COPENHAGEN, Denmark, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Ascendis Pharma A/S (NASDAQ:ASND) today announced the formation and launch with Frazier Life Sciences of Eyconis, Inc., a separate company created to develop, manufacture, and commercialize TransCon ophthalmology assets globally, together with an investor syndicate that includes Frazier, RA Capital Management, venBio, and HealthQuest Capital. Ascendis Pharma has granted Eyconis exclusive rights to develop and commercialize TransCon ophthalmology product ...

BUCHAREST, Romania, Jan. 09, 2024 (GLOBE NEWSWIRE) -- Er-Kim, an international pharmaceutical company specializing in the commercialization of novel therapies, today announced it has entered into an exclusive distribution agreement with Danish Company Ascendis Pharma A/S (NASDAQ:ASND) for its endocrinology portfolio. Under the agreement, Er-Kim is appointed as the exclusive Ascendis A/S endocrinology distributor in Albania, Bosnia and Herzegovina, Bulgaria, Croatia, Cyprus, Czechia, Estonia, Greece, Hungary ...

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]

FORM 6-K Filing Information Ascendis Pharma A/S filed Form 6-K for April 2023, detailing its incorporation by reference and the included interim financial statements [Filing Details and Incorporation by Reference](index=1&type=section&id=Filing%20Details%20and%20Incorporation%20by%20Reference) Ascendis Pharma A/S filed Form 6-K for April 2023, incorporated by reference into Form S-8 and F-3 registration statements, and files annual reports under Form 20-F - Ascendis Pharma A/S filed **Form 6-K** for April 2023, indicating it files annual reports under **Form 20-F**[1](index=1&type=chunk) - This **Form 6-K** report is incorporated by reference into the Company's registration statements on **Form S-8** and **Form F-3**[2](index=2&type=chunk) [Report Content and Signatures](index=2&type=section&id=Report%20Content%20and%20Signatures) The Form 6-K contains the Company's Unaudited Condensed Consolidated Interim Financial Statements and Management's Discussion and Analysis for the period ended March 31, 2023, and was signed on April 27, 2023 - The report includes Unaudited Condensed Consolidated Interim Financial Statements and Management's Discussion and Analysis of Financial Condition and Results of Operations for the period ended **March 31, 2023**[3](index=3&type=chunk) - The report was signed on **April 27, 2023**, by Michael Wolff Jensen, Executive Vice President, Chief Legal Officer[5](index=5&type=chunk) Unaudited Condensed Consolidated Interim Financial Statements This section presents Ascendis Pharma A/S's unaudited condensed consolidated interim financial statements, including statements of profit or loss, financial position, changes in equity, cash flows, and accompanying notes [Index to Unaudited Condensed Consolidated Interim Financial Statements](index=5&type=section&id=Index%20to%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section provides an index to the unaudited condensed consolidated interim financial statements, including statements of profit or loss, financial position, changes in equity, cash flows, and accompanying notes - The index lists the Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (Loss), Statements of Financial Position, Statements of Changes in Equity, Cash Flow Statements, and Notes to the Financial Statements[8](index=8&type=chunk) [Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Comprehensive Income / (Loss)](index=6&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Profit%20or%20Loss%20and%20Comprehensive%20Income%20%2F%20%28Loss%29) For **Q1 2023**, Ascendis Pharma A/S reported a net loss of **€110.9 million**, an improvement from **€125.5 million** in **Q1 2022**, driven by increased revenue and finance income despite higher operating expenses Consolidated Statement of Profit or Loss (Three Months Ended March 31, 2023 vs. 2022) | Metric | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | Revenue | 33,589 | 6,828 | | Cost of sales | 4,621 | 4,246 | | Gross profit | 28,968 | 2,582 | | Research and development costs | 106,114 | 83,193 | | Selling, general and administrative expenses | 66,539 | 47,418 | | Operating profit / (loss) | (143,685) | (128,029) | | Share of profit / (loss) of associate | (1,227) | (4,873) | | Finance income | 45,135 | 13,044 | | Finance expenses | 9,840 | 5,399 | | Profit / (loss) before tax | (109,617) | (125,257) | | Income taxes (expenses) | (1,297) | (241) | | Net profit / (loss) for the period | (110,914) | (125,498) | | Basic and diluted earnings / (loss) per share | € (1.98) | € (2.21) | - Total comprehensive income / (loss) for the period, net of tax, was **€(111.7) million** for **Q1 2023**, compared to **€(125.1) million** for **Q1 2022**[12](index=12&type=chunk) [Unaudited Condensed Consolidated Interim Statements of Financial Position](index=7&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Financial%20Position) As of **March 31, 2023**, total assets decreased to **€966.3 million** from **€1,089.7 million** at **December 31, 2022**, primarily due to reduced marketable securities, with total equity also decreasing to **€167.2 million** Consolidated Statement of Financial Position (March 31, 2023 vs. December 31, 2022) | Metric | March 31, 2023 (EUR'000) | December 31, 2022 (EUR'000) | | :------------------------------------ | :----------------------- | :-------------------------- | | Total assets | 966,274 | 1,089,738 | | Total equity | 167,201 | 263,348 | | Total liabilities | 799,073 | 826,390 | | Non-current assets | 156,429 | 166,267 | | Current assets | 809,845 | 923,471 | | Non-current liabilities | 600,712 | 655,119 | | Current liabilities | 198,361 | 171,271 | - Marketable securities decreased significantly from **€298.2 million** at **December 31, 2022**, to **€84.5 million** at **March 31, 2023**[14](index=14&type=chunk) - Cash and cash equivalents increased from **€444.8 million** at **December 31, 2022**, to **€501.3 million** at **March 31, 2023**[14](index=14&type=chunk) [Unaudited Condensed Consolidated Interim Statements of Changes in Equity](index=8&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Statements%20of%20Changes%20in%20Equity) Total equity decreased from **€263.3 million** at **January 1, 2023**, to **€167.2 million** at **March 31, 2023**, primarily due to a **€110.9 million** net loss, partially offset by share-based payments and capital increase Consolidated Statement of Changes in Equity (Three Months Ended March 31, 2023 vs. 2022) | Metric | Equity at Jan 1, 2023 (EUR'000) | Equity at Mar 31, 2023 (EUR'000) | | :------------------------------------ | :------------------------------ | :------------------------------- | | Total Equity | 263,348 | 167,201 | | Net profit / (loss) for the period | N/A | (110,914) | | Share-based payment | N/A | 13,688 | | Capital increase | N/A | 1,866 | | Equity at Jan 1, 2022 (EUR'000) | 883,635 | N/A | | Equity at Mar 31, 2022 (EUR'000) | N/A | 672,816 | - Total comprehensive income / (loss) for **Q1 2023** was **€(111.7) million**, compared to **€(125.1) million** for **Q1 2022**[16](index=16&type=chunk) [Unaudited Condensed Consolidated Interim Cash Flow Statements](index=9&type=section&id=Unaudited%20Condensed%20Consolidated%20Interim%20Cash%20Flow%20Statements) Cash and cash equivalents increased by **€62.9 million** in **Q1 2023**, driven by **€210.6 million** from investing activities offsetting **€147.0 million** used in operating activities, contrasting with **Q1 2022**'s larger increase from financing activities Consolidated Cash Flow Summary (Three Months Ended March 31, 2023 vs. 2022) | Cash Flow Activity | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | Operating activities | (147,044) | (130,788) | | Investing activities | 210,646 | 38,542 | | Financing activities | (702) | 397,735 | | Net increase / (decrease) in cash and cash equivalents | 62,900 | 305,489 | | Cash and cash equivalents at March 31 | 501,281 | 755,643 | - Cash flows from investing activities increased significantly by **€172.1 million**, primarily due to net settlements of marketable securities[19](index=19&type=chunk)[136](index=136&type=chunk) - Cash flows from financing activities decreased by **€398.4 million**, mainly due to the convertible notes issuance and treasury share acquisition in **Q1 2022** not recurring in **Q1 2023**[19](index=19&type=chunk)[137](index=137&type=chunk) [Notes to the Unaudited Condensed Consolidated Interim Financial Statements](index=10&type=section&id=Notes%20to%20the%20Unaudited%20Condensed%20Consolidated%20Interim%20Financial%20Statements) This section provides detailed notes to the unaudited condensed consolidated interim financial statements, covering accounting policies, significant events, revenue, and financial instruments [Note 1—General Information](index=10&type=section&id=Note%201%E2%80%94General%20Information) Ascendis Pharma A/S, incorporated in **2006** and headquartered in Denmark, is a global biopharma company utilizing its **TransCon technologies**, with **ADSs** listed on **Nasdaq** under **"ASND"** since **2015** - Ascendis Pharma A/S was incorporated in **2006**, is headquartered in Hellerup, Denmark, and applies its **TransCon technologies** to build a leading, fully integrated, global biopharma company[21](index=21&type=chunk) - The Company's American Depositary Shares (**ADSs**) have been listed on The **Nasdaq Global Select Market** under the symbol **"ASND"** since **February 2, 2015**[21](index=21&type=chunk) [Note 2—Summary of Significant Accounting Policies](index=10&type=section&id=Note%202%E2%80%94Summary%20of%20Significant%20Accounting%20Policies) Interim financial statements are prepared under **IAS 34** consistent with prior year **IFRS** policies, with **IAS 1** amendments expected to reclassify **€399.9 million** convertible notes and **€116.8 million** derivative liabilities to current in **2024** - The unaudited condensed consolidated interim financial statements are prepared in accordance with International Accounting Standard 34, "**Interim Financial Reporting**," and should be read in conjunction with the **2022** audited annual consolidated financial statements prepared under **IFRS**[23](index=23&type=chunk) - The accounting policies applied are consistent with those of the previous financial year[24](index=24&type=chunk) - Amendments to **IAS 1**, effective **January 1, 2024**, are expected to reclassify convertible notes (**€399.9 million**) and derivative liabilities (**€116.8 million**) from non-current to current liabilities[25](index=25&type=chunk)[26](index=26&type=chunk) [Note 3—Significant Accounting Judgements and Estimates](index=12&type=section&id=Note%203%E2%80%94Significant%20Accounting%20Judgements%20and%20Estimates) Management's ongoing revisions of critical accounting estimates have not revealed any material impact, and no changes to significant accounting judgments or estimation uncertainties have occurred since **December 31, 2022** - Management's ongoing revisions of critical accounting estimates and underlying assumptions have not revealed any material impact in any of the periods presented[28](index=28&type=chunk) - There have been no other changes to the application of significant accounting judgments or estimation uncertainties compared to **December 31, 2022**[28](index=28&type=chunk) [Note 4—Significant Events in the Reporting Period](index=12&type=section&id=Note%204%E2%80%94Significant%20Events%20in%20the%20Reporting%20Period) The company assessed the impact of the global banking situation (**SVB** closure), the Ukraine/Russia conflict, and the **COVID-19** pandemic, none of which had a direct material impact on the financial statements - The Company did not hold deposits or securities at **Silicon Valley Bank (SVB)** and an assessment of the global banking situation did not reveal a material impairment loss[29](index=29&type=chunk) - The ongoing conflict in the region surrounding Ukraine and Russia did not have a direct material impact on the financial statements, though it impacted clinical trial activities[30](index=30&type=chunk) - The **COVID-19** pandemic did not have a direct material impact on the unaudited condensed consolidated interim financial statements[31](index=31&type=chunk) [Note 5—Revenue](index=13&type=section&id=Note%205%E2%80%94Revenue) Total revenue for **Q1 2023** significantly increased to **€33.6 million** from **€6.8 million** in **Q1 2022**, primarily driven by **€31.6 million** in commercial product sales, with North America contributing the majority Revenue from External Customers (Three Months Ended March 31, 2023 vs. 2022) | Revenue Category | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | Commercial sale of products | 31,551 | 1,888 | | Rendering of services | 1,170 | 372 | | Sale of clinical supply | 254 | 3,936 | | Licenses | 614 | 632 | | **Total revenue from external customers** | **33,589** | **6,828** | Revenue by Geographical Location (Three Months Ended March 31, 2023 vs. 2022) | Geographical Location | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | Europe | — | 135 | | North America | 33,070 | 6,456 | | China | 519 | 237 | [Note 6—Segment Information](index=13&type=section&id=Note%206%E2%80%94Segment%20Information) The Company is managed and operated as a single business unit, and therefore no separate business or geographical segment information is disclosed - The Company is managed and operated as one business unit, with no separate business areas or geographical units identified[33](index=33&type=chunk) [Note 7—Share-based Payment](index=13&type=section&id=Note%207%E2%80%94Share-based%20Payment) Ascendis Pharma A/S operates warrant, **RSU**, and **PSU** programs, with share-based compensation costs at **€13.7 million** in **Q1 2023**, down from **€20.0 million** in **Q1 2022**, despite increased **RSU** and **PSU** grants - Share-based compensation costs recognized were **€13.7 million** for **Q1 2023**, compared to **€20.0 million** for **Q1 2022**[35](index=35&type=chunk) RSU and PSU Activity (March 31, 2023) | Metric | Restricted Stock Units (Number) | Performance Stock Units (Number) | Total (Number) | | :------------------------------------ | :------------------------------ | :------------------------------- | :------------- | | Outstanding January 1, 2023 | 82,492 | — | 82,492 | | Granted during the period | 609,695 | 112,268 | 721,963 | | Forfeited during the period | (10,494) | — | (10,494) | | Outstanding March 31, 2023 | 681,693 | 112,268 | 793,961 | Warrant Activity (Three Months Ended March 31, 2023) | Metric | Total Warrants (Number) | Weighted Average Exercise Price (EUR) | | :------------------------------------ | :---------------------- | :------------------------------------ | | Outstanding January 1, 2023 | 6,864,011 | 81.30 | | Granted during the period | 113,585 | 103.60 | | Exercised during the period | (176,253) | 10.40 | | Forfeited during the period | (40,047) | 118.69 | | Outstanding March 31, 2023 | 6,761,296 | 83.30 | | Vested at March 31, 2023 | 5,013,862 | 70.58 | [Note 8—Share Capital](index=15&type=section&id=Note%208%E2%80%94Share%20Capital) As of **March 31, 2023**, the Company's share capital consists of **57,328,548** fully paid ordinary shares, each with a nominal value of **DKK 1** - The share capital consists of **57,328,548** fully paid ordinary shares, all in the same share class, with a nominal value of **DKK 1** each[46](index=46&type=chunk) [Note 9—Treasury Shares](index=15&type=section&id=Note%209%E2%80%94Treasury%20Shares) The Company held **1,113,152** treasury shares as of **March 31, 2023**, representing **1.9%** of total outstanding shares, unchanged from **January 1, 2023** Treasury Shares Holding (March 31, 2023 vs. January 1, 2023) | Metric | Nominal values (EUR'000) | Holding (Number) | Holding in % of total outstanding shares | | :------------------------------------ | :----------------------- | :----------------- | :--------------------------------------- | | January 1, 2023 | 149 | 1,113,152 | 2.0 % | | March 31, 2023 | 149 | 1,113,152 | 1.9% | [Note 10—Financial Assets and Liabilities](index=16&type=section&id=Note%2010%E2%80%94Financial%20Assets%20and%20Liabilities) Total financial assets decreased to **€610.3 million** at **March 31, 2023**, from **€758.7 million** at **December 31, 2022**, mainly due to reduced marketable securities, while financial liabilities decreased to **€753.6 million** with lower derivative liabilities Financial Assets by Category (March 31, 2023 vs. December 31, 2022) | Financial Asset Category | March 31, 2023 (EUR'000) | December 31, 2022 (EUR'000) | | :------------------------------------ | :----------------------- | :-------------------------- | | Trade receivables | 16,121 | 11,910 | | Other receivables | 8,464 | 3,884 | | Marketable securities | 84,460 | 298,180 | | Cash and cash equivalents | 501,281 | 444,767 | | **Total financial assets** | **610,326** | **758,741** | Financial Liabilities by Category (March 31, 2023 vs. December 31, 2022) | Financial Liability Category | March 31, 2023 (EUR'000) | December 31, 2022 (EUR'000) | | :------------------------------------ | :----------------------- | :-------------------------- | | Convertible senior notes | 399,880 | 399,186 | | Lease liabilities | 105,501 | 109,191 | | Trade payables and accrued expenses | 131,438 | 101,032 | | Derivative liabilities | 116,768 | 157,950 | | **Total financial liabilities** | **753,587** | **767,359** | Marketable Securities Composition (March 31, 2023 vs. December 31, 2022) | Security Type | March 31, 2023 (EUR'000) | December 31, 2022 (EUR'000) | | :------------------------------------ | :----------------------- | :-------------------------- | | U.S. Treasury bills | — | 79,086 | | U.S. Government bonds | 42,955 | 99,337 | | Corporate bonds | 36,907 | 104,236 | | Agency bonds | 4,598 | 15,521 | | **Total marketable securities** | **84,460** | **298,180** | - The convertible senior notes had a carrying amount of **€399.9 million** and a fair value of approximately **€388.0 million** as of **March 31, 2023**[56](index=56&type=chunk) - Derivative liabilities, related to the foreign currency conversion option embedded in the convertible notes, decreased by **€41.182 million** from **January 1** to **March 31, 2023**, to **€116.768 million**[57](index=57&type=chunk)[61](index=61&type=chunk) - A **10%** relative increase in volatility would increase the fair value of derivative liabilities by approximately **€14.0 million**, while a **10%** increase in the share price would increase them by approximately **€21.8 million**, both indicating a decrease in profit or loss and equity before tax[58](index=58&type=chunk) [Note 11—Subsequent Events](index=19&type=section&id=Note%2011%E2%80%94Subsequent%20Events) No events have occurred after the reporting date that would influence the evaluation of these unaudited condensed consolidated interim financial statements - No events have occurred after the reporting date that would influence the evaluation of these unaudited condensed consolidated interim financial statements[64](index=64&type=chunk) Management's Discussion and Analysis of Financial Condition and Results of Operations This section provides management's discussion and analysis of financial condition and results of operations, including company overview, product development, financial performance, and market risk disclosures [Introduction and Forward-Looking Statements](index=20&type=section&id=Introduction%20and%20Forward-Looking%20Statements) This section provides management's discussion and analysis of financial condition and results of operations, prepared in accordance with **IAS 34**, including a special note on forward-looking statements and potential risks - The discussion and analysis are based on financial information prepared in accordance with International Accounting Standard 34, "**Interim Financial Reporting**"[65](index=65&type=chunk) - Forward-looking statements cover regulatory approvals, commercialization, **R&D**, pipeline expansion, market opportunities, intellectual property, financial performance, and external factors[66](index=66&type=chunk)[67](index=67&type=chunk) - Actual results may differ materially from current expectations due to known and unknown risks, uncertainties, and other factors, including those listed in the Annual Report on **Form 20-F**[68](index=68&type=chunk) [Company Overview and Strategy](index=22&type=section&id=Overview) Ascendis Pharma A/S is a global biopharma company leveraging its **TransCon technology** platform to develop best-in-class therapies across **Endocrinology Rare Diseases**, **Oncology**, and **Ophthalmology**, guided by its **Vision 3x3** strategic roadmap - Ascendis Pharma A/S is building a leading, fully integrated, global biopharma company using its innovative **TransCon technology** platform to create new and potentially best-in-class therapies[71](index=71&type=chunk) - The **Vision 3x3** strategic roadmap through **2025** includes obtaining regulatory approval for three independent **Endocrinology Rare Disease** products, growing the pipeline, establishing a global commercial presence, advancing an oncology pipeline, and creating a third independent therapeutic area (**Ophthalmology**)[72](index=72&type=chunk) - The company's algorithm for product innovation focuses on identifying indications with unmet medical needs, clinically validated parent drugs/pathways, suitability to **TransCon technologies**, potential for differentiation, established development pathways, and large market potential[74](index=74&type=chunk) - The **TransCon technology** platform is designed to combine the benefits of conventional prodrug and sustained release technologies to extend drug action, aiming for improved efficacy, safety, tolerability, and convenience[79](index=79&type=chunk) [TransCon Product Development](index=25&type=section&id=TransCon%20Product%20Development) Ascendis Pharma is advancing its pipeline across **Endocrinology Rare Diseases**, **Oncology**, and **Ophthalmology**, with **SKYTROFA** approved, **TransCon PTH** facing FDA deficiencies but progressing in EU, positive Phase 2 results for **TransCon CNP**, and new oncology and ophthalmology candidates in development [Endocrinology Rare Diseases](index=25&type=section&id=TransCon%20Products%20%E2%80%93%20Endocrinology%20Rare%20Diseases) **SKYTROFA** is approved in the U.S. and EU, **TransCon PTH** faces FDA deficiencies but anticipates an EMA decision in **Q4 2023**, and **TransCon CNP** showed positive Phase 2 results for achondroplasia - **SKYTROFA (TransCon hGH)** is FDA approved (**August 2021**) for pediatric GHD and received EC marketing authorization (**January 2022**); a commercial launch in Germany is planned for **Q3 2023**[81](index=81&type=chunk)[82](index=82&type=chunk) - The FDA identified deficiencies in the **TransCon PTH** NDA for hypoparathyroidism, which may delay the final regulatory decision, while an EMA decision on the MAA is anticipated in **Q4 2023** with a planned Germany launch in **early 2024** if approved[86](index=86&type=chunk)[87](index=87&type=chunk) - The Phase 3 PaTHway Japan Trial for **TransCon PTH** met its primary objective, with **12 out of 13 patients** achieving normal serum calcium levels and independence from conventional therapy[88](index=88&type=chunk) - The ACcomplisH Phase 2 trial for **TransCon CNP** in achondroplasia met its primary efficacy endpoint, demonstrating a consistent dose-dependent increase in annualized height velocity (AHV) at **100 µg/kg/week** (p=0.0218) and was generally well tolerated[96](index=96&type=chunk)[97](index=97&type=chunk) [Oncology](index=29&type=section&id=TransCon%20Product%20Candidates%E2%80%94Oncology) Ascendis Pharma is developing **TransCon TLR7/8 Agonist** and **TransCon IL-2 ß/g** in **Oncology**, with the former's Phase 2 dose declared and initial monotherapy data for the latter expected in **Q2 2023** - **TransCon TLR7/8 Agonist**, an investigational long-acting prodrug of resiquimod, is in a Phase 1/2 clinical trial (transcendIT-101), with the recommended Phase 2 dose declared at **0.5 mg/lesion** for up to two lesions[101](index=101&type=chunk)[102](index=102&type=chunk) - **TransCon IL-2 ß/g**, an investigational long-acting prodrug, is in a Phase 1/2 clinical trial (IL-Believe), with initial monotherapy dose escalation data expected in **Q2 2023** and combination therapy data in **Q3 2023**[103](index=103&type=chunk)[104](index=104&type=chunk) - The Company plans to evaluate the clinical activity of a combination of **TransCon TLR7/8 Agonist** and **TransCon IL-2 ß/g** in **2023**[105](index=105&type=chunk) [Ophthalmology](index=30&type=section&id=TransCon%20Product%20Candidates%E2%80%94Ophthalmology) **Ophthalmology** is the third therapeutic area, targeting a **€10 billion+** market with **TransCon Hydrogel** platform for sustained drug release, and **TransCon RBZ** as the lead candidate for conditions like wet AMD - **Ophthalmology** was announced as the third independent therapeutic area in **January 2023**, targeting vision loss caused by abnormal blood vessel growth and/or fluid build-up[76](index=76&type=chunk) - The global market for ophthalmology treatments exceeds **€10 billion**, with a key unmet medical need to extend the duration of therapeutic effect and reduce treatment frequency for conditions like **wet AMD**[108](index=108&type=chunk) - The **TransCon Hydrogel** platform is designed to provide sustained local drug release over at least **six months**, supporting twice-yearly administration to potentially increase patient adherence[109](index=109&type=chunk) - **TransCon RBZ (ranibizumab)** has been selected as the lead pipeline candidate, leveraging ranibizumab as a clinically validated parent drug[110](index=110&type=chunk) [Results of Operations](index=31&type=section&id=Results%20of%20Operations) Ascendis Pharma reported a net loss of **€110.9 million** for **Q1 2023**, an improvement from **€125.5 million** in **Q1 2022**, driven by increased revenue and finance income despite higher operating expenses [Net Profit / (Loss)](index=31&type=section&id=Net%20Profit%20%2F%20%28Loss%29%20for%20the%20period) The Company reported a net loss of **€110.9 million** for the three months ended **March 31, 2023**, an improvement from a net loss of **€125.5 million** for the same period last year - Net loss for **Q1 2023** was **€110.9 million**, an improvement from **€125.5 million** in **Q1 2022**[112](index=112&type=chunk) [Revenue Analysis](index=31&type=section&id=Revenue) Revenue for **Q1 2023** significantly increased to **€33.6 million** from **€6.8 million** in **Q1 2022**, primarily driven by **€31.6 million** in commercial product sales - Revenue for **Q1 2023** was **€33.6 million**, an increase of **€26.8 million** compared to **Q1 2022**, primarily driven by higher commercial sale of products and rendering of services[113](index=113&type=chunk) Quarterly Commercial Product Sales (2022-2023) | Quarter | March 31, 2022 | June 30, 2022 | September 30, 2022 | December 31, 2022 | March 31, 2023 | | :------------------------------------ | :------------- | :------------ | :----------------- | :---------------- | :------------- | | Sale of commercial products (EUR'000) | 1,888 | 4,435 | 12,252 | 17,084 | 31,551 | [Cost of Sales](index=31&type=section&id=Cost%20of%20Sales) Cost of sales increased by **€0.4 million** to **€4.6 million** in **Q1 2023**, primarily due to higher costs from increased commercial revenue, partially offset by lower clinical supply costs - Cost of sales for **Q1 2023** was **€4.6 million**, an increase of **€0.4 million** compared to **Q1 2022**, primarily due to higher costs from increased commercial revenue[115](index=115&type=chunk) [Research and Development Costs](index=32&type=section&id=Research%20and%20Development%20Costs) **R&D** costs increased by **€22.9 million** to **€106.1 million** in **Q1 2023**, mainly due to higher development costs for oncology programs and increased employee-related expenses - **R&D** costs for **Q1 2023** were **€106.1 million**, an increase of **€22.9 million** compared to **Q1 2022**[119](index=119&type=chunk) - The increase was primarily due to higher development costs for oncology programs (**TransCon IL-2 ß/g** and **TransCon TLR7/8**) and higher employee and other costs attributable to organizational growth[119](index=119&type=chunk) External Project R&D Costs (Three Months Ended March 31, 2023 vs. 2022) | Project | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | TransCon hGH | 18,010 | 19,939 | | TransCon PTH | 12,514 | 11,686 | | TransCon CNP | 10,945 | 9,555 | | TransCon IL-2 ß/γ | 10,135 | 1,446 | | TransCon TLR7/8 | 8,492 | 2,137 | | Other project costs | 3,288 | 602 | | **Total external project costs** | **63,384** | **45,365** | [Selling, General and Administrative Expenses](index=32&type=section&id=Selling%20General%20and%20Administrative%20Expenses) **SG&A** expenses increased by **€19.1 million** to **€66.5 million** in **Q1 2023**, driven by higher commercial expenses for **SKYTROFA** and **TransCon PTH** pre-launch activities, and increased employee costs - **SG&A** expenses for **Q1 2023** were **€66.5 million**, an increase of **€19.1 million** compared to **Q1 2022**[120](index=120&type=chunk) - The increase was primarily due to higher external commercial expenses related to **SKYTROFA** and **TransCon PTH** pre-launch activities (**€8.6 million**), higher employee-related expenses (**€4.4 million**), and an increase in other general and administrative expenses (**€5.8 million**)[120](index=120&type=chunk) [Net Profit / (Loss) of Associate](index=32&type=section&id=Net%20Profit%20%2F%20%28Loss%29%20of%20Associate) Net loss of associate decreased by **€3.6 million** to **€1.2 million** in **Q1 2023**, reflecting a smaller share of loss in **VISEN** - Net loss of associate for **Q1 2023** was **€1.2 million**, a decrease of **€3.6 million** compared to **Q1 2022**, reflecting the Company's share of loss in **VISEN**[121](index=121&type=chunk) [Finance Income and Expenses](index=32&type=section&id=Finance%20Income%20and%20Finance%20Expenses) Finance income increased by **€32.1 million** to **€45.1 million** in **Q1 2023** due to higher remeasurement gain on derivative liabilities, while finance expenses rose by **€4.4 million** to **€9.8 million** - Finance income for **Q1 2023** was **€45.1 million**, an increase of **€32.1 million**, primarily due to a **€40.1 million** higher remeasurement gain on derivative liabilities[122](index=122&type=chunk) - Finance expenses for **Q1 2023** were **€9.8 million**, an increase of **€4.4 million**, primarily due to **€8.2 million** higher interest and amortization charges on convertible notes[122](index=122&type=chunk) [Impact from COVID-19 Pandemic](index=33&type=section&id=Impact%20from%20COVID-19%20Pandemic) Ascendis Pharma has avoided significant disruptions to clinical and manufacturing activities from the **COVID-19** pandemic, though its future impact remains highly uncertain - The Company has managed to avoid significant disruptions to its clinical and manufacturing operations despite the **COVID-19** pandemic[124](index=124&type=chunk) - The future impact from **COVID-19**, including the magnitude on operational results, remains highly uncertain and unpredictable[124](index=124&type=chunk) [Liquidity and Capital Resources](index=34&type=section&id=Liquidity%20and%20Capital%20Resources) As of **March 31, 2023**, total liquidity and capital resources were **€585.7 million**, deemed sufficient for the next twelve months, with investing cash flows increasing and financing activities decreasing year-over-year Liquidity and Capital Resources (March 31, 2023) | Metric | Carrying amount (EUR'000) | Fair value (EUR'000) | | :------------------------------------ | :------------------------ | :------------------- | | Marketable securities | 84,460 | 83,525 | | Cash and cash equivalents | 501,281 | 501,281 | | **Total liquidity and capital resources** | **585,741** | **584,806** | - The Company believes its existing capital resources as of **March 31, 2023**, will be sufficient to meet projected cash requirements for at least twelve months[129](index=129&type=chunk) - Historically, operations have been funded primarily through issuance of preference shares, ordinary shares (including IPO and follow-on offerings), exercise of warrants, convertible debt securities, and collaboration agreements[129](index=129&type=chunk) Cash Flow Summary (Three Months Ended March 31, 2023 vs. 2022) | Cash Flow Activity | 2023 (EUR'000) | 2022 (EUR'000) | | :------------------------------------ | :------------- | :------------- | | Operating activities | (147,044) | (130,788) | | Investing activities | 210,646 | 38,542 | | Financing activities | (702) | 397,735 | | Net increase / (decrease) in cash and cash equivalents | 62,900 | 305,489 | - Cash flows from investing activities increased by **€172.1 million**, primarily attributable to net settlements of marketable securities[133](index=133&type=chunk)[136](index=136&type=chunk) - Cash flows used in financing activities decreased by **€398.4 million**, primarily due to the convertible notes issuance and acquisition of treasury shares completed in **Q1 2022** not recurring[133](index=133&type=chunk)[137](index=137&type=chunk) [Off-balance Sheet Arrangements](index=36&type=section&id=Off-balance%20Sheet%20Arrangements) Ascendis Pharma A/S has not entered into any off-balance sheet arrangements or holdings in variable interest entities - The Company has not entered into any off-balance sheet arrangements or any holdings in variable interest entities[138](index=138&type=chunk) [Qualitative Disclosures about Market Risk](index=36&type=section&id=Qualitative%20Disclosures%20about%20Market%20Risk) The company faces financial risks from foreign currency, interest rates, and equity price changes, managing liquidity and credit risk through policies, with equity risk impacting derivative liabilities [Foreign Currency Risk](index=36&type=section&id=Foreign%20Currency%20Risk) The Company is exposed to foreign exchange risk, primarily with respect to the **U.S. Dollar**, **Swiss Franc**, and **British Pound**, mitigated by maintaining cash positions in expected expense currencies - The Company is exposed to foreign exchange risk, primarily with respect to the **U.S. Dollar**, the **Swiss Franc**, and the **British Pound**[140](index=140&type=chunk) - Foreign currency risk is minimized by maintaining cash positions in the currencies in which the majority of future expenses are expected to be incurred[140](index=140&type=chunk) [Interest Rate Risk](index=36&type=section&id=Interest%20Rate%20Risk) The Company's convertible notes and lease liabilities have fixed interest rates, but future interest income and derivative liabilities' fair value are exposed to interest rate changes - Outstanding convertible notes have a fixed rate of **2.25%**, and interest rates on lease liabilities are fixed at commencement[141](index=141&type=chunk) - Future interest income from interest-bearing bank deposits and marketable securities may fall short of expectations due to changes in interest rates[141](index=141&type=chunk) - The fair value of derivative liabilities is exposed to volatility from changes in interest rates, impacting profit or loss[141](index=141&type=chunk) [Inflation Risk](index=36&type=section&id=Inflation%20Risk) Inflation could increase **R&D**, **SG&A**, and manufacturing costs, but did not have a material impact on the Company's results of operations for the three months ended **March 31, 2023** - Inflation may increase **R&D** costs, **SG&A** expenses, and manufacturing costs as vendors pass on increased costs[142](index=142&type=chunk) - Inflation did not have a material impact on the Company's results of operation for the three months ended **March 31, 2023**[142](index=142&type=chunk) [Credit Risk](index=37&type=section&id=Credit%20Risk) The Company's investment policy requires high credit-ratings for counterparties and marketable securities, resulting in low credit risk and no material impairment loss recognized - The investment policy establishes minimum ratings for institutions and concentration limits for marketable securities, with all material counterparties considered creditworthy[144](index=144&type=chunk) - Credit risk on bank deposits is limited as counterparties holding significant deposits are banks with high credit-ratings (minimum **A2/A-**)[144](index=144&type=chunk) - No material impairment loss for expected credit loss on bank deposits and marketable securities was recognized for the period[146](index=146&type=chunk) [Equity Risk](index=37&type=section&id=Equity%20Risk) The Company is exposed to equity risk from its share price development, which impacts the fair value remeasurement of derivative liabilities calculated using the **Black-Scholes** option pricing model - The Company is exposed to equity risk from the development in its share price, which affects the fair value remeasurement of derivative liabilities[147](index=147&type=chunk) - Derivative liabilities are measured at fair value using the **Black-Scholes option pricing model**, where pricing is exposed to changes in the Company's share price[147](index=147&type=chunk)