Ascendis Pharma A/S | ||||||
Date: August 10, 2022 |
By: |
/s/ Michael Wolff Jensen | ||||
Michael Wolff Jensen | ||||||
Senior Vice President, Chief Legal Officer |
Page |
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F-6 |
Three Months Ended June 30 |
Six Months Ended June 30 |
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Notes |
2022 |
2021 |
2022 |
2021 |
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(EUR’000) |
(EUR’000) |
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Statement of Profit or Loss |
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Revenue |
5 |
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Cost of sales |
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Gross profit / (loss) |
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Research and development costs |
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Selling, general and administrative expenses |
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Operating profit / (loss) |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Share of profit / (loss) of associate |
( |
) | ( |
) | ( |
) | ||||||||||||||
Finance income |
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Finance expenses |
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Profit / (loss) before tax |
( |
) |
( |
) |
( |
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( |
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Tax on profit / (loss) for the period |
( |
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Net profit / (loss) for the period |
( |
) |
( |
) |
( |
) |
( |
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Attributable to owners of the Company |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
Basic and diluted earnings / (loss) per share |
€( |
) | €( |
) | €( |
) | €( |
) | ||||||||||||
Number of shares used for calculation (basic and diluted) (1) |
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(EUR’000) |
(EUR’000) |
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Statement of Comprehensive Income |
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Net profit / (loss) for the period |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
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 |
( |
) | ( |
) | ||||||||||||||||
Other comprehensive income / (loss) for the period, net of tax |
( |
) |
( |
) |
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Total comprehensive income / (loss) for the period, net of tax |
( |
) |
( |
) |
( |
) |
( |
) | ||||||||||||
Attributable to owners of the Company |
( |
) | ( |
) | ( |
) | ( |
) | ||||||||||||
(1) |
As of June 30, 2022, a total of warrants outstanding, each carrying the right to subscribe for one ordinary share, and convertible senior notes which can potentially be converted into ordinary shares, can potentially dilute earnings per share in the future but have not been included in the calculation of diluted earnings per share because they are antidilutive for the periods presented. Similarly, a total of warrants outstanding as of June 30, 2021, are also considered antidilutive for the periods presented and have not been included in the calculation. The weighted average number of shares takes into account the weighted average effect of changes in treasury shares during the period. |
Notes |
June 30, 2022 |
December 31, 2021 |
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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 |
10 |
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Marketable securities |
10 |
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Current assets |
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Inventories |
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Trade receivables |
10 |
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Income tax receivables |
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Other receivables |
10 |
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Prepayments |
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Marketable securities |
10 |
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Cash and cash equivalents |
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 |
8 |
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Distributable equity |
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Non-current liabilities |
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Borrowings |
10 |
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Derivative liabilities |
10 |
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Contract liabilities |
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Current liabilities |
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Borrowings |
10 |
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Contract liabilities |
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Trade payables and accrued expenses |
10 |
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Other liabilities |
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Income taxes payable |
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Provisions |
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Total liabilities |
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Total equity and liabilities |
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Distributable Equity |
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Share Capital |
Share Premium |
Treasury Shares |
Foreign Currency Translation Reserve |
Share-based Payment Reserve |
Accumulated Deficit |
Total |
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(EUR’000) |
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Equity at January 1, 2022 |
( |
) |
( |
) |
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Net profit / (loss) for the period |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||
Other comprehensive income / (loss), net of tax |
— |
— |
— |
( |
) |
— |
— |
( |
) | |||||||||||||||||||
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|
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Total comprehensive income / (loss) |
— |
— |
— |
( |
) |
— |
( |
) |
( |
) | ||||||||||||||||||
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Transactions with Owners |
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Share-based payment (Note 7) |
— |
— |
— |
— |
— |
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Acquisition of treasury shares (Note 9) |
— |
— |
( |
) |
— |
— |
— |
( |
) | |||||||||||||||||||
Capital increase |
— |
— |
— |
— |
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Equity at June 30, 2022 |
( |
) |
( |
) |
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Distributable Equity |
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Share Capital |
Share Premium |
Treasury Shares |
Foreign Currency Translation Reserve |
Share-based Payment Reserve |
Accumulated Deficit |
Total |
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(EUR’000) |
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Equity at January 1, 2021 |
( |
) |
( |
) |
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Net profit / (loss) for the period |
— |
— |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||
Other comprehensive income / (loss), net of tax |
— |
— |
— |
— |
— |
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Total comprehensive income / (loss) |
— |
— |
— |
( |
) |
( |
) | |||||||||||||||||||||
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Transactions with Owners |
— |
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Share-based payment (Note 7) |
— |
— |
— |
— |
— |
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Capital increase |
— |
— |
— |
— |
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Equity at June 30, 2021 |
( |
) |
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Six Months Ended June 30, |
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2022 |
2021 |
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(EUR’000) |
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Operating activities |
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Net profit / (loss) for the period |
( |
) |
( |
) | ||||
Reversal of finance income |
( |
) |
( |
) | ||||
Reversal of finance expenses |
||||||||
Reversal of gain and loss on disposal of property, plant and equipment |
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Reversal of tax charge |
( |
) | ||||||
Increase / (decrease) in provisions |
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Adjustments for non-cash items: |
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Non-cash consideration relating to revenue |
( |
) |
( |
) | ||||
Share of profit / (loss) of associate |
( |
) | ||||||
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 |
( |
) |
||||||
Receivables |
( |
) |
( |
) | ||||
Prepayments |
( |
) |
( |
) | ||||
Contract liabilities (deferred income) |
( |
) |
( |
) | ||||
Trade payables, accrued expenses and other payables |
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|
|||||
Cash flows generated from / (used in) operations |
( |
) |
( |
) | ||||
Finance income received |
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Finance expenses paid |
( |
) |
( |
) | ||||
Income taxes received / (paid) |
( |
) |
( |
) | ||||
|
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|
|||||
Cash flows from / (used in) operating activities |
( |
) |
( |
) | ||||
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Investing activities |
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Investment in associate |
( |
) | ||||||
Acquisition of property, plant and equipment |
( |
) |
( |
) | ||||
Reimbursement from acquisition of property, plant and equipment |
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Development expenditures (software) |
( |
) | ||||||
Purchase of marketable securities |
( |
) |
( |
) | ||||
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 |
( |
) |
( |
) | ||||
Net proceeds from convertible senior notes |
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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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Cash flows from / (used in) financing activities |
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Increase / (decrease) in cash and cash equivalents |
( |
) | ||||||
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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 June 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 June 30 |
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• | What is meant by a right to defer settlement; |
• | That a right to defer must exist at the end of the reporting period; |
• | That classification is unaffected by the likelihood that an entity will exercise its deferral right; and |
• | That only if an embedded derivative in a convertible liability is itself an equity instrument would the terms of a liability not impact its classification. |
Three Months Ended June 30, |
Six Months Ended June 30, |
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2022 |
2021 |
2022 |
2021 |
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(EUR’000) |
(EUR’000) |
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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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Total revenue from external customers |
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Attributable to |
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Commercial customers |
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Collaboration partners and license agreements (1) |
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Total revenue from external customers |
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Specified by timing of recognition |
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Recognized over time |
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Recognized at a point in time |
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Total revenue from external customers |
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Revenue by geographical location |
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Europe |
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North America |
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China |
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Total revenue from external customers |
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(1) |
For the three months ended June 30, 2022 and 2021, and for the six month ended June 30, 2022 and 2021, “Total revenue” includes recognition of previously deferred revenue/internal profit from associate of € million and € million, and of € million and € million respectively. |
Total RSUs |
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Outstanding at January 1, 2022 |
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Granted during the period |
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Settled during the period |
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Transferred during the period |
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Forfeited during the period |
( |
) | ||
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Outstanding at June 30, 2022 |
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Specified by vesting date |
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December, 2022 |
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December, 2023 |
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December, 2024 |
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|
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Outstanding at June 30, 2022 |
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Total Warrants |
Weighted Average Exercise Price EUR |
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Outstanding at January 1, 2022 |
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Granted during the period |
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Exercised during the period |
( |
) |
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Forfeited during the period |
( |
) |
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Outstanding at June 30, 2022 |
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Vested at June 30, 2022 |
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Nominal values |
Holding |
Holding in % of total outstanding shares |
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(EUR’000) |
(Number) |
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Treasury shares |
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At January 1, 2022 |
% | |||||||||||
Acquired from third-parties |
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At June 30, 2022 |
% | |||||||||||
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June 30, 2022 |
December 31, 2021 |
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(EUR’000) |
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Financial assets by category |
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Trade receivables |
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Other receivables (excluding VAT receivables) |
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Marketable securities |
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Cash and cash equivalents |
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Financial assets measured at amortized cost |
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Total financial assets |
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Classified in the statement of financial position |
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Non-current assets |
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Current assets |
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Total financial assets |
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June 30, 2022 |
December 31, 2021 |
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(EUR’000) |
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Financial liabilities by category |
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Borrowings |
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Convertible senior notes |
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Lease liabilities |
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Trade payables and accrued expenses |
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Financial liabilities measured at amortized cost |
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Derivative liabilities |
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Financial liabilities measured at fair value through profit or loss |
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Total financial liabilities |
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Classified in the statement of financial position |
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Non-current liabilities |
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Current liabilities |
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Total financial liabilities |
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|
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June 30, 2022 |
December 31, 2021 |
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Carrying amount |
Fair value |
Carrying amount |
Fair value |
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(EUR’000) |
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Marketable securities |
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U.S. Government bonds |
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Commercial papers |
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Corporate bonds |
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Agency bonds |
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Total marketable securities |
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|||||||||
Classified based on maturity profiles |
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Non-current assets |
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Current assets |
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Total marketable securities |
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|||||||||
Specified by rate structure |
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Fixed rate |
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Floating rate |
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Zero-coupon |
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Total marketable securities |
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|||||||||
Specified by investment grade credit rating |
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High grade |
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Upper medium grade |
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Lower medium grade |
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Total marketable securities |
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< 1 year |
1-5 years |
>5 years |
Total contractual cash-flows |
Carrying amount |
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(EUR’000) |
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June 30, 2022 |
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Borrowings |
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Convertible senior notes |
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Lease liabilities |
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Trade payables and accrued expenses |
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|
|
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Total financial liabilities |
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• | the timing or likelihood of regulatory filings and approvals for our product candidates; |
• | our expectations regarding the commercial availability of TransCon Growth Hormone, or TransCon hGH, and related patient support services; |
• | the commercialization of TransCon hGH and our other product candidates, if approved; |
• | our commercialization, marketing and manufacturing capabilities of TransCon hGH and our other product candidates and associated devices; |
• | the scope, progress, results and costs of developing our product candidates or any other future product candidates, and conducting preclinical studies and clinical trials; |
• | our pursuit of oncology as our second of three independent therapeutic areas of focus, and our development of a pipeline of product candidates related to oncology; |
• | our expectations regarding the potential market size and the size of the patient populations for TransCon hGH and our other product candidates, if approved for commercial use; |
• | our expectations regarding the potential advantages of TransCon hGH and our other 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 technologies and file Investigational New Drug Applications (“INDs”), or similar for such product candidates; |
• | 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 and file INDs or similar for such product candidates; |
• | our development plans with respect to TransCon hGH and our other product candidates; |
• | our pursuit of additional indications for TransCon hGH; |
• | our ability to develop, acquire and advance product candidates into, and successfully complete, clinical trials; |
• | the implementation of our business model and strategic plans for our business, TransCon hGH and our other product candidates and technologies, including global commercialization strategies; |
• | the scope of protection we are able to establish and maintain for intellectual property rights covering TransCon hGH and our other product candidates; |
• | our expectations regarding our ability to apply our technology platform and algorithm for product innovation to develop highly differentiated product candidates to address unmet medical needs; |
• | our ability to apply our platform technology to build a leading, fully integrated biopharmaceutical company; |
• | our use of our TransCon technologies to create new and potentially best-in-class |
• | estimates of our expenses, future revenue, capital requirements, our needs for additional financing and our ability to obtain additional capital; |
• | our financial performance; |
• | developments and projections relating to our market conditions, competitors and industry; and |
• | the potential effects on our business of the worldwide COVID-19 pandemic and the ongoing conflict in the region surrounding Ukraine and Russia. |
• | First Approved Product – Our first marketed product is SKYTROFA ® (lonapegsomatropin-tcgd), developed as TransCon Growth Hormone (“TransCon hGH”), which has received regulatory approval in the United States (“U.S.”) for the treatment of pediatric patients one year and older who weigh at least 11.5 kg and have growth failure due to inadequate secretion of endogenous growth hormone, also known as growth hormone deficiency (“GHD”) and which is now commercially available for prescription in the U.S. TransCon hGH is also approved in the European Union (“EU”) under the name Lonapegsomatropin Ascendis Pharma for the treatment of children and adolescents aged from 3 years up to 18 years with growth failure due to insufficient endogenous growth hormone secretion. |
• | Endocrinology Rare Disease Pipeline – We are developing three product candidates in our endocrinology rare disease portfolio spanning seven different clinical programs. These include TransCon hGH for pediatric GHD in Japan; TransCon hGH for adults with GHD; TransCon PTH for adults with hypoparathyroidism; the last classical hormone deficiency for which complete hormone replacement has been elusive; and TransCon CNP for achondroplasia, the most common form of dwarfism. VISEN Pharmaceuticals (“VISEN”), to which we have licensed rights to TransCon hGH, TransCon PTH, and TransCon CNP, and under certain conditions, has a First Right of Negotiation for other Endocrine product candidates for the Chinese market in case Ascendis decides to out-license such territory, is developing TransCon hGH, TransCon PTH and TransCon CNP in China. In addition, we are planning new trials in other endocrinology rare disease indications, including TransCon hGH for Turner Syndrome; TransCon PTH for children with hypoparathyroidism; and TransCon CNP for infants (age 0-2 years) with achondroplasia. |
• | Oncology Pipeline – In oncology, we are leveraging our TransCon technologies in effort to enhance anti-tumor effects of clinically-validated parent drugs and pathways and to provide sustained modulation of tumor microenvironments and activate cytotoxic immune cells. We have initiated clinical development of two product candidates: TransCon TLR7/8 Agonist, an investigational, long-acting prodrug of resiquimod, a small molecule agonist of Toll like receptors (“TLR”) 7 and 8 for intratumoral delivery and TransCon IL-2 ß/g for systemic delivery, which is designed for prolonged exposure to an IL-2 variant that selectively activates the IL-2Rß/ g , with minimal binding to IL-2Rα. Our clinical development program for these product candidates also includes evaluation of them as a potential combination therapy. |
1 |
Developed under the name TransCon hGH |
2 |
In development in Greater China through strategic investment in VISEN Pharmaceuticals. |
3 |
Japanese riGHt Trial. |
4 |
Global foresiGHt Trial. |
5 |
Top-line results from the North American and European PaTHway Trial were reported on March 13, 2022. |
6 |
Japanese PaTHway Japan Trial. |
7 |
North America, Europe, and Oceania ACcomplisH Trial. |
8 |
transcendIT-101 Trial. |
9 |
IL-ßelie g e Trial. |
• | A national study has shown 66%, or 2/3 of patients miss more than one injection per week. We believe reducing injection frequency is associated with better adherence and thus may improve height velocity. |
• | In a Phase 3 clinical study, TransCon hGH demonstrated higher AHV compared to daily somatropin with similar safety profile in treatment-naïve children with GHD. |
• | With a weekly injection, patients switching from daily injections can experience up to 86% fewer injection days per year. |
• | After first removed from a refrigerator, SKYTROFA (lonapegsomatropin-tcgd) can be stored at room temperature for up to six months. |
• | Sales Force: In the U.S., the sales team covers approximately 1,400 prescribers who represent approximately 80% of the prescription volume. |
• | Medical Affairs: Our Medical Affairs organization is educating stakeholders and broadening SKYTROFA (lonapegsomatropin-tcgd) awareness. |
• | Market Access: Our Market Access organization engages payors and pharmacy benefit managers in an effort to garner reimbursement for SKYTROFA (lonapegsomatropin-tcgd). |
• | Mean serum calcium levels remained stable and in the normal range. |
• | All study subjects discontinued active vitamin D supplements in the earliest weeks of the trial and have remained off it since then. In addition, 93% of subjects were taking calcium supplements <600 mg per day. |
• | Mean urinary calcium excretion remained stable and in the normal range. |
• | TransCon PTH was well-tolerated at all doses administered. No treatment-related serious or severe adverse events occurred, and no treatment-emergent adverse events (“TEAEs”) led to discontinuation of study drug. |
• | Injections were well-tolerated using pen injector planned for commercial presentation. |
• | All mean summary and subdomain SF-36 Health Survey scores continued normalization between week 26 and week 58 despite all mean scores starting below norms at baseline. |
• | Bone mineral density Z-scores trended towards normalization and stabilization over 58 weeks in PaTH Forward. |
• | Encouraging employees to work remotely, reduce travel activity and minimize face-to-face |
• | Establishing home offices, and ensuring proper and secure IT infrastructure to improve the safety and efficiency of the remote work environment; |
• | Implementing remote visits for patients enrolled in our clinical trials, including ensuring safe delivery of clinical drugs; and |
• | Addressing COVID-19 in relation to logistics and manufacturing at Joint Steering Committees with manufacturing partners. |
Three Months Ended June 30 |
Six Months Ended June 30 |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(EUR’000) |
(EUR’000) |
|||||||||||||||
Statement of Profit or Loss |
||||||||||||||||
Revenue |
6,160 |
1,022 |
12,988 |
1,767 |
||||||||||||
Cost of sales |
1,086 |
— |
5,332 |
— |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Gross profit / (loss) |
5,074 |
1,022 |
7,656 |
1,767 |
||||||||||||
Research and development costs |
90,383 |
83,306 |
173,576 |
171,455 |
||||||||||||
Selling, general and administrative expenses |
56,584 |
35,345 |
104,002 |
72,591 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Operating profit / (loss) |
(141,893 |
) |
(117,629 |
) |
(269,922 |
) |
(242,279 |
) | ||||||||
Share of profit / (loss) of associate |
(1,166 |
) |
(4,817 |
) |
(6,039 |
) |
23,289 |
|||||||||
Finance income |
71,127 |
145 |
84,171 |
23,268 |
||||||||||||
Finance expenses |
9,434 |
12,141 |
14,833 |
1,703 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Profit / (loss) before tax |
(81,366 |
) |
(134,442 |
) |
(206,623 |
) |
(197,425 |
) | ||||||||
Tax on profit / (loss) for the period |
47 |
68 |
(195 |
) |
259 |
|||||||||||
|
|
|
|
|
|
|
|
|||||||||
Net profit / (loss) for the period |
(81,319 |
) |
(134,374 |
) |
(206,818 |
) |
(197,166 |
) | ||||||||
|
|
|
|
|
|
|
|
Three Months Ended June 30 |
Six Months Ended June 30 |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(EUR’000) |
(EUR’000) |
|||||||||||||||
Revenue from external customers |
||||||||||||||||
Commercial sale of products |
4,435 |
— |
6,323 |
— |
||||||||||||
Rendering of services |
612 |
226 |
983 |
395 |
||||||||||||
Sale of clinical supply |
470 |
217 |
4,407 |
217 |
||||||||||||
Licenses |
643 |
579 |
1,275 |
1,155 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total revenue from external customers |
6,160 |
1,022 |
12,988 |
1,767 |
||||||||||||
|
|
|
|
|
|
|
|
Three Months Ended June 30 |
Six Months Ended June 30 |
|||||||||||||||
2022 |
2021 |
2022 |
2021 |
|||||||||||||
(EUR’000) |
(EUR’000) |
|||||||||||||||
External project costs |
||||||||||||||||
TransCon hGH |
22,927 |
28,622 |
42,867 |
55,200 |
||||||||||||
TransCon PTH |
10,892 |
8,149 |
22,578 |
16,542 |
||||||||||||
TransCon CNP |
7,558 |
7,886 |
17,113 |
16,196 |
||||||||||||
TransCon IL-2 ß/g |
1,909 |
2,907 |
3,355 |
7,098 |
||||||||||||
TransCon TLR7/8 |
5,511 |
2,191 |
7,648 |
5,763 |
||||||||||||
Other project costs |
1,684 |
487 |
2,285 |
786 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total external project costs |
50,481 |
50,242 |
95,846 |
101,585 |
||||||||||||
Other research and development costs |
||||||||||||||||
Employee costs |
31,353 |
26,626 |
61,771 |
58,472 |
||||||||||||
Other costs |
5,844 |
3,684 |
10,534 |
6,493 |
||||||||||||
Depreciation |
2,705 |
2,754 |
5,425 |
4,905 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total other research and development costs |
39,902 |
33,064 |
77,730 |
69,870 |
||||||||||||
|
|
|
|
|
|
|
|
|||||||||
Total research and development costs |
90,383 |
83,306 |
173,576 |
171,455 |
||||||||||||
|
|
|
|
|
|
|
|
Carrying amount |
Fair value |
|||||||
(EUR’000) |
||||||||
June 30, 2022 |
||||||||
Liquidity and capital resources |
||||||||
Marketable securities |
322,488 |
318,774 |
||||||
Cash and cash equivalents |
672,387 |
673,387 |
||||||
|
|
|
|
|||||
Total liquidity and capital resources |
994,875 |
991,161 |
||||||
|
|
|
|
|||||
Classification in consolidated statement of financial position |
||||||||
Non-current assets |
39,721 |
38,576 |
||||||
Current assets |
955,154 |
952,585 |
||||||
|
|
|
|
|||||
Total liquidity and capital resources |
994,875 |
991,161 |
||||||
|
|
|
|
• | In 2016, with net proceeds of $127.1 million (or €116.6 million); |
• | In 2017, with net proceeds of $145.2 million (or €123.1 million); |
• | In 2018, with net proceeds of $242.5 million (or €198.6 million); |
• | In 2019, with net proceeds of $539.4 million (or €480.3 million); |
• | In 2020, with net proceeds of $654.6 million (or €580.5 million); and |
• | In 2021, with net proceeds of $436.5 million (or €367.9 million). |
• | the manufacturing, selling and marketing costs associated with TransCon hGH and with our other product candidates, if approved, including the cost and timing of building our sales and marketing capabilities; |
• | the timing, receipt, and amount of sales of, or royalties on, TransCon hGH and any future products; |
• | the sales price and the availability of adequate third-party coverage and reimbursement for TransCon hGH and for our other product candidates, if approved; |
• | our ability to establish and maintain strategic partnerships, licensing or other arrangements and the financial terms of such agreements; |
• | our ability to collect payments which are due to us from collaboration partners (if any), which in turn is impacted by the financial standing of any such collaboration partners; |
• | the progress, timing, scope, results and costs of our preclinical studies and clinical trials and manufacturing activities for our product candidates 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 and the costs of post-marketing studies that could be required by regulatory authorities; |
• | 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 technologies; |
• | the achievement of development, regulatory and commercial milestones resulting in the payment to us from collaboration partners of contractual milestone payments and the timing of receipt of such payments, if any; |
• | our progress in the successful commercialization of TransCon hGH and of our other product candidates, if approved, and our efforts to develop and commercialize our other existing product candidates; 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. |
Six Months Ended June 30, |
||||||||||||
2022 |
2021 |
Change |
||||||||||
(EUR’000) |
||||||||||||
Cash flow from / (used in) |
||||||||||||
Operating activities |
(255,181 |
) |
(196,820 |
) |
(58,361 |
) | ||||||
Investing activities |
48,430 |
(19,082 |
) |
67,512 |
||||||||
Financing activities |
395,500 |
1,411 |
394,089 |
|||||||||
|
|
|
|
|
|
|||||||
Net increase / (decrease) in cash and cash equivalents |
188,749 |
(214,491 |
) |
403,240 |
||||||||
|
|
|
|
|
|
• | additional net settlements of marketable securities of €47.2 million in line with our liquidity management strategy; |
• | reimbursement from property, plant and equipment of €9.6 million primarily related to leasehold improvements for our U.S. facilities; and |
• | the Series B investment in VISEN of €10.2 million made in January 2021, which reduced the cash flow for the six months ended June 30, 2021. |