UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 6-K
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of May, 2018
Commission File Number: 001-36815
Ascendis Pharma A/S
(Exact Name of Registrant as Specified in Its Charter)
Tuborg Boulevard 5
DK-2900 Hellerup
Denmark
(Address of principal executive offices)
Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.
Form 20-F ☒ Form 40-F ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): ☐
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): ☐
INCORPORATION BY REFERENCE
Exhibits 99.1 and 99.2 of this report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-203040, 333-210810, 333-211512, 333-213412, 333-214843 and 333-216883) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882 and 333-223134) of Ascendis Pharma A/S (the “Company”) (including any prospectuses forming a part of such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Furnished as exhibits to this Report on Form 6-K is information regarding the Company’s financial results for the fiscal quarter ended March 31, 2018.
Exhibits
|
Exhibit No. |
Description | |
| 99.1 | Unaudited Condensed Consolidated Interim Financial Statements. | |
| 99.2 | Management’s Discussion and Analysis of Financial Condition and Results of Operations. | |
| 99.3 | Press Release dated May 30, 2018. | |
| EX-101.INS | XBRL Instance Document. | |
| EX-101.SCH | XBRL Taxonomy Extension Schema Document. | |
| EX-101.CAL | XBRL Taxonomy Extension Calculation Linkbase Document. | |
| EX-101.DEF | XBRL Taxonomy Extension Definition Linkbase Document. | |
| EX-101.IAB | XBRL Taxonomy Extension Labels Linkbase Document. | |
| EX-101.PRE | XBRL Taxonomy Extension Presentation Linkbase Document. | |
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| Ascendis Pharma A/S | ||||||
| Date: May 30, 2018 | By: | /s/ Michael Wolff Jensen | ||||
| Michael Wolff Jensen Chairman and Senior Vice President, General Counsel | ||||||
Table of Contents
Exhibit 99.1
INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
| Page | ||||
| F-2 | ||||
| F-3 | ||||
| Unaudited Condensed Consolidated Interim Statements of Changes in Equity at March 31, 2018 and 2017 |
F-4 | |||
| F-5 | ||||
| Notes to the Unaudited Condensed Consolidated Interim Financial Statements |
F-6 | |||
Table of Contents
Unaudited Condensed Consolidated Interim Statements of Profit or Loss
and Other Comprehensive Income / (Loss) for the Three Months Ended March 31
| Consolidated | ||||||||||||
| Notes | 2018 | 2017 | ||||||||||
| (EUR’000) | ||||||||||||
| Revenue |
4 | 28 | 372 | |||||||||
| Research and development costs |
(30,540 | ) | (20,608 | ) | ||||||||
| General and administrative expenses |
(4,662 | ) | (3,325 | ) | ||||||||
|
|
|
|
|
|||||||||
| Operating profit / (loss) |
(35,174 | ) | (23,561 | ) | ||||||||
| Finance income |
702 | 130 | ||||||||||
| Finance expenses |
(7,010 | ) | (1,722 | ) | ||||||||
|
|
|
|
|
|||||||||
| Profit / (loss) before tax |
(41,482 | ) | (25,153 | ) | ||||||||
| Tax on profit / (loss) for the period |
107 | 14 | ||||||||||
|
|
|
|
|
|||||||||
| Net profit / (loss) for the period |
(41,375 | ) | (25,139 | ) | ||||||||
|
|
|
|
|
|||||||||
| Other comprehensive income / (loss) |
||||||||||||
| Items that may be reclassified subsequently to profit or loss: |
||||||||||||
| Exchange differences on translating foreign operations |
(9 | ) | 4 | |||||||||
|
|
|
|
|
|||||||||
| Other comprehensive income / (loss) for the period, net of tax |
(9 | ) | 4 | |||||||||
|
|
|
|
|
|||||||||
| Total comprehensive income / (loss) for the period, net of tax |
(41,384 | ) | (25,135 | ) | ||||||||
|
|
|
|
|
|||||||||
| Profit / (loss) for the period attributable to owners of the Company |
(41,375 | ) | (25,139 | ) | ||||||||
| Total comprehensive income / (loss) for the period attributable to owners of the Company |
(41,384 | ) | (25,135 | ) | ||||||||
| EUR | EUR | |||||||||||
| Basic and diluted earnings / (loss) per share |
(1.07 | ) | (0.78 | ) | ||||||||
| Number of shares used for calculation (basic and diluted)(1) |
38,699,204 | 32,428,908 | ||||||||||
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|||||||||
| (1) | A total of 4,657,891 warrants outstanding as of March 31, 2018 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 period presented. Similarly, a total of 3,613,757 warrants outstanding as of March 31, 2017 are also considered antidilutive for the period presented and have not been included in the calculation. |
F-2
Table of Contents
Unaudited Condensed Consolidated Interim Statements of Financial Position
| Notes | March 31, 2018 |
December 31, 2017 |
||||||||||
| (EUR’000) | ||||||||||||
| Assets |
||||||||||||
| Non-current assets |
||||||||||||
| Intangible assets |
3,495 | 3,495 | ||||||||||
| Property, plant and equipment |
2,461 | 2,557 | ||||||||||
| Deposits |
1,112 | 293 | ||||||||||
|
|
|
|
|
|||||||||
| 7,068 | 6,345 | |||||||||||
| Current assets |
||||||||||||
| Trade receivables |
34 | 188 | ||||||||||
| Other receivables |
1,128 | 1,410 | ||||||||||
| Prepayments |
7,119 | 6,907 | ||||||||||
| Income taxes receivable |
1,067 | 778 | ||||||||||
| Cash and cash equivalents |
348,410 | 195,351 | ||||||||||
|
|
|
|
|
|||||||||
| 357,758 | 204,634 | |||||||||||
|
|
|
|
|
|||||||||
| Total assets |
364,826 | 210,979 | ||||||||||
|
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|
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|
|||||||||
| Equity and liabilities |
||||||||||||
| Equity |
||||||||||||
| Share capital |
7 | 5,577 | 4,967 | |||||||||
| Distributable equity |
341,836 | 182,244 | ||||||||||
|
|
|
|
|
|||||||||
| Total equity |
347,413 | 187,211 | ||||||||||
|
|
|
|
|
|||||||||
| Current liabilities |
||||||||||||
| Trade payables and other payables |
17,413 | 23,768 | ||||||||||
|
|
|
|
|
|||||||||
| Total liabilities |
17,413 | 23,768 | ||||||||||
|
|
|
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|
|||||||||
| Total equity and liabilities |
364,826 | 210,979 | ||||||||||
|
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|
|
|
|||||||||
F-3
Table of Contents
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
| Distributable Equity | ||||||||||||||||||||||||
| (EUR’000) | ||||||||||||||||||||||||
| Share Capital |
Share Premium |
Foreign Currency Translation Reserve |
Share-based Payment Reserve |
Accumulated Deficit |
Total | |||||||||||||||||||
| Equity at December 31, 2017 |
4,967 | 422,675 | (14 | ) | 22,793 | (263,210 | ) | 187,211 | ||||||||||||||||
| Loss for the period |
— | — | — | — | (41,375 | ) | (41,375 | ) | ||||||||||||||||
| Other comprehensive income / (loss), net of tax |
— | — | (9 | ) | — | — | (9 | ) | ||||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Total comprehensive income / (loss) |
— | — | (9 | ) | — | (41,375 | ) | (41,384 | ) | |||||||||||||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||||||||
| Share-based payment (Note 6) |
— | — | — | 4,679 | — | 4,679 | ||||||||||||||||||
| Capital increase |
610 | 209,415 | — | — | — | 210,025 | ||||||||||||||||||
| Cost of capital increase |
— | (13,118 | ) | — | — | — | (13,118 | ) | ||||||||||||||||
|
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|
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|
|||||||||||||
| Equity at March 31, 2018 |
5,577 | 618,972 | (23 | ) | 27,472 | (304,585 | ) | 347,413 | ||||||||||||||||
|
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|
|||||||||||||
| Distributable Equity | ||||||||||||||||||||||||
| (EUR’000) | ||||||||||||||||||||||||
| Share Capital |
Share Premium |
Foreign Currency Translation Reserve |
Share-based Payment Reserve |
Accumulated Deficit |
Total | |||||||||||||||||||
| Equity at December 31, 2016 |
4,354 | 298,567 | (79 | ) | 13,084 | (139,313 | ) | 176,613 | ||||||||||||||||
| Loss for the period |
— | — | — | (25,139 | ) | (25,139 | ) | |||||||||||||||||
| Other comprehensive income / (loss), net of tax |
— | 4 | — | — | 4 | |||||||||||||||||||
|
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|
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|
|||||||||||||
| Total comprehensive income / (loss) |
— | 4 | — | (25,139 | ) | (25,135 | ) | |||||||||||||||||
| Share-based payment (Note 6) |
— | — | 2,705 | — | 2,705 | |||||||||||||||||||
| Capital increase |
11 | 633 | — | — | — | 644 | ||||||||||||||||||
|
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|
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|
|||||||||||||
| Equity at March 31, 2017 |
4,365 | 299,200 | (75 | ) | 15,789 | (164,452 | ) | 154,827 | ||||||||||||||||
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F-4
Table of Contents
Unaudited Condensed Consolidated Interim Cash Flow Statements for the
Three Months Ended March 31
| Consolidated | ||||||||||||
| Notes | 2018 | 2017 | ||||||||||
| (EUR’000) | ||||||||||||
| Operating activities |
||||||||||||
| Net profit / (loss) for the period |
(41,375 | ) | (25,139 | ) | ||||||||
| Reversal of finance income |
(702 | ) | (130 | ) | ||||||||
| Reversal of finance expenses |
7,010 | 1,722 | ||||||||||
| Reversal of tax charge |
(107 | ) | (14 | ) | ||||||||
| Adjustments for: |
||||||||||||
| Share-based payment |
4,679 | 2,705 | ||||||||||
| Depreciation and amortization |
198 | 169 | ||||||||||
| Changes in working capital: |
||||||||||||
| Deposits |
(819 | ) | 1 | |||||||||
| Trade receivables |
154 | (91 | ) | |||||||||
| Other receivables |
282 | (1,281 | ) | |||||||||
| Prepayments |
(211 | ) | (3,662 | ) | ||||||||
| Trade payables and other payables |
(6,364 | ) | 4,419 | |||||||||
| Deferred income |
— | — | ||||||||||
|
|
|
|
|
|||||||||
| Cash flows generated from / (used in) operations |
(37,255 | ) | (21,301 | ) | ||||||||
| Finance income received |
702 | 130 | ||||||||||
| Finance expenses paid |
(4 | ) | (25 | ) | ||||||||
| Income taxes received / (paid) |
(183 | ) | (54 | ) | ||||||||
|
|
|
|
|
|||||||||
| Cash flows from / (used in) operating activities |
(36,740 | ) | (21,250 | ) | ||||||||
|
|
|
|
|
|||||||||
| Investing activities |
||||||||||||
| Acquisition of property, plant and equipment |
(102 | ) | (377 | ) | ||||||||
|
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|
|
|
|||||||||
| Cash flows used in investing activities |
(102 | ) | (377 | ) | ||||||||
|
|
|
|
|
|||||||||
| Financing activities |
||||||||||||
| Capital increase |
210,025 | 644 | ||||||||||
| Cost of capital increase |
(13,118 | ) | — | |||||||||
|
|
|
|
|
|||||||||
| Cash flows from / (used in) financing activities |
196,907 | 644 | ||||||||||
|
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|
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|
|||||||||
| Increase / (decrease) in cash and cash equivalents |
160,065 | (20,983 | ) | |||||||||
|
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|
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|
|||||||||
| Cash and cash equivalents at January 1 |
195,351 | 180,329 | ||||||||||
| Effect of exchange rate changes on balances held in foreign currencies |
(7,006 | ) | (1,698 | ) | ||||||||
|
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|
|||||||||
| Cash and cash equivalents at March 31 |
348,410 | 157,648 | ||||||||||
|
|
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|
|||||||||
| Restricted cash included in cash and cash equivalents |
5,142 | 63 | ||||||||||
|
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F-5
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 5, 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 May 30, 2018.
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 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.
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 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.
F-6
Table of Contents
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
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 three 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.
Note 4—Revenue
| Consolidated | ||||||||
| Three Months Ended March 31, |
||||||||
| 2018 | 2017 | |||||||
| (EUR’000) | ||||||||
| Revenue from the rendering of services |
28 | 372 | ||||||
| License income |
— | — | ||||||
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|
|
|
|
|||||
| Total revenue |
28 | 372 | ||||||
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| Revenue from external customers (geographical) |
||||||||
| USA |
28 | 372 | ||||||
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| Total revenue |
28 | 372 | ||||||
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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.
Note 6—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 of our employees, members of our Board of Directors and select external consultants.
Warrants are granted by our Board of Directors in accordance with authorizations given to it by the shareholders of Ascendis Pharma A/S. As of March 31, 2018, 6,487,812 warrants had been granted, of which 19,580 warrants have been cancelled, 1,600,845 warrants have been exercised, 2,168 warrants have expired without being exercised, and 207,328 warrants have been forfeited. As of March 31, 2018, our Board of Directors was authorized to grant up to 1,531,592 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 €54.10 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.
F-7
Table of Contents
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Warrant Activity
The following table specifies the warrant activity during the three months ended March 31, 2018:
| Total Warrants |
Weighted Average Exercise Price EUR |
|||||||
| Outstanding at December 31, 2017 |
4,621,154 | 17.62 | ||||||
|
|
|
|
|
|||||
| Granted during the period |
47,000 | 42.85 | ||||||
| Exercised during the period |
— | — | ||||||
| Forfeited during the period |
(10,263 | ) | 24.25 | |||||
| Expired during the period |
— | — | ||||||
|
|
|
|
|
|||||
| Outstanding at March 31, 2018 |
4,657,891 | 17.86 | ||||||
|
|
|
|
|
|||||
| Vested at the balance sheet date |
2,298,231 | 12.38 | ||||||
|
|
|
|
|
|||||
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.
| Consolidated | ||||||||
| Three months Ended March 31, |
||||||||
| 2018 | 2017 | |||||||
| (EUR’000) | ||||||||
| Research and development costs |
2,386 | 1,289 | ||||||
| General and administrative expenses |
2,293 | 1,416 | ||||||
|
|
|
|
|
|||||
| Total warrant compensation costs |
4,679 | 2,705 | ||||||
|
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|
|
|
|||||
Note 7—Share Capital
The share capital of Ascendis Pharma A/S consists of 41,523,765 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.
Note 8—Subsequent Events
No events have occurred after the balance sheet date that would have a significant impact on the results or financial position of the Company.
F-8
Exhibit 99.2
ASCENDIS PHARMA A/S
MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND
RESULTS OF OPERATIONS
You should read the following discussion and analysis of our financial condition and results of operations in conjunction with our unaudited condensed consolidated interim financial statements, including the notes thereto, included with this report and the section contained in our Annual Report on Form 20-F for the year ended December 31, 2017 – “Item 5. Operating and Financial Review and Prospects”. The following discussion is based on our financial information 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. IFRS as issued by the International Accounting Standards Board, and as adopted by the European Union, might differ in material respects from generally accepted accounting principles in other jurisdictions.
Special Note Regarding Forward-Looking Statements
This report contains forward-looking statements concerning our business, operations and financial performance and conditions, as well as our plans, objectives and expectations for our business operations and financial performance and conditions. Any statements contained herein that are not statements of historical facts may be deemed to be forward-looking statements. In some cases, you can identify forward-looking statements by terminology such as “aim,” “anticipate,” “assume,” “believe,” “contemplate,” “continue,” “could,” “due,” “estimate,” “expect,” “goal,” “intend,” “may,” “objective,” “plan,” “predict,” “potential,” “positioned,” “seek,” “should,” “target,” “will,” “would,” and other similar expressions that are predictions or indicate future events and future trends, or the negative of these terms or other comparable terminology. These forward-looking statements include, but are not limited to, statements about:
| • | our ongoing Phase 3 pediatric studies of TransCon Growth Hormone or GH, and our Phase 1 study of TransCon C-Type Natriuretic Peptide, or CNP; |
| • | our receipt of future milestone or royalty payments from our collaboration partners, and the expected timing of such payments; |
| • | our expectations regarding the potential market size and the size of the patient populations for our product candidates, if approved for commercial use; |
| • | our expectations regarding the potential advantages of our product candidates over existing therapies; |
| • | our ability to enter into new collaborations; |
| • | our expectations with regard to the ability to develop additional product candidates using our TransCon technology; |
| • | our expectations with regard to the ability to seek expedited regulatory approval pathways for our product candidates, including the potential ability to rely on the parent drug’s clinical and safety data with regard to our product candidates; |
| • | our expectations with regard to our current and future collaboration partners to pursue the development of our product candidates; |
| • | our development plans with respect to our product candidates; |
| • | our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials; |
| • | the timing or likelihood of regulatory filings and approvals for our product candidates; |
| • | the commercialization of our product candidates, if approved; |
| • | our commercialization, marketing and manufacturing capabilities of our product candidates and associated devices; |
| • | the implementation of our business model and strategic plans for our business, product candidates and technology; |
| • | the scope of protection we are able to establish and maintain for intellectual property rights covering our product candidates; |
| • | estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; |
| • | our expectations regarding the time during which we will be an emerging growth company under the Jumpstart Our Business Startups Act of 2012; |
| • | our financial performance; and |
| • | developments and projections relating to our competitors and our industry. |
These forward-looking statements are based on senior management’s current expectations, estimates, forecasts and projections about our business and the industry in which we operate and involve known and unknown risks, uncertainties and other factors that are in some cases beyond our control. As a result, any or all of our forward-looking statements in this report may turn out to be inaccurate. Factors that may cause actual results to differ materially from current expectations include, among other things, those listed under the section in our Annual Report on Form 20-F for the year ended December 31, 2017 — “Item 3.D. Risk Factors”. You are urged to consider these factors carefully in evaluating the forward-looking statements. These forward-looking statements speak only as of the date of this report. Except as required by law, we assume no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future. Given these risks and uncertainties, you are cautioned not to rely on such forward-looking statements as predictions of future events.
You should read this report and the documents that we reference in this report and have filed as exhibits to this report completely and with the understanding that our actual future results may be materially different from what we expect. You should also review the factors and risks we describe in the reports we will file or submit from time to time with the Securities and Exchange Commission (the “SEC”) after the date of this report. We qualify all of our forward-looking statements by these cautionary statements.
Overview
We are a biopharmaceutical company applying our innovative TransCon technology to build a leading, fully integrated rare disease company. We are developing a pipeline of prodrug therapies with potential best-in-class profiles to address significant unmet medical needs. We have created a portfolio of potential best-in-class rare disease endocrinology product candidates to address unmet medical needs by utilizing our TransCon technology with clinically validated parent drugs. We currently have three product candidates in clinical development.
Our most advanced product candidate, TransCon GH, is in development as a once-weekly therapy to treat growth hormone deficiency, or GHD, and other indications. In January 2018, we completed enrollment in the pivotal Phase 3 trial of TransCon GH, the heiGHt Trial, in children with GHD and the observed aggregate data from the heiGHt Trial continue to demonstrate a safety profile consistent with the published safety profile of the active comparator, Genotropin. We anticipate top-line data from the ongoing heiGHt Trial in the first quarter of 2019. We are also conducting two additional trials, the fliGHt Trial, which evaluates TransCon GH in subjects previously treated with daily GH, and the enliGHten Trial, which evaluates long-term safety of TransCon GH in subjects from both the heiGHt and fliGHt Trials. We believe that TransCon GH may offer a once-weekly therapy for pediatric GHD with comparable safety, efficacy and tolerability to currently approved daily recombinant human growth hormone, known as rhGH or GH. Clinical trials of TransCon GH have demonstrated a comparable efficacy, safety, tolerability and immunogenic profile to that of daily growth hormone. If approved, TransCon GH may reduce the burden of daily treatment by requiring significantly fewer injections, which may improve compliance and treatment outcomes.
We are also using our TransCon technology platform to develop TransCon PTH, which is designed as a once-daily long-acting injectable prodrug of parathyroid hormone, or PTH, as a potential treatment for hypoparathyroidism, a rare endocrine disorder of calcium and phosphate metabolism. We completed a Phase 1 trial in healthy subjects in May 2018, the results of which were consistent with our target product profile for TransCon PTH. In this trial, TransCon PTH showed the predicted pharmacokinetic and pharmacodynamic response, suggesting the ability to normalize serum and urinary calcium levels in patients with hypoparathyroidism. We believe our TransCon PTH may provide patients suffering from hypoparathyroidism with a PTH replacement therapy that is designed to fully address all aspects of the disease more than standard of care or currently approved therapies.
We are also developing TransCon CNP, a long-acting prodrug of C-type natriuretic peptide, for the treatment of achondroplasia, the most common form of dwarfism. Currently, there are no medical therapies for achondroplasia approved by the FDA. TransCon CNP utilizes our TransCon technology platform to deliver a long-acting C-type natriuretic peptide, or CNP, prodrug as a therapeutic option for achondroplasia and potentially other skeletal disorders. CNP as a therapeutic approach is supported by extensive preclinical and clinical data. In May 2018, we initiated dosing of healthy subjects in a Phase 1 clinical trial of TransCon CNP. We anticipate top-line results from this trial in the fourth quarter of 2018.
In addition to our wholly-owned candidates in rare endocrine disorders, we have developed a pipeline of sustained release prodrug product candidates through strategic collaborations. These include TransCon anti-VEGF in the field of ophthalmology, which is partnered with Genentech, and the TransCon peptide program for treatment of diabetes, which is partnered with Sanofi. We are eligible to receive up to an aggregate of €200 million in development and regulatory milestone payments for products currently being developed under our collaboration agreements, as well as sales-based milestone payments and royalties on future net sales of products.
We believe that the effectiveness of our TransCon technology is supported by data from our preclinical research and the ongoing clinical programs, including our TransCon GH and TransCon PTH programs, as well as findings from our ongoing development of other product candidates, including our multi-product collaborations with Sanofi and Genentech. We have applied the TransCon technology in combination with parent drugs with clinical proof of concept using our algorithm for creating products with the potential to be best-in-class in endocrinology rare diseases, and we will continue to apply this algorithm for product selection in new therapeutic areas. We believe this approach may reduce the risks associated with traditional drug development.
Our TransCon technology enables us to create long-acting prodrug therapies with potentially significant advantages over existing marketed drug products. Our TransCon technology transiently links an unmodified parent drug to a TransCon carrier via our proprietary TransCon linkers. Our TransCon linkers predictably release an unmodified active parent drug at predetermined rates governed by physiological pH and temperature conditions, supporting administration frequencies from daily up to half-yearly. Depending upon the type of TransCon carrier we employ, we can design our TransCon prodrugs to act systemically or locally in areas that are difficult to treat with conventional therapies.
We commenced operations in December 2007 in connection with the acquisition of the company that invented our TransCon technology, Complex Biosystems GmbH. Since we commenced operations in 2007, we have devoted substantially all of our efforts to developing our product candidates, including conducting preclinical studies and clinical trials and providing general and administrative support for these operations. We do not have any approved products and have never generated any revenue from product sales.
We had a net loss of €41.4 million for the three months ended March 31, 2018 and a net loss of €123.9 million for the year ended December 31, 2017. Our total equity was €347.4 million as of March 31, 2018 compared to €187.2 million as of December 31, 2017.
Results of Operations
Comparison of the three months ended March 31, 2018 and 2017 (unaudited):
| Three Months Ended March 31, |
||||||||
| 2018 | 2017 | |||||||
| (EUR’000) | (EUR’000) | |||||||
| Revenue |
28 | 372 | ||||||
| Research and development costs |
(30,540 | ) | (20,608 | ) | ||||
| General and administrative expenses |
(4,662 | ) | (3,325 | ) | ||||
|
|
|
|
|
|||||
| Operating profit / (loss) |
(35,174 | ) | (23,561 | ) | ||||
| Finance income |
702 | 130 | ||||||
| Finance expenses |
(7,010 | ) | (1,722 | ) | ||||
|
|
|
|
|
|||||
| Profit / (loss) before tax |
(41,482 | ) | (25,153 | ) | ||||
|
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|
|
|||||
| Tax on profit / (loss) for the period |
107 | 14 | ||||||
|
|
|
|
|
|||||
| Net profit / (loss) for the period |
(41,375 | ) | (25,139 | ) | ||||
|
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|||||
Revenue
The following table summarizes our revenue for the three months ended March 31, 2018 and 2017 (unaudited):
| Three Months Ended March 31, |
||||||||
| 2018 | 2017 | |||||||
| (EUR’000) | (EUR’000) | |||||||
| Revenue from the rendering of services |
28 | 372 | ||||||
|
|
|
|
|
|||||
| Total revenue |
28 | 372 | ||||||
|
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|
|
|
|||||
Total revenue for the three months ended March 31, 2018 was €28 thousand, a decrease of €344 thousand, or 92%, compared to total revenue of €372 thousand for the three months ended March 31, 2017. This change was due to fewer services rendered by us under our collaboration with Genentech.
As of March 31, 2018, we had no deferred income arising from collaboration agreements compared to €0.1 million as of March 31, 2017. Such deferred income is recognized as revenue as we and our collaboration partners advance the projects that are subject to our collaborations.
Research and Development Costs
Research and development costs were €30.5 million for the three months ended March 31, 2018, an increase of €9.9 million, or 48%, compared to €20.6 million for the three months ended March 31, 2017. The increase was primarily attributable to a €4.2 million increase in external development costs related to our TransCon GH product candidate, including costs for preparation of the manufacturing of validation batches, or process performance qualification batches, and increasing costs of the ongoing clinical trials for this product candidate. The validation batches are required as part of the regulatory approval process with the FDA, and as such recognized as development costs when incurred, but after potential marketing approval, the products from those validation batches can be used for commercial sales, thereby reducing the cost of sales for the first period after market launch. External development costs related to our TransCon PTH and TransCon CNP projects increased by €1.9 million and €1.3 million, respectively, reflecting the continued development and progress with these two product candidates. Other research and development costs increased by approximately €2.5 million, primarily driven by an increase in personnel costs of €2.7 million due to a higher number of employees in research and development functions, reduced by lower IT costs and professional fees compared to the same period in 2017. Research and development costs included non-cash share-based payment of €2.4 million for the three months ended March 31, 2018, compared to €1.3 million for the three months ended March 31, 2017.
General and Administrative Expenses
General and administrative expenses were €4.7 million for the three months ended March 31, 2018, an increase of €1.4 million, or 40%, compared to general and administrative expenses of €3.3 million for the three months ended March 31, 2017. The increase is primarily due to an increase in personnel costs of €1.2 million for additional administrative personnel. Other general and administrative expenses increased by €0.2 million due to the general increase in operating activities. General and administrative expenses included non-cash share-based payment of €2.3 million for the three months ended March 31, 2018, compared to €1.4 million for the three months ended March 31, 2017.
Finance Income and Finance Expenses
Finance income was €0.7 million for the three months ended March 31, 2018, an increase of €0.6 million compared to €0.1 million for the three months ended March 31, 2017. Finance expenses were €7.0 million for the three months ended March 31, 2018, an increase of €5.3 million compared to €1.7 million in the same period of 2017. The €4.7 million increase in net finance expenses was due to negative exchange rate fluctuations, primarily between the U.S. Dollar and Euro in the first three months of 2018, primarily affecting our cash position maintained in U.S. Dollars, which was significantly higher compared to the same period last year. We seek to minimize our exchange rate risk by maintaining cash positions in the currencies in which we expect to incur the majority of our future expenses and we make payments from those positions.
We did not hold any interest-bearing debt for any of the periods presented.
Tax for the Period
Tax for the three months ended March 31, 2018 was a net credit of €107 thousand compared to a net credit of €14 thousand for the three months ended March 31, 2017. Taxes for the three months ended March 31, 2018 were comprised of an estimated tax credit of €184 thousand in the group of Danish companies partly offset by tax payments of €77 thousand in our U.S. and German subsidiaries. Taxes for the three months ended March 31, 2017 were comprised of an estimated tax credit of €132 thousand in the group of Danish companies partly offset by tax payments of €118 thousand in our U.S. and German subsidiaries.
Liquidity and Capital Resources
As of March 31, 2018, we had cash and cash equivalents totaling €348.4 million compared to €195.4 million as of December 31, 2017. Since our formation, we have funded our operations primarily through issuance of our preference shares, ordinary shares and convertible debt securities and payments to us under our collaboration agreements. In February 2015, we announced the closing of our initial public offering, with net proceeds of $111.5 million (or €101.4 million at such date). In 2016, we completed a follow-on public offering of American Depositary Shares, or ADSs, with net proceeds of $127.1 million (or €116.6 million) and in 2017 we completed a follow-on public offering of ADSs, with net proceeds of $145.2 million (or €123.1 million). On February 21, 2018, we completed a follow-on public offering of ADSs, with net proceeds of $210.8 million (or €171.2 million), and on February 22, 2018, we completed the exercise in full of the underwriters’ option to purchase additional ADSs, with net proceeds of $31.7 million (or €25.6 million). Our expenditures are primarily related to research and development activities and general and administrative activities to support research and development. We do not have any debt to third parties.
Based on our current operating plan, we believe that our existing cash and cash equivalents as of March 31, 2018 will be sufficient to meet our projected cash requirements for at least 12 months from the date of this report. However, our operating plan may change as a result of many factors currently unknown to us, and we may need to seek additional funds sooner than planned. Our future funding requirements will depend on many factors, including, but not limited to:
| • | our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; |
| • | the achievement of development, regulatory and commercial milestones resulting in the payment to us from our collaboration partners of contractual milestone payments and the timing of receipt of such payments, if any; |
| • | the progress, timing, scope, results and costs of our preclinical studies and clinical trials for our product candidates and manufacturing activities that have not been licensed, including the ability to enroll patients in a timely manner for clinical trials; |
| • | the time and cost necessary to obtain regulatory approvals for our product candidates that have not been licensed and the costs of post-marketing studies that could be required by regulatory authorities; |
| • | our progress and the progress of our collaboration partners in the successful commercialization and co-promotion of our most advanced product candidates and our efforts to develop and commercialize our other existing product candidates; |
| • | the manufacturing, selling and marketing costs associated with product candidates, including the cost and timing of building our sales and marketing capabilities; |
| • | the timing, receipt, and amount of sales of, or royalties on, our future products, if any; |
| • | the sales price and the availability of adequate third-party coverage and reimbursement for our product candidates; |
| • | the cash requirements of any future acquisitions or discovery of product candidates; |
| • | the number and scope of preclinical and discovery programs that we decide to pursue or initiate; |
| • | the potential acquisition and in-licensing of other technologies, products or assets; |
| • | the time and cost necessary to respond to technological and market developments, including further development of our TransCon technology; and |
| • | the costs of filing, prosecuting, maintaining, defending and enforcing any patent claims and other intellectual property rights, including litigation costs and the outcome of such litigation, including costs of defending any claims of infringement brought by others in connection with the development, manufacture or commercialization of our product candidates. |
Additional funds may not be available when we need them on terms that are acceptable to us, or at all. If adequate funds are not available to us on a timely basis, we may be required to delay, limit, scale back or cease our research and development activities, preclinical studies and clinical trials for our product candidates for which we retain such responsibility and our establishment and maintenance of sales and marketing capabilities or other activities that may be necessary to commercialize our product candidates.
The following table summarizes our cash flows for each of the unaudited three month periods ended March 31, 2018 and 2017:
| Three Months Ended March 31, |
||||||||
| 2018 | 2017 | |||||||
| (EUR’000) | (EUR’000) | |||||||
| Cash flows from / (used in) operating activities |
(36,740 | ) | (21,250 | ) | ||||
| Cash flows used in investing activities |
(102 | ) | (377 | ) | ||||
| Cash flows from / (used in) financing activities |
196,907 | 644 | ||||||
|
|
|
|
|
|||||
| Net increase / (decrease) in cash and cash equivalents |
160,065 | (20,983 | ) | |||||
|
|
|
|
|
|||||
Cash Flows From / (Used in) Operating Activities
Net cash used in operating activities for the three months ended March 31, 2018 was €36.7 million compared to €21.3 million for the three months ended March 31, 2017. The net loss for the three months ended March 31, 2018 of €41.4 million was adjusted by non-cash charges of €0.2 million for depreciation and €4.7 million for share-based payments. Net finance expenses, primarily comprising exchange rate adjustments, of €6.3 million and net tax credits of €0.1 million, were reversed. The net change in working capital of €7.0 million was primarily comprised of a €6.4 million decrease in trade payables and other payable and an increase in deposits of €0.8 million, partly offset by a €0.2 million net increase trade receivables, other receivables and prepayments. We received net finance income of €0.7 million and paid taxes of net €0.2 million in the three months ended March 31, 2018.
Net cash used in operating activities for the three months ended March 31, 2017 was €21.3 million. The net loss for the three months ended March 31, 2017 was €25.1 million, which was adjusted by non-cash charges of €0.2 million for depreciation and €2.7 million for share-based payments. Net finance expenses, primarily comprising exchange rate adjustments, of €1.6 million and net tax credits of €14 thousand, were reversed. The net change in working capital of €0.6 million was primarily comprised of a €4.9 million increase in prepayments and other receivables, partly offset by a €4.4 million increase in trade payables and other payables. Deposits and trade receivables increased by a net amount of €0.1 million. We received net finance income of €0.1 million and paid taxes of net €54 thousand in the three months ended March 31, 2017.
Cash Flows Used in Investing Activities
Cash flows used in investing activities for the three months ended March 31, 2018 of €0.1 million were related to the acquisition of property, plant and equipment for use in the laboratories of our German facility.
Cash flows used in investing activities for the three months ended March 31, 2017 of €0.4 million were primarily related to acquisition of equipment for use in the laboratories of our German facility.
Cash Flows From / (Used in) Financing Activities
Cash flows from financing activities for the three months ended March 31, 2018 of €196.9 million were solely related to our follow-on offering completed in February 2018.
Cash flows from financing activities for the three months ended March 31, 2017 of €0.6 million were solely related to exercise of warrants by current and former employees.
Off-balance Sheet Arrangements
We have not entered into any off-balance sheet arrangements or any holdings in variable interest entities.
Qualitative Disclosures about Market Risk
Our activities primarily expose us to the financial risks of changes in foreign currency exchange rates and interest rates. We do not enter into derivative financial instruments to manage our exposure to such risks.
Foreign Currency Risk
We are exposed to foreign exchange risk arising from various currency exposures, primarily with respect to the U.S. Dollar, the British Pound and the Danish Krone. Our functional currency is the Euro, but we have received payments in U.S. Dollars under our collaborations. Further, the proceeds from our series D financing in November 2014, our IPO in February 2015 and our follow-on public offerings in October 2016, September 2017, and February 2018 were in U.S. Dollars. We seek to minimize our exchange rate risk by maintaining cash positions in the currencies in which we expect to incur the majority of our future expenses and we make payments from those reserves.
Interest Rate Risk
As we have no interest-bearing debt to third parties, our exposure to interest rate risk primarily relates to the interest rates for our positions of cash and cash equivalents. Our future interest income from interest-bearing bank deposits and short-term investments may fall short of expectations due to changes in interest rates. We do not consider the effects of interest rate fluctuations to be a material risk to our financial position.
We have adopted an investment policy with the primary purpose of preserving capital, fulfilling our liquidity needs and diversifying the risks associated with marketable securities. This investment policy establishes minimum ratings for institutions with which we hold cash, cash equivalents and marketable securities, as well as rating and concentration limits for marketable securities that we may hold.
Credit Risk
We consider all of our material counterparties to be creditworthy. Our exposure to credit risk is continuously monitored, in particular, if agreed payments are delayed. While the concentration of credit risk is significant, we consider the credit risk for each of our individual customers to be low. Accordingly, we have made no provision for doubtful accounts. The credit risk on cash and cash equivalents is limited because the counterparties are banks with high credit ratings assigned by international credit-rating agencies. To spread our credit risk, we deposit our cash reserves with several banks.
Liquidity Risk
We manage our liquidity risk by maintaining adequate cash reserves and banking facilities, and by continuously monitoring our cash forecasts and actual cash flows, and by matching the maturity profiles of financial assets and liabilities.
Exhibit 99.3
Ascendis Pharma A/S Reports First Quarter 2018 Financial Results
- Continued execution and achievement of planned milestones across three wholly-owned clinical programs in rare endocrine diseases -
- Conference Call Today at 4:30 p.m. Eastern Time -
COPENHAGEN, Denmark, May 30, 2018/ Globe Newswire/ – Ascendis Pharma A/S (Nasdaq: ASND), a biopharmaceutical company that utilizes its innovative TransCon technology to address significant unmet medical needs, today announced financial results for the quarter ended March 31, 2018.
“Our endocrinology pipeline is moving forward with strong momentum and three wholly-owned TransCon technology product candidates in the clinic. We continue to execute on our Phase 3 program for TransCon Growth Hormone in pediatric growth hormone deficiency (GHD), we have completed the phase 1 trial for TransCon PTH, and we recently initiated dosing of subjects with TransCon CNP in a phase 1 trial as planned,” said Jan Mikkelsen, Ascendis Pharma’s President and Chief Executive Officer. “With ongoing success advancing our broad pipeline, we are building out our commercial team with the hiring of Tom Larson as our Chief Commercial Officer. We are thrilled about the continued clinical validation of our TransCon technology and its potential application to other disease areas with unmet needs beyond endocrinology.”
Recent Corporate Highlights
| • | Continued execution of the TransCon Growth Hormone (GH) phase 3 program, with the observed aggregate data from the heiGHt Trial continuing to demonstrate a safety profile consistent with the published safety profile of the active comparator, Genotropin. |
| • | Completed the TransCon PTH phase 1 trial, and presented new data at the European Congress of Endocrinology. These data from the complete multiple ascending dose (MAD) cohorts continue to support the differentiated target product profile of TransCon PTH as a true parathyroid hormone (PTH) replacement therapy for hypoparathyroidism. |
| • | Initiated dosing of healthy adult subjects in a phase 1 trial for TransCon CNP, a long-acting prodrug of C-type natriuretic peptide (CNP) in development as a therapeutic option for achondroplasia and potentially for other fibroblast growth factor receptor (FGFR)-related skeletal disorders. |
| • | Announced appointment of Thomas A. Larson as Senior Vice President and Chief Commercial Officer. Mr. Larson brings 25 years of experience building and leading commercial organizations, as well as successfully launching products across the orphan drug and specialty markets. |
| • | Ended the quarter with cash and cash equivalents of €348.4 million. |
First Quarter 2018 Financial Results
For the first quarter, Ascendis Pharma reported a net loss of €41.4 million, or €1.07 per share (basic and diluted) compared to a net loss of €25.1 million, or €0.78 per share (basic and diluted) for the same period in 2017.
Research and development (R&D) costs for the quarter were €30.5 million compared to €20.6 million in the same quarter of 2017. Increased R&D costs in the 2018 quarter reflect costs for preparation of the manufacturing of validation batches for TransCon Growth Hormone, and increasing costs of the ongoing clinical trials for this product candidate, as well as costs of the ongoing clinical programs for TransCon PTH and TransCon CNP.
General and administrative expenses for the first quarter of 2018 were €4.7 million compared to €3.3 million in the same quarter of 2017. The increase is primarily due to higher personnel costs.
As of March 31, 2018, the company had cash and cash equivalents of €348.4 million compared to €195.4 million as of December 31, 2017. This includes net proceeds to the company of $242.5 million, or approximately €196.8 million at the time from an underwritten public offering of 4,539,473 American Depositary Shares (ADSs) completed in February 2018. As of March 31, 2018, Ascendis had 41,523,765 ordinary shares outstanding.
Conference Call and Webcast information
Ascendis Pharma will host a conference call and webcast today at 4:30 p.m. Eastern Time (ET) to discuss its first quarter 2018 financial results. Details include:
| Date |
Wednesday, May 30, 2018 | |
| Time |
4:30 p.m. ET | |
| Dial In (U.S.) |
844-290-3904 | |
| Dial In (International) |
574-990-1036 | |
| Access Code |
7192599 | |
A live audio webcast of the event will be available in the Investors and News section of the Ascendis Pharma website at www.ascendispharma.com. A webcast replay will also be available on this website shortly after conclusion of the event for 30 days.
About Ascendis Pharma A/S
Ascendis Pharma is applying its innovative prodrug technology to build a leading, fully integrated rare disease company focused on making a meaningful difference in patients’ lives. The company utilizes its TransCon technology with clinically validated parent drugs to create new therapies with potential for best-in-class efficacy, safety and/or convenience.
Ascendis Pharma has a wholly-owned pipeline of three rare disease endocrinology product candidates in clinical development. These include once-weekly TransCon Growth Hormone, which is being evaluated in a phase 3 program for children with growth hormone deficiency (GHD), TransCon PTH, a long-acting prodrug of parathyroid hormone for hypoparathyroidism for which a phase 1 trial has been completed, and TransCon CNP, a long-acting prodrug of C-type natriuretic peptide, which is also in phase 1 development for achondroplasia and other FGFR-related skeletal disorders.
Additionally, Ascendis Pharma has multi-product collaborations with Sanofi in diabetes and Genentech in the field of ophthalmology.
For more information, please visit www.ascendispharma.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, included in this press release regarding our future operations, plans and objectives of management are forward-looking statements. Examples of such statements include, but are not limited to, statements relating to (i) our ability to apply our prodrug technology to build a leading, fully integrated rare disease company, (ii) our expectations regarding our
2
ability to create therapies with potential for best-in-class efficacy, safety and/or convenience and (iii) our product pipeline. We may not actually achieve the plans, carry out the intentions or meet the expectations or projections disclosed in the forward-looking statements and you should not place undue reliance on these forward-looking statements. Actual results or events could differ materially from the plans, intentions, expectations and projections disclosed in the forward-looking statements. Various important factors could cause actual results or events to differ materially from the forward-looking statements that we make, including the following: unforeseen safety or efficacy results in our TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs; unforeseen expenses related to the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs, general and administrative expenses, other research and development expenses and our business generally; delays in the development of TransCon Growth Hormone, TransCon PTH and TransCon CNP or other development programs related to manufacturing, regulatory requirements, speed of patient recruitment or other unforeseen delays; dependence on third party manufacturers to supply study drug for planned clinical studies; and our ability to obtain additional funding, if needed, to support our business activities. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to our business in general, see our current and future reports filed with, or submitted to, the U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F for the year ended December 31, 2017, which we filed with the SEC on March 28, 2018. Forward-looking statements do not reflect the potential impact of any future in-licensing, collaborations, acquisitions, mergers, dispositions, joint ventures, or investments we may enter into or make. We do not assume any obligation to update any forward-looking statements, except as required by law.
FINANCIAL TABLES FOLLOW
3
Ascendis Pharma A/S
Unaudited Condensed Consolidated Interim Statements of Profit or Loss and Other Comprehensive Income / (loss)
(In EUR’000s, except share and per share data)
| Three Months Ended March 31, | ||||||||
| 2018 | 2017 | |||||||
| Revenue |
28 | 372 | ||||||
| Research and development costs |
(30,540 | ) | (20,608 | ) | ||||
| General and administrative expenses |
(4,662 | ) | (3,325 | ) | ||||
|
|
|
|
|
|||||
| Operating profit / (loss) |
(35,174 | ) | (23,561 | ) | ||||
| Finance income |
702 | 130 | ||||||
| Finance expenses |
(7,010 | ) | (1,722 | ) | ||||
|
|
|
|
|
|||||
| Profit / (loss) before tax |
(41,482 | ) | (25,153 | ) | ||||
| Tax on profit / (loss) for the period |
107 | 14 | ||||||
|
|
|
|
|
|||||
| Net profit / (loss) for the period |
(41,375 | ) | (25,139 | ) | ||||
|
|
|
|
|
|||||
| Other comprehensive income / (loss) |
||||||||
| Items that may be reclassified subsequently to profit or loss: |
||||||||
| Exchange differences on translating foreign operations |
(9 | ) | 4 | |||||
|
|
|
|
|
|||||
| Other comprehensive income / (loss) for the period, net of tax |
(9 | ) | 4 | |||||
|
|
|
|
|
|||||
| Total comprehensive income / (loss) for the period, net of tax |
(41,384 | ) | (25,135 | ) | ||||
|
|
|
|
|
|||||
| Profit / (loss) for the period attributable to owners of the Company |
(41,375 | ) | (25,139 | ) | ||||
| Total comprehensive income / (loss) for the period attributable to owners of the Company |
(41,384 | ) | (25,135 | ) | ||||
| EUR | EUR | |||||||
| Basic and diluted earnings / (loss) per share |
(1.07 | ) | (0.78 | ) | ||||
| Number of shares used for calculation (basic and diluted) |
38,699,204 | 32,428,908 | ||||||
|
|
|
|
|
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4
Ascendis Pharma A/S
Unaudited Condensed Consolidated Interim Statements of Financial Position
(In EUR’000s)
| March 31, | December 31, | |||||||
| 2018 | 2017 | |||||||
| Assets |
||||||||
| Non-current assets |
||||||||
| Intangible assets |
3,495 | 3,495 | ||||||
| Property, plant and equipment |
2,461 | 2,557 | ||||||
| Deposits |
1,112 | 293 | ||||||
|
|
|
|
|
|||||
| 7,068 | 6,345 | |||||||
| Current assets |
||||||||
| Trade receivables |
34 | 188 | ||||||
| Other receivables |
1,128 | 1,410 | ||||||
| Prepayments |
7,119 | 6,907 | ||||||
| Income taxes receivable |
1,067 | 778 | ||||||
| Cash and cash equivalents |
348,410 | 195,351 | ||||||
|
|
|
|
|
|||||
| 357,758 | 204,634 | |||||||
|
|
|
|
|
|||||
| Total assets |
364,826 | 210,979 | ||||||
|
|
|
|
|
|||||
| Equity and liabilities |
||||||||
| Equity |
||||||||
| Share capital |
5,577 | 4,967 | ||||||
| Distributable equity |
341,836 | 182,244 | ||||||
|
|
|
|
|
|||||
| Total equity |
347,413 | 187,211 | ||||||
|
|
|
|
|
|||||
| Current liabilities |
||||||||
| Trade payables and other payables |
17,413 | 23,768 | ||||||
|
|
|
|
|
|||||
| Total liabilities |
17,413 | 23,768 | ||||||
|
|
|
|
|
|||||
| Total equity and liabilities |
364,826 | 210,979 | ||||||
|
|
|
|
|
|||||
| Internal contact: | Media contact: | Investor contact: | ||
| Scott T. Smith | Ami Knoefler | Patti Bank | ||
| Chief Financial Officer | Head of Global Communications | Westwicke Partners | ||
| (650) 352-8389 | (650) 739-9952 | (415) 513-1284 | ||
| ir@ascendispharma.com | ack@ascendispharma.com | patti.bank@westwicke.com |
5