Ascendis Pharma(ASND)

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Ascendis Pharma(ASND) - 2023 Q3 - Earnings Call Transcript
2023-11-08 01:22
Financial Data and Key Metrics Changes - Total revenue for Q3 2023 was €48 million, with SKYTROFA revenue at €47 million, up from €35.9 million in Q2 2023 and €12.3 million in Q3 2022 [20][21] - Operating loss decreased sequentially by 5% to €134 million from €141 million in Q2 2023 [21] - Cash, cash equivalents, and marketable securities totaled €455 million at the end of Q3 2023 [22] Business Line Data and Key Metrics Changes - SKYTROFA revenue growth was primarily driven by increased demand in the U.S., with low double-digit penetration into the U.S. pediatric growth hormone deficiency patient population [20][21] - R&D costs in Q3 totaled €111.4 million, up 6% sequentially, driven by higher endocrine rare disease-related costs [21] - SG&A expenses declined 9% sequentially, reflecting lower commercial and G&A external costs [21] Market Data and Key Metrics Changes - The company expects full-year 2023 SKYTROFA revenue to be between €170 million and €175 million, reflecting strong market demand [9][22] - The addressable U.S. growth hormone market is estimated to be significantly larger than current penetration levels, indicating growth opportunities [21] Company Strategy and Development Direction - The company aims to become a leading global pharma company focused on endocrinology rare diseases, with plans to launch three independent products by 2025 [8][19] - The strategy includes direct sales models in select European countries and partnerships in other markets [7][8] - Future growth will leverage fully integrated capabilities and partnerships in oncology and ophthalmology [19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving profitability and highlighted the importance of addressing co-morbidities associated with diseases treated by their products [18][30] - The company is preparing for its next vision for growth to 2030, focusing on sustainable value creation for patients and shareholders [18][19] Other Important Information - TransCon PTH is expected to launch in Germany in January 2024, pending European Commission approval [10][11] - The company is exploring combination therapies to enhance treatment outcomes for achondroplasia [15][41] Q&A Session Summary Question: Strategy with oncology and ophthalmology programs - The company will focus on rare disease endocrinology while exploring out-licensing and partnerships in other therapeutic areas [25][27] Question: Update from the Phase II accomplish trial - The company aims to provide data on sustainability of treatment benefits beyond height velocity [29][30] Question: TransCon PTH positioning in Europe - The company expects a strong market position in Germany due to high patient demand and reimbursement support [31][32] Question: Competing hGH products in the U.S. - Management noted strong interest and market performance for SKYTROFA despite competition [35][36] Question: TransCon CNP benefits beyond height velocity - The company is investigating various endpoints, including patient-reported outcomes and co-morbidities [52][53] Question: Plans for TransCon IL-2 expansion - The company is encouraged by initial data and is exploring additional indication cohorts in lung cancer [50][51]
Ascendis Pharma(ASND) - 2023 Q2 - Earnings Call Transcript
2023-09-05 23:43
Ascendis Pharma A/S (ASND) Q2 2023 Earnings Conference Call September 5, 2023 4:30 PM ET Company Participants Tim Lee - Senior Director, Investor Relations Jan Mikkelsen - President and Chief Executive Officer Scott Smith - Executive Vice President and Chief Financial Officer Conference Call Participants Li Watsek - Cantor Paul Choi - Goldman Sachs Andreas Argyrides - Wedbush Securities David Lebovitz - Citi Leland Gershell - Oppenheimer Operator Hello, and welcome to Ascendis Pharma Q2 2023 Earnings Confer ...
Ascendis Pharma(ASND) - 2023 Q2 - Quarterly Report
2023-06-29 16:00
Exhibit1.1 REF. 72543-500 26June2023 ArticlesofAssociation of AscendisPharmaA /S (CVR-nr. 29918791) (Registrationno29918791) Name, Registered Office and Objects of the Company: Article 1 The company's name is Ascendis Pharma A/S. Article 2 [Deleted by resolution of the shareholders on 23 April 2015] Article 3 The object of the company is to develop ideas and preparations for the combating of disease medically, to manufacture and sell such preparations or ideas, to own shares of companies with the same objec ...
Ascendis Pharma(ASND) - 2023 Q1 - Earnings Call Transcript
2023-04-28 02:34
Ascendis Pharma A/S (ASND) Q1 2023 Earnings Conference Call April 27, 2023 4:30 PM ET Company Participants Tim Lee – Senior Director of Investor Relations Jan Mikkelsen – President and Chief Executive Officer Scott Smith – Executive Vice President and Chief Financial Officer Joe Kelly – Senior Vice President, Head of Commercial Endocrinology Mads Bodenhoff – Senior Vice President, Head of Finance Conference Call Participants Jessica Fye – JP Morgan Tazeen Ahmad – Bank of America David Lebovitz – Citi Paul ...
Ascendis Pharma(ASND) - 2023 Q1 - Quarterly Report
2023-04-26 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 6-K REPORT OF FOREIGN PRIVATE ISSUER PURSUANT TO SECTION 13a-16 OR 15d-16 UNDER THE SECURITIES EXCHANGE ACT OF 1934 For the month of April, 2023 Commission File Number: 001-36815 Ascendis Pharma A/S (Exact Name of Registrant as Specified in Its Charter) Tuborg Boulevard 12 DK-2900 Hellerup Denmark (Address of principal executive offices) Indicate by check mark whether the registrant files or will file annual reports under cover of ...
Ascendis Pharma(ASND) - 2022 Q4 - Earnings Call Transcript
2023-02-17 04:10
Ascendis Pharma A/S (ASND) Q4 2022 Results Conference Call February 16, 2023 4:30 PM ET Company Participants Tim Lee - Senior Director of Investor Relations Jan Mikkelsen - President and Chief Executive Officer Scott Smith - Executive Vice President, Chief Financial Officer Stina Singel - Executive Vice President, Head of Clinical Development Oncology Joe Kelly - Senior Vice President, Head of U.S. Commercial Endocrinology Conference Call Participants Jessica Fye - JPMorgan Tazeen Ahmad - Bank of America Da ...
Ascendis Pharma(ASND) - 2022 Q4 - Annual Report
2023-02-15 16:00
Exhibit 99.1 LOGO Ascendis Pharma Reports Full Year 2022 Results – TransCon™ PTH PDUFA date of April 30, 2023, for adults with hypoparathyroidism; European MAA decision expected in the fourth quarter of 2023 – Expanding TransCon hGH geographic reach with planned launch in Germany in the third quarter of 2023; Phase 3 data in adult GHD indication expected in the fourth quarter of 2023 – Initiated Phase 2b ApproaCH Trial for TransCon CNP in achondroplasia; expected to complete enrollment in the second quarter ...
Ascendis Pharma(ASND) - 2022 Q4 - Annual Report
2023-02-15 16:00
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 American Depositary Shares, each representing one ordinary share, nominal value DKK 1 per share ASND The Nasdaq Stock Market LLC FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2022 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF TH ...
Ascendis Pharma(ASND) - 2022 Q3 - Quarterly Report
2022-09-29 16:00
R E F. 7 0 4 4 9 - 6 5 1 2 9 Sep t e m b e r 2 0 2 2 E x h i b i t 1 . 1 A r t i c l e s o f A s s o c i a t i o n of A s c e n d i s P h a r m a A / S ( C V R - n r. 2 9 9 1 8 7 9 1 ) (R eg is t r a t i o n n o 2 9 9 1 8 7 9 1) Name, Registered Office and Objects of the Company: Article 1 The company's name is Ascendis Pharma A/S. Article 2 [Deleted by resolution of the shareholders on 23 April 2015] Article 3 The object of the company is to develop ideas and preparations for the combating of disease medic ...
Ascendis Pharma(ASND) - 2020 Q4 - Annual Report
2021-03-09 16:00
Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington D.C. 20549 FORM 20-F (Mark One) ☐ REGISTRATION STATEMENT PURSUANT TO SECTION 12(b) OR (g) OF THE SECURITIES EXCHANGE ACT OF 1934 OR ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended December 31, 2020 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _______ to _______ OR ☐ SHELL COMPANY REPORT P ...