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Cytosorbents (CTSO) Q2 2019 Earnings Call Transcript

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Cytosorbents (NASDAQ: CTSO)
Q2 2019 Earnings Call
Aug 06, 2019 , 4:45 p.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:


Operator

Good afternoon, and welcome to the CytoSorbents second-quarter 2019 financial and operating results conference call. At this time, all participants are in a listen-only mode. Following the formal remarks we will open the call for your questions. Please be advised that the call will be recorded at the company's request. At this time, I like to turn the call over to your moderator, Jeremy Feffer.

Please go ahead.

Jeremy Feffer -- Managing Director

Thank you, Jenny, and good afternoon. Welcome to CytoSorbents' second-quarter 2019 financial and operating results conference call. Joining me today from the company are: Dr. Phillip Chan, chief executive officer and president; Vincent Capponi, chief operating officer; Kathleen Bloch, chief financial officer; Dr.

Eric Mortensen, chief medical officer; Dr. Christian Steiner, senior vice president of sales and marketing from Germany; and Christopher Cramer, vice president of business development. Before I turn the call over to Dr. Chan, I'd like to remind listeners that during the call management's prepared remarks may contain forward-looking statements which are subject to risks and uncertainties. Management may make additional forward-looking statements in response to your questions today.


Therefore, the company claims protection under Safe Harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Actual results may differ from results discussed today, and therefore, we refer you to a more detailed discussion of these risks and uncertainties in the company's filings with the SEC. Any projections as to the company's future performance represented by management include estimates today as of August6, 2019 and we assume no obligation to update these projections in the future as market conditions change. During today's call, we will have an overview presentation covering the operating and financial highlights for the second quarter by Dr.

Chan and Ms. Bloch. Following that presentation, we will open the line to your questions during the live Q&A session with the rest of the management team. At this time, it's my pleasure to turn the call over to Dr.

Phillip Chan. Phil?

Phil Chan -- Chief Executive Officer

Thank you very much, Jeremy, and good afternoon, everyone. I'm pleased to report a resumption of our historical pattern of growth with 67,000 plus Cytosorbents treatments delivered up from 46,000 a year ago. Our trailing 12 month total revenue was $23.2 million including product sales, and grant income versus $19.2 million a year ago. Our second-quarter 2019 product sales were $5.9 million compared to $5.3 million a year ago. Our results achieve the highest quarterly product sales in our history, driven by record direct sales and a rebound in distributor sales.

The average euro to dollar exchange rate remained unchanged, second-quarter 2019 product sales would have exceeded $6 million, in fact $6.2 million for the first time. We were pleased that a major distributor that did not order in the first quarter of 2019 began reordering in the second quarter of 2019 but even without these orders, product sales would still have been a quarterly record. Fresenius Medical Care was another one of our partners that did not order in the first quarter as they exchanged several of their countries in the EU with Mexico, South Korea and the Czech Republic, and during the quarter we worked closely with Fresenius Medical Care and submitted the CytoSorb registration for Mexico and South Korea and expect an update on progress by the end of the year, if not our grant registration. Meanwhile, we have jointly initiated commercialization planning and prelaunch activities including conference marketing and other key opinion leader events. We had a healthy cash balance of approximately $20 million at the end of July. Another milestone was the publishing of the U.S.

REFRESH1 study. This is published in seminars in thoracic and cardiovascular surgery, a journal of the prestigious American Association for Thoracic Surgery or AATS, where our results were first presented at the conference. The paper confirmed the safety of CytoSorb in complex-cardiac-surgery patients and the top-line results that were reported previously on the statistically significant reduction of activated complement in all patients and plasma free hemoglobin in patients undergoing valve replacement surgery on cardiopulmonary bypass for greater than three hours. There is an associated editorial commentary by surgeons at the University of Washington and St.

Louis, not associated with this study and in that editorial commentary they had the following quote, they said the 'Achilles' heel of complex cardiac surgery has been the deleterious effects of prolonged cardiopulmonary bypass characterized by the cascade of hemolysis, release of plasma free hemoglobin, activation of inflammatory mediators and end organ dysfunction' the Holy Grail of research in the subject would be to find something able to mitigate or eliminate the mediators responsible for these potentially catastrophic downstream effects of prolonged cardiopulmonary bypass. Gleason at AL have eloquently explored the use of human absorption technology, specifically designed to reduce plasma free hemoglobin during prolonged cardiopulmonary bypass in a multicenter randomized controlled trial. REFRESH 1 led to the development of the U.S. REFRESH 2-AKI pivotal trial. Again this is a 400 patient randomized control trial that is a premarket approval trial among many centers, targeting the reduction of postoperative acute kidney injury using CytoSorb during complex cardiac surgery.

Currently there are now 109 patients enrolled, roughly 27% of the targeted 400 patients at 24 active trial sites and we are currently actively adding new sites and increasing the awareness of the study to summary enrollment, as the timeline below shows were targeting enrollment of 200 patients by the first quarter of 2020 fault by an interim analysis and then completion of enrollment targeted by the end of 2020 provided that we are able to increase enrollment targeted by the end of 2020 provided that we are able to increase enrollment to roughly 20 patients per month, which should be feasible. With the completion of the study, we will have multiple activities going on in parallel and plan to complete data analysis and PMA or Premarket Approval Submission that is intended to lead to U.S. approval by middle of 2021. Moving on to the REMOVE endocarditis trial, this again is a 250-patient-randomized control trial funded by the German government, that is evaluating the safety and efficacy of CytoSorb to improve organ dysfunction when used intra operatively during valve replacement surgery for infective endocarditis.

The trial is nearly 90% complete with 222 patients of a targeted 250 patients enrolled at 15 active centers. Enrollment is expected to complete before the end of this year and as -- but as a government-sponsored multicenter study, we cannot influence the timeline, but believe that top-line data by mid-2020, I apologize mid-2020 is feasible. In terms of HemoDefend, this is a point-of-care filter that rapidly and efficiently removes noninfectious contaminants from transfused packed red blood cells that can cause transfusion reactions. This is a program that is funded up to $4.7 million by National Heart Lung and Blood Institute, a division of NIH as well as U.S. SOCOM or Special Operations Command. This technology is technically compatible with pathogen reduction technologies that are being offered by a number of other companies in the space.

We are targeting a total addressable market of 100-million-packed-red-blood-cell transfusions administered annually worldwide, however initially, we intend the device for patients receiving multiple units of blood, where the risk of transfusion reactions is very high, including in diseases, such as trauma, gastrointestinal bleeding, high-risk surgery, cancer and other blood disorders. The pivotal-trial design is a post-transfusion recovery and survival assay for autologous blood. The goal is to have the FDA IDE submission this year falling requisite bench testing for efficacy. Meanwhile, our CRO and clinical trial sites have been selected.

Following ID approval, the clinical trial is expected to be completed within three to six months. With that let me turn it over to Kathy to give financial highlights for the quarter. Kathy?

Kathy Bloch -- Chief Financial Officer

Thank you, Phil, and good afternoon, everyone. For today's call, I will provide an update regarding Cytosorbents second-quarter 2019 financial results including product-sales progress and in addition, I'll provide an update around our working capital and cash runway. CytoSorb product sales for the second quarter of 2019 were a record $5.9 million, which represents our best quarterly product sales ever. This is an 11.5% increase over product sales of approximately $5.2 million for the second quarter of 2018 and this brings the company's annual product sales run rate to approximately $23.4 million. This increase was driven by an increase in direct sales from both new customers and repeat orders from existing customers as well as an increase in distributor sales. The euro to dollar exchange rate declined from an average rate of $1.19 in the second quarter of 2018 to an average rate of $1.12 in the second quarter of 2019. If the euro had remained unchanged from Q2 2018 than Q2 2019 product sales would have been approximately $357,000 higher than product sales actually reported, where our product sales would have been approximately $6.2 million, an increase of 18% over second-quarter 2018 product sales.

Our total revenues which includes product sales and grant revenue were approximately $6.2 million for the second quarter of 2019, as compared to approximately $5.8 million for the second quarter of 2018, which is an increase of approximately 8%. And our second-quarter 2019 gross profit grew to approximately $4.4 million, which is an increase of 11% or $428,000 over gross products of approximately $4 million for the second quarter of 2018. Now our gross-profit margins on product sales were approximately 76% for Q2 of 2019 that's up from 74% for the prior year and that is primarily as a result of the achievement of manufacturing efficiencies. And we believe we are closing on our target of 80% blended gross margins on a quarterly basis by the end of 2019. Turning to our six-month financial results, our product sales for the first half of 2019 were approximately $10.4 million which is an 8% increase over product sales of $9.7 million for the first half of 2018.

And once again the euro to dollar exchange rate declines in fact if the euro had remained unchanged from 2018 are six months 2019 product sales would have been approximately $737,000 higher than we actually reported or approximately $11.2 million which would have been an increase of 15% over the prior-year's product sales. Grant revenue was basically unchanged at $1 million for the first half of 2019, as compared to the first half of 2018 and our total revenues which include product sales and grant revenue were approximately $11.4 million for the first half of 2019, as compared to $10.7 million for the same period in 2018 and increase of approximately 7%. The next we'll look at our quarter-over-quarter product sales and we note that we continue our trend of 27th consecutive quarters of year-over-year product sales growth. Q2, 2019 sales of 5.9 million represent a record for quarterly sales and we believe it puts us back on our historical path of growth.

Management remains optimistic about continued year-over-year sales growth for the remainder of this year and into the future. And next we look at our trailing 12-months-product sales and as you can see from this chart overall our annual product sales growth continues to exhibit a very strong growth trajectory. And despite quarter-to-quarter variability we expect continuation of this overall positive trend in the future. This as a result of our progress with regard to first expanding our sales team resources, second organic growth in existing markets third, increased international expansion fourth, publication of new clinical data in a wide variety of clinical applications and finally increased partner support.

We want to talk about the new loan amendment with Bridge Bank on July 31, 2019 we executed an amendment to our loan agreement with Bridge Bank. And upon execution of this amendment we drew down an additional $5 million in debt bringing our total debt from Bridge Bank to $15 million. Importantly this provides non-dilutive working capital strengthening our cash position and allowing us to continue to aggressively pursue our clinical-trial objectives and to rapidly grow worldwide product sales. I view this amendment as providing actually 9 million in near-term capital.

There is the 5 million in cash from the term loan but then in addition we were able to extent the interest-only period on our entire debt facility another six months and potentially 12 months provided that certain conditions are met. And this will postpone principal payments until November of 2020 freeing up another 4 million in short-term working capital. So with that let's take a look at our working capital position. As of June 30, 2019 we had approximately $16.3 million in cash with the additional 5 million in funds from the Bridge Bank term loan puts our cash in hand at approximately $20 million which we believe provides a solid operating foundation for the company.

We believe the existing cash runway will allow us to meet our operating needs well into 2020. Now in the second quarter of 2019, we also established an at-the-market facility of up to $25 million with co-agents Jefferies and B. Riley FBR. This ATM provides an efficient and cost effective way for us to raise funds for the company if they are needed.

And as you are aware in the past, we have been very careful with regard to our use of the ATM. We're always trying to strike a balance between having a strong balance sheet which provides adequate capital to meet our operating and clinical trial objectives and also avoiding shareholder dilution. Now turning to our capital structure as of June 30, 2019, we have approximately 36 million common shares outstanding on a fully diluted basis. And with that, I'd like to turn the call back to Phil.

Phil?

Phil Chan -- Chief Executive Officer

Thank you very much, Kathy. In terms of guidance Cytosorbents has not historically given specific financial guidance on quarterly results until the quarter has been completed. However, we expect that the third quarter 2019 product sales will exceed third quarter 2018 product sales and we also expect that the second half of 2019 product sales will exceed the first half of 2019 product sales. Lastly, we also reiterate our guidance that we expect to achieve blended product-gross margins of 80% on a quarterly basis this year. That concludes our current prepared remarks. Operator, please open the call up for the Q&A session.

Questions & Answers:


Operator

[Operator instructions] Our first question comes from the line of Josh Jennings with Cowen and Company. Please proceed with your question.

Josh Jennings -- Cowen and Company -- Analyst

Thanks for taking the questions and congrats on the record-product sales this quarter. I was hoping to start with just-I know you gave some details on distributor sales picking back up after some of the short-term disruption expansion in the first quarter. But can you talk about whether those just to be clear whether those issues are fully resolved. And then how do you see the pace of distributor sales picking up over the back half of 2019 and 2020.

I realize there are some countries that are going to registered Mexico and South Korea through Fresenius if any other tailwind that are in play for the distributor sales of channel?

Phil Chan -- Chief Executive Officer

Well, thanks Josh. In terms of the distributor sales so the issue that we face in the first quarter with that three distributors one of which was Fresenius Medical Care did not order related to inventory issues and other things. What we said in the first quarter is that we expect that those issues would resolve among all three distributors by the end of the year. And again into the second quarter one of those distributors began reordering again and that was a very good news.

In terms of Fresenius as we talked about they still continue to have inventory in Europe that they're working down. They are doing a very nice job on that and might ask Chris to comment on some of the progress there, but they will not or cannot order for Mexico and South Korea until they receive registration. But we expect again to hear more about registration if not get that registration out right before the end of the year at which point we expect that Fresenius would be ordering again. And then the third distributor, we believe and have fairly good visibility that they will be also ordering before the end of the year. But again without those three distributors we were still able to achieve record performance this quarter on certainly the resumption of ordering from one of those three are certainly was helpful.

Josh Jennings -- Cowen and Company -- Analyst

And are you still continuing to see strong growth out of Germany and I was just wondering I know it's probably hard to track each CytoSorb procedure with or case where CytoSorb is implemented in the therapy. But is there any kind of trend in terms of where you're seeing the growth in Germany in terms of indication cardiac surgery versus sepsis versus some other indication or is it more broad-based across oXiris indications knowing that there are numerous indications for CytoSorb?

Phil Chan -- Chief Executive Officer

I think it's a fairly broad-based, I would say that based upon our numbers roughly a third of our uses are in cardiac surgery and roughly two-thirds are in the intensive care unit either postoperative to cardiac surgery or for critical illnesses like sepsis, trauma, burning through and other things. But let me turn it over to Christian for more commentary. Christian?

Christian Steiner -- Senior Vice President of Sales and Marketing from Germany

Yes and all evening from here. First stage already there is a progress major application fields. The three major application fields we are serving at the moment is cardiac surgery as in my opinion fastest drawing which includes, especially also the sepsis patients and the new in future big part of our application goes into liver support therapy. We have spoken about this over the last earnings call.

So cardiac surgery -- the chances to become standard therapy on the term future that is -- and then we have multiple IITs running in Europe will be finished and published over the next few quarters. I think the number of supporting QS and sites have constantly going and one special effect in Germany plays into this. The Helios Group which is owned by Fresenius has started to pick up after we have -- for four years. Now especially in cardiac surgery they are hoping and we have increased our footprint there over the last two quarters. And then on cardiac surgery also control-cost benefit and the first two indications and this was accomplished and then of course marketed over the next couple of quarters.

So this was the first overview for you Josh.

Josh Jennings -- Cowen and Company -- Analyst

That's great. Thanks. Thanks for that answer. Appreciate it.

Phil Chan -- Chief Executive Officer

Christian, sorry, your phone is breaking up quite a bit and so but I think we got the general just what was said. If there is any need for clarification I can certainly do so.

Josh Jennings -- Cowen and Company -- Analyst

Thanks, Phil. My last question is just congratulations on adding new sites for REFRESH 2-AKI and congrats on the publication for U.S. REFRESH 1 as well. I was hoping this may seem little bit -- it was mentioned you did some of this on the -- in your prepared remarks.

So maybe just kind of outline for us on REFRESH 2-AKI just the path forward here, do you expect enrollment pace to pick up or you are going to have more sites, just maybe remind us how many sites you have planned on activating in total and then any updates on your thoughts on the interim analysis when you hit 200 patients, the halfway point. Thanks again for taking the questions.

Phil Chan -- Chief Executive Officer

Sure, Eric why don't you try to provide some color on that. Thank you.

Eric Mortensen -- Chief Medical Officer

Sure, Phil. Let me unpack a couple of those questions. You asked about the current kinetics of the study. You also want to have sense of what we're planning and doing in terms of increasing number of sites.

Then finally regard to the interim-analysis. So my first point that we're actually satisfied we've been able to maintain a very strong normal to date. We are obviously not satisfied. Our objective is that beyond just trying to meet the objectives for this year to make sure we have pro enrollment in 2020 and so we currently have 24 active sites. Our expectation is to bring on at least the additional product site to this [inaudible] and the summertime is always a little bit slow in terms of finalizing contract, because of staff and hospitals often being on holiday, but we expect to be able to increase the rate of recruitment with the addition of [inaudible] from the fall.

The final number of sites we had is really being determined based upon our desired rate of recruitment. Our goal is to try to maintain maximum study quality by being able to make sure that were really monitoring very aggressively. These types of studies in AKI really require that you stay on top of the site because the endpoints that are required, measurement of the announcement, measurement of creatinine, follow-up on adverse event really is best done by having your own staff really fall to directly with study coordinators. So we don't intend to add our additional 35 beyond what's required to meet our objectives but I'm not going to give you a final number of 30 versus 35 until I actually have seen what the output is more additional incentives.

With regard to your question about the interim analysis, we expect that to be I am talking to the timing I will not be able to tell you the results of that because of the need to maintain study integrity. We do have a detailed study of -- there's some filed FDA with the objective of being able to look both for overwhelming efficacy, futility, as well as the potential need for adjustment in patient numbers based upon the outcomes we've seen but we will not be reporting out any observation to the grant to AKI rate for the obvious reasons of making sure that we detain the integrity of that child. Did I answer your question?

Josh Jennings -- Cowen and Company -- Analyst

You did absolutely. Appreciate it. Thanks.

Operator

Our next question comes from the line of Andrew D'Silva with B. Riley. Please proceed with your question.

Andrew D'Silva -- B. Riley FBR -- Analyst

Thanks for taking my questions, Sorry, if you highlighted any of this but I was moving between calls. But as far as the Fresenius inventory work through goes and then the other two servers I know you kind of highlighted a little bit about that in your prepared remarks and in previous answer, but should we anticipate any of those outside of the one that already ordered to come in as revenue during Q3 or would you expect that to be more of a Q4 event?

Phil Chan -- Chief Executive Officer

I think I had -- we expect that both will be coming in Q4 and whether or not they'll be able to come in Q3 I guess remains a question. But suffice it to say, the first distributor has worked through their inventory and has back into a traditional ordering pattern.

Andrew D'Silva -- B. Riley FBR -- Analyst

And then due to the just general EU exposure that you have, any sense how this quarter might turn out as far as the Q3.Obviously, summer months in Europe can swing a lot depending on just how often people are out of the office and stuff like that, is there any sort of normalize trend that you're seeing or should we expect sales just in general to be more weighted toward Q4?

Phil Chan -- Chief Executive Officer

So last year was really the first year we saw seasonality in the third quarter and as you say, given that the vast majority of our revenue are coming from the European Union and July and August are particular -- are particularly busy months for holidays, things slow down quite a bit. So elective surgery slows down, a lot of hospital shutdown, operating suites and last year was particularly a slow year for infections and sepsis. That being said ,this year I think it's still too early to say given that we're just at the beginning of August, but to date we've been tracking better than we have last year and we hope that -- and again, we've given guidance that we believe the Q3 this year will be better than Q3 last year.

Andrew D'Silva -- B. Riley FBR -- Analyst

Good color, and just was skimming through your Q and noticed just rest of world direct sales went about 14%, 15% year over year, which was slower than the growth seen out of Germany. I am sorry, they were about in line with what was seen out of Germany and I was just curious could you added so many new regions during the quarter if there was any sort of movement toward the third quarter when you saw recognizing revenue in new regions or did it actually start in the second quarter?

Phil Chan -- Chief Executive Officer

So as we mentioned before, a lot of the new territories that we added. So there are five additional territories, which include Poland, which began sales in April of 2019 and then the Scandinavian countries of Denmark, Norway, Sweden and -- while they basically started at the beginning of January.So it takes time for them to get up and running and again, Poland is one of the biggest countries of the five and they've been making some really great progress in terms of establishing their infrastructure and establishing market awareness of the technology and working on key opinion leaders. And we expect that all those accounts actually will begin to accelerate in terms of sales less likely for Q3 more likely for Q4.

Operator

Our next question comes from the line of Jason McCarthy with Maxim Group. Please proceed with your question.

Jason McCarthy -- Maxim Group -- Analyst

So, as I am approaching an ID for HemoDefend like to see if you could give us the FDM like the [inaudible] if I heard correctly that trial is expected to take like you said three to six months. So does that mean that HemoDefend could make it to the U.S. market before CytoSorb. And then how much are you expecting that trial to run would it be substantially covered by the 4.7 million from the U.S.

government?

Phil Chan -- Chief Executive Officer

Yes, so exactly, so HemoDefend there's a quite a bit of work that is done to try to drive approval one of those so it really is in two parts. One is, dent studies which are designed to establish the efficacy of the filter in terms of being able to remove the substances that we are looking to remove. And then there is a human post transfusion recovery and survival assay where we have healthy volunteers who basically donate their blood. We age that blood or the sites will age that blood and then that blood gets filtered through our HemoDefend filter radio-labeled-packed blood cells get filtered through our filter. And then get transfused back into the same patient and basically they look for 24 hours later at the recovery of that radioactivity and expect to see roughly 75% recovery.

And so that is meant to measure the survivability of those red blood cells once they are transfused back into the bloodstream and make sure that our HemoDefend filter is not doing anything untoward to that blood because it's have a decrease longevity. This is a very standard assay in the blood transfusion industry very well-accepted and points across the board. So that is a very short study as you can imagine. We're talking less than 25 patients and yes so that that part of the study is expected to happen very quickly falling ID approval.

There's clearly some activities that have to happen including making sure that we have the agreement in place with the sites and the budget in place with the sites. Ethics committee approval with the sites, but once we get those done the trial itself is actually very quick. And we plan to get the requisite bench testing looking at efficacy done prior to filing our ID submissions so that is expected to be done this year. So yes to your question HemoDefend should everything go well is expected to be on the market here in the United States prior to CytoSorb.

Jason McCarthy -- Maxim Group -- Analyst

And then just second part on the cost of the trial if you think that 4.7 million is going to cover a good bit or your big chunk of the total cost?

Phil Chan -- Chief Executive Officer

So we have a grant from National Heart, Lung, and Blood Institute that is a Phase IIb bridge and that is a one-to-one matching grant up. And so NHLBI will provide up to $3 million in funding toward the development, as well as clinical studies leading to potential U.S. approval for all activities. Our goal is to match that obviously again one-to-one. So at the very least it's a 50% discount and off the trial and from a total-cost perspective we believe that it will not exceed the amount of money a total of $6 million that are provided under this grant.

So that's $3 million from NHLBI and $3 million in matching funds from Cytosorbents

Operator

Our next question comes from the line of Jason Kolbert with Dawson James. Please proceed with your question. (Operator instructions)

Jason Kolbert -- Dawson James -- Analyst

Can you just congratulations fantastic quarter can you just go through the timelines with the U.S. trial again in detail? Thanks.

Phil Chan -- Chief Executive Officer

Yes, so and I think that basically HemoDefend-I assume you're talking but the REFRESH 2 AKI trial not HemoDefend?

Jason Kolbert -- Dawson James -- Analyst

It was but could touch on both that would be helpful.

Phil Chan -- Chief Executive Officer

So in terms of the -- I apologize Jason your line was breaking up a little bit, but I think you said REFRESH 2 is that right?

Jason Kolbert -- Dawson James -- Analyst

But I'll be interested in HemoDefend as well? Thanks.

Phil Chan -- Chief Executive Officer

So I think that based upon the current pace of enrollment that we're on right now we expect to achieve 200 patient enrolled by the end of the first quarter at which point we would be doing an interim analysis. Now as Eric mentioned previously his team is working very hard to accelerate the rate of enrollment by increasing the number of active trial sites and making sure that were actively involved and visiting sites and doing all that kinds of things that we need to do to be able to accelerate enrollment. Our goal is to get somewhere on the order of one-patient-per-site per month which we believe is very doable, but obviously you know when you're dealing with many sites it becomes very challenging. That being said provided that we can get to that 20 patients per month per site we believe that we should be able to complete enrollment by the end of 2020 at which point than we would go into data monitoring and review and database lock.

And that would be followed by data analysis and statistical analysis and then PMA submission. And our goal is to try to get to that point by mid-2021 where were in a good position to sometime probably midyear to the third quarter submit the PMA filing for our PMA filing.

Jason Kolbert -- Dawson James -- Analyst

That's very helpful. I know Michael was focusing on HemoDefend if you could just touch on those timelines for me as well? Thanks.

Phil Chan -- Chief Executive Officer

Yes, so HemoDefend I think our goal is to file that IDE submission by the end of this year and maybe actually let me give an opportunity to Vincent Capponi to comment Vince would you like to comment on the timeline?

Vince Capponi -- Chief Operating Officer

Sure thanks Phil so basically we've continuing to make progress on the HemoDefend program. We're at the stage now where we're actually beginning to fill devices specifically for what Phil alluded to earlier which was the bench-testing which is the next step that we need to complete in order to do the IDE submission. We plan to do the IDE submission by fourth quarter sometime in fourth quarter with the expectation of being into clinic the first quarter of 2020. As Phil mentioned it's going to be about a six-month trial so by mid-2020, we expect to have completed that trial.

It's a very small number of patients that's one of the advantages of these types of products with respect to blood filtration using the clinic like packed red blood cells, etc. It's a very fast trial and so we expect that that we should be able to complete that by mid-2020. And so to the earlier question, we think there is a chance that we could have this in the FDA for approval and possibly approved by the end of 2020.

Operator

Our next question comes from the line of Brian Marckx with Zacks Investment Research. Please proceed with your question.

Brian Marckx -- Zacks Investment Research -- Analyst

In terms of the regulatory process and timeline for Mexico and South Korea, do you have a sense of how long or how long that may taken and when you may have a regulatory approval?

Phil Chan -- Chief Executive Officer

Yes, Vince has been leading that effort. Vince would you comment.

Vince Capponi -- Chief Operating Officer

Sure. So we've made all the submissions both for Korea and Mexico. We hope to hear something by the end of this year. It's somewhat out of our control so you never know what these various regulatory bodies exactly you know, what their scheduling timelines going to be.

So we we're hoping that we will hear at least based on our discussions with FMC in Korea and Mexico that if there's a chance that we could hear by the end of the year or by the end of this year and then probably more than likely by first quarter of next year. But I think there's a chance, we could get approval this year but it would more than likely be into the beginning of next year.

Brian Marckx -- Zacks Investment Research -- Analyst

And how significant do you think those two territories are in terms of our revenue and then is there a reimbursement component after regulatory approval?

Phil Chan -- Chief Executive Officer

So maybe turn that over to Chris, who's been working very closely with FMC as well. Chris?

Chris Cramer -- Vice President of Business Development

Sure, thanks. Hey, Brian, thanks for the question. We've been working with the senior sales leadership in both countries, have a lot of support at the highest level, that's important because when you have that they tend to prioritize your product so we see a good responsiveness happening from that team. Both of these markets are big.

I don't have the exact population in front of me but they're quite large. I think we have them in the original press release that we put out. And there's a significant unmet need in both of these markets. The biggest difference between the two is that Mexico has more of a self-pay component.

So to look it will set up a little bit more like our business in India, where we're in some cases there will be a self-pay component to it, but in both cases we will look to go through and A, take advantage of existing reimbursement codes that are there today that we can use and then longer-term look to establish a dedicated code like we have in Germany and then in the interim. As you know we've been putting a lot of investment into our health economics team to give tools who are direct-- salespeople and distributors to make the economic case. So that will be something that we actively work with both of these organization -- both of these countries. I should also say that just to piggyback on to what Vince was saying, we are preparing some pre-marketing activities in both countries.

We're optimistic that something will come through around the end of the year or early next year, so we're starting to key up some KOLs and get out to some major conferences to get that that market launch started as soon as we can. So I think both will be good markets for us.

Brian Marckx -- Zacks Investment Research -- Analyst

And one on cardiac surgery REFRESH 2. Phil you talked about a potential timeline for the PMA. I assume it's just the REFRESH 2-AKI study and maybe the REFRESH 1 that will support that filing. Is there anything in addition clinical data -wise that you think that FDA's can all see.

Phil Chan -- Chief Executive Officer

Vince or Eric, would you like to take that.

Eric Mortensen -- Chief Medical Officer

I guess, we just commented obviously FDA is all interested in efficacy data and I can say that Vince and I are working very hard to make sure that we leverage the extensive experience that has been developed in Europe. I think that's going to hopefully be a very strong point given the number of utilization, the number of times in using cardiac surgery, we are hopeful that will be supported but obviously that's the review issue.

Vince Capponi -- Chief Operating Officer

Yeah, just to piggyback on what Eric saying, I mean this is a pivotal trial. So in theory we should have all the information we need to make a registration of the device for commercialization, so you know, basically there should be adequate information to bring this device forward than I don't believe anything else will be required but again to Eric's point you never know, but again, it's been power to show the endpoint and providing that we're successful there as we think we will be then I don't expect that there should be any additional information required.

Operator

Our next question comes from the line of Sean Lee with H.C. Wainwright. Please proceed with your question.

Sean Lee -- H. C. Wainwright and Company -- Analyst

Just a quick update on the REMOVE study. I know that's been loved by the German government but with the enrollment in 90% so we can probably expect to see data as early as the end of this year or early next year. I was just wondering, is endocarditis a major indication for you guys right now in Germany and these two results obviously is positive what kind of the impact would you expect to see on your commercial efforts there?

Phil Chan -- Chief Executive Officer

Yes, so what's quite interesting is the pace of enrollment that they been able to enroll that trial. So they began in January 2018 with only hand of -- handful of sites and now 15 sites they are enrolling that. That trial actually very rapidly and what I think it speaks to is the growing population of people at risk for endocarditis both from the traditional path of map Flora seeding the blood stream from dental procedures in elderly people but also from the growing problem of the opiate crisis and that use of dirty needles for IV drug abuse. And certainly in the United States it's a massive problem and we have a lot of interest to bring CytoSorb search in the United States for that particular application.

But I think that endocarditis although historically has not been a big application like valve-replacement right. The valve replacement is tenfold, a greater-sized market than endocarditis. On the other hand, endocarditis is one of those applications where the patients are so sick oftentimes, particularly from IV drug abuse where the offending agent, the offending organism is often staphylococcus aureus, which is skin bacteria but very dangerous -- are very dangerous bacteria. You heard of Staphylococcus aureus from MRSA Methicillin-resistant Staph aureus and the adverse events rates, the complications, the hemodynamic instability, the day rates of sepsis and postoperative infection and other complications are mind-boggling and the value of CytoSorb has been seen in many, many centers around Europe, because it helps to stabilize those patients intraoperatively, as well as postoperatively. And as Christian mentioned before, we believe that it is one of those indications where should we have success in a number of these studies, we could potentially become standard of care in that application.

Sean Lee -- H. C. Wainwright and Company -- Analyst

Great. Thank you for the additional info. My last question is on the direct-sales operations. Are there plans to expand that in the second half this year?

Phil Chan -- Chief Executive Officer

So we -- so that kind of multifaceted question. So there is direct sales in our direct territories that we currently are in, and yes, we have had an ongoing program that expanding the sales teams and sales support teams in those countries, particularly in Germany, but also in other countries where we have considerable momentum. But there are still a lot of countries that we have not -- that are not claimed by distributors or partners, and in certain of those countries, we would look to potentially go direct, as the economics of going direct are often highly favorable in terms of product-gross margins, but also the fact that we are typically -- our company and our salespeople are typically the most efficient sellers of our product given that we are so closely tied to the product and that's all we sell. So, yes, so both expansion internally within our current direct territories, as well as the expansion of additional territories are in the plan.

Operator

Thank you. Ladies and gentlemen at this time, I'd like --

Phil Chan -- Chief Executive Officer

Well thank you everyone for your participation today, and if you do have any other questions please feel free to reach out to Jeremy Feffer at jeremy@lifesciadvisors.com, and we will reply to your questions where possible. Thank you very much, everyone, and have a good night.

Operator

[Operator signoff]

Duration: 53 minutes

Call participants:

Jeremy Feffer -- Managing Director

Phil Chan -- Chief Executive Officer

Kathy Bloch -- Chief Financial Officer

Josh Jennings -- Cowen and Company -- Analyst

Christian Steiner -- Senior Vice President of Sales and Marketing from Germany

Eric Mortensen -- Chief Medical Officer

Andrew D'Silva -- B. Riley FBR -- Analyst

Jason McCarthy -- Maxim Group -- Analyst

Jason Kolbert -- Dawson James -- Analyst

Vince Capponi -- Chief Operating Officer

Brian Marckx -- Zacks Investment Research -- Analyst

Chris Cramer -- Vice President of Business Development

Sean Lee -- H. C. Wainwright and Company -- Analyst

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