DUBAI, United Arab Emirates, Jan. 08, 2024 (GLOBE NEWSWIRE) -- Vector Pharma FZCO (Vector) today announced that it has entered into an exclusive distribution agreement with Danish company Ascendis Pharma A/S (NASDAQ:ASND) to commercialize both Skytrofa™ and Yorvipath™ in the Gulf Cooperation Council (GCC) countries of Saudi Arabia, United Arab Emirates, Kuwait, Oman, Qatar and Bahrain. Under the terms of this exclusive distribution agreement, Vector will employ its sales and marketing expertise to distribut ...

Strategic roadmap to achieve blockbuster status for multiple products and expand the Company's engine for future innovation COPENHAGEN, Denmark, Jan. 07, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today introduced selected 2024 corporate milestones and Vision 2030, its strategic roadmap through 2030. Ascendis President and CEO Jan Mikkelsen will present the update tomorrow, January 8, at the 42nd Annual J.P. Morgan Healthcare Conference. "With unwavering focus on our values of Patients, Sci ...

Core Points - Specialised Therapeutics Asia Pte Ltd (ST) has entered into an exclusive distribution agreement with Ascendis Pharma A/S for three endocrinology therapies, expanding its portfolio in the region [1][2] - The agreement covers key markets including Australia, New Zealand, Singapore, Malaysia, Brunei, Thailand, and Vietnam [1][2] - Two of the therapies, SKYTROFA and YORVIPATH, are already approved internationally, while the third, TransCon CNP, is in development following successful Phase 2 trial results [1][2][3] Product Details - SKYTROFA (lonapegsomatropin) is a once-weekly injectable human growth hormone treatment approved in the US and EU for pediatric patients with growth failure due to inadequate secretion of endogenous growth hormone [2][8] - YORVIPATH (palopegteriparatide) is a first-in-class parathyroid hormone replacement therapy approved in the EU for adults with chronic hypoparathyroidism, addressing a significant unmet medical need [2][3][12] - TransCon CNP (navepegritide) is an investigational therapy for achondroplasia, showing promising results in Phase 2 trials for improving growth velocity in children [1][2][14] Strategic Importance - The partnership marks a significant milestone for ST, indicating its expansion into endocrinology and pediatric medicine [3][4] - ST's CEO emphasized the importance of this agreement in launching critical endocrinology products in the targeted regions [3][4] - Ascendis Pharma's selection of ST as a partner is based on ST's strong track record in commercializing specialist medicines across multiple regions [4][5] Market Context - The agreement aligns with ST's mission to provide specialty therapies where there is an unmet need, enhancing its therapeutic pipeline [6][4] - ST has established itself as the largest independent specialty pharmaceutical company in the region, navigating complex regulatory and commercialization environments [6]

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 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 ...

[Articles of Association](index=1&type=section&id=Articles%20of%20Association) [Company Identity and Objects](index=2&type=section&id=Name%2C%20Registered%20Office%20and%20Objects%20of%20the%20Company) This section defines Ascendis Pharma A/S's identity, specifying its name and core business in medical preparations and related company investments - The company's name is **Ascendis Pharma A/S**[2](index=2&type=chunk) - The company's object is to develop, manufacture, and sell medical preparations and ideas for combating diseases, and to own shares in related companies[3](index=3&type=chunk) [Company Capital and Shares](index=2&type=section&id=Company%20Capital%20and%20Shares) This section details the company's capital structure, including total share capital, Board authorizations for capital increases, and warrant issuance history Share Capital Structure | Description | Value | | :--- | :--- | | Total Share Capital | DKK 57,335,496 | | Par Value per Share | DKK 1 | - A total of **12,375,332 warrants** have been issued under articles 4a, 4g, 4h, and 4i, with **5,508,224** exercised, annulled, or lapsed as of June 26, 2023[8](index=8&type=chunk) Board Authorizations for Capital Increases & Instruments | Article | Authorization Type | Max Nominal Value (DKK) | Expiration Date | Pre-emptive Rights | | :--- | :--- | :--- | :--- | :--- | | 4d(1) | Share Increase (Cash) | 9,000,000 | May 28, 2024 | With rights | | 4d(2) | Share Increase (Cash/In-kind) | 6,125,000 (reduced) | May 27, 2026 | Without rights | | 4e | Convertible Bonds | 9,000,000 | May 29, 2027 | Without rights | | 4f | Warrants (Mgmt/Employees) | 1,000,000 | May 29, 2027 | Without rights | | 4h | Warrants (Board/Mgmt/Employees) | 2,000,000 | May 28, 2025 | Without rights | | 4i | Warrants (Mgmt/Employees) | 2,000,000 | May 27, 2026 | Without rights | - Shares are issued in the holder's name, registered in the company's shareholder register, are non-negotiable instruments, and no share certificates are issued[104](index=104&type=chunk) [General Meetings](index=17&type=section&id=General%20Meetings) This section governs shareholder general meetings, detailing location, language, notice periods, annual meeting timing, agenda, and voting rights based on DKK 1 per share - General meetings are held in the Greater Copenhagen area and conducted in English[106](index=106&type=chunk) - The annual general meeting must be held within **5 months** after the end of the accounting year[107](index=107&type=chunk) - Each share of **DKK 1** carries one vote, and matters are generally adopted by a simple majority[111](index=111&type=chunk) - The ordinary general meeting agenda includes the board's report, annual report adoption, profit/loss resolution, election of board members and auditors, and other motions[110](index=110&type=chunk) [Board of Directors and Management](index=19&type=section&id=Board%20of%20Directors%20and%20Management) This section details the company's governance, outlining the Board of Directors' composition, term limits, retirement age, management team appointment, and binding authority - The Board of Directors consists of **3 to 10 members** elected for **two-year staggered terms**[113](index=113&type=chunk)[114](index=114&type=chunk) - Board members must retire at the ordinary general meeting following their **75th birthday**[115](index=115&type=chunk) - The Board employs a management team of **1 to 5 members** for day-to-day management[116](index=116&type=chunk) - The company is legally bound by the joint signatures of the chairman and one management member, or by three board members[117](index=117&type=chunk) [Audit, Accounting, and Communication](index=20&type=section&id=Audit%2C%20Accounting%2C%20and%20Communication) This section outlines the company's audit requirements, accounting year, language for financial reports, and authorization for electronic shareholder communication - A state-authorized public accountant, elected annually by the general meeting, audits the company's annual reports[118](index=118&type=chunk) - The company's accounting year is the calendar year, with annual and interim reports presented in English[119](index=119&type=chunk) - The company utilizes electronic communication for all shareholder correspondence, including meeting notices, annual reports, and stock exchange announcements[120](index=120&type=chunk) [Appendices](index=22&type=section&id=Appendices) [Appendix 1 & 1a: Terms and Conditions for Warrants](index=22&type=section&id=Appendix%201%20%26%201a%3A%20Terms%20and%20Conditions%20for%20Warrants) These appendices detail the company's warrant incentive scheme, outlining vesting schedules (monthly and cliff), exercise periods, termination conditions, and anti-dilution adjustments for capital changes - Warrants are granted free of charge to employees, consultants, and board members as an incentive to focus on company value increase[123](index=123&type=chunk)[150](index=150&type=chunk) Vesting Schedules for Warrants | Appendix | Recipient | Vesting Schedule | | :--- | :--- | :--- | | **Appendix 1** | Employees & Consultants | 1/48th of warrants vest monthly from the grant date | | **Appendix 1** | Board Members | 1/48th monthly for initial grant; 1/24th monthly for subsequent grants | | **Appendix 1a** | Employees & Consultants | 25% cliff vest after one year; remaining 75% vests 1/36th per month thereafter | | **Appendix 1a** | Board Members (Initial) | 25% cliff vest after one year; remaining 75% vests 1/36th per month thereafter | | **Appendix 1a** | Board Members (Subsequent) | 50% cliff vest after one year; remaining 50% vests 1/12th per month thereafter | - Warrants may be exercised during four periods annually, starting two trading days after quarterly earnings report publication[128](index=128&type=chunk)[153](index=153&type=chunk) - The terms include detailed anti-dilution adjustments for warrant number and exercise price in response to capital structure changes like bonus share issues, non-market capital changes, mergers, or significant dividends[130](index=130&type=chunk)[156](index=156&type=chunk) - Warrants generally lapse automatically on the **tenth anniversary** of the grant date if not exercised[142](index=142&type=chunk)[167](index=167&type=chunk) [Appendix 2: Additional Terms and Conditions for Warrants](index=40&type=section&id=Appendix%202%3A%20Additional%20Terms%20and%20Conditions%20for%20Warrants) This appendix outlines terms for an earlier set of warrants, including monthly vesting, accelerated vesting upon an 'Exit-event,' specific exercise periods, and adjustments for capital changes or termination - Warrants under this appendix generally vest at a rate of **1/48 per month** from the date of grant[176](index=176&type=chunk) - An accelerated vesting clause applies in an 'Exit-event' (merger, split, or sale of **over 50% capital**), with **50%** of unvested warrants vesting if before January 1, 2014, and **100%** if on or after[176](index=176&type=chunk) - The last exercise period for these warrants was **21 days** following the publication of the interim report for the first half of 2023, or the nine-month report in 2023 for specific grants[177](index=177&type=chunk) [Appendix 3: Summary of Granted Warrants](index=50&type=section&id=Appendix%203%3A%20Summary%20of%20Granted%20Warrants) This appendix provides a detailed ledger of all warrants granted under various articles, summarizing total issued, exercised, annulled, and lapsed warrants as of June 26, 2023 Warrant Status Summary (as of June 26, 2023) | Category | Warrants under Arts. 4a, 4g, 4h, 4i | Warrants under Art. 4c | | :--- | :--- | :--- | | **Total Granted** | 12,375,332 | 566,504 | | **Exercised** | 4,361,391 | 525,364 | | **Annulled** | 19,580 | 0 | | **Lapsed** | 1,127,253 | 32,354 | | **Outstanding** | **6,867,108** | **8,786** | - The authorizations to issue new warrants under articles **4a** and **4g** are fully exhausted[204](index=204&type=chunk)[205](index=205&type=chunk) - Warrants granted up to November 2021 generally vested **1/48th per month**, while those from December 2021 onwards follow a cliff vesting schedule (**25% after one year**, then monthly vesting over **3 years**)[206](index=206&type=chunk)[210](index=210&type=chunk)[211](index=211&type=chunk) [Appendix 4: Indenture for 2.25% Convertible Senior Notes due 2028](index=59&type=section&id=Appendix%204%3A%20Indenture%20for%202.25%25%20Convertible%20Senior%20Notes%20due%202028) This appendix presents the indenture for the company's 2.25% Convertible Senior Notes due 2028, detailing terms, interest, conversion rights, redemption options, covenants, and default procedures Key Terms of 2.25% Convertible Senior Notes due 2028 | Term | Description | | :--- | :--- | | **Issuer** | Ascendis Pharma A/S | | **Trustee** | U.S. Bank Trust Company, National Association | | **Issue Date** | March 29, 2022 | | **Maturity Date** | April 1, 2028 | | **Interest Rate** | 2.25% per annum | | **Interest Payment Dates** | April 1 and October 1 | | **Initial Conversion Rate** | 6.0118 ADSs per $1,000 principal amount | [Covenants](index=91&type=section&id=Article%203%20Covenants) This section outlines the company's covenants under the indenture, including payment obligations, SEC reporting, and provisions for Additional Interest and Additional Amounts to cover withholding taxes - The company must send copies of all required SEC filings to the Trustee within **15 days** of their filing date[303](index=303&type=chunk) - Additional Interest of **0.50% per annum** will accrue if the notes are not 'Freely Tradable' during the six-month period beginning six months after the issue date or after the De-Legending Deadline Date[306](index=306&type=chunk) - The company is obligated to pay 'Additional Amounts' to ensure beneficial owners receive the net amount due, even if withholding taxes are required by a Relevant Taxing Jurisdiction[308](index=308&type=chunk) [Redemption](index=96&type=section&id=Article%204%20Redemption) This section details note redemption conditions, including holder rights upon a 'Fundamental Change,' the company's optional 'Provisional Redemption' based on ADS price, and 'Tax Redemption' due to tax law changes - Upon a Fundamental Change, holders can require the company to redeem notes for cash at **100% of principal** plus accrued interest[320](index=320&type=chunk) - The company may redeem notes on or after April 7, 2025, if the Last Reported Sale Price per ADS exceeds **130% of the Conversion Price** for at least **20 of 30 consecutive trading days**[329](index=329&type=chunk) - The company may redeem all notes if a Change in Tax Law necessitates paying Additional Amounts, though holders retain an opt-out election[330](index=330&type=chunk) [Conversion](index=106&type=section&id=Article%205%20Conversion) This section details note conversion rights into ADSs, including the initial conversion rate, anti-dilution adjustments for corporate actions, and increased conversion rates for 'Make-Whole Fundamental Changes' - Holders may convert notes at any time until the close of business on the **second scheduled trading day** before maturity[340](index=340&type=chunk) - The Conversion Rate is subject to adjustment for corporate actions including share dividends/splits, rights offerings, spin-offs, significant cash dividends, and tender/exchange offers[353](index=353&type=chunk)[354](index=354&type=chunk)[356](index=356&type=chunk)[358](index=358&type=chunk)[359](index=359&type=chunk) - If a 'Make-Whole Fundamental Change' occurs, the conversion rate will increase for notes converted during a specified period, based on the effective date and ADS price of the transaction[368](index=368&type=chunk) - In an 'Ordinary Share Change Event' like a merger, the right to convert into ADSs will be replaced by a right to convert into a unit of the new Reference Property[376](index=376&type=chunk) [Defaults and Remedies](index=129&type=section&id=Article%207%20Defaults%20and%20Remedies) This section defines 'Events of Default' for the notes, including payment failures, covenant breaches, and bankruptcy, outlining remedies such as acceleration of principal and special interest for reporting defaults - Events of Default include non-payment of principal or interest, failure to convert notes, covenant breaches, cross-default on other indebtedness exceeding **$100 million**, and bankruptcy proceedings[389](index=389&type=chunk)[390](index=390&type=chunk) - Upon an Event of Default (excluding bankruptcy), the Trustee or holders of at least **25%** of the notes can declare all outstanding notes immediately due and payable, with automatic acceleration upon company bankruptcy[391](index=391&type=chunk)[392](index=392&type=chunk) - For a 'Reporting Event of Default,' the company can elect to pay 'Special Interest' as the sole remedy for the first **180 days**, after which acceleration becomes a possible remedy[393](index=393&type=chunk)

Financial Data and Key Metrics Changes - SKYTROFA revenue for Q1 2023 was €31.6 million, with total revenue reaching €33.6 million, including other services [18][19] - Operating loss for Q1 2023 decreased by 3% sequentially to €144 million from €147 million in Q4 2022 [19] - Cash, cash equivalents, and marketable securities totaled €586 million at the end of Q1 2023 [20] Business Line Data and Key Metrics Changes - SKYTROFA revenue is projected to reach between €150 million and €160 million for the full year 2023, based on Q1 performance and patient addition goals [13][20] - The company is on track to launch SKYTROFA in Germany in Q3 2023 and expects top-line results from the Phase 3 foresiGHt trial in adult growth hormone deficiency in Q4 2023 [21] Market Data and Key Metrics Changes - The U.S. market for growth hormone is experiencing consolidation, with daily growth hormone companies reducing investment as they phase out existing products [12][14] - The company anticipates that the current supply challenges of daily growth hormone products will further support the uptake of SKYTROFA [12] Company Strategy and Development Direction - The company is focused on executing its Vision 3x3 strategy to build a sustainable and profitable biopharma company [9] - Ascendis Pharma aims to expand its geographic and label reach for SKYTROFA while also advancing TransCon PTH and TransCon CNP in their respective markets [14][16] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the approval of TransCon PTH, citing positive clinical data and feedback from patients and physicians [9] - The company is managing its business for long-term value creation and aims to achieve cash flow break-even without additional dilutive equity financing [17][20] Other Important Information - The company is preparing for an R&D event focused on oncology in May 2023, where updates on TransCon TLR7/8 agonist and TransCon IL-2 beta/gamma will be shared [17][22] - The open-label extension of the Phase 2 path forward and Phase 3 PaTHway trials for TransCon PTH continues, with a significant number of original trial patients still on treatment [15] Q&A Session Summary Question: Can you comment on the deficiencies that the FDA has regarding the PTH NDA? - Management stated they cannot comment on the deficiencies and have no further comments [24] Question: What are your expectations for PTH that are embedded in the breakeven assumption? - Management indicated they are considering various scenarios and expect to launch SKYTROFA in Germany and TransCon PTH in early 2024 [26] Question: What changed during the quarter to make you confident in your sales guidance? - Management expressed confidence based on solid Q1 sales data and the experience with SKYTROFA, stating they are not losing patients [29] Question: How should we look at SKYTROFA growth in the U.S. versus Europe? - Management clarified that the guidance provided reflects only U.S. sales, with European sales expected to be additional [32] Question: Can you provide guidance on OpEx going forward? - Management emphasized a focus on optimizing business operations and maintaining a solid financial position without needing to increase expenses significantly [42][45] Question: What is the competitive landscape for TransCon CNP? - Management highlighted the potential for TransCon CNP to address not only linear growth but also comorbidities associated with achondroplasia [69]

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 ...

Financial Data and Key Metrics Changes - For the full year 2022, total revenue was €51.2 million, including SKYTROFA revenue of €35.7 million, with an operating loss of €147.4 million for Q4 2022, up from €144.5 million in Q3 2022 [17][18] - SKYTROFA US revenue for Q4 2022 grew to €17.1 million, exceeding previous projections of €16 million [16][17] - The company ended 2022 with cash, cash equivalents, and marketable securities totaling €743 million [17] Business Line Data and Key Metrics Changes - SKYTROFA experienced commercial success with revenue growth, providing a strong foundation for growth in 2023 [10][17] - TransCon PTH is expected to launch in the US by the end of Q2 2023, with a PDUFA date of April 30, 2023 [7][18] - TransCon CNP is on track for potential approval by 2025, with ongoing clinical trials [8][12] Market Data and Key Metrics Changes - The company is preparing for the launch of SKYTROFA in Germany and expects to expand into additional European markets [8][18] - The consolidation of the daily growth hormone market is noted, with several manufacturers exiting, which is expected to benefit SKYTROFA [10][48] Company Strategy and Development Direction - The company aims to fulfill its Vision 3x3 goal of building a sustainable, profitable biopharma company with new product approvals every one to two years [7][16] - The focus is on developing best-in-class products that address significant unmet medical needs, with a robust pipeline across multiple therapeutic areas [7][13] - The company is leveraging its existing commercial infrastructure for the launch of TransCon PTH, similar to SKYTROFA [39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in exceeding consensus estimates for SKYTROFA revenue in 2023, driven by increasing awareness and physician knowledge of the product [23][24] - The company anticipates a strong launch for TransCon PTH, with a focus on addressing the unmet medical needs of patients with hypoparathyroidism [11][37] - Management highlighted the importance of continuous monitoring and understanding of patient needs in the development of their products [53][55] Other Important Information - The company is actively engaging with regulatory agencies to ensure a broad treatment labeling for TransCon CNP [12] - Management emphasized the unique product profile of TransCon PTH, differentiating it from existing treatments like NATPARA [34][58] Q&A Session Summary Question: Can you comment on your comfort level with consensus estimates for TransCon PTH this year? - Management indicated they have not collected consensus numbers for PTH and could not address that directly [21] Question: How many cumulative new patient prescriptions were there for SKYTROFA as of your end? - Management noted an increase in new reimbursed patients and strong retention rates for SKYTROFA, expecting to exceed previous revenue estimates [23][24] Question: Can you give us an update on how many patients you've enrolled in the Early Access Program for PTH? - Management expressed satisfaction with the program's progress but did not provide specific enrollment numbers [29] Question: Could you give us any insight into what the label might ultimately look like for PTH? - Management does not expect any black box warning for TransCon PTH, emphasizing its stable physiological profile [34] Question: What feedback has your sales team received from payors and physicians regarding PTH? - Management noted increasing awareness of hypoparathyroidism and the benefits of TransCon PTH among physicians and payors [37] Question: Are you seeing higher switch rates from daily growth hormone? - Management confirmed higher switch rates from daily growth hormone and an increase in new patients [62]

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 ...