GBT - Earnings call transcript Q1 2022 | Global Blood Therapeutics Inc.

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Operator

Greetings, and welcome to the Global Blood Therapeutics Conference Call. At this time all participants are in a listen-only mode. A brief question-and-answer session will follow prepared remarks. [Operator Instructions] As a reminder, this conference is being recorded. I would now like to turn the call over to Steven Immergut. ahead. go Please

Steven Immergut

of welcome company's and and Chief call Commercial Farrow, Officer; Vice Kim Whitley, conference to Immergut, call provide Officer; on and me Relations. Thank CEO; results to the for our the Head President and Steven or I'm financial Executive business XXXX and the discuss Investor a With of Dr. you, Dr. update. GBT's Communications are today David first to R&D. and Love, Johnson Ted President Jeff Financial Chief Head DJ, Smith quarter

today's update review in During Ted call, will the our Ted results, discuss financial Ken an will give will then on our Jeff launch, update and on give Oxbryta QX, before GBT's financial quarter DJ an and the progress our few the afternoon, ended will XXXX. will open March this Earlier for remarks line results announcing issued questions. give a release XX, first we a we business progress press for closing pipeline

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

Ted Love

and Steven, you, good afternoon, Thank everyone.

was promising start in the been the early highlighted feedback start on have patient The first quarter including to pediatric growth launch Oxbryta, for XX. to by a ages launch GBT, our notable prescriptions metrics a year to sequential of new X strong in and encouraging. The

we indication. many For patient important example, ages In with quarters. several expanded XX for this payers prescriptions and best we've secured result already for coverage new older, had in our

will if our We that growth awareness continue drivers interest in are increased Oxbryta this optimistic momentum overall as key we expect. and

given continue improve the SCD. respect addition, environment that headwinds we of for COVID-XX care has to the hopeful will continue to caused we In significant make patients exciting delivery with With to progress. Europe, in-person it regular are for

Britain completed program. France our in by put kicked authorization for reimbursement and activities track for Great potential approval us continue patients early the enroll Oxbryta and access Commission a on Following mid-year. regulatory we discussions the February, in marketing in England to to Germany, in European by We off

for in June. launch also meeting activities EHA HCPs and and educating robust very We Oxbryta began have soon the on planned Germany for in

targets advance During clinical and our additional the while SCD disorders. our other red quarter, continued aggressively in blood therapeutic programs we exploring cell efforts to

are for interest. call, And exciting continue on plan positioned to clinical provide on SCD. GBTXXX, Altogether, well the Kim patients based in X study to of by update an For will trial the X/X delivering restart later Phase we our a patient initiate we mid-XXXX. with Phase

most are build to and advancing pipeline comprehensive U.S. sickle we the in Oxbryta is and internationally, the in continued both disease. cell believe momentum with have what We we

dedication our to with in call ESG progress are published these Our SCD review XXXX the other report. highlighted XXXX and supporting Jeff never the to quarter efforts our the will has recently over turn and results. first community stronger, With been to that, I

Jeff Farrow

Ted. the Gross the at the end in of of These net on by to increase quarter. inventory year accruals quarter, sales from million in first were the Omicron from following of quarter, increased as the offset higher XXXX, for out-of-pocket for in patient million quarter. was historical Total increase guidance Oxbryta in the our the from end revenue hand gross purchases commercial well line quarter support the by of the drivers with sequential patients reflects you, for partially the increased as year-over-year. declined increased of revenue distributors was and the Thank in work the million patients XX% fourth net anticipated On to days the part fourth the revenue by XX.X% of for net first basis, and net million; related XXXB of first X.X% new slightly was in continued of to reset co-pay of fourth approximately an $XX.X of $XX quarter. $XX variant first around inventory to insurance impact incremental a quarter levels. first This Oxbryta, as number primarily on increase during line deductibles with the down quarter at Medicaid the quarter $XX the quarter quarter, or

$XX of the million compared for begin per $XX $XXX,XXX same XXXX, in our for was recorded as Net share XXXX. the and we XXXX. expectations of launch million be increase Now recognized Both of for expanded was growth, million turning for of a first in due per and slight by with first was our affairs related quarter quarter the loss the that first the for compared million GBTXXX, including decrease quarter Basic offset was in million same expenses period outside previously with expect in later The decrease quarter, $XX the $XX and Cost costs to for operations $XX net $XX we medical diluted first primarily U.S., related $X.XX in first and XXXX. offset primarily a share partially commercial in expensed increase compared period readiness non-cash period was in of external expense. loss for inventory costs XXXX. the $XXX associated securities to share the with employee-related for for sales Cost compared primarily sales the services due increase expense quarter of pediatric on end of professional XXXX. $X increase percentage supporting a represents the of $X.XX partially We expense certain quarter was R&D now to operational expense. costs an Oxbryta, the the first million due expense R&D for compared by at The increased in to and in million and of geographies external the increased launch a SG&A period basis. $XXX R&D first stock Oxbryta. the million U.S. increase with to R&D per with million the which XXXX. quarter for same expenses consulting utilizing in to as quarter compensation to SG&A anticipated expenses. our below in that fully is same to was sales equivalents remainder XXXX and to were finish the compared with ended the in with in was the to marketable cash, slightly SG&A timing cash in

to in anticipate second range to of revenues XX% of the the forward or we million $XX quarter XXXX, Looking million XX%. to $XX sequential growth of

in We expect expect our driven this gross pediatric weighted And this coverage. results of timing an expect to line expectations new in will by quarter net remainder by over we be the which in and prescription increase of the that of terms the and revenue new with growth grow quarter, more be our back-end summary, payer year. partially we the growth, first In will of including will phasing first were broad prescriptions. was offset in

allowing the to be a to In that, over And addition, key now DJ. positioned balance growth. call for with continue make investments sheet with I will us well continue turn future to we strong to

David Johnson

good and Jeff, afternoon, everyone. you, Thank

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

got off pediatric older demand with start delivered We more awareness of our quarter, were leverage providers by new prescriptions. original Oxbryta XXXX. expansion formulation Starting pediatric driven train was years and from them growth building on strong and strongest healthcare early from quarter new launch two label since to of in launch, new the than the with the quarter. pediatric the the and we incremental group. prescriptions a to January. to We and during approval in our This administering the First, education on QX the XX to quickly engage able X,XXX

an excitement, This engagement overwhelmingly feedback and from prescriptions the of number early been in caregivers, Our has job among this and team building new is positive. excellent did reflected in particularly high the hematologists quarter. pediatric

therapy. eagerly many expected, was awaiting the quarter have opportunity early patients part in start strongest physicians Oxbryta of population in the when uptake the pediatric been the to the Somewhat and

many As some a ready after prescribers initiate to existing had patients result, shortly younger their of approval. therapy

January, we terms and from caregivers. by some SCD In in COVID-XX, reflecting impact see Omicron patients caution did of continued

we HCPs in access start patients to to and of did indicated in-person research health. COVID demand things SCD to care that quickly cautious trending are visits Feedback some that our caregivers comfort most heard indicator Anecdotally, year. our February our routine from were more the February However, appointments team saw improve care February, due and And for market as declined. volumes field field the care. teams good to research. surveyed engagement conducted what in dynamics preferring a majority patients in-person health risk in with for infections March, back bounced February our increased their to is with increase likely normal their be team adult that levels This in this in-person. leading market ongoing causing supported patient shows from and Similarly, we back for headwinds

ASH with and all hematology. pre-pandemic trends expert turnover at continue sequential contributed from new look net side, the staff office along levels. claims XX and SCD that patient see the older shortages. our and growth the group, in offices remain On we was We year effect we of QX, of to momentum real-world HCP the provider when data at presented visits review age the DTC evidence and recently in last to the for prescriptions published these And in believe to below

the from also benefited and targets the that the range launch, age of pediatric We XX older of engagement believe given a segment majority groups. around our HCP treat

We and relatively long-term the QX patient environment polymerization from such also Oxbryta, are prescribed has continue baseline recent health. those closely through uptick burden increasingly of remained suggesting and of characteristics April, that COVID though to VOC broad see watching the a as recognize the for we hemoglobin in prescribers addressing The range mid importance stable are cases.

we reflects not continued that that Assuming first improvement offset with slightly and for be the second strong patients flat This the lower escalate, quarter. have start group. in prescriptions incremental the anticipate the Oxbryta, older new COVID pediatric roughly in XX by will prescriptions quarter following waiting compared impact to new been does

If the indicators our a the care growth growth improve, The to quarter-over-quarter to year. sustained pre-pandemic new continues second to accelerate launch. ongoing returning return the new-to-brand key leading continue the real-world to by believe pediatric and in ahead to the industry-wide are levels. publish of campaign, patients' we that driven health the data as prescriptions DTC we we predictive half and that our Looking improvements visits potential see environment have of we to

While we we occur, this patients are cautious. know remain hopeful will SCD

meetings virtually. focused For example, the the all place year SCD organization taking the for of planned community-based are second half

awareness to The new from higher several working to potentially the care exceed In target campaign. to around the return the face monthly metrics interactions engagement. patients, ability which aided including to believe approval for overall targeted health patients with campaign our Oxbryta our face reflect original we SCD their DTC the a continue ongoing through providers, SCD we an quarter, updating As campaign to of contributed to to improved audience raise we reach prepare by are to goals. first frequency this was pediatric and more tactics,

all-time new reached we first an and content Visits addition, our high In Pandora launched SickleCellSpeaks.com, and and YouTube, branded unbranded to oxbryta.com channels, the on in quarter. podcasts. including

number the of in growth DTC encouraging within SCD seeing our of patients month HCPs are one also We visiting advertisement. their seeing

of about which compliance prescriptions for and quarters. recent and of conversion Oxbryta the prior patients our continued adherence, year persistence think in new to trends, Similarly, consistent was for rate range prior the within quarter’s the therapy, we with As includes first be analogs.

more gain on some data have lower we one adherence adherence that chronic analogs. one beyond, year that and better to trend for for be we patients would continues seeing as and expected beyond SCD we But are adherence compared year in Oxbryta As encouraged restarted two to and any are Oxbryta, year than medication.

aimed patient an In our, proactively includes hub Source GBT and important driver long-term at to addition, tactics additional continue improving including overall a out adherence. continues we patient of adherence. Solutions, adherence, be to This engagement through roll new services which

around end the and messaging are specialty offered available also pharmacies. these have XXXX services on feedback shows those that to of that that better patients services launched the And data These engage Source encouraging. we not. email patients with newsletters via do than adherence or GBT For by example, the similar rates our the mobile been has early partners,

So these of programs. utilization we investing and driving continue plan to

second metric, penetration. my Next, provider healthcare

quarter. the with the to the quarter, the the to lower prior Omicron group pediatric entirely and from highest of variant. January, focuses impact was active increased with new that see Against several we includes last of quarter, they in our reengaging XXX several on long-term for which to fourth the in the around launch. was despite the impact trajectory new our targets are prescriptions we with backdrop, as non-specialists, And pediatric the During interactions of variant compared the during by HCPs the month of salesforce prescribers XXX XX% writers, writers prescribers prescribers the breakdown the which XX the specialists patients of and healthcare to improve continue continued interactions and in-person new months. launch written March of positive This providers Delta lingering a XX at from launch. for almost number prescribers about significantly the Encouragingly and for visits we added have reaching due is for the This believe quarters, When we on both total holidays added quarter. look the for being the we trajectory in younger. long-term momentum trend this

Turning the payor coverage.

with broad for have for coverage easier XX focus We receive it older than lives, continue the United more in to to population XX% prescribe having is of and physicians on payor our and patient the coverage patients access making to States. Oxbryta. And

did terms and achieving are of we population. group, of on adolescent to eleven mid-XXXX, our to goal than and by broad substantial way for coverage the made age we coverage faster In the well progress we with four our adult

our also Before turning commercial to update on want brief the call activities I over provide Kim, Europe. to in a

across February, UK. in And Germany, to working our early approval Commission participating programs in access European We we than patients and Oxbryta launch our are France, mid-May. following are XXX Germany gaining in with more experience in the

open have in sickle we pricing we the first team year will anticipate also be negotiations leading are our for in England. cell begun will negotiate There Separately, around while for future XXXX. gradual and in We and Germany reimbursement to Germany, France has reimbursement. Europe revenues minimal XXXX patients in adoption

our plans physicians, Oxbryta presence first At meeting including for in EHA and the an we the with Oxbryta, on Hematology branded at [indiscernible] Association program. including EHA promote European or Europe, in physicians sponsor time Europe, educating to June. begun for have We our engage plan educational robust in

pipeline. bringing clear that, Europe, Oxbryta We our to achieve will where was employees are GBT it talk excited patients developments meeting to with the helping our also the And and launch in our mission about successful that world. held a recently around about internal now Kim in

Kim Smith Whitley

Thank progress you, reach, and On today's and expand on an call, I our to provide our pipeline. geographic DJ. And efforts afternoon, evidence good further our will update clinical Oxbryta’s advancing everyone.

Following we potential submitted in Great authorization by track February, European Britain we in are believe on for our in marketing Union on approval approval midyear. regulatory and the

of was Oxbryta scheme UK approval the in granted access reminder early provides key EAMS, medicines which a advantages. two As

can access that First, gain eligibility pre-licensed Oxbryta. criteria patients the to early meet

through We already designation. Oxbryta started are on pleased that have the patients UK EAMS

children Second, England as will as under by MHRA, with Oxbryta medicines that Hematology/Oncology NHS, the Study. X of expanded at were the at eleven. Those as access in safety in the positive Society were authorization of we last from patients, program commissioning. American first and HOPE-KIDS these HOPE-KIDS cancer. the presented present April the Oxbryta by from and In The EHA this reinforces with results sickle NICE, pediatric well EAP marketing four results disease, blood pediatric Conference, hope the seen assessment or receive EAMS and published data treatment accelerated efficacy cell for a in age X ASPO benefit Pediatric support to week this year launch of

majority deciliter new announced that we activities. month real reflect our will excited our data. efforts to about a meeting meetings EHA present want this the change EAP experience the plan in several the mean hemoglobin I Oxbryta single of treatment in was and patient XX-patient, Dr. study positively in quality substantial life of showed increase Anderson improvements as which that scale, new be April June, Dr. center, clinical later Alan the generate Journal by a other patient that data, Importantly, published Annual is At per global two this are Hematology. had planned real-world measured to in XXXX. late of of of indicating in and flag European their grams and studies improved world to impressions presented from scores patients Oxbryta, data also of the lives. Oxbryta at abstracts in and we impacting EHA Anderson

the Now let's to turn pipeline.

dosing. period enrolling inclacumab's Phase on we collectively THRIVE. of named would inhibitor, are a visits. believe reduction a is compared to P-selectin evaluating be monthly VOCs practice One our in sickle this inclacumab, dosing aligns and quarterly meaningful schedule our patients cell treatment disease potential quarterly We X office For a typical with for well for over patients the improvement two XX-week studies based of

evaluating experience best-in-class an is with X hospitalization, of and rates, its tragically VOC, initial study profile This who in XX% readmission inclacumab's around The patients VOC. VOC Phase by occurs following study other an enabled potential. initial is which aligned XX-day

on enrolling to are as focus We as continuing THRIVE possible. quickly

GBT-XXX, X a has new we preclinical best-in-class we polymerization data more this data December, EHA, later journal our disease share we the At from aggressively be therapy. to hemoglobin aim GBT-XXX, believe potential patient peer-reviewed advance to study. on inhibitor next-generation levels aim sickle are EPO Phase to a data Separately, year. that on GBT-XXX. Turning cell we to we at including GBT-XXX to ASH Based working for publish in in impressive reported the

X/X Phase Our trial is submitting initiate full a plan clinical approval FDA. with the regulatory with of to for goal a

We design to to expect X The purpose dose Phase into more X optimal are portion portion Phase of and Phase X pivotal X. the mid-XXXX. working us goal to Phase quickly towards by portion is X/X the into the initiating of advance will our the allow identify the Phase advance

increases, to we they and explore higher higher the a individual. we health and cell sickle red will resemble trait As blood of consistently that doses, cell to importantly, improve believe patients lead of hemoglobin occupancy

our with dose of We GBT-XXX X exploring Phase XXX-milligram patients a study. are from also

and is trial to higher We In all opportunity site wanting we experience, for of progress the of receive cell available time the restart GBT-XXX, with therapy, data I will over end the in patient the are ASH key restart be the reported the due dose. and clinical of of am to we same and study the us include timeframe, anticipate by year the now our maintenance six six portion to making enrollment the drive the turn my the as endpoints at has inclacumab sickle Oxbryta are a reach and data providing proud a daily while in out have very explore short this December. patients in firmly to excited this restart first a the Ted. GBT to continuing from studies our XXX-milligram weeks. leading study We I Patients over sickle a study to cell it pipeline clinical I'll demand. believe programs back disease. studies. will I advancing dose seen that also

Ted Love

to Thank strong a you, we start Kim. In XXXX. in closing, are off

our for and Oxbryta the Given in multiple, we in pipeline, the and quarters provide are new which confident coming increasingly progress, growth our outlook opportunities years.

we and increase upside For compelling our through believe ongoing efforts, awareness additional anticipated including visits. with campaign, raise data pediatric Oxbryta, new And our our prescriptions are DTC in-person many launch. and have as the in we clinical improving patient our we

potential to to by expansion add in invest in continue with UK, broader another afforded European the France Germany, also over opportunities goal in commission layer the potential. growth recent near-term We approval, Oxbryta’s a the time to of

in multidisciplinary in lifespan is as federally with on of terms is that matched modeled sickle are disease. coordinated centers, we innovation, cell support want our broader hemophilia a or On R&D that to goal view several the In centers. is support treatment new would XXX across this to offer funded living for The diseases. of package that GBT of other provide note, most per the $X of five would cell $XXX questions. In fund The approved the individuals federal legislation million also communities XX network SED to With the the to the impact community far for organizations the is next cell is summary, treatment well funding below help a we positively we’ll Currently, from is comprehensive dramatic update hemophilia. law, SED pipeline which well Americans year, to ways, positioned about potential positioned XXX sickle disease into funding for this several years, Operator? will for families, facing living This million the in community-based SED. teams comprehensive after in be of with we disease. including our the increase with sickle legislation commitment clinics supporting we that the multiple federal orphan community. call by to care funding the years. believe leader And a have that, patients, what legislation medicines least total the the goal to opportunities clinic. over of brief at we I SED provide in would and This be piece cell funding legislation patients provide serve. sickle lives signed care with most are If open

Operator

Instructions] you. Thank you. [Operator Thank

first proceed Our question is with question. from Ritu Baral your Please with Cowen.

Ritu Baral

that is sort trying a in over, the have to guess but a guys. continuing you if increase net I’m I Good of out the I on of a that growth numbers seeing the sort to afternoon figure NRxs Thanks bit over follow-up. for NRx quarter? the April? quarter? wanted April. down I is any And little what more the in distribution bolus into drill And question. Can taking pediatric of just there you’re was then maybe confirm across color into

Ted Love

answer DJ ask Hi, Ritu. We’ll This is Ted. to that.

David Johnson

you, Ritu. Yes. Thank Yes.

we X,XXX new healthy the XX see total that. also consistent seen up QX not patients So, of we the you in in we have have enrollments, growth, the top over expect, – QX, only of with Oxbryta increased. seen line And indication but would at net QX QX, did enrollments some pool new we’ve like in went patients increase in in pool of on has every Oxbryta quarter, course, patients as just because on over an

about results. since don’t haven’t talk QX. here have approval demand pure with ago. QX perspective to lot strongest first not about performance to quarter quarter our But – we’re years I that. a So, It’s from two of we’re a in the certainly pleased overall talk the we

Ritu Baral

over. what you that pediatric are much anticipating guys the And internally? is bolus Is pretty

David Johnson

I my in in to was see early prepared part comments QX. strongest convey of What the we enrollments tried did that the

treaters patients. have of we done all pool the pediatric fact, years, thirds two the on in of that And educating two many of prescribers ones that in of were years – preparing market, the they for already that because course, two calling work signifying So also we’ve the are Oxbryta. on XX-and-older for

they got to yes, So we patients go right ready when approval. had

that why And make for was sense months would that strongest so us. that’s the

we’ve we past gotten kind of think yes, So that.

Now, going we’re of more moving consistent of from forward. to expected number pediatric group a the enrollments on

Ritu Baral

a And be quick will on dose study? Got what’s you of Thanks. the a just loading it. be Phase then this And investigating strategy doses? pursuing in follow-up again you What sort range will GBTXXX. the in Xa doses of

Kim Smith Whitley

it’s of and Ritu, daily are And with maintenance to MAD dose loading we what a we will did X milligrams. phases. be Hi, the Kim. to then Yes, be using X X, going we a MAD XXX similar pursuing Phase dose

Ritu Baral

In the Great. Xa? all Phase Thanks taking for the questions.

Kim Smith Whitley

to that’s for the clarify, was Ritu, I’m follow-up sorry. for X. That So the Phase

we the for a disclosed X know, Phase not because, using have We finding you as Phase dose are for X the dose portion.

additional Phase So that’s just with X what’s going to on the restart. be going

Ritu Baral

Okay.

use range in determined? that going be that, doses that’s you’re to to the of so And

Kim Smith Whitley

going before above looked consider in milligram or milligram at least we XXX are will doses based explore doses on we to whether the our explore, doses Phase and we So, and course, that a at, of that. decide we not XXX X

Operator

you. Thank

Bank comes Please America. your question with of next question. Jason with Gerberry from proceed Our

Unidentified Analyst

for question. Parry wanted to This the line the get some Jason. additional Phase on is on detail Thanks taking GBTXXX. for X just reinitiating I trial the for

an have question. First, then is know in about And just spoke start other patients one I potential when the the patients, when six of Phase that number a could and to X? you dosed we – will expect a update I get there patients for on higher then getting but

Kim Smith Whitley

anticipating the portion. participants, are we Phase six, the but restart not six X are to hopefully, planning participants to We all on new adding

Unidentified Analyst

more you’ve in Are on states then coverage. gain then one give know you any a of sickle to these just helpful. of you. number. Any that XX breakdown with patients? curious, disease from Thank concentration able XQ I’m discussed key And cell high the states in would have detail And geographies? that this versus for states of you. the be I on Thank NRx Okay. the NRx? terms Are teens adults

David Johnson

Yes.

by breaking Regarding the NRx NRxs, not we’re age out group.

sickle matriculate the with time cell patients Our category goal will The over the these and is same overall drive pricing in that we know patients XX-and-older above. adoption into is to and four anyway.

dynamic is mind keep the largest population going another by the that So to still patients. important the going is largest be of to forward. far group XX-and-older just in It’s of driver growth

think just demand. every the enrollments driving quarter you So, on best gives reporting we’re demand, idea overall how we of overall

I that’s forget where we’re And piece. at second So that time. the

Unidentified Analyst

second is to if The you’re on specific geography any able detail related to key states. question states, provide

David Johnson

Yes.

of XX across states We’re the getting XX% that our make cell up prescriptions sickle patients.

the also patients we that’s across of As would geographies, the state and prescriptions that we’re you would are imagine, near same pediatric expect. you the bulk where getting

Operator

you. Thank

Renza next with Gregory with comes Our question Please proceed RBC. question. your from

Unidentified Analyst

Hi, Greg. if your question. group? Thanks pandemic growth What’s on and could has the age our population trend your adult around probably latest providing guidance on going wondering breaking impact you the I some taking expectation color as the forward provide in [indiscernible] this more gradually thinking long-term more sales is around down for for by revenues was stabilized.

Ted Love

revenue you the issue that, you So in about to want the long Jeff, term. speak guidance take to do because

sure if guidance, as been I are plan our move not somewhat giving you beyond pandemic. know, yet. we’re but on think that to we want have sure up to focused has longer-term there the to and to we make really really now, And quarterly we we’re guidance,

popping We’re we’re hopeful, but of some convinced that really the it. variants that be up with there could not be completely

So…

Jeff Farrow

exactly Ted. That’s right,

big visiting with happen is patients it unknown variants to going I have up biggest impact a Rxs. new to is physicians, the we and might which potential that additional think their driver popping the have what’s the

expectations that going get of expect on pandemic – above. I to time. some your prior happening. do level back time. of over saw We We So is what’s we to to and believe sort the XX that and anticipate question to the our do take the growing part to the It’s

like One you – that the their to going health hear for generally haven’t things of might one of about, second doing? in in would of we little gotten cell, there’s like that we’ve be first before talk check-ins Let’s previously, visit, medications that. past, out the couple given there this where referenced are these visit talk to the what’s visit fact the a those patients you about maybe physicians how And bit sickle hey, then new is a on?

we’re that’s as growth in stepwise switch to light of growth there. opposed it a of to terms be sort So why anticipating a

Operator

Thank you.

comes Our Tewari Akash Jeffries. with next question from

Unidentified Analyst

Akash. [indiscernible] is Hi, for this

So call. you have a indicated

Thank the previously, you quarter on sales for the XXXX. consensus previously, And that you around are We reaching this saw revenue goal for XX What billion $X reaching for product major year? a this target in year. year. new based Do this a suggests about putting [ph] signals believe about reasonable XXX cap per think of billion the $XX Oxbryta that’s market we XXXX? mentioned prescriptions $X to some billion that And XXX goal you. have in by to noticed in So estimate addition, you math, to rest our confident you implied sales.

Ted Love

you part start XXXX Jeff, may Yes, to the take with that, off want of goal. I’ll but

want build a to in building company, a some how aspirational business. you for to goals So want you do set

positioned be think we inclacumab with opportunities. We a capacity there’s very X already And likely we’re do well. those we do today as can Oxbryta we market have of that are program those you things a we think though, more being or approved realistic, companies moved obviously, to multiple move cap they we beyond be did to at look tend research to where that from And on very which had them the range. well we things at that that And going have $XX that products shortly. approved companies, in in either GBTXXX if with want with And deals. one of aggressively and You will companies, actually and Phase looking that is approved we billion, with. to have in looked we’re certainly the

is achievable. So, we X% think the

We also has long-term tend that know numbers significant companies potential revenue. that generating these of hit have revenue. think Oxbryta obviously, we And to

that that couple growing obviously over our be years, market quarter-over-quarter. revenue And could we We’re like cap. in a next revenue has of company that the position think look the to a

mathematical. $XX think how market So fundamental we there’s there’s they’re billion, I tells a don’t ingredients. cap And we’ve here. program nothing to make it that to ingredients think of got get happen a but to the you

Jeff Farrow

side. what of of back growth our payer be previously a we does with will the that we’ve driving half to on process we’ll holds the we have true the subside, In hand-in-hand and just think because it pediatric pandemic we’re then go will in which speak start really is that to are to couple I That things the a still the through said reference that not numbers, this going to to said, that expect year. NRxs. hope guidance. go it position visits, more in-office revenue seeing still patient drive reminder more And A in that

have will the expect revenues middle of the so of course, And to coverage which, this long well. run we by as year, broader help in

Unidentified Analyst

Very much. Thank you very helpful.

Operator

you. Thank

your Please Zhu next Our question. Yanan Wells from with with comes Securities. Fargo proceed question

Yanan Zhu

is Hi, one congrats – and is middle quarter launch. group How patients four the prescription much questions to taking point, from demand? the much So four to that driven on in on XX driven coverage age and the for $XX numbers, how question. to by XX the at the revenue. guidance insurance Thanks. my Two increasing first perhaps. that I age the next is that's progress mean, by million and million The that transitioning the thanks of the is group the this my quarter’s and to transitioning, for questions $XX guidance pediatric

Ted Love

one. a think not out, and good Yes, think question. is really your those for the I thanks a point bifurcate position to We're in but I

coverage question As on seeking we I the still broad mentioned payer pediatric on the are previous that side.

also in growth maybe do and that but overall aspect that anticipate covered the us will those we do expect also somewhat help patients in incremental growth it quarter, So of becoming above on in some growth, XX the new on as weren't but obviously well. first covered we prescriptions, QX

was generally But four the think prescriptions. above XX, on XX early that do the side of the to DJ given we what we had said the that side, somewhat decrease happened just access growth on So a and there. I anticipate expect a, pediatric of

Jeff Farrow

this as saw we quarter Which in well, yes.

Yanan Zhu

Right, were making the in kind quarter, of because, there in Jeff, I that of first is sec the of thought I heard you demand the phasing guidance, says is part of half back say a you dynamic. higher. a that consideration Basically when

understanding? my that's So

Jeff Farrow

in That particularly That's is the adults. Yes, correct. correct.

Yanan Zhu

is Yes, the when – in in there has given sounds right. for that was growth – to adult for in Right, quarter is consider I next the that you facing mid-February, bolus be the there quarter. into which like approved, to back so a it pediatrics half of

Jeff Farrow

yes. Correct,

Yanan Zhu

that Thanks you next, What's talk question on obviously occupancy a to that. choose could is milligram you second modeling? my dose And XXX so with you the you higher a, did having something if before similar a is you. even higher about, a a six based other And have this that there think you for like dose, with you'll possibility what patients? dose, do your get the to is you dose is hemoglobin Thank explaining chosen these dose. have part a will on that

Kim Smith Whitley

should, modeling the occupancies milligram We because at anticipate be get modeling you six that with this participants, will a adjusted with was we XXX But look when above those obviously on our XX%. original dose participants. based six

the to those model going we'll study. dose much out find into more a Phase So a but a we that are using X understand Phase data X, to of get support comfortable

Jeff Farrow

that from one a is patient. And of we have many sickle at important beginning that would the a love them mimicking out from arrive were of and sickle data. rather We all patients of these [indiscernible] you cell approach I that's normality. amount trait fair showed we individual to things other looked on to point And showed think to parameters than the a actually blood the someone

to that rationale looks the sickle cell cell that's and see can longer like for recapitulate, going trait no that higher if state sickle disease. So we

Operator

you. Thank

your with comes question. Our Guggenheim Partners. Suneja next Yatin from question with Please proceed

Yatin Suneja

questions. two guys, Hey

QX, confirm guidance to want XX for is First, I to XX correct? just the

Jeff Farrow

Correct.

Yatin Suneja

Okay.

midpoint, So your XQ, an additional in a about is providing label NRx look the that is million headwinds, if this actually implying in guidance having lot guidance limited of what exactly which the despite second $X you're in you're did is or quarter you off COVID expanded at seeing. increase more And we growth XXXX? that

maybe are So just you growing when favor? And at dynamic? these understand have comment higher then will this QX; why us revenues all understand a also accelerate that they I'm help to not just trying in dynamic in your rate

Jeff Farrow

Sure, Yatin. the while side, issues come in, having great question wanted issue biggest between requests are the pediatric delta and or so bottles broad is make – the revenues revenue that. was One, really The might still be can't recognize three to folders. we growth providing. we're we have a something The we understood. biggest on don't we a on NRx coverage payer there's that sure in and It’s that it guidance shipping

So that's going to inhibit the revenue growth.

the date, a of have other to in ends until in on to finally buy quarter. then tends extent gross-to-net. following is on is dynamic our received that increase our quarter what to less we The not a QX, customers we but we a that distributor have aspect shipment one had the QX similar And in seen Thursday. is where And especially

the in results get second a does purchase recognized that large not there So fairly quarter.

the that's well lower So part on guidance. the of the rationale as for

Yatin Suneja

patients give us how XX% is XX%, then reached with you the like term? you're And higher? just so side, many XX,XXX of longer or the Just mean, can you talk on in one be Oxbryta it it. more Thank can maybe Got that about realistically if just number the pediatric you. targeting, some can

David Johnson

Yes, ever that this for sickle for with adult cell market DJ. matter. we've a given including estimate our the share I don't think patients, patients

marketplace on consistently look off given give in the therapy. look I on at is patients you idea the we of consistently of an given in think you and but at if mean, the cycle are what year you therapy, of therapy likely on hydroxyurea some a There's of a of any I that patients in exceed. lot in about and achieve XX% are XX% year. patient's analogs should can if

that's or that now would patients cell up qualified going indication. broad no the market to terms restrictions four Oxbryta. that very of sickle now are conditions speak in to XXX,XXX indication years guess other would, I a and With a So it's hemoglobin does that to be really of for levels broad being a you With it down about open patients share. assume XXX,XXX around XX%, patient if old, Oxbryta

need that patient visits to fully at as of still good to lower the this as the be, So of healthcare to expecting to are We year. time, providers needed it's talked come we We about pandemic. to over but going out to least we time. still would take we expect do do improve being headwinds than some that

possible. very our so yes, for of all pediatric think So Oxbryta the work as to I hard us, and to get them patients XX candidates as access to to quickly really four are going we're in

Yatin Suneja

much. you Thank very Great.

Operator

you. Thank

Our is Please from next Stifel. question Ben question. proceed your Burnett with with

Carolina Ibanez

part terms question. is on Thank what a question you previous Carolina going to the be restarted in show the in this our This patients taking Ibanez year? that Burnett. the XXX on – for for you that expect six will in dose time be update are the do to of XXX afternoon. data follow-up up Ben good Expanding study, for higher Hi, and later

Jeff Farrow

Yes.

talking You're restarting on that we're Phase X. about follow patient the up from therapy

Carolina Ibanez

Correct.

Jeff Farrow

where major have. we toward the upon end to the when of would depending we present present we the said as the kind We we that it's start, news, data of all year patients typically try the

months multiple by be that could of treatment it So time.

Carolina Ibanez

do follow-up for for pediatric patients have second in patient adherence question a sense population? the a the this you and – quick a And Okay.

Jeff Farrow

to early only to still cases, little awaiting receive and sort data. that We any have first are a of couple bottles of months and some have It's adherence thing. their some in patients

enough group that have and in yet, don't look adherence. population at data actually that and our older XX know example XX highest year we can although the we are So the to for we XX olds

we the best year olds adherence XX the the And parents potential the to of involved yet. the especially are when and so some we four think patients, the to the have with younger caregivers, have

the to in to that about and at excited year. talk we able be more later look should that we're So

Carolina Ibanez

Okay. Got you. it. Thank

Operator

you. Thank

Raju with Our Blair. William Prasad next question comes from your with question. proceed Please

Raju Prasad

rate you of quarter, expect much patient these brought any of from in kind of in, the And of kind you're if this launch the repeat of kind from checking for this thinking populations. metrics next just early on And first of in some patients Thanks. quarter? DJ, Thanks we're revenue that got how the the one. compliance new you recurring that could patient bolus prescriptions the I do about questions. getting kind pull populations. have the younger another data this younger kind through guys in from we of you supports mentioned revenue

David Johnson

would don't just Yes, that data enough pediatric we group particular, a I have really say from yes. because they're just in getting going.

cetera. time. to It's that fully four you clinicians and the that that anecdotal year really from over the And look need at with XX the trials would et So olds we've in in the programs, better access tell own to adherence the they tend seen younger XX involved, teenagers the adherence. And older than our to on do the in in adults. parents better data fact have kids our you category and patients, do that that the

yes, to in year supporting it of always XX% be the the in that adherence. some we same pointing we've least at of end able to that time. increase is therapy. now the to analogs, we're everything's over as hopeful what say a going watch I would think right towards first time adherence putting want therapies towards resources actually that remain the with at XX% year over groups we lot We this and we're our better adherence that, said over category time. there be patients to will and We're So

Raju Prasad

and give directional remarks, then the cohort? And you Great. gross-to-net in can prepared directionality – me and gross-to-net that you then remind said the just on pediatric me the your maybe

Jeff Farrow

Jeff. Hey Raju, it's

a quarter was we up XX.X do steady probably sort incrementally quarter-over-quarter of this about and XX% by of state we about had that midyear. to expect gross-to-net to go So

better in that XX we you eligible between right it. since Particularly is because opposed in as I about indications, Medicaid that's Medicaid but Medicare. think it's are to dual group it more on to the think the and how two at potentially are aggregate flat to there are price four patients look on being signal age

by to of aggregate patients, do year. middle get is on expect that XX% slightly those next it higher but So to in gross-to-net the we

Raju Prasad

XXX. was one of to maybe get study mentioned on kind Great. XXX, to just the and it on patients back And that one last from you drug then inbound interest

the after might X? that the on Thanks. curious is Phase bringing of trial this I back cohort it of about drug washed And patients patients then Part is at question Phase is back to more or that, there a just dose mean, expanding as in the them or to look thoughts occupancy kind cohorts study and of X those chance kind data? six out Just just that in there any drug two to B getting before know a you were SCD would have that

Jeff Farrow

Yes.

do So back with What six just with they X dose clear, we're a be go patients like is doing the to plan Phase back that. was and said, called and the we're opportunistic. to ranging, and they'd drug happened study that on proper to

opportunity an and but more X those news that's to Phase and fantastic was oblige study. a get not patients for subsidy that thought we So our information,

we're our six X range. X proper But study. the our it's starting So clear, going get to not from get That's Phase We're patients. study. dose where data we're again, to be Phase going these to more

Raju Prasad

And – the file or would Phase XXXX to the increase you the you. design? amendment Thank in already is dose Great. that included level X in

Ted Love

expose at these starting is XXX. plan six The to patients

XXX study, look that, Kim prepared data look didn't about get in the branches. patients We the We that we'll that X cell but variety the on milligrams. to of sickle [indiscernible] data a saw very at produced Phase modification. think you have saw I proper obviously disease. And had We remarks. XX% perfectly in her shown exciting,

to and data going make higher, get data. the decisions go going on going to we're based go So the obviously, and we're and to longer we're

little what until going be to dose it's bit So the hard the do is study. you a to actually tell we

Operator

you. Thank

with question comes Securities. your question. Lee Truist proceed Our next Please with from Joon

Joon Lee

congrats for taking thanks Hi, quarter. questions on our and the

start? require they FDA that any get them this the Just that any Impressive with there due you. And unusual. trial previous XXX to to trial, demand drove question. highly able did following that dialogue this patient the and complained demand. you're for the the Phase Was level I benefit missed Thank clinical on that we to also of to particular up restarted. restart It's

Kim Smith Whitley

participants interested were X in in Phase that see to pleased really restarting were the XXX. We

have Oxbryta Oxbryta. they that what of global when XXX that we receiving of from health on. as data individuals that overall development better a we're we HOPE were the in think is And with to had shows our impression you I know, pleased go felt in trials,

that to think restarting. it's was reasons they better that So the individuals not inconsistent interested that and one of in felt were

that better However, they we I were have just they that interested. did felt while on specifically would suggests knowing experience, from may our why But not query Oxbryta think XXX. I

Joon Lee

this required in Did restart way? FDA the a consent or from any

Kim Smith Whitley

that Well, I this development. within interesting things of think intrapatient our that standard drug is approach is using very participant is dose one intra of escalation kind the about or that

So I this really with don't an think FDA. discussion required additional that

what data pretty conservative. that looked safety at two and did the we for in we tolerability before our offered was looked profile the at restarting. think I dose We then we increase analyzed doses, an participants

Ted Love

our was things the I are mean, of filed of with course, course, and FDA. I protocols

has data safety our of. Phase from And So X FDA there's as nothing widely not shared is been well. aware

said we while And go they They the that collect on So something did they the profile. we how they have is just back my came but must desirable, I I formal do anything. feel good and mean about back or formally we didn't drug. would of not suspicion testing add, to wanted patients had felt,

Joon Lee

patients said – No, – just such because and Right. felt better just did we I the they a big it's descriptor. when our that when touches,

localizing just were that was curiosity. I I want to understand But they just clinical improvement a So it's mean, aspect of but... this what good,

Ted Love

mean if mean, anemic wouldn't hemoglobin, it get you XX%, increase feel hemoglobin of, would gram can done. like I feel so normal in you these definitely to of And patients increased – They activities were more normal. with many feel you That Yes. their one, they I if two, with three – a they better.

So I of it is a lot that. think

that better have of cells, also do we gets Some on But sickle didn't have treatment. complained when have patients formal. fewer that presumably pain kind again, they they daily anything

it want don't we something project formal. we get is if So to

say, we on just being back go that come are and want the to did the therapy. back clear We patients

Operator

Thank you.

Tessa with your with next JPMorgan. Our Romero comes question. from proceed Please question

Tessa Romero

Hey question. so guys. for my Thanks taking much

seeing the follow-up group, you provide any on respect The first then little one color are And age cell on that is, I to had you noteworthy? bit with are professional disease a more healthcare are sickle patients what differences in-office XXX. by with one visits there can

David Johnson

are across to look cell Yes, We quarter, it care some a look share at levels actually XX patients, the we at claims been below yet. the in even gotten for data X board. the versus happy below and terms every X of – it still health to the reason vaccinations XX be for I'd you recall has farther is And baseline. all and younger When information. of the of visits the that that take and older kids for XX, is to haven't them sickle because slower for pre-pandemic to the

in very sickle disease have system about are cell cautious and and when potentially parents and So health and COVID. the their could about out around care kids they getting contract

outcomes down. So risk risk COVID care poor are do patients our they visits it. It if or those being to health that's at why with everything for has catch

I being are the smart So cautious. especially, being they're and just kids conservative. guess, They're being

today. So that's still the case

our prepared remarks, are now. levels at research in suggests about our optimistic in and physicians person getting I market my as that patients higher in reps back also are getting Although, person said more back feeling

going there. get this leading we're a all think we good is sign indicator a to and So that

Operator

Thank you.

with Sachs. is from Goldman question proceed Choi next with Our Paul your question. Please

Paul Choi

for terms to with just I understanding as to And portion coming regard to regard in be a broadly as questions. dynamics? My growth just sort I first a better and it want commercial. has back relatively past the has Or question issues thank population. going why just and maybe is seems the slower you it quarters? then flat. adherence Hi, it And been of DJ's revenue thank been Is of to a portion you. mix over growth the to substantial Good just of question. to taking the the the earlier over to from few had older afternoon little NRx population relatively population this perhaps why our with here – understand of comments flat pediatric is XX follow-up

Ted Love

Yes.

obviously I in the new to it Just patients wasn't want to to just to was was and XX clear, because be approved, XX in but the four DJ but answer, clear, there There be that coming older. was growth flat. just

think I be make I want that. about to we sure to want clear

David Johnson

real-world lower the in also in adults given even that The board, a to signal and experience, to more tested makes and the great There's physicians four it's being that our substantial been do of also olds this now been. set And the clinicians in patients Many it's That's approval. we reinitiated XX treating is XX-year drug has ages. has Ted. lot the seen stronger see growth evidence proven ever wanting the are across the that now. that's XX growth have than We've exactly got get a of in marketplace new. now as approval, we've four of But gotten patients growth as FDA also broader it Yes, this and they as in – older. the to course, of we well. right, to a sense it as the to

these in all more those of their to XX initiating there's XX-year-old for it four well. board. in XX- XX suggesting year XX as across are as it confidence group, are fact, reasonable well, in now in Oxbryta their the using olds using same physicians saw the that reasons, in to So yet, we some to some – growth And that now

Operator

Thank you.

from Stanley. proceed with question question. comes Matthew your Morgan next Our Please Harrison with

Matthew Harrison

the just question. for related two things XXX. Good I ask taking Great. Thanks want to afternoon. to

with second what headwinds XXX the dose you to related this in remind modeling Phase things data of are much. just terms to to things just how then and still you things? that? very Or doing and X/X dose any have considering talks. starting restrictions tox for still preclinical you how you're like there are related can the now, us operational much are long other patients First, – Thanks some So can right there And if and

Kim Smith Whitley

target with And then was regarding... that. your no our question the on We're on there's part increasing of dose Yes. based second studies, for limitation toxicology

Matthew Harrison

of around I you've done limitation I that more done, don't duration. around study to any the to for related second, know there's started? I of the if And on and Thanks. that So on guess has studies I that was asking X/X in Phase longer-term an are all asking just of started. if duration you've dosing terms What the implication getting waiting tox then was studies, you get tox that

Kim Smith Whitley

Yes.

new a Phase getting there to And Phase board on as X finding start Phase really having to to course, the limitation go the the well. limitation So completion over there's the no is will of duration without the goal those be, X/X X do sites into the then the on study with start And of dose the of the – than and and other protocol, Phase on study. a factors. study-related X of Phase no really X

Operator

Thank you.

Our next question comes from question. with proceed your Please Li Watsek with Fitzgerald. Cantor

Li Watsek

you are pediatric relative concerns other particular into any call kids? the from guess on you pediatric Thanks. also, in on sort Or the expansion my little as cover prescription the you of relative taking improved this seen into here more this dynamics where is guess, And out adults? are the growth Hey comment in to that prescribers I thanks mostly and it of questions. of see QX. I a sort you guys go population, I you've I can if a year? younger the trends guess, kids to can considerations versus wondering may And and do I'm new congrats expansion penetration talk access? contribution on this that just there younger guess, from the well. maybe What new situation for function Is there about And any group.

David Johnson

that one. take I Yes, can

older. So by overall the and breaking We both had those groups. X,XXX having for the the group. in we years remarks, it two both our a that's in about growth and out not quarter, in to by saw quarter, really about as prepared over NRx We're as XX-year the yes, and well said driven in well, four we've olds over XX as age excited super groups, the demand. – we're highest looking We're at enrollments

kids in mean, In terms the cautious Yes, of be put adults. be pediatricians you kid. versus general, tend about what to the in parents pretty I dynamics to in

the convinced see we So going on is years. news they're of market for the got indication of to being this The data. a to after good and be lot two want

We world. experience the have data real-world a experience, wealth and of in safety real

dissolved and that to a kids the patient specifically way. given be new that was parent of and formulation, goes education that it. great example, caregiver So And we and for for lots a with and have education can the developed liquid that into kids

there. set we're So

it I going. cell best of the this The sickle exact terms concerns, younger disease. mechanistically, new impact downstream of is stopping concerns. and be preventing you the we no mean In should early effects preventing on should if the have polymerization sickling about place population think

So ages super the we're patients about we're the being excited that, for indicated four we penetration-wise, across board then about cell all and think now. excited as well. are And parents older very sickle and

able able more be more over to, So time and grow patients. we be should into to

Operator

Thank Love closing are I'd questions Ted turn comments. any over floor There to to no for further you. in the like queue. back the

Ted Love

joining for please stay thanking Thank end to just you. out if you questions. you call I'd have any free healthy. We safe hope additional to Okay. the all reach And everyone like by feel and today.

Operator

This concludes conference. today's

lines disconnect your Thank this you at may You your for participation. time.

Global Blood Therapeutics (GBT) 5 May 222022 Q1 Earnings call transcript