ASND - Earnings call transcript Q1 2024

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Operator

Good day, and welcome to the Q1 2024 Ascendis Pharma Earnings Conference Call. [Operator Instructions] As a reminder, this call may be recorded. I would now like to turn the call over to Tim Lee, Senior Director, Investor Relations, Ascendis Pharma. Please go ahead.

Timothy Lee

Thank you, operator, and thank you, everyone, for joining our first quarter 2024 financial results conference Call. Director Relations Senior Ascendis Lee, Tim of at Investor Pharma. I'm

Chief are on Smith, President and Oncology; Stina and the Manager. Clinical me U.S. President Jan Executive Executive Officer; Vice Singel, call President Joe Scott Joining Development Officer; today Mikkelsen, of Dr. Executive and Vice General Kelly, Financial Chief

by the FDA statements law. undue towards outside in Litigation our required change, on commercialization; Before endocrinology the we contain these remind and information under and statements expectations expectations their commercialization EU and in regulatory Act. potential differ, circumstances are plans; that regarding We launch results; to statements, safe are in goals reliance clinical as forward-looking for planned of is our and including of ability include, based to as such be the may those our progress the the strategic decisions; multiple the the place clinical areas could with of except PTH this rare and statements our review covered by regulatory Securities to no well in of our today. expected obligation regarding pipeline, to statements. and continued filings; should timing TransCon and of XXXX. These regarding that Vision limited as but therapeutic begin, from results not certain for you of timing I'd and our the and on harbor YORVIPATH you of timing update of expectations our and our SKYTROFA and assume to Examples are ongoing materially result as financial candidates our development our statements that provided respect available potential value progress create our disease us differ the European commercialization U.S. intended Reform Actual forward-looking to: U.S.; like will markets conference Private to may XXXX; and call pipeline statements our continued development not

information EU the actual materially, the and received hormone most annual of United for and additional hGH, treatment section in European filed the and forward-looking pediatric from please today's release MAA Risk concerning Hormone, for XX-F Commission For report that to on Growth can our has Regulatory indicated X, statements are therapy TransCon Agency TransCon Factors that of February the have marketing results granted product approved treatment or our section see press recent with of and U.S. commercial SEC for approved the Form differ not Kingdom note factors in and Commission use. is by Healthcare the the our XXXX. TransCon Medicines cause FDA, the chronic hypoparathyroidism. the authorization Otherwise, candidates as please The for products European investigational growth deficiency. with replacement PTH adults authorization on

our approved product effectiveness agency. investigational of the statements candidates be regarding conference promotional. this None as the not or during of any candidates and safety reviewed been regulatory As products, have call by shall viewed product

our first results today, updates. business call quarter discuss further the financial On provide we'll we'll and XXXX

with coming to turn comment any on questions. open we questions this not prepared not our will ongoing will the it topic Jan. With less be let for date we'll over me today. Following and we call up weeks, Note, TransCon for up FDA, taking X with remarks, that, PDUFA some than PTH our the discussions on in

Jan Mikkelsen

Good Tim. you, afternoon, Thank everyone.

and on and across Two and the difference end TransCon commercial believe in Ascendis partnerships. growth patients' applying approved strong flow focused the by Ascendis operating to a breakeven programs, products basis its progress solid We platform of presence on sustainable a XXXX. technology integrated is cash quarterly build a on making leading is company transport fully biopharma lives. path meaningful to growing

up the supply efficient to in leaner X, years X and and profitable and XXXX Our robust streamline company to last chains. organization. long-term [indiscernible] we And the more commitment build took the in decision

cash other the with see and we our deliver disease data this positioned product well can we building development progress endocrinology pipeline for flow out You towards continue year. compromising approvals X our close to goals and a rare operating strategic therapeutic believe process, Vision areas. Without successfully our on independent in are commercialization XxX and regulatory

XXXX, each pipeline future blockbuster our to of believe for achieve and endocrinology. innovation. Vision Patent our platform we X rare transport also while to expand Looking status, further disease we

PDUFA date weeks PTH launch less to in in TransCon is the we May up our We Germany If the validation in and for launch U.S. U.S., U.S. than coming it the ongoing thereafter and XX. again In X seeing are be in on expect with success successful to the approach of YORVIPATH Austria. commercialization of seen ready have the quarter. the in third approved, of SKYTROFA soon with

one, me let in of about U.S. had update give the an market become market. to launched second SKYTROFA programs. each X $X When SKYTROFA U.S. make product drive we to leading billion Now ago, a to goals: the our we the years X on there;

leader Thousands Our strategy is treated in now patients the with working. SKYTROFA, are U.S. value of the

U.S. estimate have benefit that the in from that of SKYTROFA insurance company. XX can We the approval grow ] quarter. population growth penetration deficiency have ensuring from a We reliable every to they once first the patient pediatric [ SKYTROFA at about hormone end supply patient chain, the

SKYTROFA with to on in the of quarter to SKYTROFA believe a we third increase U.S. observe the leadership 'XX sales this to doubled with than XXXX, in its only in as quarter-to-quarter based become value compared blockbuster proud growth potential more the the market will grow And pace. quarter to the steady U.S. SKYTROFA first of are expand go-to-market hormone results. product alone. the a We value reported extend quarter in

We rest this of expect to continue this trend year.

representing XXXX million SKYTROFA will revenue year-to-year between of full With the growth XX%. XXX EUR XX% year to million, these SKYTROFA EUR we results, expect XXX continue strong be to to

deficiency first-label SKYTROFA plan expect to in expansion of to third further solidify growth. to the penetration continue quarter pursuing BLA submit this year. we're in grow adult pediatric in through the supplement to and which sales we for our FDA also the To hormone further growth, We

data expect in addition, Phase fourth In quarter top II our trial we of [indiscernible] from line the XXXX.

for Now with turning positive. with experience and TransCon objective YORVIPATH has was launched Initial of of at early end building physician to Austria PTH. January, In launch been in Europe, the physician Germany feedback YORVIPATH YORVIPATH. the

the to physicians the comfort begin we the about of to physicians programs, with patients. patients patient, decision. the expect patient As XXX we to get patient, form X expand including by provide And Europe reimbursed of written U.S. estimate been around XX representing preparation and commercial our and the In the prescriptions more the benefit profit. U.S., direct to prescribing we underway, YORVIPATH YORVIPATH treatment as in base needs take geographic more weeks and reach Just we target of with in supply our international have field of XX% while infrastructure of plan market we the to doctors, first receiving the our expansion supporting name of are meet segment, FDA's are are prelaunch waiting

Moving now TransCon CNP. to

CNP for with all TransCon is patients value ages proposition achondroplasia. with of simple. to a Our establish It's treatment

of year, life not to quarter, to quality growth. line which comorbidities parameters. as that Later pivotal function, as ambition composition, and linear growth plan body quality this the our Our life results also address report we linear in but is significant the associated achondroplasia well with for APPROVE impact is measuring third of trial, top health physical and only

contemplation We with are also with as evaluation than of TransCon possible CNP CNP that TransCon early as years X associated might mitigate believe in newborns treatment comorbidities. less age. We

In addition, receive not did provide treatment. we to to catch-up growth early

CNP tumor. in TransCon We evaluating with are TransCon growth combination

with will and as patients for to showed address XX-week to this has are is Both multiple after our candidate approach activity pembro. care Agonist the promising show and and that best-in-class studies. Switching quarter TLR treatments. top towards IL-X into to this In continue integrated one X/X has both in standard these to product of all across treatment enroll to monotherapy line quarter with building combination data patient, all of disease multiple differentiated trials beta/gamma clinical TransCon that provide our potential now are in this oncology. goal: TransCon progressed disease. highly expect that And treat optimistic we We fourth achondroplasia year. This line

trial. Next I/II that month year at ongoing at ASCO, been we last reported the I will report Phase believe patient data updated from has ESMO.

new We program. data will present that clinical biomarker further data, updated clinical a our differentiates

TransCon and melanoma, early data We TransCon X/X aging ongoing will who have expansion of also from from TransCon in disease programs. combination using checkpoint IL-X in TransCon beta/gamma we population and the well-defined with of fourth patients from the year, our progressed this quarter, patients. Later TLR EBITDA report promising Agonist beta/gamma IL-X cohort expect several data the TLR

endocrinology the Scott. place Our strategic it to pipeline this more ophthalmology, a disease that and to fulfill further industrial achievement come. much X strong me in to confidence over give now with all independent to I product, oncology, turn are rare our and diseases quarter metabolic goal elements will deliver

Scott Smith

growth and currency of seasonal X% on our financial cash please XXXX, compared reported SKYTROFA basis of QX, offset some slower offset of surrounding a compared QX X-K flow the line revenue negative touch first impact steady XX of was refer million a headwinds points X.X doubling Strong with with than channel currency internal goal high a today. mix, XX.X quarter financial of of behind negative the year-over-year. slight to of quarter a with million. operating significant we percent quarterly XXXX. breakeven increased prior first volume In details, a quarter insurance more Jan. our and filed new persist. This adds key build, SKYTROFA increase EUR in will a increase demand growth was period becoming demonstrated was Thanks, the our expectations a primarily XXXX. further driven inventory, and quarter an to basis, by but significant demand reauthorizations, X.X toward mid-teens modest expected pace our to by EUR progress of million revenue for million. On I EUR results, the on XXX% XXXX in sequential EUR was first year for to resets, modest by seasonal and coverage by of the patient fourth co-pay end combination to of impact the in compared channel volume,

of of in million, continue Germany revenue be TransCon directly retail out for there result, Closing the at typical revenue ship channel SKYTROFA, pharmacies for line, with full inventory exchange U.S. XX.X to where EUR months with total the saw compared to first to specialty to revenue formation average top no EUR including revenue XXX million which EUR was of X.X patient is buildup a inventory. quarter Iconas, we expect like quarter million to of to hold service operating X year we this pharmacies the relation first million, a XXX as and million time pickup. for And launch Austria, to representing in YORVIPATH EUR of EUR shipments. and the related In channel range is of XX.X PTH. to contributed rates. Shifting expenses. offset X license We noncash recognized million XXXX the SKYTROFA in revenue EUR

expenses. costs to and of offset by R&D period R&D during compared as million TransCon first in in tied to XXXX. Hormone programs, was decline to an costs prior Turning increase write-downs inventories the quarter quarter PTH, million EUR partially reversal development costs. as external XX.X including EUR lower oncology declined the CNP costs TransCon The of TransCon of Sequentially, a for well XX%. XX% Growth prelaunch first XXX.X largely totaled

XXX.X and revenue quarter was Sequentially, million the quarter impact the XXXX. Sorry, expansion, of quarter SG&A commercial and was essentially XX.X EUR external partially from Higher by million employee EUR compared quarter flat the during expenses lower costs, in XX.X the million, including first prelaunch administrative totaled offset X%. to Sequentially, to loss Total the operating for quarter, SG&A compared first a during in first were operating the declined first expenses expenses as comment XXX.X quarter our EUR expenses XX% to compared was EUR Overall, a expense EUR sheet. million Finance expenses. increased outstanding XX%. the X.X decrease million finance convertible of operating XXXX. Sequentially, million operating during operating of noncash of operating of driven EUR in on totaled last a an largely loss EUR loss XXX.X in This the EUR by quarter expense fourth first the quarter compared XX.X lower derivative result million XX.X to million XX%. expenses. loss increased to the of increased balance our expense tied notes. Quick year. higher XXXX the

million notes presented As IFRS value with though the you'll mature IFRS current are in and convertible XX, requires of case due USD EUR not now require March convertible liabilities April into XXXX, January came rules, do million. face amended associated effect XXX within of carrying to be reported notes by derivative holders. which current settlement cash XXX the even our still value X, notice on they and not XXXX, of total conversion together which liabilities separately would until XXXX of to liabilities, as

equivalents amounts impact XXX We million. rates. the first we As revenue applied plans, full the million million statements. and on the comparative to per in rules, based other current presentation. reflect have to cash been the totaling SKYTROFA EUR IFRS The range XXXX no $XXX exchange ended for XXXX, of year at cash amendments quarter And in $XXX to average had financial change with the reclassified expect be on

be EUR million, cash to basis the by be R&D to We and breakeven quarterly flow total XXXX. a on expect expect and expenses, end operating operating approximately we SG&A XXX of

also Let milestones. highlight selected key me now

TransCon Growth in submit Hormone, trial FDA compared the results of for now XXXX top fourth plan to II report plan our XXXX. from the we Turner of GHD to syndrome quarter we previous to QX. third line to And expect SBLA Phase the in an For quarter adult of

international U.S., direct For as and to we YORVIPATH PDUFA and U.S., XXXX is path possible underway YORVIPATH TransCon roll the in our date it over to out Germany Europe XXXX. If with plan we the of our in throughout as as XXXX. segments Outside thereafter. XX, plan May the PTH, rollout commercial quickly in and approved, markets Austria, launch

dose we NDA we our to and to TransCon XX cohorts line beta/gamma X/X Within fourth top Hormone, a line week our report C&P, XXXX. the from achondroplasia, that, agonist we from combination report therapeutic with provide TLR fourth expect TransCon Growth of With of COACH plan results update data the questions. ready well XXXX, both treatment are Phase indication-specific now APPROACH as quarter expansion of during to as in fourth XXXX, for from from trial pivotal TransCon area, the with submit TransCon our children top quarter and clinical the the oncology trial of quarter also II the trials. also clinical IL-X operator, For in in take

Operator

question first comes Fye Jessica [Operator with Instructions] Our from JPMorgan.

Jessica Fye

XQ more you hoping in about was a how April of some I and looked for could YORVIPATH mentioned elaborate on you for little Europe those talk maybe dynamics SKYTROFA.

Scott Smith

Yes.

at resets partners dynamics, updates mix the we to essentially, April, And said, on cleared YORVIPATH February. And we'll appropriate. development we of primary led typical would saw to SKYTROFA, a the take What second launches, see different the slightly -- pretty as with QX inventories be with part those the what coverage in feels So the where And the insurance happy co-pay updated Jan for out question the related related with would continue that the first. maturing to of his our to we beginning all of an as in the basically channel. then reauthorizations, the their launch it in remarks. I revenue out would -- But to I'll describe end update you as a seasonality with results laid -- led year. in other we're channel of overall basically the -- like out this also year later come prepared by the we and first that goals

Jan Mikkelsen

you X more they prescriber them the And as broad the period we to German typically prescriber this was we're some this. our Austrian just give own will up get really structure board over And what of on we treatment. little X unique expectations. to adapting inside German comfort, getting way a treatment. that -- really base, take seeing really from expected market, to for the to typical base. The perhaps you patients feedback, a as what they to the Then you're assumption market. get we comfort are more, bit and yes, really see we good long So soon that typical that We where get of hope on sorry, from the take in flavor market, benefit

got have I of we weeks when was when XX% in position it believe target successful our some launch seen. -- saw X So prescription. to I of most already we the

We started there is we're XXX, that ourselves patients of physicians not number ERP seeing early around in have or in that program is few that. The meaning imagine a our Germany.

patients. product Some of up XX patients the are benefit them to they already are up XX, now how really on unique already this building because on discomfort had giving

this really hoped So we see hope for. were out start and is what really turned we wanted why we we're where looking on stuff KPI, feeling for, we to what really different this is the it the to the had

Scott Smith

to YORVIPATH. go no retail to reiterate, the just with the essentially the the direct pharmacy, patient results sales to inventory There's And are patient. channel up. picks They

Operator

with Our comes Citi. next from question David Lebowitz

David Lebowitz

were year your YORVIPATH's your versus potential a and how If now like you preparation, a setback, looks see market about what things status jump similarly the of like your back in to you juxtapose sales approval current current and it regulatory when -- you you then the could or or the what differently? looks runup

Jan Mikkelsen

I much, believe better we in are place. much a

much, awareness think need better the we much place. And why need EU to I much But all already direct only it, Advisory next already a in voice coming drilling we medical program. program in repeat how is from to that the in the as the when the of all, these can countries, today. a of medical element patient. believe awareness patient and FDA reimbursed mainly Germany, to of it much, think year I is the patient-driven much our you I levels [indiscernible] for of win, of the our hyperpara unmet where is we was We unmet that in really in this see the launch during and and is And I know soon that year really realization see Board. market, think level patient with if precision are part as better end of the better we the just has one effort in always in are think the have And in our to success up the been been physician a hear that a programs, the why on coming awareness YouTube explains which get beginning this fully the initial First patient is of hypopara I want seen we international mainly a Austria. reflecting 'XX. We

you So the need that in stage unmet and better way. One new I really the up long-term a describing not that can believe, medical driven from a medical and have how providing where I can call you can U.S. general complications never and between other short-term and avoid places, symptoms guidelines right. to therapy, awareness basic I optimal about that a the saying we really, I it an if hypopara, that really is hope a unmet gone thing basic, understand this is for has came get also much treatment, need to treatment, was balance basically to really treatment

when diseases which treat are not the recommendation that position always insulin it way in like with this treat obvious will treat you disease, them insulin. therapy the PTH is you So are really with to yes, insulin a diabetes, pretty basically of

Operator

Rosemary from comes question with next Cantor. Our Li

Li Wang Watsek

I'm Li Watsek put should've Watsek. Cantor. Li I from Sorry,

have had TransCon from on as pushback you for rate joint in just benefits formulatory or and any such benefit? terms of payers clinical access So placement, hospitalization PTH, kidney payer

Jan Mikkelsen

Europe that related to or question U.S.? Is

Li Wang Watsek

may. you if Both,

Jan Mikkelsen

Okay.

we of treatment, of experience call are of all have immediately addressing benefit again, we're normal short-term do life how think I this advanced patient the our life, And the make the what symptoms, when to benefit important, Europe, quality on treatment. of starting integrating we impact after a we having the economic more calcium. aspects health in patient's

risk. also just what is calcification and impairment, other long-term get long-term The of and real is the organs, of rent you're other dependent will different time. That the like complication achieving part call that is why is and a thing long-term cardiovascular impact, damage. what we risk we on call hyperpara lot with One cataract part

this we evaluation the we're is our quite to each getting be right sure to on element built reimbursement providing right being of economic health prices. European All that into that are single countries

reasonable, how on responsible really patient the built have a providing calculation benefit basically we it's to in accessible patient, of the helping a benefit the to are we being basically in health way both the really where to our the European cost. So a pricing, society economic on on

Operator

Leerink question next from with comes Schwartz Our Joseph Partners.

Joseph Schwartz

was how EAP have it's SKYTROFA who talk been have versus talk soon? if YORVIPATH novo commercially be in targets how also in And about you U.S. the for out the physicians you YORVIPATH the I and experience of launched interacting with many could had many about wondering de how going once to you'll could already? hopefully many their you be might using with patients for physicians

Jan Mikkelsen

it's question reflecting because U.S. first the you what ERP and stopped got have our general the I Europe, YORVIPATH very, think approval of now I good program aspect can the to Germany. which aspect very we The our had was in different ERP in give can what general commercial I program. got we do, and ERP And of been compared after program. U.S. our

to handle. are meaning into X%, a at X%, that experience, U.S. of is addressing our electable that program. The that is institution patients basic program really last Our hyperpara to basically academic patients X% it's ERP program are is only ERP difficult very program ERP in of for come subset

the decision. contracting because big them of and because So for is program really the not high not incentive a it's for

be only therefore, a in an private a that you of side. of lot small typical find always subset this will hypopar be will of program. patients really such more side, has So It will part not site

have experience and both we the XXX% in have enthusiastic seen that our been has II ERP ERP treatment Phase the with program, we from our and We what III extremely the trial, patient there. what have clinical about observed and confirmed seen Phase are we program benefit

Joseph Schwartz

Okay.

patients you that with will then treat many or to in had not the hypoparathyroidism have EAP sites are new have who using -- go And experience SKYTROFA? that so to how

Jan Mikkelsen

SKYTROFA, in ERP ERP at ever SKYTROFA we running. program don't any have didn't all way. this site had any

it's to So really X. compare hard from perspective, these that

Joseph Schwartz

I is shortly. meant how get footprint have between with that now, you'll the SKYTROFA YORVIPATH. just sense -- trying the commercial overlap much the a products for I'm or EAP to of there X

Jan Mikkelsen

basically lab You take not phase say physician is sites to [indiscernible] or directly because in more that will of care the prescription both that typical specialist it's sides.

One example, is, first of for pediatric them a indication.

indication. The other an is one adult

overlap there So out for built when are product on decision indicate Whether building, seeing basic most the covered exactly infrastructure. support we made a as in that same endocrinology the really And commercial will sales can independent at what prescribing basically great possible. not you right forces fast XX% that are taking the building there's and look to is the we it's that, have are that it's big where the the I'm effort -- is I XX%, same being data decision as a large of overlap. And not I area. saying any overlap, a

Operator

Clark-Gartner from comes with question Evercore next ISI. Our Gavin

Gavin Clark-Gartner

on the were the NATPAR of in with and your Congrats patients in out wondering progress. Germany, many YORVIPATH -- expectations XXX of line previously these on heading was in? how this I'm just

Jan Mikkelsen

patients surprisingly, many see see. more we actually that we we solved, have say will naive will I

the I would expected. that at patients also And we par taking that that are where it physician was of say to on we patients believe focused more of of regime. on looking we on have the have new are one is but one seen the patient just surprises is surprises, least many there actually many for this the saying basic in so I we patient, seen treatment, have change initially patients the So was into that have a the that not have and been treatment the me, we

Operator

Jefferies, line Shi Kelly your with is open.

Dingding Shi

like we On hormone landscape, whether actually if could there. the your other you that the also, schedule like one to competitive launch provide same. products gross commercial given curious strategy on Rx. And check long-acting And TRx approaching scripts your of both and out SKYTROFA, for the into remains you perspective them,

Jan Mikkelsen

databases So utilizing sets look one at I really different data the because In least can of you to sampling have, to of the this is use you always never different get absolute to is is complications, case, scripts. get but with can providers. levels different this trends on kind the

So you're only the where base you sampling get from. of prescribing a information small amount the

out absolute from you cannot compare level. really that So perspective, the

it also unit, when because really products. unit different the about the between is compare different cannot we talk the You

is So providing some unit you giving -- then.

therefore, if a effective I to line solid see most revenue basis. This and doubt on look we get they need So how that. go no company, when item you you look really the want there are data, about into and best is take get progressing. we single the on and where each to really the confirmation is And data

the only data of we for seen how have were everyone declined, For the one in market was saw the it reported grown quarter. is which the the typical growth hormone QX what and really first where we see market, has a have very really we'll difficult

Operator

with question Wells Fargo. Derek next from comes Archila Our

Derek Archila

progress. the on Congrats

this it EUR a in progression might We XQ OpEx, bit the XXX have a fair on like come guess the below OpEx question year. guidance. on based seems million you the I

any just that? be there how on color thinking should about So we

Jan Mikkelsen

is so because question. Scott think happy good a I really today he's getting

Scott Smith

for Yes, Derek, on OpEx thought, plans. to but -- remains basically growing yes. our year We've full based doubling thanks a bad XXX as million the pretty current No, for the of now, while proud guidance question. been significantly our pretty It's revenue. OpEx pretty EUR we're of reduce not -- ability

Operator

Paul question comes next from Sachs. with Our Goldman Choi

Kyuwon Choi

might ahead And starts? for Let as could mutation progress. my about just thinking an road what the sort comment suggest switches do line look on the potentially the then research FDA? on year me to those endocrinologists different I terms like TransCon how you either given offer launch? results you pending what your maybe the requirements how the market down look of if about of And a sort this kind congratulations want of you're from your CNP could you terms might might dosing top approval your in possibly CNP shares approval be thinking of CNP frequency moment. TransCon in for from and to maybe maybe anticipate on turn like later what using comment of Or of

Jan Mikkelsen

a they really have strong viewers, a And interesting reserves topic not really the and address interactions that. And like all providing been have look patient key already our how for weakness been feeling comorbidity has Being been I the have looking sign to really on the parents fundamental site, impact is the other this first, how agencies to having in we bring will that also both avoid the access to key to short got and to It's providing we also is because life it means the that really in which but is the primary the and when no things comments different retentions. the care anything and has I've questions is about program. addressing the program focus months. On the accept in the adjusting And seen objectives what from months. commitment show is as on cannot on with I this less commitment. X from and we physicians, discussed TransCon been the see received is it caregivers, the CNP the regulatory on that basic Because [indiscernible], achondroplasia. we product the we can comorbidities. really have have linear that. feedback this disease. we we But growth approval really get to will to regulatory linear we it disease. we're extremely of to see key on see the pathway quality If also kind getting in comorbidities we never we're when And address address our done. also our our efficacy Europe. endpoint When the the benefit perspective how difficult It in I to is U.S. of have have when we recruitment, the both all than built of in of our we because to but are the afterwards, change talk they treatment. growth, somewhat about in patient we is agencies, for not before. from where Related could of our program today. and to established all other that really integrated and this comorbidity physician to given benefits up both we is have be a have why really, have growth we comorbidities. We our X linear addressing reviewed retention the pivotal And patients And our address places it's trial treatment. think of any question or have must seen really And regulatory

Operator

Our next Vikram question comes from Stanley. with Morgan Purohit

Vikram Purohit

pipeline. on had one just We the

and progressing about? with ago, a we your discussed months So is and semaglutide your novel this a I just through and study. the be milestones to work program a platform few with learn platform, you could us TransCon novel internal cited could the how you're case what here work GLP-X that see next with carrier wanted here

Jan Mikkelsen

we're excited had TransCon we were extremely candidate are way and have we're molecule up type regime our engagement way we you because to the risk the go, you that that no to We not typically we built pipeline cynical when target we lead for the basically because pipeline, on when that taking product came show treatment There's basically technology same highly building to fundamentals differentiated benefit the this everywhere. that make call is and the broadest about I that a out. clinical building doubt it up are all once the

compound also We are discussion we as going. And we about metabolic you value decision how best updated what with we as doing an this will we a because metabolic same intense of proposition of time, basically the At someday we the have are have diseases. progressing this and about keep diseases talk are that. soon we era way made

Operator

Cowen. TD question next with Our Yaron from comes Werber

Joyce Zhou

the for population? X/X where how Joyce prescriber base? can planned of PTH roughly and the terms In Germany initial Yaron. for your much And of target strategy about strategy in you're the population is launch targeting will in initially you it your U.S., total mirror This on talk of TransCon

Jan Mikkelsen

program. to integrating a loans launching and doing contributor what think first country And the we're is you're really where I we're Germany, from the getting Austria, learning in first now the is confirmation seen I because should have it we we how this what learn. of have say, got to do everything good launch. lot basically have basically about we in we for hoped

So it's different with completely on not a like we're coming strategy.

we what region, call exactly more execution how from the playbook. the after in commercial the proud made it basically I our are about We this people

Operations. sure coordinating base. heading building approach as come is our playbook right direct. be that always I the the of when committee global Head to leading commercial up U.S. a called coordinating strategic international for into we're our that on of Commercial Global Any She's basic have from optimal bonds market So everything to U.S., into EU place up

seen in Europe first be the person on there. product and took living commercial Germany a the will delay to out have person the U.S. that can we We is on U.S. the product huge say have we get fly U.S. the here or really the for interest. I and product consequence to basically basically commercial in

seen we We really their how we see our And patient, really for So choose have really we see know the life it. different this back. patients them it, path, know also benefit. get making

Operator

Gershell next Oppenheimer. Our from Leland question comes with

Leland Gershell

from us. Two

any there YORVIPATH the had First, you doing indication be on again, not an pursue. rolling you're that will you that hypochondroplasia immediately comment mentioned Is if just approval. following could the or the plan you And to -- past, for out were Great you've in Britain, is decided secondly, in delay? something

Phase coming change the and/or you'll that if pursuing the be may hyperparathyroidism. following the seeing looks from are be that that the data companies up wondering later like III any this from year -- information Just

Jan Mikkelsen

Europe a and Yes, rollout U.K. rollout. EU integrated have this our in is line. is direct of direct U.K. part we And in is our on countries that all our

are So getting the are also countries in now. approval like after now that approval, approval an EU basically from had which other we separated U.K. we

everywhere from filing we We need everywhere continue Australia, the where different approval. also countries. an And for independent example,

basically and we main that that, is a as we patient to basically program, many product patient provide have but the been we example, reached and also in do then get are are these and a come commercial you building will direct in countries, medical typical specific patients about we a in countries, come doing and the the What program other we structures Germany have in in that really that in reimbursing we to they out frame, on a a the of meantime to be call have or of launch price, until this typical built have where commercial the In have go doing this can will coming impact launch, commercial can will be a meantime into done launch. until where and similar most we're already programs. and of affairs, up direct EU time we we're teams. reimbursed we fully all established, full done are nametag physician for different you country we economic we commercial, with reimbursed infrastructure, lot in we're specific We we describing the what countries. And what have commercial patient good and which EU fully have done agencies an general, call countries. full have assess go doing ready All health Austria. In in when agreement filing to can market in the the

It is direct, dual market the Europe we will be be handed agents. also call our typically but and holder strategy we sales will which the this in what M&A are to international someday in the not market. utilizing implement in we international we will the distribution the So

because only have are Growth XX, disorder us really, disorders. growth in is an is that the hypochondroplasia, about thing For the really company store different other it's X about diseases. interesting we XX aspect for

have are properties once-weekly once-weekly growth mode the a these the best-in-class with that CMP We X really of a of molecule both only hormone, company for actions.

an are XXXX, leading we them are growth company of other some we believe address that but hypochondroplasia best disorder. of in what -- we treated the integrated not to going is our be address in that doing, other the how diseases is the Vision is to making part And And XX So strategy, be disorder. hormone. growth including with will only growth that and other

have the Some XX disease. be best X basic many cornerstone disorder all to be why the will them a will be this believe also them for why but we positioned CNP, can in be combination therapy. And of potentially we is to with the integrated in treated of leader growth we handle because

with more we're our be we to up much when how leading we So to next come strategy, up in year will company come come integrated building where the orders. growth

Operator

from question And comes Hernandez Kempen. with our last Sushila

Sushila Hernandez

elaborate blockbuster in on a you What are the needs drivers? the What Could U.S. happen? alone? SKYTROFA becoming to key

Jan Mikkelsen

doing. The key exactly we're continue driver we're to is is what what This doing.

the disorder. the get getting We treatment has are doing opportunity SKYTROFA, a the showing, continued patient really the inside the to best-in-class physician, group product benefit of

is by with payers major a daily the consolidation of growth all of one major different the daily growth saw of player hormone We hormone not lot We market. of be the stopping. The stopping. things. will helped We see

where of beginning will daily the cash it's of in segment, We're or be left less X it. really, in really growth it. now XX% part more potentially really, consolidation grow of the or We it we players growth deficiency, hormone, only the So the X a in growth growth deficiency. than of have pediatric adult small efficiency. also We hormone hormone still in less a hormone believe can

see trial limit don't and that that there's this And only our give name because say have people need we also the to some get experienced guy We product. for now. I there's the choice. up more coming really in they the one only realize then more long-acting, And

Operator

This Thank for questions. may now Everyone, further a conclude does no day. and are have you There great the program, your participation. you disconnect.

Ascendis Pharma A/S (ASND) 2 May 242024 Q1 Earnings call transcript