BioCryst Pharmaceuticals (BCRX) 6 May 212021 Q1 Earnings call transcript

Company Profile

Participants

John Bluth	SVP, IR and Corporate Communications
Jon Stonehouse	CEO
Anthony Doyle	CFO
Charlie Gayer	Chief Commercial Officer
Dr. Bill Sheridan	Chief Medical Officer
Megan Sniecinski	Chief Business Officer
Dr. Helen Thackray	Chief R&D Officer
Jessica Fye	JP Morgan
Liisa Bayko	Evercore ISI
Ken Cacciatore	Cowen & Co
Serge Belanger	Needham & Company
Kenny Chan	Jefferies
Brian Abrahams	RBC Capital Markets
Tazeen Ahmad	Bank of America
Swapnil Wagle	Barclays
Jonathan Wolleben	JMP Securities

Call transcript

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Operator

Ladies and gentlemen, thank you for standing by, and welcome to the BioCryst's First Quarter 2021 Earnings Call. Please note that today's call is being recorded. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. [Operator Instructions] I would now like to hand the conference over to your speaker today, Mr. BioCryst. of Bluth John is floor yours. the John,

John Bluth

our we'll morning, Thanks, Stonehouse; quarter press to me Doyle; Commercial Helen Officer, Thackray Chief Dr. Sheridan; on Chief Officer, first Charlie welcome corporate Dr. and Jay. Chief release Anthony R&D are Officer, Officer, Megan Gayer; update Jon answer available Following Business Bill Today's Good XXXX call. and BioCryst's conference with Sniecinski; and financial CFO, your remarks questions. CEO, Medical Participating our website. is today results and Chief

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

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

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

Jon Stonehouse

This evidence Thanks, BioCryst the to very latest this company were discover, revenue commercialize that first This execution for now our more result QX Sales develop our from through focused taking John. Patients The have all are off oral I great patients great drug. is quarter few major great can first This excited of launch works. and we because in with that transformation. rare from is the of they Great couldn't sell of we one It a reductions desire the company the a by and in our the marketplace. attacks, can and on-demand direct trials, in a our out in switches three. earnings the a don't leading suffering especially diseases, can successfully exactly their playing what ORLADEYO. a very this research our product. therapy. is launch clinical call medicines market be start do build to already companies capsule drugs have plan and is of team, BioCryst a a encouraging day. by launch and considering patient saw going experiencing meaningful is once it's prophy themselves. is from injectable to It's achieve

Alan working and an and our more more many great experienced through We and reach couldn't importantly achieving with the we're U.S. pleased We so getting, assembled obstacles news, good the challenges going like start but also with Charlie just fantastic USGM have to in COVID a results. team, more Hodge, the they're team, patients together be working and

U.S. While around the other we is approval market, territories major the largest now in have world.

markets from We're peak EU. launch is countries different partner to in Factor complement but contribute full we Torii the these of PNH Japan studies take are too. ramp many million rare in these from with the heading and our the in syndications. and the is finally, with pivotal suffering have expect pipeline patients goal were $XXX And in sales. plus proof-of-concept U.S., investments into will longer Our for oral achieving different inhibitor to here made our global opportunity recently approval mediated same BCXXXXX The in prior planning received diseases. The our D we've and as we launching overtime

rare through as XXXX diseases. for oral create commercializes to suffering that We off patients multiple even program will drugs apply build HAE value to greater and discovers, all the and learnings company from success a of develops market that

over our more go Now, ORLADEYO Charlie success. I'll Charlie? launch turn the details call about to to over

Charlie Gayer

The also a pleased We're psychological patients we drug but John. surprised. not want launch the off ORLADEYO patients We therapies. had Thanks, knew when are for reduction, injectable confident us physical, of start. range of tell on is the of prescribing great safety tolerability. and the broad in Physicians a they great a because to they data long-term and burdens ORLADEYO logistical attack they're tired see

competitive prophy. are for now In seeing that from Here's what switching they the so acute switching switching starting treatment once ORLADEYO an the prophy first we're injectable ORLADEYO. option. to are time far. patients daily The very a rest market, half Over are only have oral patients from

ORLADEYO The rest on to trials of were continues from from The patients patients our transitioning QX those of In program. in who expand. the access switched fact, also early were by the prescriber end products. majority base other clinical

intend minority Former a XXX investigators minority but treat tell and so ORLADEYO, all thus clinical has accounted of trial ORLADEYO prescribers reached far. QX, physicians in for HAE only to them. a has team prescribe they of nearly XX% our roughly of physicians Most these us done patients of

there of and in the And but products Most QX many also established PBMs a coverage growth. room So, for reimbursed payers to through reacting came are is ORLADEYO. of payers favorably policies. lot exceptions, finally, medical

Our launch team and coverage the commercial of made to an execute. by we The how was knows investment ORLADEYO momentum this that most building with in experienced patients majority is to to strong for we have important expect great payers midyear. access

Manager, Sales, a team disease U.S. to market They every for market talented always BioCryst knew fighting the a protein. understands what a an patients of importance Our first and in Allen competitive created HAE successfully they General our that drug ago rare Ron because agile patient U.S. They decade and like wants is Dullinger came HAE. for oral the over Hodge that of Cinryze VP wanted. really and attracted

getting vaccines the as to excited limited but started. QX this As just person this. COVID starting results we is calls, team in are is are sales change about

and prescribers is more even in ORLADEYO. patients are Our switching marketing giving and to reimbursement in starting expanding to just programs kick comfort access

is believe trajectory, million. We understanding but prophylaxis are Awareness $XXX global the and use options. lagged sales HAE and we reach expect largest of that opportunity, peak on will and meaningful of of the has HAE north Europe U.S. is U.S., lack part and but sales of very based confident targeted of on first with about Europe. The ORLADEYO in par growth we

active worked that how the will investing European or Europe share with rare We're to will an XX% another at United physicians prophylactic Kingdom. and Our quarter this as to specifically Pharmaceutical treatments options describe and patients Japan. early that to than are us disease in of Europe in the approach launch tells new under look therapy our right the availability now double sharing and Torii patients. know in forward approaching commercial this the teams in coming ORLADEYO to once more Megan taking over programs about opportunity. same are products. in experienced launch the France there access I'll and turn way and yet daily U.S. ORLADEYO in the Germany is partners oral to quarters, more We in more call

Megan Sniecinski

the Europe. I completing Thanks and and We're regarding last in Charlie. are commercial There again excited now NHI important successfully is Japan few launch a month. underway the opportunity it from to U.S. points emphasize want the the what makes different negotiations price Japanese after

head First, oral medicine suited market building population over once and has prophylactic prefer With start well the the to in that only for is our approved injections. is therapy Japan. a daily in tends oral no ORLADEYO protein a drugs a competition, Torii

on and identified was chose patients of Secondly, while successful accomplished with are to what us, and access launch. by Their strategies only successful as fully on helping lags we HIV based Japan vast This similar U.S. a and almost XX% focused Torii the heading of standard focused well patients are providing majority supporting Gilead's the launch. about One in the strategy patient driving has advance their first EU as experience are today. into approved medicine. and is registry to of to strong to amongst HAE business in Torii was the focused $XXX on behind in been served patients Torii they diagnosed, million prophylactic this And This finding advance grew already increasing identification. on ORLADEYO's reason care foundation franchise. annually. awareness a the preparing they physicians very

decade see We similar in economics, XX% opportunity. of we of and to strong the we care. following prophy triggered a Torii's pricing, have we HAE $XX of Overall, of standard of in to patient the from milestone sales. to royalty partnership payment as path get expansion see a and million Japanese the our diagnosis XX% share outstanding tiered potential net what market, part and by in last market driven the adoption long-term treatment through to success an U.S. Lastly, the with a provides follow

this of lot in not a launch, is As U.S. by Charlie shared, start. we're surprised there momentum the early and excellent

you do year, new will this the disease to clinical patients data, overtime. under on are getting on of ORLADEYO their their has course impact Patients continue lives highlighting reducing control, see while independence. treatment and the how Over well

offers more ideal they work Our a an and of attack choice once also daily patients. is discreet desire to for understand a treatment and how oral the of freedom physicians ORLADEYO benefits patients all is the helping convenient, It control pill. lifestyle

Our this focused strategy remains treatment paradigm. on shifting

over D the patients a our working. to for Bill earlier, switching, now XXXX complement unmet need more early very our about see turn which our evidence spoke similar I'll Charlie program. with are progress. it in We opportunity is Factor strategy As is on and Bill? space

Dr. Bill Sheridan

Thanks, Megan.

well. and here trial doing the around so great it collaborators to the ORLADEYO everyone their world, developed So and see discovered all clinical ORLADEYO launch is

trial in dramatically BCX suffering other results a oral to treatment success clinical like XXX extravascular In the controlling the pivotal very inadequate not be standard outcomes reached fatigue will benefits still X.X hereditary in patients with the grams the of the to to PNH and trials measure per impact release and start obvious administration get it nocturnal nasal in dose disease include of response reported both inhibitors as very BID. of outstanding is support and substantially naive complement hemolysis, releases CX of cannot inadequate very those inhibitors. size with available baseline we because job hemoglobin a both trials on categories hemoglobinuria. One hemolysis. approved biomarkers great endpoint improve similar For paroxysmal X.X and program the of of is will will trials, to rare relief control had opportunity we've these of BCXXXXX treatments with that disease including CX primary main currently serious in patients agreement clone design because pivotal and patient monotherapy is advantages this are lifelong change on symptoms. transfusions oral who come capture and The both reduced quickly we infusions. PNH changed direct will baseline and intravenously both BCXXXXX in from milligrams measure are will is with in drugs. the oral we The such patients, intravenous secondary agreed response as Patients on fatigue. grams trial beginning patients it in include A deciliter per our an angioedema CX These and indication ORLADEYO inhibitors the pivotal two symptoms to currently PNH FDA That's naive for all many physician receiving PNH. no medicine will with of is inhibitors, from are oral top the good March, well treatment be in important trial. to need we PNH to a The CX scores, the of non-anemic, patients during moving FDA clinical from with anemia and effective, also endpoints for BCXXXXX very to I'm safe shift for and endpoints continued the anemia. patients patients and treating diversity do from transfusion hemoglobin The to and pivotal deciliter control The transfusions other care but pleased dependent report hemolysis. now infused trials. intravascular has therapy, PNH.

heard eliminate the patients prospect of with a March As IV outcomes needs in excited you and hematologist PNH of are infusions. treatment and that very could the by improve dramatically

paradigm oral complement that PNH our drive in addition We BCXXXXX. a in are will pivotal convinced success towards in proximal with studies shift

second now program, we designs in in directly using to ready in the agreed into the next the pivotal this what's the move with are year, trials So, of now FDA. PNH half the

very BCXXXXX We representative quickly half patients will this excited concept a also molecule to of year. are program to move in selected trial we pipeline waiting. into nephritis the proof be is we're so this in the of indications because know second moving

the call like to Anthony. I'd over to hand Now

Anthony Doyle

great investments can three territories, we drive said With U.S. focusing are Bill. value. that team to well off the launch executing are positive we where our future Thanks, continually greatest key data the strategy in now are that start getting the commercial and very BCXXXXX, global the a we We've in approved and ORLADEYO for a positioned the growth. they we the have

this our U.S. like earnings to release in find in was a Net today's for sales I'd came million the detailed financials can attention few from all $XX.X $XX.X You call press your the items. and the million of to revenue of quarter ORLADEYO

impact to to give us revenue, cash. full couple shipments approach We continues contains our revenue BCXXXXX. quarter take now runway the and XXXX. in QX non-cash investment pharmacy you directly to access driven will inventory see our biggest I the shipment XX-day specialty These expenses cash, million revenue from specialty When items. sourced operating to ORLADEYO a incremental our focused the patients, to the you addition by previous $XXX $XX want of remind compensation when stocking this not and or including with from from to Our we at into Each moment minute the million supply look of will is additional are a from the recognized XX sold, to million ORLADEYO. so are you of This was of of gross for channel Athyrium non-reimbursed with pharmacy of to key true the be numbers. a cash quarters on Since they in use. for We ended ORLADEYO shipments. shifts not revenue development and in net, patients first sales ORLADEYO any quarter a

be within differentiator a a Our quick growth adjustment assistance patient center of being is than ORLADEYO, be submitted. access start form now start real in start customers resulted XX program once getting both net but is the to should program in mature products. are the with and the has the to in a our our phase. and higher we launch, is more growth in Because so net progress adjustment growth with launch our it as program sometimes of guidance, launch, being proven ease to disease the other you gross not expect delighting in in will line speed continue in quick of early move The providing fluid rare hours and we to to

QX did strong in our for of future bolus does quarter. clinical Charlie's the job first what periods? trial patients, a giving us So, great mean a team converting patients of

really this from great for switched the a helping in only team success periods. has us gives injectable achieved or prophylactic new Additionally, patients medications. Together, many strong acute foundation future

impact guidance better that understand. We growth have will to we as need the variables more still not of revenue provided several trajectory revenue that are time there

monthly time of state play While it the encouraged steady with need we the to prescriptions? very out. see numbers to-date, more is what First, we've been

customer weeks, trials, retention was XX% control. providing this look time? In a well-tolerated through us was that about number clinical telling Next, outstanding like is ORLADEYO does and longer what XX attack over our

when The we While majority still we what does this case. reimbursed. trend whose $XX.X the are the have early in look ORLADEYO are this of is And like will see persistence from the market, net revenue only the level patients that too patients believe prescriptions of to is lastly, in confirm reporting it's we reimbursement. vast million

of quarter revenue reimbursement making we're of the for of the good growth especially will remainder the getting But driver policies. the a in over As be onto ORLADEYO Charlie rate key year. the us second progress, over, described, in pace

launch, very While we early encouraged to-date. results in the by are the

of We have lot work patients a more too. lot and to of to generation get a do, next this drug

We and launch $XXX in a making have years. it we the is our coming the over for back product on to plus it, success to John. great peak ORLADEYO. of patient demand million a team our execute I'll that, strong us hand target in and to With have getting There

Jon Stonehouse

molecule. to be will peak to a into global and plus to pipeline product. the the finally, revenue, $XXX is it execution U.S. that ORLADEYO with product into balance BioCryst a plan flexibility creation, that, is one pipeline, And more. looks This what full with will launch and like. produce evidence these million advance value into clear and generation the We're having in revenue us believe open produce Anthony. allows pivotal with major launch parts great PNH prepared world, and We'll all contributing concludes engine on Add is moving your studies remarks. a we that comes with the XXXX start of continue starting transforming sales Thanks, sheet focus in strong of what now a discovery to questions. the execution to parallel that financial our and for the other our and indications off up to company other a That in in compounds with a in this

Operator

instructions] the Jessica question you. line of of comes JP first [Operator from Our Thank Fye Morgan.

is line Your open.

Jessica Fye

guys, was specifically some if you you a strong from? are see color good I switching Congratulations patient could which ORLADEYO switching add a quarter. agents morning. on about Hey, do more on curious

Jon Stonehouse

to you Bill, want take that.

Dr. Bill Sheridan

seeing proportion their to mark from morning, patients good really Jess. what switch Hey, Thanks therapies Yes. the the share. the expect for you'd different from market We're question. all in

Haegarda, their prophy than So, and are injectable as the means share. half switching that than I Takhzyro, to Cinryze more market mentioned, patients from more proportion

Jessica Fye

not mentioned not in scripts quarter. what scripts first say of you were you some proportion And the that Can Okay. reimbursed? reimbursed were quarter

Dr. Bill Sheridan

continued comments, we with specific off starting patients in with details, in nearly in mid access through our prior And to all go and payers doing but but with as program. And expect quick we're we what the his exception, authorizations. most patients on year. through QX, through providers make and work is great medical start making we're get then commented We to haven't progress patients mentioned Anthony progress

Jon Stonehouse

are on in the And that doctors by both there's and Charlie where physicians. formulary, remarks be to around place ORLADEYO more is prepared more made policies just comments his in interest the going

Jessica Fye

one it. Got question. last the just on And

move that longer other with term that'll mentioned disease rate You line drugs. in

you what are typical So, disease? growths just can in characterize or

Jon Stonehouse

frame. looking type perspective, From growth the teens kind at of we'd what be of getting a into is XXs

Operator

you. Thank

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

Your open. line is

Liisa Bayko

quarter. And to I studies my add on turn congratulations moment. the going PNH for a to I'm a to wanted great

You sort of the will already discussed look what in both of control like studies?

Dr. Bill Sheridan

Sure. I Hi, a the study Liisa. into of inadequate the response not other trial are had moving patients patients excited in will against am taking group have Thanks super question. the one about superiority studies, be for of inhibitor a in course, and CX inhibitors who these CX study placebo. an control who and to

Liisa Bayko

I the, Okay, the how How on can superior people patients maybe group? you will for describe inadequate be to that then responders and that guess, inadequate looking combination will moving at be are or be responders you'll at you monotherapy? work CX? therapy looking the Will for

Dr. Bill Sheridan

Sure. have as designed Both studies monotherapy. fit to BCXXXXX

So their continue treatment. monotherapy patients trial. BCXXXXX current CX and will current discontinue to treatment randomized or randomized the be inhibitor in We stop

is is monotherapy. with treat outline a a is, this designs PNH support label reaches just goal to indication the to to the this label. study a the There broad reason to patients is So, and here from

Liisa Bayko

Is onto from kind How combination do monotherapy how of and that How switch a is And Okay. then work? it work? on withdrawal? or does does there that just a something go therapy a patients CX?

Dr. Bill Sheridan

is switch. just started, the No, the a oral XXXX drug stopped CX and is this started, inhibitor

Liisa Bayko

Okay.

that the we being II? a that Phase We of us see you terms sense Phase when your Can in in on in data monotherapy. might I, of haven't seen yet population give

Dr. Bill Sheridan

particular and be The will that's call, the specify share data but physician able Sure. a of protocol to expect chosen the the doesn't timeline end we the year. we that at

same, of are start same. disease more and disease the Now, naive order patient confident the data is set from basis for study regulator in the target results the the that because the very dose disease us is on is we the the population. in The the to the drug monotherapy asked

necessary start So, before it's data not study. to for see that us we the

Liisa Bayko

rest is patients prescriptions on And I or great this kind that color obviously color final of of additional the additional any quick on there? launching you Those then to to of the percentage any of great of And could us question if your the can and percentage the to receiving guide provide key of start? turning my way are that the year, persistence? and questions provide were So, Good. Okay. ORLADEYO, guess color you either that's as help drugs in think really some start gates, on like help there just you just really program, you. the about thank off to

Dr. Bill Sheridan

Sure, Lisa.

so, of QX, quick start, nearly on So, strategy. started that's on all and of quick-start the percentage in our part patients

then policies. access, patients we as year, mentioned, world. we they'll we great question we Anthony the them with with established of clinical QX, on most in our least what far at as do about for a As real work get trials reimbursed until results if your payers had expected stayed XX% And about we got had persistence, that's patients to it in through expect and as that in I continue to as were on mentioned, the good able not free year medical exception,

early great, far long-term what been has persistence rate So patient say it's but to the experience will be. the too

Liisa Bayko

Okay. quick prescription it And is monthly program about, on start didn't a And is reimbursement? until get it

Dr. Bill Sheridan

is patient month quick-start in program. reimbursement there or will That's assistance either if a on right. not month, we continue It's and our there, them a on

Liisa Bayko

it approximately guess me is one final taking long how reimbursement I at question, point? that on to get Okay. leads just to this to

Dr. Bill Sheridan

plans. from as to patients of the a and majority through mid-year, will the being we expect on program days by Everything great still to stabilize their that So access have the in few all it's over QX, board. coverage patients to really

Jon Stonehouse

fewer more That's, have And quick paid and Lisa, we that's the year theme the fewer people start. plan. here that, and is on will and on more drug as progresses, the

Operator

you. Thank

Ken comes & Co. the from line Cacciatore Cowen of question from Next

is open. line Your

Ken Cacciatore

guys, early progress. on congratulations Hey, the

things patient your the good wondering, we really via hear Just interactions on both clinician level hub. about and

wondering, kind competitive that learnings the terms feel but but as there, bit you here at you kind again, bit feel you're around be to more of So, underway that about approach seems staff Can changing your if shot just patients more personalized to enroll from should really I to better you're the more? know you. nuance get bit go when of know, data going from in little a might of it really this you a about Thank as that these these to at your for maybe early looks of feel, talk potential some but if staffing little it's fairly announcing of maybe going kind expect early, little it talk selling be getting things as faster, any take wondering EU, do results, to some of or on Then difficult? start injectibles, things maybe it domiciled? bit easy would just see Maybe be fantastic? Bill, the and maybe just to learnings a a And nuance things Is Europe? you ramping, timing are to you really lastly, of efforts are focus landscape I of and appropriately? like little patients, where a then at a some shot we well, fairly pivotals, the

Jon Stonehouse

for Great, the questions Ken. thanks. Thanks

patient staffing. first specialty just program So, about question our pharmacy and the services had you

great a this right about things And the we as then sources, really see great from the staffing. working One SP a patients. his the sole having prepare pivot Hodge, job to done Allen we demand has team of for with

those patients well, and increasing serve the they're making appropriately making really and So, increasing staffing to quick it's procedures, difference. a changes

As the or really that. treatment thing EU, is the about, and are difficult how patients is question EU The good far centers as to very that about great access concentrated. easy

have can patients of hundreds center. within you literally a So, given

ORLADEYO them coming out what doing is and patients to experts their And so centers that the aware teams that bring and make is the our reach working center. are to into them those HAE to with

opportunity we're So, really there. the about enthusiastic

Dr. Bill Sheridan

And clinical Europe. these treat is trials first doing generation Ken, all I'd to in way add a known HAE our the we've BioCryst entity that to doc's progress. back been that, And

we've the in fantastic so, involved relationships, excitement time. level Company, been got and their they trials, they've know our and And so

Jon Stonehouse

give what Ken, finished? question great I a wish prediction. and be I the you study a specific could when will

I this I to we at get great a can really team that What need execution and think running. stage you them difficult up here at tell clinical have it's is we and is the we this And BioCryst. are advance major that to really going patients approach need to be it's we in drug, this a going on basis PNH this what believe.

cases And is be competitive so that here great like done. activity to on effective believe just as fast world HAE all may most patients, a has centers clinical possible. the ramping to all trials it in get patients the And the like related as with best go getting around we'll will studies And offerings inhibitor. just HAE, in

position they be study forward I finish. look think to -- will seeing better in the the to we start So accrual and and it making a

Charlie Gayer

what extra sponsor just rate in will in big PNH. what that Bill's help make we've be, the and predict. But It's attention we excellent a at know enrollment I difference will in right, be study the don't that pay gives to hard choice, space of I'd it's hard add, say, so a competitive just a larger just studied one because than far Yes. super in much TLC necessarily you, aim the doesn't of their is and team is enrollment. small companies is this least say to is thing where to

will that. And do Bill's that so, super confident I team am

Operator

Thank you.

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

Your is line open.

Serge Belanger

on are patients ORLADEYO, taking first a of covered transitioning this you access for guess disclose were trials drugs many questions. how Few And on the before, the I or at my Thanks them you morning. of good clinical did Hey, the end apologies first, from patients early of number quarter? if programs?

Jon Stonehouse

Serge. Hey, morning. Good

to have ORLADEYO. the ORLADEYO patients of we the to is on number grow disclosed majority the is every continues program I that. In patient end did clinical can then and say not by What switch and them on that in day the the We detail that, what transitioning patients, were say finished QX, QX. switching, and patients EAP, quarter rest trials transition new the were that, from our of of of as those

about growth, as going to bowl as complete forward is switch and is talks that ORLADEYO. everything that So patients Anthony

Anthony Doyle

like one they're process same just on of And the are complete have any clinical clarification reimbursement, that to from that, go quick-start patient to that point means assistance. trials or of They Yes. other switched through patient.

have been And not. some so, some have reimbursed,

Serge Belanger

physician talked think base the other big Okay. address? the HAE And next the you you about serving about XX% set physicians XX% that XXX, I of about to How is need of patients. serving

Jon Stonehouse

easily another out that HAE. X,XXX have are just they -- concentrated plus there We're really there them on as more Top know and patients they because really XXX they and reaching Serger, physicians well. we're

our well, as So, that's getting prescribing priority, we're and other doctors but from reaching we're them the too.

Dr. Bill Sheridan

achievement they with year better COVID, Serge vaccination, the I'd have first as did And that's is, quarter to what only things And in this even sales open goes get course on. more makes it in of going the the to generated we're Charlie starting add, his seeing so, with right? the and team that already up remarkable

Serge Belanger

seeing as lift? we're while overall that, switches? you And has been expect restrictions Are something patient number the impact limitations then what you with on will And that restrictions? Okay. on COVID, the is increase of

Dr. Bill Sheridan

our limited we're a XX% to talking calls make it. providers all of I Jon despite think our in-person that's great going this. And as in-person COVID about a visits. were in-person, big able interaction of with we than as fewer Serge, of all, more to do difference quarter first had was

is that, for easy Another doctors prescribe. is to piece oral

been have that more just something many visits their remote in though, for it's come. it's comfortable and more So, environment excited to prescribing a physicians patients. in-person ORLADEYO With what's it's opportunity to we're

Operator

you. Thank

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

Your open. line is

Kenny Chan

versus levels? is LDH what specified a with And This have would on questions. ICER formulary so safety effectiveness pushback from healthy a second was And Thanks. have two on is any are LDH Raycroft. adoption the PNH on cost going Kenny insurances the feedback encountered the FDA you question the reimbursement's And for reimbursement ORLADEYO, Chan concern? are insurances? on the I there reports? trigger Maury conversations on net how program, One threshold that medical exception, by on the progress the

Jon Stonehouse

Yes, thank thanks, Kenny.

of payer no, In drug. prophy lot QX. our medical on And patients well pricing it's And effectiveness, it lowest progress well. of acceleration to the price market. that really coverage the put going well reacted and is, policy ORLADEYO getting but profile to several the payers the then was over we payers our it's far they said as progresses, the is were quickly. from mainly see if payers switching Cost that over establish coming to the policies as as we we As demand strategy really the access, for this really QX, encouraging a comments, expect exception in ORLADEYO, have formulary. of And on PBMs

So, where we're with very pleased are. we

Charlie Gayer

staying they're therapy, And drug our on let controlled me the right. stress works, remarks drug made prepared prophy this If one that on and drugs. are in point people switching our are I

effectiveness, drug feedback take this So of want want Bill, the stress FDA on you work really LDH? that. to to do just idea is this

Dr. Bill Sheridan

safety question. secondary for do endpoint a either a an as There and or thanks percentage of the endpoint have change threshold baseline matter. that Kenny, as no Sure. from concern LDH. for We is

So, person transfusion life the cost a outcomes. of avoidance number with hemoglobin, in Romania LDH important improvements going tools another endpoint with is transfusion important assessment clinical burden transfusion also very such going things the but a down of with And score. worth in useful important evaluation most quality as the hemoglobin It's stressing, secondary in very fatigue change of baseline is biomarker up.

too. measuring fatigue important is So,

Kenny Chan

and benefit, Biomarkers And clinical you benefits clinical just about right. more was on are the important, it focused might important. interaction that but want FDA Bill, with talk the to

Dr. Bill Sheridan

regulator's the clinical course wants so, as Right, outcomes important of to see endpoints trials. in clinical treated being

all. from So, a as treatment changed have transfusion that's inch a endpoint in avoidance that's after we a primary and evaluating key of endpoint secondary the and in us says anemia give why hemoglobin baseline pain

of really we're endpoint. them. important primary interesting viewed to very going range as a not whole LDH biomarkers, measure enough simple. It's this to For be is

Operator

[Operator Markets. comes Abrahams RBC Brian Next line from the question of Instructions] of Capital

line open. Your is

Brian Abrahams

on launch. for was questions in if maybe launch. is existing to could guess the and prophylactic switching ORLADEYO? I'm as parse wondering, I Good you from congrats well into I the demand the you quarter's new patients first My first out wondering, to rate the long morning. pent-up Thanks or expect of continue? question my taking for acute therapy how might early year

Charlie Gayer

Hey, Brian, it's Charlie. demand pent-up and was Good question. And yes, there that. we expected

So is about pleased continuing. the they're always demand early we're really adopters. What is,

the their haven't with prescribed. to in prescribed there so day. opportunity lot is physicians us seeing in future, telling who of to reached, my as And the switched lot to come conversation a year. as have we've throughout come we're mentioned they're literally but these all the yet that then So, opportunity and patients a of remarks, every I patients planning ORLADEYO to They're

Jon Stonehouse

Yes. going just in the be we course to and through quarter million think we plus to confident And plus one more out, this continue the a that. peak to sales even then expect this strong and product, Brian, We is $XXX it's don't going year. that of said is it's peak we're that global

Brian Abrahams

respect really to That's it. and sort there? any expanded safety then days, on, you're And versus quick-start? getting real-world setting, to Got trial seeing how early patients persistence what helpful. of and new tolerability its surprises is for I'm the the I'm efficacy I clinical what the you're the but access And feedback rollovers therapy curious curious from compliance know and to with and then, comparing

Jon Stonehouse

take you if be Charlie, great. could part, first that the second take I'll the would

trials. do told that, question, smiling, I'm drugs as do than these better docs and the us in because clinical asked the that So you way world they real patients in

benefit up on it so, control getting capsule their once right? better, benefit. they're of and way, People again. getting say data we're doesn't represent are mentioned patients. at I'll day. the real disease, XX clinical think, I the APeX-X it the looking by weeks real keeps so, that, a just one from seeing looking And And Megan our This now to doing drug works. and They that really a we're trials from it are

huge, benefit. So, huge it's just a

Charlie Gayer

and Brian, through back pharmacy, new ORLADEYO specialty about then, they're the we great of from switching feedback because is world from the experience, to rollovers the word majority patients experience such versus patients we newly on the having your our very and patients, patients experience expect a early the trials great we are physicians to as our it. via And question who back strong, a that clinical back early commercial hear ORLADEYO as our hear of continue reps, and chose on great or having

expect point from continue switch pleased their about hear to to we more what So, ORLADEYO based patients on and my we're to peers earlier, their they experience.

Operator

Thank you.

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

Your is line open.

Tazeen Ahmad

you market more have think, clear the you're and new are reopen of patients once that, ORLADEYO, for in what to taking of couple any launch? that relative morning On relates you naive treatment Thanks will a to or to latest the is questions. naive guys. COVID waits normalize as to not I to, what percentage telling offices are the early of HAE, currently to patients, have patients receiving starts on more then of percentage my stages do that Hey, of good treatment follow-ups. wondering, I guess seeing the data just it And your who therapy? patient I'm related about are And scripts

Jon Stonehouse

the your different XX% me ORLADEYO of are it on I patients address is in let think parts. couple of of a I've got What think, about I let prophylaxis. See, saw question, we me, launch but prior to

be we're half switching of so ORLADEYO, the to are prophylaxis, but only. other in been to patients with of only quarter, treated switching the from switching prophy And Most from remainder they've patients more of so ORLADEYO may products. the treatment, than they those naive seeing acute coming first

are to on now prophy That's not an future, it once patients these but those not of acute treated least and do the in opportunity HAE treatment most prophy small. option. to to on have are the doctors switch daily of us can Our research truly by is small tells number oral deciding they a that therapy naive acute well their at patients patients with that an they're

Dr. Bill Sheridan

is away on a demand people this with switching it's right. this and this -- you walk stress is a That prophy can't is enough. and working, This with I they're marketplace therapy, drug, strategy switch on is walk where away an oral today So, anything right. are if to and acute therapy

point in And think COVID, harder. things playing maybe that's think, they about more, reps visit. really in doctors produce what, now some it I result I putting in here It's the clinical is market And patients, goes parts their I it's the they've a We think diligent been access great. to the docs of as in but great it's country, open quarter. our that resourceful. of get right? and we quarter, just And out think telemedicine, challenging So, saw first going the I they're research. only the and your And there's up for trials, in the been to and better. been right? It's it's been the has which saw marketplace, opportunity to first same off

better doctor. as the more see to gets I get think so, that And people start more go vaccinated and people

Tazeen Ahmad

very the U.S. expect it would trajectory Jon. we but thanks in typing just in see be And what know I then what to terms in it's any have to visibility that to very, colors launch, Okay, in similar early Japan, expect what the you of do on for Japan the And to is?

Jon Stonehouse

take to Megan, you want them?

Megan Sniecinski

sure. Sure,

trajectory as to be market and a on Japan sharing So, think, I we've different U.S. been Europe a the behind. than very the decade as and is

thrilled absolutely we're Torii and so, really has opportunity about to that And shape the build it.

But we're we're so that COVID a different treatment. me, think as slow point we tempered our that more So, may is they're out through of and your all-in-all, second also of proud trajectory year. out U.S. a can equally last for to like market the excited it gate Torii strong for near-term I negotiations $XXX,XXX per month, represents remarks, And net in also week, as in to with patient last potential so been a then and it the as completed the expansion question, currently price for state I patients of the see few and months, they to that to opportunities now in our this emergency initial the Torii for rollout shared my deliver. the diagnosis excited with excited ramp. really or about Japan is vaccine, of drive we the and long-term what protein more last and but with adoption And see around really with be and has pricing, per a price for excuse also our,

Tazeen Ahmad

could it's you. Thank that are to to how then PNH. few And running, expect to it's Okay. one on difficult know going I you take a I take question are if just maybe on There trials the guess responder but long the and inadequate could enroll do or other? recursive time, you read same the enroll, place me, would naive out you at think excuse one around to trial, both placebo for see than faster

Jon Stonehouse

this It's to either one the read to could say difficult time other. same could of at Sure. at pass, than They stage, the or those much possibilities right. very quicker approximately could come move

think I it's early to know. too

Operator

line the from Our of of Gena Wang next question comes Barclays.

is line Your open.

Swapnil Wagle

is Swapnil This morning. Hi. Gena. Good for on

PNH. on one Just question

go overall ahead this specific BID XXX you us expect with looked that So, what mg can versus of then PKPD you Phase let could dosing mg? tell the the trial size about be for and XXX III the to

Dr. Bill Sheridan

for question. your Thanks

about might like we're later to additional details that. at the reserve or studies this be year, for a medical So, meeting going something

modeling LHD and actually last the obviously the is biomarkers as superior This clinical where assay higher outcome disclosure fairly the at the that details through have all the So, we selection follow those all in biomarkers doses complement about information of quite the that will doses. With you dosing on be lower uses for regards and example dose, vitro like before how like the that responsive of and year happy PKPD to stage. share LDH. of useful is things to rapidly

goals into that So, I that drug goes well of as started the the as model as think levels.

Jon Stonehouse

trials, when in drug you trials, disease the rare let safety, a And over be so, these Bill HAE if And And I on of like with filed. add rare right? XXX disease is, it'll size. patients typically a therapy. we program, a something chronic XXX just couple the me for need the in for on the it's are expectation year mean,

So, it's roughly about.

Swapnil Wagle

Okay. Thank follow-up you. question. And then one

X.X maybe the duration pigment below for shorter do see expect you get a limit that period smarter of so previously levels we size, make normal? slightly that of mg for So LDH that upper higher of time over presented a XXX and to sample and you was

Jon Stonehouse

So, target that end study. point our not particular is an in

that's response to think important I the So, the most question.

end of fact, it's it's biomarker point. more inhibitor And relevant upper a improving and in is included actually nothing starting there In LDH. is the magical setting high the when it on therapy. not limit LDH as as the secondary measure the is It's transfusions CX a times will normal X.X about certainly and useful hemoglobin not But reducing and important fatigue. and with you're out as LDH the increasing the and

of So, studies, specifically long data thing. in all the have patient and the I we've that'll typical other individual fluctuates. expect of what in over a when inhibitors, period of the published sponsors seen to be this see see we complement And the the LDH think, other same disease see that time, all I you question,

achieved time. of by So, of if transfused of and principal taper we've it's But people the if treatment are all can nothing and LDH then feeling well, long objectives PNH. anemic fluctuate not the the enough,

Dr. Bill Sheridan

exciting have the FDA is is most an that the what's change Yes, which we is from really hemoglobin now exciting. baseline, primary agreement endpoint with

Operator

Thank you.

Your of Wolleben final question comes Securities. JMP from the lines of Jonathan

Your line is open.

Jonathan Wolleben

launch. congrats my sharing on and good morning, Hey, strong the

and I'm in and if payment few million ORLADEYO, there's France? for a Just royalty wondering if any contribution net your if figures meaningful of for the me. that's from XX.X ATU

Anthony Doyle

of the income net are then across reminder operating And below payments line between royalty over not X.XX% Yes, interest once those royalty of an get expense, a so just that income mesh XXX. then about as to to up payments. revenues we X.XX, to XXX The is the here as Jon? million the are $XX.X we and basically,

Jon Stonehouse

nothing, nothing, nothing. terms In no, of ATU, the

Charlie Gayer

was U.S. So, of XX.X. that that sales was all

Jonathan Wolleben

the on prophylaxis. the you're do on then, over future of that the guys you And just acute, the who HAE patients with sense levels switch with are one And of you're on you market? percentage if think kind switches in of market you out all prophylaxis? saying from patients seeing on any more now the patients have question Great. And where now

Charlie Gayer

Jon. question, Good

As confident were patients U.S. what prophylaxis. very that the about we I at the see, mentioned, we're HAE of XX% ORLADEYO of launched on time

from also to only expect treated what be is so, grow. switched ORLADEYO, And And to with XX% in acute the to that XX% prophy. of that tell of going patients patients, physicians is number future, therapy about they as patients that is us

same occur we Europe market So, the to is there. kind that launch and trend in shrinking expect our every after acute of day

Jon Stonehouse

been that playing out is Charlie in that the research marketplace. out turning it's And market doing the has

Operator

back turn you. further time. questions this Thank are closing no at I Stonehouse call for Jon There remarks. will now to the

Jon Stonehouse

got just I've and the of this product and of, ones to started. lot with my one getting done we've a most a I've that and is And So, fun a I XX-years part got a exciting great of calls say, been earnings at launch in great great BioCryst. a team we're

And revenue. a that's really product so, exciting to have generating it's real

studies go We our program. have a a an entire in pivotal into with green light That's molecule. next to pipeline

starting up be year. to going we're so, later this pivotal And studies

do just And continue better is focus incredible just they team proud now I'm get it So, the that. and so a than lot the of deliver whole that to our that. execution we'll execution. that, doesn't and focus and

in great company a for and day. thanks So, our have interest your

Operator

joining. today's you conference Ladies this Thank concludes and for gentlemen, call.

Have a disconnect. now day. great may You

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