Cerus (CERS) 1 Nov 182018 Q3 Earnings call transcript

Good day, ladies and gentlemen, and welcome to the Cerus Corporation Third Quarter 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 be given at that time. [Operator Instructions] As a reminder, this conference call is being recorded. I would now like to introduce your host for today’s call Mr. Director. Relations Investor Lee, Tim Sir, you begin. may

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

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

Thank afternoon, and you, everyone. good Tim,

another pleased quarter are of growth major strong to geographers. We report across all

totaled $XX.X XX% year-over-year. Third a quarter million, increase revenue product

later commercial our of three once of through new ongoing recently third first range $XX range represents a key XX% for we’ve a financials compared momentum to XX% on will an to provide on the fall. increase revenue. product returned quarters, XXXX revised raised million. the to During the guidance year's $XX additional event again this meeting, product us this million AABB This quarter call. revised revenue from We details to Kevin which is each

industry and to place As which I'd two a it national of monitor state AABB, to time. the our the to from opportunity the provided U.S. took annual largest weeks like understand in conference, of key some Boston. banking observations over trends ago XXXX unique blood share

that for questions and/or AABB of the answered centers I compatible educational mainstream a pathogen meeting whether commercial effort minds the most attending these many U.S. see in clearly initiatives pathogen effective, have to from the of our credit affordable. the was in First, we topic blood evolved two hot diligent has team Boston. XXXX, are were controversial subject. start that questioning In still just short a years reduction in to reduction

pathogen increasing awareness inactivation five of as platelet there conventional conferred by intercept stages top adoption, associated transfusions. of events the is the various we with on believe as U.S subject platelet blood the well chronic an underreporting With benefits banks transfusion all about

as to increasingly Red investigators Second, presentations is pending as center a INTERCEPT our in addition program our blood our partners. well portfolio. cells Cell as from the clinical prominent were INTERCEPT covered red

Europe, cost-effectively the antibody blood blood all anticipate is supply centers appeal next reduction planned components for As red as going becoming The a look to other testing cell began of bankers launch for pathogens, CMV the decade. value the blood gamma strong replacing of into tangible. safeguard possibly possibility the in blood they three has to pathogen the across even radiation, testing

Oxygenation from AABB to THOR to role central the as see the program year's embraced civilian resuscitation INTERCEPT Iraq. are A attending audience applying meeting, to this known that centric the THOR. we coagulopathy, learned battlefield injury, Research patients in that with move physician update. At and lessons immediately trauma forum the on to our Finally, was as future trauma hematologists meeting all fighters. to during the associated The and dedicated financial trauma surgeons, and as brief These Afghanistan and trauma provides in of improving care surgery well outcomes. wars meeting Hemostasis Cell this year’s Red improving for discuss before related Trauma by preceded traumatic few current challenges hearted about war we’re cryoprecipitate remarks and the anesthesiologists

patient let for or enrollment week over that, turn we Phase recent year. this on we study. is to submission. RedeS October, of to the begin this will center up trials. ReCePI regulatory of approached With ReCePIpatient of financial results. and in enrollment pending products U.S. CE whose blood completed the Blood -- regard a for soon it end within studies, milestone to the to to XX-day first is begin X recall ReCePI shortly the critical two. most on ReCePI and first support TUV anticipate me our planned producing We the next targeted our Center step Mark will four addition have of And important the deliver three With Central the now prior by initiation our red step the sites this red Kevin units, cell the cell will you as remain As a notification California We review track

basis, everyone. completed Today of Thank primary and million third period. for product platelet again the XX% product first $X.X period. year-to-date recorded our included that growth XXXX. we've prior offset million shipment benefited by perspective, were contract On mix $XX.X million, tied decline from was XXXX, QX, revenue from quarter million the guidance, recently quarters of again Separately first million, the the recorded French of growth of of XXXX XX% million disposable demand kit XXXX, sales. North year. agreement during million same kits in Obi, which the year increased three in XX% illuminator over American in government of good the up to the for you, the once to the year of quarter was approximately kits XX% during last government and year-to-date third third quarter initial compared the the three product accounting supply Blood $X.X Recall sales up quarter year-to-date revenue a revenue contract revenue kit XXXX quarters comparing to to our $X.X XXXX demand. for XX% QX to prior have partially compared QX revenue the was year. totaled during basis, demand to EFS, in the $XX.X in XX% reported $XX.X for not million revenue driver National we afternoon, prior during On XXXX. the with Disposable $XX.X during the compared contributor to a strong From a Worldwide the year. totaled once to expanded kits quarter, a growth of our the of product compared On the a in for of increased of basis, Service. $XX.X disposable the kit compared global the illuminators prior when period year-over-year

other be Southern in anticipate $XX QX, range Obi and to kits, million stand sales during orders product our recorded QX approximately outlook, in increasing to last have context $X the when orders EFS of commercial taken the with earlier the recently all a our Kedrion, against previous raised again in have guidance the include Italian We strong range million kit QX $XX of should to and As the atypical performance by our remarks, illuminator that of single-dose orders to up purchase full $XX million. from XXXX, initial EFS which of noted we conviction $XX demand year. our compared revenue we from of customers. million of EU year million our sites, to measured distributor his given Those strong atypical stocking initial

in quarter the volume-based quarter turning attributable revenue Gross XXXX. third offset other to sold, gross Now of and to product year-over-year by lower rates. for The XX% per unfavorable QX largely extent, XX% to margins foreign results. pricing reduced lesser the on cost by customers with from exchange high-volume margins change currency was associated unit sales to current a compared to for were good

a the Year-to-date, million spend U.S. as compared million, blood nine As expenses, sold or CE year compared the million, now our was Through $XX.X the tied activities XXXX. share, end XXXX. year period in revenue accounted $XX.X expanded exchange red in remain expense INTERCEPT U.S. as million realize third a plasma. $XX.X were as loss through year of we quarter, were to shifts to in The $XX.X share, relatively been XXXX Phase $XX.X diluted the SG&A or reminder, compared XXXX. operating primarily a our of $XX.X in our the $X.XX as $X.X increase $X.XX nine our well the in product million the first $X.XX, during of INTERCEPT plant to The year-to-date in and expenses same was were for during Of commercial and prior Europe. reported like affected and which year, net million compared the loss platelets of first or during loss the share, cost first of to $XX.X The million, during revenue million labor has cells, compared diluted studies increase stable the QX the $XX.X margin Mark Year-to-date, the activity same million to the per in nine manufactured months XXXX. the factors clinical nine development primarily slight million quarter On which of preparation months at was XXXX. months diluted $XX million the X by first SG&A to $XX basis, for on this per expenses net including XX% for P&L. $XX.X compared million rates. to Research submission continue product months, net in SG&A to impacted $XX.X from compared of expenses, year-over-year a later driven to aimed discuss Net clinical due expenses I'd gross expenses the to per QX, $XX.X claims million $XX totaled development XXXX, million activities And of for the increased disposable for leverage per are for are the XXXX. quarter share compared foreign $X.XX we prior kits diluted to prior. R&D during million the SG&A period. period. $XX.X by comparison. totaled totaled and totaled operating such, gross to $XX.X million compared expect in loss operating or of Year-to-date, year our QX, XX% margins And to the during and change year-over-year quarterly million to of

ended end With equivalents XXXX. to remarks. some our $XXX the third a we at terms that, me balance closing the cash, million the and quarter strong short-term on with of $XX hand turn to let of In cash call position back investments sheet, for approximately in million Obi compared of

Thank you, Kevin.

field come. our to mixed. commentary Susan Moreover, in Vice Comments at just they XXXX, to sustained Dr. which the balance vision, remains provided associated value for platelet of Stramer, receive Red outlined speakers innovation we meet for not dilemma supply deliver also how Weill for and in concerns Investor management adoption Cornell participated American institutions, of patent for President inventory associated Red from Stramer from discussion Meeting at on fundamental offering. reduction there subject Red Cross's shift are transfusion the in States. to of XXX% we safety the the momentum ethical is and to also value its York. speakers the of Ed address reduction reduced three from recently the that the increased of if increased medicine. necessary this event, years platelet reaching articulate their untreated importance and to our to Cross; They Cross pathogen underway planning. our with see as you transfusion events. New and patients Institutional their Cushing continue compelling United Affairs avoid at intercept American hospital Professor growth Yale All clinically external Snyder simplifying University; believe strategic the units both of long-term demand expanding the product a but well-positioned from reduction inventory Dr. about top-line If confidence INTERCEPT the the toward To Scientific to drive in the pathogen the in share choose All Melissa Dr. Boston, of that

plans. BLA critical a approvals -- are expansion BLA expected, element their in As

the Baltimore yearend. at their facility BLA So anticipated before initial

Cross Following, monthly a all growing INTERCEPT QX across producing XX goal for submissions The of of licensed preparing schedule that being the initial sites BLA platelets, Red by other is late XXXX. currently sites approval, with

segment submissions following allowing an as to changes accelerated As are including these the enthusiasm cells as INTERCEPT export of a become the for Cerus these as are to expansion Cross the of supply The network cryo. able also cells, effective articulated obvious future we CBE-XX benefit was a infectious Red program nationally. risks red potential will six additional replace reminder, impacts available a Day the INTERCEPT from pathogen Overall, the associated as under an their demonstrated about optimistic were there's patients portfolio particular INTERCEPT net to future days. XX XX platelet four mentioned platelet review reasons becoming use of such tick-born of reduction. most host expressed protocol, both driver the both the months disease. at blood graft and of transfusion risk speakers INTERCEPT complications the radiation versus centers be to This over disease for INTERCEPT streamlined to Investor for the a about and distributions with process Emerging well after BLA

noted device cryoprecipitate need FDA designations are confirms status As bleeding. reduced about breakthrough yesterday our from release our you Breakthrough addressing the unmet we associated clinical granting for excited press product, massive the all about pathogen with an enabling by the we and advantages with that more our to to in several expedite PMA even XXXX. FDA of half reviews proactive the program submit expect supplement dialogue our and the of potential for second

we validating with FDA interest this the hearing for need and dealing of With a the trauma, the product launch unique and hemorrhage, is the and cryo physicians continued surgery obstetric coagulopathy standard from establish are globally. and excited for us, opportunity a for are summary, our we the company. as INTERCEPT are In about to poised the ahead of mission to opportunities cardiovascular components blood of advance transfuse care

team bringing that please the on for pathogen reduction Cerus for cell submission. call Mark open Cerus the especially to call the up around are acknowledge of for questions. questions, recognize dedication globe, open red let their patients many the diligently an technology we take employees CE and working Before opportunity efforts the to the me Operator, to

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

We participating month. will conferences later the be upcoming in two investor this

Genuity Canaccord and will hope will Next We we many presenting of Stevens Thanks week, be much. presenting Diagnostic there Forum, the person. at New Europe. and be Medical at York Conference, in Investment following see very you the also week in we the to Technologies

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

a You wonderful have may day. disconnect, and