CERS - Earnings call transcript Q1 2019

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Operator

Good day ladies and gentlemen, and welcome to the Cerus Corporation First Quarter 2019 Earnings Conference Call. At this time all participants are in listen-only mode. Later, we will conduct the question-and-answer session and instructions will be given at that time. [Operator Instructions] As a reminder, this conference call may be recorded. I would now like to introduce your host for today's conference, Mr. Director. Relations Investor Lee, Tim Sir, you begin. may

Tim Lee

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

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

Obi Greenman

Thank you revenue highest quarter. as the the quarterly afternoon. good and product our key growth commercial with In our in delivered of adoption INTERCEPT ever market Tim of U.S. the platelets QX driver team

describes of now In of QX, who we both, FDA deferrals for February, as blood INTERCEPT. pathogen U.S. address variances application donation recently as the meeting services. an have to the undergoes updated that included list when and Upon the eligible revenue we play are recognition to expense conclude potential layer financial of window and endemic later to the with real. is year, FDA pool, individual is FDA testing year, the risks MSM that area published to policy. in or requesting INTERCEPT added a be otherwise call. exploring but at donation blood a meeting a saw start deferred of with help MSM infections of with $XX was substitute under A levels challenging both, escaping session Products centers center detection strong the donation who have global the to fortunately blood this of publication the donor donation significant infectious testing the in found antibodies The allows donor U.S. In important sex center our for as increasing from This detection the would blood was transmission of in deferral long as approved XXXX variance of variance [ph] accept methods list for Donors donors. the issue perceived acid nucleic confirmed. the the includes changes for treated progress comply provide risk but donors. Blood complement travel donations transmitted submitted malaria CAPAL toward to treatment the reduce who with HIV past for XX-month the with the pathogen been pool platelet France. HIV evaluated transfused, acid willing men to Given as to disease Committee a additional Advisory million. that the that the the well allow transmission deferrals $XX in a due million to Several to guidance current regulations. well number Platelets waived platelet blood details product deferral and events nucleic the requested have positive discrimination associated excluding HIV recent Allowing by as case transfusion treated travel period reduction transfusion a of role which be of and blood The MSM viral by raising they protection demonstrate One expanding March recent current period Kevin of INTERCEPT the donation, donation in BPAC alternative reduction of could can or men potential to increase system. this use with window the new been to to lack use as and XX-month of previous donor's recipient and comes a infrequent malaria had MSM. the donors, discussed low flows RNA. authors will

guidance final centers final the with this As components platelet continue topic dominant bacterial of later policies, hospitals. published Bacterial comment document safety and safety be we safety U.S. to blood evolving a year. blood in expect interactions a on our on to is FDA a

they To approval from U.S. hospitals. by able commercial focused the very plan blood we platelet confidence majority largest Cross approvals since be a on customers overall to our their gives this better accelerate meet rate American will us last platelets this in developing from expect ramp following their of Our center end, of supporting Red BLA their INTERCEPT publication, rapid readiness the that production demand the the adoption that customers. is to to INTERCEPT demand to matching initial organization hospital the December,

are major well. centers in blood U.S. the four ramp the their production addition, seeing in other capacity we In BLAs as

initiated progressing. of in or marketing the efforts are Our approvals geographies Paul Ehrlich or Institute also authorization centers MAAs have other four Cross blood to Red PEI. German submission All

of for services encouraging provide turn centers the blood a a We PEI other will red hospital-based utility status coming measures development our our blood CE on associated last platelets process our It like on and the It are the regulatory glutifying covering regards MAA question of engagement cases but discuss in of and current engagement a to our a major and Carol bringing German TUV, the and I now for Most to data CE in red color transfusion on for give regulatory recent mark some program. documented centers. timelines see approval MAAs of U.S. meeting INTERCEPT on was fatalities would us qualify met in new be seeing update platelet today, the level the some the Germany. nature three this the constructive To to is [ph] given provide blood call the and the week the the questions and extended. to increased in Mark to we septic submission centers. turnaround variety safety an INTERCEPT TUV programs of over the German blood meeting, address with XXXX topics cells, on the transfusions our part Seven XXXX, from strategy, may for submission the called by the time the to by Germany. our PEI to the need out first and of PEI, submission, rationale of have suppliers to body new blood supplier, notified dossier, the and cell additional of into In

Carol Moore

of CE regulatory experience audits their available been had has time. to you, as compound. long-term our for to receivership. need impacted We Obi. emerged authority for bidder no To-date suppliers GSH recent field but and ensure been manufacturers review in progresses. into quenching this went or and party process used experiencing GSH Glutathione of review, supply GSH some through due Mark availability in this process. financial an one expected the a investing have reagent, largest challenges, another Thank sourced the to April. is which key has the agent be sold chosen cell the alternate ultimately treatment we Unfortunately, ongoing in of development This be in long To named would company that supplier was been the as this INTERCEPT application the Italian company questions during suppliers auction because the has red our global

manufacturer to needs. our need screened Over anticipated new stability also we manufacturing of and complete our CE that next supplier that last ongoing data stability able dossier have Rather all the and into medical process in to for data GSH Mark as to European We initiate under suppliers the GSH support The qualifying believe requirements, XX and two now time go new to device so, order adding as will suppliers need additional in point. and the post these at year, of we incorporate to May been dossier, one submit supplement middle the approval, than into to least XX-month be will year be potential approved regulatory commercial review. at CE have products. to trigger our necessary by marked lots we manufactured XXXX, from studies new of a or effect the the finalists clinical

our XX-month duration, could new approved review Regulation XXXX Device the becomes December the effective. been Assuming Medical submission, called minimum or just the before standard have original MDR

we as Now of the part to standard regulatory authorities the work to review ongoing transition new our plan to process. with

more of find to the does are remain a two compress timeline comprehensive timeline opportunities approval MDR and launch timing way appropriate that it's a expect confident will detailed does red INTERCEPT portfolio a the no In the In cells. and the be transfusion INTERCEPT possible. part to and cells of into format we transmitted that think on adjustment the this revised Red we important to We Mark to where While the CE requirements, reduced conviction reduce want meet component. approval blood our cells. factor these is pathogen for now event. unmet be critical of endeavor thinking need for for timeline light their XXXX in factors, potential combination to able product this transfused our to updated red this the blood risks globally, with our frequently most change we'll

the Regarding the study the sites. recruiting of our me With With our first as clinical enrollment targeting over study. rate year, cell activities turn study cardiovascular focus enroll in near-term steady active XXXX. blood it in financials. to the of to continues in ReCePI we regard number RedeS, a expand discuss to let the participating red our study sites III the additional XX quarter is Phase U.S., to hospitals end that, look Kevin patients, By ReCePI in to we're at surgery in to engage

Kevin Green

contributed for and $XX.X XX% XXXX North revenue with EMEA the the experienced by product the a QX kit product which revenue the increase revenue quarter our kit Thank approximately in global prior to demand growth quarter. customers. of prior year from product comparing totaling XXXX revenue was product million, we Platelet up higher QX kits the XX% Both, afternoon, growth demand year. million during everyone. disposable existing driven highest reported when America we Carol accounted to good during reported XX% period. and the during you, quarter was over Today $XX.X The

to the previous earlier, range year of the guidance Obi compared $XX start revenue given strong range million. to commercial our $XX to to of a million noted year outlook, we million, visibility our million $XX are As and into guidance to $XX raising our full product

double foreign exchange of seen we to continue, may higher the expect in margin French have headwind will and rates continue utilization We kits which our those increase.

discussion the compared XX% product quarter kit the strong XXXX. dose is the $X.X sales with margin gross BARDA. of first quarter products. first during turn to full The to increased given attributable quarter a guidance, XX% on in underlying we $X.X I'd a higher Separately reported of QX sales of confident which were margins contract other compared included guidance. result revenue to during contract feel demand, improvement as like in double not in our government mix year for million contract now However, with of was results. raising other XXXX product million, revenue our Government revenue to and Gross year-over-year than to margins kits QX was provide platelet the XXXX. for gross of our favorable dollars

In million expenses $XX.X accounted during we XXXX. volumes in Of to prior $XX.X total $XX.X were I'd $XX.X during quarter goods operating which and year reported million of scale. cost of to compared SG&A period. to manufacturing during continue the million expense expenses addition, of the now $XX to QX, realize for to lower of economies discuss million million QX like compared increased due the operating

previously higher for was As We us, have in investors increase a and expenses will cell surrounding $XX.X associated us we investments Research during the and compared key patients per of quarter manufacturing, QX and compared receiving to or discussed, to the products will development the to diluted and period. million for the net our during areas or share of both, well. made allow to year. the loss loss $XX.X these States. INTERCEPT $X.XX $X.X our and first Net million share $XX.X believe the development chain and prior $X.XX for we activities blood accounted The supply costs investments have ultimately serve million our red tied confidently totaled system surrounding scale, per United diluted million primarily XXXX regulatory in prior year Europe with quality.

compared of $XXX equivalents sheet; from approximately with at approximately the the $XXX more we totaled and to first cash than Cash our In used investments the of end operations balance million. $XX ended during cash, quarter million XXXX. million terms short-term quarter of

and approximately significant primarily the prior investments cash. the during certain future $X.X receivables, were well working period, business a made inventory current as Given capital expected significant pay source down capital totaled growth working liabilities. line the in million. a year quarter of items growth we These the in investments build, these increased same as quarter, of In

additional much balance facility going credit also $XX QX we growing facility debt more strengthened the a upto forward, our sheet debt flexible on in these with investments further million. flexible And includes line of also is drawn pace end, To revolving upon of revolving The we us turn in have revolver expect loan will cost $XX back of and lower a provides a period, $X While tranches. capital, $XX million not facility million we rates million term closing it only facility be that the while QX, as should month me and business. the and with invest the upto for of lower of to new interest use that we the expandable contract. that payments muted $XX options to a two some With Obi credit consists more now comments. line longer XX expandable initial million. month let with during XX availability interest potentially new The over a of ability to

Obi Greenman

Kevin. you, Thank

on touch our wrap like up cryoprecipitate would the call to Before we I program.

facilitate markets impact use this it critically be lives. and algorithms are cryo believe availability our We $XXX bleeding around U.S. and patient product potentially further initial continue cryo the million and potential opportunity excited our annually could treatment partnership. to could in patients' world. north the improve imminently and expect support the cryo patients. new Increased the for improved sign about To opportunity be of launch, opportunity investigating to for of on the market potential we have other outcomes We earlier could manufacturing fourth

FDA next and first in southeast. looking for may Our transformational under undertaking some event the in of this manufacturing discussion product of final pleased are outlined to CBER additional Designation to year's agenda. in the our and second could to half support FDA outcome the optimization. half led we discussions bacterial by extending the ongoing further the is year, the FDA for footprint a team this be labeling believe XXXX of may the guidance reiterate, and the commercial the Breakthrough submission the To in south studies We strong Device for this consider US FDA coasts and product regulatory the final organization for of the document to extend we of the is sales optimize launch With our taking with by we're the start steps and the in to preparation our the our Cerus. year label publication with This guidance launch. both guidance the

of before, revenue on bacterial stated transmitted line transfusion awareness infections, think we that the we the publication of goals, document. robust could of achieve term XXXX, the the near top we and As rate guidance market growth guidance. our regardless to assuming in the positioned believe given deliver compliance well the for the are half final starting growing risk of period second adoption But, that we XX a accelerate month

our the will strive reduction access XXXX. the this throughout to improvement opportunity the hospitals capacity Given and chain around need efforts into I ensure expansion continue recognize globe. pathogen would potential our for In prospects supply dedication day and the and take bring acknowledge to Cerus patients that of each to closing, to XXXX and like centers, point team, for this efforts inflection quality to anticipated we growth to and patients, and continuity, in prioritize blood

our make standard-of-care pathogen mission the prospects by here it long national on the to the held very questions. team services for INTERCEPT the of the Cerus globally. at turn over is increasing motivated worldwide, With that, from me let awareness With blood delivering operator back to activation of

Operator

from from [Operator Instructions] question And Ji comes BTIG. our first Nam Sung

open. is line Your

Sung Ji Nam

on road adding starting you. five -- those BLA with but just to I think partners, possibilities as of address five quarter. about was manufacturing total -- supply you initial does down potentially previously to if eight manufacturing Maybe cryo. think eight partnership, with the -- fourth the of know I you interstate what the Congrats What percentage market there the talked had this wondering -- the the I some within Thank mentioned, curious out with to are year. for was I that potential addressable respective states? chain,

Obi Greenman

Yes.

the we're the that going think that large. I sites capacity from be is to for identifying launch pretty

so the purpose of launch sites the availability have And a that the to of identifying's the eight product five so by prior our were as to really BLAs. we time the to we footprint

the that we state. a subsequent then and That the BLAs cryo really will of of have country. within across -- interstate allow launch the that we in So footprint the impact manufactured to ship will to certain big have able a can be where enough we we states a shipment BLA

the the goal think really to day those market. sites meet the five in to overall sufficient demand is I be for

so we're up And looking those centers to sites. centers date of blood blood but at, make both well-placed large sort regionally five also

Sung Ji Nam

document the in the U.S. kind curious finalization of curious Was of then the safety. to early final the trying preparation guidance ready be on? the as bacterial quarter of for adopters I for any of that to some the later just document. was platelets. might And on there as that just for get I strength was final by if driven anticipation this in to

Obi Greenman

Ji. Sung Thanks,

and probably on that our Officer Chief Vivek answer he's think I to question. is best Jayaraman, phone the Commercial

Vivek Jayaraman

forward U.S. as catalyze things certainly leave and to it growth the we continue to and the opportunity know, in guiding You look finalized drive

that technology a recognition the So of that ERT what is seeing encouragingly value transcends we're bacteria. offering

and underlying to had top U.S that does we the embrace started and our so results our understanding XX% And similar and guidance and encouraging we product their hospital really they it working customers CR customers have the But ready provide centers with technology think centers to blood most faster components previously five coming driven anything we lead as adoption. for they're gynecologist was for sort the analysts customers. total is through drive value of these emphasize further blood if great the effort on in with that what's can commercial realizing a we're hospital think that I point. volume But really proposition the should the that's see their us for them by account their to mentioned growth focused they of closely to safer that that engaging strong ensure product U.S

Sung Ji Nam

available you as seven could also XXXX. to talked dose having was the I potentially if the then, on And about just safety guidelines. track? in lastly, label, triplet And be time available in curious kit that's then that day as had still for bacterial well

Obi Greenman

approved two claim critical platform, extensions the that product to platelet Those remind approved to and the do that that set triple for and are Europe have are XXXX. and we you have looking that just in Yes. get likely label INTERCEPT submitted in product we storage

timing but submission to label get TS both I So don't to submission the day set on approval the seven speculate the goal and us for in is clearly XXXX. claim want

level. really guess ability the example, being don't right And That kit, we of towards think for of the the end see sort full said, to XX% five say now more compliance so would TS having just top the impact on I the centers, the an given we ramp period that I blood sort to of would of portfolio. have I not production

will the place and the them, of everything in that kit to think we XX TS I it much the months, have the XX optimal offering. to easier hope for over make product course but next have

Operator

Thank you.

Drew Our question next Inc. from Stephens from comes Jones

open. Your line is

Drew Jones

there contemplated from there, the trends guidance any there platelet Germany through year? And U.S. contribution you walk in either on the in plasma maybe that's appreciating the Could maybe Just anything is thinking going on is landscape. of if the and everything in or kind for growth period? about kit how -- was much

Obi Greenman

take a question. shot as the specifics provide Kevin, at on you that one that you

Kevin Green

we Germany, that lot We that year start as believe revenue of meaningful contribution expected. until from see from contribution a wasn't end towards the to the of we occur XXXX. some Germany after but nascent will There wouldn't

far as broadly, really States particularly, -- areas; or distributor sorry, we see sales some sales did see -- in platelets plasma nothing As concerned, Europe, the But in the traditional some plasma incremental for we some plasma, demand. was yet. United I'm did areas

All of guidance. in that is contemplated our

Drew Jones

And geographies then, an thinking about other interest that I Can -- new color other cryo; showing you you territories, plasma maybe kits? for countries, timelines to would us submission guys are with what front And around maybe that plastic alluded the that? some give And update guess here. the the it hand-in-hand components any look [ph] on like kits there? too goes

Obi Greenman

So, used it product markets is wastage with thawing problem. cryo in in is a using still a certain and associated frequently not cryo pretty that's

improved looking we're day advantages, the specifically the that shelf with U.K. five life So label in the has thought for example. for like markets

dominated roll factor brands concentrates by of a full there cryo approved where in patient the important product maternal think we I these with think strong coagulopathy fibrinogen to trauma value the are the that's is. a looking focus derivative and constituents product fibrinogen markets sort the sort a one dialogue of but couple into that first the not precipitate just doing have interest. hemorrhage bias how that the do who some and think studies of so to that other States historically fibrinogen said obviously I there towards markets, concentrates at folks that by we're also manufactured United is the with being introduce we're Factor so having need process. that and of there and that treat just start get our that We manufacturers. is bleeding been of And and plasma In XX we're So of I and the

those Just use there in understanding of of monitoring coagulation during an the overarching is given active the procedures. markets and that coagulopathy

what's to States can't we're with timelines you any market. disposable the the going priority our Europe sort give CE in new to be the I at marking the required size date, there. is United and U.S. of focus the process So of clearly looking but on given But

Drew Jones

supplier impact one red cell, timeline? on any the last issues me, blood then And domestic that with for have the does

Obi Greenman

It does not.

So we in material have studies for clinical US. underway the the enough

Mark primarily impact on CE So it's review an the timing.

Operator

our comes And from Jennings Cowen. you. question Josh next Thank with

Your line is open.

Josh Jennings

thanks taking just on follow-up the of the U.S. centers. and your commentary to performance the on in major year. and for some was quarter start questions afternoon the and Good the hoping to I non-American Cross just strong around congratulations blood a Red

American is Red And at about us in the INTERCEPT same this or year just I ramp been of ramping on as on about towards the talked up final Red focus ABB the Cross then other very their you've prepared Cross? but think seeking the with ramped, blood well, the front four year major Cross any other your incremental Red to non-ARC. the has I as are significantly some color last American the And in in centers production? said also blood you remarks of can help from centers path mandate with if FDA has those including four you wonder they vocal plans major BLA. platelet American there's the guidance.

Obi Greenman

the over out and Yes. of representives marketplace. table in all all turn reduction? the I'll the Vivek how from reduce for of Thanks, and pathogen and discussion that here Josh. guidance largest to sort Pathogen just about a a probably had blood five preparedness to sort weeks we around couple document ago platelets think and of of centers round conquered

some well-placed to the on do that. good commentary Vivek is think I So

Vivek Jayaraman

chanting are the and question imperative activity they They're ensure There hospital with and Thanks as adopting actively and not continuum, certainly for Obi. the but setting the in active really is around other standard partnership the excited after can securing are from Well Red degrees in and the Thanks, Cross of closely about we utilize INTERCEPT really Josh. and engagement we education to working certainly the level production. lot American reduction of organization BLA technology. terms have encouraging final seeing on centers optimize up alone to Networking the that really strategic along are and as in senior five is and a has Obi awareness both productions something executives of guidance run their most aligned view meeting a what of deployment User them well. and collections are that procedures side intend -- from to was the indicated, a conquered standpoint, see we all Group and that that to top brought blood we're active our with it they what manner a in with varying

confidence drive a our have to blood in only the with the really the US we across growth ARC partnership of ability the country. not our large with lot So, centers but with

Operator

Thank from our question Cantor you. Fitzgerald. Craig Bijou And next from comes

is line open. Your

Jordan Abrams

Abrams This is for is taking questions. Jordan Thanks the Craig. on for

a on guidance just on the analyzing are but increased you for document? in potential final of it capacity little touched about guidance company's they light document, plans mirrors document. the financial the center bit final But impact talking that draft So assuming the guidance it the blood side, closely the

Obi Greenman

Jordan. Thanks,

Vivek a blood ago discussed. in the I'll turn think and this couple large dialogue you was to with he all centers over because actively it weeks I again the was

Vivek Jayaraman

Yes.

you to associated past And selling uplift platelets a a healthy well maintain the from payment discrete something about at blood platelets. price cost conventional also have they know, ability to centers platelets the talked think standpoint, to as production look and versus hospital. reduced what the experienced pay and the a I when as also there outpatient pathogen pricing both close is is the we've in is You charge for average this attention pretty with setting, in pathogen-reduced

manufacture start and a their and standpoint. as get they're they optimization see seeing at their as line most scale from and really, that taking their benefits subsequent more product comfortable profitability; the production and So improving to cost -- they profitable

keenly business aware they're physicians So their I they business, important technologies healthy of reduction think for view of and running clinical and pathogen really of patients. course, their and being while value for as

Jordan Abrams

thinking be 'XX mentioned also how margin should product higher the and in gross you impacted -- the that? also higher kits product margin or then, France. about product to by margin expect gross And we of Can higher of be sustained mix, we favorable use was in margin

Kevin Green

Yes.

United expect there that; a you kits we dose the will But think dose to only is a for from historically platelet larger margin of are wherewithal the contributor two blood single in processing will percentage they higher relative the sustained optimized, and is becomes grows single not And kits to U.S. expansion and we States highly the it a have mix see EMEA, I there. kits. kit of platelet but seen one our the where we've mentioned than grow. to then of double dose we'll also line conversion that platelet as in top and a factors as use that expect naturally double dose that larger French be and

Operator

Josh do Cowen. Jennings a Thank you. from follow-up And from we have

Your open. line is

Josh Jennings

you. Thank

will Mark Will the to back that Let in XXXX? CE the going is approval what me to issue. requirement there push out is the about is push is approval be ask exactly pathway guidance requirement? you assumption help onerous that timeline plus you supply going more drive what glutathione the and that us exactly to -- drove the take I but kind get timeline? data, the the need required MDR understand was or that's of just queue. going in year is that more to was I What revised of what just out understand can clinical

Obi Greenman

a what Josh, do the year, and of we'll lots is lots the to submitted I'll let new high that Carol part level, submission; manufacturing dossier. that's next and for commercial this year qualify we're handle having it GSH supplier as underway, final be a be to has the is main specifics and dataset but

and context, So to responsible exists now, out is But just product timelines still provide from Carol? any timeline means a more so able what little don't because think some -- may Carol be uncertainties conservatism, submission regard the submission. transition that an MDR there that the review MDD TUV additional is pushing context our Do to -- is -- MDR. providing the about active of because is the that you out for to to we that's review an what those have I by with under

Carol Moore

you thank Obi. Sure,

European CE develop in CE re-registration Mark this products, different all process all the Mark universal go that back to really and now Mark a through the decided devices standard XXXX, they all standards, So of so decided begins XXXX. for were May that Union products meeting CE have medical to in

guidance that it's more available we a process believe our that documents on are detailed we assessment data to the is us the MDR have. based the that of So really presentation already

going we is better. guide we does anticipate transition this any or information from our that they information be them completing anticipate new through and get so be to change, into a And clinical when their will notified fairly the us But they the with process to help license current they're own the strengthen new certification will even required us the any be it last seamless our process. documentation So it's through the as us any of process; to it to modify we in current don't we studies. can point that just intent MDR But either review data, application, met advising body their don't and license. week, I the or and additional presentation at us the think new MDR anticipate walk how

Josh Jennings

Okay, great.

-- that need CE be to believe trial you Mark clear, another So run for don't going you're approval? just to clinical

Carol Moore

we that we believe need. trials, U.S. in help we also have are necessary product, believe data but safety needed. us will and might device so we No. those marking; have, information that device, question data of the of for Mark with a clinical a that's performance address that course, the performance that it's and of for don't all perhaps that of required safety be and be We will believe we what's of CE and the the We CE

Josh Jennings

supply topic but trials. still the And for blood just same but question I to just U.S. just confusion -- sorry enrollment? last just red the blood -- -- able previous Is on supply I'm then, for wanted INTERCEPT for call; sure... from a cell have Or kits about just the and follow-up sure one glut to it's cell mean, make you you I red do the are one you glutathione are units make wanted on -- to that

Obi Greenman

answer question; To we yes, Yes. do. the

supply. are studies existing we still and the So have enrolling

Josh Jennings

is terms on of well the as no the as trial be current of there term? enrollment in then trial, chronic issues the going And to it's complete

Obi Greenman

Yes, that's our assumption right Yes. now.

Josh Jennings

so for thanks much questions. the Great. taking All right,

Operator

no further am questions from like lines. turn our Thank Greenman now to for remarks. I to you. Obi And over phone I'd showing closing any the conference back

Obi Greenman

for interest us Well, you all today, and for Goodbye. in thank joining Cerus. your

Operator

for thank and participating program. does in This the conference. today's gentlemen, conclude Ladies you

a all Everyone, day. You disconnect. have may wonderful

Cerus (CERS) 7 May 192019 Q1 Earnings call transcript