GBT - Earnings call transcript Q4 2020 | Global Blood Therapeutics Inc.

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Operator

Greetings. And welcome to Global Blood Therapeutics Conference Call. At this time, all participants are in a listen-only mode. [Operator instructions].

As a reminder, this conference is being recorded. to conference like to now would turn over this Mr. I Immergut. Steven ahead, Please go sir.

may You begin.

Steven Immergut

welcome conference and to the And Communications update. you. Thank GBT's Head Immergut, results to a of the I'm and Steven company's Investor call for fourth XXXX quarter Relations. full-year and provide business financial discuss to

the will Farrow, and Chief ended we the call and Ted update on Commercial close quarter on high-level or financial Chief the on Love, fourth release with a me an who an a update and Dr. who Ted activities will Jeff initiatives. David our and our fourth year D.J., give overview update press financial progress XXXX. progress will provide long-term this in Earlier full-year XX, president Financial on Officer, Joining other the of issued announcing are growth Johnson, afternoon, and then our results will results; quarter Oxbryta GBT's over an CEO, the launch. pipeline XXXX; December for who provide our and our Officer, our

than begin, this Form annual on SEC SEC we filings not in should call could differ our page on place but that obtained company undue on be time would to Before may our The to materially law. subject as at report from beliefs any statements. only made press facts forward-looking that passage the those as time not to turn I most expressed release. of other obligation will call such such in reliance forward-looking remind can uncertainties. that any releases the actual cause filings, concerning today's this risks including, as forward-looking our recent Ted. statements of update and cause historical to, or With are the contained well and website implied are statements to Copies statements we be of by are that, call they may to statements limited events disclaim forward-looking are press results Future as or our the required make simply not our we gbt.com. and like from certain statements Investors of over that you made are change, Information by I on and to factors XX-K,

Ted Love

Thank you, pipeline. by year R&D for everyone. the historic significant was of and and Steven, Oxbryta good afternoon, GBT, a headlined launch progress on XXXX our

fundamentals years. in awareness. continue commercial, and We are months coming value with and in facts: first, a the we and position strength, It build by This clinical and clear to is that adoption of milestones multiple strong is regulatory, Oxbryta's supported several strong. are

This in During the successful launch, first despite pandemic. history. making full it $XXX sickle most happened nearly cell revenue, in disease the we once-in-a-century generated a year of million launch the

and patient is of addition, prescribed Nearly who Oxbryta have professionals In awareness of it are aware extremely Oxbryta plan to. physician high. or healthcare XXX% of either

workforce. patients including report getting statistically their access. Both Oxbryta data, blood And into the real-world of And in experience We've improvements robust transfusions Oxbryta patients shows clinical health in and broad to reductions know hemolysis including and treatment. I daily weeks real-world XX activities, and in published The seen, overall third, normal improvement HOPE significant that over hemoglobin in status. HOPE data body growing many VOCs. shows have Study, durable Second, in back data. that the of the taking resulted Study the data, most returned

broad become is are which less of broad benefits history HCPs prescription these of patients of foundational than in payer way age. we the analysis Oxbryta, Oxbryta. of trends Based a believe starting range this comes, that has position our irrespective in on care. ahead and coming of team, a the our VOC and Oxbryta pandemic. COVID-XX established out learn their of to sustain one will and process stronger XXXX for baseline our we points, to that on confirm on believe understand growth adapt. Our hemoglobin, quarter we We in demonstrates current goal, look year, payers its well you prescriptions every In our put can to when launch, pandemic GBT even SCD the new Until that opportunity levels to an time accelerated the believe this continue subsides. accelerate we and coverage of forward

of appreciation racial in sickle on deep patients impact a the the We healthcare, pandemic. cell inequalities and have magnified have by COVID-XX the for which disproportionate been

each the financial will our support support sickle we Program. launch in Disease very Annual care of for increased working commitment, couple organizations urgent we include, $X in And Conference XXXX are in fourth-quarter our Overall, we that, happy clear further to Jeff to in GBT and people full-year in cell nearly Therapeutics to SCD and progress. community pandemic. update was part number we and a living our With hosted our and Grant call the variety Cell for to through examples leader are a have ongoing with helped Sickle patients disease of poised ways healthcare on and Total sickle over contributed advance to with one, access disease. are we ACCEL has cell results. I Xth cell turn than and thirdly, provide beyond. more support sickle and this a the to an community As patient our improve for deliver the million, is of year XXXX. GBT, also long-term specific to GBT's of to funding needs directly provided to two, board members employees, non-profit $XXX,XXX related to COVID-XX our Number the family proud

Jeffrey Farrow

$XXX.X clinic. million fourth quarter the healthy Total into of also investment million quarter as we the over XXXX Ted. for Christmas sales and new driven SCD full-year the partially for This results full-year see to have exciting and the third fourth grew XXXX, patient delivered is sequential new ongoing $XX.X was maintain the fourth pandemic prescriptions impact prescription in made net solid the quarter. our the we GBT we the to offset by continued two you, due primarily for the to The impact balance have was XX% and XXXX. COVID-XX, Despite the pipeline of refills. or and by It in Thank from million revenues by was revenue on sheet. demand Oxbryta, growth move a quarter revenue holidays. of from $X.X Oxbryta Thanksgiving assets evolve and

XX% Our the was fourth gross-to-net adjustment approximately quarter. in

noted, the time, continue to copay we prescriptions D patient gap, over insurance adjustment increase by to and patient Part previously driven As coverage filled coverage, our expect assistance. XXXB pharmacies, Medicare gross-to-net by

adjustment of fourth-quarter related our Our in reserve to approximately benefited for gross-to-net $XXX,XXX by revenue a return reversal Oxbryta.

of launch review we to been end returns, appropriate actual de our first of As to which of the we've adjusted minimis, reserve and have levels. year levels the come return

higher days hand level in three was distributors the quarter. days than inventory, on inventory of our of we experienced approximately at terms In elevated the third

So, quarter first the XXXX. could bottle inventory as less from utilize we XXXX, in the in purchases Oxbryta with QX Overall, the revenue distributors of think about I'm built as result and in pleased this QX. up

adjustment. which first we revenue quarter quarter to XXXX, gross-to-net includes fourth compared about a As higher flat the think the we XXXX, anticipate of expectation of the

approximately estimate subsides. half will not year, remain efforts. of of $X the Cost new may incrementally flat, was was year FDA will thinking, which sales significant $XX,XXX fourth were prescriptions $X the costs Based be about sales for more until to not Oxbryta occur approval, incurred our for prescriptions ongoing for some this D.J. as year able million we of second increase prior after the anticipate quarter-over-quarter. thus recorded R&D we talk of the also compared manufacturing with the our The best that expense. and see to cost the expect sales to quarter the of is latest full-year related do million fourth and the low in new and were on as full quarter growth was we We prior and as this majority approximately to the pandemic expect XXXX. until to

as of revenues expensed to manufactured will cost is increase as to continue of sales Oxbryta expect FDA that product a We the fully utilized. percentage approval prior

a And needs estimated not to XXXX We has contract COVID-XX robust impacted million were period Oxbryta production $XX orders. compared quarter our $XX by continue same government-mandated the commercial million the sustain manufacturers believe been supply XXXX. of by patient that we XXXX. production vaccine have fourth R&D to with for into the of Oxbryta expenses for

with quarter of the For agreement million December Pharmaceuticals $XX signed expenses the million related year. to XXXX full $XXX year, fourth Syros in The included in million were prior expense collaboration XXXX. R&D compared in $XXX

research decrease This Oxbryta Syros partially the fourth period expense, manufacturing XXXX. lower Sales, quarter inclacumab Syros million activities for fourth expenses FDA preclinical manufacturing in to approval, the related capitalized inventory. quarter we external R&D the XXXX the the increase decrease for was were by million to offset general, due primarily our to $XX for in in with related $XX following of same costs as costs program Excluding our in costs and an compared was and administrative collaboration.

including year, SG&A and to the was employee-related operations and consulting million other increase of primarily services in commercial compensation non-cash of expenses $XXX compared For the due SG&A with launch $XXX costs, in million was the full increased prior build-out professional The our to year. stock associated and Oxbryta.

with share quarter expenses in promotion and million per in $X.XX year In net $XX balance loss XXXX. and the period in compared an was share $XX for in a with patient the the with was to marketable cash $X.XX to of share year. $XXX efforts We at I'm education ended Net year, pleased million for XXXX. and reflected HCP Basic Basic the for and diluted was increased strong $X.XX per per XX, XXXX. securities loss fourth per unpredictable results. the million for in Our same Net prior also $X the compared prior same SG&A to full for period $XXX.X cash, loss full are diluted share million with million September year and $XXX XXXX. year loss per net $XXX.X share equivalents, QX compared GBT's sheet and per was the year. the XXXX extremely compared in for summary, million with compared share

long-term accelerate Oxbryta a remain the turn with I remain call the also when confident revenue has to position. And will will that, our strong. exceeded strong our positioning growth in pre-pandemic over we're expectations I that financial subsides, COVID-XX Our for now will D.J. and from far and Street

David Johnson

good team. with of of achieved I our We passion delivering progress testament want COVID-XX employees dedication ended and you, cases the which XXXX spite of everyone. another growing across quarter US, launch. of afternoon, the for We Thank all by throughout the our to the thank solid the launch. in Oxbryta Jeff. And to is a this efforts

three for the insight around I've adoption; informs providers environment metrics with progress. As progress captures the Oxbryta, update which give new key making quarters, prior provide done for These you I healthcare will will payer coverage, into the underlying prescribing further patient revenues, which that, and prescriptions in our are number which speaks access combined the demand; an net metrics to Oxbryta. we're Oxbryta, in of

were rise continued decrease cell fourth level and First, holidays. due Nearly X,XXX between during of new cases, that we approximately and the maintain in with impact coupled the provider of end including able XXXX, healthcare is rapid prescriptions. XXX dramatic the prescriptions COVID-XX to given the to new of written sickle the the quarter launch We're and for a QX. pleased pandemic. This patient of this interactions were Oxbryta normal prescriptions level new in despite

our lab a VOCs. we broad patients a one-third patient As per reflects data, Oxbryta more claims more the three annual baseline of increase or above continue it deciliter than we profile about have half and X in an have of patient continue for now patients, to patients of average number hemoglobin base X,XXX to Nearly see Oxbryta. and grams

year. than a impressions in XX% increased websites Oxbryta more At patients QX second the XXX impressions visits the than trends We HCPs healthcare from XXXX, the half million our interactions broad of XXXX, and end on Cell program, combination in per In educate as Facebook. for are to grown to ability day with our awareness social XX,XXX think SCD. the digital it that has patients range These regimen. of Oxbryta of of well of disease recorded our shows several HCP-focused of a Beginning over in that's more addition, had followers Sickle in more and growth And QX, with the the more in we we of on half than than drove bode a now websites. QX. half our on patient-focused providers new future media second indicator Speaks, We out XX great to rolled use.

and leveraging roll materials. a new content continue of marketing XXXX, in educational broader toolbox out We to

getting and to patients brochures, For now started discussions Oxbryta. provided on be we to offer which example, guides can support

high-touch provide information and now For healthcare shown adherence in Source we Oxbryta. has staying rates. Solutions, starting launched the GBT better result recently exclusively website to we to And model, offer for about our professionals patients, caregivers, and gbtsource.com which on

including and process, cap will sheets, alarms the with effect We ESSENCE advertising. sponsored everything caregivers our And presubmission via to magazine following also brand and Oxbryta's we recently tools, and patients accelerated from side treatment under with stickers new iconic management improving approval and goal and journals, digital adherence. overall partnered tip bottle the the finally, have the patient requirements of FDA smart motivate of content after educate

which XX-week analysis in the the already presented compelling ASH at our data. field, XX-week Phase Study, in supplementing addition, teams December the HOPE have of In field III to on trained use was been our

trained and real-world field teams the medical Our also been HCPs have these on important educating on are emerging data findings.

maximizing engagements the the that interact our This addition, allows of they metric, better prescribing by with more healthcare will provider for to as address in-person believe interactions limited patient of their decreased new penetration. me well opportunities to field COVID-XX continued of while keep recently support can to new professionals fourth impact challenge outcomes, patients real interactions. build patients, MSL so and awareness continue while causing a capability therapy in-person healthcare in meeting field my In quarter, offering launched which second them with helping professionals healthcare our time. the and in In also digital with on-demand team our hopes be We to us headwind leads a as achieving on physicians Oxbryta, teams. the both

and in engagements interactions able in in-person geographies continue drive virtual areas. to we continue so where to all are We the do

pandemic, discussions the patient While curtailed we a relationships continue even interactions focus engage quarter during to were fostering deeper the of with on in to HCPs an gaining understanding due the and with journey. better

have plan to Oxbryta. who nearly want of bring future. mentioned what continue aware in We earlier, Oxbryta, Ted the greater XXX% to either of are and I flag GBT prescribed those or And to awareness HCPs to it

breakdown Oxbryta Our that new prescribers This efforts of new from by and start a non-specialists, the contributed healthcare my of about a written consistent we have providers writers, believe for because through have X,XXX the end XXXX the prescription continue to important on the launch we year, is who prescriptions at unique the trend of all see a of prescribers multiple writers achieving QX. in start is and This in solid a trajectory long-term know specialists launch. career. which including typically being XXX Oxbryta. great and the launches both written is to with for look we in patients positive When base we

learnings HCPs with dynamics. referral our to As territories the these position will targeting efforts most our sales includes active of year two and we of even access, maximize year adjusting better launch, institutional the we from trends, future. believe This and optimizing better are improvements enter We for us one.

to payer Turning coverage.

of to in will As I in covered the XX, focus Ted also This summary, coverage. these continue potential provides I potential I taken to the to we believe will new and an a as the the how that incremental of adoption to the now actions, gains, broad In materials of position enhance expansion previously expanding are In supporting we work from have the we made COVID-XX QX, of stronger discuss market. reported, continue coverage have the United we we in XX% and be we we out our organization we call year acted turn and to first Oxbryta of on one learnings and access nimbly confident the long-term We've and rolled approach quarter small of because adherence. payer over Oxbryta. pipeline. to back to of launch in of our as September optimize States. goal. achieved lives ahead coverage face

Ted Love

D.J. Thanks,

we refine we As made in heard progress Oxbryta tactics our you've today, XXXX. with launch and to continue the of significant

to access continue broaden efforts regulatory make to also to We our Oxbryta. in good progress

We expanded XX to to the the label continue with application Medicines first our children. alleviate X access to regulatory to the Oxbryta potential sickling Oxbryta FDA to patient clock of their to modify top accepted complications. by our expand enrolled our European mid-XXXX. for or the approval take Agency review access to to disease standard plan the and believe red in that timelines, destruction to XX provide the its announced the one Based In including for priorities. approval. we access program, include on mitigating ages our will Oxbryta In file stoppages, regulatory children of we will to that We Providing submission is estimate Oxbryta patients younger pediatric early we in life-threatening and XX cell prior serious life recently for blood about course younger US, EAP, months. and January,

works Europe GCC As review, intend we to to to distributor are SCD with their region's countries outside live. the of through East, six eligible to through bulk other make Oxbryta the the work where our partner, the a the including US. Brazil, continue patients physicians Latin an in establish we partnership regions launched for Middle available. the Biopharma-MEA, In similar gain EMA that with EAP able experience We in and patients for Oxbryta America,

and Head thrilled in made Philadelphia, Kim track She I'm Kim progress Hospital where from join a the patients of May. of our the year. is we appointment to Development. announced continue we Research She record. cell us impressive December, Smith-Whitley and EVP see global sickle our R&D she Children's will officially really Now, leader an about accomplished of turning disease will joins this leadership In in with team past highly to part-time. Dr. as pipeline.

Let a the me you take moment on pipeline. to update

potently, potentially gives is ASH, we dosing patients currently best-in-class that believe inhibit enable inhibitor. XXX in the cell us in inclacumab P-selectin than intravenous dosing. non-sickle safety. program, a to the to it that This monthly which dosed has shared been site more a unique we inclacumab First, more P-selectin quarterly its available will shows At versus allows data binds in therapy previous confidence which

quarterly versus distinction infusion, intravenous III of an studies, for to first very For dosing plan half two in XXXX. pivotal Phase initiate studies patients. important We a for monthly is inclacumab the

study first The will treatment on focus a XX-week VOCs over reducing period.

second enabled hospitalization. separate XX-day VOC inclacumab's potentially for by hospital enable designed readmission potential, on study, indications. The The quarterly are following independent initial will dosing regulatory studies two an submissions focus reducing to two

potential Moving or to be cure plays normalize also that pill. the and improved If organ functional XXX survival in has XXX out provide clinic, hemoglobin function. our inhibitor, class. potential the cell through once-daily red to a blood we in potential best polymerization has improved XXX, to to presented a hemoglobin has the in the ASH, data next-generation GBTXXXXXX At this shows

in three healthy outlook GBT. In patients volunteer points We closing, in and have a regarding data study key enrolled reiterate patients have year-end. by is to cell our want proof-of-concept sickle the I goal to for

the highly scalable living with continuing effective, on and delivering Every are for sickle path this to in we day, therapies our First, safe team and is discovering, terrible leader developing, disease. disease. patients on focused our cell be

commitment a execution of and have strong to track the community. a We SCD deep record

in We the are a to these patients disparities and determine proud suffer. to make difference end healthcare

we become are great launch The been SCD Second, oral will this in has and therapy a the fundamentals believe foundational Oxbryta strong, first-in-class success. care.

long for and global we our building pipeline with the Lastly, term expansion. are

they without impressive best-in-class in have not employees, cure made the do it want every them candidates and disease. and inclacumab quarterly potential, clinical thank cell and to dosing, could XXX data functional a our continued any potency we more contributing bring of day. to XXXX, lead the I passion this two may for and sickle for with with provide early progress potentially We suggesting Our

goal that, We of closer mission call for we'd getting driven a like to to our well-managed be the transforming by we SCD into Operator? condition. open questions. With continue our to and are

Operator

Instructions]. [Operator

the question RBC with Our Renza first comes from of Markets. line Gregory Capital

Unidentified Participant

This steady question sustained? should Thank you that is for notably and assistance doc was on taking our wondering, push feedback Thanks. the of Maybe on congrats right level I quarter. state? positive patients has Xin aggressive. and foresee Lu the program, the which just at and how been And question being for what on we a is Greg. very on support

Ted Love

that to understood getting about Ted. asking you Were is This I question. the we're I the from make want just sure physicians? feedback

Unidentified Participant

from from maybe patients, physicians Yeah, and too, just if feedback possible.

Ted Love

has excellent. The been feedback

HOPE in As manageable of their think to would and patients. it patients were patients you the significantly that health that think and was ASH, the about on or effects I Study. every that of been was know, the HOPE point we that was gathered of quite placebo-controlled consistent side think, related issues, one drug always of GI moderately have blinded actually about after minority reported least effects XX% from status reported, have well in reversible you GI generally I study, terms effects side at improved is had can And manageable. therapy. with data XX% being and of abstracts I the side I a the to it From feedback, was our But that that the patients'

remarks, it's mentioned anecdotal seen So, we've were to these that show patients It's back the excellent to as not that get who And we blinded, documented definitely in work. able to placebo-controlled who've the better. through into patients have prepared just also I work, feel workplace. data unable then, been

exciting for it's I us all news think that's great patients. for and So, very

Operator

Our of with Securities. next from question line comes Liana Moussatos Wedbush the

Liana Moussatos

be us flat would will QX. flat be QX. QX And told now, over over QX telling you're had You us that

since describing what as seems than a worked. attention? were be was going was it, show because more to them it the for success QX But comments? might increased patients it higher you But wondering revenues, flat it me now, that with hand-holding saying that's apparently, you're for days. Just QX to to QX. that some that And Any of you due if higher inventory of – than that couple over were

Ted Love

So, for question. Liana, the this is Ted. Thanks

to I speak some ask specifics. think Jeff the to I'll of

Jeffrey Farrow

of, I in still the new reared we pandemic get were half the that, quarter really we to the that that a team's Rxs. characterize XXX QX, But a more have some of take about mentioned forward. non-routine second helping it if able really in I flat them do think X had We did ugly of there events its would happened QX. quarter a them of couple, move that in Despite efforts is been of you D.J.'s out, have fourth buildup as Clearly, head the you an in was sort QX. days. inventory

quite are we the much distributors expect it, not and where and month here a frankly, the seen of buying So the – first in half do we've as quarter initially.

the Now, could it's than in a fourth change end the but, quarter. rate the towards the we saw currently, little of quarter, that less run bit

won't the reduction a to incrementally in our gross to the of to reversal of we $XXX,XXX. continue quarter. gross the that have of first net to given net And also quarter-over-quarter. We that expect return had impact benefit the about also We move up in

are a to the compares flat reasons QX of those we expect sort So, quarter. as it that the fourth really

Operator

line Alethia Young comes next with Our question from of the Cantor.

Alethia Young

as bit script that to continue to it a work terms go of feel this. as add another guys the small refills. Is see a like up talked they that you about that's it of It's to of through you I you Thanks. going are year working all – there's fair a as on, in do a little through of for bump you to relates your fundamentally? tranche like doctors sort associated And kind add like to perhaps up Kudos script, lot picking coming with through. of to kind little we of demand kind think be the I and in you guess patients? guess of doctors new kind bit

David Johnson

Alethia, out. did see QX We and us that in strong refills helped yes. were

data just course, really And tactics have month, tactics starter our more QX. rolled do national out QX more patients. to field, do of patient meeting think we're course, of we kits, effective the we including there. rolled helping to we many for a XX-week and of this lots we where hub activating We the materials, the the including out HOPE So even brochures, new into our that throughout are had and

So, QX that interactions with That a the said, cell do all this help going tailwinds of is decrease in said, in did some the But between we we help think COVID, that see QX from in healthcare to community and of number have of the patients because that going spike spike. in sickle us. us. to QX are providers we

So we're very the to confident able about this especially past get we grow, once year being pandemic.

Operator

the Ritu Our Baral next line question with comes from Cowen. of

Lyla Youssef

you could have Ritu. would to impact an potentially for Or NRXs when This plan? this in high-touch on left guess remind your Lyla Thank what to is this model? anticipate I of maybe exactly the seeing us model, with high-touch you switching you maybe terms rollout and you. with exclusively using

David Johnson

more last them better and Solution a works had found at to What patients GBT was we've the patients or always need of a encouraging high-touch model we on throughout high-touch year in low they in on the program Source a turned high-touch adherence choice touch. to therapy. one stay model when information and is giving they a year. – The We model the gave do enroll high-touch

low-touch So, just the year. last we've of in at away the enroll end was simply folks with model done the QX initiated high-touch That model. we and

model. in year forward going that patients the will all be So this

to hub. down go SP because the get straight to straight the level some we that our same partner the some XXXB services we want addition, In they or we as to whatnot SP as know sure make well will pushed to patients opposed support. to program through the And

So as some like level also copay and things going be well. that SP adherence initiated programs, at are the assistance, to

expect So, messages, efforts, to through calls, high-touch outbound that reminders, in all year. of patients more therapy. especially we of text first benefit throughout initiating services would this from month phone the these just these is And model

Operator

Guggenheim with Partners. question comes Our Yatin from next the of Suneja line

Yatin Suneja

us gross we And Just I for this for In apologize if should have missed maybe could to much XX-ish then high if if the you you you it. but the you've trajectory? questions reversal, help up? Jeff, quantify What two you Number how can percent. I go? me. net going model can one, how – understand said long is term, We

I update that or phasing, prescription. provided metrics have and adherence maybe rate, little give you think ASH? you us color relative a Thank three in during you. provided in lag more an bit rate, abandonment to time you the on picking update like December Can past, the four

Ted Love

you other speak And the speak some to DJ, metrics. want to you could to net? Jeff, gross the of to maybe,

Jeffrey Farrow

I the think QX, pretty pharmacies we will to start which to the And larger to see when what in just ended it's eligible that increases would model, QX. l given discount the see return have been reversal, place, XX.X% XX%, have tough we'll more of we online, absent they discount that would that when incremental taking XXXB XX%. close come are that's for. around for probably we up think had

the middle end pick I of think range. probably once if pick we we And of expect in around get sort steady-state, start we think expect the the second to year. to So, would to again XX% will we we up, up when about Rxs sometime half to to new that up then

at in it And will of year. So, more move and state, we'll it XXXX, rate. hope significantly up probably a little around steady XX% be half be in will we second through step-wise sometime then the which be the we the ramping as

David Johnson

into hub high rates on those mainly new and from patients of the in Yatin, we appreciably still very range a there in didn't terms start. coming lot wasn't metrics anything different metrics. into patient XX% our being comment converted the QX Conversion because a remain

rate, year, it's at consistent Abandonment we new are within annual well of first-year still we adherence Adherence range the for rates rate. that So kind the still right? successful the rate XX% that XX% at majority We're a QX. of to and products at, are rates in start. again, but remains to well same level consistent, being vast that very of an within been within patients ended converting

about co-pay of us needs, the payer. kind prior the we've we support and start converted times, then And a process, prescription, changes into it's shipment. the optimized two work about get patient applying think time then times our weeks no authorization takes a the any start it to two So, or assistance there. with to weeks. The I for other From

it so, was QX. two consistent about QX at in with weeks And

Operator

Our next Gerberry of question comes from Jason Bank the line of with America.

Sadia Rahman

is Rahman Jason. on This Sadia for

percent can the current as little as more far about as more flows market normal Just interactions talk provider you recently. like patient healthcare wondering detail with in environment if a of a

Ted Love

much what It's would pretty expect. we

cases rise, physician-patient go And COVID that seen that, certainly As we've consistently was in interactions Jeff referred downward. something we've the very to as that QX. seen significant was

you to our that's that do will quite want able that to there a QX. of many in beyond recovery enrollments patients a without we're, physicians. gone specifically the the to significant and you improve happy anything maybe these as have why expect probably even have obviously We we've in be because we been D.J., COVID, there? seeing add frankly, a period hold range, bit So, very X,XXX XXX get of

David Johnson

a our holidays the some was had and QX. engagement in our field list lower than do in that target our QX, that teams bit to little Just with two and QX overall with of

we engagements in addition, about was higher New of about despite like the it able where of York our maintain, interactions some In markets increase in COVID, to XX% person, half board well. were were in QX virtual bit across in shut the were But we're markets And person. where more interactions as lower in it's a our course, doing, other little down. in of

because engagement holidays, COVID. of the the lower QX, So bit and little of on a because

Sadia Rahman

durability just on from started quarter numbers percentage remaining the do for of the XXXX, drug have drug, in adopting who specifically, what patients those early on you cohort on remain drug? first the of Also the

Ted Love

Well, I because think we numbers only really only thing report out one-year you to. compare can really the that's

persistence right, to say, older, likes down, D.J. patients As they die. get because goes always

go long So, if to mortality persistence ultimately the zero through follow you just people will enough effect.

to number, compare consistent with other products. educate have then to, we the really and we So, to one-year to want that, the be number consistent kind you and something look are at when compare one-year to just comparable of

Operator

of Our Oppenheimer. next from question comes Mark Breidenbach with the line

Mark Breidenbach

to requiring trial? sure a label EMA Just from Oxbryta's also wondering label to the materially just post-approval make US And since expect should European isn't the we different I confirmatory be wanted from or prescriptions Europe US new all program XXX the that early of other XQ, ex-US contribution prescriptions? access in that in recorded or territories you those the include does any that if are

Ted Love

is early access no. The non-revenue. program So,

EMA, either. patients not would that we are So, don't with count are All within enrollment are also will The is the US, to And access ultimately we We enrollment that of that paying with enrollment. had, label as of that obviously, work them question in enrollments. new to be as as we the out majority good Even with count a how with obviously enrollments cases, in restarting regard therapy question. the patients interactions an good of enrollments don't but date. we've would very – not children the EMA count patients. early know things

the anemia sickle Our Europe treatment of of cell hemolysis and in requested disease. for the indication is

US. cell wording all So, than hemolysis. the have it's a different anemia Essentially disease slightly sickle in patients and with

but until know it's a not such we to we've question different label, of about course, don't to And the but anticipate it. with of a terribly that does, that on know drug fact. regulatory that, study, confirmatory something no a going happen it you So, is a them in discussions what's label get your in We don't requesting topic. process to you through that had speaks

Operator

Fargo. the line Wells with Our Tobin next Joe question of from comes

Joseph Tobin

you're profile provide get efforts for not then back coming can patients XXX, progress. remind maybe target by taking to the color occupancy year-end, efficacy on us the therapy, translates what's Ted, on have with you improved maybe you quickly, D.J., on how maybe proof-of-concept can the Congrats any therapy? persisted just just hemoglobin who on there? us next-gen patients And data and into for

Ted Love

and transition then start first I'll Maybe to D.J.

So, a of want of genetic about occupancy is derived what from lot data. the kind information you

individuals in but of know lot fetal more of molecule. hemoglobin is the of it's expression we for a a are from a hemoglobin work same Oxbryta, individuals that ultimately, that we find or modifying relevant And hemoglobin XXX, hemoglobin. normal sickle is did hemoglobin, we initially as that with functionally XX% molecule example, fetal essentially persistent introducing their when with about those For

of be sickle in at showed for the in levels The of range. disease mice sickle targeting were similar we cured that being XX% modification, data actually was, we'd showed looking that fact, ASH, modification. essentially cell So, which about XX%

cells then maximum be much on So, effect do And kind And raising things how hemoglobin. looking be for regard on essentially occupancy. the like of elongate we can think would the would cells expect we reaction, target. their functional-looking right to you we likely for the technology what the and maximum at stress. the finally, data, be hemolysis the showing We'd that's to effect a we're at them, to looking flexible in proof-of-concept also are, with how LORCA some using oxidative look to

of looking So, some functional we'd at data well. be those as

David Johnson

even out them office up somebody way to different continue if before said, first, really missing a to does doctor's of discontinuations, course a a we That patient classify missing the discontinuation. would follow-up the encourage calls. don't them. a discontinuation as and weeks over the four on on still based approach to them someone classify Regarding reengage. we and from mechanisms. by wouldn't phone We support Educating reach of to a as someone do give and we months lot shipment background, few We of discontinue,

reconnect. GBT Our with hub does Solution engage Source to patients outpatient outreach to

and patient. is and on in in talking to we staying advocacy team of them lastly, the to touch community, educate have advocates we the and with patient partners Our engage very are trying And the very engaged with importance that SP a reengage the strong the therapy. the on community

year. four that ultimately we've found out mechanisms, our successful. those been have restart. we About We and of So, XX% discontinuations throughout last

Operator

comes Choi line Goldman of Paul question Sachs. next with the from Our

Paul Choi

question your to Let as your congrats guess. progress regard with to well. My is I me add efforts, commercial my

you the the As your feedback, it sales are in addressable actionable payer the you what sales regard has the think recent term, get levers been which the rate do patient abandonment just the force Is maybe funnel? rejections? I Or payer of you. your do and of or rate guess XXXX, there, top the with that payers? to sort from by force? coverage at of it's and near most on think over feedback by course Thank coverage part of you last And

David Johnson

the think is on sales focused force I funnel. very our filling

use and So speaker example. that with enrollments We for educate trained month, our lots and We this XX% just going their on. in always an new to are materials them and physicians go on network where is biggest for driving our of found to through demand. be increase had program, speaker physician impact incredible attended meeting a out

So, We're data patient going have we're then and helpful. that the we be share we're can the a support increasing now increasing we kits, amount our that very speaker programs. are XX-week to including distributing, of materials starter information

the of But So, don't field driving enrollments one is for name the our force. team. we sales game have just

medical We payer an a and team team navigator field-based team. science also have a and access

working to also channels all they're patients. within So, support their

making on of sure Our are the best starting have patients staying therapy. navigators field kind are out and our GBT and team don't that access chance Solution are Source therapy of engaged discontinue and

focus impact that like on. will adherence. new they with their their materials, think And things to what be that's is abandonment So, and we able

We're the job. that. done focused great payer And very a there. they're So, done has on team not

We not there's But XX% coverage, have still not always it's perfect, we're covered right? XX% and that in.

active, with very So payers. they're still engaged

out educating payers And daily we're for very, a next do but we been very caught our payer coverage have early aren't still off payers team active very payers. labels start year course, good, our excited guard to Of there a with the picture basis. expansion the payer of on conversations pediatrics that. teams make can has that planning about very this and We're with sure those into

Operator

of with Morgan comes question Stanley. the next from line Harrison Our Matthew

Matthew Harrison

I picture. guess assumptions sort just the for I demand wanted to your confirm underlying of

it headwinds patients, of them, overcome like one-time a a get marginally. to handful underlying demand quarter. You've actually sounds But expect highlighted picture I obviously into the but to for better realize heading you bit maybe first the

you a that on thinking half? second the could you So, of pandemic that and the two comment you're how there's the sort over just think significant in relative pickup quarters to next about before

Ted Love

the is obviously get out We as prescribe the to we've that even infect not to them. really to with the up is the cell or into getting mass likely world prescriber go a down country think they sequester country that biggest able have infections of the to challenge and don't afraid people the and the been could patients are the be off higher infection rate community, and saying interact that be against the get more And sickle to out on home simply that venture that transit to are they interaction infected. it's their safe I'll in know going and in start patients people and feel at in medication. an by relax could with and

anticipate So, whole that's much hoping, less in I really the don't that the the country the that a obviously, more getting going think we in lot and of year. the year, concerned feel to half about very first second to We're interacting COVID. change of begins half about comfortable

issue. big the really that's So

Operator

James. from of with line the Danielle comes question next Our Brill Raymond

Danielle Brill

of surpass the and Do release can you've in to back you this community? into you half press how the think recovery your then, you if the signs some levels first still of to new vaccines sickle any follow-up a in over Thanks. the that question. as time. commented cell improve of the curious, early and from And pre-COVID guess the that part one, get insights ramping second also you have tracking just things are year your year within is pre-COVID I last the prescriptions to seeing expect pandemic, now levels that are we're

Ted Love

to quarter hear about that hear Every what's going about and day, idea really to I commenting because of we things the no with one you and is news to just really us, all tried think on strains. one new have the of we've on. listen restrain to We COVID. go we going reasons ourselves ahead

by much we're we now, right seeing in try on So, Based QX. we'd really we'll out predict quarter. quarter what able than don't rather be think not do more and really enrollments to get X,XXX to

for We we XX%, strains. very just people that to into in and going As us feature we what's future as that to get, going have to get into will behavior lack to getting QX of to and vaccinated, to much the but happen of happen to can to try the exceed think you as with want give really, XX% be confident we new feel insight will really we difficult what's that's we going truly the back we with really, driven Danielle, sight that really think change related far predict these make COVID really We it's definitely dying. to anticipate but by enough out. of country do performance, progress, don't the fear getting to

Operator

Our from with J.P. question next Morgan. comes line the of Matthew Holt

Matthew Holt

if I'm trial III a of we one can status curious confirmatory me. get an on Phase for for quick Just the update the Oxbryta?

Ted Love

I enrolling. of long tell a dying risk somebody's in can if have for them Because benefit. They really enrolling. patients trials to you not opposed a in aren't orphan are COVID front longer-term a less that's trading particularly diseases, of they benefit cancer high all when these they're as get a survival reasonably I of, certain, six know dying the off of next that months,

blood clinics So, it's for risk getting and to draws difficult to these come visits sickle and very, cell hospitals and COVID. into patients very ask

enrolling. up. trials great that getting not We we've of job, however, a these are the really So, think infrastructure been doing

to sites those the COVID. want But to really a spending we of responsible to TCD, around anybody dying for been to be remote to time really children example. educate we're those example, high-quality learning not sites world bring making lot for of wouldn't trying we've in So do because sure get doing for we're that well, really the

Operator

of Prasad Blair. Our comes with the question line William next from Raju

Raju Prasad

how are on, a taking any sickle what Thanks. in launch, the cell given learned kind the from cell given those how Maybe thinking your earlier, them? is of other just but as think, one EMA world? engaged vaccines I about launch with as noticed into the going sickle Have the of vaccine the groups, community, age community? distribution was follow-up that COVID And you you've asked you well with with the US how apprehension

Ted Love

D.J., after I'll and you question, can take that. comment vaccine the

hesitancy by this relates know the read. I in there the in the lot of as historical So, absolutely vaccine as what probably around communities. know about you on And it's actually system. an well to and I world mistreatment of healthcare that a that And based highest is minority issue country things

great are the told be vaccine. it's group, So, vaccine but it. hospitals, as not lot that to certain could guinea exists. I been take XX% as some XX%. this groups. of has this because don't is want pig. a many of XX%, how in think, high been I not individuals better It's in in I've willing been to one that, It's to the necessarily the do get I high to as by rate as the don't any first however, major be declining get much want the XX%,

front very hodgepodge offered have And So, just can individuals vaccine. these recently. sickle for vaccine may of think don't been take not eligible want I around cell the also They the many the may even to in rules of in many the until that California group. have come to I around who's even today. be vaccine you tell we a patients

it's in conclusive. just more communities be the But say your it's it's of think real But probably days I would even community. acute concern. not about color. early It's cell sickle question vaccine So, I to in a that hesitancy,

Operator

Joon comes question from Lee next Securities. line of Our Truist with the

Miguel Coelho

question. Joon for in Thank Coelho taking you Miguel filling our is Lee. This for

based of on trial readout numbers improvement, from here? but to patients tenfold additive other LentiGlobin to could there the to numbers VOC? the for higher you had increase patients that for is X we in tailwind the So show then, Any the higher any clinical bluebird be And happened? of information patients why is improvement the expect two Oxbryta this XX-week to pause? started analysis And the for gram clinical show what as hemoglobin,

Ted Love

But VOC that VOCs, quite that's rate lower me hemoglobin hemoglobin up, the One is showing a but That reason there going sense the VOCs, hemoglobin with with although me never of you because leads the preventing in which what more the is which lowering is What no on your the correlation raising hemolysis, goes, primary to in the seen been we've a because before. lowering the let is and ways. there's of goes correlation been and So a to VOC. try hemoglobin vascular that perfect up frankly, to Oxbryta to seen Oxbryta. are not few makes that seen has and really is the ordinarily, with is inflammation data disease, we've question raising touch between cell problem leads sickle exception, Oxbryta. that

you the quantitated really haven't from where I patients But very, see look actually We XX if curves think had with above low can very go VOC abstracts rates. it. hemoglobins most ASH, you and recent our at

probably demonstrated differences. know raise we your that very super take shows or data a Differences of shows damage, in hemoglobin, the doesn't that grams to regard back declines. your stroke. would we increase that And damage powerful refer ASH ASH, big as before, we've of issue, kidneys, small hemoglobin to not broader also your lower back major So, of other your ton and X.X at you would your With your other outcomes. that the predictor multi-organ X.X, to was your TCD it to per but data significantly TCD to deciliter I hemoglobin, the CNS one infarct where meetings. as presented I this encouraging. decrease a you that go having brain. We've past as And year, demonstrated your a rate risk of that is your the damage worse abstracts

the it ton go that hemoglobin And a raising red wealth is disease to of of we cell rate is hemoglobin course, this be by very through is really destruction the the there's lowering there to shows benefit. due but the a of US. that data likely So, basis kind and But call. of on in the low data, accelerated the approval a don't bad to was of a have thing all that time of

Miguel Coelho

trial And Oxbryta? bluebird to pause the readouts the from

Ted Love

probably I you at bluebird? don't [indiscernible I for to since you bluebird. – work not what bluebird bluebird. are sure XX:XX] asking readout from what am liberty Oh, not about I'm

Miguel Coelho

Just would road. pause might to be expect therapy the targeting in a therapy I this that for due about down cancer the gene indication? cause same will Oxbryta trial the tailwind the positive that gene concerns

Ted Love

on it's to because reserve and get tell bluebird. level, options just for team I'd been outcomes. question at patients been you, and for a for patients personal to that has I with think dealing Nick me our painful They're for more a I his situation. obviously goal can great have

I know this working sad through. So, of poor that the some positive then still in they'll are through But to it's And watch way. been and a kind outcomes. FDA get hopefully, bluebird

Operator

next line question from Catanzaro comes Sandler. of Piper the Our Joe with

Joseph Catanzaro

follow to bit little want question, I on up a ask but this a maybe differently. prior

when So, Ted, you to see I think prescriptions need you in And growth back business. X,XXX XQ new the the at predict meaningful said that you've in to in least in should we to saw growth? get past the But get keep understand sequential when meaningful to I still benchmark think it's difficult back is might that the we mind very there. to about that returning you

Ted Love

big. not variable and interactions start last see only and healthcare numbers, has community of professionals. we sickle greatly affected The of course, big to them, quite has which on to with this year obviously if I here tragically, QX are cell is the you back that's their really, is their COVID. population Oxbryta. tragically could The is vast And between the get majority those would diminished of today growth thing The pandemic, different think be robust.

a So, your safe there's QX were their begin to leave they they'll once like we're that in homes, to behaving these very that last will perception behave bullish and of home, leave patients it's year.

Operator

line Canaccord. Newman comes next Our of with John the from question

John Newman

curious you a going could prescriptions sort might been if First is is question, way potentially just tell – it which such drug time of question going mail-order of sickle us long forward time they heading but DTC a prescription? it order? cell last approach a been also, have broader where encourage D.J. GBT question Perhaps, consider consider. you to prescribe that I the was like possible is that is via there a And quantity for it be that just out can Second to a you for it's had of an are disease. I D.J., kind a there wouldn't any that long, would larger advertising? there targeted seems And since patients forward? mail therapies haven't have would percentage just for I'm some maybe that's that of

David Johnson

because, but we exactly questions, programs. just perfect yes, thought have DTC and about didn't I plant John, I those they're swear targeted

a lot people. have last of DTC through year year of first really which web a our We websites now, this to the bunch because in and right seen media of digital targeted second half dramatic traffic lot we social We've it. includes example, for increase, going that of a on a the half of driving in initiated of

the at looking There's media with that's use So, very lots of you we look as it DTC, one form of of everything. but and targeted, proliferation streaming that can know, we're television. at, be whether

out-of-home TV as before, a on radio could You like now, and very and cost-effective way never be well. in targeted you can

And year. more have announcements all at I'm that. later So that we're looking we'll this sure stay on tuned.

our Regarding mail yes, actually mail prescriptions XXX% order, of are order.

our door. of to right are shipped prescriptions the patient's All

So, go any through channel. don't retail we

We a That's channel. have and closed small channel. tight a very distribution

So we relationships right get with all bottles partners, tight very SP house. shipped have the our and those of patient's to

guess, XXXB up program. I order percentage their small institution at their through to a of is, can there Now, if decides their that institution patients pick it

ship specialty to but patients more and decides really So, The But, a you let three order, that we're expensive there's payer mail of access of that. rare percentage that's in the happy the do mail payer. it orphan of rest controlled payer bottles quantity by drug. the won't order. John, are a And terms a that yes, usually small of way,

you in to send uncommon sure that was they manage That out-of-pocket, and it's switching contact approval said, to a to beginning anyone them wouldn't that around than single that to sure to we get that and talk more could insurance, therapy. make proactively of gap wanted highly did about make their co-pays bottle. we for our patients the we the So, year, so

ship did the advance sure program didn't during free bottles to our out through drug year in we gap make some patients some So, there.

Operator

over Ladies closing questions I would the back turn management like floor gentlemen, further to comments. and are no time. for there at this to

Ted Love

today. simply safe and to I'd encourage any additional all healthy like to you. to close to I by and everyone stay if for us reach have also out you want you thanking joining wish you Thank questions.

Operator

This today's conference. concludes

Thank You evening. for may and at your disconnect liens your rest enjoy you this your of time. the participation

Global Blood Therapeutics (GBT) 28 Feb 212020 Q4 Earnings call transcript