CorMedix Inc. (CRMD) Q4 2015 Earnings Report, Transcript and Summary

Greetings and welcome to the CorMedix Fourth Quarter and Year-end Review Conference Call. At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. [Operator Instructions] As a reminder, this conference is being recorded. It is now my pleasure to introduce your host, Randy Milby, CEO of CorMedix. Thank you. Mr. Milby, you may begin.

Good morning and welcome to the CorMedix fourth quarter and full-year 2015 investor conference call. In the room with me, is Jim Altland, our interim CFO; Dr. Tony Pfaffle, our CSO, and Jack Armstrong, our Executive Vice President of Technical Operations, who will be available during the question-and-answer portion of the conference call. First, I want to remind you that this conference call may contain certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks and uncertainties. All statements other than statements of historical facts regarding management’s expectations, beliefs, goals, plans, or the Company’s prospects, future financial position, future revenues and projected costs should be considered forward-looking. Forward-looking statements include statements about our clinical development plans and timing, regulatory actions, and cash needs. Our actual results may differ materially from these projections or estimates due to a variety of important factors, including uncertainties related to the 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 Web site 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. Thank you for joining us. We are encouraged as to the progress we’ve made and hope to continue to make to drive the company forward, both from the standpoint of strategically positioning the Company for long-term success, as well as executing tactically in the near-term. For those of you who maybe new to the CorMedix story, we’re commercial stage company developing a truly novel anti-infective solution designed to prevent dangerous and costly bacterial and fungal infections that can arise in patients who have implanted central venous catheters. This includes hemodialysis patients as well as patients with advanced cancer who are on total parenteral nutrition or are in the intensive care units. It is important to note that the active ingredient contained in our lead product Neutrolin, a compound known as taurolidine is not an antibiotic, and therefore is not susceptible to the various bacterial resistance mechanisms that limit the long-term use of antibiotics and have given rise to a very serious public health concerns about the ability to treat infections effectively. Neutrolin has been cleared by the EMEA and is currently CE marked and commercialized in Germany and the Middle East. We’ve recently initiated a pivotal Phase III clinical study that has been designed to support a new drug application for FDA submission in 2017. Taurolidine itself has broad application as a novel anti-infective and we’re exploring the development of anti-microbial medical devices that incorporates taurolidine for potential use in surgical and dermatological settings. So with that overview, I’d like to give you an update on several important areas, clinical development, scientific affairs, operations and financials. First, in terms of advancing our clinical development program, we initiated our first U.S Phase III clinical study to evaluate Neutrolin and hemodialysis patients in December of last year. The study is called LOCK-IT, for catheter lock solution investigational trial. LOCK-IT continues to enroll patients and they add sites in line with our expectations, and we’re focused on continuing to execute successfully in this study. With the primary objective of demonstrating a reduction in the occurrence of catheter-related blood stream infections compared to the current standard of care heparin, we expect to complete enrollment in this event driven study during this calendar year with the completion expected in 2017. Second, we’ve received further guidance from the FDA on the protocol design of our second planned pivotal Phase III study of Neutrolin in oncology TPN. We are in the process of finalizing the details of this study, which we expect to commence by year-end in 2016. Third, we continue to generate a compelling body of clinical data to support the use of Neutrolin. In December, we completed our Neutrolin Usage Monitoring Program, a post-marketing surveillance survey conducted at sites in Germany, which clearly demonstrates the efficacy of using Neutrolin in patients with central venous catheters. Specifically, the survey showed greater than 96% reduction in infection and thrombosis as measured against the current benchmark. These clinical data used demonstrate the ability of Neutrolin to address an unmet medical need and improved patient care by reducing infections, which also has a major added benefit of reducing hospital costs associated with treating these infections. Finally, we continue to evaluate opportunities to explore the use of taurolidine in new areas of treatment and expand our business. We’ve done some preliminary work to achieve proof-of-concept for using taurolidine to improve outcomes beyond reducing catheter-related infections and have been diligent in protecting our intellectual property for these new endeavors. As such, we’ve filed provisional patents in five areas: antimicrobial sutures, nanofiber webs, wound management, osteoarthritis, and visco-supplementation. We are incorporating taurolidine in these materials to prevent infection and reduce inflammation. In summary, I’m very pleased with our accomplishments during this past quarter. I now want to give you a more detailed update on the key near and longer term catalyst that could drive CorMedix’s growth and provide new opportunities for the Company. The clinical development of Neutrolin. Neutrolin is commercialized as a Class 3 medical device in the European Union. But the FDA regards it as a drug for purposes of obtaining regulatory approval in the United States. In December, we began enrolling patients in LOCK-IT, a pivotal Phase III clinical study for the use of Neutrolin in patients on a central venous catheter line associated with hemodialysis with the total anticipated enrollment of approximately 632 patients. While we’re still early in enrolling in the trial, we’re pleased with the progress to date, both in terms of patients enrolled and the number of clinical sites that have been initiated. We do not plan to provide specific updates on enrollment, but we will remain on track to complete enrollment by the end of this year. Consistent with the study protocol, we expect to conduct an interim analysis when we have 316 or about half of the total patients enrolled, or when we record 81 infection of deaths, whichever of these occur earliest. Site selection is the critical aspect of this process, and we’re working closely with our clinical research organization PPD in this regard. As we’ve discussed on previous calls, it’s estimated that approximately 127 million catheter days in hemodialysis in the United States per year. A projected unit usage in this market is 0.44 vials per catheter day, or said in another way one every two plus days. So there is a substantial market opportunity here if it is supported by the clinical data. As I mentioned, we’re working with the FDA to finalize the remaining details of our second Neutrolin study, which is currently expected to enroll approximately 560 oncology patients who are receiving total parenteral nutrition treatment. It is estimated there are approximately 90 million catheter days due to the treatment for various kinds of cancer, but the projected usage -- unit usage as a lock and flush is higher or more frequent in this market than in hemodialysis with an on average three vials used per catheter day. In each of these studies, the patients will be monitored for catheter-related bloodstream infection and the relevant comparison with Neutrolin versus heparin or saline alone as a control arm. In addition, we’re planning to develop a smaller 200-patient Phase IV study to further elucidate the use of Neutrolin for critical and intensive care patients in an effort to further expand the Neutrolin label. There are an estimated 28.5 million catheter days in the ICU/CCU settings in the United States each year, with the highest unit usage per patient of approximately five vials per catheter day when used as a lock and flush, based on our market research. We are committed to maximizing the global opportunity for Neutrolin, which we believe has tremendous potential to gain rapid acceptance as a new standard of care for preventing catheter-related infections. As has been previously discussed, we received fast track designation from the FDA for the review of Neutrolin in the prevention of catheter-related bloodstream infections in patients receiving hemodialysis. Fast track designation is intended to encourage the development and expedite the agency’s review of drugs to treat serious conditions and address unmet medical needs. So, naturally we’re encouraged by this designation and the signal that it sends as to the potential importance of Neutrolin as a prophylactic agent in reducing the rates of infection. Importantly, products designated as fast track are eligible to obtain rolling review of the marketing application that may lead to an expedited approval. In addition, Neutrolin has been designated a qualified infectious disease product or QIDP, under the Federal GAIN Act, which provides incentives for the development of new anti-microbials. This provides for an additional five years of market exclusivity after drug approval, beyond the standard five years granted to a new chemical entity. Combined with the possible additional extension for pediatric use, Neutrolin could benefit from up to 10.5 years of post-approval exclusivity in the United States from the date of launch. Before I move to the financial highlights and commercial update, I’d like to spend a moment discussing our efforts to gain additional clinical data to support future marketing and reimbursement. As I mentioned, we initiated a 200-patient post-marketing registry study, called the Neutrolin Usage Monitoring Program, or NUMP for short, in selected dialysis centers and hospitals throughout Germany. We’ve completed this study and recorded 0.142 infections and 0.085 thromboses during 1,000 hemodialysis catheter days. This compares favorably to the numbers from the literature in which you would ordinarily expect on average 3.5 infections and 2.5 thromboses per 1,000 catheter days. This represents a greater than 96% reduction in infections and thrombosis. I think you will agree with me that this is very encouraging indeed. Although this study was not powered to show statistical significance against a comparator, we believe it provides compelling clinical use data demonstrating the anti-infective and anti-clotting value of Neutrolin. These data accumulated from the NUMP registry support our expectation for a favorable outcome and bolster our confidence in the successful outcome of our current U.S Phase III studies. We are encouraged by these NUMP results and we intend to use this data as part of our safety package with the FDA. These data will enable us to more effectively market Neutrolin in Europe and the results have been accepted for publication in the American Journal of Kidney Disease in 2016. We expect to present these and other findings highlighting a therapeutic and pharmocoeconomic benefits of Neutrolin and various scientific and medical forms throughout 2016. We also believe that taurolidine has the potential to address significant medical needs in other important areas, including sutures, topical wound closure materials, jells, nanofiber webs, and implanted devices. Based upon post-operative infection rates, there is a clear need to control and protect against surgical site infections upon closure with sutures, and we believe taurolidine could offer benefits not available in currently marketed anti-microbial sutures. In February, Dr. Paul Lorenc, a world-renowned board certified aesthetic plastic surgeon on the faculty of Cornell, presented at the 14th Annual South Beach Symposium, highlighting observations gathered from in vitro test examining the efficacy of suture materials incorporated with CorMedix proprietary anti-microbial taurolidine against clinically significant microorganism. In these test, taurolidine performed very well. We also believe that the nanofiber webs used for absorbable mesh products could benefit from taurolidine to demonstrate its effect of reducing inflammation and promoting infection control. Taurolidine also could be incorporate into fibers or hydrogels in connection with wound management, especially in the case of severe wounds that have occurred in less sterile environments or in burned patients. Lastly, incorporating taurolidine into formulations for osteoarthritis and visco-supplementation may be useful in light of taurolidine’s anti-inflammatory and anti-infective properties. I’m going to provide a detailed summary -- financial summary in a few minutes, but for now I just want to emphasize that the Company is on solid financial footing with approximately $35.3 million in cash and short-term investments on our balance sheet as of December 31, 2015. This position enables us to confidently continue with the contemplated clinical work, including the Phase III study in hemodialysis patients. We currently have $35.9 million shares of common stock outstanding. On a fully diluted basis, and without taking into account additional shares subject to issuance under our outstanding ATM vehicle we’ve 50.4 million shares including those that are subject to pursuant to warrant options, and convertible notes. Let me now address briefly our ongoing efforts to increase overseas sales of Neutrolin. We continue to add regional sales and marketing partners selectively focusing mainly on the Middle East, where we’re making solid progress in Saudi Arabia, Bahrain, Qatar, Kuwait, United Arab Emirates and several other countries. Working with our partners, we’ve successfully registered the product and are submitting government tenders in accordant with local bid process which can appear cumbersome to the uninitiated, but is very accretive over the long-term. In operations, we’re implementing a multi-faceted cost reduction program that is designed to significantly reduce the cost of taurolidine manufacturing up to 65% by the time we launched in the United States. Our focus on these changes is to have a high quality regulatory filing for the U.S NDA. The U.S market potential appears robust, which supports our projections of the American market opportunity. Based on the number of total patient catheter days and infection prevalence, we believe there is a real need for this product and a high level of receptivity to using it. In fact, we think Neutrolin could be $1 billion opportunity. As many of you know, the market potential of a product often is not characterized or presented as a single opportunity, and Neutrolin is no exception. As there are clear needs involving patients in hemodialysis, oncology, and critical or intensive care. As our clinical trial work advances, we expect to evaluate these various opportunities further by assessing physician interest and reimbursement prospects in light of CMS guidelines and the quality metrics established under the Affordable Care Act. To that end, we presented two health economic abstracts at the American Society of Nephrology, and we’ve a third health economic study under review for potential publication in a peer-reviewed critical care journal. We’ve also initiated a pharmocoeconomic study to assess the economic impact of a central venous catheter infection in oncology patients. As noted in last quarter’s conference call, CMS released their in-stage renal disease prospective payment system final rule, which suggested that the agency is open to considering alternative reimbursement schemes for products such as Neutrolin, that have been designated as priorities by the FDA under the GAIN Act or the Qualified Infectious Disease Product Act. We met with the CMS and discussed Neutrolin specifically and hope to position it favorably in light of its potential to reduce infections and lower healthcare system costs. We’ve an ongoing dialogue with CMS around the pharmocoeconomic endpoints incorporated into the Phase III study. In summary, this quarter has been an important period for advancing the Company. CorMedix initiated our first U.S. Phase III trial with Neutrolin in hemodialysis, the LOCK-IT clinical study, which is tracking favorably compared to our target enrollment projections. We continue to collaborate with regional marketing partners that should further expand the availability of Neutrolin in patients in additional countries, including the Middle East where we’re seeing increased acceptance. We presented two health economic abstracts, which articulate the value of Neutrolin, and we plan to publish a third article in a peer-reviewed critical care journal. We continue to assert our intellectual property rights in the context of patent infringement and unfair competition law within claims brought in Germany, and we believe we’re making great progress in executing our plan to reduce our cost of goods. In the end, it all comes down to execution. We’ve added clinical and market access expertise to our team, which we believe will enable us to augment our commercial efforts in Europe and potentially in the United States. These are people who have done it before and know how to complete a clinical study and launch anti-infective products. We believe we’re in a stronger position than ever to capitalize on Neutrolin over the near and long-term. Before I move on to Q&A, I’d like to review the Company’s financial information that was filed yesterday with the sec. For the quarter ended December 31, 2015, CorMedix recorded a loss of $3,866,000 or $0.11 per share versus $2,214,000 or a loss $0.10 per share in 2014. In the fourth quarter a sale of $300,000 through distributor did not need all the requirements for income recognition and was recorded as deferred revenue and will be recognized in 2016 as the product is used. In 2015, the Company had higher R&D and SG&A expenses of $1,726,000. For the 12 months ended December 31, 2015, the Company recorded a loss of $18,221,000 or $0.58 per share versus the loss of $20,536,000 or $0.96 per share in 2014. The improvement in loss per share is primarily due to an increase of over 9,900,000 shares in the number of weighted average common shares outstanding and diluted. For the 12 months ended December 31, 2015, R&D and SG&A increased by $7,900,000. In 2015, there was a non-cash charge of $1,583,000 for a back-shop agreement. This was offset by a non-cash charge of $11,401,000 for extinguishment of derivative liabilities in 2014. For the 12 months ended December 31, 2015, the Company raised $43,629,000 from the sale of common stock, exercise of warrant and stock options. In 2014, the Company raised $8,358,000 through the sale of preferred shares, stock options and equity securities. For the 12 months, the Company used cash in operations of $12, 527,000 versus $6,321,000 in 2014. The Company is in a very strong cash position ending the year with approximately $35.3 million in cash or of short-term investments on the balance sheet. This compares to only $4.3 million during the same period last year. On a final financial note, in 2014, the Company’s auditors issued a growing concern opinion with material weaknesses to the Company’s internal controls that had not been fully remediated [ph] in 2014. I’m happy to say, in 2015, the Company received an unqualified opinion on both the audited financial statements and the effectiveness of the Company’s internal controls over financial reporting. This is a major milestone for our financial team. Before I turn the call back to the operator for your questions, I want to address a couple of the most commonly asked questions that had been raised by investors in the past few weeks. The first question. How is the Phase III trial enrollment progressing? Well, we’re still early in enrollment -- enrolling the trial; we’re very pleased with the enrollment to date both in terms of patients enrolled and the number of clinical sites we’ve initiated. We do not plan to provide specific updates on enrollment, but we remain on track to complete the enrollment by year end 2016. The second question I hear is what is the expected timeline for the interim analysis and the completion of the Phase III study? And then follow-on questions asked, will you have to raise additional money to complete the study? We initiated the clinical study in hemodialysis in mid December. Our Chief Scientific Officer, Dr. Pfaffle is spending the bulk of his time evaluating and enrolling dialysis centers that have a significant number of dialysis patients who would potentially be eligible to participate in the trial. The interim analysis will be performed at the earlier of two outcomes. Once we have enrolled 316 patients or once we’ve seen 81 infections in our trial. Statistically speaking, we expect to achieve one of these outcomes by the fall of 2016. We are working with PPD by leaving CRO based enrollments in North Carolina to conduct the Phase III study and dialysis. And we have at least 12 months of cash at our expected level of operations. We currently do not have cash sufficient to complete the first Phase III study, although we do not believe the trial was particularly expensive nor long, but we will need to raise additional capital to complete the study. The third question I hear, if the dialysis trial is halted for efficacy, what is the procedure to see if FDA will approve the drug in the dialysis setting on one Phase III study or will they likely wait for the oncology data? The DSMB will take an interim look at the trial once we have either enrolled 316 patients or have seen 81 infections in our Phase III trial. At that time, one of three things can happen. We believe the most likely, as if the trial looks good and DSMB will continue the trial, requiring us to continue enrolling up to 632 patients. Given the safety and efficacy we saw on our Phase II trial and the data from our NUMP trial, the second outcome we think is highly unlikely but the DSMB could stop the trial for safety concerns on utility and meeting the efficacy endpoint. The third potential outcome is that the DSMB stops the trial early because the interim data demonstrates compelling efficacy and it is unethical to continue the randomization of patients to the control arm. CorMedix would then engage in discussions with the FDA to stop the trial early and grant product approval. Such an approval would be for the dialysis indication only, thus it would be in our best interest to conduct another clinical trial to expand our label to include oncology TPN and ICU. With an improved product, we could do a series of Phase IIIb and Phase IV trials in those indications. And with that, I would like to turn it back over to the operator for questions.

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Our first question comes from the line of Ram Selvaraju with H.C. Wainwright. Please proceed with your question.

Hi. Thanks very much for taking my question. Can you hear me?

Yes, we can.

Okay, three very quick things. Firstly, I wanted to see whether you could provide us with some more granularity regarding the cost of manufacturing improvements on the taurolidine side, and whether this is related to taurolidine or Neutrolin, the product itself. Where are the manufacturing savings and improvements and efficiency coming from? What exactly have you done to the process to make it more efficient and cost effective? The second question pertains to the interim analysis specifically. You mentioned in your most recent comments that, this would potentially if the interim analysis were positive, allow you to pursue accelerated approvals specifically for dialysis indication hold [ph]. I just wanted to clarify whether, had in fact the speed such guidance from the FDA or do you anticipate seeking and obtaining such guidance from the FDA, is a wake of a positive interim analysis? And then the third question relates to the developments of [technical difficulty] relations of taurolidine. At this juncture, do you anticipate doing any active work in that area or would you first look to bring in additional funding in order to spur those initiatives? Thank you.

Thanks, Ram. Answering the first question on the COGS …

Okay. It’s Jack Armstrong. Actually it took several levels. It involves the [indiscernible] taurolidine, Heparin, as well as the cost of manufacturing. So it’s a combination thereof. As you know, FDA have used this as a drug, so we are being judicious as we approach implementing these things to make sure we have the highest quality possible to insure that the CMC section works very well the first time through. But it’s a multi-faceted things, it’s all the above.

Your second question on interim analysis, Dr. Pfaffle will take that.

Hi, Ram. Yes, under fast track which we’ve been grated by the agency -- by the FDA, we are eligible for accelerated review, which means that, we are able to request the review after the interim analysis results are reviewed by DSMB. So that is already in place, should we be lucky enough to attain those results.

And then the last question, Ram was on the development alternatives. We are -- we have a couple of things going on there. We are not spending a lot of our money here, but we are working on partnerships with a couple of companies that can do the first couple of phases. And as you know, these are medical devices, so these are 510(k). We also will be initiating discussions for potential partnerships and different applications. Does that answer your three questions, Ram?

Yes, absolutely. Thank you very much.

You are welcome.

Our next question comes from the line of Ed White with FBR & Co. please proceed with your question.

Thanks for taking my question. The first one is just following up on Ram’s question. When looking at the five other indications outside the catheter, is the suture product the lead product there or how should we be thinking about the order of importance of those and the timing of those?

You’re correct. The sutures and that’s why we were able to present the data. The suture product in this case is the lead product as we’ve talked in the past, we’ve done a core extrusion with taurolidine within the suture material, and we’re advancing it to get that provisional patent to PCT patent. The second one would be the nanofibers. Here again it’s using extrusion technology with taurolidine, and incorporating it either as a coating or extruding it within the nanofibers. So both of those are open for partnership discussions, and as I mentioned with Ram, we’re spending a minimum amount of our money in this area, and we’ve submitted FBI grants and some other government -- submitted for other government grants to move these along.

Okay, great. Thank you. And now just looking at the revenues, you had said the majority of the revenues were from Germany and Middle East. Did you get any revenue at all from the Netherlands and also, has Neutrolin received product registration in South Korea and should we expect to see sales in South Korea in 2016?

I can answer the South Korean first. The South Korea follows the US FDA. So on that case they have, as you correctly state, they do have the license for South Korea. But that won't be approved or marketed until after we’ve received US FDA approval. As far as the Netherlands, we don’t have sales. We pretty much deemphasize the Netherlands. We’ve done sampling there, and we’ve deemphasized some of the activity than Germany. The focus right now is on the Middle East. We’re trying to manage our cash flows or focus mainly on the US clinical development.

Okay. Thank you. And then, lastly just on G&A, two questions. One, what was your headcount at the end of the year? And also, the consulting fees of $554,000 in 2015, was primarily due to the executive search fee. Can you just give us an update there on the search and should we see a similar amount being expanded in 2016 for the search as well?

I can address the executive search first, and the process as you know is well under way. We are working with Korn Ferry International, a leading search firm. And as you know it takes time to find the right person. And I have committed to remaining in the job until we do with the full support of our Board of Directors. We have seen some interest in candidates to date, and we are very close to a final decision. It is my opinion this candidate will represent the company very well and it is my opinion that this most likely will be my last quarterly call. As far as the headcount, we have nine people at year end and we use a lot of consultants. So your comment about the consulting fees we’ve used consultants for marketing access and other applications as well as even in the clinical area.

Okay, great. Thanks for taking my questions.

You’re welcome.

[Operator Instructions] Our next question comes from the line of Doug Schwegel, who is a private investor. Please proceed with your question.

Yes. Good morning, Randy. Could you address two questions. One, could you shed a little bit of light with regards to potential market size in the two alternative indications, the principle lead indications with regards to sutures and nanofiber webs?

Absolutely. So, I haven’t provided, as you’ve seen Doug in the PowerPoint that we just recently released. I don’t talk about -- we’ve done, we’ve looked at it globally. So on the sutures the global market in 2015 was $3.5 billion, and in topicals its $900 million -- $700 million -- and this fiscal supplementation around $800 million. So what we’ve done is, we’ve just done a ballpark based upon talking with some experts of what the penetration would be. We’re going to be doing a little more market research in that space. But it’s safe to say that the sales potential was greater than $1 billion in this space if you add all those up.

As a medical device, what's the relative timeframe with initiating any trials and potential FDA approval? Is it shortened relative to what we see with developing it for a drug indication?

Yes. So these are going to 510(k) as we expect them to be at this point. We haven’t had any discussions with the FDA at this point. It could be that it’s possible they view them as the drug combination, but at this time we view them as a 510(k). The 510(k), as you know it takes between 12 months to 18 months. Now that does require some clinical work. So the earlier question about, how much resources we’re putting into this and that’s why we’re partnering and working with other -- couple of other companies that can do at least the Phase I, Phase II work.

And would we -- could we safely expect if there was to be something that was worked out with regards to partnerships that we might see something in this calendar year?

That’s one of my objectives, yes.

Okay. And lastly, could you shed a little bit more color with regards to the proceedings that are going on in Germany and where we’re at with legal proceedings?

So, as you know we have two things going on in Germany, and we hold patent positions on various aspects of Neutrolin, and our underlying technology in U.S, Europe and other territories. As we’ve spoken in the past, we’re confident that we have the freedom to operate and commercial our product in the manner that we are now doing, and we in the midst of bringing a series of legal challenges to our rival in Europe. We expect that there will be a ruling concerning our patent position, and the activities of the unfair competition by mid 2016. Beyond that I can't say much more, but we are determined to press these matters to defend our intellectual property rights and those of our predecessor filing.

Great. Thanks.

You are welcome.

There are no further questions at this time. I would like to turn the floor back over to you Mr. Milby for closing comments.

Well, thank you very much everybody for dialing in. I think you’ll agree that we made tremendous progress in the last quarter and for 2015 and you can expect more of the same in 2016. The team is working diligently to get the patients enrolled and get the sites onboard. As you heard from Jack Armstrong, the initiative to reduce the COGS so that we will be ready for the launch in 2018 is well underway. We’re making solid progress. We’ve got quarter-by-quarter objectives. We’ve got monthly objectives for Tony, for the enrollment of pensions, and you’ll see more positive results in 2016. I appreciate everybody dialing in. And if you have any questions, you can always reach out to me. Thank you very much.

This concludes today's teleconference. You may disconnect your lines at this time and thank you for your participation.