Good afternoon, and welcome to the CytoSorbents 2018 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 our moderator, Jeremy Feffer. Please go ahead, sir..

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 Chris 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 March 7, 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 2018 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?.

Thank you very much, Jeremy, and good afternoon, everyone. Among the highlights from our earnings press release earlier today, we are pleased to report that we achieved greater 56,000 CytoSorb treatments delivered cumulatively, up from 35,000 a year ago.

We also recorded annual total revenue of $22.5 million and product sales of $20.3 million with a mix of strong direct and distributor and partner activity in a total of 53 countries. We have increased that number to 55 with the addition of Mexico and South Korea with our partner Fresenius Medical Care just recently.

We also achieved blended product gross margins of 74% for 2018, up 300 basis points from 71% in 2017. These blended gross margins are expected to rise to greater 80% on a quarterly basis later this year, propelled by the launch of our new manufacturing facility in June of 2018.

We are well capitalized with a healthy cash balance of $22.4 million at the end of 2018, providing sufficient working capital into 2020. Amongst the various highlights we were cited by the Deloitte 2018 Fast 500 as one of the fastest growing companies in North America for the second year in a row.

And again, we were added to the Russell 2000 Small Cap and the Russell 3000 indexes. In terms of an update of our clinical trials, our U.S. REFRESH 2 pivotal trial remains on track.

This is a 400 patient randomized control trial, multi-center study, targeting the reduction of post-operative acute kidney injury using CytoSorb during complex cardiac surgery. The trial has now enrolled 56 patients with a recent increase to 21 initiated clinical trial sites with another 8 undergoing startup activities.

We are targeting 200 patients enrolled total in the next 12 months and an interim analysis for safety and futility shortly thereafter. The REMOVE endocarditis investigator initiated trial funded by the German government is also making very good progress.

This is a 250 patient randomized control trial evaluating the safety and efficacy of CytoSorb to improve organ dysfunction when used intraoperatively during valve replacement for infective endocarditis.

Recently, the scientific advisory board and data safety monitoring board, recommended continuation of the trial following an interim analysis on the first 50 patients focused on inflammatory mediators including cytokines. The trial recently passed the midway point with 130 patients enrolled at 13 centers.

And finally the HemoDefend pivotal trial is a pivotal evaluating a point of care filter that is designed to remove non-infectious contaminates from transfused packed red blood cells. This pivotal trial has been delayed due to the sale and loss of key technical personnel at our main parts supplier.

However, we are working diligently with the new team at the supplier to reprioritize our project and we'll update investors on the timing of this trial soon. With that, I'd like to turn the call over to Kathy for our financial overview.

Kathy?.

Well, thank you, Phil, and good afternoon, everyone. For today's call, I'll provide an update regarding our full year and fourth quarter 2018 financial results including product sales progress. And in addition, I'll provide update around our working capital and cash runway.

So starting with Q4 comparative revenue results, CytoSorb's product sales for Q4 2018 were approximately $5.5 million, which represents a 27% increase over product sales of approximately $4.3 million for Q4 of 2017.

This increase was driven by an increase in direct sales from both new customers and repeat orders from existing customers along with an increase in distributor sales. The decline in the average euro to dollar exchange rate had a negative impact of approximately $189,000 on Q4 2018 sales.

Total revenues, which includes product sales and grant revenue was approximately $6.1 million for Q4 2018 as compared to approximately $4.6 million for Q4 2017, an increase of approximately 31%.

Q4 2018 gross profit grew from approximately $4 million, an increase of approximately 18% or roughly $600,000 over gross profit of approximately $3.4 million for Q4 2017. And our gross profit margins on product sales were 75% for Q4 2018, which is in fact the highest quarterly gross profit margin on product sales in our history.

This compares to 72% for the fourth quarter of 2017 and this is primarily as a result of the manufacturing efficiencies that were achieved at our new production facility. And we look at our comparative annual revenue results. Product sales for 2018 were approximately $20.3 million, a 51% increase over product sales of $13.4 million for 2017.

Both direct and distributor sales increases were the major contributors to our year-over-year product revenue growth. Also approximately $792,000 of this growth in product sales was due to an increase in the average euro to U.S. dollar exchange rate for 2018 versus 2017.

Our grant revenue was approximately $2.3 million for 2018, which is an increase of 27% over grant revenue of $1.8 million for 2017. And our total revenues including product sales and grant revenue were approximately $22.5 million for 2018 as compared to total revenue of $15.2 million for 2017, an increase of approximately 49%.

Our gross profit was approximately $15 million, an increase of $5.4 million or 56% over gross profit of $9.6 million in 2017. And our overall gross profit margins on product sales for the year were approximately 74% as compared to 71% for 2017. As I mentioned this is as a result of the production efficiencies that are being achieved.

Next we'll look at our quarter-over-quarter product sales. So Q4 2018 product sales of $5.5 million were a new record in quarterly product sales. And as I mentioned earlier, the fourth quarter 2018 reported sales would have been even higher if not for a negative impact from the decline in the average euro to dollar exchange rate.

That being said our track record of 26 consecutive quarters of year-over-year sales increases continue. Next let's look at our trailing 12 months product sales, which we've always said we believe provides the best representation of our overall sales growth.

Note that over the past three years, the company has achieved a 71% compound annual growth rate. And overall as you can see when you look at the chart, annual product sales exhibits a very strong growth trajectory and we expect continuation of this trend into the future.

I also want to say a few words about the achievement of operating break even on a quarterly basis, which we have defined as operating results excluding non-cash expenses and clinical trial costs. And in fact we came very close last year with a couple of quarters missing by only a few hundred thousand dollars.

And at the point, the reason that we are always talking about operating breakeven was that we want to demonstrate just how profitable our business could be at a relatively low revenue number.

In Q4 2018 however, we began to shift to a more aggressive growth mode, because we believe with faster top line growth and the high profit margins we are experiencing, which are expected to further improve in 2019, we can expect improvement in operating results and increased generation of cash.

One such example of this investment strategy was a recent expansion of our direct sales efforts from 5 to 10 countries with the addition of the direct sale territories of Poland, the Nordics and the Netherlands. Please be assured however that we will continue to manage our spend in a very responsible and deliberate manner.

And then finally turning to working capital and our cap table. As of the end of 2018, we remain very well capitalized with approximately $22.4 million in cash, which we believe provides a solid foundation for the company. During 2018, we were able to generate capital through the use of our at-the-market equity facility with Cantor Fitzgerald.

We sold approximately 1.5 million shares at an average sales price of $9.61, with net proceeds generated of approximately $14.1 million. The ATM does provide an efficient and cost effective way for us to raise funds for the company. We believe that this existing cash runway will allow us to meet our operating and clinical needs into 2020.

And just briefly on our capital structure as of December 31, 2018, we have approximately 36 million common shares on a fully diluted basis. And that concludes my report, so I'd like to turn things back to Phil at this time.

Phil?.

Thank you very much, Kathy. Historically, we have not given specific financial guidance on quarterly results when some of the quarter has been completed. However, in the short term we expect that Q1 2019 product sales will exceed Q1 2018 product sales. And then 2019 we expect to achieve blended product gross margins of 80% on a quarterly basis.

Longer term we are targeting significant and sustained sales growth and GAAP profitability. As we continue to see the massive unmet medical needs in critical care and cardiac surgery, we strongly believe that we are in the right place with the right therapy at the right time to make it happen and we appreciate your continued support.

That concludes our current prepared remarks and I would now like to open it up for a live Q&A session..

Thank you. We will now be conducting a question-and-answer session. [Operator Instructions] Thank you. Our first question comes from the line of Josh Jennings with Cowen & Company. Please proceed..

Hi, good afternoon, and congratulations on the 2018 results, quite a year..

Hi, Josh..

I hope to start off - thanks for the guidance for 2019 on the gross margin line. And I was just hoping to better understand where gross margins can ultimately get to. 80% is the target for 2019.

How should we think about the longer term gross margin trajectory?.

Sure. Well, thank you, Josh. And that 80% is actually a blended gross margin between higher-margin direct sales and lower-margin distributor and partner sales. And that implies that the direct gross margin is actually significantly higher than 80%.

But with that said, let me turn it over to Vince and Kathy to perhaps give a little bit more color on why we feel confident about achieving this objective this year and also what are some of the levers that can be pushed to be able to drive us potentially even higher. Vince? Vince, you may be on mute..

Yeah. Sorry about that. Hi, Josh. So we believe we can exceed the 80% gross margin and there are a couple of things that we'll factor into that. Obviously, it's product mix as Phil mentioned, the mix between direct and distributor sales.

But in addition to that is - also as we go to additional scale, going even beyond where we are now, we'll gain even further efficiencies. So it can go, I would say, significantly higher from where it is now. But we really need to go to the next scale to drive that or drive more direct sales.

Does that help?.

Thanks. It does.

And maybe as a follow-up, Phil, thinking about - and get the update on the Switzerland code and the value assignment process, have you seen any impact there yet or how you're thinking about the impact in 2019? And then also similar question, just on - earlier in 2018 the - expansion of the EU label to include reductions of bilirubin, myoglobin for acute liver disease and severe trauma, any impact you've seen or how we should think about going into - heading into 2019 with that label expansion?.

Yeah, so for the Switzerland procedural code, just like the German code, we're waiting for reimbursement assignment, so a value to be dedicated to that procedural code. That can take anywhere from 6 to 12 months to obtain. And we know that that's currently an active process right now. So when we know we'll definitely let investors know when that hits.

So the impact on 2019 financials is currently unclear. That being said, sales continue in Switzerland, even without that reimbursement designation, but we'll just have to see how 2019 turns out.

In terms of the label expansion that included the removal of bilirubin, as well as the reduction in myoglobin for the treatment of acute liver disease and severe trauma. The value of having this particular label expansion is really on reimbursement.

And that being said, we have seen a lot of interest in the use of CytoSorb as the next generation liver dialysis therapy, unlike existing liver dialysis therapies that exist on the market today that typically just remove bilirubin and bile acids and some other liver toxins, CytoSorb is very unique, because it not only removes those, but it also removes cytokines and other inflammatory mediators that are often the root cause of acute on chronic liver disease, these acute exacerbations that chronic liver disease patients often run into during the course of their illness.

And so, in terms of the impact on 2019 sales, it's too soon to say. But what we do know is that there is a lot of interest. A lot of people are looking to use this in substitution of other types of dialysis therapies. But we'll hopefully have a little bit more visibility on that later this year..

Thanks for that. And my last question on - congrats on the progress enrollment in REFRESH 2 - but actually, I wanted to ask about the REMOVE trial.

Could those results get you an indication in Europe? And then, also maybe if you could just talk to us about how you're thinking about the endocarditis indication and just sizing up that potential opportunity? Thanks a lot for taking all the questions..

Absolutely. Well, I think in Europe, we are already approved to actually treat patients undergoing cardiac surgery as well as endocarditis, because of our broad label which is - our technology is actually a tool to more cytokines, the cytokine absorber for use in any situation where cytokines are elevated.

And so, currently today, CytoSorb is being used on label for the - during open heart surgery for ineffective endocarditis, again, on label.

So that been said, what we expect out of the REMOVE trial if it is successful is just to be - just to drive really usage of standard of care in these types of surgeries and as we've discussed a number of times before, endocarditis surgery and valve replacement surgery is very complex, has a high expected mortality of somewhere on the order of 15% to 20% and is associated with a host of problems including hemodynamic instability during the procedure and after the procedure and a host of other adverse events that can often be fatal.

And so with the blooming opiate crisis that this issue has gotten much relevant. In the United States the incidence of infective endocarditis has historically run on the order of 10,000 to 15,000 cases a year.

However, with the opioid crisis it's really being viewed as a growing epidemic with many major hospital centers doing 100 to 200 of these valve replacement endocarditis surgical procedures, valve replacement surgical procedures every year. And it's only becoming a more and more of a problem.

In fact The New York Times did an article on this exact problem of infective endocarditis and the recidivism that often occurs in patients who get one surgery for endocarditis, but then continue injecting IV drugs and wind up getting a second infection on a prosthetic heart valve, which - where the mortality is even higher than for native valve.

And they estimate that the cost per case is approximately $150,000 per case. So using a product that is several thousand dollars to try to reduce a lot of the complications of this illness could well be worth it.

And for that reason, we believe that it can become - if the trial is successful and if we have other successes and other studies that are ongoing, we believe that it can become standard of care relatively quickly..

Great. Thanks again and thanks for the clarification on the endocarditis being on label..

Thank you. Thanks, Josh..

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

Hey guys. Thanks for taking the question.

So related to the Fresenius collaboration expansion, I'd like to see if you could provide some more clarity on the timelines for launch in those countries? And then also what kind of market opportunity those two present, given the large combined population of over 180 million?.

Thanks, Jason. Chris, would you like to take this one..

Yeah, sure. Thanks, Phil. Hi, Jason, this is Chris Cramer. Thanks for the question. For the first question about market clearance, I think that each country - I think you are referring to Mexico and Korea - South Korea..

Yes. You're correct..

Each country has its own - okay. Each country has its own health authority process and timelines for registration and currently our regulatory experts are reviewing the requirements and we started to compile the registration dossier in collaboration with the FMC regulatory teams.

And the other think I'd say, the review time for the health authorities can be variable, but we expect to have more feedback after the submission of these dossiers and I think once we have the feedback from the health authorities we'll be sure to pass it along to everyone. So I think that's in process as we speak.

As far as the opportunity Korea, Mexico are large and strategically important markets for CytoSorb and together they represent about 181 million people with about 129 million in Mexico and 52 million in Korea.

And in each country there is a large unmet need and burden of disease, hundreds of thousands of lives are lost from hyperinflammatory conditions due to lack of effective therapies each year in both of these countries as such we believe there is a critical role for CytoSorb.

In particular we see a growing demand for CRT treatments for acute kidney injury and cytokine removal in acute care. On top of that FMC has a very strong and motivated commercial organization in both countries. The partnership itself is fully backed by senior leadership at the highest levels in both the FMC Mexico and FMC Korea organization.

And this ensures that the CytoSorb sales and marketing efforts are appropriately resourced and supported. FMC has a strong commercial presence and organization in both countries with sales, marketing and medical affairs resources clearly introduced new therapies.

And we have assigned dedicated international sales resources to support the market launches. I think we are very confident following market clearance, we'll see a strong market launch coming from both FMC sales teams in both countries..

Yeah, thank you. And then just as a quick follow up, I'd like to see, if you guys could talk about some of the regulatory pathways and your development strategy for expanding the used cases for CytoSorb. I know you guys discussed on a previous question that label in Europe is pretty broad for pretty much any situation where cytokines are elevated.

So I'm wondering how you would position CytoSorb, the treatments for something like, say cytokine release syndrome and CAR T, would you look at additional trials to prove its usefulness in that indication or would this be more of a marketing effort..

Yeah, I think in terms of that particular application, we are seeing a lot of strong interest both in the United States amongst leading investigators in the CAR T cell immunotherapy space to demonstrate the potential utility of CytoSorb and treating cytokine release syndrome, but with the approvals of Kymriah and Yescarta in the European union, we've been in close contact with some of the leading centers that were involved in those approvals in Europe.

And there is also very strong interest to evaluate the therapy. At the moment our experiences is limited in the treatment of cytokine release syndrome specifically. Although, we've mentioned before that we have more than a dozen cases now of the treatment of secondary HLH or Haemophagocytic lymphohistiocytosis, which is very similar to CRS.

And in fact, recently in December, there was a young patient 13 years old with refractory acute lymphocytic leukemia, who actually - was not on CAR T cell immunotherapy, but was being treated with biologics therapy and developed the cytokine storm, essentially a cytokine release syndrome that persisted for weeks and sent this person into multi-organ failure with an IL-6 greater than 200,000.

And again, us, on the phone should have an IL-6 of less than 10, so this was true cytokine storm. And in fact with the treatment of CytoSorb, they were actually able to bring her rapidly out of cytokine release syndrome and she went on to recover.

So we feel very confident that this is a true application for us and as that market develops, we hope to simultaneously gain further experience and be able to report that to the public..

Okay. Thank you very much for taking the questions. And congratulations on the quarter..

Great. Thank you very much. Thanks, Jason..

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

Hi, Phil, congrats on the quarter and the year. Phil, I think you previously - relative to HemoDefend, I think you had previously mentioned that you had hoped if everything went well that you could start a pivotal study this year in Q2.

Can you talk about how the manufacturing delays may impact that timeline?.

Sure.

Vince, would you like to take that question?.

Sure. Hi, Brian, this is Vince. So here is what's happened last several months. We've been experiencing delays from this key part supplier that's responsible for actually all the HemoDefend parts.

They were recently required by another company and the results of that acquisition, they actually - as it happens in many M&A activities and number of the key personnel were actually let go that were working on the product and this has impacted the timeline.

So in revising kind of our tables and forecasting we are probably instead of those first half we're looking for a second half submission, I've been in constant contact with these folks and obviously, even in the acquiring company to get them to focus on our project.

So just talking to one of the senior engineers today actually, we're hopeful that they will be getting these parts to us shortly to be able to carry the project forward, because it's really, because it's really, the polymer is ready, it's just been matter of getting the parts now.

So it's really going to be more of a second half type event with respect to submissions to the FDA..

Okay. And then in terms of Poland and the Netherlands, in terms of your direct sales efforts.

Has that already launched or is that in process of launching? And then do you have a sense of how many people you need to add to service those territories?.

So Christian, would you like to take that one?.

Yeah, sure, Phil.

Yeah, as you said we have added a number direct sale territories and as always, we start with a relatively small number of direct sales reps and building the relationships to the extent of the KOLs and so on and with the growing business, obviously, we'd be dividing territories and adding more sales reps to get to the same variety of indications as we - so for example, in Germany.

So in all the countries except Poland we have already started the activities and the sales have started to have an impact on the results. In Poland we are having the team already assigned and we are going to start in Q2. Hope this answers the question..

Yes, it does. That's it. That's all I had..

All right, thank you..

All right. Thanks, Brian..

Thank you. [Operator Instructions] And thank you. Our next question comes from the line of Sean Lee with H.C. Wainwright. Please proceed..

Hi, guys. Congratulations on a great year and thank you for taking my question..

Sure. Thanks, Sean..

My first question is on the REFRESH study. In the opening remarks you said that you expect to reach 200 patients enrolled in the next 12 months, which will trigger an interim analysis.

So could you provide a little more color on what this interim analysis would comprise of? Is it just a the DSMB position or do we get any data releases and would they look at just safety or both safety and efficacy?.

Thanks, Sean.

And Eric would you like to take that one?.

Sure. No problem. Sean, thank for the question. The interim analysis had 200 patients. It's intended to - we have an ongoing DSMB I should note so that we are continuously looking at safety throughout the program.

We also have a clinical events committee because we really want to make sure that we are getting as much as possible a uniform blinded assessment to events to minimize the potential risk of bias that may come from sites.

We got what will be examined at the time of the interim analysis, we'll be looking at both safety as well as efficacy, but we - if we continue on our expectation is not to release any efficacy data nor to avoid potentially contaminating the studies conduct, since it, obviously becomes very difficult that you are seeing a positive result to justify putting patients in the control arm.

We do have the capacity depending upon the strength of the results to potentially terminate the study for a very positive result, but that would require a very strong p-value that we have to then discuss about DSMB to indicate whether we felt that it was appropriate to continue patients on the controlled group.

Does that answer your question?.

Oh, yes. That's okay. Thanks for the additional color. My second question is on the split between distributor and direct sales and how each part is growing.

Could you provide a little bit more color on that, like, what percentage of your sales came from the direct sales last year versus distributor and how does that compare to 2017?.

Sure.

Kathy, would you like to take that one?.

Sure, Phil. So Sean, one thing that I would tell you is if you look at our Form 10-Q, we have a very robust revenue disclosure that breaks down the direct sales from the distributor sales, so you can use that to exactly answer your question. I will say that we've had double digit increase in both direct and distributor sales..

I see.

Are there any territories that were going particularly well or that any that you think could definitely do a bit better in 2019?.

Yeah, I guess - yeah, so I think also just to add to Kathy's comments.

I think what you'll see is that direct sales accounts for roughly 72% of our total product sales and the balance is for international distributors and partners and that's remained fairly constant over the past couple of years, it's roughly been three to one, right, three quarter of our sales are direct and a quarter is distributors.

And the fact that that ratio has been stable suggests that both buckets, both the direct sales as well as international sales occurring at roughly at same rate. So that being said there is always more work to do and we certainly have a lot of countries that are outperforming and doing very well and we certainly have others that could use some help.

And I think that part of the growth strategy in 2019 is to really go back and put a significant amount of effort and resources towards making sure that all the drivers of our revenue are working well. And so that includes not only our direct sales, but also our international sales as well.

And I think that we remain very committed to this hybrid sales model where we are mixing direct and indirect sales and we hope to demonstrate how that's working in 2019..

I see. Thanks for the helpful response. That's very help and thank you for taking my questions..

Right, thanks, Sean..

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

Good afternoon. Thanks for taking my questions. And my apologies I was hopping between calls and I did miss the beginning of the Q&A, so just let me know if it was answered, I'll go back and review the transcript.

But just - for the first question, as far as the total distributors that you are currently working with and countries you are in, I know you historically had two numbers, one being the number of countries that you are actually selling into and the other being, country that you established partnerships in, but aren't actually selling product yet in.

Can you give me the breakout of what that is?.

We haven't broken that out for a while, Andy, and we don't have that number handy. But, I guess what I would say is that the majority of our distributors have been contributing to revenue.

We have certain countries that are still - we're still working on registration for example, like Israel and of course the new territories like Mexico and South Korea. But I would say that the majority of the countries have been moving along and we have strong expectations for them in 2019..

Okay, got it. And just looking at the history between a direct sales and indirect sales through distributors, strategic partners.

Obviously, many more countries are going through the partnership route through the sales channels versus their direct sales, but the overwhelming majority has always been primarily at Germany and the surrounding regions that you sell directly.

How do you bridge that gap, so that the other countries are able to fill in or at least get somewhat closer to the direct sales countries? And is it related to more data or it's just a situation where it's never really going to get there all the way or likely at least? And you're more likely to start investing in new direct sales opportunities across different regions and similar to what you announced earlier in the week?.

I think that the direct sales benefit from the fact that we as a company have a singular focus, which is the sale of CytoSorb. We have a lot of resources and a lot of experience from our direct sales territories to be able to bring to bear on those markets.

And of course those - the margins are significantly higher in our direct sales territories than they are in our indirect and distributor and partner territories.

That being said, distributors, we benefit from that - from distributors and by leveraging their infrastructure, their contacts within various countries, and of course, give up some margin for that benefit.

But there we do not have direct contact with the customers and distributors often have multiple products in their product line that they are also trying to sell. So, we typically don't have the singular focus that we benefit from indirect sales.

That being said, we are actively working to make sure that that channel is humming along and we do a lot of training. We have a lot of communication with these sites, with these distributors and we work actively to make sure that the data that we have is available to them for their sales process.

So we don't ever expect them to perform the same way as our direct sales territories, but it is a way to blanket the world, so to speak, again, we are now in 55 countries around the world without incurring the massive infrastructure costs that are associated with that type of coverage..

Okay, got it. Just a couple of more quick questions from me, so just from the competitive landscape, Baxter's oXiris product fairly recently got approval for cytokines as well.

I was curious as to how you're viewing the competition and then has there been any sort of any material impact that you've noticed through that? And if so, what are you essentially trying to do to counter that at this point?.

I think of the various competitive threats out there. Baxter as the one of the leading dialysis players in the world in critical care is probably the most relevant.

Of course, we are partnered with Fresenius Medical Care, which is the largest dialysis company in the world and the number one or number two player next to Baxter in critical care all over the world.

That being said, Baxter acquired Gambro, which was the second leading dialysis player in the world, a number of years ago and inherited their acute care product line, which included oXiris Septex and a number of other acute care products. oXiris was launched by Gambro back in 2009 as a - initially as an endotoxin filter.

They had actually marketed another product called Septex, a high molecular weight cut off filter for the removal of cytokines. But Septex was ultimately not a successful product and ultimately is not being actively marketed anymore.

And oXiris also, despite being marketed for gram negative sepsis as an endotoxin filter, was also not highly successful and always in the shadow of another product called Toraymyxin which was - and I believe still remains the leading endotoxin removal filter out there.

But Toraymyxin has had issues because of a number of failed pivotal studies demonstrating no mortality benefit of endotoxin removal.

That being said, recently, I think the expanded Baxter through some in-vitro data, expanded the label of oXiris to include cytokines, and all I would say is that just because you have a label for reduction in Cytokines doesn't mean that it will actually work.

And I think the clinical - the very long term clinical experience, 10 years of oXiris being in the market is perhaps indicative of the efficacy that the fact that it has not really taken off as a therapy is a reflection of its efficacy.

And so, I think, yes, it creates some market confusion, some market noise, but I think that as that plays out, I think that we'll see how we deal against them, so..

Okay, great, great. And thank you for that color. And last question and I know the previous caller kind of touched on it a little bit. But I'm just curious as far as with Kymriah and Yescarta, starting very early to be used in Europe. I think there is total of three or four patients last year treated.

Is there a way for us to think about how you're positioned to be utilized alongside them for CRS? I mean, are you partnered with any of the hospitals or health centers that are actually capable at this point of even providing the treatment class to patients yet or has there been a discussion that you can share, to provide color on it?.

The short answer to that is yes. In terms of collaborations rather than partnerships, I think that there is a lot of interest to collaborate with us on clinical studies, looking to evaluate CytoSorb as a therapy to treat cytokine release syndrome, particularly as a rescue therapy when standard treatments fail like tocilizumab and steroids.

We continue to maintain that steroids could potentially be harmful in patients undergoing CAR T-cell immunotherapy, both for the CAR T-cell immunotherapy itself, but also potentially for the patient.

And at the end of the day, what we're looking to do is evaluate this in the clinical trial setting as a way to establish the value of this therapy in this particular indication, which again, we have a lot of clinical - there is a lot of reasons why we believe that this could be successful..

Okay.

But you are partnered - or not partnered, some of your hospital customers are actually hospitals that are currently able to provide CAR T therapy to patients, because I know there is an issue with a lot of facilities not actually being properly equipped or certified, registered to be able to actually provide that service?.

Yes, that is correct..

Okay, wonderful. Thank you so much for answering my questions and best of luck going forward in 2019..

Great, thank you, Andy..

Thank you. And at this time, I would like to turn it back over to management for additional or closing remarks..

Well, thank you, everyone, for participating in today's call. If you have any questions, please reach out to Jeremy Feffer at jeremy@lifesciadvisors.com, and we will try to reply to your questions where possible. Thank you very much, everyone, and have a good night..

Thank you. That concludes our conference for today. I'd like to thank everyone for the participation. Have a great evening..