Ascendis Pharma A/S (ASND) 28 May 212021 Q1 Earnings call transcript

Ladies and gentlemen, thank you for standing by, and welcome to the First Quarter 2021 Ascendis Pharma Earnings Conference Call. At this time, all participant lines are in the listen-only mode. After the speaker’s presentation, there will be a question-and-answer session. [Operator Instructions] Please be advised that today's conference is being recorded. [Operator Instructions] I would now like to hand the conference over to your host, Scott Smith, Senior Vice President and Chief Financial Officer at Ascendis Pharma. ahead. go Please

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

Mikkelsen, Punnonen, me Head Operations; President Mark Joining of Senior of Global Development Jesper President Head and Medical Vice call Dr. Chief today’s are Commercial Bach, and Executive Officer; of Officer; on Oncology. Chief Dr. Sciences; Høiland, Juha Endocrine Dr. Jan Dana Pizzuti,

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

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

on marketing recent and are concerning section the release that Annual TransCon please information for foreign most Agency in results Risk of Drug the our and the candidates Factors Form differ note the statements other product cause actual product forward-looking Food could by Medicines investigational and press XX-F. approved factors see or to our European additional that authorities. regulatory candidates Report section not U.S. Please For are materially, today’s Administration,

effectiveness on not As will reviewed On shall the financial or as TransCon which product agency the candidates made and their investigated. product update. None discuss regulatory regarding we investigational candidates of provide viewed safety conference no our for by or a made first any today's be call, quarter the safety our for the representations of commercialization. products, been effectiveness as business product have and/or the they approved TransCon and and XXXX to statements purposes, being call are promotional are results

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

good and everyone. Scott, afternoon, Thanks,

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

Thank you, Jan.

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continue on a the of date XXXX, for GHD the pediatric for for XX, we by fourth with a quarter quarter, Commission in followed remain launch commercial track third June XXXX. milestones PDUFA quarter. For GHD anticipate to our in approval in we the for lonapegsomatropin US pediatric anticipate second approval in the corporate hitting and We European

open-label to the Europe program of clinical a provide for TransCon quarter and we America PaTHway line the III TransCon HP fourth to Phase the CNP, the quarter. extension results from top XX-week we update North report in Trial in PTH, results Trial. expect the and portion adult For expect for PaTH fourth Forward in

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activities Before anticipate for we the want anticipated our GHD points open in call for a for the PDUFA on XX. XXXX. lonapegsomatropin up few reiterate pediatric commercial I of date questions, to about We approval June

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

open. line is Your now

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you like? my broad coverage with how into online Do to expect work to what ultimately you array the wide the a expect year? or you Once payers, TransCon taking you expect you approved, expect as how of to do selective you very with be year hGH payers? And next for might in come payers landscape progresses more do going go Thank look gets do question. much for

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