UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM
REPORT OF FOREIGN PRIVATE ISSUER
PURSUANT TO SECTION 13a-16 OR 15d-16
UNDER THE SECURITIES EXCHANGE ACT OF 1934
For the month of November,
Commission File Number: 001-36815
(Exact Name of Registrant as Specified in Its Charter)
Tuborg Boulevard 12
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
This report on Form 6-K shall be deemed to be incorporated by reference into the registration statements on Form S-8 (Registration Numbers 333-228576, 333-203040, 333-210810, 333-211512, 333-213412, 333-214843, 333-216883, 333-254101, 333-261550 and 333-270088) and Form F-3 (Registration Numbers 333-209336, 333-211511, 333-216882, 333-223134, 333-225284, and 333-256571) 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such registration statements) and to be a part thereof from the date on which this report is filed, to the extent not superseded by documents or reports subsequently filed or furnished.
Information Contained in this Form 6-K Report
Financial Statements
This report contains the Company’s Unaudited Condensed Consolidated Interim Financial Statements as of and for the period ended September 30, 2023, including Management’s Discussion and Analysis of Financial Condition and Results of Operations for the period presented therein.
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.
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Ascendis Pharma A/S |
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Date: November 7, 2023 |
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By: |
/s/ Michael Wolff Jensen |
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Michael Wolff Jensen |
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Executive Vice President, Chief Legal Officer |
TABLE OF CONTENTS
1. |
Unaudited Condensed Consolidated Interim Financial Statements – September 30, 2023 |
F-1 |
2. |
Management’s Discussion and Analysis of Financial Condition and Results of Operations |
1 |
ASCENDIS PHARMA A/S
INDEX TO UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
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Page |
F-2 |
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F-3 |
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F-4 |
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F-5 |
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Notes to the Unaudited Condensed Consolidated Interim Financial Statements |
F-6 |
F-1
Unaudited Condensed Consolidated Interim Statements of Profit or Loss
and Comprehensive Income / (Loss) for the Three and Nine Months Ended September 30, 2023 and 2022
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Three Months Ended |
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Nine Months Ended |
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Notes |
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2023 |
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2022 |
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2023 |
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2022 |
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(EUR’000) |
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(EUR’000) |
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Consolidated Statement of Profit or Loss |
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Revenue |
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5 |
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Cost of sales |
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Gross profit |
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Research and development costs |
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Selling, general and administrative expenses |
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Operating profit / (loss) |
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( |
) |
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( |
) |
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( |
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( |
) |
Share of profit / (loss) of associate |
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( |
) |
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( |
) |
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( |
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( |
) |
Finance income |
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Finance expenses |
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Profit / (loss) before tax |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Income taxes (expenses) |
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( |
) |
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( |
) |
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( |
) |
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Net profit / (loss) for the period |
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( |
) |
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( |
) |
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( |
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( |
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Attributable to owners of the Company |
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( |
) |
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( |
) |
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( |
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( |
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Basic and diluted earnings / (loss) per share |
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€ |
( |
) |
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€ |
( |
) |
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€ |
( |
) |
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€ |
( |
) |
Number of shares used for calculation (basic and diluted) (1) |
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(EUR’000) |
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(EUR’000) |
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Statement of Comprehensive Income |
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Net profit / (loss) for the period |
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( |
) |
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( |
) |
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( |
) |
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( |
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Other comprehensive income / (loss) |
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Items that may be reclassified subsequently to profit or loss: |
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Exchange differences on translating foreign operations |
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( |
) |
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( |
) |
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( |
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Other comprehensive income / (loss) for the period, net of tax |
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( |
) |
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( |
) |
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( |
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Total comprehensive income / (loss) for the period, net of tax |
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( |
) |
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( |
) |
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( |
) |
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( |
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Attributable to owners of the Company |
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( |
) |
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( |
) |
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( |
) |
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( |
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F-2
Unaudited Condensed Consolidated Interim Statements of Financial Position
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Notes |
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September 30, |
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December 31, |
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(EUR’000) |
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Assets |
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Non-current assets |
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Intangible assets |
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Property, plant and equipment |
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Investment in associate |
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Other receivables |
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10 |
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Marketable securities |
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10 |
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Current assets |
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Inventories |
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Trade receivables |
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10 |
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Income tax receivables |
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Other receivables |
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10 |
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Prepayments |
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Marketable securities |
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10 |
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Cash and cash equivalents |
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10 |
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Total assets |
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Equity and liabilities |
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Equity |
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Share capital |
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8 |
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Distributable equity |
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( |
) |
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Total equity |
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4 |
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( |
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Non-current liabilities |
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Borrowings |
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10 |
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Lease liabilities |
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10 |
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Derivative liabilities |
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10 |
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Contract liabilities |
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Current liabilities |
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Borrowings |
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10 |
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Lease liabilities |
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10 |
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Contract liabilities |
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Trade payables and accrued expenses |
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10 |
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Other liabilities |
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Income tax payables |
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Provisions |
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Total liabilities |
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Total equity and liabilities |
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F-3
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
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Distributable Equity |
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Share |
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Share |
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Treasury |
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Foreign |
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Accumulated |
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Total |
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(EUR’000) |
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Equity at January 1, 2023 |
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( |
) |
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( |
) |
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Net profit / (loss) for the period |
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— |
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— |
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— |
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— |
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( |
) |
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( |
) |
Other comprehensive income / (loss), net of tax |
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— |
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— |
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— |
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( |
) |
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— |
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( |
) |
Total comprehensive income / (loss) |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
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Transactions with Owners |
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Share-based payment (Note 7) |
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— |
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— |
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— |
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— |
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Capital increase |
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— |
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— |
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— |
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Equity at September 30, 2023 |
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( |
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( |
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( |
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Distributable Equity |
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Share |
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Share |
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Treasury |
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Foreign |
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Accumulated |
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Total |
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(EUR’000) |
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Equity at January 1, 2022 |
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( |
) |
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( |
) |
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Net profit / (loss) for the period |
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— |
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— |
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— |
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— |
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( |
) |
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( |
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Other comprehensive income / (loss), net of tax |
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— |
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— |
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— |
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( |
) |
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— |
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( |
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Total comprehensive income / (loss) |
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— |
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— |
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— |
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( |
) |
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( |
) |
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( |
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Transactions with Owners |
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Share-based payment (Note 7) |
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— |
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— |
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— |
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— |
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Acquisition of treasury shares (Note 9) |
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— |
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— |
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( |
) |
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— |
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( |
) |
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( |
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Capital increase |
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— |
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— |
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— |
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Equity at September 30, 2022 |
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( |
) |
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( |
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F-4
Unaudited Condensed Consolidated Interim Cash Flow Statements for the
Nine Months Ended September 30, 2023 and 2022
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Nine Months Ended |
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2023 |
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2022 |
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(EUR’000) |
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Operating activities |
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Net profit / (loss) for the period |
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( |
) |
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( |
) |
Reversal of finance income |
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( |
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( |
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Reversal of finance expenses |
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Reversal of gain and loss on disposal of property, plant and equipment |
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Reversal of income taxes (expenses) |
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Increase / (decrease) in provisions |
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Adjustments for non-cash items: |
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Non-cash consideration relating to revenue |
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( |
) |
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( |
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Share of profit / (loss) of associate |
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Share-based payment |
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Depreciation |
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Amortization |
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Changes in working capital: |
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Inventories |
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( |
) |
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( |
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Receivables |
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( |
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( |
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Prepayments |
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( |
) |
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( |
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Contract liabilities (deferred income) |
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( |
) |
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Trade payables, accrued expenses and other payables |
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Cash flows generated from / (used in) operations |
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( |
) |
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( |
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Finance income received |
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Finance expenses paid |
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( |
) |
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( |
) |
Income taxes received / (paid) |
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( |
) |
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( |
) |
Cash flows from / (used in) operating activities |
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( |
) |
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( |
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Investing activities |
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Acquisition of property, plant and equipment |
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( |
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( |
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Proceeds from disposal of property, plant and equipment |
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Reimbursement from acquisition of property, plant and equipment |
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Purchase of marketable securities |
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( |
) |
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Settlement of marketable securities |
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Cash flows from / (used in) investing activities |
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Financing activities |
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Payment of principal portion of lease liabilities |
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( |
) |
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( |
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Net proceeds from borrowings |
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Proceeds from exercise of warrants |
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Acquisition of treasury shares, net of transaction costs |
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( |
) |
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Cash flows from / (used in) financing activities |
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Increase / (decrease) in cash and cash equivalents |
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( |
) |
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Cash and cash equivalents at January 1 |
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Effect of exchange rate changes on balances held in foreign currencies |
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Cash and cash equivalents at September 30 |
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Cash and cash equivalents include: |
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Bank deposits |
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Short-term marketable securities |
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Cash and cash equivalents at September 30 |
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F-5
Notes to the Unaudited Condensed Consolidated Interim Financial Statements
Note 1—General Information
Ascendis Pharma A/S, together with its subsidiaries, is applying its innovative TransCon technologies to build a leading, fully integrated, global, biopharma 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 (“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 (the “Board”) approved these unaudited condensed consolidated interim financial statements on November 7, 2023.
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, 2022, and accompanying notes, which have been prepared in accordance with IFRS as issued by the International Accounting Standards Board (the “IASB”) and as adopted by the European Union (the “EU”).
The accounting policies applied are consistent with those of the previous financial year. A description of the accounting policies is provided in the Accounting Policies section of the audited consolidated financial statements as of and for the year ended December 31, 2022. In addition, the accounting policy for royalty funding liabilities, applied for the first time in this reporting period, is described below.
The preparation of financial statements in conformity with IFRS requires the use of certain significant accounting estimates and requires management to exercise its judgement in the process of applying the Company’s accounting policies. The areas involving a higher degree of judgement or complexity, or areas where assumptions and estimates are significant to the unaudited condensed consolidated interim financial statements are disclosed in Note 3, “Significant Accounting Judgements and Estimates”.
Royalty Funding Liabilities
Royalty funding liabilities relate to the Company’s contractual obligations to pay a predetermined percentage of future commercial revenue until reaching a predetermined multiple of proceeds received, according to the detailed provisions of the synthetic royalty funding agreement (the “Agreement”).
Where relevant, royalty funding liabilities are separated into a financial liability and embedded derivative components based on the terms and conditions of the Agreement. Embedded derivative components are accounted for separately, unless these are deemed closely related to the financial liability. The Agreement includes a buy-out option where the value is dependent on non-financial variables that are specific to the Company. Accordingly, the buy-out option is not accounted for separately as a derivative.
The financial liability is recognized when the Company becomes party to the contractual provisions of the Agreement and measured at amortized cost until it is extinguished upon exercising a buy-out option or upon achieving the predetermined multiple of proceeds received. The effective interest rate is estimated at initial recognition and takes into account incremental transaction costs and anticipated amount and timing of future cash flows, which further depends on future commercial revenue forecasts and the probability of exercising the buy-out option. The amortized cost is remeasured prospectively when there is a material change in expectations to amount and timing of future cash flows, which will increase or decrease future interest expenses. Remeasurement gain or losses are recognized through the profit or loss as finance income or expenses, respectively.
The financial liability is presented as part of borrowings in the statement of financial position.
F-6
Change to Presentation of Borrowings
At December 31, 2022, lease liabilities were presented as part of borrowings in the consolidated statements of financial position. At December 31, 2022, carrying amount of lease liabilities was €
In connection with entering additional borrowing activities in September 2023, lease liabilities are from September 30, 2023, presented separately in the consolidated statements of financial position. Comparative amounts have been reclassified to reflect the change in presentation. Accordingly, at September 30, 2023 and December 31, 2022, borrowings comprise convertible senior notes and royalty funding liabilities, and convertible senior notes.
The change to presentation had no other impact on the unaudited condensed consolidated financial statements.
New International Financial Reporting Standards Not Yet Effective
The IASB has issued a number of new or amended standards, which have not yet become effective or have not yet been adopted by the EU. Therefore, these new standards have not been incorporated in these unaudited condensed consolidated interim financial statements.
Amendments to IAS 1, “Classification of Liabilities as Current or Non-current”
In January 2020, the IASB issued amendments to paragraphs 69 to 76 of IAS 1, “Presentation of Financial Statements”, to specify the requirements for classifying liabilities as current or non-current. The amendments clarify:
If approved by the EU, the amendments are effective for annual reporting periods beginning on or after January 1, 2024, and must be applied retrospectively. The amendments are expected to require the convertible senior notes (“convertible notes”) (presented as part of borrowings in the statement of financial position) and derivative liabilities, both presented as non-current liabilities at September 30, 2023, to be presented as current liabilities.
On September 30, 2023, the carrying amount of convertible notes and derivative liabilities were €
The consolidated financial statements are not expected to be affected by other new or amended standards.
F-7
Note 3—Significant Accounting Judgements and Estimates
In the application of the Company’s accounting policies, management is required to make judgements, estimates and assumptions about the carrying amounts of assets and liabilities that are not readily apparent from other sources. Judgements, estimates and assumptions applied are based on historical experience and other factors that are relevant, and which are available at the reporting date. Uncertainty concerning estimates and assumptions could result in outcomes that require a material adjustment to assets and liabilities in future periods.
The unaudited condensed consolidated interim financial statements do not include all disclosures for significant accounting judgements, estimates and assumptions, that are required in the annual consolidated financial statements, and therefore should be read in conjunction with the Company’s audited consolidated financial statements as of and for the year ended December 31, 2022.
Estimates and underlying assumptions are reviewed on an ongoing basis. Revisions to accounting estimates are recognized prospectively. While the application of critical accounting estimates is subject to material estimation uncertainties, management’s ongoing revisions of critical accounting estimates and underlying assumptions have not revealed any material impact in any of the periods presented in the unaudited condensed consolidated interim financial statements.
Other than as set out below, there have been no other changes to the application of significant accounting judgements, or estimation uncertainties regarding accounting estimates compared to December 31, 2022.
Measurement of Royalty Funding Liabilities
The carrying amount of royalty funding liabilities is measured according to anticipated future cash flows, which further depends on the amount and timing of future commercial revenue. Assumptions that impact amount and timing of future commercial revenue are subject to estimation uncertainties, and subject to a number of factors which are not within the Company's control.
The Company will periodically revisit anticipated amount and timing of future commercial revenue and to the extent such amount or timing is materially different from the current estimates, a remeasurement gain or loss is recognized through the profit or loss as finance income or expenses, respectively, which would further increase or decrease future interest expenses. Further details are provided in Note 10, “Financial Assets and Liabilities”.
F-8
Note 4—Significant Events in the Reporting Period
Global Banking Situation
In March 2023, the Federal Deposit Insurance Corporation (the “FDIC”) announced that Silicon Valley Bank (“SVB”) had been closed by the California Department of Financial Protection and Innovation, which appointed the FDIC as receiver. The Company did not hold deposits or securities or maintain any accounts at SVB. Following the closure of SVB and subsequent developments in the global banking sector, the Company considered the risk of expected credit loss on bank deposits and marketable securities, including the hypothetical impact arising from the probability of default, which is considered in conjunction with the expected loss caused by default by banks or securities with similar credit-ratings and attributes.
In line with previous periods, this assessment did not reveal a material impairment loss, and accordingly no provision for expected credit loss has been recognized.
Conflict in the Region Surrounding Ukraine and Russia
The ongoing conflict in the region surrounding Ukraine and Russia has impacted the Company's ability to continue clinical trial activities in those countries. The conflict did not have a direct material impact on the unaudited condensed consolidated interim financial statements.
Royalty Funding Liabilities
In September 2023, the Company entered into a $
Equity Development
As of September 30, 2023, the unaudited condensed consolidated interim statements of financial position presented a negative balance of equity of €
Based on its current operating plan, the Company believes that the existing capital resources as of September 30, 2023, will be sufficient to meet projected cash requirements for at least twelve months from the date of this report. However, the Company's operating plan may change as a result of many factors that are currently unknown, and the Company may need to seek additional funds sooner than planned. Further details regarding lease liabilities and borrowings including maturity analysis are provided in Note 10, “Financial Assets and Liabilities”.
F-9
Note 5—Revenue
Revenue from commercial sale of products relates to sale of SKYTROFA® (lonapegsomatropin-tcgd), primarily in the U.S. market, which is sold to specialty pharmacies and specialty distributors. In addition, the Company began shipping products to wholesalers in Germany in the third quarter of 2023. Customer payment terms are typically
Other revenue is generated primarily from three license agreements, which were entered into in 2018.
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Three Months Ended |
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Nine Months Ended |
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2023 |
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2022 |
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2023 |
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2022 |
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Revenue from external customers |
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Commercial sale of products |
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Rendering of services |
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Sale of clinical supply |
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Licenses |
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