CERS - Earnings call transcript Q1 2021

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Cerus Corporation's First Quarter 2021 Financial Results Conference Call. [Operator Instructions]. Please be advised that today's conference is being recorded. [Operator Instructions] It is now my pleasure to introduce Matt Notarianni, Senior Director of Investor Relations. Please go ahead.

Matt Notarianni

afternoon. good and you, Thank I'd like us for thank everyone joining today. to

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

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

ended of are operating differ and under uncertainties efforts, that call including press performance, growth with on we'll actual shortly. statements. future to undertake at gross These risk announcement events of described access Kevin events release to year You those and results. factors of XX-K activities. financial XX-Q future to of the to you and today's and December forward-looking and copy to related for in and product to this review statements product as product ongoing and including identified from future and can the Vivek statements anticipated commercial and guidance in cash com. operating and development results, call, our include and www.cerus. and financial materially. rather our are used forward-looking statements today's historical that a operations quarter revenue we on relate Examples involve website events, our the timing followed XXXX Obi, activities, duty forward-looking make the update remind facts statements. some the risks as margins our launches, remarks cause ongoing the They like these well and future and which regulatory future I'd growth than On results forward-looking We goals, future performance from will to development company product we the expenses, sales, strategy, our clinical trials, and our or forms opening can no XXXX, by will XXXX, begin March provide for ended update XX, file obligation commercial XX, and this

from Cerus' to and And OBI update We announcements President regarding Greenman, pipeline remarks. our will on Chief introduce closing Obi Executive and commentary pleasure my it's conclude with Officer. and recent now

Obi Greenman

and Matt, earnings you, review Thank good pleased you've afternoon, earlier a to had today. our results, to report I hope QX release chance I'm everyone. our which from

some Kevin make I'd greater few business the of of about Before the balance year. to discuss how the and quarter financial remarks for like our updates the detail, in commercial are Vivek and and we a about thinking

driving force As platelet results, exiting revenue are building to first the quarter be momentum adoption the of behind you XXXX, a during in had our can in U.S. to the see our business our strong start the XXXX. we off on continued INTERCEPT growth XXXX. from

up customers FDA across more INTERCEPT the cases, had country. quickly to many than we moving, customers provide With in to anticipated months to hospital pleased deadline platelets away, compliance see are ramp we capabilities X the production to

is call. ahead on team will with hospitals this share progress commercial responsible making our Complex of at and On later for the therapeutics product more you good first we sales, our INTERCEPT Fibrinogen details front, our

provide year, guidance in Vivek to is with and Our U.S. remarks. commercial executing team will more compliance blood across FDA later prepare the centers support country they his for well perspective as this prepared the

consistent are closely more to able product year-over-year proud growth we I'm revenue QX years back now. pattern that report of multiple revenue, little product goes that a at the a to Looking continue

to start product $XXX strong. our XXXX the of between the $XXX market our momentum million, and full million at to a we the representing saw guidance, to year growth XXXX are revenue in been guidance our range product raising year And of has XXXX revenue XX% as higher of we from full Moving a result, results. year-over-year XX%

of for While, We as over opportunities adoption cells. in and this the $X to When red continue geographies close about INTERCEPT about billion, talk fibrinogen providing usual, each opportunity of not near-term the which to is INTERCEPT INTERCEPT of addressable approved often platelets, are at and portfolio itself business $X.X billion. complex. quarterly of of our quarter for and alone, INTERCEPT we opportunities we pipeline a not remains considering current guidance, to global in products upside yet very commercial penetrating plasma, year. our blood licensed lot There course hospital like build markets total the momentum the expect current we for believe opportunity where is the includes significant being to

with product we future and expansion significant extensions, believe the runway Latin growth. revenue growth these to of Pacific ultimately line end America continue addition, markets, geographic In and for Asia our organic is into there

INTERCEPT the I update, to Fibrinogen Complex few highlight over the Vivek a turn would updates Before call commercial to or I for like for IFC.

August the NTAPs help has year gain of breakthrough patients critically like our providers correspondingly Complex. patients. commercialization to FDA CMS' focus anticipate a fibrinogen in October their X, decision that and early for some and Add-On for NTAPs another materials to and I step is bleeding IFC New ahead or of in to we were released provision in to want see on of Fibrinogen of that Medicare ISC Payment, use field our share fiscal CMS' its date on XXXX.Additionally, will technologies their Technology decision timely clotting INTERCEPT final sales marketing effective developed early. outcomes days of benefits We the very approve for with underscores This NTAP. to of including for the access released the a and reviewed will start the the access week, of factors, and IFC, last new preliminary forward improving First, team CMS that With pleased and the be

once anticipated are We sometime approval for a nationwide launch next year. partners our production receive preparing BLA

our physicians cryoprecipitate. expiration Vivek over With key prospective and customers for of Fibrinogen Some this to operations. We're that, to product management messages to with rates let the the for of with as conventional more included immediate detailed critical patients bleeding for day the call hospital life, as to has of product forward a the more better to well enable availability reduce resonate me meaningfully associated which shelf turn looking that INTERCEPT getting Complex challenging wastage events. X commercial post-thaw its potential review

Vivek Jayaraman

everyone. Thank you, good Obi, afternoon, and

discuss As discussed, today. the start, of quarter XXXX and with you pleased results I'm strong is off to our first to a

centers the that consecutive As for Obi INTERCEPT blood team to platelets America the QX Specific to INTERCEPT are offer we platelet as responsible FDA in which, in in Blood kits significant the the year-over-year. of grew commercial these XX% the the you in X for for compliance mentioned, will a supply is third XX%, of of U.S., market, centers sales U.S. the of building and XX% market top presence overall to quarter platelet growth year-over-year. platelet This X recall, moving in System demand October North QX October. year-over-year domestic the customers deadline in our ahead to to the aggressively clear is and about increased evidence U.S. ahead during deadline. above XX% blood quickly the Quarterly the XX% are it's

our over customer half platelets our goal to from sampling. expand of to partners X be basis. for days the For inactivation the demand produce and the shelf product more with a life day Red largest driving approved continues in revenue its efforts are the large year-over-year on American blood detail continue life, for our XXX% the INTERCEPT rapidly, and of In But they clearly see the platelets first pathogen is adoption center even Cross, a to region, days. towards LVDS reported in X% current treated. delayed strong now versus shelf ARC INTERCEPT or grow we some EMEA share the INTERCEPT INTERCEPT volume Obi X increased quarter X and pathogen-reduced leader will The platelets. stated of U.S., to adoption continues regarding to

During as sales the from well Europe we our unfavorable illuminators contributions of timing saw certain progresses. expect year in markets normalize the major EMEA. as this as to quarter, Western customers growth, in of Offsetting regions, in impacted in established by which we orders was QX

and business international over the last the our from first year, this continued INTERCEPT plasma has Additionally, of quarter. sales in benefited

aid reminder when is in not COVID-XX business, supply, seen that we've pandemic particularly an new platform tool significant safety that pathogens important an can from a emerge. epidemic INTERCEPT the our driver demand of While in of the customers blood the the during a is

of the of first teams therapeutics Moving to in business top making and a customers the at advance our Obi call, unit, our online have progress coming as of the commercial operational lot shortly. been mentioned

Three are signed and as actively already initiated readiness. Our production agreements begin lease operational product and commercial strides new ordering. partners ready would hospitals are for that completed have its inventory are validation partners or making building be to

to dates in provide with that additional to demand. expected meet production we the and year, of partners additional support discussions also production center addition launch BLAs in XXXX blood will in in to Finally, capacity nationwide production ongoing current next launch for are applying partners access

the with business, evaluation prospective am commercial a I the in multiple contracting. therapeutics customers, funnel On that pleased have side in of either strong we or

you the turn year. begin Kevin over success first we basis review forward broad updating So financials. on to contracting to we for I as more more With a of quarter the our throughout the look call that, on a hospital will

Kevin Green

what good year. Obi the of product increase continues demand To we afternoon, Thank prior XX% the QX to $XX.X first everyone. increase. Vivek, of XXXX $XX.X million, you, INTERCEPT revenue a million quarter recorded recap during from reported for and Global mentioned,

For number platelet doses of QX, increased calculated treatable XX% year-over-year. the

total product mix remarks, while of the XX%.As platelet of Of for for for in plasma remaining accounted sales our for Vivek terms sales, XX%, represented outside quarter, sales. product XX% approximately demand kit kit again INTERCEPT his kits accounted U.S. the kit saw QX mentioned those of In the QX strong plasma sales

illuminator about X%. we healthy see which of contributed globally, placement addition, In devices to continue

contract the totaled our QX. revenue government to in and product XXXX. not in revenue addition of totaled In million guidance, our Comparatively, first $X revenue in million government quarter contract $X.X included

remainder XXXX, for the patient activity reduction as initiative revenue trials contract FDA increase government whole ramps. pathogen blood clinical with BARDA and associated the we reimbursed of to with enrollment by For expect funded

QX reported were the and call year prior in the let's was The XX.X% Gross our margins. compared to for XXX expectations our year Now XX.X% decline line prior our in for to margins from we gross February. period. discussion the the point move quarter provided basis commentary on with

this As expected the our driven reminder, a the commercial growth by U.S. relative to in other outpaced dip was markets.

customers a platelet rule, our particular, customers use dose Cross, opposed in EMEA more use kits. American U.S. kits of as double and the our to As who dose general Red predominantly single

to dose platelet kits. platelet margin kits gross single Our carry contribution our double dose a generally lower compared

the given about the $XX.X first for total totaled the expenses and prior million result, the rest to EMEA. the to our and in of sold expenses fibrinogen operating we Of in year. a included driven like million development during play from which SG&A surrounding increased similar million to were $XX.X expected kit QX the compensation. I'd U.S. compared increased the due anticipate prior to $X.X and expenses, million Research $XX.X to for $X.X expenses, remainder million in world, the the by now year, noncash noncash investments the a INTERCEPT discuss stock-based of for versus accounted As $XX.X compared totaled to launch out and outperformance during relative operating mix complex compensation. quarter million the difference dynamic by quarter configuration U.S. the approximately year higher the stock-based

the increased CE illuminator more Reported quarter, blood compared same increased per with year research net $XX.X diluted for Mark lower for loss offset when share ended the were QX elsewhere. the or $X. for to or $X.XX by activities, LED XX, in March to share than compared loss such other per Reported diluted red our During months development prior net spending XXXX. pipeline $XX.X million and period. XX period the totaled in XXXX, million the X associated development and as cell expenses INTERCEPT

of year In the cash, ended we prior million the with for and strong short-term Cash quarter million $XX used quarter approximately to a in terms from the of period. our equivalents, sheet, operations first on for hand. million $XXX balance position compared cash was $XX.X investments

are to we customers into to products As ensure to growth revenue able without interruption. chain and our leaning visibility deliver for investments continued increases, our our we supply inventory that and are

growth adoption on to durable ramps continue on line Finally, focused cash globally, as revenue see to we're our breakeven. leverage significant top as or path we flow operating driving INTERCEPT profitability

as While upcoming and it to we intended not over quarterly us based it our for to because next long-term this is guidance, mention results. focus the serve is few our forward significant look I on showing years, a progress

Moving on to guidance XXXX. for

we the XX% to range we to $XXX $XXX the demand good new mentioned revenue believe million. of earlier, us new into that XXXX. compared our from Obi to continue products, growth when product to This raise million As $XXX XX% $XXX to for range have to million range XXXX our to million visibility guidance reflects leading

INTERCEPT driver enthusiastic product. primary product's launch from let but potential, turn Fibrinogen call our that, in XXXX for some While the modest we back the launching for prior expect for to term sales a is the comments. relatively this U.S. the are closing over Obi continue nationwide remain the me immediate With to Complex strength, rollout. We platelet business to the

Obi Greenman

Thank you, Kevin.

like you some provide our with to insight Beyond pipeline progress, I commercial initiatives. the into would

working -- respect INTERCEPT and the day team to study on later our efforts FDA in submit FDA been platelets U.S., to ongoing track the the X to around complete with this First, remains the quarter. has our to

we the the Assuming approval a of XXX-day end hope year. have window, review to calendar by

module you track of last our am end X the a the and to on the we cell third modular update for I with on share final and on CE are blood to submit QX. submitted Moving of month, submission was that our part a quick module red program. Mark by pleased fourth to

XXXX, have on U.S., disruptions to launch based year, ReCePI to populations our the potential stated III anticipate of during the patient specific continue is and we in studies RedeS In focused second to As half we COVID-XX the trend the regulatory the enrollment on think discussions with Phase a enroll we patients throughout possible. and previously, assuming our continue ramp authorities, abate.

for program mentioned I case focus concerns. [CMTR] a XX in the crystalloid days because forward start appreciate potential we food Cerus. resuscitation Another with associated it study clinical this The National using of resuscitation trial in closing, care versus but Lung The of this study, Trauma this In for it effort X on Resuscitation current as study. decisive called and are and Coalition the for look to Without highlights moves collaborating a treatment study plan with enrolling take is a support at is part year use for study. or to burn highlight quarter Injury which I the forward wanted solid Research. Plasma a moment the updating is PROPOLIS INTERCEPT of our the for to the you U.S. the this was first It in sites the plasma of We initial the injuries of to of methods. in has is plasma early today hours as burn still solutions INTERCEPT which safety market, challenges use standard treatment

and organization adopting focused advantage Our deadline. that have a entire truly product is offering solutions opportunity the on in a unique aligned taking rapidly near-term we a differentiated with is market against of

that of translate results call, that, I have the solid for today's full very been in the And the for with grow I to back use the over business market in the product we of call continues growth and coupled and launch transfusion line complex finally, fibrinogen our levers updated place to momentum the INTERCEPT the gain will revenue on favor, The business, operational has ease encouraging turn With various are and for guidance think recurring strong confident our our nature in the this the and XXXX reception and me let Q&A. availability actively relates we it beyond. succeed service, to steam. for am to operator as putting Our about as for top year. into

Operator

[Operator Instructions].

question comes Cowen. first Josh with Our from Jennings

Josh Jennings

ask a to I by off $X our $X year Congratulations, guidance at the million beat the the raise midpoint, and about estimate and to nice start to wanted you about revision. guidance start a million.

than that in you trends just that of rate, makes PR year, complex million into and the you your adding incremental range? INTERCEPT better and than Is the sense, of anything ton are trends more parse there guidance? cryoprecipitate improving you confidence you're it XQ the that So Anything the it stronger can which a trends a I beginning at revision B on launch platelet range of just considering driving have of procedure results. But suggests guidance are get B stronger of on April fantastic. the XQ guidance anticipation to like better adoption? kind better understanding guidance $X wanted of in that seeing fibrinogen Is would -- be out what's

Obi Greenman

Yes. Thanks, Josh.

guidance revision more to over I'll of driven bit So a performance provide but turn States, the context largely off United Vivek business maybe in the to it that. the the for little

Vivek Jayaraman

happy Sure. I'd to. be

-- think the also we but do our strong one. increasing have U.S., about contributions the correct is strength confidence seen internationally. business sentiment Your I in have the your We of

for look through are that the we that are starting few we to And create balance there a converge so the the will think factors business. year, continued of tailwinds as out

respect big The first we in in production with X to compliance and platelets the PR U.S. deadline increase is approaching, that is guidance blood centers. the the see an at fact the the capability

X where And Cross seen and them certainly progress to has blood then but with engage great times big other operations produce been and well. American the numerous partnering PR led centers can team X way, families slightly making on we've their before, Red get has discussed at we've the sure customers As strategically as the sufficiently assisting on our centers, needed blood their board. the hospital focus

we so are starts We -- we of access driver an of starting continuing as see the sunset. a U.S. the pandemic year. COVID that's to to course to do increase throughout the terms hopefully hospital the And of a in bit in that contribute see

And so will this line well. commercialization improving. and customer access year, will huge start that half will, the appear anticipate in see to be of we while issues to contribute second contribution year, the we cryo calendar the top we then don't help certainly as And

that combination most to factors ability a in of importantly, of give to and strong results post to patients confidence terms of need. these those really it's our and So provide all in continue us products technologies

Josh Jennings

those for Thanks extra CMS great the cryofibrinogen see untapped Maybe for pathogen recommendation complex. the details. It was one reduced follow-up. just by proposal to and

Just is Is that bit calculations that's level in kind the your that TAM. into in U.S.? that average. built CFC ask wanted Or was of around to document. patient TAM TAM that pricing of the per It's a stronger baked million mentioned into PR $XXX on on pricing $X,XXX the pricing of a for that, plus little

Obi Greenman

on I'll and really She's who's probably happy call Yes, the around to the Technology as then New the Josh, that with Dr. architect ruling today. over it question, Hanover, our Payment turn this the week. answer well us on specifically were joined we strategy, Add-On global reimbursement that see to start but last preliminary to behind

fibrinogen, spectrum, the I the between would be talked a per about the product conventional more of is of But sort put $XXX application of we've think the price of Complex we looks $XXX that. the is somewhere at you would of to cryo, the range what the INTERCEPT sort of implications be Jessica? $XXX gram fibrinogen basis that what per Fibrinogen which way that about ruling, in ruling and preliminary into versus gram, other to can sort that is midpoint which on on pricing a NTAP perspective of then in per the which Jessica give somewhere NTAP the like. So sort the some end fibrinogen gram of gram per $XXX is of historically, middle on concentrate,

Jessica Hanover

question. Yes, happy for sure. the Thanks I'm to.

application. up on that and CMS Obi we the said, to pricing So following our is NTAP that proposed what had

have be the pleased So it decision. based patient studies see we would that clinical on stage at anticipate were what the And a a conducted surgical this is patients in in a on group. patient reiterated population. a of is patient Medicare which that the And population, we trauma most applicable per that population younger $X,XXX to Medicare population been reminder we preliminary receive average based anticipate will of usually just to similar is more as a that opposed

patients DRG for that Medicare that something So is overall, typical reimbursement incremental the not And not rate, the incremental conventional Medicare inpatient payment system NTAP available, based over is payment uses. currently is which and available that that's cryoprecipitate. applicable for provides reimbursement is currently a

we something be as positive new see at that's hospitals that quite for in-house. bringing So looking will the they're product

Kevin Green

I and just could. not, I to IFC the clear increased this Josh, the around U. contribution really or your The this cryo as it year described on from but was guidance. I'm a is result, it's hasn't Kevin, question. sure increased guidance our Vivek wanted S. circle changed. if for driver or if the as not back guidance thinking not coming EMEA. And is

Josh Jennings

the -- been just And discussions, that of or any increased level. $XXX the of optimism and a of plus Excellent. pricing any increased in this up the to guys approval your your U.S. days million just customer taking I early at higher calculation TAM have recalculations cryo the and think you is getting TAM? then of or -- or your

Obi Greenman

range that Yes. considered when we Thanks, of Josh. was It really sort the that the we've TAM Complex. INTERCEPT in I Fibrinogen mean, about for talked hasn't.

just high think sort growing market digits is single an I of on the that of sort basis. annual challenge organically roughly is still

that with preliminary for market attempting information to roughly certainly sort likely XXX,XXX that's equivalents think get the using is how And I NTAP think, we're a annually, of gram so provides market years us better TAM a opportunity. But of the fibrinogen gone up, sort we, today. of real-time confidence so that when ruling more and large I in out there couple put ago,

incremental per DRG, that does and right with the this the other mentioned, that products now. is provide Jessica for doesn't payment exist hospitals patient to a As

So even I though only well really been think thus -- customers it's it's by far, week. a very received it's been

JoshJennings

of your therapeutic I Congrats Well, product first but on the appreciate taking all the the in Excellent. marketplace, questions. entrance

Operator

comes next question Stifel. Blackman from Our with Mathew

Mathew Blackman

-- adoption. from couple was platelet curious, you me. I relation and think, is Obi, U.S. this a in I Just to, said

there moving You to you these that path that you were Red Cross? anticipated. be seeing INTERCEPT some customers dragging follow-up. bit? you perhaps feet are Or acceleration down been are already, accounts than expand color in faster a of their some said one there accounts have some of bit bit? sort the had trajectory then may any Could similar that helpful. Are that a little a heading and the Just on would the hedging were And

Obi Greenman

the discussions. key having few to Thanks, of Cross. provide turn there Cross, over is their really the like then for answer market. we're the also he sort sort lot success to X. are moving Red X account quickly and XXX% towards a best just hospital I'll back Yes. beyond And of context which can their other families translate that and with the it as But seeing them the the Red a we of start to of with sort of of question Vivek really Matt. U.S. big that moving or the seeing But

a provide we -- what think unexpected little Vivek, the more I that's say, guess, I color? would do starting want was I to of year. sort So you But

Vivek Jayaraman

happy Hello, Sure, Matt. be to. I'd

a that As Obi certainly play indicated, role. did

need the accelerated COVID-XX is awareness terms prepared. driver for another pandemic think of did seeing and I of growth safety in to be increase the

hospital the that about So start you what was the have a really center -- multiple on. lot of start offer of to And other blood event in discussions if would have started going to been certain suppliers resonate we've see center PR they as do one products being of and PR, front preparedness on well. having put supplier suppliers. you the of move pressure And ready customers to blood to center blood because an to

to of to technology, a across starts network see of blood hospitals center that types And and where a so the to Joneses dissipate you effect you bit the start started with keeping blood almost effect the hospital sort centers started more markets. place to see up and take the both of certain adopt

the So and at all reason go gives have of way encouragement. are things still trending headroom in but which U.S., for the we to plenty rate certainly, us

Mathew Blackman

generating that just if for a sort as sort That's lag on this your me. or bit if of through to maybe, there I'm was sort into curious process, out then, missing Thanks. appreciate sort turn lead little And be I that was of phenomenon out a a fear Vivek, of way Okay. I sense wondering was trying perhaps. turnaround the have while that. playing of any? I can it time, just you, Can little would And interest. maybe conversations new early give you understand its us I you and these I of revenues? of guess, quickly a Any work however customer some how been the understand there's color I had? you revenues? on long want it, these how board to days. phrase on What's cryo. you've getting pushback time. conversations appreciate significant more bit of

Vivek Jayaraman

question. Yes, That introductions Matt. product in answer uniform course, appreciate variety happy a that, markets, there that as answer tell clinicians And no, of can to seeing to environment, isn't tech you we've by reception. whether new been of or can necessarily activity had or strong market other that that the with clinical research there gave conversations has interest the is we What approval. and validated I be would in customer did, pharma different a preapproval med since sensing you us confidence that

rest the single dissipate cryo, healthier was level. time a starting see clinical engagement in to second big dominating in long because translate of and takes in product there terms to it a see answer that treaters of I during cookie-cutter terms physicians COVID interest understanding uniform value recognition encouraging and and that tent, at of how us blood and to contracting. trauma clinical a starting into of docs that attention can part sort on it's or it a for enthusiasm new a very plays that in certainly give interest in terms level hear, We're is clinical was really we're such isn't and in of GPO management take. on that of hospital may The and the of candidly, IDN been that center to may so part if the and application. its process interest is long within pole And introductions, these in product for but indicators us confidence terms hospital tell they of champions whether are getting if institutions. been leading the that of that independent we And the a who are is, there's hospitals, that really ordering. the enthusiasm there's and hospital process, what responsible a we of or terms hospital But surprisingly, have that of identify end. larger in product for hospitals, or standalone us can how is close that's And individual role number of by or you hospital put a who hospital but things, cancer a confidence But few the not hold long consistent give it's fairly as family were

Operator

from Johnson Jacob question comes Stephens. with next Our

Jacob Johnson

today? Can you you Congrats as the between question. platelets, year. $X.X cryo, just start first sit break Can this that billion out plasma, Obi, remind us, on out here roughly you you today? nice and Maybe to TAM called just

Obi Greenman

the mean we up that I I that had time. wish I all have Yes. slide

currently the $XXX if Kevin opportunities get million where markets can we in plasma are Jessica TAM fibrinogen equivalent platelet but wrong, And roughly we the I this me concentrates. or correct the for identified for sell. maybe roughly So then and it's

point up of aggressively, main currently $XXX the million, more remarks and a in and the to TAM. being geographically room get we're product once start was of that full expanding billion providing approved really the $XXX but prepared $X LATAM where the we're portfolio. we into comment grow to cells guidance approved the right and million that think now I markets we APAC once That opens with the current there's of lot said, red So in business

Jacob Johnson

expect to Should the XX.X% margins the of for just margins so caution the the of said or assume And or against product Obi. Thanks for gross dynamic a that? you it. throughout any we for similar Got remainder year. year gross then, of kind Kevin, rest

Kevin Green

going kind from an think from we QX the Red they I a dose impact we that's function are the consumer. of since right. to predicted No, have overweight the when this really U.S. happen. the single and going that's growth coming have to call, I was It's that of mean, the it's Cross, extent to

we that's XXX reason So believe move have basis commentary we it's to guidance. different on last we year's to given no seeing. XXX from we're points that revised forward, be results, expected And going to and what the our as

Operator

[Operator Instructions].

Mark with next Our comes BTIG. question from Massaro

Unidentified Analyst

for on Mark. This is Vivian

approval? broad I the securing you we post steps XXXX. a is early expecting Should mentioned launch walk us involved sometime cryo, too also a the some it be So believe And on in QX if BLA of XXXX you in approval national could to launch BLA Or through call? there?

Obi Greenman

Yes.

middle going in FDA. we partnered unless will submissions that and they're centers BLA that of XX partners, sort quickly the that of take our making support. the production take the And with that So in months will with, moves this that more be anticipate with it the to we've is submission again, still this blood year, the place

they far right BLAs submission So hasn't as process, their that's it yet. underway haven't -- the submitted now as but

there's some clear need -- of obviously sort are in a XXXX product. would significant middle nationwide that of rollout. that that, In unmet a states with So for additional patients and order to this parallel predict access where

to and several additional of quarters. partners advanced additional in the add We production with next course the are states over looking are discussions

in that rollout those nationwide the in allows states us mid-XXXX. to So of advance access

Unidentified Analyst

ask progressing, if the in NMPA well the as partnerships also could region ZBK could update how LATAM And if in provide been as have the an China And with on then China? I specifically? you

Obi Greenman

for what's looking a stem guys To them. that's that what, remind in studies great provide? been clinical additional thus in more clinical large of Vivek, to that did working are recipients. joint NMPA our with in has transplant of the regard U.S. we've a that there partner cell combined Yes. and is than required study our can And that maybe historically that ZBK you, around add are because be at data this context now, now, not just am. -- discussions I'll hemovigilance in a far, we years that's aggregate transfusion Europe be the But we're is data, for relatively Chinese to NMPA any if trial is Hong it discussion proven the with with Right do Kong the patients. on really the any, required provide was submission. a then scope significant, the China study excited you'd and and Vivek participating Hong only sort looking start other Kevin or Kong, market the in study in and really to frequently of all to you from data venture and I

Vivek Jayaraman

and I for that think China. by covers kind large of it

recently COVID there And point a in couple has is, just Brazil announced pretty about The particular, I think Brazil. -- a LATAM well. of in in one there make securing was been that in impact I'd we'll fairly question as significant. tenders Latin get America, a tender

there's we as continue blood certainly Latin that in said facing across I we a But America, seen that, well. we're terms the be but Brazil. of points that have headwind headwind China bit centers penetration. further COVID of been online bring a Having think So captured a related to in will

Operator

like any at back would for to now I'm Obi remarks. [Operator Instructions]. any the Greenman turn showing questions not call closing to time. I over further this And

Obi Greenman

It's be call, year likely will us of on Well, which thank exciting at further look our much. the for to you you Thanks today. very all an updating July. end Cerus, QX for and joining forward we

Operator

call. Thank Ladies conference you. today's this you gentlemen, for Thank participating. and concludes

now may You disconnect.

Cerus (CERS) 5 May 212021 Q1 Earnings call transcript