidance with respect to FDA's position regarding our filing the Neutrolin NDA based on the LOCK-IT-100 study results. Until then, we may consider opportunistic financing to strengthen our ability to negotiate with partners or build our commercial infrastructure in preparation for the launch of Neutrolin for hemodialysis in the U.S. market if the timing and terms of such would be in our shareholders' interest. The Company also announced today that its Board of Directors has approved a 1 for 5 reverse stock split of its common stock that is planned to become effective before trading begins on Tuesday March 26th, after which time, the CorMedix's common stock will trade on a split adjusted basis under a new CUSIP number. As a result, a stockholder owning 1,000 shares of CorMedix's common stock will own 200 new CorMedix stock shares as of the opening of trading on March 26, 2019. The par value of the stock will remain $0.001 per share. As previously disclosed at the CorMedix annual meeting of stockholders held on June 26, 2018, the Company stockholders approved the proposal authorizing the Company's Board of Directors to effect the reverse stock split at a ratio of between 1 for 5 and 1 for 10. The Board elected to effect the minimal stock split in accordance with the range approved by the stockholders, given the positive outcome of the Company's LOCK-IT-100 study that has resulted in a significant increase in the Company's stock price since the stockholder approval was attained. The reverse stock split will uniformly affect all issued and outstanding shares of the Company's common stock. It will not alter any stockholder's percentage ownership interest in CorMedix except to the extent that the reverse stock split results in fractional shares. No fractional shares will be issued in connection with the reverse stock split. Stockholders who would otherwise be entitled to receive a fractional share will instead receive one whole share of the Company's common stock. The reverse stock split will proportionately affect the number of shares of common stock available for issuance under the Company's equity incentive plan and will proportionately reduce the number of shares of common stock issuable upon the exercise of stock options, warrants and preferred stock outstanding immediately prior to the reverse split. The exercise prices of the Company's outstanding options and warrants and the conversion price of its outstanding preferred stock will be adjusted in accordance with their respective terms. The reverse stock split will reduce the number of shares of common stock issued and outstanding from approximately 119 million to approximately 23.8 million shares. This action is being undertaken now for several reasons. It is important that the Company have available unissued shares in order to take advantage of future opportunities that may present themselves whether to include as part of the licensing or partnership agreement, promote investment by quality institutional investors or finance commercialization efforts in anticipation of the launch and as early as 2020. As we more aggressively seek institutional interest in our stock, a stock price below $5 limits the universe of funds that may invest based on the fund’s investment performance -- fund's investment policies. And the price below $3 becomes an even more significant barrier to investment in our stock. In connection with the $7.5 million convertible debt financing we closed in December 2018, we are required to have sufficient common stock reserved for that transaction by April 30, 2019. And finally, given the positive Phase 3 data from the LOCK-IT study, the possibility that it will be sufficient with which to file an NDA and our vastly improved liquidity position, we believe this is an opportune time to effect a reverse. And with that, I will now hand the call back to Khoso for his closing remarks. Khoso?

Thank you, Bob. What Liz, Paul and Bob covered with you hopefully provides you insight into the important events on which we are focused that have occurred since our last update in November 2018. I'm pleased about the progress we are making. I would like to reemphasize, first, as Paul elaborated, our current discussions with the FDA are occurring prior to an end-of-phase and a pre-NDA meeting. We are having this discussion now, because we would like the FDA to reconsider the previous guidance on requiring two studies in order to file an NDA. We saw this additional step because of the great results we saw from LOCK-IT-100. As Liz indicated, we are diligently working on completing the analysis requested by the FDA. The focus here is to ensure quality and completeness. As Liz indicated, this may not significantly change the overall timeline. Bob provided a lot of color, not only on CorMedix balance sheet and cash flow, but also the steps that were taken in financing the Company. We are effecting the reverse split, which was approved last year now, because we believe it is an opportune time to do so. The 1 to 5 split ratio is the smallest we can do based on the shareholders’ approval. We believe the cash we have in hand is sufficient for us to complete the regulatory discussions with the FDA and file an NDA, if the FDA agrees with our request to file based on a single study. If approved, we've believe Neutrolin will become the standard-of-care for preventing catheter-related bloodstream infection, and taurolidine will have significant other applications against inflammation and infections. I'm very pleased with the strength of our management team, adding Liz and Paul last year and recently appointing Alan to the Board earlier this year. We will continue to evolve by augmenting our team over the coming year. I'm also confident that the strategy we embarked on in early 2017 will continue to move steady fast forward at an ever-increasing pace. I look forward to providing you with material, developments, updates via the CorMedix website, press release and conference calls. Thank you for your continued support of CorMedix. Let me now hand the call back to Dan.

Ladies and gentlemen, we'll be conducting a question-and-answer session. [Operator Instructions] Our first question today is coming from Ram Selvaraju from H.C. Wainwright. Your line is live.

Hi. Thanks very much for taking my questions. And thanks very much for detailing all of this progress. A couple of housekeeping items for Bob, if I may. I presume that the CRO settlement is a one-time event and there will be no future recurring impact from this CRO settlement going forward in future quarters, is that correct?

Yes. Ram, that is correct. I mean, there are some payments, as I mentioned that are being made in 2019 that we agreed to make when we signed the settlement agreement. But, once that is done, that's it. So, in my view, it was a one shot deal. And what we're going through now is basically just closing -- finishing the study and then finalizing the amount of the payments that were due to our CRO under the settlement agreement, and then making those payments, which I indicated, should be completed by the end of the second quarter.

And then, could you just refresh my memory as to what changes there have been on the cash level since the end of 2018 with respect to any activities that you had on the ATM?

Well, as I said, Ram, I mean, we used the ATM in the fourth quarter. I think, I said, we had raised $11 million, by the end of December. And then, we used it to raise another $15 million up to today. And at this point, we have achieved what we wanted to achieve in terms of having sufficient liquidity to run the Company for a good period of time. So, it was important to us that we get the auditors situation fixed, so that we don't have to worry about a going concern anymore, and we've done that. And we want to have enough runway to complete the work that we're doing now with the study and also to have guidance from FDA. So, hopefully being positive we’ll be able to file the NDA this year. So, we are financed to the point where we can focus on the business and raising money to continue operations for another quarter, it’s not something that we have to spend time on.

Okay. So, just to clarify. The convertible debt financing closed in January that was for gross of $7.5 million and so far -- since the end of 2018, you’ve brought in another $15 million off of the ATM, is that correct?

Yes. That's correct.

Okay, great. And then, just a couple of things regarding the NDA filing preparation. Have you -- I don't recall whether you said that you have formerly requested the actual pre-NDA meeting, yes or not? And if not, if you could just remind me what specific gating items still remain before you actually request it?

Yes. Our plan is to, first of all, complete the analyses and finalize the FDA package for the items they requested when we met with them. Once the package is completed, we’ll send it to the FDA with a meeting request. It is not the end-of-Phase 3 meeting, it's a meeting request to talk with them about their data. It's up to the FDA if and when they give us a meeting. And if a meeting is granted, it generally occurs within a 75-day period of the request. So, this is before the end-of-Phase 3 meeting.

And when you say end-of-Phase 3 meetings, is that synonymous with pre-NDA meeting?

Well, the end-of-Phase 3 meeting is when you usually have the final clinical study report. And when that's done you discuss the findings with FDA. That is then followed with the pre-NDA meeting. And the pre-NDA meeting talks a lot about the technical details of the filing, how we're going to file, rolling submission, et cetera. So, it's a series of meetings that are building on the previous one, providing more information to FDA, getting more information from them. So, it's a stepwise process.

Okay, understood. So, just for clarity sake, going into the actual pre-NDA meeting, will you know whether at that juncture the FDA would be permitting a rolling submission or not or is that going to be part of the pre-NDA meeting discussion as well?

Yes. It’s all part of the pre-NDA submission -- pre-NDA meeting.

Okay. And just if I could ask hypothetical question. If the NDA were to be permitted by the FDA to be submitted on a rolling basis, could you tell us whether this is likely to be a 3 module submission or 4 module submission or you have no idea at this juncture?

I think, it's too early at this point, Ram. We're going to be putting the cart before the horse if I were to respond to that. I think our first intent is to respond to the FDA requests for the analyses they recently requested and we're going to take it from there.

Okay, fair enough. And then, one quick question for Khoso, if I may. With respect to potential preparation for commercialization in the United Sates. Could you, A, give us a sense of what the training of initiation of those commercialization preparations might be? And secondly, if you could perhaps give us some commentary on what they might consist of? Thank you.

Thanks, Ram. So, two pieces. In the U.S., we’ve really not done much commercial preparations since 2017. You heard Bob color in his talk a little bit of efforts that we started to put on that front. And the focus areas where we spend now some time and we will continue to spend some time on it is linked to two main key areas. One of them is the brand name. There are some very specific regulations that we need to pass-through to get that prepared, so that we could submit it to the FDA. And so that effort -- we’ll spend time on that effort because that is time-sensitive. And the second is to begin to get below the skin in terms of market access. Now, this work will continue, but we will keep it at a little burn till we've got clarity from the FDA. And we have enough timing then to be able to up the burner and be ready in time for a launch in the U.S.

Out next question today is coming from Jerry Isaacson from ROTH Capital. Your line is now live.

First thing I want to do is just clarify one of the comments that have been made. It seems like you said the FDA has said that Neutrolin could be eligible -- or is eligible for OPEB status, but also you don't have definitive word yet from the FDA on whether or not the NDA can be filed with just the one Phase 3 study. Wonder if you can kind of put those two -- square those two statements for me and give a little more context there.

What FDA said was that we are welcome -- CorMedix is welcome to request OPEB status. That's something that's made that decision whether that application is accepted by FDA, would be during NDA submission, so that we’re eligible to request it. But, it's not automatically granted until they have the NDA in hand.

Okay, thanks. That's actually the only question I had after Ram's questions. So, thanks a lot. I appreciate it.

Thanks, Jerry.

Thank you. That does conclude our question-and-answer session. I'd like to turn the floor back over to management for any further or closing comments.

Thank you very much. Well, I'd like to thank everybody who's on this call but also the team and the Board in the guidance as we continue to move forward. We're very excited at where we are at the stage of the Company. And we look forward to providing updates, again through our website, press release or conference calls depending how material the information is. So, thank you very much and thank you for your support. Good bye.

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