Cerus (CERS) 26 Feb 212020 Q4 Earnings call transcript

Ladies and gentlemen, thank you for standing by. And welcome to the Cerus Corporation’s Fourth Quarter and Full Year 2020 Financial Results Conference Call. At this time, all participants are in a listen-only mode. After the speakers’ presentation, there will be a question-and-answer session. [Operator Instructions] It is now my pleasure to introduce the Cerus management team. ahead. go Please

everyone good myself. and Cerus’ like begin to to Director today. Thank name afternoon. is introducing thank like I’d My Investor I’m joining Matt by us of you Relations. I’d for Notarianni, Senior and

we today’s you simultaneously displaying As can webcast, slides follow. part are of that

Green, Executive the Operating You and call Cerus’ Greenman, are from website Chief Officer; Jayaraman, ir.cerus.com. Chief Investor Cerus’ Chief Cerus’ Vivek access Kevin can slides With Officer; at Officer; Obi President Relations the me the Financial and Cerus’ on Quality. company’s for the XX, Moore, our release Senior Carol December Regulatory Vice describing results Affairs Cerus today recent President business and the financial press ended and of fourth highlights. quarter issued a XXXX announcing

described These our gross including as the trials, copy at forward-looking as and and this company of event financial product update future and development to commercial results, the Risk are to my results recent provide some you anticipated operating including those will review to file timing could related introduce financial of the and forward-looking Obi, will Obi operating release announcements, to statements that launches, to growth and and remind to uncertainties related They forward-looking actual On rather sales, we remarks a www.cerus.com. facts Officer. who activities. of like ongoing some on undertake than our duty on and website in Cerus’ update, commercial December We results, which followed a future product are to and our these of XX-K and XXXX, Executive future strategy, and margins, our Factors efforts, Form by that growth the financial the President future well statements. Obi, in our today’s our no and materially. we’ll differ include under performance, make future activities, operations for regulatory from year press XX, it’s Chief Examples and performance shortly. product followed some provide events, we obligation XXXX and identified call, cash or used clinical from risk involve ended announcement can statements. update statements begin events with and expenses, on ongoing forward-looking opening guidance now, by You and pleasure make Kevin And goals, future pipeline and call I’d this today’s access historical Vivek to development comment Greenman, remarks. closing cause will

Thank but review challenge, you, make In afternoon, our saying chance face a it the a of to progress rose stretched out everywhere, the of team to fronts. healthcare you’ve turned year significant our By XXXX to fourth the global Matt, be multiple and our a with year year progress was a the challenges, dedicated many systems press continued for that of XXXX goes filled capabilities everyone. on to Cerus. pandemic and had quarter that full hopefully now results. It release detailing without good

goal global supply blood remains medicine, Our INTERCEPT in standard-of-care pandemic and as other to threats. transfusion for safeguarding against establish the the

those company emergency could that in As I’m health was COVID-XX recognized history, founders threats days, I that a influence global our and an in ways. medicine That another pandemic, reminded early supports result think about the emerge In largely the of today. our founded unexpected as HIV.

real proud time and in is seeing the of are I’m this that play forefront at Cerus pandemic preparedness. We out

this easy commitment their global goal blood to known. and calendar not a customers that their team challenges not of our potential for of our system But It’s are the for work partners unending As for we with I’m yet as evidenced for to employees turn tirelessly by their not safety working our protecting grateful those goals commitment we There’s Well, much to threats, commercialize our virtually. XXXX the our end, we results, faced been from look of shared always the patients into has supply the did including accomplish forward. our much so the XXXX. this to head the around to dedication, world. as to blood supply forward to

the cases, deaths surge winter remain and during hospitalizations COVID-XX and anticipated, As experts the months elevated.

soon, disruptions we associated and momentum at continuing COVID-XX expect fronts focused during not on do anytime XXXX. remain Cerus we to we the While abate generated on multiple

results the year. and I’m report pleased ahead, to for look full fourth quarter we our Before

reflects record As INTERCEPT you XX%, for XX% crisis. continue our continues COVID-XX product we guidance year-over-year year year, be the which a we million. range this despite will to provided revenues, at of XXXX, expect this to with product in XXXX results. revenue at Earlier January, year-over-year and look between to full time, Demand of $XXX first full from grow year growth range for XXXX respectively. announced saw of fourth XX% and This $XXX we quarter XX% million to the our in

ongoing April safety and a seen will have recall, of the its for X, a as announced set Previously, blood During quarter XXXX. deadline deadline result in in response guidance. compliance disruption to for COVID-XX, the platelets was the the delay the centers FDA you

compliance new this we we that X, when result Both our the contemplated and now as XXXX. deadline, XXXX were change, the a changing of deadline October factors put together of impact included ongoing the well plan. COVID-XX is As as

compliance we our of in order production as While not plan about year momentum increase centers blood continual timeline that online guidance, compliant come to deadline. be the the throughout customers as say new their by will and platelets provide overall existing we do what INTERCEPT-treated quarterly to expect new for new we the is

suggest of strong to discussions time order capacity platelets new this production that Our blood hospital hospitals in provides to deadline with and increase centers INTERCEPT additional meet demand.

the comply and using guidance, blood LVDS, INTERCEPT of extension hospitals does our The customers in step will continue to the U.S. order standard-of-care hear FDA given center with preference and/or during advantages other that on FDA delayed be single additional INTERCEPT in sampling. remarks. his large provide our details market has become implement the We change the compliance numerous will will the U.S., deadline not to for plate with U.S. to guidance. volume versus options Vivek the expectation of methods the the that it

help the announced unmet a Well, need are patients. FC, thousands for During market for approval pathogen-reduced to of days excited fibrinogen and our hundreds short. FC we fourth to to bleeding early events for the has for product be or of quarter, PR-Cryo that currently remains we PR-Cryo very FDA addresses complex it bringing product a stabilize cryoprecipitate potential

for is on With the Cerus we of building Today, set who product to hospital this to these therapeutic relationships. front see formation the our proposition Therapeutics out focused a PR-Cryo hemorrhage of immediate and new and a the and pleased that business, in puts in value customers hemostatic clinicians are therapeutics value team of us well populations. surgical trauma resonates access treating for with controlling FC patient

nationwide availability we With our shortage the of conventional product once of unique cryo the PR-Cryo of believe realize access, post-BLA also able overall approvals. increase current opportunity conferred but production to ease label, the across we not distribution we are only to by product the a U.S. FC have and advantages

Our this volume U.S. states XX% about Level year, of of will centers targeting trauma the cover and focus key launch cases. X Cerus trauma for X

to we year the look sharing rollout as the timing XXXX. progresses, the on as of well nationwide As insights expectations reception, forward commercial a for in

for With the operations. is this the Centers me under more NTAP year. or turn our Medicare to and decision new for a let later commercial with that, detailed application technology reimbursement review the currently still On over front, our Vivek by add-on call Medicaid Services of payment a review expected

I’m Obi, record full quarter Cerus. results good everyone. afternoon, and to pleased discuss the of and Thank year for you, another

quarter in and we blood XX% some the the that the and to color tremendous XX% on XXXX. demand team Our quarter. in our increased in Among increase in fourth an almost kits commercial for continued the future. like for U.S., sequentially goals XX% the saw are our growth has approximately platelet done sales America executing I’d on us North year-over-year Quarterly largest field positioning efforts during in networks in product center INTERCEPT the work five fourth year-over-year share of

shared site reduced Red uptake platelets. have As INTERCEPT to in last went XXXX. American a patched site fully production a reduced treated. terms making they XX% the all of by stated platelet Earlier the produced ARC platelets of remains Red are the pathogen have by and INTERCEPT leader of Cross and of producing supply transitioning we total platelet now platelet the a previously, Cross goal XX ARC American publicly month, this Roughly live production for a

still with end of will has all is priorities blood resources significant ways, the are of that from deadline. extend to extension anticipate the but had and that recently and that need well and site. for XXXX. FDA the The In revenue for was the its do safety platelets safety globally compliance highlighted the one contamination deadline X, platelets surprising. guidance this caused the the Obi shift the As compliance remains from COVID-XX customer to Well, bacterial mentioned, fact not With October disruptions COVID-XX, disappointing, and extended March threat INTERCEPT. also a We on pandemic that pandemic platelets to focused many anticipated we global patient previously INTERCEPT has beyond ramp preparedness. for

and customers bringing reduced underscoring the alternative active options is for of in team online versus Our benefits patch field compliance. and the

expect continue We U.S. in will become standard-of-care platelets INTERCEPT that to the the

solution across the XX% the days year-over-year deadline. lower key We options. lead Europe. treatable region, as are five rates, new of in quarter contributing the The and targeting enable the superior by was claim, XX% region clearly platelet product FDA the be to growth. doses inventory which in a life International to current drivers a to Western believe of revenue the seven-day extending have reported our on and the will approval possible other sales hand as EMEA better product we One shelf compliance beyond fourth number management increased regional calculated early following wastage as life INTERCEPT position can of shelf up we’ll year-over-year the compared In basis,

XXXX. business among to of plasma across product revenues customers region. during positively the was This driven INTERCEPT the CCP use Our also by contributed EMEA

are customers efforts address the to We their our center and with to blood pandemic. able all pleased be partner to

we initially. are commercial As last four an surrounding mentioned, launching for we call, Obi update want launch. now give in product, approval moment activities a states to FC which also to on I the our this spend FDA PR-Cryo received the since

PR-Cryo will much academic our From As large level In trauma have turn each built Kevin the this hospitals call have to to sales of hospitals that to year Level is position this already need work patient those activity into more product. accounts centers to encouraging. fourth the population. hospital There who these engagement the much them during This rollout. best financial. recognize succeed year-end of been interest I do likely initial address calling that, put has the mentioned, prospective four healthcare the the it done product is previously forward progresses. to over on are sharing for the leadership critical X and the be. turn to to team we us review unmet clear sales conversations, and and states, in on will sales has in understand we adopters as look among the With for already better quarter educate and FC providers very dedicated for but team and about is to early the many and X group order customers, work I that team

the Consistent which Vivek, million, $XX.X today you, afternoon, recorded we good represents XXXX a fourth million with and during Thank from QX revenue $XX.X product month, XX% last our the quarter year. prior pre-announcement increase of everyone. reported

XXXX the the during XX%, to the $XX.X XXXX. Global million fourth and continued million, demand reported product full $XX.X For for to year for quarter revenue to up full totaled year. INTERCEPT the for compared increase

on platelet QX, year-over-year, XX%. doses calculated the a worldwide treatable doses platelet calculated year XX% of For of full the increased number treatable increased number and basis,

X%. accounted sales quarter kit platelet kits accounted product the total fourth remaining approximately of of sales, terms while In for for plasma mix, XX%

For accounted kit of plasma and sales sales total full year, the XX% the XX%. represented platelet remaining for kits

XXXX. for As the during we’ve higher CCP shared activated plasma pathogen previously, share and demand drove of sales

think we XXXX the anticipate a we significant plan, CCP from As not do production. about contribution

of a will majority product platelet So to that for kits continue the of the as percentage likely account sales kit sales. it’s

$X.X periods. our government In million totaled year million year to in not $XX.X for respectively. full our QX $X.X included $XX.X revenue the prior guidance, million million revenues, product XXXX, totaled addition for government and and contract corresponding contract Comparatively, revenue and and

to due COVID-XX. not For sites assuming significantly XXXX, are enrolling delayed

We gets contract blood to the by with enrollment the clinical government funded work pathogen reduction FDA. expect trial revenue as underway increase BARDA for initiative whole reimbursed and patient with our

volumes let’s flat year economies margins higher for Also compared margins euro, quarter XXXX, the drove in our On margins year driven were margins to by half benefited for to contributing XX%, Now XX% margins. production period. anticipated full growth as XXXX. to back U.S. gross strong a to weakening a kits, quarter XX%. These the the XXXX for Gross move scale at relative reported manufacturing. the in benefit to of XXXX. during Gross and XXXX during of production was the the of a from dollar from particularly were increased in compared discussion gross basis, the demand the well gross quarter the INTERCEPT as the prior growth we experienced disposable

fairly XXXX, expected U.S. For in driven other the outpaced This down. to our is margins stable be relative expect the commercial slightly will growth we by markets. to gross

rule, a EMEA to single-dose kits As customers. use our U.S. predominantly general platelet our customers compared

which Our approximately $XX.X operating full $XXX.X increased single-dose higher platelet launch. and platelet PR-Cryo operating lower to to kits $XX.X to generally $X.X SG&A total now Of kits. the expenses, and year, by million discuss the totaled the like quarter investments non-cash related compensation about double-dose our margin year. for during QX driven stock-based expenses, and compared during gross I’d compared accounted expenses the billion contribution million million our carry prior to by FC were a

expenses were result compared SG&A basis, diluted of XX, totaled or million to XXXX diluted development the $XX.X $XX.X same Red compared compared prior annual quarterly to have XXXX. $XX.X would expenses development expenses lower net XX XXXX. $XX.X and or totaled year, for Cell totaled months The losses narrowed otherwise million by million program, diluted and full loss when business, marketing in $XX.X $X.XX basis, ongoing to with months $X.XX ended period. a during was or million year. share, well platelet costs per Reported Blood associated share travel lower $XX.X new XXXX. the net reported the million, a expand spending increase totaled year million $XX.X to Similarly, U.S. per claims related a per SG&A our for the share $XX.X QX million and a loss on pandemic. to loss share full COVID-XX per billion, net full million and as of to than compared as Reported share, illuminator. as the expenses three December loss in for $X.XX billion, $X.XX year On diluted compared driven XXXX, for slightly the to the to our for the prior net tied of compared been, or a they during initiatives basis, the Research R&D a For product enhancement and R&D during $XX.X period. year quarter On $XX.X year expenses prior intended programs was label and per for period

In ended short-term equivalents a approximately strong terms we position, the investments of hand. cash, $XXX.X with balance million sheet, year in cash on of and our

expanded In our in availability continue invest the revolving working allow in capital. December, of regards addition, growth of credit, in which line primarily of us we the to to our business, will to

was million SG&A The was to compared from working flexibility. $XX our $XX.X additional leverage increased in million, steady for in XXXX. of spend of providing improve driven later by us margins, and improvement operations capital year XXXX, with remaining extended also revenues, to our management. million the full use availability $XX.X We continued the debt for the gross facility Cash

and year mentioned last product Obi million, for saw expect earlier, we total as reflecting year-over-year in $XXX the as of you XX% XXXX, to be for guidance growth. the month, to of million to on to revenue Moving range $XXX XX%

of be development over initiatives, transition continue the conclude strong for the focus look and to Obi to our our With our as commercial Cash achieving me we to pipeline investments some ahead, plan As strong over a value that, focus programs let are of some to call will we to on horizon enhancements. expect profitability mature back comments. operating and transition from adding leverage a and turn additional management of course closing ours. the more continue SG&A and

Thank you, Kevin.

Before to update. for open I I like and would spend last call questions, pipeline some up the have few minutes a announced discussing also a since news provide call we our additional quarterly

this standpoint, Brazil, our touch from three-year geographic briefly. with has In just wanted I’m announced with for the progress team create in meaningful platelets represents significant markets expansion Chinese opportunity platelets. partner with a for excited our these remains we and for us that represents system a First, be result, transfusion HemoMinas the only Foundation our a the a about a worldwide, a ZBK them INTERCEPT CEI it to regulatory to And and to made local opportunities of one some reduction term region. announced largest on LatAm tender December, potential and transfusion the pathogen approval into INTERCEPT for longer has INTERCEPT. market. and won China the beachhead and just the for plasma we blood significant joint venture as plans

transfuse is in which and and develop you our platelets to our excited for manufacturer are fully progress to identified products will red partnership will market many Well, to and Chinese in unlikely get Alongside we with ZBK. move phases, we largest us and forward felt decade, market, as a growth new blood for eclipsed that The to System and And we’ll next to that position the expect blood ultimately work growth region. would given is commercialized have ZBK, partner, components critical has opportunity the size transfusion the the coming We in of the was long-term abate. together demand the the long-term transfusion we success over years over on the it we we the for our market work register of the China. the leader be update cells. a and have for XX INTERCEPT U.S. but Blood This still and

for components Development given remains all transfused Red market portfolio benefits number an potentially center Cell complete large a customers. red cells of for to red INTERCEPT the a globally, our transfuse of on blood blood attractive opportunity, program Moving INTERCEPT Blood having for our cells

track program two a two CE the focused with progress team progress red already our modules modules for blood Mark the submission is and Again RBC patient process. on specific work for XXXX. European the two submitted on of Based first of you the efforts populations the our FDA currently the upon of Our remain for in began commercialization half Europe, could made commercialization Mark the for streams, we U.S. Europe with quarter are final CE to part have and will of recall around toward as PMA in We future cells review second the regulatory XXXX. the expectations submit timelines, INTERCEPT in launch in second

we completion most done the filing dossier. INTERCEPT launch, chronic has of patient FDA Phase to most and the with as item plan work populations, CE remains strides U.S., X Beginning market we ongoing submission, studies, for elements critical the approach leveraging our clinical focus preparing the of two the made have In in data some being Mark PMA the various the significant we cells. PMA the for generated ReCePi. As our that ReDeS to anemia, of on team where of involves red targeting segments the such the

of in COVID-XX and sites We and enrollment. studies addition site our are enrollment new expansion has a and slowed patient period both patient still of for

study and continue calibrate We regulatory submission. estimates for completion our ultimately to

years normal It sight timeline. be to in line clear able to on a post-pandemic, market the outside on it is to INTERCEPT are for a the U.S. speculate to likely bring a is without that us before However, we will return for U.S. the premature for cells the system a of red few commercialized precise

normal be report many and over that and despite to INTERCEPT working trials, adapt on reduced our made to our the red on to Q&A. real in working having EMEA. updating XXXX X with addition clinical during world global we experience we achieving will point you adopters the we body early XXXX in pathogen hopefully let momentum in back the goals progress to I’m to U.S. our build the considerable it cells look With XXXX. on turn of continues standard-of-care, for me mission make progress operator blood that evidence throughout to year period, forward In to on executing some ways at new of our During our closing, for to in that, fronts, and safely. to pleased returning Phase

[Operator with question Johnson Instructions] from Our Inc. comes first Jacob Stephens,

Your line is open.

for is This Jacob. on Nathan Hey, guys.

Just quick from few a ones me.

Kong JV just With announcement the we level high the that us looking forward? give regulatory then color just you the a some from on China, yesterday could and about pathway should announcement, Hong think in how and

Hi, Yeah. Nathan.

submission. the actually the with trial the putting the working what translated to just We Unfortunately, now we’re dossier. will requirements be. full clinical through So ZBK work on together have we

As trial requirements going clinical limited we give recall, that about get through, be clinical going clarity, what sufficient have you did once of in for sort that’s the submission, relatively completely to are study to we not plan when a to we may to more the submission but scope. historically, Kong, done. just you And then Hong be for be that specificity able we’ll a working

the the you’re there sales then manufacturing and done, is more plan this Got anything on seems force, year? on And it. launched year, you which else their the manufacturers focused here? be outside to of throughout filing Do PR-Cryo on BLAs you partners adding hiring largely

it’d Vivek, X roughly of and at can we remarks, almost and in team. next I trauma four XX% mean, the in color the where enthusiasm being States XXX in to of currently early initial sort Level prepared we BLAs. we’re more that have we’re the as in of launch couple states states. on launching more you through sales sort hearing trauma That to probably, have X, included Level from there’s guess, the nice in those regard launch give year the to cases the little I hospitals this and represent I with a the a United the said, four states Yeah. bit of the be think, sort before this we’re highlighted

Yeah.

think little key ensuring with Obi, everything that we’re out you we the hospitals. I we hospital captured remains can the issues But a bit thing themes, that with through a that anticipate on contracting working now issue just those then with other restrictions Obi lift restricted of get pandemic-related access COVID. clinical had and positive. I the right as lot will is key that’s the as we mean, get enthusiasm that’s will be going there. There’s mentioned, But feedback on

move of went think further about that in as into we’ll talking about along we commercialization. be certainly more submission, this the terms I So the still be believing we resonates. thing our true to the marketplace And

Awesome. Thanks for taking the guys. questions,

Yes. Thank you.

with from comes Matthew Stifel. Our question next Blackman

Your open. is line

got Is afternoon, a everyone, explicit of then the be To that think think end But or first lower the questions. to about And the back just way year of shape as of to fair Good for, range Kevin, my fair about taking and and I you’re of upper being first I’ve just end. maybe just of the then year? the start and not the a quarterly maybe giving also XX% guidance. year, we would appreciate couple sort think maybe thanks to quarter half XX% the half shape year at the at of ups? follow the about the of for

thanks. Matt, Yeah.

occur. in first pre-release, typically we’ll think, it resolves. characterize likely year our with We how back would on would higher to will year, which of Clearly, the that the it And of be is half at expect four, will here. the right the the that range characterized you’ve end as acute we steady of range. slower of the half be quarterly before the And the from growth a quarter hope QX, impact in that, end we see think COVID the is lower I basis. this I in to the of Following -- guidance that

you’re correctly. think it I thinking So about

Okay. questions side you Great. of a And then illuminator of the the have -- business. on while got couple I’ve I got

trends. can in I’ll you historical the there, couple what and And then was ups the if revenue outsized, -- little You relative quarter wait of it bit that, perhaps, follow that. you’ve provide a for illuminator a got generated was to

Yeah. for pointed earlier, as a kit had I illuminators for demand. we mean, We this of particular well bolus placed. quarter, bodes were we that that think future out

$X.X the so outsize of for million, that’s quarter somewhat roughly a was an For a quarter us.

newer existing customers be which any box Any And to pretty there skewed that new sort up way types capacity quickly there leading that these that characterize would of and point adopt. whether way illuminator either that of are indicator revenue? is some thumb Is starting or it color to then they’re sales. those customers kits expanding to good are illuminators where Is Thanks. of accounts? for went, towards great? how any a of on are a generating rule of any And is there

Yeah. mean, rule real of thumb. no I there’s

the throughput As a placed per device kit from far device. is we until when delay as throughput a see or the

centers are require Some throughput capacity in they require much two the centers one higher cases lower centers and devices. Other number. same and most and have have

illuminators metric of mixed those or lot you the of to as characterizing overall efficiency. and placed to thumb their that you far So mix model and really production I of that increase real a have there’s lot it’s can a as that customers algorithm of bag, customers, rule sites allow a to no it. new sites But provide existing and

will foreshadows that and what about contribute to growth bullish in that optimistic XXXX. remain we So, and expect it the

it. appreciate much. really I so Thanks

Our Josh Jennings next question comes Cowen. with from

line Your open. is

strong This for low figures. that to congratulate Josh. on exceptionally about the for some a you. taking Eric for market and donation Thinking Thank year U.S. recent blood here. are is months we’ve Hi. second, centers the end facing [ph] question discussing in Thanks seen the articles

winter months, hit starting now hearing what from how regarding So just trending? and I’m emerge customers donation to they’re harder we’re the you curious just guys are that levels from

want Vivek, that. to do you handle

the some we days. upon the of based Just in saw of information last couple

of weather overcoming sort and blood severe in The terms part, we’re them. impact issues think, and Sure. of have these donors dealing for an centers overall capable of going the are that with acute the to donations, most I

So longer anticipate impact. I don’t any term

bit, the on. treated steadily may ultimately donations seen as has in have total, become is kind of PR the grown. other donations a drags all the the this, note in to pandemic recovery of the donations thing too drop course We proportion But well, of

And terms you’ll on long-term both that see so nothing volumes. we donor of durable think believe ends, recovery be there will ultimately in impact but we

Understood. then in quarters? had could that in coming some think hearing Thank the medium-term? there to be Could hearing progress we’re do something you in What we be on Asia-Pac, Japan other near- you. And great in region. countries you’ve updates the the

a Japan market very Yeah. opportunity. large is

As see and I the still of grow their remarks, growth in years, evolves. mentioned how to China’s that’s thing quickly market mean, they’re around the enough let’s players the been to and not five say, system sort fascinating prepared I last, Chinese go over double-digit healthcare

happening attitude a wait Japan to with bit little think Beyond the regard a of what’s Japan, in and United will take of States. to I see sort continue

large U.S. I really and market that’s our forward. elsewhere, will evaluating Korea ongoing we Cross it’s global of globally, actually, at national think see and really approach of where looks we on in have use. how remembering activation other anything the like the there’s American Cross progress of are until Japan and a got communicating large Red going a the sort the lot transfusion don’t that services and progress front But opportunities, sort that Taiwan that INTERCEPT discussions think the play. each we’re But encouraging with making INTERCEPT in So where of can in specifically bearing say to is to Red we on true, we general I realization the utility and routine that broader pathogen have

for Thank Excellent. you taking the question.

Thanks, Yeah. Eric.

Folkes Brandon Cantor from comes Fitzgerald. question next with Our

Your line is open.

about think real think, maybe of that near-term, familiar following the Hi. And but growth as obviously, sort And term to on front with should basis term, we have congratulations Thanks ex-U.S. on good just at about sort questions then And and asked quarter. what I that’s we in we U.S.? guidance how the ago. you the taking the longer and from size maybe month gave we longer the if my a U.S second for I just of of on my growth okay. a look that, expect in you another versus opportunity question

But may sort seeing anything the at in that terms from assumptions I’d moving seems there’s love ago? have from a the you. guess anything watching I to So the in of part, that changed your least you if month It hear have that you little stage? Thank changed, bit that at perfectly in we right you of may environment you’re direction. made a anything

and first the will Brandon. of maybe Yeah. Thanks, I the that ask then part. part you to take question I’ll Vivek second handle

States, going plasma, -- this a we’re U.S. into in for launch and out questions, see coming opportunity I these do opportunities to year to growth the small red But about fairly are United INTERCEPT lot and a there’s cells and platelets, XXXX long-term, and the really excited as the -- there’s where for compared PR-Cryo product the large for obviously, think, tales, that the FC you for of of So, your cryo. global well. XXXX, for but growth the medium- very

in initially launching broadly. obviously, expand then, on into So red cell the and to we XXXX move that in trying ultimately, then then, more and EMEA system

long-term for really just of years, very availability partner. that There they conventional from transform role will Government really in setting the identify nicely think of INTERCEPT in we’ve safety made given Chinese been was on safety it’s various the the term companies, lot right working trying five sort something last to interest think a and approaches. say, growth this a the the likelihood the up opportunity and JV has play longer that China I leapfrogging in about announcement we about and for, China, I’d availability blood how been is Clearly, to blood Chinese really So -- -- yesterday prospects. this our

ZBK, with strong regard manufacturing has and modern across centers with blood but found operation. not sales only we a a direct who also into selling so to very China, And someone the force foothold their

there to handle around, on you other the few but want last forward focusing with for of looking we’ll red question thoughts have guess to Vivek second program initially we’re that considerable and platelets, rolling cell out add just also the to China. then So your color in Any that guidance size I our opportunity over the how the months? evolved

Yeah.

captured key points, of the you Obi. think most I

kind emerging expanding our add up and and long-term. of realize line developed that penetrate. geographic combination compelling strategy product the As in that will role we opportunities the there through in into really mid-term we And of starting arrows we’ve can adding, driving to furthermore, a Asia-Pacific terms are product lines extensions talked near-term, augmenting a markets expansion, and continue such maintain the quiver, markets key have to line new has in to about some been play and growth. also terms of rest But in to that’s of then, growth into and past, the we’re opportunities what

an be opportunity off large investments coming to years. would made pay start of we’ve and Germany So, a should in we example market the that see where

quite And so one key in small a that basis. markets sort we mission, growth technology this to that post-compelling another, importantly, community allow to that blood to bit as global access of us safe is to flywheel us is relatively which gains a on adoption our a allow a it’ll and with engages positive to and continue continue numbers, most to realize should expand create believe

change in. enables this that There hospital associated welcome to guidance and us restriction team the and and continue how encouraging our travel we’re it would it’s access premature seeing Obi When cause demand to anything been Kevin bit understands and In guidance. issues to early days. now, some but still first though navigate environment, it’s to approval what to I issued of to much for be weigh we’re comes extent to terms we any in think I vaccines time, say product relative alleviated see Certainly, I very do that, strong it’s to rollout, over current to can continues we these supply our and that is we about levels the the of customers, of even provide resilience that face conclude to in some challenges. show pandemic-related point. service of team change certainly lot the high the to when still new and it of support logistics to issues ensure a of signs. ongoing chain encouraging a point the our at been month a view it have and

we’ve accelerate remained I’d yeah, growth that material compelling that can confident anything month I if to any expand terms us like you’d to in things still definitive. past don’t So, could premature lead deliver further. even we probably it’s changes believe numbers. But a bit of the that on in point say, to know that.

No.

it think the of at opportunities, looking to of I XXXX. guidance to it’s we’re I you about have some normalcy, say yeah, Very way the we characterized around back premature think, until but clarity then, get better anything. sort kind excited getting for

all Appreciate very color. Thank Great. much. the you

Brandon. Thanks, Yeah.

the to for questions. further any call to remarks. back Obi Greenman are no turn I’d There like over closing

imagine Care speaking next Annual Monday Thanks and many the call thanks, XXst next and Health week on we’ll on presenting today Tuesday be phone today. joining today, Well, We’ll for it. for at of be I you everyone, of appreciate week. the the Conference with joining again and Cowen

and Ladies Everyone great disconnect. and now have day. gentlemen, a this does concludes the you may program