CERS - Earnings call transcript Q2 2018

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day, ladies and gentlemen and welcome to the Cerus Corporation Q2 2018 Earnings Conference Call. At this time, all participants are in a listen-only mode. Later, we will conduct a question-and-answer session and instructions will follow at that time. [Operator Instructions] As a reminder, this call is being recorded. I would now like to introduce your host for today’s conference Tim Lee, Investor Relations Director. begin. may you Sir,

Tim Lee

Officer; financial and Quality. the Kevin Financial joining I on us results Greenman, Corash, Chief and are operator today Medical our President thank of Dr. Vice Moore, our Cerus’ Officer; Vivek Officer; the like Senior Chief everyone quarter Obi Laurence Executive release and President second for Jayaraman, the also today. Scientific business press our Cerus’ Affairs Richard for Chief Cerus good you, and ended Benjamin, would Chief Officer; Commercial afternoon. announcing Chief to call XXXX a Dr. Green, Thank With our Officer; company’s and Carol XX, highlights. issued Regulatory June recent describing me

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

Obi Greenman

you, and Thank Tim good afternoon.

half to sales increase million to bottom for the to Vivek $XX.X with sections, are performance prospects previous the of million perspective, our a our $XX the commercial we and but are remainder made second quarter team of raising $XX report million second We product compared quarter of line. our to With the our totaled our on continued top we product quarter revenue Kevin progress first guidance to in on representing on revenue XXXX. provide in momentum details into additional into XX% solid range top and XXXX year, pipeline $XX pleased line, range at $XX our another From good our million. to compared high million, visibility second based which current and a a the the performance. solid another strong commercial line will quarter delivering their respective level, on

XX% over of to growth XXXX revenue. represents XX% range full guidance year product new Our

proven can around by nucleic been associated in awareness as hepatitis pathogen to transfusion Our believe assays. benefits multiple the Navy most transmitted for increased of the of driven globe increasing routine Even proud and the the expected sites reduction projections to We to revenue Walter risks in demand an the assist the recent be emerging infections we has established result of of measure. INTERCEPT. transfusion to addition apheresis B months platelets use hepatitis factor acids clinically The are growing cases was components with of surface global documented transition transmission assays mission. and publication coming at U.S. Navy testing all out pathogen demand safety Reed, comprehensive for their a in risks A for Navy via technology state-of-the-art X to Bureau collected Program. highly pathogen pathogens transmitted address the sensitive have the mandate Europe Medicine in to reduction able of the and of collection The five to by blood by ability the Program Blood decision antigen Blood preemptively limitations. are flight the site by important

X center components patients, platelet blood for and Fortunately, now with who undetected treated same decade for Slovenia INTERCEPT the hepatitis has blood in in this transmission the received from INTERCEPT B B documented used a system over the prevention hepatitis platelets infection. donors of study

transfusion blood they safest a increasingly instead Beyond the the reduction not to we pathogen not are disease inherent INTERCEPT risks emerging pathogen is a afford can there risks in Blood are believe ensure if possible. current fundamental addresses centers, of afford shift and level, Zika the the hospitals transfusions infectious also can testing and underway like offer blood to of paradigm Babesia, against asking the protection transfusion. transmitted reducing deficiencies and of supply pathogens paradigm. aware they At help but reduction, clinicians to the

contamination safety safety clearly document. patient now however improve continues the U.S. FDA was example, voice platelet recent Products nation’s by are to supply. it believe of desire driven also is believe It was additional adding the that the urgency we opposed month, perhaps hear most for in as we seeing safeguards of interesting product that speakers’ supply, last community’s blood What are opportunities a offers. to interest to encouraging We see years guidance me federal for and With a INTERCEPT government need that the in now and for is Vivek mandate. finalizing the and aligned scramble Vivek FDA’s results. it we have has is strong company of medical meeting commercial the let demand update to been acknowledged. value the over to the For sense mission leadership Advisory to to attracting Blood of actual we Committee to The risk team the respond X excited his that of our is impact commercial an to on provide corporate the speaks the almost with to scale us. talent the that, compelling on commercial the ahead utility a This to global organization. QX goals our and around clinical turn to

Vivek Jayaraman

Thank experienced adoption you, that our customer Obi. product meaningfully interest increased North QX. East I as We in am Middle Europe, in and and INTERCEPT in well regions America. demand in increased Africa or pleased as to report EMEA of

our of countries commercial around the on majority the growth pathogen and we the pathogen of educates team our also the U.S. strengthening customers is transfusion the and as adopt quarter, reduction France drove were the for reduction. market see world. community While benefits In our blood technology number to U.S. the revenue pleased this increasing of an demand

of the As think risks increasing. of infections that we awareness Obi transfusion is transmitted mentioned,

technologies. measures and The and the fatalities hospitals when Despite article bacterial Disease for with weekly recent most associated avoidable. the donors protocols, two Prevention, a one additional resulted report, the transfusion case in safety persist. measures, of platelets. over California. platelets, centers published sepsis. even article sepsis of highlighted events and bacterial the clusters for bacterial believe separate current article Utah dose need safety deaths Centers is additional split which severe one mortality in patient These bacterial platelets risk of contamination two current followed of utilizing details advantages showcased by significant that and infections morbidity in in transfusion-related reduction the that blood example, The an Control offers three As from for pathogen were detection We other and conventional the and separate and detection

transfusing pathogen pathogens reduction detection for available. not U.S., preemptively producing have BLA other are centers of the risk received X to As over offers over hospitals are X we for address now which the and coming platelets, approval have the XXX range tests over we broader anticipating With ability from XX the an in progress blood to reduce emerging of customers example, in commercial center pathogens respect blood and a approvals our currently centers INTERCEPT quarters.

base. It hospital their requirement safest across for blood blood As are BLAs in possible a typically multiple goal access centers state blood our centers that reach the components customers is states reminder, to full blood many patients are critical all to have approvals supply lines. for BLA customer and and shipping U.S. products a

publication guidance document, instead FDA clinical and strengthen technology document. we steady final our U.S. We of product believe FDA independent is market, progress an acceptance Given guidance demand company. growth the We INTERCEPT evidence pathogen to see on is by safe dependent a for blood. the a driver driven uptake demand not but of expect for issuing reduction the the demand for clinical of and of platelets key developing for accelerated become

to Europe. a platelets largest distributor INTERCEPT Germany center reimbursement produce extremely by platelets and while an was to revenue life, Last the very all Europe. Blood Warsaw awarded the the Eastern year our part into tender than financial important a be while and with platelet to day largest of expected influential Ehrlich in different INTERCEPT estimate improving platelets we The another produced Polish blood We we translate patient Turning realize to customers blood hospitals in treated opportunities, of annually, of in believe Paul estimated of an the approvals work a platelets then the to Poland winning Center, Institute With also is the in market, foundation in our the presence which the annually. tender, the the which transfused in we international will centers The market establishes is and provide account for create benefit XX and world. Cerus in are to garner XXXX hospitals. opportunity efforts benefits XXX,XXX we improved beyond. of units our shelf safety. is Germany for the realizing units Germany reference this laying continue anticipate regulatory Poland to what across platelet quarter, to for we able INTERCEPT operational By in of additional XXX,XXX more strong be foothold

contributor quarterly performance. Finally, once again in strong was our the EMEA, France key to

XXX% As were kit we is call, kit QX utilization, in available EFS QX noted at dual storage driven single-dose in sales predominantly conference the the by France, while configuration. our now now during is

anticipate to the production storage their this portion and the EFS operational of to shift benefits the DS Given cost dual kit, of a format meaningful we year.

adoption impact full summary, in likely and of revenue provide conversion drive Overall, the may are the through While to to we the have back enthusiastic uptake and Cerus an this we are global in half in in the will we are XXXX. to believe we about accelerated In EFS France well-positioned also margin basis. adoption seen a DS INTERCEPT on experiencing the U.S. improved transition we XXXX

turn Now, results. QX the provide let an on update to me Kevin call financial over to

Kevin Green

XXXX a and contract $XX.X to On to quarter compared $X.X year-to-date million increase $X.X million XX% Thank second the of quarter million $X totaled you, compared XXXX. product Government during Today, government of QX half compared revenue XX% product during Vivek for worldwide revenue overall INTERCEPT Platelet second $XX.X XX% than during up kits XX% relative more good contract first total contribution to the continued revenue their the coming reported period. XXXX. increased of totaled to compared million, year-to-date XX% now the was that prior of increase during we basis, reported compared everyone. basis, million the the the to first reported year demand when XXXX kits with sales XXXX, prior increased in compared comparing On greatest of million to the revenue for $X.X from during product approximately a million for revenue, product $X.X of period. revenue afternoon year. accounting QX the demand of When than year million, more looking $XX kit prior approximately a XXXX XX%. to platelet of our half Worldwide to growth the U.S. period INTERCEPT percentage kits at to the with

range outlook, given and guidance in our in of full his the remarks, our a year Obi million. our outperformance range to $XX noted commercial from strong raising product million the to previous in As QX million conviction we are revenue of million $XX $XX to $XX earlier

gross the margins. first QX results, Year-to-date, Now, from to XX% were of high volume-based The million would in the margins compared million revenue. who during half of quarter like current on product margins XXXX. let’s reported customers to other our XX% Gross margins quarter to of with to $XX.X sales the attributable change gross volume the $XX expenses, XXXX our second I XX% during for for operating the associated year-over-year turn XX% were to was discuss revenue pricing largely with gross QX now XXXX. XXXX. quarter to which starting during contributed meaningfully compared to compared totaled

with continuing expenses to million SG&A year-to-date With XXXX. continue top model to for the stable Specifically, costs compared flat million back prior line. be And the basis, half in development system million in investments during for expenses add the the largely in selectively the a sales to half $XX.X million $XX.X expect of we our million and tied the we of during year-to-date totaled planned to growing anticipate of year XXXX clinical our CE both spending U.S. $X.X a a office million quarter the business the $XX that activities compared year-over-year. sometime $XX.X incremental to SG&A anticipated associated totaled quarter of to in we QX accounted first while compared cell million costs modest first SG&A, SG&A in SG&A in R&D $XX Similarly $X.X development those are the essentially On during our activities our increase place in in we will in to Research INTERCEPT the prior. realize Mark to leverage basis, preparatory top growth. year. red for now, teams primarily to for The clinical the $XX.X compared blood higher expenses million to compared submission line was Europe and totaled with launch investments on

during totaled $XX.X for the compared red to million in losses increase we first As funded Operating tied cell the expenses revenues. R&D Throughout million period. to $XX.X for loss loss million to corresponding U.S. diluted half the a first second our diluted expect XXXX. Year-to-date, million for accelerate, program Net the prior to compared clinical $XX.X the quarter were second the and of quarter per or of losses activities BARDA progress $XX.X million to share XXXX. $XX.X operating with compared or second million million $X.XX quarter to loss $XX.X or net in share increase also share the narrowed of compared per $X.XX half $XX.X diluted share net the or $XX.X $X.XX $X.XX narrowed diluted to loss million first year in per per of to net a half, of XXXX.

lastly, our a hand. approximately strategies cash sheet, We business and of momentum execute cash, back me commercial global that U.S., we the to the million let and we and quarter believe with point storage turn Obi. hospitals our terms on INTERCEPT, inflection pathogen over the at equivalents to and In that, Europe bring accelerate cell is in and business of the maintain both ended well-positioned in $XXX positive of extended program short-term With call investments and cryoprecipitate our are that to patients. on our advance to red balance reduced

Obi Greenman

Thank want update conclude on pipeline programs. you, I to an Kevin. our with

the for cell the We to are U.S., program anemia announced With Mark pipeline potential BARDA. In revenue pre-submission Biomedical platform exceeds to largely BARDA cell month. in with Authority, additional manufacturing total our million calendar we our meetings incremental and engaging on contract notified for the U.S. million or the amendment, scale growth expect the Europe, approval TUV years file support and and year body and in these major in cell of ahead. we red the the in this initiatives provide red $XX track studies. effort Starting chronic $XXX drivers These proceeds our for CE this our are in red be now at launch an potential this supplemental acute Development Research from Advanced development to fund funding INTERCEPT up

happy Center with pathogen partnership to patients. continue treat regional there this cryo bleeding or to that cryoprecipitate Orleans. program, strong signed and planning to our Blood our second is be the having in continues also we advance Launch today INTERCEPT interest to we readily critically underway We New reduced product of available report clinician are

We U.S. capacity leverage the those have the in amendment INTERCEPT of changes set plasma and second cryosubmission some INTERCEPT half decided year. chosen expansion to into to single aggregate with a the for in have changes targeted next PMA

commercial we launch review XXX-day process, anticipated XXXX. the expect in With

opportunity this on as world. takes forward make INTERCEPT to our time with of and partnerships Cerus exciting of mission the around we an the to of we availability launch providing the future As the forward shape, care for components our blood manufacturing look and This to preparation. expansion improve safety standard push is updates

components sense deserve of within bacterially risks is they The needed. improve in there to the that there be and As safer current is and blood of safety. we awareness sufficient contaminated not patients growing believe testing rises, paradigm of will increasing assurance an blood physicians when an blood and community urgency it bank

a all with that single We later components the solution to for ensure filing the is products. our in would the INTERCEPT ability acknowledge please pathogens address to this INTERCEPT blood smooth Mark for closing, major open Operator, expanding are Furthermore, for standard have and we best to with I questions? beginning known clearly cross-functional multiple my we teamwork collaboration. our blood year-to-date system transition three that share planned CE efforts and are work responsibility red the and are that portfolio know these strong The to care and confident year. safety. is our dedicated call results blood encouraging team. both the my that given treat just of to concerns I important new pathogen-reduced a Cerus conviction colleagues like In platform the the are and with an rapid cell emerging its of product of

Operator

Instructions] of you. Thank [Operator Cowen. Your comes Josh first Jennings from question

Your line is open.

Josh Jennings

Hi, INTERCEPT using you about us are also XXX in market, you start but first terms in platelet center platelets, how seems opportunity, I XX way give we just on the good U.S. of runway are with was afternoon appreciate on in mean, think shared deep customer it the you can penetrated the I you still approvals, the is the idea what here to long can terms an of quarter. and out go strong that U.S. for year, there where open up then U.S. that strength and in some the still single-digits here franchise, to the hoping customers, business think to the believe I you the in those are delay, quarters? the and the, approvals, data see five a been of I the the half coming how side, another BLA has start the despite confident hospitals the congratulations in of has driven guess what delay you blood

Obi Greenman

handle to closes will is it. Thanks, let I these Josh. he questions, because Vivek

Vivek Jayaraman

questions. Josh the Yes. for thanks

start comment quarters producing terms optimization we in out marketplace. market a days headroom then in those still share to and at the and reporting driving in process, left the will are these is practice And the bring and still we production I there optimizing with they INTERCEPT early of seeing but of can they subsequently amount point In I you percent working back very now are to so the of their hospital about adopt the say are the around meet this of we U.S. not that made U.S. maybe seeing production really centers U.S. significant demand them blood are few or back in we growth. metrics much their time, metrics, into would levels penetration,

teams made us respect FDA. terms that’s to and to manufacture. in center that, in without On going that to those the and probably is answered receiving are working blood said mentioned, supply critical, whatever with us being the where blood organization we individual BLA for they It’s regulatory can have BLA between questions the states center expeditiously be because to-date progress our most having constrained speculate with do for But processes states only reason front, to able gives supply the and be blood customers closely the encouragement. the as in to BLA arise and deployment imprudent ensure certainly on centers multiple

Josh Jennings

week cryo submit more and just Excellent. a before doing to plans, secondarily, to follow-up Journal article some you of is, of think there generation again and of your big a And pre-hospital wondering And I terms can the today. in else FFP that thanks thought the be taking the then benefit that if center, details can opportunity, victims updates total there on trauma of needs questions. in-vitro for by to anything administering in how you supplemental filing? being addressable segment? the New data I – are just that then steps was Maybe are kind us trauma wanted about required, market side the on think demonstrated Thanks help lieu you done is I trauma mortality England last Medicine for just the just

Obi Greenman

with turn Journal about Yes, of talk article. England Medicine the deal Josh. I thanks Larry first the over to question New and will the to

class the to INTERCEPT crowd studies in the basically at it’s looking vitro precipitant the regard with profile So submission, in product. coagulation

now. studies those are underway so And

is I think need for that data the really to stability the submissions. is the get the timeline we [indiscernible]

and studies as have plasma reminder a to We plasma a this the this so is very something for INTERCEPT we in familiar are and that lot amendment doing PMA with. INTERCEPT experience an it’s like of

able and be submit it trying pre-hospital defined with and second with the will sort Larry to plasma plasma required in then to to the to trauma interest clear the it’s amendment. of what’s overall address question studies with to and I over have and regard completing And early of turn use with also mortalities time just points FDAs the We our getting stability that pathway to cryoprecipitate.

Laurence Corash

for States. people under the cause of the of in death XX So, hemorrhagic the United trauma is leading age

significant value of plasma a fibrinogen population we address is a that early So, patients to fibrinogen studies the used in very Other for can which pre-hospital levels component as and plasma article elevate need to thought showed see possible. clearly critical be the pre-hospital. X-day as benefit have shown it’s that in a cryoprecipitate, therefore and

pre-hospital that So, validation value to transfusion substantial of change tremendous in outcomes earlier we see for this has article as population patients.

Josh Jennings

for Thanks answers. Great. those

Laurence Corash

Josh. Thanks,

Operator

Thank you.

Your next question comes Stephens from Inc. of Drew Jones

line Your open. is

Drew Jones

Good Thanks, guys. afternoon.

Looking just kids for to on a do around? get little trying of we the to from maybe French parse you of revenue feel a way to is bit back conservative out for is how dual half us one year, could impact maybe the that the guidance moving that from would be feel can if a single-dose, the give something

Obi Greenman

I that Drew, Kevin. to Yes, turn will over

I has on got think some insights that. he

Kevin Green

Drew. Sure,

So a call exited French we with we on QX that mentioned the QX XXX%.

of into is QX we that to platform. in more double French we kits conversion fact, late have double-dose starting want know fairly Their the them dose saw with the aggressive the begun In us the quarter. and INTERCEPT and throughout is utilization their to convert that continues continue What QX. with to be we they selling guidance that to

there And and so top as that our so a guidance impact contemplates to impact. we that be result line the feel will

Drew Jones

of see XXXX kind And going first centers you that there, opportunity? is going in that we maybe like the opportunity, come contribution something that Okay. sizable thinking other that more accreditation to revenue or to a Germany at second look about online are obviously of XXXX then half of for when half opportunities pretty are is of here, looks

Obi Greenman

I let that Vivek handle will one.

Vivek Jayaraman

Yes.

the in it’s when the certainly our online. blood to BLA, are will think the half, regulatory but closely year I clearances to you teams the been and Germany to the start see into working get to So, Paul regulatory very some there centers on clearances, Institute. scale centers those have German been speculative Again, through modest to as first applications and in weigh Ehrlich with will in more trying deployment revenue Drew we about start come contribution similar question that organization

we confident of of of the the feel has of and year. in the to that extent in we working that anticipate some we interest encouraging, part will So with frankly half impact see been customer that start so really first us

Obi Greenman

The I facilitating sort team other the the talent Vivek and and submissions have of thing that how we on we recruited on and just so with that is to of blood are focus the want IMA the centers? comment

Vivek Jayaraman

point. a that’s good Yes,

since – to we increased in have the the talent of strong we reimbursement recruited cross-functional team. Germany have some really learned German We

So in sales the advocacy also do to in hospital of of areas government health regulatory lot affairs a side. the and deployment on continue work policy and

And and Intercept that so drive results. and attract our of to margin the so a to are level aside in it’s the type interest the tell organization, to is an ultimately countries see continue half to the because of that’s and tale the we the hospital talent different it’s encouraging understanding team on ground and significant going the in clinician our past to growing really a and the quarter as

have And team have group had so a strong builds for newly a we German of of our now. been upon to-date employees we hired with and period pleased that Germany time in that

Drew Jones

Thanks, guys.

Obi Greenman

Drew. Thanks

Operator

Thank you.

Bijou Craig comes Cantor Fitzgerald. question with next from Your

Your open. line is

Craig Bijou

you with the medical the into I drill the wanted meeting community kind months from the for next and what as want driving reduction, back will see next your guys. is comments that you then of start demand guess BPAC to maybe taking your I but I of the X of questions just maybe to I Thanks the and for meetings over some see of steps the tone kind maybe kind the on couple of weeks to into meeting ‘XX? and and relative prior appreciate thoughts just of pathogen

Obi Greenman

Thanks, Craig.

them Carol key Larry I since let of culture seen really can the maybe it that by had something primary the some the and I the but no setup comment, at because was I all think were, was takeaway the strongly us was and think they my participants, that meeting. that sufficient wasn’t primary Richard longer and meeting from from and I meeting takeaways clearances BPAC has

Richard Benjamin

Richard Thanks, I can It’s Craig. in. Maybe Benjamin. step

forward need bacterial that move many unmet opportunity was with I us what we can in a is and the guidance, an think issue and intention that a to discussed there the the meeting real we options have reaffirmed I gave didn’t safety great the room contest accomplished there were that effect. that to on update everyone an think FDA’s present need

So, think a away positive the with view I outcome. walked on I

Carol Moore

that very questions like every think although it regard up comes that to to I’d centers the a was the they the that real address what important of And we the some when positively seeing people convert having were for see extremely This treating go XXX% to to value to Carol. provide in that we to have saying this they come verification supply blood asked It are expert say which the entire very for optimal that a and able one activated in and to that that we to make just on with I it do Cerus solution allowed activation, the to was solution back us to we fact as question products, interested could could in would was continued going think presentation answer we product and the an that pathogen and pathogen about And were that meeting like we that INTERCEPT were if was the after the that to bacterial as a market an there clarity do platelets. the area, is the think And the Cerus invited market. are experiences we to are I questions in good us mandate allowed process. using of we that? helpful. data do, really specifically I

Obi Greenman

blood commented on in of aspects of presented this groups to and the than of one BPAC five presentation, prior meeting different efficacy for contrast, we clearly single solutions more data. performance white enhance bacteria, showing the the and None years for Europe bacterial was the limited and solution to which amount our think I of In clinical notable five presented from that cells different demonstrated So, technology. the detection. a clinical optimal data statistician extensive XX parasites of viruses,

contrast a to as remarkable single that think opposed I multiple solution So a to was un-vetted it solutions.

Craig Bijou

for you the there, U.S. – perspective. for of and helpful just Europe selling a and gross color new I your strategy of is piece lower margin will Kevin, going is to that the due that then strategy volume, lower be how a that forward? any Very Great. on how a maybe big based, higher is guess that the prices

Kevin Green

historically, So, distributors. offered pricing our we to volume-based have

and signing their customers larger up, to larger have incentivize them penetration. increase we we want to As

and European it’s metric, do And across size so U.S. with is really to certain power customers just the multiple of or customers. not it a purchasing and so has it a

Craig Bijou

question, And how over part Kevin? evolve that time is the then does of

Kevin Green

an customers we Well, but nascent those as over evolves right it which our time also effect, have will see in now it and contribute to more pickup dose, double to as and is fairly customers gross line, as top more the a convert margins.

Obi Greenman

existing wanting manufacturers. think have get was just sort is I up I our the the of that volume with other part, price terms we to

see any time is to grow, volumes a do we this scale. expect of improvement margins our in As function over

Craig Bijou

Okay, great. the taking Thanks for questions.

Obi Greenman

Craig. Thanks

Operator

you. [Operator from Instructions] question Your Schulte comes Baird. of Catherine Thank next

open. Your line is

Catherine Schulte

and thanks the the for Hey, quarter nice questions. congrats on

marketing you first platelets they I’d the could love if an Red talk update are about American your wondering that’s today how INTERCEPT last and changed how progress Just the or with on year over so? to get Cross,

Obi Greenman

will to U.S. over is closest the the he I dynamic to it since in Again, turn Vivek

Vivek Jayaraman

manufacturing which how resulted their question facilities the hospital the able ultimately really they and distribute that of pretty are to customers. produce for production then and would single the thanks INTERCEPT platelets say biggest in their adopted been to driver that’s increase I have significant has amount Yes, in they that of optimization the rate a change Catherine. at steps

a of the optimization and there last driver presented been steps. is biggest They growth on of headroom there. year bit still their quite that’s ABB take intention single the production to So at about

And so with practice. year, to we really I think into first seen the have to those come this saw the are of them the results half steps byproduct starting

Catherine Schulte

those commentary some their the American approvals what’s the centers status who Okay, on blood have ramped helpful. Cross and get receiving BLA? then that’s X can then since how have BLAs received their volume And of Red you

Vivek Jayaraman

I start Cross deal. So, the with Red will American

them that. actively pursuing we working they we BLA and are First, know on clearance with

Cross not party, to that’s other a and specific are of BLA a aggressively know are product regulatory have is between the them the is that start nicely dialogue but and and out of sort the with situations now and which As something related adopted optimization the we Red to strategies do them meaningfully be of considerable FDA them something being to we they continues production send hospital they able supply and respect demand seeing have currently up production many the they the picking really have for INTERCEPT. because they is what have state do not others, are With of manufacturing in where in outside in to interest similar steps. customers to we received are that producing process states now do to the tie are that few facilities to them, centers blood hospitals

certainly side side can things those from tying process. to that and trying the go the extent just the that knock so growing have facilitate two and So, barriers both and growing from see methodically on are we center we together, supply hospital about the we demand we blood that

Catherine Schulte

like great. we final had go with there then, for touched Since you it curious Okay, meeting, or seems BPAC guidance. switch one push And straight if the me just a to to FDA. was conversations last on have a potentially any the

So, any change thinking FDA on there?

Carol Moore

the supply of Carol. Again, expanding about This is the FDA progress our all license towards we utility to to the time applications. our talk our ability

us because make remarks I they reach questions, additional ask We guidance about guidance to going out fully document. hesitate communication, are think document to in I are specifically, might that but would regular the aware we to haven’t our to and not say, we be of whatever prepare do on are talked the capability helpful, such

Obi Greenman

Yes.

sort it’s the this final a us document a or this they as sort publication coming come revised guidance draft guidance to revised I for current whether out final. of year, is as of going described a what for to imprudent it’s referenced in think was speculate to out as year, a not

Catherine Schulte

you. Thank great. Okay,

Obi Greenman

Thank you.

Operator

Thank to the showing back remarks. I you. Obi at over questions am this no for Greenman And time. like call turn I to closing further would

Obi Greenman

their to our we opportunities for your on in October in will and the XX pathogen a institutional experience ABB call hope pipeline Thank you. speakers for will and perspectives the commercial an thanks will provide interest the Boston. meeting comprehensive review be after with many that in INTERCEPT on evolving and investor to operations reduction guest meeting provide see several medicine. Cerus. there of again role hosting like announce Senior I would just of transfusion and today you blood joining systems of there and the We management

Operator

all and gentlemen, thank you for and today’s have day. disconnect. in conference. Everyone the you Ladies conclude wonderful participating This may does a program

Cerus (CERS) 2 Aug 182018 Q2 Earnings call transcript