Ascendis Pharma A/S (ASND) 3 Mar 222021 Q4 Earnings call transcript

Good day and thank you for standing by. Welcome to the Q4 2021 Ascendis Pharma Earnings Conference Call. At this time all participants are in a listen-only mode. After the speakers' presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is recorded. now today, hand Mr. would to conference I speaker your Instructions] like the to over [Operator Tim Senior Lee, Director of Investor Relations.

floor the Lee, is So yours.

year Director, Investor Thank joining of Ascendis call Thank everyone, Relations I'm XXXX full today. Senior operator. conference financial Lee, you, Tim Pharma. results you, our for

Development and Pizzuti, Chief President Dr. and me Financial and of Operations Joining President Officer; today's Head Commercial Scott Dr. Officer; Jesper Head of is call Executive on Global Officer; Stina Clinical Chief Dana Dr. Smith, of Mikkelsen, Hoiland, Officer; Punnonen, Medical Jan Chief Senior Head Chief Oncology. Singel, Vice Development Juha and Oncology;

under like commercialization the Securities may call we forward-looking to, intended include, Examples statements Reform I would that covered provided our limited U.S. you are Act. development statements U.S. SKYTROFA will market. safe the by continued to the Before Litigation of harbor Private contain but conference this such for that not of begin, be and are remind to

Our goals pipeline or progress place forward-looking statements. disclosed statements regarding plans you should that the our and plans, we SKYTROFA market and our candidates strategic statements, for with as on expectations our undue in today. materially results candidates These Actual pipeline, our carry regarding continued information our reliance these to not out our our from to is may expectations us potential statements, and available those meet and their events our on our in not or regarding forward-looking goals, respect differ achieve intentions could regulatory projections the progress, clinical and statements are U.S. on statements filings. statements product regarding our pipeline based

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

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

context once X hGH TransCon with name In the of in due to Commission the for hGH as years unless marketing has to a injection In hormone. adolescents general, secretion growth refer for the the as candidates hormone. investigational to referring Otherwise, this approved failure XX.X of note ages XX Ascendis the treatment we TransCon product a addition, our we endogenous inadequate weekly weight authorization under year use. insufficient secretion lonapegsomatropin, of are by develop granted product was and for please are have subcutaneous candidates kilograms a European due the endogenous growth XXXX of at one the United States least or the older FDA and particular jurisdiction, to commercial that August such SKYTROFA growth patients who treatment product in pediatric approved and product the European Pharma failure growth to as of Union. for not children

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

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

an XxX. was product were extraordinary disease and transform approvals immuno-oncology of leadership independent two build our also of global TransCon profitable, clinical capabilities In oncology, our These achieve achieve CNP the we the the market our essential products. and are XXXX In we our combination biopharma growth our validation Vision cancer and advanced successes approvals endocrinology differentiated regulatory highly include expansion immunotherapy significant Tim, a U.S. reach but We Vision products. each TransCon achieve key believe embarrassing place and including and endocrinology we Europe program Vision in people validation to achieving program of of advances U.S. our and continue hormone company, achondroplasia. strategy progressing a year. clinical here. U.S. the Ascendis. to our we XXXX, offer TransCon this innovation algorithm leading year XxX. other second central in We in Europe in in didn't our confirm to for the our expanding studies spaces of of To and afternoon. areas infrastructure adult our disease goal for global and rare platform. The the we The in Both technology label our of in approvals important have capabilities three products, development. hypoparathyroidism, milestone realized a programs that treatment and product, area, of global these achieving Validation goal we sustainable, manufacturing. rare with XxX PTH for programs Europe regulatory in of the being and in in through can were for biological Thanks, to TransCon have TransCon to the approvals good hormone and the growth for believe stop right our therapeutic

major conducting third Ascendis our we algorithm a therapeutic and Lastly, product addressing to medical technologies for candidates product of unmet that need. research create TransCon our using independent are area, for independent innovation pipeline

and continue opportunity. is element sustainable achieve our candidates We a will established As the bring using for of area with key product we to the leadership build create TransCon plan continue differentiated in Vision product developing high dollar across possible therapeutic our for areas, intend XxX safe, same organization global another unforgettable as Ascendis each product candidates growth. the as for have third in highly expectation all We be to candidates, to multibillion multiple new product I to to our to geographies. our that expect innovation. indication the aim XXXX capability technologies patients therapeutic product and algorithm the and quickly product A year.

efforts, support of awareness Access provide of and independent multiple U.S. is us data Because with and the only of to relationships provide clinical long-term SKYTROFA four launch, to maximize on updates to growth endocrinology regulatory our weekly growth. levers grow. our experience You you that commercialization that target In share throughout expense the plan knowledge and Equally can to solid for teams through the this assess programs market. SKYTROFA a the months Today, pediatric continues once milestones short In in Europe industry option U.S. growth progress we for of to adoption the since here to meet build deficiency. important its expect in SKYTROFA the Program. area channels planned the demonstrate growth we interest launch and SKYTROFA related are through as across year hormone, the important, and the physician to of five and indicates and events patient Signature hormone Ascendis treatment and prescribers, treatment leading commercial approved the brand. launch global the towards our commercial had hormone

In XXX As XXXX hormone of growth more Commission positive prescriptions for in one been of of have by than have hormone European by opinion written TransCon November mid-January SKYTROFA pediatric February for prescribing patients. their followed XX, XXX written we prescribers. physicians a Europe, growth in received deficiency quickly for XX% approval the XXXX. prescriptions CHMP

Europe and hormone bring reimbursement plan pediatric an portfolio growth establish look In to based But partnership market for the broad over and unmet us to deficient important time European a European and in the country, way, to TransCon to Danish to and patients. is distribution intend to sales hormone is varies some for country maximize this a medical capabilities bit others. to just lines market and we opportunity direct because of growth as countries time physicians a we As value forward establish product from in to company, patient secure great. need

adult expect different hormone from growth TransCon make suffering a to to hormone the adults meaningful we growth efficiency. deficient indication, adult Moving growth hormone

maybe expect somatropin, Hormone TransCon different We the the disease able Growth address benefit. to of releasing overall restore endocrine by aspects many unmodified and

chromosomal In addition, second internal a during in the fee development to XXXX, affecting protocol plan disorder the we submit rates. to and [indiscernible] quarter FDA of

We help market-leading brand a more are growth this to patients label therapy. and in create hormone pursuing expansion

not Today, at faced maintaining both is available. yet reducing HP aiming therapy calcium supplement now serum the living XXXX with hormone is in very Conventional with the significant a with deficiency health normal in range quality not and TransCon the of and which is short-term calcium and able life. important replacement of the who vitamin hope the symptoms, address challenges large believe PTH. be last to underlying therapy Turning disease. D for We hormone activate will year classical patients remains for to hypoparathyroidism,

chronic these addition, renal department often in classification, that on In reported experience such emergency stays resulting despite publications Numerous continue and kidney complication to cardiovascular and and being long-term other short-term conventional therapies conventional include patients complication have therapies, diseases, damage. can severe that bone diseases visits. lead as to symptoms, hospital

of month, paratide life other same forward levels mind, to Finally, of daily at With pathway with many X reports Later than in diseases we restore to top-line this patient look results designed quality sharing or activities. our the significant Phase chronic this below normal level with TransCon from impact PTH on PTH. HP physiological hormone worse trial. we

option in PTH this tolerability from America approved reminder, HP. physiological in investigating that believe HP of could TransCon benefit safety, clinical in an become adults treatment believe with a randomized, six a and Europe that – placebo-controlled patients. of did trial PTH in is As all restoration double-blinded, North chronic we We TransCon patients And efficacy for the if could months and a these important PTH. beneficial levels

that other TransCon in asked other We how are have market. often does PTH differ been PTH from therapies

of First, TransCon of predictable levels physiological release in range PTH the XX-hour PTH the period. the across allows

to we replacement hemostasis TransCon PTH and designed of be therapies by from Second, conventional calcium restoring the requirement first-line hormone potentially therapy, a life. quality eliminating

therapy per for open-label are this trial. in whereof potential In XX% product our endpoint the us XXX-milligram calcium, conventional in of serum me recap being parameters that of part and important six, candidate. subject initial Phase X activated the less taking at study, the month Let D These X extension as normal vitamin of the day used insight Phase the primary calcium. gave data same the of the than had the

quality reported subject scores are summary life all addition, of sub-domains. normalized In and

that in these continue of the line trial weeks demonstrate portion extension week randomized believe why to PTH to open-label normalization improvements of one six. from main six a to of part of two in continued out compared be subject to the placebo blinded be months four the patients TransCon could the quality improvement years. even of after Importantly study, now XX statistic XX after We reason and

we and FDA on ASP results like we exposure would As NDA the the to has think fourth be M&A potentially more PaTHway Phase underway, and plan PTH Japan treat a And we can Japan, inhibition study in Phase of HP in Continuous could quarter to lack this growth. PTH in the Japanese expect remain options have the of for disease, product assuming believe all X, fully and you in the by seen results update children of submit In and could the you initiate an paradigm top patients X also We study where stimulate become of far. EMEA CNP a TransCon ages, the mutation followed PTH is introduce with With Because Phase shift PTH during U.S., TransCon disease XXXX, submission associated so TransCon of to quarter. billion if the CMP know, affect line TransCon of suffering positive, data to the to of address third an X XXXX. Among is excited quarter. to achondroplasia for product. how we hypothyroidism PTH third we in endocrine than achondroplasia. XXX,XXX plan FGFRX rare in effect the fourth TransCon €X underlying counteract market HP the opportunity. could to are Europe largest TransCon by TransCon we plus the from treated. to PTH the shown I approved estimated, believe with the to we think alone growth our only quarter

ability levels provide quarter the line rates CMP’s In trial. improve. time TransCon to expect data prolonged can for to of We that pathway the the into the exposure from or allowing predictable are we penetration growth we rebalance investigating to top in CMP, at XXXX, target ACcomplisH share fourth

Our and subjects Phase X with and TransCon Australia, age of are few children two CNP in in two countries placebo-controlled North achondroplasia. other XX% double-blinded, America, to from in ACcomplisH group with trial randomized, from the In clinical the XX age to of Zealand five New years. the trial, Europe

really We results by data December R&D to in quarter year. thrilled of update. our line are blinded we're share fourth looking reported the at the And this safety last the forward top

have potential promising, further cancer Agonist years. in to two escalation trial and patient planned to now an candidates second transform we our validation dose from disease, year. Given IND the this therapy. serious of Switching file for later of Infant the the during similar trial of early product see we we TLRX/X also expect impact zero in our has or been oncology oncology, and immune this the age TransCon this technology adverse application data to first-in-human the believe to year to Initial quarter ACcomplisH and process

without transcendIT-XXX, For advanced Phase Agonist with metastatic TLRX/X enrollment study or X/X TransCon tumors. patient solid of a continues TransCon inhibitor TLRX/X in and in with Agonist, checkpoint

escalation TransCon quarter monotherapy TLRX/X expect top dose for XXXX. with combination in line checkpoint the and data inhibitor in We therapy of third Agonist

quarter in For XXXX. we data line monotherapy expect the beta/gamma, TransCon IL-X fourth the from IL-βelieγe top trial of

represents viable, IND XXXX, are progressing moving opportunity. We we we first IL-X profitable towards to step therapy. XXXX becoming alone combined our by TransCon TLRX/X a sustainable submit towards investigate beta/gamma Vision or cohort therapeutic TransCon During and similar combination for Phase a major X plan rare We disease endocrinology a an our biopharmaceutical global to XxX. of quarter billion US$XX of believe expansion the area Agonist fourth company. estimate and We that market as in took

We also the updating therapeutic year as up financial have third and a I we to now open the forward area. a highly differentiated for Scott turn review call for to to further a add before over oncology we I look plan questions. progress. pipeline, you will

Jan. Thank you,

December of and basic financial during to €X.XX XX, of our the €X to Turning results million net for basic share or reported compared We a ended loss net full diluted XXXX. million €XXX.X or a XXXX. loss €XXX per share year per and diluted

license, of results. now Let U.S. XXXX €X.X Total by in SKYTROKA during run sales provided through well stocking. SKYTROFA sales Reported estimated was U.S. €X.X sales million The launch. and inventory reflecting initial provisions to XXXX services XXXX, some for of we product sales majority SKYTROFA launch €X October This cover revenues of related returns were to to million. reduced and for primarily term initial deductions compared the were Pharmaceuticals. these me components supply million the in that made third were as VISEN to include XXXX. clinical Revenues as parties,

and of patient. reminder, distributor not revenue by upon to the upon the and product a pharmacy customers, recognize our receipt specialty dispense specialty we As

lower reach and clinical primarily Now by a in hGH, partially €XXX.X label were benefit the quarter in during to capitalization activities XXXX result an the turning its was name to And R&D of development TransCon our TransCon hGH, global operating expenses. costs expansion. increased of R&D of SKYTROFA. were to clinical onetime continued due then known approval capacity expand million €XXX.X in our pipeline, the This increased costs advancement costs XXXX. Research a increase and related including overall future of trial-related for well million with third reflect as support personnel-related. trade primary of XXXX to as U.S. drivers increase, of for to investments inventory as the to manufacturing by offset FDA compared

as batches higher building For TransCon as successful of inventory. trial-related initial PPQ primarily PTH, development spend substance were well costs costs manufacturing clinical including and to completion costs due drug increased device of costs, R&D commercial the

higher increased trial-related related clinical Agonist to Selling, costs. due and finally, costs costs to TransCon due therapeutic in the due Europe. to TransCon to costs and compared of R&D and equivalents dollar preclinical we of for €XX cash million launched and for million higher translation manufacturing income were and during expenses commercial exchange area, increased the €XX.X marketable €XXX.X SKYTROFA CNP, costs gains expenses Finance totaling manufacturing as expenses increase and for million. for also our trial primarily million clinical our in TLRX/X were cash, of XXXX, administrative For clinical rate and U.S. IT trial a as oncology infrastructure beta/gamma. XXXX higher other These cash reflect to net of €XX.X with costs personnel unrealized We in general U.S. and included systems an for well manufacturing, compared XXXX million were gain to in increased to primarily and TransCon XXXX holdings expenses €XXX.X a loss IL-X XXXX. related and securities and as securities primarily And net on foreign marketable ended prepared

Turning be one where authorization XX% prescriptions SKYTROFA of those prior making have PBMs for plans continue a launch with MIT. is members health access From prescribers, for GHD. an per U.S. strong coming interest has of our we are covered the XX, for SKYTROFA. to one we active prescribed SKYTROFA by to you more pediatric as dialogue patient XXX been of and since also demand launch for percentage care in and processes progress forward With available XXX XXXX. our were reimbursement other look to on over end payers broaden physician and continue updating written to year. And patient. update have continued we market of the Of see Each written excited increasing lives on we more in or the approved major SKYTROFA, time. than February usually XX% summary, medical of perspective, their And the to to to In to grow prescribers. prescription needed. access Through XXX in by SKYTROFA quarters. an in exception October SKYTROFA Overall, through prescriptions SKYTROFA patient to February,

advance disease TransCon platform. Turning Growth Hormone, the commercial in XXXX. invest to commercial continued expenses support build TransCon continue increase expansion oncology pediatric our in the for our in activities preparation investment ongoing to continuing to anticipated execution endocrinology in for Union, MAA additional launches to technology as capacity approval to expect for and rare our in clinical Including XXXX, product geographic in anticipated continued as our capabilities organization we in geographic in we following and we pipeline, expand trials. expanding in January future and manufacturing GHD of label expansion demand XXXX, European our And

hypopara TransCon of PaTH including include Phase commercial program, trial the execution will PTH, Forward and activities for Preparation ongoing including of Phase For key pediatric the batches trial. initiation X trial trial adult Phase activities the X PPQ of build clinical and inventory. Japan the manufacturing the in hypopara to continued program PaTHway a X PaTHway the and

includes TransCon trial ACcomplisH TLRX/X ongoing TransCon execution achondroplasia, coordinated continued clinical IL-βelieγe China in is execution CNP, which oncology trials continued VISEN include program, For the trial therapeutic which And Pharmaceuticals. X clinical randomized, of placebo-controlled double-blind, in key beta/gamma. the IL-X activities transcendIT-XXX two include for being area, clinical TransCon and the trial key Agonist through trial, ACcomplisH of Phase our our activities for lastly, our the in

activities infrastructure and portfolio and expect in SKYTROFA U.S., launch organization. progressing support in addition PTH activities, include systems rapidly investments commercial our SG&A to prelaunch activities to we will continued and In growing other TransCon the personnel,

lot happening Ascendis. As at a Jan have noted, we

and key an So our milestones events. now update other let on provide remaining me also corporate

continue a invasion the Ukraine to to X initiate For deficiency, TransCon has protocol Phase Growth Russia in of we our hormone the our plan ability impacted clinical to submit adult to growth trial trial Turner in trial, Hormone, in a syndrome Ukraine, trial FDA XXXX. to and in Belarus. activities Related QX foresiGHt

the is no situation. there affect may our impact currently time lines, to material our this business While from

QX TransCon results this and in from month, FDA QX NDA America we expected are submission line MAA submission expect our hypoparathyroidism an XXXX. For XXXX. And to in top to Japan equivalent trial this report PaTHway in we results expected submit EMA top QX expected in an X to year. PTH, or PaTHway XXXX and Europe pediatric North line followed IND plan for in Phase finally, by QX to an

Phase For gamma, in line expected oncology trial X QX year. file TransCon CNP, we TransCon ACcomplisH are expected XXXX. are to therapeutic monotherapy for an in in or QX our accomplished top line IND the Within data year. And results this beta this equivalent infants top plan the trial area for IL-X from QX

line in escalation IND equivalent For in are combo expect cohort oncology, QX data year. combination of lastly, expected therapy for TransCon for expansion evaluating submit And fourth transcendIT-XXX this the clinical beta top or TLRX/X the dose Agonist, trial TransCon we an IL-X monotherapy to TransCon gamma quarter. in and X the for TLRX/X therapy Agonist and Phase a

therapeutic plan third in quarter we with operator, now take And fourth to this that, announce the to are we questions. our Finally, ready year. area

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

is Your line open.

to about script are for a a first the XX taking say sure Or is script as written XXX month patients, those worth any And make refills? the seeing single of a really you said good Thanks that’s And a you Did when to scripts given equate for of of for afternoon. February each XX XXX I of like for refills? Guys, a usually full like are prescriptions the being product? written is what question. my has year, year? it year’s have script Or follow-up. for therapy script a you written

Jess. Thanks,

a one under lot written we refill, is prescription it’s be clarification it a a prescription. clear building for of covering to being there is get we we is I when still it’s because that the are because same that to covering good but And think year. wanted will sure,

Scott XXX, all number this independent we basically XXX. me, patients. the believe of about correcting is them talk that are we when So

Okay. Great.

and affect discussions Next the CRL to FDA played does were waiting contracting contracts out to somatrogon decision with for that guess, any is, payers payers at all. I prior potential the product that with how one with finalizing Ascendis. of your see

only are we all, the of once-weekly in product First approved the market. U.S. opportunity

We have seen long-acting how has been approved. not

explanation What about moving our believe it. we’re hoped planned forward launch as we and is executing really it, no we knowledge we have for. are had commercial we’re strategy, that following and We only and

when that So we was this we product was believe opportunity, it for CRL also there saw a part expectations. of our

scenarios, one and we’ve expect different market this was that at working we and scenarios have strategy. to job long we Jesper’s also numbers We there it believe our definitely an is into where we of access market Jesper plan covers were get getting up the is seen under I how the the doing to team time to And are amazing exactly assets. we’re and now. living I think be the the team

and have market the will only are the U.S. other market fast over one believe or be about of the should product there read two what is only market if been we on conversion we long-acting launch, segment how to U.S. my going. see in more the total there more is So leading it’s entire in We independent the about long-acting when summarize I brand will the opportunity.

by in built day the be look it and we when doubt have to leading we doing here from build no have we in our product up profile, day. U.S. a believe seen have see brand in everything we our what We we label,

Thank you.

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

line Your open. is

to it out as And to see very Good where a then of a you to expect Thank my out from just quarter you of Maybe heightened progresses? Omicron the of December? any you. the We of for you’re impact net. Thanks goes, particularly kind sense did get year in us you additional variability going far around gross as want where clarification starting forward. early flatten from Hi. days as afternoon. Can questions. and sense, point give think it’s might taking will of a COVID any kind

has all in Scott they’re think can change how different commercial of question. COVID. first And how and to explain the yes, I to the infrastructure adapting scenarios will take the kind we adapted the

net, so the disclosing reduce provision, about this nimble financial point guidance. with we’re as in at your to would We statements now any say, you to gross and we I on the for the – initial is other can I we’re a look to sold go. might you expect and not launch it prompt that Tazeen, specifically and have discount, the would question sales as did products where through see wouldn’t accounts fact But and you reported that necessarily pay phase at net that that discounts returns, have say, rebates. I in might product chargeback forward-looking take

Jesper?

in now. add, doing Yes. course, where representatives from That If locked that right not them. were pleased we to do the have calls centers can of we virtual our able then very has I we And of are with we being be we transformed calls. has with view to been When point place. are sitting the pediatric launch, did COVID anticipate face-to-face seen into

giving However, which we seeing and a call us are face-to-face is, preference certainly a to i.e., opening as hospitals access up market, the course, the us. we on of are speaking,

into we it coming also, COVID our expectations. is going And we the to now market and in see So certainly, baked opening short, us. anticipate be behind hopefully, had as to is up spring

Jesper. Okay. Thanks,

just to Scott bit that I to Can better. discount a back net? gross this Are you did little want first a jump to clarify quarter? understand to for on second. that you not saying you Just just

pharmacy top of single digits we the set have on There’s could especially on-invoice That million. you provision reduced net fairly the reflect about our that discounts that’s see a start-up price. So booked in aggregate. network specialty I to sales And distributor was provision up. say, that the on-invoice down phase we from the that, in minimal financials €X.X and that would are, also,

Thank you.

Our question of comes next Genuity. Michelle Canaccord Gilson from

Your line is open.

Hi. question. Thank my for one you for taking to I start guess Scott.

one the on us to PTH? understand as two the some an you to programs? mentioned and design in set discussions shown much NATPARA PTH primary X had too, from a that Phase revenue then remind is Phase differentiation And what labeling to the regulators of then in for trial distributor. to And extent the get how maybe had help guess, the regulatory can to endpoint. the therapy FDA what Can specialty kind adjunctive of therapy differentiate, you in me the in a in replacement what I data that versus within you’ve really the want X needs recognition to around what And You input the us see is terms channel? label PTH be

Michelle, But Dana I that speaking should the But Scott many I take think second was get let we some and combine part. think I can questions. time.

be he first. So will

the so channel the inventories what’s versus believe I sold was Michelle, what through. in question

As December gave of we on prepared think course, of the initial reported we at the said sales stocking I of remarks, were separately, you the the largely as XX, we same as metrics through February. launch that But that of period. end JPMorgan

see overall So demand you grown. how has can patient

composite a And and going us will look I will about what over to then But this the Dana we have. how explain and go it for just interaction she on. start, therapy? back do will mean I you really Michelle, it are and back we taking let home turn replacement to why and is endpoint

believe D, like in is back First north away then each success what of just serum And a we be the of than all, that normal serum the because for taking parameter. calcium. the cancer, endpoint away primary single definition But some of X.X% have really labeling. of that taking to higher adjunct everything we you need taking basically call something meters Normalization is an our vitamin comes we to calcium patient in have supplement. we seen same

successful pay, labelling, take you away. be D, do, to highly I’m go activated my What you we if zero vitamin no to example, normal D. then adjunct because an to into If down say, to take vitamin for person knowledge needs with just I XX% activated it doing

to XX% If you supplement. the to go of need you adjunct calcium labeling, reduce the

multivitamin adjunct per labeling. multivitamin the unnatural So to a We successful if you’re not cannot if are because need take people of for take – an down to Then an what take calcium to you my HP which with X-grams it X.X supplement, gram take a tablet. you tablet we in level day patient. you take

the go have a just So is basically hormonal parameter, replacement you is where take regulatory tablet. how therapy. you serum TransCon same and a is we vitamin endpoints. – reflecting about can you the And D That we’re basically a with we X how primary everything get a and then discussing have replacement the basically Dana, it, that if what have of even calcium, don’t and therapy, activated of that vitamin our our normal interaction, in same normal is a you can to PTH multivitamin take treatment we’re on Phase why you our progressing, how agencies. comment really take agreed hormone amount the discussed we see, endpoint daily

talked we the sent numerous the designed them with Sure, we X with question. fairly actually, We’ve And we a wanted Yes. a FDA. the to data that even Phase Michelle. before our be and X So had replacement the even protocol, okay? about rigorous and fact Thanks trial. for therapy, we started them Phase interactions

back progress So started as the we done protocol patients before sent was sent that, of protocol, the we through finalize up soon double-blind them talked months, period, they we few patients our a as the right until enroll as FDA to as last And and interactions the we send had the with sort we anything. we’ve of few of trial. we enroll do before end the to we agency, people, that comments. plan the And hit to the analysis about before sort had then

we’ve has planning analyze think a their and FDA to with consistent and the place, input the so what are And acknowledged we’re data advice been. we good pretty in

So it’s been an ongoing collaboration with them.

So really to proud coming we next out data have week. in the the

you. Thank

Josh Our next question Evercore. of Schimmer comes from

Your open. line is

Have much CNP for they been Thanks I tree might X the the Thank taking schedule Phase there if certain traction barriers bit for for trying And think returns on some data, seeing And the It TransCon you to benefits are you. what hypoparathyroidism see any life Why did PTH the the quality promote thus seem a of product NATPARA decision year, of guess far of the primary already be? last on the so provisions program, so, of and getting PTH as early. much could broader question replacement? like we support of at seems supportive launch. like but end why? accelerated audience. broader do looks you have you of cardiorenal NATPARA. to first Takeda adoption then They some the to outcomes It And product think the you and benefits didn’t for returns? as were a questions. that the about filing for noting are little what they for approval? was

Thanks. Yes.

We more will questions. say,

start So let – I but Scott I will first. think

expect although provision my you the so related chargebacks an we course, a we like reason time, conservative position account Josh, it commercializing, a are perspective, are would based product number is The none a have things end if we early, for question, realized. is the seeing those off rebates, is bleed and no, take experience that returns, that. be the To things accounting just provision on the of we of of Over the returns. fact knowledge, small. there’ll take to to from write-offs,

way use right, that goes short just to Related the I have it understood PTH acting the optimal why is basic got back as asking right not how Scott. to the shorter question. Thanks, the And But of you’re the best the acting. really some PTH you you penetration.

pump. cartridges. the take infusion the open it You into content, an Take

of level hours, So, That you days a seven is is into the happening that. a XX with it can give what lot physiological week.

activated acting, supplement. of you see that partly calcium on vitality, get [indiscernible]. short normalization a case If the give can is you Parting the a best can adoption past adoption of you

not expected urinary capture You’re the benefit. seeing XX-hour

kind seeing of life. effect to of not quality You’re statistic related any

the her et to Josh, really sufficient So, about showing have replacement want when team difficult you of clinical patient has the Everything the Phase not discussed diabetes And physiological coming the And is show get important is in it PTH, to all clinical hormone quality continuing having that et working out in question Really meaning clinical is type it’s you diabetes, explained to Will level hormone and have the in have we’re the and There unbelievable replacement restoring do strategy I get to is or compare what a always life, as have interaction primary induces it not end life up the up therapy. team when the think show this her not that’s should want we’re how is normal cetera, X therapy. get next she with by target to can any cetera bone this short-acting just to And X built patient patient to aiming team I on to done. of PTH. remodeling Dana lack true this from in we you’re so one. product normalize patient believe product profile is everything calcium right the what same Dana the CNP that is addressing physiological one a really, in to trying is with and with therapy. dedicated PTH that. trials. product development be guarantee everyone from of trial interaction what how week really to insulin. to this point our hormone change coming this you, What a at a we the basically that of of think replacement think regulatory urinary agencies, of the is at what also possible. that. how sure PTH the thing see. we Why And to The Dana can And our good benefit regulatory. I what

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important package believe building many but related Achondroplasia, not only TransCon we’re other believe now passed where could be an around So, I for CNP our unique, the disorder, we actually from important growth is because up compound. CNP

Morgan Instructions] you. question of comes next [Operator Thank from Our Vikram Purohit Stanley.

Great. for my Thanks question. taking

two So, SKYTROFA. on I had

the secondly, with applicable been treatment-naïve their staff. their And patients with administrative discussions since over could how much for long from First, that being that’s the so terms daily how they growth have it many that you prescriptions process of are authorization you’ve had patients have patients have for far, previous any versus then been from where insurers described posted an hormone? you took therapy switched comment have And of burden seen launch, a written the may on how prescribing how in to get doctors you. the of Thank approved? conversations

lot. a Thanks

think adding switch help and between naïve in to fact we in I with both of the saw What the development a is wait what majority the I was test switched patients, What patients compared call stepping multiple see, involved patients. were of forget vast including to growth right will of didn’t for I we and see then hormone can Scott beginning it. I start diagnosis in because some Jesper they the a me ratio patient stem stimulation. tests the from need we

setup initial patient. was are sure think this are converting general more be as really to fast is really over from possible we that in part what more patients. to our and after effort to Jesper? the many the done. we is mainly now switching that. most quite it’s this But over the we as from patients I of And have a saw surprised hub things Jesper perspective, naïve we commercial got our our explain what getting as And to as patient. one switch in possible unique a So fundament I one can We of about just week, was first see commercial

patients six the weeks we what the have standard And that that $X,XXX that on two work very case of weeks opportunity have daily than that injections. all prior a patients that and is, medical an Fast are for in once once growth Start help sure it we routine I’m is you you more treatment Vikram. normally cost their seen Basically, going take in for from call patients the involved, thereby drugs terms office could normal Jan. are month, transferring are from, then hard better common Prior going remembering say, patients anywhere which here. going are getting weekly to you as common to much having what of Absolutely, anticipate called forward, the is the and And exceptions about program. program a And to to takes is through. to we the is also compliance paperwork that of between of hormone and will there but ASAP course, is, talking the we which doctor off, typical rejection, have see

scheme will the coming And place focusing patients new patients queue that because the by, patients transferred. first see all get and as all, in the to Jan are certainly patients were course, in, we as on said, in Bolt. So switch that’s we of goes then, through. the on time in they naïve also go And the

you, Great. Thank Jesper.

Thank you.

Joseph question SVB of Schwartz next comes from Leerink. Our

open. is line Your

but taking days, Joori our I I’m for sales when Thank questions. Joe. guidance to for see SKYTROFA? it’s early we in dialing you can for expect know Hi,

into it one reflecting is sales the how least giving to When going we’re feeling first that believe will in be of the sufficient during confident we meaningless period the but in to really you look enough think And good and for you, is at of is can then quarter, about and we it progressing at it time. numbers seen guidance least least and we a of And least really really that I’m means range some is everyone full give have we have What we cord-free full at at quarters. really different about then see I what we I something really because would I not you, to guidance that financing modeling saying one two myself, at don’t But call quarter. first the you this for when discussion know, Jesper. two care this give like to you want really is to and guidance. saying,

We hormone involving we’re from want development, that plan the executing leading in are U.S. a the building commercial We the but hormone the And on growth that growth even prescribed here we’re go the this not want product. also is built right where entire we be hormone label out global market. And up growth side, can yes we’re product, how but a that only we sure to a in so that and we leading be address clinical is most the to in the out but basis. is And to brand, on. expansion strategy brand. on, high-value have most also build not building what only our Scott,

then And Great. Okay. a question I CNP. have TransCon relating to

their children placebo growth favoring agent competitor a announced than velocity. saw to trends in they So recently that compared five, less an annualized on

two differences there that children appears infants. young CNP that seen haven’t as even it but you’re on know as TransCon some younger accomplish studying We the age. and an I based in data, and could accomplished be

if that younger you children. anticipating you’re I’m in what of Thank make much. differences any very curious So, and you

lot. a Thanks

some are R&D the – safety her I Trial more the ACCOMPLISH for the our also one-year XX% them, of five. are we and facts think Day. we update comment two the looking our have database. provide about age And safety children and of many have really facts have between is and team we the But than in into Dana in a at in we I can and of always safety

a have blinded way from Dana, of basis. and on you the sum seen it you So take we some someways easiest what up can perspective for just perhaps a safety

Yes. or that. problems we things related been has side seen and like the any Well, extremely compound cardiovascular so haven’t effects safe, far, to

we So, advantage. that pleased also the CNP we’re with very continuous And that. feel of is release an of sort

of the their once the group other on changes I your that that’s there our younger sort data. of growth. they – have opportunity the unblind kids have biggest right? even a faster, that history though, an sort point, do some think we notice in is potentially But we natural shows can the grow of so And to again, impact to that greater that

group. better down, So, even able tease out the by so about age of in are group, excited the whether more break get right, we’re being it and to magnified a effects can very it that age finally idea younger we

Thanks patient year of you last development Scott see But provided think can a or a in all the slide date with somebody that safety we I link have. the can where research you basis. the our had provide on Trial, December and our we concrete also related lot. ACCOMPLISH blinded elements to in an There extensive update our we

you. Thank

Lebowitz David next Our of from comes question Citi.

line Your is open.

two here. very you for taking SKYTROFA. much got questions. one A for I’ve on quick you my Thank

patients? it because mind, And physicians D compare that have intangible the of flipping each things of from Could what these TransCon PTH, of And life is you do mean? it Given two terms prescriptions, on what type endpoints. in on type items with quality uptick would going to meaningful in active these of basis points? secondary forward prescribers? how cadence prescribe quality can over more actual different such as that – And think the on for in we for And vitamin D and the be of year? you end vitamin on in on calcium Is earlier based items. life those throughout sales as endpoints to how typically reduction January drug they

on direction. lot he week related think question first looking going with share But XXXX year. to really secure KPIs. we in let us PTH. you. There about SKYTROFA to the different what are week and of this about we was right Okay. Jesper, about KPIs matching But and read by a He's has is start with And how three

product happen. what So is patients call U.S. SKYTROFA number basically in the in our And have we increase number the actually will KPIs, this And and to bases to we a how opportunity are don't state And initial we really is This prescription. one pretty month in market. XXX proud U.S. inside this organization because get of follow the we we sure under to of this really numbers, believe the using I this good KPIs. XXX. different are are why treatment that be performed are I'm have pretty that with marking revenue loans, that, by month. of now at the current our it I'm we managed of predicting proud quite the the and

it. in to what we because market in them we up the faster. to believe we we have that anything feel okay day have So the mistake. this when we always but KPIs, penetrate continue to patients continue. using stop launch actually faster, not can we commercial add to not assessment to can Jesper we in to that that is it go that position faster, prescription have – to the until And we get more believe also I PTH. or we we expected. trend different can what to want and to know it the integrated doing do we we're see only and better. the this we're have look on more not also faster we living get better. I we it's I know all to And follow long, see what are And do think the do I done, to is we a make if before now will a get it everything And But seen pretty you

it's No, I bang think on.

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future. giving trust So us for of momentum course, the that's, and

the will segment. long-acting the We market leader in be

Yes.

our about specific daily getting have our to the the the We compliance see. people saw with softening see really back expect patient we we it and open-label the PTH. really to experience not question only open-label my that are understand have And true. back happening a don't I don't one. in have And extension expected question are this using signs. and And is that have what just years the out Do, in years, actually some in a is somebody what back Two where open-label a on because see their all major, more we're of is when being extension to for we benefits long-term with have benefit to benefit. I so of it Phase think quality signs not the when seen they where and open-label the because or there patient we the long-term And happen any are now science going disease-specific the of me feeling life this back. to extension we extension XX study. invested you It's go thing we to publication complication the and two because in subdomains impact they of to the some part. open-label what But that to of the many a life. both the seeing we reported is short-acting taking But we is the a about Going factors. that's Because where infusion goes we're we that is physiological your in major been because They with, pumps. They do the look trial X PTH trial. in summary SF-XX seen something facts, typical, is XX, for same seeing PTH have think proven that inject. this outcome an

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Thank you.

of Cowen. Werber Yaron from comes question next Our

Your line is open.

for Thanks for taking my This on Gabe is questions. Yaron.

shared as that XXX XX. you've first, written have December about been prescriptions So of

us was rate be then the sense least I previously? I into of give And that all now which also some these those ago. follow-up. provide a so Can success you would are on the would believe months a patients have about many And asked insight authorization of help therapy process prior of how of at two

think Jesper have, that I have fast indicated the we what program. we a start-up

that program. of call fast I we patients believe So are coming what the start all majority into our

where on to eight So take from move something the will that on talked And weeks, weeks converted over commercial the during into some will or process the to some to this basic related commercial we can of dependent up the patients two speed be about be like Jesper patient. then as treatment. what that we period a getting expect

Okay. Yes, that sense. makes

more as eight can you converted been the weeks a of first among have going. to of many how those just December there any XXX insight Or is of would So patients provide us how those be give XX since ago? than sense the conversion

after The going the expected in we conversion what exactly patient first have commercial is I said, as week. coming Maxwell so indicated, we which as one

from So growth what the we knowledge exactly expected to to growth expected hormone are commercial treatment. function, be how compared to hormone we market how see patients the as coming our

that. to compared different very not are We

Thank you.

Gershell from Oppenheimer. comes question next Our of Leland

Your line open. is

afternoon. Thanks questions. for good Hey, the taking my and update

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comments, manner. And Do team right and You it the any more what you do in is doing. have his is Jesper? think I Jesper this

are ongoing so mean, that the with are, we pleased things also getting. of approval are the we also time we the point as that access are and negotiating far, we're of at having, we're in and course, where these and we rate No. I indicating are coming quite

our So which develops course, all with. in of are, to it according pleased all, we plan,

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covered. of lives XX% Yes.

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Yes, XX%.

XX%

PTH. just Thank question you. a on And

what X review data account pending with X and FDA Phase to Thanks. results to the Phase open-label taking application regulatory the the respect your process, presentably the and as from be will extent extension into PaTHway. Just they the

you're correct. Yes,

are We have the further in out, And – building both for some Dana, you safety example, database price. comments about from that? do

yes, be the PaTHway will Well, trial flagship think sort X the Phase I registrational trial. of

said, working more will just that what think lot be path the the a helpful, in bone, instrument life on durability right? I been to only the information XX we've the results disease-specific give us that are out to happens to of still trial. about that help quality the of forward, as the long-term well. though, of And us of will also sort show sort response, validate XX right? Jan extremely As from not And of

I So the the sort supportive. trial, then one in would going I of mean And sort hand. be two registrational hand call the one it. would you think be trials pivotal of is could other strongly

what Before we explained we we from have even Phase of forward. to sort in terms of the would long-term path trial, X safety the started FDA

the I totality but have think trial were be them review. do the sufficient such would even adherence safety satisfied for we database to we great expect of in they would their that that didn't

are important. extremely both think trials So I

PaTHway as trial well. the think concept I though, replacement the linchpin sort is the of for

Dana. Thanks,

Thank you.

Our of comes Berenberg Anita question from Markets. next Capital Dushyanth

is open. line Your

Thanks question. afternoon. my for taking Good

the maybe able the be about when to cover you the number the Could SKYTROFA, for Just XXX. to – internally, think team prescribers sales I commentary, mentioned you X,XXX of prescribers? regarding talk the in team

we I and strategy do targeting. doing already are how to is think long our been now what have

yes, the market – the growth caring only are be done targeting hormone think being in of more prescriber. me, XX% I XX% correct – we the it's of So by it's prescription

of all market. launch wrong the in So prescription typical we our we states, the being right. in covered actually in growth hormone the written initiated XX% was Yes, understanding this

No. we breaking sort basically where you best the What on And then, deciles. we into of are could X,XXX that's targeting the we and keep of is highest prescribers, course, say, are we penetration. have, are the doing

on to can do will particular the we So and opens continue it up market do can it in that expanding now face-to-face that We we work it. calls.

of We Novo and with have the in forces both a force competition Pfizer. match competitive size terms our with of

of certainly maintain having have to only right the that, the on market, we we're the are leadership as we believe and continue that focus when the we're on going one see we course, that market. in to can So we market coming to but also now competition

Anitha. Thank you,

Yes, thank you. Yes.

Thank no for you questions call. concludes This want see conference Thank all participating. further to you. in the everyone. thank I queue. I today's

pleasant now and day. may have disconnect, a You