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6-K Filing
Ascendis Pharma A/S (ASND) 6-KCurrent report (foreign)
Filed: 12 Nov 20, 6:11am
Exhibit 99.1
ASCENDIS PHARMA A/S
INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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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 | ) | |||||||||||
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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 | ) | ||||||||||||
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Profit / (loss) before tax | (121,760 | ) | (25,174 | ) | (280,192 | ) | (137,850 | ) | ||||||||||||
Tax on profit / (loss) for the period | 19 | 61 | 202 | 196 | ||||||||||||||||
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Net profit / (loss) for the period | (121,741 | ) | (25,113 | ) | (279,990 | ) | (137,654 | ) | ||||||||||||
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Attributable to owners of the Company | (121,741 | ) | (25,113 | ) | (279,990 | ) | (137,654 | ) | ||||||||||||
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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 | ||||||||||||||||
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(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 | ||||||||||||||
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Other comprehensive income / (loss) for the period, net of tax | (75 | ) | 37 | (136 | ) | 2 | ||||||||||||||
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Total comprehensive income / (loss) for the period, net of tax | (121,816 | ) | (25,076 | ) | (280,126 | ) | (137,652 | ) | ||||||||||||
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Attributable to owners of the Company | (121,816 | ) | (25,076 | ) | (280,126 | ) | (137,652 | ) | ||||||||||||
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(1) | A total of 5,527,218 warrants outstanding as of September 30, 2020 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 5,138,389 warrants outstanding as of September 30, 2019 are also considered antidilutive for the periods presented and have not been included in the calculation. |
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 | — | |||||||||
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92,523 | 65,565 | |||||||||||
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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 | ||||||||||
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953,601 | 611,167 | |||||||||||
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Total assets | 1,046,124 | 676,732 | ||||||||||
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Equity and liabilities | ||||||||||||
Equity | ||||||||||||
Share capital | 9 | 7,172 | 6,443 | |||||||||
Distributable equity | 944,413 | 590,671 | ||||||||||
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951,585 | 597,114 | |||||||||||
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Non-current liabilities | ||||||||||||
Lease liabilities | 26,952 | 30,720 | ||||||||||
Other payables | 3,160 | 908 | ||||||||||
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30,112 | 31,628 | |||||||||||
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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 | ||||||||||
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64,427 | 47,990 | |||||||||||
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Total liabilities | 94,539 | 79,618 | ||||||||||
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Total equity and liabilities | 1,046,124 | 676,732 | ||||||||||
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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 | ) | ||||||||||||||||
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Total comprehensive income / (loss) | — | — | (136 | ) | — | (279,990 | ) | (280,126 | ) | |||||||||||||||
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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 | ) | ||||||||||||||||
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Equity at September 30, 2020 | 7,172 | 1,717,184 | (170 | ) | 118,712 | (891,313 | ) | 951,585 | ||||||||||||||||
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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 | ||||||||||||||||||
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Total comprehensive income / (loss) | — | — | 2 | — | (137,654 | ) | (137,652 | ) | ||||||||||||||||
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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 | ) | ||||||||||||||||
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Equity at September 30, 2019 | 6,410 | 1,116,821 | 5 | 68,650 | (530,961 | ) | 660,925 | |||||||||||||||||
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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 | ||||||
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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 | ) | |||||
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Cash flows from / (used in) operating activities | (181,216 | ) | (126,700 | ) | ||||
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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 | — | ||||||
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Cash flows from / (used in) investing activities | (220,067 | ) | (4,030 | ) | ||||
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Financing activities | ||||||||
Payment of lease liabilities | (3,480 | ) | (2,992 | ) | ||||
Capital increase | 627,189 | 524,023 | ||||||
Cost of capital increase | (31,373 | ) | (31,701 | ) | ||||
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Cash flows from / (used in) financing activities | 592,336 | 489,330 | ||||||
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Increase / (decrease) in cash and cash equivalents | 191,053 | 358,600 | ||||||
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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 | |||||
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Cash and cash equivalents at September 30 | 763,454 | 658,660 | ||||||
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Cash and cash equivalents include: | ||||||||
Bank deposits | 719,698 | 658,660 | ||||||
Short-term marketable securities | 43,756 | — | ||||||
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Cash and cash equivalents at September 30 | 763,454 | 658,660 | ||||||
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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
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, 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 estimates.
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, 2019.
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 which COVID-19 impacts our business will depend on the future development, which is highly uncertain and cannot be reliably predicted. While COVID-19 continues to impact the world in several aspects, the development is monitored closely by our management, including any impact this may have on the financial performance and financial position.
Submission of Biologic License Application (“BLA”)
On June 25, 2020, the Company submitted a BLA to the U.S. Food and Drug Administration, or the FDA, for TransCon hGH to treat pediatric growth hormone deficiency. In order to accommodate market demands, the Company has initiated manufacturing of inventories prior to obtaining marketing approval. Please refer to Note 3 regarding description of critical accounting judgments and estimation uncertainties on pre-launch inventories.
In addition, the Company has continued building up the commercial organization, including ensuring proper IT systems are in place to support the commercial launch of TransCon hGH.
Completion of Follow-on-public Offering
On July 7, 2020, the Company entered into an underwriting agreement with J.P. Morgan Securities LLC, Morgan Stanley & Co. LLC, Evercore Group L.L.C., and SVB Leerink LLC, as representatives of the several underwriters named therein (collectively, the “Underwriters”), pursuant to which the Company agreed to issue and sell 4,225,352 American Depositary Shares (the “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 $142.00 per ADS, and were purchased by the Underwriters from the Company at a price of $134.90 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 633,802 additional ADSs at the public offering price, less the underwriting commissions. On July 8, 2020, the Underwriters exercised their option to purchase the additional 633,802 ADSs in full.
On July 10, 2020, the Offering closed, and the Company completed the sale and issuance of an aggregate of 4,859,154 ADSs. The Company received net proceeds from the Offering of $654.6 million, or €580.5 million at the date of closing, after deducting the Underwriters’ commissions and offering expenses payable by the Company.
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 5—Revenue
The Company’s revenue is primarily generated from three license agreements, which were entered into in 2018. The licenses grant our associate VISEN Pharmaceuticals (“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 has received up-front, non-refundable, non-cash consideration of $40.0 million in form of 50% ownership in VISEN. Consideration received is recognized partly as license revenue, and partly as rendering of services over time. In addition to granting exclusive rights, the Company will provide clinical trial supply and development services to VISEN.
Three Months Ended September 30, | Nine Months ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(EUR’000) | (EUR’000) | |||||||||||||||
Revenue from external customers | ||||||||||||||||
Revenue from the rendering of services (recognized over time) | 164 | 1,586 | 2,255 | 8,874 | ||||||||||||
Sale of clinical supply (recognized at a point in time) | 1,959 | — | 2,206 | — | ||||||||||||
“Right-to-use” licenses (recognized at a point in time) | 634 | 657 | 1,957 | 1,994 | ||||||||||||
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Total revenue (1) | 2,757 | 2,243 | 6,418 | 10,868 | ||||||||||||
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Attributable to | ||||||||||||||||
VISEN Pharmaceuticals | 2,757 | 2,243 | 6,418 | 10,864 | ||||||||||||
Other collaboration partners | — | — | — | 4 | ||||||||||||
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Total revenue | 2,757 | 2,243 | 6,418 | 10,868 | ||||||||||||
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Revenue by geographical location | ||||||||||||||||
North America | 634 | 2,243 | 1,957 | 10,868 | ||||||||||||
China | 2,123 | — | 4,461 | — | ||||||||||||
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Total revenue | 2,757 | 2,243 | 6,418 | 10,868 | ||||||||||||
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(1) | For the three months ended September 30, 2020 and 2019, and for the nine months ended September 30, 2020 and 2019, “Total revenue” includes recognition of previously deferred revenue/internal profit from associate of €634 thousand and €1,461 thousand, and of €2,849 thousand and €5,337 thousand, respectively. |
Note 6—Segment Information
We are 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, we do not disclose additional information on business segments or geographical markets.
Note 7—Warrants and Share-based Payment
Share-based Payment
Ascendis Pharma A/S has established warrant programs, equity-settled share-based payment transactions, as an incentive for all its employees, members of its Board of Directors and select external 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, 2020, 9,864,587 warrants have been granted, of which 19,580 warrants have been cancelled, 3,842,350 warrants have been exercised, 2,168 warrants have expired without being exercised, and 473,271 warrants have been forfeited. As of September 30, 2020, the Company’s Board of Directors was authorized to grant up to 1,762,700 additional warrants to employees, board members and select consultants without pre-emptive 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 at the time 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 €130.96 depending on the grant dates. Vested warrants may be exercised in two or four annual exercise periods. Apart from exercise prices and exercise periods, the programs are similar.
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Warrant Activity
The following table specifies the warrant activity during the nine months ended September 30, 2020:
Total Warrants | Weighted Average Exercise Price EUR | |||||||
Outstanding at January 1, 2020 | 5,820,211 | 46.36 | ||||||
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Granted during the period | 485,800 | 123.23 | ||||||
Exercised during the period | (571,100 | ) | 26.50 | |||||
Forfeited during the period | (207,693 | ) | 58.89 | |||||
Expired during the period | — | — | ||||||
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Outstanding at September 30, 2020 | 5,527,218 | 54.70 | ||||||
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Vested at September 30, 2020 | 3,072,194 | 34.73 | ||||||
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Warrant Compensation Costs
Warrant compensation costs are determined with basis in the grant date fair value of the warrants granted and recognized over the vesting period.
Three Months Ended September 30, | Nine Months ended September 30, | |||||||||||||||
2020 | 2019 | 2020 | 2019 | |||||||||||||
(EUR’000) | (EUR’000) | |||||||||||||||
Research and development costs | 7,034 | 5,060 | 24,093 | 15,239 | ||||||||||||
Selling, general, and administrative expenses | 3,382 | 3,015 | 14,688 | 10,966 | ||||||||||||
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Total warrant compensation costs | 10,416 | 8,075 | 38,781 | 26,205 | ||||||||||||
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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 and its fair values are specified in following table:
Carrying amount | Fair value | |||||||
(EUR’000) | ||||||||
September 30, 2020 | ||||||||
Marketable securities | ||||||||
U.S. Treasury bills | 118,294 | 118,304 | ||||||
Commercial papers | 24,240 | 24,239 | ||||||
Corporate bonds | 44,285 | 44,424 | ||||||
Agency bonds | 7,252 | 7,259 | ||||||
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Total marketable securities | 194,071 | 194,226 | ||||||
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Classified based on maturity profiles | ||||||||
Non-current assets | 27,728 | 27,811 | ||||||
Current assets | 166,343 | 166,415 | ||||||
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Total marketable securities | 194,071 | 194,226 | ||||||
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Notes to the Unaudited Condensed Consolidated Interim Financial Statements
The Company’s marketable securities are all denominated in U.S. Dollars and have a weighted average duration of 3.0 and 20.2 months, for current and non-current positions, respectively. The entire portfolio of marketable securities has a weighted average duration on 5.5 months.
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 considering in conjunction with the expected loss given default from securities with similar credit rating and attributes. This assessment did not reveal a material expected credit loss, and accordingly, no provision for expected credit loss has been recognized.
Note 9—Share Capital
The share capital of Ascendis Pharma A/S consists of 53,416,091 outstanding shares at a nominal value of DKK 1, all in the same share class.
Note 10—Subsequent Events
No events have occurred after the reporting date that would influence the evaluation of these unaudited condensed consolidated interim financial statements.