CTSO - Earnings call transcript Q4 2018 | Cytosorbents Corporation

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Operator

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. sir. ahead, go Please

Jeremy Feffer

and results Welcome conference Rory, financial CytoSorbents' and operating call. good you, to afternoon. XXXX Thank

Joining me Chief Chris Germany; today Mortensen, Vice Chan, Business Bloch, Chief President from of Financial Cramer, Chief the company Officer Chief and Christian Development. President; Vice are: Medical and of Officer; President Vincent Steiner, Dr. Sales and Capponi, Officer; Operating Dr. Kathleen Executive Officer; Eric Dr. Senior Phillip from Marketing

Litigation additional remind Dr. make I statements Act Actual for uncertainties company's forward-looking during more Therefore, listeners with today. to the of to results of risks include response as XXXX protection these to over I'd Harbor Before remarks which company claims Securities forward-looking Management under to may that to forward-looking call may contain market management in Chan, to refer Reform we prepared turn differ subject X, change. as March your no you the and the from therefore, questions estimates we in results contained performance future Safe detailed assume management's projections of XXXX. projections statements in and statements the uncertainties. as like to and the Private the call represented may discussion and SEC. Any today, in obligation conditions today company's future a update discussed the these risks by the filings are

covering an presentation Chan have we the and Bloch. today's During by will for overview Dr. financial operating call, and Ms. highlights XXXX

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

Phillip Chan

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

with million of countries. strong and million of in a distributor and direct product activity We and XX $XX.X annual $XX.X revenue total of recorded partner mix also sales of total a

number South Korea with with increased addition recently. have Medical XX of that the We to our Fresenius just Care partner Mexico and

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

various of fastest end are We were sufficient year the balance the working $XX.X Russell with by of to North XXXX, we America Deloitte one And as XXX XXXX the XXXX for growing added again, highlights row. a we Small XXXX Cap Fast the the cited of second Russell healthy well companies capitalized at capital the providing in and indexes. in a cash were Amongst XXXX. million into the

clinical an In reduction trials, is update randomized REFRESH on clinical patient the remains post-operative trial now a terms of XX initiated targeting our with X activities. control track. increase This acute surgery. sites our kidney CytoSorb a during trial cardiac multi-center study, injury of U.S. enrolled to complex startup patients The trial, another trial X of pivotal XXX undergoing with recent has XX using

packed endocarditis. and trial scientific replacement board Recently, organ patient for safety XXX a improve infective monitoring also futility advisory intraoperatively by used randomized CytoSorb the the from XX enrolled patients progress. loss XXX point funded an This efficacy passed evaluating contaminates government the trial during at making The an next of focused is XX analysis inflammatory and The XXX targeting patients evaluating personnel total good initiated cells. in shortly investigator that on of patients months the to data at following mediators pivotal remove our pivotal when safety for continuation the key a finally trial point very endocarditis and XX including enrolled parts interim are first REMOVE red technical cytokines. and German And safety board, interim trial to trial analysis delayed trial control centers. dysfunction and valve the recently recommended HemoDefend care of We the main is thereafter. with designed on non-infectious of is is the filter a This blood supplier. to sale been pivotal due transfused the has midway

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

Kathleen Bloch

you, good thank Phil, and Well, afternoon, everyone.

provide For and And results regarding working full update progress. and provide cash including today's runway. in I'll addition, product quarter update an financial sales our our fourth year I'll around call, XXXX capital

look both growth facility. XX%. our quarter of sales history. approximately euro starting direct which on sales driven XXXX a from to revenue $X approximately is for XX% is customers profit QX million were the represents new from of major and exchange distributor we grant were year-over-year for product profit approximately grew QX our XXXX at were in increase of results. as which XXXX. increases QX sales approximately $X.X approximately sales annual a our fourth million sales product QX our rate of XX% $X.X in Product result approximately with direct XXXX. So million increase $XX.X compares XXXX. CytoSorb's comparative gross primarily results, increase from And an were for product of of existing sales increase had revenue an dollar QX that gross XX% along compared manufacturing an sales on XXXX $X.X decline new million, increase growth. XX% for product in approximately as million, XXXX, for for a product this revenue over at QX The includes impact to profit increase a to approximately profit on the euro U.S. XXXX $XXX,XXX XXXX QX $XXX,XXX to rate orders roughly revenue XXXX the was sales. comparative for negative average XXXX. million, for by to revenues, sales or product versus million This an efficiencies XX% Total $X.X and which of to $XXX,XXX of achieved in this And over in our QX production the contributors repeat sales XXXX, gross in and XXXX product million approximately Both an sales average exchange of increase of QX was gross sales. This the customers Also fact $X.X in increase dollar quarterly highest were the approximately due $XX.X with for and product for approximately distributor margins margin over was

Our approximately which to sales revenue for including of million total million XXXX. And XXXX, for $X.X revenue million XXXX, increase as an was our approximately increase million grant an of XX% product and is $X.X of revenue $XX.X of over revenues revenue $XX.X compared were total for approximately grant XXXX grant for XX%.

of were approximately on for $X.X profit XX% Our to was of gross gross product overall XXXX. increase approximately profit profit our in XXXX. million, the sales over margins million or XX% year million for $X.X as gross And XX% $XX compared an

this of as that a mentioned As I result efficiencies are the achieved. production is being

sales. quarter-over-quarter product we'll Next at our look

quarters in earlier, product So of XX the as if track a consecutive a new $X.X being have mentioned That from And fourth the increases record dollar would of sales. I quarterly our not sales higher quarter record million were the XXXX euro been for to product sales QX impact average negative even continue. sales of said decline in XXXX rate. reported exchange year-over-year

a a our however be cap very our And this demonstrate rate. was and strong of let's years, that achieved operating overall to said direct expect can QX chart, XX% the sales strategy Next as of overall the to I that business you a growth. could break few basis, relatively compound which generation want annual sales with believe when that even clinical on line spend the continue will future. Note as improvement continuation company we to number. and example and we our of we which deliberate expenses look say missing finally the non-cash we table. assured want expansion into the operating the also top a results a product and breakeven results growth a and we responsible over mode, XX improve we capital profitable further margins see has the about defined excluding such the of trial our our past words a Netherlands. operating sale began operating at annual working be to have quarterly investment year achievement turning low point, because addition quarters experiencing, reason XXXX, One product this few costs. recent In profit X growth sales exhibits XX more always look And the aggressive however, expect shift the of faster talking close growth couple and you how dollars. representation a a and And XXXX a at can in from then just provides trajectory to of with hundred about territories of revenue Please last was the direct the manage best efforts in always we we trend are trailing high And the very we are expected thousand manner. months in in countries to to sales, Nordics three increased we've are fact at Poland, we growth at we cash. which to our believe of came that with only by very of

in As for cash, remain approximately of well company. solid foundation of the capitalized with we believe very we end $XX.X XXXX, the which provides a million

runway to sold believe of existing of X.X Cantor turn I'd meet XX this Phil on our an for XXXX. XXXX, ATM have to with facility and capital XXXX, at allow briefly our were of Phil? us to During us average price into Fitzgerald. provide XX, the And so at sales able this December way with we an and company. time. operating through net a effective to my shares approximately common We generated diluted shares at-the-market $XX.X cash proceeds approximately cost use does the like on to concludes for raise million generate million just back structure $X.XX, things capital basis. we our equity The clinical of fully that efficient that And million. funds needs report, approximately We will as

Phillip Chan

Thank have on financial much, quarterly of quarter Kathy. results guidance you has not been specific when the given completed. some Historically, very we

basis. quarterly that expect And then gross XXXX growth term blended sales. are QX product and short and of QX the XX% on we we However, a product product in XXXX XXXX achieve GAAP sales term Longer expect exceed sustained will sales to we significant profitability. targeting margins

time we As we needs unmet the cardiac with continue now like concludes would make strongly prepared to right appreciate it care the we session. right the we to in and are in critical live for that open massive place to continued medical happen remarks a therapy our see Q&A current support. I up the right That at and your surgery, believe and it

Operator

Thank you.

question-and-answer conducting [Operator We a Thank session. will you. now Instructions] be

question comes proceed. Josh from with Please Cowen of first & the Our Jennings Company. line

Joshua Jennings

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

Phillip Chan

Josh. Hi,

Joshua Jennings

off the can line. How was XXXX. to gross the term think to. guidance is trajectory? about hope the margin thanks hoping target the for I we gross for margin gross where ultimately to XX% should just on margins get longer XXXX understand start for better I And -

Phillip Chan

we and direct And thank direct even may and little to be it that you on gross lower-margin this partner year said, drive blended is sales. you, to Vince feel higher. are color also give can and mute. a Well, Vince, us sales what But more and about margin implies let achieving Kathy some bit of that objective be actually turn potentially And me with Sure. Vince? this the over significantly pushed why XX% gross to on a levers distributor perhaps the be to that confident that able higher actually XX%. than higher-margin is Josh. between margin that

Vincent Capponi

Yeah.

Hi, that. Josh. about Sorry

now, we to product a XX% of we couple the is even things going believe further beyond But where in we mentioned, Obviously, as are direct there So as it's can go gross Phil margin distributor the scale, sales. that exceed addition we'll even mix gain and factor efficiencies. that - additional mix are that. and to also between we into we'll

that or help? can go, drive scale to direct I Does more But is So that from we significantly would sales. where say, it need really to now. higher drive the to it next go

Joshua Jennings

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

Phillip Chan

process for the procedural And so code. to reimbursement obtain. from currently now. the anywhere Yeah, German waiting That be XX for assignment, can to we like to take months value dedicated that know an so that active X Switzerland just a that's right code, code, we're procedural to

when that know we know hits. we'll when investors definitely let So

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

generation reimbursement. it included these interest patients in really inflammatory mediators other this the lot of label as is disease often dialysis acute reduction that removes seen remove bile exacerbations also liver and as and next And chronic expansion the the typically use of cause liver their In existing and because therapies the severe course trauma. that said, liver unlike liver is in into disease, expansion but of and bilirubin not some label treatment illness. market unique, on the root liver removes for exist on as we removal disease are that only today on of terms the liver being just have well toxins, particular CytoSorb acute therapy, the bilirubin, having of dialysis that run of acute of those, chronic that it other that CytoSorb cytokines often a during of value very acids The the myoglobin the

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

Joshua Jennings

REMOVE just a actually, in an Thanks for X I maybe also get Europe? about that. if just the REFRESH opportunity? And question - up progress how could trial. about last to for results the that on the us - you Thanks about to talk my indication And wanted thinking enrollment you then, taking congrats ask you're on but endocarditis sizing lot the in Could questions. all indication potential and those

Phillip Chan

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

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

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

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

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

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

believe the worth could if using are And illness that and become So is care trial standard well several that quickly. complications that to a of product a become can studies is that ongoing, it lot the that other to relatively of be we successes have reason, we reduce dollars we if successful and it. can of for other this it thousand try - believe

Joshua Jennings

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

Phillip Chan

Josh. Thanks, you. Thank

Operator

you. Thank

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

Jason McCarthy

for Thanks guys. taking Hey the question.

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

Phillip Chan

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

Christopher Cramer

Yeah, the sure. is Jason, for Cramer. question. Thanks, Phil. Thanks Hi, Chris this

each you clearance, For think the - South I market Korea. think are first Mexico referring and question that about - Korea I to country

Jason McCarthy

Yes.

correct. You're

Christopher Cramer

for from the has but be health feedback expect and registration for Each has sure to the it the more registration Each health the in compile to we think time be - started these feedback dossiers authorities review everyone. the the authority think we'll the other say, along to have FMC of submission process to okay. and I'd I the pass country its can authorities after we And health have variable, once we currently the requirements its dossier are teams. and regulatory regulatory experts with own and country own collaboration our timelines reviewing

think that's So we process in I speak. as

a On lives assigned as a they Mexico opportunity and strong in in Mexico from there of both and cytokine commercial the hyperinflammatory CytoSorb need and for in countries sales, in countries of to organization. strong treatments we and ensures for CRT year that has marketing burden Korea far of thousands and FMC care. to strategically is kidney and are And As CytoSorb. are both motivated we Mexico FMC FMC countries. efforts top lost of introduced both as hundreds of XX together presence markets with acute is both FMC particular each important leadership medical XXX the dedicated people organization and in fully role about these appropriately resourced a resources and and removal represent therapies. in new that organization launches. Korea. conditions we supported. senior sales backed have international itself a highest see in unmet market due are about commercial CytoSorb is demand the marketing each such disease, sales And and large by believe levels large with million Korea, of has growing injury lack at And therapies a in million the In affairs support effective the very The acute and XXX country for resources clearly partnership critical for there this million

market see countries. a launch I think clearance, confident we coming from very both strong in FMC market both teams sales are we'll following

Jason McCarthy

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

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

Phillip Chan

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

And cytokine weeks should a the less into person cytokine who lymphohistiocytosis, And phone more the so Although, CRS. therapy patient XXX,XXX. - her before with fact similar were an secondary she with have T we've to was of fact, which very treatment mentioned syndrome cell of treated XX have was true on not Haemophagocytic And a immunotherapy, acute out sent cytokine and years recently than greater release storm. we with of went dozen the a biologics for lymphocytic refractory rapidly multi-organ treatment than old that was on essentially was now the in IL-X of CytoSorb, and cases HLH actually of and in on failure to being this actually leukemia, syndrome able storm, than developed CAR there December, again, in is this that or XX, release young with persisted cytokine recover. to us, but they an IL-X bring

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

Jason McCarthy

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

Phillip Chan

you Thanks, Thank Great. much. very Jason.

Operator

you. Thank

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

Brian Marckx

that you the a QX. timeline? about study in to this year the if the on Can you may you year. impact had I HemoDefend, Phil, you relative think delays I well manufacturing could talk quarter and that think mentioned everything pivotal had previously start hoped - that congrats went previously you how Phil, Hi,

Phillip Chan

to Vince, like question? take you Sure. that would

Vincent Capponi

Hi, is Vince. this Sure. Brian,

key part supplier by results several the parts. recently last happened actually and were happens what's in that's of another the We've M&A from has all of company this activities as They the personnel on that is go required that were it and the HemoDefend this many number product timeline. responsible let actually here the they been and So were months. experiencing key working actually for delays acquisition, - impacted

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

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

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

Brian Marckx

Okay. territories? add And direct service in already in to launching? of terms that people And need Poland how or terms Has then sense is sales those that of of in efforts. the to many and you process your of you have then launched Netherlands, a do

Phillip Chan

So Christian, like one? to you would take that

Christian Steiner

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

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

Brian Marckx

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

Christian Steiner

All right, you. thank

Phillip Chan

Brian. right. All Thanks,

Operator

you. Instructions] [Operator you. thank Thank And

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

Sean Lee

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

Phillip Chan

Sure. Sean. Thanks,

Sean Lee

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

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

Phillip Chan

Eric And you take that one? Thanks, would to Sean. like

Eric Mortensen

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

what the very to arm. to a much sites. very uniform a assessment your to it bias that group. the terminate felt have also to are the events since was make to study difficult of because that it, control really clinical on we that patients discuss as We results require a sure answer seeing putting are potential We that as we continue from indicate studies committee risk to would may events we to have result strong got that p-value but that possible the you minimize come DSMB want data getting obviously blinded conduct, will interim release be have continue any be to potentially we Does result, justify both at for patients at the well to the examined expectation analysis, we we the then as that time safety on We but not is if of to about efficacy, our becomes positive very looking as whether nor - avoid the controlled we'll a appropriate contaminating the upon do in positive of a capacity depending the potentially strength question? efficacy

Sean Lee

what distributor to came additional on a and between each of okay. bit Oh, your more That's sales direct the on little that, Thanks percentage and color. XXXX? how sales the is like, direct provide you year split growing. sales is yes. from part Could versus My second distributor last color question and that for compare how the does

Phillip Chan

one? take to like you would Kathy, that Sure.

Kathleen Bloch

Phil. Sure,

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

Sean Lee

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

Phillip Chan

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

one, accounts what that occurring quarter is fact suggests both well as it's buckets, past constant total is been the think rate. and is quarter roughly sales our for roughly the couple sales years, of product that's at that partners the XX% as direct sales see that international been distributors. has our of over same and balance both the direct a sales international stable and remained fairly direct right, ratio three distributors I are And that to roughly of you'll for and at three sales

I have to countries So that being others work that very certainly outperforming more and strategy really the certainly and well. that and and in of could to of we all are resources a drivers said that our doing always help. towards is use some do working we have lot amount there significant And that is and effort of are sure revenue put well the part think XXXX growth of a back making go

we And and to sales, as model includes in to direct that I that's only our we sales so remain and well. indirect but direct very we where that also working hope are sales committed our how think XXXX. hybrid mixing not international this sales And demonstrate

Sean Lee

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

Phillip Chan

thanks, Right, Sean.

Operator

you. Thank

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

Andrew D'Silva

apologies the distributors Good the number into Can transcript. know and it back far as of you for questions. afternoon. Q&A, with I that answered, question, between established me the you just for first so and was hopping yet calls beginning did working as I'll I total selling in, And the in, just you my two that but country if But of other taking let review the - are being, me historically being the Thanks you and go had numbers, I countries the my was in. the are actually you that of that partnerships one selling give aren't you know are countries and what is? actually product currently miss breakout

Phillip Chan

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

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

Andrew D'Silva

least? at least to direct countries? or just closer to or really able there different to opportunities but going investing to to it. somewhat history that data similar to strategic versus sell directly. new it's primarily you more route the And announced Obviously, is way got bridge it many the at sales countries going sales the always countries likely at sales it's their get And in and situation you're distributors, are gap, direct sales, the so and do Okay, direct overwhelming been are a Germany the the get regions more related sales across the How other through And looking partners. that surrounding and you between channels more likely never through all partnership what has you start that through the just or the fill majority in regions week? at sales direct in where a indirect earlier

Phillip Chan

I have singular think the focus, is the a benefit of direct the company that from as we fact a sale CytoSorb. which that sales

within bear territories We in a are experience they are have of sales a our territories lot to to resources than and and and bring line territories. sales higher product countries, those distributors give are said, have with distributors, to their customers margins not But up able and trying benefit. our That that course, sell. direct we lot direct they infrastructure, and products multiple in the have also And of often do - we from some benefit leveraging markets. various - contact from for distributor being and course indirect that significantly by contacts the to of be partner in margin direct on that their of those distributors from their our there

focus of don't said, indirect typically we from training. a actively that the benefit to So, that sales. have we lot and that are along working is sure humming we being we make singular do That channel

that lot communication to them with a sales sure available and the we with actively for to have their we process. is these of that work have sites, these We distributors data make

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

Andrew D'Silva

Okay, got it.

has trying landscape, that? for that couple do are material then from from Just viewing that fairly impact through you counter the quick sort was approval recently to so any a noticed competitive got And essentially questions product of me, and at what curious so, well. I if of to this point? how more competition the oXiris any there you've been just Baxter's cytokines as you're as to

Phillip Chan

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

care launched negative and high Gambro actually But is player Fresenius course, ultimately which always as called filter, or Septex, another Baxter marketed of products. an the we successful removal shadow and the an endotoxin which for called - remains in Toraymyxin of had believe the leading critical care not because in a has issues in one the there. product highly a - acquired still dialysis was product Toraymyxin I the filter But filter. marketed out of and weight include and to That some being and expanded data, all Medical not despite cytokines, oXiris included the I the label demonstrating mortality of recently, two number in-vitro line, benefit endotoxin ultimately not think of Care, world failed the no over player being Septex Baxter expanded ago through the acute filter and removal. removal pivotal next world. studies number said, Baxter company other a Septex number I years that you experience, was initially largest of That mean - oXiris endotoxin by clinical a and cytokines. XX all in in dialysis Of the in will partnered product because the just another being of therapy say with They XXXX second the number acute its was number it that fact are leading Gambro, care of as oXiris being very of work. is would And was actually it a is Cytokines efficacy for not the said, successful the label that for the also, years reflection was has a which perhaps clinical their gram market off sepsis as cut product have I being of oXiris long indicative term endotoxin actively a had the doesn't And a of really marketed which also anymore. think world, to reduction is off oXiris molecular that as efficacy. in is taken inherited a back

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

Andrew D'Silva

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

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

Phillip Chan

to answer is The yes. short that

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

could this the to in CAR what at in of patients be the we're And why to of believe therapy immunotherapy, immunotherapy do is day, end - in lot looking this but that have way of the harmful steroids setting value that for we again, evaluate reasons potentially indication, itself, to lot for CAR T-cell successful. continue the patient. this clinical undergoing We of which maintain T-cell be a clinical both a particular the the also this as potentially trial establish there we could a is

Andrew D'Silva

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

Phillip Chan

Yes, that is correct.

Andrew D'Silva

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

Phillip Chan

Andy. you, thank Great,

Operator

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

Phillip Chan

today's participating everyone, you, in call. for thank Well,

will have your try Thank jeremy@lifesciadvisors.com, any to you good please to very reach If possible. Jeremy we reply where everyone, a Feffer and much, questions, out to questions at night. you have and

Operator

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

Cytosorbents (CTSO) 7 Mar 192018 Q4 Earnings call transcript