Exhibit 99.1
CONDENSED CONSOLIDATED STATEMENTS OF PROFIT OR LOSS (UNAUDITED)
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For the six months ended June 30, |
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Note |
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2023 |
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2022 |
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(In thousands of Euro, except per share amounts) |
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Revenue |
3 |
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Research and development expenses |
4 |
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( |
) |
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( |
) |
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Selling, general and administrative expenses |
5 |
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( |
) |
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( |
) |
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Total operating expenses |
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( |
) |
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( |
) |
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Operating (loss) / profit |
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( |
) |
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Finance income |
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Finance expense |
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( |
) |
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( |
) |
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Fair value change – earnout and warrants |
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( |
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— |
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Foreign exchange gains |
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(Loss) / profit before tax |
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( |
) |
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Income tax expense |
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— |
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— |
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(Loss) / profit for the period |
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( |
) |
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Earnings per share (in Euros) |
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Basic* |
10 |
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€ |
( |
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€ |
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Diluted* |
10 |
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€ |
( |
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€ |
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(*) |
Restated - see Note 10 |
The accompanying notes are an integral part of these consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE PROFIT OR LOSS (UNAUDITED)
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For the six months ended June 30, |
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Note |
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2023 |
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2022 |
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(In thousands of Euro, except per share amounts) |
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(Loss) / profit for the period |
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( |
) |
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Items that may be reclassified subsequently to profit or loss: |
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Translation differences |
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( |
) |
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Other comprehensive (loss) / profit for the period, net of tax |
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( |
) |
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- |
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Total comprehensive (loss) / profit for the period, net of tax |
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( |
) |
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The accompanying notes are an integral part of these consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (UNAUDITED)
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As at |
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Note |
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June 30, |
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December 31, |
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(In thousands of Euro) |
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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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Long term prepaid expenses |
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Total non-current assets |
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Current assets |
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Prepayments and other receivables |
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Cash |
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Total current assets |
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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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Other reserves |
9 |
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Translation differences |
10 |
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( |
) |
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- |
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Accumulated loss |
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( |
) |
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( |
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Total equity |
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Non-current liabilities |
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Deferred revenue |
3 |
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Lease liability |
6 |
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Derivative earnout liability |
7 |
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Total non-current liabilities |
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Current liabilities |
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Trade and other payables |
6 |
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Deferred revenue |
3 |
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Lease liability |
6 |
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Derivative warrant liabilities |
7 |
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Total current liabilities |
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Total equity and liabilities |
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The accompanying notes are an integral part of these consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (UNAUDITED)
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Issued |
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Share |
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Other |
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Translation |
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Retained |
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Total |
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Note |
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capital |
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premium |
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reserves |
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differences |
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earnings |
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equity |
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(In thousands of Euro) |
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Opening balance at January 1, 2022 |
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— |
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( |
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Series A - Tranche II |
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— |
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— |
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— |
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Share-based compensation |
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— |
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— |
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— |
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— |
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(Loss) / profit 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 (loss) / profit 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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Total comprehensive (loss) / profit for the period |
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— |
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— |
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— |
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— |
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As at June 30, 2022 |
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- |
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Opening balance at January 1, 2023 |
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- |
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( |
) |
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Exercise of Warrants |
8 |
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— |
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— |
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— |
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Exercise of Company Options |
8 |
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( |
) |
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— |
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— |
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Share-based compensation |
9 |
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— |
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— |
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— |
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— |
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(Loss) / profit for the period |
10 |
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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 (loss) / profit 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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( |
) |
Total comprehensive (loss) / profit 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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As at June 30, 2023 |
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( |
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( |
) |
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The accompanying notes are an integral part of these consolidated financial statements.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
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For the six months ended June 30, |
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Note |
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2023 |
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2022 |
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(In thousands of Euro) |
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Operating activities: |
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Loss before tax |
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( |
) |
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Non-cash adjustments to reconcile loss before tax to net cash flows: |
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Depreciation and amortization |
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Finance income |
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( |
) |
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( |
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Finance expense |
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- |
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Fair value change - derivative earnout and warrants |
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— |
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Foreign exchange gains |
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( |
) |
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( |
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Share-based compensation |
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Changes in working capital: |
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Changes in trade receivables |
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- |
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( |
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Changes in prepayments and other receivables |
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( |
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Changes in trade and other payables |
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Changes in deferred revenue |
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( |
) |
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Changes in non-current assets/liabilities |
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Changes in long-term prepaid expenses |
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— |
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Interest paid |
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( |
) |
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— |
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Net cash provided by/(used in) operating activities |
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( |
) |
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( |
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Investing activities: |
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Purchase of equipment |
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( |
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( |
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Interest received |
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Net cash provided by/(used in) investing activities |
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( |
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Financing activities: |
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Proceeds from issuing equity securities (Series A) |
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- |
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Proceeds from issuing equity securities (exercise of Warrants) |
7 |
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— |
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Proceeds from issuing equity securities (exercise of Company Options) |
9 |
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— |
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Payments of lease liabilities |
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( |
) |
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( |
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Net cash provided by financing activities |
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Net change in cash |
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( |
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Foreign exchange differences |
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( |
) |
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Cash at the beginning of the period |
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Cash at the end of the period |
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The accompanying notes are an integral part of these consolidated financial statements.
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED FINANCIAL STATEMENTS
Note 1 — Group Information
NewAmsterdam Pharma Company N.V. (the “Company” and together with its subsidiaries, the “Group”) is a global biotechnology company focused on the research and development of transformative therapies for cardio-metabolic diseases. The Company was incorporated in the Netherlands as a Dutch private company with limited liability (besloten vennootschap met beperkte aansprakelijkheid) under the name NewAmsterdam Pharma Company B.V. on June 10, 2022. On November 21, 2022, in connection with its merger with Frazier Life Sciences Acquisition Corp (“FLAC”), the Company’s corporate form was converted to a Dutch public limited liability company (naamloze vennootschap) and its name was changed to NewAmsterdam Pharma Company N.V. The Group’s principal place of business and registered office is Gooimeer 2-35, 1411 DC Naarden, The Netherlands. These unaudited condensed consolidated financial statements comprise the financial statements of the Group.
Terms in these accompanying notes take on the same meaning as defined in the Company’s Annual Report on Form 20-F for the year ended December 31, 2022 filed with the U.S. Securities and Exchange Commission on March 31, 2023 (the "Annual Report"), unless otherwise defined.
Note 2 — Basis of Preparation and Summary of Material Accounting Policy Information
Basis of Preparation
These unaudited condensed consolidated financial statements as at June 30, 2023 and for the six months ended June 30, 2023 and 2022 should be read in conjunction with the Annual Report as the unaudited condensed consolidated financial statements are prepared on a condensed basis in accordance with IAS 34 Interim Financial Reporting and do not contain all information required for a complete set of financial statements prepared in accordance with International Financial Reporting Standards as issued by the International Accounting Standards Board (“IFRS”). Unless stated otherwise, the unaudited condensed consolidated financial statements as at June 30, 2023 and for the six months ended June 30, 2023 and 2022 are presented on a basis consistent with the accounting policies set out in the Annual Report.
There were no significant changes in accounting policies, critical accounting judgements and key sources of estimation uncertainty applied by us in these unaudited condensed consolidated financial statements compared to those used in the Annual Report.
The unaudited condensed consolidated financial statements have been prepared on a historical cost basis, unless otherwise disclosed. The unaudited condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern, and which contemplates the recoverability of assets and the satisfaction of the liabilities and commitments in the normal course of business.
Based on the Group’s current operating plan, management has assessed that the existing cash and cash equivalents will be sufficient to fund the Group’s anticipated level of operations for the twelve months following the date of the issuance of these financial statements.
The functional currency of the Group has historically been EUR. In the first half of 2023, the Group reassessed its functional currency and determined the United States Dollar (“USD” or “$”) to be the Group’s functional currency beginning January 1, 2023. Significant elements involved in the determination of the functional currency change include a shift in the Group’s sources of financing from EUR to USD given its access to the U.S. public market and an increase of operating costs incurred in USD due to Phase III trials taking place predominantly in the United States, among other factors. Given these significant changes, management considered the economic factors outlined in IAS 21, The Effects of Changes in Foreign Exchange Rates and concluded that the majority of the factors supported the determination of the USD as the functional currency.
The unaudited condensed consolidated financial statements are presented in Euro (“EUR” or “€”). In these notes, Euro amounts are presented in thousands, except for share and per share amounts and as otherwise indicated. The Company has elected to present its financial statements in EUR in order to provide information comparable to the historical financial information included within previous Company filings.
New and Amended IFRS Standards that are Effective for the Current Year
New standards and interpretations effective for the annual period beginning on January 1, 2023 did not have any material impact on the Company's condensed consolidated financial statements.
New Standards, Interpretations and Amendments Issued but Not Yet Adopted by the Company
At the date of authorization of these financial statements, the Group has not applied new and revised IFRS Standards that have been issued but are not yet effective. The amendments to the standards and interpretations presented are not expected to have a material impact on the consolidated financial statements in future periods.
Note 3 — Revenue
The Group earns revenue through a license agreement with A. Menarini International Licensing S.A. (“Menarini”) (the “Menarini License”), pursuant to which it granted Menarini an exclusive, royalty-bearing, sublicensable license under certain of its intellectual property and its regulatory documentation to undertake post approval development activities and commercialize multiple brands of obicetrapib. The Menarini License includes a non-refundable upfront payment, fixed reimbursements for the Group’s continued development costs, payments based upon the achievement of defined development, regulatory and commercial milestones, sales-based royalties, and certain cost sharing payments made by Menarini to the Group and by the Group to Menarini.
In January 2023, the Group achieved a clinical milestone related to our Phase 2 ROSE2 clinical trial which resulted in a €5 million milestone payment from Menarini in April 2023. Revenues related to the achievement of milestones under the Menarini License are attributed to the license performance obligation.
Revenue consisted of the following for the six months ended June 30:
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2023 |
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2022 |
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License revenue attributed from license performance obligation |
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License revenue attributed from R&D performance obligation |
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— |
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Total revenue |
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At January 1, 2023, the Group had total deferred revenue of €
Note 4 — Research and Development Expense
Research and development expense consisted of the following items for the six months ended June 30:
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2023 |
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2022 |
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Clinical expenses |
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( |
) |
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( |
) |
Non-clinical expenses |
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( |
) |
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( |
) |
Personnel expense |
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( |
) |
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( |
) |
Manufacturing costs |
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( |
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( |
) |
Regulatory expenses |
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( |
) |
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( |
) |
Other R&D costs |
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( |
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( |
) |
Total research and development expenses |
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( |
) |
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( |
) |
Note 5 — Selling, General and Administrative Expenses
Selling, general and administrative expenses consisted of the following items for the six months ended June 30:
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2023 |
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2022 |
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Included in selling expenses: |
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Commission expense |
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( |
) |
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( |
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Included in general and administrative expenses: |
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Personnel expense |
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( |
) |
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( |
) |
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Travel costs |
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( |
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( |
) |
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Intellectual property |
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( |
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( |
) |
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Legal costs |
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( |
) |
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( |
) |
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Licenses |
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( |
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- |
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Finance and administration |
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( |
) |
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( |
) |
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IT |
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( |
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( |
) |
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Rent and office services |
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( |
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( |
) |
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Marketing and communication |
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( |
) |
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( |
) |
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Insurance |
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( |
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( |
) |
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Depreciation and amortization |
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( |
) |
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( |
) |
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Commercial costs |
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( |
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— |
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Business development |
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( |
) |
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( |
) |
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Board fees |
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( |
) |
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( |
) |
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Miscellaneous |
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( |
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( |
) |
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Total selling, general and administrative expenses |
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( |
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( |
) |
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Note 6 — Financial Risk Management
The Group’s risk management activities are the same as those disclosed in our Annual Report.
The table below summarizes the maturity profile of the Group’s financial liabilities based on contractual undiscounted payments. Payments related to foreign currency are included at the exchange rates applicable as at June 30, 2023.
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Less than |
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3 - 12 |
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More than |
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On demand |
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3 months |
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months |
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1 year |
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Total |
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As at June 30, 2023 |
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Trade and other payables |
|
— |
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— |
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— |
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Share based payment liabilities |
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Lease liability |
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— |
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Derivative warrant liabilities |
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— |
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— |
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— |
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Derivative earnout liability |
|
— |
|
|
|
— |
|
|
|
— |
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|
|
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|
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|
||
Total financial liabilities |
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Note 7 — Financial Assets and Liabilities Fair Value
Financial liabilities consist of trade and other payables, lease liability, derivative warrant liabilities and derivative earnout liability.
The carrying amount of cash, trade and other payables approximate their fair value due to their short-term nature. The fair values of these financial assets and liabilities are included at the amount at which the instrument could be exchanged in a current transaction between willing parties, other than in a forced or liquidation sale. Lease liabilities are measured at amortized cost based on the present value of the contractual payments due to the lessor over the lease term.
Derivative Warrant Liabilities
At January 1, 2023 a total of
The fair value of the outstanding Warrants increased from $
Derivative Earnout Liability
The Business Combination Agreement contemplates the issuance of Earnout Shares, totaling
At December 31, 2022, the fair value of the
Fair value measurements
The financial liability for the derivative warrants is accounted for at fair value through profit or loss. The Public Warrants are considered liquid and are actively listed on Nasdaq and have been measured at fair value using the quoted price (Level 1).
The Private Placement Warrants have been measured at fair value using inputs other than quoted prices included in Level 1 that are observable for the liability (Level 2), since the terms of the Private Placement Warrants are considered to be nearly identical to the Public Warrants, and the Public Warrants have an observable price in the active market. For these reasons, the measurement of the Private Placement Warrants can be indirectly derived from the quoted price of the Public Warrants.
Based upon an assumed
The following table shows the carrying amounts of the financial liabilities measured at fair value through profit and loss on a recurring basis:
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Level 1 |
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Level 2 |
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Level 3 |
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Total |
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||||
Liabilities measured at FVTPL |
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||||
Derivative warrant liability (Public Warrants) |
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|
|
|
|
— |
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— |
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||
Derivative warrant liability (Private Placement Warrants) |
|
|
— |
|
|
|
|
|
|
— |
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|
||
Derivative earnout liability |
|
|
— |
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|
|
— |
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|
||
Total financial liabilities |
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Note 8 — Share Capital and Share Premium
During the six months ended June 30, 2023, the Group issued
Note 9 — Share-Based Payments
The Company has three Share-based payment plans and one restricted share award in place as at June 30, 2023:
Long Term Incentive Plans
The Plans are equity-settled, and the Company may grant various forms of equity awards, including the granting of options to purchase Ordinary Shares (“Company Options”) and restricted stock units (“RSUs”), pursuant to the Plans.
The contractual term is
The changes for the six months ended June 30, 2023 in the number of options outstanding related to Ordinary Shares and their related weighted average exercise prices are as follows:
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2023 |
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||
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Weighted average exercise price |
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Number of options |
|
||
Outstanding as at January 1 |
|
|
€ |
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||
Granted during the year |
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|
$ |
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|
||
Exercised during the year |
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|
€ |
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( |
) |
|
Forfeited during the year |
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€ |
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( |
) |
|
Outstanding as at June 30 |
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€ |
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|
As at June 30, 2023,
|
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2023 |
|
||
Expiry date |
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Exercise Price |
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|
Number of options |
|
|||
July 6, 2031 |
|
€ |
|
|
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|
||
November 22, 2032 |
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$ |
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January 1 - June 5, 2033 |
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$ |
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Outstanding as at June 30 |
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€ |
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Fair Value of Options Granted
The Black-Scholes option pricing formula has been applied for measuring the fair value of the options granted.
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|
2023 |
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Share value (EUR) |
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Option exercise price (EUR) |
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Volatility (%) |
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Expected life (years) |
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Dividend yield |
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% |
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Risk-free rate |
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Fair value per option (EUR) |
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The expected option life is based on management’s best estimate of when the options will be exercised. Expected volatility is estimated by considering historical average share price volatility of a group of comparable companies over a period before the grant date being equal to the expected option life. The expected dividend rate is
Share-Based Payment Expenses Recognized for Options Granted
The fair value of the options is expensed over the relevant vesting periods using the graded vesting method, based on management’s estimate of the number of options that will eventually vest. For the six months ended June 30, 2023 and 2022, the total share-based payment expense recognized for the equity-settled options amounted to €
In addition, during the six months ended June 30, 2023 and 2022, the Group recognized €
Restricted Stock Units (“RSUs”)
As at June 30, 2023 the Company had allocated
The development milestone consists of the achievement and public announcement of Positive Phase 3 Data for each of the Company’s BROADWAY clinical trial and BROOKLYN clinical trial at any time during the period beginning on November 22, 2022 and ending on the date that is five years after such date.
There is no impact on these financial statements with respect to these RSUs due to the uncertainty of achieving the clinical development milestone.
Chief Executive Officer Restricted Share Award
In July 2021, our chief executive officer, Michael Davidson, M.D., paid the fair market value of the underlying ordinary shares (in aggregate €
In connection with the award arrangement, if Dr. Davidson leaves the Group, all unvested Ordinary Shares will be cancelled against payment by the Company to him of the lower of the (i) the purchase price paid and (ii) the fair market value of such Ordinary Shares at the time of forfeiture. In order to reflect the consideration paid and the possibility that the Ordinary Shares would be repurchased if Dr. Davidson becomes a "Good Leaver" (as such term is defined in the award agreement) during the vesting period, the Company has recognized the consideration as a financial liability until the award has fully vested, at which time it will be reclassified to equity provided that Dr. Davidson remains with the Group. This liability is measured at the lower of (i) the purchase price paid and (ii) the fair market value of the Ordinary Shares at the end of the reporting period. The liability for unvested Ordinary Shares as at June 30, 2023 amounted to €
For the six months ended June 30, 2023, the movements in the number of Ordinary Shares outstanding are as follows:
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|
2023 |
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|
Number of Ordinary Shares |
|
|
Outstanding as at January 1 |
|
|
|
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|
|
Granted/purchased during the year |
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|
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Outstanding as at June 30 |
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|
As of June 30, 2023, a total of
Note 10 — Earnings per Share
Earnings per share for the period presented has been determined by dividing the earnings attributable to shareholders by the weighted average number of shares outstanding during the period. NewAmsterdam Pharma’s former non-voting ordinary shares and voting ordinary shares are considered to be the same class of equity for purposes of determining the loss attributable per shareholder class per share.
In accordance with the Business Combination Agreement,
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June 30, 2022 |
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Shares for basic EPS of NewAmsterdam Pharma - as reported |
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Shares for diluted EPS of NewAmsterdam Pharma - as reported |
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Exchange ratio |
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Shares for basic EPS of NewAmsterdam Pharma - restated |
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|
Shares for diluted EPS of NewAmsterdam Pharma - restated |
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|
In total,
The following table sets forth the computation of original and restated basic and diluted loss per share for the six months ended June 30:
(In thousands of Euro, except share and per share amounts) |
|
2023 |
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|
2022 |
|
||
|
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|
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(Loss) / profit for the period |
|
|
( |
) |
|
|
|
|
Weighted average basic number of Ordinary Shares - as reported |
|
|
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|
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|
||
Weighted average diluted number of Ordinary Shares - as reported |
|
|
|
|
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|
||
Basic earnings per share - as reported |
|
|
( |
) |
|
|
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|
Diluted earnings per share - as reported |
|
|
( |
) |
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Weighted average basic number of Ordinary Shares - restated |
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|
||
Weighted average diluted number of Ordinary Shares - restated |
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|
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|
||
Basic earnings per share - restated |
|
|
( |
) |
|
|
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|
Diluted earnings per share - restated |
|
|
( |
) |
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|
|
At June 30, 2023, outstanding share-based awards and unexercised Warrants were excluded from the calculation because their impact would be anti-dilutive. At June 30, 2023, the total number of potential Ordinary Shares excluded amounted to
Note 11 — Related Parties
During the six months ended June 30, 2023 and 2022 the Company did not have any material transactions with related parties.
Terms and conditions of transactions with related parties
Transactions with related parties, other than the remuneration of certain non-executive directors as disclosed below, are made on terms equivalent to those that prevail in arm’s length transactions. Outstanding balances at the year-end are unsecured and interest free and settlement generally occurs in cash. There have been no guarantees provided or received for any related party receivables or payables.
Compensation to Directors and Senior Managers of the Company
The Company’s compensation includes base salary, as well as short and long-term incentive schemes.
Key Management Personnel (“KMPs”) are those persons having authority and responsibility for planning, directing and controlling the activities of the Group, including the directors of the Company. KMPs include the Chief Executive Officer, Chief Financial Officer, Chief Science Officer, Chief Operating Officer, Chief Business Officer and Vice President of Research and Development.
|
|
2023 |
|
|
2022 |
|
||
|
|
|
|
|
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|
||
Short-term employee benefits |
|
|
|
|
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|
||
Share-based payments |
|
|
|
|
|
|
||
Total compensation paid to key management personnel |
|
|
|
|
|
|
Additionally, certain non-executive directors of the Company who serve as representatives of the Company’s shareholders and as such, have of received cash remuneration from the Company during the six months ended June 30, 2023 and 2022 totaling €
Note 12 — Segment Reporting
Operating segments are components of the Group that engage in business activities from which it may incur expenses, for which discrete financial information is available and whose operating results are evaluated regularly by the Company’s Chief Operating Decision Maker (“CODM”) to make decisions about resources to be allocated to the segment and assess its performance. The activities of the Group are considered to be one segment which is reflected in its organizational structure and internal reporting and comprises the research, development and subsequent commercialization of innovative and proprietary compounds that have a potential therapeutic effect in cardiovascular disease. The Group does not distinguish in its internal reporting different segments, neither business nor geographical segments. The Chief Executive Officer is identified as the CODM and reviews the operating results regularly to make decisions about the resources and to assess overall performance of the Group.
Total revenues recognized from the Menarini License of €
The following table shows the breakdown of the Group’s non-current assets (i.e., intangible assets, property, plant and equipment and long-term prepaid expenses) by geographical location as of:
|
|
June 30, |
|
|
December 31, |
|
||
Non-current assets |
|
|
|
|
|
|
||
Netherlands |
|
|
|
|
|
|
||
USA |
|
|
|
|
|
|
||
Total |
|
|
|
|
|
|
Note 13 — Events After the Reporting Period
The Group evaluated all events through August 3, 2023 and determined that there were no reportable subsequent events to be disclosed or adjusted in the undaudited condensed consolidated financial statements.