Exhibit 99.1
Oculis Holding AG
Unaudited Condensed Consolidated Interim Financial Statements
2
Oculis Holding AG
Unaudited Condensed Consolidated Interim Statements of Financial Position
(in CHF thousands)
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As of June 30, |
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As of December 31, |
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Note |
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2024 |
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2023 |
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ASSETS |
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Non-current assets |
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Property and equipment, net |
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Intangible assets |
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6 |
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Right-of-use assets |
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Other non-current assets |
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Total non-current assets |
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Current assets |
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Other current assets |
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8 |
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Accrued income |
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8 |
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Short-term financial assets |
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10 |
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Cash and cash equivalents |
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10 |
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Total current assets |
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TOTAL ASSETS |
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EQUITY AND LIABILITIES |
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Shareholders' equity |
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Share capital |
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Share premium |
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Reserve for share-based payment |
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9 |
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Actuarial loss on post-employment benefit obligations |
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( |
) |
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( |
) |
Treasury shares |
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14 |
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( |
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- |
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Cumulative translation adjustments |
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( |
) |
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( |
) |
Accumulated losses |
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( |
) |
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( |
) |
Total equity |
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Non-current liabilities |
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Long-term lease liabilities |
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Long-term payables |
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Defined benefit pension liabilities |
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Total non-current liabilities |
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Current liabilities |
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Trade payables |
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Accrued expenses and other payables |
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12 |
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Short-term lease liabilities |
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Warrant liabilities |
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11 |
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Total current liabilities |
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Total liabilities |
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TOTAL EQUITY AND LIABILITIES |
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The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
3
Oculis Holding AG
Unaudited Condensed Consolidated Interim Statements of Loss
(in CHF thousands, except loss per share data)
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For the three months ended June 30, |
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For the six months ended June 30, |
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Note |
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2024 |
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2023 |
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2024 |
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2023 |
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Grant income |
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7. (A) / 8 |
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Operating income |
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Research and development expenses |
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7. (B) |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
General and administrative expenses |
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7. (B) |
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( |
) |
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( |
) |
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( |
) |
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( |
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Merger and listing expense |
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4 / 7. (B) |
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- |
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- |
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- |
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( |
) |
Operating expenses |
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( |
) |
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( |
) |
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( |
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( |
) |
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Operating loss |
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( |
) |
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( |
) |
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( |
) |
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( |
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Finance income |
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7. (C) |
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Finance expense |
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7. (C) |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
Fair value adjustment on warrant liabilities |
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7. (C) / 11 |
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( |
) |
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( |
) |
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( |
) |
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Foreign currency exchange gain (loss) |
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7. (C) |
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( |
) |
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Finance result |
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( |
) |
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( |
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Loss before tax for the period |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
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Income tax expense |
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( |
) |
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( |
) |
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( |
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( |
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Loss for the period |
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( |
) |
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( |
) |
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( |
) |
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( |
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Loss per share: |
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Basic and diluted loss attributable to equity holders |
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15 |
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( |
) |
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( |
) |
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( |
) |
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( |
) |
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
4
Oculis Holding AG
Unaudited Condensed Consolidated Interim Statements of Comprehensive Loss
(in CHF thousands)
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For the three months ended June 30, |
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For the six months ended June 30, |
||||
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|
2024 |
|
2023 |
|
2024 |
|
2023 |
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 loss: |
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Items that will not be reclassified to Statements of Loss: |
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Actuarial losses of defined benefit plans |
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( |
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( |
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( |
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( |
Items that may be reclassified subsequently to loss: |
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Foreign currency translation differences |
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( |
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( |
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( |
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Other comprehensive loss for the period |
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( |
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( |
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( |
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( |
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Total comprehensive loss for the period |
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( |
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( |
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( |
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( |
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
5
Oculis Holding AG
Unaudited Condensed Consolidated Interim Statements of Changes in Equity
(in CHF thousands, except share numbers)
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Legacy share capital |
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Legacy treasury shares |
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Share capital |
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Treasury shares |
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Note |
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Shares |
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Share capital |
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Shares |
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Treasury shares |
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Shares |
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Share capital |
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Shares |
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Treasury shares |
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Share premium |
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Reserve for share-based payment |
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Cumulative translation adjustment |
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Actuarial loss on post-employment benefit obligations |
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Accumulated losses |
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Total |
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Balance as of January 1, 2023 |
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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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( |
) |
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( |
) |
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( |
) |
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( |
) |
||||
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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- |
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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 loss: |
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Actuarial gain on post-employment benefit obligations |
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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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- |
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- |
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- |
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- |
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- |
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|
( |
) |
|
|
- |
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( |
) |
Foreign currency translation differences |
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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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- |
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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 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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- |
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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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( |
) |
Share-based compensation expense |
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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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- |
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- |
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- |
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- |
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- |
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- |
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Conversion of Legacy Oculis ordinary shares and treasury shares into Oculis ordinary shares |
|
4 |
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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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- |
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- |
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- |
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- |
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Conversion of Legacy Oculis long-term financial debt into Oculis ordinary shares |
|
4 |
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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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- |
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- |
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- |
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- |
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Issuance of ordinary shares to PIPE investors |
|
4 |
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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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- |
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- |
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- |
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- |
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Issuance of ordinary shares under CLA |
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4 |
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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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- |
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- |
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- |
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- |
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Issuance of ordinary shares to EBAC shareholders |
|
4 |
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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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- |
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- |
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- |
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- |
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||||
Transaction costs related to the business combination |
|
4 |
|
|
- |
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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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- |
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( |
) |
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- |
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- |
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- |
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- |
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( |
) |
Proceeds from sale of shares in public offering |
|
4 |
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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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- |
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- |
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- |
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- |
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||||
Transaction costs related to the public offering |
|
4 |
|
|
- |
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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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( |
) |
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- |
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- |
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- |
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|
- |
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|
( |
) |
Issuance of shares in connection with warrant exercises |
|
11 |
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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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- |
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- |
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- |
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- |
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||||
Balance as of June 30, 2023 |
|
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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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( |
) |
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( |
) |
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( |
) |
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Balance as of January 1, 2024 |
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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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( |
) |
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( |
) |
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( |
) |
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|||||
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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- |
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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 profit (loss): |
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|
||||||||||||||
Actuarial loss on post-employment benefit obligations |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
( |
) |
Foreign currency translation differences |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Total comprehensive loss for the period |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Share-based compensation expense |
|
9 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
||
Issuance of ordinary shares related to Registered Direct Offering |
|
4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Transaction costs related to Registered Direct Offering |
|
4 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
( |
) |
Issuance of shares to be held as treasury shares |
|
14 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
||
Stock options exercised |
|
9 |
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
||||
Balance as of June 30, 2024 |
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
|
|
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
|
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
6
Oculis Holding AG
Unaudited Condensed Consolidated Interim Statements of Cash Flows
(in CHF thousands)
|
|
|
|
For the six months ended June 30, |
||
|
|
Note |
|
2024 |
|
2023 |
Operating activities |
|
|
|
|
|
|
Loss before tax for the period |
|
|
|
( |
|
( |
|
|
|
|
|
|
|
Non-cash adjustments: |
|
|
|
|
|
|
- Financial result |
|
|
|
( |
|
|
- Depreciation of property and equipment and right-of-use assets |
|
|
|
|
||
- Share-based compensation expense |
|
9 |
|
|
||
- Interest expense on Series B and C preferred shares |
|
7. (C) |
|
- |
|
|
- Interests on lease liabilities |
|
|
|
|
||
- Post-employment (benefits)/loss |
|
|
|
( |
|
( |
- Fair value adjustment on warrant liabilities |
|
11 |
|
|
||
- Merger and listing expense |
|
4 |
|
- |
|
|
Working capital adjustments: |
|
|
|
|
|
|
- De/(Increase) in other current assets |
|
8 |
|
|
( |
|
- De/(Increase) in accrued income |
|
8 |
|
( |
|
( |
- De/(Increase) in other non-current assets |
|
|
|
( |
|
( |
- (De)/Increase in trade payables |
|
|
|
( |
|
( |
- (De)/Increase in accrued expenses and other payables |
|
12 |
|
|
( |
|
- (De)/Increase in long-term payables |
|
|
|
( |
|
- |
|
|
|
|
|
|
|
Interest received |
|
|
|
|
||
Interest paid |
|
|
|
( |
|
( |
Taxes paid |
|
|
|
( |
|
( |
Net cash outflow for operating activities |
|
|
|
( |
|
( |
|
|
|
|
|
|
|
Investing activities |
|
|
|
|
|
|
Payment for purchase of property and equipment |
|
|
|
( |
|
( |
Payment for short-term financial assets, net |
|
10 |
|
( |
|
( |
Net cash outflow for investing activities |
|
|
|
( |
|
( |
|
|
|
|
|
|
|
Financing activities |
|
|
|
|
|
|
Proceeds from EBAC merger and listing |
|
4 |
|
- |
|
|
Transaction costs related to the business combination |
|
4 |
|
- |
|
( |
Proceeds from sale of shares related to Registered Direct Offering |
|
4 |
|
|
||
Transactions costs related to equity issuance related to Registered Direct Offering |
|
4 |
|
( |
|
( |
Transactions costs related to ATM Offering Program |
|
4 |
|
( |
|
- |
Transactions costs related to loan facility |
|
4 |
|
( |
|
- |
Proceeds from exercise of warrants |
|
11 |
|
- |
|
|
Proceeds from stock options exercised |
|
9 |
|
|
- |
|
Principal payment of lease obligations |
|
|
|
( |
|
( |
Net cash inflow from financing activities |
|
|
|
|
||
|
|
|
|
|
|
|
Increase in cash and cash equivalents |
|
|
|
|
||
|
|
|
|
|
|
|
Cash and cash equivalents, beginning of period |
|
10 |
|
|
||
Effect of foreign exchange rate changes |
|
|
|
|
( |
|
Cash and cash equivalents, end of period |
|
10 |
|
|
||
|
|
|
|
|
|
|
Net cash and cash equivalents variation |
|
|
|
|
||
|
|
|
|
|
|
|
Supplemental non-cash financing information |
|
|
|
|
|
|
Transaction costs recorded in accrued expenses and other payables |
|
|
|
|
The accompanying notes form an integral part of the Unaudited Condensed Consolidated Interim Financial Statements.
7
Oculis Holding AG
NOTES TO THE UNAUDITED CONDENSED CONSOLIDATED INTERIM FINANCIAL STATEMENTS
Oculis Holding AG (“the Company” or “Oculis”) is a stock corporation (“Aktiengesellschaft”) with its registered office at Bahnhofstrasse 7, CH-6300, Zug, Switzerland. It was incorporated under the laws of Switzerland on October 31, 2022.
As of June 30, 2024, the Company controlled five wholly-owned subsidiaries: Oculis Operations GmbH (“Oculis Operations”) with its registered office in Lausanne, Switzerland, which was incorporated in Zug, Switzerland on December 27, 2022, Oculis ehf. (“Oculis Iceland”), which was incorporated in Reykjavik, Iceland on October 28, 2003, Oculis France Sàrl (“Oculis France”) which was incorporated in Paris, France on March 27, 2020, Oculis US, Inc. (“Oculis US”) with its registered office in Newton MA, USA, which was incorporated in Delaware, USA, on May 26, 2020 and Oculis HK, Limited (“Oculis HK”) which was incorporated in Hong Kong, China on June 1, 2021. The Company and its wholly-owned subsidiaries form the Oculis Group (the “Group”). Prior to the Business Combination (as defined in Note 4), Oculis SA (“Legacy Oculis”), which was incorporated in Lausanne, Switzerland on December 11, 2017, and its wholly-owned subsidiaries Oculis Iceland, Oculis France, Oculis US and Oculis HK, formed the Oculis group. On July 6, 2023, Legacy Oculis merged with and into Oculis Operations, and the separate corporate existence of Legacy Oculis ceased. Oculis Operations is the surviving company and remains a wholly-owned subsidiary of Oculis.
On April 18, 2024, the Company completed the dissolution of Oculis Merger Sub II Company (“Merger Sub 2”) which had been incorporated in the Cayman Islands on January 3, 2023 and which was a wholly-owned subsidiary of Oculis. Merger Sub 2 had been created for purposes of consummating the Business Combination described in Note 4 below and did not contain any business operations of the Company.
The purpose of the Company is the research, study, development, manufacture, promotion, sale and marketing of biopharmaceutical products and substances as well as the purchase, holding, sale and exploitation of intellectual property rights, such as patents and licenses, in the field of ophthalmology. As a global biopharmaceutical company, Oculis is developing treatments to save sight and improve eye care with breakthrough innovations. The Company’s differentiated pipeline includes candidates for topical retinal treatments, topical biologics and disease modifying treatments.
2.
The Group's accounts are prepared on a going concern basis. The Board of Directors believes that with the proceeds from the Business Combination, the June 2023 public offering and the April 2024 Registered Direct Offering, the Group has the ability to meet its financial obligations for at least the next 12 months.
The Company is a late-clinical stage company and is exposed to all the risks inherent to establishing a business, including the substantial uncertainty as to whether current projects will succeed. The Company’s success may depend in part upon its ability to (i) establish and maintain a strong patent position and protection, (ii) enter into collaborations with partners in the biotech and pharmaceutical industry, (iii) successfully move its product candidates through clinical and regulatory development, and (iv) attract and retain key personnel. The Company’s success is subject to its ability to be able to raise capital to support its operations. Shareholders should note that the long-term viability of the Company is dependent on its ability to raise additional capital to finance its future operations. The Company will continue to evaluate additional funding through public or private financings, debt financing or collaboration agreements. The Company cannot be certain that additional funding will be available on acceptable terms, or at all. If the Company is unable to raise additional capital when required or on acceptable terms, it may have to (i) significantly delay, scale back or discontinue the development of one or more product candidates; (ii) seek collaborators for product candidates at an earlier stage than otherwise would be desirable and on terms that are less favorable than might otherwise be available; or (iii) relinquish or otherwise dispose of rights to product candidates that the Company would otherwise seek to develop itself, on unfavorable terms.
These unaudited condensed consolidated interim financial statements as of June 30, 2024 and for the three and six months ended June 30, 2024 and 2023, have been prepared in accordance with International Accounting Standard ("IAS"), IAS 34 - Interim Financial Reporting. They do not include all of the information required for a complete set of financial statements prepared in accordance with IFRS Accounting Standards (“IFRS”) as issued by the International Accounting Standards Board (“IASB”). In the opinion of the Company, the accompanying unaudited condensed consolidated interim financial statements present a fair statement of its financial information for the interim periods reported.
Prior the Business Combination on March 2, 2023, the audited consolidated financial statements as of and for the year ended December 31, 2022 were issued for Legacy Oculis and its subsidiaries. Legacy Oculis became a wholly-owned subsidiary of the Company as a result of the Business Combination. In accordance with the BCA and described in Note 4, Oculis issued
8
The interim condensed consolidated financial statements of the Group are expressed in Swiss Francs (“CHF”), which is the Company’s functional and the Group’s presentation currency. The functional currency of the Company's subsidiaries is the local currency except for Oculis Iceland whose functional currency is CHF.
Assets and liabilities of foreign operations are translated into CHF at the rate of exchange prevailing at the reporting date and their statements of profit or loss are translated at average monthly exchange rates. The exchange differences arising on translation for consolidation are recognized in other comprehensive income.
During the three months ended June 30, 2024, the Company recorded a CHF
3.
There have been no material changes to the material accounting policies that have been applied by the Group in its audited consolidated financial statements as of and for the year ended December 31, 2023, included in Form 20-F filed with the SEC on March 19, 2024 and available at www.sec.gov, except as follows:
Warrant liabilities
The Company recognizes the warrant instruments as liabilities at fair value and adjusts the instruments to fair value at each reporting period (refer to Note 11). Any change in fair value is recognized in the Company’s consolidated statements of loss. Warrants are classified as short-term liabilities as the Company cannot defer the settlement beyond 12 months.
The Blackrock Warrant issued in conjunction with the Loan Agreement is classified as a liability since its exercise price is fixed in USD, which is not the functional currency of the Company and therefore it does not meet the requirements to be classified as equity under IFRS. The fair value of the Blackrock Warrant is determined using the Black-Scholes option-pricing model. This valuation model as well as parameters used such as expected volatility and expected term are partially based on management’s estimates. The expected volatility is estimated using historical stock volatilities of comparable peer public companies within the Company's industry. The expected term represents the period that the warrant is expected to be outstanding. The Blackrock Warrant is included in Level 3 of the fair value hierarchy. Refer to Note 11.
The fair value of the EBAC Public Warrants is based on the quoted market prices at the end of the reporting period for such warrants. For the EBAC Private Warrants, which have identical terms to the EBAC Public Warrants, the Company determined that the fair value of each
EBAC Private Warrant is equivalent to that of each EBAC Public Warrant. EBAC Public Warrants are included in Level 1 and EBAC Private Warrants in Level 2 in the fair value hierarchy. Refer to Note 11 - Warrant Liabilities.
In preparing these unaudited condensed consolidated interim financial statements, the critical accounting estimates, assumptions and judgments made by management in applying the Company’s accounting policies and the key sources of estimation uncertainty were the same as those applied and discussed in the audited consolidated financial statements for the year ended December 31, 2023.
The accounting policies adopted in the preparation of the unaudited condensed consolidated interim financial statements are consistent with those followed in the preparation of the Company’s annual consolidated financial statements for the year ended December 31, 2023.
There are no new IFRS Accounting Standards, amendments to standards or interpretations that are mandatory for the financial year beginning on January 1, 2024, that have a material impact in the interim period. In April 2024, the IASB issued IFRS 18, Presentation and Disclosure in Financial Statements, which provides requirements for the presentation and disclosure of information in general purpose financial statements. The standard is effective for periods beginning on or after January 1, 2027. The Company is in the process of evaluating whether IFRS 18 will have a material effect on the consolidated financial statements. New standards, amendments to standards and interpretations that are not yet effective, which have been deemed by the Group as currently not relevant, are not listed here.
9
4.
Loan Facility
On May 29, 2024, the Company entered into an agreement for a loan facility with Kreos Capital VII (UK) Limited (the “Lender”), which are funds and accounts managed by Blackrock, Inc. (the “Loan Agreement”). The Loan Agreement is structured to provide the EUR equivalent of up to CHF
In conjunction with the Loan, the Company entered into a Warrant Agreement (the “Blackrock Warrant”) with Kreos Capital VII Aggregator SCSp, an affiliate of the Lender (the “Holder”), under which the Holder can purchase up to
In connection with this transaction, the Company incurred approximately CHF
At-the-Market Offering Program
On May 8, 2024, the Company entered into a sales agreement with Leerink Partners, LLC (“Leerink Partners”) with respect to an at-the-market offering program (the “ATM Offering Program”) under which the Company may offer and sell, from time to time at its sole discretion, ordinary shares of the Company having an aggregate offering price of up to $
In connection with this transaction the Company incurred approximately CHF
Registered Direct Offering and Nasdaq Iceland Main Market listing
On April 22, 2024, the Company closed its registered direct offering with gross proceeds of CHF
Public offering of ordinary shares
On May 31, 2023, the Company entered into an underwriting agreement with BofA Securities Inc. and SVB Securities, LLC, as representatives of several underwriters, and on June 5 and June 13, 2023, the Company closed the issuance and sale in a public offering of an aggregate of
Business combination with European Biotech Acquisition Corp (“EBAC”)
On March 2, 2023, the Company consummated a business combination with EBAC (the “Business Combination”) pursuant to the Business Combination Agreement (“BCA”) between Legacy Oculis and EBAC dated as of October 17, 2022. The Company received gross proceeds of CHF
10
PIPE and CLA financing in March 2023
In connection with the BCA, EBAC entered into subscription agreements with the PIPE investors for an aggregate of
In connection with the BCA, Legacy Oculis and the investor parties thereto entered into CLAs pursuant to which the investor lenders granted Legacy Oculis a right to receive an interest free convertible loan with certain conversion rights with substantially the same terms as the PIPE investors. Following the mergers, Oculis assumed the CLAs and the lenders exercised their conversion rights in exchange for
Together, the PIPE and CLA financing resulted in aggregate gross cash proceeds of CHF
Merger and listing expense
The Business Combination was accounted for as a capital re-organization in the first quarter of 2023 within the scope of IFRS 2 Share-based Payment, as EBAC did not meet the definition of a business in accordance with IFRS 3 Business Combinations. Any excess of the fair value of the Company’s shares issued over the fair value of EBAC’s identifiable net assets acquired represented compensation for the service of a stock exchange listing. This expense was incurred in the first quarter of 2023 and amounted to CHF
Earnout consideration
As a result of the BCA, Legacy Oculis preferred, ordinary and option holders (collectively “equity holders”) received consideration in the form of
The earnout consideration is subject to forfeiture in the event of a failure to achieve the price targets during the earnout period defined as follows: (i)
The Company is managed and operated as
The table below provides the carrying amount of certain non-current assets, by geographic area:
in CHF thousands |
|
Switzerland |
|
|
Iceland |
|
|
Others |
|
|
Total |
|
||||||||||||||||||||
|
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
||||||||
Intangible assets |
|
|
|
|
|
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
- |
|
|
|
|
|
|
|
||||
Property and equipment, net |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||||
Right-of-use assets |
|
|
|
|
|
- |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets as of June 30, 2024 and as of December 31, 2023 were CHF
11
Grant income reflects reimbursement of research and development expenses and income from certain research projects managed by Icelandic governmental institutions. Certain expenses qualify for incentives from the Icelandic government in the form of tax credits or cash reimbursements. Icelandic government grant income for the three and six months ended June 30, 2024, were CHF
The tables below show the breakdown of the Operating expenses by category:
in CHF thousands |
|
For the three months ended June 30, |
|
|||||||||||||||||||||
|
|
Research and development |
|
|
General and administrative |
|
|
Total operating |
|
|||||||||||||||
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||||
Personnel expense |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Payroll |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Share-based compensation |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
External service providers |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Other operating expenses |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Depreciation of property and equipment |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Depreciation of right-of-use assets |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Total |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
in CHF thousands |
|
For the six months ended June 30, |
||||||||||
|
|
Research and development |
|
General and administrative |
|
Total operating |
||||||
|
|
2024 |
|
2023 |
|
2024 |
|
2023 |
|
2024 |
|
2023 |
Personnel expense |
|
|
|
|
|
|
||||||
Payroll |
|
|
|
|
|
|
||||||
Share-based compensation expense |
|
|
|
|
|
|
||||||
Operating expenses |
|
|
|
|
|
|
||||||
External service providers |
|
|
|
|
|
|
||||||
Other operating expenses |
|
|
|
|
|
|
||||||
Depreciation of property and equipment |
|
|
|
|
|
|
||||||
Depreciation of right-of-use assets |
|
|
|
|
|
|
||||||
Merger and listing expense(1) |
|
- |
|
- |
|
- |
|
- |
|
- |
|
|
Total |
|
|
|
|
|
|
(1)
The increase in external service providers for research and development expenses is related to clinical trial related expenses as a result of the Company's active clinical trials during the respective periods, mainly the ongoing Phase 3 Stage 2 DIAMOND-1 and DIAMOND-2 clinical trials of OCS-01 in diabetic macular edema (DME), the Phase 3 Stage 2 OPTIMIZE-2 clinical trial of OCS-01 in inflammation and pain following ocular surgery, and the Phase 2b RELIEF clinical trial of OCS-02 (Licaminlimab) in dry eye disease (DED). The increase in share-based compensation expense for research and development expenses is related to certain options that were modified to accelerate vesting upon the death of an employee, resulting in the acceleration of expense recognition. Total expense attributable to the modification was CHF
The table below shows the breakdown of the finance result by category:
in CHF thousands |
For the three months ended June 30, |
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|
For the six months ended June 30, |
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2024 |
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2023 |
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2024 |
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2023 |
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Finance income |
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|
||||
Finance expense |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Fair value adjustment on warrant liabilities |
|
|
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
Foreign currency exchange gain (loss) |
|
( |
) |
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|
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|
|||
Finance result |
|
|
|
|
( |
) |
|
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|
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|
( |
) |
Finance expense in 2023 represented mainly interest related to the preferred dividend owed to the holders of Legacy Oculis preferred Series B and C shares incurred prior to the Business Combination. Preferred Series B and C shares qualified as liabilities under IAS 32 - Financial
12
instruments: Presentation and the related accrued dividends as interest expense. The preferred Series B and C shares were fully converted to ordinary shares at the closing of the Business Combination on March 2, 2023 (refer to Note 4).
Finance income in all periods presented consists primarily of interest income earned from the Company's short-term financial assets.
Refer to Note 11 for further discussions of the fair value adjustment on warrant liabilities.
For the three and six months ended June 30, 2024 and 2023, the foreign currency exchange gain (loss) is primarily related to fluctuations of U.S. dollar against Swiss Franc. In 2024 the U.S. dollar strengthened against the Swiss Franc leading to foreign exchange gains on short term financial assets and cash balances. In 2023 the favorable currency exchange was primarily due to the fluctuations in the U.S. dollar and Euro exchange rates against the Swiss Franc on payable balances denominated in U.S. dollar and Euro, which was partly offset by negative currency exchange in cash and fixed term deposits and the revaluation of the U.S. dollar denominated Series C long-term financial debt, prior to the Business Combination in March 2023.
The table below shows the breakdown of other current assets by category:
in CHF thousands |
|
June 30, 2024 |
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December 31, 2023 |
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Prepaid clinical and technical development expenses |
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Prepaid general and administrative expenses |
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VAT and other receivable |
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Total |
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|
The decrease in prepaid clinical and technical development expenses as of June 30, 2024 compared to prior year end was due to advancements of clinical trials in 2024 that commenced during the fourth quarter of 2023, which resulted in recording of expenses and lowering of prepaid balances. The increase in prepaid general and administrative expenses as of June 30, 2024 compared to prior year end is due to transaction costs capitalized as other current assets related to the ATM Offering Program and Loan Agreement, as well as public liability insurances prepaid balances.
The table below shows the movement of accrued income for the six months ended June 30, 2024 and 2023:
in CHF thousands |
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2024 |
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2023 |
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Balance as of January 1, |
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Accrued income recognized during the period |
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Foreign exchange revaluation |
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( |
) |
|
Balance as of June 30, |
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|
Accrued income is generated by incentives for research and development offered by the Icelandic government in the form of tax credits for innovation companies. The aid in Iceland is granted as a reimbursement of paid income tax or paid out in cash when the tax credit is higher than the calculated income tax. The tax credit is subject to companies having a research project approved as eligible for tax credit by the Icelandic Centre for Research (Rannís).
2023 Employee Stock Option and Incentive Plan
On March 2, 2023, the Company adopted the 2023 Employee Stock Option and Incentive Plan (“2023 ESOP”) which allows for the grant of equity incentives, including share-based options, stock appreciation rights (“SARs”), restricted shares and other awards. The 2023 ESOP lays out the details for the equity incentives for talent acquisition and retention purposes.
Each grant of share-based options made under the 2023 ESOP entitles the grantee to acquire ordinary shares with payment of the exercise price in cash. The Company intends to settle any options, RSU’s and SARs granted only in ordinary shares. For each grant of share-based options, SARs and RSUs, the Company issues a grant notice, which details the applicable terms of the award, including number of shares, exercise price, vesting conditions and expiration date. The terms of each grant are set by the Board of Directors.
Option awards and SARs
The fair value of option awards and SARs is determined using the Black-Scholes option-pricing model. The weighted average grant date fair value for options and SARs granted during the six months ended June 30, 2024 was CHF
The following assumptions were used in the Black-Scholes option pricing model for determining the value of options and SARs granted during the six months ended June 30, 2024 and 2023:
13
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For the six months ended June 30, |
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2024 |
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2023 |
|
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Weighted average share price at the date of grant (1) |
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USD |
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USD |
|
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Range of expected volatilities (%) (2) |
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Range of expected terms (years) (3) |
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Range of risk-free interest rates (%) (1)(4) |
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Dividend yield (%) |
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(1)
(2)
(3)
(4)
The following table summarizes the Company’s stock option and SAR activity under the 2023 ESOP for the six months ended June 30, 2024 and 2023:
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For the six months ended June 30, 2024 |
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For the six months ended June 30, 2023 |
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Number of awards |
|
Weighted average exercise price (CHF) |
|
Range of expiration dates |
|
Number of awards (1) |
|
Weighted average exercise price (1) (CHF) |
|
Range of expiration dates |
Outstanding as of January 1, |
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|
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Options granted(2) |
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||||||
SARs granted |
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— |
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— |
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— |
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|||
Earnout options granted |
|
— |
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— |
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— |
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Forfeited(3) |
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( |
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|
|
— |
|
— |
|
— |
||
Exercised(3) |
|
( |
|
|
|
— |
|
— |
|
— |
||
Outstanding as of June 30, |
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|
|
|
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|
(1)
(2)
(3
The number of options and SARs that were exercisable at June 30, 2024 and 2023 were
Restricted stock units
Each restricted stock unit (“RSU”) granted under the 2023 ESOP entitles the grantee to one ordinary share upon vesting of the RSU. The Company intends to settle all RSUs granted in equity. The fair value of RSUs is determined by the closing stock price on the date of grant and the related compensation cost is amortized over the vesting period of the award using the graded method. RSU’s have time-based vesting conditions ranging from to
|
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For the six months ended June 30, 2024 |
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|
|
Number of awards |
|
Weighted average grant date fair value (CHF) |
|
Range of expiration dates |
Outstanding as of January 1, 2024 |
|
— |
|
— |
|
— |
RSUs granted |
|
|
|
|||
RSUs forfeited |
|
— |
|
— |
|
— |
RSUs vested/released |
|
— |
|
— |
|
— |
Outstanding as of June 30, 2024 |
|
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Restricted shares awards
Each restricted share granted under the 2018 ESOP was immediately exercised and the expense was recorded at grant date in full. The Company is holding call options to repurchase shares diminishing ratably on a monthly basis over three years from grant date. For each grant of restricted shares, the Company issues a grant notice, which details the terms of the grant, including the number of awards, repurchase right start date and expiration date. The terms of each grant are set by the Board of Directors. Restricted shares were granted and expensed at fair value.
14
shares were awarded under the 2023 ESOP during the six months ended June 30, 2024 and 2023. As of June 30, 2024,
Share-based compensation expense
The total share-based compensation expense recognized in the statement of loss amounted to CHF
During the quarter ended June 30, 2024, certain options were modified to accelerate vesting upon the death of an employee, resulting in the acceleration of expense recognition. Total expense attributable to the modification was CHF
Earnout options
As a result of the BCA, Legacy Oculis equity holders received consideration in the form of
The table below shows the breakdown of the cash and cash equivalents and short-term financial assets by currencies:
in CHF thousands |
|
Cash and cash equivalents |
|
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Short-term financial assets |
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by currency |
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As of |
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As of |
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As of |
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As of |
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Swiss Franc |
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US Dollar |
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Euro |
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Iceland Krona |
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- |
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- |
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Other |
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|
|
|
|
- |
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|
|
- |
|
||
Total |
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Short-term financial assets consist of fixed term bank deposits with maturities between and
The following table summarizes the Company’s outstanding warrant liabilities by warrant type as of June 30, 2024 and 2023:
|
2024 |
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2023 |
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in CHF thousands (except number of warrants) |
Blackrock Warrant |
|
EBAC Warrants |
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Total Warrant Liabilities |
|
Blackrock Warrant |
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EBAC Warrants |
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Total Warrant Liabilities |
Balance as of January 1, |
- |
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- |
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- |
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- |
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Issuance of warrants |
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- |
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- |
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Fair value (gain)/loss on warrant liability |
( |
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- |
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||||
Exercise of public and private warrants |
- |
|
- |
|
- |
|
- |
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( |
|
( |
Balance as of June 30, |
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|
- |
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The Blackrock Warrant, described in Note 3, is classified as a liability because its exercise price is fixed in USD, which is not the functional currency of the Company and therefore it does not meet the requirements to be classified as equity under IFRS. The fair value of the Blackrock Warrant is determined using the Black-Scholes option-pricing model and is included in Level 3 of the fair value hierarchy.
The following assumptions were used in the Black-Scholes option-pricing model for determining the fair value of the Blackrock Warrant on the date of grant and as of June 30, 2024 as indicated:
|
|
May 29, 2024 |
|
June 30, 2024 |
Share price on valuation date |
|
USD |
|
USD |
Expected volatility (%) (1) |
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Expected term (years) (2) |
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Risk-free interest rate (%) (3) |
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Dividend yield (%) |
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(1) The expected volatility was derived from the historical stock volatilities of comparable peer public companies within the Company’s industry.
(2) The expected term represents the period that the Blackrock Warrant is expected to be outstanding.
(4) The risk-free interest rate is based on the U.S. Treasury yield curve in effect at the measurement date with maturities approximately equal to the expected terms
15
For the three and six months ended June 30, 2024, the Company recognized a fair value gain of CHF
The movement of the warrant liability is illustrated below:
|
2024 |
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2023 |
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in CHF thousands (except number of warrants) |
Warrant liabilities |
|
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Number of outstanding warrants |
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Warrant liabilities |
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Number of outstanding warrants |
|
||||
Balance as of January 1, |
|
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- |
|
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- |
|
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Issuance of warrants |
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Fair value (gain)/loss on warrant liability |
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|
- |
|
|
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|
- |
|
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Exercise of public and private warrants |
|
- |
|
|
|
- |
|
|
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( |
) |
|
|
( |
) |
Balance as of June 30, |
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|
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The table below shows the breakdown of the Accrued expenses and other payables by category:
in CHF thousands |
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
||
Product development related expenses |
|
|
|
|
|
|
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Personnel related expenses |
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|
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General and administration related expenses |
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|
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Other payables |
|
|
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Total |
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The increase in product development related accrued expenses as of June 30, 2024 compared to prior year end relates mainly to the advancement of our development pipeline in multiple clinical trials in 2024.
Research and development commitments
The Group conducts product research and development programs through collaborative projects that include, among others, arrangements with universities, contract research organizations and clinical research sites. Oculis has contractual arrangements with these organizations. As of June 30, 2024, commitments for external research projects amounted to CHF
in CHF thousands |
|
As of June 30, 2024 |
|
|
As of December 31, 2023 |
|
||
Within one year |
|
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|
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Between one and five years |
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Total |
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The conditional capital at June 30, 2024 amounts to a maximum of CHF
CHF
16
CHF
During the six months ended June 30, 2024,
CHF
CHF
(B) Capital band
The Company has a capital band between CHF
(C) Treasury shares
In connection with the establishment of the ATM Offering Program described in Note 4 - Financing Activities, the Company issued
The following table sets forth the loss per share calculations for the three and six months ended June 30, 2024 compared to the three and six months ended June 30, 2023.
|
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Net loss for the period attributable to Oculis shareholders - in CHF thousands |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Loss per share |
|
|
|
|
|
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|
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|
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|
||||
Weighted-average number of shares used to compute basic and diluted loss per share |
|
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|
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|
||||
|
|
|
|
|
|
|
|
|
|
|
|
||||
Basic and diluted net loss per share for the period, ordinary shares |
|
( |
) |
|
|
( |
) |
|
|
( |
) |
|
|
( |
) |
Since the Company has a loss for all periods presented, basic net loss per share is the same as diluted net loss per share. Potentially dilutive securities that were not included in the diluted loss per share calculations because they would be anti-dilutive were as follows:
|
As of June 30, 2024 |
|
|
As of June 30, 2023 |
|
||
Share options issued and outstanding |
|
|
|
|
|
||
Earnout options |
|
|
|
|
|
||
Share and earnout options issued and outstanding |
|
|
|
|
|
||
Restricted stock units subject to future vesting |
|
|
|
|
- |
|
|
Restricted shares subject to repurchase |
|
|
|
|
|
||
Earnout shares |
|
|
|
|
|
||
Public warrants |
|
|
|
|
|
||
Private warrants |
|
|
|
|
|
||
Blackrock Warrant |
|
|
|
|
- |
|
|
Total |
|
|
|
|
|
17
Key management, including the Board of Directors and the executive management team, compensation were:
in CHF thousands |
For the three months ended June 30, |
|
|
For the six months ended June 30, |
|
||||||||||
|
2024 |
|
|
2023 |
|
|
2024 |
|
|
2023 |
|
||||
Salaries, cash compensation and other short-term benefits |
|
|
|
|
|
|
|
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|
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|
||||
Pension |
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|
||||
Share-based compensation expense |
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|
|
|
|
|
|
|
|
|
||||
Total |
|
|
|
|
|
|
|
|
|
|
|
Salaries, cash compensation and other short-term benefits include social security and board member fees.
The number of key management individuals reported as receiving compensation in the table above was increased from
There are no material subsequent events.
18