Ascendis Pharma A/S (ASND) 11 Nov 202020 Q3 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the Third Quarter 2020 Ascendis Pharma Earnings Conference Call. At this time, all participants are in a listen-only mode. [Operator Instructions] I would now like to hand the conference over to your speaker today, Scott Smith, Senior Vice President and Chief Financial Officer at Ascendis Pharma. Please go ahead, sir.

Thank you, operator. joining quarter for conference financial everyone today. call you, our XXXX third results Thank Chief of Financial Smith, Scott I’m Officer Ascendis.

Development Bach, Joining Punnonen, me Chief of Endocrinology Mark and Dana Jesper Officer; Juha Høiland, Head Mikkelsen, Jan Affairs Global Clinical Rare Head Chief Diseases; on today’s Dr. Executive of Oncology. call Officer; Development Head are and and of for Medical Dr. Commercial President Pizzuti, Dr. Operations;

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

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

statements supplement product and commercial on section factors the XXXX. cause July our could prospective Please approved note press in see materially, differ are please TransCon the results filed product the use. of information and candidates Risk investigational not additional actual Factors are to that section our concerning forward-looking today’s For that release X, candidates for

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

Thanks, afternoon, Scott good everyone. and

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

Jan. you, Thank

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

your with may You question. proceed

for afternoon. Good Thanks guys. my Hey taking questions.

or anticipate Can be think we strategy? the the you’re lag for to which Growth how and should any able launch on Do launch to being able post-approval, you’ll immediately the you about share get little As we think you reason within thinking Hormone. a whatever TransCon approach timeframe, commercial how about plans? more commercial for we should about about

great all, always Jesper here room. It’s you. And to have of I’m in you. first to really hear Thank pleased the

some you, U.S. executing the the is of but this So, we this are on our he for what questions, is for currently, said and plan have what think can take have I we what away is now, we and shared

So, way we with on executing upcoming be when will on European come near really stage, and some expected will, actually also going the are how seeing to focused we we approval, also – later he Jesper the talks, are out mainly U.S. which in hopeful now. coming are

the plan overall So to strategic Jesper, will market? you tell related the about U.S.

thanks the once-daily I spent transformational I patients endocrinology lonapegsomatropin I’m say I question, having in parents in the years U.S. look well us all and to. area certainly once-weekly opportunity be XX have Absolutely, going only think could what take from can of And the for than we’re forward growth is it can the to more Jessica. that and hormone. about super-excited

shortly next We are to in hiring be the know. which in you ready of launch as the June year, after XX is to process date, PDUFA people of

be on and team. in be to energy level are when ready the up The of place, we entire completely So in we shortly according recruiting hopefully the to come certainly and is will and full running we the with under will of plan, market. thereafter, we me management and

the at product already the having guessed of to – And of You guessed this all is market someone be the focusing. make we talk know that course, that’s that’s approval segment before which I is strategy. pricing, the the also will about and in that we of the where of Commercial what commercial launch. point time that is decision commercial about will will

approval. are is Adding ready getting one our yes, manufacturing perspective, we from Jesper we to the launch to after comment exactly

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producing We are the drug.

there. are We

and period, start go established. for is out we manufacturing already where are having not lack it we need to a So,

Thank Great. you.

you. Thank

Gilson with Canaccord comes question next Genuity. from Michelle Our

may with your proceed You question.

to with years maybe a could for my question. into ACcomplisH achondroplasia. patients you taking patients? and why current XX TransCon have to young you then two Could you how remind old. trial the Thanks the bit CNP The versus about the CNP plans to would program. I debilitating Do enrolling years go in anticipate is Hi. addressing little bring guess overall talk FGFR you And to younger you more CNP us associated And right comorbidities approach achondroplasia inhibition? need is Trial

Thanks.

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basically can that from cardiovascular preventing basically, also knows You everyone CNP diseases. also perspective, is and cardiovascular say protecting

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different Going back ways. can our had to complete in somebody overall program, said you before conduct trial Phase X

the then of from into this X and we This why to CNP. easy setting. we trial case mitigate You what want Phase then of risk you TransCon here, can we we not did independent for two only is basically double-blinded. not the parameter will X continuous we basically have we we can really basically What Phase heiGHt, a Phase trials. basically, position believe, see efficacy, to be because we only compare X data are is continuous Phase our the developing this disease. this can address a And have one a a is really phase Both to trial, we and is CNP, measure a Phase have having historical that X single-arm we not trials, in have where analyze that we we of what pathway outcome that major of is that through FGFRX Meaning them X independent are comorbidities now only exposure which trials. into inhibition believe of have improvement, placebo-controlled, two in will X

call expansion, dose. in the what patients have one, a will you We many is call you where more an cohort cohort basic when ACcomplisH and we select we dose what China, have are optimal you optimal

go This you is have is this the as up to newborn. we basic to and is avoid The is the we the the we other from to element need in need what back treatment basic treat on the two bone will only need early to is to way Yes. why address also are plan, fusion this years as to way first comorbidities. happening the really we to that closing are you stenosis, newborn address If filing to opportunity children newborn? of go to life spinal before optimal we the and basic can have now basically on down take down possible.

you – phase you have chosen trial since were have initiating to expand? that China, in the So, planning you are doses the you X

dose and we we dose expansion. And we we’re velocity, we out it the call cohort and basically doing that We right to see safety go still ant is what see learning that do we be right. doing ensuring what to quite now. – We are right the we before really escalation, sure I to basic a broadly want growth

this more sure optimal patient in month-by-month to group. we’re this So, have ensuring also to be basic dose for that a basically, potentially, we treating we would trial cohorts and enroll that the position are following still we

Okay. taking Thank you my for so much questions.

Michelle. Thanks,

Thank you.

with Schwartz Joseph from comes question SVB next Our Leerink.

question. proceed your You with may

runs two-year on and what the on in CNP dialing CNP? your impact Joe. just Andrew through groups question. competitor’s for the wondering the this TransCon possibly CNP. for FDA data TransCon thoughts assuming wanting wondering your taking I Thanks My our is FDA strategy on data, one age in based I are does first achondroplasia for different Hi, was for – was filing your

have where continue the and also a will This thing, marginal potential, small product that Japan. like one it’s data which saying in a years, you centimeter see what and the same effect, had to your because hard you great that in is believe someway believe the question, basic could your I if basic is, data have two approved that do a

of into question, how situation, one and and And the see and continues could growth get that scientific has us. how you it already use more time. in growth our very, kind because basic compared an achondroplasia. very You will it basic Dana, comment potentially of what in in can I achondroplasia And one hard you hormone had velocity centimeter group applying growth impact over why prove you established think this that to reasons the been have potentially can about been to clinical hormone. your will trials is patient that

Sure.

I assess and a safety, reviewing think the FDA efficacy. advisory interval that as that that good output as recommendation to of the guidance two years committee continuation a of is the was well

time. of placebo-controlled years the because flexible. they think in was were two articulate that or the expressed with about long you concerns there believe that that may for I come that a advisory committee be that trials, these that up years I of kids two placebo way somewhat don’t specific on keeping

I think wouldn’t for program way able of two be that So a our potential current there’ll at impact a for patients to be us that – the to it filing. accumulate our but within really years, of context number plan so certain

question? that Does your answer

market and in your from on expecting TransCon – the are then, how for Yes. That’s gradual based patients approval, do switch helpful. Thank patients And of from from to you Or hGH, ready just TransCon – your when – you anticipate Should research launch for ramp patients lot switching hormone? growth over? more aggressive? be daily expect demand for hGH a to we switch you it very you. are could a detecting

the the One they’re growth will benefit filing back switching patients. one sufficient also knowledge, also currently also only what they should trial to for we idiopathic naive also have patient because that also was basic both a new safe remember That goes to the wanted switch that and But to daily hormone couldn’t reason a patient Jesper you sufficient base I before have deficiency, need think and that regulatory a – of switching the that algorithm patient two achieve majority the understanding what some a high is from step basic part see and was by efficacy of X ensuring in. to major related step the three the growth that taking then made because to we coming prove Phase patients. basic number saw was we our and years but Jesper, years. four with three to to your entire on Phase X to about call safety, expect why we we switch trial of good an patients, we and for an of you did also treatment a than that trial hormone. four made we investment about because can of same patient And recycle, years But before treatment there out years the in how basic the less in comment the patients, physician we much established population trials. focus

Absolutely.

the and be of is lonapegsomatropin. be push also believe have also market with on we get course, as much on into PBMs great first we putting to we are foremost, a will side. health switches. Switches very, do ones certainly it really gradual strategy access from we a important our and basis access, and point we that but Patients for come have market would newly and then, that very course, very start. that is the that negotiations And of diagnosed see a hopefully will the we of First anticipate to plans, new pull market patients the the of a with

patients unless are get that we well-established patients I hormone will are for, growth we sort we with innovative less believe really on of way For access new likely, market that get aiming of currently going forward. a that really treating and that

sales background place is market in strong everyone marketing, access XX than only to spent in have this I in not in have operation. the a also said, colleagues also and years we endocrinology. very, that more attracted and area hormone, growth As From but very

wait present So, running we be not-too-distant I will to next future. end a up of in and cannot year. And

you. Thank

with from Our of next America. question Tazeen comes Ahmad Bank

with You may question. proceed your

Good so about general Thanks to afternoon, you’re receptivity much guys. for my questions. in get on pricing. how taking thoughts Hi. Wanted to thinking your

you to wouldn’t I you have that And I guess, in for demonstrated with growth hormone? – obviously then, And with daily ask premium a would data clinical why a hormone, superior that are treatment. daily at mind, clinical to growth in follow-up. I you’ve So, want price to

that think will that question Jesper take is I clear so it.

too, interest are net going of it’s aim here. price but we course, of to down meaning we it pricing the whack the course, that that have what the for. It’s I boils price to And that down list negotiations mean, are price, not boils is But I a PBMs to the demand true pointing there, we market. mean, the of and that’s you is are as put superior introducing you product. that never on phone Apple plans. will seen I the And than that price. was phone have through are health of course, superior new having previous the a anticipate with out, cheaper they going

Okay.

you can think talk for Thanks. about potential whether comfortable treatments, how you parents would in thinking your dynamics that current how patients I think anybody, us be would switch who mind, might will to be should what physicians, you the the referring with do But for take to prescribe the doctors away. that the we daily would with to patients, new for market, that? it be So product? the for be convert long about or TransCon assume right

three that First in four patient years. years of basic to all, in – all patients dynamic through you a cycle switch is the

switch all half this years, on some about and Jesper’s So, what switch seen have organization, this because see have your one the it only And is it’s years, done years, over, everything [indiscernible] first years, also for a where the switching need impact modeling after pacing, talking you to where basic an to four that Jesper three impact is two perspective switch the if but the on modeling. you’re from for basic after patient you is three years, it’s two impact the about. because talk years, first and is that patients two that something can basic, four only I’ve is takes. basic –

I one take child and the would just perspective has perspective. to also parent add, like to

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Thank you.

with Stanley. comes Our David Lebovitz next question Morgan from

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Jim with Our Fargo. next from question Wells comes Birchenough

your may with You question. proceed

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Thank you.

Our next Alethia Young from Cantor. with comes question

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Okay, great. Thanks

Thank you Leland our from Gershell next Oppenheimer. question comes with

You question. with your may proceed

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the All questions, much you the right. Great. taking Thank progress. for very congrats and great on

Thanks.

gentlemen, Thank you. call. concludes for today’s participating. conference Ladies you and this Thank

disconnect. now may You