CTSO - Earnings call transcript Q1 2021 | Cytosorbents Corporation

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Operator

Good afternoon and welcome to the CytoSorbents First Quarter 2021 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 our moderator, Amy Vogel. Ms. ahead, go Please Vogel.

Amy Vogel

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

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

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

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

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

Phillip Chan

had you non-COVID that that core activities COVID-XX for year growth broad believe sales two higher. $X.X first sales for XXXX rapidly Europe if much, sales would would restrictions declining business afternoon, up and impacted and XXXX XX% quarter been of first XX% and with $XX.X higher, We quarter. of very and We globally throughout were in first the XX% the countries of also We underlying months the sales moment. even of other ago, in that the of in have Blended productive new been from believe XXXX. million sales with everyone. gross lockdowns the a CytoSorb cases Amy of in and another quarter product quarter versus XX% first million, One the good Thank XX% accounting margins quarter not have year-over-year.

Excluding non-recurring in detail presentation. later the in items on will XXXX her first of Kathy were margins XX%. in gross one-time Product quarter that

quarter debt. a cash solid We also with ended balance no with million $XX.X the and long-term in sheet

which greater than distribution we date, with to quarter, countries. During cumulative delivered up the CytoSorb XX across XX% a XXX,XXX is from XX,XXX cartridges ago, year

We in in also Use in XXXX. cumulatively treated April more United here Emergency countries, of the XX than States Authorization FDA patients X,XXX more now under granted including than COVID-XX

Canada patients targeted approval in million - during authorized trial sales. EU use about to In B also recently with also Braun with approved received the Safety, million And company worldwide Food a for in during and XX we IDE indications the Medical the FDA the into in for South Avitum, and people. partner third our patients first COVID-XX for Korea, just the Korean first quarter, year. Korea in with hospitalized we all X.X equivalent in also agreement Braun, a Drug of the Ministry a STAR-T with KMFDS, conditional this EUR Fresenius population collaboration US Canada, Health in in B world begin population CytoSorb Care. of of quarter a has the of global that approved largest the XX CytoSorb entered We of third also with co-marketing quarter, and billion quarter dialysis division

guide During that the in quarter, us backgrounds, we the success also appointed two future industry medical strong veterans, future. help will with device

James knows of East was Integra Affairs. Cox Medtronic Dr. US Vice joined Lifesciences. Group Tissue area President Vice who who of Vascular is at cardiac the Komsa, well. Restorative Regulatory and formerly David President Vice Vice formerly Affairs appointed was of also for President as of the Group and us Technologies a and the first and formerly Therapies The division and of He surgery at Vice at as extremely Marketing Medtronic was Pain the President Regulatory Group Global the Regenerative President Sales North a Cardiac

our our We of in webinars last we of manufacturing sales support different to margins in marketing $XXX new a areas, new with of dialysis wide signed in to cardiac of is applications, gross liver also that and variety with lease but therapy New XX%. our not as for notably Jersey in-depth And in a accelerated particularly began million $XXX Princeton, million facility excess out in disease most and sales. patients headquarters clinical building product anti-thrombotic liver expected And roughly CytoSorb removal. surgery potential least, our

warehouse new the accommodate our growth. Logistics future an and also we and the quarter, Hub distribution facility in During Berlin, current opened CytoSorbents expanded Germany, to

our what about doing let's relates this worldwide how to So a business. COVID-XX talk and bit

roughly grown Europe new middle as well We the As activity in Middle in starting the to in surge East, presented that see America, as left-hand on a experiencing in in - months, and day. activity in heard as XXXX. the we've last Europe. all in of India, was see COVID as earnings XXX,XXX where forward dramatically of they're two our of by you have call, this numbers were America, upper well Fast side, just March Latin cases a cases South in new can the we that

first here roughly quarter. XXX,XXX cases quarters, the after what can is in January, On the peaking dropped COVID-XX early you the of the to cases dramatically quarter see very quite can the the cases or first lower the in And see of so right-hand side, green numbers in of COVID that within worldwide, day. first two a you bars new is

helped a cases to quarter, in plateauing a CytoSorb that and a lot the of of think towards started fuel But of not COVID-XX the that COVID-XX anymore. we worldwide. see did of rapid business our optimism in of the to be the serve And sure regarding of business end areas. of can a lot that rise enough, and problem cited the vaccines, think earnings related you we has our as much people new a would had I strengthening call, across last see COVID-XX availability

is depend sales product likely second of But story. the that rates of multiple So including the COVID-XX to of the expected a States, magnitude may very quarter different for we remainder to contribute vaccination. In the factors, on year. expect the it's the in and XXXX United

low early right-hand you relatively X.X% also can this, cases XX and date. only dose, world, of March, a And like you in of can or least even XXX a in scattered, level one Washington State, the May, corner see were was that early one upper like some in there States activity And the least can or you or flat. at administered fully worldwide generally are get X% people country. numbers world's health Oregon or hotspots see than the the look As the new have their been this COVID-XX And in speaking, And at rates and been you fully when see is population one not see Michigan kind you throughout previously, with even having now although million rates the there But people roughly dose have can Germany, one for million, fortunately dose dramatically. the of more vaccinated that likely been of red doses dropped it the million and least total the that death are the that fully XX, the only hospitalization graph, it US a have US of see even you vaccinated. plateaued. to the the XX% of accounts leading population patients XXX And of people. have vaccinations United with XXX are with only worldwide. to of million with have cases worse an finally population case at where vaccinated case And may all large of And new of numbers have had although fully impact the X.X% XX% million can the third people. XX% the with in contrast countries with million XXX vaccinated X.X of care countries in or

sure that being first continues presented we this the can not normal to you yet. slide, are have see next slide pre-COVID-XX can the to say earnings in we in our coming the So, that quite new quarter. COVID that But we back accomplished call, strategy. delay growth on in the turn to we're safely clinical give I We're what standing said, last still it as our not certainly making business let To - Medical you Deliargyris. growth that background now Makis? working we me Makis over Officer, in and activities, on to return soon more Chief our our non-COVID-XX diligently as growth our possible. non-COVID color the Dr.

Efthymios Deliargyris

everyone. Phillip. Thank good And you, afternoon,

minutes, that updates to information. like the few press you also we'll next clinical we additional refer just on programs. some has of important the issued review also But the release I'd Over to our

FDA lead We programs that us approval. are will prioritizing the clinical US to

Device have We're Exemption conditional that And first surgery. approval on happy we activity As new we received report to resuming Investigational study addition sites, of disclosed, have majority I'm Ticagrelor removal REFRESH recently in we to screening also started patient our cardiac the enrolled. the also to the execute X-AKI trial. during FDA in

for real accumulated [sic membrane progress cardiac The getting Registry also that otherwise end COVID-XX XXXX. mechanical patients be meant in is world by sufficient known this to recently approval, quarter, target and the as the surgery of been and with CTC a or now summer, have the studies, completed. trials is important requiring refractory Germany, in septic a for significant making COVID-XX undergoing for submissions has will have entry Europe removal year Therapy this driven we're We and launching Registry, active this focusing two data for reasons. in ready oxygenation HepOnFire progressing study before of This are extracorporeal their ill we're And use known the have on STAR capture acute close oxygenation] trial otherwise progress. with shock, trials. critically least trials made by the ethics. failure in to ECMO. and submitted decision The We - to on data UK. was first device patient publication septic patients shock the the that in Both made TISORB both those on in two which in of the starting at to main waiting chronic the been trial of PROCYSS in support CytoSorb are the significant begin liver two these ethics we we're countries anti-thrombotic evidence end to extracorporeal in in remaining

First which the STAR-T also enrolling were executional all, hand submission. setting the German other the plan. significant able begin strategy actively of the of with data of for prioritization clinical UK three patients in the of as of CYTATION our now steadfast evidence sites and in on to pandemic the on generation encountered in Currently our we'll our was first and quarter this year. that remain FDA the and delays the the is primary and trial, will be study

STAR-T has all of year. new right device. real ensure now to going in clinical later patients I third have the partnership guess our this And that you continue The the with that could so The the in that is XX the have get to to and QX approach two our data of academic the CYTATION capture throughout report about study and since and say a first begun generating We're enroll, continue our continue in our to as has to by approval enrolling the a be been analysis On TISORB trial. team patient make plan. top we're start multicenter, to lines, economic of of going trial value leadership year. and in past happy programs timely and with Registry real before resumption. we'll we're presentation in quarter. right will now focus STAR-T stage we'll our cost do again year been up start outcomes the from we the of our study execution STAR to we're we company-sponsored we end there's registries And we're world-renowned first world clinical the of plan effectively powered, of for X, patient the has in rigorous, are trials, detail using study, randomized this stated, evidence clinical I more REFRESH And as And to to teams is gearing and to review. also and the targeted the going to up expand complementary data early associated capabilities; the in summer. expand finally, the of the do And on proposition trials. efficient XXXX. enrolling you will top to our health discussed, ethics some expect of enrolled this a share at in We world IDE this middle institution anticipating that the we academic to I going members see we're the obtained. slide, previously submission added enrolled operational the enrolling In XXXX the readiness busy gearing milestones progress that generate stopped. the capturing to use data to internal year. we've We're investigators.

by Care is critical also I this in commence will the of arm, we the despite it by finalized year. the quarter. collected the The to to QX. in Germany. end to And we been patients Registry this our review enough Critical single we to has able we or trial, of delays it to now and in has multicenter, end plan situation also trial expand Care expect towards the applies in associated of the HepOnFire care be data multiple COVID-XX the a expand plan applications still capture and and Similar by with space, that the to and as anticipate the which QX beginning we enroll Critical to submitted in sepsis Europe. already of PROCYSS Relating publication Registry been committees protocol the ethics CytoSorb Importantly, again into submitted. enrollment stated, US CTC And Therapy have end the we for submit

slide, Next please.

the the forward of we approval has the studies, now by REFRESH dual two have XXX with active is and we Relating up patients we active begun, I enrolled interim and Our end X clear date. screening the we study to path to Refresh study. and sites and FDA and The is milestone will priority patients and The resumption the open are have second STAR-T approximately maintain of to our the enrolling the half are stated to sites analysis. and believe X, next remaining of quarter. look to the as

assist take investigators. April that committee. more the begun important Regarding green received clinical to introduce identified, the light to including study. our a two committees the IRB like the our us the enrolled principal contract research have The start the that The the to the will disclose STAR-T the XXXX, the is are the Most approval contracting we'd to already Surgeon of already which events a Dr. have quarter conditional and you vendors White; and today, previously, leaders investigators we participate to going IDE trial, sites process the initiation in going us including The year. two Gibson, board investigators data to activities. have submission Harvard. you been in to gave be, importantly, Michael Cardiologist of Baylor in of our It academic and in we'll we're study, Dr. organization. have third we detail study currently we principal selected Michael the Interventional stated safety site study effectively and to is from this been site progress Scott an minute in and And patient from be Mack, are monitoring established first targeting & be as to Cardiac study

an programs obvious the during that First taking cardiovascular in Team the a in the syndromes, acute became surgeons. and approach. targeting century cardiovascular suffered And it's When coronary Heart for we're to a very that event, the we're the valve disease they of opportunity transcatheter knowledge our necessary. input devices, probably the Team both from acute our in a approach. most case, and patients approach of the important cardiothoracic cardiologists development and He interventional require great was utilize all, innovation Heart multidisciplinary

but we such the CEO also Medical School. world-renowned As have is Institute. setting, the Scott also the investigators also for Service of at non-profit Editor-in-Chief Baim Medicine and Michael a physicians. President Dr. And is Chair equivalent of President Line the White Clinical Wikipedia, the of selected of Mack as WikiDoc, He's Cardiovascular of Institute. the & most the he's which Professor Research Harvard Baylor Scott of in Founder two and Harvard formerly Research the & the of at known the Dr. He's Institute, Baylor is White. Gibson

about Mack, the the Pioneer he that transcatheter important what's Heart first to Dr. part the FDA therapies clinical trials However, he's was use. of and to of the and pivotal Team to leadership of approval valve brought the also note

were and I'd Clinical as of to and Global management. portfolio like very execution held operations has in He think coming global optimization. years Tumaian, for brings used the management continued risk-based driving hire we're and excited with critical Back like lead he remote products technology Quintiles into large both of He very Parexel, in We This about to a monitoring. in also Nexium, teams the Director in Thank to you addition team clinical players and and Ed our and and clinical and like Global successfully including at Ed, operations him Team. Novartis, Ed roles and activities Gleevec. CytoSorbents. leadership built led our AstraZeneca such to and more operational Phillip. industry previously is And Prilosec, drive progress. the clinical has Clinical experience you, blockbuster the career, global and team but is to than XX lifecycle in role the critical solutions introduce his Finally, development quality programs key fill trial CROs a monitoring lifescience has in key contribution he's teams' Sanofi. Plavix Clinical Operations, implementing his efficiency, Executive of He his you. on throughout to

Phillip Chan

for Makis overview. you, Thank that

give the Now, please Kathy, you overview? would financial

Kathleen Bloch

Certainly. Thank you, and Phil everyone. hello,

call, results, March and regarding providing and update I capital an financial also be our our XXst, today's runway. an will XXXX cash update For around working

start distributor sales of So includes And for in $XX.X revenue $XXX,XXX we'll is the $X.X Product of first first $X approximately an to $XXX,XXX as approximately million. quarter the this increase by the XXXX to the first an $XX.X quarter primarily XXXX. million first to compared was increase was in for million approximately million, compared the increase $X.X quarterly for of by of sales well sales first XXXX. income Grant product results. sales as quarter million. as with also total our of million for comparative sales or And increased XX% over revenues, of revenue product XX% of which which in an and driven $XXX,XXX grant XXXX XXXX direct increase quarter as XXXX was quarter first quarter $X.X approximately of of

XX%. product QX gross margins were Our XXXX

the XXXX. retention quarter approximately XX% in employee tariff negative and credit XXXX. of 'XX were And positive That impact XXXX, first tax the XX% of non-recurring $XXX,XXX, $XXX,XXX. adjustments QX product to of of gross 'XX in the offsetting the compares Excluding of non-recurring margins impact

please. Next slide,

quarter-over-quarter Now we'll sales. at our take product look a

we COVID-XX including in reps had The our prevented Germany, restrictions and Italy the been the And others. sales. widespread believe hospitals quarter previously been first first and every our been XXXX delayed to three of lower we and quarter, calling the higher, normal, Europe, were And already in approximately quarters. product sales have for million trying from sales the growth though to to and lockdowns strategy accessing new it's and discussed. for in Austria, quarter so sales, to cases saw not our UK, hospitalizations quarter. quarter Phil that than third in of what difficult the Phil $X.X and rapid we're terms of And quarter quantitate, do it COVID-XX XXXX, as million return first be of that estimated for we've distributors to $X.X new non-COVID-XX which throughout COVID million the decline even $X.X in two-thirds approximately lockdowns could best Our the was prior in XXXX compared the as mentioned, sales

COVID-XX COVID-XX stock if clinical XXXX, orders one March, approximately strengthening have of CytoSorb. operations of and EBITDA final seen the the quarter we resurgence a positive first expenses, of exclude a With expenses our non-cash related And of note of trial we $XXX,XXX. just since on core generated compensation

Next slide, please.

take a chart, months trailing you sales maintain to Now growth. gross blended can look And and and XX continue margins. we as this at sales we'll margin see product product our gross by year-over-year strong

months March trailing increase XX% of of one an XXst, year ago. $XX.X million product trailing XXXX, over $XX.X sales million product sales or of months As $XX.X XX XX were million,

previously adjusted to note observe XX% as also of also quarter trajectory Year-over-year I annual we the And to margins for approximately of quarter benefits gross gross non-recurring first rate we'll first our CAGR and charges in the was in our review discussed for continuing margins a lastly, XX% with XXXX regard. continue of climb blended capital positive XXXX. that We three this years, the compared over position. growth XX% very past or working to and are compound

gross the XXXX, any allow need funding And without million that capital March us to very is XXst, we which operate breakthrough experienced on result clinical provide in to execute we strategy. commercialization to trial sufficient with fall every for have continuing quarter to believe is we spending We less associated dollar our the CytoSorb quarterly to in $XX.X margins, adequate the XX robust percentage as GAAP additional of GAAP million to of we We burn plus to for by our profit. balance. a sales solely first of activities. further with the reach once than of operating burn cash, well As breakeven. have clinical way, of believe breakeven, of we $X XX% cash approximately XXXX. to healthy is incremental our And as And continue XX% a expected that a trial had to liquidity

Lastly, we March as on call $XX.X like of diluted million And fully at Phil. time, Thank a to shares XXst, common this turn back approximately Phil? had XXXX, basis. I'd you. to the XX -

Phillip Chan

Thank you very much, Kathy.

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

the exceed provided However, order current for pandemic, quarter continues, second related XXXX sales well contribute in markets, the of Because the expect the the and though in those uncertainty for the quarter vaccination will of and on of COVID-XX in activity, withstanding of surge rates second of remainder recent the globally. including the to magnitude product that factors, COVID-XX we COVID-XX to expect pattern positively XXXX. the that not the quarter multiple in major depend of to as these second as year, sales sales we XXXX of will

continue year growth. represent to XXXX will another expect We of that

now prepared this Q&A open So current to the that, concludes with call live session. up for I our remarks. a would like

Operator

you Thank -

Phillip Chan

Moderator?

Operator

will of Instructions] question. from Please We Thank take our Jefferies. Anthony you. state question first [Operator your Petrone

Anthony Petrone

the here. strong Thanks. start Hope year everyone's well congratulations, to and

approaching XX% a and Phil little growth could Kathleen, level. COVID sales year-on-year of maybe, You - know underlying out product when bit dig we to in a sort back we

in out pickup procedures, think being, usage seems just but that buckets. of be sort to reversal in by one, there certainly uptake to also well. there as non-critical CytoSorb and about wondering COVID triggered One sort areas And you've two how underlying seen a some of

were that elsewhere procedures the number a driven couple So have how recaptured share think I'll procedures? and all versus about surgical COVID And we gains do by follow-ups. that driving of

Phillip Chan

Yeah. Well, very much, thanks Anthony.

Europe because I increasing. that the go been procedures rates of United in Eastern the think think well in But I touch well. been of the States, related Europe, are non-COVID lockdowns Europe, around as that it's countries various as in as has and

is, post-operative can able comment on now. Christian environment you that to know, bit also, We're So, conferences, get using a in They're attended. looks Christian But to of be elective what little over continuing of the seeing CytoSorb. seeing we're in typically reduced into of to Christian? our the like sales bit probably color also But typically give what often more surgeries numbers see me on have - still reps were the what right been lower ability effectiveness he's turn to little hospitals. are And conferences, let less then scientific a where to Europe. that it poorly period.

Christian Steiner

Thank thank still situation pointing kinds out, we question. is lower compared you, significantly of was COVID-related to for of as One Yeah, business the Phillip Yeah. much and parts Phil COVID have you, Anthony two is the was the our very QX. impacting business. And situation.

the exchange between dollar. it's same, considering the You can of roughly X.X rate see this QX, XXXX, QX and euro USD X.X million and QX, change USD million. to But compared the

So has in patient what week The ICU second happened declined. QX?

in for there to out COVID less in led US. less US, in led were roughly activity. patients, beginning And to the patients patients ICU In the well, pointed which there Latin were business QX. less example, the America, the stable summer Phil So of as as

restrictions markets, On hardest and the there throughout the the our were COVID other whole in hand, still pandemic. the were

timing I elective in there is the a to at down of over growth XXXX surgery the to QX the imagine reps more and markets. if like have would XX% So industry down not I doctors energy all the to, the 'XX, distributors all if hospital better business. even detail I in the is despite even to elective to do that totally have shown access look for got of they you could is are a professionals harder. to if healthcare COVID-related go of have they exhausted sufficient. even say sales can and this has surgery one say, to but little growth, programs positive representatives. XX% think have the impact our time speak QX we we And bit And want, you to programs, most would are the much XX% I important without and restrictions The and

Anthony Petrone

be I'll That's in and last And that patients point? that Two a just are for at hop there more one key sites question me, then on you on STAR-T, elective in bit detail got me, some is the we would back follow-up how consider the and in for then this to headwind there a extent is Thanks the markets. again. can still share the XX%? you US this expected many Was questions fine. one, stocking endpoints little

Christian Steiner

stocking there I your say, right, we no no, treated. So There's the any was of. are aware It's in have there like can out was whether if or get with distributors? patients stocking and no question, in customers understood I stocking. product the

Phillip Chan

Yeah. And -

Christian Steiner

you. Thank

Phillip Chan

In terms is of STAR-T detail. and both FDA nature trial, the number primary in other all has we'll said to, the of know size the the give exactly we've sites the approval on of terms we IDE detail the of more get agreed - yeah what endpoints, trial, the of study, once and full the what that of that, the

Anthony Petrone

Phil. Thank you again,

Phillip Chan

Thank Anthony. Great. you,

Operator

of question your is Cowen. Our Please question. Josh state next from Jennings

Josh Jennings

products EUA COVID-XX. any discussions interim could was know about despite talked And [ph] CytoSorb ask they for FDA And and the evening. questions achieved that. be CytoSorbents this Thanks the to good the And an [Avimed] with formal if wondering and for with Phil, care EUA path on I there's hoping approvals we the was strong are Hi, quarter for the critical to FDA about have that between streamline Congratulations a there the about a potential approvals. ongoing that on for streamline but of about challenges. I indication? whether call echo all lobbying had spoke we've just I probably before, comments I taking to year executives. Anthony's some start

Phillip Chan

Yeah, distress can have do on treat we had is something not thanks this comment and COVID. overall interest, at Josh. And in the have of acute But considerable syndrome. much, time. actually that amount It's respiratory relative very we numbers an to we it ECMO to experience

not approving you United time. potential treating but, the of that we in a but So CytoSorb comment benefit there this it's so ARDS is that do on believe at know, in general, for we can something States having

Josh Jennings

Clearly do patients then data? potential US and the do? that ramifications supportive and COVID future I COVID-XX on the the increased globally, streamline interim any CTC you to then just in catalyze of mean, outside be could but that on CTC analysis. expect that Great. What the pattern? set of data, utilization registry data is And - it COVID-XX registry in for that could

Phillip Chan

to you kind mortality of rescue more non-COVID that in You actually of be know, it's may uses a as promising in the patients, plus that think and know, treatment therapy when ECMO currently think I positive and mechanical respiratory in respiratory even is roughly have And, injury, CytoSorb We've syndrome, environment what there, be when has been that, seen benefit of distress a a we've I seen aggressively, very strategy a for primary weeks. is ECMO patients acute a long it's of and ventilation treat used acute used here not intervention potentially hard preventing where still those to know, rest with lung cases, early play and syndrome. hyper-inflating CytoSorb a ECMO there earlier today with used mechanical a but as XX%. distress which to ventilator-induced lot use different weeks on they've patients, being you CytoSorb

that think it's study, - So it of order - data application, I scale a require the, know, concept. large I would you larger registry gain will that think be the in to not that supportive but multicenter but

Josh Jennings

Great.

And Now thanks questions. get for queue. the back taking I'll in

Phillip Chan

you very thank Yeah, much.

Operator

Danielle question SVB of question. is Leerink. next your Our from Antalffy state Please

Danielle Antalffy

much so the Thanks for everyone. taking questions. afternoon, good Hey,

Europe and on growth from in But able and COVID into being lot ticagrelor year imagine Europe. of comes there's I this competence your I rivaroxaban centers portion there. have a a that to still moving back to issue in get a European indications. good question the really a big of is Just and removal appreciate parts market

in so adoption in follow-up. adoption have just of bit a where little gives that ramp And once are you're what to seeing ramping actually And yet a one there And on the of, confidence sort get get centers I Europe? you wanted I sense in there? can of back you more sort guys the there

Phillip Chan

we non-COVID the think to as surgery. advantage that Europe this Sure. core team and in and care a of in take commercial cardiac we've marketing, Yeah, overall previously, and I really infrastructure sales bit in that quite opportunity said our critical invested and

in XX% actually mentioned, business as well and the sepsis quite core illness business So And cardiac critical we healthy. that grew surgery year-over-year. as other as is in

I to think to particularly And this strategy. are I little doing, doing provide bit non-COVID example, back a you able looking the think the we here, and microcosm that get moving what to on market. forward surgery, to try in application, blood additional of to tell Christian? some more Germany, cardiac how thinner in, about might for we're as detail Christian in be a in we're

Christian Steiner

and Danielle Yeah. Thank for thank you, question. the you, Phil

little happening bit you to Just Europe. flavor give on in a more what's

development think the to I perspective. whole one see in has

centers are this are have is could the before, just As the said and last were have that access southern in of have - Not indication body XX% before the the mentioned also CytoSorb the case, restricted growth also in more. in hospitals even this increase we be nowadays, decline the of those, in sales us. in the heart pandemic. taking And And have XX% appointments has reps by heart of to XX% roughly closed, we into the this new our our normally mentioned COVID of reflect much and And I I more XX% XX% of restrictions to to But this very in surgery I programs customers. think than more application. seen The than perspective. almost elective Germany call of to the our despite removal is despite indication, antigen all using are And you able, Germany account, XX%. centers earnings fluids. this they also core

customers heart the those nowadays. of in are XX% XX% centers is CytoSorb who now new than have as more using application We our this and

a in it So you other that in we we new But outside had Maybe is bit can opener you mutations. as insight door we then in markets, this see, Germany, in also markets is application. direct of use a once despite accounts also started giving all once And more also these number this this our in the to of we little progress other development. spreading Benelux, in, restrictions, are a for there is see a example, progress.

Danielle Antalffy

trial. helpful. then of And quick that's follow-up incredibly Thank Dr. so I mean, one very Michael STAR-T you getting on much, Christian. Yeah, know highly Appreciate no, on And very him I regarded. congratulations he's that. Mack. the well and

guess timing going for a is that's STAR-T? for Because to think enrollment you point that's I from sort think company inflection the the I be, of really perspective approval. a US I big So around what the guys. the for the gating factors are win sales

around Thanks So just thinking want the to appropriately bear bull so and sort and putting our of we're timing barriers make there. scenarios enrollment about sure that we case much. case were

Phillip Chan

Makis, that? to like Danielle. would take Thanks, Yeah. you

Efthymios Deliargyris

Yes, thank you, Phil.

a So has record Mack, yeah, very antithrombotics, Dr. Michael also, incredible an development, you also and in Mike regarded. about know, track great point, but you know, that's Gibson Dr. well it's

you surgery very, additional, a from with help, of now with that have number know, centers. sites know, US been of we very connections, with So their large US, from we've you interest. a also REFRESH-X seen and in personal lot network of some we had and contact And cardiac large

we're long sites have slowly high we start them going know, performing of list So a that on. bringing to we are, you

we can right, that's them that vet sure using you probably one agent to top from interest we the we're And and enrollment, But really syndromes. number what's factor obviously, this all drive line the ticagrelor for we coronary they're, So, have the a execute. making think actively sites. usage sites, the is seeing about resource right drug getting know, important capabilities acute as the then

unmet clinical study. has the this this to about deal know, And of need, part nightmare extremely surgeons been in a with. they're for longstanding literally practice excited being You a

seeing we're fair sites lot a enroll. the you kind to want sites us you amount able that we level, on continue bringing a we're board, to the interest So, of of REFRESH-X including gives the sites a with will from know, to research that the of kind be of confidence us, momentum know, that

you that, having urgent require number or limited of to ACS the emergency Now, said will total surgery know, patients. compared are patients the

on have of know, be around Phil earlier, disclose, said Once the know, the, FDA. the number you the full are we'll our So very we that's completed, details support you right from lot the study, robust to you intend board know, like why discussion be - ongoing a approval discussions the enrollment, and once soon. able to we our, should we bring sites to of

So, the we information be disclosing will Does more then. help?

Danielle Antalffy

helpful. Thank That is you so much.

Efthymios Deliargyris

Yeah.

Operator

Andrew D'Silva Please your B. Securities. Riley from next of Our state question. is question

Andrew D'Silva

question. good Hey, afternoon. taking for my Thanks

I mentioned calls. between any these, you of was if Sorry, jumping

on strategic cases Just traction Obviously, increased as region been press uptick releases partner of the you're as was longtime COVID there, to in to it call. seeing in I times start, in the you've cases, Biocon. a Biocon CytoSorb, a know, did any you India. if well with relates reference couple curious conference their as in

seems current it's know, like given conditions. it you So, regarded being well

Phillip Chan

Yeah, thanks, Andy.

and commentary turn Christian? some me Biocon. to to Christian give over color on Let it India

Christian Steiner

you, a India maybe and general. Thank bit Phil, color more Yeah. little Andrew on in

all and and our expanded have now, areas. we currently working in can these are are of of us so application and evaluating course, long Biocon segments, the that in know, fields grow they for speed as a and last up Biocon with with time We represent also our on you we over indications, how years, India to growth in how application relevant the

in installed to So, we have have Indian manpower market has and to additionally the the partnership, of support own Biocon number to developments. led a this we

wave in growing now that and For example, massively. the the so India COVID pandemic second is

like of treatment hospital COVID patients, have as Friday, whether leaders of of specialties a organized We groups I Apollo. this, with were in the medical different last you of also meeting the involved big leaders but know don't aware all

Biocon tighter and this so will also be And increasing, by collaboration and our this COVID reflected orders in side. situation their with from is several obviously,

we can think that's review. what I

Andrew D'Silva

context. very useful that was No, no

COVID. at nature of COVID-XX. this So, know their some and areas, but I COVID-XX far be then, - CytoSorb, physicians can indication with realize cases no for the know, And that when amount of using transient they drops, start goes of beyond CytoSorb that being you I COVID company, said, in COVID-XX a least long-term, obviously, that imagine kind would a isn't related utilized

I'm of analogous an sort I'm that utilization, is can you're that asking a thanks curious any been potentially there to stickiness situation you to that has curious, but region. of know, you India the COVID identify, there. COVID? such the kind as you And, large of obviously, I'm is see utilized outside if reason So developing

Christian Steiner

with I So, continue this? Phil, Shall

Phillip Chan

- I Yeah, come can in sure. Or

Christian Steiner

Yeah. Yeah.

in you So disease. liver example right the maybe market a very is worked India private not indications, India as we for India But this might also have including in also different including this, because with and sector all know, cataract public sector. - the and specific the surgery, already a is

in treatments lots have of the this case, pay public sector, in privately. customers the even to patients So or

America nevertheless, have XXX healthcare but I think, the can where from the and much as million last year. to have with market started. question we we is in I be million people So just in able we with started case But pay the Latin better XX between was answered it the know think territories pandemic, And your which actually [indiscernible].

shock and statuses of with including other other shock but and on disease. from treat patients, last countries they also with patients So also we Latin patients. have most America, them year start know, including patients, added, including inflammatory liver started as region to treatments, XX you in the successful And based COVID-XX septic

inspired to So COVID say, treat let's what we other absolutely that you suggesting that the and were other pictures. based see get, on clinical experience patients with doctors

Andrew D'Silva

Okay. Very useful.

Phillip Chan

storm gets that. patients day add diseases, such were And infection then cancer complications Again, burst failure, kidney who not to CytoSorb complications is see inflammation same failure, Yeah, the different by mean treat or that central of such COVID-XX patients that I to know in role or those - plays leads in we you to immunotherapy different a that all treat example not other or lung in every know, so trauma to appendix, COVID-XX. are I types infected in organ is and to pancreatitis it's uncontrolled infection, burned just many injury. with, of patients, and the you the things. shock think patients for used the generated cytokine viral just

to kind as this CytoSorb very shock and non-COVID in easy lot And patient so shock, to also that helps see patient It's this are a in think, of use in me it's stabilize you if where trying translation patients. these Right that's know, a who's let it well”. we new markets. in they of know, a you think direct, in COVID-XX “Hey, about

Andrew D'Silva

And was driving I first Okay, where want Is correctly. quarter, sure character Germany, such it still the I'm our areas make great. lockdowns this to just you a COVID to okay, very or of likely types COVID the However, relative least the you cases seeing XXXX. from? ill amount generate it revenue of of weren't the dropped COVID-XX you at patients stringent as fair portion say understanding that during the and that know to, majority sequentially significant were know, maybe of state for severe critically as meaning, you

much basically, as they ill get So as COVID-XX. of patients, lockdowns, necessarily weren't you you your legacy volume of patients had the a a percentage treating that but from non-COVID critically because as benefit related, of many total impacted COVID-XX didn't as were a business,

Phillip Chan

And think all numbers correct. that's I Yeah, that. support the

that the you in of hit the of deaths, in peak December when and February, dropped early ICU and numbers after the all look and hospitalizations, January If capacity, of they dropped at utilization, cases numbers late January. having precipitously numbers

dropping had COVID-XX a lockdowns because the countries instituted very worldwide of though continued even began those know, of rapidly. cases lot You lockdowns of that. But

to know, new COVID the look manage as or a us for to So to it know, and cases dropping business normal. was we, as back little bit a back you getting usual of transition you that

Andrew D'Silva

that and additional BGA? updates know makes is you previously, referenced me. there of CytoSorb a lot to another candidates, or was correctly. curious then, was how of just or developing? on Any HemoDefend-RBC for pipeline And CytoSorb-XL Yeah, understanding sense. I Okay. was question Last make I I outside sure the wanted that you that just

Phillip Chan

Yeah.

the drive has as a $X.X HemoDefend-BGA, slowed the, making these in I little think year, in received from development to that, which about from you a very government particularly know, the been recently. development COVID-XX mainly very saw, work actually we our Army, But grants various certainly programs. bit million you US last of of nice progress,

fact, moment folks of you distanced in new in have terms - actually the at the get labs, and more so, been done. and And work with socially lot stay the programs, a new the development lab in and, in and these get research back to the facility they're at our their able know, space

so really know, program but CytoSorb-XL, well. And the including slightly all on the is program, some the are been progress making you site of And still programs, CytoSorb-XL program. we some as the they've that our great progress I delayed, making HemoDefend-RBC the mean, in HemoDefend-BGA program, to CytoSorb-BGA

Andrew D'Silva

you Best Thank perfect. very of luck Okay, going forward. much.

Phillip Chan

Andy. much, very Thanks

Operator

question is Sean state next of Please Wainwright. Lee question. Our your from H.C.

Sean Lee

taking a prepared guys my I you think of saw distributor afternoon, and bit sales. that from Phil question, My Good for in first quite questions. you thanks mentioned remarks, the growth

a provide that's more think geographies example, biggest go color So and I from the that, was bit Thanks. wondering growth distributors for which going on you are could you little if you to seeing and where which do this year?

Phillip Chan

Yeah.

Europe. a in COVID-XX saw territories strength Latin America, for COVID I for think East, some example, our given we Eastern catalyst that particularly, as Middle distributor of is how Christian in well mentioned, know, has as the in We prevalent - around our non-direct strength Europe you been certainly, in and the sales, world. saw

non-COVID those lot a - physicians know, environment. responses in all from you going COVID of expect will that in a so, territories. positive we even those activity a And There's that continue from forward from or been

Sean Lee

clinical side, the And great Thanks. resuming. also, hear - is to on the it's it's that REFRESH-X

to of making was for changes call modify the study expected protocol compared or timeline to data the to before? collected? study have what's previous So the Are any you the I any had you wondering, that you now? And

Phillip Chan

Let Makis of answer over Makis? me some to questions. to turn those

Efthymios Deliargyris

question. Phil and for the you, thanks Thank

not any did make modifications to to have the we So, major protocol.

the you on we saga, the greatly the captured by we everything. was data quality the remember REFRESH-X hold If and that CRO triggered and that the was whole being probably improved and recall, changed voluntary of you

throughout how couple study procedure data the had didn't treated remained following or suggested points. trial, related some capturing change review collected the to protocol a are, be we patients of meaning, So, you know, they same the additional by the points we additional DMC, just data all, we're the at same with procedures,

was process. that sole we those resumption the to in during difference So - were protocol. the the But had obviously, resubmit,

the usually faster familiar, previous sites familiar what beginning the I hoping the that and of a rate enrollment. do where than will running because now up of lot sites to trial of little we're study in initial the timelines, of be start a and think although are probably the not Regarding study with know, sites, months, very is, a evaluate for up on ramp the all few resumption. enrollment with next based the you a We're get their looking the are

I be to over the should idea timeline, a or us to how and able the for So think should we'll performing better so, quarter of next enrollment better to we probably then observe you able guidance. be provide give is

Sean Lee

for Thanks that.

all I questions that's So have.

Phillip Chan

Great. Thanks, Sean.

Operator

additional or closing for At like to remarks. the I question-and-answer We back the turn this any have would reached it end of time, to management session.

Phillip Chan

for today conference everyone on you, your appreciate participation. us today's thank Well joining earnings We call.

to Virtual Take Annual join you Xst. If meantime, And very do avogel, feel any Vogel In for for your please possible. we'll out our on questions today. you'll the where have at questions, free reply us much joining to hopefully June reach care. to you, other to @cytosorbents.com. the A-V-O-G-E-L Meeting Thank try everyone Amy

Operator

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

Cytosorbents (CTSO) 5 May 212021 Q1 Earnings call transcript