Ascendis Pharma A/S (ASND) 27 Apr 232023 Q1 Earnings call transcript

Thank you for standing by and welcome to the Q1 2023 Ascendis Pharma Earnings Conference 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] As a reminder today's call is being recorded.

I would now like to turn the call over to your host Mr. Tim Lee, Senior Director of Investor Relations. floor the ahead, go is yours. Please

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

Commercial and President, Joining me on Dr. and Officer; Oncology; call Endocrinology. of today Stina President Joe Head Singel, Smith, Vice Senior Financial President and Chief and Clinical Mikkelsen, Executive Head is Scott Chief Executive Jan the of President Vice Officer; Executive Kelly, Vice Development

SKYTROFA of profitable into to regarding areas the of timing biopharma ability regulatory I approval for our the hGH to intended begin, remind regarding respect approval create statements their TransCon safe that PTH U.S. potential and our commercialization our candidates, covered limited continued regulatory market, results, regarding timing we of such and of the Private results statements to Before the commercialization would forward-looking the regarding may of TransCon expected global statements of and clinical our filings, of goals our you in Examples a the the clinical our the PTH, statements revenue our statements progress this approval regarding ongoing our expected regarding not the statements with like to, the market, expansion of for timing contain the the in and progress, the SKYTROFA, expectations sustainable Securities include, our will U.S. regarding our projects timing statements under the Europe, TransCon potential Act. development the are market statements potential Litigation – our continued company. and timing of harbor by U.S. for pipeline, conference launch for TransCon new to and of our call plans, provided PTH decisions, that strategic EU Reform statements planned are be market, leading size pipeline product pipeline expectations our therapeutic expected but including regarding regarding and candidates and

These goals, forward-looking be us today. statements our we could available are Actual may statements. in differ is results to events our disclosed from And that materially carry not achieve those our our out not our information plans, in forward-looking our these based our and able to on statements, – intentions, and projections projections our or place in on expectations, undue our should statements. you reliance forward disclosed

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

cause of additional today's XX-F, sections filed and February section information concerning XX, release results XXXX. to forward-looking differ that annual actual on press the For our in see most our statements factors please factor risk the report materially, could Form

and having TransCon one hGH of due approved the least of older endogenous XX.X SKYTROFA year secretion growth growth Human under FDA inadequate U.S. treatment failure Growth and weighing the kilograms Hormone TransCon the for in the name pediatric is by brand at patients to hormones. or

failure injection X the to name children jurisdictions the such States insufficient refer addition, to the a for growth TransCon to SKYTROFA under hGH marketing Pharma Ascendis of as In endogenous TransCon product general, developed weekly of once granted adolescents aged for Commission and a European to the the European particular the product authorization subcutaneous as In the as has referring XX unless we're for growth treatment growth we Union. hormone. United in context of this due or secretion hormone, to

and product use. commercial our that please Otherwise, are not for note are investigational candidates approved

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

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

Following open remarks, questions. some the we up prepared call for will then

to Officer. over call Jan President Mikkelsen, the turn Chief you. Executive Jan to and now I'll

everyone. Tim. Thanks, Good afternoon

working to we for Ascendis the unmet patient we from positive later option. treatment new expected in important on and the is in to medical quickly XX, TransCon significant up a track Vision of lives decision our get out needs we to on biopharma the patient to our laid our as EU commitment FDA feedback and with execute with regulatory date on clinical year. by the the April that In continues regulation soon strategy are PDUFA data of coming market U.S., to of strengths PTH forward. the this living an expect our can bring TransCon have steps We from their on we be dedicated building And FDA feedback PTH, and profitable leading hypoparathyroidism, XXXX physician as next to sustainable, improve remain Based become with an and the remain U.S. and this product convinced patients XxX approved including possible. company.

are In scenarios. possible multiple heiGHt there

more leading built and team of with With on in the We value on in of growth leader the market. growing this provability Our making prepared unchanged. is we our that and this in in TransCon Skytrofa a launched the U.S. value more and become product it growing with a U.S. Skytrofa to believe in track belief commercial is goal market product hormone market well it hormone a PTH that product. the growth is clear blockbuster the in strategy a strength is product,

believe by now driven the we We is seeing factors. Skytrofa three are success following the of

Many growth that physicians experience time real-world is improvement Skytrofa, patients have to had in XX months with experience. the now an period and treatment benefits. with endocrine First, observe necessary other linear

with business this three, with reduce time out out to further daily when phased the that We of optimize companies daily companies their are of the hormone once phase ago came uptick product period. of will market. consolidation growth to years weekly began consequence daily This growth products investment in hormone supply started hormone and treatment support daily market. Second, current the daily growth growth when a believe consolidation of four Skytrofa. be realize the this challenge saw We among existing

Ascendis endocrinology. dedication Third, investment and in

with patients, affairs in are with investment commercial our caregivers, building providers endocrinology medical We in supporting physicians, relationship and team our investing a efforts. dedicated organization

supply for a We also chain are supply building a a that chain. robust we physician and partner patient, indicating providers Skytrofa solid trusted with to

our between revenue first new million. €XX reimbursed of on patient a many quarter of adding as we result, first using XXXX described for year outlook in and XXXX algorithm As sales we XXXX in did €XXX million million. expect XXXX we to Based Skytrofa grew year €XXX the earlier quarter this €XX.X as revenue now Skytrofa and XXXX, goal million full

for outlook provides new revised Our higher a foundation XXXX XXXX. for

growth foresiGHt line deficiency, is and The We quarter the geographic expect the track body Skytrofa Germany in in impact commercial top X patients, designed label the on quarter in are hormone we pushing growth third for expansion. Skytrofa global the launch to for is which adult of trial market composition adult deficiency. expansion results potential to fourth leadership for Phase the on hormone of In demonstrate Skytrofa XXXX.

to TransCon now PTH. Turning

issues TransCon As to to the I know we are caused health hypoparathyroidism. suffering patient mentioned goal. get community from today's dedicated that patients we at the by PTH of call, our of share and serious the And start life quality

excited to TransCon medical about continue on needs We PTH potential the of addressing patients. be significant have the could hypoparathyroidism unmet

PTH of of extension PTH open-label and now three for path XXX are Phase with on ongoing The TransCon X trials the for of XXX trial Phase continue clinical TransCon our forward patients to X years. with up PaTHway treatment original

And we to U.S. M&A fourth addition, Medicines if feedback. a infrastructure. XXX received patient from pleased very by EC the In Europe levering comprehensive on early status, Day the and in every Program response our launch we Agency the Extended decision in XXXX, with previous the are In anticipate announced, as new during approved our Germany Access continues European enroll commercial the expect to we in the our week. We quarter.

initially this Germany. initiate program for and the We also program, in access TransCon quarter. indicate expect Approval this we PTH enrol in patient first early to Germany to applied for an

achondroplasia, to Moving TransCon CNP.

and to that of potential drug in has CNP development, physician it a pillars key and continues efficacy, safety, data four our Our profile the TransCon feedback and conviction clinical positive product convenience. best-in-class differentiate reinforce tolerability

R&D has why this CNP we profile. we is beneficial and started year, X on Phase our we comorbidity in promoting have to an also focused CNP besides believe ACcomplisH increased XX all linear a this will is clinical data extension. share TransCon importantly, on effect remain who that More achondroplasia best-in-class We believe support new believe that the TransCon in event science Later patients open-label growth. trial

beta/gamma. and ahead with moving TransCon we to doses have specific agonist Phase Switching programs IL-X indication. TLRX/X in two oncology, recommended X TransCon

month of give you event May, on the and this share an from to key oncology in trials. two escalation an York with will Ascendis At studies ASCO we experience our data leaders important key update in in event, these programs. Next two opinion clinical our plan hold will R&D around New first-in-human dose portion

like aim before, said achieve I flow for equity dilutive even business cash long-term without need value as and continue creation financing. the Finally, additional are for to to we managing our

to now over will questions. financial for Scott review call open I we turn for before the

surrounding our touch few I Jan. points quickly you, Thank will on a financial results.

X-K Form please details, refer further filed For our today. to

of XXXX quarter currency million. parties SKYTROFA Pharmaceuticals. services license, been was noted, excluding the Total Jan clinical VISEN As foreign €X.X for quarter impact Revenue primarily SKYTROFA including QX well million €XX.X have first higher, was of XXXX. would revenue negative to supply as to €XX.X and a as revenue compared provided the revenue third in million fourth

to expenses PTH. continue up for employee During first QX. related driven offset commercialization endocrinology costs Overall discipline quarter sequentially in primarily sequentially, X% higher SG&A our to from were grew increased by R&D lower costs. expenses by sequentially, X% the in XX% oncology due the seasonally demonstrate activities costs increase for €XXX we SKYTROFA the declined fourth quarter, an Total million offsetting cost and related partly of TransCon operating quarter, XXXX. primarily for pre-launch support costs

for loss fourth X% in declined of to €XXX quarter million operating €XXX first the quarter our XXXX. the million sequentially Overall, from by

expenses expected campaigns than first the XXXX, expense Our to of main the cash be half reduce second further XXXX are completed in commercial capitalized would which product half. manufacturing which are in rather

totaling Ascendis quarter results, first SKYTROFA of starting cash realized with expected estimate Supporting remarks, marketable are beyond. as for we compiled track financing, improvements, achieving the implementing laid QX to is out QX his €XXX Based SKYTROFA. XXXX. break in exceed ended the million reach productivity we XXXX we algorithm are securities equivalents million million. on to cash, in €XX our and the flow cost dilutive million €XXX for additional Finally, consensus which Using full on Jan will year cash goal and equity additional of even we anticipate to revenue be and €XXX without current controls

milestones. Let selected me on key an now provide corporate also XXXX update

SKYTROFA For Germany our GHD, Phase second line hormone, in track are in data QX on and X in top foresiGHt TransCon we to to trial report growth we adult launch the global indication QX. expect from in

For TransCon is XX, we PTH application PDUFA our on so coming clarity NDA April date our U.S., the in additional the in expect days.

QX, TransCon Commission product early approved, We in our in PTH XXXX. second is expect in decision European launch plan the Germany we if

Phase open-label ApproaCH we And on data long-term extension are on share this from trial later enrollment ACcomplisH patients our complete XXX Xb will of Phase our up TransCon CNP, QX. we in of in track achondroplasia trial. year, follow micrograms the For X from to

and Within as KOLs underlying May on Review with York who of clinical his XXst initial in research oncology candidates. our product experience data in both TransCon host review have mentioned on a oncology to event hear therapeutic New science we'll our area, beta/gamma portfolio. the remarks, our from IL-X oncology Jan

and our receive PTH to the As is response FDA by the a you XX, Sunday we April then. from date know, for PDUFA NDA for this expect TransCon

this not to we Given for the the be this PDUFA NDA additional PTH, for proximity TransCon time. regarding at providing the NDA date will details

take operator, questions. to we now that are ready With

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

open. is line Your

letter. has difficult my outlined you a at can but PTH taking advance regarding for you PTH know I the to the PDUFA, know Thanks deficiencies that question. afternoon. of the the were now I in NDA? now? previously Good not say just believe Great. comment FDA it’s them know in the those Do if you minimum

to your further comments. no no and say can have I question

goal embedded dilutive that Okay. about of of And your like assumption? for can breakeven for you achieve flow equity without the business PTH then kind the elaborate breakeven that in the financing, you talk just managing when to on expectations are need cash are what

different the of worst working lot not the best And a know we with dealing call of with case. what before, case we because are scenarios deficiency. we as – a It’s we are exact indicated do the we nature and

that. We leading build and are both our We looking to We We still biopharma XxX. want to Vision want sustainable that can fulfill at this. to on profitable. continue a up

assumption from here So perspective into taking are launching in QX. we our Germany is are the SKYTROFA that in we

We system into are in in assumption TransCon different Germany taking to the XXXX. launching and Europe are we beginning of PTH

case fulfill building and we is have to things that the Vision still even and that U.S. in we assumption best the the SKYTROFA in are in will case, get to from We laid going out XXXX continue the together the worst XxX. XXXX growth can and our two

you. Thank

question next comes the Thank Ahmad, Instructions] line from of you. Tazeen [Operator of Bank America. Our

Your line is open.

can GHD. I if questions of couple A afternoon. good on guys, Hi

recently beginning year. think guidance You’ve issued I as year, the as the for sales of the

of been on that rest I when compliance putting perhaps guess make such you can that have prospect. would major year. assumptions of one the patients what’s the versus be quarter any tentative starts the some the into can I project you tell You feel as confident rates us guess share new consideration well. might to And drivers sales during number great can together more switch out changed you. as the on you took Thank you and guidance you

the for question. Thanks

can now We’re that because without accumulated feeling even confident top sum we now much big to MBA more a an a a of mathematic [ph]. QX algorithm on I is we when go understand

very simple. very, the is duration So

in million have here QX. You XX

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for solid patient in and and agreement with it’s think stand XXXX we simple this I add So can to XXX XX million the XXX getting why in new built if as is this we the between I’m are then and and multiply very X I number I times number year. on amount a did exactly just exactly same XXX, feel of this

everyone I for sign senior to the on have organization in this.

I’m So guidance this. why we we the can come feeling that use can feeling, fulfill we feel when you give modeling. we is can guidance reliable with will that in confident this you we And up

that we that feeling that number can So in you’re – give for. stand we feeling you a we

Thank of next you. comes line Lebovitz question from [Operator Instructions] Our David the Citi. of

is Your line open.

growth look at how and year much very the at my that in into taking U.S. of you’re When rest for expecting, Well, look versus should the question. thank SKYTROFA you the you then we dramatic Europe?

sales. to we The guidance are providing you is only U.S. reflecting

We be that. have Europe. will a guidance given you to not of top There on related

into And I of can expect next we just are got it. what going updates when your guess CNP and TransCon the could you that? expectations I remind us

do event in of forgotten indicated signs we will Because we May, update I we the to we as for clinical the as likely how we oncology get signs the and now its in outcome. The outcome here in will where and beginning behind has the It provide think when in come the the that fall, and QX, CNP. you, we here New of sometime, research York host own product clinical mode will decides and understand he go to action. the through every will signs it’s getting in

have are linear addressing We for not we always growth. here just said

believe what data best you era. is believe building a focused thinking really treatment We can behind and this need in event at up are of the the we in way that what opportunity we And give comorbidities of class key on. and signs give the we you can in disease here data, the research product that are we the addressing for for been have that treatment [indiscernible] element that always I

taking for my Thanks question.

Goldman [Operator the you. comes next Our Choi line question of from of Paul Instructions] Sachs. Thank

open. line Your is

investors afternoon Hi thank to and team, you for with and Jan questions. I good and that guess, thanks taking our regard PTHs. question one have

you weeks As data the call you any the agency? few there your been clarification FDA since statements Or earlier ago where a provided additional think the – updates? expect about you that from requests – the any have you Have other shortly. from held

we statement that this up not have at think wrote we comments interaction need we of that time. the clearly Scott on further FDA any to refer to I will

launch then some and preliminary on comment in hormone, or European think with on of other to the regard And the the you had Okay. the category? can versus pricing just with discussions kind the GKSV reference for available reference maybe in either versus have side products any commercial Germany IREG the you of to how growth about pricing potential

is U.S. That I the we have here hormones the the in we they daily in U.S. issue in believe same exactly same growth in dynamic happening U.S. how Europe. that that established in saw have and the tackled way is

We patient responsible superior have in Europe. pricing superior is that with and the we do the I U.S. will that come in in a for will regime the we same believe treatment also

Okay, thanks. I’ll hop back in queue.

Li question Instructions] next Thank from [Operator Our line you. the Watsek Cantor. comes of of

Your open. line is

Hey, side? earlier thanks questions. on with starting have provide QX PTH delay and maybe may I I mentioned I that And access guess OpEx us you program taking focus in you control. this? be the you eligible are in OpEx the mean, will guidance TransCon that some you can for for help have think should our a about how Germany, forward. guess Maybe we a given early patients going many how understand for cost on

basic in first it’s compared approval me for U.S. different is U.S. question let patient because restricted initiated for is and highly all as in Germany the we Hypopara Yes, with that where is not applied where have both last Germany because experience. an program to the electable for start to and take PTH the we patient for program highly

different, getting automatic broader day approval program conversed patient. to reimburse example is patient is also be you’re automatic The dynamic is and the the would because it for a the – most program. there So over terminated

different it’s have system. than U.S. actually So a system the you in

is to unmet Natpara highly is Natpara why that medical under know then of patient is So in XXXX. some the that access today give same because need we will the multiple constraint that of of patients this series hundreds the a restricted on patient way is disappearing beginning

physician want because give to it time some opened actually to have you they really changed say up before. other TransCon At seen patient to also that all it the have PTH program must and [ph] desire this patients So can from the was same PTH. all treatment time to there never over for patient to strong we

So a why it’s this is different program.

your optimizing of outside running always to of we we that function how back to ensuring we actually way have cash very, Ascendis the we path bucket, basic Going want some comments and I way ago years U.S. it about into simple is not two how what water have with one by are financials the our also in this made optimizing there today amount at our bucket water this a revenue it. very run procedure, grow with not will in this it in we and SKYTROFA it, it productive most and with solid do then take is other our now for can every and grow function it, we grow we is and do we business, U.S. way the and to U.S. with we that perform it something adapt business, we we see day way grow

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it. got Okay,

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open. is line Your

taking Hey the great. Good for afternoon. questions. Thanks

one. mentioned commenting is yes Just on? interactions two assume comment you’re interactions call, it since deficiency that with letter the that so want had not So FDA earlier you’re the in you’ve not you on fair that’s the do to to that question you some number us. from Jan,

players you these attrition growth the for is, because it’s and maybe them in or competitors Question one and maybe exit other two market so profitable expecting to about talked the market. you’ve number leaving strategy kind this of hormone two not the market,

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next question line Oppenheimer. Gershell Our comes of from Leland the of

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Hey, good afternoon, my thanks and taking for question.

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next Our Purohit from comes Stanley. Morgan of of Vikram question the line

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We just viewing data Hi, our you fourth for for for hGH. good the of And foresiGHt speak adult us frame how part help commercial Could hGH quarter? population? population one the on expected TransCon afternoon. question. bit also had Thanks this you’re the GHD in potential for expectations the a taking the Thanks. pediatric in versus about GHD

situation Really, really interesting really adult a the linear many are way the as of to hormone, look primary hormone other where is outcome. so use that is trial growth deficiency we growth in us, because and why the for growth interesting indication were used

to endpoint deficiency, primary the have, want which really related the we built daily have the hormones. you endpoint. are growth on not hormone a in element benchmark the also it’s change population. to one body primary pediatric where adult consideration What But also in is the in of Here have composition, we we achieve

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from Securities. SVB Our next Schwartz from the line of question Joseph comes

open. Your line is

very much. thanks Hi,

I know find mind pursuing. across on a conditions. physicians when of to a these on So seems fragmented we it how can us endocrine speak never and these three almost bit two, currently never three force who endocrine you're we to is speak leverageable look for sales topics, indications anyone

can So whether currently you order significantly achondroplasia reach hormone to actually you in and specialists structured it force in little sales hypoparathyroidism is have about just talk how expand growth bit folks? addition a the to won't to and

This the Yes. holistic is picture.

on are really, really basically endocrinology. we on building why strong really focus independent three up of saying products You did a focused as pipeline

So the pediatric indication. first adult one It both a we have is and have SKYTROFA.

pediatric the the now adult. go we pursued have We for

TransCon We but PTH, pediatric. also the main is a have adult, have indication they

We expect I are extremely soon get this approval do is, we the get what the deficiencies? to as feedback, we market. ensure fast this to we going can an is call and said adult what what as the it we we address When the what hypoparathyroidism know before we and going product out the deficiencies in is now, as will

will We also pediatric indication pursue segment. the in this

the discuss We people to come this for things the is focused Then we growth. CNP, we life. have also state. rest that because regime one is disease on their basic is of believe linear a achondroplasia this will when believe pediatric we like they're to And basic just TransCon research and also treatment of

it, specific you yes when out, on about a go we us you part holistic see synergy reach of gives to into. So the it think lot when

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you sales Joe this up building his between actually that and actually I just have all and because can exchange PTH, we team about it the to sales capability dedicated the They're basically way. force think done. force think are U.S., to in different have the SKYTROFA, If both what but what dedicated call back basic forth to be

operating. to have of way much have synergy I this so So that we in believe

Thank please. you. One moment

open. your Argyrides, is of question next Argyrides the Our from comes Again line [Wedbush]. Andreas line Andreas

A one question. the quick here our Yes. TransCon Good on afternoon. Thanks CNP. for taking

and and to So expand years of at are support potential us impact high landscape, under or you you TransCon addressed? already looking tracking was old, to forgive could expand growing see you if the CNP and [ph]. into on patients data what children Did to the outside that achondroplasia provide competitive a two plan market

that is when potential we where want in I No, have also a believe a can to some do lot. an is way, effects element we sure, And data, growth, comorbidities. linear what between SKYTROFA we that side effect can help The when we accelerated what presentation, the is our achondroplasia-specific call which combination couldn’t we we lot we contest believe that do a regardless. basic the of We released can achondroplasia-specific in an see element meaning that and we did TransCon CMP. you on we indicated

are basic speed We trial, that clinical are all building to and have our on is potentially that a full we this in we Xb, more manner we regulatory and we interaction, in in our have now how pivotal specific patient prove quarter can recruiting here. that hope Phase hope for which

and of us growth, where addressing is we treatment correcting that ensure comorbidities. see really to of element we are achondroplasia only the this linear also providing So not but the

for Great. question. taking Thanks our

comes next Our question Werber from Instructions] Yaron the [Operator of you. line Cowen. of Thank

open. Your line is

for held this the May, thinking PDUFA date so of is moved our in think this think for and [indiscernible] were deficiencies. on investors the call the I and ahead early call update QX get this Yaron. Hi, might we some was that you’ve time get on up maybe I questions. Thanks much taking to that an Historically,

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comment expecting lack guys interactions And then are to but of the with given you. if it I just do much, Thank not FDA, the think can secondly, that know does seems you a refile? quickly able happen, quickly, just you how you’re you And CRO. that

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we’re, So everything just we’re a think, pressing finalized. Scott, I but button then and get we Mads.

for report just for earlier the reported will earlier as quarterly report. the annual so we Yes, now report

look into say would specific nothing to it. I So,

if In we’ll next I think fact, even Mads? right the report earlier, year annual probably anything,

XXst of January.

next January of XXst year. The

increase do I and because It’s hope productivity we answer your to faster. question. it just

you Thank so much. Okay.

the of you. [Operator Our next comes Thank question from Berenberg. Caroline of Instructions] line Palomeque

Your line is open.

question. Hi, Thanks good taking for afternoon. the

in expenses the expenses, any on Do And stop and U.S.? second the add people application any the there updated in a that, Like my the will guidance. versus MAA differences in application European you to more were I’ll material sales SKYTROFA hasn’t force? revenue then adjustments been the any So just Agencies. just such in there also Regulatory is follow feedback understanding, MBA from up Given there? question a SG&A anticipate given as Thanks. in Europe you

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Great. Thank you.

today’s for gentlemen, you. Thank Ladies all conference. this participating. I’m you conclude does no at further showing time. Thank this and questions

a now day. disconnect. great You Have may