Earnings Labs

Cytosorbents Corporation (CTSO)

Q2 2016 Earnings Call· Wed, Aug 10, 2016

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Transcript

Operator

Operator

Good day everyone, and welcome to the CytoSorbents Second Quarter 2016 Financial Results Conference Call. [Operator Instructions] Today's call is being recorded. And at this time, I would like to turn the conference over to our moderator, Amy Phillips. Please go ahead.

Amy Phillips

Analyst

Thank you and good afternoon. Welcome to the CytoSorbents second quarter 2016 operating and financial 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; and Chris Cramer, VP of Business Development. Unfortunately Dr. Christian Steiner, VP of Sales and Marketing from Germany is not able to join our call today. 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 the 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 August 9, 2016, 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 financial and operating highlights for the first quarter by Dr. Chan and Ms. Bloch. Following that presentation, we'll open the line to your questions during the live Q&A session with the rest of the management team. At this time, it's now my pleasure to turn the call over to Dr. Phillip Chan. Dr. Chan, go ahead, please.

Phillip Chan

Analyst

Thank you very much, Amy, and welcome everyone to the call. CytoSorbents is a critical care focused immune therapy company using blood purification to prevent or treat life-threatening inflammation in the intensive care unit and cardiac surgery using CytoSorb blood purification. CytoSorb removes the fuel to the fire of inflammation and target the $20 billion opportunity in critical care and cardiac surgery. CytoSorb is approved in the European Union as the only specifically approved extracorporeal Cytokine filter and is clinically proven to reduce key cytokines in the blood of critically ill patients. It is approved for use in any situation where cytokines are elevated and more with standard dialysis in heart-lung machines in hospitals worldwide. It also removes many other inflammation mediators such as free hemoglobin, bilirubin, bacterial toxins, activated complement and host of other inflammatory mediators that are contributing to this uncontrolled life-threatening inflammation. The safe and well tolerated now in more than 14,000 human treatments performed worldwide. The goal of CytoSorb is to control this deadly inflammation to prevent or treat organ failure rather than allowing patients to spiral down into organ failure caused by this uncontrolled deadly inflammation, our goal is to reduce key inflammatory mediators from blood as a way to treat this life-threatening inflammation to the edge of the inflammation so that it does not cause organ failure and organ injury. The goal here is to treat aggressively upfront hopefully trying to limit the adverse events that happened from this inflammation, thereby improving patient outcome and survival while decreasing the massive cause of ICU and patient care. But it’s not just the millions of people who are admitted every year for diseases like sepsis a key respiratory distress syndrome burn injury, trauma, pancreatitis, influenza, and complications of surgery. But what I think is very unique…

Kathleen Bloch

Analyst

Thank you, Phil and good afternoon everyone. For today’s call I will be provide an update regarding CytoSorbents’ second quarter 2016 financial results including product sales progress, a review of the recent financing we completed with Bridge Bank and also an update around our working capital and cash run rate. CytoSorb product sales for the second quarter of 2016 were approximately $1.9 million, which is a 140% increase over product sales of $773,000 for Q2 2015. Our Q2 2016 annualized product sales run rate rose to $7.4 million, which is more than double our annualized run rate of approximately $3.1 million one year ago. Total revenues, which includes both product sales and grant revenue were approximately $2.2 million for Q2 2016, as compared to approximately $964,000 for Q2 2015, which is an increase of approximately 131%. In Q2 2016 our gross margins rose to approximately $1.3 million, an increase of approximately $850,000, as compared to gross margin of approximately $499,000 for the second quarter of 2015. We continue to experience strong gross profit margins on product sales. For Q2 2016 gross profit margins increased to approximately 68% largely as a result of the sales mix as compared to gross profit margins of approximately 63% for Q2 2015. Now let's take a look at our quarter-over-quarter product sales. Q2 of 2016 product sales of approximately $1.9 million represented our best quarterly product sales ever. Q2 2016 product sales were approximately $255,000 or 16% higher in Q1 2016 product sales. Q2 2016 represents the fifth consecutive period for which we have reported quarter-over-quarter product sales growth. It’s also our fourth consecutive quarter of record sales. We make a note here that the change in the euro relative to the dollar did not have a material impact on our sales when comparing 2016…

Phillip Chan

Analyst

Thank you very much, Kathy. What I like to do now is cover key operational items before going into the live Q&A period. So first off is our REFRESH 1 trial and as most of you recall, this is a 40 patient 8 center study, evaluating the safety and efficacy of intra-operative use of CytoSorb in a heart lung machine during complex cardiac surgery and elective non emergent cardiac surgery that is expected to last longer than three hours. This includes things like aortic reconstruction, cabbage reduce, multiple valve replacements, congenital defect repair and other types of complex cardiac surgeries. The primary endpoints of the study are safety, and the reduction of plasma free hemoglobin that can cause post-operative complications. Plasma free hemoglobin is a result of hemolysis of blood, as the blood coursing through the artificial blood circuit. It is also caused by cardiatomy suction under negative pressure red blood cells will explode or release the contents of those red blood cells, which is free hemoglobin. And is also caused by the administration of blood transfusion products, particularly pack red blood cells that have typically life starting storage, and add a burden of free hemoglobin to the patient. Free hemoglobin as you recall is very toxic. Because not only is the iron radical -- the iron ion in hemoglobin very toxic causing the formation of oxygen radicals that can damage blood vessels and tissues, but it is also very potent scavenger of nitric oxide, the body’s most prevalent base dilator that causes blood vessels to dilate and blood to flow throughout the body. But that nitric oxide present, patients following surgery will often suffer from decreased blood flow either to the lungs, to the intestine, to the kidneys and other vital organs, potentially leading to organ dysfunction, organ failure…

Amy Phillips

Analyst

Thank you Dr. Chan. Operator we're ready to pull for questions.

Operator

Operator

Thank you. [Operator Instructions] We’ll take our first question from Jason Kolbert with Maxim Group. Go ahead.

Unidentified Analyst

Analyst

Hi, guys. This is Gabrielle [ph] for Jason.

Phillip Chan

Analyst

Hi, Gabrielle.

Unidentified Analyst

Analyst

Congratulations on a solid quarter. We are really excited for the growth. So I have couple of questions here. The first one is, what are the criteria you put in place when you sign up distributor? And how do you set the benchmark goal and how you measure the performance of distributor? Thank you.

Phillip Chan

Analyst

Sure. That’s a good question. We seek distributors who has extensive experience in critical care sales. They also typically are required to have experience in some type of extra-corporal life support, whether or not it be dialysis, chemo filtration, ECMO or other types of apheresis type technologies. We are looking for committed partners that are typically have a well-balanced portfolio, that potentially have synergistic product portfolio with CytoSorb, but also have a manageable portfolio, where they can commit to the type of attention that we would expect from them to sell CytoSorb into the marketplace. Now all of our distributor agreements come with exclusivity for their particular territories, but they also come with expectations on minimum purchases of CytoSorb in order to maintain exclusivity. And we follow our distributors on a very regular basis to make sure that they are achieving their goals. We support them extensively with marketing materials with clinical data, with reimbursement support most recently, and other types of support, as well as training of distributors on a regular basis. In order to make sure that, they are bringing the latest and greatest knowledge of how to use CytoSorb best to their customers in their territories. And so we track our distributors and their orders on a regular basis. And that is one of the main ways that we follow them.

Unidentified Analyst

Analyst

Okay, great. So can you walk me through what it takes to reach the critical mass in Europe. And at what point the use of CytoSorb become a routine modality? And how many KOLs needs to adopt the product for it to become the mainstream product in the marketplace? Does it make sense for us to be tracking the KOL adoption at this point?

Phillip Chan

Analyst

Yes. So we used to use KOL adoption as kind of a benchmark for interest in CytoSorb sales. But since -- but as of probably more than a year to two years ago we stopped doing that, because the number of KOLs has become too numerous for us to count. And as our awareness -- as the awareness of CytoSorb has expanded throughout the marketplace. There are just so many people thinking about how to use CytoSorb in clinical usage that we can’t keep track of them all. There are literally thousands of intensivist throughout the European Union and throughout the world. And what -- how we are trying to keep track of them are buy key accounts, and by in our direct sales territories of Germany, Austria and Switzerland. And through distributor sales and distributor reports, on their activities in various different countries. So in terms of becoming standard-of-care, clearly that is our goal. And I’m pleased to say to-date that, there are number of hospitals already, particularly in our direct territories that have adopted CytoSorb as the fact of standard-of-care for the treatment of a number of different illnesses. Based upon their successes that they have seen already using this amongst many such patients in their hospitals. So even without having large scale pivotal studies, large scale randomized controlled studies demonstrating the benefit of CytoSorb in these particularly applications. They’ve seen it work in their own hands, and I think that is ultimately what has been the most convincing in terms of bringing this to become standard-of-core in these hospitals. So of those hospitals they include many of the major university hospitals and public hospitals in Germany and we expect that number will continue to grow in the future.

Unidentified Analyst

Analyst

Great. So can we now switch gear to the U.S. trial. So what are the next regulatory steps for you to move forward the refresh trial?

Phillip Chan

Analyst

So we are looking to do a soft lock on our database after the last patient is enrolled and we expect the last patient to enrolled within the next couple of weeks. We anticipate an analysis of these data and announcement of top-line data as I mentioned that the EX Conference at the beginning of October. But we also plan on doing a much more extensive analysis of the data and are looking to go the FDA most likely in the fourth quarter of this year and with the goal of negotiating and discussing the path for the refreshed queue, registration trial. And as we mentioned I think the FDA is waiting for our data from this REFRESH 1 safety and feasibility study before opining upon the exact path for regulatory approval. But it could be De Novo 510(k) path as a free hemoglobin filter for example or could be the traditional PMA path which we expect to be the default pathway in a much larger trial roughly 300 to 400 patients where we would be looking at clinical outcomes such as the need for vasopressors, days in the intensive care unit, timeline the ventilator as endpoints for that registration trial.

Unidentified Analyst

Analyst

Okay, great. Thank you, Phil again congratulations.

Phillip Chan

Analyst

Thanks very much, Gabriel.

Operator

Operator

And we'll take our next question from Sean Lee with HC Wainwright.

Sean Lee

Analyst · HC Wainwright.

Hi, Phil and Kathy. Congratulation on the strong quarter and thank you for taking my questions. I might have missed this earlier, but how do you [indiscernible] would there be any [indiscernible] in the near future?

Phillip Chan

Analyst · HC Wainwright.

I'm sorry Sean. If you could repeat the question. I think.

Sean Lee

Analyst · HC Wainwright.

[indiscernible] manufacturing capacity handling [indiscernible] increase demand from low distributors would you be supply constraint at any time in the near-term?

Phillip Chan

Analyst · HC Wainwright.

Yes, I can certainly let Vince talk to that point. But currently we believe that we have enough capacity particularly with improvements in manufacturing that we’ve had recently to be able to supply demand for the next one to two years. Maybe Vince you like to give a little bit more color.

Vincent Capponi

Analyst · HC Wainwright.

Sure. Hi, Sean. So basically as Phil mentioned we are continuing to do a number of operational improvements at this and to actually increase the capacity that we have in the current location and to Phil’s point we believe that we have adequate capacity to go out the next one to two years. We also have obviously put in contingency plans on our own planning should that volume increase significantly how to essentially duplicate what we have here in another location if we had to do that to double the capacity for instance. So I think it’s safe to say from the next one to two years we have enough capacity.

Sean Lee

Analyst · HC Wainwright.

Great to hear. Second question is on the recently launched distributors, which ones are contributing already to the second quarter number and which one do we expect to come online during third quarter or will see in the next quarter’s numbers?

Phillip Chan

Analyst · HC Wainwright.

Kathie, did you want to take that?

Kathleen Bloch

Analyst · HC Wainwright.

Yes, sure. So we said we are in 37 countries and like we were able to -- if we just look at our slide on the countries of those 37 countries we currently have I think it's 28 to contributing to revenue, that doesn't mean Sean that they necessarily contributed to Q2 revenue, but most of them have but they contributed to revenue through June 30, 2016.

Sean Lee

Analyst · HC Wainwright.

I see. Thank you for the clarity. That’s all I have.

Phillip Chan

Analyst · HC Wainwright.

Thanks, Sean.

Operator

Operator

[Operator Instructions]. We'll go next to Andrew D’Silva with Merriman Capital. Andrew D’Silva: Hey, good afternoon guys. Thanks for taking my call just a couple of quick questions. First off could you elaborate on where there any large stocking orders during the quarter that could have distorted the Q2 results or where that fairly in line with previous quarters from a stocking standpoint?

Phillip Chan

Analyst

Yes I think it was fairly inline from previous quarters from a stocking standpoint. We believe that the growth that was exhibited in Q2 was fairly organic in nature and expect that trend to continue going forward. Andrew D’Silva : Thank you for that. And as far as initiatives go [indiscernible] are you getting updates from them on the progress out of their sales team. And then as far…

Operator

Operator

I'm sorry Mr. D'Silva you are cutting out. Andrew D’Silva: Can you hear me okay?

Phillip Chan

Analyst

Yes we can hear you now Andy. Andrew D’Silva : My apologies. Yes I'm just trying to get a sense on how often you are betting updates from the sales team at Fresenius? And then [indiscernible] and they're willing of CytoSorb when they're in the market.

Phillip Chan

Analyst

Could you just repeat that you cut out there for a second there Andy. Could you just repeat that second part of the question so first part of your question was have you been getting regular updates from partners like Fresenius and then the second question was? Andrew D’Silva : Yes do you feel like they're up to speed on the product? And is their willingness to upsell there and is it charting your expectations right now?

Phillip Chan

Analyst

Sure. So why don’t I turn it over to Chris Cramer our VP of Business Development who has work very closely with Stefan Baudis our International Sales Director on these particular accounts. And Chris would you like to give some color on that?

Chris Cramer

Analyst

Sure thanks so, hi Andy this is Chris. I think to your first question we see in very first close contact with all of our partners and distributors. We typically meet with them or talk to them on the phone at least once every two weeks. For Fresenius in particular as Phil has mentioned the focus for them has really been on selling activities across all countries. And so today they’re actively promoting CytoSorb throughout the territory. Just to give you a sense of some of the success stories they've had and there has been a couple I can just kind a give you a few here. But and so for example in Finland they’ve recently conducted what they call Scandinavian ICU days where they bringing physicians from all across Scandinavia to talk about new therapies. And CytoSorb was a key focus there. Subsequent to that they had four centers that were trained on CytoSorb and they had their first patient treated in early July. And the patient there was e-coli sepsis and the feedback from the doctors there, the ICU doctors was that they were very satisfied and impressed with how quickly the treatment helps. And so obviously that was a very positive. And in that case we’re hoping to get a case report back from that treatment. Then in Poland, Poland as you may recall was one of the first FMC countries to record CytoSorb sales and they've been off to a fast start there. Recently they've offered CytoSorb in a tender and so we're hoping to hear more about that I think that's positive news. So just to bring some color to some of the activity going on with FMC I hope that helps. And we're hoping to have more of these kind of success stories to have for future calls. Andrew D’Silva: So basically you guys are fairly happy with the way things are charting right now with Fresenius it’s on path with your expectations.

Phillip Chan

Analyst

Yes absolutely, I think that we've seen from them a tremendous amount of commitment and resources going towards the launch of this product and we have full confidence in their team. As Chris mentioned we are in contact with them very frequently after during the launch. I think Chris was talking with them much more frequently than once every couple of weeks. But they participated in our training, they participated in our users meeting. We had a program of training of the trainer so that we can get the most recent data out to them and they’ve been a very committed partner and full of confident that they we’ll be able to have success in those countries. Andrew D’Silva: Got it, great, well thank you for answering my questions and good luck for the rest of the year.

Phillip Chan

Analyst

Sure Andy, thanks very much.

Operator

Operator

And we’ll take our next question from Brian Marckx with Zacks Investment Research.

Brian Marckx

Analyst · Zacks Investment Research.

Hi guys nice quarter. Kathleen a couple for you product margin as you mentioned was up quite a bit just wondered if you talk about that you mentioned product mix had something to do with that, can you just address that? And then with the additional territories coming on that are obviously distributors does that affect gross margin at all?

Kathleen Bloch

Analyst · Zacks Investment Research.

Yes okay Brian. So to the first part about product mix, so our gross margin was improved over prior quarters. Large percentage of that was due to direct sales that was further impacted by just the mix of sales among the distributors we do have different pricing in different countries. So it happened to be that way we’re not predicting, if that will be what we experience necessarily in the future. And then in terms of distributors, direct sales have been primary driver however there will come a time when distributor sales which are of course at a low margin than direct sales generally, may overtake direct sales and that all other things being equal might impact gross profit margins I will say though that we have been really successful even out of our facility here in changing and improving our operations to try to reduce our cost per device. In fact this year our standard cost probably about 10% to 15% lower than what they were last year and we expect to achieve continual improvement. So that should boost the margins a bit.

Phillip Chan

Analyst · Zacks Investment Research.

Yes and maybe to give a little bit more color, as we gain volume and as we gain manufacture efficiencies and particularly as we move to a larger plant right now we were staying in the current plant because we have a nice runway here in terms of product production, but as we move to the larger plant which is plant in the planning and will happen in the future. We expect to gain additional economies of scale and manufacturing efficiencies. So although the blended gross margin for this quarter was 68%, we believe that even overtime based on just a variety of different factors that we can drive the direct gross margin to greater than 80% and the blended gross margin therefore with it. But the quarter-to-quarter blended gross margin is of course a mix between higher margin, direct sales and lower margin distributor and partner sales and depending on what that mix looks like it will have a quarter-to-quarter variance in terms of the overall gross margin.

Brian Marckx

Analyst · Zacks Investment Research.

Got you. Okay, that makes sense. In terms of the revenue growth recently is it possible to kind of quantify how much of that revenue growth is coming from your direct sales territories versus the new territories that came on line? Yes actually I didn’t say that right is what I’m looking for is it possible to quantify how much of the recent growth is coming from reorders which is probably most of your direct sales anyway versus the new territories that came or new accounts in general I guess.

Phillip Chan

Analyst · Zacks Investment Research.

Kathy, would you want to comment?

Kathleen Bloch

Analyst · Zacks Investment Research.

Yes so Brian in any given quarter probably 80% to 90% of our sales are coming from the repeat orders or reorders from existing hospitals or distributors.

Brian Marckx

Analyst · Zacks Investment Research.

Okay, alright. And then I guess it’s fair to say based on the new territories that are coming on line fairly rapidly it sounds like in particularly or maybe particularly with Fresenius at least in addition to other territories, that mix may change a little bit at least, I guess here in the near-term, is that fair to say?

Phillip Chan

Analyst · Zacks Investment Research.

Yes, I think that’s within the realm of possibility. But what we are seeing when you look at the numbers is particularly in our direct sales territories, that started -- where we started commercialization full year earlier than any other territory throughout the world. We’re really seeing that momentum build. And so we expect direct sales to continue to be a major contributor of our revenue going forward.

Brian Marckx

Analyst · Zacks Investment Research.

Okay. So if we can talk about refresh just a little bit. It sounds like you are targeting 44 total patients for a 40 patient clinical set. Does that mean that you have 36 that are enrolled right now? Or is there may be a patient cushion or two there?

Phillip Chan

Analyst · Zacks Investment Research.

No. In fact, we have enrolled above the 40 patient targets. So we now have enrolled 44 patients total into the REFRESH 1 trial. We have the ability to go up to approximately 52 or so patients in the study. But let me explain that for a minute, because it maybe unclear. When patients are enrolled into the study, they are rolled based on the expectation that of course they’ll complete the study, but also based on the estimation of the physician on particularly how long the patient will be on cardio pulmonary bypass, and on the operating room table. And so -- and they make this estimation based upon the typically the complexity of the cardiac surgery procedure. Now we have criteria for example in our study that patients are expected to be on cardio pulmonary bypass for longer than three hours with minimum amount of cardio pulmonary bypass required. Sometimes the surgery goes extremely smoothly and the patients are for whatever reason the operation doesn’t take as long as expected, and patients don’t achieve that minimum time requirement on cardio pulmonary bypass. That’s just one example for why a patient would potentially not complete or not be -- not complete the study, because of missing that endpoint. So there are factors like this that happen all the time in trials, which is one of the reasons why we’re over enrolling in order to account for those patients that don’t meet the full criteria of the study.

Brian Marckx

Analyst · Zacks Investment Research.

Okay. So in terms of when you think -- I think you said that you think that maybe in the next few weeks, maybe fully enrolled. It sounds like, there has been a little bit of delay relative to initial expectation. So if you can kind of just talk about what the differences between I guess, initial expectation? And then how it’s just been delayed a little bit? And kind of what was behind that?

Phillip Chan

Analyst · Zacks Investment Research.

I don’t think that there was any delay. I think our -- what we have guided has been that we would finish the trial mid-year. And I think that, we’re on pace to do that. I think our goal is to try to get the data ready for presentation at or at least to talk about during the EX Conference in early October. And that is our interim goal. But I think that when you have a study, you expect to start off with eight centers or you expect to start off with all your centers right away. But practically speaking that doesn’t happen and for whatever reason, particularly contract negotiations between a clinical site and the company in any study is always complicated, and that takes time. And sometimes, there are delays, when study sites enroll, our last study center that came on board is the second top enroller in the study. So it is a -- things can turn around very quickly.

Brian Marckx

Analyst · Zacks Investment Research.

So kind of more administrative stuff than really anything fundamental to the actual design of the trial, I guess or anything related to that, is that fair to say?

Phillip Chan

Analyst · Zacks Investment Research.

Yes, that is fair to say. I think that we expect that in a fully staffed and with all the clinical sites onboard that this study can enroll extremely quickly. The patient population is there, we are not dealing with esoteric patients, we are dealing with what it amounts to 20% to 25% of the overall cardiac surgeries that are occurring every year in the United States. These are the complex cardiac surgery procedures. So there is 100,000 to 150,000 let's say of these types of surgeries that are happening every single year in the U.S.

Brian Marckx

Analyst · Zacks Investment Research.

Okay, great. Thanks a lot, I appreciate it guys.

Phillip Chan

Analyst · Zacks Investment Research.

Sure. Thanks, Brian.

Operator

Operator

We'll now take our next question from Jonathan Aschoff with Brean Capital.

Jonathan Aschoff

Analyst · Brean Capital.

Hi, guys. Congrats on the strong quarter. I was wondering what are your top at least let's say five or so distributor countries for sales to-date, can you give us that?

Phillip Chan

Analyst · Brean Capital.

We haven't disclosed to-date, Jonathan and I apologize. But I think that when you look at our territories the one just started first are typically the ones that are the strongest because they have had more time in the marketplace to gain market awareness of the product and to gain customers support and other things. And so we do see that time plays a very important factor in productivity.

Jonathan Aschoff

Analyst · Brean Capital.

Okay. More so than the size of the market in that country, at least now, correct?

Phillip Chan

Analyst · Brean Capital.

At least now, but I think that we have very large expectations for countries like India, Russia that are -- Russia is a big believer in blood purification for example. Even Vietnam have started recently that is another territory that has a lot promise, Middle East and others. So it is a combination of both.

Jonathan Aschoff

Analyst · Brean Capital.

Okay. And just to be clear, there wasn’t some large initial shipment to Fresenius that was a factor in the strong second quarter. Is that true there was or there wasn't?

Phillip Chan

Analyst · Brean Capital.

There was not, Fresenius had bought ahead of the launch as you would expect them to do and we do expect them to be contributors in the quarters coming up.

Jonathan Aschoff

Analyst · Brean Capital.

Okay. So clearly the better margins are driven by direct sales in second quarter?

Phillip Chan

Analyst · Brean Capital.

That is correct.

Jonathan Aschoff

Analyst · Brean Capital.

And how could refresh succeed in of itself yet not inform how to proceed there after at least in the eyes of the regulators?

Phillip Chan

Analyst · Brean Capital.

Could you just repeat that one more time please?

Jonathan Aschoff

Analyst · Brean Capital.

Yes, how could the trial that you are running right now succeed in and of itself but yet in the eyes of the regulators not be informative enough to allow you to proceed as you wish to proceed after this trial concludes?

Phillip Chan

Analyst · Brean Capital.

It's interesting the randomized controlled studies that are ongoing or that have completed in Europe including for example, the one in Medical University of Vienna, the University of Hamburg-Eppendorf as well as the University of Cologne and others. Those trials have focused predominantly on the mid -- on the mild to moderate risk cardiac surgery patients by necessity. I think their ethics committees using new product in cardiac surgery they wanted to establish safety and feasibility in a lower risk patient population. So REFRESH 1 is actually one of the first randomized controlled studies, in fact probably the first randomized controlled study that is looking at the use of CytoSorb in this high risk cardiac surgery patient population, where the event rate is for example, kidney injury is expected to be in the 30 plus percent range for example. And where the incidence of adverse events such as post-operative circulatory collapse, respiratory failure and other adverse events are quite high. So, so far as of the analysis of the DSMB in May that the device has been safe and in this procedure and if the -- and the primary endpoint again of the feasibility safety study is safety. And if it shows to be safe we expect then it will provide the evidence needed for clinicians throughout the world to use this in their complex cardiac serving patients where CytoSorb is expected to have the most profound benefit. So I think that's very important. And regardless of what happens in refresh and what whatever the FDA says that safety data will be very important. Because there are a lot of key questions that are being asked about safety and again REFRESH 1 is designed to look at an answer those questions. Now in the area of free hemoglobin reduction. This…

Jonathan Aschoff

Analyst · Brean Capital.

Okay, thank you Phil.

Phillip Chan

Analyst · Brean Capital.

Sure.

Operator

Operator

And we'll now take a question from Steve Brozak with WBB Securities.

Unidentified Analyst

Analyst

Yes, hello this is [indiscernible] on for Steve Brozak. How are you all doing?

Phillip Chan

Analyst

Hi, how are you?

Unidentified Analyst

Analyst

Good. Just have a couple of quick questions, regarding your FMC partnerships, to what degree did your direct to consumer -- your direct sales experience help inform their launch in the processes there?

Phillip Chan

Analyst

Yes I think Fresenius has known about our technology for many, many years and has following along with our market launch in Germany. As you know Fresenius is based out of Germany. And their people have been watching how CytoSorb has been rolling out. Obviously they had key contacts with all the -- most of the major key opinion leaders throughout Germany. And so they've been hearing how CytoSorb has been doing. And I think that has contributed to the establishment of this partnership and contributed to their expectations of what CytoSorb could do in their hands in their countries. So we clearly have not been leaving things to chance, I mean our goal is to make sure that has to do whatever we need to do to ensure that they're successful. And so there has been an ongoing dialog and ongoing transfer of information discussions with our sales team and et cetera to ensure that they have what they need to be successful. What I would say is that this is not the first time that their sales people have heard about cytokine reduction to treat clinical illnesses. Fresenius actually has a product called EMiC 2 Ultraflux, which is a high molecularly cut off filter that they had introduced a number of years ago as a technology to try to remove cytokines. But I think this is a very similar technology to SepteX by Gambro, but SepteX is not seeing much anymore in the critical care space. And the reason for that we believe is because it was not effective. And I think Fresenius partnership with us is I think a nod to our technology as a potentially superior technology.

Unidentified Analyst

Analyst

Okay, thank you for that. And I'm going to go back to something that was stated earlier in the presentation. The user conference that you had, it was mentioned that Fresenius was actually in attendance there. Could you tell us a little bit about the user conference? And because the bite of and the sort of roll out, a lot of it is contingent upon feedback from users and physicians. And so that it will be interesting to hear about the conference that you guys just hosted. And then any discussions you’ve had with FMC on how to -- have you had any discussions with them to expand the conference? Or how they can contribute or help to promote the conferences more detail?

Phillip Chan

Analyst

Sure, so in terms of our direct marketing effort, we held our third international CytoSorb users meeting in Brussels at the ISICEM Conference in March. And that was a third conference in roughly a year and half. And this particular conference brought in approximately 107 people from I believe 23 companies from around the world to discuss their experiences with CytoSorb and to share information on help us to treat. Now Fresenius sent 18 representatives to that conference. And so -- and I think this is a working conference, where there is a lot of open discussion, there is a lot of presentation of data. And I think Fresenius, I believe got a good feel on how CytoSorb was being used today. But that I think belies the more than 1,400 human treatments that have now been performed with CytoSorb, only a fraction of those are actually presented at this conference. And there is always more to learn, more to teach. And so I think we expect Fresenius to be active participants going forward in those conferences. But what I would also note is that, we have been participants in their conferences that they have held in critical care meetings as well. And at their invitation, our key opinion leaders and our people have been present there, been present in there booth device, in their booth et cetera to help support their marketing efforts. So I think all that is -- there is a good give and take between Fresenius and CytoSorbents. And we expect that to continue.

Unidentified Analyst

Analyst

Okay. Well, thank you for taking my call.

Phillip Chan

Analyst

Sure. Absolutely. Thank you.

Operator

Operator

At this time, I’d like to turn it back to management for any additional or closing remarks.

Phillip Chan

Analyst

Well, thank you very much everyone for taking the time today to get on the call. And we certainly appreciate your participation. If you do have any other questions, as usual please feel free to reach out to Amy Vogel at avogel@cytosorbents.com and we will try to get answers to your question where possible. Thank you very much, everyone, and have a good evening. Good night.

Operator

Operator

Thank you. That concludes our conference for today. I would like to thank everyone for their participation. Have a lovely evening.