CTSO - Earnings call transcript Q3 2019 | Cytosorbents Corporation

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Operator

Good afternoon and welcome to the CytoSorbents' Third Quarter 2019 Financial and Operating Results Conference Call. At this time, all participants are in a listen-only mode.

Following the formal remarks we will open the call for your questions. Please be advised that the call will be recorded at the company's request.

At this time, I'd like to turn the call over to your moderator, Jeremy Feffer. ahead. go Please

Jeremy Feffer

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

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

forward-looking Dr. to remarks to Chan, like in I statements, claims Litigation contained turn discussion additional over Before Safe in more protection SEC. results to the Actual the may and for you prepared call under Act of listeners Reform forward-looking risks remind management's company's today, uncertainties differ which Harbor refer risks a the Securities response company during make discussed your may I'd we that results Management to in with the to from forward-looking XXXX. may the questions of uncertainties. statements and the are filings detailed today. these therefore, call, Private subject and contain Therefore, statements

of represented we these Any the to company's today future the future XXXX assume in projections change. Xth, management projections include conditions estimates performance as no obligation as update November and by to market as

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

your with during rest team. the Following management their will line live the of presentation, we session Q&A the questions open the to

Phil? call the to Chan. time, Dr. it's this At pleasure to turn my over

Phillip Chan

as the quarter aspects our particularly I'm generally came much pleased results well summer very foreign Jeremy seasonal afternoon in you and exchange effects. line to say the given as everyone. that third quarter Thank with of expectations in good

$XX.X gross Trailing million and distributor year product in $XX.X During the versus margins XX,XXX quarter. up ago. in expanded grant call product million, a including the sales the XX,XXX total of ago. And we the XX% Cytosorbents that three achieved was third delivered discussed months partners earnings to in income quarter. two XX a ordered treatments from quarter quarter, year Blended were revenue had third orders from first

the our May We CytoSorb of countries annual Colombia, XXXX to XX an to Costa annual distribution we renewal CytoSorb America manufacturing total Rica with September through and of CE extended ISO Brazil, XXXX. facility Latin and through Mark our -- certification and received of XXXXX our expansion

the trial and clinical to start T-Cell the quarter, cytokine TISORB clinical United the of by made of thinner progress. we of REFRESH a and immunotherapy encephalopathy for caused blood bleeding. trial, our the treatment completion emergency the patients also During cytokine ticagrelor, first Also X-AKI CAR syndrome the CytoSorb trial also near patients. for trial that surgery of a Kingdom REMOVE significant syndrome new causes study evaluate progress designed start including is that often the release release a in And unwanted removal problem of

the of Kathy Kathy? turn over how again the about to highlights afterwards be talk to talk me let plan that, to significant and quarter about With financial it XXXX. in drive I'll growth to back we

Kathleen Bloch

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

financial capital provide an results, So, and I'll around quarter today's provide regarding call, addition, sales in working third update progress I'll cash for our includes runway. an XXXX and which update product our

decrease increase from an in of set direct and XXXX. approximately by million, approximately by resulting a of customers the $X.X $XXX,XXX This of those sales over orders offset for existing a So, in from XXXX sales distributor third approximately sales $XXX,XXX. $X.X increase to new sales customers, repeat XX.X% million driven of for sales of quarter which QX product increase was were product CytoSorb is

exchange $X.XX of dollar fact, if quarter the average dollar in quarter to Euro And third rate have rate or XXXX. of the rate XX% $X an from of approximately in had an remained average than QX to unchanged would been third over product in of the represents reported approximately product declined of $X.XX The actually higher million, $XXX,XXX which exchange XXXX third the to increase Euro sales. rate XXXX, an XXXX quarter QX from of XXXX sales

well QX an XXXX Our were of quarter total $X.X as our approximately increase $X.X sales X%. for as compared million for include product which to the of of revenues revenue XXXX, approximately third as approximately grant million

XXXX Third third our $X.X million, pleased of approximately gross grew quarter third of margins of increase gross profit QX that to manufacturing $XXX,XXX for this the than of XX% is XXXX were as of And or to of a approximately also as for approximately for to sales $X.X the result efficiencies. XX% quarter primarily XXXX. profit XXXX. compared report XX% achievement on the quarter million gross And of profit an product of we're more

sales, the of sales would turn actually or higher financial which an had average million exchange of the over million, sales again, the approximately sales. nine been prior first increase $XX.X And rate months reported euro exchange the nine than rate dollar first year -- the average be an Product we'll approximately of product of months have And dollar unchanged to same XX% XX XXXX. XXXX of over to remained the $X $XXX,XXX is from months an X% would now were XXXX months of approximately product or which XXXX of $X.XX exchange from rate declined our period first again, results nine for for XXXX. XXXX euro million, nine if once rate once $XX.X to in the months in an dollar euro to of $XX.X to results. So, of product increase nine rate

compared $XX.X XXXX, for million was period the compared million increase to revenue million of to the approximately were X%. nine the Grant XXXX of for to first XXXX, the timing revenues. nine approximately due XXXX $XX.X first approximately same an $X.X of grant our period approximately of And months for as total revenues for of $X.X of just same the million months

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

were a product record approximately in million. sales $X.X $X.X from slight is XXXX similar sales Our in third in in in we QX XXXX quarter-over-quarter million decline product a and result months the slight is in in year in sales This This reported to decline prior our of XXXX. QX as what occurred in particular slowdown believe, summer the procedures Europe operating in Germany. the quarter

to XX variability, trend we trailing So, And growth return a particularly product look rates more continuation our higher in growth overall will can positive discussing to our overall from you this in the a annual a minutes. trajectory. continues growth sales, this strategy. And in of we'll as a with future detail of in very expect this be quarter sales our next at see solid Phil of growth XXXX quarter result as and exhibit to sales, in despite sales product chart, months few

product We've been year observe and our direct for through gross making our also the can margins one of in gross XXXX XXXX. year-over-year the blends margin margins. blended quarter plotted margins are These this on And sales. chart improvement the we've with sales continuous each distributor our growing margin third lower red line, gross higher

fourth looking we to gross XX% the quarter to blended XXXX. rose For and target quarter continue of third margins of forward, XXXX, in XX% gross achieving our the margins

on So, finally words working capital. a few

we $XX which and have XX, believe Jefferies the We at-the-market in XXXX, B. will September As operating Riley operating previously, foundation place, a needs provides allow we believe facility in existing with approximately solid million company. had $XX our cash in discussed well cash, us co-agents up to us we million into to the meet for runway XXXX. the And which equity. allows as raise we FBR to of

for cost to company an raise this if funds for ATM is haven't way We yet. us it effective used that But needed. provides efficient the

the you of as have we regards are the with to use And careful aware, ATM. in been very past, our

XX.X shares balance always shareholder a common capital clinical a strong to having basis. And approximately have also million strike on to to turning September dilution. XX, of avoiding capital a balance sheet We’re adequate objectives, provides operating diluted we and outstanding structure, meet which but trying our our trial fully as between

to I'd with that, call Phil. the And to back over Phil? like turn

Phillip Chan

you Thank very much, Kathy.

strong XXXX, faster why is we ahead. Cytosorbents of predicting believe where growth reasons the a this is story But finish we're a we year XXXX, to many believe expect There's real growth. modest We possible.

in years, Denmark population Poland, our million effort we first where of all, Luxembourg, sales been XX% and Austria, number the XX product of XXXX, higher and territories going for a people. the Switzerland, XXX Belgium Norway all Germany, direct of Netherlands, So of with to our from with adding to Sweden, product double and countries have combined sales to because are approximately an of gross margins sales number made direct approximately of direct that, five we the of existing

add at XX, people major expanded with serve. overall than Mexico, Korea, our countries that Colombia also countries, Brazil, pending including population that XXX to more South potentially CytoSorb the could We million to registration and

six an easy key many the increase added hires XXX three Since in people XXXX, we with was XX% in This across headcount, an company, to employees approximate not months. the XX now past task. or to

in In fact, in a way. general, the people challenge ability XXXX laws, significant bring delayed Europe to in Germany, impact a as these as right sales on in tight labor time well our in and very labor people to challenging to market find the in

is and right we team believe However, time for in sales. we impacting have board that the having our bulk on board XXXX them of on

and that particularly the all countries. We Germany. facing able in have We commercial opportunities significantly sub-divided into to we to organization direct across by be management take the customer the those sales business account XX specialist, strengthen of sales doubling reps of

We new and sales. leadership partner leadership of our also and distributor brought a expanded

growth Sales new support, Dr. who quality, our Christian We This well to also accounts in manpower, as and as reimbursement Steiner, be a manufacturing increase headcount this report marketing Marketing, a of but major personnel. clinical catalyst strong SVP key impact we and is will to with head increasing expected of brought bolstered this targeting of in believe, modest more in will a XXXX. for enable year, focused

reorders demand grow. of many And On at from average to that demonstrating repeat primarily our we CytoSorb increased the and for of customers. believe grow adoption. sales invoices top approximately continues accounts, to seeing we invoice XX% continues that, is CytoSorb driven have what are cartridges of that been per by CytoSorb usage with number

their honed of well, adoption sepsis, physicians and and more other XXX These broader expected are continues clinicians failure, applications. generation controlling works in in drive to control medical key rapid new to complications believe, robust very because scientific data The of and CytoSorb usage liver Clinical more have areas sick new cardiac journals, publications usage. applications, increasing, and is helping the is surgery, data with many inflammation. in CytoSorb where on be peer-reviewed particularly patients, regain base such than we as

discussed this recently with we shock. studies their in a those have on of in and CytoSorb One retrospective use study, factor with death press independent a implies which evaluating that patients therapy, shock renal of replacement the failed, is risk septic release an was patients kidneys which for in septic

they One to set In patients. replacement this and of endpoints two of retrospective continuous alone whereas just patients study treated validating of about amounted receiving therapy patients, XX-day evaluated renal of XX CytoSorb that XX primary patients patients. sets was patients mortality, with were

the the in a saw in treatment in measured CytoSorb Failure XX% which sicker, in predicts this is XX.X versus two control Organ before by of groups -- that Assessment we arm, Sequential treatment the was the in and XX.X SOFA in arm, CytoSorb the control. patient of started patients ever mortality arm the What versus the these were XX% that, population score as score,

Authors the observational is in in used baseline to or Inverse That adjust studies differences stabilized Probability Treatment IPTW. Weights, used the called commonly something characteristics. of for

look articles analytical this reported JAMA of if In England others, is you a used fact, New technique. statistical at the and Journal commonly in being Medicine, and

And CytoSorb characteristics impact patients a of patients, -- suggests therapy doing one so, versus led baseline the at with be mortality decrease that XX% of to treatment shock XX CytoSorb arm, this studies replacement XX% in on looking demonstrated CytoSorb. with you mortality. at these might renal in showed and every septic they data In that for control control when are decreased XXX CytoSorb data continuous the the patients largest is This the saved very on encouraging. of mortality

been -- investigational was called remove we've drugs of antithrombotic recently use of another study thinners. These to use has Now and ticagrelor. about are rivaroxaban been that like done CytoSorb that CytoSorb the often blood talking the

drugs. which the sales people of drugs around millions of Plavix these names. antithrombotic on of class and amongst this Brilinta billion, And drugs Xarelto, common These are world some worldwide more Pradaxa, the of than have Eliquis, have $XX are where collective

States estimate, placement United attacks try of and heart risk or they're in the alone, have used are had risk recent in on in to reduce of actually artery blood these where coronary because past. the XXXX So for a who as stroke to X attack undergone people stent million a patients thinners who disease, the either heart

used fibrillation, There deep people are people factors disease, underlying pulmonary stroke risk people require some the this an or their event The also with that urgent prescribed underlying will patients other attacks, in or most either types cardiac such class of drugs patients will or embolism emergent underlying are is of world. cardiac commonly X% have disease of with acute are with surgery. with and that in comorbid atrial in this the with heart approximately as or due drugs that for other cardiac problem artery peripheral vein these thrombosis developing disease to

open are, coronary a CABG or damage coronary kill artery pain find aortic Bypass operation, clot placed this will Coronary operation, the only of and example, a is something aneurysm done inside in requires rupture if artery for someone to in dissection them artery like a with chest of in that have not that who a a newly Artery Examples to out they a that dissecting heart immediately. complaints or stent coronary potentially comes Graft

perioperatively these massive patients of board, thinners emergency blood in surgery when with that ability reduces And severe However, to approximately it suffer come undergo clot. greatly these cardiac their patients XX% bleeding will on

Of Germany, Hamburg, the retreated as with XX hospitals of Xarelto on this oldest also St. known Was major is intra-operatively surgery. recently either and XX a Cardiac these investigational known evaluated that from ticagrelor, CytoSorb in also rivaroxaban which Brilinta and application. They came out Hospital emergency Center. were in in Surgery Europe, as underwent cardiac patients one very a Georg interesting study

required cell found CytoSorb They had And very XX.X% platelets. significant rethoracotomy bleeding red interesting. the many cases. need having reduction need in in significant statistically had drainage, reduced was They a that and potentially also their had transfusions in using stay re-exploration significant. the and operation reduced the those for length not cavity CytoSorb intensive of what patients in reduced be and could of what bleeding, and of a arm of of rethoracotomy. control saw blood significantly they They patients of using Patients for statistically re-opening which time care CytoSorb the complications, chest had arm all surgical reduced required in where none hospital and treatment whereas were it a a unit reduced

analysis Kingdom, cost-effectiveness separate was clinical done these a approximately the a in in $X,XXX per to case due And concluded that they United of benefits. savings

could for is we sales the that this obtained XXXX. that believe very of Union an we European this application, application although expansion if therapy, investigational of So this driver this for CytoSorb potentially be label significant a currently in

is data talking catalyst. another the data are projected catalysts about Now near-term

major on this ones ongoing started the and We that either shown are are slide. have have studies of a number or here

expected at data is their Once well to decided target that their all endocarditis have XXX the presentation done, investigators enrollment to And conclude the believe data -- year that is that by dropouts. once in They've of schedule. roll-up patients removed XX ahead potential of the they of study account randomized analysis will mid-XXXX. additional now and Germany for of end. patients, an is its of trial control First to to

second X-AKI patients at XXX interim Second a XXXX. at of of pivotal patients. enrolled the the And randomized the XXX study trial, analysis the where of now end REFRESH quarter quarter trial, into is is are out patients expected U.S. first currently XXX of target control an

as in cost in blood of well bleeding in of Kingdom about effectiveness a sponsored of a the that will United is events slide. new The third we to company where on thinners a talked platelet specifically trial study at where and it also terms and analysis, ability this be study the is one in looking at its efficacy function, reduction companion will look study remove CytoSorb is that will study. we TISORB effect a as we trial And the these prior ticagrelor,

expected that Mortensen, will Eric, general The to Medical study in XXXX. Chief comment a our the primary is importance study little this and bit Officer the quarter And Eric of in program Dr. third of on complete later.

And our in is fourth the with then fully do IDE end XXXX. approval study. expect the of HemoDefend hard study very And our IDE we to HemoDefend working this And that to is year. have by the filed we're potential

said, the in been guidance, completed. of now we’ve financial until guidance results, that historically So has quarterly with on given quarter terms specific

year sales. sales of the those that, goes this product we exceed product fourth will fully will a half half expect first product XXXX, the of expect However, do year, of year. exceed second this quarter that we sales fourth And the quarter

our mentioned, As basis guidance achieve this that blended reiterate gross XX% to product we we on Kathy expect quarterly of margins year. a

With that, operator, formal that the And please our open the call for session. Q&A ends up comments.

Our Cowen from [Operator Please of & Instructions] you. Jennings first ahead. is Company. question Josh Thank go

Josh Jennings

where Thanks, your Hi, but in – direct outlook commentary further sales for good into also in the apologize for Kathy. get some just on this this, color update some level broadening and stronger to But towards wanted just high force new are I of Phil distributors move the you background with the terms territory. of XXXX noise reach afternoon. The here.

distributor battling in terms seems early reps still it headwind adding just revenue on and, Have side direct very also still you and in the territory. and different a as if you're of

guess about sales the the but just to Germany, want where can be? getting of I So and ex terms engineering in salesforce just direct you direct question talk it is, you

up XXXX? you three the you I you territory. are said then, of you ramping they're know, distributor an update in you terms Can side, in taking two of orders revenues distributor in give us And are the to where believe taking on distributors so far. orders? just expect do a also of then And new grow

Phillip Chan

Thanks, Josh.

first, of we moment, know, the stop first year, for that disclose in as the distributor ordering So you we because distributors taking the of that this issues. issue inventory had three primarily quarter major

including and Fresenius Republic bit those have in European inventory of seeking Care. France, Europe, sites the they from that particular were that the was quite Medical is a registration Czech their with Korea, One transition a issue sales Mexico European to or of And of they as left that territories Finland. and in current South

They registration until we we that have inventory. in inventory continue they they to registration they and countries. get progress Korea. off get Mexico in against can't holding they and to But until can't transfer European ordering, that South Korea, order registration in Mexico been those good until, because make South They're and on get

are ordering So, but the typical distributors they other back two of pattern. now and kind their order are to

region, We that a local have and Head that now the to trying territories is basically it Sales International countries. those manage XXXX. in territories that on and to very distributors the a in helping the instead distributor at are brought done of fantastic she for have work very New resident – from know, you languages been in We're, in where Germany, regional focused organization. and example, that out building of speaks, develop their managers our And has at hard various job of beginning partners we

goodwill and to been we we, so of efforts infrastructure the that strong be countries this development generated, we the market that the feel a readily driver will XXXX. distributor of think a and sales of And of of year, in a that a lot cohort, lot are there's have where I impact built actually not XX although distributor, – their lot apparent

sales before as Union about terms Germany, in and think market important the, for direct XX% device third the very largest largest our as in So I sales, a so clearly mentioned country this is I medical quarter, the of of world. of and the Germany, in the outside accounted European

strong in sales way we that on drive core have can order that detail accounts, Germany, advantage demand we our them in take doubled Germany – detailed to And, the of focus in in reps facing order subdivided so Germany, the folks to and see. that again, them in to they we've really our the need customer

That value year said, I the of in Switzerland the outside Austria a procedure reimbursement to achieved also a think for example, of for with robust, be Switzerland. hopefully that ago, pending to sales, more than assignment we sales a and that should Germany, code that continue catalyst Switzerland

the potential. lot have of that talked also countries Now, are about other we a

great in we Poland. One what and strongest and healthcare support, year. our in of and selling team report generating Poland with April and this drive Polish Poland of the force any working the to efforts here sales keep of is progress And is and going to we in ones started this that awareness with a just direct lot been amongst physicians leader conferences within there's can workers and, interest really product. of sales And usage

in sales. XXXX, to For Poland expect be example, we solid overall contributor will a So to

But I head also, brought focus. up renewed mentioned, other we a think, from I countries sales as in a the outside Germany. And, of of direct have are benefiting x,

board specifically couple focused so have outside where other focus, we on progress been of on for very and he's going nine I Germany, one new the the new He's person we're focus specifically a far. that think a that just encouraged been And Germany, just we've months direct. person by countries made So of on now.

can integrated will really having with strategy But the those drive many heard him that to direct think for times in And having he's very continued his be well. very I confident able and after I'm countries. to that growth met now, that he ex-Germany, countries

past takes don't to know a get implement to it know we three you. that, strategy. But people on time think brought in the and players there's company, coming know with key to build get again, lot And recently bit the know know the to and a on the really little I So, strategy get months. of to the a to helpful this people, product, that of the if six to I get that's

QX XXXX start, in and about and this -- we're strong is having that on strong we a why But which confident believe the well then definitely will we positioned a ending for we're board again, feel benefit year infrastructure expect that we very way.

Josh Jennings

super was helpful is That No. equity.

just is thank and equation are like a reversing and surgery cardiac a we signal follow-up scientists in you. And appreciate or clinical Torben an So patients regulated status.

a part multi Just question wanted here.

really wanted that could you talk a or, the just correctly, in sure data, need approval that submit whether make press today with see think you a you in this do this be data and I First, previous to you you you Mark driver I the downloaded whether about when heard indication can pathway, XXXX, mean more set release. that that then

then lot on clinical road the well? pipeline? And a secondarily, using but you just well. future potentially the that That front I with there a announced, he also in that is as trial was questions. taking Thanks you. know the are that of for had initial revisions in question Is have trial as

Phillip Chan

beyond. who's This potential is really absolutely. that important Yeah, -- important category. really believe turn and today we're effect a in in Thanks, we are pronounced. I for them of these me such Eric that point is to are a developing that would the studies Josh. is what very are some some very this over Mortensen, we is to application very taking that Medical Well, Officer, instrumental it Chief actually where and then -- our the taking where of such the -- we let been so say scientists And,

that maybe that application, the helped to this if on particular the -- about you maybe heard maybe some And -- comment maybe you've some were on other wanted cost you economic then on drive, of you that color application. Eric, this comment analysis So, feedback state

Eric Mortensen

up Happy because for speak. very in Phil. It’s and and I’m this particularly area a satisfying speak has program. unmet very program that development opportunity having of significant been a quarter extraordinarily busy We this of to there a also that up ended open then about actually really busy patients. year very to satisfying progressing represents to happy Sure, this region need

year, talked George Hamburg. Phil from the has this in already believe, You've about that I earlier St. I've from work seen Hospital

basically and for Germany be France And I if in the in how these don't really what for that these who you is and physicians can fully for appreciate interns we know, U.K., people surgeons when and a end patients just in Because managing U.S., surgery. are basically from the heard the here emergency patients. from need and challenging having up have

have law. no choice the them hand, to but to take on realize You the one you

hand, you the nightmare have a and bleeding On it severe can idea can turn just into other how complete no be. the

potential So, registration then were of also let having be using in move to both that characterization ongoing anticoagulant this end in and reimbursement opportunity. -- those, other leverage remove a the other they're tableau very as antithrombotic data we've of and provide opportunity and fortunate the to medications. And data been to able to Hamburg, a Georg collecting solid from exploratory a to data St. we as well up retrospective benefits this the indication --

that of last the St. actually Phil enough that we've out or -- Newcastle manuscript U.K. data be was be able to to been Now, extremely considered economist of the at put month, students able from in to presented just the very to a mentioned be robust the to that find the very, it to able there's published university at dominant work strategy patients. satisfying Georg Hamburg we together for the work with was Georgia economists treatment what of

an provided not approximately assessment of results in you'd that St. about talking it may based Georg that Hamburg, we're the patient U.K. bleeding patients. mentioned mention already the per model saved, hospital upon be that significant to $X,XXX Phil's in the risk reimbursement And seeing decrease these from for for

we're with payers to obviously end ongoing upon having work discussions that that up So data. based and presenting

a week decided way results a to initiated intended prospective consistency of the last and with patients. prospective investigator that reverse and opposed initiate included prospective both to potential demonstrate to that's now U.K. ticagrelor the have patient in We multicenter retrospective removal for as trial trial

which just just XXXX. patients that's, upon a last were to initiated half started Now second to Once we already the for with it week, the we same have patient have and of anticipating the that based but on results rate week. have a have was -- problems available these first

personalize that, this they're area and they end when hearing a with little they is speaking And per basically and the when Scotland just coming to in week often patients up U.K., bit, one what in in three basically to have temporize to I physicians And or and trying being have the have enough if surgery, them try ask might to then they're to while face have disease. they to engineer -- to look just severe forced them take ischemic they them studying graduate either will consequences. they're

of Cardiothoracic of bleeding. matter -- two presentation to associate he the Meetings improvement of indicated device explore basically data at just used terms the shocked that in in use was surgeon an during on our Lisbon he had actually saw patients as traumatic not fact, one who last the company, label the by a patients off month, As the European

therapeutic are data able be we experimental you So we forward, to for what be extraordinarily to to hope of still noted, the opportunity to excited we I've have have as next We're second important advance. bring hope half an an will but an -- year. mode,

Phillip Chan

Great.

Josh. label the the, efforts? And Vince wanted you expansion maybe Okay. if EU I apologize, on to comment

Vincent Capponi

that our you, data to in talk expansion pursuing Good label Basically, Hamburg. we Great. on were Thanks of observed are Phil. aggressively Josh. to based

statistics behind as mentioned a that data possible had expansion. compelling forth was to great which we think quite Eric that As very label bring is it,

assessment hoping that of specifically on on So, soon filing expansion our from for back their And, of ticagrelor. a and the regulator we are now. label actively to the hear working

Josh Jennings

Yeah.

again. great. Okay, Thanks

Operator

from D'Silva B. Riley is next go ahead. of The FBR. question Andrew Please

Andrew D'Silva

for my Thanks afternoon. good taking question. Hey,

with sorry And just between far was as highlighted but moving you as I calls. I'll it go. that this, start they'd if presenting

during direct. or from going they for still hospitals this Are What they happens countries point to sales, it the were transition over working touch handed I and a light transitioning -- with that your that you period? you? switch you're was presenting see everything from managing While them is with then

banner go overlap as seems that there Is examining Mexico as under and we then fall corporate can U.S. like between there. a of with progress the their your And take structure? lot American both It far forward with and as away the things anything kind of REFRESHX? North

Vincent Capponi

catch that about last could U.S. maybe please? quite more one your part the didn't I It the of and wasn't, REFRESHX, time state you question

Andrew D'Silva

Yeah.

there the completed Mexico the of Mexico the that at able overseeing looking progress a and any was know, you is market? banner both how launch, under division corporate aspect be since that after fall to structure the REFRESHX their U.S. is just you're is the of American presenting U.S. enter So leadership and going cases, can curious sense of to assuming, I and obviously and -- North

Vincent Capponi

Yeah.

South that we've exclusive over. -- that been This you was negotiated -- Fresenius, for to pretty So rights return Mexico exited. rights think countries smooth Fresenius, in to and handoff I in know, taken in And with Korea. the giving exclusive item, the Fresenius the they've has for distribution

of of is can the transition our say very some what have you that the, kind distributors has I been Most But tail. know, smooth.

I think to And these markets. in so, our that over running. we're and years, our are And, built working sales expertise resources we've our well. bring experience, And things direct been up to we've knowledge, going our many and

of drive that's product. therefore will partnership the I the the the the successful that, really of we product the make And, mandate I North of in what because, is you important States, having level a is percentage the top Fresenius, we're America from very I say, to in ultimately team. pleased very think sales think think Mexico enthusiasm the think, of a leadership I United by person as this head basically

both of hospital company also before, chronic in machines, dialysis. I think, discussed markets. based as And disposables think we've But machines expert Fresenius blood they for and care that I the those an is also dialysis. leaders one in are a is acute purification

much renal in and understand with I is example, having margin failure a that people the tap ICU market does I positive very it that larger for think strategy. a a And that high disposables that, good is

Kramer, Chris works with also any VP know, business other if comments, Fresenius. Chris. you So, development is our online, with I had closely don't who of

Chris Kramer

Phil. thanks, Yeah,

Poland cooperative everything. we've you that is, managing to negotiated that happen, our the think direct with just With I territories, maybe been under FMC in us. very that you've And respect making sales. and tenders by of with has covered about you're exception a enlarge few Europe, those transition. new we're right,

thing. and management does, has the fantastic. team, with. now, know, been team into management own Mexico good Right access to correct. its give does its FMC Mexico America. And we've structure, own us a think you're Mexico, Andrew, interacting With org North is It I been US has some they've which you which fall primarily -- It

market prioritize you They've our And they to put with they how clearance. in product. really resources it. We're terms respect of can and see it just support it towards getting how

It's run it we're can I'm that in of activities lot the Authority Mexican pretty my And the we end we're Health now. year. the with a we're think being crossed. the Mexico keeping before I organization. right But FMC hopeful fingers pre-launch seeing, close get of by Mexico.

of branded set our created store We've actually that impressive. distributors. collateral. of one bigger had booths, is nice the and from exhibition It's a they've with marketing seen sales completion quite I've better of training which And already really ones

enthusiastic I'm really So about that.

last week, time first conference, the exhibited for then, in a customer Mexico. at they EU And and

coming FMC lot They're a growing. things of we seeing I'm see up. territories, So, the good healthy. them In

And we've, reorganized we've coming the organization sales territory. too. progress been also of shouldn't a supportive. the of FMC support out also the they've organization, out them and we're After seeing leave Mexico lot Korea very I good

Andrew D'Silva

go, expectation sales much with be of sales as sales a hear. a to Germany there's mess the would time in the the direct then, to of as German the law to the as just But highs or great direct lows. going as Okay, average, generate a far sales Obviously, person be would. on And and averages. outside be rep able from a force, sales over that

should we or about a a expect also far US goes as how soon to after completing trial as it the approval talking to get the that similar in successful, if remove were then, can price we label the there. result refresh that's in as expansion you And as

Chris Kramer

direct they highly and think, of of of sales number of in reps productive are actually the believe outside different I being direct a of we So outside Germany, -- productivity -- can they in that the terms certainly the countries.

I the in pieces support. think any in significant keeps Germany, we benefit leader very from all place, having

we're product, the the all didn't Medical of for having going reimbursement In direct, long period -- in data are to those that where put some hard pieces compelling. aren't we and have reimbursement that not new Germany very quite a actually pieces countries -- time. necessarily our support But place, in Direct working other place. for of we particularly Society is in the

a reasons there's in so Germany, rep But quarters one one is to vast the and already just of the why -- people, And ability this the XXXX per more impact on much the $X be millions sales. at potentially expanding sales vast said, sales and you of on significant force with opportunity is of this headcount brought reasons the we we increase have again with because which When that believe that would majority three are that being in now very a Germany the of more efficient board, this will that's it Germany. that has that look rep direct board the why do on they're sales been million on we've sales. to dollars the in believe one in we've

to marketplace, actively in already you, EU global trial question in the data already second to this that about seeking Vince are product as data for the is has the your QUASAR provide, as we upon trial. or mentioned Eric but Now, additional scientists the mentioned to we intended support based ties expansion The have.

should use that relates of is a sales, world worth over world, people in States so of drugs patient highest. a where States again $XX probably and anti-platelet over all drugs dual on is agents the these gets all right, but millions the is one it particularly this be U.S. example, in of United these these these Now, problem every strategy, the on the aspirin penetration of is and the of where, a anti-thrombotic problem are agents, clinical United of billion as stent anti-platelet the for therapy to that global, the

-- is countries. that, there westernized or also the up because so of highest And at medicine, but amongst the modern medicine problem least

detail it say the regulatory So, in U.S. strategy on regulatory strategy. we'll is more future. this our that all data have to towards very our But helpful U.S. suffice

Andrew D'Silva

for XXXX. Hey, thank much and great. luck taking Okay, out questions you closing very my good

Eric Mortensen

Andy. lot a Thanks Great.

Operator

Sean Please from is Wainwright. go with H.C. next question The ahead. Lee

Sean Lee

questions guys, Hi, I’ve on the taking pipeline. thanks and for research got my questions. couple

So according slide, we readout analysis? first you provide see Could bit to the of more color X in from little we can interim this see study the that from year. a next what REFRESH half can't to an interim expect on

Jeremy Feffer

want Sure. Eric, do question. you to take that

Eric Mortensen

were to be rate our reemphasize, -- unanticipated estimation, to or re-released certain the any I upon for able will AKI. a rebalancing analysis of have been based But to I've we with have FDA see rate, want asked be from that information. whether the before we not assumption need What since we’ll do

results In of the order sharing to the integrity maintain study, will interim with analysis the we the be not analysts. of

will nor useful that to data. will significant FDA Our that was that with goal to patients is of sure re-estimation number on to results the in for will track to make are achieve to trial. that and need the we us make regards no sure extremely if that be be is the able conducted provide compliant this questions very But robust has a way to

Sean Lee

Okay.

kind see will public of any disclosures? we So

Eric Mortensen

numbers compromise mean it's trial potentially by of that the I a so analysis. the blinded we trial, -- integrity terms basis, of results in interim the would of Not we, releasing if

Phillip Chan

What would but in that continuation message. or one would the that, results issues the safety not any I major that, if any were were be would be that or of the positive think trial, of what DSM of expanded, message not results very trial or terms is interim be there that obviously, concerned, needs whether from analysis be whether that the analysis, any to recommended

Sean Lee

Okay.

for the the studies determine whether criteria essential rebalancing. expanded are for those using rebalance? to case the What expansion or in are You the or mentioned either you

Eric Mortensen

for under-powered The are assessment futility interim analysis whether safety not assessments up designed any for we overpowered, findings. assessing is or to well as as end

for noted, make concur Monitoring results sort to make is basis As analysis study. a need study that already Board see the larger the I've the one -- because were that with there If will were terms increase of of speculate to that can number in one of analysis. about if than Phil a some sure rate downward of now, one signal, that patients if that anticipated Safety for was to one I a similarly, in that the Data and they there is reasonable reviewing not progressing decision the be the imply done interim smaller right change number. sees the that a would might event will

Sean Lee

looking clarification. I terms in My second patient for? bit little what for CytoSorb a you the on of provide that the study. size you see. exactly and Thanks detail are points, is question more Could on

Phillip Chan

do. to Happy sure. Oh

that So also the note I posted will that go. trials study clinical we have on

Ticagrelor happy are perspective writing sometimes see significant up things statement. OR verbal of to speak clinically those circuit Ticagrelor to trial pharmacodynamic in They now. reducing or Brilinta a will designed be showing to of in that parallel in a presenting from patients the use the is But is end for CytoSorb function events as confirm I'll So can than onboard. who during both be that a bypass of ischemic The trial in setting -- easier the as produced multi-center platelets. you cardiopulmonary it we if to well to the in of emergent by way with platelet as treatment reversing surgery concentration that a of inhibition the Ticagrelor

But clinically we have the periop incidence removing red value need function. will platelet designed endpoint of be So in well is drug end transfusion, of the up providing academy. for demonstration that terms also as patients to both a of the perioperative number primary improving of endpoints bleeding, the public relevant as assessing that blood course we're [ph] platelet transfusion, value reimbursement cell the and

were model. so publish that study, impressing also the to because greatly the only that therapy reviewers in ended up of but demonstrated of online of to NHS an findings the benefit not All the pharmacoeconomics paper CytoSorb impactful,

economic this societies. able some be thereby to is benefit, fashion and with hope confirming only to have prospective end not but that that also benefit up our So demonstrate clinical

Sean Lee

all And clearing. that's for have. Thanks I

Phillip Chan

Great. Thanks John.

Operator

from Your ahead. Group. next of go question is Maxim Jason Please McCarthy

Michael Okunewitch

Okunewitch Michael for a It Jason. on few months. guys. Hey, the like going past on been progress. lot there's congrats on seems these which And

So this one.

think data that. based to of anticoagulants because we forward? the cardiovascular could interesting and update the on very the we existing label First expansion an you setting, at one's path a some hear the do on Considering how expansion or saw relating from surgical least data, removal see pursuing early you're

Phillip Chan

let Vince that one. answer will I

Jeremy Feffer

Right again Vince maybe a comment please.

Vincent Capponi

regulatory the a label early them where it's this. timing They exactly you Again submission. at for Europe have XX too a a like statutes least respond tell don't on the FDA statute under expansion. function day within It's body for to Sure. the to on

transition the and MDD done now this with all So the frank to quite working Europe of say they bodies that's between right exactly get yet position occurring I looking notified in the Again the to quickly MDR, with a work with closely with as and overwhelmed much them try right to amount I'm think are we be you have. now are pretty as what timing of can. not and we that But in be. might

clarity more give the timing at of can't I unfortunately, point. that this least on So at

Michael Okunewitch

One patient impact, that this anyway. savings us of the around economic healthcare Thank a impact big total markets? the European economic could per on an you $X,XXX. Could Understandable. the considering of idea how give have more on you of

Jeremy Feffer

haven't has. Phil happen to sure not value. I analysis. that that. focus on don't done We'll I have patient I'm

Phillip Chan

that I this a unmet Yeah. lot mean major a is so think I medical there's actually need. of --

get you'll answer. ask if Antithrombotic value a clinical I that and think a severe mortality. surgeon about morbidity you emergency uniform causes a these cardiac any patient surgery very of from So this issue problem challenging It's cardiac very

economic a it's problem from that I estimate how hard exactly think this big to standpoint, an is. of

in is the the put dual stent drugs United afterwards. type account these drugs for in a on year therapy platelet for for typical recommendation these a be get you But should States after again example when you you

And these so on under could chronic problem, so chronic you and be least, underlying at indefinitely. have you if drugs

there's States. that say place X million you X in if United every so, stents year And the approximately there's million,

surgery, talking when X% about anti then who you're patients be care X% patients patients. more platelet large of these patients You require But if about then agents these on one of roughly of to number is fraction stent. cardiac some standard emergency a agents, and know, about to you're a the of on than obviously get you talk talking

you yet don't surgery. we board. talk they But what need about they is they haven't what are the but these and where talked may then, can't patients the surgery -- urgent But blood is need because to they and have really about immediate on not go surgery these patients thinners

high Otherwise, of they are at risk bleeding.

the for days out sit clinical patients for bad can sit something in of hospital to they to centrally cardiac from drug days, the these before standpoint, So wash a considered three waiting to often surgery. them happening be five at risk they

to incurring And, is sitting significant population than patients, significant at there is a of hospital a just much a a bed in these systems and emergent larger There's the this time. are a -- basically hospital week population. cost a up because for, of

we also their a them. therapy patients take is they to it to CytoSorb so need at But best we of if for the large because can cardiac so hurt those they has surgery, just real, why ultimately had interest that hospital. away. talked using take to many that patients, reason cohorts if risk, them a because we've the said, And is again, cardiac ability in cardiac benefit who to problem significant and I if -- surgery who have and actually That may wait like confidence the these underlying cost the the are waiting patients surgeons and of OR right

a so of of anyway, little so the and hard the problem. so, bit And that's but quantitative, to color the

Michael Okunewitch

again, And progress. congrats on much. the thank Very very you And helpful.

Phillip Chan

you, Thank Michael. Great.

Operator

The question ahead. of Dawson from next Please Jason James. is Kolbert go

Jason Kolbert

appropriate and the a little thank IDE XXXX very, possible. by on to the how an end close much. you we very year can I know, of help Thanks. talk hour, follow guys, HemoDefend. understand, a briefly, know I end that bit you is get just guess to plan to you Hi, as mentioned so the me it's you've approval about but

Phillip Chan

you. Jason, Sure, thank

over who's Vince, this effort. Vince? leading me been to hand Let it

Vincent Capponi

Great. Thanks, Phil. Hi, Jason.

banks of now device potassium. the at of all respect So with removal to external also HemoDefend cetera, process for IDE doing engineering, testing and completing includes right Jason, we're in et the that the the several blood validation,

by is end file Our year. of the to the intent

preparing actually So now. in the IDE we're right process the of

the to end and So file I goal again, by targeting is think, you of aggressively know, our year, the we're that.

you compared for side, evolve. is and going is what, unbelievably sites, you filter it'll to two blood on be have do you and we would know, know, Germany is the a in Eric the Lee That simple the know, clinical things that this trial to to

I think XX about it's patients.

getting believe novo So XXX a is we about k XX de possible. really

your with You know, complexity ill it have the associated doesn't typical exit it therapy that in patients. just coral critically treating,

in So XXXX. we think approved and obviously that good you there's to files that, know, opportunity get approved

Jason Kolbert

might at on margins bit different, product? can the a you you are what known about little a talk be -- I Millipore, little I are of out other [ph], there the you Paul market where to if some look the they're the albeit be filters going and the to might businesses pretty do but opportunity sizes market talk think at were that blood mean, be Can that significant margins what

Phillip Chan

reactions different, goal million overall I reduce market blood red so that nice different HemoDefend and transfusion we've caused is blood designed still the I a think the It's think non-infectious where's complications greatest And -- purpose is need, So, yeah, contaminants the to worldwide then cell a that transfusions of you we to that packed think, is be able those devices. transfusion -- year. by of price on blood range factors. and includes I focus points XXX so try market wide the specifically a from to transfusions But requires. our to making the to HemoDefend, know profit of of really hit

surgeries blood bleeding help in for also there's loss well is blood and these to the of particular the loss people cardiac bleeds surgery who critically high is of patients transfusion orthopedic lot undergoing surgery, devices that really a where large so the is and who are are in like fill. population reaction risk from where And some are ill of The patients, pediatric so resuscitation these and blood patients GI get common. are risk needs example suited

yet. we not the opportunity, business that So market model finalized have

the ability have I risk high as that mentioned a surgery. applications direct We to bring care, critical of lot this the

And business this this these CytoSorb. able And experience bring certainly in have get those in product the other we because into the of direct. United heard being channels quite for a bit have before we in to easily. model You've our developed relatively ability that States, to of

field. have number connected strategic of That the there are we partners major players whom Many of said, a are today. in the to

the of blood the largest example, one world. BCT, transfusion transfusion Terumo largest companies For companies of companies and Kabi, Fresenius another largest in blood of one And of one in another blood Humanatics like the – -- the world. the largest [ph] again, the others. one

So that potential we -- to we best potential so we much haven't of we'll closer to try closer get -- to we lot to approval, as greater And get ongoing the evaluate you. approval, already again that for have detail a strategy. is we what efforts a have as

Jason Kolbert

way. of Phil, thank your a comments hear along come kind companies those team, Thanks. so detailed always to and much. you It’s your pleasure

Phillip Chan

Thanks a lot Jason. Appreciate it.

Operator

Research. Zacks from of Brian go is question ahead. Marckx Please next Investment The

Brian Marckx

necessarily study. pursue. on you expansion the not to Phil, leading the Hi, results risk guys. mentioned Relative that period label those the of dependent CytoSorb that is

E.U. is book is ticagrelor it and general to or label anti-thrombotic? expansion, Just for specific to other the include would relative clarity more it

Phillip Chan

which goal CytoSorb ones to ticagrelor to are initially of also of be Plavix other it for very is the is and will following the some our part important. that, placement, stent of expand the strategy. that specific the in other anti-thrombotic cardiac cath, example is is are Warfarin but currently agent drug and most that usage But to for It favorite

Brian Marckx

ticagrelor the that studies in anti-thrombotic. Perfect. Is similar you assume other is to think with successful it that follow would

Phillip Chan

different goal. Yes, but the yes with There's dynamics that different drugs, different there's the is

Brian Marckx

Great. Okay. Thanks. it. Appreciate

Operator

Dr. question-and-answer closing Chan any for back turn this This At remarks. to concludes time, would the or additional it I to session. like

Phillip Chan

Well, today. participation thank for everyone you your

much. please free out and where reach you other to to very we everyone call. to forward to look possible. Good questions you Feffer at reach night. jeremy@lifesciadvisors.com, quarterly next will any If do – questions, reply just Thank our We Jeremy feel have your

Operator

Thank you. That concludes for your our participation. conference for today. you Thank

Cytosorbents (CTSO) 6 Nov 192019 Q3 Earnings call transcript