CERS - Earnings call transcript Q3 2019

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Operator

Good afternoon, ladies and gentlemen and welcome to the Cerus Third Quarter 2019 and FDA Guidance Update Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded.

I would now like to turn the conference over to your host, Mr. Tim Lee.

Tim Lee

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

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

the You at access slides Investor the can Relations www.cerus.com/ir. from website

President President Corash, Co-Founder Moore, Officer; Chief the Quality. Obi call Financial With Cerus' Kevin and of our and and Executive Cerus' Officer; me Laurence Greenman, Carol Vivek Scientific on Jayaraman, Cerus' Regulatory Dr. Affairs Officer; and Green; are Vice Chief Officer; Senior Chief Commercial Chief

announcing business our ended today results issued for and quarter release Cerus a third financial September describing the press the highlights. XXXX, XX, company's recent

You can company’s of announcement website on access the a copy at www.cerus.com. this

than operating I'd of strategy, guidance sales, expenses our future make like call growth events development our activities. events financial regulatory those and relate and statements some of goals, commercial and ongoing activities future remind rather are and growth XXXX including that margins, future include gross our on facts and future trials, future statements. future forward-looking the historical statements forward-looking well of the related and product financial Examples this and you we to to these timing results, ongoing and and will performance, clinical operating to as development product as launches, product efforts, and

Risk materially. We duty obligation XX, under forward-looking forward-looking are XXXX, we for quarter and our identified XX, the year no uncertainty statements. risk events, in which ended XX-Q in or December that shortly. file ended for differ and XXXX, press and results XX-K update Form our the to statements will release to They September undertake involve performance and These could our cause and actual today's Form described Factors

Kevin document, from by strategy, we'll call, opening of with review guidance and then closing to to Larry today's remarks. our On with review Obi our results Vivek provide the commercial FDA to overview financial Obi, followed an followed remarks by begin

Greenman, Obi Executive to Cerus’ Officer. President and pleasure my introduce it's Now Chief

Obi Greenman

Tim finalize safety of and policy U.S. FDA is well afternoon, not deliver new relevance medicine event for The standard is good has to the a transfusion regard global action that for finalization in coming FDA safety, positioned everyone. very it off a of AABB watershed a of this to only that guidance believe you, major The regulatory meeting care transfusion platelets. the platelet a and patient safety safety blood also for ensure for with are but the on we bodies Thank how successful we moment to guidance document of Cerus,

the by platelet initiative U.S. every issuing prepared important the today XX collected Cross letter of as their will guidance, the One by be in platelets healthcare INTERCEPT to hospital INTERCEPT the held the In end platelets of month currently units U.S. X.X of obsolescence as this for view could that one an new the in centers million all U.S. safety. to year period, conventional requirement to blood a each that community compliance standard single is their intention of role U.S. about an in FDA Immediately make the final Red available open release customers. that will the operations of months. American the after obsolete leadership validated the be to the broadly play the to their XX and

available of and adequately hospital bacterial is requirements for The reduction they enhancing while grants services transfuse making to the availability products and controlled. safer, that of for “The transfusion Pathogen the this hospitals of patients. the They preferred FDA of platelets approach American Federal can ready purpose Red of document blood the to guidance to centers blood the in economical reduction how growing Regulations platelets final stated are transfusion.” safety meet direction risks providers is of technologies FDA Code Cross clear that, ensure provide specified pathogen and about contamination to the expansion for offsets of

of After Blood address transfusion complicated Committee undertake. methods finalized platelet the multiple culture-based and an safety. logistical reduction, concerns The several and to about fundamental draft options those considerable rapid FDA guidance guidance guidance Products testing the and require versions testing the Advisory to efforts pathogen topic, meetings the even if contains operational alternative on to secondary as

protection now With the pathogens and the emerging INTERCEPT the overall sales in combined growth. its sets the believe broad cycle final a place of stage guidance the simplicity in supply the in of blood spectrum U.S., we against with document for multi-years technology current

the execution with growth geographies, for to across quarter a pleased all growth revenue report As in headwind. expected despite another foundation currency strong a reported U.S. are we business, sales this of major

product Third $XX with on XX% a the growth. leading basis a totaled market U.S. reported increase quarter revenue the million,

different Having risk illustrate options final to and it Founder the our of FDA available contamination INTERCEPT for centers Chief have be in just guidance blood returned bacterial over meeting strategies AABB from the and through the Texas, to the we you the Officer, of in detailed to thought worthwhile Dr. Larry walk would other advantages Corash, reduction Scientific document.

this provide Following next framework for for Larry, commercial our XX strategy months are actions to and our customers discrete the help Vivek a taking transition. we with the will

Laurence Corash

and Obi afternoon. good Thanks,

the specific compliance operational March will defines hospital it impact customer option. to center in guidance has regulatory each deadline that Austria factors XX, blood care and for and transfusion Switzerland, Similar compliance. Each in and a On in is procedures the U.S. The the vetted of final determine achieved costs of been approach and to defining These Belgium, will new France, next XXXX. by safety. logistics, platelet achieve slide, community Kuwait. transfusion this standard by important guidance medicine decisions

economic of and compliance, benefits logistic of case blood INTERCEPT, the a risk it with clear centers and hence makes hospitals not a transfusion action The be U.S. final and beyond majority the in blood compelling must taken. U.S. option safety seminal the are advantages Today, in for is the reducing infection. document only guidance bacterial safety, of

some two landscape. lower me strategies the two step in outlining section multiple the blood step options let and The contamination, for and the procedures, the strategies hospital The days order two by section. some The release single the On blue preparation and in defined in using options. has bar seven options options FDA by complex timeline require timing in center the slide, and step with are platelets address top day the bacterial platelets to top to shown in next start transfusion. marks various for the to collection, day the transfusion of from zero

the for as the I'll and focus my two strategies I'll step the apheresis attractive of Today, market XX% single for are on hospitals during centers. on platelets specific as questions most they strategy account options address blood and comments they on the Q&A. step

bacterial important required it the INTERCEPT. specific dating the no time for XX bacterial be On be three, bacterial culture time required of understand the which to sensitivity days after exploration Slide seven sampling released time testing initiated starts options. day Hold Expiration is for is X for is period is last of either when after they to day and or an the time quarantine is testing. culture day, of Collection are for transfused for I'll various platelets This platelets platelets initiation the as guidance, can can of platelets. collection the collection hours five collection. understanding is period transfusion. There The to and apheresis the explain not is during terms platelet the hold prior culture improve for before limited is INTERCEPT zero.

transfused. can pathogen transfusion be that testing bacterial the Available transfusion than days relevant day. more for after times the reduction the Available are platelets release time is from expiration

hold a are that testing testing bacterial for culture decrease the amounts Sample all require for transfusion. options and available transfusion. taken days time available not As thus sample for volumes

for guidance sample XX platelet milliliters volume bottles platelet two aerobic of pre of be On sample guidance Slide the monitored cultures the specifies X per anaerobic must container expiration of and aerobic of culture routine X All a until in only. the product. end culture versus for milliliters the

on to This require at we indicating from Slide three do under strategy. step single to the Hence, is of procedures the available using a added strategy. strategy AABB market hospital. the received only step platelets single single prefer At that not step the are options. step for let's options. focus the on strategy majority the Now we technical use There ready feedback options single hospitals expect they X possible opt

reduction X.X centers The do guidance more, The pathogen first approved reduction no the option delay. The system only compliance. by INTERCEPT This pathogen they green already is no available INTERCEPT. to time X are the option time release in time for that and FDA bar. days shown states hold need has is earliest using transfusion to

hours XX or of or bacterial transfusion. other testing culture The delayed with collection and incubation after options XX hold are release requiring LVDS before hour times XX either for sampling large culture two volume

unit sample XX of platelet and triple collections will that's a for double the platelet XX milliliters volume doses. and rates The requires from is collection loss LVDS split respectively. number milliliter XX total available and dose impact loss each the

With with available of of after the days, platelets the and hours at collection, transfusion leaving more transfusion XX available XX LVDS procedures. earliest X.X a the INTERCEPT, the times of options to to but expense for fresh are technical possible time maximum transfusion similar life

split must procedures When alerted, the any cultures must prophylactic personnel creates positive require informed primary With blood patient's logistics, and will the hospitals a of is these components culture. clinical prescription require culture impacts associated be cultures increased patients. the monitored these which adds to withdraw platelets in patient and must evaluations or after bacterial been transfused, Each capital cost for manage until platelet care of of and be detected, If the release, antibiotics. anxiety cultures. This equipment may have physicians performed, of LVDS all all investment expiration. number with positive

over seven currently testing. is for culture the approved. LVDS is this my offers FDA in the listed following bacterial Lastly, clear option LVDS device not advantages option the day INTERCEPT guidance,

five. were platelets days responses. and be line four platelets at better this First one tested on bacterial experience two transfusion to Academic Notably, this majority largely at in a with blue, were in culture bacterial conventional case care in a transfused INTERCEPT study bacterial U.S. conducted older Medical from on will The compared the comparison tertiary shows Slide five of platelets age which shows provide the study on clinical Center. day that to and average days. XX INTERCEPT orange platelets than of the testing, Fresh the to LVDS transfused

Secondly, INTERCEPT by CMV testing. irradiation, blood can costs bacterial the viruses tests stopping comprehensive and bacteria, T-cells, for INTERCEPT provides and centers and [indiscernible]. parasites more serology with INTERCEPT than reduce inactivates gamma safety Zika

have shown blood cultures. bacterial follow-up most days Slide key shortest As with using available no to centers X and delay to hold favorable no on time, X.X the transfusion, INTERCEPT transfusion XX, metrics for

in a if premium Europe were validated centers over added premium to be cost last INTERCEPT’s safety, is single use LVDS in by a the INTERCEPT, this use have effective for national prospective the benefits choosing platelet multiple has new for charged improve charge most a technology the blood of for logistics and blood INTERCEPT decade can in to as aspects primary step a of hospitals ready unclear to factors and INTERCEPT of whom tested the The Given routine patient not cost able INTERCEPT. safety. centers product, It patient's centers means component. platelets. been platelets, provides only blood more transfusion been value is

over me our of guidance in strategy With now document Vivek hand. to overview commercial call the an the that, let with turn for

Vivek Jayaraman

afternoon, and good Larry everyone. you, Thank

top INTERCEPT FDA are become standard as that belief that by strong uptake Furthermore, guidance of results our As in of document line Obi we care. QX the the of issuance mentioned, our final the encouraged demonstrated XXXX. validate will by continued the INTERCEPT customer

prove the a will bacterial event. and Obi is centers platelets, for Larry measures pivotal believe which in by preferred compliance. standard the method both of hospitals change and care publication this achieve the accelerate be and INTERCEPT with that respect will that to agree of I Ultimately final I with a blood safety guidance to

market. debated I the the the The by executives XX% and Clearly, at a September of past five of serve week, despite surprise. largest meeting, a the each XX over Last the bit centers. years, opportunity combined U.S. blood on several had platelet with to being U.S. from of the AABB final took them centers guidance issuance to speak modified over all

better us, with gain the address for time center incorporate their guidance approach point the offered them with they that a and meeting to positioned to partner how assure AABB are INTERCEPT their to an well of to as opportunity primary compliance. we engage Fortunately excellent the centers, plan to understanding in into them

level. at will preferred While both the approach and that the accumulate guidance each the blood readiness center organization of hospital varies pathogen confidence reduction be

blood more the accordingly platelets will which margins simply offers bacteria, with earlier, uplift, ability an realize their to improve INTERCEPT platelet centers, solution than For addresses provide the price and hospitals innovative economics. to that and release

transfusion operational perspective, hospital they technology supportive a product patient with a ready a impact. global and limited From with safety. of receive most And record a track with INTERCEPT, will importantly, to clinical no evidence

we U.S. previously as fully As healthcare has embraced American have the Cross pathogen noted, proactively option their and Red the to preferred communicated that as community. reduction

to safety Fundamentally, their they with approach INTERCEPT patients' motivation is their and starts guidance their choice. clear that state primary as as such

the pathogen During pathogen blood continuing very AABB, of centers leadership strong reduction was held it to respect encouraging the take adoption with reduction largest see a to to representatives technology. we the position a meeting networking and five from ARC with

available. patients diligently to for quite has blood and blood that gain with now With of specifically, remaining this the underway we partners end. XX ensure compliance some More months access following focused working we are are on safest to key the centers year Much work between time. action the been our in period,

First, accordingly. desired starting level to and INTERCEPT supply with secure kit blood production making the understand we centers, QX and big commitments are XXXX, sure by the working five allocate to

to centers we of help demand use platelets. hospital Second, their order align with and production to with closely efficient working blood PR distribution in are optimize

our production with our processes in onboarding mapping current optimize production. to the are platelets processes team, collection production streamline actively Third, hospital during the transition to Four, schedule INTERCEPT needed deployment modify we and formalizing collection compatibility the or blood operation and enable maximum targeting is are INTERCEPT by hospital period. utilizing compliance center to platelet INTERCEPT led order we team, and to affairs

that models and hospital INTERCEPT have contracting Fifth, facilitate compliance. we achieved ensure makers and to and decision address materials economic educational to quickly can from for actively prepared hospital and motivated for non-clinical are providing questions to they're economically platelets,

team work are guidance a better In parallel, the the engaged. past of just part XX of examples our ensuring which has commercial the we few are months These in operations the actively is that streams team to XX ready. spent

customer we both should spike levels kit have expanded along example, see For disposable significant with enhanced in supply demand. a we with inventory hand chain manufacturing increased our capacity on

compliance AABB, are solutions While, on Coming that the period, it blood encouraged still is very the solutions was our the greatest the all clear benefits key they serve. customers out one-step early we to center confers of that are from indications in and those the it initial and stakeholders. by one-step INTERCEPT hospitals preferred

Looking we does their Middle quality outside Many implications worldwide. safety the and production of example, the the take from for U.S., with guidance to believe have for AABB. East regions, the standards respect final FDA policy platelets cue

reflect to place guidance comply standards the the soon will with new AABB guidance. those Given the document, practices in FDA best

further U.S. progress at strong with experience ease adopted context global In as addition, standard countries care. that have us becoming of continues of be validated make combined of well coming we the for INTERCEPT our the XXX%, pathogen and to use in as reduction broad in other the benefits will experience. When France believe economic that the INTERCEPT

our times With patients sale. will of XXXX top access now and to that line provide. quarter revenue world, outlook, be many that two INTERCEPT current more XXXX the more Across has benefits safety the fourth than have

people the the I to can certainly times we forward, exciting a reality. growth that that even have technology compelling make and confident and have at more importantly, Looking are place platform Cerus. in drive am very we that grow plans These

over results. With hand Kevin that, our now let to review to me it financial

Kevin Green

the we dollar of recorded $XX.X The Euro and up a good by QX continues during of afternoon, million, headwind, impacted to third which last be million year-over-year revenue product to year. reported U.S. Vivek, XXXX strength the relative the from X%. XX% Today, you, quarter Thank of the $XX approximately everyone. growth

to compared a by year-to-date the strengthening revenues to of $XX.X of to impacted X% XXXX million compared due Similar product revenue XX% first $XX totaled revenue reported product dollar basis, U.S. nine the On the months results, the were to during Euro. year-to-date million, the the to relative XXXX. up approximately quarterly

treatable increased INTERCEPT calculated demand doses of looking the XX% over calculated doses The at platelet the quarters, to year-over-year. continues first number nearly worldwide of increased Global through growth number XX%. three platelet increase. for I’m treatable

In for sales XX% revenue. sold kit platelet product terms quarter, accounted approximately of the mix of during

with did sales slightly we usual placements spread quarter, the During see than incremental illuminator globally. more

The running underlying momentum is of our is business plan expected further. ahead and to accelerate of

However, the FX headwinds, we persistent. are facing our

represents guidance of $XX to to growth such, million, XX% range As XX% which an reaffirming we revenue product product rate to full million our compared year XXXX are revenue. $XX

$XX.X the for XX, $XX.X totaled revenue are million September reported from periods both contract comparable XXXX nine-month Government These million million ended million respectively. three period in the and the and during and $X.X $X.X XXXX. up

reported throughout the margins. move to to Gross been sales let's discussion Now improve margins product continuing have XXXX. gross our on

were For period. improvement for was COGS kit lower manufactured. volume and the from year XX% compared quarter, per attributable the margins to of XX%, gross of the prior increased to kits The resulting scale economies significant

a of those margins lesser product result and year-to-date compared the to during in gross double a kits XX%, rates. improved ability months a to first of the XX% XXXX. extent shift FX France On favorable basis, as margins were nine gross to Additionally, mix in platelet

expect the of for year. the be the gross balance in will We sustainable mid-XX%s margins

to I’d $XX.X $XX.X for quarter expenses, SG&A now to million which expenses of XXXX. $XX $XX.X the operating discuss during million accounted compared made supply quarter, the like us during totaled capabilities, driven and efficiently ramp our The increase demand INTERCEPT we effectively XXXX. more allow chain which was for and kits. QX from expected in during the million, have the compared to during total, Of to QX supply million investments will

current compensation $XX higher preparatory U.S. costs. XXXX. pathogen anticipated to basis, year-to-date to activities In reduced our during spending nine addition, quarters of first totaled the during as first On well cryoprecipitate due months period the the million compared non-cash the launch, a initiated $XX as SG&A for SG&A during expenses were three million, higher

to the We I'm looking ahead, stable we to expect for the remain expect year. drive SG&A leverage. balance of

development million, to The platelets extended tied prior life year. expansion, quarter our $XX.X increase compared Research activities the of including for $XX.X totaled was enhancement and label platelet and claim to and kits. R&D to the due million product initiatives during INTERCEPT dose expenses shelf expenses triple in largely

development of activities activities development to expenses On addition, pathogen the PMA reduced cell well $XX.X basis, our R&D. period. the in increase during program In as portions blood as a the anticipated year-to-date compared drove prior to for our support supplement to red tied cryoprecipitate million, totaled of year $XX.X R&D million

per loss loss Net Year-to-date, net per quarter per $XX.X net period. diluted for during share $X.XX compared $XX.X was the million share $XX of to net quarters of third of three first million or $X.XX or compared or share, diluted diluted the $X.XX totaled $X.XX $XX.X prior million XXXX. the diluted loss a to share year or million loss per for a

of In $X.X payment accrued Fresenius terms used since we one-time been to operations, quarter, third of was from cash million, Kabi XXXX. milestone and has have contractual during a which the special

invest addition, in capital, to the In working continued anticipation increased we've namely demand. inventory in of

forward, inventory totaled Going this $XX.X during accounts excluding from the forma line and operations investments both the without one-time and in working on from a third grow million. quarter in and normalize we to bill used receivable sales. pro Therefore, cash the expect payment, basis, with capital

the we is and execute expect on with closer and cash hand, strategy. for our believe to operations million. we $XX.X term million two We cash, at to fund the be runway operations provide third investments to quarter, $XX from to years of which cash fourth ended equivalents least ample sufficient quarter ahead on short use Looking to

revolving options In on credit. we addition, borrowing increased debt and of facility our line have

the Obi me some let turn closing back that, With over for comments. to call

Obi Greenman

take development an I'd U.S. like Thank few program the you, and reduced a programs, minutes provide cell key and pathogen Europe on our cryoprecipitate red update here Kevin. blood to to in in two our

possible the XXXX of out hospitals small these our of supplement, the plan building to for to the interest XXXX. the the where in we're this PMA we infrastructure two designation. the an and FDA a cryo in breakthrough States timing, able under trauma on Based events with First, manufacturing on tracking level expect approval of partnerships. to have In to device first regulatory efforts, half with submission regard in parallel are and the be the treatment be major half in that second we our product we team The continues one successfully bleeding within our hospitals. strong launch product initially for in

progress of and qualification to XXXX. cell blood half the red effort for track our on vendor making we're our first is Turning glutathione validate to supplier, program, in

out it body relates at the submission, our As in of closing and our TUV, submission Mark are file review. notified is under process the to CE our still we of review sections

Mark juncture, from regulation final timing expect review XXXX approval this as transition current opportunities to device the At we to timeframe, we to we process realize mid-XXXX directive. our medical medical still CE device to compress the such, the in timing. our And unless the in NVR review anticipate be

RedeS the on and Phase X XX in studies, to enrolling our U.S., by two year end that our goal with the of ReCePI up getting year. the In goal. tracking in We're study deliver this continues in ReCePI sites enrollment

in INTERCEPT shaping for XX year, months, second INTERCEPT up With U.S. year and plan for coming for a of Cerus. document great to our over is the that half the final cryo the pace and be setting XXXX in platelet the guidance tempo adoption next launch

XXXX a compliance. our we and FDA to manage coming to While the transition guidance in do lot help have period of the XXXX work to customers over the

on plan standard relevant nationwide is France facilitating track this in record the the our more like conversions XXXX. the of our historical ever. than to the Our of customer and end take in facing comfort in and We team mission to in care defined make talent clearly U.S. execute of in is INTERCEPT

Majority the we're INTERCEPT stake meeting. has operations. the with believe role ground of the team strategy have optimism blood of the still a guidance. centers it's being the their subset of convey will compliant that and central to out hospitals, around play in in AABB that for final developing put Cerus centers I important coming All blood a

on is maximize now safety. platelet platelet year. help component looking it to standard We're transition to clearly the of a strong adoption a team and of the in to hospital facilitate them to close Theranos forward INTERCEPT ease new Cerus the care the to their production

turn operator let to for it me back Q&A. the that, With

Operator

first Your from Instructions] question open. [Operator your Cantor comes Bijou of line the now from is line Craig, Craig Fitzgerald.

Craig Bijou

Great. Good the for Thanks afternoon, guys. taking questions.

could plans guidance of provide anything up final I Let me concerns? key that. with work wanted centers I guidance. couple the centers, kind blood to And you of guys on, start the the the that with hearing ended a How just are they early different what have just wondering more see you decision weighing What points? discussions but you're then I details and some if if from was to their the from some are and on maybe the options? One, by know your guys were discussions, that secondly, surprised have and in you

Obi Greenman

then will first the let And I the hand part Vivek Great. second handle question, that of Craig. part.

any a manipulations additional prepared and during the the of because it And platelets. out of remarks. clearly for reflected So and that one-step was draw graft. and being between previous the one as definitely this, there processes, distinctions note I by ones the Larry thing we outlined of take think the to surprised far processes that that two-step anything, preference undertake were, that The to they AABB think hospitals guidance, coming did the don't the really strong want don't I the as

that And think the any so so the was was that such clearly I various that it FDA confusion. options, wasn't good there outlined –

came do Vivek, the Maybe of want to question handle what AABB? of second you about the out part

Vivek Jayaraman

most the some perhaps the even that Cross strategic encouraging filed from past that when the in indicated American guidance not to time pathogen are reduction now, to has them. is technology for priority prior the We've those for a be thing is and continues stated Red

ARC So nearly XX% about the of market. when the total represents U.S. we think

technology. the is XX% our the out So gate, that clearly you're behind talking of market of about

interest executives PR meetings of of board, from Similarly, And some we five had technology. with now big a the adopting we forward across centers. number heard blood the in

I allows that are thing to us that to okay, think understanding, those now work is folks make are underlying what trying the real. mechanics through the

So we maximize we a so what operational INTERCEPT things are from the to the need in can place standpoint, put production that that production.

do they are of of so will and think so our U.S. hospitals adopt I contracting as blood about can centers stream here sort How through products, number need we hospital that our in to and of work and working meeting to need this onboard go with new my relative patients hospitals, to offer came about feeling certainly, think standard. I ability agree more INTERCEPT excited But would to that colleagues really out the there

Craig Bijou

the It's That��s open about follow-up And approach, helpful. evidenced their then talked it. as Got that, adopting and very you have do as a by the obviously, guys letter. INTERCEPT. at ARC just on they've been preferred the forefront of

several your been of U.S. a growth lot quarters. the driving that's for platelet So last

the thoughts, stronger this quarters? last So there forward, the even actually see have just point can of your growth going that you so that over – wondering several you than ARC get is from can to accelerate out

Obi Greenman

what we as But produce understanding want certainly, and granularity of adopting they'll follow address first. serve further will get more believe accelerated platelets to technologies. there customer as headroom is they that to they the I think others obviously, have do where We'll growth. within hospital And that think they that. a reduction marker pathogen drive as ARC to want can into that I the better demand about

or us only not had to ARC. room growth for So growth U.S. in certainly there's drive more the specifically yes,

Craig Bijou

Great. Thanks. I'll hop back in the queue.

Operator

from line is Mathew, now Your open. Stifel. of Mathew comes your the next line question Blackman from

Mathew Blackman

to trying all Good could here We're the Thanks how out next for afternoon, are. XX framework months everyone. sitting for you as questions. just taking through think a play the

more contracting that faster it just INTERCEPT about existing loaded say perhaps five being we terms, months, with and as Could should period existing let's through the maybe a training, the et big work said, cetera? acceleration balanced the over XX time infrastructure, be customers so ramping the you horizon? over next in and And education potential backend simplest adoption think over more with

Kevin Green

how blood meet Yes, clearly, they the centers looking think compliance I the will be timeline. that do

in And think do acceleration I So like the of increasing feel of from of from know, that And be fulfillment backend be will loaded. will to like an momentum production level. the to there allows hospital what as context the be I decided more sort capacity think we for it we've they'd that hospitals broader INTERCEPT the period, distinctly the as you overall heard XXX%. adopt have INTERCEPT throughout

– the they And that's so into the by And capacity want compliance as acceleration. they see you'll to of may system, end the not period, go. where there more comes time by the but clearly get

So question loaded, it will to backend more period. completely, acceleration I throughout answer your be definitely the think but

Mathew Blackman

quick all of a Then after And sites? of important get couple to follow-up sets can U.S. in there double follow-ups. Okay. it Is for these approved approval you then that the you gating that? for How timing at remind is of one just us now more of the factor some and just

Obi Greenman

be approvals double Yes, both for clear, so and do single today. just to sets have we

triple what we Europe. so probably kit that storage to in the you're alluding And as have approved

of the the be anticipating next period, compliance submitted filed, actually year. in are that second during will approval We half for we

centers compatible INTERCEPT the a factor, but get that independent like that they it we've be TS to with kit to Red is So I what of even ultimately even close blood maybe large American XX%, and seen, able with the will the availability. beyond think are XX% Cross

I It at So before, we period, the as have backend gaining. I the should of will the mentioned throughout that'll period. this be compliance –we think don't think compliance

Mathew Blackman

think But the I of red much I then your first into as new think you half may be cell And you'd I said qualification question Europe, program comments. set for sort get now bit the a Okay. the XXXX a timeframe. last of mid supplier. on a And reading in too past in XXXX it

moving the did right? and faster? is if Or that it bit just am So I little overthinking hear a I case, that's

Obi Greenman

for what remarks, I I miss quickly, think Well, CE XXXX was that I it's said prepared validated moving mid we it think maybe but having spoke, our submission. mark the in

I So quickly. it is think moving

we're but calls mentioned I've happy progress with previous the We that historically qualifying, today. have on we've two suppliers made we're as

Mathew Blackman

in All so right you guys, I'll queue. much. get Thank back

Obi Greenman

you. Thank

Operator

comes is from question your line Josh the Jennings from Cowen. Josh, next open. line now Your of

Unidentified Analyst

question. for the on Josh. I appreciate [Indiscernible]

pathway So, just on how remind can you the platelets, risk that INTERCEPT us guess, day the is the the and timing already of pathway approval have And in had regulatory Europe pipeline you experience for there I considering far? seven approval? this

Obi Greenman

answer the many, about in it now for XXX that six, of let the be or second next without file just experience me Right seven claim and clock Well, Europe year. to products anticipate the seven in let comment anticipating stops, part of had question. that day now six day we're Larry any that I’ll with half submitting many for we've We'd would first period. approval right day day review years. that about

of compliance. an of sort again, final approval within timeframe So

So benefit. think a we added that's nice

of guidance being in we've That overall position in outline the life call, a think other to early we a of shelf said, as had lead document INTERCEPT. day because into from an a perspective, strong product the with in we've the X seven release just shelf Larry to got the products. just and outlined platelet Europe line comments Larry, options, few relative the Maybe about X.X the experience for that

Laurence Corash

particularly in really we published valuable in for all paper some do experience showing, gained supports platelets where But platelets Cross what with United clinically effective from Yes, INTERCEPT, INTERCEPT they're time. Josh, by that first Boser We seven these experience will day transfusion Andy XX% only States. have transfusing about day in and Red that seven used platelets. of the the the are Basel of been quite a Switzerland just we've led so

Unidentified Analyst

Thank Great. you.

Operator

line next your line Catherine, Baird. Catherine question of now comes is from Your open. from Schulte the

Catherine Schulte

the Hi. questions. for Thanks

in new incremental placements some geographies specific illuminator mentioned Any the quarter. those for to highlight placements? you First

Kevin Green

not really that No, higher of really. were given than our XX% Nothing throughout just bit They little were smattered in platelets a was the globe. revenues. particular, historically

Catherine Schulte

just to looks $X we an existing that over spread in a then or the were that an win Slovenia this And million tender customer Is earlier found a next of Okay. $X.X years. awarded million it guys you could five this extension like contribute customer? new month

Obi Greenman

favorable other of customer been earlier INTERCEPT just that, board a sort were continue XXX% within looking I so they're on was that to actually has they’re a with customer happy throughout and roughly like of decade think one now, that maybe they think experienced It’s had but adopters the one or we expand and on market period that to had we've of INTERCEPT would to site on. were small I close I Slovenia, And about think for time. of some it for

Catherine Schulte

Thank you. Great.

Obi Greenman

Nice, Catherine.

Operator

is from Jacob, of Stephens. Jacob your now comes the line Johnson Your line open. next from question

Jacob Johnson

guys thanks. quarter. doses release about the platelet XX% U.S. the you Hey, this in press increasing In talked

any can quarter? Just you you uptick is demand frame recent in quarter that interested to to way there last relative compares up how your of Just to this of saw sort an know much performance how experience? that or

Kevin Green

as platelet fairly to relative Yes. to it's doses proportionately. I kits, far grow consistent. U.S. as continues The mean,

of reported quarter So, that consumed this number as the doses growth we far is… as

Jacob Johnson

then you top outlook additional we the Should to line? as revenues that potential do remind any growth outlook? SG&A us support on need And for the just following lot grow? make see line obviously margins of guys on the it. And gross opportunities Got to could a margin growth for investment you guidance. the focus expansion But about

Kevin Green

in do of investments the we'll the we supply as for continue we that. can making margin far I expect as be in been said we that uptake and that year. We've the prepared think the But expansion, ensure balance we our to remarks, mid-XXs to would

course and XXXX, line function and growth of of top scale. it's into As move all economies of a the revenue we

Jacob Johnson

last that? quarter. just on update And XX American Any question I of Okay. BLAs they Red XX for then quick me. had last Got it. The think Cross,

Obi Greenman

a they're shipped overall not driver XX mostly XX, big currently being have platelets as are still now BLAs of state. their out They’re that's right of exports. as sites their on availability Because the really that far net

So XX BlAs and they early roughly throughout – they're I in sites. the currently year think think see we the remainder have production will around of I next, additional the

sites getting regard coming. I hospital online. they how what run to overall to think the and be that's meet with that capacity those capacity up sites, drive compatibility to looks like able they're can to the the full So, And demand within they then the just

Jacob Johnson

taking the for questions. Thanks it. Got

Obi Greenman

Jacob. you, Thank Yes.

Operator

at further conference the I’m back now turn Mr. time. showing like to no this to I would Tim questions Lee.

Tim Lee

for Thank for and us interest Cerus. joining today you again your in

and York. much. call. will participating be reminder, Stifel be today's in a in person. the the our Healthcare We website you And after available the will Nashville as Stephens hope Conference we Thanks in to New Next in very Conference on also there slides month, see of many

Operator

have concludes your Thank wonderful gentlemen, conference. this for and Ladies and a participation you day. today's

Cerus (CERS) 30 Oct 192019 Q3 Earnings call transcript