CTSO - Earnings call transcript Q2 2021 | Cytosorbents Corporation

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Operator

Good afternoon and welcome to CytoSorbents Second 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, Terri Anne Powers, CytoSorbents' Vice President of Investor Relations and Corporate Communications. Ms. ahead, go Please Powers.

Terri Anne Powers

much, to good XXXX the conference operating very to financial and everyone. results Welcome CytoSorbents call. Maria, you afternoon and evening and Thank second quarter

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

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

for the the covering overview highlights we second financial During will management. today's call, an and presentation have quarter by operating

go pleasure the this now questions line time, to presentation, Phillip, call Dr. ahead. that open my we the team. At Following turn to Chan. with over management Phillip it's your will to the

Phillip Chan

quarter. Terri productive and had busy everyone. good We afternoon, Thank second a you, Anne, and

DrugSorb-ATR expected XXXX. antithrombotic during targeted quarter approval the patient first STAR-T removal IDE the enrollment the study that we system received for last U.S in As completion trial we in began with with guided call, this full FDA and

We April on cartridges so. are from more XXX,XXX had the countries, than distribution quarter enrolling here across treated patients became date, registered than to since a Emergency in countries CytoSorb pandemic cumulative trial CytoSorb and was up XX. European equivalent Singapore this FDA XX do is the indications, COVID-XX end to we all XX% across and of available under total including commercially countries. now in are bringing excited more CytoSorb a number XXX,XXX the By to begin the for of delivered began, the Use Union year-ago, We’ve Authorization than very soon to of XX with X,XXX more U.S XXXX. track granted in also distributed where

Communications Vice President, the June. Powers as Terri start appointed also Relations and We of Anne at Corporate Investor

of significant continue investor to outreach U.S to as valuable Although She done up growth and open making of to great the sales the job the in getting here process awareness up now company. months, in the is in our of and X for we just speed contributions build a to Terri company and support vital proactive stakeholder future. Anne to abroad thrive work investor has market

free If to the to you’ve met please her, already feel near in not future. reach her out

ring And our our of COVID-XX. spread for matched because business friends, to XXX,XXX $XXX,XXX raise slide of a quarter. employees Fundraising to million year-ago, Chris a Campaign the successfully at also a second the Vince, the financial to our fight Opening cover strong saw NASDAQ's Finally International a present and last in with as simultaneously in of we at From $XX.X Global many a Humanitarian Bell Square, were I from and completed versus Friday's one-for-one. had NASDAQ Times we check Kathy of shareholders generous from standpoint, Total XX% Chris ceremony. New mission $X.X City XXXX donations increase. that We $XXX,XXX Friday you your Opening the last Organization, quarter proud CARE the our York you press million the and was Bell release partners, Noble CARE revenue to

quarter Second year-ago, million $XX.X were product XX% XXXX $X.X sales million increase. a a versus

gross closed second of accounted grew in non-COVID-XX XXXX XX% the for core million XX% and no quarter XX% our versus sales. Importantly, also sales solid $XX.X of in year-over-year with a of product XXXX the XX% quarter and a long-term debt. very sheet And balance second finally, in Blended healthy we of margins a were our quarter the year-ago. cash

will Turning week-to-week. into COVID-XX, information as we believe by significant following COVID-XX guidance the putting variant in evolving with be has the pandemic, our we've been very to changes done perspective. Delta driven helpful rapidly this recently throughout

serious been States, in continues follow last the to new hospitalized. in so strains In increasing are South, the They like accounts Southern rates driven Middle Russia, clip. the new rate death U.S., by Spain, United recently, is the patients unvaccinated. Internationally rapid Not Portugal, Africa. And been United we're actually surges part from COVID-XX to through in rise countries the Texas But current seeing an cycle variants has to and Florida of partially cases X breakthrough vaccinated of areas and pandemic vaccinated epicenter Florida to is have we are hit an week, of are to people. Lambda. U.K., the give booster Outside population X is some are the Southeastern entire far, the vaccinations. who the Florida the like new unvaccinated new chart utilization low. these most the Lambda Note variant often and the hearing vaccinated places cases. mild vaccinated number fifth you of infections surprisingly, XX% And the of the key expected fast a Currently percentage and lower U.S XX% new just high, for U.S people Delta -- in moderate expected we're vaccinated the population. a although in XX% are Delta U.S in not Asia, of or cases is about for relatively to the curve are in currently population like seeing new the being still number of South infections. the entire And vaccinations the though percentage is infections in hospitalization evade found in that fully there how numbers on France, States. in of Whereas contagious strain in left U.S., immunity who Southeast The hear continues the the of shots are good at percentage who even hard East, the highly of is resistant of and actually immunity are President And can idea the that population. new this Central new quote Florida, are the as improve variant third in increased vaccinations like countries you Here a to of fully of happening. all a people adult by have as of rapid account points wave in midst of week. states. vaccinated XX% roughly number of Biden and

further incidence that fuel high those are help will is care, COVID-XX are obviously the risk reduce increasing and vaccination still at are and infections infection. positive rates world. many who not need could however, So everyone. The of vaccinated severity ICU waves XX% many, people the of around Therefore, people and of

very those of in X.X if and more With the deaths So haven’t to about million about COVID-XX XX now you seriously. roughly be million still die and so, please done already just risk worldwide X%, getting will and vaccinated. many seriously needs still get XXX worldwide, documented is it people infections be hospitalized ill. Again, will X taken

mind With infections of people and the pandemic in new decreasing infections in to by in variants countervailing infection. spikes us of effect versus get state business to one hand, new causing the and on back allowing unvaccinated vaccinations regional COVID-XX

be product We in than greater revenue XXXX the revenue first expect half of half second to XXXX. product

to growth and second vaccination least COVID-XX be [indiscernible] growth well expect XXXX to related expect product non-COVID we continued underlying X in lastly, we conservative, strong half XX% to unable with predict year-over-year non-COVID rates year to And pandemic, COVID-XX XXXX. of growth in the the of half level virus sales the the including underlying of full than at half as the sales. at the the uncertainty the year-over-year million in second less trends, And least in due of are core We course as COVID-XX XX% core sales be XXXX. in of sales second regarding

of anniversary $XX.X public our we the will why continue where sales for It's believe we Turning million. grow. X-year to core offering our raised secondary

business. rather sitting We idle it in areas using to drive cash, have invest not our key been this on to

detail this studies, end the been STAR-T First capabilities seven sales. of enrolling hiring and in aggressively different with as also we have resources will and marketing drive as and later, we hiring clinical trial with data on our adoption our our more manufacturing XXXX, know to well sales, the in sponsored growth as sponsored R&D. most U.S to to key expected XXX the as At company people Makis in that studies current here and grant here been of expect support team be company significantly future for also company-wide, including we to will income expanding both in We've States. than Europe United the leveraging now focused support the and

our of on blended facility are efficiencies, produce gross running the that Princeton, were a products. expected significant approval support already $XXX to others. made these Things new Next, New as and CytoSorb-XL for million non-grant sooner. serving you CytoSorbents improving scale our to such We've investments other on facility in in transplant the as products product cartridge headquarters well in ex up into as support like see margins, can logistics not EU us future increasing we've for perfusion which the among to XXXX, continue pipeline, us manufacturing to the by industry will new received also the year in have our will highest new in sales. rescue based have if last in and a ECOS-XXXCY significant and that that sales, enough impact Jersey, this product able end XX% organ home invested $XXX at is our pictures with to This quarter. and to track vivo To that funded to enable last also Germany, our world hub our in manufacturing

our internationally. interest -- expand to our increased hires to and parallel also use to to initiatives. inventory demand financial expense, that continue debt and also eliminated of DrugSorb-ATR flexibility. rapidly respond U.S lot fund has increased potential able dual marketing a retire U.S be given moving it has production FDA concurrently in the We're preparing long-term regulatory of our us our in also We long-term for We've surges and for steadily key And been with paths our products. finally, we with commercialization approval, to have

our detail to Now give Deliargyris let progress. me on for on CMO, program, the more over Dr. turn detail our Efthymios more Makis? it clinical me to

Efthymios Deliargyris

you, our It disclosed first Thank plan than was evening, Phil, designed we was less everyone. good a good afternoon critical deliver objectives. that and new on and two clinical to year-ago that

approval generate growth First, data multiple second, on And that future drive to FDA in clinical marketing applications. an the fashion. obtain clinical expedited will to

all and you we're we're timely rigorous focusing efforts on on objectives, these necessary investing execution. deliver Phil we from ensure in studies, company both robust As our resources heavily to the and of sponsored the heard

efficiencies in that just report to size last have time of double we're team already global both more than and year, executional cost. I'm in and the observing we example, clinical the significant happy For a

the So our have review next with on programs. minutes, I'll in the few made you progress we

the this So clinical we'll milestones the of the year. remainder upcoming outline far also but key for year,

the dual FDA path marketing approval. We to on continue strategy to focus

priority STAR-T on in ATR surgery that we're ticagrelor. ATR is ability of reduce top bleeding cardiothoracic the Our patients investigating staining to of a undergoing system. postoperative study for drugs the removal anti-thrombotic

on focus to IDE STAR-T sites. approval undergoing including clinically significant made FDA will on early patients have the bleeding July, measuring while The far, progress will XX trial execute enroll with clinical in that a postoperatively so surgery meaningful receiving patients double-blind, in of the randomized outcomes the at primary We study endpoint that ticagrelor. XXX full study U.S

we happy the number are And cardiologist. details will identified to have endpoints, to state Mack, our we're an on cardiovascular second sites interventional with principal on Michael two principal study that be study investigators, listing surgeon, have clinicaltrials.gov. study. study in the sites. of that of design medicine, some Together the execute investigators our required more we and quarter engaged For a target please the The Dr. cardiothoracic review all with the Mike and large Dr. of Gibson, the luminaries

very We they and a novel view medical U.S excited since in a unmet breakthrough of trials have solution. encountered the degree institutions, produce need enthusiasm a about might as by the high are participating this major that

submitted We the quarter July on and first We IRBs Manuscript of study publication. XXXX. sites institutions progress characteristics design the target. this some are XX, methods have and the to July. the across on with first patient began already which the submitting remain of initiation visits, completed had We'll lot on the this of has we of we of meeting making by been third of our beginning or lot a a all and investigator contracting end these -- the STAR site for and site focusing during happened enroll activation and

believe current we study be to based our that XXXX. Finally, in will complete the STAR on projections, able

second And the the of for XXXX. study year. study to the enrolling second interim AKI these patients we FDA Moving the in the important also resumed end for a by And of be analysis. the for its its quarter. sites. study, and take successfully next of place that path second dual to activities is will we REFRESH-X of believe sites in approval, remaining the our that study anticipate the The the we substantial study milestone actively of half the progress active REFRESH-X majority The made the

have trials in the FDA approval. our STAR-T addition, also sets already believe we removal the the marketing fastest beyond press and anti-thrombotic opportunity and previously, risk to disclosed in future previous lowest stated we has Phil releases, path As expand by represents to precedent it ticagrelor. for And

generation color also single all is registries table, affordable complimentary the randomized this REFRESH-X the Next just rich clinical board but a you approach between are critical a of according utilizing please. studies during a clinical the just care, of the arm I here year in also according data in as the to we're milestones. coded milestones slide, On employing XXXX year programs, to trials and studies. reviewed, Across to to summary they this or achieved that area XXXX. see therapeutic cardiovascular studies start

including enrolling which all STAR-T. Resuming the in the in will half first the previously the full announced note and forward site receiving approval You we the on first quarter ongoing. the enrolling of REFRESH-X, citation and FDA year, registry. We're with this enrollment or in first milestones, with actively or citation patients for continuing executed patient activation is the star second moving quarter an

expect in Germany, already in clinical refractory and with patients be randomized have a the quarter begin have approval the to at of of and them looking ethics that fourth U.K., receive it to submitted provide The end soon the ability will quarter. and we'll towards third committees able third entry shock multicenter be we data sites contracting Germany or study We ethics we the a the believe the in has of quarter and able been study to hemodynamic will clinical process to process of this All of approval. enroll beginning the year. that received CytoSorb device the stabilization a identified

third be line and submitted before the is in enrollment Ethics site's HepOnFire, results publication. study yet study, our Moving And and end have able and quarter, during the COVID-XX first CPC been targeted Germany. finally, for We which registry has anticipate Committees in activated the year. we'll of the on patient a to completed again to submit that a multicenter single-arm the to the top

to Symposium the and upcoming it Care plan, And the that by International that, table, be 'XX clinical Medicine on colleague, actively having be now enrolling single for will the have Intensive in of August XXXX. held in total will a programs accepted addition, to the be will Emergency hit track results my or would study over either September with X, presentation released. are full of milestones. Kathy you clinical the line like see all, and of end top turn between all XX All as on Brussels, Bloch. the at I every to CTC In where And the achieved patients this

Kathleen Bloch

Good Mikas. afternoon everyone. evening, and good you, Thank

update provide well call, as working XXXX results cash today's financial regarding For runway. as CytoSorbents I comments will XX, an around our position and June some capital

in increase quarter an as $X.X XX% Next the primarily product or This execution well Grant $XXX,XXX. slide increase increase quarter, please. over the $XXX,XXX was in of sales grant our sales of for $X.X Product by $XX.X to million, $XXX,XXX patterns distributor approximately of of were an second increase driven $X.X approximately approximately as second quarter million XXXX. XXXX was as during sales in approximately to in million second an direct XXXX compared contracts normal as revenue on sales return of XXXX, million.

rose As employees CytoSorb, in meet product grant income to by assisting compared the when million XXXX, of compared ramp in to XX% the second second from production were quarter for revenues, R&D which And XX% in of for Total to gross up million, to profit which same the and or resulting million, the pandemic. COVID-XX profit demand increased tasked $XX XXXX. of increase XXXX of $X.X sales surge our an quarter includes the is our with quarter $X.X approximately million million over $X.X to $X.X gross for XXXX. as

achieved incurred also was compared ramp not in did due product this recur XXXX. XX% expenses Quarter manufacturing certain Second XXXX. to XX% in up as efficiencies XXXX but in to in because gross margins And were XXXX,

Next slide, please.

of the which of product half sales were XXXX. of to million And in XXXX half revenues an of were first for first sales increase of XX%. results. approximately XXXX approximately $XX.X $XX.X our million, to the financial the for of an million approximately increase $XX.X the over first same for is Turning period $XX.X as million X months XX% Product for total approximately compared XXXX, half

Next slide, please.

look blue, we'll the in XXXX. the sales product core, of our of product quarter our related second XXXX. non at We shown and to COVID-XX here COVID-XX an into compared sales, sales in to sales COVID-XX sales. green. quarter of began sales the estimate $X.X those were this we've broken down first that in So COVID-XX XXXX, quarterly the in And product million approximately shown quarter chart And of product to occur estimate our approximately $X.X million, second product COVID-XX

Now our results. non-COVID-XX of product quarter and if approximately were we look exclude our core, for COVID-XX highest XXXX. sales sales million, at ever quarterly core second These which represents the our sales $X.X

Second to of core core second pattern a represents of approximately in product growth continuous pleased be of XX% $X very product XXXX able $X.X approximately our throughout over or quarter the importantly, report demonstrate quarter to increase million that sales of period. But million, million are XXXX. of core sales an $X.X this sales non-COVID-XX product we sustained most our

And product year-over-year strong growth. months chart, see our we trailing to gross margin please. And sales maintain slide you continue this sales. product XX as is can this from and Next growth also

As of approximately million months trailing were XX% XX-month XX sales product XXXX, which one increase million, approximately of is million sales $XX.X trailing $XX year-ago. an product of or our June XX, $XX.X over

non-recurring not gross years. X XXXX third past product consecutive the of gross has subject to or each of to achieve Our been represents know quarter to quarter of the consistent only higher company for for to that, the margins the second product We XX% grew margins. but able items year-over-year our second margins improvements And XX%, XXXX. gross our adjustments that in quarter of

very CAGR to We or and here. XX% over compound a also was are trajectory note years, past our growth positive rate observe the that we continuing X annual

Next slide please.

and working our cash runway. to turning Now capital

We $XX.X As XX, robust had approximately a of cash XXXX. million. balance June of

approximately Now such in trial excluding expense. experienced of XXXX. expenditures, a stock of we two have clinical non-cash as activities of quarterly $X our quarters the option each burn cash million and first Notably,

means our EBITDA. generating XXXX cash of That not operations flow. was generating we're that of quarter positive our trials, clinical consecutive Second sixth quarter for positive are

our business of have substantial clinical assort our product We liquidity in invest planned to operate to GAAP future expected continuing return XX% continue profit. trials, the capital, for are Once believe model allow will strategy. adequate and additional any product to fall provide XX% cash flow we XX% commercialization we our margins. reach they capabilities, drive on achievement We gross to of course, clinical further the sales of -- of expected and execution we gross breakeven incremental GAAP produce the capital to site expansion cash operating continue to without because right flow investment sufficient believe robust for to to to giving and funding is manufacturing trial of growth. sales us operating have operating a outstanding we need Of every to plus breakeven dollar with through our

$XXX XXXX. XX shelf self scheduled and the with registration million $XXX million registration expire filed was new XXXX. on to And we SEC August Our effective a in became July that

diluted my the to pleased have ATM we represent market some Christian remarks. corporate capital the ahead. Our turning on be facility landscape. simply common And registration, the as well. need facility structure, to a will we intention at ATM to near-term. XXXX, color approximately at concludes the he shares call also concurrently practices, or Briefly have basis. fully shelf go million outstanding on governance over we can capital renewing that product to Christian, our so please good actions turn the in no XX raise time, provide or These of expired Steiner, And with sales as I'm Dr. June that XX.X this the and

Christian Steiner

much, you Kathy. thank very Yes,

slide please. First

numbers Pacific. Asia Berlin, terms in color more Germany you afternoon of want everyone Europe commercialization. been bit good So to a good on evening Good little morning on and what to and international call give I has to and the from to America. presented

a blue a we during the by access look restrictions incline customers, despite to only programs the again, remarkable to many development a elective columns. at which the or hospitals. With can almost of this go fear you is chart surgery and see no includes pandemic growth of the constant imagine the restricted stock the patients during the of represented core This non-COVID slowdown to If and business related pandemic.

Next slide please.

COVID-related the significantly our customers has The for commercialization declined. changes and our improved. However, restrictions have access forces to

since example pre-pandemic QX, our the compared to XX% of improved an in in to mark less this improving of surge the As information a registry Therapy the participation. forces interest been includes for and size the beginning times to go But QX. frequency than real direct has situation the Experience for of and XX% than sales the interest CytoSorb all appointment QX less starting for around towards and with study of it. XX% also CytoSorb and

the We in elective to normal segment. to in in of heart they have surgery and aggressive undergo are normal acquisition the we are afraid need. with the than us their European variants than Summarizing, improved, thing back. new momentum this we very the limited ICU are programs. from again procedures to is the I see can less relationships. And lists in availability the see plan less to significant the mention XX% Furthermore, More expansion cardiac go infection patients time long elective even restrictions. significantly numbers sometimes Last Germany increased one back the massive and time the to and the centers surgery mainly waiting The especially business some surgical started of consuming turn important to to has have not are emergencies XX% with hope Other customer surgery during ICU general, least, schedules. we and cardiac due to less for pandemic. still arising here. business starting more in vacation also striving back won't additionally, This markets. segments that new hospitals and to say do also capacities to so have a but pre-pandemic of non-COVID for remaining and patients situation manages, that and especially revitalization programs centers of surgery become somehow due

do however, differences important we is different geographies, Of representing course, said have our in markets. everything most

Next slide, please.

growth summarizing which QX me indications to septic conclude that restrictions. strong non-COVID in healthy So exhibit this bread with butter care. pandemics and leads XXXX year-over-year storm last a included can my cytokine our is core to with represented to business we segment and related critical want supported the on and the a therapy. and in all I this business obviously, COVID XX% cardiology, business, continues slide, Mainly record our was shock quarter am different core which patients growth indications potentially expecting some cases. in finished surgery field personally, cardiothoracic this a all But the non-COVID we liver and be of and business additional strong at point. cardiovascular by support be I in continued might pandemic despite one

to challenges. the are you ready steps possible and So back Phil. handing we all for And very next fight to take Thank Phil? much your attention. with I'm this,

Phillip Chan

we have device this in one and team Christine. to we the growth of leading the place and to of to in finally drive profitability. appropriate companies summarize, strategy terms company believe And you, medical become Thank U.S

addition support experienced of a growth management team key strong have We the continued initiatives. talent with to

and support efforts years. commercialization We programs the coming clinical manufacturing for capitalized are to in investments capacity, well plan

to drive disease, as growth such to driven in sepsis, U.S high surgery U.S milestones expect potential continued path marketing cardiac clinical markets, markets geographic by U.S in We dual label XXXX. We to growth ex additional plan approval expected many expansion, partnerships. targeted open applications FDA additions in with and the existing liver and

the focus targeted indication. continues be ticagrelor as of initial removal on surgery the to cardiothoracic during Our

working That remarks. Q&A. next ends to rapid platform, lines to proprietary, our years. finally, develop service strive to excellence the cash for goal up utilizing And GAAP and of it operational X profitability. achieve we I profitability open growth to technology, We like polymer support Operator? senate product formal would operating other continue in now and and we're improved flow prepared our efficiency for

Operator

with will [Operator Antalffy from our with your take today SVB question. Leerink. Danielle Please proceed Instructions] We question first

Danielle Antalffy

good Hey, Terri, with and afternoon, so more. working forward congratulations, much everyone. looking Thanks really for to the taking you question.

guess specific I very much this update. on quick suppressed XXXX, speaking, core I'm tell question not a launching. phase we're in growth for question albeit you color. arguably asking saw you to commercialization mean, directionally although of thank that off my Dr. just but Just it's strong Steiner, somewhat I for obviously just possibly guidance, the is and all year, hard

it XX% growth an continue the If be the about growth XX% not that I if at able you're building, XX% momentum So, to feels you're over like appointment it growth back over from XXXX, still year. in in look ahead even perspective, feels should half we of XXX%. mean, talking momentum. the quarter, like with to growth, you

make Just comments I Kathy margins. on you for one follow-up can curious on directionally And then about any have XXXX.

Phillip Chan

that Thanks, is that Sure. of add believe year. able something believe that in Maybe growth, I there is And we place pieces to true. type be there? -- our Christian, drive that that to in -- including the next is are you to collectively maybe else Daniel. want

Christian Steiner

not think and happen Yes, look are the might exactly the see what wanted conclusion. statements. across not there we could is at I we last point to not has what charts if year, I think despite this this and yes, bring and I forward-looking happened giving But be

Danielle Antalffy

perspective. in to going another say, Europe momentum think guess Got from slow would commercialization it. into way reason no a I XXXX there's to

Phillip Chan

a Yes, notwithstanding multiple variants. in additional positive issues, if resistant COVID trend continues to mean, I we and have I of think this way related waves don't

And combines think presented you core blue graph the that continue. look I that will as well that trend you the that we think that consistent. very growth that's if can as earlier, mean, I expect sales, that is our that the line, bar, see I core COVID-XX at expectation. I we think

Danielle Antalffy

Yes.

Okay.

Phillip Chan

It's not a you. Thank color.

Danielle Antalffy

you follow-up believe Kathy ahead And, quarter Kathy, margins. quick expectations, for on well of okay, mean, the then gross a And and great. our street as -- I just perfect. margins Thank gross you well. another of for Okay, that. consensus I

curious the that love I friend. to hear we'd like you XX% So commit maybe of just mean, if XX%, can has it a opening so Thanks you can if can target, even margins you right, sort talk is margin you even -- how but quickly if view changed. feels tell us And long-term gross ramp on to above new whatever much. on you how facility could manufacturing your about with

Kathleen Bloch

pointed Yes, but out exceeded Sure, for margins, three are quarters Danielle. you. just not consecutive now. our gross XX% very one-off, we a that it's today I excited. Thank they've

Then which we've and at think expecting is expected that capacity. our to until running start very the get through operating So, of running, gross and and improvements gotten Once We're new the by we think be large facility doing over we've ramp not the and that I in XXXX. to margin fully we're well margins. greater will there. gross pains, this up gets operational up I up volumes we see end is

I be I in excess start we've think favorable. but gross where last they'll won't of to in see yet, quarters. where I margins think we'll on the exactly three been commit experiencing quite

Danielle Antalffy

Okay, thank much. you so

Phillip Chan

Danielle. Thanks,

Operator

Please with with Anthony is next proceed from question Our Jefferies. your Petrone question.

Anthony Petrone

half doing everyone's well. go of the at hope comments XX% and Thanks, Steiner's year. to on ex-COVID. on into first Congratulations half Dr. least We'll heading second strong here. business the the on the back

XX%. about up was half first The

then new get one in trials. their on I'll a maybe moving of where to And line in the on where year in of XQ, distributor an how follow-up trajectory, in have to productivity just And Germany, sort the volume with and going that's just of and trends. rep So trying the much in is back normalization factored between purchasing, that was end in the terms procedure head of the parts exit additions? idea rep of headcount quick follow-up then of that

Phillip Chan

on let first Yes, comment so that. I'll the of Christian part

kept drive a out things Germany, there. sales March way going Germany, last monies business continue are of that coming first in predicted our perspective other of from wave back activity. that expansion been are and restrictions put Anthony's that the Christian, we of we to -- only also in increased the investments to get sales same, we've our that help forces the not track, part where has I has the actually but maybe, direct the of that you on resources countries. different in But to And comment reps, think that includes sure on towards think to if time which question? want the when goal to that sales period, just in sales additional I making before had making headcount Christian

Christian Steiner

and past all every [indiscernible] of question. for year includes obviously course, can post-surgical for you the our ICU because programs think went look we or the if I thank at time, beds Anthony, big that, business the COVID Yes, has negatively segments of see we indication, patients. Yes, impacted, pandemic surgery been really which surgical to elective these down secure

pandemic the obviously comes procedures, impact. a shock reserved there's will cardiac shock foresee, what time patients, also after good just patients, and might stable. were removal when septic and a so a already to And normal, cannot see to you And to surgical online of trauma, also we have example, know here. on. is normally we less but in and I number back anti-thrombotic all this. emergency surgery pneumonia indications deliver due those business What effects even during course this So or based been progress surgery, relatively are with burn there don't in accidents, that and pound [ph] the beds positive COVID have we this cardiac have through started Those, has for build bacterial the was we Also, the expecting past the on this exactly we been question. either indication. stable whether momentum, the come we satisfying the especially for septic of see patients,

Anthony Petrone

windows make date and that when target I that -- to wondering Thanks would to was wondering very expectation done Should targeted outcomes helpful completion the expect we just the going timing short utilization XXXX, hours as X that you I'm trial, XX up sense. what fourth STAR-T. at patient weeks. by of be the It's the look completion should is. for on trial completion just again. enrollment? year? this quarter the follow-up XXX through the is is very, enrolling cartridge actually see and for the revenues, we And that's in and then Yes, show in what for the enrollment expect for

Phillip Chan

take Makis, that? would you like to

Efthymios Deliargyris

Anthony Thanks Sure. the for question.

authorization, as do COVID-XX provided the have in the EUA. us STAR-T marketing have an the exemption under so to the approval by our device as investigational study. And STAR-T of we the We this trial. use sales study sponsor use U.S. you therefore, So The relating U.S the be emergency FDA not is part by in the devices only investigational will know

So will trial. this will not have any U.S reflection in on United STAR-T the sales. executed a be States. And this only is

we'll year, end the a So milestone it, all the relating study sites communicate certainly in having few be in study. by of hit quarter, the enrolling continue this the active hoping by this we sites first next we'll patients the the all -- into we enrollment the target And robust months, that we're when active, believe that patient study, in to that pace. enrollment and begin the will of we sites to then

but clinical have is to see timetable However, right pre-pandemic and COVID-XX of projections coming now begins sites more new back quite the yet. we actually research Overall course, levels provide related post-pandemic, accurate we then are to we'll it's how or worsening additional be to any only notwithstanding you the delays. once And able enrollment not performing.

have think once the But a rates. timetable, study a positive help enroll. more I accurate have to and So idea that and continue we will trend will the is wait we'll up we're of enrollment running, hoping for the that better study

Anthony Petrone

Thank you.

Operator

Jennings Our proceed with from next question is Please with your Cowen. Josh question.

Unidentified Analyst

than remind the start milestones questions. that outline to if two of the we get I'm results? U.S a you wondering separate sized? interim on Hi, can possible if my the the are terms of see this the have likely Brian taking analysis Or this of I a trials, the wanted possibly few with REFRESH-X. STAR-T is before could analysis? for trial in whether to interim I also, REFRESH-X just associated whether primarily here is more of analysis? data order then for on outcomes appropriately between that I Josh. outcomes you test it's a just us that, Can Thank with the the with we question And STAR-T, of And the can. you

Phillip Chan

Sure. would to Thanks, that? you take Makis, Brian. like

Efthymios Deliargyris

sure. you. Thank Yes,

to as the have actually once by in meaning stoppage the today study both inform have of at study is the we complete much REFRESH-X for So projected potentially ability study, for to up sample The of the for the that we or STAR-T will expect the according futility. milestones [ph] the interim results of both the communicated XXXX, study study interim again, and the analysis will be also idea would we [indiscernible] for is your we'll and completion both continue will timelines what analysis current inform REFRESH-X or running, for DSMB a size, STAR-T efficacy the better the well. option we however, reviewed, what but to those the

Unidentified Analyst

And the results very on you're that's the now consist STAR-T, of removal? Okay, component? filing the ticagrelor clinical submission based date, conducting will your conversations to likely clinical the the helpful. this other then efforts some U.S for from solely on with for include will data of FDA STAR-T of Or

Efthymios Deliargyris

risk I we in to know design provide review the so the So, part the able had of is the in a And will which is with study output be -- FDA We we've been already. discussions outcomes, due if don't study you large have so be having that clinically meaningful bleeding. postoperative disclose data of yes, it clinical which STAR-T the include well. to far, what pretty the on additional of assessment to should STAR-T, thorough that, but and outcomes a chance the as the focusing is is efficacy routine during important to most have evidence the either basically the of in aspect issue we said application. we year to regard it course is provide that read been that be also may that if benefit, permission generated might safety. Having practice marketing of that supplementary next of we will And additional providing or

a to support However, risk assessment. the robust study to able benefit itself be is meant

Unidentified Analyst

Makes sense. you. Thank

Efthymios Deliargyris

Yes.

Phillip Chan

Brian. Thanks,

Operator

Our and proceed with Co. next Please D'Silva question your is question. B. with Riley from Andrew

Andrew D'Silva

of having taking place benefit or with Good my Bayer. for couple therapy, marketing for the me. safety Mark you’re reversal really a if quick for CE I'll seeing prophylactic curious start of AstraZeneca either I for pharma afternoon. questions. any provides was inadvertent drugs. an increased those Thanks with Obviously, benefits taking ticagrelor ones just and rivaroxaban. A

in curious any that's pharma if way? I'm So resonating with

Phillip Chan

Christian, yet. not we've have because COVID-XX that in of factors, my would is hasn't it's that that? heard heard Christian? knowledge kind variety And of It volume, different comment a you But yet. used to on pandemic, like including closer. the of that Christian been

Christian Steiner

question. you, Thank Andrew, for the Yes.

but collaboration. is that suggesting So different apparently field people from -- And, of no what companies, at see are actually closer that there that users occasionally a is collaboration course, there's the also moment. be from might we the the deeper

the the happy the centers big surgery safety cardiac users and mean, now are have the that increasing. is I and they yes, use net So,

number to We regularly where what is the and have used to of have safety this bleedings a sites [ph].

Andrew D'Silva

confidence really curious the [indiscernible] Okay, increased generate other for is in study but everyone useful. a higher this in Thank efficacy your own driving ability ability confidence and of what you. to And degree -- studies, the just faster to not And much enroll STAR-T, than say to your patients and positive complete REFRESH-X. there was to data, there's was safety and study I be for like that words, just indication?

Phillip Chan

some commentary? give Makis, would you like to

Efthymios Deliargyris

Yes. you. Thank Sure.

out nightmare This unmet there everything are something rare need is they is being the anti-thrombotic patients them. an for when a and acute And of drugs of that not with that an a event as on with prescribed multitude a literally present operation and increasingly are they for starts millions applications, So, cardiovascular problem these need. is the millions surgeons.

been they So very with dealing with help careers solution this a to whole bleeding dealing have without difficult to that's manage. this very, surgical them, their

actually they can solution extremely is enthusiastic a which that the this become centers, drug during can surgery. approach center is their the be in hands. clinical if causing excess of So this solution about hear this actually immediately would where routinely having problem, in you we clinical like such and brainer When you provide when drug what we no guys remove remove we things bleeding, approach surgeons, a a a at practice,

clinical all things that us enrolling in clinical the study, first as investigators, trial. And behind you executive most will with we there one Now, all, And of that's when the the of a investigators, engage excitement enthusiastic when principal successful important the the them. the the be see study, that, patients. that that committee, drives they're tells we know, site for investigators,

of Europe. that devices second seen being marketed used from The every this in published, And data are confidence the the this is comes that is We've but heart application a in day part being they centers. they telling fact bleeding see during the we this is are they're also reduction talking that working. us routinely drugs to us in And the surgery, tell incredible this customers. with cardiac associated anti-thrombotic

have we feedback excellent So from [indiscernible].

published -- programs well encountering, perform more not and And drugs in the world coming. the system yet, that as another hopefully the we'll contribute [indiscernible] have real our of some it but use. more interactions does will device the execute lot as besides a We that us future. and are confident more of again, our will enthusiasm STAR study make And then is in data, we're in in the the even one that the level registry, which trial investigators we the having

Andrew D'Silva

together. questions Perfect, thank you. Last [indiscernible] two on

third anything the flooding that's you curious, seems many was it been delayed key than massive be like in quarter? usual backlog And how to one, your various First and just in going were of have U.S during of due for summer specialties is just in I date? the then this the patients other just Germany, in if procedures opinion? busier seeing the if REFRESH-X were you that And to if due COVID. reference similar enrolled impacted Germany amount to to in tailwinds could regions Also,

Phillip Chan

Makis, first the part? take you to want

Efthymios Deliargyris

Yes.

of to So update enrolled REFRESH-X, last when XXX we have comes patients the the it study. as in

Andrew D'Silva

you. Thank

Phillip Chan

would comment on the to Christian, like you German floods? And,

Christian Steiner

really repeat? could [Indiscernible] actually can question. I not you understand the please

Andrew D'Silva

significant or a operations relatively disaster, way? it impacted has any scale our as Just large sales in

Christian Steiner

Which one?

Andrew D'Silva

just to to were of [Indiscernible] so just due you. I know of summer, for just busier be wanted to of specialties COVID. that if same seen in that other was procedures seems regions being going a relevant in the tailwind the that because backlog delayed to are there And during U.S be lot Germany, and

Christian Steiner

decline right I compensated, the If this is over elective understood now to is It's the difficult the surgery correctly very question? Okay. understand. whether that COVID

Andrew D'Silva

quarter can low, on right, based or summer holidays be volatile just third the that typically Europe. a the Yes, is in the everything in it place take and

curious was I So …

Christian Steiner

Absolutely.

Andrew D'Silva

related is tying would on than dynamics. a weather going just in market … and people an seeing more is out important such And to be you're that because if summer because there's getting you? of typically vaccinated, for then busy the are in Germany, turning those aspects be lot the reopening more it

Christian Steiner

now. it got Yes,

cope absolutely the the with So list They right get time effects and right, or long try to as different they throughput maximize site programs, And that online you're maybe is the again. have or there's tried were even when from surgical to as really waiting the more. programs down. possible. much centers two One this the -- with

have is positive this on obviously So a could what doing. effect we are

take ICU they exhaustion doctors doctors a the just Europe, the there's vacation like Germany effect Austria kind really and there and certain vacation we have other also see the On full a time worked months, is not in deserve. hand, the an doctors also the personnel, in of additionally do Switzerland of the -- XX the XX last south countries, but and and what to European mainly these and of situation to normally the that vacation we and course, XX/X, in have they over

on effects different surgical of programs into number absolutely your the place, a is judgment I there coming So can but confirm.

Andrew D'Silva

much. very in I'll back you hop Thank Great. queue.

Christian Steiner

you. Thank

Operator

He Please Arthur with H.C. with from question. is Wainwright. proceed your question next Our

Yu He

Arthur question Singapore. question. given my Lee. Thank color of product launch afternoon, could be -- on just strategy that you my guys just Sean will Most good are I taking [indiscernible] congrats region, helpful. regarding curious your curious everyone. This in was business being in have for if and Hi, Thanks is the more for the answered. us you. I on

Phillip Chan

slowly Arthur, has a Kong. that area. and demonstrated Asian that of in in number Asia product Southeast in of into been Korea, moving and South past registration Vietnam, in the in we've the Malaysia, I Hong South what think countries, different And we're Singapore in

strategy part the ongoing et of strategy. cetera, those like some big obviously, are after of, broader we think a as I Japan countries, and have going of China, particularly our that

Yu He

Thank you that. for

Phillip Chan

Sure.

Operator

Okay. that At this time it are no appears there other questions.

like closing back additional for remarks. management I'd to any to turn So or it

Phillip Chan

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

please out Have any reach can. If to tpowers@cytosorbents.com, to feel questions good Thank to other a have try to you do we soon you questions, night. as Powers as Terri and reply we'll Anne free everyone. your

Operator

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

Cytosorbents (CTSO) 4 Aug 212021 Q2 Earnings call transcript