ASND - Earnings call transcript Q3 2024

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Operator

Good day, and thank you for standing by. Welcome to the Ascendis Pharma Third Quarter Earnings Call. [Operator Instructions] Please be advised that today's conference is being recorded.

I would now like to turn the conference over to your speaker for today, Scott Smith, Chief Financial Officer. Please go ahead.

Scott Smith

and Financial everyone, Results operator, Third joining much, XXXX Quarter Conference so thank for you, our Thanks Call.

Mikkelsen, joined I'm and Scott by I'm Chief President Chief Jan today Financial Officer Officer. Smith, at Ascendis Executive President and Vice Executive Pharma.

regarding statements like I Litigation that conference provided statements but the remind you Examples continued commercialization financial intended pipeline our candidates of ongoing progress market and and and strategic our regarding regarding by markets, commercialization, of goals to, may safe therapeutic the Reform clinical not expected our SKYTROFA and including harbor to decisions, be our the partnerships, in endocrinology opportunities expectations plans planned for Before areas our call would include, results filings regulatory our continued potential that contain Securities YORVIPATH the of the will expectations rare are the regulatory their as Act. clinical developments of such U.S. of we development certain timing market to to disease. expectations, of our and and and our begin, the limited exploration pipeline, our trials, Private forward-looking are statements this timing and European covered and well under with respect and as results and

by these those circumstances differ not these from obligation to except of should update statements today. as reliance materially on is our Actual and us required are differ change, assume statements statements. available information may -- on as no undue as These could that based forward-looking to law. place results We you in statements,

our February XXXX. our recent Form press could the factors cause SEC Factors XX, on most please with differ results XX-F section prospectus the Risk of release annual X, today's supplement additional filed of report September section our filed XXXX, materially, statements on the actual For and concerning forward-looking to and that information see on

Growth adults Commission the of from Healthcare and and approved growth is EU by treatment with in for the Otherwise, in adults in by authorization the granted products U.K.'s TransCon and Agency MAA or of hypoparathyroidism. a TransCon hypoparathyroidism for indicated European PTH commercial deficiency. our hormone and are treatment the use. authorization PTH treatment the investigational approved pediatric note Hormone European is the Medicines for please for the approved U.S. product FDA and the received candidates marketing Regulatory as that FDA U.S. the the Commission TransCon TransCon hGH has replacement therapy for the chronic not of have

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

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

Following it questions. some prepared remarks, up for we'll then open

me With let Jan. turn it that, over to

Jan Mikkelsen

Scott. Thank so you much,

address X XXXX clinical has have major disease transformative product program to be unmet programs its demonstrating out Ascendis. rare endocrinology the status, is positioning Three data. for each needs been blockbuster in or Each of of us delivered differentiated year our market receive medical and leader area. to potential pivotal another

to indication. position against These a SKYTROFA. team's competition multiple highly and SKYTROFA's achieved the are single and companies. big excellent differentiated with once-weekly pharma in growth market has best-in-class a is its product, U.S. execution performance approved first hormone, leading competitive testament profile Our a from a

We growth opportunity SKYTROFA expect for ahead. additional

product third are hypoparathyroidism multibillion hypoparathyroidism who in of we the adults adults. U.S. launch treatment in YORVIPATH would excited U.S., that highly to about in the in only the this approved approved is that treatment. this XX,XXX for first for the upcoming the from further of if XX,XXX YORVIPATH candidate, market treatment our TransCon to strengthens positive announced with becomes be CRE very pivotal data and achondroplasia There benefit product are in dollar We FDA in opportunity. the choice The it our potentially belief September could of

with the for platform success attempt we Nordisk creating partnership patients, Novo staying our high-volume we our stakeholders. highlights passion, ability areas. on large, and extraordinary new our into focused Our and to TransCon science values therapeutic of By are of value believe patients

The and benefit now I strong. provides. volume SKYTROFA are these of SKYTROFA to physicians, continue key products caregivers third Starting comments and with year-over-year will than more of increased quarter other on the Demand the recognize of each as in patients SKYTROFA. provide progress. fundamentals areas more XX% detailed for

around We have hormone. have but growth its net compromised per on maintaining achieved broader Xx SKYTROFA of value that patient daily market not assets of value, a for

Over a see label opportunity SKYTROFA we on deficiency growth there adult of In an BLA we submitted supplement pediatric growth to with September, number growth hormone hormone time, deficiency. drive expansions. a for

Phase to trial age next trial expect syndrome. such II we syndrome. Next indication And short a for idiopathic established line hormone small one, our from the stature, shock genetic SKYTROFA condition Turner imitate top Turner includes year, growth expect as we and basket in data which

the market. written Importantly, SKYTROFA converts therefore is believe is and is preferred compete that when positioned going to hormone. choice prescription as The daily the Today, we of weekly for the for hormone once a to market growth such to market still growth consolidation treatment. Lilly XX% players Genentech SKYTROFA We announcing well product. being daily to exit giving repeatedly plans the with the see

into dedicated are the blockbuster alone. make We to our in SKYTROFA U.S.

expansion, those the value adherence daily both duration treatment pricing Our focus and and increasing and through its recognize that market supported on long-acting of will growing treatment new label by stay from therapy. growth hormone, with share switching patients naive

YORVIPATH. moving Now to

launch the for imminent preparing U.S. are YORVIPATH in We of the

for preparation accepting treated we all product prescription month, start XXX in XXXX. prescriptions X, plan YORVIPATH December, patients adult January already we to expect begin to in process hypoparathyroidism. mid-January commercial Next accepting being around for in to and with with for reimbursement availability begin From chronic

to has U.S. infrastructure, invested building have successful treat that team that opinion field focused of engaging commercial providers including Since a SKYTROFA. on leaders many is adults, number launch, expand field for U.S. the we strong expanded organization our health Xx covers a are hypoparathyroidism. our and YORVIPATH, To treatment care support the who endocrinologists in and who including key involved actually approval,

This driven physicians patients average market is XX in concentrated by around around an hypopara chronic X,XXX relative have patients or endocrinologists, we and about estimate each. a XX,XXX their care specialty,

U.S. the We X,XXX YORVIPATH, and XXX is that special the experienced to of patients the from PTH naive X,XXX in the to segments. use X PTH XXX already population to program of XX,XXX around There broader YORVIPATH NATPARA on expect patients patients around initial come are uptake in last population. ending treatment soon, XXX

uptake Outside robust. of to be the U.S., YORVIPATH continues

patients programs XXX other YORVIPATH of We therapy commercial where and many in truly there launch on countries. As commercial are across the today, began believe this is year multiple Austria, and now patient in Germany product. unique in around a January

We guidelines treatment have And other key the the action physiological any PTH in which in recently body PTH the levels development for the with YORVIPATH attributes. have the therapy become endogenous is to compounds of hypoparathyroidism, we share to that decided active days of established for in majority adults same hypoparathyroidism adults. provide for within and We the believe with that these aligned don't will XX as mode and a week. of see X distribution hours, the

now provide will some CNP. TransCon I on commentary

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

for endpoints impacted trial only clinical leadership other other profile in market. efficacy to results trial, that with This similar has for stage the not with placebo, growth achondroplasia injection believe pivotal and site also safety randomized for the best-in-class weekly showed CNP TransCon have but Our dosing. TransCon individuals tolerability and an CNP in achondroplasia. excellent important including that that a benchmark tolerability once exceeded been sets We slated are its

the to expect TransCon submit XXXX M&A XXXX. of the the with FDA the third to during EMEA of We achondroplasia for first an of to quarter an children during treatment and for quarter NDA the CNP

believe of our leader growth CNP, SKYTROFA is once-weekly positioned With disorder. and products to portfolio, promoting growth in the TransCon treatment X in become we Ascendis

data years week the quarter trial our and of TransCon Hormone in achondroplasia topline XXXX. children first with of COACH, expect in We TransCon aged second CNP XX to from XX combination Growth X

triple Novo our as GPL-X global therapeutic monthly area obesity believe type the in Novo validation the Once-monthly is XXXX. Nordisk than a double exceed to for a GPL-X of to expected the in to year benefit that collaboration. like will innovation, market become our this once described diabetes. in $XX and platform billion GPL-Xs, The of treatment drive or X XX years. patients moving next semaglutide could announced more to with program future this capacity We larger this the to strong infrastructure are target and value this our leader And The and Nordisk, the world realize recently we working market. lead is technology manufacturing a with commercial opportunity. in Vision a TransCon agreement and be is ability Now to to pleased the expand initially collaboration of choice

USD we global sales sales and escalating of Financially, upon and payment royalties receive milestones. XXX development, along net an products mid-single-digit million upfront TransCon on closing, tiered will of with regulatory

first cohort oncology results at patients beta our showing IL-Believe with treated chemotherapy. was we that ovarian Trial that in IL-X Phase antitumor September, second of response of with beta/gamma indication-specific pretreated the cancer combination This XX meaningful update showing signs presented cohort of of will ESMO clinical patients. efficacy-related the an I activity from observed In TransCon antitumor program. the heavily in IL-X with in TransCon close on I/II, platinum-resistant

expansion of on to agonist beta/gamma. enrollment TLRX/X cohort trial Given these and closed TransCon the our dose results, recently, highly transcendIT-XXX to TransCon IL-Believe IL-X prioritize we in effort

believe the revenue our to profitability. endocrinology in invest at our are them summary, expansion support reach and sheet time, to position strong, candidate product build by launches, rare will our to management to new and product platform progress status. blockbuster to all In of same we sustainable and label give global and of the for expected continue the each TransCon life X strength balance cycle us technology growth created invest program of we in and ability our And

to I will now Scott update. financial for turn it over

Scott Smith

Jan. Thanks,

raised and revenues In We have in financially also extending with year tandem significantly. we became endocrinology success into capital much Ascendis Product the of progress diabetes, the quarter. stronger obesity our rare grown of this X and third X type made XXXX. programs the with TransCon have in our disease platform application the

We are and capital disciplined Novo additional Nordisk securing we with through our remain spend. non-dilutive collaboration the

financial countries expand approval for preparations in submit CNP home direct the product; international and launch and TransCon in and achondroplasia. for in U.S. and and our in Europe multiple to with U.S. launch towards priorities: initiate growth build head We the YORVIPATH on in successfully EU leadership as capability hormone deficiency markets; year our and its key position XXXX on SKYTROFA to ample strategic the for growth label execute next a best-in-class adult

to by quarter in higher I'll revenue third in more details, quarter million. X-K negatively third our touch on SKYTROFA results, surrounding volume EUR quarter key for a than period quarter prior third financial third also revenue EUR filed prior to the as points in increase related access. to XXXX related quarter of compared year. was year XX.X the the to by last quarter last year, volume the impacted today. compared XX% million of of deductions result of our approximately compared XX but lower channel EUR the of some refer the offset revenue quarter increased while to further inventory sales The X.X XXXX, XXXX please SKYTROFA was adjustments in X.X the million reported in was compared third to primarily deductions third sales was reported XXXX. broader third to million SKYTROFA of market EUR

XXXX in million EUR SKYTROFA for over the XX% EUR same increase to XXXX. XXX.X of a the year-over-year million, months period totaled XXX.X compared first X during

few higher GHD. first in the an see For stable January in including related extra shipping XXX to doubled, we expect XXXX of and year. despite days that With of but Overall, realized true-up X.X true-ups million and be XXX EUR X, QX accrual we XXXX. growth volume SKYTROFA based by partially data, indication to and been year of sales offset QX, the related pricing to has approximately QX a revenues claims of beginning periods estimate X% increasing pricing, QX overall sales hand, can more stable by years, to deductions accrual to SKYTROFA pediatric since SKYTROFA with prior EUR EUR with more the on end million. treated the penetration XXXX, months revenue, million was our sequentially than third-party expect to was prior deductions full the X demand, We XXXX increase in hormone market single for the excluding

SKYTROFA leaving In market addition, of total of prescriptions, on XX% sales growth for expansion. lots about data, third-party for hormone that based further of U.S. room represent growth we estimate daily products and

than Shifting by X.X Final demand be period to year. and quarter offset TransCon reflecting quarter. outside XX% U.S. expected growing end Germany revenue next to EUR third YORVIPATH the free physician patient pricing by more in the PTH, the completed increased in Third partially is pricing accruals driven to million, of the

topline, total quarter was to X.X EUR the the XX.X including revenue. license million, tied out Closing third services revenue million rendering for of and EUR

to as expenses. in HGH, to XX% the totaled TransCon EUR to CNP due XXXX during Turning million decline transaction. development third quarter Eyconis was for the well TransCon compared of largely costs quarter R&D and PTH as third the XXXX. lower XX.X costs of TransCon XXX.X million EUR The external

expenses EUR XX.X million. during the EUR expenses totaled quarter Total of higher third third due quarter were third to the Total were million XXXX. The was expenses of million including compared compared decrease XXX.X for XXX operating the million expansion. primarily the first SG&A global employee increase XXXX. for to quarter of impact EUR operating of from EUR XXX.X months during million quarter XX.X commercial X an costs, the in the EUR million to XXXX EUR XXXX, XX% X

finance the last in in compared year. expenses EUR million to quarter income EUR finance million quarter XX.X Net the X.X was third of of

notes. the As by noncash related driven can net to outstanding in our a line convertible reminder, items part quarter-to-quarter, fluctuate finance

which EUR following totaling compared EUR closing upfront payment million to equivalents Finally, December include cash, Nordisk, not as total we XX, clear, cash securities be quarter with $XXX of marketable To XXX XXXX. million cash transaction. XXX ended the is expected of does and the third the from due million Novo

For SKYTROFA to expect current plans, U.S. the full and from YORVIPATH product grow. year ex to XXXX, revenue based we continue on

R&D to expect EUR prior SKYTROFA approximately which be SG&A related the U.S. launching includes operating in to million, XXX to excluding million XXX years to revenue, total to expenses, Specifically, XXX we and and sales EUR deductions EUR million, related expenses be YORVIPATH

well are in availability We with product launch in mid-January. ready of a capitalized and YORVIPATH expected the successful U.S. to deliver

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

Operator

comes Jessica Fye Our for JPMorgan. Instructions] first from question [Operator today of

Jessica Fye

be initial have You laid in why entering seeing YORVIPATH, able Can out keep confidence that for various a launch strong the case market? that for you to of clearly and already. you potentially a ex the that you U.S. U.S. light we're about up talk you'll competitors patients pick

by And expectation XXXX. past, second in your a follow-up one my operating or just still is flow Is reach to the you've end of talked breakeven an that cash the expectation? about

Jan Mikkelsen

Jess. Thanks,

Because a about I the basically question. will to really it reflected I therapy described, NIH, then when multiple I'll are we keep talking at have -- think we X way initial short-acting what like normal can the life, specific we to PTH that to yes, first in used question, in Scott is where taking X replacement functional delegate second the diabetes. sufficient hours, our type pumps, really been true infusion characteristics, not take publications, we patients And which look take have remarks. what into the the week. and but a that a some XX a up proven because PTH, is they physiological days from have industrious concentration hormone they to And

that be that to activating, to basically, the mode receptor have about to taken need you many pathway [indiscernible] it are the get need think need physiological call have multiple hormone. so way the the activating therapy have function. signal as we there some a normal what of And organs you need because when you we true replacement action, So same is in like what to right

is right is else to profile. the to. the the to organ The it need the PK in that go you second and thing to an have the distribution. And just both, Because the it needs thing go everything example, also blood to hit side brain, need urine last for both to need basic and kidney,

I anyone I XX is call to that what a days have I X living week. replacement on of to clinical find right program the a cannot I need look the up the concentrating do, And level You just hours, that's when therapy. whatever

first That question. was for

second Scott will one. the think take I

Scott Smith

to and with believe be goal that cash flow regard and cash still the achieve we With our to the have remains breakeven, goal, cash can that we that we hand. equivalents on

Operator

And our be coming of of question Securities. America Bank will from line of next the Tazeen Ahmad

Tazeen Ahmad

preparing is to or your pathway need us are can just guide meeting application? whether agency have And not FDA submission to give open on Can you with Mine's there where that sufficient indeed before you data? you in also the for items where your be on and/or you are is us extended a be application, you CNP. data data rolling provide update your if and what completed basis for the for on potentially looking the going to that a an start

Jan Mikkelsen

Thanks lot that in the of regulatory to have integrated agencies submission. part need with is and after for that both the our U.S., and question. Europe, the packet knowledge, interaction to And a be we data

we with have what doing finalize actually the that for missing we're here, data We've to basically example, generating pretty that to in filing, will the QX basic ready to getting no So and is we been happen be FDA. application for near need now.

address are we with is the children, best-in-class packet, providing treatment continue only the comorbidities. something providing first growth of achondroplasia I of will really this we And packet that for not on we really instead also, we can look share a the I you linear how of providing when but think And are a providing growth. time, to just

growth them continue to the is to why unique opportunity you that give best really package data give just And address are hormone the will I to submitted regulatory would comorbidities. are is from coming I we growth, the linear have we agencies. because we linear growth. to is this the position provide wanted data just And how hormone think really you to really we the have If

Operator

our next Derek will coming And of question Archila Fargo. be Wells from

Unknown Analyst

Simona for is Derek. on This

you do the just entry? on payers? And launch to access YORVIPATH. any approval, you for on on for formulary with made SKYTROFA medical So new any any require Will have a it's or And this the progress blocks for market there's have if updates drug? exception one if

Jan Mikkelsen

The first of SKYTROFA. part

market happened this clear in results I has assess think our which was lot we have improving way. our are really year in how QX impacting situation pretty been we this a

in go medical still where the think definitely are different we believe this need can you of assess really see We are it's SKYTROFA positioned We best-in-class situation I and how what to its but into a market want balance we we in are one. complete believe getting hormone really exception product be growth here, in SKYTROFA a I areas back nature, as market. situation, a we and But seeing the to because opportunity. high-value

the We to how on that helping make just than have the believe to providing. is value blockbuster SKYTROFA benefit we're price in value. is is also of And hormone our And is this strategy consolidation. us a this a to daily I key to all is is our what element responsible the net higher growth think commercial in keep Xx alone, because U.S.

product big you're to daily you don't way in one actually sitting first if it. now hormone believe market. of other one pharma way, have left And it. I growth we see the with another a or going leave of any And once-weekly big the kind and this farm are you saw We leaving that

have this but utilize be slower we happening. really, come. every little Potentially consolidation And to they predicted, to the time So opportunity happening. will bit it's there is we than a really

supply on company of kind a that shortlist. been most been have that by not strong company has have really a We're We're also a a that have never reputation. chain We disrupted the delivery. any

are when specific and to it's a diseases for the you key there's for can of comment YORVIPATH, element are One that group the because majority launched an the is the I in product rare of patients. label a that. product on Related X to, interesting to And out in being basic we belong thing that you on from things uptake. the we guarantee look is

years a you for on And have are that Second hypopara the such really are inside point, for issued please in that majority I do that patients. a we ago the position. you guidelines for was read few guidelines guidelines We the of a U.S. treatment. around are both we basically unique the also here in adult patients position. label, And in think promote

are We guidelines. inside the

benefit there. don't the that we basically products No feel patient. there. out the product are that providing we other only So forget, just And we are to

very, from in be you no way. inside see you're product, X get a you're the have actually the the when strong and in out position, I one else on to So you you a most fully believe are single the elements, choices, very U.S. reimbursed guidelines, prescription label easier journey very, to

Operator

the line question And will next Yaron the of Werber of be from coming TD Cowen.

Yaron Werber

Jan, on couple maybe YORVIPATH. just a

is Can pulled I think this by run the also expectations? out is Can a in NATPARA Takeda before I of of give get your little it sense, bit the run you're for just work? will the on to how it a date driven you the little we the hard Is that timing, pair were an waiting year. supply? takes us inventory the bit market give Or us of end expecting going of by And off. XX? like then this know update to YORVIPATH in by when past, out off a Europe, driven you by they really December

Jan Mikkelsen

Yes.

will position in because possible out staying with fast is U.S. to come they have my as are when cannot seen me U.S. I market drug are believe Europe, free a big happening. all out as are will inventory batches. And somewhere in a the do every that. stock. an basically now they estimate, ceased are know they're as provide means where them the question, to of running U.S. In get interesting the out They and year, out are asking they and we out know to try We see different each single the to best We we NATPARA I to in trying outside as to they our next it of using You're possible production you running doing is transition control they everywhere. the will patient that Because pattern be in control. fast

the X But said saw In same different we because in in the patterns Germany, different NATPARA time, at was treatment. there X countries. an I switched patients they improved

Germany, Now keep as patient running because and over NATPARA in long they as is Austria patients NATPARA of out. are new the patients possible pool new now then NATPARA taking let's take different. They patients. the and said, on

So what U.S. about, we talked is happen groups in will switched. these the going patterns, the see different believe and to X them we all X from I be X when of countries,

Operator

And of of question Evercore. line our Clark-Gartner will Gavin from be next the coming

Gavin Clark-Gartner

Congrats on all progress. the

And these just on you X,XXX believe care to be the of long specifically, do in actively noted. system. the patients the health I year, within patients would in the PTH to So could these more YORVIPATH? guess Are ask the experienced helpful. it wanted U.S. Could X,XXX take years? to patients Any I estimate about managed X you've all first be to how get majority it that

Jan Mikkelsen

group question. this believe PTH I to they're used administration. daily do the for experienced Thanks

X know because years physiological If day. are have the times them FORTEO, for super X level of for doing and some you they're short But of acting, you're example, coming for many FORTEO only a from, providing. a PTH injection time limited the frame patients

NATPARA on that that look got the started the is to X,XXX basically I majority have patients couldn't X,XXX, come program recall. they when the the when So into

to patients. our only the take best estimate, use So X NATPARA of program XX could out

any was PTH without kind sitting option. treatment So of that starting

into really possible. will This We're and product is patient patient the you fast as in go an that we're this middle the start the January, to be group as will in availability get I have try now the of here coming and prescription. believe why organization. basically to in with talking endocrinologists talking here U.S.

the patient beyond will really to a hub drug. unique reimbursed that in basically element the We are have prescription program, ASAP our journey a position the fully the from and they be help to in

We patients to believe infrastructure know that many are And have done. waiting get how it do just to it. treatment. get is we We the opportunity for so this a to there

Operator

question next of coming Cantor. from Li of the line the Watsek is And

Li Wang Watsek

Turner relative should comment to the we a sounds pediatric the syndrome. And about initiating growth basket hormone market, market guess the I well think on like revenue adult to just as relative opportunity you're market trial. the from the market? the growth hormone it Maybe how contribution by there

Jan Mikkelsen

deficiency. we label, to hormone When Yes. pediatric by growth that look segment market, on access only is market growth the have covering on we the hormone

adult We deficiency. with underpenetrated which X% the interesting is of for have segment at about X% established it's growth currently highly, is being now filed a hormone treated estimate the but XX% highly deficiency, growth hormone hormone open adult up treatment a population growth only complete the Best market, to in have U.S. we

all blockbuster should why we're So as nearly And is hormone same the size growth quite to this the be it's have on being sure -- we the that a SKYTROFA we be the focused are the in we we're will market. include this can we our where indications market be pediatric really the . We where trial making a develop to and market. choice entire ISS, the be. -- in build which Turner it this nearly market. to label shock, basket SCA growth expansion, And taking hormone SKYTROFA is having should covering position vision by that the

immunological coming pediatric, coming majority what going we majority the from market. genetic quite of basic Going are coming were hypopara, call diseases. with it's because Patients not is the but segment different adult to The PTH the more hypopara. to from post-surgery

adult a different smaller it's than in more this the is much quite segment So and way segment.

just available it the the We to are segment. initiating now a It and planning make segment. the the authorities in also European pediatric it's also in part in of a our obligation pediatric will be trial

Operator

be Leerink will the coming from Schwartz Partners. of question next line our of Joe And

Joseph Schwartz

monitoring First requirement which the then your significant was Europe to the of launch curve general? the in to compare question I expect U.S. U.S. patients, for be launch the you is on in likely YORVIPATH. at in how deterrent YORVI a is calcium monthly all in just impacts to And serum do wondering, the view?

Jan Mikkelsen

on What Joe. last as places. the never me being I've seen, Let some criteria criteria. start the for UM any of of the seen installed kind seen I've question, that I And have

don't think know will I the often So is have patients this missing. the this case. of I kind really

not it, it a will UM be not it's have I'm it in criteria like to So seeing from the burden anyone. but

different Austrian or different U.S. the to penetration from quite Austria German, Germany market, market Related curves is compared slopes. had the quite U.S. than to

is the it's perspective open X mindset seeing now U.S. There we're much such the U.S., it's goes now tried that new segment more if in that patients, Germany, is going with or to try up. -- X from things in what a in market treatment So faster unified everyone

So was patient physician per X between and X. the average

first larger penetrate, come much, this And in states in a what is But be we kind you going X they're and the into we see U.S. is Now then where much physician. faster some of, I first to X call, it. uptake. to the expect the and you for what broaden

Joseph Schwartz

beyond carry understand adjustment And then saw both? volume, price any previously or help and these revenue XXXX? have the is you what us Okay. adjustment today's to lower to guidance XXXX additional into whether the on is why necessary potential SKYTROFA, due dynamics Can we over to

Jan Mikkelsen

I think Scott that. take will

Scott Smith

here pretty more we little in had joe, bit QX cautious until in we than days. data. more I to but a to selling little be fewer We're but see want we a bit off was lower expected, start good think, QX, volume also a

today, we in So given you the we call number came that saw. had with the

prescriptions, rates yet. be say that that expect could higher just or that's in the don't but things would dependencies seen we to with haven't previous increase refill experience enough periods buying for we have that something channel in number to Some QX like QX

Operator

And the Vikram line be next from Purohit question Stanley. coming will the of of Morgan

Vikram Purohit

So we Nordisk? next from just had learn what be, could expect what as on curious Novo Nordisk collaboration. recently announced We forward, one the Novo public can there we yourself that disclosures to moves the were and/or

the partnerships and oncology what for efforts have for progressing and the And might with might economics place like you're be then next oncology good partner efforts about you there secondly, what the in look partnership potential a curious we or those in future? how were the milestones thinking pipeline,

Jan Mikkelsen

to the And X of them the too. out from TransCon for product and of approved pivotal and stream endocrinology the seen algorithm our this Nordisk Thanks X for powerful have idea with is questions. making are technology that up data until first question, innovation states technology, now. we X Related TransCon took basic product Novo

basically exactly a And properties, the thing. monthly potentially do can a can once make efficacy it and we same in our the to well-known we TransCon position safety, proven to in with see diabetes obesity, in like time, but peptide, we provide diseases can at are technology improve in same efficacy proven time. take same the potential what a tolerability also we when I already is metabolic So

the $X billion, in And There's capacity a have to on they proud one progress, case. they're a the my And And not like we're make best product. how to make $X and product, to multiple, manufacturability Novo the to technology, apply update a only actually really infrastructure really companies they're utilizing the progress continue a to Nordisk answer Novo believe for this only in partner about to X it multiple product to will it. Related $X in specific with. Nordisk. will specific have to the that X TransCon in world really we I of be view unique billion, collaboration on related great these have one this companies commercial using billion that

oncology. to back Going

seen encouraged We pursuing we and really the and to in really hope. in the extremely focus best been that benefit trying cancer patients we're clinical platinum-resistant and by in have this, manner late-stage patients. meaningful in actually help on fastest have no have possible this to what is see effect We really basically ovarian these

said, also we pipeline As different in structure value most getting creating many possible for we the as that we possible and structures all pursue open to while of oncology our we will will value the are focus create out fast out on stakeholders. as as patients as in way

Operator

question coming Kelly Jefferies. the And from will our line of next Shi be of

Dingding Shi

XXX.X want to million EUR at in numbers the to totaled confirm, at full like the EUR guidance of X XXX release, the was EUR mentioned million. just So press XXX quarters several year million first I XXXX and that it

the bound. So that to to this XX.X gives QX adjustment? lower the And reach be million and sales EUR is without sales

curious, to TransCon submission? you that have talked the agencies secondly, submission, enough data CNP just NDA regulatory And XX-month for the is for

Jan Mikkelsen

of I think and I now. Scott will your all first numbers, question part to the wrote down the delegate he just them double and checking

Scott Smith

Yes.

guidance deductions impact to to deductions XXX updated of million the or prior million periods XXX excludes of sales the January sales period prior to related X, XXXX. -- Our EUR of revenue EUR

Jan Mikkelsen

clear. second your it's question, to Related

request have We efficacy. to than deliver data XX that related any more not months the got

we of always where you safety you date filing, have update regulatory cut have a call you the During have been the and giving safety period evaluation. during always what different that

Operator

the question David line from Lebowitz Citi. of will of Our be next coming

David Lebowitz

two for got you. I

on agonist. long-acting First, the GLP-X

perspective what second you, are long-acting Given does question on present that is then be normal the I new -- as price titrated part us regard? GLP-Xs evolved type give to will view SKYTROFA. as in and this payers forward? going of should purpose Could guess, treatment, this us we modeling And the how of you've perspective challenges average added on and give has how the just net or for

Jan Mikkelsen

fast and the a or trough in refer knowledge the level When I in the back -- GLP-X, basic long-acting Thanks you doing about and that issue lot. our to level, tolerability driving like really would that. biology it. level really Okay. issue how what is because are where the talk the This called when through peak to from you the go tolerability GLP-X the see of is at this is lowest is you you

see dose, to be when fast with you you have lower go where to they're trough sure you a patients a therefore, treatment on from This going a problem dose, you treatment the acclimating, with peak. to deal stopping is that have start So up next tolerability. is this why you titration the because up just

you we seen peak the do tolerability also with have own our on you of extremely element what can uniqueness that of trough a you see basically that And think data for it have And a you also very, in profile than means saw to very, a go JPMorgan or position the a our in in places, better to have that one extremely our that more you other takes level. in Tech animal we very you our go which When therefore, much where being max short-acting you long long studies It from the have mean? profile Tmax. dose. that fast up basic TransCon an technology that is

clear, value. clear had remarks the to daily of that prepared Xx and in take a statement pretty it's think take has hormone I it we our still legal level you if growth SKYTROFA Xx,

Operator

coming And question line our Choi be from will Paul Goldman next of Sachs. of the

Kyuwon Choi

that open licensing monthly to validated, want given also the potential like would to ask GLP-Xs agonist. deal. on And seem I it pathway GLP-X XXX(b)(X) Novo are a recent your development is

times shorter to you be do And development start here? your so what helpful. partners? program a the that's for sense revenue recognize When be have full agree might there for GLP-X. development clinical Do this? super with monthly of Any any a be would from timelines might than development if you And might comment royalty case, you

Jan Mikkelsen

many than shorter also normal with exactly agree cases It it Thank opportunity potential we a take using a you to be development to the XXX(b)(X). pathway. timeline, Related of with and you for you, this is get have beginning comments. your can the XXX% a Novo how labeling will need pathway, And the Nordisk for a only one to will only benefit and refer is development discussion. broad to indication. That I specific

Operator

our next Gershell Leland Oppenheimer. will coming line from question be of And the of

Leland Gershell

from one Just us.

Is commercialization pursue that on as And was the I you cadence France in be by end European wondering commercialization, it the further various this might I further sure think, if countries of XXXX? had year. Jan, track? clarity on any missed you rollout have not I if comments. mentioned that in starting also of in I'm you your prepared through

Jan Mikkelsen

are France. And X Austria. them have program commercial got we called it's that got are it in full Germany I . non-promotional we number give we about needs we in Yes, is commercial we unique. coming really say, but And since and weeks This we -- a be program elected physician-driven, to what a air can call APX. right. physicians really reimbursed believe you commercialize cannot have France, basically the X, established is because to seen special only drug. is for been where What established as In

a where there in countries the next commercial be Europe, them commercial Going majority full QX full quarters, coming of countries forward, year the commercial be be basic will will and year. call lot we it will we have fully countries where direct next Europe There of QX, EU. in different will in into

of In start to saw going distribution about countries. XX giving we where Austria see and And you full-blown year, next through have So of will are about by what into we are in repeating our patients we there agreement named also see patient patient this commercialization. to Germany, currently countries more also X, we And but international market, we XX country more XX are direct program. market covered the in a basically our international other of now success that in program, lot Europe named countries. also or

done getting have beginning now know approval resources basically we meaning already on next commercial a year. spending what full in are It's countries. in getting these countries, be also all will lot we filing, getting but many dependent is -- we approval this of is we which this And on And year. that of many, year we're

Operator

will next of from question Our Stifel. coming line Alex be of the Thompson

Alexander Thompson

YORVIPATH, bit talk little -- launch. for supply guess mid-January the can I commercial readiness for your a supply you about

Or to basket Could broader other study to that scripts focused CNP, all? appetite supply are you're now constraints? on open take you for indications? constraints that do SKYTROFA a current you an running have then some or on from there in And Or mentioned additional you up going December. YORVIPATH you are patients there? of still think I

Jan Mikkelsen

no patients suddenly if entire can suddenly. that PTH, want one. we been got There to chains manufacturing done have We laid take in even time out which is the has supply. manufacturing. We have robust have all sure point demand unlimited limitation have we that in major already with we're we every year's batches, locked unique more same be out to SKYTROFA, building the we supply every

for be the get go YORVIPATH. should ever is not no we fulfilled really thing of same the can top on YORVIPATH, So to are prescription happening and sure and in patient

CNP, right. there some But that treated is with with treated best to best also CNP. Going We I indication -- indication is is SKYTROFA. definitely, ask you're think

on And of either of some a short treated combination them, them only on a with of the or are duration. both basis constant best

this diseases will other So CNP we go what of only back. or we to missing normal providing we as to element is the what planning functional call see that be call where can by are physiology meaning disorder diseases, CNP in a CNP-related back we what into growth

is which besides CNP-related planning be are also the that planning for way in take a multiple single planning indication hypochondroplasia, one trial. will in initiated So trial think We of that we a we easy diseases now. for where trial we doing next year, into basket also can is

be disorder. a us restricting to in label SKYTROFA growth just not to we So We are expansion. dedicated leader

XX We diseases through. go to have plus

of some And take them, will SKYTROFA. we

Some take of CNP. TransCon them, will we

on And of or shorter other. the a some them, constant of on treatment combination or one receive happening a both duration, optimal base them we with the either of

Operator

the you time for conference thank joining much today. is answers questions you we That today. so session. for your that the and have much for all the Thank We call so

disconnect, may a of your have all and day. rest great You

Ascendis Pharma A/S (ASND) 14 Nov 242024 Q3 Earnings call transcript