ASND - Earnings call transcript Q2 2021

Due to licensing restrictions, you must log in to view earnings call transcripts.

Operator

Good day and thank you for standing by. Welcome to Ascendis Pharma Q2 Earnings and SKYTROFA Approval Call. At this time, all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. Pharma. now today, hand President Scott Financial at would to conference and I Officer speaker your Smith, Ascendis Instructions] like the to over Chief [Operator Senior Vice Please go ahead.

Scott Smith

Scott for Thank operator. conference I Officer Thank Ascendis. everyone Smith, you, joining Financial Chief you call our today. of am

Punnonen, Joining and Operations Commercial of and Dana Officer; Head Executive me Pizzuti, are Dr. and Jesper Officer; Head President today’s Mikkelsen, call Development Chief Dr. Officer; Medical Hoiland, Juha on of Jan Chief Global Oncology. Chief

and on Before Actual differ regarding regarding pipeline; like forward-looking this statements we our statements our are remind conference Examples or may in product statements. under by available and pipeline statements potential that intentions are us candidates to include, call SKYTROFA; be could regarding on carryout of our Act. progress; and and is or not should to our those such continued plans our that progress today. Reform our our these provided market These events forward-looking information and SKYTROFA, and regulatory statements the candidates; plans, of to based materially in achieve you the I but place to filings. or our projections pipeline or on meet may from the our we statements regarding are our reliance undue the statements disclosed statements results goals, the not begin, expectations statements would of not Litigation you their commercialization Private Safe Harbor will that goals with clinical contain our development respect expectations strategic continued intended Securities covered our forward-looking limited to,

impact update by may except reflect into acquisitions, or assume We Our the as licensing we ventures to joint terminate. circumstances these law. of forward-looking as agreements, statements no enter required or investments statements that change, do any not dispositions, obligation mergers, potential

been our and been approved investigational any None regulatory of candidates our candidates by actual on section promotional. provide use, Risk cause SKYTROFA on of by be please for have product On XX.X due SKYTROFA reviewed and we or of that quarter depletion hormone. available the will safety statements concerning as recent statements today’s patients failure the Report who most pediatric to additional the and was investigational the the forward-looking our the the products, not information of website least and in factors business results have We'll further section that kilograms Factors agency. weigh of candidates see materially, our discuss today's of are to older, have XX-F. effectiveness approved and For Otherwise, call could second walk as approved the Form to not shall today Annual differ release FDA commercial product at viewed growth endogenous regarding conference our the results of through inadequate one-year approval SKYTROFA. note and for discuss call, updates. product financial please product candidates treatment XXXX press FDA growth and the made on

we remarks, and the I up call Jan Mikkelsen, to the will prepared some Following Executive now our will then call turn to Chief questions. over Officer. open President

Jan Mikkelsen

afternoon. good and Scott Thanks,

where today an agenda. when the bring. But Sometime you in have days day about I wake of someway you will was up one had what someway morning, say you the think to

say. You dominant adapt to must I it like a

happy life. We what a today. that never a place new to and is have so forget, science develop innovative our think in with patients' that to best focus You in and need technologies great, that will But medical data, achieved very, potential element of all make products Jan, can are our meaningful you we key feel to TransCon we adapt at see you, basic if values use strongly I core best-in-class the in improvement address And Ascendis this we to needs. way say, happy today. And great unmet on a major I survival. see the very I have couldn't

With the SKYTROFA Hormone have deficiency XxX a biopharma U.S. hormone our fulfill step today, pediatric for approval growth the Growth to we become in leading TransCon to vision one near or company. our

give more a related to approval update related provide update pipeline more now would general broad like business of opportunities, and I SKYTROFA. the to of to advancing our a I product Before short

the found Scott you our be can to like would As refer the slides said, I slides. to on website. And

three. number the SKYTROFA, the with U.S. it. the U.S. slide, in the is same FDA time, from pieces. first have slide basic once-weekly growth really about technology the design to it's approval the technology, see now labeled taken TransCon is approved first to When now hormone the to clinical, next to go of product first we we think technology approval you and a the the TransCon developed our and preclinical Going we different for it's the At can The also the approved in proud TransCon but And deficiency. product I pediatric technology

science, how at is journey basic a see we with the you the Growth safety with confident to to right we the Hormone have describing But we the it SKYTROFA the be easy I the feeling seen are efficiency, leading will the where seen Today data up approval hopeful. hope an of I were been to the has releasing for TransCon to the the it. action -- not go we’re clinical have Your patients. really, strong and mode out could hormone really to and brand. build and it what so labeling basic fundament repeat labeling label have have, much a right we same as time, to going not And the look entire growth opportunity go of it's with from everything we basic what discussion, because because flexing with but have data will will is start basically basic that we it

of I and is what we to to long make basic SKYTROFA that have loved temp had in call same you If single kinds that market is five. specific has XXs. optimal the currently heiGHt have have despite a injection. you providing been have room programs new The basic the trials approval to to have entity the U.S., date, the stability. the built in first induce into our today what the support sum patient, an in developing you And that by in deficiency talk where on When been development we Trial, the daily the will which concepts that patients. the to What a in with call see patient advancement on clinical it's devices. Auto-Injector, element and facilitate treated more Europe, opportunity on about see temp for given the are the that XX providing years once-weekly we enliGHten basic to execute has room the the same different product also could population with we There in I go There we growth clinical addressing this advancement we up need stability. approval SKYTROFA, pen like to product that opportunity or with really often one Japan, is It have discussion. hormone. FliGHt daily Trial, agency acting Trial. you slide develop just unmet try also Trial, clinical in this pediatric heiGHt medical been possible But go that about a

heiGHt data trial the switch up both comparison daily the is rate. you you into related a commitment related generate our two really growth this long-term hormone Slide perspective we a ensure at element that. it's in the And had we we XX-week the enliGHten in competence Trial, product can also approval. most main basic We the efficacy. to we Trial recall, see of And at safety. a on our analyzed same FliGHt to dose. continue patient to statistic and that and developing for are eight, randomized velocity the long-term the result to really the how one, as and direct of saw support benefit in program from Trial compressive as efficacy on clinical building the to and the That approval basis, illustrated high that to was The

talk in that. we hormone, daily for, look similar a treatment, is Going can and pediatric compromise included all And safety we adverse think you you had what when everything you to hormone, And about hard and that when important, the as growth summary like safety profile event there in to treatment. you have about the a saw daily believe of profile. basic growth safety. immunogenic extremely we But when established from that

geographic addressing from global TransCon We space. next to the to to region. We develop coming develop want Growth a product strategy. want are single Hormone up a Hormone TransCon we Now don't to one commercial Growth

We we building the are it the commercial we have because already largest we really our established want to pipeline. we are a how commercial up organization, two do where U.S., market, own address

We matchable disease, the have a pipeline product therapeutic era. in product, rare of endocrinology same

the in And have a of from a he there. in to few market. growth perspective But go and like and basic We you Jesper hormone we'll before are presentation give start, that position in would that more I we'll in ready the detail. go next we slides, are you the

than more billion. billion. in growth hormone U.S. $X $X.X the around market setting around The of a see You is market global

the We that where the been innovation we with is been are we with really basic the years. market dedicated to about pediatric segment. has And the prime you've over million. for to is product. multiple effort. go the commercial more market that that only also believe treatment, improve and and have for and But is to growth as U.S. talk And seen we lacking for highly market come Jesper, have fragmented also will is believe a this is estimated prime related And expand improve we disruption, $XXX had the you with. products we this hormone but what why not possibility a that XX possibility same

Jesper Hoiland

me. than to say waiting years XX I've to moment that Absolutely. been of truth moment. for This is more this for the have very I

for point market. So, the everyone back shape can little growth it's the saying, With even at why we John, and very I have my weekly emotional. a the hormone sold it done. was for a was market of truly hormone SKYTROFA, first we Now XXXX. patients? in that time, change growth not once can And

only the see myself is and you the can the independent can the like. pave For career leadership that I ambition? you launch ask that have my Ascendis we'll are term, is pointed And only for market way absolute truly that in drive space, spent for that, SKYTROFA can market Market will some should XX. And with part to of with in been were me me slide And the you'll and it I are your success a at then as we say this the hopefully make out look what is the of for. entire because commercial waiting say on first front you, slide there then leadership. that determine pillars what

you credibility. First build

right you the done. realize hire market the access. who And That's people You can do job.

access are end the market day, need we can because in the We drug. world's the caregivers we of process at also Then for motivate have get need to SKYTROFA. of best to the working the you that

the patients make strong any it, will strives. engaged do caregivers not not the you have into you If and

And the that. on. working doing on all and working providers are course, are of We in that are then, of healthcare we we process

that have unique a our and more sign the XX, and have that SKYTROFA does to outgrowth, we're February. for GHD We One is coming take than interest been in that a building is we if visitors back huge of on would truly working we strongly XXX,XXX the efforts, a stands And that it slide as to go is difference. first markets believe for. on, site, that efforts lonapegsomatropin. believe to we you can working to are educational the launched what make out We of for we now, as right the

to it's because way, pediatric the segment, addressing concentrated I'm the a speaking It's XX, We we address market. About about very prescriptions forward that going market we are about we physicians. talking, certainly and in the am XX% right right prescribers us certain also now to holding And be I of X,XXX slide doing the the steps very market. XX% and all is going come to relatively U.S. from that a in absolutely in going for And of fortunate on total. small. are place. which endocrinologist

moment on colleagues, my a absolutely for from ready with built forward. move team we to So, have me, we with that this are

We I of have moment and been waiting now is for as the it said. truth

has key different to we the to it. area ASAP. in, pharmaceutical components area industry. of but it's it us, in colleagues endocrinology, long, are has work with going All One the that certainly be long for And Signature Ascendis the going area Program, the in of the I'm a the Access also of elements working the in tenure that to

It be from Signature SKYTROFA going And I now. wait ASAP of done So part. on and I cannot the are what the that right And build to on. put motivation feel to are it really, And you we takes forward market. Ascendis Program to enrollment, together we takes that comfortable the know working for the the where all takes of now Access in true to do It we meet has all or these components access program of have patient work and access. also really we

with staggered engagement We the colleagues. have the

So to rest now the on first and foremost team and we're the ones, board. hire the on important we took of going

have conferences. being mind, the future financial we you want even And that what So SKYTROFA in would to and and U.S. for that to wait have not the very listen. I a are actual doing, to over in to where been Jan, also to believe outside at like to doing. I the in expand that on are spot everyone pass too I distant cannot it be. of with we all all And preparation has you absolute thanks we the we the But see do to happened. with you for lot back student things we

Jan Mikkelsen

hormone the expansion. Thank we China, in a expect trial on year. is this clinical for enrollment III riGHt quarter M&A fourth from our Europe, in of hormone for this enroll deficiency pediatric growth the Phase label year. In deficiency. Japan, for you, Hormone Growth hormone TransCon Jesper. vision TransCon our read of continue patients Growth growth A pediatric in key completed VISEN EMEA we March part of of Pharmaceuticals Commission Phase XxX in decision Hormone with these In and global the growth to III the our clinical foresiGHt And treatment trials in for of children

Hormone. label We growth III have our foresiGHt Trial TransCon for also deficiency underway global adult support expansion the for planned hormone Growth Phase to

to beyond Looking effort teen we to expect growth additional and past studies the foresiGHt our Trial, label support expand deficiency. pediatric hormone the

and replacement why it's about Ascendis, I hormone, patients, patient. growth there are not with our we slide, of from expected of back going and where that extension only including last benefits our realized, From patient, labels now the the the living interaction has with fast hormone adult stories South era phosphate, these which calcium, are started we is to TransCon study, first U.S., working PTH II of as HP. in to hormone, Going patients, All the data, We the growth TransCon are HP the seeing is to PTH. to our be serum a will around XXX,XXX in the as Korea normalization the are open Japan, urinary for are potential in vision And do many calcium, patients turnover one label life. in of towards we as in XX-week dedicated hopeful. that the is patient, and and I of Europe, And the we why five available PTH, this we at era of get the update. the with. what our were can and part also with possible. or we PTH Ascendis. the regions. quality move most TransCon serum And treatment Phase pipeline of other of for In and diseases exactly change start to important the we find journey these just this China, first physiological

this doable XX-week We demonstrate adult results XX really essential these PTH is patients the symptoms. eliminating hope TransCon remain is have patient. having the term patients. TransCon What PTH The in response standard-of-care really safety promising is label this positive with tolerated patients HP achieved result profile I believe and exciting open that short- in shows that extension. these the treatment on for we to continue impact by

cost. both better PTH have of They seen experience mainly year how top treatment quarter, from randomized site clinical benefit adult turn and broad are influential adult can PaTH Forward. weeks to hearing and With In Later life hypoparathyroidism we and Phase on are TransCon HP representation the can may The patients’ subject that from we active do in syndrome to HP such our now line the have trial, XX that provider similar in our leading demographics independent patient expect and PaTH primary to III XX to activities, North of understanding Europe. and unmet in patient demographics. II are We the this enrollment in dosed a subjects, again, II medical fourth The including needs. America back work. trial, improving, ADHX. Phase include Phase [indiscernible] become early as with Forward of data, daily data our non-surgeon have patient and been includes

PaTHway of trial. adult the Phase PaTHway the VISEN patient HP. the trial China China of PaTHway In top a line a the And XXXX. expect submit PTH of to trial the trial, TransCon if quarter We the subject successful, TransCon PaTHway initiated design trial single-arm result in acceptance notification of Japanese the the announce and in with The III trial first in with of III indication clinical expect the minimum Phase III design Japan, NDA an China of the XX we trial mid has for XXXX. the announced Phase in to Japan of PTH greater of HP. mirrors In

we approach a PTH. can are see, As global taking with you clinical TransCon

data first-line forms potential the for the adult TransCon be generated all establishing active by the PTH being therapy replacement is of Given with in driven signs to therapy hypoparathyroidism.

to Turning CNP. TransCon

We an update trying year. our to provide this third in clinical of the are on quarter program

eight in two placebo double know, Phase trials randomized, old ongoing. children to blind are you II As years controlled XX

a The North mainly subjects XX first and America, conducted ACcomplisH and Australia, XX these escalation in Trial dose Europe. of to cohort is

a by is least of which China won in at is expensive China. conducted XX trial second Trial, VISEN The the ACcomplisH Pharmaceuticals cohort subject

for we trials. year control placebo completed keep for We to Once from have core. are randomized the two data robust planning independent double-blinded one blind data each clinical would

patients, priority and that address effective to For and just and top comorbidities differentiated oncology. our to develop achondroplasia the highly treatment is height. option disease commercialize of safe not the Switching

We continue programs. both to make progress on

for last Our TransCon local a allowing for year IND potential first achievement IND Agonist delivery, TransCon intratumoral company. major It the is minimal for was release events. efficacy localized adverse with for delivery. TLRX/X Filing long-term designed levering hydrogen for sustained systemic superior sustained technology the was

kick-start in response, we potential drive tumor, intended tumor. but by disappear hydrogen to our traditional a on sustaining not comments the the the the normal technology. kill few sustained systemic tumor technology. highly where draining What also will to want on at are this intratumoral delivery activating the tumor with them concentration an would intratumoral we contain to only Ascendis injection. system compound the the in into aim local delivery formulation a Just is with injection hours drug immune just delivery and unmodified that locally kill tumor based of not a site. achieve to immune and developing injection technology true This in the inside tumor is is from injected release immune The and designed without toxicity intratumoral system at to This the the the to with a active site non-injected is TransCon months few over weeks

with the with dose dosing and been subjects in arm we the inhibitor. combination TLRX/X have We Agonist checkpoint a monotherapy initiated escalation recently in TransCon

for We monotherapy results for expect Agonist to escalation TransCon TLRX/X the have fourth quarter. initials dose in

the year. program, quarter ß/y an oncology second our of this third planning for IL-X TransCon to For submit IND in we are

the optimized has will independently, potential elements different have with IL-X of By we biology related be independently efficacy potency potential we believe realize first solving understanding full a bias our approved possible schedule. the receptor designing the pathway. IL-X product. a now product create to it us safety Our to guided of and in pharmacokinetic To compound to best-in-class summarize,

improve We SKYTROFA are life. patients focused successful on committed launch deliver we remain to and for a

North and market are We TransCon America, growth to opt confident US$X that are be We thinking global we hormone estimate our strategic billion. to market than the opportunity Europe, in rare around we billion. about and daily programs, Japan. as product disease address address $X commercially opportunity. the in We'd way market a PTH clinically large XXX,XXX with believe all greater We patients both

disease of are the each market be We committed to these endocrinology segments. leader in rare market

is medical With that technology address of and we believe we rate. SKYTROFA, the can us high validation the that approval needs a hope of major with great give TransCon success unmet

Ascendis vision independent I fully again, never a therapeutic with repeat changed. integrated a leading as within has And of market we leading areas. want again, Our portfolio product will company establish biopharmaceutical to multiple global different

financial review me to to to a the let open for questions. over Now, we Scott before call

Scott Smith

Thank you, Jan.

during financial in for XXXX. loss XXXX. We quarter to of our diluted basic the million per million compared ended results loss reported to €XXX.X basic €X.XX June net share per share or €XX.X same a €X.X diluted and and of period XXth, net or a Turning the

continued me and of €XX.X pipeline, quarter in results. compared million the costs. same costs Research overall advancement to million personnel including run through increase XXXX. our development Let in of an R&D related now during some for with costs second primary these €XX.X in drivers, the reflect period components the The were key increase

trial related For pre-launch manufacturing TransCon to higher as up increased build or hormone due inventories, activities. costs as our were a expand growth investments to well capacity, clinical future lonapegsomatropin,

currently costs. goods, advance be these will capitalized a approval. inventory costs benefits the time in of R&D may as in of which activities costs work materials, one-time approval, raw portion and as R&D At the finished manufacturing reversed R&D reminder, lonapegsomatropin to and of result progress product As expense we of in

would been approximately have €XX this today, million. of As

or clinical related palopegteriparatide, trial due development increase costs. were PTH costs manufacturing device primarily and higher, to TransCon For

to IT of primarily loss trial offset other marketable Financial And loss increase personnel the launch our manufacturing were the costs quarter €XX.X compared therapeutic second ended higher were CNP, increased were infrastructure IL-X an manufacturing for TransCon related of to quarter SKYTROFA. rate in related and related costs. costs due second rate foreign securities costs. manufacturing €XX.X costs €XXX.X to the clinical second TLRX/X million the TransCon for oncology and for during in For million with second higher as million. ß/y cash we TransCon expenses of costs higher XXXX, increase the preclinical of same expenses were costs higher marketable due exchange finally, related securities for preclinical and €XX.X cash lower and our prepare period clinical exchange euros. and primarily quarter and Agonist primarily of U.S. the by in translation included These We million to in general administrative of partially totaling and quarter cash, Selling, million and the to and reflect expenses XXXX. to holdings foreign for income dollar equivalents a compared €X.X area,

XXXX, XXth, company outstanding. ordinary June shares had of As the XX,XXX,XXX

Turning to XXXX. remainder the of

Phase investing lonapegsomatropin, launch of including key platform, TransCon rate in technology support continued launch the randomized up our commercial clinical pipeline, with investment capacity disease with Trial, a GHD execution our in for expenses activities, run oncology and Japan. of the the We clinical with drivers, and a children SKYTROFA, endocrinology to inventory of commercial the execution randomized continued variability, commercial anticipated build trial the the global year in quarter-to-quarter of first launch, the advancing future of with expanding for III demand, reflect adults rare our activities anticipated III in in riGHt including trial operating a reported Phase rest half ahead execution controlled foresiGHt Trial, to GHD expect in of expanding some manufacturing controlled

trial, North hypoparathyroidism the execution along XX Forward Phase the continued PPQ execution a randomized III II to in palopegteriparatide, extension, of PaTH American ongoing continued with the and adults manufacturing Trial, PaTHway trial European with open-label batches. of controlled subjects retain of continues clinical which For in and Phase

in of in our which being Agonist, Pharmaceuticals. investment CNP, program conducted lastly, controlled strategic in trial for ACcomplisH China clinical ACcomplisH and the achondroplasia, trials our the clinical includes VISEN execution TransCon the therapeutic ß/y IL-X randomized For two TLRX/X development. transcendIT-XXX is advancing into trial, execution ongoing oncology II clinical the our program, And clinical the through trial area, of Phase which TransCon and TransCon

We SG&A will lonapeg commercial and and activities expect in progressing organization. growing activities other infrastructure expenses, investments including rapidly continued and SKYTROFA a systems pre-launch support personnel, to portfolio include

milestones. on an now update provide our me Let clinical upcoming

received For SKYTROFA GHD treatment lonapegsomatropin, in States. the today we have for FDA approval for the of United pediatric

to in Commission European approval continue We fourth anticipate of year. quarter pediatric GHD this for the

discussed, in the we of as palopegteriparatide, For results the line top the first enrollment quarter now target exceeded in XXXX. PaTHway trial, and expect to report

to fourth provide the program update quarter this a expect year. CNP, TransCon in we clinical For

fourth data plan to IL-X have arm IND the we this and quarter transcendIT-XXX dose the Agonist initiated an year. TLRX/X inhibitor And with in TransCon escalation we later for monotherapy For for plan combination ß/y, dose to report escalation we finally the TransCon initial this quarter. of submit checkpoint in

up points call about few to anticipated open questions, our Before for for reiterate we want a the SKYTROFA commercial I in activities XXXX.

With to patients is to access available, Once the dedicated approval SKYTROFA pediatric FDA for expect support SKYTROFA of shortly. provide available have product to anticipate our beginning we through patient we program. today, product GHD

are And finally, operator, and take during medical QX, Commission prepared we ready now to activities. the questions. launch currently execute for marketing Ascendis ready we again, and our approval organization are With U.S. commercial Our to European entire affairs, that anticipate team pediatric GHD.

Operator

Morgan. JP line Jessica from Fye [Operator from of First Instructions] question comes the

Your line is now open.

Jessica Fye

our the A Hey, guys. Good for thanks me. couple and on questions. afternoon. approval for taking Congrats

Is the SKYTROFA XX% you the to Second … lower study data in of First, superiority of part the please efficacy explain section? four it label of investors the the Genotropin? of that clinical look can reflects over interval should the which bound in confidence table

Jan Mikkelsen

Exactly.

Jessica Fye

late what's the all? approval window Okay. milligram for conversations the timing of and summer if possible session your it to payer per impact at this list price catch How can going the be? Is coverage does for you

Jan Mikkelsen

And my least that how basic is higher with the first a velocity. can you at describe where is XX% From with interval start that perspective me Let into describe Jess. because question, way, competent the for analyzed competent. you your is achieve a are it's -- what improved to you one an different best

long-term the basic address is the how conversation a we work. not want a how say the was paragraph the approval. building the get rest with Ascendis is see of I that what we This a what XXX%, about now That analyzed pipeline the I where question. pointing with they discussion somebody's So competent I product About -- also something start of for providing intense discussion but higher basic public sure, payer, one two to in and have achieve my a U.S., what years have discussion Related it, paragraph opportunity are, I you basic if Jesper, the something will can now when relationship that. limit system, a have worked to, on but is I in we reflecting comfort that system, can where to last mainly the and up that our velocity payer right? because the can and XX% the give payer we it's see even into potentially or we with heard we materialize on, working you in where what you you that say we is you that think, from U.S., short comment statement, only

Jesper Hoiland

this ago. Jessica, would and Jan that, -- Basically, has started been Ascendis, of I out time a we things course, say long Yeah.

we run. into. super And in long what are are entering know we the totally We all prepared and have a place team for in are it good for we we

It's So, getting circumstances. certainly the access. And weeks also that's and in getting on speaking -- at just it's least the not under as we days to what almost about we access come. right working are

are right truly where now. So, welcome we

Jessica Fye

Great. Thank you.

Jan Mikkelsen

connect I bit If about little it. Jess, to you, a

piece. same growth also commercial for But product to we Jesper although a strategy launch the time, hormone. on looking the as know, a have basic our foundation the the the best-in-class commercial maximizing you As that endocrinology in is laying strategy basic, value future said, long-term position in be we at of and

So market proposition, why we but one we a building of both building best-in-class this only basic provider. biopharma single but hormone. this we because element, maximizing company. this growth value leading for is is the for and caregivers, we And And why that, strategy share on be leading our patient why on based overall is want not have a of to strategy a term value developing long our healthcare

pricing. it. see European because we you in our this what that at have look the we where one. answer is it talked And reason, coming responsible we stakeholders, about will So And a we premium we fundamental see responsible responsible including this your clearly are going pricing. our because is of data. we setting responsible the is this all we last that service, is then saying way focus everyone say, question. and healthcare Jess, is And look a is are are from payers. where pricing, good This And to pricing? you that is premium And this pricing. proven caregivers, yes, economic what is why pharmacoeconomic from this is premium is basic We some basic call bill, on outcome premium And have patient part it. physicians

Operator

from is Next Bank one on America. Tazeen Ahmad of the queue

open. Your line is

Tazeen Ahmad

me as announce launch congratulations pricing actual -- price hoping it is Good able relates to I just we well good the from can to be it plan day the before to approval, you the on before as get know work. one walk up or clarify to drug Jan, afternoon pricing, the would hard point on the on it initially me the ends patients formulary. let's Jesper, becomes can how I'm then, through that access available? you And product will say and

I think is to will doctors that what you Thank go that a those us? have sorted process and you can share there with process steps is through, have you.

Jan Mikkelsen

Yeah. Absolutely.

reflecting less we in this privacy. responsible can call premium and more what show first The part, just I thing or it's

part slide We Jesper can become have it. the of a best price And deck And is shortly think potentially you want you basic where in about be and I this discussion we negotiation what from would to our current in view out with clear the pricing. think where XX. it's the we'd steps I that basic we to the was, where And up deck Program. going call in actually back I what Ascendis it refer about talking thought basic the sup there to Signature Jesper slide a are are ASAP, systemize, Access our basic

Jesper Hoiland

we paying we I mean, is say is many you for you're it price then it know, the which Jan is is the things, SKYTROFA. to be the if being from lonapeg sell will I going is I often a then do the formula price what out then plan, suitable in price. is would evaluated on the why and very comparison come rack it it's as and circumstances, have happen is, back points you're go request net patient will And to on to mean, you could this what's without going physician terms once Yes. frequently means and be and if Ascendis happen will to rack rejected would route, for then And heard price, that traditional And will and formula. ASAP will -- health have then our that happening you physician requalify is basically all prior weekly for, then not certain Program to actual in not under Signature best asked the through SKYTROFA. what basically

And go access and the out. doing negotiate course, into PBMs we and then, will into thought we of So, was get that's contracting the by, we why ourselves as by that.

being price being with all sensitive, in of an to premium. will priced approach the So, we market come all,

but of us about where say, we get end I the all I for would from sense a the think do at makes sure way to -- job our also side. also make that's it optimized say can it the that we we profitability. what in day, is

So shooting that's be we for. will what

Jan Mikkelsen

a Jesper. Thanks lot,

Tazeen Ahmad

mentioned So be sense are of of part should a really dynamics you because do it'll long in you I if numbers quarter, treatments? the of Can the put a large expect fourth in just any early see we time in launch? So the follow-up? before the script, doctor you Thanks. how on just ask from to take writes Yeah. receive drugs the that have the a the patient launching actually could patients

Jesper Hoiland

patients Signature will two to programs, a doing put from program nickname, program, weeks is get the weeks do fast basically it, of on, and when to for. doc course, upfront ASAP provide into before the weeks There, the in get but the It the patients we the Program. and it for what six companies can eight access getting all our drug, doc fast be health and take are meantime our with plans Ascendis thereby will the call then drug And we paid approval auto injector they the to we the being Access as patients. the transferred will

certainly product, will first that we any come. that our in come it strong to position also you will -- time So see market drive advantage, not I've as forward. program program, remember we uptake, wrong -- in sorry put segment to will mover leadership. very move pediatric coming the fast us the but and are things to for time got will something a Ascendis we certainly the you ASAP we market Again, the enjoy will to you do a And that as in the but see in progress, the believe certainly first

Tazeen Ahmad

Okay. Thank much for you so the color.

Jan Mikkelsen

question. Thanks a lot for the

Operator

Michelle one Canaccord from Gilson the is Next Genuity. line on

open. now is line Your

Michelle Gilson

will with pull do beyond initial interchangeable other Michelle. in through just indications? looks will happy label's the daily very growth daily run noticed see any similar growth hormone. SKYTROFA into way do I'm with congratulations. in label. this and physicians demand very Hi, you guess as think indication approved mind, I to very, also It a hormone the growth hormone you anticipate the there the be I the that

Jan Mikkelsen

supporting spec the molecule all reflected what active we when labeling physician, into hormone. when as Currently, publication, pediatric indicate communicate confident approval also when the somewhat have I And labeling, we believe for hormone. hormone SKYTROFA. also from discuss concept in SKYTROFA, look we in to with from that. talk illustrate feel the affairs we labeling, look Michelle, on have think actually the as from same And entire data, we hormone that I see our the I I growth the the benefit entity daily have in patient starting and deficiency. said, same And we over the we -- when to daily signs look clinical believe that medical compound. we in basic data is the you the growth that can as the all I thing the patient we really to same are of illustrated we have released growth as the believe generated we native the from growth daily switching are of

on working extensive label are We expansion.

indication. deficiency having see you of will the trial, As growth market, have growth indication know, we To potential one all hormone daily the when the proceed your adult today. basic initiated of approval an hormone the and none we different hormone or knowledge, other we two growth

the on So, clinical compound. element scientific are where evidence the building it's an out we

Michelle Gilson

And from the you remarks. acting they differentiation if the profile hormones, future. in SKYTROFA to approved do I other mentioned I are prepared can plan in also add immunogenic long a follow-up, know if communicate how you your

Jan Mikkelsen

will same you really, of safe but compare that the that start similar with with will trials, to comes distribution really was mentioned Phase growth we Michelle, -- I don't a because that if actually have in I actually molecule, all I I the beginning, the never data. you see mode daily. achieve thing right you are a you that think right readout you people tissues, treatment. had it What clear, then you think the somebody basic back believe hormone And the differentiation to achieve immunogenic different the III a action think I daily -- to don't really can with when the have in

after treated is growth why in so still of markets major the that all So, old XX small I the this years the molecule. depend basic, think patients P with some eighties. daily being per still And are in se, hormone got invented U.S. Europe,

Michelle Gilson

Okay. Thank my questions taking so you for much congratulations and again.

Jan Mikkelsen

that you happy And we happy Michelle.

Operator

queue ISI. the from on Schimmer one Josh Next Evercore is

open. is now Your line

Josh Schimmer

taking questions. for the Thanks

has step it'll about And to considering for through? of talk looks likely can like uptake, it what in for be is $XXX you adoption? maybe next we formulary do widespread push SKYTROFA, likely So you hesitancy? to the the some long ballpark to it Thanks million key in Is gain been year headwinds reasonable, on that that think to be you'll how sales. sticking physician then, for to consensus is Is have the or much. lunch general take gating so SKYTROFA think of

Jan Mikkelsen

the question. with Thanks, creations. your for start can If just last I Josh,

long-term about XXXX. the We provided take our ones basic weekly -- not the today have any product I really the strategy And we Meaning I we XX% feel prescription. believe is if and pick our opportunity. of compliance. physician to guidance bit see look a your kind We the therapy for of question, physicians, little a you basic addressing view about have is create that our first up when in think know only of When are that value know in sales the to expected from patient the can XX% they U.S. market less that a than the XX% segment. in position this or

the from once So weekly know, that better outcome with they and we physician can product. giving a a know, get perspective, out

likely cool What all traveling, if cool grandparents, a down many daily to the you Going take to with that growth is a be having like with they the time caregiver many, do the a things you or do, a and going once and many, you in Or to daily other choice, want time, back need the and to the sitting weekly front child take injection, is that can get hormone, then that. need the to basic in potentially all a so sure take be is five the the injection can week go patient you patient and seven you to welcome. shade can comfort.

the can and safety have and the patient caregiver tolerability. choice the believe do the from notice So and can believe all when if that we you things, and same this, the efficacy it’s we market provide other I same

from system. the then how question reimbursement, I efficacy And up you responsible this view and product think we build can fast right, because long-term what if premium a right, building we we Going building reimbursement the but to to want where safety company about believe opportunities. different you'll into pricing, to of the we the I up on premium what Ascendis your this deserve also tolerability, optimum have really go call value call the we of we is back pricing, the come

our game, are commercial So value that And we not in up is in how game. a strategy. a volume we we build are

Josh Schimmer

Okay. Thanks very much.

Jesper Hoiland

Yeah. preparedness I I can this. for lot you, one and of a just to done add, tell date, have we day can

moment but successful We launch worked to of for about this the years build talking for was not with for have to platform ready future. get to and certainly doing also and this Jan for place the his the for only a in introduction. also in the all very going last things forward, be want couple company SKYTROFA, become we

Jan Mikkelsen

Jesper. Thanks,

Operator

Alethia Next Young from question line of comes the Cantor. from

open. Your now line is

Alethia Young

of at either like am SKYTROFA, ask next Hey is congrats some back efficacy. think and noted little the kind question of question world, then you And either we basis going that the you billion about then Medicare/Medicaid can combination commercial. of have Asia? like about break might like what expect that be we any mix, is, study governmental the you're should is, how TLRX/X how you a can we'll to year. year to talk hopefully just bit that that versus patient And you're like $X.X to of out My versus to at a the there's numbers expecting second the wonderful watch. think that some on show But about going doses kind revenue think if on kind to approval. been mix, to questions rest just of probably a how guys. about program, Europe SKYTROFA. end my to the or it for related guess one by Thanks. my do I last data I a road first couple taking not going It's for actually Thanks the one. That's and the

Jan Mikkelsen

question a a It nice was outside get Thanks lot. to actually hormone. growth

to your question. Let move some hormone growth back us of

is breakdown the up two the easy market. you very year, years, basic -- to but because market because when been Let every China single market, producer Currently, expect number competing producer being but or it target. second pass bit me Japan than That's this on can on little our local year. And are and a two, Asian largest three. under that trial little a single we in. to reflecting $XXX basic question this is is more will in strategy the come U.S. basic we or basic the where as local because then Japan hormone have that largest is built has major, for take interesting the for been growth you Japan have say for just innovation XX enter it's this market Then have there it's million the also is market. Europe. really major advancement bit moving single,

still how life is strategy. specific We is it this what that, a in medical a now from the we But we believe have product would running to on commercial reach global call have development China. brand, market this where build for what the marketing have to we strategy We the run more. where -- we global Yes, And commercial deals, market, era. have building we as building creation. up patient society, we it part a will umbrella, have we global want This patient. now commercial believe greater Related or and everything value clinical commercial to aspect basic few we not thing, don't of where And that. measures, to VISEN deal, a single because this basic question have don't infrastructure also be a in it single not to also the a leading will our we do pipeline be still related local Doing here. when to U.S. that have doing we we clinical go global in that, we or our would on Japan. us, in up commercial to global have a the is is We one global affairs, both place global strategy. related Pharmaceutical places support ourselves. Meaning

focus you I say where clearly move think can Jesper, wherever to last we be, back clear will can question. have the view a and be. shortly to I want you our

Jesper Hoiland

mind Absolutely. Medicare/Medicaid large is space. commercial to is, is keep that the pediatric. this of really playing That's Again, -- space I key focus that course, any mean, CMS in extent. in not

So be are our focus is million space. XXX the -- on the in patients that found the to commercial

saying, is And the hitting to pharma China And hit So of in going key that Europe, of seven focus and is keep markets going XX% forward. onto what world, focus the than U.S., to markets. course, in meaning more our there. Japan, where add if you're and that's, the just top you Jan mind world be

Jan Mikkelsen

really can I to call to, say thing thrilled product have we with and related we're thrilled technology are with the time we an what oncology, will basic intratumoral opportunity And year, this aspect. of first what a give and One true speaking is said I we delivery end update. that what for we

Operator

right. All

queue David Next Morgan the on is Lebovitz one Stanley. from

open. Your is now line

Unidentified Analyst

couple access the [indiscernible] is for today. on us This on Hi. for A questions more side. David

therapy been requirement alternative Firstly, would what percent engaged? premium looks a like? pricing Thank can cheaper And finally, have a payers you of adoption? responsible through how you. what already impacting step major Secondly, see you quantify

Jan Mikkelsen

more we first insight provide. And I not think forward. how strategy, moving hard we think had thing it's somewhat really can So, are I long provided for us the because and our Jesper we provide had we to disclosing

that payer product because patient, we has And call physician, benefit We detailed we the how an for have our basic what including discussed we it our for I the done pricing. the the are pharmacoeconomic in picture at done. long a the And believe is before is of pricing position system. the opportunity, it the overall strategy, disclosing of have everyone exactly premier all and that because strategy, Premium what responsible premium for what we stakeholders, provides we manner. pretty product we believe served our think we been pricing for

So to do few the that. last a Jesper, not you if know, I comments question, have

Jesper Hoiland

No.

think, for ongoing to I mean, course, add. don't call hot I I plans. anything of close a health different very and it negotiations much is pricing, have PBMs really with to

they the I And we're look you're bear strategy the information you I moving and become only announcements public in when to mind forward. think say really, I really PBMs, is make in in place forward as can are that for Also very tight negotiations. coming year. talking to basically up, there. now we the in PBMs right very the where September is that a And for due out are being working announcements system way had next set on early August, spot

Jan Mikkelsen

Thanks Jesper. a lot

Operator

the comes Fargo from yourself stay Yanan Zhu Securities. Wells Next one line with question. question of to from Please

is line open. Your now

Yanan Zhu

Hi. Thanks approval. for taking my the and congrats question

I'll So SKYTROFA. of adoption limit to just on the one myself question

a growth X.XX real So setting, above mg/kg/week. it's our world daily physicians understanding prescribe that the in hormone labeled often

ongoing adoption. you. higher convince they at prevalent label a use So higher that's for SKYTROFA? and or dose is those guess, And you proceeded all, physicians additional think you And to how need do your including studies label do those how interpret physicians that? I Thank open of a dose for for then to greater in who those study, -- physicians, first the

Jan Mikkelsen

we is concentration, growth X.XX both from observed and wherever What and was all on to different trial that in in outcome physician milligram. to basic is our parameter switched X.XX the this got in daily labeling of what in reflecting we mg/kg/week. them what clinical for what took did new important different observed and patient patient. that of also other patients trial So patient levels this titrated dependent over different we did initially basic And hormone we dosing is the switch

product, We important had in what that that dose expected what What previous it could that done and basic is a down titrated can you physician, important titrated can we a trial, called indicating is is we be where as the what response. have escalation. this II a titrate that in in see manner for the in So is effect doses, predictable. observed. and definitely can have we classical be a because on that that compound for compound up a a you have has is -- very we be make to which is we that And that that Phase -- clear different case a

Yanan Zhu

you. Thank helpful. it. Very Got

Operator

from SVB the Leerink. from line question Next Schwartz comes Joseph of

line is open. now Your

Unidentified Analyst

the expecting Thank Hi. that [Indiscernible] XQ. the TransCon for Joe. you PTH, you we're going taking for question. actually ask on our in to data I'm

could I kidney you're just wondering results, insight in us data, study. kidney the was the will interpreting give of ahead function thinking into if considering on how So about drug you everyone the be

a effect, calcification you for do be a Thank considered would what on patients very years? you of different much. who how good over have those What drug? So, and be results could result small with big degrees interpret everyone the the or

Jan Mikkelsen

XX for observed in is, when it think we we basic hour weeks XX in what you Yeah. got the actually we normalization achieving most analyze, effect, the when kidney. was we on capacity not And positive of call from was XX basic do already are way on perspective year. same here hour in And saw the independent we which with saw look what I I reabsorption example, extremely that see this results. receive can a trend hope saw did validated that basic hope a that positive on we to we urinary the the what that from reabsorption we weeks. establishing saw basic -- positive the part urinary my related of at end calcium, it had really real the we saw to lot and extremely, have again of response impact wanted, data And look to to the subanalysis had We background months, case. we XX the The at have patient what poor doable call that is XX a was We impact. weeks the it demographic we calcium. because will six of we we continuation what And same we of interesting continue subgroup will response same a already we already prognosis perspective. established doable

Operator

comes line from the Wouters of Rene Kempen. from question Next

is line now open. Your

Rene Wouters

And good Hi, question. taking for evening. thanks Yes. my

of First my all, end. also congratulations from

Jan Mikkelsen

Thanks.

Rene Wouters

ask growth regards deficiency. extension impacts wanted plans how looking I to does beyond label with hormone approval your adult to further

is hormone growth where indications there impacted? are So,

Jan Mikkelsen

additional just belief get not When probate. make I approval the would actually we strong I will imitated us all what actually it -- been activities. we long expansion have growth planning hormone because had it say I had we indication. we to like strong call the label And that have belief expansion activity, approval no a a we already to time -- we a such deficiency did before we other adult packet label

that element to we needed activities, I what approval were this the this So is all a time the what indicated that that before. just continue for long is that saying activity

Rene Wouters

Thank much. very helpful. you super That’s

Operator

from line of question the Next Oppenheimer. Trevor from comes Allred

open. is line now Your

Trevor Allred

question the guys. my Hey for Thanks as well. congrats taking and

ask wanted the in CMP Thanks. what anyone to update you Will we velocity? growth Just upcoming about going sharing? see be XQ, -- to have you're determined any initial

Jan Mikkelsen

dataset, in to give you show we update to will related We position we what at this currently that definitely that a are and an analyzing we program. going

fast want overall we the make that as this patient. is perspective for possible Our accessible as product to

is and can that price find the where quite we say is two development things So, time her these Because What blankness is sure compromising team that without galvanize forward. information basic we we therefore, trials? are can and and Dana a blinded. we at we between clinical give what are What I information And will balance cannot the going and these of best share? not back I'm we find And out two to completely the can balance to same keep really the a to support continued can share? that strong be to share how things.

Operator

from line of Markets. the Next Anita question Capital Dushyanth comes Berenberg from

open. now is line Your

Anita Dushyanth

Congratulations afternoon. and good on taking thanks the approval for my Hi, question.

for the me formulary. know to this So, it's vet a Jesper maybe you some help the understand you going I could time on that bit. mentioned take to earlier get

are And expecting authorizations some your providing QX? the then, know in patient actually in prior of kind region, you application just rated are provide kind still access? wanted European to the regarding support tax approval to we of So, to I

Jan Mikkelsen

the our the you the the the ASAP drug -- think, reimbursement. patient and I period, that about in Jesper providing it to change process getting program spacing the So, seem compared to explained basic

the has is basic in deck, that basic the Jesper [indiscernible] So, -- product. about talked in slide this

our pipeline how call integrated what of two and with that out strategy in pipeline conversation, region. expansion which in we have and the basic very important European is different out is Our an most regions. a to find still enrollment cash the working we market elements, balanced it's of strategy, is Europe, Europe I diverse

but because that updated to have countries flatter. space to XX process, clarification for either months getting almost should, you why This basic up European when you one, you strategy. XX will about is Some we reimbursement, the takes have keep more

Operator

There are concludes at time. Thank you this call. no This for further conference questions participating. today's

now disconnect. may You

Jan Mikkelsen

Bye-bye. Thank you.

Ascendis Pharma A/S (ASND) 26 Aug 212021 Q2 Earnings call transcript