Cytosorbents (CTSO) 6 May 202020 Q1 Earnings call transcript

Company Profile

Participants

Jeremy Feffer	IR, LifeSci Advisors
Phillip Chan	CEO and President
Kathleen Bloch	CFO
Ethymios Deliargyris	CMO
Christian Steiner	Senior Vice President of Sales and Marketing from Germany
Christopher Cramer	Vice President of Business Development.
Vincent Capponi	COO
Andrew D'Silva	B. Riley & Company
Sean Lee	H.C. Wainwright

Call transcript

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Operator

Good afternoon and welcome to the CytoSorbents' First Quarter 2020 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 would like to turn the call over to your moderator, Jeremy Feffer. Mr. ahead go Please Feffer.

Jeremy Feffer

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

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

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

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

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

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

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

Phillip Chan

everyone. afternoon, good and Jeremy, much, very you Thank

Chief Officer. promoted Vince Capponi, to to Before we President has who congratulate get now started, like been Operating and I'd

I he done job want that from to release him And Chris saw publicly in XX service here has thank company. to an yesterday's done. press his you all my in of years for As just outstanding the here comments has

treatments more first $X.X XX% achieved XX,XXX delivered the quarter quarter sales the Turning grew quarter. product first quarter In first ago. and the $X.X to In or to the XXXX. XX% XX,XXX in to a operational year million highlights CytoSorb we first up revenue grew over million for the total from

due achieved blended up to We the of first scale ramped near from respond current with the full but up of a of to pandemic. flexibility rapid the ago, margins backlog to in to year CytoSorb XXXX XXXX XX% XXXX, order the product first to with ended quarter or gross up XX% lower than have down $X.X production ability in capacity and situation. million quarter expenses COVID-XX the and of go QX We with

China Holding and on-pump the the XX CytoSorb the U.S. first under expanded is with have now in first CE Authorization. quarter patients with including the Of patients more patients, treated XXX EU Mark first than approved treated ticagrelor - Limited. the and label we China FDA surgery treated Use first during Systems XX in Medical very now COVID-XX partner cardiothoracic we treated, including Emergency now

life-threatening initiated cytokine the patients. in throughout During completed readout done XXXX. to That T-cell randomized patient is on that came CRS syndrome centers Grade controlled an CytoSorb CAR or release successful of out, expected as also trial Germany. in REMOVE Germany, XXX investigator was in endocarditis study XX quarter first the immunotherapy treatments reports X or we case two in the to And

have our partner also approval Medical Mexico in Care. of with CytoSorb marketing Fresenius We achieved

this yourself could Officer, little in new you Chief on a a and you on expert Medical thoughts to matter give background talk to little your Makis. Dr. recent to ticagrelor designation. Ethymios our subject this about Now the Deliargyris, like a who name Deliargyris goes give our Ethymios as bit also area I'd breakthrough by introduce and more Makis, application.

Ethymios Deliargyris

my is absolute you, such Thank It tremendous Phil. exciting be and of pleasure afternoon joining growth potential. Cytosorbents an incredible at to good time And everyone.

background a a the physician XX regional first Europe States cardiology Pharma. cardiology. in in and cardiology certified role ago and I part with years cardiology, at and Medicines PLx In internal of opportunity interventional joined the Company medicine, triple later had board the United practice industry a is at and to at and the My my approximately I career on

two acute research in most bilirubin antithrombotics the by to important the I and career involved my commercialization in of be been Throughout and care had today, very in support market cardiac a thrombosis, namely and lucky [ph]. an of development I've the cangrelor

already excited has shared with that and the In developments recent very that two milestones. I've the Phil FDA light, been

recent like off, would critical First the Authorization, cases. I Emergency to the comment COVID-XX Use on

almost For an developments, as the now opportunity storm a as many seem narrative. for moment this pick ha to cytokine may

However of is surge uncontrolled what of that for patients. this critically validation a a thesis can is CytoSorb’s cytokines that to is clarify standing many long lifesaving intervention the for ill quenching the important be

patients is bypass shock, acute this trauma those cardiac relevant patients undergoing for but suffering with COVID-XX, surgery. it's Now also on septic or

of removal for The to that especially breakthrough which requiring receive are for with patients especially fundamental closer actually treatment. emergent development coronary designation recent second Anti-platelet patients can urgent heart syndromes, ticagrelor drugs acute in the as is or their those is stents my cardiac part surgery.

class attack. agent XX% today United around States heart the estimated market its Ticagrelor the in a is close is patients best its steadily among that and in use share viewed surviving is world. as is It the growing its to

that emergent surgery. become is while require on and important the urgent and one risk risk rest treatment or put to However patients they agents ticagrelor threatening is that these of can patients bleeding, higher life these that downside, antithrombotic at these when there one for now

out. of take This frequent. the situation. risk patients such also impossible of needed sending OR these bleeding watch delaying process the doctors are drugs until a A at that struggle can the to be it's to the In scenarios can with up choice serious week. these Unfortunately or pretty an surgery

another emergent. specifically ticagrelor they for slide, have one proceed and the bleeding patients and bypass grafting surgeries XX,XXX drug excess while in require either artery to out, a short XX,XXX the on approximately that estimated having that to operations see in of therapy patients clinicians emerging If it with urgent for surgery, to either or risk is urgent talk wash cardiac lot five and those for in can acting or cases Europe. this currently this in you the is to approximately US we wait choice hospitalization. As coronary agents that Among injectable or alone bridging opt is on

stay surgery surgery, to or with or a bleeding. effective Patients a were of This simple, treated previously the surgery excess ticagrelor any get ticagrelor However have new safe we if thereby Plavix Effient. solution, The effectively on with now until agents mitigating such and bridged as removes is risk solved. cardiac is solution. can ticagrelor during CytoSorb other they problem

bleeding enormous. Furthermore, the in and been This new noted Phil of indication is support this approach and the standard necessary will value Europe approved truly make education care. op pre as has we proposition post-operative complications hospitalization all that the of eliminating already to plan

in We get plan near breakthrough to FDA designation the to to the also work closely indication required with and data future. US approved in the leverage determine this the recent the

Phil. to now it And back Thanks. will turn I

Phillip Chan

China XXX Thank is reports in resulting in about of COVID-XX. used reduction a and you ill Germany, and a little This Italy, U.S. much overview countries, just many [indiscernible] CytoSorb give critically in more bit is CytoSorb COVID-XX been of cytokine mediators. to very other to patients preliminary in Makis. than and now you And treat storm positive inflammatory

ratios, improved respiratory PF Also from with signs improved of lung improved acute improve respiratory mechanical oxygenation, syndrome most ventilation. weaning importantly and distress function complaints and in ECMO

have we of least, an shock. heard patients a not hemodynamic improved also but about reports reversal last And many and of stability

and to Authorization treatment received cytokine the in with in age well. confirmed enabling XXth purification guidelines hallmark the XX hospitals in to specifically of COVID-XX to CytoSorb ill storm of critically is all features now sold COVID-XX imminent XXXX, China Panama failure. treatment. the with One And CytoSorb older be guidelines on CutoSorb years respiratory treat CytoSorb April or patients commercially Use producing of U.S. COVID-XX FDA or blood Emergency as recommended Italy

that use nearly reorders more short half to treated United of date with patients of in the currently approximately in accounts and XXX multiple a with received these are prioritizing but time, we've States. in active We hospital XX than CytoSorb in inquiries or now XX period very shipped

is which has Germany In to obtain including as to effort well data of date. underway the clinical randomized at treated many centers, major as report A case case most registry series. COVID-XX patients data, reports in the trials, controlled

business. can but that spotlighted role and are we and our believe note play as in COVID-XX term And a be company in COVID-XX important long has for Makis COVID-XX our think storm catalyst our Cytosorbents, it company mentioned CytoSorb, company. not a I cytokine our treating it's to

I'd to like break point. at this I'd finally, And clinical add - out normally activity

making around environment patients However most world and for put hold the has favor infection this activity in been this to of the there's of potential on patients. and not room personnel preventing of non-essential unprecedented much currently Because report. COVID-XX trial clinical in

make However report that you. pick to will up when we sure to to activity begins out

like With the call over to Kathy financial our that, for overview. turn I would to Kathy?

Kathleen Bloch

And afternoon Thank you, good everyone. Phil.

And regarding For XXXX runway. XX financial our position capital Cytosorbents update an around providing March I'll in today's and be working results. our update call, cash addition

was XX% quarter product they $X.X first increase $X.X with an XXXX primarily increase both approximately increase first sales well starting new customers, repeat of an sales. in as million sales increase for the which This driven So sales from as quarter were XXXX orders an $X.X by approximately customers of distributor existing or of product from is million million. over direct and in

which and March as COVID-XX revenues Grant first a of $XXX,XXX as to income middle of million QX XXXX, revenue in to $XXX,XXX compared quarter compared XXXX XXXX million sales first increased XX% quarter XXXX. was QX XX% quarter demand for first total XXXX, $X.X include rose to QX grant margins the were for in by XX% product of result and to the the in And the of product pandemic. as our of for XXXX. compared gross the sales $X.X

quarter-over-quarter our at sales. product look let's And

quarter currency $X.X XXXX million. represents actually been would with product XXXX $X.X QX On basis, have sales constant product another sales quarter of for million. First record a

Newly COVID-XX $X.X increase to management the approximately million for ICU pandemic. that created in contributed $X.X CytoSorb of the to though quarter this to demand treat sales estimates COVID-XX XXXX sales, to first to related difficult patients were quantify, in

second – the order entered of We we quarter approximately in with for sales also which of growth in quarter the positions believe us that we well a million, XXXX. backlog $X.X note second sales QX

revenue as first half catalyst experience XXXX of expenses, our cash the as from to second of of revenue may impact we we growth positive is operations XXXX, the a In reduced. in this in of the pandemic excluding compared approximately COVID-XX impact eases, decrease XXXX, the of half of quarter the of for trial clinical as first note $XXX,XXX and quarter flow second that we achieved

However, business strong our that of and believe robust. revenue core remains drivers growth we remain underlying the

result already core markets In the fact, have is growth pandemic a growing and our a passes. Phil even interest an future is mentioned, as this in of fuel there COVID-XX in and the awareness CytoSorb Makis to sales of expected once pandemic as

Next the maintain product strong year and our of see past gross we'll And positive approximately rate at was years note annual compound can month trailing We we CAGR we by and growth. XX% product this over sales you maintaining or very year over blended growth. sales to XX trajectory as sales a chart, that look four our growth margins. are continue

result our we've in a And to working efficiencies to improvements sales review achieve. from we as lastly, our gross we'll margin able of And that as growth, position. capital continue been primarily benefit manufacturing

March of as XX So $XX.X had cash. in approximately million XXXX we

sale net received March Jersey in the further bolstering our transactions In capital $X.X company an million addition, to $X.X approximately operating New non-dilutive our of additional from position. unsettled capital approximately in working the losses April million and ATM related

through raised million we B. In co-agents facility with aftermarket equity Riley. our first and XXXX of Jefferies, the quarter FBR approximately $XX.X

the However, given not we since strong ATM. position, cash our April have current XXXX. utilized Xnd

agreement, into loan strive also solid us scheduled with shareholders believe loan enable of only our million shareholders do have period. XXXX. XXXX. the like as well payments the the to with strategy a remind Bridge intends to foundation well in to our collective and plan term facility Bank we goal to operating extending And which company we on $XX Management refinance principal we execute Under its November are begin sound are our and in we to what interests. that The would current will is best clinical trial interest

on Finally, we at approximately XX XX.X March basis. common diluted XXXX had million a shares fully

Phil. And call like this turn at I'd Phil? time, the back to to

Phillip Chan

Kathy. much very you Thank

specific given CytoSorb guidance of has - has terms not completed. In guidance on has until historically financial results quarter Cytosorbents the not quarterly been

pattern patients our second business to we our to product CytoSorb, with strength produce global provided up in XXXX ability COVID-XX expect scale order first for core continues quarter sales serve treat exceed XXXX However, CytoSorb continue demand and current and product that sales. the will to that quarter and

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

Operator

Thank & Instructions] our Company. from will question Riley Andrew [Operator B. We first D'Silva from you. take today

You may proceed with question. your

Andrew D'Silva

And great questions. quarter congrats very taking much. hear your my healthy you for thanks glad everyone sounds Thank and Also too. I'm on to

the So can about to you of should we on de be talking study the path give just color XXX(k). I'm little the started can get approval just what with the in relevant me, a for trial think kind novo U.K. CAGR, U.S? And about PMA or

your acquisition and that at from least - for your in be mindset? Portola means I'd what Also your that the with company thoughts interested

Phillip Chan

Andy. you that. appreciate Sure. certainly much Well, thank We very

terms of cardiac for under awaiting from update we the path are give CytoSorb we will FDA we when issue the in breakthrough the guidance that for an ticagrelor particular and the know. regulatory designation In of surgery, removal on

had a interesting the terms orphan Agent a a which of acquisition company called Portola, is the acquired Alexion of activated today. has only you very This know $XXX antagonism and think roughly Andexxa. second Factor Xa Portola million that of is as Alexion $X.X on Reversal for market billion of them indications focuses acquisition, of question The complement for Inhibitor sales in the on this

events. in not study CytoSorb but reduce that remove ability ticagrelor as complement such rivaroxaban, that Xa to as also activated could Hassan talked So that the about last the shown we removes showed Inhibitor it's of bleeding in removal a the by we CytoSorb only have interesting that Factor post-operative observational rivaroxaban paper year and

But space of have and that their our just anti-thrombotic sorry CytoSorb just So this we it we Portola yet, - don't well. in of do as revenue shows think could quite the Alexion potential what revenues yet. I agent have am products be just think but shows products the what I does that it's together the don't curious – reversal I

Andrew D'Silva

an obviously to to can vitro as there, And but have expand your a relates you situation approval Right. in it an anticoagulant rivaroxaban, studies in like is do for the blood this thinner you label that warning something you're a device has even focused a that to comp on against now? and see right product interesting the be is it or up would how Europe in that Portola’s field? black box in

Phillip Chan

done but Inhibitor, the recently, I on of Yes, removal has of so just the a ticagrelor, of a by collaborator had variety vitro of shown actually some another the George Factor been anti-thrombotics. these removal of where pioneering just these has removal in rivaroxaban. he work paper believe wide not initial only published the on the Dr. data and agents published also of Xa who ours colleague removal anti-thrombotic different Angelou, including

about it's think of a very it a for is $XX,XXX single as has somewhere a the black $XX And pre-thrombotic risk drug. is, box I in as interesting thing It the warning. to Andexxa dose. range say, expensive So you a

than quoted have Some numbers that. higher

are of potentially it you risk as heart stroke event, the But to system that has agent be effect can doesn't because with in embolic or organs. to cardiac dealing as of inject to being of that said, to make lead don't patient attack other event in a particularly you're thromboembolic the a when want you given a other risk arterial cardiopulmonary anything risk reversal the used into fact sense, bypass pro-thrombotic or that surgery

data feel of the could confident facto blood agents forward reasons care these much should easy a a could that why remove priced to at de able agents. of with we move and to easily So we one solution. that's think standard our that, that from bypass we cardiopulmonary as use, it fairly various And be makes we installed, during these become better plans device marketing CytoSorb the for plans

so would well, have data ticagrelor agents market very other study. these type ongoing some news in more And citation that TISORB hopefully support have in and we'll application U.K. be But another said, all called for as the will study, to on terms helping particular study this the helpful of the the being in we Germany in removal future.

Andrew D'Silva

two I for very you Thank quick have questions. update much Okay. the on more just that.

or You provided believe an and X-K, scaling capabilities. update I in last an at you of your manufacture it manufacturing the month – end was X-K expanding referenced the your

curious a on should in capacity be or interesting you tie if facility? a just was color be existing in where the could that little And also bit too? just there. establish are your that in useful. add you to we be just facility now Any Would looking capacity thinking be what new would I utilization would right within about you

Phillip Chan

Sure.

Vince a terms that Let up Capponi in me turn who's taking over doing been to great job capacity. of Vince? managing

Vincent Capponi

Yes. you, Thank Phil.

let me couple that So a take and parts here. of just just

we've the in. this First, requirements the backlog a order demand meet at, surge of coming related in in to the And had now the to week, Phil we obviously currently really right COVID-XX, up end a day, are obviously still orders a with mentioned, hours days to at Cathy seven as XX cranked QX. we're and capacity

to that. we're rapidly working very fulfill So

we're essentially of using potentially at a expansion business. plant. $XX said a to could Obviously of the level give of going be. percentages, We'll is an supply look the We taking we significant million exact what but we're the capacity next portion

and to kind work fact just within is this here. et really from it it's Germany a not scale large at in this need existing to what business do sepsis, we to drive quite get do core the that starting not look take to of and now in designed pretty the a that probably and sales would that treating cetera, we experienced we've standpoint because and continuing Given Christ facility is

facility. So outside be looking we would this

closely we for in currently is that path the us market that evaluating But are to the obviously looking will very going trend and what be determine forward. what best

Andrew D'Silva

Or you be last in XXXX, And believe as relates fair Okay, to just the XXXX, given at Thank proxy how as Would years. that past very me, assume great. in seasonality that this to much. for you a seasonality. it would shouldn't that things on congrats fair And quarter. be just look do question should we seasonality far tumultuous are? - you traditional for

Phillip Chan

Thanks, Andy.

I seasonality, happens depends really think COVID-XX. it in that on what with of terms

the social the contemplate on surge infections, reversal into in a infections, so of be past been there the and distancing hospitals that countries of a particularly potentially to As has preventing burden surge season just a over third to effective potentially further risk the second even all of infections and in may is recent world. where move exacerbate COVID-XX we people flu the coexist and together flu as may and expected

of beginning the at we're now May. right currently So

are starting life. thinking of get about We way to just to normal to getting back back

some I of to sharp in but I back in think is get in mortality. to have know increase upticks United tried - already cases as the economic states COVID-XX new And a pressing seen to as an do well States that infection, have and need that there work.

the for we being what in winds thinking work maybe so long. and on terms little Christian, if particularly know, do be a in could QX slowdown think European it everybody seasonality Europe, you're business remains of home not in to that Maybe you bit want remotely at during you in a to up traditional that this, and know since I Christian's on been time typically you after or whether and everyone there going color mid-March get of maybe QX? that has working give see So but will be perspective back seen, we Europe to

Christian Steiner

to afternoon you. Yes. And everyone. those evening from to Europe. Certainly, Phil. Thank Good good

I a points effect. about and or is think which of we think one-time there Altogether part is considered are that be healthy there a have business number the be very to I not. we a when might seasonality think have

the with very as situation But number there's very said, think evolves. I depend effects. on of Phil But sustainable also this how will COVID-XX a much

will be experiences the translated in into results think diseases. treating the and we have other I COVID-XX So patients

but septic includes influenza obviously is shock or involves this So patients, patients. also this

because a got with absorbers. also a are treating And CytoSorb, have quite those and using pandemic, patients of are this of we while treating more who customers number earlier and new they

these I normal all the So effects to add business. will think

wider the And and the number company three, we of to I different phenomenon. our lockdown of and a awareness therapy in our listing think that of also another countries have leads

programs to of With the the the are have normal hospitals programs and the and at postponed rise or the two elective obviously we starting three pandemic have moment started their of or see a lot be next that those again within been weeks.

pandemic robust a business the we very So has been even expect solved. after

Andrew D'Silva

again. Thanks

Operator

Jennings And with your question from is Josh Please & our next from Company. Cowen question. proceed

Unidentified Analyst

for you Josh. Thank taking This have Hi. start. I question is here part COVID-XX two for my Bryan to on questions.

of the can for the share in in First, you number quarter saw first specifically and the cartridges used the quarter. per average stocking COVID-XX COVID-XX for patients trends you

each do forward And regarding I then backlog, you'll And COVID-XX? where demand, as with quarter Thank you. dynamic to expect normal well. up a have follow exit then for a question you specifically backlog become excess going

Phillip Chan

Yes.

usage center So treating. from I that patients to you that varied is also know, on of based varied It's think center. CytoSorb they're the the

or after having most after they're they doctors the treatment have been put ventilation develop patients and where of early success on infection the with shock. is mechanical think physicians soon I COVID-XX soon

bring example. think They patients reports was in – back. numbers those long far only world hours and of XX series weeks that of treatment. - usage vary had - ago cartridge used the case of the are across only one when published it I of use mechanical case patients webinar was that that CytoSorb in again, in have to they much - several gone our for presented one they vary all the We've is cartridges stays harder ventilation seen on the

the a We necessary patient improving. cartridges patient with flexibility is typically four are per recommending to if if do about treatment more

it. I most physicians think are how looking at that's

response they know reduction different you will reversal of an or a of observing, that that outcomes happens or of positive of mechanical or either initial a down know know, levels one continue in to are if you an mediators, outcomes. off You ability more clinical shock they're clinical someone types to get inflammatory other they ventilation number normal until seeing of

the your backlog. terms In question about

in the began I third quarter our demand time. of just were had a actually - CytoSorb we process excess that as mentioned of So patients. already month the inventory very needs the first robust was QX early scaling business we think you the planning the that - for to our in just quite press at We of at the in and and I were an in release to and scale to know needs build meeting the trying COVID-XX meet then up

the I QX And little supply. a of ahead got in so think that demand

you of try you the get know to can know engineering up think that so we we've this our - done Vince scale production team ahead team want you quality, I production, to that R&D managed - and curve. the just that to congratulate know really has

know that is But the good part process is our very about manufacturing you it flexible.

different We have And scale expenses. can the of quickly and be a incurring up ability scale lot very we flexible. very down without fixed to

I our continue that backlog know, you of that would are. So to curve be guidance of and at that we of predicated to likelihood ability be as ahead less, course we upon the but rate the is the to produce remains seen our think get

So an I is think the backlog just indicator.

to to is need. because whatever of and backlog can in patients - backlog out lot a there know, demand you meet that going you means we that we're it think that that know, do this I and there's

obviously so make that goal be is sure that able to to And our need is fulfilled.

Unidentified Analyst

a product so to That's that you on a COVID-XX, and the something use U.S. in the past you're to COVID-XX. approval remain seeking considering for possibility happen? the recently of helpful. discuss emergency can of allow Thank topic make clinical the the this staying this need And discussed data if you. market competitor you'd Is would the interval permanent

Phillip Chan

willing I willing the be do, that so - to at premature this Yes, don't it think is something able what comment FDA that think speculate like review to I'd I would not that, on to to or time. be on

Unidentified Analyst

Thanks. Okay.

Phillip Chan

Sure.

Operator

with Our from Group. question Maxim Jason is next question. your from Please McCarthy proceed

Unidentified Analyst

question. Dave It's Jason. Hi, my everyone. on taking for line Thanks for

Just outlined switch you update can wanted were by you see recommendations kind of X REFRESH the an on DMC? to were studies and respect us where and you want AKI Thanks. in give just here if meeting where with to gears the to the briefly

Phillip Chan

hear repeat I apologize, that couldn't part you please of would - last your you part, that I could – question.

Unidentified Analyst

Oh, just the were X-AKI outlined studies like the you with the you by meeting to DMC? where REFRESH and in of where recommendation terms prior were respect

Phillip Chan

we Okay. think on that Very are Yes, good. I track.

issue the work our I pandemic people, all with outside think know COVID-XX sites non-essential the within many one the entering the from hospital. that excluded organization is contract including have building who activities our and hospitals, trial including of research people for you from non-essential any

plus centers open procedures time that lot and and data, remotely scrubbing up majority to done and at things also that validation data a data to data of through that XXX hearing done and you're hospitals of been happened, they our lockdown CRO to working other this the beginning selected scrub qualification remotely. certain you now at date think know the of and the I to patients the they've that the we've have try amongst was

But again, some short that open centers to that to to last fairly done it's up that not be much be should scrubbing, I able in think that able get order. work And are finish to that open that - of done. data are we needs provided just

have address be terms put that and would of summer the in the analysis DMC would data issue to the needs goal this bed of we think I shortly sometime and the hopefully data thereafter. quality

Unidentified Analyst

circle quickly just kind of to That's Great. wanted And helpful. back here.

a number of into think - mentioned the going was was You right. that I it. sort missed backlog All again second that an it had I quarter, you that order

Phillip Chan

million. $X.X was It

Unidentified Analyst

right, you. All Appreciate great. Thank $X.X. Okay, it.

Phillip Chan

Sure.

Operator

Sean next H.C. from our is Lee Wainwright. Please with your from question. question proceed And

Sean Lee

guys. and quarter questions. have Congratulations questions. just Hi, on a great quick for my two taking thank you I

first U.S. commercialization. the is The on

started in XX reordering active you that hospital has and product. some already already the U.S. mentioned accounts You the facility have

do So handled is I separate a European plan on right and for operations? U.S. how structure was compared building now that to commercial your wondering the you

Phillip Chan

So within a force we've developed COVID what we the call company. task

of As our commercial of to full all in the around of have operations Europe, a you primarily XX needed commercialize a necessary out functions we know In of States, the countries outside complement the Europe, world. United but sales product. team the are with all effectively also in spread

up to In have not and the Authorization. from been studies this Use did clinical United the has the - new meet the manufacturing and focused set States, on Emergency ahead it more based States on be infrastructure FDA United the able to of we demand time

we That have here that this effort has company well. said, all been commercialization I as by a multi-disciplinary aspects with had in the European chipping supported help the the to people in effort company that operations, from of at think

hard coming in And manner. so to prioritize inquiries very again safe and a up we've sites in been to be to been and working have able start the these that responsible

what the So and hospital, I major represent to the is think hospital but relying therapy systems introduce drive a leaders that good key does to country on to obviously throughout to We're we've the sales, the been country. so it not throughout job far. doing opinion US way a a

enthusiasm States, early there's been a just of and - to excitement that here some therapy some cases And I of the lot success. getting of of lot fact, in cases about the therapy, a say in have with United early

United know manage making one and but without - most that States about have use the it So will know, I here think sales just and of - don't need be a utilizing what's We're build to we because really we I'm having the happening in the at team to we able what very it. you you moment. excited

Sean Lee

I to maybe on see. sales. question second a is My breakdown

since bit if was approved now for you provide wondering more shock a little and removal. CytoSorb for cardiac I could being So ticagrelor clarity on, septic now surgery for compact

indications seeing also which areas, growth? And growth? maybe are geographies biggest you the seeing the So which you are biggest also,

Phillip Chan

surgery third area treatments the the in the were pandemic I fairly know, XX,XXX So and cardiac in two we care, remains that the we've date, is cardiac the one you thirds that roughly think getting ticagrelor hit. split application before just of critical stable, COVID-XX in Clearly there surgery. of to started had

alone we a I for very over application. for the growth very as current for overnight, just have be removal So Mike the CytoSorbents' we revenues initial of become believe the - therapy application standard to some as press could is this and that won't that in in product, area of mentioned, quantitative said, terms potentially compelling is the Europe double this there a that that time, but we the that in being made for this release, mentioned care it be to believe demand do of large anti-thrombotic case

will - into revenue. will so that goes in market and And as that I that increases significant hopefully will translate think become clearer time by

continues you direct our that think sales know, I so And to dominate results.

before, can good COVID-XX having and COVID-XX if believe very - market business, that in international demand using success that post-COVID-XX from therapy for for company. business a term been the need lead they environment brisk the potentially from physicians as to are long will non-COVID our we the has to with therapy in and particularly we However, many, Christian sales, that many result mentioned think the pull more

Sean Lee

Thank you for I additional have. all the that’s color. And

Phillip Chan

Thank you.

Operator

Research. proceed question next Zacks from is [ph] lashing our Bocian Ania out Please from question. And with Investment your from Anita

Unidentified Analyst

Congrats questions. thank Hi, for good you on the quarter and taking afternoon. my

Phillip Chan

Thank you.

Unidentified Analyst

Dr. First me help Makis on maybe can clarify this.

I better able FDA. be would ticagrelor trial know goes, after guidance give you the mentioned as you to that the far with meeting As

wait ticagrelor, those study part actually risk for about be the complications. In who of but terms require the be Would might they emergency patient elimination patients at possibly surgery, of the the ischemia can the of too? demographic, what besides who of they

Phillip Chan

Yes. on you to comment Makis, wanted that. if

Ethymios Deliargyris

the Great Thank question. questions. Great, for thank you you.

to and ability ticagrelor been model, study shown a the has in of a of from in while in done effective return device function, circulation. in evidence the drug this know, circulation. the And removal also undergoing remove addition both patient platelet completely removed is therapy. And experiment in laboratory very now we a of So humans from Hamburg you have the the of almost from

which week need but get in washed in an hospital for can in a the way. urgent, indication very is with it removed drugs the the be they target that also for And that would you this wait so-called very, with as event are their out, bleeding emergent therapy, the stop and drug case, cases a a ticagrelor been population so be proven. variable. like not be and can have the diagnosed Why people that presenting therapy, patients regard, people managed addition this drug operation to cardiac acute the outpatient, where mentioned, already you urgent the first week. has to acute biological to an and So risk plausibility the already for the need opt on can for have Within now a they important to

of problem these you a rebound The events. increase drugs, ischemic patients in there's is take these when

who medication diagnosis, event plan that place, operation. they they're has in for an So has knows they the waiting in suffering treatment need stop as a however a their somebody the have imagine operation, how to

necessary will So with surgery They waiting course your Does mitigate - any that anymore. risk CytoSorb not the the and now with risk. straight surgery zero ticagrelor removal ischemic bleeding having have OR this this answer to thereby question? the during very the of and for therapy, this and be during march on period access effective indication can

Unidentified Analyst

PXYXX the - classes really CytoSorb was and helpful. Thank clinical other And you. antagonists? curious a to wanted of Oh, on if as agents anti-thrombotic up, know tested to being yes. follow is just Factor Xa in just besides That studies

Phillip Chan

as by Xarelto, which patients York rivaroxaban, as colleagues on authored the ticagrelor, in mixed a St. study is think and Xa Hassan inhibitors. one I population Hamburg, Hospital observational mentioned well I population before, Yes, the that in - of Factor study from Germany the of studied a

been studies removal done rivaroxaban showing - So again, example. by the have George for Angelou's effective future of and

it us worldwide for and or used deep - for could Factor or I for they thrombosis. Portola going the clotting rivaroxaban patients very inhibitors, can given have Factor the XX venous to a us. billion top in about pulmonary for know cardiac patients widely you cardiac what they cardiac it you so And high be and think relates and that's are need in and two of so surgery that that or think I market because as our a vascular show PE, higher emergency potential of or space, viable think embolism viable risk There represents other evidence Xa have other product patients risk I that and surgery. have Alexion, forward. And or these it Xa of developing are the apixaban sales inhibitors, a population very

Ethymios Deliargyris

add Andexxa Andexxa of on Andexxa more have discussion right, being clinical here. parallels comment bleeding. would with a topic. Andexxa life accident. comment this can Think is after deployed I if very being is Fairly CytoSorb. of versus different airbag, in used one I after addressed and the the occurrence the the on the There that's threatening is as need

seat of the using to excess and being CytoSorb as has and room. the bleeding anyone they Think we will therefore the will any who operating CytoSorb the enter be belt. standard approach circulating prevent drugs

the application different therapy, get any managing that bleeding right So the patients before be can will it of clinical event having happening population. to it catastrophic requires be preventing patients a is doing And the catastrophic very different used. CytoSorb bleed be now, from of versus a its very Andexxa size which its will also therapy

Phillip Chan

Markis, great. a That's thank you.

Unidentified Analyst

Yes. that. That for you clear. distinction Thank was very Yes. that

the give like waiting you on initial color also registration The how looks the some recently approval to relates other South thing a just from you are Korea? follow up got in from that us And to that, Mexico. still Fresenius? you Could like order

Phillip Chan

Sure.

to that Cramer, Vice me over Development. Let Chris? of Business President turn Chris

Christopher Cramer

Yes, by device is mentioned home million Health is in medical hi. Thank for people at the you America after Mexico March. the context to largest was Latin XXX And Brazil. Authority second market the as approved question. and end Yes, of Mexican officially the you just some for CytoSorb over

As previously to officially in CytoSorb and in CytoSorb they care the the for rights Mexico. approval this now so FMC import announced, Mexico as may with of product medical and distribute seniors well maintains commercial commence can sales

medical they've to a in and docs learned several major colleagues one. priority top well. Mexico force also quickly management we've and this and has and prepare As and motivated to come their building very and with work they've conferences think us very and market strong And ICU made that from Europe the Mexico. these to has as noted Their international that a excited they've includes with I and is our direct a this from we've speed group promoting mentioned, guys support been teams medical in awareness partnered working day with closely leading sales up in CytoSorb got they've very in amongst sales

that's and Mexico person lead CytoSorb to recently brought ICU this I specifically which new the dedicated One and is extensive of the a that things product. they've that, is the in accelerate network think and and worth mentioning with help good is in connections of really the sales commercial experience of comes head hospital and introduction business the sales, will

Christian that placed already they doing FMC top the else. XX its everywhere product order, demand place that first because warehouse has anticipate CytoSorb been New some mentioned, and you been that over question shipped and from for And on institutions. several they'll as as from indeed your has orders they've of To has Jersey washes our of already the know in work also have Mexico, had major COVID-XX it increased see free we CytoSorb’s

believe So pleased CytoSorb say success. positioned we're things how overall very I'd I are well FMC for and with are progressing and

Unidentified Analyst

you. a Germany the they And procedure European in like CytoSorb Thank that sales the region. have but a dedicated call do We more just one regarding that Switzerland, reduction? to for the know market, what territory about strong is do

Phillip Chan

question. like would to take you Christian, that

Christian Steiner

in two medical for general In terms also Thank supply. Germany the the and think markets of rate I, and compare of Yes, Switzerland certainly. the we you infrastructure can question. Thanks.

a in this behind. bit As Germany little you the is process reimbursement with a Switzerland dedicated know and reimbursement have we code in

it. health dedicated think this like always a have analyzed be we than comparable to code this, and So not behind And on years has yet data. code payments insurance is the I different But the two from other very market. but the

Unidentified Analyst

the study Yes. one Good. Thank the Are to from you. last data question. in expect sometime we the just And summer? REMOVE

Phillip Chan

throughout and in most have hospitals by delays that Europe as personnel. United at workers think caused these you've and limited COVID-XX any not again, States the notwithstanding essential hospitals hostile to I seen potential

sure indications now, we as of to let kind any think that have data update And But as that track. so you the believe for that make if And now, - still all by known. expectation we is right I on know, for we'll from they're right But an think delays on I mid-year.

Unidentified Analyst

Great. questions. Okay. taking be my you all. Thank That will for

Phillip Chan

you. Thank Sure.

Operator

Foster And question question. Please our Incorporate with next from SRG Bradley proceed Larose from Keith is [ph] your

Unidentified Analyst

developments the recent Hi. for question taking on quarter. and congratulations with Thanks my

the protect to how the the So on COVID course, way and me your you forward? the give that Can going when you. supports lives. crisis, used story and data emergency save trying filter collection a is support of objectives color Thank that in can and around process of some and around that your

Phillip Chan

Sure.

home, as the I the home. from if that care to it away further you're intervention. think The back. the you other coming get business when find I and critical around away walking like often being failure takes things of back from with - and organ have when better walk mentioned longer happen that bad late with early an I therapy analogy world, as before intervention than our we is

out that to recover. I amount organ so it's of for just bring go the think very in difficult failure, will cytokine further reduction back No a And cell, you necrotic example.

patients inflamed, to is okay. And to goal we So are but trying the I try otherwise here who are on intervene that to not intervene think early. highly

heart fever, on signs dysfunction are and cetera, fast patients, organ we to So is and fast those some of high count, but we're organ start intervening inflammation, symptoms when when et white they with intervening. develop rate, that failure breathing not

doing and very ventilation So rapidly hospitals, where deteriorating. intervening know, some are you But mechanical for COVID-XX, some another seeing often also CytoSorb on go that is and patients it's nice particularly think. data are early intervening escalate when people Germany in trigger very begins when mechanical when a patients worse they're ventilation to I think in point time when similar I with is

So I think it runs the gamut.

unique disease infection is learning new they've ever that compared as learning we of a forward. worst novel so think lot I called seen. to going the pathogenesis pneumonia The be Italy lot. In very they've the other pneumonias. viral Everybody COVID-XX we're a they appears this is to are and viral

a process treatments how therapies anti-viral use they're or think various And immuno not of these to therapies. I or whether so is modulator learning best it

Unidentified Analyst

of make support controlled of you I Is how relative a would said any in do is to efficacy type application a in that it's you way to be Like where used in or and theater the CytoSorbents can comments there way. think being.

intervention like ways whole COVID fair? at Is experiences. view. points significant draw from different different of in range might Sounds used different being this and - interventions that it's Or do a to be it you conclusions difficult a have

Phillip Chan

ever that they where I the been the done was have in treatments with CytoSorb COVID-XX trying different China were first on of variety wide think that patients. patients and experience really it a

early organ all suddenly, is which failure, early of term. relative a so had Some

here early pathway the in to as United in emergencies of the that life last States and be under expanded for the a end resort used relegated therapy treatment. of access kind the of CytoSorb think under I old example treatment

authorization it's that they now doctors when emergency gives have that think to the However, the we flexibility wide important. treat

early, a to of I recent with patients membrane are are most extracorporeal at but more the these and treat been are control randomised with wisdom [ph] the And but get a also upon based of think treating of your experience lot CytoSorb in there trying of trials, in other randomised in controlled studies that collective One way the that COVID-XX [ph] University investigators patients. ongoing that are to point, standardised our think oxygenation to ECMO guidance has trials there I CytoSorb using the Freiburg process. is

United your data try is from here the you such coming controlled And data know to studies also answer that in to and to will study a randomized best do those States. coming. looking we So the the is question be are

Unidentified Analyst

Thank you very much, helpful. very

Phillip Chan

Sure.

Operator

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

Phillip Chan

to taking all you certainly support. call. Okay. for Well, afternoon the appreciate this We listen time the thank this of to everyone

feel at please questions, night. reach you other thank any Jeremy next Until free time, a to have do LifeSci you to Advisors. Feffer good If out everyone. Have

Operator

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

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