Full Press Release Details
Table of Contents
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, 2018 and 2017 | F-2 | |||
| Unaudited Condensed Consolidated Interim Statements of Financial Position as of September 30, 2018 and December 31, 2017 | F-3 | |||
| Unaudited Condensed Consolidated Interim Statements of Changes in Equity at September 30, 2018 and 2017 | F-4 | |||
| Unaudited Condensed Consolidated Interim Cash Flow Statements for the Nine Months Ended September 30, 2018 and 2017 | F-5 | |||
| Notes to the Unaudited Condensed Consolidated Interim Financial Statements | F-6 |
Table of Contents
Unaudited Condensed Consolidated Interim Statements of Profit
and Other Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30
| Three Months Ended September 30 | Nine Months Ended September 30 | |||||||||||||||||||
| Notes | 2018 | 2017 | 2018 | 2017 | ||||||||||||||||
| (EUR 000) | (EUR 000) | |||||||||||||||||||
| Revenue | 4 | 20 | 434 | 66 | 1,250 | |||||||||||||||
| Research and development costs | (31,511 | ) | (29,067 | ) | (102,286 | ) | (71,555 | ) | ||||||||||||
| General and administrative expenses | (6,796 | ) | (2,840 | ) | (16,684 | ) | (9,396 | ) | ||||||||||||
| Operating profit / (loss) | (38,287 | ) | (31,473 | ) | (118,904 | ) | (79,701 | ) | ||||||||||||
| Finance income | 4,262 | 165 | 20,532 | 453 | ||||||||||||||||
| Finance expenses | (42 | ) | (2,809 | ) | (53 | ) | (10,765 | ) | ||||||||||||
| Profit / (loss) before tax | (34,067 | ) | (34,117 | ) | (98,425 | ) | (90,013 | ) | ||||||||||||
| Tax on profit / (loss) for the period | 100 | 240 | 306 | 291 | ||||||||||||||||
| Net profit / (loss) for the period | (33,967 | ) | (33,877 | ) | (98,119 | ) | (89,722 | ) | ||||||||||||
| Other comprehensive income / (loss) | ||||||||||||||||||||
| Items that may be reclassified subsequently to profit or loss: | ||||||||||||||||||||
| Exchange differences on translating foreign operations | (9 | ) | (5 | ) | (16 | ) | 41 | |||||||||||||
| Other comprehensive income / (loss) for the period, net of tax | (9 | ) | (5 | ) | (16 | ) | 41 | |||||||||||||
| Total comprehensive income / (loss) for the period, net of tax | (33,976 | ) | (33,882 | ) | (98,135 | ) | (89,681 | ) | ||||||||||||
| Profit / (loss) for the period attributable to owners of the Company | (33,967 | ) | (33,877 | ) | (98,119 | ) | (89,722 | ) | ||||||||||||
| Total comprehensive income / (loss) for the period attributable to owners of the Company | (33,976 | ) | (33,882 | ) | (98,135 | ) | (89,681 | ) | ||||||||||||
| EUR | EUR | EUR | EUR | |||||||||||||||||
| Basic and diluted earnings / (loss) per share | (0.81 | ) | (1.04 | ) | (2.41 | ) | (2.76 | ) | ||||||||||||
| Number of shares used for calculation (basic and diluted) (1) | 41,888,908 | 32,607,497 | 40,757,686 | 32,513,641 |
Table of Contents
Unaudited Condensed Consolidated Interim Statements of
| Notes | September 30, 2018 | December 31, 2017 | ||||||||||
| (EUR 000) | ||||||||||||
| Assets | ||||||||||||
| Non-current assets | ||||||||||||
| Intangible assets | 3,495 | 3,495 | ||||||||||
| Property, plant and equipment | 3,513 | 2,557 | ||||||||||
| Deposits | 1,241 | 293 | ||||||||||
| 8,249 | 6,345 | |||||||||||
| Current assets | ||||||||||||
| Trade receivables | 21 | 188 | ||||||||||
| Other receivables | 2,750 | 1,410 | ||||||||||
| Prepayments | 12,390 | 6,907 | ||||||||||
| Income taxes receivable | 1,491 | 778 | ||||||||||
| Cash and cash equivalents | 310,333 | 195,351 | ||||||||||
| 326,985 | 204,634 | |||||||||||
| Total assets | 335,234 | 210,979 | ||||||||||
| Equity and liabilities | ||||||||||||
| Equity | ||||||||||||
| Share capital | 7 | 5,645 | 4,967 | |||||||||
| Distributable equity | 298,560 | 182,244 | ||||||||||
| Total equity | 304,205 | 187,211 | ||||||||||
| Current liabilities | ||||||||||||
| Trade payables and other payables | 31,021 | 23,768 | ||||||||||
| Income taxes payable | 8 | |||||||||||
| Total liabilities | 31,029 | 23,768 | ||||||||||
| Total equity and liabilities | 335,234 | 210,979 |
Table of Contents
Unaudited Condensed Consolidated Interim Statements of
| Distributable Equity | ||||||||||||||||||||||||
| Share Capital | Share Premium | Foreign Currency Translation Reserve | Share- based Payment Reserve | Accumulated Deficit | Total | |||||||||||||||||||
| (EUR 000) | ||||||||||||||||||||||||
| Equity at December 31, 2017 | 4,967 | 422,675 | (14 | ) | 22,793 | (263,210 | ) | 187,211 | ||||||||||||||||
| Loss for the period | (98,119 | ) | (98,119 | ) | ||||||||||||||||||||
| Other comprehensive income / (loss), net of tax | (16 | ) | (16 | ) | ||||||||||||||||||||
| Total comprehensive income / (loss) | (16 | ) | (98,119 | ) | (98,135 | ) | ||||||||||||||||||
| Share-based payment (Note 6) | 12,787 | 12,787 | ||||||||||||||||||||||
| Capital increase | 678 | 214,782 | 215,460 | |||||||||||||||||||||
| Cost of capital increase | (13,118 | ) | (13,118 | ) | ||||||||||||||||||||
| Equity at September 30, 2018 | 5,645 | 624,339 | (30 | ) | 35,580 | (361,329 | ) | 304,205 |
| Distributable Equity | ||||||||||||||||||||||||
| Share Capital | Share Premium | Foreign Currency Translation Reserve | Share- based Payment Reserve | Accumulated Deficit | Total | |||||||||||||||||||
| (EUR 000) | ||||||||||||||||||||||||
| Equity at December 31, 2016 | 4,354 | 298,567 | (79 | ) | 13,084 | (139,313 | ) | 176,613 | ||||||||||||||||
| Loss for the period | (89,722 | ) | (89,722 | ) | ||||||||||||||||||||
| Other comprehensive income / (loss), net of tax | 41 | 41 | ||||||||||||||||||||||
| Total comprehensive income / (loss) | 41 | (89,722 | ) | (89,681 | ) | |||||||||||||||||||
| Share-based payment (Note 6) | 6,923 | 6,923 | ||||||||||||||||||||||
| Capital increase | 530 | 114,975 | 115,505 | |||||||||||||||||||||
| Cost of capital increase | (7,210 | ) | (7,210 | ) | ||||||||||||||||||||
| Equity at September 30, 2017 | 4,884 | 406,332 | (38 | ) | 20,007 | (229,035 | ) | 202,150 |
Table of Contents
Unaudited Condensed Consolidated Interim Cash Flow Statements
Nine Months Ended September 30
| Notes | 2018 | 2017 | ||||||||||
| (EUR 000) | ||||||||||||
| Operating activities | ||||||||||||
| Net profit / (loss) for the period | (98,119 | ) | (89,722 | ) | ||||||||
| Reversal of finance income | (20,532 | ) | (453 | ) | ||||||||
| Reversal of finance expenses | 53 | 10,765 | ||||||||||
| Reversal of tax charge | (306 | ) | (291 | ) | ||||||||
| Adjustments for: | ||||||||||||
| Share-based payment | 12,787 | 6,923 | ||||||||||
| Depreciation and amortization | 631 | 537 | ||||||||||
| Changes in working capital: | ||||||||||||
| Deposits | (948 | ) | (15 | ) | ||||||||
| Trade receivables | 167 | (157 | ) | |||||||||
| Other receivables | (1,340 | ) | 32 | |||||||||
| Prepayments | (5,482 | ) | (5,243 | ) | ||||||||
| Trade payables and other payables | 7,237 | 6,554 | ||||||||||
| Cash flows generated from / (used in) operations | (105,852 | ) | (71,070 | ) | ||||||||
| Finance income received | 3,065 | 453 | ||||||||||
| Finance expenses paid | (53 | ) | (80 | ) | ||||||||
| Income taxes received / (paid) | (400 | ) | (245 | ) | ||||||||
| Cash flows from / (used in) operating activities | (103,240 | ) | (70,942 | ) | ||||||||
| Investing activities | ||||||||||||
| Acquisition of property, plant and equipment | (1,587 | ) | (706 | ) | ||||||||
| Cash flows from / (used in) investing activities | (1,587 | ) | (706 | ) | ||||||||
| Financing activities | ||||||||||||
| Capital increase | 215,460 | 115,505 | ||||||||||
| Cost of capital increase | (13,118 | ) | (7,210 | ) | ||||||||
| Cash flows from / (used in) financing activities | 202,342 | 108,295 | ||||||||||
| Increase / (decrease) in cash and cash equivalents | 97,515 | 36,647 | ||||||||||
| Cash and cash equivalents at January 1 | 195,351 | 180,329 | ||||||||||
| Effect of exchange rate changes on balances held in foreign currencies | 17,467 | (10,684 | ) | |||||||||
| Cash and cash equivalents at September 30 | 310,333 | 206,292 | ||||||||||
| Restricted cash included in cash and cash equivalents | 5,507 |
Table of Contents
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 technology to build a
leading, fully integrated rare disease 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, or IPO, 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 28, 2018.
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
consolidated financial statements prepared in accordance with International Financial Reporting Standards ( IFRS ) have been condensed or omitted. Accordingly, these condensed consolidated interim financial statements should be read in
conjunction with the Company s annual consolidated financial statements for the year ended December 31, 2017 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 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 condensed consolidated interim financial statements are disclosed in Note 3.
Changes in Accounting Policies
As of January 1, 2018, the Company has adopted IFRS 9, Financial Instruments , which introduces a new impairment model for
financial assets measured at amortized cost based on an expected credit loss model, which currently applies to the Company s bank deposits and trade receivables. The adoption of IFRS 9 had no material impact on the Company s financial
reporting. Further, the Company has adopted IFRS 15, Revenue from Contracts with Customers , which establishes a single, comprehensive framework for revenue recognition, based on a five-step model, which applies to the Company s
licensing agreements with multiple activities. IFRS 15 was adopted using the retrospective method with the cumulative effect of initially applying this standard recognized at the date of the initial application . The adoption of
IFRS 15 had no impact on the Company s financial reporting.
Except for the adoption of these two new standards, the accounting
policies applied when preparing these condensed consolidated interim financial statements have been applied consistently to all the periods presented, unless otherwise stated and are consistent with those of the Company s most recent annual
consolidated financial statements. 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, 2017.
Table of Contents
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, we are 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.
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 financial statements relate to revenue recognition, share-based payment, internally generated intangible assets, and joint arrangements / 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 relate to impairment of goodwill and to recognition of accruals for manufacturing and clinical trial activities. There have been no changes to the application of significant accounting estimates, and no
impairment losses have been recognized during the first nine months of 2018 or 2017.
The unaudited condensed consolidated interim
financial statements do not include all disclosures for critical accounting estimates and judgments that are required in the annual consolidated financial statements, and should be read in conjunction with the Company s annual consolidated
financial statements for the year ended December 31, 2017.
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| (EUR 000) | (EUR 000) | |||||||||||||||
| Revenue from the rendering of services | 20 | 434 | 66 | 1,250 | ||||||||||||
| Total revenue | 20 | 434 | 66 | 1,250 | ||||||||||||
| Revenue from external customers (geographical) | ||||||||||||||||
| USA | 20 | 434 | 66 | 1,250 | ||||||||||||
| Total revenue | 20 | 434 | 66 | 1,250 |
Note 5 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 information on business segments or geographical markets, except for the geographical information on revenue included in Note 4.
Table of Contents
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 6 Warrants and Share-based Payment
Pharma A/S has established warrant programs, equity-settled share-based payment transactions, as an incentive for all our employees, members of our Board of Directors and select external consultants.
Warrants are granted by the Board of Directors in accordance with authorizations given to it by the shareholders of Ascendis Pharma A/S. As of
September 30, 2018, 6,841,937 warrants had been granted, of which 19,580 warrants have been cancelled, 2,109,602 warrants have been exercised, 2,168 warrants have expired without being exercised, and 229,782 warrants have been forfeited. As of
September 30, 2018, our Board of Directors was authorized to grant up to 3,774,375 additional warrants to our employees, board members and select consultants without pre-emptive subscription rights for
the shareholders of Ascendis Pharma A/S. 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 our ordinary shares at the time of grant as determined
by our Board of Directors. The exercise prices of outstanding warrants under our warrant programs range from 6.48 to 60.23 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.
The following table specifies the warrant activity during the nine months ended September 30, 2018:
| Total Warrants | Weighted Average Exercise Price EUR | |||||||
| Outstanding at December 31, 2017 | 4,621,154 | 17.62 | ||||||
| Granted during the period | 401,125 | 53.37 | ||||||
| Exercised during the period | (508,757 | ) | 11.16 | |||||
| Forfeited during the period | (32,717 | ) | 26.23 | |||||
| Expired during the period | ||||||||
| Outstanding at September 30, 2018 | 4,480,805 | 21.49 | ||||||
| Vested at the balance sheet date | 2,318,357 | 14.57 |
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
| Three Months Ended September 30, | Nine Months Ended September 30, | |||||||||||||||
| 2018 | 2017 | 2018 | 2017 | |||||||||||||
| (EUR 000) | (EUR 000) | |||||||||||||||
| Research and development costs | 1,963 | 894 | 6,313 | 3,305 | ||||||||||||
| General and administrative expenses | 1,922 | 1,018 | 6,474 | 3,618 | ||||||||||||
| Total warrant compensation costs | 3,885 | 1,912 | 12,787 | 6,923 |
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Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 7 Share Capital
The share capital of Ascendis Pharma A/S consists of 42,032,522 shares at a nominal value of DKK 1, all in the same share class.
On February 26, 2018, the Company completed the sale and issuance of 4,539,473 ADSs in a public offering, increasing the Company s
share capital from 36,984,292 shares to 41,523,765 shares.
In April and June 2018, an aggregate of 317,825 warrants were exercised,
increasing the Company s share capital from 41,523,765 shares to 41,841,590 shares.
In September 2018, an aggregate of 190,932
warrants were exercised, increasing the Company s share capital from 41,841,590 shares to 42,032,522 shares.
Note 8 Subsequent Events
On November 8, 2018 the Company announced the formation of Visen Pharmaceuticals, a company established to develop, manufacture
and commercialize Ascendis endocrinology rare disease therapies in the People s Republic of China, including Hong Kong, Macau and Taiwan ( Greater China ). In connection with the formation of the company, Ascendis granted Visen
Pharmaceuticals exclusive rights to develop and commercialize endocrinology therapeutic products based on our proprietary TransCon technology in Greater China, subject to certain exceptions. As consideration for the rights granted to Visen
Pharmaceuticals, Ascendis received 50% ownership in the outstanding shares of Visen Pharmaceuticals and concurrently, entities affiliated with Vivo Capital and Sofinnova Ventures purchased shares in Visen Pharmaceutical for an aggregate purchase
price of $40,000,000 in cash.
No other events have occurred after the balance sheet date that would have a significant impact on the
results or financial position of the Company.