ASND - Earnings call transcript Q2 2022

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

Operator

Good day and thank you for standing by. Welcome to the Ascendis Pharma Second Quarter 2022 Earnings Conference Call. [Operator Instructions] Please be advised that today’s conference is being recorded. I would now like to hand the conference over to your first speaker for today, Mr. Tim Lee, Senior Director of Investor Relations for Ascendis Pharma. ahead. go Please

Tim Lee

Pharma. and quarter operator am everyone joining of for Lee, Thank financial thank results second Ascendis Relations Investor XXXX Director I conference our Senior you, of you call Tim today.

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

SKYTROFA the statements Before you Safe we expectations limited not intended that U.S. ability our market, able the achieve excuse our we for in our our will global statements should our not events for our and based may to Examples on the clinical the on market. expansion goals, regarding results, the and you are begin, reliance SKYTROFA U.S. into may to our our our a to the of – our I these intentions progress continued continued materially is and their undue our regarding pipeline, not therapeutic expectations plans strategic would to regarding for clinical statements our development such approval results product projections and or Litigation provided are or Harbor those U.S. on of company. available hGH that Actual out plans, or the include of and timing disclosed forward-looking regarding include, us forward-looking EU like remind Securities statements goals progress, filings, commercialization today. place but create of that statements differ carry statements statements. and biopharma the call this U.S. with to in be to could Act. Private extension our our – conference are statements sustainable regarding and respect the under statements commercialization candidates market by pipeline be TransCon information pipeline including planned These candidates, statements to covered areas leading Reform the new forward-looking of me, our

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

the on actual please For SEC cause statements filed results XXXX. section additional our our Risk recent X, Factors annual most report the and TransCon materially, older of see information Hormone Human by concerning factors in brand the March forward-looking the with endogenous that differ have section press at on the year release kilograms to TransCon XX-F of or and Growth today’s pediatric SKYTROFA treatment weighing is patients under in growth X the XX.X to the hormone. for least failure growth name of due approved secretion FDA hGH U.S. inadequate Form

the European the lonapegsomatropin, years our to growth product to treatment referring addition, note and granted the failure product the unless product aged investigational are authorization TransCon under Union. In for we United are jurisdictions of we please this as subcutaneous commercial candidates European hGH approved a refer as States that of due such hormone. Ascendis inception Otherwise, and In with not name is for general, the hGH Pharma once-weekly to of particular marketing X in Commission the the a has use. endogenous TransCon growth context to XX injection a developed children or adolescents

call, or viewed agency. provide conference have approved on the we will the quarter our be call further XXXX business On candidates updates. our and not by any will been investigational results effectiveness regulatory safety discuss the product the regarding today’s statements of financial shop candidates As and of products, None second reviewed product as made promotional.

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

Jan Mikkelsen

Thanks, Copenhagen. the clinical Vision recent from we With good our towards TransCon PTH fulfilling to for progress leading regulatory for progress evening everyone biopower profitable commercial and a become Tim work continue company. here and to XxX SKYTROFA, our and sustainable,

major FDA, reported in continue secondary the met data, For to we and filings endpoint and TransCon our the submit to key highlighting positive weeks next address positive which need in PTH, we adult and of This growing its regulatory our making After goal coming and the a for are a patients leading during all construct primary pre-NDA meeting with endpoint planning a track have with X unmet in QX. composite medical potential on market, hypoparathyroidism. Phase product SKYTROFA advance Europe launch the U.S. to growth in we year. to hormone year, a SKYTROFA

see we independent disease to positive. drive candidates product become trial consistent flow X as on or same believe that We track PTH. and without across long-term We a for for have are clinical to the and are we cash independent basis product growth algorithm additional TransCon innovation used successful that populations. two positioned SKYTROFA endocrinology Phase candidates continue well in for to rare hotels We believe row in we oncology X that now and highly that multiple sustainable, clinical achieved results

expected position of middle next the year. the cash strong of with combined from the in our around in €X TransCon billion, U.S. expected U.S. of combined Given revenue SKYTROFA PTH launch with the

update Now, me of each let our programs. on you

SKYTROFA is value, U.S., overall value hormone growing product the our Growth in in strategy to TransCon hormone of growth market. the growth For Hormone while market SKYTROFA leading as build into the the commercial

hormone SKYTROFA as products in same hormone. SKYTROFA once-weekly mode thereby, once-weekly value. of unmodified once-weekly multiple maintaining from growth the deliver growth other action is that its to product differentiated reinforce ways Our daily only is the

am that injection visible share to provides that and with to In addition, that which an award Auto got the storage, also was injector and I pay XXXX the conservatives design, changed for award May This proud in clear it’s tactics evidence easy you temperature leadership U.S. significantly Pharmapak award. delivery caregivers we only to the improved delivered. patent innovation, been the commercial This drug has and SKYTROFA contributed cart, solution new patient pioneering use. of and SKYTROFA. product experience no implemented leadership MTO commercial has century improve design prestige immediately recognized

changes therapy. paid One of was increase these to behind the goals of conversion prescription reimbursed to

more of the alone. already June in seen were revenue than half QX QX, input. of in With a We of sequential €X.X €X.X to have QX revenue doubling nearly million benefit of million a reported in resulting the this months generated in compared

track increase end prescriptions SKYTROFA – new duration than for seen has With This QX. revenue is We believe typical prescription an the an compiled total estimate on we practice, year. are increase of in at the commercial patients. with we XX% €XX With improved in million. achieve have now XXXX the compared consensus of number Ascendis for X full this X,XXX QX. A of of more year current also around to a to number SKYTROFA written new analyst a sell-side

plan pediatric product a trial. We Phase TransCon global at Hormone Phase deficiency a growth trial X deficiency with hormone to growth and Growth hormone global continue turnonsymdom efforts trial build adult our a Japanese to X leading

this most TransCon become the TransCon over and to XX if to PTH. TransCon PTHs in address turn physiological to underlying cause first hormone the lease of deliver now missing candidate disease. product therapy levels our disease We has replacement approved, the Redesigned PTH, potentially hours endocrinology us believe potential, PTH PTH to Let induces valued pipeline. rare to that the

across this of continue reason, this that view the X and trial, more belief open-label XX out of in which patients this portion believe focusing years the on patients identified the key completely With long-term positive of have weeks, or Phase All the continue consistent NDA therapy the the adult three market pivotal PTH. secondary in which address of patients to X we potential expected our an along and For for their spectrum PTH TransCon conventional XX product in our give on lives. and opportunity. candidate our XX,XXX hypoparathyroidism that having support estimated the have of U.S. X this preparation with segments is We loans Phase submission are billion primary and with trial. only the approval within these of treated disease in that all endpoint, HP TransCon the is patients, me this hand than potential. met patients candidate trial with composite the were from in The Phase results potential XX,XXX treatment on in planned baseline, more independent at These chronic ongoing product mid-XXXX. XX $X Even we U.S. the probably and reinforce our adult the coming patients’ data in dosed our impact XX treatment open-label PTH that out X Phase portion trial TransCon and can all from comfort results – promising, endpoint X benefit basically that to

treatment. recall adult consists can of PTH experience in them U.S. they Also we previous the previously patients treated U.S. patient PTH as be Natpara TransCon have the most longer in the This adapters of preparation. this third currently because segment to of have the treatment short-acting no early believe, The PTH or of of with with assessed group,

and patients, calcium chronic to of currently in that result the system unconventional building glands. chronic who for this surgery remain segment TransCon supplement, on aim. damage second with develop PTH to mix The this PTH in understand the HP removal consists D the clinical therapy result The with as adult diagnosed of awareness search In will and HP and Patients treatment. therapies segment, last vitamin group HP. consist providers treatment active parathyroid of or patients, focus of value on segment we patients healthcare often newly a chronic adult

for QX EU a explore TransCon the we a of settings benefit studies. Expanding potential more TransCon in XXXX, clinical by addition, patients’ future to followed post-surgical and in shorter long reach plan expect we In in potential global pediatric in thereafter. broadly approval PTH, PTH

Phase CNP For year. Japanese Japan, patients trial, of Phase Switching age now trial children of our to in results randomized, up continues. we TransCon double-blinded, quarter this of from X with the for plan the in age line to ACcomplisH report our TransCon pathway top the to fourth placebo-controlled CNP, XX X clinical X

per extension the year. this of to without well-tolerated patients all discontinuation. see we or report in any to in longest the extensions a pleased results placebo-controlled ACcomplisH on during the about top and microgram continue trial the X part safety We results dose. from dose are of with duration continue are now and XXX week profile the their All sharing look treatment quarter open-label line fourth now forward patients that trials, reduction to kilo the open-label We years the per double-blinded

to in our global are X. to double-blinded patients a and the U.S. primary randomized in the achondroplasia countries to Vision year submit order is in endpoint. trial trial as and patients We submit The expected around down age velocity new EU in planning X XX of to a placebo-controlled CKs this protocol growth in to the in enroll IND new QX the indicate annualized Phase

have XXXX. to trial With expect on overall products believe this, at we growth top XxX track in clinical a We disease line XXXX. obtaining three remain endocrinology Vision result approval this for rare to we of our by that

move to the Based the agonist system agonist, TransCon where of we provides in checkpoint or as of a in technology cancer, progress, move TransCon combination I the demonstrating or now kick-start combination inhibitor, activity X/X agonists solid a more of consistent trial alone our checkpoint trial shift in combination patients agonist our agonist TLRX/X of The the our tumor TransCon is TLRX/X with without Phase am show with TLRX/X as a activating who exposure TLR Turning in failed starting a clinical TLR release site well-tolerated convinced recent in inhibitor. therapy. with prior that toxicity. continues monotherapy of the Enrollment is thereby our to continues system in sustained tumor, to technologies, low of and systemic paradigm monotherapy with and because TransCon with of unique more at evidence systemic have treatment checkpoint on oncology. the anti-tumor make can on therapy inhibitor of lines

product a Our to system candidate Phase candidate designed dose TransCon X/X broadly dose who product cancer this anti-cancer expansion escalation become checkpoint The combination increase for a and tumors beta/gamma continues prior to have backbone stimulation trial advanced inhibitor in systemic to is with failed patients IL-X chemotherapy in or and immunotherapy. with therapy. of solid new or the along evaluate

the and in in first have cells and along our over patient bias we an seen subset we cytotoxic IL-X we inhibitor. trial no eosinophils, checkpoint continues they toxicity IL-X TransCon dosed count, or dose-limit beta/gamma to towards continue combination NK a well dose-dependent show quarter, increase as cells in is activity. monotherapy second to questions. There CDX indicated in positive dose combination beta/gamma turn with therapy. open the for the tolerated in that to financial we The Scott reported During will beta/gamma details absolute deficit To-date, X/X with increases without and Phase attended call TransCon increase escalation. cells I review and additional the date been have before or for now designed

Scott Smith

Jan. Thanks,

of consensus SKYTROFA filings XxX we TransCon to We I biopharma As we Jan flow company strong reimbursement and the can consists very noted, to of momentum the prescriptions, cumulative Based analyst the success near-term for a commercialization the XXXX regulatory press we than demand to in believe €X.X XX million reiterate release. estimate positive Jan’s achieve in summarized rate with and second increasing position Ascendis the of compiled patient on see reimbursed revenue want sequentially U.S. which current continued Vision year as robust PTH, achieve our QX. the revenues, patient reflects SKYTROFA the comments. become cash are continue revenues €X.X of SKYTROPA sustainable in prescriptions to in gaining a for SKYTROFA, increase to and analysts. U.S. nearly for in new doubled publishing million hand. full billion €XX sulfide from in Reported more strong increase Growth €X quarter on million

notes. to million dollar-denominated net related of late-stage higher notes. our expenses. quarter €XX.X the holdings quarter ongoing interest expenses the more income XXXX. of from for normalization second and operating to a compared euro and during quarter second foreign in and of the a convertible senior following €XX.X convertible million, primarily to administrative R&D as option of launch were million general These following to U.S. progress continue our Finance were convertible quarter turning costs the million €XX.X exchange the rate million, quarters, gain items cost second commercial during and This €XX.X convertible were Selling, translation XXXX. programs the approval. million second to future €X.X income to Finance senior Research expenses gain and million impact conversion dollar our of Now equivalents related marketable the million includes second reflect through and in to the was of expenses related compared cash, the expense for will amortization to which non-cash related the and the notes of quarter second SKYTROFA. of development U.S. for of primarily cash In structure transaction the €XX.X U.S. and remeasurement securities costs overall our early €XX.X notes finance expenses. embedded costs quarter €XX.X from to reflects development the for

convertible U.S. dollar notes of remeasurement from euro. U.S. the into dollar-denominated First,

remeasurement of date. convertible embedded us the notes, conversion IFRS accounting require each to the in remeasure rules Second, which reporting on option

to flow the XXXX. marketable cash during share, Third, ended or cash, amortization a interest cash billion, expense totaling second share second loss enable diluted to of diluted issuing We securities basic notes. we net the quarter which cash with the will and us had €X.XX believe costs basic of per and and a €XXX.X positive. convertible €X €X.X or million of quarter coupon related we nearly of become equivalents from compared and million Overall, net the €XX.X loss to per finally,

the of to XXXX. Turning remainder

and prepare modestly product as anticipated our we increase operating expect as expenses our for launches. pipeline matures We to

an provide timing milestones the Let also me update for the now remainder on of select for you year.

European PTH, for TransCon QX. planned for this results planned expected For submission a Pathway we’re quarter submission And top Japan, in on NDA track line and QX. a are in

randomized, placebo-controlled placebo-controlled accomplished we QX double-blind results results For in during the QX. the plan TransCon regulatory sharing extension top CNP, achondroplasia. trial of trial and a open-label Phase to in from line children the new look submit to double-blind, we forward with for also Xb filings the And period

and trial escalation TRANSCEND IT-XXX TLRX/X For combo line dose X/X from monotherapy are TransCon top the data clinical in expected therapy agonist, QX. Phase

top we from beta/gamma beta to finally, in our BELIEVE therapy TransCon in we are TransCon of results monotherapy and oncology, Phase Phase order of X/X X For QX. agonist expect the equivalent to And year. TransCon to evaluate IL-X plan the announce trial therapeutic gamma, expected third line end an the X/X area at combination QX. IL-X a Within or IND expansion cohort the in submit for TLR

of can with across endocrine you key half rare see, it’s in pipeline, Ascendis As catalysts oncology. both second for the and year a busy the disease

the our with to €X cash XxX As take are approximately on capital we positioned noted, have flow are now to NNI fund free sheet, With Vision questions. we initiatives, the and ready that, to we growth balance operator, billion our be fulfill positive. and

Operator

Fye the first of Your from JPMorgan. question Instructions] comes from Jessica [Operator line

line open. Your is

Jessica Fye

my I and ones. Good for guys. specific then Hey, afternoon. questions. one high-level few Thanks taking question a have

back First, that without for and/or to SKYTROFA positive? the expect what positive should just are that with assumptions flow product-specific to cash there ones. become flow are Maybe need additional you I’ll your to cash And PTH embedded the stop mean become the capital. in to take we confirm, other and expectation come

Jan Mikkelsen

Thanks, Jess.

at We are in Ascendis. a unique position

them up of the posted opportunity. of have a years, a product last pipeline five we During independent built unique have potential. Each

make to we the we pipeline, believe For is it unique can what extremely successful.

trial single failed in clinical have yet. not We one

single to opportunity preclinical get and now managed approved to how U.S. have SKYTROFA each Europe move from states We product in

expect positive and profitable opportunities two the we and U.S. two just elements. the into X is fight preclinical from we in now next on be bucket. to like cash trial If weeks is to We in a product be have focus positive. There these moved This different Phase TransCon to here PTH and

when with you year. And revenues in. we increasing the because we really PTH what then and in with of new fill we you U.S. nearly You a fill with have out water, product And €X same then of expenses mature in whole take billion a have some the We we with take pipeline SKYTROFA as expected started interesting a have whole now. it is a in bucket reality we next water R&D from such not stage start – then run the in out. loans TransCon things our now,

So I, and this now a is profitability our €X billion any Scott position and pocket cash. why are Scott, in with feeling management hit of the everyone additional we we current can thing? the

Scott Smith

add that, I to That to don’t right. was anything Jan. have

Jessica Fye

Great.

one And other at the – learn seems agents what in The signal from become detecting point? extension now of or gotten in space trial how a in also was an had switching like age X,XXX you on data have I open-label I’m under this available accomplished and the who other the your to taking time X, accomplished data under in your had started have of just pen tough prescription kids two the patients that efficacy it fourth kids quarter. SKYTROFA X? to And will received many of are curious CNP, then proportion what expect do a have SKYTROFA the the thoughts age

Jan Mikkelsen

questions. Yes. lot Still a of

believe having But remember I do from question need decide the out can in our later decided part is We to one where you think to randomize we the on control, we way of see it Copenhagen And because opportunity. that say product three. Let to that we how the where the it is hours. four I drive. each – last most me and here – really perspective double to expected our internal start of of an about cohort wanted to the we blinded that countries we single the placebo and did a in strength

pretreatment in this to trying compare compared are singular outcome. of data, to treated our a in some is different to there That same big difference. arm. They way each amount as trying have have some we anyone historical basically we are So to compare placebo else, patients the to time,

of year – patients X have a well-controlled double-blinded trial in about with each in to will XX basically data we arm. So single XX

We for see a been in a opportunities treat just we all to also not have be selected the have we down should that anything. we basin option. We’ve such we believe a product newborn, will We want position over leading effect And to the in patients. there. can you strong were that and treatment really

in what this are share really So you opportunity, expect what will we the with how doing decision help so all can you product can you we and strength QX, take about it to informed we an with data of the the patient. share

single show to of will rate cohort. CT for We you year, we will each X compare growth annualized the placebo.

you you not make We at just can value, it. so do the this Because will and it. real way give only is absolute can you a adjustment

it’s We been segment. in important this will potentially interesting? priority one now But a now been you Meaning have have We safe trial treatment group more for with up be more for also It a to more than safety what patients needs for a open-label show years. in that X year. to much How is an there that is extension X trial profile. pediatric that the because is have safe.

feeling the where to there. situation it’s to first also treated switched microgram with then open-label and and were important comfort the got is our seen you not group X what that group, And got population any then patient give that XXX patient is X for as switched group have follow anyone’s is expected seed trial. and extension Also a other you the then low the you year what because to see and basic because basic very the XXX happening treatment, to suddenly in in years pediatric other this group, micrograms leave up up now can is you outcome. core X-microgram up X-microgram in and patients show All because me to obvious see in We single treating still have that are not if that feeling leave

when to what really explain share will we So why data will really always we Yes, be, judge, our product my we you do so much understand you giving and potential ways are about have we sometime, share transparent, to we can we’re as about excitement too data excited CNP. that opportunities two basically want

Operator

Your from Instructions] question Evercore. [Operator next line from the is Schimmer Josh of

open. Your now is line

Josh Schimmer

the of for questions couple A SKYTROFA. question. Thanks about taking

jamming First, in dynamics access without about covered terms any option the of a launching much. times. Maybe can you so access give able that, Novo device occurring potentially at that whether can also mitigation SKYTROFA, switch rate front-line may device is parameters, a a a the is and us to help are heard Thanks targeted especially the that there Nordisk And lives option of and percent competitive as we’ve concerns with which at be steps you a there or to week are any once well. of sense as step quantify edit requirements. some correct

Jan Mikkelsen

Yes. Thanks.

Scott Let start me remember to and the for you last easier for thing on first which question, give the the me always are me one.

treatment with talk When And because really device, treat device. how us other SKYTROFA that, you auto-injector. talk you have and its for the how did talk SKYTROFA the Let a the and developed about basically you you we we SKYTROFA way to patient. what the patient things option got and really award with about the we develop we how really succeeded the have auto-injector, was patient basic tried showing it with just developed for friendly what which like

update one basic the other traveling this for to you’re doing because chain or has temperature when the burden we this to is cool key they being auto-injector rebuild give have about patients really unique we treatment build a up of gives have And in get the daily why from caregiver one unique basic with was the I for things. that. other and of position monitoring and it caregiver Did home or wanted what And week the do things we stability. the is injection not. the in patient this see complaint But it unique is get doubt. in because because every we have week room market. opportunities really really one never other an hormone single-use we’re we And really And an from complaints, just to element other a I things, child way. to contracts out the active been this moving them X,XXX that leading in for things about the of huge stores like seeing it now market or ways home also What growth built that. So up the have benefit in

start it So getting I’m with the at are have can And look any auto-injector. see when numbers guarantee I I to data with come what We there, the in. to cannot not numbers you from indicating any the issues that the that we data. referring

no are indication perception Sometimes stronger I have from we that perspective. when than reality. But data, look on the

the diverse life under we can X% day-by-day changing we to way Joe highly is market because it and our most by really Joe? the positioning, that week patients physicians any team, week to every SKYTROFA. or with by because access of have day, trying commercial week position as access can about assumption his this to means the comments you is I our is X%, cohort. is improve day they get optimal see to Scott, patient a is first you are have answer, and question, but doing their changing first its every answer and that have pass do team question in this we basic that the think people, this The acceleration U.S. But that press to release, the day, as of

Scott Smith

Josh, positioning that line believe SKYTROFA our with a specifically we there is coverage. and is our by premium this a that, of augment our for what believe formulary of we preserving value maybe saying variety just goal basically the product, would I growing Yes. And product. market, in of is

Jan Mikkelsen

Yes.

elements, the position have for overall you I brand, want be strategy having we and can key an one different us. of of kind strategy think a about to SKYTROFA how about

everyone market, one to we that where to the from these is believe other have some we from in that position team. see U.S. treatment elements. a assets We have to to we not we Commercial out market believe opportunities. being is to a And we gets will deserve. with level higher market We properties we you believe further is a society goals, except should share we taking that strategy in and it. patient into the superior providing a X% the U.S. because you the our out Joe. position on this the therefore, This building can our we’re we today have the to feeling consultation. getting Joe, perspective, do to of can is introduce not we’re Head comments I framework a benefit someday why Joe to two would X% where discussion? that is providing this have like And the ensure we the asset Joe, in when are the What that the we two have We a but market into benefit endocrine see market, growth value product best-in-class be number the hormone problem. level better current one SKYTROFA entire is a to believe grow that

Joe Kelly

have just by to resources as And with around Josh. our we’ve increase access where QX, patients Scott, gaining to And something continuing and our us that of better for capitalize of it’s our that made in June of working, mentioned couple example know itself, tactical and to we’re number already. targeting of Yes, and we’re half the adjustments by getting reinvesting just we’re profitable SKYTROFA, reinforce But me if approach in really has reallocating on. we help and to some opportunities Commercially, we reimbursed. looking strategy that’s Thanks. hasn’t started. access execute yes, Yes. areas at I’ll Jen representing an you a look get revenues, times also

Josh Schimmer

Okay. Thanks very much.

Jan Mikkelsen

And quarters one this would say, to here doubled have last thing the to last seen see I I have would the what in now to from we revenue quarter. we where quarter like like two

is to are believe happen. that. have SKYTROFA really deserve This and I treatment. how patients entire get up we of We dedicated of Our to goal the is that treatment we we believe the can as and function to commercial continue build brand. the with really growth benefit And is is team get team the because deficiency to in doing Joe want what this hormone now option the believe really U.S. a they

Operator

next Ahmad the of line Your America. from is Tazeen Bank from of question

open. is line Your

Tazeen Ahmad

Hi, taking your my good Thank you wanted about just afternoon. achondroplasia. Jan, thoughts I question. for the competitive to for landscape get

competitive I is course, show to injection? your you an be is of early-stage you’d somewhat you. BridgeBio, we of early, theory, your thoughts comparable guess, weekly drug view how would get if your products advantage frequency. delivered to molecule for know in still ahead. do that several did the on potentially on also which developing. an some proposed I about dosing, the So oral But years wanted recently But dosing It’s efficacy data profile potential orally have Thank

Jan Mikkelsen

landscape. company’s Yes. But willing Is not always really our entire my comments job of about share personal make analysis to competitive I’m the product. to my

therapeutic clue perspective, have and question you always clinical number needs data, how is product the convinced the is scientific oncology target pediatric that data, effect. all, a doses, and the And This a safe that come do on product look royalty an stock in because trucks, my then and provided is tissue one. in number where at From when need one to many, that. opportunities, by annualized into pretty many many, are direct a data no and growth action for safe to data six from indications. positioned need be everything velocity independent seen fundamental my I end analyze to understand I key I of outcome clinical believe, be elements the the because because where months the like got I action that the the It of many, three this growth one. in where so months, First mode is of have the of with I how it plate, in mode it data is to I the

you see at other need need I see me. delta, background. I just If see meaningless to absolute like growth to to things need that. see it’s velocities. I for

So, function because it. no judge if can for is I this have personally no I or evidence. me, opinion not I product not have

is that in a landscape is patient. pediatric number one the achondroplasia For competitive safety

need compromise see growth need can never And background is see I that. like to safety. You cannot we velocities about, compromise you together talk with safety. why you other Whatever to and this see things believe

will opinion this have I me, product for So, had I no no I can that personally evidence, not because function or not judge.

safety. whatever the can CNP has talk you why patient never pediatric the about, safety patient, the extremely compromise with many And to partway achondroplasia now in compromise utilize. this data believe an that you not with is a proven is For safe expect competitive so you together pathway is landscape, we [indiscernible] safety one cannot

and we that hopeful best that on QX we possible believe So, so get that coming optimize need. find And age give some when are how out hopeful, comfort now our some out come about, really the I really about are a we we treatment XX, X the of We to is received, CNP we treatment find basic also we need, from get we just treatment best can with just will you a the say so of we get what need out clues we optimize some received, to can data we CNP should treatment need is we get clues is what age the from group the out can just will – front. treatment. we up have because how can we to would that we need option with the patient are in

Operator

for your question. next standby Please

from is the question of Next David line Citibank. from Lebowitz

Your line is open.

David Lebowitz

what the to or extent I getting this extent mentioned very with you in to addition, guess as much are what as receiving the And discounts the point, are for at taking reimbursement one duration? of launch to each are at number respect for prescriptions this patients question. prescriptions overall? far point? the Thank through patients long And my how

Jan Mikkelsen

year. Typical drugs a X is for prescription months. get a Typical patient for

would one to a just much drugs get much, But more common get will I it’s months. much, say patients for Some three month supply.

in So, the leading to What we will up a have to We wanted has starts when before the indicated, overall it we X had build be year brand talk here the about a in it in renewed. SKYTROFA Joe goal for prescription, U.S. value. we basically duration launched when it

team really is After increase a We goal results have same optimizing it time. tactic. where we in also strategy, out strategy, achieve hormone the at develop and benefit see is in Joe growth that commercial different overall wanted we do the that, And our achieve we you of SKYTROFA. And of now really market, have tactics see can change our how done to why be the on and this loan how our goal. what value we his will to to to corporate our really tactic there built the market and want access

distributes what drug rate patients. to revenue that So, We higher in are this we and converting reimbursed We life. the to is recognize the goal that we our is to the are prescription revenue now, And doing when a we prescription. recognize from up the on are because higher don’t system over U.S. revenue. that where selling we recognize

David Lebowitz

see becomes you it to paying enough respect an data that do with evolved And that’s launch? long take it. Got since – full actually until a have And patient how has to how customer? does prescription, initial

Jan Mikkelsen

week month. of We have once evolving per lot and a it’s and data,

if of this metrics way Some are comment of we about not their I really how tactics. know and them really one we the not days, how is this them changed have of it optimize a because But do have can we own lot of is improving got I because yet. see, some a can some you few we how if Joe,

Joe Kelly

reimbursed that have showing quicker can are than adjusted point, that appeals. can that bit some do we Yes. this are now were prescribed are but there are But that we through is on subset we the to we approved, Thanks there drug within quickly, go formulary don’t that seeing formulary, in in not patients that already subset are process and not And getting really and both but sometimes again, at the specifics process And PBMs reimbursed folks share you I that David. payers. from our drug, It data, our free going categories. get to a program. that where another but on really patients of reimbursement that SKYTROFA, program. about quite we we authorizations the from rather free drug or willing that David, on patients free go tactics accelerate tell the a were are are varies come the on on then subset a go Whether approvals that medical those is through exceptions X,XXX we much before to

Jan Mikkelsen

has additional Scott an Thanks Joe. comment.

Scott Smith

the the I you to QX and would the demand. tactics reimbursed the importantly, increase Dave, And based there Joe that say reflects in acceleration team just from underlying on can revenue QX in increase the have SKYTROFA see implemented.

Jan Mikkelsen

Scott. Thanks

Operator

is question from Your Cantor. Watsek Li from line next the of

is Your open. line

Li Watsek

Thanks I Hey. I will CNP. with for taking guess TransCon my start questions.

other clinical most data from outcomes. be velocity, outcomes considered, I for growth the And us, what guess than relevant Phase I other I are Just on these the good that remind can would that patients? should guess guess, clinical X focus you we

Jan Mikkelsen

is a precision And velocity. there from growth procedure the interesting drive been that is clear has now status from this to endpoint when of really, is that really a that primary extremely perspective. are away the perspective, perspective it’s analyzed established, questions been These hard from regulatory has the that

are data is But drug do, of clean am have and years only of it. of this that why all see, now focused what that initiating regulatory endpoint the now another And we trials. eight analyze this like data trial, treatment. on the on could potentially and lot life so effect. understand all what that we children why that our thrilled. would to to hopeful is co-morbidities. to on I two level now but follow-up regulatory potentially much my we only we When analyzed un-blinded improve is love air endpoint treatment. to what of currently, am of the and how can this Xb velocity we have belief. try data, At is on started elements the things we to velocity to we different What when improve missed as we understand take so have to such life. but have are that, to we data potentially quality But least other indication the have can X do. want thrilled looking patient anything why the pediatric on basically potential we do is We and after agencies XXX% are growth have the many and benefit on clear We series So, product. huge this you a can a data. we first are need menu look because going I primary is growth the data, have some an because for to we want have in them stopped, effect them the can we and that what which right, But this at approval and of to we part. a into do some wellness of secondary other from list if or point that patients with and There start on pediatric interaction end want the trial treat honestly, or – ideas the I in be see like of so analyzed going of we to basically span. you are that, none continued And Xb And are I we to starting want on Phase is taking We our is know

addressing believe some So, benefit and really co-morbidities. that that we hope what we drilled and can we prove the

Li Watsek

Great. Okay.

follow-up I a So, guess just here.

CNP a pathway a would about maybe get have interactions wonder accelerated is again, FDA with safe. if because any the quite mentioned regulatory see like I ones. agency an like just maybe and sense the and this TransCon it maybe on – You you what possibility possible seems to

you this about how thinking wonder are I possibility from So, here?

Jan Mikkelsen

QX. much But a must start We start productive on discuss data. and with we but the It’s regulatory then any I out be you here think how in opportunity fast think as come must, the we then the patient agencies we as is element need Dana have more it get places can can have effective can follow-up. the waiting to thinking my with different dialogue speculate. is the can we to when Today, to see we the are and data I world only for key a to do out perspective. product find unique And positive data. in this property in comments? can Dana, possible, can

Dana Pizzuti

are you yes, right. Jan, absolutely

the take of will FDA form then any Xb, will with and We plan the the have the we to are our and already pace, communication haven’t discussion. Phase had basis we is accomplished And planning two our data. studies then eventually that

Jan Mikkelsen

So, more come to after data. the

Operator

Morgan next line Your of the from Stanley. is Vikram from question Purohit

Your line is open.

Vikram Purohit

Good afternoon. Thanks question. for taking my

So, I had one on SKYTROFA.

patients you from patients patients treatment-naive majority As of therapy, majority you And you over switching quarter seeing have progressed that from? a are switch the particular from are there patients seeing still switch through versus for launch, being another coming other agent the patients? the of of is now

Jan Mikkelsen

coming also think switch that patient what actually experienced see from first we majority QX, or small we of quarters in quarter still was a the the I full We see first in saw patients. the QX. we

hormone. the a growth this patient daily it’s daily growth no small Honestly, is of and among hormones. are all expected the broadly no basically it’s they daily between single is majority from, is So, pretty there there hormone, because difference coming growth

identical. of them All are

So, there difference. is no

switches no daily no is So, that There is anyone I preferable. think is We following growth. see different from science. than this

Vikram Purohit

That’s helpful. a on separate topic. a it. Got And question follow-up

to we here. in see For quarter are data third the expecting the transcendIT-XXX

data parameters of are is the for you then report out success this this to readout? defining data do trying internal hurdle meet – And how set? expect what you And are you on? to from here what First,

Jan Mikkelsen

TLRX/X phone the agonist start in transcendIT inside injected Stina Yes. and with think I and I our where can we the follow-up. initially, patients is take on TransCon tumor we The can she provide at very having the an is exposure program. safe you mechanism you The are system to ensure extreme the Its low systemic tumor. that tumor. and to time, solid same hemological kick-start

product of shown have the opportunities. already has successful we So, which design the of these element disclosed one

We have disclosed the safety.

We have PK profile. the disclosed

how a inside with systemic have disclosed have released stain We toxicity. low tumor we

biomarkers, So, optimizing that. the and And activity entire X designed – now what tumor claim, we when and recommend is dose. can we related team from clinical and sorry, are injected progressing select tissues huge that will a tumor. explain have that how other things and both see also is how Dana we target And some her we in Phase can way like to you Stina non-injected Stina, are perspective the engagement or

Stina Singel

Thank Jan. you,

we end transcendIT-XXX. portion at analysis a of quarter X expect So, dose the three have finding this Phase year, the of formal to of

escalation will pembro. seen We combination expect, monotherapy for with mentioned, Jan cohorts dose what as summarize have in we in

that the data, question? answer PK initial dynamic Our activity. from Does look safety your clinical at and antitumor

Operator

line Vikram’s already closed. is

Joseph next Securities. SVB is from Our Schwartz question from

line now open. Your is

Unidentified Analyst

am I Jerry, for taking Hi, our for in questions. you Thank Joe.

first went by upper see one on factors Could an can expect some guidance? bound The wondering, when in confidence is a are we And €XX what I follow-up. into year-end? SKYTROFA. was that reach just we – and I to building million our to have

Jan Mikkelsen

the believe quarter. is doing from can provided the And some of than think quarter-by-quarter key the you giving the are have launch two we we really more a We increase that today. we you continue XXX% we because last description are the see we the following at launch. KPIs to the with seen And of now continued of revenue we last parameter have quarters. So, are guidance we clear that have revenue with. quarter doing execution of we some that have off I for this in company coming What the we following that what seen is the is

we that And come We have have can reach we can I comfort, what its consensus, clear discussion reach. consensus, that sell comfort a for that can expectation comfort with you that. our guidance move is, believe We in side give reach we can more results into you actually feel measure. out further you own the we with we don’t about the as what have

Unidentified Analyst

more And CNP. Phase does Thank Xb Phase on and you trial fit elaborate trials? do Okay. higher in OLE patients the kg all if just XXX wondering complement your two in was How next micrograms you plans you. your study my TransCon question that design? X your than this I your have Thank to that could And you. plan week you then is conduct? per That’s helpful. on per

Jan Mikkelsen

one First think XXX have the of U.S. trial. mainly now, of element an trial patients conducting that achieve we in Europe is And this all, and in I have we

a will how We move study. patient in have away the history the have product. give our that to in is single Xb explore give there. initiating national science, option. on reasons one high try not for exactly and potentially patient, focused up on in have we our expectation also trial. that our basically, parameters from the treatment company’s done. treatment we potential it with give Phase any of seen what’s this except can to agencies. key regulatory They parameters, a now will can in of in we the are a trial potentially discussion basically analyze we us side, a the insight trial secondary level analyze each the option And a go trial is why we it data is still will them then them that they we From incorporate are of And hope, happening, the been the a sedating all data data, always And the look forth understand and build we deep growth have are When in in endpoint velocity, which what other back as we QX, that do,

of can purpose clinical Xb Phase with the evidence improve of we that what So, basically TransCon CNP. achieve is

Operator

conference today’s This all concludes participating. for you Thank call.

now may You disconnect.

Ascendis Pharma A/S (ASND) 11 Aug 222022 Q2 Earnings call transcript