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INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
| Page | ||||
| Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30, 2020 and 2019 | 2 | |||
| Unaudited Condensed Consolidated Interim Statements of Financial Position as of September 30, 2020 and December 31, 2019 | 3 | |||
| Unaudited Condensed Consolidated Interim Statements of Changes in Equity at September 30, 2020 and 2019 | 4 | |||
| Unaudited Condensed Consolidated Interim Cash Flow Statements for the Nine Months Ended September 30, 2020 and 2019 | 5 | |||
| Notes to the Unaudited Condensed Consolidated Interim Financial Statements | 6 |
Unaudited Condensed Consolidated Interim Statements of Profit or Loss
and Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30
| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||||||||
| Notes | 2020 | 2019 | 2020 | 2019 | ||||||||||||||||
| (EUR 000) | (EUR 000) | |||||||||||||||||||
| Consolidated Interim Statement of Profit or Loss | ||||||||||||||||||||
| Revenue | 5 | 2,757 | 2,243 | 6,418 | 10,868 | |||||||||||||||
| Research and development costs | 7 | (64,059 | ) | (46,258 | ) | (185,152 | ) | (141,343 | ) | |||||||||||
| Selling, general, and administrative expenses | 7 | (17,523 | ) | (10,000 | ) | (56,243 | ) | (31,396 | ) | |||||||||||
| Operating profit / (loss) | (78,825 | ) | (54,015 | ) | (234,977 | ) | (161,871 | ) | ||||||||||||
| Share of profit / (loss) of associate | (3,101 | ) | (1,338 | ) | (6,501 | ) | (5,452 | ) | ||||||||||||
| Finance income | 136 | 30,547 | 1,677 | 30,285 | ||||||||||||||||
| Finance expenses | (39,970 | ) | (368 | ) | (40,391 | ) | (812 | ) | ||||||||||||
| Profit / (loss) before tax | (121,760 | ) | (25,174 | ) | (280,192 | ) | (137,850 | ) | ||||||||||||
| Tax on profit / (loss) for the period | 19 | 61 | 202 | 196 | ||||||||||||||||
| Net profit / (loss) for the period | (121,741 | ) | (25,113 | ) | (279,990 | ) | (137,654 | ) | ||||||||||||
| Attributable to owners of the Company | (121,741 | ) | (25,113 | ) | (279,990 | ) | (137,654 | ) | ||||||||||||
| Basic and diluted earnings / (loss) per share | (2.31 | ) | (0.53 | ) | (5.64 | ) | (2.99 | ) | ||||||||||||
| Number of shares used for calculation (basic and diluted) (1) | 52,715,204 | 47,590,837 | 49,647,471 | 46,066,493 | ||||||||||||||||
| (EUR 000) | (EUR 000) | |||||||||||||||||||
| Consolidated Interim Statement of Comprehensive Income | ||||||||||||||||||||
| Net profit / (loss) for the period | (121,741 | ) | (25,113 | ) | (279,990 | ) | (137,654 | ) | ||||||||||||
| Other comprehensive income / (loss) | ||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||||||
| Exchange differences on translating foreign operations | (75 | ) | 37 | (136 | ) | 2 | ||||||||||||||
| Other comprehensive income / (loss) for the period, net of tax | (75 | ) | 37 | (136 | ) | 2 | ||||||||||||||
| Total comprehensive income / (loss) for the period, net of tax | (121,816 | ) | (25,076 | ) | (280,126 | ) | (137,652 | ) | ||||||||||||
| Attributable to owners of the Company | (121,816 | ) | (25,076 | ) | (280,126 | ) | (137,652 | ) |
Unaudited Condensed Consolidated Interim Statements of Financial Position
| Notes | September 30, 2020 | December 31, 2019 | ||||||||||
| (EUR 000) | ||||||||||||
| Assets | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 4,653 | 3,495 | ||||||||||
| Property, plant and equipment | 47,325 | 45,069 | ||||||||||
| Investment in associate | 11,574 | 15,538 | ||||||||||
| Deposits | 1,243 | 1,463 | ||||||||||
| Marketable securities | 8 | 27,728 | ||||||||||
| 92,523 | 65,565 | |||||||||||
| Current assets | ||||||||||||
| Trade receivables | 2,722 | 804 | ||||||||||
| Other receivables | 4,511 | 3,136 | ||||||||||
| Prepayments | 15,266 | 7,648 | ||||||||||
| Income taxes receivable | 1,305 | 1,473 | ||||||||||
| Marketable securities | 8 | 166,343 | ||||||||||
| Cash and cash equivalents | 763,454 | 598,106 | ||||||||||
| 953,601 | 611,167 | |||||||||||
| Total assets | 1,046,124 | 676,732 | ||||||||||
| Equity and liabilities | ||||||||||||
| Equity | ||||||||||||
| Share capital | 9 | 7,172 | 6,443 | |||||||||
| Distributable equity | 944,413 | 590,671 | ||||||||||
| 951,585 | 597,114 | |||||||||||
| Non-current liabilities | ||||||||||||
| Lease liabilities | 26,952 | 30,720 | ||||||||||
| Other payables | 3,160 | 908 | ||||||||||
| 30,112 | 31,628 | |||||||||||
| Current liabilities | ||||||||||||
| Lease liabilities | 6,328 | 5,899 | ||||||||||
| Contract liabilities | 223 | 858 | ||||||||||
| Trade payables and accrued expenses | 38,108 | 27,765 | ||||||||||
| Other payables | 19,549 | 13,349 | ||||||||||
| Income taxes payable | 219 | 119 | ||||||||||
| 64,427 | 47,990 | |||||||||||
| Total liabilities | 94,539 | 79,618 | ||||||||||
| Total equity and liabilities | 1,046,124 | 676,732 |
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
| Distributable Equity | ||||||||||||||||||||||||
| Share Capital | Share Premium | Foreign Currency Translation Reserve | Share- based Payment Reserve | Accumulated Deficit | Total | |||||||||||||||||||
| (EUR 000) | ||||||||||||||||||||||||
| Equity at January 1, 2020 | 6,443 | 1,122,097 | (34 | ) | 79,931 | (611,323 | ) | 597,114 | ||||||||||||||||
| Loss for the period | (279,990 | ) | (279,990 | ) | ||||||||||||||||||||
| Other comprehensive income / (loss), net of tax | (136 | ) | (136 | ) | ||||||||||||||||||||
| Total comprehensive income / (loss) | (136 | ) | (279,990 | ) | (280,126 | ) | ||||||||||||||||||
| Transactions with Owners | ||||||||||||||||||||||||
| Share-based payment (Note 7) | 38,781 | 38,781 | ||||||||||||||||||||||
| Capital increase | 729 | 626,460 | 627,189 | |||||||||||||||||||||
| Cost of capital increase | (31,373 | ) | (31,373 | ) | ||||||||||||||||||||
| Equity at September 30, 2020 | 7,172 | 1,717,184 | (170 | ) | 118,712 | (891,313 | ) | 951,585 | ||||||||||||||||
| Distributable Equity | ||||||||||||||||||||||||
| Share Capital | Share Premium | Foreign Currency Translation Reserve | Share- based Payment Reserve | Accumulated Deficit | Total | |||||||||||||||||||
| (EUR 000) | ||||||||||||||||||||||||
| Equity at January 1, 2019 | 5,659 | 625,250 | 3 | 42,445 | (393,307 | ) | 280,050 | |||||||||||||||||
| Loss for the period | (137,654 | ) | (137,654 | ) | ||||||||||||||||||||
| Other comprehensive income / (loss), net of tax | 2 | 2 | ||||||||||||||||||||||
| Total comprehensive income / (loss) | 2 | (137,654 | ) | (137,652 | ) | |||||||||||||||||||
| Transactions with Owners | ||||||||||||||||||||||||
| Share-based payment (Note 7) | 26,205 | 26,205 | ||||||||||||||||||||||
| Capital increase | 751 | 523,272 | 524,023 | |||||||||||||||||||||
| Cost of capital increase | (31,701 | ) | (31,701 | ) | ||||||||||||||||||||
| Equity at September 30, 2019 | 6,410 | 1,116,821 | 5 | 68,650 | (530,961 | ) | 660,925 |
Unaudited Condensed Consolidated Interim Cash Flow Statements for the
Nine Months Ended September 30
| Nine Months Ended September 30, | ||||||||
| 2020 | 2019 | |||||||
| (EUR 000) | ||||||||
| Operating activities | ||||||||
| Net profit / (loss) for the period | (279,990 | ) | (137,654 | ) | ||||
| Reversal of non-cash consideration relating to revenue | (2,850 | ) | (5,334 | ) | ||||
| Reversal of share of profit / (loss) of associate | 6,501 | 5,452 | ||||||
| Reversal of finance income | (1,677 | ) | (30,285 | ) | ||||
| Reversal of finance expenses | 40,391 | 812 | ||||||
| Reversal of tax charge | (202 | ) | (196 | ) | ||||
| Adjustments for: | ||||||||
| Share-based payment | 38,781 | 26,205 | ||||||
| Depreciation | 6,462 | 4,716 | ||||||
| Changes in working capital: | ||||||||
| Receivables | (2,082 | ) | (285 | ) | ||||
| Prepayments | (7,618 | ) | 4,478 | |||||
| Contract liabilities (deferred income) | (635 | ) | (5,529 | ) | ||||
| Trade payables, accrued expenses, and other payables | 20,732 | 3,596 | ||||||
| Cash flows generated from / (used in) operations | (182,187 | ) | (134,024 | ) | ||||
| Finance income received | 1,653 | 8,087 | ||||||
| Finance expenses paid | (1,152 | ) | (526 | ) | ||||
| Income taxes received / (paid) | 470 | (237 | ) | |||||
| Cash flows from / (used in) operating activities | (181,216 | ) | (126,700 | ) | ||||
| Investing activities | ||||||||
| Acquisition of property, plant and equipment | (15,596 | ) | (4,030 | ) | ||||
| Reimbursement from acquisition of property, plant and equipment | 4,004 | |||||||
| Development expenditures (software) | (734 | ) | ||||||
| Purchase of marketable securities | (340,391 | ) | ||||||
| Settlement of marketable securities | 132,650 | |||||||
| Cash flows from / (used in) investing activities | (220,067 | ) | (4,030 | ) | ||||
| Financing activities | ||||||||
| Payment of lease liabilities | (3,480 | ) | (2,992 | ) | ||||
| Capital increase | 627,189 | 524,023 | ||||||
| Cost of capital increase | (31,373 | ) | (31,701 | ) | ||||
| Cash flows from / (used in) financing activities | 592,336 | 489,330 | ||||||
| Increase / (decrease) in cash and cash equivalents | 191,053 | 358,600 | ||||||
| Cash and cash equivalents at January 1 | 598,106 | 277,862 | ||||||
| Effect of exchange rate changes on balances held in foreign currencies | (25,705 | ) | 22,198 | |||||
| Cash and cash equivalents at September 30 | 763,454 | 658,660 | ||||||
| Cash and cash equivalents include: | ||||||||
| Bank deposits | 719,698 | 658,660 | ||||||
| Short-term marketable securities | 43,756 | |||||||
| Cash and cash equivalents at September 30 | 763,454 | 658,660 |
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
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, Hellerup, Denmark.
On February 2, 2015, the Company completed an
initial public offering which resulted in the listing of American Depositary Shares, or 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 11, 2020.
Note 2 Summary of Significant Accounting Policies
Basis of Preparation
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, 2019 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, 2019. In addition, our accounting policies for
marketable securities, and internally generated intangible assets regarding software, applied for the first time in this reporting period, are described below.
The preparation of financial statements in conformity with IFRS requires the use of certain critical accounting estimates and requires
management to exercise its judgment in the process of applying the Company s accounting policies. The areas involving a higher degree of judgment or complexity, or areas where assumptions and estimates are significant to the unaudited condensed
consolidated interim financial statements are disclosed in Note 3.
Marketable Securities
Marketable securities may comprise government bonds, treasury bills, commercial papers, and other securities traded on established markets. In
addition, our investment policy only allows investments in marketable securities having investment grade credit-ratings, assigned by international credit-rating agencies.
Marketable securities are primarily held to mitigate concentration of credit risks on cash deposits and preserve capital. In addition, we
manage our liquidity risk by maintaining adequate cash reserves and banking facilities, and by matching the maturity profiles of financial assets including marketable securities, with cash-forecasts including payment profiles on liabilities.
At initial recognition (trade-date), contractual terms of individual securities are analyzed to determine whether these give rise on specified
dates to cash flows that are solely payments of principal and interest on the principal outstanding. This assessment is referred to as the SPPI-test. All marketable securities held at the reporting date, have passed the SPPI-test.
Marketable securities are initially recognized at fair value at trade date, and subsequently measured at amortized cost and are subject to
impairment to accommodate expected credit loss. Gains and losses are recognized in the consolidated statement of profit or loss when the specific security or portfolio of securities is derecognized, modified or impaired.
Marketable securities, having maturity profiles of three months or less on the date of acquisition are presented as cash equivalents in the
consolidated statements of financial position, where securities, having maturities of more than three months on the date of acquisition are presented separately as marketable securities as current (i.e., those maturing within 12 months at the
reporting date) or non-current assets, as appropriate.
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Internally Generated Intangible Assets regarding Software
Software assets, that is internally developed, comprise administrative applications and serve general purposes to support operations.
Development costs that are directly attributable to the design, customization, implementation, and testing of identifiable and unique software
assets controlled by the Company are recognized as intangible assets from the time that; (1) the software asset is clearly defined and identifiable; (2) technological feasibility, adequate resources to complete, and an internal use of the
software asset can be demonstrated; (3) the expenditure attributable to the software asset can be measured reliably; and (4) the Company has the intention to use the software asset internally.
Following initial recognition of the development expenditure as an asset, the asset is carried at cost less any accumulated amortization and
accumulated impairment losses. Amortization of the asset begins when the development is complete, and the asset is available for use. Software assets are amortized over the period of expected future benefits. Amortization is recognized in research
and development costs, and selling, general and administrative expenses, as appropriate. During the period of development, the asset is tested for impairment, at least annually, or if there are indications that a software asset is impaired.
Expenditures, that do not meet the criteria above are recognized as an expense as incurred. The Company does not capitalize software with no
alternative use, or where economic benefit depends on marketing approvals of product candidates and where such approvals have not been obtained.
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.
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 3 Critical Accounting Judgments and Key Sources of Estimation Uncertainty
In the application of our accounting policies, the Company is required to make judgments, estimates and assumptions about the carrying amounts
of assets and liabilities that are not readily apparent from other sources. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Actual results may differ from these
The 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.
The unaudited condensed consolidated interim financial statements do not include all disclosures for critical accounting judgments and
estimation uncertainties 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,
Critical judgments made in the process of applying our accounting policies and that have the most significant effect on the amounts
recognized in our unaudited condensed consolidated interim financial statements relate to revenue recognition, share-based payment, internally generated intangible assets related to drug development, and to our collaboration agreements.
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. In addition, during the first nine months of 2020, the Company has for the first
time, made accounting judgments and estimates related to pre-launch inventories, as described below.
There have been no other changes to
the application of critical accounting judgments, or estimation uncertainties regarding accounting estimates.
Pre-launch Inventories
In order to accommodate market demands, the Company initiate manufacturing of inventories for late-stage development product candidates prior
to obtaining marketing approvals ( pre-launch inventories ). In determining the accounting for pre-launch inventories, we consider the probability of future benefits, and accordingly, whether pre-launch inventories qualify as assets. Manufacturing of pre-launch inventories are initiated for late-stage product candidates and are recognized as inventories. However,
since pre-launch inventories are not realizable prior to obtaining marketing approvals, pre-launch inventories are immediately written down to 0, through research and
development costs. If the marketing approval is obtained, write-downs of pre-launch inventories are reversed through research and development costs.
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 4 Significant Events in the Reporting Period
Impact from COVID-19 pandemic
As reported in the audited consolidated financial statements as of and for the year ended December 31, 2019, a novel strain of
coronavirus, ( COVID-19 ), was reported to have surfaced in Wuhan, China, in December 2019. Since then, COVID-19 has spread around the world into a pandemic,
including into countries where we are operating from, where we have planned or have ongoing clinical trials, and where we rely on third parties to manufacture preclinical and clinical supplies, as well as commercial supply.
The COVID-19 pandemic may negatively impact our business in many ways. There is a potential evolving
impact on the conduct of clinical trials of our product candidates, and any challenges which may arise, may lead to difficulties in meeting protocol-specified procedures. In addition, while we rely on third parties to manufacture preclinical and
clinical supplies and materials, we can potentially experience delays in providing sufficient supplies according to our planned and ongoing clinical trials. Further, if our product candidates are approved, we will need to secure sufficient
manufacturing capacity with our third-party manufacturers to produce the quantities necessary to meet anticipated market demand, which may be delayed by the pandemic.
In order to deliver on business objectives and to ensure the safety of the patients when conducting clinical trials, we have implemented
several measures. Those measures include implementing remote-visits and ensure safe delivery and dosage of clinical drugs and are continuously monitored and reassessed to ensure efficient and safe conduction of the trials. In addition, we monitor
and have a close dialogue with third-party manufacturing suppliers, in order to mitigate the risk from COVID-19 supplier disruptions.
As of the reporting date, we have not identified significant COVID-19 related disruptions to our
business, including clinical trial operations, or identified any of our third-party manufacturers not being able to meet their obligations. In addition, no significant transactions, as a result of COVID-19,
have been recognized during the first nine months of 2020.
To minimize the risk of spread of
COVID-19, we have taken precautionary measures within our organization, including encouraging our employees to work remotely, reducing travel activity, and minimizing face-to-face meetings. To accommodate efficient procedures for financial reporting, including internal controls, we have, also before the pandemic, structured our work environment to enable our employees to
perform their tasks remotely. Accordingly, it has not been necessary to make material changes to our internal control over financial reporting due to the pandemic.
However, while the global outbreak of COVID-19 continues to impact global societies, the extent to