CorMedix Inc. (CRMD) Q3 2019 Earnings Report, Transcript and Summary

Greetings. Welcome to CorMedix's Inc. Third Quarter 2019 Earnings Conference Call. [Operator Instructions] Please note, this conference is being recorded. I would now like to turn the conference over to your Dan Ferry, Managing Director from LifeSci Advisors. Mr. Ferry, you may begin.

Thanks, operator. Good afternoon and welcome to the CorMedix third quarter 2019 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; Phoebe Mounts, Executive Vice President and General Counsel; and Jack Armstrong, Executive Vice President Technical Operations. 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'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.

Thank you, Dan. Good afternoon, everyone, and thank you for joining us on our call. On today's earnings call we will cover with you our continuing efforts to bring Neutrolin to the US market as catheter LOCK Solution for hemodialysis patient first and then in other market segments. So this call Bob, Phoebe and Jack will participate. We will be covering four topic first an update on the significant progress we've made on the regulatory pathway for Neutrolin. I'm delighted to report that we have completed the discussions with the FDA on board, the pre NDA and the CMC interactions that we stated during our last earnings call we would do. Phoebe will get into further details but overall the FDA will supportive on stable items that we had covered previously. For example the priority review the rolling submission and LPAD. As you may recall during our quarter two earnings call in August, we stated that we have plan to have both the pre NDA and the CMC interactions with the FDA in quarter 2019. We have achieved those goals. We will also cover with you the progress we've made to establish the supply chain for with do that we had previously the review commission, we interactions with 2019 achieve those goals progress we've made to establish the supply chain for CorMedix and what we will use to manufacture and distribute Neutrolin in the U.S market. We will also discuss how the care of hemodialysis patients has evolve over the recent path and the steps we're taking to meet those needs from a product prospective. In addition we will also cover with you further work we're undertaking to expand Neutrolins product offering that may better facilitate the clinical practice in the different setting. And finally we will update you on the progress we've made in improving our balance sheet. We will not going to as much detailed as we've done in the past, the information is available for you to review in the 10-Q that we plan to file today. So, let's get started with Phoebe first. Phoebe?

Thank you, Khose. It is a pleasure to be back here again and report on the continuing progress we've made on regulatory activities required to secure marketing authorization for Neutrolin in the U.S. During the last earnings call I emphasized that it is important to keep in mind that in addition to the clinical evidence the NDA require extensive manufacturing information including method use to manufacturing of the drug and the controlled use to maintain the drugs quality to insure the drugs identify, strength and purity. The manufacturing information is closely scrutinized by FDA prior to drug approval to insure that there are no safety or efficacy is concerned. FDA regulation do not describe in detail how a manufacture must proceeds as a design to manufacture at specific drug product which will obviously be dependent on the chemistry and formulation of the drug. Just as we have been engaged with FDA on clinical data to support safety and effectiveness of Neutrolin we have been engaged with the agency and discussions on CMC information. Manufacturing of the drug product must be shown to be reproducible and reliable through validation study. Stability is a product needs to be demonstrated with extensive data and subjective to conditions likely to be encountered in commercial distribution to ensure the quality as a product. As manufacturing experience expand data on drug substance and drug product are generated and we saw feedback from the FDA in quarter four to discuss the data that have been developed to support the NDA. We believe that it is important to obtain guidance from FDA to ensure that we have all of the CMC information that the agency is expecting and can proactively address any question FDA may have. As we announced the press release on October 16, FDA provided guidance on the CorMedix CMC program and indicated data that will need to be available in the NDA for through them. Jack will now provide some further color on the outcome of that meeting and what it means for securing marketing authorization for Neutrolin. Jack?

Thanks, Phoebe. The interaction with the FDA on the CMC known as the chemistry manufacturing controls. As Phoebe as indicated, is important and critical for the NDA and depending on what is requested chromatics needs to assure the short completes the work in time to not the way the NDA filing. As our press release of 16 October indicated the outcome of our inner action with the FDA was very positive. FDA was supportive of the core manufacturing processes for the drug product and the active pharmaceutical ingredients for the inclusion as part of the NDA submission. FDA did request some additional data which we are working to complete, so we're optimistic that the CMC module we completed a plan for filing with the FDA. FDA did indicate that it will conduct a thorough review of all of the CMC information as well as assess the commercial readiness of the various manufacturing facilities at the time of the NDA review. No further CMC meetings with FDR are planned prior to the NDA submission. With that summary let me pass the floor back to Phoebe to cover the other regulatory milestones we achieve this quarter. Phoebe?

Thanks, Jack. As I mentioned on our last earnings call, in addition to the CMC meeting we plan to have a pre NDA meeting with the FDA in the fourth quarter. The purpose of the pre NDA meeting is to finalize the agreement with FDA on the administrative details for the actual submission of the NDA. Insuring the appropriate content and format of the information required in the NDA is critical to have FDA accept the NDA for filing. When the NDA submitted to FDA, the agency conducts an assessment in its essential 60 day review period. If FDA didn't see NDA to not be complete, FDA will refuse to file the submission. A refuse to file determination can cause significant delays for the NDA and for securing most of the authorization for the product. We receive positive responses from FDA to our pre NDA meaning question on preparation of the NDA. First, NDA has agreed that Neutrolin is eligible or priority review. Accordingly CorMedix intends to include a request for priority review designation with the NDA. FDA will notify CorMedix within 60 calendar days of receipt of the NDA if priority review is garneted. If the FDA agrees to priority review then the goal for the review period by FDA is six months instead of under review period of 10 months. But just to be clear the review period are goals for the FDA and not absolute timeline. Secondly FDA agreed that the Neutrolin NDA is eligible for rolling review and the proposed submission plan is reasonable. CorMedix now needs to file a formal request to rolling review to the existing investigational new drug application. Net FDA agreed that it is appropriate to submit a request for approval of Neutrolin under LPAD or limited population test for antibacterial and antifungal drug. You may recall from previous earnings call that this is relatively new pathway for FDA and provide the FDA with additional flexibility in its determination of whether the clinical data submitted in the NDA adequately demonstrate the safety and effectiveness for the limited population. LPAD takes into account the severity and prevalence of the infection that the drug is intended to treat and the last of alternative treatment in a limited population for whom the drug is intended for use. FDA will make determination of whether a drug meets the criteria for the LPAD pathway at the time of Neutrolin approval. Next, we're grateful that FDA provided some additional guidance on expectation for a specific data set and now sees a narrative that will being used in support safety and efficacy in the NDA. The agency has assured us that the electronic that the electronic submission system for this center of drug evaluation and research is able to handle terabyte submission so there are no issues with handling data submissions of a large size which this NDA well-being. FDA reminded us that until it perform a seller review of the data for LOCK-IT-100 it cannot determine that this single trial will be adequate to support and indication. As we have noted previously to adequate and well controlled trials are usually required to provide substantial evidence of safety and effectives of the product. CorMedix believe that the robust from LOCK-IT-100 demonstrate that Neutrolin provides a highly reliable and preclusive clinical benefit. CorMedix is working diligently to provide the analysis and information for the NDA. Since receiving the unwanted top line data from LOCK-IT-100 at the end of January 2019, we've moved very quickly over the past 10 months to interact frequently with FDA to prepare the information required to submit the NDA based on single study. Therefore, based on our current estimate as we've covered during last earnings call, we remain on schedule for NDA submission and a potential for approval during the second half of 2020. I'm excited about the progress and developing the information needed to secure marketing authorization to Neutrolin in the U.S and remain confident that internally we have the team and capabilities to be successful. Finally in addition to continuing with the preparation of the NDA for the hemodialysis indication for use, we are working on developing the regulatory pathways for additional indications for use in oncology patients and for patients requiring total neutrino or TPN. We're focusing on securing the indication for use in hemodialysis patient first with the data from LOCK-IT-100 because we believe it will provide more options for generating a clinical data for additional inductions for you. As part of the program planning to develop new inductions for soon need to be one, as a capital --solution. We have been using the experience gained with LOCK-IT-100 as we discussed in a few minute With that, I would like to turn the call back to Jack, who will provide you an update on supply chain for the U.S.

Thank you, again Phoebe. During the last call, I noted that CorMedix is been manufacturing and selling Neutrolin outside the US for the last five years. We've successfully carried out technical transfer and validation of the manufacturing process which is enable the successful production of product at three different manufacturing sites. As mentioned previously, I have working with me a very experienced and competent team, they have the needed breadth and depth in the requirements for sourcing, manufacturing, distribution and quality assurance that is necessary for both the US and foreign markets. During the last earnings call, I covered with you that we are now in the process of finalizing the supply chain and distribution network for the initial product that will be used for launch in the US. The initial finished product will be manufactured in Europe. Further, we plan to qualify a second third-party manufacturing site in North America. Longer-term, based on our preliminary forecast, we expect to be manufacturing at two or more contract manufacturing site in order to supply the volume of product needed to meet our forecast for the US market. So that background, I would like to make several additional comments with regard to the establishment of the US supply chain. I use the establishment because, CorMedix literally started with nothing in place since we had no sales in the US before. Hence no establish supply, distribution network in place for the US. With that in mind, there are several key things I'd like to address about the US supply chain. First, we began working on the US supply chain in some cases several years ago to ensure that the critical elements are in place as early as practical and necessary. Secondly, we set up the supply chain for the active drug substances, also known as active pharmaceutical ingredients, APIs. CorMedix will have two sources for the purchased API heparin, neither of which will be sourced from Chinese pig mucosa. This important in light of the recent shortages due to the outbreak of the swine bars in China. We're continuing to track that development. Thirdly, CorMedix has validated our taurolidine source and has its own drug master file for taurolidine, which is manufactured in the U.S. Fourth, the drug product manufacturer, that's [indiscernible] is in place and processes have been established and appropriate validation testing completed to enable manufacture of launch quantities. Fifth, CorMedix has established the logistics network to move the various needed items. For the U.S. distribution network, we have selected our 3PL, third party logistics partner. Our 3PL will assist in setting up the customer database, will take orders, ship to customers, do order to cash and integrate to our financial and planning systems. Just one last comment on the supply chain. We are in the process of installing an ERP system to integrate our forecasting planning systems with the financial and quality data systems internally, and as appropriate with external partners. So in summary, with regard to the supply chain, a significant portion is ready and the remaining items are on schedule. I will now turn the call back over to Khoso.

Thanks, Phoebe and Jack for describing clearly the important work you are responsible for at CorMedix as we continue to move forward into the next phase for Neutrolin. Now let's turn our attention further downstream and look at the market via an updated lens. For some time now, we've been carefully looking at the most optimal delivery option for Neutrolin in the hemodialysis patient. As we carefully examined the data from LOCK-IT-100, we saw growing trend how Neutrolin was administrated. Shortly after LOCK-IT-100 started, we noted that many sites began using two vials of Neutrolin per patient per dialysis session, one for each catheter lumen instead of the one vial, despite the fact that there was enough solution for both lumens in one vial. As the study progressed, we recognized that this practice was being adopted by more and more sites. We began speaking with many of the sites and our nurse educators and learned more about the one needle one syringe practice where each vial is only penetrated once. Dialysis units are always looking for ways to be more vigilant about infection control. By only drawing from each vial once, the potential risk of infection is lessened, which is why this practice has been adopted. So with this in mind, upon Neutrolin's approval, we will present to the market a package that will have a vial with a pre-amount fill that should be sufficient for any one lumen. Therefore, two vials would be used per hemodialysis session for each patient to ensure that we help maintain the higher compliance standard economically. In addition, during the last earnings call, it was stated that the estimated size of the market for catheter lock solutions in the hemodialysis segment to be around $40 million catheter lock solution doses per year and growing. For clarity sake, given that the central venous catheter used in hemodialysis have two lumens each, our annual estimate of 40 million catheter lock solutions actually represent 80 million vials, two vials for each session. I would now like to discuss product delivery need for additional therapeutic markets in which Neutrolin is being developed. Based on the extensive work that CorMedix has undertaken, we see that the product delivery systems for the hemodialysis and the oncology segments are very different. We therefore plan to introduce a vial for the hemodialysis market. And once we launch into the oncology segment, we will have a pre-filled, needle-free syringe. Our market research supports that a pre-filled, needle-free syringe would support adoption in the oncology segment and provide value to the medical community. Now, let me ask Bob to cover at a macro level the steps we've taken during the quarter to improve our balance sheet. Bob?

Thanks very much, Khoso. The company has filed today its quarterly report on Form 10-Q for the third quarter and nine months ended September 30, 2019. I urge you to read the information contained in the report for a more complete discussion of our financial results. In September 2019, the company closed an exchange agreement with funds managed by Elliot Management Corporation, its largest investor. In connection with the exchange agreement, Elliot agreed to make a cash payment of $2 million and to exchange all of its outstanding warrants to 10% senior secured convertible notes and the series C2 D and F convertible preferred stock for a new series G convertible preferred stock. The new series G convertible preferred stock is convertible into an aggregate of about 5.6 million shares of common stock, subject to a claw back, depending upon the recurrence of certain stock price related conditions. With the completion of this exchange, the company raised additional capital and substantially reduced the amount of outstanding warrants as well as its classes of outstanding preferred stock. By eliminating the debt, we put CorMedix in a stronger position for negotiating whatever strategic arrangement we may prefer as we move closer to bringing Neutrolin to the U.S. market. As a result of the exchange agreement, the company recognized a deemed dividend of $26.7 million. The deemed dividend was comprised of four elements. First, the remaining beneficial conversion related to the convertible note recognized at extinguishment. Second, the difference between the allocated fair value of the series G preferred stock issued and the carrying values of the convertible note, the series C2 preferred stock, series D and the series F preferred stock. Third, the difference between the fair value of the exchange warrants before and after the exchange agreement. And fourth, the difference between the fair value and the carrying value of series E preferred stock, less the fair value of the series E warrants that were cancelled as part of the exchange agreement. As you can appreciate, the accounting for this transaction was complex and required significant work to estimate the fair value of each of the old and new instruments, and in the case of the old instruments, to compare those values against the carrying value on our books. The amount of the deemed dividend is significant because of the carrying value of the old instrument. It is not an indication of the amount of incremental market value given to the series G investor, which on a fair value basis was essentially equivalent to the fair value of the old instruments plus $2 million in cash. The deemed dividend had no effect on cash. Also in September in this year as part of our continuing efforts to simplify the company's capital structure, the company agreed to reduce the exercise price on $1.2 million warrants expiring in August 2022 in return for their immediate exercise, which generated cash of $4.9 million. In completing this transaction, the company recognized another deemed dividend of approximately $370,000. The exchange agreement and the warrant strike price reductions, along with exercises of warrants held with other investors during the third quarter of this year, resulted in the company receiving gross proceeds of approximately $10 million during the quarter and reducing its warrant overhang by approximately 2.9 million shares. Warrants to purchase approximately 345,000 shares are currently outstanding. Total cash on hand and short term investments as of September 30 amounted to $32.4 million excluding restricted cash of $0.2 million. The company believes that based on the company's cash resources at September 30, 2019, it has sufficient resources to fund operations into 2021, including the submission of the NDA for Neutrolin and initial preparations for commercial launch. As I covered earlier, our spend this quarter was relatively low, so we finished with approximately $32.4 million in cash on hand at September 30 compared with $26.4 million at June 30, 2019. We expect our burn rate to increase starting in early 2020 as we begin building inventory for launch and hire key personnel to prepare for commercialization. The other topic on which I would like to update you relates to the continuing evolution of the company's shareholder base. As the company continued along its path towards receiving marketing approval for Neutrolin in the U.S., executed a reverse stock split and was placed into the Russell Index, we have seen a significant increase in the number of shares held by institutional shareholders, including several BlackRock funds. Based on recent investor filings and other analyses we have undertaken, we believe that institutional ownership of outstanding CorMedix stock is currently approaching 30%. On a fully diluted basis, institutional ownership is approximately 40% of outstanding common and common equivalent shares and warrants. While several of the institutions are index funds, which added CorMedix shares along with our re-entry into the Russell Index, we are also seeing investment by actively managed funds and have engaged with more institutions who appear ready to take positions as we move toward NBA filing and hopefully approval. We continue to focus our messaging and effort with institutions with a particular emphasis on healthcare institutional investors. And with that, I would now like to hand the call back to Khoso for his closing remarks. Khoso?

Thank you, Bob. What Phoebe, Jack and Bob covered with you hopefully provides you insight into the work efforts on which we are focused that have occurred over the last three months. I'm pleased about the progress we are making and I'd like to reemphasize a couple of key points. We are extremely pleased to report to our shareholders that the effort to move the regulatory process forward with the NDA is on track. Both the CMC and the pre-NDA interactions were positive and CorMedix hopefully will have Neutrolin FDA approved during the second half of 2020. The progress to prepare the Neutrolin supply chain to the U.S. market is moving along as planned. Jack and his team are planning to have this completed before CorMedix receives marketing approval for Neutrolin from the FDA. The product presentations with the introduction of a user friendly, pre-filled, needle-free syringe into the portfolio will help get providers transitioned away from today's standard of care to making Neutrolin the new standard of care easier and quicker. We believe reducing the complexity of the equity section of our balance sheet increases our attractiveness to potential partners and bringing in additional cash without increasing fully diluted common stock was important. Finally, we have received questions since we announced our upcoming annual General Meeting and issued the proxy. It appears based on the questions that there is some misunderstanding amongst some of what proxy Item 2 is trying to achieve. The adoption of a new stock plan with additional shares available for issuance is intended to help address the company's growing needs to attract, reward and retain top talent as we move the company programs forward. The allocation is meant to cover the needs of the company over the next several years. The new stock plan was designed by a well-known independent compensation expert who proposed a minimum allocation of shares that fall well within the acceptable guidelines for companies of our size and stage of development. We were pleased to see that the plan received IFS recommendation for approval. In terms of the update you have been receiving, all are connected to LOCK-IT-100 studies for specifically the hemodialysis segment. Please note that this is just step number one. At CorMedix, we're determined to seek additional indications for Neutrolin use in oncology and TPM. We've had discussions with the FDA on clinical trial design for Neutrolin use as a catheter lock solution in oncology and TPM, and are working to develop the protocols with the goal of finalizing the regulatory pathway for these patient groups after the NDA for hemodialysis is filed. Our goal is to maximize shareholders' value. Because hemodialysis is a very concentrated payer provider market, we are continuing to prepare CorMedix to launch Neutrolin in the hemodialysis segment while at the same time being open to potential partnership. All options are on the table. We continue to build awareness for Neutrolin, and just last week at the American Society of Nephrology in D.C., we met with major dialysis providers to provide updates on Neutrolin and ensure that whenever Neutrolin is at all levels of their organization. We also acknowledge particularly that the areas of oncology, TPM and critical care are very broad, and therefore may be more appropriate than a larger, more strategic player who is already in place in such a place, may be best able to maximize shareholders' value. I continue to believe that if Neutrolin is approved, it will become the standard of care for preventing catheter-related bloodstream infections in the hemodialysis patients. As Phoebe covered, the last 10 months have been very productive in moving Neutrolin through the required regulatory process. I'm very pleased with the strength of our management team and we will continue to evolve by augmenting our team over the coming quarters in the areas of strategic need. As I stated in our press release some 10 days ago, we have begun a search for a new CFO with a top search firm. This concludes our presentation, so I'm going to hand the call back to the operator to open it up for questions.

At this time, we will be conducting a question-and-answer session. [Operator Instructions] Our first question is from John Ledon, Novel Consulting Group. Please proceed with your question.

Good afternoon. Thank you for the wonderful detail. In terms of the other products in the pipeline, it has been mentioned in the past meshes, sutures, other types of products. Can you speak to that, the previous work that has been done on that and how that'll help establish you in the future?

Thank you very much for your question. In terms of what is written in our pipeline, at present over the last few quarters, we've really not put much effort to bear -- all our resources and bandwidth has been spent on moving Neutrolin to the regulatory pathway. We're delighted the progress we've made with Neturolin and our goal is to now beeline it to get the NDA filing and ensure that we've got the NDA submitted to the FDA before we begin to turn our attention back on the pipeline.

Thank you for that. But I'm under the understanding that you have had prior studies or prior experience with that in terms of some level of development in early stage.

Correct. We did work in late 2017 and into 2018 particularly with neuroblastoma and that was presented in ASCO already, and that is available on our website.

Wonderful. Thank you.

We have reached the end of the questions and answers session. I will now turn the call back over to Khoso Baluch for closing remarks.

Thank you very much, Dan. I guess the only conclusion I'd like to make is the strategy we embarked on in early 2007 will continue to move forward. We look forward to providing you with updates both on the development via our website press release and conference call. I also want to take this opportunity to thank Bob Cook, our CFO for his services over the last nearly three years. I very much appreciated his effort and his services. I wish him the best of luck in the next chapter of his life, and want to thank all our investors and supporters for CorMedix. So thank you very much. Thank you, Bob.

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