BCRX - Earnings call transcript Q2 2021 | BioCryst Pharmaceuticals, Inc.

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Operator

Thank you for standing by, and welcome to the BioCryst's Second Quarter 2021 Earnings Call. Please note that all participants would be in listen-only mode until the question and answer session of today's conference. [Operator Instructions] Please also note that today's call is being recorded. I'll now turn the call over to your host John Bluth. Sir, you may now begin.

John Bluth

Jesse. Thanks, welcome conference quarter call. and and corporate BioCryst's results financial to morning, XXXX second update Good Today's available on release our press and website. accompanying slides are Anthony Charlie me Chief Dr. with today CEO, Stonehouse; Participating are Commercial Chief Gayer; CFO, Officer, Medical Officer, Jon Doyle; R&D and Dr. Chief Bill Officer, Sheridan; Thackray. Helen

we'll questions. Following our remarks answer your

These known be will performance well to future and results we and results, which from statements Before subject call forward-looking please and/or as including statements implied risks financial are that and performance uncertainties, or future may unknown results, note forward-looking in actual or begin, any as this or expressed cause the unaudited materially our future Company's those performance achievements. achievements conference information, today's presentation. to contain statements regarding different

on statements. undue You place should not these forward-looking reliance

I'd additional can a including refer Exchange the Company's risk discussion Securities to Jon accessed filed our be Commission, the on like to Stonehouse. of and information, For the website. to with turn now documents call which over factors, please detailed our

Jon Stonehouse

John. Thanks,

that COVID our done interactions ability reduce in therapies of a has are our executing you injectable we've combination marketplace because was revenue switching and face-to-face launch numbers patients that have are growing the They half The year. disease of achieving and to drug. ORLADEYO customers of for million circumstances of quarter. evidence well. reported with extremely $XX.X very consistent now on from the ORLADEYO. challenging second from month of job commercial see most therapy We're the ninth of burden the can their the go launch first million and with the despite staying controls $XX net the limiting including in ORLADEYO on continues today fantastic they're The the a revenue As in the on and body control benefiting team of disease,

direct U.S. growing execution switches, to launches world, best for detail Bill talent X approvals team. offer in potential with we thrilled an of first sales we The an pipeline, benefit with treatment in later directly our continue tell result ORLADEYO drug center. are burden and that from patient's the believe Phase pivotal by success patients great current on trajectory Phase will advancing patients, patients extremely therapies Charlie, less plan a a started This of other that this prophy us effective infusion that to this year a our hear an our suffering has They is patients want, important outside ORLADEYO burden us, be this X hours are entering treatment. start in of we exceed to and a global update will in enrolling want of from and this us with these We a medicines the with the the and share diseases. HAE, to us you us of launch trials puts U.S. in example begin We're Like XXXX revenue a than to half can get experience strong ORLADEYO from to an confidence, in with launch and disease. tell the significant from therapy of will the around shortly. PNH they in pivotal program. to the the million low patients trials As year. BCXXXXX more is which and rare moved in give in you'll enables an stream having centered around sales. $XXX year A and oral invest achieve peak million $XXX no to excellent plan PNH,

XXXX of while be a of ORLADEYO growing and to what complement well. launches to more complement diseases up PNH, I'll to disorders. suffering shaping across rare BioCryst Our continue ORLADEYO. the goal diseases developed patients discovered commercial pipeline many is details is has to parallel and turn call medicines demonstrating renal in other and approvals as very you attractive Charlie from oral for on give rare and over capabilities now the disease we're our pursuing

Charlie Gayer

Quite that after at XX% ORLADEYO presented XX EAACI an who mg Jon. data drug. in we our on QX compared ORLADEYO is to very Data is in from showed weeks. simply, Thanks baseline term fast on what started patients a ORLADEYO in launch APeX-X had trial clinical With the going knew, confirm start Long July effective reduction XXX attacks our also building great. QX.

median with just attack level control patients months is day zero. potential attack The and the rate outstanding one being prescribers. of most motivates his For a what pill of

our to prophy QX prescriber the fact, base by XX% and injectable therapy patient continue drive In and from acute-only grew in agents switches launch.

in the beyond is Haegarda, We of That's and to switches other XX% happening. want the like classifications prophy mild, outdated QX of exactly prevent and has patients the treatment attacks. to of ORLADEYO androgens. what XX% lowest moderate in or acute other burden of U.S. the patients the acute-only. launch. prophy ORLADEYO expected is HAE any therapy attacks not why ORLADEYO Of as quarter control contributing is followed to treatment. Cinryze, the as goal that many over of XX% did HAE come order breakthrough to is be modern a of starting already patients disease. from moved continues XX% who ORLADEYO therapies. to switches largest prophy QX of impact possible therapies as also second time now is with prophy severe with from most What switched treated possible expansion decline. patients The prophy came reduce their market by at attacks paradigm The treatment of in prophy from for the to of of prophy and in representing business the Takhzyro source were use

the HAE injectable past. ORLADEYO return transforming of after segments, up acute-only treatment where was therapy. Some to attacks across all on the in expectations, eight trial. patient small, HAE the line patients a now attracting Once low landscape new in since patients the switch, patient one-year of their retention we treatment. retention patients important switchers population ORLADEYO the months ORLADEYO as trending given XX% with possible but products our see clinical with prevent of to was prophy allowing launch, is to burden meeting APeX-X on with

find patients differences no are simply, daily we used. self-motivated a prior related easy take to see saw patients treatments also compliance in Because we they Importantly, oral prevent attacks high, Medication nearing very that very retention to are rates therapy. clinical trials. in to what it and

progress limit in significant and and uncertainty made also to new QX. for We medications could hassle that physicians the with HAE switch. willingness coverage payers Patients warned us surrounding

prescribe the high existing support launch. base to covered the expect face-to-face additional we program confidence is will medical approximately of many of a will calls, market add by also still of are with allow product their to the who policies and offered HAE ORLADEYO. service to today our payers the congresses, launch to transition those prescribed As is high coverage start its and ORLADEYO. of future. year. promotional HAE in base This patient target XX% Intent the The patients over across stages all in our increase bullish plus early more treaters yet prescribers about the services policies on events rest and reassurance level broad we to already have of new combined momentum for coverage will ORLADEYO. give This patients have gradual and not including The even for

the no achieve team reasons over ORLADEYO Germany, recently France all announced are in file the the than next For are markets other regulatory million and to we launch year. in U.K., European our our these Launches in are We XX Israel confident will this underway less several around Japan continuing and world. and very to preparing sales in also filing we is months. $XXX that and

As I've in strong the you are with ORLADEYO shared today, launch. the trends

to treatment expect contributing has call potential believe to transform we peak the new to in be the ORLADEYO with financials. transform sales. HAE each market turn Anthony we As for States, plus care to in million now the we HAE what globally, I'll United also $XXX the to over seek

Anthony Doyle

Thanks, Charlie.

the the heard we the impact well global year. real COVID have for value when that continues on the consider And to second shareholders the to have a very been patients, going half we ORLADEYO a foundation just and especially confident company of you've As that alike. has of create are basis. for launch strong ORLADEYO continues we built

partner million, today's came You of sales few Japan. a to Net to from was can from in pricing and And revenue the quarter of $XX.X Torii call our negotiations global following your our of like ORLADEYO for and I'd detailed million $XX this earnings press financials approval find attention items. million completion net $XX release. in

million opportunity And proactively runway like QX not were we million quarter. addressed $XXX had some expenses generation give XXXX. we quarter available hand to on I'd cash. questions from again the stock Athyrium the so for in the $XX We non-cash us Last including operating take additional to this ended and continues Our with into cash $XX received. compensation revenue addition quarter to access million. that to to This in do cash

be start and the specialty inventory our for reminder, upon the stocking. patient Strong our net or we no revenue adjustment. patients recognize channel a main driver to programs of uptake of continues gross use, patient assistance from As quick to shipment pharmacy new our success

As we in peak we should XX% XX% said sales. range to get as previously, towards normalize the this

confident uncertainties them are play will continue we than be opportunities As need specific the and be but there date. by launch very million, And providing the revenue both We're time and us no net could more Charlie for described, more the before to we ORLADEYO guidance. accelerate could results for very that less see down. that year slow encouraged to $XXX to out that upside develop trajectory

monthly so time we're what to into we further. accurately these the remain as more of of the encouraged early of still we to we And as We by second far, Some still year be but seeing need launch. steady-state areas our firstly, customer half prescriptions retention too in and go such, cognizant are, the that develop early guide. let forecast to we're need

reimburse policies Charlie product. work Secondly, existing complete patients as getting still do thus far. and ORLADEYO But we've new to transition have great in onto this and effort we said, to made to strides

for see But thing ORLADEYO influence no delta to there's the watching trajectory. are to COVID. ascertain periods the if of less opportunities based coming in need of the are our this Next is impact help that And due holidays naturally lastly, freedom slower the and million both impact ascertain due $XXX a than is months patients. treatment the With for next be confident that attack these very on doctors months. they the and in summer One data will and helping how our More half we HAE trajectory. variant, reduced impacts I for of launch uncertainties revenue that HAE this sure performance that continuing and more year. this in we their launch our us patients brings. end-of-year manage a product, a first that declining burden patient couple to said, might ORLADEYO time is of as be the for reduction year the impact how visits with to the We'll great will switches historically net was

we'll half With make beyond. with second excited opportunities for will the that, hand combined to very potential discuss, BCXXXXX to that I'm of Bill. year over that the and With I'll Bill it the the see in of the this progress treatment

Bill Sheridan

profound The BioCryst is it unique drug, this is patients. exciting and very Anthony. of having who discovered the can that for because of the team impact lives of we see developed ORLADEYO successful Thanks, HAE launch on the

PNH indications. and results on therapy. disease leading intravascular CX correcting we anemia, our our D advantages heard Next and in with extravascular met Factor Phase a can X top is and about agreement on BCXXXXX from at up it the on concept details needs infused pipeline we to regulators, study, vertical a the pivotal BCXXXXX, complement-mediated both relieving physician is development address with living our inhibitors, D reached broadening fatigue I'd development of diseases. the opportunity designs oral expected patient oral And the and a enthusiasm Today, our steps dramatic BCXXXXX to provide has March research in accelerated in expert and study clinical reducing our come of about inhibitor their of for R&D PNH control These an trials. and of in into our Day, advocate unmet dose-finding But share who Based trials Factor heard inhibitor. reduction intravenously hemolysis. available our pivotal substantially trial about compared for transfusions. update next directly currently PNH, proof-of-concept to our rental we great also red blood other like because improve discuss cell have on proven from

REDEEM-X trials the set rigorous two Our of can found PNH in broad pivotal have goal with studies and controlled around labels world. of randomized be oral the Details BCXXXXX trials as website. with REDEEM-X in been supporting these slide patients designed of the on our monotherapy

not XX trial BCXXXXX both to a The For with BCXXXXX endpoint week both anemic hemoglobin randomized REDEEM-X XXX both studies inhibitor. the XX-week a period, to with a XX roll per of anemia received of approximately with BCXXXXX BCXXXXX to response PNH monotherapy approximately two is formal then REDEEM-X trials from extension. patents in a reticulocyte detect is of inhibitors. open marrow is trials response controlled a blinded clinical baseline must in In and dose and patients treatment deciliter. evaluation approximately PNH of and trials effect show week randomized long-term trial both inadequate count. patients through over XX CX and be complement a bone milligrams safety grams currently the changed XX patients The in primary into is after a all powering taking increased clinical BID. label

The hitting clinical and endpoints Given in effect key health relevant that study, include confident seen we in trials. include quality on end we're the secondary endpoints proof-of-concept very additional of fatigue and primary both point in other the and life much hemoglobin both assessment trials outcomes. greater of have transfusions related our laboratory of

outcomes. in to us opportunity scores blinding REDEEM-X the life allows unique of and quality understand of related Importantly, fatigue rigorously health the other BCXXXXX impact the on

high is change the in trial. patients Finally, and that urgent baseline have key a from percentage must in on additional and REDEEM-X only screening endpoint an LDH secondary

have rollover trial, months duration maintenance study cell nine BCXXXXX and red nine size. with are on Turning dosing of BCXXXXX to longest continued ongoing therapy. on of have of blood of benefit these have all dose to take continued to our patients in responses, nine drug from of maintenance and naive XX The patients exceeding who inhibitors blood PNH biomarkers hemolysis monotherapy All hemoglobin transfusions, average to months. ranging no CX for BID with the improvement clone red patients continued cell the now time

while BCXXXXX. hemolysis including continuing discontinue with patients investigators vaccination monotherapy. have blood now Turning levels the are Remember our to required all patients five benefit in of ravulizumab to following COVID-XX one And inhibitor vascular setting CX decided inhibitor continue the now extra oxidization hemolysis. six response who marker inadequate PNH on that's CX of in trial, at four baseline. patient five these patients CX from red to BCXXXXX. Recently, high a transfusions for on four cells up being had BCXXXXX had and treated both These

proportion had complement in medical of our We've pre-study, from of of hyposplenism baseline, red patient transfusions indicating that decided safety signals only to In to by individual's very oxidized rate PNH this seen that continued factor the was be hemolysis BCXXXXX although with for cells profile duration PNH. confidence well compared and in and patient associated our inadequate response BCXXXXX to are from proof-of-concept pre-existing at Overall, CX pivotal the to with main was red has conditions to anemia. in benefits discussed and PNH. were very patients likely with blood increased safe reduced trials we and trial burden And basis large with to a up and tolerated not no with exposure. XX was trial. complement-mediated other cell the pre-trial complicating the March safety a moving this has the withdraw for encouraging X.X, transfusion patient continued who of inhibitor months Another this dosing.

PNH that from us can we patients now pivotal patient results our trial later year. this and for the program begin activities proof-of-concept our Although to the clinical trials competitive top space around world confidence these PNH underway investigators advocates a recruited. on Startup the provides and enrolling from be for are based trials, enthusiasm is excellent expect

inhibits our be complement-mediated this enroll our diseases we We across membranous exciting in indications. in blocking end comprehensive multiple these leading development pipeline of evidence begin trial pivotal and compelling, for this development moving need on will regulatory truly up. to to by involving patients year. BCX a to hand Because with are will each Each mechanism to collect The is fully world. due And of basket call confirming [ph] an activity of unique this forward and a up or renal thus and pathway launches now, approximately facilitate clinical this drive and and time size additional track fast to program estimate speed pathology cohorts John selection This is for wrap investing it. to complete endpoint around CX the many trial biomarker alternative to I'd patients. with cohort because over to molecule. including nephropathy effect action it the medicine BCXXXXX proof-of-concept like is the as glomerulopathy, who XXXX Because approvals submissions of indications We're will plan IgA possible the bring as represents also studies XX all to This three diseases nephropathy. the study primary factor pathway. outcomes clinical and to the of treatment patients D

Jon Stonehouse

company. with pivotal our advance program the Thanks, time for shareholder. it It continues and Bill. forward keeping as to to we're start to remarks. prepared at exciting it follow. Operator, R&D progress team clinic. with And to is We're updated off even a XXXX BioCryst for with on ORLADEYO we open you indications exciting questions. the be to launch is fantastic an a to to to launching up PNH molecules towards our We and of more time continue additional our our come. BioCryst build success look going The more now That's

Operator

Instructions] Thank Cowen Ken of from you speakers. of & line first Speakers, questions Company. Cacciatore the [Operator

is Your now open. line

Ken Cacciatore

the rollout. to just It's success fantastic Congratulations team on of see. the

And where roughly point. can at if paid And $XXX of understanding us a nuance starts around quarter, make the the some can that. patients get you all I confirm. than XX% million just Just of were we to year were commentary exiting. to you this and through patient I to believe of good said to want wondering the drug of the so we understandably give try sure no pacing an good we confirm about less reasons. balance just

initial start. we in see of think this year. patients about of through terms the they the wondering Just clinician balance pacing And about of the how as

patient one normally they're two So, or patient average visit. on visits

Just ability you how apple trying many understand convert the patients. to get your capture of bites kind to to of

nuance the But any Europe. maybe early commentary So so And patients how in clinicians? just themselves about around kind of also it's any we're much. just nuance know then, Germany. to Thanks typically so on seeing there these present I far? early what

Anthony Doyle

take Charlie, last the I'll two.

You two. Thanks, the could Ken. first take

from over in start prescribers and XX% increase seen. consistent really part think pacing it's So, of the new month strong launch, month of that on we've that's right of the been I since patients so the reflection a beginning, and

strong. very So,

we established. year. new the But policies with policies about payers some already today coverage QX, half of the product existing What reimbursed of asking paid our I to XX% in we'll said as product. the our In patients coverage majority that now the patients over were both of now rolling were have the is You second Anthony receiving coverage. of have said, and

Jon Stonehouse

you We and increase closer have regard visits, million really and just -- than pacing directionally a us Ken, I terms like with would summer positively year. could of then, But clinic the I this two Anthony and And good no very the in less million, $XXX uncertainties August the drug. that mean, visits months. things keep you're roughly job $XXX things launching the could those per Charlie the did the in beyond that $XXX we think of million right to July that telling is go first the to and that this that of

some should And they we in underway. that So, before on uptake remarks, then expect ramp is the COVID see play the pretty just the finite out released. slower. to restrictions than U.S. that said Europe, give more that guidance. is launch we just is different his want Charlie as in heavy had that the prepared you Germany, They

I'm I like. coming into restrictions back now think going sure they're the those and and July, variant put clinics with as that delta in not to limited the the patients universities

his additional will plays remarks got And just contributors that to prepared next think those as I agreements. we we'll as see out. Over countries So time, pricing get Charlie how bigger launching we be year. be said seeing

Ken Cacciatore

much. so Thanks

Jon Stonehouse

You're welcome.

Operator

Next line question is the Brian Fitizgerald. Cheng of from Cantor of

is line open. now Your

Brian Cheng

team. Good on taking another Congrats morning, quick thanks quarter. my for And question.

years? comment last Thanks. medical reach next And the how versus you're So both patient trial through on-demand to I prophy this quick about on-demand changed prophy and shakeout have quarter? you're from going just and versus on few adopting curious, versus access the the how patients a you're ORLADEYO. follow-up. quarter can exception options in seeing you We're has thinking formula switching And

Jon Stonehouse

first the take the take second. you I'll Charlie, one

to And with and Brian regard us it's therapy. not their are So, shrinking, with that it Takeda, just every CSL prophylactic it's day. prophy on-demand shrinking market,

patients just said And I lot -- be ultimately that a there's oral how settles So, really of seeing out always now just they it it prevent honestly, XX/XX option, wanted we're XX/XX to They enthusiasm. prophylactic could given want attacks. when we think therapy. an Could it.

Charlie Gayer

that of And sooner to success that now about about is mean confidence paid of coming exception coverage to getting of going We product had the as new covered it's access patients XX% having via is? a we've a on I a then exception. to lot Yes. onto with market in said and in product, That And patients they're great getting my before medical that lot lot talked question coming Brian What's half remarks, process. the start what lot the first medical ORLADEYO faster, to trend. for your in. in going a gives the prescribers patients

we medical formal there, be through will policies. when We still increasingly have So, but coverage needed. still pursue exceptions successes coverage

Ken Cacciatore

rationale and Okay. the LDH if taking And related my PNH, endpoint the to And just a as REDEEM-X difference can there primary endpoints behind for change the versus the XXXX a in in secondary of REDEEM-X. you included for Thank you the curious us then tell be in will part REDEEM-X. question.

Bill Sheridan

smaller hemoglobin in could change perfectly REDEEM-X baseline a database, need results. size safety you the This is studies. Bill. Yes. different baseline The powering proof-of-concept size the primary in additional for two put what approximately in we have in And the terms endpoint same. sample in safety both we and based Remember, exceeding repeat The we've And for had of different easily changed hemoglobin a ability have confident in grams power in on difference we're little subjects second your the of two question? slightly It's powering for quite target of also with provide studies [ph]. can hemoglobin. these of frankly, what a the is because is you so But NADA just from for detect sample studies the between a bit very to and of might purposes.

Ken Cacciatore

LDH as Regarding whether study? the included be a that REDEEM-X part of change, would

Bill Sheridan

No, it won't.

CX response intravascular to hemolysis biomarker is of and a hemolysis. inadequate I most So who issue an is think extravascular inhibitors the really have that LDH for patients

it's biomarkers, all not measure secondary a we but REDEEM-X. key endpoint the So in

Ken Cacciatore

Got it. Thank you.

Operator

of line the Liisa from Bayko is Evercore question ISI. of Next

Your open. line is now

Liisa Bayko

patients of quarter point? kind Great that to to you a were net said drug. kind nets thanks reimbursed what taking question. adjustments? quarter more is of provide majority think maybe receiving the at does of Can you -- the I gross you're we what guys. Hi, gross about on seeing little and But what this as the second for in know, color mean

Bill Sheridan

Thanks Liisa. Yes.

continue improve to they quarter-on-quarter. So,

come or going So off free new get And across say to on get kind we strongly way things Charlie approach out quicker feel to of product we're But details as give as are small product, from was we happy seen the to them onto still really XX% honestly, more we not directly XX% in absolutely with more line said, quarter-over-quarter. we patients and better net. to really there reimburse move patients idea playing onto molecules we've that as did other T-cells. over that what with from We're as in. specific about reimbursed the or going

Liisa Bayko

And I last Okay. were you guess quarter. majority at the

Just kind have how of about evolved? things thinking

Jon Stonehouse

majority you're The what that is paid, asking?

Liisa Bayko

Yes.

Jon Stonehouse

majority In were were QX majority were QX Liisa -- on in product free and the paid. we the

this. -- is the So trend the pay

Liisa Bayko

Got it.

compliance persistence you what seeing? seeing in terms you realize Thank can Okay. launch. you. factor But And compliance then, of sort first of these are persistence, for in I so maybe that's of us of kind six future. the unknown an far tell you're since months kind What

Jon Stonehouse

we the then relates to what So, and clinical want just that. in might trial reference how saw to you it

Bill Sheridan

Yes.

in that. so patient So months within we're trending Liisa, far is one-year eight the into what retention. saw launch XX% we seeing And APex-X we're

And the the data works drug this of as that EAACI I So really think well. do to patient we attacks versus with close in patients And part of XX% just been in really very well baseline big this XX% a on which this retention the were And -- good. a trials far at I really mentioned our this shows reduction is presented clinical drug. high, range. then rate, reflection compliance, is is it's as

Jon Stonehouse

high was XXs. It

Bill Sheridan

patients And prevent one and day when that attack. it's reflection I just of that's take it's a clinical It they trials. in help easy was high think a pill them know XXs going to

so. do to self-motivated they're So

Liisa Bayko

more doing basket turning then how point. thinking assuming kind renal is were good be would give proteinuria When reduce interested study? on color that? in to you is this of of levels sort a really do to diseases. on that you now little that Thanks. competitive? to us what factor And that be you about Maybe -- the all And D, kind need think just and approach? oral like, of great. talk you across -- end about measure I'm Okay, about to a you're Can of thinking you that important diseases? kind I'm of complement going study you're how And these

Jon Stonehouse

quality Maybe Hey, patients around doing sure the then that on make Bill. we're clarity and to end have of that Yes. points. the selecting we have the that focus really disease. truly What

Bill Sheridan

Right.

So nephrology active help making these previous in we've who think meetings what's is of that mentioned discussions in and had disease. fantastic us burns think that the out not -- all disease first I have calls we've to external patients place really about series And we've with have of critical questions. a in we experts sure

doing why mentioned that's the pathology. call, we'll I be as kidney there's on So

In So a the baseline to idea of of We're very a and kidney these a each That's study suite this, one. assess proof-of-concept the we're of So, follow-up everything, diseases. of measure right? of in like I single a That's the measuring we'll very number And doing don't and endpoint. a like role complement like biomarkers. that. assessments whole well to the important. pathology there'll comprehensive I be system everything. measuring standardized be biopsy and

quite complement-mediated stabilization topic of is with in diseases, -- that the kidney reduction correct way or attractive and that FDA's a by neural has endpoint in CX the the of of headed initiative diseases. glomerulopathy around the combination is proteinuria very and rate independently the field and proteinuria direction academia of absolutely You're this whole industry and in that filtration the endpoints

pretty with a see for And terms choice of in existing discussion complement endpoint After that you each the primary quickly example disease. evidence for a that phase makes of be proof-of-concept people in study. benefits out a pretty glomerulopathy can active got think with clear results So, regulators. that separate. -- there on CX effect But disease is the of it I pivotal we've the will for inhibitors in

Jon Stonehouse

And in thing from is, PNH to to looking of we're the year disease. study at Liisa, point indications in pivotal more other the out second I'd And patients. be renal on we we've three in -- Phase where X were half patients PNH gone the going a then -- studies

is four the to very, going So pursuing year, for very exciting we're indications of us. the be which end by

Liisa Bayko

you. Thank great. Okay,

Jon Stonehouse

you. Thank

Operator

Fye of Jessica of JPMorgan. line the from is question Next

open. Your now line's

Jessica Fye

in you how Good this, of anything of you the from contribution I extra not about from coverage the number? see we million sales, half a morning. the basically break to but gross is Congrats net might sure anyway I should think if came there tailwind improving quarter. Europe in And if free less drug? or miss pan what ORLADEYO back just first, much on out and $XX.X ex-U.S. can guess, to or I'm that then, any due

Bill Sheridan

U.S. Jon Japan Europe way majority. it had Yes. just off, Almost XX.X in Thanks to in off from the vast about Jess. QX. think best kicked all said, the is the June, Germany kicked of came The

So in I think they'll XXXX. be more of generation in terms valuable revenue

the of sorry, -- this revenue that the going come for is for So the U.S. year then majority and from to QX

pay our in of second get to to the more the year, would to expect the more the terms the right? we nets, themselves will coverage, said patients get gross continue growth half continue, we on. tighten. In as more payer that and continue to of Charlie, trend will So, I'd net I say And as

via patients there Now coming on then off medical onto coverage, new But adjustment. transition reimbursed that reimbursed existing be some as of to it'll be will by the exception patients and product. move we overweighted on and

So will to my year gross really of the rest the that's is to expectation lower. continue net

Jessica Fye

is similar And Can over on? Or if happen you to trial. steady that patient better retention is I time? like which going figure early patients course this stay on help to great. the Okay, the time over out Does they're us of kind more XX%, mentioned understand think drugs? it you

Charlie Gayer

said we year. XX% toward we're what for Jess, one that Yes. is trending

that world. trials then what in So, clinical we're in the seeing the what and make decision That's typically that's patients real saw we months. few first in

Jon Stonehouse

thing say, data you see the other doing Jess we EAACI is, And this that I'd better have over time. where patients

is encouraging effective it as One of that really full that baseline which and that so to benefit, from is right? So give a said, give get really a incredibly shot weeks, fair the time the things was patients we're point. it get to to reduction to over patients XX% need XX Charlie,

Jessica Fye

you. Thank Great.

Operator

question Company. Needham Belanger from of Serge is of line Next the &

is line Your open. now

Serge Belanger

good for the Hi, progress. questions. Congrats my taking morning on thanks and

on second idea the But many the how us know an therapy haven't can ORLADEYO of patients you in First question quarter? you ORLADEYO. I number new on of give drug. disclosed started patients

Jon Stonehouse

again, So, you patient the can our specific has and since demand of is, expand the to been consistent also base. we our commented you're What I now new haven't base are Serge, number. we then, strong right. majority say on And prescriber patients the great and we launch. -- continue

and in XX% prescribers QX, So more we trend in that we than continues. did had QX

in front have a of lot us. growth of we So

Bill Sheridan

we very you this Yes. in a consistent It's is And very around Serge, is a bolus just this point anything. It growth, or is if time. -- leave -- very with a question consistent. if

Serge Belanger

it. Got

are Okay. the that talk how to products. policy. you And patients that Can reimbursement XX% compares piece? HEA then coverage And when Charlie, remaining mentioned maybe now about expect other on of policy of a you you XX% for

Charlie Gayer

question, Serge. Thanks. Good

thus prophy of products. all parity the are far other So, at policies established with

can treatment strategy. receiving We're So are having at how well it want and good a that actually stop payers. reflection choice. with sure patients really ORLADEYO. payers We that's make prescribers the continuing make XX% to to and think not our their additional we're it's I discussions going And of

expect go even to the we end of and the year. by stronger up number be that will coverage So

Serge Belanger

one on for me FDA thoughts But let you're us squeeze one [ph] half the providing second there's you And can second and R&D some quarter. -- ramp both for Okay. not color I in guidance. Anthony. the in know up give not directional OpEx last some after maybe

half those how we items? line So the for think about should second

Jon Stonehouse

investments so, I just making And of we are here. Anthony focus the kind think, where on

Anthony Doyle

Serge, good it’s question. a

talked then into rollout the a well the of expansion about the that. in basis. on and global talked We've U.S. Europe invest launch in ORLADEYO beyond markets about to We've continue We going

continue talked we the So about the deal side in Bill the we'll And then in invest then, have. commercial house. big of is and pivotals proof-of-concepts terms to of the really a that both for us which BCXXXXX,

continue areas. will invest those we So to in

as I create a take as moment, value that value. that and investment? and we you I additional at look there's can to where the continue we at be will invest mean, makes as long it are -- areas we so, in for And sense Yes. unlocked it if created expect to those run rate to then and

Serge Belanger

Thank Okay. you.

Jon Stonehouse

Serge. Thanks

Operator

Tazeen Next question is from of Bank the Ahmad America. of line of

Your line's now open.

Tazeen Ahmad

for me well Thanks taking question color. my wanted spectacular Hi, bit as on I guys. from a Good to just and really quarter. morning. of congratulations get little a

the million caveats maybe really on been sales your vacation projected to about COVID. $XXX sense caveats just and how little year mainly I a to least wanted you've that. could some color of bit couple But So, thoughtful at rest the about get in a summer look and with of providing of those schedules

exited to I'm enter far the we August, how of relative this of trending kind just two those you And of a so couple have I then, middle So as are factors how wondering quarter follow-ups. XQ?

Jon Stonehouse

Charlie?

Charlie Gayer

said, So, summer. And vacation, first good questions Tazeen. And is this going people yes, our on patients. as and doctors are Jon

And been watching. so consistent far. thus we're strong something But demand that's has and

team, a sales make able as in But was they're The comes. done team -- far for QX. We've prepared that prepared been difference. to that anything And to in COVID. As COVID, we were launched more COVID. calls able this. in-person makes our We've for throughout we well

variant, watching $XXX the million of it's But et we're it. in less in terms delta of our in rest million slowing $XXX we're the could just things meetings with that year the affect something confident very cetera. than for the in-person no But medical So year. --

Jon Stonehouse

we've that face-to-face again to the -- College is to we're happening, is opportunity. missed College hoping very, opportunity. that attendance $XXX in will year. if -- prevents opportunity that if yes, COVID in Meeting the face-to-face add stuff together, the if like getting But there's a Tazeen. just confident But fall the patients be less no lockdown from that'll Getting is we're it meeting and and medical happen a less or that than November would that that for missed fantastic. face-to-face I If heard meetings, Yes. an doesn't be it's a very virtual million the that's positions together the

Tazeen Ahmad

And seeing COVID. the we Texas, I that for Jon. that Florida, of highly another states that you're uptake, get Thanks like to there see surging delta to we correlation reports in question states of populated Is your Are seeing traction guess Okay. any maybe you any in California. wise so higher there? are kind believe ability rates geography that and impact the on cases on are between those

Charlie Gayer

affect The face-to-face. is. terms in any trends are What's to seen ability of a do throughout But we've state Austin read patient could that. the variability Texas mask. mask, of great a year our of to we're COVID of how state. example. require and City So within high the not seeing uptake that right? prevalence is What is directed doesn't the the we policies COVID even requires kind local just But what the there's

Tazeen Ahmad

the for on then me maybe PNH is Okay. Thanks. And last question the market.

recent a approval So for inhibitor. their CX the there was from TELUS

think the in how positioned that and As how could evolving. you think your change about you drug this any about market Does way there? be the market is way

Jon Stonehouse

Yes.

and drug I day or think that a we've answer Charlie every oral days. four simple twice got the really three a is is me remind

Charlie Gayer

week XX injection. milliliters Twice per a

Jon Stonehouse

Yes.

in they've been real a burden have about of gives that injectables. to be of combo regime it's learned it's a anything HAE, could treatment from that I a So, therapy. think disease and patients all opportunity we've about very burden and reduced if Tazeen, right? So about, we controlled competitive therapy, dreaming And with

Tazeen Ahmad

Okay. Thanks Jon.

Jon Stonehouse

welcome. You're

Operator

Jon from JPM is the of question line Securities. of Next Wolleben

line Your is now open.

Jon Wolleben

A taking morning. on congrats good progress. for ORLADEYO. And on questions. Hey, thanks And the the couple

that new on You if the color targeting of how on kind any mentioned have you tell prescribers of ORLADEYO? are Can have prescribers. there's that per number And how been us you your average many now has approach patients XX% you prescriber and going?

Charlie Gayer

Jon. questions, Good

them into But of really But group. still is number before treat about have amongst of prescribed. said HAE not is of great targets I've And made doctors what progress, existing is that So, high patients. prescribe penetration great intent majority about that them. the XXX one tier our the we've to XX%

the of a we per want the ORLADEYO point. We've have go with started patients doctor What average doctor. there ORLADEYO prescriber for progress multiple the the across prescribed then patients year who And goal then of prescriber this deep the opportunity that's getting of prescribers. number we've our lot broad have of and bullish made lot we're with list. a I'll about. very into say within and prescribers that about kind the at had still of base is to But the next So, we

the of prescribers expect more we future. in those a lot multiple So

Jon Stonehouse

the the And put to of Yes. course rest the of leads of at Jon on, of day to more on year. and all that start over patient have maybe end doctors put experience a who one the upside, good that the

Jon Wolleben

And you're expect we're That's maybe Can REDEEM-X? one helpful. XXXX. in starting any both a Thanks. you timing for the enrollment that earlier? Do without at about And titration or outcomes versus what thinking how or higher proof-of-concept. did you difference dose you did that and on you two given on REDEEM-X comment in responses the

Jon Stonehouse

So, Bill.

in might You because we that to clarify want study. first, that XXX have did dosing

Bill Sheridan

Sure. Yes.

milligrams of and experience differences. We So we dose. in escalation There day the twice different of go too several we've with dose in levels to milligrams no intra-patient safety the had of plus proof-of-concept individual the plenty were had XXX higher also XXX chose at cohorts twice a we and have that day. a range

had We any signals. safety haven't

in a very rare to dose. and see that And comfortable With of learnt that to we predict going HAE in that go. to we've milligrams to diseases day enrollment. So very regard you're good Until started of did. we really XXX how programs enrolling sort we responses the the twice expect it's hard

What do we we approach world and a the way with all that? sites we broad that's cast it. terrific uncertainty do cope net about how and So, the is select around

patient reasons with improve we that that remarks, about it's for of data is So, very patient enthusiastic advocates to March. as the And and the mentioned in fact deal. I about testing drug the a interactions I leading big we've all that mentioned in oral this They're had care. fantastic hematologists my shared medicine an with

to hard really it's So predict.

the in and to enrollment then up better having start we look studies forward we'll be how so, the goes and a seeing And position.

Jon Stonehouse

Yes, that. Jon, add I'd too

of it's won't drug in going on and about which choice. Bill other their and Helen studies market challenging. competing a U.S. say rare I'll sponsor it's should, one But brag thing be With is appellate work and the the that on they teams disease, the and but to this,

relationships the with with build is the best staff, honestly. that coordinators, So with the the site site PI the study they

that in terms with so, enthusiasm working difference us. a of makes And for

Jon Wolleben

the Thanks great quarter. and on congrats again Got it.

Jon Stonehouse

Thanks Jon.

Operator

of is line Raycroft Maury the question Jefferies. Next from of

Your line's open. now

Maury Raycroft

Hi. Good my quarter. morning on the everyone. congrats And I'll add

it what compared world X ORLADEYO on real do For data the the have you world for point at you studies? seeing that some you're renewal know any provide collect But you're a the Phase of to publish is update reference? to at can a this latest specifics. lot there? more potentially point? real efficacy I of what's And to seeing guess providing you're I some your perspective plans not way And into script

Jon Stonehouse

Do you want to take that.

Charlie Gayer

Yes.

weeks reduction the over call, So works somewhere really as long XX% this the I term. in attacks drug mentioned shows on over XX the just

from world are Yes. data then as and hearing. doing products, XX% they're can from far And the to real things the our long-term around data, looking expect in clinical world to only most which We're we're is you going asking… but not keep also -- as additional the I publish acute-only or and U.S. And future. is of other which you're Patients patients at what plan. We us to regardless other look world whether think well prophy so, on of really of coming this that's switching real from do our XX%. drug the

Maury Raycroft

Script renewal.

Charlie Gayer

real a really drug of very one really pill a we and compliance it reflection And close was works. in day and high that's this in does Patients what to our the and it's very renewal, rate. trials a clinical world. script high know easy What compliance, saw yes, we're they're compliant. that XX% take The to being seeing

Maury Raycroft

any more helpful. can specifics And Got one you perspective XXXX if then just PNH study, that more discontinued combo? for on patient remains it. the And patients the four CX the on any into That's wondering provide when into CX?

Jon Stonehouse

to that? want you Bill, take

Bill Sheridan

Sure.

the and to took as to if data and patient the reported by program switched a individual made inhibited know they that, that patients it we've a they three CX each from the fact you monotherapy many existing investigator ten you is inhibitor of to been that months decision many, the out mentioned the move at calls to another year evidence previous hadn't time. discontinue still in in and by think look I sponsor from the site

was not remarks, discontinuations we're I have ahead the made need don't data was that hurry in four We're inhibitor And that patients the -- [Indiscernible] particular So, in for mentioned here. any it investigators many of whether decision with recent. the as now. the CX We already right moving the reason my studies.

you'd recent. in over data so to So the time, it very like mature PNH see was

decision in yet? The the about your time study investigator other matter question just was the of the other of think. it's individual I part a like hasn't the to make switched for Just

Maury Raycroft

it. Got

Okay. That's questions. my for very Thanks taking helpful.

Jon Stonehouse

Maury. Thanks,

Operator

Next of question Abrams Brian line of is RBC from Capital the Markets.

Your now open. line is

Unidentified Analyst

is for Brian. Steve quarter. the This Thanks congrats on on again for our Hi. taking question and

to So received week's looking you've from comment physicians GI are this FDA reduction for were Adverse few it you can events feedback for on looks GI Thanks. And reported. Event any dose issues? that there due Report, like ORLADEYO reports any a of

Jon Stonehouse

we need package our color Bill take mean, circular the that's known XX% due fairly in add had I'll GI a if and to if event one even quickly. to you it. clinical we've in adverse that's I any in seen maybe the we've It think Steve. Yes. I I'm a it And mild. study. clinical that goes retention one sure maybe It's adverse away not to events. trials. And typically had the dropout

the other anyway, the our in group the properly. have any with really what you the it's drug. issues that's not they're if I seeing. And Because And counsel our also and controlled meeting then physician really people launch carefully. then, think nine important the about of expectations is, our into when be that think terms expectations So thing making to opportunity patient you on patient it, have we're to we're really sure working setting and absolutely well months the sales very services tolerability

try, key give that's this. oral, day right? you once time why and a If to the so And a wouldn't enough you it it's

good. so far so And

Bill Sheridan

hearing happy really on we're are patients hearing we're the this Jon, that drug.

Charlie Gayer

for would sales and drug. I seeing consistent safe we're in database add with effective a our labeled is example, what adverse just have -- the description, the yes, FDA totally So, event that we

Unidentified Analyst

Great. Thanks.

Operator

is from line Chris Sandler. Piper the question Raymond of the Last

Your line is now open.

Nicole Gabreski

and squeezing us the Chris. for on morning. in. This Congrats Gabreski is thanks Nicole for Good quarter

ones going I on commented So I to I guess been guess AEs. know with retention, of the the driver time or most on two back just market, just else? more I ORLADEYO. then HAE tolerability just the on how And quick success just initial how Has discontinuation just guess what's you you But will been it so response Kind and as patient just active common patient far? trying much second growth patients gauge or related access word patient something had on switching. the lead is? community future us Just or to issues remind mouth ORLADEYO of to one. Can potentially the of have

you if there? feedback Just Thanks. wondering have any

Jon Stonehouse

do to Yes, want one you that second Charlie, first. take

Charlie Gayer

Sure.

a really the this well is U.S. very in communication of community, active community, HAE As far organized, as active lot the between a patients.

a not we So to COVID have far is that see patients opportunity. What just able in-person big thus of have been as do meetings. because

patients word start missed some And and about have of very of patients so, good to a talk opportunity. as and more talking mouth as more expect become other experience earlier going Jon with we is that as each ORLADEYO. But becomes was strong to a really to

Jon Stonehouse

clinical We're And today. range just of times stress said first on saw three in discontinuations, Yes. within these what me that Charlie has trial. the the we let the as

So in stay XX% greater our or on our drugs.

And it all in be low. adverse over is mix is works rate drug No can right. discontinuation board, the everybody. That pretty events. So the the

efficacy really a broad in but be of could mix. it So lack mix. It's some, a it's

Nicole Gabreski

It's Thanks. very Okay. helpful.

Operator

the I'll Stonehouse over turn to final for now call remarks. Thank Jon you participants.

Jon Stonehouse

Great.

they they've the They patients do up patients suffering to with know And of employees. it is able our to with from discover, diseases now develop wrap amazing absolutely and a rare market of I to me be commitment to shown are a waiting. innovative bring me. Let call you thank sense the that to mean, drugs huge, urgency. that for huge all

you all rest of So, I so updated to much the a keeping year particular to have thank to BioCryst. And shareholders the future really you are those great employees that our and unfolds. you stuck you in with we look excited of thanks of And we're as about of for hope the have Thanks But us. too. company. the day. forward the

Operator

concludes that joining. all And for today's you conference. Thank

disconnect. now You may

BioCryst Pharmaceuticals (BCRX) 5 Aug 212021 Q2 Earnings call transcript