Cover Page
Cover Page | 9 Months Ended |
Sep. 30, 2021 | |
Cover [Abstract] | |
Document Type | 6-K |
Amendment Flag | false |
Document Period End Date | Sep. 30, 2021 |
Document Fiscal Year Focus | 2021 |
Document Fiscal Period Focus | Q3 |
Entity Registrant Name | Ascendis Pharma A/S |
Entity Central Index Key | 0001612042 |
Current Fiscal Year End Date | --12-31 |
Condensed Consolidated Interim
Condensed Consolidated Interim Statements of Profit or Loss and Comprehensive Income / (Loss) - EUR (€) € in Thousands | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | ||
Profit or loss [abstract] | |||||
Revenue | € 1,113 | € 2,757 | € 2,881 | € 6,418 | |
Research and development costs | (58,761) | (64,059) | (230,216) | (185,152) | |
Selling, general and administrative expenses | (39,284) | (17,523) | (111,876) | (56,243) | |
Operating profit / (loss) | (96,932) | (78,825) | (339,211) | (234,977) | |
Share of profit / (loss) of associate | (3,855) | (3,101) | 19,434 | (6,501) | |
Finance income | 21,321 | 136 | 44,589 | 1,677 | |
Finance expenses | (877) | (39,970) | (2,580) | (40,391) | |
Profit / (loss) before tax | (80,343) | (121,760) | (277,768) | (280,192) | |
Tax on profit / (loss) for the period | (5) | 19 | 253 | 202 | |
Net profit / (loss) for the period | (80,348) | (121,741) | (277,515) | (279,990) | |
Attributable to owners of the Company | € (80,348) | € (121,741) | € (277,515) | € (279,990) | |
Basic and diluted earnings / (loss) per share | € (1.47) | € (2.31) | € (5.13) | € (5.64) | |
Number of shares used for calculation (basic and diluted) | [1] | 54,639,597 | 52,715,204 | 54,085,793 | 49,647,471 |
Consolidated Interim Statement of Comprehensive Income | |||||
Net profit / (loss) for the period | € (80,348) | € (121,741) | € (277,515) | € (279,990) | |
Other comprehensive income / (loss) | |||||
Exchange differences on translating foreign operations | 1,016 | (75) | 2,781 | (136) | |
Other comprehensive income / (loss) for the period, net of tax | 1,016 | (75) | 2,781 | (136) | |
Total comprehensive income / (loss) | (79,332) | (121,816) | (274,734) | (280,126) | |
Attributable to owners of the Company | € (79,332) | € (121,816) | € (274,734) | € (280,126) | |
[1] | A total of 6,046,356 warrants outstanding as of September 30, 2021 can potentially dilute earnings per share in the future but have not been included in the calculation of diluted earnings per share because they are antidilutive for the periods presented. Similarly, a total of 5,527,218 warrants outstanding as of September 30, 2020 are also considered antidilutive for the periods presented and have not been included in the calculation. |
Condensed Consolidated Interi_2
Condensed Consolidated Interim Statements of Profit or Loss and Comprehensive Income / (Loss) (Parenthetical) - shares | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Warrants [member] | ||
Statement [LineItems] | ||
Warrants outstanding | 6,046,356 | 5,527,218 |
Condensed Consolidated Interi_3
Condensed Consolidated Interim Statements of Financial Position - EUR (€) € in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Non-current assets | ||
Intangible assets | € 5,384 | € 5,717 |
Property, plant and equipment | 126,295 | 108,112 |
Investment in associate | 43,639 | 9,176 |
Deposits | 1,713 | 1,375 |
Marketable securities | 71,614 | 115,280 |
Total non-current assets | 248,645 | 239,660 |
Current assets | ||
Inventories | 55,270 | 0 |
Trade receivables | 533 | 387 |
Other receivables | 20,258 | 6,957 |
Prepayments | 22,239 | 13,994 |
Marketable securities | 165,347 | 134,278 |
Cash and cash equivalents | 692,941 | 584,517 |
Total current assets | 956,588 | 740,133 |
Total assets | 1,205,233 | 979,793 |
Equity | ||
Share capital | 7,638 | 7,217 |
Distributable equity | 985,924 | 831,494 |
Total equity | 993,562 | 838,711 |
Non-current liabilities | ||
Lease liabilities | 95,553 | 85,116 |
Other payables | 0 | 3,162 |
Total non-current liabilities | 95,553 | 88,278 |
Current liabilities | ||
Lease liabilities | 6,748 | 6,859 |
Contract liabilities | 36 | 363 |
Trade payables and accrued expenses | 76,471 | 21,897 |
Other payables | 32,362 | 23,384 |
Income taxes payable | 501 | 301 |
Total current liabilities | 116,118 | 52,804 |
Total liabilities | 211,671 | 141,082 |
Total equity and liabilities | € 1,205,233 | € 979,793 |
Condensed Consolidated Interi_4
Condensed Consolidated Interim Statements of Changes in Equity - EUR (€) € in Thousands | Total | Issued Capital [member] | Share Premium [member] | Foreign Currency Translation Reserve [member] | Share-based Payment Reserve [member] | Accumulated Deficit [member] |
Equity at Dec. 31, 2019 | € 597,114 | € 6,443 | € 1,122,097 | € (34) | € 79,931 | € (611,323) |
Statement [LineItems] | ||||||
Loss for the period | (279,990) | (279,990) | ||||
Other comprehensive income / (loss), net of tax | (136) | (136) | ||||
Total comprehensive income / (loss) | (280,126) | (136) | (279,990) | |||
Transactions with Owners | ||||||
Share-based payment (Note 7) | 38,781 | 38,781 | ||||
Capital increase | 627,189 | 729 | 626,460 | |||
Cost of capital increase | (31,373) | (31,373) | ||||
Equity at Sep. 30, 2020 | 951,585 | 7,172 | 1,717,184 | (170) | 118,712 | (891,313) |
Equity at Dec. 31, 2020 | 838,711 | 7,217 | 1,728,747 | (76) | 133,101 | (1,030,278) |
Statement [LineItems] | ||||||
Loss for the period | (277,515) | (277,515) | ||||
Other comprehensive income / (loss), net of tax | 2,781 | 2,781 | ||||
Total comprehensive income / (loss) | (274,734) | 2,781 | (277,515) | |||
Transactions with Owners | ||||||
Share-based payment (Note 7) | 52,684 | 52,684 | ||||
Capital increase | 397,068 | 421 | 396,647 | |||
Cost of capital increase | (20,167) | (20,167) | ||||
Equity at Sep. 30, 2021 | € 993,562 | € 7,638 | € 2,105,227 | € 2,705 | € 185,785 | € (1,307,793) |
Condensed Consolidated Interi_5
Condensed Consolidated Interim Cash Flow Statements - EUR (€) € in Thousands | 9 Months Ended | |
Sep. 30, 2021 | Sep. 30, 2020 | |
Operating activities | ||
Net profit / (loss) for the period | € (277,515) | € (279,990) |
Reversal of finance income | (44,589) | (1,677) |
Reversal of finance expenses | 2,580 | 40,391 |
Reversal of tax charge | (253) | (202) |
Adjustments for non-cash items: | ||
Reversal of non-cash consideration relating to revenue | (1,749) | (2,850) |
Reversal of share of profit / (loss) of associate | (19,434) | 6,501 |
Share-based payment | 52,684 | 38,781 |
Depreciation | 10,784 | 6,462 |
Amortization | 333 | |
Changes in working capital: | ||
Inventories | (55,270) | |
Receivables | (9,295) | (2,082) |
Prepayments | (8,246) | (7,618) |
Contract liabilities (deferred income) | (327) | (635) |
Trade payables, accrued expenses and other payables | 54,302 | 20,732 |
Cash flows generated from / (used in) operations | (295,995) | (182,187) |
Finance income received | 2,919 | 1,653 |
Finance expenses paid | (1,056) | (1,152) |
Income taxes received / (paid) | (207) | 470 |
Cash flows from / (used in) operating activities | (294,339) | (181,216) |
Investing activities | ||
Investment in associate | (10,187) | |
Acquisition of property, plant and equipment | (18,907) | (15,596) |
Reimbursement from acquisition of property, plant and equipment | 4,004 | |
Development expenditures (software) | (530) | (734) |
Purchase of marketable securities | (87,544) | (340,391) |
Settlement of marketable securities | 118,512 | 132,650 |
Cash flows from / (used in) investing activities | 1,344 | (220,067) |
Financing activities | ||
Payment of principal portion of lease liabilities | (4,885) | (3,480) |
Proceeds from exercise of warrants | 9,209 | 15,274 |
Net-proceeds from follow-on public offerings | 367,692 | 580,542 |
Cash flows from / (used in) financing activities | 372,016 | 592,336 |
Increase / (decrease) in cash and cash equivalents | 79,021 | 191,053 |
Cash and cash equivalents at January 1 | 584,517 | 598,106 |
Effect of exchange rate changes on balances held in foreign currencies | 29,403 | (25,705) |
Cash and cash equivalents at September 30 | 692,941 | 763,454 |
Bank deposits | 692,941 | 719,698 |
Short-term marketable securities | 43,756 | |
Cash and cash equivalents at September 30 | € 692,941 | € 763,454 |
General Information
General Information | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
General Information | Note 1—General Information Ascendis Pharma A/S, together with its subsidiaries is a biopharmaceutical company applying its innovative TransCon technologies to build a leading, fully integrated biopharmaceutical company. Ascendis Pharma A/S was incorporated in 2006 and is headquartered in Hellerup, Denmark. Unless the context otherwise requires, references to the “Company,” “we,” “us” and “our” refer to Ascendis Pharma A/S and its subsidiaries. The address of the Company’s registered office is Tuborg Boulevard 12, DK-2900, On February 2, 2015, the Company completed an initial public offering which resulted in the listing of American Depositary Shares (“ADSs”), representing the Company’s ordinary shares, under the symbol “ASND” in the United States on The Nasdaq Global Select Market. The Company’s Board of Directors approved these unaudited condensed consolidated interim financial statements on November 10, 2021. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Summary of Significant Accounting Policies | Note 2—Summary of Significant Accounting Policies Basis of Preparation The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2020 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union. The accounting policies applied are consistent with those of the previous financial year. A description of our accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the year ended December 31, 2020. In addition, the accounting policies for inventories, applied for the first time in this reporting period, are described below. The preparation of financial statements in conformity Inventories comprise raw materials, work in progress and finished goods. Work in progress and finished goods comprise service expenses incurred at Contract Manufacturing Organizations, raw materials consumed, incremental storage and transportation, other direct materials, and a proportion of manufacturing overheads based on normal operation capacity. Inventories are measured at the lower of cost incurred in bringing it to its present location and condition, and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale. Production processes are complex, where actual yields and consumptions are sensitive to a wide variety of manufacturing conditions. Work in progress and finished goods are measured under a standard cost method that takes into account normal levels of consumption, yields, labor, efficiency and capacity utilization. Standard cost variances are reviewed regularly and adjusted to ensure inventories approximate actual costs of production. If net realizable value is lower than cost, a write-down is recognized as the excess amount by which cost exceeds net realizable value, as part of cost of sales when incurred. The amount of reversal of write-down of inventories arising from an increase in net realizable value is recognized as a reduction in cost of sales in the period in which the reversal occurs. Manufacturing of pre-launch pre-launch pre-launch pre-launch so the inventories are measured When inventories are sold, the cost of inventories is recognized as part of cost of sales in the period in which the related revenue is recognized. New and Amended IFRS Standards Adopted by the Company Several new amendments and interpretations became applicable for the current reporting period, but do not have an impact on the accounting policies applied by the Company. |
Critical Accounting Judgements
Critical Accounting Judgements and Key Sources of Estimation Uncertainty | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Critical Accounting Judgements and Key Sources of Estimation Uncertainty | Note 3—Critical Accounting Judgements and Key Sources of Estimation Uncertainty In the application of the Company’s accounting policies, management is required to make judgements, estimates and assumptions about the carrying amount of assets and liabilities that are not readily apparent from other sources. Judgements and estimates applied are based on historical experience and other factors that are relevant, and which are available at the reporting date. Uncertainty concerning judgements and estimates could result in outcomes that require a material adjustment to assets and liabilities in future periods. Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods. While the application of significant accounting estimates is subject to material estimation uncertainties, management’s ongoing revisions of significant accounting estimates have not revealed any material impact on the consolidated interim statements of profit or loss for any of the periods presented. The unaudited condensed consolidated interim financial statements do not include all disclosures for significant accounting judgements, estimates and assumptions, that are required in the annual consolidated financial statements, and therefore, should be read in conjunction with the Company’s audited consolidated financial statements as of and for the year ended December 31, 2020. Significant judgements made in the process of applying our accounting policies and that have the most significant effect on the amounts recognized in the unaudited condensed consolidated interim financial statements relate to revenue recognition, share-based payment, internally generated intangible assets related to drug development, classification of collaboration agreements and recognition principles related to pre-launch The key sources of estimation uncertainty that have a significant risk of causing a material adjustment to the carrying amount of assets and liabilities within the next financial year, primarily relate to recognition and measurement of accruals and prepayments for manufacturing and clinical trial activities. Other than as set out below, there have been no other changes to the application of significant accounting judgements, or estimation uncertainties regarding accounting estimates compared to December 31, 2020. Warrant Compensation Costs IFRS 2, “Share-Based Payment” requires an entity to reflect in its consolidated statement of profit or loss and financial position, the effects of share-based payment transactions. Warrant compensation costs are recognized over the vesting period as research and development costs or selling, general and administrative expenses, as appropriate, based on management’s best estimate of the number of warrants that will ultimately vest, which is subject to uncertainty. Warrant compensation costs are measured according to the grant date fair values of the warrants granted. Estimating fair values requires the Company to apply generally accepted valuation models and apply these models consistently according to the terms and conditions of the specific warrant program. Under all warrant programs, the Black-Scholes option-pricing model has been applied to determine the fair value of warrants granted. Subjective judgements and assumptions, which are subject to estimation uncertainties, need to be exercised in determining the appropriate input to the valuation model. These inputs include expected volatility of the Company’s share price for a historic period equaling the expected lifetime of the warrants, reflecting the assumption that the historical volatility over a period similar to the life of the warrants is indicative of future trends. For the nine months ended September 30, 2021, the expected volatility has been calculated using the price of the Company’s ADSs, each representing one ordinary share of the Company. |
Significant Events In The Repor
Significant Events In The Reporting Period | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Significant Events In The Reporting Period | Note 4—Significant Events in the Reporting Period Impact from COVID-19 Pandemic The COVID-19 We monitor the risks from this pandemic closely, and work with relevant stakeholders to avoid and limit disruptions, and to develop and establish working measures. However, while COVID-19 COVID-19, COVID-19 VISEN Pharmaceuticals Investment On January 8, 2021, the Company entered into an equity investment of $ million in its associate, VISEN Pharmaceuticals $ million Series B financing. Following VISEN’s Series B financing, the Company retained approximately % of non-cash € million, which is presented as part of “Share of profit / (loss) of associate” in the consolidated interim statement of profit or loss. The Series B financing did not change the Company’s accounting treatment of VISEN. U.S. Regulatory Approval of SKYTROFA® (lonapegsomatropin-tcgd) On August 25, 2021, the U.S. Food and Drug Administration (the “FDA”), approved TransCon hGH, known by its brand name SKYTROFA and its INN name lonapegsomatropin-tcgd in the U.S. for the treatment of pediatric patients one year and older who weigh at least 11.5 kg (25.4 lb) and have growth failure due to inadequate secretion of endogenous growth hormone. As a once-weekly injection, SKYTROFA (lonapegsomatropin-tcgd) is the first FDA approved product that delivers somatropin (growth hormone) by sustained release over one week. As a result of obtaining marketing approval for SKYTROFA (lonapegsomatropin-tcgd), the Company reversed prior write-down of prelaunch inventories through research and development costs. The reversal had a positive impact of € million on the Company’s statement of profit or loss. At the reporting date, inventories comprise raw materials and work in progress. No revenue was recognized for SKYTROFA (lonapegsomatropin-tcgd) for the nine months period ended September 30, 2021. Completion of Follow-on-public Offering On September 1, 2021, the Company entered into an underwriting agreement (the “Underwriting Agreement”) with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C. and SVB Leerink LLC, as representatives (the “Representatives”) of the several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell 2,500,000 ADSs, each of which represents one ordinary share of the Company, DKK 1 nominal value per share, to the Underwriters (the “Offering”). The ADSs were sold at a public offering price of $160.00 per ADS, and were purchased by the Underwriters from the Company at a price of $152.00 per ADS. Under the terms of the Underwriting Agreement, the Company granted the Underwriters the right, for 30 days, to purchase from the Company up to 375,000 additional ADSs at the public offering price, less the underwriting commissions. On September 2, 2021, the Underwriters exercised their option to purchase the additional 375,000 ADSs in full. On September 7, 2021, the Offering closed and the Company completed the sale and issuance of an aggregate of 2,875,000 ADSs. The Company received net proceeds from the Offering of $436.5 million, or €367.7 million, after deducting the Underwriters’ commissions and offering expenses payable by the Company. |
Revenue
Revenue | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Revenue | Note 5—Revenue The Company’s revenue is primarily generated from three license agreements, which were entered into in 2018. The licenses grant VISEN exclusive rights to develop and commercialize TransCon hGH, TransCon PTH and TransCon CNP in Greater China. As consideration for the granting of such rights, the Company received up-front, non-refundable, non-cash Consideration received is recognized partly as license revenue, and partly as rendering of services over time. In addition to granting exclusive rights, the Company provides clinical trial supply and development services to VISEN. Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (EUR’000) (EUR’000) Revenue from external customers Revenue from rendering of services (recognized over time) 203 164 599 2,255 Sale of clinical supply (recognized at a point in time) 316 1,959 533 2,206 “Right-to-use” 594 634 1,749 1,957 Total revenue (1) 1,113 2,757 2,881 6,418 Attributable to VISEN Pharmaceuticals 1,004 2,757 2,554 6,418 Other collaboration partners 109 — 327 — Total revenue 1,113 2,757 2,881 6,418 Revenue by geographical location North America 702 634 2,076 1,957 China 411 2,123 805 4,461 Total revenue 1,113 2,757 2,881 6,418 (1) For the three months ended September 30, 2021 and 2020, and for the nine months ended September 30, 2021 and 2020, “Total revenue” includes recognition of previously deferred revenue/internal profit from associate of €0.6 million and €0.6 million, and of €1.7 million and €2.8 million, respectively. |
Segment Information
Segment Information | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Segment Information | Note 6—Segment Information The Company is managed and operated as one business unit. No separate business areas or separate business units have been identified in relation to product candidates or geographical markets. Accordingly, no additional information on business segments or geographical areas is disclosed. |
Warrants and Share-based Paymen
Warrants and Share-based Payment | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Warrants and Share-based Payment | Note 7—Warrants and Share-based Payment Share-based Payment Ascendis Pharma A/S has established warrant programs and equity-settled share-based payment transactions, as an incentive for all its employees, members of its Board of Directors and select consultants. Warrants are granted by the Company’s Board of Directors in accordance with authorizations given to it by the shareholders of the Company. As of September 30, 2021, 11,174,143 warrants have been granted, of which 19,580 warrants have been cancelled, 4,428,982 warrants have been exercised, 2,168 warrants have expired without being exercised, and 677,057 warrants have been forfeited. As of September 30, 2021, the Company’s Board of Directors was authorized to grant up to 2,453,144 additional warrants to employees, board members and select consultants without preemptive subscription rights for the shareholders of the Company. Each warrant carries the right to subscribe for one ordinary share of a nominal value of DKK 1. The exercise price is fixed at the fair market value of the Company’s ordinary shares on the date of grant as determined by the Company’s Board of Directors. The exercise prices of outstanding warrants under the Company’s warrant programs range from €6.48 to €145.5 depending on the grant dates. Vested warrants may be exercised in two or four annual exercise periods. Apart from exercise Warrant Activity The following table specifies the warrant activity during the nine months ended September 30, 2021: Total Warrants Weighted Average Exercise Price EUR Outstanding at January 1, 2021 6,148,004 69.97 Granted during the period 309,425 115.21 Exercised during the period (252,337 ) 38.22 Forfeited during the period (158,736 ) 120.76 Outstanding at September 30, 2021 6,046,356 71.91 Vested at September 30, 2021 3,777,047 49.61 Warrant Compensation Costs Warrant compensation costs are determined with a basis in the grant date fair value of the warrants granted and recognized over the vesting period as research and development costs or as selling, general and administrative expenses. For the three months ended September 30, 2021 and 2020, and for the nine months ended September 30, 2021 and 2020, warrant compensation costs recognized in the consolidated interim statement of profit or loss was €13.3 million and million and |
Marketable Securities
Marketable Securities | 9 Months Ended |
Sep. 30, 2021 | |
Categories of current financial assets [abstract] | |
Marketable Securities | Note 8—Marketable Securities Marketable securities are measured at amortized cost, and fair values are determined based on quoted market prices (Level 1 in the fair value hierarchy). The composition of the portfolio is specified in the following table : September 30, 2021 December 31, 2020 Carrying amount Fair value Carrying amount Fair value (EUR’000) Marketable securities U.S. Treasury bills — — 46,243 46,245 U.S. Government bonds 80,044 80,056 62,088 62,101 Commercial papers 2,158 2,158 10,583 10,581 Corporate bonds 136,204 136,128 121,282 121,234 Agency bonds 18,555 18,556 9,362 9,369 Total marketable securities 236,961 236,898 249,558 249,530 Classified based on maturity profiles Non-current 71,614 71,580 115,280 115,277 Current assets 165,347 165,318 134,278 134,253 Total marketable securities 236,961 236,898 249,558 249,530 Specified by rate structure Fixed rate 220,163 220,100 175,757 175,732 Floating rate 14,640 14,640 16,975 16,972 Zero-coupon 2,158 2,158 56,826 56,826 Total marketable securities 236,961 236,898 249,558 249,530 Specified by investment grade credit rating Prime 6,529 6,529 7,716 7,714 High grade 116,055 116,057 142,339 142,352 Upper medium grade 112,270 112,206 99,503 99,464 Lower medium grade 2,107 2,106 — — Total marketable securities 236,961 236,898 249,558 249,530 The Company’s marketable securities are all denominated in U.S. Dollars. At September 30, 2021 and December 31, 2020, the portfolio has a weighted average duration of 6.1 and 6.0 months for current positions, and months for non-current positions, respectively. At September 30, 2021 and December 31, 2020, the entire portfolio has a weighted average duration of . All marketable securities have investment grade ratings, and accordingly, the risk from probability of default is low. The risk of expected credit loss over marketable securities has been considered, including the hypothetical impact arising from the probability of default which is considered in conjunction with the expected loss given default from securities with similar credit ratings and attributes. This assessment did not reveal a material expected credit loss, and accordingly, no provision for expected credit loss has been recognized. |
Share Capital
Share Capital | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Share Capital | Note 9—Share Capital The share capital of Ascendis Pharma A/S consists of 56,877,723 outstanding shares at a nominal value of DKK 1, all in the same share class. |
Lease Liabilities
Lease Liabilities | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Lease Liabilities | Note 10 —Lease Liabilities The Company primarily leases office and laboratory facilities. Lease arrangements contain a range of different terms and conditions and are typically entered into for fixed periods. Generally, the lease terms are determined according to the non-cancellable two two non-cancellable Maturity analysis for lease liabilities recognized in the consolidated statements of financial position at September 30, 2021 is specified below. < 1 year 1-5 years >5 years Total contractual cash-flows Carrying amount (EUR’000) September 30, 2021 Lease liabilities 6,840 47,653 70,054 124,547 102,301 Total lease liabilities 6,840 47,653 70,054 124,547 102,301 |
Subsequent Events
Subsequent Events | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Subsequent Events | Note 11—Subsequent Events No events have occurred after the reporting date that would influence the evaluation of these unaudited condensed consolidated interim financial |
Summary of Significant Accoun_2
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Basis of Preparation | Basis of Preparation The unaudited condensed consolidated interim financial statements of the Company are prepared in accordance with International Accounting Standard 34, “Interim Financial Reporting.” Certain information and disclosures normally included in the annual consolidated financial statements prepared in accordance with International Financial Reporting Standards (“IFRS”) have been condensed or omitted. Accordingly, these unaudited condensed consolidated interim financial statements should be read in conjunction with the Company’s audited annual consolidated financial statements for the year ended December 31, 2020 and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union. The accounting policies applied are consistent with those of the previous financial year. A description of our accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the year ended December 31, 2020. In addition, the accounting policies for inventories, applied for the first time in this reporting period, are described below. The preparation of financial statements in conformity |
Inventories | Inventories Inventories comprise raw materials, work in progress and finished goods. Work in progress and finished goods comprise service expenses incurred at Contract Manufacturing Organizations, raw materials consumed, incremental storage and transportation, other direct materials, and a proportion of manufacturing overheads based on normal operation capacity. Inventories are measured at the lower of cost incurred in bringing it to its present location and condition, and net realizable value. Net realizable value is the estimated selling price in the ordinary course of business, less estimated costs of completion and the estimated costs necessary to make the sale. Production processes are complex, where actual yields and consumptions are sensitive to a wide variety of manufacturing conditions. Work in progress and finished goods are measured under a standard cost method that takes into account normal levels of consumption, yields, labor, efficiency and capacity utilization. Standard cost variances are reviewed regularly and adjusted to ensure inventories approximate actual costs of production. If net realizable value is lower than cost, a write-down is recognized as the excess amount by which cost exceeds net realizable value, as part of cost of sales when incurred. The amount of reversal of write-down of inventories arising from an increase in net realizable value is recognized as a reduction in cost of sales in the period in which the reversal occurs. Manufacturing of pre-launch pre-launch pre-launch pre-launch so the inventories are measured When inventories are sold, the cost of inventories is recognized as part of cost of sales in the period in which the related revenue is recognized. |
New and Amended IFRS Standards Adopted by the Company | New and Amended IFRS Standards Adopted by the Company Several new amendments and interpretations became applicable for the current reporting period, but do not have an impact on the accounting policies applied by the Company. |
Revenue (Tables)
Revenue (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Schedule of Revenue Recognized in the Statement of Profit or Loss | Three Months Ended September 30, Nine Months Ended September 30, 2021 2020 2021 2020 (EUR’000) (EUR’000) Revenue from external customers Revenue from rendering of services (recognized over time) 203 164 599 2,255 Sale of clinical supply (recognized at a point in time) 316 1,959 533 2,206 “Right-to-use” 594 634 1,749 1,957 Total revenue (1) 1,113 2,757 2,881 6,418 Attributable to VISEN Pharmaceuticals 1,004 2,757 2,554 6,418 Other collaboration partners 109 — 327 — Total revenue 1,113 2,757 2,881 6,418 Revenue by geographical location North America 702 634 2,076 1,957 China 411 2,123 805 4,461 Total revenue 1,113 2,757 2,881 6,418 (1) For the three months ended September 30, 2021 and 2020, and for the nine months ended September 30, 2021 and 2020, “Total revenue” includes recognition of previously deferred revenue/internal profit from associate of €0.6 million and €0.6 million, and of €1.7 million and €2.8 million, respectively. |
Warrants and Share-based Paym_2
Warrants and Share-based Payment (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Warrants [member] | |
Statement [LineItems] | |
Summary of Warrant Activity | The following table specifies the warrant activity during the nine months ended September 30, 2021: Total Warrants Weighted Average Exercise Price EUR Outstanding at January 1, 2021 6,148,004 69.97 Granted during the period 309,425 115.21 Exercised during the period (252,337 ) 38.22 Forfeited during the period (158,736 ) 120.76 Outstanding at September 30, 2021 6,046,356 71.91 Vested at September 30, 2021 3,777,047 49.61 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Categories of current financial assets [abstract] | |
Summary of Marketable Securities | The composition of the portfolio is specified in the following table : September 30, 2021 December 31, 2020 Carrying amount Fair value Carrying amount Fair value (EUR’000) Marketable securities U.S. Treasury bills — — 46,243 46,245 U.S. Government bonds 80,044 80,056 62,088 62,101 Commercial papers 2,158 2,158 10,583 10,581 Corporate bonds 136,204 136,128 121,282 121,234 Agency bonds 18,555 18,556 9,362 9,369 Total marketable securities 236,961 236,898 249,558 249,530 Classified based on maturity profiles Non-current 71,614 71,580 115,280 115,277 Current assets 165,347 165,318 134,278 134,253 Total marketable securities 236,961 236,898 249,558 249,530 Specified by rate structure Fixed rate 220,163 220,100 175,757 175,732 Floating rate 14,640 14,640 16,975 16,972 Zero-coupon 2,158 2,158 56,826 56,826 Total marketable securities 236,961 236,898 249,558 249,530 Specified by investment grade credit rating Prime 6,529 6,529 7,716 7,714 High grade 116,055 116,057 142,339 142,352 Upper medium grade 112,270 112,206 99,503 99,464 Lower medium grade 2,107 2,106 — — Total marketable securities 236,961 236,898 249,558 249,530 |
Lease Liabilities (Tables)
Lease Liabilities (Tables) | 9 Months Ended |
Sep. 30, 2021 | |
Text block [abstract] | |
Summary of Maturity Analysis for Lease Liabilities | Maturity analysis for lease liabilities recognized in the consolidated statements of financial position at September 30, 2021 is specified below. < 1 year 1-5 years >5 years Total contractual cash-flows Carrying amount (EUR’000) September 30, 2021 Lease liabilities 6,840 47,653 70,054 124,547 102,301 Total lease liabilities 6,840 47,653 70,054 124,547 102,301 |
Significant Events in the Rep_2
Significant Events in the Reporting Period - Additional Information (Detail) $ / shares in Units, € in Thousands, $ in Millions | Sep. 07, 2021EUR (€)shares | Sep. 07, 2021USD ($)shares | Sep. 02, 2021shares | Sep. 01, 2021$ / sharesshares | Jan. 08, 2021USD ($) | Sep. 30, 2021EUR (€) | Mar. 31, 2021EUR (€) | Sep. 30, 2020EUR (€) | Sep. 30, 2021EUR (€) | Sep. 30, 2020EUR (€) |
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Realized non cash gain recognized towards Shares | € 42,300 | |||||||||
Research and development expense | € 58,761 | € 64,059 | € 230,216 | € 185,152 | ||||||
Revenue | 1,113 | 2,757 | 2,881 | 6,418 | ||||||
VISEN Series B Financing [Member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Proceeds from Borrowings classified as Financing Activities | $ | $ 150 | |||||||||
VISEN Pharmaceuticals [Member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Equity Investment in Associates | $ | $ 12.5 | |||||||||
Proportion of Interest retain in issued and Outstanding shares of Associate | 44.00% | |||||||||
Revenue | € 1,004 | € 2,757 | 2,554 | € 6,418 | ||||||
Marketing Approval [Member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Research and development expense | 53,200 | |||||||||
Revenue | € 0 | |||||||||
Public Offering [Member] | American Depository Shares [member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Stock issued during period shares new issues | shares | 2,875,000 | 2,875,000 | ||||||||
Share issue price | $ / shares | $ 160 | |||||||||
Proceeds from public offering | € 367,700 | $ 436.5 | ||||||||
Public Offering [Member] | American Depository Shares [member] | Underwriters [Member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Stock issued during period shares new issues | shares | 375,000 | 2,500,000 | ||||||||
Share issue price | $ / shares | $ 152 | |||||||||
Public Offering [Member] | American Depository Shares [member] | Underwriters [Member] | Top of range [member] | ||||||||||
Disclosure of summary of significant accounting policies [line items] | ||||||||||
Number of additional shares option to purchase | shares | 375,000 |
Revenue - Additional Informatio
Revenue - Additional Information (Detail) - VISEN Pharmaceuticals [Member] $ in Millions | 9 Months Ended |
Sep. 30, 2021USD ($) | |
Disclosure of operating segments [line items] | |
Upfront payment received non cash consideration towards license revenue | $ 40 |
Percentage of ownership in the customer company | 50.00% |
Retained percentage of issued and outstanding shares | 44.00% |
Revenue - Schedule of Revenue R
Revenue - Schedule of Revenue Recognized in Statements of Profit or Loss (Detail) - EUR (€) € in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Disclosure of operating segments [line items] | ||||
Revenue from rendering of services (recognized over time) | € 203 | € 164 | € 599 | € 2,255 |
Sale of clinical supply (recognized at a point in time) | 316 | 1,959 | 533 | 2,206 |
"Right-to-use" licenses (recognized at a point in time) | 594 | 634 | 1,749 | 1,957 |
Total revenue | 1,113 | 2,757 | 2,881 | 6,418 |
Revenue by geographical location | ||||
Total revenue | 1,113 | 2,757 | 2,881 | 6,418 |
VISEN Pharmaceuticals [Member] | ||||
Disclosure of operating segments [line items] | ||||
Total revenue | 1,004 | 2,757 | 2,554 | 6,418 |
Revenue by geographical location | ||||
Total revenue | 1,004 | 2,757 | 2,554 | 6,418 |
Other collaboration partners [Member] | ||||
Disclosure of operating segments [line items] | ||||
Total revenue | 109 | 327 | ||
Revenue by geographical location | ||||
Total revenue | 109 | 327 | ||
North America [member] | ||||
Disclosure of operating segments [line items] | ||||
Total revenue | 702 | 634 | 2,076 | 1,957 |
Revenue by geographical location | ||||
Total revenue | 702 | 634 | 2,076 | 1,957 |
China [member] | ||||
Disclosure of operating segments [line items] | ||||
Total revenue | 411 | 2,123 | 805 | 4,461 |
Revenue by geographical location | ||||
Total revenue | € 411 | € 2,123 | € 805 | € 4,461 |
Revenue - Schedule of Revenue_2
Revenue - Schedule of Revenue Recognized in Statements of Profit or Loss (Parenthetical) (Detail) - EUR (€) € in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2021 | Sep. 30, 2020 | Sep. 30, 2021 | Sep. 30, 2020 | |
Revenue [abstract] | ||||
Deferred revenue from associate | € 0.6 | € 0.6 | € 1.7 | € 2.8 |
Segment Information - Additiona
Segment Information - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2021Segment | |
Disclosure of operating segments [abstract] | |
Number of reportable segment | 1 |
Warrants and Share-based Paym_3
Warrants and Share-based Payment - Additional Information (Detail) € / shares in Units, € in Millions | 3 Months Ended | 9 Months Ended | ||||
Sep. 30, 2021EUR (€) | Sep. 30, 2020EUR (€) | Sep. 30, 2021EUR (€) | Sep. 30, 2020EUR (€) | Sep. 30, 2021kr / sharesshares | Sep. 30, 2021€ / sharesshares | |
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Share nominal value | kr / shares | kr 1 | |||||
Bottom of range [member] | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price of outstanding share options | € 6.48 | |||||
Top of range [member] | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Exercise price of outstanding share options | € 145.5 | |||||
Warrants [member] | ||||||
Disclosure of terms and conditions of share-based payment arrangement [line items] | ||||||
Aggregate number of other equity instruments granted | 11,174,143 | |||||
Aggregate number of other equity instruments cancelled | shares | 19,580 | 19,580 | ||||
Aggregate number of other equity instruments exercised | 4,428,982 | |||||
Aggregate number of other equity instruments expired | 2,168 | |||||
Aggregate number of other equity instruments forfeited | 677,057 | |||||
Number of other equity instruments authorized | 2,453,144 | 2,453,144 | ||||
Warrant compensation costs | € | € 13.3 | € 10.4 | € 52.7 | € 38.8 |
Warrants and Share-based Paym_4
Warrants and Share-based Payment - Schedule of Warrant Activity (Detail) - Warrants [member] | 9 Months Ended |
Sep. 30, 2021€ / shares | |
Disclosure Of Warrant Activity [line items] | |
Beginning balance | 6,148,004 |
Granted during the period | 309,425 |
Exercised during the period | (252,337) |
Forfeited during the period | (158,736) |
Ending balance | 6,046,356 |
Vested at the balance sheet date | 3,777,047 |
Beginning balance | € 69.97 |
Granted during the period | 115.21 |
Exercised during the period | 38.22 |
Forfeited during the period | 120.76 |
Ending balance | 71.91 |
Vested at the balance sheet date | € 49.61 |
Marketable Securities - Additio
Marketable Securities - Additional information (Detail) | 9 Months Ended | 12 Months Ended |
Sep. 30, 2021 | Dec. 31, 2020 | |
Marketable Securities [Abstract] | ||
Weighted average duration of marketable securities current | 6 months 3 days | 6 months |
Weighted average duration of marketable securities non-current | 17 months 18 days | 17 months 9 days |
Weighted average duration of marketable securities | 9 months 18 days | 11 months 6 days |
Marketable Securities - Summary
Marketable Securities - Summary of Marketable Securities (Detail) - EUR (€) € in Thousands | Sep. 30, 2021 | Dec. 31, 2020 |
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Non-current financial assets available-for-sale | € 71,614 | € 115,280 |
Current financial assets available-for-sale | 165,347 | 134,278 |
Financial assets at amortised cost, class [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 236,961 | 249,558 |
Non-current financial assets available-for-sale | 71,614 | 115,280 |
Current financial assets available-for-sale | 165,347 | 134,278 |
Financial assets | 236,961 | 249,558 |
Financial assets at amortised cost, class [member] | Prime [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 6,529 | 7,716 |
Financial assets at amortised cost, class [member] | High grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 116,055 | 142,339 |
Financial assets at amortised cost, class [member] | Upper Medium Grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 112,270 | 99,503 |
Financial assets at amortised cost, class [member] | Lower Medium Grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 2,107 | 0 |
Financial assets at amortised cost, class [member] | Fixed interest rate [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 220,163 | 175,757 |
Financial assets at amortised cost, class [member] | Floating interest rate [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 14,640 | 16,975 |
Financial assets at amortised cost, class [member] | Zero Coupon [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 2,158 | 56,826 |
Financial assets at amortised cost, class [member] | US Treasury bills [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 0 | 46,243 |
Financial assets at amortised cost, class [member] | US Government bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 80,044 | 62,088 |
Financial assets at amortised cost, class [member] | Commercial papers [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 2,158 | 10,583 |
Financial assets at amortised cost, class [member] | Corporate bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 136,204 | 121,282 |
Financial assets at amortised cost, class [member] | Agency bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 18,555 | 9,362 |
Financial assets at fair value, class [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 236,898 | 249,530 |
Non-current financial assets available-for-sale | 71,580 | 115,277 |
Current financial assets available-for-sale | 165,318 | 134,253 |
Financial assets | 236,898 | 249,530 |
Financial assets at fair value, class [member] | Prime [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 6,529 | 7,714 |
Financial assets at fair value, class [member] | High grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 116,057 | 142,352 |
Financial assets at fair value, class [member] | Upper Medium Grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 112,206 | 99,464 |
Financial assets at fair value, class [member] | Lower Medium Grade [member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 2,106 | 0 |
Financial assets at fair value, class [member] | Fixed interest rate [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 220,100 | 175,732 |
Financial assets at fair value, class [member] | Floating interest rate [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 14,640 | 16,972 |
Financial assets at fair value, class [member] | Zero Coupon [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets | 2,158 | 56,826 |
Financial assets at fair value, class [member] | US Treasury bills [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 0 | 46,245 |
Financial assets at fair value, class [member] | US Government bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 80,056 | 62,101 |
Financial assets at fair value, class [member] | Commercial papers [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 2,158 | 10,581 |
Financial assets at fair value, class [member] | Corporate bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | 136,128 | 121,234 |
Financial assets at fair value, class [member] | Agency bonds [Member] | ||
Disclosure Detailed Information About Marketable Securities [Line Items] | ||
Financial assets available-for-sale | € 18,556 | € 9,369 |
Share Capital - Additional Info
Share Capital - Additional Information (Detail) | Sep. 30, 2021kr / sharesshares |
Disclosure of classes of share capital [line items] | |
Share nominal value | kr / shares | kr 1 |
Number of shares outstanding | shares | 56,877,723 |
Lease Liabilities - Additional
Lease Liabilities - Additional Information (Detail) | 9 Months Ended |
Sep. 30, 2021 | |
Bottom of range [member] | |
Statement [line items] | |
Lease term | 2 months |
Lease extension and termination option term | 2 months |
Top of range [member] | |
Statement [line items] | |
Lease term | 12 years |
Lease extension and termination option term | 10 years |
Lease Liabilities - Summary of
Lease Liabilities - Summary of Maturity Analysis for Lease Liabilities (Detail) € in Thousands | Sep. 30, 2021EUR (€) |
Total contractual cash-flows [member] | |
Disclosure of maturity analysis of operating lease payments [line items] | |
Lease liabilities | € 124,547 |
Total lease liabilities | 124,547 |
Carrying amount [member] | |
Disclosure of maturity analysis of operating lease payments [line items] | |
Lease liabilities | 102,301 |
Total lease liabilities | 102,301 |
Within 1 year [member] | Total contractual cash-flows [member] | |
Disclosure of maturity analysis of operating lease payments [line items] | |
Lease liabilities | 6,840 |
Total lease liabilities | 6,840 |
Within 1 to 5 years [member] | Total contractual cash-flows [member] | |
Disclosure of maturity analysis of operating lease payments [line items] | |
Lease liabilities | 47,653 |
Total lease liabilities | 47,653 |
After 5 years [member] | Total contractual cash-flows [member] | |
Disclosure of maturity analysis of operating lease payments [line items] | |
Lease liabilities | 70,054 |
Total lease liabilities | € 70,054 |